bioihbjkbjnl/mcl2 huggingface dataset:
Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised controlled open-label clinical trial to compare the outcome parameters after
      ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on
      day 2 of the cycle versus start in the late follicular phase of the cycle.
    

Detailed description: 
      Objective: To determine whether late follicular stimulation using recombinant-human FSH has
      comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a
      flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.

      Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio

      Patients: Oocyte donors (aged 18-36 years)

      Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH
      (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist
      (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.

      Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225
      IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound
      and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum
      LH (Luteinizing Hormone) > 10 IU/L, till day of trigger.

      Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.
    

Intervention name(s): Late follicular phase stimulation with recombinant-human FSH; Early follicular phase stimulation with recombinant-human FSH
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger.; Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oocyte donor; Ovarian stimulation
Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.
Condition: Peripherally Inserted Central Catheters; Centrally Inserted Central Catheter; Transpulmonary Thermodilution; Hemodynamic Monitoring
Study type: Interventional

Summary: 
      Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit
      (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous
      infusion. In the present study the investigators try to assess their reliability for
      measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.
    


Intervention name(s): transpolmonary thermodilution
Intervention type(s): Diagnostic Test
Intervention description(s): Thermodilution was attempted via PICC and via CICC in the same patient
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: PICC; CICC; Cardiac output; shock
RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study
Condition: Cardiac Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate that that the device is safe and potentially efficacious for use as a left
      ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support
      post weaning from cardiopulmonary bypass.
    

Detailed description: 
      To demonstrate that the device is safe and potentially efficacious for use as a left
      ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support
      post weaning from cardiopulmonary bypass. Postcardiotomy patients, weaned from a
      cardiopulmonary bypass system (CPB) in need for hemodynamic support due to ineffective
      standard medical therapy will be considered for enrollment. An attempt shall be made to
      reverse the hemodynamic situation with medications (e.g. inotropes, vasopressors). The
      IMPELLA RECOVER LP/LD 5.0 will be implanted by the surgeon when no improvement in
      hemodynamics is observed.
    

Intervention name(s): IMPELLA LP/LD 5.0
Intervention type(s): Device
Intervention description(s): IMPELLA LP/LD 5.0 Support System is intended to be used for up to seven (7) days as a left ventricular cardiac assist device for postcardiotomy patients who, despite having been weaned from cardiopulmonary bypass (CPB), require hemodynamic support
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: All patients presenting for high-risk cardiac surgery and who might post-operatively meet the study inclusion criteria are potential study candidates.
Rivaroxaban Post Coronary Bypass Surgery
Condition: Post Coronary Bypass Surgery Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low
      dose rivaroxaban
    

Detailed description: 
      This study is a 1-year randomized, double-blind placebo-controlled trial to evaluate the
      effects of adding rivaroxaban to the treatment of patients after coronary bypass surgery. All
      patients referred for either off-pump or on-pump coronary bypass surgery to 3 academic
      hospitals in Shiraz, Iran were screened according to inclusion criteria. Clinicians at these
      sites were informed of this study and asked to refer patients after coronary bypass surgery.

      A total of 414 patients were initially included in the study, but 171 of them were excluded
      based on the exclusion criteria (Figure 1). The remaining 243 patients were then randomly
      divided into two groups: group 1, receiving aspirin 80 mg daily plus placebo; group 2,
      receiving aspirin 80 mg daily plus rivaroxaban 2.5 mg twice daily.

      Clinical outcomes were assessed at the end of first year post-operation. Subjects will
      undergo a complete history and physical examination and the study variables were assessed.
      Patients were followed every 2 weeks for any occurrence at these visits, patients' compliance
      was assessed, standard medication was adjusted as appropriate, and all interventions, outcome
      events, and adverse events were recorded. The patients were followed for the occurrence of
      major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial
      infarction (hospital visit for myocardial infarction reported by patient or hospital
      admission for myocardial infarction reported by cardiologist); and 3) cerebrovascular
      accidents. Occurrence of major bleeding and chest pain, and functional capacity exercise
      (assessed with exercise tolerance test) were also evaluated. Additional variables that will
      be collected at baseline include demographic and clinical characteristics of patients as
      follows: sex (male, female), age (mean (SD)), hypertension (yes/no), and diabetes mellitus
      (yes/no).

      To document any unfavorable occurrences, the patients were questioned via telephone monthly
      about any potential side effects.
    

Intervention name(s): Rivaroxaban and aspirin 80; Aspirin 80
Intervention type(s): Drug; Drug
Intervention description(s): rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery; aspirin 80 mg orally post coronary bypass surgery
Intervention MeSH terms: Aspirin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double blind of placebo and intervention group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary bypass surgery; aspirin; rivaroxaban; MACE
Natalizumab High Titer Immunogenicity and Safety
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study was to evaluate the immunogenicity of natalizumab
      (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E)
      administered intravenously (IV) to participants with relapsing forms of multiple sclerosis
      (MS). The secondary objective of this study was to evaluate the safety of natalizumab high
      titer.
    


Intervention name(s): BG00002-E (natalizumab high titer)
Intervention type(s): Biological
Other intervention name(s): Tysabri
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: natalizumab; Tysabri; Multiple Sclerosis; Relapsing Forms of Multiple Sclerosis
A Study to Assess the Safety, Tolerability and Effects of Single Ascending Doses of ASP3652 in Healthy Subjects
Condition: Pharmacokinetics; Pharmacodynamics; Healthy Subjects; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the safety (including the effect on cardiac
      intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS
      side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and
      female subjects.
    

Detailed description: 
      Each subject receives 3 single ascending doses of ASP3652 and a single dose of matching
      placebo during one randomly selected investigational period. Randomization is conducted
      separately for males and females.

      The washout period between dosing occasions is at least 7 days. Screening takes place from
      Day -22 to Day -2. Subjects are admitted to the clinic in the afternoon of Day -1 of
      investigational period 1, 2, 3 and 4 for pre-dose assessments.

      On Day -1 of all investigational periods, subjects do not take any food or drink for at least
      10 hours before the anticipated dosing time on Day 1. For the duration of their stay in the
      clinic, subjects are not allowed to consume caffeine or other xanthine-containing drinks.

      The subjects are discharged on Day 4 of each investigational period. The End of Study Visit
      (ESV) is planned to take place 7-14 days after early discharge or after Day 4 of
      investigational period 4.
    

Intervention name(s): ASP3652; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase I; ASP3652; Dose escalation; Maximum Tolerated Dose (MTD)
Zinc Supplementation and Behçet's Syndrome
Condition: Behcet Syndrome
MeSH terms: Behcet Syndrome; Syndrome
Study type: Interventional

Summary: 
      To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50
      patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of
      30 mg/day elemental zinc) for 12 weeks. All participants will be asked not to alter their
      diet, medication, and physical activity during the study. At the first and the end of the
      intervention, genes and proteins expression, the serum level of inflammatory factors, quality
      of life, disease activity, anthropometric measures, physical activity and serum level of zinc
      will be assessed and compared between groups.
    


Intervention name(s): Zinc gluconate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 120 mg each tablet containing 30 mg elemental zinc; Placebo (microcrystalline cellulose): 1 tablet (120 mg each)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The present pharmacokinetic study is designed to compare bioavailability and assess
      bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both
      formulations will be tested in fasting healthy volunteers
    


Intervention name(s): RSG XR
Intervention type(s): Drug
Intervention description(s): RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water.
Other intervention name(s): BRL-049653
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimers Disease; healthy volunteers; bioequivalence
Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it
      is currently heavily used in this population. In fact, per evidence of barcode scanning via
      Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non
      Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed
      that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline .
      Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is
      an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic
      fibrosis.

      We hereby propose a prospective randomized trial to compare the efficacy of hypertonic
      saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis,
      mechanically ventilated patient.
    


Intervention name(s): Normal saline:; Hypertonic Saline; Dornase alpha
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).; Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).; 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Other intervention name(s): Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Atelectasis
Milk Supplementation and Energy Balance.
Condition: Obesity; Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The aim of the project is to determine if milk supplementation during a caloric restriction
      program facilitates the lost of weight, improves the appetite control and attenuates the
      decrease of bone mineral content in low-calcium consumer women.
    

Detailed description: 
      Calcium deficiency is related to a higher risk of obesity. Some studies showed a lost of
      weight by elevating the calcium consumption to reach the recommended level. Milk
      supplementation could be a good alternative to reach this objective, but its impact on weight
      loss and on appetite sensations has not been verified. Furthermore, losing weight leads to
      some negative consequences like a decrease of bone mineral content. Considering the benefits
      of milk on bone health, a higher intake of this food product during weight loss could
      represent a healthy strategy.
    

Intervention name(s): Supplementation of milk (35% more calcium)
Intervention type(s): Dietary Supplement
Intervention description(s): The supplement provides 1000 mg of calcium and 250 kcal daily.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Milk; Calcium; Weight loss; Bone density; Appetite
Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC
Condition: Cholestatic Liver Disease
MeSH terms: Liver Diseases; Cholestasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical
      effectiveness of UDCA may be limited by its poor absorption and extensive
      biotransformation.The more hydrophillic bile acid tauroursodeoxycholate (TUDCA) is the active
      ingredients of UDCA,and has been approved by state food and drug administration in China for
      treatment of cholesterol stones.So it is necessary to verify the efficacy and safety of TUDCA
      in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,
      double -dummy, parallel-controlled and multicenter clinical trial, we detect the proportion
      of patients who had AKP decline more than 25% as the primary outcome;decline of ALP,total
      bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated with TUDCA or
      UDCA for 24 weeks.
    

Detailed description: 
      This is a double-blind, randomized, parallel controlled, multicenter, clinical trial.
      Subjects inclusion by randomization after passing the screening, continuous administration
      the test drug (Taurolite) or control drug (Ursofalk) treatment for 24 weeks. Compare the
      safety and efficacy of Taurolite vs Ursofalk.

      At the end of the double-blind period，enroll 100 subjects from both two group randomly ,for a
      consecutive treatment use TUDCA up to 24 weeks. Further evaluate the efficacy and safety of
      tauroursodeoxycholic acid (TUDCA) in the treatment of adult primary biliary cirrhosis (PBC)
      for a long time up to one year. Also evaluate the regimen's efficacy and safety that udca
      take placed by TUDCA in the treatment of adult primary biliary cirrhosis (PBC) for the
      patients who use udca treatment for 24 weeks.
    

Intervention name(s): tauroursodeoxycholic; ursodeoxycholic acid
Intervention type(s): Drug; Drug
Intervention description(s): Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal; ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal
Other intervention name(s): TUDCA; Taurolite; UDCA; Ursofalk
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tudca PBC Cholestasis tauroursodeoxycholic acid taurolite
Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of intestinal microbiota therapy on gastro-intestinal
      symptoms in patients with systemic sclerosis (SSc). This is a mulicenter randomized
      controlled trial conducted at university hospitals in Oslo, Tromsø, Bergen and Trondheim in
      Norway. In part A1, half of the patients will receive active substance (intestinal microbiota
      cultured in the lab - "ACHIM") in the small intestine twice by gastroduodenoscopy, the other
      half will receive placebo. The primary outcome will be measured on week 12 by patient
      reported outcome measures. In part A2, all participants receive ACHIM at week 12, with an 8
      week follow-up for all. A step-wise follow-up will be done in part B up to 16 weeks after
      week 20 until the last participant finish week 20 visit, which is defined as end of study.The
      blind from the first intervention will not be opened before end of study.
    


Intervention name(s): "ACHIM" as solute (10^9 intestinal microbes/ml)
Intervention type(s): Drug
Intervention description(s): Culture of intesinal microbiota originally derived from a healthy subject are administered to a person with presumed dysbiotic intestinal symptoms with an objective to treat these symptoms.
Other intervention name(s): Fecal microbiota transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 20-week study period consists of a 12-week induction phase (Part A1), with randomized, double-blind parallel group interventions by endoscopic infusions at weeks 0 and 2, and an 8-week maintenance phase (Part A2) where all participants receive one single open label endoscopic infusion on week 12. Additionally, all participants who complete the 20-week study period are followed for a maximum 16 weeks monitoring period (Part B) to obtain longer-term data on safety and durability of intervention effects.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Frequency Needed for School-based Obesity Intervention
Condition: Obesity, Child
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This randomized controlled trial compared changes in Mexican-American, adolescent
      standardized body mass index (zBMI) from a school-based obesity intervention given zero, one,
      three, or five days a week.
    

Detailed description: 
      Efficacious school-based interventions have been intensive making it difficult for
      interventions to be scaled. The more components there are to an intervention, typically the
      better the results. Instead of decreasing intensity via the removal of intervention
      components, this randomized controlled trial aimed to compare changes in Mexican-American
      adolescent standardized body mass index (zBMI) based on the number of days per week they
      received a multi-component intervention. Mexican-American middle school students (n=203) with
      overweight or obesity were recruited from an independent school district in Houston. Students
      were randomized to receive an obesity intervention with established efficacy zero (control),
      one, three, or five days/week. In each condition, 80% of intervention time was allocated to
      physical activity and 20% to nutrition. Directly measured height and weight were used to
      calculate zBMI.
    

Intervention name(s): School-Based Obesity Intervention (FLOW)
Intervention type(s): Behavioral
Intervention description(s): The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment