bioihbjkbjnl/mcl2 huggingface dataset:
Percutaneous Peripheral Nerve Stimulation and Performance
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      Percutaneous Peripheral Nerve Stimulation is a relative new intervention applied by physical
      therapists. Although it has been hypothesized that this technique could improve pain and
      function, no studies have investigated changes in physical performance in soccer players.
      This study will evaluate changes in physical performance after the application of
      Percutaneous Peripheral Nerve Stimulation in a sample of healthy soccer players.
    


Intervention name(s): Percutaneous Peripheral Nerve Stimulation; Control Group
Intervention type(s): Device; Other
Intervention description(s): Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.; No intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous Peripheral Nerve Stimulation; Performance; Soccer
Sensorimotor Maps of Vowel Perception and Production
Condition: Vowel Perception and Production
Study type: Observational

Summary: 
      Speech develops through a co-structuring of auditory and motor representations, especially in
      the first years of life during language acquisition. In the present study, we will test by
      means of functional magnetic resonance imaging whether vowel perception and production might
      depend on a coordination of auditory and motor, articulatory, cortical maps. The outcome of
      this study will lead to a better understanding of whether both vowel perception and
      production are processed in the human brain and will provide important insight into
      brain-language relationships. Besides new theoretical perspectives on speech perception and
      production, this project might raise important questions concerning patients with speech
      disorders by identifying which aspects of speech perception and production are functionally
      linked.
    

Detailed description: 
      The goal of this study is to explore the functional neuroanatomy of vowel processing. To this
      aim, we will investigate the neural basis of both attentive auditory perception and
      production of natural French vowels using functional magnetic resonance imaging. More
      specifically, we will compare vowels that varied along a given phonetic feature dimension
      while keeping other feature characteristics constant. The phonetic features to be tested are
      roundedness (rounded/unrounded vowels), place of articulation (front/back vowels) and height
      (close, close-mid, open-mid vowels). Our study posed three specific questions. First, where
      exactly in the human brain is the perceptual and motor segregation of different vowel
      categories accomplished? Second, are these stimulus dimensions implemented topographically in
      an orthogonal manner, as they vary orthogonally in natural speech? Most specifically, one
      would expect a topographic segregation between two vowel categories (e.g., front vs back
      vowels) in both auditory and motor cortices that are characterized by widely distinct
      acoustic and articulatory values. Third, does these possible sound-related topographic
      activations in auditory and motor cortices overlap during vowel perception and production?
      This latter result would support a functional coupling between speech perception and
      production systems.
    

Intervention name(s): fmri (functional magnetic resonance imaging)
Intervention type(s): Device
Intervention description(s): functional image acquisition (75mn) anatomical image acquisition (15mn)
Other intervention name(s): functional magnetic resonance imaging, sparse sampling
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy adults
A Phase 1 Dose Escalation and Expansion Study of AK117
Condition: Neoplasms Malignant
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open label, single arm, Phase 1，dose escalation and dose expansion
      study designed to evaluate the safety, tolerability, pharmacodynamics, PK, immunogenicity,
      and preliminary antitumor activity of AK117 administered intravenously to adult subjects with
      relapsed/refractory advanced or metastatic solid tumors or lymphomas.
    

Detailed description: 
      The study comprises a dose escalation phase and a dose expansion phase. The phases will be
      conducted sequentially. Approximately 162 subjects will be enrolled in this study.
    

Intervention name(s): AK117
Intervention type(s): Drug
Intervention description(s): An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antineoplastic Agents; Immunological
Fast Advanced Closed-Loop Therapy
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A double-blind, multinational, multicenter, randomised, 2-period crossover study to assess
      the efficacy and safety of advanced closed-loop insulin delivery with Minimed 670G 4.0 system
      comparing Faster Insulin Aspart to Standard Insulin Aspart therapy over 4 weeks in active
      children and adolescents with type 1 diabetes.
    


Intervention name(s): Fiasp; Novorapid
Intervention type(s): Drug; Drug
Intervention description(s): Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp); Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study
Condition: Pain; Obesity; Surgery
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The use of preoperative TAP block in laparoscopic bariatric surgery can improve the
      postoperative pain and quality of recovery in patients undergoing these procedures.
    


Intervention name(s): Placebo; (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Intervention type(s): Drug; Drug
Intervention description(s): Bilateral TAP block using sterile normal saline.; (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: TAP Block; Pain; Obesity; Surgery; Laparoscopic Banding
Methylphenidate for the Treatment of Acute Mania
Condition: Mania
MeSH terms: Mania
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims at evaluating the efficacy and safety of methylphenidate in the initial
      treatment of acute mania in patients with bipolar affective disorders.
    

Detailed description: 
      Mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. There is
      increasing evidence that psychostimulants that increase vigilance may be effective in
      treating mania. However, controlled studies are lacking.

      This is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase
      IIIb exploratory study to evaluate the efficacy and safety of methylphenidate in the initial
      treatment of acute mania in patients with bipolar affective disorders.
    

Intervention name(s): methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablets for oral use; tablets for oral use
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      The investigators believe that iloprost will improve gas exchange in COPD patients with
      pulmonary hypertension.
    

Detailed description: 
      Pulmonary hypertension and right heart failure can complicate the management of the patient
      with advanced COPD. Attempts to treat this pulmonary hypertension with systemic vasodilators
      frequently result in a worsening of ventilation perfusion matching and an increase sense of
      dyspnea. This study will look at the effect of an FDA approved pulmonary vasodilator,
      iloprost, on gas exchange and pulmonary mechanics in patients with COPD. Ten clinically
      stable patients will be enrolled. They will report to the lab on the morning of the study and
      after an arterial line is placed, pulmonary function measurements and arterial blood gases
      will be obtained. Iloprost (2.5 mcg via nebulizer) will be administered and the effect upon
      arterial blood pressure, respiration and arterial saturation will be monitored. Pulmonary
      function tests (PFTs) and blood gases will be repeated after 30 minutes. Patients who remain
      clinically stable without evidence of a fall in arterial PO2 or systemic blood pressure would
      inhale a second dose of 2.5 mcg of iloprost. The patient will be monitored for a minimum of 2
      hours after their last dose of iloprost. Primary outcome variable will be the alveolar
      arterial O2 difference while secondary outcomes will include PAO2, venous admixture, FVC and
      FEV1, DLCO and ventilatory equivalents for O2 and CO2. All comparisons will be made using
      Student's t-test with a Bonferroni correction. The number of study patients was chosen on the
      basis of a power analysis to provide an alpha of 0.05 at a level of 0.9.
    

Intervention name(s): iloprost Inhalation; iloprost
Intervention type(s): Drug; Drug
Intervention description(s): inhale 2.5 mg, repeat times one; inhaled 2.5 mg, repeat times one
Other intervention name(s): Ventavis; Ventavis
Intervention MeSH terms: Iloprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic obstructive pulmonary disease; pulmonary hypertension
Role of Matrix Metalloproteinases (MMPs) and Tissue Inhibitors of Metalloproteinases (TIMPs) in Children With Myocarditis
Condition: Myocarditis
MeSH terms: Myocarditis
Study type: Observational

Summary: 
      Children can have or develop certain problems with their heart function, specifically with
      the heart muscle or myocardium. This problem can be caused by many things specifically by
      infection resulting in myocarditis (inflammation of the heart muscle) or dilated
      cardiomyopathy (caused by many factors including high blood pressure and heart attacks). The
      body goes through many processes to repair the injured tissue including using proteins that
      cause the muscle mass to increase called matrix metalloproteinases (MMPs). The body also uses
      proteins that direct the MMPs to stop increasing the muscle mass called tissue inhibitory of
      metalloproteinases (TIMPs). Currently, there are no published studies that explain or
      evaluate the relationship that MMPs and TIMPs have in myocarditis and dilated cardiomyopathy
      in children.

      The investigator wishes to perform a prospective study of the serum levels of these proteins
      and their regulators in children with myocarditis and/or dilated cardiomyopathy and compare
      them with children that have no heart disease.
    

Detailed description: 
      All children who present with signs and symptoms of myocarditis and have laboratory findings
      consistent with cardiomyopathy will be eligible. After prospective consent, all subjects will
      receive: (1) a complete physical examination, (2) complete transthoracic echocardiogram to
      better characterize the disease process. Follow-up echocardiograms will be performed at 24-72
      hours after admission into the protocol and at discharge from the hospital. Approximately 2
      teaspoons of blood will be drawn at: (1) enrollment, (2) 24 hours after, (3) 72 hours after,
      (4) and at hospital discharge. Those subjects that receive a heart transplant will have blood
      drawn at the time of transplantation. For those that have a cardiac catheterization or have a
      muscle biopsy as part of their standard of care, will also have a biopsy of their right
      ventricle performed.

      Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), vital
      signs, clinical course events/data (i.e. need for dialysis, length of stay, surgical time
      points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data,
      and standard of care laboratory results.

      The investigator wishes to evaluate the relationship of this data with the patient's
      diagnosis, clinical course, and serum levels of MMP and TIMP proteinases.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients of the Cardiac Service at Children's Medical Center.
      
Biospecimen description: 
      Biopsy tissue, if available.
Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients
Condition: Inflammation; End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to compare the dual use of telmisartan and captopril vs the
      individual use of such drugs and placebo on the systemic inflammation of patients on
      hemodialysis (HD).
    

Detailed description: 
      Once included, patients will be randomly allocated (by a computer-generated randomization
      list) to one of the following groups: group 1 will receive Captopril, group 2 Telmisartan,
      group 3 Captopril plus Telmisartan, and group 4 Placebo. Drugs will be provided as tablets
      during a period of 3 months. All patients will have 3 HD sessions per week, with the same
      kind of single-use dialysis membrane and dialysate Monthly visits will be scheduled for
      clinical and biochemical evaluations. A blood sample will be taken at baseline and every
      month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids,
      and electrolytes (measured by usual methods). In serum samples at 0, 1 and 3 months, tumor
      necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) concentrations will be measured by
      ELISA using high sensitivity kits. Additionally, in the same serum samples, C-reactive
      protein (CRP) concentrations will be measured by nephelometry using high sensitivity kits.
      All laboratory measurements, including inflammation markers, will be performed in the Central
      Laboratory (Hospital de Especialidades, Centro Médico Nacional de Occidente), by the same
      personnel blinded to patient's details.

      Treatment compliance will be recorded by counting tablets left in the container at the end of
      each monthly visit.
    

Intervention name(s): captopril plus placebo; telmisartan plus placebo; Telmisartan plus Captopril; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): This group will receive captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day; Patients of this group will receive telmisartan 80 mg/day (1 tablet 40 mg orally twice a day) plus 1 tablet of placebo twice a day; Patients of this group will receive captopril 50 mg/day (1 tablet 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet 40 mg orally twice a day); Patients in this group will receive 2 tablets of placebo (starch) twice a day.
Other intervention name(s): Capotena; micardis; Capotena; Micardis; Starch
Intervention MeSH terms: Telmisartan; Captopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inflammation; telmisartan; captopril; hemodialysis
Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy
Condition: Lung-protective Ventilation
Study type: Interventional

Summary: 
      Robot-assisted laparoscopic radical cystectomy (RARC) increases the incidence of
      postoperative complications. We conducted a study to determine the effect of lung-protective
      ventilation strategy.
    

Detailed description: 
      Robot-assisted laparoscopic radical cystectomy (RARC) performed with patient in the steep
      Trendelenburg position under pneumoperitoneum increases the incidence of postoperative
      complications. Approach termed lung-protective ventilation (LPV) strategy which refers to the
      use of low tidal volumes and positive end-expiratory pressure (PEEP) may lead to a reduction
      in inflammation and prevent the occurrence of atelectasis. Computed tomography (CT) requiring
      transportation is the golden standard for measuring atelectasis, which is not suitable for
      perioperative observation. Lung ultrasound (LUS) which is noninvasive and easily repeatable
      at the bedside appears to be an accurate diagnostic tool for early detection of atelectasis.
      Thus, we conducted the trial to determine whether an LPV strategy has benefits in patients
      scheduled for RARC through a multifaceted method. We hypothesized that the use of
      prophylactic low tidal volume and PEEP would decrease postoperative inflammation and
      atelectasis, thereby, improve outcomes, as compared with the standard of nonprotective
      mechanical ventilation.
    

Intervention name(s): lung protective ventilation strategy; nonprotective ventilation
Intervention type(s): Procedure; Procedure
Intervention description(s): low tidal volumes and positive end-expiratory pressure mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer; large tidal volume and zero PEEP mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Lung-protective ventilation(LPV) group (low tidal volume 6 ml kg-1 predicted ideal body weight (PBW)+ 7 cmH2O positive end-expiratory pressure(PEEP)) vs. nonprotective group (control group) (large tidal volume 9 ml kg-1 + zero PEEP (ZEEP)) mechanical ventilation in patients undergoing RARC
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lung-protective ventilation strategy; low tidal volume; positive end-expiratory pressure; Lung ultrasound; postoperative pulmonary complications
The Objectives of This Study Are Study the Safety, Reactogenicity and Obtain Preliminary Data on the Immunogenicity of Flu-M Quadro, 4-valent Inactivated Split Influenza Vaccine, in Healthy Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of
      Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers
    

Detailed description: 
      The maximum period of the volunteers' participation in the trial will be 35 ± 2 days.
      Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period
      - 28±2 days.

      All volunteers are followed by a clinical investigator for 6 months after vaccination outside
      of this trial with the aim of detecting possible late adverse reactions. If a volunteer has
      any delayed-type reactions, the volunteer will be invited to the clinic for correction of
      his/her condition.
    

Intervention name(s): Flu-M Quadro [inactivated split influenza vaccine] with preservative; Flu-M Quadro [inactivated split influenza vaccine] without preservative; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): solution for intramuscular injection, 0.5 ml; solution for intramuscular injection, 0.5 ml; solution for intramuscular injection, 0.5 ml
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: influenza; flu; vaccine; Flu-M; FluM Tetra; Tetra; SPbSRIVS; Quadro
Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock
Condition: Ocular Physiology
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing,
      2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.
    


Intervention name(s): Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock; Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock
Intervention type(s): Device; Device
Intervention description(s): CONTROL; TEST
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Diphenhydramine in Children and Adolescents
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetics of diphenhydramine in two pediatric populations:
      children, ages 2 to < 12 years, and adolescents, ages 12 to < 18 years.
    

Detailed description: 
      This study has an open-label, single-dose classical pharmacokinetic design with no comparator
      treatment or group. Twenty-four (24) children, ages 2 to < 12 years, and 12 adolescents, ages
      12 to < 18 years, with symptoms due to hay fever or other upper respiratory allergies will
      complete the study. To ensure that younger children are represented, at least 35% (8) of the
      children enrolled will range from 2 to < 6 years of age.
    

Intervention name(s): diphenhydramine HCl
Intervention type(s): Drug
Intervention description(s): A single liquid dose of diphenhydramine HCl (12.5 mg /5 mL) followed by water, according to an age-weight dosing schedule
Other intervention name(s): Children's Benadryl Allergy Liquid
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science