bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke
Condition: Muscle Spasticity; Stroke
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      This is a single center, randomized, double-blind (patient and evaluator), sham-controlled
      study. The main objectives of this study are to evaluate the performance and safety of the
      MyoRegulator® device in active versus sham treated stroke patients with lower-limb spasticity
      after 5 consecutive days of treatment.
    

Detailed description: 
      Spasticity prevalence after stroke is highly variable, ranging from 17% to 43% three months
      post-stroke. In the lower limbs, adduction and extension of the knee with equinovarus foot is
      the most observed pattern. Spasticity can lead to pain, ankylosis, and tendon retraction
      which may limit the potential success of rehabilitation. Spasticity can also affect
      quality-of-life and can be highly detrimental to daily activities such as walking.

      An initial clinical trial of safety and feasibility suggested that five sessions of treatment
      with the MyoRegulator® device temporarily reduces spasticity and overall stiffness of the
      affected extremity with optimal reductions in spasticity occurring 2-3 weeks post stimulation
      intervention.

      MyoRegulator® is a non-invasive neuromodulation device using multi-site direct current
      stimulation for the treatment of spasticity. The main objectives of this study are to
      evaluate the performance and safety of the MyoRegulator® device in active versus sham treated
      patients during and after 5 consecutive days of treatment sessions. Patients can take part in
      an optional 3-month follow-up.

      The primary performance endpoint is defined as the reduction in ankle joint spasticity. The
      study will be considered to have a successful outcome if the actively treated subjects
      demonstrate a statistically greater reduction in spasticity, as measured by the Tardieu
      Scale, as compared to the sham treated subjects after five treatment sessions.

      The primary safety endpoint is defined as the incidence of device-related serious adverse
      events. The safety of the device will be demonstrated if there are no incidents of serious
      adverse events caused or contributed to by the device treatment that are clinically
      unacceptable in light of the treatment benefits.
    

Intervention name(s): MyoRegulator®
Intervention type(s): Device
Intervention description(s): Trans-spinal DC stimulation paired with peripheral DC stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: stroke rehabilitation; spasticity; neuromodulation; trans-spinal direct current stimulation
MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics
Condition: Healthy Volunteers
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional

Summary: 
      The goal of this research study is to learn more about the pancreas. The investigators want
      to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a
      normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the
      pancreas. The investigators also want to figure out how much fluid the pancreas releases in
      response to secretin. Secretin is a chemical in the body that causes the pancreas to release
      fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify
      dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the
      pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.
    

Detailed description: 
      Introduction/Methods: Pancreatic fibrosis is the end stage of chronic pancreatitis (CP),
      which leads to loss of acinar volume and secretory capacity, and ultimately pancreatic
      insufficiency (PI). CP and congenital PI affect the pediatric population, and are both
      increasingly recognized in children. PI has serious negative implications on a child's growth
      and health but, if diagnosed early, PI can be treated, minimizing the detrimental effects of
      PI. Currently, direct pancreatic function testing (PFT) via collection of pancreatic fluid is
      the "gold standard" for diagnosis of PI but it is an invasive testing that may require
      sedation or general anesthesia. Magnetic resonance cholangiopancreatography (MRCP) with
      secretin administration (MR-PFT) and MR elastography (MRE) may allow non-invasive, and
      potentially early diagnosis of CP and PI. Currently, however, normative data with which to
      compare MR-PFT and MRE results in pediatric patients with suspected CP/PI is not available.

      Aims: The investigators propose to determine the normal range for secreted pancreatic fluid
      volume in response to secretin administration and determine the normal range for pancreatic
      parenchymal stiffness in a pediatric population that is not affected by pancreatic disease.
      To date, the investigators have validated their MRCP technique and have successfully
      performed both MR-PFT and MRE in CP patients; however normative data is essential for
      validation of our non-invasive technique.
    

Intervention name(s): Secretin
Intervention type(s): Drug
Other intervention name(s): ChiRhoStim
Intervention MeSH terms: Secretin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Methotrexate; Pharmacokinetics of 7-hydroxymethotrexate; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole
      will be assessed alone and in combination with methotrexate.
    

Detailed description: 
      Subjects will check-in to the clinic on Day -1 and remain confined through completion of the
      study procedures on Day 10.

      A follow-up telephone call will be made on Day 16 to check on health status.
    

Intervention name(s): isavuconazole; methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557
Intervention MeSH terms: Isavuconazole; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; Pharmacokinetics; Healthy Subjects; BAL8557; BAL4815; methotrexate
Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the consistency of response for Treximet (formerly
      known as Trexima) when treating four acute migraine attacks at the mild pain phase and within
      1 hour of onset of head pain.
    


Intervention name(s): sumatriptan succinate/naproxen sodium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): comparator; placebo to match
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: consistency of response; migraine; satisfaction; early intervention
Efficacy of Balance Training in Patients With Rotator Cuff Disease
Condition: Rotator Cuff Injury
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether balance training is effective in patients
      with rotator cuff disease.
    


Intervention name(s): Rehabilitation and balance training; Rehabilitation program
Intervention type(s): Other; Other
Intervention description(s): Stretching will be applied as hold-relax technique in Proprioceptive Neuromuscular Facilitation for shoulder flexion, abduction, internal and external rotations. Isotonic exercises will be done with elastic bands for strengthening.
Home exercises will include postural, stretching and strengthening exercises. Balance exercises will receive as non-supervised program.; Rehabilitation program will be same in this group except balance exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effectiveness and usability of the Master
      Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.

      The purpose of the study is to evaluate the effectiveness and usability of using Master
      Caution 12 leads Garment for stress test.

      The purpose of the study is to reassess the adequate size of the Master Caution Garment.
    


Intervention name(s): Master Caution System
Intervention type(s): Device
Intervention description(s): The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.
The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.
The purpose of the study is to reassess the adequate size of the Master Caution Garment (MCG).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Eligible subjects admitted and diagnosed as acute coronary syndrome, before or after
        catheterization, who need to be monitored for evaluation of treatment efficacy.

        Eligible subjects referred to stress imaging test, with current or previously depicted STT
        changes.
Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the effect of increased metabolizing enzyme
      (cytochrome P450 [CYP] 3A4) due to carbamazepine, a strong CYP3A4 inducer, on the
      pharmacokinetics (PK) of darigabat in healthy adult participants.
    


Intervention name(s): Darigabat; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablets
Other intervention name(s): CVL-865
Intervention MeSH terms: Carbamazepine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to compare the relative vasoconstrictive effects of test and
      reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy,
      female subjects.
    


Intervention name(s): Betamethasone Dipropionate 0.05% Cream
Intervention type(s): Drug
Intervention description(s): Small amount applied and evaluated over the course of several hours
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: bioequivalence; betamethasone dipropionate; Bioequivalency
Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research
      on Glycemic Index (GI) diets has been largely developed, however the combination with
      metformin in humans was not investigated yet. We hypothesized that the low-GI diet in
      combination with metformin would elicit greater improvements on glucose metabolism, lipid
      profile and body composition on overweight or obese type 1 subjects. This study aims to
      evaluate the metabolic effects of the adoption of dietary advice to follow caloric
      restriction high/low GI diets, and low-GI diet associated with metformin on glucose
      metabolism, lipid profile and body composition on overweight or obese type 1 subjects.
    

Detailed description: 
      All groups (Low/High-GI and Low-GI + Metformin) showed significant reduction in
      anthropometric parameters, but only Low-GI and Low-GI + Metformin groups have an improvement
      in body composition parameters. In addition, the Low-GI group achieved better results in
      metabolism of carbohydrates (glucose, insulin, Cederholm Index, and HOMA-β) and lipids (Chol,
      TAG, LDL-C, VLDL-C, and TC/HDL-c). These results show the benefits of Low-GI diet on
      metabolic parameters in overweight or obese type 1 subjects.
    

Intervention name(s): Glycemic Index Diets and Metformin hydrochloride
Intervention type(s): Other
Intervention description(s): 1g of Metformin hydrochloride a day in High Glycemic Index Diet
Other intervention name(s): High Glycemic Index; Low Glycemic Index; High Glycemic Index plus Metformin
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycemic index; Caloric restriction; Energy intake; Glucose; Lipid Metabolism; Cholesterol; HDL Cholesterol; LDL Cholesterol; Obesity; Metformin
Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the
      airways characterized by fixed airflow obstruction, with important systemic co-morbidities.
      The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette
      smoking is the major cause of this disease. COPD is an important cause of morbidity and
      mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in
      the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide
      anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative
      processes at the cellular level. These molecules can alter the extracellular matrix
      remodeling, cell respiration, cell proliferation, cellular repair and the immune response in
      the lung. All these events are key elements in the pathogenesis of COPD.

      Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled
      corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal
      inhalation treatments are a therapeutic strategy used since many years in an empirical way in
      patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with
      COPD are very limited.

      The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water
      inhalation on oxidant stress in the airways of stable COPD patients.
    


Intervention name(s): Sulfur Thermal water; Placebo
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Thermal water; Oxidative stress; Inflammation
Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section
Condition: Obstetric Anesthesia Problems
Study type: Observational

Summary: 
      The goal of this observational study is to assess the level of oxidative stress during
      cesarean section depending on the type of anesthesia applied and to determine the factors
      that can affect the level of oxidative stress.

      The main questions it aims to answer are:

        -  is there any association between specific parameters of pregnancy, socio-demographic
           characteristics and laboratory analyses with an increased level of oxidative stress

        -  is there any association between type of anesthesia for ceasarean section with an
           increased level of oxidative stress

      Blood sample would be taken from the participants in the study for these analyses on three
      occasions in 3 test tubes (before cesarean section, during cesarean section and after
      cesarean section).

      Researchers will compare patients that received general anesthesia with patients under spinal
      regional anesthesia to see if there is any difference in level of oxidative stress measured
      by laboratory parameters.
    


Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy pregnant women
Biopsy Size and Pain Perception During Colposcopic Biopsy
Condition: Pain Uterus; Tenaculum
Study type: Interventional

Summary: 
      The investigators will investigate patients pain and biopsy size during colposcopic biopsy.
      The investigators will use tenaculum randomized patient with or without intracervical
      blockage.
    

Detailed description: 
      The study was designed four arms. The investigators will perform colposcopy because of
      various causes. The first arm is used tenaculum and performed intracervical blockage. The
      second arm is not used tenaculum and performed intracervical blockage. The third arm is used
      tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and
      not performed intracervical blockage and then we will study patients pain and biopsy size
      during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and
      diagnose of the cervix cancer.
    

Intervention name(s): Tenaculum replacement
Intervention type(s): Other
Intervention description(s): Tenaculum replacement during colposcopic biopsy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Phase II Study of Irinotecan and Cisplatin in Extensive-stage Small Cell Lung Cancer
Condition: Extensive-stage Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned
      to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of
      efficacy and toxicity of IP regimen was analyzed.
    

Detailed description: 
      This is a randomized, multicenter study. Patients are randomized to irinotecan/cisplatin (IP)
      or etoposide/cisplatin (EP) treatment arms. The IP regimen consisted of at most 6 cycles of
      irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface
      area on day 1. The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of
      body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. Cycle
      length for the two arms was 3 weeks. The dose adjustment was allowed in at most within ±5%
      per investigator discretion if necessary.
    

Intervention name(s): Irinotecan and cisplatin; Etoposide and cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cisplatin; Irinotecan; Etoposide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults
Condition: Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to test the safety and efficacy (how well it works) of
      exenatide as a treatment for weight gain associated with olanzapine in obese adults with
      Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

      Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.

      It has not been approved for the treatment of weight gain associated with olanzapine in obese
      adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective
      Disorder
    

Detailed description: 
      Double-blind studies suggest that olanzapine is highly effective for the treatment of
      individuals with bipolar disorder. However, weight gain and impaired glucose tolerance remain
      significant concerns associated with olanzapine. Exenatide is an anti-diabetic medication
      that is associated with weight loss and improved glucose regulation. Therefore, the overall
      goal of the proposed study is to conduct a 16-week double-blind placebo-controlled study of
      exenatide for the treatment of weight gain associated with olanzapine in 60 obese adults with
      bipolar disorder treated with olanzapine. We propose to conduct the study over the course of
      24 months, with an expected enrollment of approximately 3 patients per month. The primary
      outcome measure will be change from baseline to endpoint in weight. The secondary outcome
      measures will include changes from baseline to endpoint, in body mass index (BMI), abdominal
      circumference, metabolic parameters, clinical global improvement of psychiatric symptoms, and
      change in manic, depressive and psychotic symptoms. Rates of adverse events also will be
      assessed.
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.; Placebo: Sterile solution in equivalent doses as Exenatide
Other intervention name(s): Exenatide (Byeta)
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: weight gain