bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube
Condition: Cuff Pressure
Study type: Interventional

Summary: 
      Endotracheal pressure with different cuff shapes can result in different cuff pressure change
      after head positional change. In this study, 52 patients underwent middle ear surgery with
      general anesthesia were randomly allocated to two group; patients were intubated with taper
      guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with
      sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22
      centimeters of water in the neural head position and was measured after the change to the 45
      degree head rotation. The change of cuff pressure was compared between two groups
    

Detailed description: 
      Endotracheal pressure with different cuff shapes can result in different cuff pressure change
      after head positional change. In this study, 52 patients underwent middle ear surgery with
      general anesthesia were randomly allocated to two group; patients were intubated with taper
      guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with
      sevoflurane with air/O2 and remifentanil. The cuff pressure was initially set at 24
      centimeters of water in the neural head position and was measured after the change to the 45
      degree head rotation. In addition, sore throat, hoarseness , dysphagia and cough were
      recorded 0, 6, 12, 24 hr after surgery. The change of cuff pressure was compared between two
      groups. The side effects associated with tube were compared between two groups.
    

Intervention name(s): Taper guard tube; Cylindrical tube
Intervention type(s): Device; Device
Intervention description(s): Taper guard tube was intubated; Cylindrical tube was intubated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate Ketamine for the Treatment of Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This 2 cohort, sequential, ascending dose study will assess the safety, tolerability and
      efficacy of oral ketamine dosed in a single 5-day BID regimen in addition to placebo, in a
      4-week cross-over design in patients with Rett Syndrome. Approximately 12 patients per cohort
      are anticipated to participate for approximately 8-10 weeks at approximately 7 US study
      centers.
    

Detailed description: 
      This study is designed to assess oral ketamine for the treatment of Rett Syndrome and
      consists of up to 4 ascending dose cohorts, each assessing 1 dose level of ketamine vs
      placebo. Patients will receive in either order, a 5-day BID regimen of both placebo and the
      cohort-specified dose level of oral ketamine. Patients may only participate in 1 cohort.
      Safety and tolerability will be assessed via patient disposition, vital signs, physical
      examination, adverse events and concomitant medication use. Efficacy will be assessed via
      physician and caregiver questionnaires and assessments, and continuous, wearable, at-home
      biosensor data collection. An independent safety committee will review safety data from each
      cohort to determine if the subsequent ascending dose cohort is warranted. A total of 12
      patients per cohort is anticipated at approximately 7 sites. The screening period will last
      between 2 and 4 weeks, the cross-over treatment period will last 4 weeks, and the safety
      follow-up period will last 2 weeks. Total patient participation is approximately 8-10 weeks.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): oral ketamine dosed twice daily for 5 days
Other intervention name(s): Ketalar
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will receive placebo and ketamine for 5 days BID each, in a double-blind treatment order, and will be assessed for 2 weeks after each treatment.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: MECP2; RTT; Retts; ketamine
Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of
      treatment in COPD.
    

Detailed description: 
      This study is a multi-center, randomized, double-blind, placebo and active controlled,
      parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled
      to randomize at least 200 subjects. Study participation will consist of a total of six study
      visits over nine weeks for each subject. This study was previously posted by Sepracor Inc. In
      October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010,
      Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Levalbuterol HCl; Levalbuterol HCl; Albuterol Sulfate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Levalbuterol 0.63 TID; Levabuterol 1.25 mg TID; Racemic albuterol 2.5 mg TID; Placebo TID
Other intervention name(s): Xopenex HCl Inhalation Solution; Xopenex HCl Inhalation Solution; Ventolin Inhalation Solution
Intervention MeSH terms: Pharmaceutical Solutions; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Chronic Bronchitis; Chronic Emphysema
Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
Condition: Gastric Ulcer
MeSH terms: Stomach Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily
      and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of
      gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug
      (NSAID)therapy.
    


Intervention name(s): Esomeprazole; Ranitidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: NSAID-associated gastric ulcer
Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension
Condition: Obesity
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Potential protective cardiovascular effect of Spirulina maxima supplementation was studied in
      a double-blind placebo-controlled trial of obese subjects with treated hypertension, each
      randomized to receive spirulina or a placebo.
    

Detailed description: 
      Numerous publications have provided evidence of the effect of natural substances-supplements
      on improving endothelial function, and thus reducing the risk of cardiovascular diseases.
      Spirulina maxima (Arthrospira maxima) is a species of cyanobacterium, used as food additive
      because of its high levels of protein and essential nutrients, such as carotenoids, vitamins,
      and minerals. Various studies point to a possible beneficial effect of spirulina on the
      concentration of blood serum lipids and fasting glucose,body weight or blood pressure,
      however, the results of studies pertained to the effects of spirulina in individuals who, at
      the time of trial, were not taking medications. The aim of the study was to estimate an
      effect of Spirulina maxima supplementation on cardiovascular risk in obese Caucasians with
      treated hypertension. The anthropometric parameters, blood pressure, insulin sensitivity,
      plasma lipid levels, and stress oxidative biomarkers were measured at the baseline and after
      3 months of supplementation with spirulina or placebo in the group of obese, hypertensive
      patients receiving standard antihypertensive treatment.
    

Intervention name(s): Spirulina; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Individuals receive 2 g of spirulina daily, for 3 months.; Individuals receive a placebo daily, for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: spirulina, placebo, obesity,antihypertensive treatment
An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as
      the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): Vanzacaftor; Vanzacaftor Placebo; Moxifloxacin; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration.; Placebo for oral administration.; Tablets for oral administration.; Tablets for oral administration.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
TAMO Therapy Versus Postural Control Exercise in Children With Congenital Muscular Torticollis
Condition: Torticollis Congenital
MeSH terms: Torticollis
Study type: Interventional

Summary: 
      A randomized control trial was conducted through convenient sampling. 18 subjects were
      randomly allocated into two groups, group A received postural control exercises in addition
      to conventional therapy, while Group B received TAMO therapy along with conventional therapy.
      analysis.
    

Detailed description: 
      Torticollis is common in children and can be congenital or acquired. Acquired cases can
      result from neck muscles or bone injuries. Though distressing for parents, it usually
      improves over time. Treatment includes postural control exercise and TAMO therapy, along with
      conventional treatment. To compare the effects of TAMO therapy versus postural control
      exercises on children with congenital muscular torticollis on cervical range of motion. A
      randomized control trial was conducted through convenient sampling. Eighteen subjects were
      randomly allocated into two groups; Group A received postural control exercises in addition
      to conventional therapy, while group B received TAMO therapy along with conventional therapy.
      The duration of the treatment was eight weeks. Goniometer, still photography, muscle
      function. Eighteen participants (n=18) were included in the study.
    

Intervention name(s): TAMO; Postural Control exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): TAMO therapy; Postural Control exercises
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Pre-rehabilitation and Rehabilitation Period on Functional Status in Inpatient Stroke Patients
Condition: Stroke; Rehabilitation
MeSH terms: Stroke
Study type: Observational

Summary: 
      Patients who underwent inpatient rehabilitation for the last 5 years were retrospectively
      scanned. The pre-rehabilitation and rehabilitation periods of the patients were determined.
      At the beginning and end of rehabilitation, patients were evaluated with the Brunsstrom,
      Barthel and Stroke Impact Scale. The effect of the specified durations on these scales was
      investigated.
    


Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): Stroke Rehabilitation Program
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        40-90-year-old post-stroke patients
Static and Dynamic Core Stability Exercises in Potpartum Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      To compare the effects of static exercises with dynamic core stability on pain and disability
      in postpartum back pain.
    

Detailed description: 
      The study comprised 28 participants. The individuals were subdivided into binary groups,
      group A performed static exercises and group B performed dynamic exercises including swiss
      ball, each containing 14 subjects. Baseline treatment (Hot pack, TENS and posture correction)
      to both groups was given along with core stability exercises. Core stability exercises were
      performed on both group for 4 weeks. The pretreatment and post treatment tests are measured
      using the scale VAS (visual analog scale) and Oswestry disability index questionnaire. Both
      groups have shown the improvement in postpartum lumber pain and an improved in daily life
      activities. But swiss ball exercises have more significant improvement on pain and disability
      in patients having postpartum lumber pain.
    

Intervention name(s): Static exercises; Dynamic exercises
Intervention type(s): Other; Other
Intervention description(s): Participants will be treated with static core muscle exercises that are traditional group of exercises :
supine bridge
plank
oblique crunch
side lying with Abduction
This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort.; Participants will be treated with dynamic core muscle exercises that were swiss ball exercises
bridging
straight leg raise in prone lying
straight leg raise with hand raise in prone lying
pelvic tilts
This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain and disability in postpartum
Effect of Clomiphene Citrate on Uterine Blood Fow in Women With Unexplained Delayed Conception
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      In a prospective observational study at a university teaching hospital, blood flow indices
      and serum hormone levels were compared between spontaneous and stimulated cycles in the same
      group of 50 patients with unexplained delayed conception.
    

Detailed description: 
      In a prospective observational study at a university teaching hospital, the mid-luteal
      (peri-implantation) endometrial thickness and volume, uterine artery pulsatility index (PI)
      and resistance index (RI), endometrial and subendometrial vascularization index, flow index,
      and vascularization flow index, and serum estradiol and progesterone levels were compared
      between spontaneous and clomiphene citrate stimulated cycles in the same group of 50 patients
      with unexplained infertility.
    

Intervention name(s): Vascularization indices observation
Intervention type(s): Other
Intervention description(s): The mid-luteal endometrial thickness and volume, uterine vascularization indices of uterine artery pulsatility index and resistance index, endometrial and subendometrial vascularization index, flow index, and vascularization flow index, and serum estradiol and progesterone levels were calculated in spontaneous then stimulated cycles in the same group of infertile patients
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had unexplained infertility
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses
      and scarring on the skin.
    


Intervention name(s): Bimekizumab; Adalimumab; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Bimekizumab in different dosages (dose 1 and 2).; Adalimumab in different dosages (dose 1, 2 and 3).; Placebo will be provided matching Bimekizumab.
Other intervention name(s): UCB4940; Humira®
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hidradenitis Suppurativa; Bimekizumab; HS; Moderate to Severe HS
Auricular Acupressure for Hemodialysis Patients With Insomnia
Condition: Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent
      years and yielded favorable results. However, the effect and safety of AAT for insomnia in
      MHD population still lacks high quality evidence. A randomized controlled clinical trial is
      planned to evaluate the effect and safety of AAT in MHD patients with insomnia.
    

Detailed description: 
      Insomnia, a worldwide health problem, is much more frequently complained in maintenance
      hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic
      sedative agents are often reluctantly prescribed with doses mounting up. Patients are
      concerned about drug dependence and drug-related adverse effects. As a non-drug therapy,
      auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is
      widely used to treat many conditions in China. The investigators had been applying AAT for
      MHD patients with insomnia in recent years and yielded favorable results. However, the effect
      and safety of AAT for insomnia in MHD population still lacks high quality evidence.
      Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD
      patients with insomnia to evaluate the effect and safety of AAT.
    

Intervention name(s): auricular acupressure therapy; sham auricular acupressure therapy
Intervention type(s): Other; Other
Intervention description(s): Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.; The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.
Other intervention name(s): auricular acupressure; ear acupressure; sham AAT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insomnia; hemodialysis; auricular acupressure; randomized controlled trial
Generation of Biological Samples Positive to Testosterone for Anti-doping Control
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Testosterone is a steroid widely known to improve physical performance due to its
      protein-anabolic effect. Like other androgenic anabolic steroids (EAA), testosterone is
      included on the World Anti-Doping Agency (WADA) list of prohibited substances.

      EAA are the most detected banned substances in anti-doping controls. Therefore, different
      analytical strategies are required to improve its detection.

      Hypothesis:

      The intramuscular administration of 250 mg of testosterone (cypionate) in healthy subjects
      allows generating detectable concentrations of the drug in urine. Positive urine samples will
      enable to identify analytical strategies for doping control.

      Objectives:

      Primary objective: To measure the concentrations of testosterone in urine for anti-doping
      control samples.

      Secondary objective: To identify metabolites and precursors of testosterone in urine. To
      assess safety and tolerability of the drug used.

      Methods:

      Phase I, open, non-randomized clinical trial, with a treatment condition (testosterone)
      administered via intramuscular injection to 4 subjects.
    


Intervention name(s): Testosterone injection
Intervention type(s): Drug
Intervention description(s): 250 mg of testosterone cypionate (equivalent to 174,8 mg of testosterone) administered via intramuscular injection in a single dose (2 mL)
Other intervention name(s): Testex Prolongatum® 250 mg/2 mL
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Testosterone; Anti-doping control; Athletic performance