bioihbjkbjnl/mcl2 huggingface dataset:
Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA
Condition: Obstructive Sleep Apnoea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with
      obstructive sleep apnea (OSA) to define the physiological effects of continuous positive
      airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal
      microvascular function during a 2 week period.
    


Intervention name(s): CPAP therapy withdrawal; Continue CPAP treatment
Intervention type(s): Other; Procedure
Intervention description(s): CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks; Continue treatment with therapeutic continuous positive airway pressure device
Other intervention name(s): CPAP treatment with subtherapeutic pressure; therapeutic continuous positive airway pressure device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multicenter study to evaluate the systemic exposure and safety of
      topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.
    


Intervention name(s): Tapinarof cream, 1%
Intervention type(s): Drug
Intervention description(s): Tapinarof cream, 1% applied topically once daily
Other intervention name(s): DMVT-505
Intervention model: Single Group Assignment
Intervention model description: Open-label, single arm study
Masking: None (Open Label)
Primary purpose: Treatment
A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
Condition: HIV Infection; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be
      randomly assigned (using a random number table) to the interviewer-administered intervention,
      the self-administered intervention, and waitlist control conditions upon completion of
      screening, informed consent, HIV pretest counseling and test administration, and collection
      of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.
    

Detailed description: 
      The specific aims of the 5-year study are to:

        1. identify the covariates of baseline substance abuse and sexual risks (including
           demographics, social risk measures, peer norms, abuse history, and mental health status)
           among a sample of 750 heterosexually active, not-in-treatment, club and prescription
           drug users ages 18 to 39 in Miami, Florida.

        2. evaluate, through random assignment, the relative effectiveness of two intervention
           conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-,
           6- and 12-month follow-ups:

             -  Arm 1, an interviewer-administered comprehensive health and social risk assessment
                intervention (CAPI Intervention) similar to the baseline instrument used in the
                parent grant;

             -  Arm 2, an identical self-administered comprehensive assessment intervention (ACASI
                Intervention); and

             -  Arm 3, a waitlist control condition (Control). Outcome measures, including past
                90-day counts of unprotected sex acts and days' drug use, will be obtained from
                brief risk behavior inventories at baseline and follow-ups.

        3. conduct qualitative process evaluation research with 40 participants in each study arm
           to contextualize the study findings and intervention outcomes.
    

Intervention name(s): Trans-theoretical Process of Change Model-self; Trans-theoretical Process of Change Model - interviewer
Intervention type(s): Behavioral; Behavioral
Intervention description(s): self-administered, computer-based intervention; interviewer-administered intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV/AIDS; substance use; club drugs; sexual risk
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
Condition: Health; Blood Pressure; Liver Function; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Purple Sweet Potato juice (PSP-juice) is a juice based on purple-fleshed sweet potato
      concentrate, containing a high level of anthocyanins. Purple-fleshed sweet potatoes have
      attracted attention to industry and scientists due to multiple physiological functions such
      as radical-scavenging, ACE-inhibitory and α-glucosidase inhibitory activities in vitro, and
      also hepato-protective, antihypertensive and antihyperglycemic effects in vivo. Previous
      studies in Japanese subjects showed potential beneficial effects of PSP beverages on liver
      function and blood pressure in volunteers with impaired hepatic function and/or hypertension.

      The main objective of this study is to examine the effect of PSP-juice on liver enzymes and
      blood pressure. The secondary objective is to examine the effects of PSP-juice juice on
      insulin resistance.
    

Detailed description: 
      Study design: The study is designed as a randomized, parallel, placebo-controlled,
      double-blind study.

      Study population: 40 healthy adult female and/or male subjects, 40-70 yr old with a BMI 25-35
      kg/m2, mildly elevated serum liver enzymes, and high normal blood pressure or mild
      hypertension.

      Intervention: Daily oral intake of 3x 125 ml of PSP-juice or control juice for a period of 8
      weeks.

      Main study parameters/endpoints: Liver enzymes (GGT, ALAT, ASAT), blood pressure, glucose,
      insulin, haematology and serum clinical chemical profile
    

Intervention name(s): purple sweet potato (PSP)-juice
Intervention type(s): Dietary Supplement
Intervention description(s): Daily oral intake of 3x 125 ml of PSP-juice or control juice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: health; blood pressure; liver enzymes; insulin resistance
Exposure Chamber Trial With Cat Immunotherapy
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this trial is to investigate if any of three different doses of cat hair
      immunotherapy is safe for treatment of cat allergic patients.
    


Intervention name(s): Specific allergen immunotherapy (placebo); Specific allergen immunotherapy; Specific allergen immunotherapy; Specific allergen immunotherapy
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks; Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.; Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks; Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cat; Allergy; Immunotherapy; Sublingual; Exposure chamber; Safety; Rhinoconjunctivitis
BOTOX® in the Treatment of Upper Facial Lines in Japan
Condition: Upper Facial Rhytides; Crow's Feet Lines; Glabellar Lines; Frown Lines
MeSH terms: Facies
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the
      treatment of upper facial lines (Crow's Feet Lines and Frown Lines).
    


Intervention name(s): botulinum toxin Type A (44U); botulinum toxin Type A (32U)
Intervention type(s): Biological; Biological
Intervention description(s): 44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.; 32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
Other intervention name(s): BOTOX®; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and tolerability of oral single dose applications of AFQ056
      in GERD patients.
    


Intervention name(s): AFQ056
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GERD; gastroesophageal reflux disease; meal-induced gastroesophageal reflux events
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
Condition: Crohns Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up
      to 5 total infusions in subjects with Crohn's disease who are refractory to one or more
      standard Crohn's disease therapies.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation study to study 3
      cohorts of subjects with Crohn's Disease including (but not limited to) those with colonic
      involvement. Each cohort (n = 9) will include PDA001 treated subjects (n = 6) as well as
      placebo (vehicle control) treated subjects (n = 3). Cohorts will be enrolled sequentially,
      beginning with the lowest dose cohort (1/4 unit PDA001) and progressing until the maximum
      tolerated dose of IV PDA001 is determined.
    

Intervention name(s): PDA001; Vehicle Controlled Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Cohort 1 Dose Level 1: ¼ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Cohort 2 Dose Level 2: ½ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Cohort 3 Dose Level 3: 1 unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.; Cohort 1 Dose Level 1: ¼ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
Cohort 2 Dose Level 2: ½ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
Cohort 3 Dose Level 3: 1 unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's disease; Fistula; Diarrhea; Colon; Stem cells
CanMove: A Physical Activity Program for Children With Cancer
Condition: Pediatric Cancer
Study type: Interventional

Summary: 
      This study will evaluate a physical activity intervention for children during acute cancer
      treatment. The intervention aims to encourage children to participate in increased levels of
      physical activity and reduce the amount of time they spend engaged in sedentary activities.
      This study also aims to evaluate different ways of assessing physical function in order to
      determine the best outcome measure to use for children during acute cancer treatment.
    

Detailed description: 
      All participants will receive the intervention which involves weekly sessions with a
      physiotherapist and the provision of an activity tracker. The sessions will aim to help
      motivate participants to be more physically active and identify barriers to physical activity
      in their environment. The activity tracker will be used to set a steps per day goal for the
      participant to achieve.

      The intervention will be assessed for feasibility using aspects of the Bowen Framework. Under
      this framework the intervention will be evaluated according to different domains:

        -  Acceptability: To what extent is a new idea, program, process or measure judged as
           suitable or satisfying

        -  Demand: To what extent is a new idea, program, process, or measure likely to be used

        -  Implementation: To what extent can a new program is successfully delivered to intended
           participants

        -  Practicality: To what extent can the program can be carried out with intended
           participants using existing means, resources, and circumstances

        -  Limited efficiency: Does the a new program show promise of being successful with the
           intended population

      In order to find out the best way to assess physical function, participants will complete 5
      different assessments. The results from these assessments will help to determine the best
      measure to use in this population.
    

Intervention name(s): Complex physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): Structured weekly sessions with a Physiotherapist over an 8 week period, including:
Evaluation of current levels of physical activity and physical function - including discussion of results
Education regarding the importance of physical activity
Supervised physical activity session with a physiotherapist
Structured weekly sessions applying behavioural change techniques which aim to increase participation in physical activity. Sessions include: provision of activity monitor (Fitbit Inspire), goal setting, monitoring, collaborative problem solving and action plan implementation. Intervention includes additional time allowance of 1 hour per week to assist in implementing action plan items
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: physical activity
Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time
      glycemic monitoring and glucose control implemented by clinical decision support system
      (CDSS) using wire and wireless communication and information technology.

      To evaluate the clinical efficacy of this system, researchers plan to compare the improvement
      of glycemic control, self-management, and quality of life among three study groups: control,
      self glucose monitoring, and U-healthcare group.
    

Detailed description: 
      Recently, the application of internet-based glucose control system showed better long term
      glucose control compared to the conventional treatment. This study has become the foundation
      of web-based methodology in the glucose control. In addition, the combined application of
      mobile device and web-based monitoring system for chronic diseases showed improvement in
      various metabolic parameters in obese patients with diabetes and hypertension.

      Thus, the application of U-healthcare based on advanced information technology would be
      helpful in the diabetes management. We plan to provide an individualized U-healthcare service
      using advanced information technology that enables more effective glucose control.
    

Intervention name(s): U-healthcare service; SMBG group
Intervention type(s): Device; Device
Intervention description(s): Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.; Glucose control with self monitoring of blood glucose.
Other intervention name(s): U-healthcare group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes
Condition: Myofascial Pain Syndromes
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objective:

        -  To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree
           of efficacy of thiocolchicoside ointment administered to trigger point regions compared
           with the trigger point injection.
    


Intervention name(s): Thiocolchicoside
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels
Condition: Vitamin D Deficiency; Cardiometabolic Risk Factors
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This study aimed to compare the effects between sunlight exposure and oral vitamin D
      supplementation on serum 25-hydroxyvitamin D concentration and metabolic markers in Korean
      young adults.
    


Intervention name(s): Sunlight Exposure; Vitamin D Supplementation; Placebo
Intervention type(s): Behavioral; Dietary Supplement; Other
Intervention description(s): Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
Completing a Sun Diary after sunlight exposure; - Supplementation of vitamin D3 500 IU/day for 8 weeks; - Intake of placebo for 8 weeks
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Metabolic Effects of Protease Inhibitors in HIV Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The use of protease inhibitors is increasing in HIV-infected children because this treatment
      has resulted in improved body weight, improved immune status and less hospitalizations.
      However, recent reports suggest that these drugs may also be associated with some negative
      side-effects, specifically a syndrome of diabetes and fat redistribution. Development of the
      fat redistribution/diabetes syndrome has recently been reported in HIV-infected children, as
      well as in adults. Diabetes is associated with complications such as increased heart disease,
      eye disease and loss of kidney function. Thus development of diabetes is a significant
      problem which could outweigh the benefits obtained by treating patients with protease
      inhibitors. One major cause of diabetes is lack of normal response to insulin (insulin
      resistance). Insulin resistance tends to be worse in family members where one or more parent
      has diabetes, and is also worse in certain ethnic groups. The first major purpose of our
      study is measure insulin resistance in HIV-infected children who do not take protease
      inhibitors, and compare our findings to those from patients who are treated with protease
      inhibitors. We will also follow patients newly treated with protease inhibitors for two years
      to evaluate changes in insulin sensitivity. These results will be correlated with each
      patient's family history of diabetes and with ethnicity, and should help us better predict
      which children are "at risk" for development of diabetes from protease inhibitor therapy.
      Children with HIV infection often have problems with gaining enough weight and with poor
      linear growth (height). One likely reason for this is the way their bodies use and store
      protein. The second purpose of our study is measure protein turnover and to correlate our
      findings with growth data. We also plan to study the effects of protease inhibitor therapy on
      protein turnover. We believe that these studies will provide knowledge to help clinicians
      formulate recommendations for nutritional and medical therapy.
    


Intervention name(s): Antiretroviral therapy
Intervention type(s): Drug
Intervention MeSH terms: Anti-Retroviral Agents
Primary purpose: Prevention
Keywords: Pediatric HIV infection
Evaluation of Physician-based Decision Support
Condition: Type 1 Diabetes Mellitus; MDI; CGM; Exercise
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The goal of this study is to assess the impact of physician-driven insulin setting changes in
      type 1 patients using multiple daily injection insulin therapy with exercise. This is a short
      outpatient study with multiple outpatient and home exercise sessions with an assigned type of
      exercise.
    

Detailed description: 
      Subjects will be on study for 28 days. Sensor glucose, exercise, insulin and meal data will
      be collected during this time. Subjects will wear the Dexcom G6 CGM system and a physical
      activity monitor. The Subjects will complete 2 exercise visits in-clinic and 4 exercise
      visits as an outpatient. Subjects will be randomized to aerobic, anaerobic or high intensity
      interval exercise sessions for 30 minutes each. Physicians will review CGM and insulin data
      every 7 days and make insulin dose recommendations that the subject will adjust in the dose
      calculator.
    

Intervention name(s): Dexcom G6 CGM
Intervention type(s): Device
Intervention description(s): Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomly assigned to one of three types of exercise.
Masking: None (Open Label)
Primary purpose: Other
Oral Bioavailability of GLPG0555 in Different Solid Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of
      GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of
      GLPG0555.
    


Intervention name(s): GLPG0555 solid dispersion; GLPG0555 nanosuspension
Intervention type(s): Drug; Drug
Intervention description(s): solid dispersion capsules, 50 mg, single dose; Nanosuspension, 50 mg, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Safety; Tolerability; Pharmacokinetics