Trial design. The study will be comprised of up to 4 groups, each of 50 CDI patients, as described in Table 16. An N=50 per arm would provide sufficient data to allow for selection of SMT19969 dosing regimen for Phase 3 and would also provide more robust data on rates of recurrent CDI. Vancomycin will be the comparator since it is recommended as the best treatment for the full range of disease severity that is likely to be encountered in the trial. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 3 pages were omitted. [**]
Trial design. The study is designed as a household-based cluster-randomized, double-blind trial with two arms. In one arm treatment is given with albendazole (single dose of 400 mg) on 3 consecutive days, while the other arm consists of matching placebo treatment (both albendazole and placebo are manufactured by PT Indofarma Pharmaceutical, Bandung, Indonesia). The treatment is provided every three months for a period of 1 year (total 4 rounds) to all household members except children below 2 years of age, while subjects aged 16 or above will undergo clinical 2 and laboratory examination. Subjects with active treatment for diabetes mellitus, HELMINTH INFECTIONS AND TYPE 2 DIABETES: THE SUGARSPIN TRIAL PROTOCOL serious concomitant disease and pregnancy will be excluded. The population was randomised by JWAS and JJH using computer aided block randomization at household level, utilizing Random Allocation Software to assign treatment groups. Both study investigators and patients are blinded for treatment codes. The treatment code will be unblinded when all data needed for analysis are cleaned and entered into the database. An additional randomization was performed in a subgroup of individuals, who will undergo an oral glucose tolerance test and immunological studies in order to study glucose metabolism and immune mechanisms in more detail. For this subgroup, we aimed to select one subject per household and stratified by age group (16-36 years of age, 36-56 years of age, and >56 years of age) to ensure that sufficient numbers of all age groups are participating. Randomization was based on households. Well trained community workers were recruited and trained to distribute the drugs. These workers were also trained to assist during clinical examination and sample collection and were involved in health promotion within the population. Community workers and research team members will directly supervise the study participants while taking the study medication, and will collect empty drug canisters at each visit to confirm compliance. Furthermore, assessment of side effects will take place during these visits and migration and death will be noted. Adverse events spontaneously reported by the patient or observed by the investigators, will be monitored throughout the study. After completion of the study, the whole study population will be treated with a single dose of albendazole (400 mg) for 3 consecutive days. Outcomes As this study aims to assess the effect of anthelmintic treatm...
Trial design. In this prospective, randomized, double-blind, placebo and single agent-controlled trial, subjects meeting the eligibility criteria will be randomly assigned (with equal probability) among the *** treatment groups described in Figure 1.
Figure 1. Schematic representation of study design.
Trial design. Unmasked pragmatic randomised controlled trial to test the effectiveness of a self- management course for chronic pain against a control consisting of usual GP care, a patient education leaflet and a relaxation CD. Two study centres will be used, one in London (Tower Hamlets, City and Xxxxxxx, Newham), the other in Warwickshire (Warwick and Coventry)
Trial design. In this prospective, randomized, double-blind, placebo-controlled study, eligible subjects will be randomly assigned to receive daily treatment with one of the following regimens: *** Subjects will be enrolled at approximately *** study sites, with the intent of randomizing approximately 100 subjects into each of the *** treatment groups. The randomization will be stratified by ***. Study treatment will consist of a 4-week titration period followed by 24 weeks of treatment. Clinic visits will occur at weeks 2 and 4 during the titration period, and subsequently every 4 weeks for the duration of treatment. Subjects included in this study will be adult men and women up to 70 years of age with BMI from *** inclusive. All female subjects who are of childbearing potential must agree to use adequate contraception, defined as a double barrier method, stable hormonal contraception plus single barrier, or tubal ligation. Major exclusions for this study include: type II diabetes; clinically significant cardiac disease; clinically significant hepatic, renal or pulmonary disease; clinically significant thyroid disease, as evidenced by signs, symptoms, or TSH >1.5 x ULN; history of bipolar disorder or psychosis, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation; obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program; history of glaucoma; and smoking cessation within 3 months prior to study enrollment. The primary study endpoints will be based on the percent weight loss at week 28, calculated as ***, and the percentage of subjects achieving at least 5% weight loss at week 28. For subjects who discontinue treatment prior to study completion, every attempt will be made to have them return for week 28 evaluations. ***. Secondary efficacy endpoints will include the proportion of subjects achieving 10% weight loss, change from baseline in waist circumference, and change from baseline in *** and *** at ***. As was done for the primary endpoints, subjects who discontinue prior to study completion ***. Additional endpoints will include *** assessments of *** and ***, changes in primary and secondary outcomes over monthly intervals during the study, and Framingham 10-year risk assessments. *** will also be evaluated. Data will be obtained using a multiple trough sampling scheme with samples collected at *** and *** from each subjec...
Trial design. The study is a randomized, double-blind placebo-controlled trial with subjects randomized to receive daily treatment with VI-0521 *** or *** or ***, with the total duration of treatment being 56 weeks. Randomization will be stratified by *** of subjects will be ***. Approximately 1250 subjects will be treated under the protocol with *** subjects randomized to *** and ***. Up to *** study sites in the USA will be employed. Subjects will be instructed to follow a mild hypocaloric diet representing a 500-calorie/day deficit and to implement a lifestyle modification program, as tolerated, throughout the study period. During the first 4 weeks of treatment (weeks 1-4), study medication will be titrated to the assigned dose level, with the dosage increased each week as determined by randomization group. During treatment weeks 5-56, the dose will be maintained at the final dose level. Subjects who are unable to tolerate the assigned dosage may be treated at a reduced dose level or may take a drug holiday as defined in the protocol. All subjects will return at approximately 4-week intervals for measurement and evaluation. Female subjects of child bearing potential will undergo a urine pregnancy test at each visit. Subjects who discontinue the treatment during the study will be encouraged to remain on study for all study-related procedures. Additionally, those who choose to discontinue the study will be encouraged to return at the 56-week time point for measurements and evaluation. The study population will consist of adult males and females up to 70 years of age with BMI ³***, fasting blood glucose ***. Female subjects of childbearing potential must agree to use adequate contraception (a double barrier method, stable hormonal contraception plus single barrier method or tubal ligation) for the duration of treatment. Major exclusion criteria include: type 2 diabetes; known or suspected clinically significant valvular heart disease; clinically significant ECG abnormality; clinically significant hepatic or renal disease; clinically significant thyroid dysfunction, as evidenced by signs, symptoms, or TSH > 1.5 x ULN; obesity of known genetic or endocrine origin; history of bipolar disorder or psychosis, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation; recent weight instability; history of glaucoma or increased intraocular pressure; prior bariatric surgery; or smoking cessation within 3 months prior to e...
Trial design. The study is a randomized, double blind placebo-controlled prospective trial with subjects randomized to receive daily treatment with VI-0521 *** or *** or ***, with the total duration of treatment being 56 weeks. Randomization will be stratified by ***, and at least *** of the subjects must be ***. Approximately 2500 subjects will be treated under the protocol with *** subjects randomized to ***, and ***. Up to *** study sites in the USA will be employed. At randomization, subjects will be instructed to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a lifestyle modification program, as tolerated, throughout the study period. During the first 4 weeks of treatment (weeks 1-4), study medication will be titrated to the desired level, with the dosage level increased each week as determined by randomization group. During treatment weeks 5-56, the dose will be maintained at the final dose level. Subjects who are unable to tolerate the assigned dosage may be treated at a reduced dose level and/or interrupt dosing for up to ***. Subjects will return at 4-week intervals for measurement and evaluation. Female subjects of child bearing potential will undergo a urine pregnancy test at each study visit. Subjects who discontinue the study during treatment will be encouraged to return at the 56-week time point for evaluation. The study population will consist of *** (BMI > *** and < ***) adults < 70 years of age with at least *** of the following obesity-related comorbid conditions: · ***; · ***; · ***; · ***. Major exclusion criteria include: type 1 diabetes; diabetes medications other than metformin; known or suspected valvular heart disease; clinically significant ECG abnormality, physical exam, xxxxx xxxxx or laboratory abnormality; clinically significant hepatic or renal disease; creatinine clearance < 60 mL/minute; clinically significant thyroid dysfunction as evidenced by signs, symptoms, or TSH > 1.5 x ULN; obesity of known genetic or endocrine origin; history of bipolar disorder or psychosis, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation; recent weight instability; history of glaucoma or increased intraocular pressure; prior bariatric surgery; or smoking cessation within 3 months prior to enrollment. Female subjects of childbearing potential must agree to use adequate contraception (a double barrier method, stable hormonal contraception plus single ba...
Trial design. In this prospective, randomized, double-blind, placebo-controlled trial, overweight and obese male and female subjects with at least *** obesity-related co-morbidities who meet the eligibility criteria will be randomly assigned among *** treatment groups shown in Figure 1.
Trial design. D6 was a multi-centre superiority cluster RCT with two parallel treatment arms (Xxxxxx et al., 2018). Clusters were primary care surgeries. Its rationale was to evaluate a cost- effective and practical way of competently delivering diabetes-informed psychological treatment. It tested the effectiveness of nurse-delivered MI and CBT skills for patients with T2D in the context of primary care. Recruitment was implemented in two phases as a consequence of organisational uncertainties in the run-up to the implementation of the Health and Social Care Act 2012. Patients were recruited in 2010 and the first half of 2011. Ethical approval was granted by the King’s College Hospital Research Ethics Committee (reference 09/H0808/97) and by the respective Primary Care Trusts (reference RDLSLBex 534 and 2010/403/W). Informed consent was obtained from all individual participants included in the study. The trial was registered with ISRCTN (ISRCTN75776892) on 19 May 2010.
Trial design. A single-blind, randomised controlled trial design was used, and participants allocated to two distinct treatment arms, each comprising three intervention visits (visits 2, 3 & 4). Regardless of the intervention group, treatment sessions were scheduled 7-13 days apart, depending on the participants’ availability. Feasibility and effectiveness of both interventional approaches were compared by measuring the change in clinical outcomes between pre-treatment (visit 1) and post-treatment assessments (visit 5). One intervention condition implemented three sessions of a self-guided psychological intervention that consisted of cognitive reappraisal techniques, modified from cognitive therapy (Xxxx, Xxxx, Shaw &Emery, 1979) and related approaches. Assigned to the second intervention condition, the rtfMRI treatment group, participants were asked to apply the same self-guided psychological strategies during three sessions of rtfMRI neurofeedback training, targeting rSATL-posterior SC correlation. It is important to mention that initially the NeuroMooD study was designed to compare three treatment arms, investigating the treatment effects of rtfMRI neurofeedback with an active, cathodal and a sham transcranial direct current stimulation (tDCS) intervention. Specifically, the original single-blind, randomised controlled design compared three sessions of the rtfMRI neurofeedback treatment as described above with three sessions of right superior temporal lobe cathodal tDCS plus self-guided psychological intervention and three sessions of sham right superior temporal lobe tDCS plus self-guided psychological intervention. Due to funding reasons, the original trial design had to be modified, and the data of 6 randomised participants, that had already been collected, was discarded.
