bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
Condition: Acne
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear
      Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
    

Detailed description: 
      Acne study
    

Intervention name(s): Tretinoin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment of acne; treatment of acne
Other intervention name(s): active medication; inactive medication
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Strong People Strength Training Study
Condition: Heart Diseases; Cardiovascular Diseases; Diabetes; Sedentary Lifestyle; Overweight and Obesity; Depression, Anxiety; Stress; Fatigue
MeSH terms: Cardiovascular Diseases; Heart Diseases; Overweight
Study type: Interventional

Summary: 
      The Strong People Strength Training study aims to assess whether a community-based
      progressive strength training program can improve risk factors for diabetes and heart disease
      in older rural adults.
    

Detailed description: 
      This study aims to evaluate the effects of a twice weekly, 12-week progressive strength
      training program, Strong People Strength Training, on cardiometabolic risk factors in a
      pragmatic, community-based randomized intervention trial among rural men and women 50 and
      older. We hypothesize that individuals randomized to the intervention group will demonstrate
      statistically significant and clinically meaningful improvements in cardiometabolic risk
      factors as well as physical function, quality of life, and physical activity compared to
      those randomized to the delayed intervention control group.
    

Intervention name(s): Strong People Strength Training
Intervention type(s): Behavioral
Intervention description(s): A community-based progressive strength training program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 participants attend twice weekly progressive strength training classes with CPR certified and Strong People trained educators in fall 2019 for 12 weeks.
Group 2 participants receive twice weekly progressive strength training classes in January 2020 for 12 weeks. During the first 12 weeks of the study Group 2 participants do not receive these classes. (Delayed)
Masking: None (Open Label)
Primary purpose: Prevention
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to determine and compare the rate and extent of absorption of
      norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone
      Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg
      norethindrone acetate) Tablets under fed conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Estradiol/Norethindrone acetate; Activella®
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg/0.5 mg Tablets; 1 mg/0.5 mg Tablets
Other intervention name(s): Mimvey®; Estradiol/Norethindrone acetate (generic name)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve
      Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment
      of uterine fibroids in a Chinese population.
    

Detailed description: 
      This study is to confirm the safety and effectiveness of Magnetic Resonance Imaging-guided
      High Intensity Focused Ultrasound (MR-HIFU) in ablating uterine tissue associated with
      symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive,
      uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal
      women.

      MR-HIFU uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system
      identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the
      study is to show treatment safety and effectiveness of the Philips Sonalleve MR-HIFU device
      for uterine fibroids marketing approval in the Chinese market. MR-HIFU will be performed in
      100 patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging
      endpoints will be evaluated in all study patients at baseline and at 6 months post-treatment.
      All patients will be followed up for 12 months post-treatment for safety.
    

Intervention name(s): MR-HIFU uterine fibroid treatment
Intervention type(s): Device
Intervention description(s): A single treatment session for uterine fibroids with the MR-HIFU device.
Other intervention name(s): Philips Sonalleve MR-HIFU
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine Leiomyomas; Fibroids; HIFU; Ablation; High Intensity Focused Ultrasound
Movicol in Childhood Constipation (ProMotion Study)
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a single centre study comprised of two stages (Parts I and II). Part II was a 12
      week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy
      on an out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the
      treatment of faecal impaction in children
    

Detailed description: 
      Two days following disimpaction (Part I of the clinical trial) patients were assigned (based
      on their randomisation number) to receive either Movicol or Lactulose as maintenance therapy
      for the remainder of the study. At discharge all patients received the appropriate supply of
      study medication. This includes 1 week's overage should they miss their next visit to the
      ProMotion clinic. They did not know whether they have been randomised to receive Movicol or
      Lactulose Dry.

      Following discharge patients were contacted after 3-5 days by telephone or home visit
      (whichever was appropriate) to encourage treatment and to ensure compliance. Parents were
      instructed to contact the Pro-Motion team who would advise appropriately if patients had any
      difficulty i.e. none, irregular and/ or uncomfortable or very loose bowel movements.

      The daily use of Movicol or Lactulose Dry during Part II was recorded in the diary. If the
      dose of Movicol or Lactulose was changed by the Pro-Motion team at any time then it was
      documented appropriately in the patient notes and the case report form.
    

Intervention name(s): Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol); Lactulose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lactulose; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Subjective Well Being of Schizophrenic Patients in Greece
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Non-interventional study aiming to provide data on the subjective effects of antipsychotic
      medication assessing subjective well-being and global functioning of patients with
      Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to
      the treatment and will investigate whether there is any correlation of these factors with the
      clinical condition of these patients.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Target Group:Patients suffering from Schizophrenia treated in private practice
      
Keywords: Schizophrenia; antipsychotics; social functioning; subjective well being; Patients suffering from Schizophrenia
Innovative Approaches to Diet, Exercise and Activity
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      The prevalence of obesity in young adults has been increasing, and excessive body weight have
      been linked to numerous chronic conditions including cardiovascular disease, diabetes, many
      forms of cancer, and numerous musculoskeletal problems. This study will focus of the
      development and evaluation of interventions that may be appropriate for young adults (age
      18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary
      aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that
      includes technology components results in improved weight loss in young adults (18-35 years
      of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24
      months. Eligible participants will also be assessed for body composition, body fat
      distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial
      measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18,
      and 24 months. Subjects will participate in a 24 month behavioral weight loss program that
      includes a reduction in energy intake and moderate-to-vigorous intensity exercise
      (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI
      are text messaging, a wearable device that provides feedback on physical activity, and access
      to a website to monitor dietary behaviors.
    


Intervention name(s): Standard Behavioral Weight Loss Intervention; Enhanced Weight Loss Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in this group will receive our standard behavioral weight control program that is delivered in an in-person group-based format. At month 7 subjects will also be given access to a study website to monitor eating and activity behaviors, and to have electronic access to standardized intervention materials. At month 7 subjects will also receive targeted study-related text messages that otherwise would have been provided in paper format.; Subjects in this group will participate in a weight loss intervention that includes technology enhancements. These enhancements will include the addition of intervention specific targeted and tailored text messaging and the BodyMedia Fit System® beginning at Month 7. At month 7 subjects in EWLI will also receive the same targeted study-related text messages provided to SBWP that otherwise would have been provided in paper format.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; overweight
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
Condition: Lung Diseases; Tuberculosis
MeSH terms: Tuberculosis; Lung Diseases
Study type: Interventional

Summary: 
      This study will determine the differential cumulative mean number of isoniazid (INH) pills
      completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1)
      peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2)
      self-esteem/life skills counseling alone. The study will also estimate the costs and cost
      effectiveness of peer adherence coaching versus control procedures; this will be done from a
      provider and societal perspective.
    

Detailed description: 
      BACKGROUND:

      Tuberculosis (TB) was responsible for almost one billion deaths in the 20th century. It is
      epidemic in the developing world and immigrants introduce TB to developed nations. TB control
      requires treatment for latent TB infection (LTBI) and active disease, as well as adherence to
      medical regimens. This study will determine the effectiveness of a public health model of
      LTBI control among high-risk adolescents. The integration of behavioral science, medical
      services, parent instruction, and assistance from schools and clinics (coordinated by the
      county health department) is based on recommendations from the Centers for Disease Control
      and Prevention (CDC). The effectiveness of this system is dependent, in part, on patient
      adherence.

      DESIGN NARRATIVE:

      The primary outcome of this study is adherence to an INH treatment regimen. For a given
      participant, adherence is assessed every 30 days, with the final outcome determined 12 months
      after treatment start date. Adherence is assessed using participant recall, urine testing for
      INH metabolites, pill counts, and medication event monitoring system (MEMS) caps.

      The key secondary outcomes are parent knowledge and practice of intervention support
      procedures, parent knowledge of TB, self-esteem effects and life skills acquisition, cost and
      cost effectiveness of the intervention, and knowledge and practice of LTBI care by providers
      at participating community clinics.
    

Intervention name(s): Adherence Program; Life Skills and Self-Esteem Training Program (Attention Control Arm)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.; Peer counseling session covering life skills (e.g., communication skills, goal setting, self-esteem) training, 14 sessions over 6 months beginning once per week and decreasing in frequency over time to once per month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if children with type 1 diabetes have adequate
      immune response to PPSV23 vaccination and to assess factors affecting immune response.
    


Intervention name(s): Pneumovax 23- pneumococcal polysaccharide; Blood draw
Intervention type(s): Biological; Procedure
Intervention description(s): PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.; 6 ml blood draw at baseline and 6 months post immunization
Other intervention name(s): PPSV23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Intervention model: Single Group Assignment
Intervention model description: Will study immunological response to vaccination
Masking: None (Open Label)
Primary purpose: Prevention
Quality of Life in Patients With Intermediate Uveitis
Condition: Macular Edema
MeSH terms: Macular Edema; Uveitis; Uveitis, Intermediate; Pars Planitis; Edema
Study type: Observational

Summary: 
      The aim of this study is to determine if macular edema is associated with less visual
      function and quality of live in patients with intermediate uveitis
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with intermediate uveitis
      
Keywords: Quality of life in patients with macular edema compared to patients without macular edema.
Acute Episodes in Chronic Stable Angina: Assessment of the Use of the Coronary Vasodilator Propatyl Nitrate.
Condition: Chronic Stable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of
      chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg)
      . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. The
      study will include three visits the patient to the study center: Pretreatment / Assessment 1,
      Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of treatment. At
      each visit, data will be collected on the medical history, physical examination and vital
      signs, and evaluation of episodes of angina pectoris, as well as the laboratory evaluation of
      adverse events and the use of concomitant medications.
    


Intervention name(s): Propatyl Nitrate
Intervention type(s): Drug
Intervention description(s): Propatyl nitrate 10mg administered orally, three times daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic stable angina pectoris; propatyl nitrate; Seattle Angina Questionnaire
Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The ability of sildenafil to aid in the return of erections after nerve-sparing radical
      prostatectomy has been established. Patients who had either one or both neurovascular bundles
      spared demonstrated dramatically better responses to "as needed" sildenafil than those that
      did not, and a positive erectile response to sildenafil was only seen in patients in whom at
      least one NVB was spared. This study has been designed to determine if sildenafil taken
      nightly works better than sildenafil on as "as needed" basis for the return of erectile
      function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid
      return of erectile function after nerve-sparing laparoscopic radical prostatectomy.
    


Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention description(s): 50 mg daily at bedtime
Other intervention name(s): Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: Laparoscopic Radical Prostatectomy; Nightly sildenafil
Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML Patients
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 4

Summary: 
      In this single-center, randomized, open-label, crossover, prospective clinical trial, a total
      of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in
      each group. Each subject is required to undergo two cycles of chemotherapy. At the treatment
      cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy
      is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions,
      blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO
      treatment are recorded during the study period.
    

Detailed description: 
      In this single-center, randomized, open-label, crossover, prospective clinical trial, a total
      of 120 AML patients who achieved remission following induction chemotherapy will be recruited
      and randomized into two groups, of 60 cases in each group. For one group, the treatment cycle
      is in the first chemotherapy cycle and the control cycle is in the second one. For another
      group, the treatment cycle is in the second chemotherapy cycle and the control cycle is in
      the first one.

      Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle,
      patients received subcutaneous injection of rhTPO at a dose of 300 U/kg body weight once
      daily at a platelet count of < 50×109/L, and rhTPO treatment ceased at a platelet count of
      ≥20×109/L if platelet is not transfused. At the control cycle, rhTPO therapy is not given.

      Each subject is required to be followed up for successive two chemotherapy cycles following
      inclusion in this study. During the follow-up period, routine blood test is performed once
      every other day, and platelet transfusion is recorded.

      The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood
      coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO
      treatment are recorded during the study period.
    

Intervention name(s): recombinant human thrombopoietin
Intervention type(s): Drug
Intervention description(s): Patients received subcutaneous injection of recombinant human thrombopoietin at a dose of 300 U/kg body weight once daily at a platelet count of < 50×109/L, and recombinant human thrombopoietin treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused.
Other intervention name(s): rhTPO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess tolerability and safety and health outcomes in relapsing MS patients
      taking FTY720.
    


Intervention name(s): FTY720
Intervention type(s): Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; MS; safety; tolerability; health outcomes