bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-human study of the formulation ABY-035/AFO2 is to investigate
      the safety, tolerability and efficacy after multiple doses in sequential escalating dose
      cohorts in psoriasis subjects.
    


Intervention name(s): ABY-035/AFO2
Intervention type(s): Biological
Intervention description(s): Analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 that 25 subjects will receive for treatment of their active plaque psoriasis
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: An exploratory, clinical study with 2 open-dose cohorts is designed to analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 in the treatment of subjects with active plaque psoriasis.
Masking: None (Open Label)
Primary purpose: Treatment
Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Condition: Sleep Apnea; Diabetes
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This is a randomized control trial in people with diabetes and obstructive sleep apnea who
      will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep
      education or healthy lifestyle and sleep education.
    

Detailed description: 
      Research over the last decade has shown that obstructive sleep apnea (OSA) is a common
      condition in people with diabetes. Observational and experimental evidence also indicates
      that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and
      worsen glycemic control. However, the impact of treating OSA with positive airway pressure
      (PAP) therapy on glycemic variability and control is not well defined. Adequately powered
      randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for
      OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and
      reverse endothelial dysfunction. The overarching goal of this study is to determine whether
      PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as
      assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b)
      glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary
      biomarkers; and (f) dyslipidemia.
    

Intervention name(s): REMStar Positive Airway Pressure; LifeStyle Counseling
Intervention type(s): Device; Behavioral
Intervention description(s): Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea; Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine if aspirin from PL2200, an investigational product, gets into the
      blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to
      prevent blood clots as effectively as enteric coated aspirin, when administered to patients
      with diabetes
    


Intervention name(s): PL2200 Aspirin Capsules; Enteric-coated aspirin caplets
Intervention type(s): Drug; Drug
Intervention description(s): 325 mg aspirin; once per day for 10 days; 325 mg aspirin; once per day for 10 days
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Childhood Asthma and Schooling: The Truth Unveiled
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Childhood Asthma and Schooling: The Truth Unveiled.
    

Detailed description: 
      Children with mild persistent asthma still performed worse than normal healthy children in
      school. The aim of the study was to evaluate school performance of children with mild
      persistent asthma in comparison with normal healthy children.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of a certain town
      
Keywords: The effect of bronchial asthma on school performance
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once
      per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS)
      patients.
    

Detailed description: 
      The proposed study will assess primarily safety and secondary efficacy endpoints of
      allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 20 patients with
      MS.

      The primary objective of the trial is freedom from treatment associated adverse events at
      4,12 and 52 weeks post treatment. Secondary objective will be efficacy as assessed at
      baseline, week 12 and 52 and will be quantified based on the following: Neurological
      assessment of the MS functional composite assessment which comprises of Expanded Disability
      Status Scale (EDSS), the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis,
      the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the
      nine-hole peg test, and 25-foot walking time. Short-form 36 (SF-36) quality of life
      questionnaire and gadolinium enhanced MRI scans of the brain and cervical spinal cord will
      also be performed at the indicated time points.
    

Intervention name(s): Umbilical cord mesenchymal stem cells
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; umbilical cord; mesenchymal; stem cells
Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)
Condition: Dilated Cardiomyopathy; Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated
Study type: Interventional

Summary: 
      First, investigators must determine the physiological standards across age classes of
      myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular
      stiffness [VD] and left ventricular [LV]). This will be done in groups of children without
      heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1
      year-5 years, 5 years-15years]).

      Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on
      different groups of children (same age group) with cardiomyopathy and examine correlations
      with the conventional parameters of systolic and diastolic function of both ventricles and
      with myocardial strain values. The total population of the study will be 120 children (40
      healthy, 80 patients).
    

Detailed description: 
      Monocenter Prospective, open-label, non-randomized. All patients included in the study have a
      specific consultation built around a clinical examination and echocardiography, in two
      stages, with estimates of the stiffness of the myocardium ShearWave Elastography (Aixplorer®)
      and measures of all echocardiographic parameters estimated in children with a clinical
      ultrasound machine (Philips and General Electric).

