bioihbjkbjnl/mcl2 huggingface dataset:
Fetal and Maternal Head Circumference During Pregnancy in Israeli Population
Condition: Maternal-Fetal Relations; Microcephaly
MeSH terms: Microcephaly
Study type: Observational [Patient Registry]

Summary: 
      In this study, measurements of fetal and maternal head circumference will be collected. This
      data will be presented in table or graph form. The effect of maternal head circumference on
      fetal head circumference will be evaluated and presented in either formula or graph form.
    


Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Keywords: Fetus; Skull; ultrasonography
Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets
Condition: Hypertension, Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and the safety of concomitant use of Ezetimibe/Rosuvastatin
      combination tablets and Candesartan cilexetil/Amlodipine besylate combination tablets
      compared to each combination tablet alone in patients with essential hypertension (HTN) and
      hyperlipidemia.
    

Detailed description: 
      To improve the ease of use of high blood pressure and hyperlipidemia to improve patient
      compliance and reduce the risk of cardiovascular disease.

      And It is recommended to identify the need to develop a combination of Candesartan
      cilexetil/Amlodipine besylate combination tablets , and Ezetimibe/Rosuvastatin combination
      tablets.
    

Intervention name(s): Ezetimibe/Rosuvastatin; Candesartan cilexetil/Amlodipine besylate; Candesartan cilexetil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Candesartan cilexetil 8 mg placebo; Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Ezetimibe/Rosuvastatin 10 mg/10 mg placebo + Candesartan cilexetil 8 mg placebo; Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg placebo
Other intervention name(s): Ezetimibe/Rosuvastatin 10 mg/10 mg; Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg; Candesartan cilexetil 8 mg
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil; Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Effects of Stevia in Type 2 Diabetic Patients
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia
      rebaudiana bertoni in patients with type 2 diabetes.
    

Detailed description: 
      This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate
      the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a
      mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms
      including an intervention arm (test group) and a non-intervention arm (controls) matched for
      age, sex and body mass index in 2:1 ratio.

      The intervention is made of two phases including

        1. A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to
           evaluate the acute effects;

        2. An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess
           medium-term effects
    

Intervention name(s): Stevia rebaudiana liquid extract
Intervention type(s): Dietary Supplement
Intervention description(s): Sweetener made of liquid stevia self administered daily for 30 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Stevia; insulin secretion; insulin sensitivity; Sweetener
First in Man Trial - BIOSOLVE-I
Condition: de Novo Lesions in Native Coronary Arteries
Study type: Interventional

Summary: 
      First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
    


Intervention name(s): AMS-3.0
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability Study and Food Effect Study of TT-00420 (Tinengotinib) Capsule and Tablet Formulations in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to
      evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to
      evaluate food effect on the pharmacokinetics of TT-00420 tablet.
    

Detailed description: 
      Subjects will be randomized to one of three treatment sequences. Each sequence will contain
      up to 8 subjects. In each treatment sequence, subjects undergo a baseline/screening period,
      three treatment periods, and a follow-up visit.

      Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet
      under fed condition, TT-00420 tablet under fasting condition, or capsule under fasting
      condition and crossed over after at least a 14-day washout period.
    

Intervention name(s): TT-00420 Capsule; TT-00420 Tablet
Intervention type(s): Drug; Drug
Intervention description(s): TT-00420 capsule formulation, administered orally; TT-00420 tablet formulation, administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
An Internet-based Self-management Program for Adolescents With Arthritis
Condition: Arthritis, Juvenile Idiopathic
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the effectiveness of the "Taking Charge: Managing
      JIA Online" Internet intervention, when compared with an attention (static education only
      websites) control group in improving pain and HRQL as well as other health outcomes (anxiety,
      depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents
      with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10
      pediatric rheumatology hospital clinics in the Canada to either the experimental or control
      groups.
    

Detailed description: 
      In summary, no rigorous Internet self-management intervention has been undertaken to improve
      HRQL, symptoms, treatment adherence, knowledge, and self-efficacy in youth with JIA. The
      proposed "Managing JIA Online" Trial will rigorously examine the effects of this Internet
      intervention on HRQL and other health outcomes thereby filling a significant gap in our
      knowledge related to promotion of self-management care for adolescents with JIA.
    

Intervention name(s): Taking Charge: Managing JIA Online; Standard Medical Care and JIA Resource Center
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing JIA Online" Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol - that consists of JIA-specific education, self-management strategies, and social support - that is available in English and French.; The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention and through the 9-month follow-up period. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about JIA ("JIA Resource Centre") and online assessments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: adoloescent; internet self-management; managing JIA
Revealed Versus Concealed Cerebroplacental Ratio
Condition: Stillbirth
MeSH terms: Stillbirth
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the role of an integrated strategy at selecting
      fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental
      ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.
    

