bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-man study of a novel investigational botanical drug complex, PUR 0110
      rectal enema, that has been shown to have potent anti-inflammatory, antioxidant and
      immunomodulatory effects following in vitro and in vivo pharmacology studies, to assess the
      safety and tolerability of sequential single-ascending doses in normal healthy volunteers and
      to determine the maximum tolerated dose (MTD). As a tertiary objective, the study will also
      investigate the presence of specific pharmacokinetic markers following the administration of
      single-dose PUR 0110 at each dose level.

      The study is designed as a single-center, randomized, double-blind, parallel-group,
      sequential single-ascending dose, placebo-controlled safety, tolerability and pharmacokinetic
      study of PUR 0110 rectal enema in 24 normal healthy male volunteers. Eligible subjects will
      be randomly assigned to 4 Cohorts of 6 subjects each to receive active drug (PUR 0110 Enema)
      or placebo enema as follows: 187.5 mg/60 g - Cohort 1, 375 mg/60 g - Cohort 2, 750 mg/60 g -
      Cohort 3 or 1500 mg/60 g - Cohort 4. Within each Cohort, subjects will be randomized in a 2:1
      ratio to receive either active treatment (PUR 0110 enema; n = 4) or placebo enema (n = 2).
      Each subject will receive only 1 dose of assigned study medication and dosing of subjects
      within each cohort will also be by sequential inclusion.
    

Detailed description: 
      Flexible sigmoidoscopy will be performed during the Screening Period within 72 to 48 hours
      pre-dose and within 9 +/- 1 hours post-dosing to visually examine the colonic mucosa for any
      signs of local toxicity and grade it as normal/abnormal; and 3 pinch biopsies will be
      obtained at each endoscopy at about the same level in the colon (<50 cm from the anal verge)
      for histology. At the baseline flexible sigmoidoscopy, subjects must have normal colonic and
      rectal mucosa (i.e., no bleeding, inflammation, edema, ulceration or other abnormal finding)
      to be included in the study.
    

Intervention name(s): PUR 0110 Rectal Enema or Placebo Enema; PUR 0110 Rectal Enema or Placebo Enema; PUR 0110 Rectal Enema or Placebo Enema; PUR 0110 Rectal Enema or Placebo Enema
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 187.5 mg/60 g; 375 mg/60 g; 750 mg/60 g; 1500 mg/60 g
Other intervention name(s): PUR 0110 Enema; PUR 0110; PUR 0110 Enema; PUR 0110; PUR 0110 Enema; PUR 0110; PUR 0110 Enema; PUR 0110
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PurGenesis Technologies Inc.; PUR 0110 rectal enema; Ulcerative colitis; Distal; Normal healthy volunteers
Laparoscopic Lens Defogging Using Anti-fog Solution, waRm Saline, and Chlorhexidine Solution
Condition: Gynecologic Disease
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      The aim of this study is to compare three popular methods of minimizing or reducing
      laparoscopic lens fogging (LLF) by heating lens using warm saline, applying anti-fog agent to
      lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.
    

Detailed description: 
      The physiology behind laparoscopic lens fogging (LLF) is well understood based on meticulous
      experiments outlining the role of temperature and humidity. Despite many efforts, including
      uses of warm saline, various anti-fog agents, chlorhexidine, betadine, and rubbing the lens
      on serosal surfaces, to reduce LLF, there remains no consensus as to which method is superior
      to prevent LLF. Furthermore, most previous studies were experimental trials conducted in a
      simulation model or a non-human in vivo model or an expert's commentary based on their
      clinical experiences , and there was no randomized controlled trial focusing LLF in human
      model. Therefore, this randomized trial aimed to compare three popular methods of minimizing
      or reducing LLF by heating lens using warm saline, applying anti-fog agent to lens, and
      rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.
    