      Following this consultation, clinic and electrocardiographic monitoring period will be
      observed for 30 minutes, to ensure the safety of our procedure.

      Required subjects: 40 healthy volunteers + 80 = 120 persons
    

Intervention name(s): Echography; Elastography
Intervention type(s): Device; Device
Intervention description(s): cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine; cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Child
The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, double-blind, single-center and controlled study comparing the efficacy and
      safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous
      bilateral total knee arthroplasty.
    

Detailed description: 
      A randomized, double-blind, single-center and controlled study comparing the efficacy and
      safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous
      bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any
      complications, particularly deep venous thrombosis and thromboembolism during the hospital
      stay and for 1 months postoperatively.
    

Intervention name(s): Tranexamic Acid; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision; 100 mL of normal saline intravenously approximately 15 minutes before incision
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect between two different single doses of
      mavamten in healthy participants.
    


Intervention name(s): Mavacamten
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): MYK-461
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertrophic cardiomyopathy (HCM); Left ventricular (LV) hypertrophy; Bioequivalence; Left Ventricular Outflow Tract Obstruction; Heart diseases; Cardiovascular diseases
Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Rehabilitation following rotator cuff surgery is characterized with high levels of pain,
      limited range of motion, and decreased quality of life. The purpose of this study is to
      evaluate the B-Cure laser photobiomodulation home-use device in addition to standard care,
      for the reduction of pain, increase in functionality, and improvement of life quality during
      rehabilitation following rotator cuff arthroscopic surgery.
    

Detailed description: 
      Patients planned to undergo rotator cuff arthroscopy will be randomized to receive active or
      sham devices for self-application at home in addition to standard care. Patients will be
      invited to up to 5 visits at the clinic: baseline (before surgery), post-operative day 1, and
      1, 3, and optionally 6 months after surgery. Evaluations will include physical examination,
      physical activity tests, range of motion measurements, Constant score, thermal imaging, and
      patient reported outcomes including subjective pain level by visual analogue scale,
      functional and quality of life questionnaires.

      The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can
      reduce pain and accelerate healing over standard care thereby improving the rehabilitation
      process following rotator cuff arthroscopic surgery.
    

Intervention name(s): B-Cure Pro; Sham
Intervention type(s): Device; Device
Intervention description(s): The B-Cure laser Pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min.; The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photobiomodulation; Low-Level Laser Therapy
A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2
      diabetes mellitus. The primary purpose of this study is to evaluate the safety and
      tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin
      under fed and fasted conditions in healthy volunteers.
    


Intervention name(s): Ertugliflozin; Placebo to Ertugliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Ertugliflozin will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.; Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution
Intervention MeSH terms: Ertugliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Single Ascending Dose Study in healthy subjects
Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study will be to assess the effectiveness of Diacutaneous Fibrolysis technique
      on pain, range of motion (Patellofemoral joint mobility test and muscle length test),
      strength and function in patients with Patellofemoral Pain Syndrome and muscle shortening.

      Muscle imbalance is one of most important factor associated with Patellofemoral Pain
      Syndrome. Shortening of lateral muscles of the thigh have a close relationship with patella
      position and tracking and patellofemoral pain. The scientific evidence for effectiveness of
      any soft tissue mobilization technique in patellofemoral pain syndrome patients is poor.

      Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique to release adherences
      and fibrosis between the different musculoskeletal structures. Diacutaneous Fibrolysis is
      applied by a set of metallic hooks having the advantage of allowing a deeper and more precise
      application, which could not be achieved manually.

      The present study evaluates the effectiveness of Diacutaneous Fibrolysis technique applied in
      the soft tissues more related with patellofemoral pain.
    


Intervention name(s): Diacutaneous Fibrolysis
Intervention type(s): Device
Intervention description(s): Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physiotherapy; Patellofemoral Pain Syndrome; Manual therapy
Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this proposal is to determine whether oral VPA is effective in
      treating SMA in adult patients.
    

Detailed description: 
      Participation in this study entails six visits and seven to eight blood draws over 13 months.
      Each visit entails a stay of two days and one night at the General Clinical Research Center
      (GCRC).

      Subjects who live within driving distance will be allowed to participate in the study without
      an overnight stay through two consecutive outpatient visits. All subjects will be evaluated
      at two screening visits 2-4 weeks apart to determine eligibility for participation. Eligible
      subjects will be randomized to receive VPA or placebo for the first six months. At the
      six-month visit, patients will be evaluated and crossed over to the other regimen.
    

Intervention name(s): Valproic Acid (VPA); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Valproic Acid and Levocarnitine; capsules; For six months, pts are randomized into placebo or treatment. After 6 months, all pts are on treatment
Other intervention name(s): Depakote; Carnitor
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; Adult
Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults
Condition: Cytokine Response to Vagus Nerve Stimulation
Study type: Interventional
Phase: Phase 1

Summary: 
      The autonomic (self-regulating) nervous system is important for the function of many organs
      in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve carries
      incoming information from the nervous system to the brain, providing information about what
      the body is doing, and it also transmits outgoing information which governs a range of reflex
      responses. It plays an important role in the immune system. A part of the vagus nerve is
      reachable for stimulation at specific locations in the ear.

      The purpose of this study is to better understand how different ways of stimulating the vagus
      nerve at the ear can affect a chemical marker of inflammation found in human blood that is
      associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus.
      This information may lead to in future studies to see if stimulation of the vagus nerve can
      improve inflammation in chronic inflammatory diseases.
    


Intervention name(s): Vagus Nerve Stimulator; Vagus Nerve Stimulator
Intervention type(s): Device; Device
Intervention description(s): Voltage 2, placed on cymba concha; Voltage 2, place on the placebo area of the calf
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cytokines; inflammation; vagus nerve; TNF
A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-14 (14C)E7386 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the absolute bioavailability of E7386
      following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR)
      tablet and concomitant intravenous (IV) microdose of (14C)E7386 (100 mcg [microgram])
      solution for Part 1 and to determine the pharmacokinetic (PK) and excretion of E7386
      following a single 40 mg powder in capsule (PIC) oral administration of (14C)E7386 for Part
      2.
    


Intervention name(s): E7386 Tablet; (14C)E7386 Capsule; (14C)E7386
Intervention type(s): Drug; Drug; Drug
Intervention description(s): E7386 40 mg tablet.; (14C)E7386 40 mg capsule.; (14C)E7386 administered intravenously.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: E7386
Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      General objective: To improve the quality of fever case management in children in government
      health facilities in Tanzania Hypothesis:The training of health workers, as well as
      provision, training and use of microscopes for malaria diagnosis will improve the treatment
      of clinical episodes of fever in children while reducing the amount and costs of drugs
    

Detailed description: 
      PHC facilities were eligible for the study if they were rural government owned; accessible by
      road during rainy season; and within 3 hours by car from Muhimbili University College of
      Health Sciences (MUCHS), Dar es Salaam

      All children attending the 16 PHC facilities under the study during daytime were enrolled if
      they fulfilled the following criteria:

        1. below five years of age

        2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days

        3. able to return to the facility on day 7 after treatment or any other day if symptoms
           were to worsen or recur

        4. the mother/guardian or caretaker consented to participate.

      Patients with severe disease and/or general danger signs requiring inpatient care according
      to the IMCI guidelines were admitted or referred to the health centers or the district
      hospitals
    

Intervention name(s): Clinical algorithm and microscopy diagnosis of malaria
Intervention type(s): Procedure
Intervention description(s): Clinical alogarithm
The content of the package included
description of signs and symptoms of malaria disease
history taking relevant to malaria and physical examination
identification of danger signs and severe illness for referral
appropriate treatment
counseling patients on the use of drugs.
Malaria microscopy. contents
make thick blood smears from patients with fever and stain with Giemsa
identify and count malaria parasites
maintain the microscope and store blood slides.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: malaria microscopy primary health care children
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the MicroVention
      Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked
      intracranial aneurysms.
    


Intervention name(s): Flow Re-Direction Endoluminal Device (FRED)
Intervention type(s): Device
Intervention model: Single Group Assignment
Intervention model description: FRED
Masking: None (Open Label)
Primary purpose: Treatment