bioihbjkbjnl/mcl2 huggingface dataset:
Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
Condition: Cough; Parkinson's Disease
MeSH terms: Cough; Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to test cough function in individuals with Parkinson's
      disease and healthy older adults. Cough is a complex, defensive function which involves
      movement of the chest and lungs. The investigators want to compare the movement of the chest
      wall and the lungs during voluntary and reflex cough.

      The long-term goal of this research is to develop treatments for people with cough
      dysfunction. Cough dysfunction increases the risk for respiratory infections such as
      pneumonia. The results from this study will provide information to help researchers
      understand the difference between reflex and voluntary cough more fully.
    

Detailed description: 
      If the participant agrees to participate, the investigators will first test pulmonary (lung)
      function. Next, the investigators will test voluntary and reflex cough. After this first
      round of cough testing, the investigators will ask participants to cough long and hard during
      voluntary and reflex cough testing. Finally, the investigators will view the larynx (voice
      box) with an endoscopic camera inserted through the nose. This test is done to see if there
      are any changes in the larynx that may influence cough.
    

Intervention name(s): Capsaicin; Voluntary cough test
Intervention type(s): Drug; Other
Intervention description(s): For reflex cough testing, all participants will receive various concentrations of nebulized capsaicin. Delivery of multiple concentrations and doses of capsaicin allows for accurate assessment of both the strength (airflow measures) of reflex, as well as cough sensitivity.; Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.
Intervention MeSH terms: Capsaicin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants with Parkinson's Disease are evaluated in parallel against a control group of health older adults
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cough; Reflex; Voluntary; Healthy older adults; Parkinson's disease; Respiratory kinematics; Cueing
Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      In recent years ketamine abuse becomes prevalent in youth in some Asian countries. Chronic
      ketamine abuse may lead to uropathology and cognitive impairments. No pharmacological
      interventions have been identified as effective for treating ketamine abuse or helpful in
      achieving or maintaining abstinence from ketamine. Cognitive-behavioral treatment is
      currently an important psychosocial intervention for addictive problems. This study aimed to
      test whether a brief cognitive-behavioral training program has a positive influence on stage
      transitions among ketamine abusers.
    

Detailed description: 
      409 ketamine abusers were recruited in this study, with 285 ketamine abusers participated in
      a 6-hour brief cognitive-behavioral intervention and 124 ketamine abusers attended
      educational lectures on ketamine abuse. A brief cognitive-behavioral intervention was applied
      to teach ketamine abusers about stimulus control, refusal skills, communication skills,
      decisional balance, and infectious diseases prevention. Stage of Change and knowledge about
      ketamine were assessed before and after the intervention.
    

Intervention name(s): Cognitive behavioral skills training
Intervention type(s): Behavioral
Intervention description(s): A brief cognitive behavioral skills training was applied to teach ketamine abusers about stimulus control, refusal skills, communication skills, decisional balance, and infectious diseases prevention.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Two arms were used to examine the relative effect of the cognitive behavioral skills training (CBSR) and a time slot for education as usual (EAU). The CBST consists of six sessions. The first session is intended to establish rapport, build therapeutic cohesion through ice-breaking activities, and educate participants about the drug regulations stated in the Statute for Drug Hazard Prevention and Control. The following four sessions are devoted to interactively practicing refusal skills, communication skills, decision-making skills, and positive conflict resolution skills. The final session is to review what has been learned and reminds participants about the association of drug use with HIV/HCV.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Substance Abuse; Cognitive behavioral treatment; Ketamine; Stage of Change
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
Condition: Pregnancy
Study type: Interventional

Summary: 
      This clinical study will evaluate the safety of PregSense™ and Comparative Performance of
      PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
    

Detailed description: 
      PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart
      rate, maternal hear rate and uterine contractions. This study will be performed to collect
      and digitally record data from PregSense™ and the standard of care (CTG) in order to provide
      evidence of safety and agreement between PregSense™ and the gold standard NST device.
    

Intervention name(s): PregSense™; Cardiotocopraphy (CTG)
Intervention type(s): Device; Device
Intervention description(s): PregSense™ wearable device will be applied for maternal-fetal monitoring; Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fetal monitoring, Prenatal monitoring
Precision Nudging Drives Wellness Visit Attendance at Scale
Condition: Women's Health; Annual Visit; Well Visit; Health Behavior; Prevention
Study type: Interventional

Summary: 
      The purpose of the present randomized controlled trial is to explore the effectiveness of a
      12-month well woman digital health intervention leveraging Precision Nudging - the
      application of behavioral science and reinforcement learning to create individualized,
      tailored health messaging at scale that matches the right message to the right person at the
      right time - in promoting behavior change. Specifically, it is hypothesized that scaling
      behavioral science through reinforcement learning will be more effective at motivating
      participants to engage with well woman messages and to schedule and to attend a well woman
      visit compared to a standard of care message.
    


Intervention name(s): Precision nudging; Standard of care
Intervention type(s): Other; Other
Intervention description(s): Precision nudging (i.e., the application of behavioral science and reinforcement learning to create individualized, tailored health messaging at scale that matches the right message to the right person at the right time); Standard of care communication (e.g., personalized letters and patient portal notices)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Digital Health Intervention; Behavior Change; Reinforcement Learning; Artificial Intelligence
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fasted Conditions
Condition: Prophylaxis of Organ Rejection
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg
      tablets under fasted conditions.
    


Intervention name(s): Mycophenolate Mofetil
Intervention type(s): Drug
Intervention description(s): Mycophenolate Mofetil 500 mg Tablet
Other intervention name(s): CellCept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
Condition: Cigarette Smoking; Drug Use
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the proposed project is to develop a novel, behavioral approach to smoking
      cessation that can be integrated with residential drug use treatment for low income substance
      using smokers with elevated depressive symptoms. The approach utilizes behavioral activation
      strategies which have been shown to reduce smoking among community samples and which can be
      easily targeted for the particular needs of low income substance users.
    

Detailed description: 
      This project will take place in two phases. In the first phase, the investigators will
      utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two
      existing behavioral activation manuals to develop the Behavioral Activation for Drug Abusing
      Smokers (BA-DAS). In Phase II, the investigators will randomize 80 patients to either: 1)
      standard smoking cessation treatment (ST) and nicotine replacement therapy (NRT) or 2) BA-DAS
      (which includes ST and NRT). Based on the outcome of this preliminary trial, the BA-DAS
      protocol will be further refined and readied for larger-scale clinical trials to develop a
      comprehensive approach to treating smoking among low income, largely minority, depressed
      smokers in residential drug use treatment, which may be instrumental in reducing smoking
      among this especially at risk group.
    

Intervention name(s): Standard Treatment; BAD-AS; Transdermal Nicotine Patch
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.; The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.; 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch.
Other intervention name(s): ST; Nicoderm CQ
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cigarette Smoking; Drug Use; Depressed Mood
Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      An investigation on the cumulative skin irritation potential of a newly developed 15 mg
      nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal
      patch.
    

Detailed description: 
      Study on the cumulative skin irritation potential of a newly developed 15 mg nicotine
      transdermal therapeutic system. A double blind, randomized, repeat patch test, single center
      study in 42 healthy male and female subjects.
    

Intervention name(s): Nicotine Patch; Nicotine Patch Comparator; Placebo Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days; 15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days; Placebo patch applied on the lower back, according to treatment sequence, daily for 21 days
Other intervention name(s): Experimental Nicotine Patch; Active Comparator Nicotine Patch; Placebo Patch Comparator
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents
Condition: Irritable Bowel Syndrome; Functional Gastrointestinal Disorders
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Syndrome
Study type: Interventional

Summary: 
      This randomized controlled trial aims to evaluate the treatment effects of an
      internet-delivered CBT-program for adolescents with irritable bowel syndrome.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is prevalent and associated with low quality of life in
      adolescents. Medical or dietary treatments lack evident efficiency, while psychosocial
      interventions, i.e. cognitive behavior therapy (CBT)has shown promising effects in
      face-to-face treatments. Therapists trained to deliver CBT for IBS are scarce, leading to a
      situation where very few adolescents with IBS receive the only evidence-based intervention.
      Exposure-based internet-delivered CBT (ICBT) for adults with IBS has shown strong stable
      effects and cost-efficency. Our aim is to develop a treatment that enhances the availability
      to evidence-based treatment for children and adolescents with IBS. Such a treatment could
      swiftly be implemented in regular health care for this large population. The main purpose of
      this study is to compare the effectiveness of exposure-based ICBT to treatment as usual
      (wait-list) for adolescents with IBS.
    

Intervention name(s): Internetdelivered exposure-based CBT
Intervention type(s): Behavioral
Intervention description(s): The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, and adapted for adolescents and their parents. The feasibility of the treatment were tested in a pilot study during 2012. Components in the treatment are exposure for symptoms and parent training. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the adolescents, and to teach the parents how parental behavior can influence symptoms in children. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICBT; IBS; FGID; functional abdominal pain; Adolescents; Children; Treatment; CBT; Exposure; Cognitive Behavior Therapy; Internet; Computerized; Abdominal Pain; Functional Pain; Functional Disorders
Nutrition and Physical Activity Counselling
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Background: Childhood obesity imposes a great burden on the healthcare system. Given the
      increased frequency of dental compared to medical visits during childhood, dentists may be in
      an ideal position to recognize patients at risk of developing obesity. This randomized
      clinical trial explored the efficacy of a brief nutrition and physical activity counseling
      for healthy weight 6 to11 year-old children in a university-based pediatric dental clinic.

      Methods: 168 children, 6-11 year old, were allocated to test and control groups and their
      Body Mass index (BMI) were recorded. Their parents/caregivers completed a questionnaire
      regarding their child's nutrition, physical activity and screen time. The parents/caregivers
      of the test group then received a brief counseling session that encouraged an increase in
      children's physical activity, and a decrease in sugar-sweetened beverages and screen time.
      Data, collected at baseline and follow-up session (within 6-12 months) were analyzed using
      general linear regression, adjusting for age, gender, socio-demographic characteristics,
      education, labour force, income and awareness of school nutrition policy (P≤ 0.05).
    


Intervention name(s): Lifestyle counseling or nutrition/physical counselling
Intervention type(s): Behavioral
Intervention description(s): A brief (5-10 minute) counseling session for caregivers of the intervention group aimed to encourage an increase in the child's physical activity and decrease sugar-sweetened beverage consumption and screen time. Additionally, the caregivers of the intervention group were provided with the following handouts: five steps to a healthy body weight for teens; beverages; physical activity tips for children 5-11 years; Canadian physical activity guidelines for children 5-11; and Canadian sedentary behavior guidelines for children 5-11.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric Obesity; Body Mass Index; Dentistry
Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants
Condition: Japanese Healthy Adult Male Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male
      participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy
      participants in order to evaluate safety and tolerability of single and multiple oral doses
      of TAK-906 in Japanese healthy male participants.

      The study will enroll approximately 24 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1 or Cohort 3.
      Study drug will be administered in a double-blind manner which will remain undisclosed to the
      participant and study doctor during the study (unless there is an urgent medical need),
      orally, once daily on Day 1 as Single Dose Period and twice daily from Day 3 to 7 as Multiple
      Dose Period:

        -  TAK-906 50 mg (Cohort 1)

        -  TAK-906 100 mg (Cohort 2)

        -  TAK-906 10 mg (Cohort 3)

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient

      Cohort 2 will be conducted after the completion of Cohort 1. This will be conducted in Japan.
    

Intervention name(s): TAK-906; TAK-906 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-906 capsules.; Placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug therapy
A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential
      to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of
      CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.
    


Intervention name(s): Debio 1450; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Debio 1450, 40 mg capsule.; Itraconazole, 20 mL of 10 mg/mL solution.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Duragen Versus Duraguard in Chiari Surgery
Condition: Chiari Malformation
MeSH terms: Arnold-Chiari Malformation; Congenital Abnormalities
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates two materials used for duraplasty of the posterior cranial fossa in
      treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix
      that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out
      of bovine pericardium and has to be sutured during application. The study compares these two
      materials used for duraplasty of patients undergoing Chiari surgery in a prospective
      randomized fashion to check the rate of surgical complications associated with each material,
      patient's outcomes, length of surgery and the hospital stay, etc.
    

Detailed description: 
      The study is aimed at comparative analysis of two frequently used duraplasty materials: one
      is made out of bovine pericardium, and the other - from bovine collagen derived from bovine
      achilles tendon. Both materials are routinely used form this intervention (duraplasty), but
      the question of superiority of one over the other remains open. This study follows patients
      with Chiari malformation from the time of surgery to the time of their discharge from the
      hospital and then another 3 months of follow up care.
    

Intervention name(s): Duragen duraplasty; Duraguard duraplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Posterior cranial fossa repair and enlargement with application of dural patch (Duragen); Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
Other intervention name(s): Duragen (Arm 1; active comparator); Duraguard (Arm 2; active comparator)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chiari malformation;; Duraplasty;; Posterior fossa decompression;; Duragen;; Duraguard
Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetic properties and safety after administration of HCP1105 and
      co-administration of HGP0918, HGP0816 in healthy male volunteers
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetic properties and safety after
      administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male
      volunteers
    

Intervention name(s): HCP1105; HCP0918; HCP0816
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment