bioihbjkbjnl/mcl2 huggingface dataset:
Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study
Condition: Provoked Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      This study examines feasibility of R&D activities in the planned randomized controlled trial
      where effectiveness of somatocognitive therapy intervention will be compared to treatment as
      usual in provoked vestibulodynia.
    

Detailed description: 
      Provoked vestibulodynia is a multifactorial, persistent pain condition, affecting young
      women. It represents the most common cause of pain during sexual intercourse. Existing
      treatment approaches are predominantly based on clinical experience, observational studies,
      or reports of expert committees. Although, physiotherapy is one of the most commonly
      recommended treatments, high quality randomized controlled trials are needed to assess its
      effectiveness.

      This is a phase I, feasibility study with the purpose of testing R&D activities for a planned
      full size RCT. Additionally, patients experiences with the somatocognitive therapy
      intervention, assessment measures and condition itself will be collected using qualitative
      interviews. The results will be applied to adjust time-line of the treatment, outcome
      measures and therapeutic approach before commencing full scale RCT.
    

Intervention name(s): somatocognitive physiotherapy
Intervention type(s): Other
Intervention description(s): Somatocognitive physiotherapy (SCT) is a multimodal physical therapy approach that has been developed in an attempt at alleviating the burden of longstanding pain. The main foci of SCT include: (1) bodily exercises and techniques increasing body awareness, ability to relax and control muscle tension in different situations; (2) education about the vulvodynia and factors influencing pain experience; (3) coping with emotions and thoughts related to bodily experiences; and (4) structured homework assignments promoting application of the learned techniques in daily situation and gradual exposure to activities associated with pain. An important goal of SCT is to facilitate integration of new bodily habits into the patient's daily activities. The most important learning process thus occurs in the space between the treatment sessions. The therapeutic techniques are to be rehearsed in everyday situations.
Intervention model: Single Group Assignment
Intervention model description: Three measurements time points: baseline, after treatment, and 8 months after baseline. Additionally two interviews per participant; first - between baseline and treatment ending and second after 8 months follow up
Masking: None (Open Label)
Primary purpose: Other
Keywords: provoked localized vulvodynia; provoked vestibulodynia; vestibulitt; physiotherapy
Testing for Bacterial Contamination During Gastric Surgeries
Condition: Gastric Surgery
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether creating a gastrotomy (hole in the stomach)
      during gastric surgery increases a patient's risk of intra-abdominal infection.

      We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant
      bacterial pathogens.
    

Detailed description: 
      We propose to investigate the bacterial load and contamination patients experience during
      laparoscopic roux-en-y gastric bypass while having their gastrotomy for gastrojejunostomy. In
      all patients who undergo laparoscopic roux-en-y gastric bypass, the stomach must be opened to
      the peritoneal cavity while placing an anvil for gastrojejunostomy.

      Samples of gastric fluid will be collected and sent for analysis in all patients. Samples of
      peritoneal fluid will be collected prior to and after the creation of the gastrotomy, using
      intraperitoneal irrigation with approximately 500 cc of normal saline. Bacterial counts and
      identification will be recorded for each sample.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        observational studies patients morbidly obese.
      
Keywords: Bacterial; contamination; gastrotomy; Complications
Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of
      multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in
      hemophilia A or B patients without inhibitor.
    


Intervention name(s): STSP-0601 for Injection
Intervention type(s): Drug
Intervention description(s): Intravenous Injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Molecular Weight Heparin for Hemodialysis Anticoagulation
Condition: End Stage Renal Failure on Dialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as
      anticoagulation during hemodialysis (HD) therapy. In this study the investigators have
      compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.
    

Detailed description: 
      In this prospective, randomized, cross-over study the investigators compared the safety,
      clinical efficacy of Clexane (enoxaparin sodium; Sanofi-Aventis) with unfractionated heparin
      in 27 chronic HD patients. Group A received Clexane (enoxaparin sodium; Sanofi-Aventis) and
      were followed up for 3 months and then crossed over to Unfractionated heparin for a further
      3-month period. Group B received Unfractionated heparin first and then crossed over to
      Clexane, each followed up for 3 months. Heparin anticoagulation, clinical clotting and
      hemorrhage were evaluated by visual inspection after blood draining of the air trap.
    

Intervention name(s): low molecular weight heparin (enoxaparin sodium); standard unfractionated heparin
Intervention type(s): Drug; Drug
Intervention description(s): Enoxaparin sodium (Clexane; 40 mg) was administered 3-4 min before dialysis as a bolus dose, into the arterial line pre-dialyzer.; Heparin (sodium heparin 5000 IU/ml) was administered as a bolus dose (50 IU/kg body weight) intravenously into the pre-dialyzer arterial line of the extracorporeal blood circuit, followed by a maintenance dose of 1000 IU sodium heparin per hour.
Intervention MeSH terms: Heparin; Calcium heparin; Enoxaparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: anticoagulation; hemodialysis; heparin; lipids; low molecular weight heparins
Using Feedback Reports to Improve Medication Adherence
Condition: Coronary Artery Disease; Adherence
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this research study is to improve statin medication adherence among Veterans
      with coronary artery disease with poor adherence to medications. The investigators are
      testing if newer technology pill bottle devices linked with individual feedback and/or social
      incentive strategies can improve medication taking behavior.
    

Detailed description: 
      Patients with coronary artery disease and previous poor adherence to statin medications will
      be recruited at Philadelphia VA Medical Center. Enrolled participants will be randomly
      assigned to one of three arms:

        1. Control Group

        2. Individual Alarm device and feedback report

        3. Individual plus patient-selected Feedback Friend report

      Patients will be given a medication-monitoring device (Vitality GlowCaps) to monitor the
      statin medication that is being currently prescribed by their primary care physician. In
      first group, the control arm (Arm 1), the device reminders will be turned off but the device
      will continue recording adherence to the medications. In second group, reminder arm (Arm 2),
      the device will be programmed as an alarm that will be activated if the patient does not take
      the medication at the time set by the patient. In addition the patient will get a weekly
      report of his/her adherence. In the third group, patient-selected family/friend/or reciprocal
      peer feedback arm (Arm 3), in addition to the activation of the alarm function the device
      will be linked to a weekly report on adherence to medications. This report will be delivered
      to the patient and to the patient identified family/friend/ or reciprocal peer.
    

Intervention name(s): Individual Feedback; Feedback Friend
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patient gets feedback reports on adherence weekly.; In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Medication Adherence; Reciprocal Peer; Telemonitoring
Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
Condition: End Stage Renal Disease; Hyperhomocysteinemia
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hyperhomocysteinemia
Study type: Interventional

Summary: 
      OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total
      homocysteine concentration in patients with end stage renal disease receiving regular
      hemodialysis therapy resulting in hyperhomocysteinemia.

      II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and
      cyanocobalamin (vitamin B12) daily in these patients.

      III. Assess the safety and tolerability of this therapy in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, placebo controlled study. Patients are stratified
      according to prestudy homocysteine levels (above or below average). Patients are randomized
      to receive placebo or one of two doses of oral folic acid, with or without pyridoxine and
      cyanocobalamin.

      Arm I: Patients receive oral placebo daily. Arm II: Patients receive oral pyridoxine,
      cyanocobalamin, and oral placebo daily.

      Arm III: Patients receive oral pyridoxine, cyanocobalamin, and folic acid daily.

      Arm IV: Patients receive oral pyridoxine and cyanocobalamin plus a higher dose of folic acid
      daily.

      Arm V: Patients receive oral placebo and oral folic acid daily. Arm VI: Patients receive oral
      placebo and higher dose folic acid daily. Treatment continues for 8 weeks.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): cyanocobalamin; folic acid; pyridoxine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Folic Acid; Pyridoxine; Vitamin B 12; Hydroxocobalamin
Primary purpose: Treatment
Keywords: cardiovascular and respiratory diseases; end stage renal disease; hyperhomocysteinemia; rare disease; renal and genitourinary disorders
Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence
Condition: Endometriosis
MeSH terms: Endometriosis; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will
      be tested for the treatment of women with endometriosis recurrence compared with classical
      GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will
      be the outcomes for establishing which medical treatment is the best in endometriosis
      recurrence treatment.
    

Detailed description: 
      Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing
      recurrence after surgery at least in 20-50% after 5 years of follow-up. Aromatase inhibitor
      plus GnRH analog may be more effective than GnRH agonist alone in the treatment of
      endometriosis recurrence.
    

Intervention name(s): anastrazole; GnRH analog alone
Intervention type(s): Drug; Drug
Intervention description(s): combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months; treatment for three months with GnRH analog (leuprolide acetate) alone
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: endometriosis recurrence; pelvic pain; aromatase inhibitor
Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
Condition: Obese Patients, One Lung Ventilation
MeSH terms: Respiratory Aspiration; Obesity
Study type: Interventional

Summary: 
      One-lung ventilation, even in patients with healthy weight, causes an impairment in
      gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung
      ventilation in obese patients would be improved by applying inverse-ratio ventilation,
      reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the
      restrictive ventilatory effects of obesity, these patients often show a decreased functional
      residual capacity and decreased expiratory reserve volume, leading to an overall decreased
      tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt
      shunting. There are few studies on the one lung ventilation in obese patients about this
      prolonged inspiratory time ventilatory method. We plan to investigate the effect of this
      ventilation method in obese patients during one lung ventilation.
    


Intervention name(s): I:E ratio 1:2; I:E ratio 1:1
Intervention type(s): Procedure; Procedure
Intervention description(s): We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients.; The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Does Nesiritide Provide Renal Protection
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This project evaluates whether nesiritide, human recombinant brain natriuretic peptide,
      confers renal protection during cardiovascular surgery by attenuating the inflammatory
      response.
    

