bioihbjkbjnl/mcl2 huggingface dataset:
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics
Condition: Pre-diabetes; Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The trial will test whether the Alive multi-channel delivery health behavior program can
      positively affect weight and glucose level in pre-diabetics.
    


Intervention name(s): Alive-PD; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support; Placebo Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: behavior change; pre-diabetes; prevention; diabetes prevention; Hemoglobin A1c; glucose; physical activity; nutrition; email; web; obesity
Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops
Condition: Safety After Oral Intake; Pharmacokinetics After Oral Intake; Immune Cells Activity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary
      plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have
      known potential biological properties, but poor bioavailability due to their low oral
      absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo
      controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout
      periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake.
      Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids
      on the function of cells of the immune system.
    


Intervention name(s): Placebo; 6-prenylnaringenin; 8-prenylnaringenin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Other intervention name(s): 6-PN; 8-PN
Intervention MeSH terms: 8-prenylnaringenin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Bioavailability; Pharmacokinetics; 8-prenylnaringenin; 6-prenylnaringenin; Prenylflavonoids; PBMC
Dermacyd Silver Frutal (Lactic Acid) - Acceptability.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To prove the safety of the gynecological formulation in normal conditions of use.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Treatment duration: 21 consecutive days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
IGIV Study for Chronic ITP Patients Ages 3-70
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by
      platelet destruction and thrombocytopenia (peripheral blood platelet count < 150 x 10^9/L).
      IVIG therapy is useful in patients in whom the platelet count has to be raised either due to
      bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary
      goal of treatment is to maintain the platelet count at a hemostatic level. This study will
      test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic
      ITP.
    


Intervention name(s): IGIV3I Grifols 10%
Intervention type(s): Biological
Intervention description(s): IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.
Other intervention name(s): Intravenous immunoglobulin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVIG; ITP
Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of
      physical illness in depression, the serotonin hypothesis seems to fail in approaching the
      etiology of depression. Based upon the evidence from epidemiological data, case-control
      studies of PUFAs compositions, and antidepressant effects in clinical trials, phospholipid
      polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the unsolved
      of depression.
    

Detailed description: 
      There are several important questions to answer regarding phospholipid polyunsaturated fatty
      acids (PUFAs) hypothesis of depression. Firstly, although case-control studies revealed that
      depressive patients had lower levels of omega-3 PUFAs, the abnormal findings in individual
      PUFA of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) or arachidonic acid (AA) are
      not consistent. Secondly, the deficits in n-3 PUFAs are related to their metabolic enzymes.
      However, the association study of polymorphisms of PUFA-metabolism related genes in
      depression is limited. Thirdly, the active component of antidepressant effect in n-3 PUFAs is
      still in debate. Fourthly, the molecular mechanisms of n-3 PUFAs' antidepressant effects have
      yet to be elucidated in human brain functional neuroimaging or in cellular models.

      This 3-year proposal is divided into 2 clinical studies. In study 1, the investigators aim to
      test the clinical and biological effects of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus
      placebo: high oleic oil) for depressive symptoms in a 12-week, double-blind,
      placebo-controlled trial of patients with drug-free MDD. In study 2, the investigators will
      measure the biological and neuroimaging markers to investigate the biological mechanisms of
      EPA (3.5 g/d) versus DHA (1.75 g/d) in 12-week, double-blind, randomized-controlled trial
      with patients with drug-free major depression disorder (MDD).
    

Intervention name(s): EPA; DHA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 & 2.; A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 & 2.; A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.
Other intervention name(s): Fish oil EPA; Fish oil DHA; oleic oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Tranexamic Acid in Pregnancies With Vaginal Bleeding
Condition: Vaginal Bleeding During Pregnancy
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Tranexamic acid has been proposed and used for prevention and management of antepartum and
      postpartum hemorrhage.
    

Detailed description: 
      Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal
      mortality. Hemorrhage in pregnancy is characterized by activation of the fibrinolytic system.
      Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis, and thus can
      be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic
      acid is category B. Tranexamic acid has been used to decrease blood loss and treatment of
      intra partum blood loss in cesarean section also it has been used for prevention and
      management of postpartum hemorrhage after vaginal bleeding, regardless of whether the
      bleeding is due to genital tract trauma or other causes.
    

Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days .
follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .
Other intervention name(s): Trenaxa , Manufacturer Macleods Pharmaceuticals; TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens
Intervention MeSH terms: Tranexamic Acid
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antepartum bleeding; Perinatal morbidity; Perinatal mortality; Preterm labor
A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2 randomized, double-blind, double-dummy, active- and
      placebo-controlled, parallel-group study designed to assess the safety, tolerability,
      efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants
      with active PsA who are inadequately responding to MTX treatment.
    


Intervention name(s): adalimumab; ABT-122
Intervention type(s): Biological; Biological
Other intervention name(s): Humira; ABT-D2E7; remtolumab
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Efficacy; Methotrexate
The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
Condition: Prolonged Pregnancy
MeSH terms: Pregnancy, Prolonged
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether castor oil is effective in inducing labor.
    

Detailed description: 
      Castor oil is traditionally given by midwives in order to induce labor. Its efficacy as an
      initiator of labor was previously tested only in one clinical trial. Unfortunately this study
      (by Garry et al.) was not sufficiently controlled.

      We intent to recruit 84 healthy pregnant women with no contraindication to vaginal delivery
      that had past their due date. Women will be randomly and blindly divided into equal sized
      intervention group and control group. Intervention group will be given 60 mL of castor oil in
      140 mL of orange juice, while control group will be given a placebo with similar texture.
      Primary outcome to be tested is the percentage of women entering active labor within 24 hours
      of administration.
    

Intervention name(s): Castor oil; Sunflower oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients who received castor oil for labor induction; Patients who received sunflower oil as a placebo
Intervention MeSH terms: Castor Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; post-date; induction of labor; castor oil
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Condition: Chronic Migraine or Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period
      in monthly migraine days in subjects with migraine.
    

Detailed description: 
      A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to
      evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic
      migraine.
    

Intervention name(s): Placebo; AMG 301
Intervention type(s): Drug; Drug
Intervention description(s): Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.; AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Migraine; Headache; Prevention; Prophylaxis
Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      in this study, the investigators compare the effect of interval training exercise and
      electroacupuncture on liver functions in non-alcoholic fatty liver disease patients
    

Detailed description: 
      fifty patients suffering from Nonalcoholic fatty liver disease (NAFLD) will be recruited in
      this study with age ranged from 30-55 years old from both sexes, chosen from internal
      medicine department at Kasr El Aini hospital and from the outpatient clinic of nutrition and
      cardiovascular disorders at the faculty of Physical Therapy Cairo University, they were
      divided in to two groups:Group (1):

      Twenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD), and taking
      their standard medications In addition to electroacupuncture at points of LR3 (Taichong),
      LR14 (Qimen), GB 34(Yanglingquan) and ST36 (Zu San Li). Group (2):

      Twenty-five patients suffering from Nonalcoholic fatty liver disease(NAFLD) and taking their
      standard medications in addition to aerobic interval training exercise.Lab investigations of:

      Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Triglycerides (TG) and
      C-reactive protein (CRP).to judge liver functions
    

Intervention name(s): aerobic interval training exercise .; electro acupuncture
Intervention type(s): Behavioral; Device
Intervention description(s): Its consisted of cycle ergometer training, 3 days a week for 6 weeks. Aerobic interval training consisted of ( 8 )minutes warm-up, followed by 4 times of 4-minute intervals with HR at 85% of sub maximum HR, with active pauses of 3 minutes of walking at 60% of sub maximum HR. The exercise session was terminated by 5 minutes cool-down; electroacupuncture (EA) of (2 Hz, 4 mA) was applied at points of:liver 3 LR3,liver 14 LR 14, gall bladder 34 (GB 34) and stomach 36 (ST36) .
Duration of the session was 15 min / each, three sessions per week for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      The study aims to test the effect of Ashtanga yoga on well-being in patients with irritable
      bowel syndrome (IBS). The intervention comprises group sessions on the Ashtanga school of
      yoga. Participants are recruited from primary care and measurements on well-being and IBS
      symptoms are conducted at pre-treatment, post-treatment and 6-month follow-up.
    

Detailed description: 
      The intervention comprises participants with IBS to undergo Ashtanga yoga sessions in a group
      led by an authorized yoga teacher for a total period of 10 weeks. The first 4 weeks consisted
      of 1 session/week and the following 6 weeks consisted of 1 session/2 weeks. All movements and
      exercises are performed based on the individual's personal capacity in order to avoid
      distinct discomfort or pain. Patients testing positive for IBS will be recruited for the
      study from primary care. Measurements of IBS symptoms, visceral sensitivity, extraintestinal
      symptoms and quality of life will be assessed at pre-treatment, post-treatment and 6-month
      follow-up. Specific statistical methods will be performed to assess changes from pre- to
      post-treatments and changes from post-treatment to 6-month-follow-up. Effects sizes for
      within group changes will also be calculated.
    

Intervention name(s): Ashtangayoga
Intervention type(s): Behavioral
Intervention description(s): This is an active and intense type of yoga, focused on physical activity and breath control
Intervention model: Single Group Assignment
Intervention model description: Each participant is given the intervention, and they are measured at pre, post and 6 month follow-up.
Masking: None (Open Label)
Primary purpose: Treatment
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
Condition: Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age,
      gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
    


Intervention name(s): NRL972; NRL972; NRL972; NRL972; NRL972; NRL972
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single intravenous dose of 2 mg NRL972; Single intravenous dose of 2 mg NRL972; Single intravenous dose of 2 mg NRL972; Single intravenous dose of 2 mg NRL972; Single intravenous dose of 2 mg NRL972; Single intravenous dose of 2 mg NRL972
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Aramchol Concentrations With Once or Twice Daily Dosing
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is an open-label, 2-period, randomised, crossover study of the plasma
      concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg
      twice daily and 600 mg once daily.
    

Detailed description: 
      The trial is an open-label, 2-period, randomised, crossover study of the plasma
      concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg
      twice daily (every 12 h) for 9 days in one period, with a single dose in the morning of Day
      10, and 600 mg once daily (every 24 h) for 10 days in the other period. A pharmacokinetic
      profile will be obtained over the dosing interval on Day 10 of each period.

      Enrolment of 16 subjects is planned with each subject taking part in the 2 study periods. The
      subjects will be randomised 1:1 so that 8 subjects receive each regimen in the first period
      and the alternate regimen in the second period.

      Subjects will be screened within 21 days before their first dose of study medicine. In each
      period they will remain resident on the ward from Day -1 until the morning of Day 11.
      Subjects will attend a follow-up visit 14 days (±2 days) after the end of the second period.
      There will be an interval of at least 7 days between Periods 1 and 2.
    

Intervention name(s): Aramchol
Intervention type(s): Drug
Intervention description(s): One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will receive oral doses of aramchol at 300 mg twice daily (every 12 h) for 9 days in one period, with a single dose in the morning of Day 10, and 600 mg once daily (every 24 h) for 10 days in the other period.
Enrolment of 16 subjects is planned with each subject taking part in the 2 study periods. The subjects will be randomised 1:1 so that 8 subjects receive each regimen in the first period and the alternate regimen in the second period.
Masking: None (Open Label)
Primary purpose: Other
Biomarkers of Antidepressant Resistance
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      According to the WHO, major depressive disorders have become the second worldwide cause of
      disability. Treatment, long-term medication, leads to frequent resistance (up to 40%).

      Establishing a cerebral molecular signature of depression is not feasible in humans (need for
      cerebral samples). The alternative is to use peripheral biological samples (blood, urine,
      saliva).

      Metabolomic is the integrated and quantitative study of all the metabolites of a biological
      system. This aims to define the metabolic status of an organism for a particular condition.

      Metabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.)
      and are detected by:

        -  liquid or gas chromatography coupled to mass spectrometry (LC-MS, GC-MS),

        -  proton nuclear magnetic resonance (1 H-NMR). The biomarkers resulting from these studies
           have become important diagnostic criteria, measured objectively and evaluated as
           indicators of a normal or pathological state, or even predictors of treatment efficacy.

      This approach allows the discovery of biomarkers that best describe the status of a disease
      for better understanding and are usable in a context of individualized medicine, with effects
      on clinical practice and management.
    


Intervention name(s): olfactive tests; blood test; Collection of faeces; Tissue Pulsatility imaging
Intervention type(s): Other; Biological; Biological; Device
Intervention description(s): olfactive tests: odor identification, odor discrimination and olfactory threshold; one sample of 4mL; Collection of faeces by patient at home - optional; Ultrasound exploration of brain pulsatility - optional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: depression; antidepressant; resistance