bioihbjkbjnl/mcl2 huggingface dataset:
DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Physicians seek a method to assess neuromuscular disease that is both non-invasive and
      quantifiable. Many patients do not tolerate standard current day assessment tools (such as
      needle electromyogram), and Electrical Impedance Myography (EIM) has the potential to serve
      as a non-invasive, quantifiable, diagnostic tool for neuromuscular disease. If successful,
      these devices will allow for improved ability to diagnose neuromuscular disease and to assess
      disease progression or remission, allowing for better care of individual patients as well as
      for use in clinical trials, where improved outcome measures for neuromuscular diseases is
      being sought.
    

Detailed description: 
      Healthy subjects and subjects with DMD will be screened during Visit 1. Screening evaluations
      will establish eligibility and will include a medical history, abbreviated physical
      examination, vital signs (blood pressure, temperature, pulse, and respirations), and weight.
      Eligible subjects will provide assent, as stipulated by Institutional Review Board (IRB)
      requirements, and a parent/guardian will sign an informed consent, after which the subject
      will be considered enrolled.

      Subjects will be enrolled into 4 study cohorts for a total of approximately 90 subjects.
      Allocation into these cohorts is planned due to considerations regarding the effect of age on
      outcomes.

      Visit 2, Study Assessments, may take place on the day of Visit 1 screening evaluations. If
      the subject cannot complete study assessments on the same day, the subject may return and
      complete Visit 2 evaluations within approximately 24 hours of the end of Visit 1.

      Visit 2 assessments will include morphological testing of muscle length and girth, skin fat
      measurement, Clinical Assessments (6-Minute Walk Test [6MWT], North Star Ambulatory
      Assessment, timed function tests, dynamometry), and 3 phases of Device Performance testing.
      Phase 1 Device Performance testing will be done by each of 2 trained raters (Rater A and
      Rater B) from the research site, designated to perform the Device Performance testing on all
      subjects at their respective site. At least 10 minutes after completion of the first
      assessments, Phase 2 Device Performance testing will be repeated by Rater A. Upon completion
      of the Phase 2 Device Performance testing, the subjects will proceed with Clinical
      Assessments performed by a physical therapist. Following Clinical Assessments, Phase 3 Device
      Performance testing will be performed by Rater B.
    

Intervention name(s): Testing with EIM
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: DMD; EIM; Duchenne Muscular Dystrophy; electrical impedance myography
Cross Sectional Study to Evaluate Effects of Kinesiotaping on Muscle Activity During Climbing Stairs and Sport Activity
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of IQ-Tape, Kinesiotaping and no Taping on muscle
      activity during daily activity and sport activity.
    


Intervention name(s): IQ-Tape; Kinesiotape; No-Tape
Intervention type(s): Device; Device; Other
Intervention description(s): RMS-values of leg muscles at pre-activation (50ms) before ground-contact and post-activation 0-30ms and 30 - 150ms after ground-contact during drop-jump, running and stair climbing.; RMS-values of leg muscles at pre-activation (50ms) before ground-contact and post-activation 0-30ms and 30 - 150ms after ground-contact during drop-jump, running and stair climbing.; RMS-values of leg muscles at pre-activation (50ms) before ground-contact and post-activation 0-30ms and 30 - 150ms after ground-contact during drop-jump, running and stair climbing.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata
Condition: Leiomyomata
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of
      uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for
      hysterectomy.
    

Detailed description: 
      Patients will be allocated to Cohort 1 or Cohort 2. Following pelvic angiogram to delineate
      the uterine vasculature, embolization procedures of the left and right uterine arteries (as
      required) will be performed on each patient, using OCL 503 as the embolic agent. Patients in
      Cohort 1 will proceed to hysterectomy 1 week after embolization, and patients in Cohort 2
      will undergo hysterectomy 1 month after embolization. Tumor response, as measured by changes
      in leiomyomata size and perfusion, will be determined by Magnetic Resonance Imaging or
      Magnetic Resonance Angiography. Histology of the resected uterus will be conducted to
      evaluate inflammatory response and viable tumour tissue.
    

Intervention name(s): OCL 503 (uterine artery embolization)
Intervention type(s): Device
Intervention description(s): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
Condition: Transient Tachypnea of the Newborn
MeSH terms: Tachypnea; Transient Tachypnea of the Newborn
Study type: Interventional

Summary: 
      Introduction: Babies born at term by elective caesarean section (CS) and before onset of
      labor are more likely to develop respiratory complications than babies born vaginally. In
      developing countries resources are scarce and it is difficult to provide expensive treatments
      as neonatal care.

      Aim of the Work: To assess the effect of prophylactic dexamethasone administration before
      elective cesarean section at term in reducing neonatal respiratory complications.

      Patients and methods: 600 women were included in the study and were planned to have elective
      caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before
      delivery. 300 patients were the control group.

      The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence
      of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS)
      and the need for mechanical ventilation.
    

Detailed description: 
      Dexamethasone which is a long acting corticosteroid can be used prior to elective cesarean
      section to decrease neonatal respiratory morbidity by enhacing fetal lung maturity.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): Long acting corticosteroid
Other intervention name(s): Decadron
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dexamethasone, term, elective cesarean section
Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care
Condition: Quality of Life
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal
      intervention (BCI) in patients with somatization symptoms which has an effect on the
      perceived quality of life front conventional intervention.
    

Detailed description: 
      Aim: to determine whether a cognitive-behavioral group intervention in patients with
      unexplicated somatic symptoms, that have come to the primary care medical in Madrid, is more
      effective than normal practice in terms of improving life quality at one year.

      Method:

      Design:cluster randomized trial. Setting: study in Health Centers Primary Care of Area of
      Madrid Health Service. unit of randomization are centres.Analysis unit: patients between 18
      and 65 years old.

      Intervention: The cognitive behavioral grupal Terapy in the internention group and the usual
      intervention in the control group.

      Sample size adjusted for design effect=242 (121 in each arm). Main response variable:
      preceived quality of life (SF-12).

      Data Analysis:comparison of the proportion of patients that improve in 4 or more points in
      the area of Mental Healthcare from the SF-12 in both groups,at 6 months and 1 year after
      patient inclusion.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Four Cognitive behavioral group sessions. Each session will last two hours a week
Other intervention name(s): Primary Health Care; Somatization symptoms; Nursing intervention; Quality of life
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Primary Health Care; Somatization symptoms; Cognitive Behavioral Therapy; Nursing intervention
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this study were to demonstrate comparable safety and efficacy of
      Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with
      severe vulvovaginal candidiasis.
    

Detailed description: 
      This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal
      Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days
      and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe
      vulvovaginal candidiasis.
    

Intervention name(s): Terconazole Vaginal Suppository; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days; orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Other intervention name(s): Tekangzuo Yindao Shuan; Diflucan
Intervention MeSH terms: Fluconazole; Terconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Heliox in Experimental Upper Airway Obstruction
Condition: Airway Obstruction; Dyspnea
MeSH terms: Dyspnea; Airway Obstruction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Currently it is common medical wisdom that HELIOX (mixture of Helium in Oxygen) with a
      fraction of Helium below 60% is not effective in reducing airway obstruction. The
      investigators test the hypothesis that HELIOX with a fraction of Helium below 60% is still
      effective in relieving airway obstruction in a double-blind, randomized and controlled
      clinical PoC study with experimental upper airway obstruction.
    

Detailed description: 
      HELIOX is a mixture of Helium and Oxygen. It is a therapeutic modality that can improve upper
      and lower airway obstruction. The lower density of Helium can help to relieve airway
      obstruction and is known to lower the work of breathing. The fraction of Helium (FHe) in
      HELIOX should be maximized (e.g. up to a fraction of 79% with 21% of oxygen added) in order
      to achieve optimal anti-obstructive outcome and according to the literature a FHe below 60%
      renders HELIOX ineffective.

      Objective: We conducted an investigator-initiated trial using different mixtures of Helium
      and Oxygen in 44 healthy volunteers in a randomized and double-blinded fashion.

      Methods: After an adjustment phase the subjects were breathing through two different external
      resistors (intratracheal tube with inner diameter of either 4.0mm or 5.0mm) while gas of
      different composition (medical air with 79% Nitrogen and 21% Oxygen as control gas and HELIOX
      with a fraction of either 25%, 50% or 75% Helium in Oxygen, respectively) was provided in a
      blinded and random fashion. A crossover design was used so that every subject was exposed to
      every HELIOX gas mixture. Subjects were asked to score their degree of dyspnea after
      breathing different gas mixtures for 2 minutes intervals. In addition the variability of
      different hemodynamic parameters was assessed (continuous non-invasive blood pressure
      (systolic, diastolic and mean blood pressure), impedance cardiography (stroke volume and
      cardiac output), ECG (heart rate variability)) were assessed non-invasively and used to
      detected a change in the degree of airway obstruction in respect to the added load and the
      gas mixture.
    

Intervention name(s): HELIOX
Intervention type(s): Drug
Intervention description(s): HELIOX is a mixture of Helium in Oxygen with a low density and the ability to reduce the work of breathing in subjects with airway obstruction. The fractions of Helium was altered in a different order depending on the arm of the study
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Airway obstruction; Heliox; Different Helium content
LutrePulse Hypogonadotropic Hypogonadism
Condition: Primary Amenorrhea With Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism; Amenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic
      hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the
      OmniPod pump versus placebo
    


Intervention name(s): Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump; Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump; Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump; Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): LutrePulse; LutrePulse; LutrePulse
Intervention MeSH terms: Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Bioequivalence Study Comparing Two Different Tafamidis Formulations
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis
      blood concentrations will be measured periodically for one week. After about 20 days,
      subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis
      concentrations from the two different formulations will be compared to determine if they are
      approximately the same.
    


Intervention name(s): Tafamidis; Tafamidis
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg of current commercial formulation; 20 mg of new formulation
Other intervention name(s): Vyndaqel; Vyndaqel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain
Condition: Nonspecific Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of the addition of the use of
      Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional
      physical therapy.
    

Detailed description: 
      One hundred and forty-eight patients will be randomized to receive either conventional
      physical therapy, which consist of a combination of manual therapy techniques, general
      exercises and specific exercises for spinal segmental stabilization (Conventional Physical
      Therapy Group) or to receive conventional physical therapy plus the addition of the Kinesio
      Taping in the lumbar spine (Conventional Physical Therapy plus Kinesio Taping), over a period
      of 5 weeks (10 sessions of treatment).

      Clinical outcomes (pain intensity, disability and global perceived effect ) will be collected
      at baseline and at 5 weeks, 3 and 6 months after randomization. Data will be collected by a
      blinded examiner who will be unaware about the group allocation. All statistical analysis
      will be conducted following the principles of intention to treat analysis and the
      between-group differences will be performed using Mixed Linear Models.
    

Intervention name(s): Conventional Physical Therapy; Kinesio Tex Gold ( Kinesiotaping )
Intervention type(s): Other; Device
Intervention description(s): Combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). The treatment will be tailored to the patient presentation (i.e. pragmatic treatment).; Kinesiotaping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the superficial back muscles (erector spinae muscles).
Other intervention name(s): Manual therapy; Exercise therapy; Specific exercises; Bandages; Tape; Taping; Kinesio Tex; Kinesio Tape; Kinesiotape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: back pain; tape; chronic
Early Diabetes Resolution After Weight Loss Surgery
Condition: Obesity; Diabetes
MeSH terms: Diabetes Mellitus; Weight Loss
Study type: Observational

Summary: 
      The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very
      short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical
      Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as
      to compare these changes to diet-induced changes in the same population.
    


Intervention name(s): Weight loss surgery; Laparoscopic abdominal surgeries
Intervention type(s): Procedure; Procedure
Intervention description(s): Weight loss surgery; laparoscopic abdominal surgeries
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects scheduled for weight loss surgery or other abdominal surgeries will be considered
        for the study.
      
Biospecimen description: 
      plasma and serum
    
Keywords: Obesity; Diabetes; Bariatric surgery
Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate
      hydrochloride in pediatric patients with ADHD.
    


Intervention name(s): Atomoxetine Hydrochloride; Methylphenidate Hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 4

Summary: 
      A case control pharmacokinetic study evaluating the effects of atazanavir-ritonavir on the
      pharmacokinetics and toxicity of lumefantrine in people living with HIV attending APIN clinic
      of the Lagos University Teaching Hospital
    

Detailed description: 
      Atazanavir-ritonavir (ATVr) based antiretroviral therapy and artemether-lumefantrine (AL) are
      commonly used drugs for the treatment of Human Immune Deficiency Virus (HIV) infection and
      malaria respectively in Nigeria. However, both drugs interact with Cytochrome P 3A4 (CYP 3A4)
      isoenzymes which may spawn clinically significant pharmacokinetic interactions.

      The study was aimed at evaluating the effects of atazanavir-ritonavir on the pharmacokinetics
      and toxicity of lumefantrine.

      In a case control pharmacokinetic study, twenty participants who tested positive for
      Plasmodium falciparum malaria were recruited and divided into two groups (ATVr-arm, n=10; and
      Control-arm, n= 10). All the participants were administered with 6 doses of AL 80-480 mg
      (Coartem). Thereafter, blood samples were collected from them at different time intervals
      over seven days. The lumefantrine concentration in each sample was determined with
      high-performance liquid chromatography (HPLC) and entered into WinNonlin® software to
      determine the pharmacokinetic parameters of lumefantrine which were compared between the test
      and control groups. Toxicity was evaluated with adverse events monitoring,
      electrocardiography, haematological and blood chemistry tests at pre and post doses of
      artemether-lumefantrine.
    

Intervention name(s): Artemether-lumefantrine; Atazanavir-ritonavir 300/100 mg
Intervention type(s): Drug; Drug
Intervention description(s): Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy; Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
Other intervention name(s): Coartem 80/480, P01BF01; Anzavir-R, J05AR23
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arm study namely: ATVr arm and AL (Control) arm each consisting of 10 participants in a parallel study design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug interaction, artemether-lumefantrine, atazanavir-ritonavir, LUTH
Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town
Condition: Chronic Vascular Wounds in Adults
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Evaluate the process for implementing a wound protocol for lesion control and
      cost-effectiveness in the context of the Family Health Strategy in the city of Santa Cruz do
      Sul, Brazil.
    


Intervention name(s): Wounds Protocol
Intervention type(s): Combination Product
Intervention description(s): Nurses who have been trained to use wound dressing supplies and also on the use of the protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nursing care; skin lesions; wound healing; varicose ulcers