Detailed description: 
      This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in
      patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with
      baseline GFR 30-90ml/min. Patients were randomized to either placebo or nesiritide
      (administered prophylactically starting in the operating room prior to incision at 0.01
      mcg/kg /minute with no bolus and continued for 48 hours).
    

Intervention name(s): Nesiritide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): infuses at 0.01MCG/KG/min for 48 hours; infuses at 0.01MCG/KG/min for 48 hours
Other intervention name(s): kidney protection post cardiopulmonary bypass.; kidney protection post cardiopulmonary bypass
Intervention MeSH terms: Natriuretic Peptide, Brain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: renal failure; cardiopulmonary bypass
Early Aerobic Training Program After Ischemic Stroke
Condition: Stroke; Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the feasibility and efficacy of an early supervised
      aerobic exercise program for patients following a minor ischemic stroke.
    

Detailed description: 
      The purpose of this study is to examine the feasibility and efficacy of an early supervised
      aerobic exercise program for patients following a minor ischemic stroke. Patients after a
      minor ischemic stroke would be randomized within 1-3 weeks of stroke onset to a control group
      (6 weeks of low intensity stretching and coordination exercises followed by a supervised
      aerobic training program) or an experimental group (immediate aerobic training program).
      Patients will be evaluated for measures of ambulation endurance, mobility, gait, functional
      assessment and clinical follow-up after 6 weeks and again 3 months later.
    

Intervention name(s): Supervised aerobic training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Rehabilitation; Aerobic training
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
Condition: Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial was conducted as a prospective, randomized, multinational, multicenter,
      double-blind study in 4 parallel groups of patients.
    

Detailed description: 
      The study was the prospective, randomized, multinational, multicenter, double-blind study in
      4 parallel groups of patients.

      Patients underwent screening examinations at Visit 1. Patients who met all inclusion/ no
      exclusion criteria were randomized at the baseline visit (Day 1) to the double-blind
      treatment for a duration of 14 days but in case of delayed final visit (Day 15) the patient
      could voluntarily take reserve study medication for a maximum of 3 additional days.

      After the end of the double-blind treatment phase, the patients underwent an end-of-treatment
      (EOT) examinations on Day 15 (+3).

      A follow-up phone call within 7 days after Day 15 (or earlier in case of premature
      termination) was performed.
    

Intervention name(s): acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg tablet; Placebo to acetylcysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acute uncomplicated rhinosinusitis, acetylcysteine
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, twelve-month safety study. There is a screening period followed by a
      run-in period to record migraine activity. Qualified subjects will receive study medication
      for up to twelve months for the treatment of multiple migraine attacks. Using the electronic
      diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will
      self-administer the patches and respond to questions in the eDiary post treatment
      administration.
    

Detailed description: 
      This is an open-label, twelve-month safety study. There is a screening period followed by a
      run-in period (14 to 21 days) to determine eligibility for treatment with study medication
      based on daily eDiary data collection. Qualified subjects will receive study medication on
      Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be
      treated with a single dose, consisting of two patches, but subjects can treat multiple
      migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing
      a qualified migraine, subjects will self-administer the patches and continue to respond to
      questions in the eDiary for 48 hours post treatment administration.
    

Intervention name(s): M207 Microneedle System
Intervention type(s): Drug
Intervention description(s): M207 Microneedle System 3.8 mg
Other intervention name(s): ZP-Zolmitriptan Intracutaneous Microneedle System; ADAM-Zolmitriptan
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Intervention model: Single Group Assignment
Intervention model description: Single dose, open-label treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; migraine headache; acute migraine; acute migraine headache
Use of Cyclobenzaprine After Vaginal Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The management of post-operative pain in patients after vaginal surgery provides many
      unforeseen challenges. Although vaginal surgery is considered a minimally invasive approach
      for the repair of pelvic floor prolapse and urinary incontinence, patients may still
      experience varying degrees of discomfort and post-operative pain. Narcotics, however, can
      introduce a host of problems in addition to the potential addictive properties of the
      medication. A vicious cycle ensues as patients seek better pain control at the expense of
      worsening constipation, but without adequate control of pain after surgery, voiding
      dysfunctions are often exaggerated.

      Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management
      of acute musculoskeletal injuries, but the practice of prescribing this centrally acting
      muscle relaxant for post-operative patients has also been successful in the management of
      pain.

      An online search of medical databases revealed that there are currently no published
      retrospective or prospective studies determining the efficacy of cyclobenzaprine in post
      surgical patients in conjunction with traditional pain management. The investigators
      hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ
      prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic
      floor muscle attributable to surgery and thereby reduce the use of narcotics. Consequently,
      the reduction of narcotics and the control of post-surgical pain may also hasten the return
      of normal urinary and defecatory function.
    


Intervention name(s): cyclobenzaprine
Intervention type(s): Drug
Intervention description(s): Cyclobenzaprine 5 mg TID for 7 days
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment