bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Condition: Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Renal Insufficiency, Chronic; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether tolvaptan is effective and safe for the
      treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney
      disease (ADPKD)
    

Detailed description: 
      The protocol will extend the understanding of the efficacy and safety of tolvaptan treatment
      in ADPKD patients with late stage 2 to early stage 4 CKD (chronic kidney disease).

      This trial will compare the efficacy of tolvaptan treatment in reducing the annualized change
      in estimated glomerular filtration rate (eGFR) from pre-treatment baseline to post-treatment
      follow-up, as compared with placebo, in subjects who tolerate tolvaptan during an initial
      run-in period. The change in eGFR, calculated by the Chronic Kidney Disease-Epidemiology
      (CKD-EPI) formula, will provide kidney function data that are complementary to the data
      demonstrating the benefits previously observed primarily in ADPKD subjects with earlier
      stages of disease.

      Also, it will compare the efficacy of tolvaptan treatment in reducing the decline of
      annualized eGFR slope, as compared with placebo, in this type of subjects. Finally, it will
      compare the overall and hepatic safety profile of tolvaptan with placebo and to compare
      incidence of ADPKD complications (outcomes) during the trial
    

Intervention name(s): Tolvaptan (OPC-41061); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.; Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease
Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study was to assess the efficacy and safety of GP MDI relative
      to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4
      separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment
      duration of 28 days.
    

Detailed description: 
      This was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment,
      placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3
      doses of GP MDI (28.8, 14.4, and 7.2 μg ex-actuator, BID) in Japanese subjects with moderate
      to severe COPD.

      Subjects who met the entry criteria had their maintenance therapy for COPD adjusted, as
      specified in the protocol. To allow for an adequate washout of previous maintenance
      medications, subjects underwent a washout period of at least 7 days, but not greater than 28
      days duration prior to returning to the clinic for Visit 2 (Randomization Visit; Day 1 of
      Treatment Period 1).

      The 4 study treatments were GP MDI 28.8, 14.4, and 7.2 μg ex-actuator, and Placebo MDI BID.
      Subjects were randomly assigned to 1 of the following 4 treatment sequences (ABCD, BDAC,
      CADB, DCBA) in a 1:1:1:1 ratio using an Interactive Web Response System where each letter
      represented 1 of the 4 treatments included in the study by random assignment.

      Subjects were to complete 7 days of dosing in each of the 4 Treatment Periods, with each
      Treatment Period separated by a washout period of 5 to 21 days.
    

Intervention name(s): Glycopyrronium MDI 28.8 micrograms; Glycopyrronium MDI 14.4 micrograms; Glycopyrronium MDI 7.2 micrograms; Placebo MDI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Glycopyrronium MDI 28.8 micrograms; Glycopyrronium MDI 14.4 micrograms; Glycopyrronium MDI 7.2 micrograms; Placebo Inhalation Aerosol
Intervention MeSH terms: Glycopyrrolate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the non-inferiority clinical efficacy of two
      different drugs in the treatment of patients diagnosed with moderate to severe back pain
      treatment.
    

Detailed description: 
      -  double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to
           treat trial.

        -  Experiment duration: 04 days.

        -  03 visits (days 0, 2 and 4).

        -  Efficacy will be evaluated for back pain relief based on visual analogic scale.

        -  Adverse events evaluation.
    

Intervention name(s): Ketorolac Tromethamine; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): 10 drops each 8 hours for 4 days.; 2 tablets every 8 hours for 4 days
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn
Condition: Persistent Pulmonary Hypertension of the Newborn
MeSH terms: Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Hypertension
Study type: Interventional

Summary: 
      Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of
      adaptation to extra-uterine life in some newborns. In the short term, the risk of death
      requires rapid and appropriate management of this transient pathology.

      In the long term, these newborns present a greater brain vulnerability, a consequence of the
      pathology itself with cerebral hypoxia but also invasive and aggressive therapies. Although
      current scientific evidence indicates a correlation with the existence of neurological
      developmental disorders, the understanding of the long-term neurological outcome of these
      babies remains poorly documented. Better knowledge of remote neuro-psychomotor development of
      the critical period
    


Intervention name(s): Ages & Stages Questionnaires®, Third Edition (ASQ3)
Intervention type(s): Other
Intervention description(s): Investigators will propose to parents of children hospitalized for the treatment of persistent pulmonary hypertension of the newborn a hetero-evaluation via the validated ASQ questionnaire to analyze neuro-psychomotor development.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effectiveness of treatment with vortioxetine on
      participant goal achievement after a change in antidepressant medication for the treatment of
      major depressive disorder (MDD).
    

Detailed description: 
      The drug being tested in this study is called Vortioxetine. Vortioxetine is being tested to
      treat depression in people who have major depressive disorder. This study will look at
      effectiveness of treatment with vortioxetine in participant's goal achievement for the
      treatment of major depressive disorder.

      The study enrolled 123 patients. Participants will receive:

      • Vortioxetine 10 to 20 mg

      All participants will be asked to take one tablet at the same time each day throughout the
      study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to
      20 mg. The dose may then be decreased by 5 mg based on participant's response and
      tolerability to higher dose as judged by the Investigator.

      This multi-center trial will be conducted in Unites States. The overall time to participate
      in this study is 19 weeks. Participants will make multiple visits to the clinic and will be
      contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Vortioxetine tablet
Other intervention name(s): LuAA21004
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
Effects of Kinesio Taping on Performance
Condition: Obesity
Study type: Interventional

Summary: 
      This study investigated the immediate effects of Kinesio taping on muscular power, strength,
      endurance, and lower limb fatigue when taping is applied to rectus femoris and around the
      patella of obese adults based on Kinesio taping techniques.
    

Detailed description: 
      This is a randomized, double-blind, crossover, and clinical trial. Ethical approval was
      obtained from the University's Institutional Review Board (#2015-51). Participants were
      recruited by flyers posted on the University campus. Informed consent was completed by all
      participants prior to the study procedures. The subjects were obese college students. A total
      of 13 subjects, four males and nine females (mean age of 24.38 ± 3.01 years, mean percent
      body fat of 39.10 ± 6.91 % [male: 41.93 ± 7.47 %, female: 38.16 ± 6.91 %]), were enrolled
      this study. All subjects underwent three different trials which include no taping (NT),
      placebo taping (PT), and Kinesio taping (KT). All individuals were assessed for peak and mean
      power, muscular strength, endurance, and muscle fatigue after each condition.
    

Intervention name(s): Kinesio taping
Intervention type(s): Other
Intervention description(s): This study was conducted in a randomized crossover double-blind design. Each subject was tested for muscular power, strength, endurance, and fatigue of the lower extremities under three conditions: 1) NT (no taping), 2) PT (placebo taping, 3M tape) and 3) KT (Kinesio taping). For allocation of treatment sequence, the participants drew straws for which treatment first (each treatment indicated different numbers).
Other intervention name(s): Placebo taping
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Kinesio taping; Obese adults; Muscular function; Fatigue
Clinical Analysis of Suction Drainage in Cementless Hip Replacement
Condition: Arthropathy of Hip
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Randomized prospective study assessing suction drainage in total hip arthroplasty. Group
      without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups
      will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually
      literature there are no benefits using closed suction drainage after primary total hip
      arthroplasty.
    


Intervention name(s): suction drainage; no suction drainage
Intervention type(s): Procedure; Procedure
Intervention description(s): After primary total hip arthroplasty closed suction drainage will be used.; After primary total hip arthroplasty closed suction drainage won't be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of patients with or without closed suction drainage after primary total hip arthroplasty.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hip; arthroplasty; suction; drainage
Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      The purpose of this single site clinical study is to evaluate the safety and effectiveness of
      the Soliton Rapid Acoustic Pulse (RAP) device for the improvement of cellulite comparing two
      different RAP treatment doses.
    

Detailed description: 
      This is a non-significant risk, single-center, prospective trial for safety, and efficacy
      using Soliton's RAP device for the improvement in the appearance of cellulite performed at 1
      (one) clinical research site in the United States.

      Approximately 15 healthy female participants between the age of 18-55 inclusive will be
      enrolled in this study.

      Participants who sign the informed consent form and meet all the eligible criteria will be
      enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on
      each of the participants buttocks and legs. The participant's right buttock and leg will
      receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.

      Total study duration is anticipated to be at or less than 55 weeks from the first participant
      visit to the last participant observation visit. A total of 3 visits, plus two optional
      visits are planned for this study as listed below:

        -  Visit 1: Baseline/Screening (-30 Days to Day 0)

        -  Visit 2: Treatment (Day 0)

        -  Visit 3: 12-week Follow-Up Visit (+/- 14 Days)

        -  Visit 4: 26-week Follow-Up Visit (+/- 14 Days) (Optional)

        -  Visit 5: 52 Week Follow-Up Visit (+/- 14 Days) (Optional)
    

Intervention name(s): RAP
Intervention type(s): Device
Intervention description(s): Treatment of cellulite with RAP device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intestinal Glucagon-like Peptide-1 (GLP-1) and the Physiological Role in Eating in Humans
Condition: Appetite and General Nutritional Disorders
MeSH terms: Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim is to further establish a physiological role for GLP-1 as an endogenous satiety
      signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on
      appetite and food intake in healthy male subjects.
    

Detailed description: 
      Understanding the exact mechanisms by which GLP-1 inhibits eating can be crucial in order to
      convert its anorectic action into useful, safe and effective drugs. So far, it is however not
      clear to what extent GLP-1 is a hormonal regulator of eating or whether the observed effects
      are rather a pharmacological phenomenon. By applying classical algorithms from endocrinology
      several criteria must be fulfilled before a hormone can be considered an endogenous
      physiological satiety signal. One is that exogenous administration of a selective antagonist
      should prevent the eating-inhibitory effect of GLP-1. At present, cholecystokinin (CCK) is
      the only peptide in humans identified to fit these criteria. For intestinal GLP-1, it has not
      been investigated whether a specific GLP-1 receptor antagonist can block the
      eating-inhibitory effect in humans. The availability of a specific GLP-1 receptor antagonist,
      exendin (9-39), now makes it possible to further investigate this pathway. Exendin (9-39), is
      a powerful tool available for human use to characterize of endogenous GLP-1 as a
      physiological regulator of different biological functions. The molecule has been used to
      document that endogenous GLP-1 is an important incretin hormone and a regulator of
      antro-pyloro-duodenal motility. The role of endogenous GLP-1 in regulating food intake and
      appetite has, however, not been investigated before.
    

Intervention name(s): Saline; Exendin 9-39; Saline; Exendin(9-39) plus ID nutrient
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement; Drug
Intervention description(s): Intravenous saline infusion and intraduodenal administration of saline via feeding tube; IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube; IV saline infusion and intraduodenal administration of nutrients; Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GLP-1; satiation peptides; food intake
Does Maternal Instruction Prevent Kernicterus in Nigeria?
Condition: Kernicterus
MeSH terms: Kernicterus
Study type: Interventional

Summary: 
      This study examines (a) whether introduction of public, health provider, and maternal
      education about risks of jaundice will decrease the occurrence of ABE compared with baseline
      prevalence (before-after design) or (b) whether antenatal or postpartum instruction to
      mothers will decrease the incidence of ABE compared with those who did not received
      instruction (concurrent opportunistic controls in phase 2).
    

Detailed description: 
      This 2 phase study first determines the prevalence of acute bilirubin encephalopathy (ABE)
      among newborns admitted for treatment of jaundice at 5 regional centers in Nigeria and
      identifies social/behavioral/medical factors associated with ABE. Information gained in phase
      1 identified high risk sub-populations and guided selection of instructional materials for
      phase 2. Core data sheets submitted monthly by participating centers included clinical data,
      demographic information, number of antenatal clinic visits, birth place (hospital, clinic,
      home) and attendant, distance from care centers and reasons for delay, if any, in seeking
      care. Receipt of jaundice instruction by mothers is self-reported. Statistical analysis
      includes Chi square and logistic regression analysis of risk factors. Sample size: 1,000
      subjects in each phase are required to demonstrate a 20% decrease in disease prevalence
      (baseline ABE incidence anticipated to be 15% of jaundiced babies) at 95% confidence level.
    

Intervention name(s): maternal education
Intervention type(s): Behavioral
Intervention description(s): Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation
Condition: Breast Augmentation; Inhalation Anesthesia; Total Intravenous Anesthesia; Quality of Recovery
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed
      and the endoscopic transaxillary approach has become the preferred incision for Asian women.
      As breast augmentation must be performed under general anesthesia accompanied by its effects
      and potential complications, types of general anesthesia may affect the quality of recovery.
      Currently, the two most common techniques of general anesthesia are inhalation anesthesia
      (IH) and total intravenous anesthesia (TIVA). The effects of these types of general
      anesthesia on the quality of recovery have been investigated for numerous surgical
      procedures. However, no prior studies have analyzed different types of anesthesia used for
      performing transaxillary endoscopic breast augmentation. This prospective, parallel,
      randomized controlled study will evaluate the effects of inhalation anesthesia vs. total
      intravenous anesthesia on the quality of recovery in patients undergoing transaxillary
      endoscopic breast augmentation.
    


Intervention name(s): Desflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia is maintained by desflurane in an oxygen air mixture of 60/40%. If inadequate depth of anesthesia is observed, the end-expiratory concentration of desflurane would be increased.; Anesthesia is maintained by propofol 100-200 μg/kg/min. If inadequate depth of anesthesia is observed, the rate of propofol infusion would be increased.
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of single doses of midazolam on the
      plasma concentration of a single dose of moxidectin in healthy young adult subjects, and to
      assess the safety of co-administration of moxidectin and midazolam.
    


Intervention name(s): Moxidectin; Midazolam
Intervention type(s): Drug; Drug
Intervention MeSH terms: Moxidectin; Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects
Efficacy and Safety of a Fish Oil Containing Lipid Emulsion
Condition: Parenteral Nutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare a fish oil containing lipid emulsion against a
      medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and
      safety during postoperative parenteral nutrition.
    


Intervention name(s): fish oil containing lipid emulsion; MCT/LCT containing lipid emulsion
Intervention type(s): Drug; Drug
Intervention description(s): medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides; medium chain triglycerides, long chain triglycerides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment