bioihbjkbjnl/mcl2 huggingface dataset:
A Safety, Efficacy and Biomarker Study of JNJ-42847922 in Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in
      participants with Major Depressive Disorder (MDD).
    

Detailed description: 
      This will be a multi-center (when more than one hospital works on a medical research study),
      randomized (study medication assigned to participants by chance), double-blind (neither the
      researchers nor the participants know what treatment the participant is receiving) and
      placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is
      compared in a clinical trial with a drug to test if the drug has a real effect) study. This
      study will consist of an eligibility screening examination (between 28 days and 1 day prior
      to the first dose administration), a parallel group treatment phase of 10 days or 4 weeks,
      and a follow-up period of 2 weeks including 2 follow-up visits. The duration of study will be
      12 months. Participants will be randomly assigned to receive either JNJ-42847922,
      Diphenhydramine or Placebo. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-42847922; Diphenhydramine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-428479, 20 milligram (mg) capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.; Diphenhydramine 25 mg capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.; Matching placebo (capsules containing neutral pellets), orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; JNJ-42847922; Diphenhydramine; Placebo
Endometrial Advancement After Rec or u-HCG Triggering
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate any potential advantages of replacing human
      chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for
      final oocyte maturation with regard to Ovarian hyperstimulation syndrome
      (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.
    

Detailed description: 
      Biopsies of endometrium were taken in different groups Pregnancy rates were compared among
      defferent groups
    

Intervention name(s): 10000 IU urinary HCG; 250 mcg recombinant HCG
Intervention type(s): Drug; Drug
Intervention description(s): bolus 10000 units for ovulation triggering; bolus 250 mcg for ovulation triggering in IVF patients
Other intervention name(s): Pregnyl; Ovitrelle
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: endometrium; histology; pregnancy
United States Pre-Market Tobacco Application Pharmacokinetics
Condition: Nicotine Dependence; Nicotine Dependence, Cigarettes; Tobacco Use; Tobacco Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures
      with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand
      Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers
    

Detailed description: 
      E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing
      vaporization rather than combustion, the generation and inhaltion of smoke and carbon
      monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid
      blends for use in e-cigarettes. This study will assess nicotine uptake during a 10-puff
      controlled and a 5-minute ad libitum use of four JUUL 5% electronic nicotine delivery systems
      (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette
      (e-cigarette), and nicotine gum.
    

Intervention name(s): Virginia Tobacco flavored JUUL 5% ENDS; Cool Mint flavored JUUL 5% ENDS; Mango flavored JUUL 5% ENDS; Creme Brulee flavored JUUL 5% ENDS; VUSE Solo e-cigarette; Nicorette White Ice Mint 4mg nicotine polacrilex gum; Usual Brand combustible cigarette
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).; Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).; Treatment with Mango flavored JUUL 5% ENDS (10 puffs).; Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).; Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).; Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method); Treatment with usual brand cigarette (10 puffs).
Other intervention name(s): JUUL; JUUL; JUUL; JUUL; VUSE; Nicotine Gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Open-Label, Cross-Over
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Combustible Cigarettes; Nicotine
The Effect of ESWT for Cubital Tunnel Syndrome
Condition: Cubital Tunnel Syndrome
MeSH terms: Cubital Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.
      The purpose of this study was to assess the effect of extracorporeal shock wave therapy on
      cubital tunnel syndrome.
    

Detailed description: 
      Investigators perform a prospective randomized, single-blinded study to investigate the
      effect of ESWT in patients with cubital tunnel syndrome.

      Patients were randomized into intervention and control group. Participants in intervention
      group received three-sessions of ESWT and single one session of ESWT was given in control
      group. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and
      24 week after the treatment.
    

Intervention name(s): extracorporeal shock wave therapy
Intervention type(s): Device
Intervention description(s): Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Drug-Drug Interaction Study: ASP2151 and Montelukast
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      CYP2C8 is involved in the metabolism of many drugs. So, it is important to assess in vivo the
      inhibitory effect of ASP2151 on that enzyme to determine any possible drug interactions. The
      aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2C8
      probe substrate montelukast.
    


Intervention name(s): Montelukast; ASP2151
Intervention type(s): Drug; Drug
Other intervention name(s): SINGULAIR
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HSV; Herpes; volunteers; drug-drug interaction
Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer
Condition: Rectal Tumors; Erectile Dysfunction
MeSH terms: Rectal Neoplasms; Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Although the high prevalence of erectile dysfunction (ED) was detected among male patients
      after the treatment for colorectal cancer, published reports depicting the erectile
      dysfunction experience of patients with colorectal cancer ot underpin service development are
      insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal cancer
      are not routinely offered information and treatment for erectile dysfunction.However,
      investigations on patients after surgery for prostate cancer could provide some potentially
      useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the
      return of erections after nerve-sparing radical prostatectomy has been established, which may
      benefit rectal cancer patients after surgery with ED.

      Laparoscopic surgery, although technically demanding and associated with a long learning
      curve, has the advantage of clear visualization for the smallest structures,including the
      autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate preservation
      of the pelvic autonomic nerves.

      This study aimed to identify whether early intervention is effective at reducing the rate of
      ED at 12 months.
    


Intervention name(s): vacuum erection device
Intervention type(s): Other
Intervention description(s): sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
Other intervention name(s): sildenafil
Intervention MeSH terms: Sildenafil Citrate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: erectile dysfunction; laparoscopic surgery; rectal cancer; sildenafil; vacuum erection device
Management of Skin Graft Donor Site Wound in Aged Patient
Condition: Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar Scale
Study type: Interventional

Summary: 
      The complication of donor site in skin grafting often acts as a causing factor for extended
      treatment period. The elderly individuals tend to be afflicted by impaired wound healing.
      Herein, the investigators presented the outcome of skin regrafting in the elderly patients.
    


Intervention name(s): skin graft; no skin graft
Intervention type(s): Procedure; Procedure
Intervention description(s): In the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing [Alleyvn, Smith, & Nephew] was placed on the regrafted skin for fixation; In the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing [Alleyvn, Smith, & Nephew] was placed on the regrafted skin for fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Abdominal Pain
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Syndrome; Abdominal Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times
      per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal nerves),
      and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation
      threshold for pain) in response to rectal balloon distension by barostat in patients with
      IBS.
    


Intervention name(s): Daikenchuto (TU-100); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.; Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rectal Compliance; Rectal Sensation; Rectal Tone
Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Open, prospective, randomized, single-centre study in patients with moderate to severe facial
      acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4
      inflammatory lesions, will be selected in acne-affected areas in the face. One area should be
      identified on each cheek and one area should be identified on the forehead. The minimum
      distance between the three areas should be at least 4 cm. For each patient the three areas
      will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl
      alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before
      application of the Visonac cream. One of the areas cleaned with saline wipe will also be
      occluded with a transparent dressing (Tegaderm) during the incubation time. In vivo
      fluorescence spectroscopy will be performed in the three areas before cream application, and
      at 1h, 1.5h, 2h, 2.5h and 3 h after cream application. After the last fluorescence
      spectroscopy reading, the cream should be wiped off and the patient should protect the three
      areas from sunlight, prolonged, or intense light for 2 days.

      The study was extended with additionally 8 patients to explore the photoactive porphyrin
      levels over a 24 hour period:

      The patients will clean their face with Cetaphil Gentle Skin Cleanser before cream
      application. For each patient the three areas will be randomized to Visonac 80mg left on the
      skin for 24 hours and Visonac (MAL8%) to be wiped of after 1 hour.

      In vivo fluorescence spectroscopy will be performed at all three areas before cream
      application, and at 2h, 3 h, 4h, 5h, 8h, 10h, 11h, 12h, 13h, 15 and 24h after cream
      application. The exact time points may be adjusted based on the result from the previously
      included patients. All patients will be instructed to protect the three areas from sunlight,
      prolonged, or intense light for 2 days.
    


Intervention name(s): Area cleaned with saline water and occluded with Tegaderm; Area cleaned with saline water; Area cleaned with Ethyl alcohol solution; Visonac left on the skin for 24 hours in facial area one; Visonac wiped off after one hour; Visonac left on the skin 24 hours in facial area two
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Moderate to severe Acne Vulgaris
Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD; Inspiratory Muscle Weakness
MeSH terms: Muscle Weakness; Respiratory Aspiration
Study type: Interventional

Summary: 
      The additional effect of inspiratory muscle training as an adjunct to a general exercise
      training program in patients with COPD with inspiratory muscle weakness will be studied. The
      main hypothesis is that inspiratory muscle training combined with an exercise training
      program improves functional exercise capacity more than an exercise training program without
      the addition of an inspiratory muscle training program.
    


Intervention name(s): Inspiratory Muscle Training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test the effect of mothers' application of yogurt
      probiotic bacteria on relieving their young children's acute gastroenteritis in children had
      two to five years old. The main hypothesis is children with acute gastroenteritis who receive
      yogurt probiotic bacteria exhibit less diarrhea, vomiting and dehydration than those who
      don't.The study subjects were divided into two equal groups (probiotic study group and
      control group).
    


Intervention name(s): yogurt with probiotic bacteria
Intervention type(s): Dietary Supplement
Intervention description(s): Children in probiotic study group were received 15 mg/kg of market available fresh probiotic yogurt after stopping vomiting every four to six hours for three consecutive days beside to the standard hospital care and the prescribed medication for acute gastroenteritis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Yogurt Probiotic Bacteria; young Children; Gastroenteritis
Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color
Condition: Tooth Discoloration
MeSH terms: Tooth Discoloration
Study type: Interventional
Phase: Phase 4

Summary: 
      This parallel, randomized, and controlled clinical trial will assess the effect of a single
      prior session of in-office dental bleaching on time required to achieve satisfactory tooth
      color with at-home bleaching. Participants enrolled will randomly allocated to receive or not
      a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min.
      Following, all participants will use customized trays filled with 10% carbamide peroxide for
      1h per day until obtain satisfactory results. The primary outcome will be the number of days
      necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color
      changes measured with spectrophotometer will be assessed.
    


Intervention name(s): Bleaching Agents; Bleaching Agents
Intervention type(s): Drug; Drug
Intervention description(s): In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.; At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tooth bleaching; Hydrogen peroxide; Carbamide peroxide; Tooth Bleaching Agents
Autoimmunity in the Pathogenesis of AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This research study is being done to find out whether autoimmune mechanisms are associated
      with the development of atrial fibrillation.
    

Detailed description: 
      The study sets out to identify an explanation for the pathogenesis of AF, potentially forming
      the basis for designing novel targeted therapies to prevent or reverse this prevalent human
      disease. The overall objectives are to determine whether autoimmune diseases are associated
      with AF development and to identify specific diagnostic and prognostic biomarkers that will
      improve the ability to accurately predict risk of AF development. The study will
      prospectively enroll patients with and without AF and determine their serum cytokine levels
      and assess the functional responses of T cells on the basis of cytokine production after in
      vitro T-cell specific stimulation, using Luminex bead-based multiplex technology.
    

Intervention name(s): Peripheral Blood Sample
Intervention type(s): Other
Intervention description(s): 30mL peripheral whole blood sample
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients 18 years and older.
      
Keywords: Autoimmune Diseases
Time-to-Detection in Culture of Mycobacterium Tuberculosis
Condition: Pulmonary Tuberculoses
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Observational

Summary: 
      determination if time-to-detection in cultures of M. tuberculosis samples is more
      discriminating than acid-fast staining in transmission
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        all cases of pulmonary tuberculosis who had a sample analysed by the laboratory of
        bacteriology of Nice University Hospital, and that was positive in culture before treatment
        and of which contact cases were explored by the CLAT
Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects
Condition: Disorders of Sphingolipid Metabolism; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        -  To determine the excretion balance and systemic exposure of radioactivity after oral
           administration of [14C]-venglustat.

        -  To determine the pharmacokinetics (PK) of venglustat and its contribution to the overall
           exposure of radioactivity.

        -  To determine the metabolic pathways, metabolite profile, chemical structures and main
           excretion route of the main venglustat metabolites and the metabolite contribution to
           the overall exposure of radioactivity.

      Secondary Objective:

      To assess the clinical and biological tolerability of oral solution of venglustat
    

Detailed description: 
      43 days
    

Intervention name(s): venglustat
Intervention type(s): Drug
Intervention description(s): Powder for Oral solution
Intervention MeSH terms: Venglustat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening