bioihbjkbjnl/mcl2 huggingface dataset:
Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage
Condition: Miscarriage in First Trimester
MeSH terms: Abortion, Spontaneous
Study type: Interventional
Phase: Phase 4

Summary: 
      Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg
      of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been
      recommended by some international guidelines . So far, there are no recent studies comparing
      cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6
      hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not
      inferior to 400µg regimen), costs reductions and lower side effects may be issued without
      losing quality of cervix dilatation.
    

Detailed description: 
      Miscarriage is defined by the World Health Organization as the interruption of the pregnancy
      up to 20-23 weeks, or the products of pregnancy weighing less than 500 grams (1). Nearly 15%
      of known pregnancies end in miscarriage, especially in the first 12 weeks. Estimates indicate
      that 68000 women die worldwide each year, as a result of unsafe abortions. Abortions are the
      major cause of maternal death, particularly in Latin America and the Caribbean. In cases of
      retained and incomplete abortions, uterine emptying is recommended. In the first trimester of
      pregnancy, either pharmacological or surgical procedure is accepted according to
      international guidelines.

      Pharmacological treatment for uterine evacuation includes the administration of mifepristone
      and misoprostol or misoprostol alone. Nevertheless, surgical methods have been shown a
      greater acceptability and patient satisfaction due to a reduced incidence of adverse effects.
      Currently, Manual Vacuum Aspiration (MVA) is the technique recommended by the Brazilian
      Ministry of Health and the Brazilian Federation of Gynecology and Obstetrics.

      MVA should be performed after cervical ripening. This pre-surgical procedure makes the
      procedure safer and more effective. In Brazil, misoprostol is the most suitable drug to be
      used in these cases because of its efficacy, ease of use, low cost, stability at room
      temperature, and availability. Misoprostol is a synthetic prostaglandin E1 analog and can be
      administered by oral, sublingual, buccal, rectal, and vaginal routes.
    

Intervention name(s): Misoprostol 400mcg Tab; Misoprostol 200mcg Tab
Intervention type(s): Drug; Drug
Intervention description(s): 400µg of misoprostol (2 tablets); 200µg of misoprostol (1 tablet)
Other intervention name(s): Misoprostol control; Misoprostol comparator
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: misoprostol; miscarriage
Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?
Condition: Cramps
MeSH terms: Muscle Cramp
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy.
    

Detailed description: 
      Healthy pregnant women between 18 and 36 weeks of pregnancy suffering from leg cramps at
      least twice a week were treated with magnesium tablets or placebo for two weeks, 120 mg x 3
      daily.
    

Intervention name(s): "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
Intervention type(s): Drug
Intervention description(s): 120 mg x 3 or placebo
Other intervention name(s): Nycoplus Magnesium tablets(R); Placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pregnancy; Magnesium; Leg Pain
Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to characterize the pharmacokinetics, safety, tolerability, and
      pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729,
      MK-8835) in Japanese healthy participants. The secondary objective is to investigate the
      safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin
      in Western healthy participants as compared to Japanese healthy participants.
    


Intervention name(s): Ertugliflozin; Placebo; Ertugliflozin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dose escalation of 1, 5, and 25 mg Ertugliflozin administered in the fasted state; Placebo tablets to Ertugliflozin administered in the fasted state; Ertugliflozin 25 mg tablets administered once daily in the fed state for 7 days; Placebo tablets administered once daily in the fed state for 7 days
Intervention MeSH terms: Ertugliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ertugliflozin; Japanese and Western population; pharmacokinetics; pharmacodynamics
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
Condition: Moderate to Very Severe Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in
      symptomatic patients with moderate to very severe COPD who are receiving standard of care
      therapies.
    


Intervention name(s): Benralizumab Arm A; Benralizumab Arm B; Benralizumab Arm C; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Benralizumab subcutaneously on study week 0 until study week 48 inclusive; Benralizumab subcutaneously on study week 0 until study week 48 inclusive; Benralizumab subcutaneously on study week 0 until study week 48 inclusive; Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Lung Diseases; Chronic Obstructive Pulmonary Disease; Lung Disease; Bronchial Diseases; COPD Exacerbation; Respiratory Tract Diseases
Vektor vMap™ Clinical Validation Study
Condition: Cardiac Arrhythmia; Atrial Fibrillation; Ventricular Arrythmia; Premature Ventricular Complexes Multiple; Ventricular Tachycardia; Ventricular Fibrillation; Premature Atrial Complex; Atrioventricular Reentrant Tachycardia
MeSH terms: Premature Birth; Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation; Ventricular Premature Complexes; Atrial Premature Complexes; Tachycardia, Atrioventricular Nodal Reentry
Study type: Observational

Summary: 
      This is a retrospective, multi center clinical study collecting existing, de-identified
      subject data from medical records to be analyzed using an independent core laboratory to
      validate performance of a computational ECG mapping system (vMap™).
    


Intervention name(s): Cardiac ablation procedure
Intervention type(s): Device
Intervention description(s): Retrospective data will be collected from cases where successful ablation was completed.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult patients with cardiac arrhythmia that have undergone successful ablation procedures.
ETI During Intubation
Condition: Intubation; Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      The objective of this study is to compared effectiveness of intubation using ETView VivaSight
      SL and standard tracheal tube during resuscitation performed by a novice-physicians.
    


Intervention name(s): Standard tracheal tube; ETView VivaSight SL
Intervention type(s): Device; Device
Intervention description(s): Intubation using Macintosh laryngoscope and standard tracheal tube; Intubation using ETView VivaSight SL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
Condition: Muscular Atrophy
MeSH terms: Muscular Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish safe dose levels of ACE-031 in healthy
      postmenopausal women following multiple dose administration. This study will also evaluate if
      ACE-031 has an effect on muscle.
    


Intervention name(s): ACE-031; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months.; Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months.
Other intervention name(s): ActRIIB-IgG1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Chemotherapy Combined With CIK Treating Colon Cancer
Condition: Colorectal Cancer; Cytokine-induced Killer Cells; Postoperative Complications; Survival
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators
      aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of
      postoperative colorectal cancer patients. And to provide useful reference for the clinical
      application of CIK in colorectal cancer patients.
    

Detailed description: 
      Over the past decade, advances in combination chemotherapy regimens for colorectal cancer
      have led to significant improvement in progression-free and overall survival.
      Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has
      demonstrated the median overall survival (OS) in patients received CIK combined with
      chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan) was significantly
      increased compared with that in patients received chemotherapy alone. Furthermore, there was
      a trend toward superior progression-free survival time (PFS) in patients received CIK
      combined with chemotherapy compared with that in patients received chemotherapy alone. The
      investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) combined with
      CIK in the treatment of postoperative colorectal cancer patients. And to provide useful
      reference for the clinical application of CIK in colorectal cancer patients.
    

Intervention name(s): Cytokine-induced killer cells+ FOLFOX4; FOLFOX4
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Collected CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.; Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
Other intervention name(s): CIK + Oxaliplatin + leucovorin + 5-FU; Oxaliplatin + leucovorin + 5-FU
Intervention MeSH terms: Leucovorin; Oxaliplatin; Fluorouracil; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4]) combined with cytokine-induced killer cells (CIK) Group 2: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4])
Masking: None (Open Label)
Primary purpose: Treatment
Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan
Condition: Medical Abortion, Fetus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether an alternative method of follow-up after
      medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.
    

Detailed description: 
      Medical abortion using mifepristone and misoprostol is a highly effective procedure, but
      access to it may be impeded by the fact that not all women can afford or want to return for a
      follow-up visit. This often results in a high loss to follow-up rate. Additionally, with
      medical abortions of those women who do return for follow-up, higher costs are borne by both
      the woman and the healthcare system.

      This study compares two methods of follow-up after medical abortion: standard of care versus
      alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol
      administration. The latter consists of a low-sensitivity pregnancy test and a
      self-administered questionnaire. Based on the results of the test and questionnaire, women
      may be flagged as needing in-clinic follow-up or discharged from the study if their abortion
      is complete.
    

Intervention name(s): Alternative follow-up
Intervention type(s): Other
Intervention description(s): Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.
Other intervention name(s): semi-quantitative pregnancy test; self-administered questionnaire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: medical abortion; first trimester; follow-up; pregnancy test
Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This is an open-label cross over study looking to compare the length of infusion set wear
      between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.
    

Detailed description: 
      Currently infusion sets are approved for 2-3 days of wear. In this study subjects will wear
      each infusion set for up to 7 days or until the infusion set fails. Subjects will alternate
      between wearing the Quick-Set Teflon catheter and the Sure-T steel catheter each week. They
      will wear each infusion set twice.

      For the study, subjects will be provided with an investigational Medtronic Real-Time
      Continuous Glucose Monitor (CGM) Enlite Sensor/Serter to help identify, serious hyperglycemia
      or hypoglycemia during the study. This sensor is not yet FDA approved, but is similar to
      commercially available sensors. If the sensor detects a high or low glucose, subject must
      obtain a fingerstick glucose to confirm the result. In the study, all insulin dose and other
      treatment decisions will be made using glucose meter results, and will not be based on sensor
      results. Subjects will be instructed on how to identify infusion set failures.

      Infusion set failure are defined as: 1) Blood ketones greater than 0.6 mmol/L, 2) Evidence of
      infection at the infusion site (such as redness of more than 4 mm), or 3) Blood glucose that
      does not decrease by at least 50 mg/dL within 1 hour of a correction bolus to treat a blood
      glucose greater than 300 mg/dL.

      Subjects will follow-up weekly in one of our test centers for a total of five visits.

      At home subjects will be asked to keep a log recording measurements of redness and induration
      at the infusion site when it is changed prior to the study visit.
    

Intervention name(s): Sure-T Steel Infusion Set Catheter; Quick-Set Teflon Catheter
Intervention type(s): Device; Device
Intervention description(s): Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time; Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Topical Alprostadil for Female Sexual Arousal Disorder
Condition: Sexual Dysfunction, Physiological
MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria
      will be enrolled and randomized to receive either active drug or matching placebo. After a
      two-month, non-treatment period, patients will receive study drug for 6 months and will
      record information about sexual encounters in a daily diary. Study drug will be applied
      directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint
      of the study is based on the use of a standard measure of sexual function (FSEP).
    

Detailed description: 
      This is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study
      involving about 300 women who are 21-60 years of age inclusive, who have undergone a
      hysterectomy (with or without oophorectomy), and who have a primary diagnosis of FSAD. The
      diagnosis of FSAD will be made based on a medical and sexual history and confirmed using a
      structured interview by trained personnel. Study subjects will undergo a 2-month
      non-treatment run-in period followed by a 6-month period of blinded study therapy. Study drug
      is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity.
      Study subjects will complete several questionnaires at various times during the study and
      will complete a daily diary. The study endpoint is based on the FSEP and other standard
      questionnaires, as well as safety and tolerability of study drug.
    

Intervention name(s): Topical alprostadil (PGE-1)
Intervention type(s): Drug
Intervention MeSH terms: Alprostadil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Female sexual arousal disorder; Female sexual dysfunction
Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical
      trial in patients with hip osteoarthritis in order to:

        -  evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive
           decrease in joint space width observed in patients with hip osteoarthritis

        -  to investigate the potential structure-modifying effect of diacerein in patients with
           hip osteoarthritis

      This study compare also after ten years the percentage of patients in each treatment group
      who require a hip replacement surgery
    


Intervention name(s): diacerein
Intervention type(s): Drug
Intervention MeSH terms: Diacerein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diacerein; Hip osteoarthritis; Structure-modifying effect / Chondromodulating effect; Double blind study
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1
      (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from
      Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with
      chronic hepatitis B.
    

Detailed description: 
      A total of 116 HBeAg-positive patients were recruited from 12 hospitals in China, and
      randomized to two groups. The combination group (n= 57) received PEG-Tα1 (1.6 mg/ml, once a
      week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 24 weeks. The
      control group (n = 59) received placebo and adefovir. Both groups received adefovir
      continuously for additional 24 weeks. The primary endpoint was the loss of HBeAg at 48 weeks.
      The secondary endpoints included 1) loss of hepatitis B virus ( HBV) DNA, 2) HBeAg
      seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36
      and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.
    

Intervention name(s): PEG-Tα1; Placebo to match PEG-Tα1; Adefovir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.6 mg/ml, once a week, taken subcutaneously; 1ml, once a week, taken subcutaneously; 10 mg, once daily, taken orally for 48 weeks
Other intervention name(s): Polyethylene Glycol Thymosin alpha1
Intervention MeSH terms: Adefovir; Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polyethylene Glycol Thymosin alpha1; Adefovir; Hepatitis B e Antigens positive
A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      to evaluate the pharmacokinetics, and pharmacodynamics of a single dose of Tai Ai injection
      in healthy adult Chinese subjects
    


Intervention name(s): Tai Ai(RC18) 80mg; Tai Ai(RC18) 160mg; RC18 240mg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): The patient received one treatment of RC18 80mg in the test group; The patient received one treatment of RC18 160mg in the test group; The patient received one treatment of RC18 240mg in the test group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending
      dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male
      and female Japanese subjects
    


Intervention name(s): AZD9742; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV Formulation; IV Formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AZD9742; Japanese Healthy Volunteers; Phase I; Single and Multiple Ascending Dose