bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects
Condition: Safety; Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed
      to evaluate safety, tolerability and PK of single and multiple ascending oral doses of AM1476
      in healthy subjects.
    

Detailed description: 
      Part A (SAD); In the SAD part of the study, single oral doses of AM1476 will be administered
      in up to 9 sequential groups, each consisting of 8 subjects randomised to recieve either
      AM1476 or placebo in a 3:1 ratio. The first 2 subjects in each group will be dosed in a
      sentinel fashion, 1 subject will receive AM1476 and the other will receive placebo as
      randomised. The SAD part incorporating a 2-period crossover arm for a food-effect evaluation
      in 2 groups.

      Part B (MAD); The MAD part of the study will explore multiple ascending dosing of AM1476 for
      10 days. AM1476 will be administered in up to 6 sequential groups, each consisting of 8
      subjects randomised to recieve either AM1476 or placebo in a 3:1 ratio.
    

Intervention name(s): AM1476; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AM1476 Capsules; Placebo Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part A (SAD) Within each group, subjects will be randomised in a 3:1 ratio to receive either AM1476 (n=6) or placebo (n=2). The first 2 subjects in each group will be dosed in a sentinel fashion; 1 subject will receive AM1476 and the other will receive placebo as randomised.
Part B (MAD) Within each group, subjects will be randomised in a 3:1 ratio to receive either AM1476 (n=6) or placebo (n=2).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cognitive Effects of Sage in Healthy Humans
Condition: Cognitive Change; Mood Change
Study type: Interventional

Summary: 
      Extracts of sage and polyphenols have separately been reported to interact with central
      nervous system (CNS) mechanisms relevant to cognitive performance but, to date, no trial has
      combined these interventions. The current study investigates the effects of this combined
      intervention in N=90 healthy males and females between 30-60 yrs, at 600 mg versus placebo,
      on cognition and mood over a 29 day period.
    

Detailed description: 
      Improved cognitive performance has been observed in humans following supplementation of sage
      extracts; including recall and mental arithmetic ability. Aspects of mood have also shown
      improvements; e.g. increased alertness, calmness and contentedness and reduced mental
      fatigue. These effects are believed to be underpinned by interactions with cholinergic and
      GABA pathways. Polyphenols too have shown promise in boosting cognition and mood and
      interaction with vasodilatory pathways and GABA neurotransmission are purported to be the
      likely mechanisms involved. Research has yet to investigate if a combination of sage terpenes
      and polyphenols could be even more efficacious via synergistic interaction.The current study
      investigates the effects of a 600 mg sage/polyphenol combination on cognition and mood in
      N=90 healthy male and female participants between the ages of 30-60 yrs acutely; on day 1 of
      supplementation, and chronically; after 29 days. Cognitive and mood data will also be
      collected every 7 days in the interim via a mobile phone cognitive task battery.
    

Intervention name(s): Cognivia; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira; Placebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will follow a randomised, double-blind, placebo-controlled, parallel groups design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Sage; Terpene; Polyphenol; Cognition; Mood
CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression
Condition: Insomnia; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study is a randomized controlled trial that tests the effectiveness of cognitive
      behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who
      have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is
      compared with a control condition of sleep hygiene education.
    

Detailed description: 
      160 youth with depression and comorbid insomnia who have just initiated a course of SSRI
      antidepressants will be randomized to insomnia-focused cognitive behavior therapy (CBT-I) or
      an attention control condition of sleep hygiene (SH) education. All participants will have
      in-person treatment sessions and will complete sleep diaries and wear an actigraph to record
      activity levels. Participants will be followed for 12 months.

      Primary depression outcomes are score on the Clinical Global Impressions Improvement (CGI-I)
      and major depressive disorder diagnostic remission; primary sleep outcomes are actigraphy
      total sleep time and score on the Insomnia Severity Index (ISI). Secondary outcomes include
      additional sleep and depression outcomes. The study will also include economic analyses.
    

Intervention name(s): CBT for Insomnia (CBT-I); Sleep Hygiene (SH)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive behavior therapy for insomnia (CBT-I) comprising stimulus control, sleep restriction, and sleep-focused cognitive therapy. The CBT-I consists of in-person sessions and homework assignments and includes stimulus control and sleep restriction to regularize the sleep-wake cycle; cognitive therapy to address dysfunctional sleep beliefs and bedtime rumination; motivational interviewing to help youth make important health changes; and parental involvement. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.; Attention placebo control focusing on sleep hygiene, consisting of in-person sessions and homework assignments. The sleep hygiene sessions address sleep-related topics such as limiting pre-sleep caffeine intake, sleep-promoting activities, and the impacts of insufficient sleep. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Depression; Teen; SSRI; CBT; Youth
Buspirone Treatment for Marijuana Dependence
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 4

Summary: 
      Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated
      pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of
      buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management
      (CM) intervention and motivational enhancement therapy (MET) will be incorporated to
      encourage study engagement and retention. It is hypothesized that buspirone combined with MET
      and CM will reduce the percent of marijuana-positive urine drug screen results in
      marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.
    


Intervention name(s): Buspirone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flexible dose, up to 60 mg daily; Flexible dose, up to 60 mg daily
Other intervention name(s): Buspar
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Marijuana; Buspirone; Contingency management; Motivational enhancement therapy
A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of
      DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in
      healthy male volunteers
    


Intervention name(s): DA-1229_01; E+M; DA-1229_01 fast; DA-1229_01 fed
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): complex single administration; co-administration of 2 drugs
Other intervention name(s): Evogliptin/Metformin XR 5/1000 mg; Evogliptin 5 mg + Metformin XR 1000 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis
Condition: Prosthesis User; Amputation
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise
      program on grip strength, movement speed, coordination, functional status, depressive status,
      and quality of life in patients with a myoelectric prosthesis with upper limb amputation. In
      the literature review, There is no robot-assisted exercise program applied in patients using
      upper extremity myoelectric prosthesis.

      The expected benefit from this study is to show that the functional status, depressive
      status, and quality of life of the patients who received robot-assisted biofeedback exercise
      were better than those who had a home exercise program only.
    

Detailed description: 
      The study was planned as a randomized prospective clinical study. The study was planned to
      include 16 patients. New amputation patients will be excluded from the study. The patients in
      the study group will have 5 sessions of exercise in the hospital for a week. The control
      group will receive a home exercise program.

      Statistical analysis Student t-test will be used for the comparison of descriptive
      statistical methods (mean, standard deviation, median, frequency, and ratio) and normal
      distribution parameters between groups. Pearson chi-square test, Yates Continuity Correction,
      Fisher-Freeman-Halton Exact Test, Fisher Exact Test, and Marginal Homogeneity Test will be
      used to compare qualitative data. The results will be evaluated at 95 % confidence interval
      and p <0.01 and p <0.05.
    

Intervention name(s): Robot; Home exercise
Intervention type(s): Device; Other
Intervention description(s): Patients with upper limb amputation using myoelectric prosthesis will done robot-assisted exercise program; Patients with upper limb amputation using myoelectric prosthesis will done home exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment group: robot-assisted exercise program Control: Home exercise program
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amputation; robotic rehabilitation; Prosthesis
A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine whether the test product, Labopharm Tramadol HCl Once-A-Day (OAD) 200 mg
      film-coated tablets, and the reference product, Labopharm Tramadol HCl OAD 200 mg uncoated
      tablets, are bioequivalent.
    


Intervention name(s): Tramadol HCl
Intervention type(s): Drug
Intervention description(s): Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet or Tramadol HCl 200 mg Uncoated Tablets based on randomization schedule.
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteers
Biomarkers of Insufficient Sleep and Sleepiness
Condition: Sleep Deprivation; Insufficient Sleep Syndrome; Sleep Wake Disorders
MeSH terms: Sleep Deprivation; Sleep Wake Disorders; Sleepiness
Study type: Interventional

Summary: 
      Sleep and wakefulness disorders impact 50 to 70 million Americans and insufficient sleep is
      epidemic with over 50% of Americans reporting less than 7 hours of sleep per night. Health
      problems associated with insufficient sleep include inflammation, depression and anxiety,
      diabetes, stress, drug abuse, poor quality of life, obesity, and fatigue related accidents on
      the job/while driving. While the contribution of sleep to overall health, well-being, and
      public safety is recognized, no established clinical biomarkers of sleep deficiency exist.
      Such biomarkers would have utility as road-side biomarkers of sleepiness (e.g., drowsy
      driving), monitoring on the job fatigue/fitness for duty (e.g., transportation, military ops
      health care), monitoring sleep health, as well as for clinical diagnostics and measures of
      clinical treatment outcomes. Thus, investigators designed a controlled laboratory
      insufficient sleep protocol utilizing metabolomics to identify biomarkers of insufficient
      sleep. Investigators propose to identify changes in metabolites that consistently occur
      during insufficient sleep. As an exploratory outcome investigators will examine associated
      changes in metabolites and cognitive performance during insufficient sleep.
    

Detailed description: 
      Impaired sleep affects millions of people each year representing an important public health
      issue. This project will utilize metabolomics approaches to identify biomarkers in the blood
      that respond consistently to insufficient sleep. The overall goal of this project is to use a
      discovery and targeted approach to identify specific small molecules in plasma as candidate
      biomarkers of insufficient sleep. Investigators will conduct a controlled in-laboratory
      insufficient sleep protocol where participants receive 2 days of 5 hour sleep opportunities
      per night on 2 separate occasions. Plasma will be collected for metabolomics analyses every 2
      hours (across 24 hours) during scheduled wakefulness at baseline and during insufficient
      sleep. Participants will complete the insufficient sleep protocol twice, separated by 23 days
      of sufficient sleep, to identify which plasma metabolites consistently change during
      insufficient sleep. Investigators anticipate these findings will be the first step in
      establishing validated biomarkers of impaired sleep that will advance our understanding,
      assessment and management of health consequences and symptoms associated with insufficient
      sleep.
    

Intervention name(s): Insufficient Sleep
Intervention type(s): Behavioral
Intervention description(s): 2 days with 5 hour sleep opportunity per day
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Validation of Tele-stethoscope System Digital
Condition: Respiratory Disorder; Heart Disorder
MeSH terms: Respiration Disorders; Respiratory Tract Diseases; Heart Diseases
Study type: Interventional

Summary: 
      Acute respiratory infections and other respiratory and cardiology diseases like COPD or heart
      failure are important causes of morbidity and mortality around the world. Telemedicine is
      defined as the delivery of health care and the sharing of medical knoledge over distances
      using telecommunication systems. Inexpensive techologies offer the possibility of a direct,
      real-time connection between the patient or the other end. These technologies help to the
      physicians to manage different symptoms and cardio-respiratory diseases. A real-time wireless
      tele-stethoscopy system was designed to allow a physician to receive real-time
      cardio-respiratory sounds from a remote auscultation, as well as video images showing where
      the technician is placing the stethoscope on the patient´s body. Actually, the lack of
      physicians in rural areas of developing countries makes difficult their correct diagnosis and
      treatment. Furthermore, in the majority of health systems, the patients are shared between
      primary care and medical specialty in hospitals. The tele-stethoscopy system through
      telemedicine could help to the physicians or health-care technicians in the majority of
      health systems and especially in rural areas of developing countries without physicians to
      manage the patients. For this reason, the goal of this project is the clinical validation of
      an open real-time tele-stethoscope systme (EHAS-Fundatel digital stethoscope) previously
      designed, with different specialist (pneumologists, cardiologists and internists.)
    


Intervention name(s): Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)
Intervention type(s): Device
Intervention description(s): We compare the respiratory and heart auscultation of clinicians using the EHAS-Fundatel digital stethoscope and a conventional stethoscope and we will observe; inter-observer and intra-observer differences by two auscultation methods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telemedicina; Respiratory sounds; Tele-stethoscopy; Wireless; Real-time; e-health; Heart sounds
Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1
Condition: Type2 Diabetes; Bariatric Surgery Candidate; Laparoscopic Gastric Bypass; Obesity
MeSH terms: Obesity; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1
      obesity, undergoing laparoscopic gastric bypass. The objective was to determine short,
      mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). A
      subanalysis was included, based on preoperative usage of one (Group A) or more antidiabetics
      ± insulin (Group B).
    


Intervention name(s): Laparoscopic Gastric Bypass
Intervention type(s): Procedure
Intervention description(s): The LGBP was performed using a classic Roux-en-Y procedure. Briefly, a gastric pouch of 30-50 cc was constructed with an antecolic calibrated gastro-jejunal anastomosis (mechanical anastomosis using a 2.5 mm load). The biliary and alimentary limbs measured ≈70 cm and ≈150 cm, respectively, and the jejuno-jejunal anastomosis was also performed in a latero-lateral fashion (mechanical anastomosis using a 2.5 mm load). Mesenteric defects were closed with running non-absorbable sutures and the omentum was divided in every case
Other intervention name(s): Roux-en-y gastric bypass
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mexican patients with T2DM submitted to laparoscopic gastric bypass
      
Keywords: bariatric surgery; obesity class 1; metabolic surgery; laparoscopic gastric bypass; type-2 diabetes mellitus
Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety profile in healthy volunteers of a single
      intravenous administration of TCN-032 as compared with placebo.
    

Detailed description: 
      Influenza is a highly communicable acute respiratory disease that is considered to be one of
      the major infectious disease threats to the human population. Annual vaccination is generally
      effective only against those strains included in the vaccine. Because of the frequent
      emergence of divergent variants and the periodic emergence of strains with novel
      hemagglutinin and/or neuraminidase surface proteins that can result in global pandemics, the
      availability of potent antiviral agents for the prevention and/or treatment of influenza
      remains an urgent clinical and public health priority.
    

Intervention name(s): TCN-032; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): TCN-032 is a human monoclonal antibody that specifically binds to a conserved epitope of the amino-terminal extracellular domain (M2e) of the influenza virus matrix protein 2 (M2). The drug is intended for use as an antiviral agent for the treatment of disease caused by type A influenza viruses. Treatments within the study will consist of single ascending dose-escalation ranging from 1 to 40 mg/kg.; Placebo - 0.9% Sodium Chloride for Injection, USP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza; Monoclonal antibody
Simulating Laparoscopy With an Eye Patch
Condition: Laparoscopic Training
Study type: Interventional

Summary: 
      Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept
      perception) to investigate acquisition of laparoscopic skills.
    

Detailed description: 
      Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic
      training exercises on both the laparoscopic computerized trainer and on a simple box trainer
      with an eye patch.

      Novices will be allowed to familiarize themselves with the laparoscopic instruments and will
      be shown short video clips to demonstrate tasks.

      They then will have five minutes to complete each of the four tasks. They will return 1-2
      weeks later to complete the same process on the alternative training method.

      All participants will complete the tasks on both the computerized lap simulator and the box
      trainer.
    

Intervention name(s): Computerized Laparoscopic Trainer; Box trainer with eye patch
Intervention type(s): Device; Device
Intervention description(s): Gold standard laparoscopic trainer using simulated computerized equipment.; Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research