bioihbjkbjnl/mcl2 huggingface dataset:
24-Wk β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males
Condition: Sports Nutritional Physiological Phenomena
Study type: Interventional

Summary: 
      Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information
      exists on the safety of chronic supplementation despite potential concerns. The aim of this
      study was to investigate the effects of chronic BA supplementation on muscle taurine content,
      blood clinical markers and sensory side-effects during 24 weeks of BA supplementation.
    


Intervention name(s): Beta-alanine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Beta-alanine in sustained-release tablets to increase muscle carnosine content; Maltodextrin is used as a placebo as it does not lead to any increases in muscle carnosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Physiological Phenomena
The Effect of Vitamin D Repletion on Insulin Resistance
Condition: Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The reason for doing this study is to learn whether raising a person's vitamin D level from
      below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D
      is well known to be an important vitamin for the development and maintenance of bones.
      Recently, scientists have learned that vitamin D may have a role in the prevention of cancer,
      diabetes, and autoimmune diseases. The investigators are specifically interested in studying
      this question in the overweight/obese population as they are at greater risk for both vitamin
      D deficiency and impaired ability to metabolize sugar (glucose intolerance).

      Primary Hypotheses:

      Vitamin D repletion (increasing the serum 25(OH)D level from ≤ 20 ng/ml to ≥ 30 ng/ml) will
      improve insulin sensitivity in individuals who are overweight/obese and insulin resistant.

      Secondary Hypotheses:

      1.Vitamin D repletion will improve biomarkers of cardiovascular risk and inflammation
      (directly altering macrophage cytokine production and/or indirectly as a result of
      improvement in insulin sensitivity.) 2.30,000 IU (0.25 mg) weekly of cholecalciferol (vitamin
      D3) will raise serum 25(OH)D levels from ≤ 20 ng/ml to ≥ 30 ng/ml overweight/obese
      population.
    


Intervention name(s): Vitamin D3 (cholecalciferol)
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin D will be taken orally, 10,000 IU (0.25 mg) three times per week.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Metabolism
A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.

      Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized,
      placebo-controlled, two-period sequential pharmacodynamic (PD) arm.
    


Intervention name(s): DS-7309; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1, 2.5, 5, 10, 20 mg DS-7309 powder in bottle.; placebo to match part 2 DS-7309
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus
Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
Condition: Prehypertension; Hypertension
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based
      foods and fish on indicators of cardiovascular disease risk at two different levels of salt
      intake.

      The study is a 20-wk randomized controlled crossover trial. The subjects follow a
      salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all
      subjects. After that the subjects are randomly allocated to one of two groups. Group 1
      consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16
      weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups
      receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).
    


Intervention name(s): Effects of a Nordic diet rich in plant-based foods and fish
Intervention type(s): Other
Intervention description(s): The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: human; clinical trial; dietary intervention study; blood pressure; cardiovascular biomarkers; nutritional biomarkers; gene expression
Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual
      reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with
      traumatic brain injury (TBI). These patients, service members with TBI, can be both with and
      without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to
      improve cognitive and motor function, as well as mood.
    

Detailed description: 
      Bright Cloud International Corp created BrightBrainer, a computerized virtual reality system
      that provides a combination of cognitive as well as motor skill training in an engaging and
      repetitive manner [1]. This project objective is to assess the feasibility and clinical
      benefit of utilizing the BBVR to augment the rehabilitation of service members with TBI. The
      BrightBrainerTM Virtual Reality (BBVR) Rehabilitation System is unique because it is designed
      to provide integrative, customized, intensive and self-guided therapy that simultaneously
      addresses the cognitive, emotive and motor deficits. Early evidence suggests that it has been
      effective for patients with cognitive deficits as the result of cerebrovascular accident or
      dementia, but has not yet been evaluated in a therapeutic intervention for patients with TBI.
      In addition to assessing the system's effect on patient's symptoms, we will also evaluate the
      feasibility of utilizing this system in a military environment by obtaining feedback from the
      patients and therapists, regarding system acceptance, reliability and ease of use.
    

Intervention name(s): BrightBrainer Virtual Reality (BBVR) Rehabilitation System
Intervention type(s): Device
Intervention description(s): During the active treatment stage (3 sessions per week x 6 weeks), each BBVR therapy session will consist of a series of custom games targeting one or several cognitive domains of executive function, attention, short-term memory, working memory and language comprehension. In addition, the BBVR device incorporates uni- and bi-manual activities by having the subject manipulate hand-held devices, which are programmed to measure in real time the subject's 3D hand movement and index flexion/extension. Therefore, in addition to completing the cognitive tasks, subjects must manipulate virtual hands through a hand-held interface to also enhance visual-motor perception, hand-eye coordination, and upper limb function. In addition, wrist weights can be added to increase upper limb strength training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TBI; Virtual Reality
Womens's Experiences of Pregnancy Loss Aftercare in the Gynecological Emergency
Condition: Miscarriage
MeSH terms: Abortion, Spontaneous; Emergencies
Study type: Observational

Summary: 
      Introduction: Scientific papers on the womens's experiences of pregnancy loss aftercare in
      the emergency department show that how announcement is made and how much caregivers show
      empathy to women, help women to face this difficult moment. However, in most studies, women
      say they did not have enough information nor support from the medical teams.

