bioihbjkbjnl/mcl2 huggingface dataset:
Atorvastatin After Aneurysmal Subarachnoid Hemorrhage
Condition: SAH
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins,
      have recently been demonstrated to improve endothelial function. Additionally, numerous
      studies have shown statins as having antiinflammatory and cell-signaling effects together
      with a selective up-regulation of the eNOS activity. These findings are of potential benefit
      for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed,
      one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of
      eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate
      effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and
      outcome at one year.
    

Detailed description: 
      Up to now, the preventive and curative treatment of vasospasm secondary to subarachnoid
      aneurismal hemorrhage has been based on three major approaches: increasing arterial pressure
      and cerebral blood flow with the use of triple H therapy, increasing the ischemic threshold
      of neurons with nimodipine and reopening proximal arteries with angioplasty and/or
      intra-arterial administration of nimodipine, verapamil, milrinone or papaverine. Recently,
      several teams have observed the efficacy of diverse statins in the prevention of vasospasm by
      improving the imbalance between the nitric oxide and the endothelin pathways, a major actor
      in the physiopathology of vasospasm. Indeed, this family of molecules improve the
      bioavailability of endogenous nitric oxide and upregulate the endothelial NO synthase.

      In humans, statin administered within the first 72 hours showed to significantly reduce the
      incidence of vasospasm up to 50% an therefore, induce a lower morbidity and mortality of this
      severely ill population. The aim of this study is to demonstrate that atorvastatin reduces
      the incidence of cerebral vasospasm-related morbidity and mortality within 1 year post
      aneurysmal subarachnoid hemorrhage (aSAH) treated by either clipping or endovascular coiling.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients admitted between April 20, 2004, and October 1, 2007, to the Pitie-
        Salpetriere Teaching Hospital in Paris with aneurysmal SAH and treated by endovascular
        coiling or surgery within 96 hrs after SAH onset were considered for inclusion.
The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Disease
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate if wearing of compression stockings influences
      the skin moisture. Conservative stockings are compared with urea containing compression
      stockings to find out if using urea prevents dehydration of the skin while wearing the urea
      compression stockings. Secondary aim was to find out if urea containing stockings increase
      the compliance to wear the compression stockings regulary by patients with diagnosed chronic
      venous insufficiency.
    


Intervention name(s): urea contained compressing stockings; compressing stockings
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Condition: Healthy Cholecystectomized
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide
      extended long-acting formulation after a single dose in humans. It will investigate the
      profile of a single dose of drug in a healthy volunteer subject in order to understand the
      timing and extent of fluctuations in octreotide concentrations in the blood with this
      formulation, the relationship of drug concentration with dose, and how long the drug remains
      in the body system.
    


Intervention name(s): Octreotide pamoate
Intervention type(s): Drug
Intervention MeSH terms: Octreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; octreotide pamoate; pharmacokinetics
A Study for the Treatment of Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Neuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if duloxetine can help patients with painful
      diabetic neuropathy.
    


Intervention name(s): Duloxetine hydrochloride - 40 mg; placebo; Duloxetine hydrochloride - 60 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): duloxetine 40 mg taken orally every day; placebo taken orally every day; duloxetine 60 mg taken orally every day
Other intervention name(s): LY248686; Cymbalta; LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SATisfaction and Adherence to COPD Treatment
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The present study will explore the patients satisfaction to COPD medical treatment (i.e.
      pharmacological and not pharmacological treatment) in a clinical real-world setting and how
      the satisfaction for medical treatment is related to clinical parameters, quality of life,
      illness perception and treatment adherence evolution.

      Moreover health care resource consumption will be observed during the observation period.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD pts
ESGVS: Sclerotherapy With Lauromacrogol
Condition: Venous Insufficiency; Saphenous Vein
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol
      400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study
      of 3% versus 1% Lauromacrogol 400 foam.
    

Detailed description: 
      A multicenter randomized double blind study to evaluate the efficacy and the tolerance of
      echoguided sclerotherapy using 3% versus 1% Lauromacrogol 400 foam in the treatment of Great
      Saphenous Vein (GSV) insufficiency.

      One hundred fifty eligible patients will be recruited during 6 months from 9 study centers
      with a follow up period of 3 years and 7 visits at day 8, 6 weeks, 3 months, 6 months, 1,2
      ,and 3 years.

      After randomization, the patients will be treated by echoguided sclerotherapy with 1% or 3%
      Lauromacrogol 400 foam (ratio 1:1).

      Monitoring is performed by doppler at 8 days, 6 weeks, 6 months , 1,2 ,and 3 years.

      Effectiveness of sclerotherapy is determined at 6 weeks, 3 months and 6 months. A additional
      injection of 4 ml of foam can be performed if needed.

      Severity clinical score and Quality-of-life questionnaire are performed at 6 months ,1 ,2,
      and 3 years.

      The absence of obliteration with a reflux of crural great saphenous vein at 6 months will be
      a criterion of therapeutic failure.

      The therapeutic success or failure criteria are evaluated by a non investigator angiologist
      for 5 patients randomized from each investigational site at 1, 2 and 3 years.
    

Intervention name(s): lauromacrogol
Intervention type(s): Drug
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: lauromacrogol; Sclerotherapy
The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain.
Condition: Hysteroscopy
Study type: Interventional

Summary: 
      The study aims to compare different filling pressures in operative outpatient hysteroscopy.
      Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine
      cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in
      group1, 60mm Hg in group 2 and 40mmHg in group 3.
    

Detailed description: 
      240 women will be randomly divided into 3 groups, each containing 80 women. Randomisation
      will be performed using a computer generated random numbers and sealed envelopes.

      Full history will be taken followed by general and local examination. One hour before the
      procedure all women will receive diclofenac 100mg (Voltaren@ Novartis Switzerland). The
      procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer
      diameter continuous flow hysteroscope with a French working channel and a 30 degrees
      direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using
      the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and
      the external os will be identified using the hysteroscope. The hysteroscope will be
      introduced in the uterine cavity. Saline will be used as the distension medium and the
      pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40 mmHg in group 3. Randomisation
      will be double blind, neither the operator nor the patient will know the pressure during the
      procedure, a third party will set the pressure according to the computer generated random
      numbers. If the procedure cannot be completed, the operator will ask for the pressure to be
      adjusted to 80mm Hg, which is the usual pressure used in Cairo university hospitals, or more
      if needed. In this case the operator will document in the data collection form that the
      procedure could not be completed with the pre-set pressure.

      The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions
      septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will
      be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 50Charr Tecchno
      medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors
      Tecchno medical GmbH.
    

Intervention name(s): Filling pressure 80; Filling pressure 60; Filling pressure 40
Intervention type(s): Device; Device; Device
Intervention description(s): The hysteroscope filling pressure will be 80mm Hg; The hysteroscope filling pressure will be reduced to 50mm Hg; The hysteroscope filling pressure will be 40mm Hg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Operative hysteroscopy; Filling pressure
Massage, Meditation, and Tai Chi for Chronic Lower Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This clinical trial is a preliminary study designed to prepare for a full-scale, randomized
      clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for
      chronic lower back pain in adults.
    

Detailed description: 
      Despite the common use of complementary and alternative therapies for back pain, little is
      known about how such therapies compare with each other or with conventional medical therapies
      in terms of effectiveness and cost. This study will lay the groundwork for a full-scale trial
      that will evaluate the relative effectiveness and costs of three promising relaxation-related
      techniques (massage, tai chi, and meditation) that are appropriate for both younger and older
      adults with chronic lower back pain. The pilot study will identify and resolve unanticipated
      problems and estimate the sample sizes required for an adequately-powered, full-scale trial.

      Participants with chronic lower back pain will be randomly assigned to one of the following
      groups: tai chi, massage, meditation, or continued usual care (control group). The
      participants assigned to each intervention will be divided equally between persons under and
      over age 65.
    

Intervention name(s): Tai chi; Mindfulness-based Stress Reduction program; Therapeutic massage
Intervention type(s): Behavioral; Behavioral; Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
The Use of Ketorolac in Surgical Neonates
Condition: Postoperative Pain Control in Surgical Neonates
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The general purpose of this study is to characterize the safety profile of ketorolac in
      infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective
      in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg
      intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9%
      normal saline as placebo.

      Primary: The primary purpose of this study is to compare bleeding events in neonates who
      receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that
      ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.

      Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine
      output per shift, platelet counts, hemoglobin levels, number of days on the ventilator,
      amount of narcotic administered, blood pressure, and reintubation events on all patients in
      this study as secondary study points.
    

Detailed description: 
      This is a Phase II, single center, randomized controlled pilot study. Hospitalized patients
      one week of age to 3 months of age who undergo an abdominal surgical procedure within the
      moderate or severe degree of pain category (see attached Table 1: postoperative pain
      categories) will be randomized to receive standard pain management regimens plus placebo
      (0.9% saline of equivalent volume) or ketorolac 0.5mg IV q8h x 72h plus standard pain
      management regimens. The postoperative management will be unchanged and at the discretion of
      the attending surgeon, as appropriate for the surgical procedure. The patients will be
      followed for 5 days, or 48hrs from the end of ketorolac therapy for primary and secondary
      endpoints.
    

Intervention name(s): Ketorolac; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ketorolac 0.5mg/kg IV q8h x 72h.; 0.9% normal saline 1ml/kg
Other intervention name(s): Toradol; 0.9% normal saline
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketorolac; postoperative pain; bleeding events
The Effects of Game Based Exercise Training on Balance and Postural Control in Patients With Ataxia
Condition: Ataxia
MeSH terms: Ataxia
Study type: Interventional

Summary: 
      This study was planned to investigate the effects of exercise training based on Microsoft
      Kinect application on balance and postural control in ataxic patients.
    

Detailed description: 
      Patients who meet the inclusion criteria will be divided into two groups randomly: 'Kinect
      and exercise training' and 'exercise training'. The assessments will be made by a blind
      investigator four times, before and after the implementation of both protocols. The
      evaluations will take approximately 1 hour. The demographic information of the cases will be
      recorded. Designed as cross over study, two treatment protocols will be used in this study.
      The first protocol will be Xbox Kinect application plus exercise program, the second protocol
      will be only exercise program. At the beginning of the study, 2 groups will be allocated
      (Group A and Group B) randomly. For group A, the Xbox Kinect application plus exercise
      program will be applied for the first 8 weeks. For group B, only exercise program will be
      applied therapy first 8 weeks. All assessments will be repeated before and after each therapy
      period. Exercise program will consist of selected balance, coordination and walking exercises
      according to the individual needs of patients. After 10 weeks washout period, patients will
      be included in the other group. All patients will take the treatment 1-hour, 3 days in a week
      for 8 weeks.
    

Intervention name(s): Kinect + Exercise Training; Exercise Training
Intervention type(s): Other; Other
Intervention description(s): Kinect + Exercise Training : Patients will play Xbox Kinect games for 40 minutes and take the treatment for 20 minutes, 3 days in a week for 8 weeks. After 10 weeks washout period, patients will take the treatment 1-hour, 3 days in a week for 8 weeks.; Exercise Training: Patients will take the treatment 1-hour, 3 days in a week for 8 weeks. After 10 weeks washout period, patients will play Xbox Kinect games for 40 minutes and take the treatment for 20 minutes, 3 days in a week for 8 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
Condition: Prolapsed Lumbar Disc; Prolapsed Cervical Disc; Intervertebral Disc Degeneration; Spondylolisthesis, Grade 1; Intervertebral Disc Displacement
MeSH terms: Spondylolisthesis; Intervertebral Disc Degeneration; Intervertebral Disc Displacement
Study type: Observational [Patient Registry]

Summary: 
      The registry has been designed as a prospective, observational program for patients
      undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in
      the development of strategic treatment pathways and improved patient care. All patients who
      agree to participate in the registry will sign an informed consent form and subsequently be
      treated by their surgeon with the VariLift device. Potential treatment procedures include
      bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar
      interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar
      spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be
      performed in either an inpatient or outpatient facility. It is anticipated that the VariLift
      devices will improve patient outcomes and lead to the development of treatment pathways to
      improve patient care.
    

Detailed description: 
      The registry is design to collect data prospectively on patients undergoing spinal fusion
      using the VariLift-L, VariLift-A, or VariLift-C device patients will be enrolled in the
      registry after reviewing the protocol with their health care provider and signing the
      informed consent. Data will be collected at recommended time points based on the standards of
      care of the participating sites. The registry will serve as a database in which retrospective
      analysis and exploratory analysis of specific research questions will be answered.

      Follow up visits will be defined by the treating physicians based on their standard practice.
      Typical clinical follow up schedules for patients undergoing this type of surgery are
      pre-operative and 12 months post-operative.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing spinal fusion using VariLift lumbar or cervical devices must be
        screened by the investigating surgeon for eligibility into the registry using the primary
        diagnosis parameters and the inclusion/exclusion criteria. In addition physicians must
        follow the associated VariLift Instructions for Use.
A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to show that a magnetic field applied to the front part of the
      brain of children suffering from Autism Spectrum Disorder(ASD) can improve function and
      ameliorate symptoms.
    


Intervention name(s): MRT-Active; MRT-SHAM
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
Condition: Traumatic Injury; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ
      between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed
      on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two
      enoxaparin dosing strategies.
    

Detailed description: 
      This is a pilot study to determine if AT-III serum concentrations differ between patients
      with normal (>= 0.1 IU/mL) versus subtherapeutic (<0.1 IU/mL) anti-Xa trough concentrations
      when placed on enoxaparin 30 mg twice daily for venous thromboembolism (VTE) prophylaxis.
      Secondarily, this study will compare two enoxaparin dosing strategies: standard 30 mg twice
      daily and a dosing strategy based on trough anti-Xa values in high-risk trauma patients.

      Specific aims include: 1) to compare the extent of reduced AT-III activity between patients
      with trough anti-Xa >= 0.1 IU/mL and < 0.1 IU/mL upon initial assay; 2) to determine the
      proportion of patients who reach goal anti-Xa and the time to goal anti-Xa achievement
      between two interventional dosing strategies: enoxaparin 40 mg every 12 hours (with
      consideration to increase to 50 mg every 12 hours if recheck anti-Xa is not at goal) and
      enoxaparin 30 mg every eight hours; 3) to compare anti-Xa enoxaparin dosing strategies based
      on VTE, bleeding rates, transfusion requirements, drug discontinuation rate and
      bioaccumulation, and 4) to determine patient-specific factors that correlate to
      subtherapeutic anti-Xa such as serial AT-III activity, weight, body mass index, age,
      cumulative fluid administration, and thromboelastography (TEG).
    

Intervention name(s): Enoxaparin 40 mg q12h; Enoxaparin 30 mg q8h
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive enoxaparin 40 mg every 12 hours. Dose will be escalated to enoxaparin 50 mg every 12 hours if steady state trough concentration is still subtherapeutic.; Patients receive enoxaparin 30 mg every 8 hours.
Other intervention name(s): no other name; no other name
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention