bioihbjkbjnl/mcl2 huggingface dataset:
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this study is to determine if addition of low frequency
      electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity
      and/or muscular strength in chronic heart failure patients.
    

Detailed description: 
      In chronic heart failure, low exercise capacity is due, in part, to peripheral muscles
      abnormalities. Exercise training performed during cardiac rehabilitation improves exercise
      tolerance measured by cardiopulmonary exercise test. Low frequency electromyostimulation
      (EMS) was proposed as an alternative to exercise training (ET) in this population.

      However, the effectiveness of the combination (EMS +ET) compared with ET alone is not proved.
      The main objective is to compare exercise capacity judged by peak VO2 after treatment by ET
      alone versus EMS+ET. The secondary end points are results on sub maximal parameters, muscular
      resistance, quality of life and effectiveness regarding clinical sub-groups.

      This study is a controlled, randomized, multicentric (14 centres) designed to include 90
      patients by group in two years period. Inclusion criteria are: CHF patients , NYHA class II
      to IIIb, with LVEF < 40% referred to complete a cardiac rehabilitation program.

      All the patients benefit from a comprehensive cardiac rehabilitation program including
      educational program, therapeutical optimisation and exercise training for 20 sessions, 3 to 5
      days a week. The group of patients randomized for additional EMS has 20 sessions of 1 hour
      electrical quadricipital myostimulation.
    

Intervention name(s): Low electrical myostimulation
Intervention type(s): Device
Intervention description(s): The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chronic Heart Failure; Cardiac rehabilitation; Exercise training; Peak VO2; Electrical myostimulation
Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study designed
      to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for the
      treatment of subjects with clinically diagnosed Alzheimer's disease.
    

Detailed description: 
      This is a randomized, placebo-controlled clinical trial designed to evaluate the safety and
      efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) or placebo in subjects with Alzheimer's
      Disease. Following a successful Safety Run-In Phase, a total of twenty-five (25) subjects
      will be randomized to (2:2:1) to receive low-dose LMSCs, high-dose LMSCs or placebo. After
      randomization, baseline imaging, and study product infusion, subjects will be followed up at
      2,4,13, 26, 39 and 52 week post study product infusion. Intention-to-treat study population
      will be used for the purpose of the endpoint analysis and safety evaluations.
    

Intervention name(s): Longeveron Mesenchymal Stem Cells; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): via peripheral intravenous infusion; via peripheral intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral
      suspension in children with Juvenile Rheumatoid Arthritis (JRA)
    


Intervention name(s): meloxicam oral suspension; naproxen oral suspension
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naproxen; Meloxicam
Intervention model: Parallel Assignment
Primary purpose: Treatment
Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this work is to compare the hemodynamic and analgesic properties of
      Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.
    

Detailed description: 
      Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1
      selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine
      has various clinical uses in anesthesia such as sedation, and prolongation of the duration of
      postoperative analgesia when used as an adjuvant through intrathecal, epidural, or
      intravenous routes.

      Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses
      nociceptive impulses through inhibition of voltage-gated calcium channels and through
      antagonism of the N-methyl D-aspartate (NMDA) receptors.

      Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to
      the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs
      when used as intravenously during spinal anesthesia.
    

Intervention name(s): Dexmedetomidine; Magnesium Sulphate; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.; This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour; This group will receive normal saline infusion
Other intervention name(s): Precedex
Intervention MeSH terms: Magnesium Sulfate; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect
      of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin,
      omeprazole, digoxin and rosuvastatin as probe drugs.
    


Intervention name(s): HRS5091 Tablets; Midazolam Maleate Tablets; Warfarin Sodium Tablets; Omeprazole Enteric Capsules; Vitamin K1 Tablets; Digoxin Tablets; Rosuvastatin Calcium Tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): HRS5091 Tablets once daily; Midazolam Maleate Tablets single dose; Warfarin Sodium Tablets single dose; Omeprazole Enteric Capsules single dose; Vitamin K1 Tablets once daily; Digoxin Tablets single dose; Rosuvastatin Calcium Tablets single dose
Intervention MeSH terms: Vitamin K; Vitamin K 1; Digoxin; Midazolam; Omeprazole; Warfarin; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Intervention model description: Single-center, single arm, open-label, fixed sequence, self-control
Masking: None (Open Label)
Primary purpose: Basic Science
Turkish Validity and Reliability of Physiotherapist Self-Efficacy Questionnaire
Condition: Physiotherapy; Self Efficacy; Education
Study type: Observational

Summary: 
      The aim of this study is to provide Turkish validation and determine the validity of the
      "Physiotherapist Self-Efficacy Questionnaire".
    

Detailed description: 
      Self-efficacy is defined as one's belief in one's existing capacity to perform the necessary
      behavior in a specific situation. "Physiotherapist Self-Efficacy Questionnaire" has been
      developed to be used in the assessment of self-efficacy for the field of physiotherapy and
      rehabilitation. In this scale, there are 13 items about how competent the individual feels in
      clinical assessment, problem solving, planning, and communication related to caseloads.

      It has been shown that the scale is a valid and reliable method in cardiorespiratory,
      musculoskeletal and neurological clinical fields, which are special areas of physiotherapy
      and rehabilitation.
    

Intervention name(s): Questionnaire study
Intervention type(s): Other
Intervention description(s): The Turkish validity and reliability of the questionnaire will be examined.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The physiotherapy and rehabilitation students who have done internship in at least one
        institution or graduate physiotherapists will be included in the study. Participants will
        re-answer the Turkish version of Physiotherapist Self-Efficacy Questionnaire within one
        week. They will also answer the General Self-efficacy Scale.
      
Keywords: physiotherapy; self efficacy; clinical practice; validation
Measurement of Diaphragmatic Dysfunction After Thoracic Surgery
Condition: Diaphragm Injury; Phrenic Nerve Paralysis; Thoracic Cancer; Postoperative Complications
MeSH terms: Paralysis; Postoperative Complications
Study type: Observational

Summary: 
      This study aims to measure diaphragmatic dysfunction with ultrasonography and nerve
      stimulation of the phrenicus nerve, in patients undergoing thoracic surgery for lung and
      esophageal cancer, and correlate measures of diaphramatic function to clinical postoperative
      endpoints.
    


Intervention name(s): Lung lobectomy OR esophagus cancer resection
Intervention type(s): Procedure
Intervention description(s): Lunge lobectomy (total) Resection of esophagus cancer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for resection surgeries for either lung or esophagus cancer.
A Single-dose Trial to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-dose dose escalation trial in a randomised, single-blind, placebo-controlled
      group-comparison design to investigate the safety and tolerability of XEN-D0501 in subjects
      with diabetes mellitus type 2 where life style changes and treatment with metformin has
      failed to effectively reduce blood glucose concentrations.
    


Intervention name(s): Placebo; XEN-D0501, 1 mg/tablet; XEN-D0501, 2 mg/tablet; XEN-D0501, 4 mg/tablet; XEN-D0501, 8 mg/tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects in the placebo arm will receive a single oral tablet containing no active drug.; Subjects in this arm will receive a single oral tablet of XEN-D0501, 1 mg/tablet; Subjects in this arm will receive a single oral tablet of XEN-D0501, 2 mg/tablet; Subjects in this arm will receive a single oral tablet of XEN-D0501, 4 mg/tablet; Subjects in this arm will receive a single oral tablet of XEN-D0501, 8 mg/tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each subject will be randomised to one of four treatments, placebo and three different single oral doses of XEN-D0501. Cohorts of 8 patients are run subsequently where of 2 patients receive placebo and 6 patients receive XEN-D0501 beginning with the 1 mg dose followed by the 2, 4 and 8 mg dose groups. Each treatment step will be completed consecutively and progression to next dose level depend on good safety and tolerability on the previous dose level.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: safety; tolerability
Elective Induction vs Spontaneous Labour in Patients With Heart Disease
Condition: Heart; Disease,Complicating Pregnancy, Pre-existing
MeSH terms: Pregnancy Complications; Heart Diseases
Study type: Interventional

Summary: 
      Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were
      randomised into elective induction and spontaneous labour groups only after bishop score was
      equal to or more than 6.It was concluded that induction of labour with oxytocin is a
      relatively safe procedure in women with low risk heart disease with NYHA class I and II. It
      resulted in a similar caesarean delivery rate and was not associated with more maternal and
      neonatal complications.
    

Detailed description: 
      Induction of labour was done with oxytocin. An infusion of 30U oxytocin diluted in 500ml
      normal saline was prepared and given through infusion pump at initial rate of 3mU/min.
      Subsequently dose was increased 3mU/min every 45 min till adequate uterine contractions were
      established.

      Epidural analgesia was provided wherever feasible or Injection Morphine 2-5mg was given
      intravenously for pain relief.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): Arm - Induction of labour
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: induction of labour; heart disease patients
Assessing the Impact of Self-directed Care, Within a Medicaid-funded Environment,on Participation and Community Living
Condition: Major Depression; Bipolar Disorder; Schizophrenia
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional

Summary: 
      This project proposed to demonstrate the effectiveness, costs, and benefits to participation
      and community living self-directed care programming within a financially sustainable Medicaid
      managed care environment. The study examined outcomes associated with the implementation of a
      novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in
      which consumers were able to access a set amount of renewable funds per year and direct how
      they were spent, both to purchase the types and amounts of rehabilitation and treatment
      services they desire (and from whom they choose) and to purchase a broad-range of
      individualized resources and services that are generally outside of Medicaid funding (e.g.,
      health club memberships, yoga classes, support in taking care of bills).
    


Intervention name(s): self-directed care
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: self-directed care; serious mental illness
Study of Multiple Oral Doses of PF-07081532 in Adult Participants 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 Phase 1, randomized, placebo-controlled, double-blind (investigator- and
      participant-blinded), sponsor-open study of PF-07081532. Study participants will receive the
      investigational product or placebo every day for 42 days.

      The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of
      multiple oral doses of PF-07081532 in participants with inadequately controlled type 2
      diabetes mellitus, on metformin and optionally in non-diabetic participants with obesity.
    


Intervention name(s): PF-07081532; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study Drug, once daily for 42 days; Placebo, once daily for 42 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Type 2 Diabetes Mellitus; Obesity
A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the impact of impaired renal function on the plasma
      pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in
      participants with overactive bladder and to guide recommendations on potential dosing
      adjustments for individuals with varying degrees of renal impairment.
    


Intervention name(s): Vibegron 100 mg
Intervention type(s): Drug
Intervention description(s): Vibegron tablets, orally, on Day 1
Other intervention name(s): MK-4618
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This study will assess the safety and efficacy of repetitive transcranial magnetic
      stimulation (rTMS) as new preventive treatment of migraine.
    

Detailed description: 
      Migraine patients according to International Headache Society criteria will be allocated
      randomly into two treatment arms. One group will receive active rTMS and another group will
      receive sham rTMS for treatment phase (5 sessions). Assessment will be made at baseline,
      month 1, month 2 and month 3 post-treatment.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation.; Sham rTMS
Intervention type(s): Device; Device
Intervention description(s): High frequency rTMS on left dorsolateral prefrontal cortex.; Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
Other intervention name(s): rTMS; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel assignment involves two groups of participants. One group receives r-TMS, and the other group receives sham placebo r-TMS.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Transcranial Doppler; Neuromodulation; Randomized Controlled Trials; Pain; Migraine prophylaxis; Dorsolateral Prefrontal Cortex; Protocol
Safety and Tolerability of COMBIVENT® HFA as Compared to COMBIVENT® CFC and Placebo HFA in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the safety and tolerability of COMBIVENT® hydrofluoroalkane (HFA) as compared
      to COMBIVENT® chlorofluorocarbons (CFC) and placebo HFA after single and repetitive dosing in
      healthy male and female subjects
    


Intervention name(s): COMBIVENT® HFA-MDI; COMBIVENT® CFC-MDI; Placebo HFA-MDI
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
Condition: Lung Adenocarcinoma Stage IV
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The single arm clinical study is to evaluate the efficacy and safety of Tislelizumab combined
      with Bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. All
      of the patients were received EGFR-TKI therapy for 1 line and disease progression. The
      primary endpoint is median PFS and safety, the seconday endpoint is ORR and one-year OS rate.
    

Detailed description: 
      Patients who meet the inclusion criteria will receive Tislelizumab combined with Bevacizumab
      and albumin paclitaxel for 4 cycles. If there is no disease progression, the patient will
      continue to receive Tislelizumab maintenance therapy, until the disease progresses or death.
    

Intervention name(s): Tislelizumab
Intervention type(s): Drug
Intervention description(s): Tislelizumab, 200mg, Q3W ,use until disease progression
Other intervention name(s): Albumin paclitaxel; Bevacizumab
Intervention MeSH terms: Paclitaxel; Tislelizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette's Disorder
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if vigabatrin, an unusual anti-seizure medication,
      will diminish the Tourette Disorder outbursts in young adults whose symptoms have persisted
      into adulthood and have not responded to usual treatment.
    

Detailed description: 
      The aims of this study are to 1) explore proof of concept that CPP-109 will reduce tics, and
      2) to obtain systematic data regarding dosing, safety and tolerability of CPP-109 in adults
      with treatment refractory TD. We will obtain preliminary data on estimate of effect size for
      tics using Cohen's d, calculating the difference between the two means (baseline and endpoint
      scores on the YGTSS), divided by the standard deviation of the difference.
    

Intervention name(s): vigabatrin
Intervention type(s): Drug
Intervention description(s): 3 tablets, bid for 8 weeks
Other intervention name(s): CPP-109 Vigabatrin
Intervention MeSH terms: Vigabatrin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tourette's Disorder; vigabatrin