      Diagnosis of miscarriage in the emergency department is the routine for the caregiver but is
      often experienced by the woman as the loss of a child.

      This study has for goal to bring to light the discrepancy between the caregivers's experience
      and the women's experience :the given information, the time for consultation, the empathy.

      Methods : 2 months after the diagnosis of miscarriage in the emergency room, patients receive
      a phone call with explanations about the project. If the patient gives her consent, she
      receives a computer questionnaire by email (questions about : reasons for coming to the
      emergency room, circumstances of announcement, information given in the emergency room,
      satisfaction with the care…) In parallel, caregivers have to complete a questionnaire about
      the same parameters.

      The main objective of this study is to evaluate womens's experiences of pregnancy loss
      aftercare in the emergency department of Montpellier Hospital.

      The second objective is to assess the discrepancy between the patient's experience and the
      caregivers' experience in this situation with the aim of suggesting improvement.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with diagnosis of pregnancy loss in the gynecological emergency department of
        Montpellier Hospital
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Condition: Acute Episode of Overt Hepatic Encephalopathy; Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Hyperammonemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ornithine phenylacetate can speed recovery
      from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
    

Detailed description: 
      The primary objectives of the study were to evaluate the efficacy of OCR-002 for treatment of
      an acute hepatic encephalopathy (HE) episode in cirrhotic patients requiring hospitalization
      and the safety and tolerability of OCR-002 in hospitalized cirrhotic patients with an acute
      episode of HE.
    

Intervention name(s): ornithine phenylacetate; placebo intravenous infusion
Intervention type(s): Drug; Drug
Intervention description(s): Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation; Placebo for continuous IV infusion that is visually identical to the experimental product
Other intervention name(s): OCR-002; Matching Placebo
Intervention MeSH terms: Phenylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatic encephalopathy; hyperammonemia; cirrhosis; ornithine phenylacetate; OCR-002
A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation
Condition: Smoking Cessation; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The purpose of the study is to obtain two year follow up data for subjects that received six
      vaccinations of NicVAX in prior phase III studies. No treatment will be administered.
      Anti-nicotine antibody levels and safety data will be collected.
    

Detailed description: 
      This study will follow subjects that participated in the NicVAX phase III studies for a
      second year. These predecessor studies, Nabi-4514 (NCT#00836199) and Nabi-4515 (NCT#01102114)
      evaluate the efficacy and safety of 6 vaccinations of NicVAX or placebo as an aid to smoking
      cessation. The two phase III studies are one year in duration, and subjects who complete
      these studies are eligible to enroll in Nabi-4522. As the phase III studies are ongoing,
      subject assignment to NicVAX or placebo will remain masked. No intervention will be
      administered in Nabi-4522. Subjects will be followed for immunogenicity (anti-nicotine
      antibody level)and for safety.
    

Intervention name(s): NicVAX vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.; Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be invited into this study following their participation in Nabi-4514 or
        Nabi-4515.
      
Biospecimen description: 
      serum samples
    
Keywords: NicVAX; Smoking cessation
Exercise Treatment of Mild-Stage Probable Alzheimer's Disease
Condition: Alzheimer Disease; Memory Disorders; Dementia
MeSH terms: Alzheimer Disease; Dementia; Memory Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine if participation in an exercise program helps memory
      loss from getting worse, and if it improves daily functioning and attitudes of those with
      probable Alzheimer's disease. It will involve participation of both the person with memory
      loss and someone who knows their daily activities (e.g., husband, wife, adult child, or
      caregiver).
    

Detailed description: 
      Currently, there is no cure for the memory loss associated with Alzheimer's disease, though
      some medications can help it from getting worse. The research study will help to answer the
      question if participation in an exercise program helps memory loss from getting worse, and if
      it improves daily functioning and attitudes of those with probable Alzheimer's disease. It
      will involve participation of both the person with memory loss and someone who knows their
      daily activities.

      The research study is a randomized-control trial: some participants will be picked to
      participate in the exercise program, while others will not. Their memory, thinking abilities,
      activities, and attitudes will be measured at baseline and follow-up assessment 5-6 months
      later. Participants are in good health, and are treated with a cholinesterase inhibitor for
      memory loss (standard treatment).
    

Intervention name(s): Participation in a monitored exercise program; Personalized aerobic and strength training.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): No contact with control group during 20 weeks.; Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild Dementia; Mild Alzheimer; Cognitive Impairment; Cholinesterase Inhibitor; Exercise; Physical activity; Behavior; Memory loss
Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)
Condition: Sexual Arousal
Study type: Observational

Summary: 
      This study will examine whether measurement of pelvic floor muscle sEMG activity is
      responsive to explicit sexual stimuli, and whether it correlates with self-reports of sexual
      arousal in healthy women. Participants' vaginal, labial and anal sEMG readings will be
      monitored during exposure to neutral, erotic and anxiety-provoking films. Participants will
      also be required to provide subjective ratings of sexual arousal before and after each film.
      If pelvic floor sEMG is validated as a psychophysiological measure, these findings may have
      important clinical and research implications by providing a greater understanding of the
      mechanisms involved in sexual arousal and for providing a relatively easy method of assessing
      sexual arousal in a clinical or research setting.
    

Detailed description: 
      HYPOTHESES:

        1. Investigators hypothesize that, relative to the neutral films, PFM EMG activity will
           significantly increase in response to the erotic film as measured by the labial, anal,
           and vaginal EMG probes.

        2. Investigators hypothesize that, relative to the anxiety-provoking film, PFM EMG activity
           will significantly increase in response to the erotic film as measured by the labial,
           anal, and vaginal EMG probes.

        3. Investigators hypothesize that continuously measured subjective sexual arousal (via the
           arousometer) will correlate significantly with PFM EMG activity during the erotic film.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy females.
      
Keywords: sexual arousal; pelvic floor sEMG
Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of
      GSK716155 in Japanese subjects with type 2 diabetes mellitus
    


Intervention name(s): GSK716155 for injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.; Subjects will also receive placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: GLP-1; type 2 diabeted mellitus; safety; GSK716155; GLP-1 receptor agonist; tolerability; pharmacokinetics; pharmacodynamics
Usefulness of a Mobile Information Management System for Haemodialysis Patient
Condition: Quality of Life; Drug Habit
Study type: Interventional

Summary: 
      The investigators developed and used the DialysisNet mobile application for physicians and
      Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration
      and exchange were based on the American Society for Testing and Materials Continuity of Care
      Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to
      evaluate user experience and usefulness were administered before and after use.
    


Intervention name(s): Use of DialysisNet for doctor; Use of Avatar Beans for patient
Intervention type(s): Device; Device
Intervention description(s): DialysisNet is mobile application for physicians for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard.; Avatar Beans is mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to assess the effect of BI 409306 on the QT/QTc
      interval in healthy male and female volunteers as measured by the QTcF change from baseline
      compared with placebo.

      Secondary objectives are to show the assay sensitivity of the trial, by reproducing the
      typical effect of the positive control moxifloxacin on the QT/QTc interval, and to assess the
      effect of BI 409306 on heart rate.
    


Intervention name(s): BI 409306; Moxifloxacin; Placebo matching to BI 409306
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Film-coated tablet
Other intervention name(s): Avalox®
Intervention MeSH terms: Moxifloxacin; BI 409306
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Computer-based Cognitive Training for Parkinson Disease
Condition: Parkinson Disease; Gait
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system
      disease that influences not only the motor but also the cognitive and autonomic systems. The
      main cognitive impairment in individuals with PD is found in executive function (EF). EF is
      defined as a set of cognitive skills necessary for planning, monitoring and executing
      sequences of complex activities.

      The primary study hypothesis is that computer-based training aimed at improving executive
      function will have a beneficial effect on gait functions.
    

Detailed description: 
      Parkinson Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system
      disease that influences not only the motor but also the cognitive and autonomic systems. The
      main cognitive impairment in individuals with PD is found in executive function (EF). EF is
      defined as a set of cognitive skills necessary for planning, monitoring and executing
      sequences of complex activities. Previous studies have revealed some relation between
      cognitive states and physical functions in healthy adults. Few studies have examined the
      effect of computer-based cognitive training on various populations. These studies showed a
      positive emotional-cognitive effect in those populations. This type of intervention plan was
      also applied to PD patients. However, there are no reports on the effect of intentional
      cognitive training on gait functions. The purpose of the study is to assess whether cognitive
      training, designed to improve EF ability, can also improve gait function in PD patients.
    

Intervention name(s): Computerized cognitive training
Intervention type(s): Other
Intervention description(s): A 12 week computerized cognitive training at home with the Attengo™ software program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Computerized Cognitive training; Quality of life; Gait Function; Executive Function