bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to compare azathioprine versus mesalazine tablets for the prevention of
      clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe
      endoscopic recurrence.
    


Intervention name(s): Azathioprine; Mesalazine; Azathioprine placebo; Mesalazine placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets; 4g Mesalazine tablets/day AND azathioprine placebo tablets; 4g Mesalazine tablets/day AND azathioprine placebo tablets; 2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets
Other intervention name(s): Azafalk 50mg tablets; Salofalk 500mg tablets
Intervention MeSH terms: Mesalamine; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Randomized; Crohn's Disease; Prevention; Azathioprine; mesalazine; mesalamine; TPMT
Study Evaluating IMA-638 in Healthy Japanese
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and drug levels for single, ascending
      doses of IMA-638 in healthy Japanese subjects.
    


Intervention name(s): IMA-638
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: healthy subjects
Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the effect of acetazolamide as a treatment for
      sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome
      living at low altitude during a sojourn at moderate altitude
    


Intervention name(s): acetazolamide
Intervention type(s): Drug
Intervention description(s): acetazolamide 2 times 250mg per day
Other intervention name(s): Diamox
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apnea, sleep, altitude, hypoxia
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100
      mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B
      status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg
      active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in
      order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day
      0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study
      which continued for 48 weeks. Participants were evaluated for sustained virologic response
      (SVR) for an additional 24 weeks following completion of study treatment.
    


Intervention name(s): Sofosbuvir; Placebo; PEG; RBV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sofosbuvir tablet(s) administered orally once daily; Placebo to match sofosbuvir administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.; Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other intervention name(s): Sovaldi®; GS-7977; PSI-7977; Pegasys®; Copegus®
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C infection Genotype 1; HCV; GT1; GT 1
Lifestyle Modification Program for Patients With Chronic Pain Conditions
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      In this observational study the effects of a Lifestyle Modification Program - offered as a
      semi-residential day care clinic - on pain, disability, quality of life and satisfaction with
      life will be investigated. Furthermore the influence of mindfulness, acceptance and coping,
      and acquired changes in lifestyle behaviors on the outcome after the program will be
      evaluated.

      Effects will be measured after completion of the program (3 months), and at 6 and 12 months
      follow up after start of the program, i.e. each outcome measure will be taken 4 times within
      12 months.
    

Detailed description: 
      see above
    

Intervention name(s): Lifestyle Modification
Intervention type(s): Behavioral
Intervention description(s): Lifestyle Modification
Other intervention name(s): see Paul, A. et al.,Eur J Integr Med 2012, 4(4):e455-e459.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 patients with pain condition admitted to the lifestyle modification program
Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The efficacy of intranasal kinetic oscillation stimulation using the Chordate System S211 as
      a preventative treatment will be examined in patients diagnosed with chronic migraine. The
      medical device system will be applied in 6 treatments at weekly intervals. The study will
      examine the effects on monthly headache days with moderate to severe intensity.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, multicenter clinical investigation of
      a medical device. The study consists of a 4-week screening period, a 6-week treatment period
      (2 weeks run-in and a 4-week observation window to assess the treatment effect), and a 4-week
      follow-up period.

      The study primarily aims at evaluating the effect of intranasal kinetic oscillation
      stimulation using the Chordate System S211 as a preventative treatment on monthly headache
      days with moderate to severe intensity.
    

Intervention name(s): Chordate System S211 in treatment mode; Chordate System S211 in placebo mode
Intervention type(s): Device; Device
Intervention description(s): Chordate System S211 in treatment mode; Chordate System S211 in placebo mode
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prophylaxis, Headache, Preventative Treatment
Oral Candida in Infants and Dietary Type
Condition: Oral Candida; Breastfeeding; Bottle Feeding
MeSH terms: Candidiasis, Oral
Study type: Observational

Summary: 
      This is an observational, non-randomised trial to evaluate the effect of dietary type on
      infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45
      breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular
      pediatric appointment. Infants with unremarkable health histories, normal weight, free of
      sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also healthy
      and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of
      antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and
      mammary candidiasis in mothers were exclusion criteria.
    

Detailed description: 
      After filling in a questionnaire about infants dietary intake, age and sex and their mothers
      education level and health condition, a pre-moistened sterile cotton swab was taken from
      dorsal surface of tongue and mid-plate. The swabs were cultured in agar plate containing
      sabourauds dextrose agar medium with chloramphenicol, and kept in 37 C for 48 hours. The
      number of candida colonies was counted and germ tube test performed to separate candida
      albicans from other types. The data was collected and analyzed by SPSS software and
      chi-square, logistic regression and mann-whitney test. Study hypothesis: feeding by mothers
      milk reduces oral candida colonization.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle
        feeding infants) who attended to Yazd nikoopur clinic for regular pediatric appointment.
      
Biospecimen description: 
      infants with unremarkable health histories, normal weight, free of sign or symptom of oral
      candidiasis or other mucosal disease.their mothers were also healthy and without sign or
      symptom of vagina or mammary candidiasis.
A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind,
      placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and
      tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be
      randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort,
      six subjects will receive the single subcutaneous E6011 administration and two subjects will
      receive the single subcutaneous placebo administration.
    

Detailed description: 
      This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up
      Period. Screening assessments will be performed within 28 to 2 days before starting the study
      treatment, and Observation Period assessments will be performed on a day before starting the
      study treatment to confirm the eligibility of study subjects. The eligible subjects will be
      randomized into either E6011 arm or placebo arm using the drug allocation list prepared by
      the random code statistician. Each subjects dosing interval will be at least a 30-minutes.
    

Intervention name(s): E6011; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg); Subcutaneous administration of placebo
Intervention MeSH terms: Quetmolimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Volunteers; Japanese; Males
Intravitreal Conbercept After Vitrectomy
Condition: Early Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the
      management of early-stage proliferative diabetic retinopathy (PDR).

      Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from
      PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual
      outcomes of surgery for early-stage PDR.
    

Detailed description: 
      The drug conbercept (an anti-vascular endothelial growth factors) was recently made available
      for management of early prolific diabetic retinopathy, but its safety and efficacy still
      require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal
      conbercept after vitrectomy for the management of early proliferative diabetic
      retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment
      group and control after they provided informed consent. The treatment group received
      intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group
      did not.

      At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA),
      intraocular pressure and central retinal thickness will be measured and fundoscopy be
      performed.

      The patients are going to be followed up for at least 6 months via BCVA measurement,
      fundoscopy, OCT, physical examinations and postoperative complications
    

Intervention name(s): Conbercept
Intervention type(s): Drug
Intervention description(s): Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Sleep Extension for Metabolic Health
Condition: Short Sleep
Study type: Interventional

Summary: 
      The study aims to examine the effects of a sleep extension intervention on the metabolic and
      cardio-vascular profile of obese people who present traditional diabetes risk factors, and
      who are habitually sleep deprived. Participants randomized to the intervention arm will
      complete a 6-week sleep extension intervention, whilst the control group will maintain their
      habitual sleep schedule. It is hypothesized that the sleep extension intervention will
      significantly increase total sleep time, and will be accompanied by significant
      metabolic-related changes.
    

Detailed description: 
      Recent epidemiological (survey) research, conducted in both in healthy populations and among
      those with existing chronic disease, shows that insufficient sleep can significantly
      contribute to ill health (including diabetes, heart disease and obesity). These findings have
      also been accompanied by credible explanatory mechanisms emphasising the role of sleep in
      regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a
      largely unexplored pathway for improving individual health, and reducing an existing risk of
      diabetes. If successful, increased sleep duration and quality could be adopted as an
      achievable public health intervention.

      The study aims to recruit a total of 20 men, overweight, presenting traditional risks of
      developing diabetes, who are habitually short sleepers. Participants are then randomized,
      stratified by weight status, to a sleep extension group, or a control sleep monitoring group.
      Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure,
      and a mixed-meal tolerance test; after the 6-week intervention, the same measures are
      repeated.
    

Intervention name(s): Sleep extension
Intervention type(s): Behavioral
Intervention description(s): The sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: short sleep; insufficient sleep; sleep extension; diabetes risk
A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects
Condition: Atopic Dermatitis (AD)
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to investigate the safety and tolerability of KBL697 in healthy
      volunteers. KBL697 has been developed as a potential new treatment for atopic dermatitis
      (AD).
    

Detailed description: 
      This is a randomized double-blind, placebo-controlled, single centre Phase I study.

      Thirty-six (36) subjects are planned to be randomised at

      1 site across the 2 parts of the study as follows:

        -  Part A (Single Ascending Dose (SAD) in healthy subjects)

        -  Part B (Multiple Ascending Doses (MAD) in healthy subjects)
    

Intervention name(s): KBL697; KBL697; KBL697; KBL697
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Part A: 1 day 460mg/day of KBL697 or placebo
Route of Administration: Oral; Part A: 1 day 4,600mg/day of KBL697
Route of Administration: Oral; Part B: 14 days
Cohort MAD1:
460mg/day of KBL697
Route of Administration: Oral; Part B: 14 days
Cohort MAD2:
4,600mg/day of KBL697
Route of Administration: Oral
Other intervention name(s): Placebo; Placebo; Placebo; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this work is to undertake a range of vision-related measures with soft toric
      contact lenses soft spherical contact lenses and spectacle lens correction across a range of
      levels of astigmatism.
    

Detailed description: 
      This will be a randomised, crossover, partially subject-masked (for contact lenses only),
      non-dispensing study, controlled by cross-comparison.
    

Intervention name(s): Soft Toric Custom Made Contact lens; Soft Spherical Contact Lenses; Spectacle Correction
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.; Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.; Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20
      to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly
      assigned into two equal groups; control group; the coronally advanced flap with the
      subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap
      with amnion chorion allograft membrane (CAF+AC).
    

Detailed description: 
      The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion
      chorion membrane or CAF with subepithelial connective tissue graft using a simple
      randomization procedure with a 1:1 allocation ratio. A computer generated randomization list
      was drawn up by a faculty member who was not involved in the recruitment. Allocation
      concealment was achieved by sealed coded opaque envelopes that contained the treatment to be
      performed to the enrolled subjects based on the randomized numbers. Consequently, patients
      were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed
      envelope containing treatment assignment was opened at time of the surgery and the number was
      picked by another person other than the operator.
    

Intervention name(s): amnion chorion allograft membrane; coronally advanced flap with the subepithelial connective tissue graft
Intervention type(s): Biological; Procedure
Intervention description(s): Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.; coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate
Other intervention name(s): BioXclude™,Snoasis Medical products, USA.; autogenous connective tissue graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Observational

Summary: 
      This study evaluates the different response of Ursodeoxycholic Acid in primary biliary
      cholangitis only and primary biliary cholangitis with high immune globulin G or
      aminotransferase at West China Hospital from 2008-2017.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All patients diagnosed with primary biliary cholangitis and treated with Ursodeoxycholic
        Acid at West China Hospital by review of medical records.
      
Keywords: Ursodeoxycholic Acid; Response