bioihbjkbjnl/mcl2 huggingface dataset:
Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)
Condition: Obesity; Major Depressive Disorder; Dysthymic Disorder; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Obesity; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional

Summary: 
      To determine whether individuals who suffer from depression and obesity are able to lose
      weight and show improvements in mood and cardiovascular disease risk factors following 20
      weeks of a combined treatment of cognitive-behavior therapy for depression and behavior
      modification for weight loss. Participants will be assigned to one of three treatments: 1)
      cognitive-behavior therapy for the treatment of depression combined with an alternative
      approach to weight loss, 2) a weight loss intervention combined with a depression support and
      education , or 3) cognitive-behavioral therapy for depression combined with a weight loss
      intervention.
    


Intervention name(s): Behavior Modification for Weight Loss; Alternative Approach to Weight Loss; Cognitive-Behavior Therapy for Depression; Depression Support and Education
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression and obesity treatment
Tracking the Brain in Myotonic Dystrophies: a 5-year Longitudinal Follow-up Study
Condition: Myotonic Dystrophy 1; Myotonic Dystrophy 2
MeSH terms: Myotonic Dystrophy
Study type: Observational

Summary: 
      The natural history of brain affection in myotonic dystrophy types 1 and 2 is still unknown.
      The investigators designed a 5-year longitudinal neuropsychological and neuroimaging
      follow-up study to address this issue. Myotonic dystrophy type 1, myotonic dystrophy type 2
      patients, and healthy controls were enrolled. All participants undergo clinical-neurological
      examinations, neuropsychological analyses according to a 13-item neuropsychological test
      battery, and 3T-brain MRI including voxel-based morphometry and diffusion tensor imaging at
      baseline and at follow-up using identical examination protocols.
    

Detailed description: 
      It is unknown whether brain affection in myotonic dystrophy types 1 and 2 is due to
      neurodevelopmental defects, neurodegeneration, or both. An exact definition of the nature and
      dynamic of brain affection is of urgent need for the identification of clinical trial outcome
      parameters and the design of therapy compounds. The investigators planned a 5-year
      longitudinal study to examine the natural history of functional and structural brain
      affection. Myotonic dystrophy type 1, myotonic dystrophy type 2 patients, and healthy
      controls were enrolled. All participants undergo clinical-neurological examinations,
      neuropsychological analyses according to a 13-item neuropsychological test battery, and
      3T-brain MRI at baseline and at follow-up using identical examination protocols. The intended
      time span between baseline and follow-up examinations is 5 years minimum. To investigate gray
      and white matter affection, voxel-based morphometry and diffusion tensor imaging are
      performed, and data are statistically analyzed including (i) group comparisons between
      patients and controls at baseline and follow-up, and (ii) group comparisons using difference
      maps to focus on isolated disease-related effects over time.
    

Intervention name(s): medical history; neurological clinical examination; neuropsychological testing; brain MRI
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The complete medical history (including cardiovascular risk factors and medication) will be assessed at baseline and follow-up.; Neurological examination will be performed at baseline and follow-up.; Neuropsychological testing using a 13 item test battery will be performed at baseline and follow-up.; Brain MRI ( 3.0 T) will be performed using the same hard- and software at baseline and follow-up.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with genetically proven myotonic dystrophy type 1 and myotonic dystrophy type 2
        and healthy controls
      
Keywords: neuromuscular disorders; MRI; white matter; brain; myotonic dystrophy
Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The rational of the study is to assess the implantation, pregnancy and live birth rates after
      the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone
      (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG)
      for final oocyte maturation and ovulation.
    


Intervention name(s): HCG
Intervention type(s): Drug
Intervention description(s): 5000IU
Other intervention name(s): pregnyl
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: natural cycle; FET; spontaneous LH pic; HCG
Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Objective: To assess the prognostic value of high-sensitive cardiac troponin T (hs-cTnT) and
      N-terminal pro brain natriuretic peptide (NT-proBNP) at ICU admission in patients with
      coronavirus disease 2019 (COVID-19).

      Design: Multicenter retrospective observational cohort study Setting: Three ICUs at three
      hospitals in Occitanie, France. Patients: Adults (≥ 18 years old) with laboratory-confirmed
      COVID-19 and at least one hs-cTnT measurement at ICU admission, from March 9, 2020, to May 9,
      2020.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Critically ill patients with COVID-19
      
Biospecimen description: 
      NC
    
Keywords: SARS-CoV-2; Troponin; hs-cTnT; NT-proBNP
The Use of a Platform Wound Device for Reducing Infection
Condition: Wounds and Injury; Burn Wound; Infection Wound
MeSH terms: Infections; Communicable Diseases; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in
      its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in
      torso and extremity wounds. The hypothesis is that the PWD will be a safe and effective
      method to provide topical antibiotics to a torso or extremity wound, non-inferior to the
      current standard of care. This treatment will reduce or rapidly eradicate infection.
    

Detailed description: 
      This is a prospective, randomized, controlled clinical trial comparing the use of a platform
      wound device as compared to standard of care to prevent or eliminate infection in torso and
      extremity wounds. Patients 18-85 years of age admitted for treatment of open wound(s) will be
      screened for inclusion criteria and asked to consent to participate in the randomized study.
      The first 10 patients will be treated with the PWD + gentamicin and will serve as a safety
      subset. Baseline measurement of serum antibiotic concentraion will be taken prior to PWD
      placement and one day after. Following the safety subset, 50 patients will be randomized to
      standard of care or to a single application of the PWD + gentamicin. Baseline assessments
      will be completed on day 0, including screening, pre-procedure wound evaluation, imaging,
      assessments, and specimen collection. Follow-up assessments will be completed and data
      gathered at days 1,2,3 and 4. All data collected of the study participants will be used to
      evaluate the PWD delivery of antibiotic.
    

Intervention name(s): Gentamycin with Platform Wound Device
Intervention type(s): Combination Product
Intervention description(s): Treatment of wounds with gentamycin and covered with platform wound device.
Intervention MeSH terms: Gentamicins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Low Calorie Diet in Morbidly Obese Patients
Condition: Obesity
Study type: Interventional

Summary: 
      This is a prospective study of morbidly obese patients that are planned to conduct bariatric
      surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior
      to the operation and be admitted to hospital for this period. On admission and after
      finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance
      test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous
      adipose tissue.
    

Detailed description: 
      The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients
      will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly
      on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal.

      At the day of admission and at day 7 a number of tests will be performed including blood
      tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue.
      Weight will be measured every morning for the study period.

      During the operation fatty tissue samples will be taken subcutaneous and from the omentum
      major.

      This study is planned as a control group to another study where blood tests and subcutanous
      adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this
      study is to compare changes in adipose tissue and blood samples for patients before and 6
      days after surgery to before and 6 days after a low-calorie diet.
    

Intervention name(s): Low calorie diet
Intervention type(s): Dietary Supplement
Intervention description(s): 6 days of low calorie diet, estimated kcal 400-600/day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Building Resilience for Healthy Kids
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      School based, mental-health intervention focused on improving self-efficacy and coping skills
      in children aged 9-13 years. The overall premise of our intervention is that by teaching
      children these skills they will in-turn become more resilient when faced with life-stressors
      and/or adverse events.
    

Detailed description: 
      Healthy Kids is a 1:1 health coaching intervention delivered in school-settings. Students
      meet weekly with their assigned health coach and together they identify both strengths and
      areas for improvement with respect to resilience, developing resilience skills, and setting
      resilience goals. Topics discussed include coping skills, self-efficacy, and interpersonal
      relationships. The program was developed using the social determination theory (SDT), goal
      theory, and elements from the social-ecological model. SDT was used within the intervention
      to promote and facilitate behavior change. Goal theory was also utilized to develop
      strategies to support youth short- and long-term goal setting. Finally, weekly discussions
      about resilience and goal setting activities accounted for elements of the social-ecological
      model which acknowledges that behaviors are not independent factors, but are influenced by
      multiple levels of one's personal and social environment.
    

Intervention name(s): Coaching
Intervention type(s): Behavioral
Intervention description(s): Child will receive 1:1 coaching with health coach.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Investigate the Safety, Tolerability and Effects of AZD8630 in Healthy Subjects and Subjects With Asthma on Inhaled Corticosteroids and Long-acting Beta-agonists
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human (FIH) clinical study to evaluate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part A) and adult asthma
      patients on medium to high dose inhaled corticosteroids / Long-acting beta-agonists (Part B)
    

Detailed description: 
      The study is divided in 2 parts, A and B.

      Part A will be conducted in healthy adults, whereas Part B will be conducted in adult asthma
      patients on medium/high dose inhaled corticosteroids (ICS)/long-acting beta-agonists (LABA)
      to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of AZD8630 by
      dry powder inhaler (DPI) administration. Part A includes the assessment of the PK and safety
      of intravenous (IV) AZD8630. Part A consists of single ascending dose (SAD) and multiple
      ascending dose (MAD) cohorts in sequential order and Part B will be evaluating multiple dose
      levels.

      Part A: This part will consist 4 sub-parts and will include healthy participants and healthy
      participants of Chinese and Japanese ethnicity. These participants will randomized to receive
      AZD8630 and to receive placebo.

        -  Sub-Part A1, SAD in healthy participants (one cohort in Sub-Part A1 will receive IV
           AZD8630 [IV formulation])

        -  Sub-Part A2, SAD in healthy participants of Chinese and Japanese ethnicity

        -  Sub-Part A3, MAD in healthy participants

        -  Sub-Part A4, MAD in healthy participants of Chinese and Japanese ethnicity

      Part B: Adult asthma patients will be randomized to one of 3 inhaled dose levels of AZD8630
      or placebo.

      The expected duration of study participation for each participants in the part A is up to 87
      days, and each patients in the Part B is up to 70 days.
    

Intervention name(s): AZD8630; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned.; Participants will receive Inhaled or IV doses of placebo as per the arm they are assigned.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Healthy adult participants; Healthy participants of Chinese and Japanese ethnicity; Corticosteroids Beta-agonists; Multiple ascending dose; Single ascending dose
Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion
Condition: Diabetes Mellitus
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Diabetes mellitus is a disease of great frequency and is a major public health problem. In
      Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year
      2025. Given the increasing prevalence of diabetes in Lebanon, the evolution of complications
      of this disease and the lack of studies at this level, it is appropriate to conduct a study
      that aims to evaluate the effects an education program for people with type 2 diabetes on
      their sense of self-efficacy and their ability to self-manage their disease to make them the
      most optimal therapeutic adherence possible. The design of this study is experimental type
      before / after randomization by diabetic patients. Education program delivered to the
      experimental group is the "Accu-Chek Education Program" of Roche. Membership will be assessed
      using a biomarker HbA1c should be <7%, and a questionnaire (Summary of Diabetes Self-Care
      Activities Measure), which measures self-care behaviors. Self-efficacy is measured using the
      Diabetes Management Self-Efficacy Scale. And this before the intervention and 3 months later.
      The sample will be 240 diabetic patients T2. Recruitment will be in outpatient diabetology a
      Hospital located in Beirut. Statistical analyzes used for descriptive variables are measures
      of central tendency, dispersion and frequency distribution. T-test and chi-square will be
      used to compare the socio-demographic characteristics of the 2 groups, experimental and
      control. To test hypotheses and determine the difference in the results of the dependent
      variables of the 2 groups, analysis of variance and covariance are used. The data will be
      processed using SPSS version 14.0.
    

Detailed description: 
      1. Following the implementation of a program of education, feeling of self-efficacy
           participants will be higher in the experimental group than in the control group.

        2. Following the implementation of a program of education, self-management behaviors:
           monitoring the diet, the practice of physical exercise, self-monitoring blood sugar,
           taking medications and care feet, participants will be higher in the experimental group
           than in the control group.

        3. Following the implementation of a program of education, the percentage of participants
           who have an HbA1c less than 7 will be higher in the experimental group than in the
           control group.
    

Intervention name(s): education program
Intervention type(s): Behavioral
Intervention description(s): education program in 6 hours and monitoring phone every 15 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetic Type2; education; self-management behaviors; self-efficacy; HbA1c
Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioequivalence and characterize the profile of
      the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects
      under fasting conditions and to monitor the adverse events and ensure the safety of the
      subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral
      dose, crossover, bioequivalence study of Olanzapine Tablets 5 mg of Dr. Reddy's Laboratories
      Limited, India, comparing with that of Zyprexa® (Olanzapine) Tablets 5 mg of Eli Lilly and
      Company, USA, in healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): Olanzapine Tablets, 5 mg
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Enhancement in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be
      able to improve cognitive problems (i.e. difficulties with thinking, memory, and
      concentration) that may be associated with bipolar disorder.
    

Detailed description: 
      To address the primary aim, the study is an eight-week, randomized, double-blind,
      placebo-controlled treatment trial of pramipexole in 50 euthymic bipolar I and II disorder
      (BPD) patients, who demonstrate cognitive impairment.
    

Intervention name(s): pramipexole
Intervention type(s): Drug
Intervention description(s): po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
Other intervention name(s): Mirapex
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
New Moves - Obesity Prevention Among Adolescent Girls
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The New Moves study will evaluate the impact of a school based program for inactive high
      school girls who are overweight or at risk for being overweight due to low levels of physical
      activity. The primary study hypothesis is that girls in the intervention schools will
      significantly decrease their percent body fat as compared to girls in the control schools.
      Secondary research hypotheses include that girls in the intervention condition will
      significantly increase their physical activity levels and improve the quality of their
      dietary intake.
    

Detailed description: 
      The purpose of the New Moves study is to evaluate the effectiveness of a school-based all
      girls alternative to regular physical education class for inactive high school girls. New
      Moves uses a large-scale community randomized controlled study involving girls from six
      intervention schools and six control schools. The New Moves class includes physical activity,
      nutritional guidance, and social support within a supportive, non-competitive environment. In
      addition the program includes individual counseling sessions.

      The primary research hypothesis is that girls in the intervention condition will
      significantly decrease their percent body fat as compared to girls in the control condition.
      Secondary research hypothesis to be tested are that girls in the intervention condition will
      significantly increase their level of physical activity and improve the quality of their
      dietary intake as compared to girls in the control condition. In addition a range of
      socioenvironmental, personal, and behavioral variables will be compared across conditions.
    

Intervention name(s): New Moves
Intervention type(s): Behavioral
Intervention description(s): The New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Girls; Physical Activity; Exercise; Diet; Body image
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions
Condition: To Determine Bioequivalence Under Fasting Conditions
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen
      doxycycline monohydrate, 100 mg.
    

Detailed description: 
      To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg
      doxycycline under fasting conditions.
    

Intervention name(s): doxycycline monohydrate; doxycycline monohydrate
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 100 mg, single, oral dose; Capsule, 100 mg, single, oral dose
Other intervention name(s): Monodox(R)
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; doxycycline monohydrate; fasting