Intervention name(s): Warm saline; anti-fog agent; chlorhexidine
Intervention type(s): Device; Device; Device
Intervention description(s): In subjects allocated to the warm saline group, a thermos flask, which was filled with heated sterile water, was used. A 1000 ml bottle of sterile water was heated to 60 ˚C in a stove for an hour at minimum. Just before introducing into the abdominal cavity, the laparoscope was placed into the thermos flask for 30 seconds at minimum . After each incidence of laparoscopic lens fogging (LLF), the scope was briefly inserted into the thermos flask about 10 seconds, and was then wrapped gauze around the lens before abdominal reinsertion.; In the anti-fog agent group, Ultra-Stop TM (Sigmaphrarm, Vienna, Austria), which is a commercial anti-fogging solution containing alcohol, surfactant, and water for medical optical devices, was used. Wiping the lens with gauze soaked in Ultra-Stop TM and allowing the surfactant to act for 5 seconds, the laparoscope was introduced into the abdominal cavity. After each laparoscopic lens fogging (LLF), the scope was removed from the abdomen and cleaned using the same corresponding method.; In the chlorhexidine group, the lens was wiped with gauze soaked in 4% chlorhexidine detergent solution (Firson, Cheonan, Korea) for 5 seconds before introducing into the abdominal cavity, and chlorhexidine was reapplied on the lens at the occurrence of laparoscopic lens fogging (LLF).
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Zinc Absorption From Zinc Citrate, Zinc Gluconate and Zinc Oxide
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this trial is to evaluate zinc citrate, a zinc compound with promising sensory
      properties and a high zinc content, as an alternative zinc compound to be used for
      supplementation or food fortification. The bioavailability of zinc citrate given as a
      supplement to young Swiss adults will be assessed and compared to the bioavailability of the
      commonly used zinc compounds zinc gluconate and zinc oxide.
    


Intervention name(s): zinc citrate; Zinc Gluconate; Zinc oxide
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10 mg of zinc as either zinc citrate; 10 mg of zinc as either zinc gluconate; 10 mg of zinc as either zinc oxide
Intervention MeSH terms: Zinc; Zinc Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for
      lamellar resection (ReLEx smile) in the reduction of myopia.
    

Detailed description: 
      Quality control study of patients treated with ReLEx smile for myopia at the Department of
      Ophthalmology, Aarhus University Hospital.

      The patients will be followed with standard clinical techniques (slit-lamp examination,
      refraction, topography) during their normal follow-up up to 12 months after treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to the Department of Ophthalmology, Aarhus University Hospital, for
        keratorefractive surgical correction of myopia
      
Keywords: Keratorefractive Surgical Procedures
Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain
Condition: Peripheral Neuropathy; Complex Regional Pain Syndromes (CRPS)
MeSH terms: Peripheral Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
Study type: Interventional

Summary: 
      The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established,
      although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has
      been shown to be effective for treating other types of pain. We propose to measure functional
      outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain.
      Measures will be made at baseline and after titrating the drug to an effective level.
    


Intervention name(s): Transdermal Fentanyl
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuropathic pain; Efficacy
Rotavirus Efficacy and Safety Trial (REST)(V260-006)
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the safety of the investigational rotavirus vaccine and
      the efficacy to prevent rotavirus gastroenteritis.
    


Intervention name(s): Rotateq™; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.; 3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
Other intervention name(s): V260
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Validating Machine -Learned Classifiers of Sedentary Behavior and Physical Activity
Condition: Physical Activity; Sedentary Lifestyle
Study type: Interventional

Summary: 
      The majority of the US population spends most of the day sitting and the we have new
      scientific evidence that this can contribute to poor health regardless of how much physical
      activity a person does. However, we do not measure sitting time very accurately and when we
      ask people to tell us how much they do, their answers are unreliable. Our study will use
      small sensors to objectively measure when people sit or do physical activity, and we will use
      sophisticated computational techniques to summarize these movement patterns.
    


Intervention name(s): Measurement
Intervention type(s): Other
Intervention description(s): Measured usual (day-to-day) behavior with body-worn sensors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: physical activity; sedentary behavior; accelerometer; GPS; GIS; machine learning
A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double blind, randomized, placebo controlled, single and multiple ascending dose
      study in healthy subjects. Safety evaluation will include (serious) adverse events, vital
      signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be
      drawn at specified timepoints.
    


Intervention name(s): QCC374; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single and multiple ascending doses of QCC374; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: healthy subjects, inhaled
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, immunogenicity,
      pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy
      adult subjects.
    

Detailed description: 
      Primary Purpose - other: Protocol designed to assess the safety, tolerability,
      immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy
      subjects

      Enrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96

      Minimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD
      Panel 70 years of age)
    

Intervention name(s): BMS-986089; Placebo matching with BMS-986089
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Effect of a Probiotic on Upper Respiratory Tract Infections
Condition: Infections, Upper Respiratory Tract
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study
      in healthy children aged 2-6 years. The study will investigate the effect of daily intake of
      a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.
    


Intervention name(s): Probiotic strain; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
C-Cure Clinical Trial
Condition: Heart Failure Class II or III
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of
      left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells
      (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.
    


Intervention name(s): C-Cure
Intervention type(s): Biological
Intervention description(s): Intraventricular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure; Cell therapy
Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The project aimed to evaluate the implementation process and efficacy of a culturally
      tailored Diabetes Self-Management and Education (DSME) program with mobile health (mHealth)
      technology integration, entitled Culturally Appropriate Strategies for Chinese Americans with
      Diabetes (CASCADe), among Chinese American adults with Type 2 diabetes.
    

Detailed description: 
      The CASCADe program includes 1) a home visit for training of monitoring devices use, WeChat
      app and acquiring family support, 2) 8 weekly education sessions with a combined format of
      group class, games, food demonstration, group exercise, video and discussion, 3) WeChat
      follow-up on education tips, monitoring data summary, and group discussion. The monitoring
      system used a smartphone to coordinate cloud data transmission from a set of wireless devices
      to capture daily monitoring data on physical activity, body weight, blood pressure and blood
      glucose levels. WeChat app was used to facilitate behavioral self-monitoring by providing
      daily messages related to diabetes education curriculum, weekly summary reports on monitoring
      data as well as reinforcement messages and group discussion on readings and monitoring
      results implication. A single group pre-post-test design was adopted to evaluate changes of
      primary (HbA1c) and secondary (Self-efficacy, quality of life and stress coping) outcomes
      assessed at pre and post of intervention. Engagement and adherence in education sessions and
      self-monitoring system, and satisfaction with the content and delivery of intervention were
      also evaluated at the end of the study.
    

Intervention name(s): CASCADe
Intervention type(s): Behavioral
Intervention description(s): Culturally tailored diabetes self-management and education sessions with mHealth integration
Intervention model: Single Group Assignment
Intervention model description: Single group pre- and post-test design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chinese Americans; Type 2 Diabetes; mHealth; Diabetes Self-Management and Education
An Integrative Platform for Preventing Children's Emotional Disorders
Condition: Emotional Problem
Study type: Interventional

Summary: 
      The general objective of the study is to test an online platform for the prevention of
      emotional disorders in children.
    

Detailed description: 
      The project aims at implementing an integrated online therapeutic platform that will be
      accessed by youth, parents and clinicians. The main original feature is the integration of
      state of the art online/mobile and gaming technologies into a unique platform that allows
      easy access to personalized, accessible and validated prevention.

      The platform aims to allow access to attractive, easily accessible and evidence-based
      prevention for youths. The system will be validated in the second step as an integrative,
      multi-componential and adaptive platform for the prevention of emotional disorders in youth.
      The platform includes tools that were separately tested in laboratory conditions and found to
      be effective: the REThink therapeutic video game and the online REThink Parenting and
      Rational Parent Coach mobile programs.
    

Intervention name(s): REThink therapeutic game; Online parenting program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.; The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The first stage investigates the efficacy of the online REThink therapeutic game in comparison with monitoring in the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the intervention, the online parenting intervention will be implemented, while the other groups will be monitored for other 4 weeks.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: emotional problems; children; parenting; online therapeutic game
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of
      the world's population. The epidemiology of pediatric psoriasis has not been well documented
      and no treatment guidelines exist for pediatric psoriasis.

      Etanercept is a biologic drug and has been licensed for the treatment of chronic severe
      plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately
      controlled by or are intolerant to, other systemic therapies or phototherapies. Although the
      long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis
      (JIA) has been studied and the short-term safety profile of etanercept in both JIA and
      pediatric psoriasis appears similar, there is limited data available about the long-term
      effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim
      of this study is to assess the safety and effectiveness of etanercept for the treatment of
      pediatric psoriasis in Europe. Patients aged <=17 with plaque psoriasis diagnosed by a
      dermatologist will be invited to participate in the registry only after a clinical decision
      has been made to prescribe etanercept. The safety of the drug and how well the drug works
      will be evaluated during the follow-up period. The follow-up period will last 5 years and
      patients will be followed up every 3 months for the first 2 years and every 6 months for the
      next 3 years or until the end of study.
    

Detailed description: 
      Non-probability sample
    

Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention description(s): Expected duration of 24 weeks as one course
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        dermatology clinics
      
Keywords: pediatric psoriasis; etanercept; PASS; safety; effectiveness
Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect
Condition: Periodontitis (Stage 3)
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of the present study was to evaluate the effect of demineralized autogenous dentine
      on treatment of infrabony defects.
    

Detailed description: 
      In this study, the investigators tested the effect of demineralized autogenous dentine as a
      bone graft in treatment of stage III periodontitis in term of probing pocket depth reduction,
      mean gain in clinical attachment level, and bone gain in defect sites.
    

Intervention name(s): Autogenous demineralized dentin nanoparticles
Intervention type(s): Procedure
Intervention description(s): Effect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment