bioihbjkbjnl/mcl2 huggingface dataset:
Physiological Changes From Hand Movement Training
Condition: Stroke
Study type: Interventional

Summary: 
      11 participants with upper-limb impairment will be recruited from community sources. They
      will be invited to participate in a 15-day trial involving the IRegained device. The study
      will involve 2 assessment visits to Baycrest, before and after the treatment, and 15
      treatment visits. The data from the pilot study will be analyzed both quantitatively and
      qualitatively, as outcomes and explicit feedback from participants will be used to further
      optimize the device for future studies.
    

Detailed description: 
      This pilot study will investigate the potential changes in the brain area controlling hand
      movement following 15 days of exercises to improve hand function in participants with upper
      limb impairments resulting from stroke. A device developed by Dr. Vineet Johnson (IRegained
      Inc.) will be used to administer standardized exercises to improve hand function. To assess
      brain changes, transcranial magnetic stimulation pulses will be delivered to the motor
      cortex. The motor evoked potential (MEP), a muscle response evoked from the TMS, will be
      measured using electrodes on the hand. This study will test the feasibility of conducting
      motor therapy using this device while assessing potential changes in motor cortex function.
      Findings from this study will contribute to developing treatment trials aimed at improving
      impaired limb function in stroke patients and quality of life in these individuals
    

Intervention name(s): Treatment using the MyHand System
Intervention type(s): Device
Intervention description(s): Participants will undergo three weeks of 1-hour hand therapy with the MyHand System. The MyHand System provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Muscle Afferent Feedback Effects in Patients With Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to find out more about the mechanism by which neural feedback
      from the working muscle affects the development of central fatigue during exercise. Subjects
      with chronic heart failure (HF) and healthy subject counterparts will be tested to determine
      the mechanisms accounting for the premature fatigue characterizing HF patients during
      physical activity.
    

Detailed description: 
      A substantial part in limiting exercise and/or physical activity in humans results from the
      development of peripheral and central fatigue during physical activity. Peripheral fatigue
      comprises biochemical changes within the metabolic milieu of the working muscle leading to an
      attenuated response to neural excitation, while central fatigue comprises a failure of the
      central nervous system to drive motoneurons.

      Patients with HF have overactive group III/IV muscle afferents and an exaggerated development
      of central fatigue during physical activity that is not explained by their reduced physical
      conditioning or cardiac insufficiency caused by their failing heart. The exact mechanisms
      accounting for the exaggerated central fatigue in HF remains elusive, however, the
      development of central fatigue during exercise has recently been linked to signaling by group
      III/IV muscle afferents. This makes the heightened neural feedback in HF a likely candidate
      for these patients' increased susceptibility to central fatigue.

      Lower pH, increased lactate and increased adenosine triphosphate has been shown to activate
      group III/IV afferents in a physiological manner and thus induce, in a rested and unfatigued
      muscle, the intramuscular milieu associated with moderate to heavy exercise. The objective of
      this study is to quantitate and compare the sensitivity of group III/IV afferents and
      associated effects on central fatigue in HF patients and healthy controls when skeletal
      muscle is subject to controlled lower pH, increased lactate and increased adenosine
      triphosphate.
    

Intervention name(s): Muscle Contraction with Metabolite Solution Administration
Intervention type(s): Drug
Intervention description(s): Participants will perform maximal elbow flexor or knee extensor contractions before and after administration of metabolite solutions of pH 7.2, pH 7.0 and pH 6.6
Other intervention name(s): adenosine triphosphate, lactate, and protons with phosphate buffer
Intervention MeSH terms: Adenosine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      To investigate headache score and accompanying symptoms during and after inhalation of carbon
      monoxide.
    

Detailed description: 
      To investigate headache score and accompanying symptoms during and after inhalation of carbon
      monoxide.

      With transcranial Doppler imaging, c-scan and laser speckle the investigators will
      investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of
      the superficial temporal artery (STA), the radial artery and facial skin perfusion.
    

Intervention name(s): Carbon monoxide; AIR
Intervention type(s): Other; Other
Intervention description(s): carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass; Room air will be administered as placebo
Intervention MeSH terms: Carbon Monoxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Observational

Summary: 
      Nausea and vomiting after surgery are one of the complications that occur after general
      anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group.
      Several studies have introduced drugs and methods to prevent nausea and vomiting after
      surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic
      and sedative effects on the prevention of nausea and vomiting after surgery. It has also been
      reported to increase its effectiveness when administered with other antiemetic agents.

      The purpose of this study is to compare the effects of administration of combination with
      midazolam and different antiemetic agents on the prevention of postoperative nausea and
      vomiting in high-risk patients.
    

Detailed description: 
      This prospective study evaluates female, nonsmoking patients undergoing laparoscopic
      cholecystectomy. The patients are divided into those with and without postoperative nausea
      and vomiting. The purpose of this study is to compare and observe the effect of
      administration of midazolam and two different antiemetics on prevention of postoperative
      nausea and vomiting.

      0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a
      pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery
      and 0.075mg palonosetron is administered intravenously immediately after induction of
      anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain
      severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        female patients aged 20 to 65 with ASA physical status 1 or 2 undergoing laparoscopic
        cholecystectomy
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TD0069 Capsule for Patients With Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19
      by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The
      reported symptoms vary from fever or chills, cough, shortness of breath, to muscle aches,
      headaches, loss of taste or smell.

      The capsule TD0069 is a product based on the traditional medicine named "Ren shen bai du san"
      which is used to treat the cold conditions, also known as the initial plague according to the
      theory of traditional medicine.
    

Detailed description: 
      The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19
      by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The
      reported symptoms have included, but are not limited to fever or chills, cough, shortness of
      breath, muscle aches, headaches, loss of taste or smell, diarrhea, dizziness, sore throat,
      abdominal pain, anorexia, and vomiting.

      The capsule TD0069 is a product based on the traditional prescription named "Ren shen bai du
      san" which is used to treat the cold conditions, also known as the initial plague according
      to the theory of traditional medicine.

      The study compares between standard dose regimen of TD0069 combined with standard treatment
      in COVID-19 patients and only standard treatment in COVID-19 patients. A sample size of 570
      patients, 380 in TD0069 arm and 190 in Placebo arm.

      All participants will be treated and followed up in 14-day period. In case the participant
      meets the discharge criteria before 14 days, discontinuing the study drug will be done at the
      discretion of the investigators.

      Firstly, screening procedures occur at Day 1. Secondly, periodic assessments are conducted
      daily from Day 2-14. Finally, end-of-study assessments are conducted according to the study
      protocol.
    

Intervention name(s): TD0069 hard capsule; TD0069 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TD0069 hard capsule (800 ± 7.5% mg/capsule) contains 600 mg fine powder of mixed herbal medicines and 200 mg excipients.; TD0069 placebo (800 ± 7.5% mg/capsule) contains excipients
Other intervention name(s): Sunkovir; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study subjects are randomized in a 2:1 ratio to 14 days treatment with TD0069 (3 capsules x 3 times/day) or Placebo (3 capsules x 3 times/day) based on a randomization block size of 6.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of Part A is to determine the safety and tolerability of natalizumab
      administered over 24 weeks in Japanese participants with relapsing-remitting multiple
      sclerosis (MS). The endpoints for this will include assessment of adverse evetns (AEs),
      changes in laboratory evaluations, vital signs, Expanded Disability Status Scale (EDSS)
      scores, and changes in physical and neurological examination findings. The secondary
      objectives of Part A are to characterize the pharmacokinetics (PK) profile and
      pharmacodynamics (PD) of natalizumab.

      The primary objective of Part B is to determine if natalizumab, when compared to placebo, is
      effective in treating Japanese participants with relapsing-remitting MS, as measured by new
      active lesions on cranial magnetic resonance imaging (MRI) scans over 24 weeks. New active
      lesions are the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly-enlarging
      T2-hyperintense lesions that do not enhance. The primary endpoint is the rate of development
      of new active lesions over 24 weeks.

      Secondary objectives of Part B are to determine over 24 weeks whether natalizumab, when
      compared to placebo, is effective in reducing the frequency of clinical exacerbations,
      reducing the number of Gd+ lesions, reducing the number of new or newly-enlarging
      T2-hyperintense lesions on brain MRI scans, increasing the proportion of relapse-free
      participants, and improving outcomes on visual analog scale (VAS) assessing the participant's
      global impression of his/her well-being. Additional objectives are to assess the safety and
      tolerability, the incidence of serum antibodies to natalizumab and the PK profile of
      natalizumab.
    

Detailed description: 
      This multicenter study has 2 parts and is designed to provide data in Japanese participants,
      as required for registration of natalizumab (BG00002) in Japan. Part A will consist of an
      open-label cohort of 12 participants who will receive 300 mg natalizumab intravenously (IV)
      every 4 weeks over a 6-month treatment period. Part B will consist of a double-blind,
      placebo-controlled cohort of approximately 90 participants randomized in a ratio of 1:1 to
      receive IV infusions of placebo or 300 mg BG00002 every 4 weeks over a 6-month period.
    

Intervention name(s): Natalizumab (BG00002); Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Tysabri
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Melatonin and the Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial seeks to compare the effects of melatonin supplementation versus placebo in
      subjects with the metabolic syndrome.
    

Detailed description: 
      The primary purpose of this Phase II crossover design trial is to examine the safety and
      efficacy of 8mg of melatonin taken one hour before bedtime compared to a placebo treatment to
      improve at least one of the five components associated with the metabolic syndrome.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg dose of Melatonin; Placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood Pressure; Glucose levels; HDL levels; Triglyceride levels; Waist Circumference
Mindfulness-based Stress Reduction for Pediatric Mental Health
Condition: Mental Health Wellness 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught
      to be mindful or present-focused. MBSR programs consist of instruction in a variety of
      mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion
      of these practices. Our study purpose is to develop and conduct a pilot mixed-methods
      randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and
      brain imaging to assess the impact of the intervention on children with mental health
      challenges.
    

Detailed description: 
      This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care
      plus MBSR. Participants will be residents of a local inpatient treatment facility for
      adolescents with serious mental health issues. Outcomes the investigators will measure
      include mental health status as well as mindfulness. The investigators will also conduct
      qualitative interviews to assess the personal impact of the intervention on the patients and
      their families. In order to map and measure cognitive changes during MBSR the investigators
      will conduct brain imaging using functional magnetic resonance imaging (fMRI) and
      Event-Related Potential (ERP) recordings. Through this study the investigators will determine
      if MBSR is helpful to our population.
    

Intervention name(s): Mindfulness-based stress reduction program; Usual care
Intervention type(s): Other; Other
Intervention description(s): Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat; The site provides family centered treatment where adolescents take part in therapy from Sunday evening until Friday afternoon. In addition to a structured day and evening schedule, standard treatment includes: Daily group therapy; ii) Medications; iii) Schooling by Edmonton Public School Board teachers; iv) Physical education and recreation; and v) Weekly Multiple Family Therapy.
Other intervention name(s): MBSR; standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MBSR; adolescent; mental health
Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients
Condition: Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients
MeSH terms: Influenza, Human
Study type: Observational [Patient Registry]

Summary: 
      Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for
      hospitalised paediatric influenza patients
    

Detailed description: 
      This study aimed to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir
      combination therapy to that of oseltamivir treatment alone for hospitalised paediatric
      influenza patients. This prospective, single-blinded study included patients hospitalised for
      influenza infection aged 1 year to 18 years, at MacKay Children's Hospital, Taiwan, between
      December 2017 and December 2019. The primary outcomes were respiratory symptom severity and
      the signs that presented within hospitalisation. The durations of fever and hospital stay
      were also documented. The secondary outcome measures were serial changes in the virus titres,
      as detected by real-time polymerase chain reaction. Totally 54 patients were enrolled (28 in
      the control group and 26 in the combination group). There were no differences in the
      patients' baseline characteristics between the groups. The time to defervescence was
      significantly shorter in the combination group than the oseltamivir group (13.2 hours vs 32.1
      hours, p=0.002). The decrease in the virus titre was more pronounced from days 1 to 3 (log
      Δ13) in the combination group than the oseltamivir group.(log Δ13: 39% vs 19%, p=0.001). In
      paediatric settings, combination therapy may be used selectively among patients with a
      history of febrile convulsion or families anxious about the discomforts associated with the
      fever itself.
    

Intervention name(s): clarithromycin-naproxen-oseltamivir
Intervention type(s): Drug
Intervention description(s): to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients.
Intervention MeSH terms: Clarithromycin; Oseltamivir; Naproxen
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study was conducted at Mackay Children's Hospital, Taiwan, between December 2017 and
        December 2019.
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared
      with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant
      depression (TRD).
    


Intervention name(s): Duloxetine; Escitalopram; BMS-820836 Placebo; BMS-820836; BMS-820836; BMS-820836; BMS-820836
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D); Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D); Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C); Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C); Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C); Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C); Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Other intervention name(s): Cymbalta; Lexapro
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability of BI 10773 and Sitagliptin in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate whether there was a drug-drug interaction between BI 10773
      and sitagliptin when co-administered as multiple oral doses. Therefore, the relative
      bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in
      combination compared with BI 10773 or sitagliptin given alone.
    


Intervention name(s): BI 10773; Sitagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment