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. 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. [**] Budget
Trial design. In this prospective, randomized, double blind, placebo-controlled trial, subjects meeting the eligibility criteria will be randomly assigned in a ratio of *** among the *** treatment groups described in Figure 1. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. ***
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. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Study Subjects 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 disord...
Trial design. Upon completion of a comprehensive outpatient CR program, patients were randomized to either the intervention (lifestyle program) or the control group (individual interview + standard care). Patients were examined 6 and 15 months thereafter. The primary outcome was changes in modifiable risk factors and related health behaviors. Participants and procedure Participants were recruited between January 2008 and January 2010 from a major cardiac rehabilitation centre (Rijnlands Revalidatie Centrum) in the Netherlands. All Dutch-speaking patients under 75 who had been diagnosed with ischemic coronary heart disease, and who were currently not receiving psychiatric treatment, were eligible for participation. Approval from the relevant Medical Ethics Committee was obtained for the study. Upon completion of a 3-month CR program, eligible patients were invited for participation in the study by their physical therapists. Upon receiving written informed consent, participants were randomized to either the intervention group or the control group using blocked randomization. In order to allow for attrition in the intervention group, participants were allocated in unequal numbers to the arms of the study. For every block of 30 participants, 14 were allocated to the control group and 16 were allocated to the intervention group by means of a random-number table. Randomization was carried out by the coordinating secretariat using opaque sealed envelopes. All participants were invited for a structured interview during which biometrical measurements were taken, risk factors and health behaviors were assessed, and self-report questionnaires were completed (T1). Using the same procedure, follow- up assessments were carried out 6 (T2) and 15 months (T3) thereafter by trained health psychologists who were blind to treatment allocation.
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. 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. 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.
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. Study Subjects 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 *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 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. Efficacy Endpoints: 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 ...
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. ***