Detailed description: 
      This is a multicenter, open-label randomized trial with groups in parallel. Singleton
      pregnancies are recruited after routine second trimester scan (19+0 to 22+6 weeks of
      gestation) and randomly allocated at that moment to revealed or concealed strategy. A routine
      scan will be booked at 36-37 weeks. For a reduction of the stillbirth rate of 3‰ (from 5‰ to
      2‰), assuming a type I error of 5% and aiming for a power of 80% a total of 11,582 subjects
      (5791 per arm) were projected. The participating centers sum up 12,000 deliveries a year. It
      is not possible to blind participants, obstetricians, or outcome assessors to the study
      group.

      General hypothesis: A proportion of fetuses with "normal" growth as per current standards
      have placental insufficiency and restriction of their growth potential. These fetuses exhibit
      biophysical changes expressed by abnormal cerebroplacental ratio. A combination of this
      marker with fetal biometry for the detection of fetuses affected by fetal growth restriction
      could identify a group of babies on which labor induction once term is reached may prevent
      the occurrence of adverse outcomes.

      Specific hypothesis

        -  The cerebroplacental ratio has predictive value in late pregnancy for placental
           insufficiency.

        -  The cerebroplacental ratio could improve the effectiveness of late pregnancy screening
           for the prediction placental insufficiency-related complications.
    

Intervention name(s): Revealment
Intervention type(s): Other
Intervention description(s): Cerebroplacental ratio revealment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stillbirth; cerebroplacental ratio; fetal growth restriction
Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Intrauterine injection of hCG around the time of implantation may increase endometrial Treg
      cells and improve implantation. It has been demonstrated that regulatory T cells expand
      during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization
      and has chemoattractant properties to Treg cells.
    

Detailed description: 
      Aim of the work:

      To study the effect of intrauterine injection of human chorionic gonadotrophin on the
      endometrial T regulatory cells (Treg cells)and the electromicroscopic endometrial
      characteristics.

      Background:

      It has been demonstrated that regulatory T cells expand during pregnancy and are present at
      the feto-maternal interface at very early stages in pregnancy.

      Rational:

      Intrauterine injection of hCG around the time of implantation may increase endometrial Treg
      cells and improve implantation.

      Methods:

      Intrauterine injection of 100 IU hCG will be done followed by endometrial biopsy to check for
      Treg cells and pinopodes.
    

Intervention name(s): human chorionic gonadotrophin
Intervention type(s): Drug
Intervention description(s): intrauterine injection of 100 IU hCG followed by endometrial biopsy .
Other intervention name(s): choriomon
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: hCG; Treg cells; implantation; pinopodes; endometrium
A Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to document the long-term safety and tolerability of
      risperidone, formulated as a long-acting injectable, in the treatment of patients with
      schizophrenia or schizoaffective disorder; in addition, to evaluate the long-term
      effectiveness of long-acting risperidone and its effect on quality of life
    

Detailed description: 
      Although many schizophrenia patients currently take oral antipsychotic medications, it is
      estimated that up to 75% of them have difficulty adhering to the daily oral regimen.
      Long-acting injectable formulations may eliminate the need for daily medication and enhance
      patient compliance with the treatment regimen. This safety study is an extension of a
      randomized, double-blind, multicenter, parallel group study that investigates effectiveness
      and safety of risperidone injected intramuscularly in patients with schizophrenia or
      schizoaffective disorder. The present open-label study evaluates 3 different doses of a
      formulation of risperidone injected into the muscle at 2 week intervals for at least 1 year
      in patients with these conditions. Assessments of effectiveness include the Clinical Global
      Impression (CGI) overall severity of illness scale. Quality of life will be assessed by the
      SF-36 Health Survey. Safety evaluations include incidence of adverse events, physical
      examinations, and evaluations of the injection site, clinical laboratory tests,
      electrocardiograms (ECGs), and Extrapyramidal Symptom Rating Scale (ESRS), a scale assessing
      muscle tone, gain, and abnormal movements. Injections every 2 weeks for at least 1 year,
      beginning at 25milligrams[mg] and increasing to 50mg or 75mg (maximum dose). Dosages may be
      increased or decreased at investigator's discretion. During the first 3 weeks, risperidone
      tablets (2mg) once daily to supplement injectable risperidone.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; intramuscular injection; psychotropic agents; long-acting risperidone
Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction
Condition: Intermittent Fasting
Study type: Interventional

Summary: 
      The goal of this study is to determine how effective repeated fasting over 26 weeks (6
      months) is at improving risk parameters that are surrogate endpoints for cardiovascular
      diseases, metabolic dysregulation and cognitive impairments.

      Subjects will be randomized 1:1 to water-only fasting or to their ad libitum usual diet, with
      randomization performed within strata based on fasting history (≤180 hours or 181-720 hours
      of total fasting for >12 consecutive hours per episode in the previous two years). Subjects
      will be assessed at 4, 13 and 26 weeks following randomization.
    


Intervention name(s): Intermittent Fasting
Intervention type(s): Behavioral
Intervention description(s): Subjects allocated to the fasting arm will undergo a fasting regimen of twice-per-week 24-hour fasting on non-consecutive days during the first 4 weeks of the study, then once-per-week 24-hour fasting during the rest of the study (22 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules
      (test product) and co-codamol 30mg/500mg tablets (reference product).
    


Intervention name(s): co-codamol 15mg/500mg capsule; co-codamol 30mg/500mg tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
An Evaluation of Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program
Condition: Teen Pregnancy; Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact Pono Choices has among youth for teen
      pregnancy and STI prevention measures such as: initiation of sexual activity; engagement in
      high risk sexual behaviors; knowledge of pregnancy and STI prevention; attitudes toward
      healthy sexual behaviors; skills in managing relationships and choices; and intentions about
      future sexual activity.
    

Detailed description: 
      The study used a cluster randomized controlled design to evaluate the impact of Pono Choices.
      Thirty-six middle schools in Hawaii were randomly assigned to participate as either a
      treatment or control school. Treatment school teachers were trained to deliver Pono Choices.
      Control school teachers did not receive training and chose their own middle school sexual
      health education curricula.

      Over 1,700 7th and 8th grade students in 34 Hawaii schools enrolled into the study. As part
      of the study, students were invited to participate in baseline and follow-up surveys. The
      student survey responses were used to determine the impact Pono Choices has on teen pregnancy
      and STI prevention measures.
    

Intervention name(s): Pono Choices; Business as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Medically accurate teen pregnancy and STI prevention education delivered through a place-based framework integrating Hawaiian cultural activities that draw upon both historical and local references.; Teen pregnancy and STI prevention education left to the discretion of the school.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adolescents; teen pregnancy prevention; sexually transmitted infections prevention; place-based programs; health education
Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by
      stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making
      tumor cells more sensitive to the drug.

      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide,
      and celecoxib following radiation therapy in treating patients who have newly diagnosed
      glioblastoma multiforme.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of adjuvant temozolomide, thalidomide, and celecoxib after
           radiotherapy, in terms of time to tumor progression and overall survival, in patients
           with newly diagnosed glioblastoma multiforme.

        -  Determine the toxicity of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily and
      oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses
      in the absence of disease progression or unacceptable toxicity.

      Patients are followed for survival.

      PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
    

Intervention name(s): celecoxib; temozolomide; thalidomide; adjuvant therapy
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Thalidomide; Celecoxib; Temozolomide
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult mixed glioma; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
Resistive Expiratory Muscle Training in COPD Patients
Condition: COPD
Study type: Interventional

Summary: 
      -  To determine effects of resistive expiratory muscle training on pulmonary functions in
           Chronic obstructive pulmonary disease (COPD) patients

        -  To determine effects of resistive expiratory muscle training on maximum expiratory
           pressure in COPD patients

        -  To determine effects of resistive expiratory muscle training on quality of life in COPD
           patients
    


Intervention name(s): Resistive Expiratory muscle Training Group; Conventional Breathing Exercise Group
Intervention type(s): Other; Other
Intervention description(s): Mild Resistive Expiratory Technique [Expiratory Muscle Strength Training (EMST150)- six-week training protocol approximately 20 min per day] The EMST requires the participant to forcibly blow into the device for 5 seconds with sufficient pressure to open the one-way valve. Each "blow" is one repetition. The device will be set at a resistance of 30 cmH2O. Participants will be instructed to complete five sets of five repetitions (total of 25 times and approximately 20 minutes per day), any five days per week, for six weeks. Whole exercise will be done in sitting position. Rest between repetitions will be given according to comfort level of patient.; Breathing Exercises: (approximately 20 minutes per day)
● Pursed lip breathing: (Sit with your back straight. Inhale through your nose for two seconds. Purse your lips like you're blowing on hot food and then breathe out slowly, taking twice as long to exhale as you took to breathe in. 4-5 times a day)
● Diaphragmatic breathing: (Lie on your back on a flat surface, knees bent and head supported. Use pillow under knees to support your legs. Breathe in slowly through your nose Tighten your stomach muscles, letting them fall inward as you exhale through pursed lips. Practice this exercise 5-10 minutes about 3-4 times per day).
● Incentive spirometer: (Hold in an upright position. Breathe in slowly and as deeply as possible. Hold your breath as long as possible (at least for 5 seconds). Then exhale slowly Rest for a few seconds and at least 10 times every hour)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resistive Expiratory Muscle training; Breathing Exercise; Pulmonary Function; Quality of Life