bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Carpal Ligament Self-myofascial Stretching in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS), also known as median mononeuropathy, occurs when the median
      nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. It is
      common in the age group of 40-60 years. The main aim of the study was to compare the
      effectiveness of carpal ligament self-myofascial stretching over conventional physical
      therapy on reducing pain and improving function in patients with stage I and II
      CTS-thirty-six subjects with stage I and II (mild) CTS were recruited. Thirty-six subjects
      who fulfilled the inclusion criteria were randomly assigned to the experimental group and
      control group, with 18 patients in each group. The experimental group received carpal
      ligament self-myofascial stretching along with conventional physical therapy, while the
      control group received traditional physical therapy alone. The duration of the treatment was
      six weeks. The outcome measures used were the Boston Carpal Tunnel Questionnaire and the
      Visual Analogue Scale.
    


Intervention name(s): Carpal ligament self-myofascial stretching; Conventional physical therapy
Intervention type(s): Other; Other
Intervention description(s): Carpal ligament self-myofascial stretching is a technique that involves applying pressure and stretching to the carpal ligaments and surrounding myofascial tissues of the wrist and hand. The objective is to release tension, improve flexibility, and alleviate discomfort or pain in the wrist and hand area.; In this technique, ultrasound therapy, nerve gliding exercise, tendon gliding exercise, and wrist splinting were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myo-fascial stretching; Pain; Function
OTO-201 for the Treatment of Otitis Externa
Condition: Otitis Externa
MeSH terms: Otitis; Otitis Externa
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa.
      Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study
      is designed to characterize safety, procedural factors and clinical effect of OTO-201
      administered in subjects with otitis externa.
    


Intervention name(s): OTO-201 (ciprofloxacin)
Intervention type(s): Drug
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Otitis externa; Swimmer's ear; Ear infection
Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as
      flutamide and buserelin may stop the adrenal glands from producing androgens. OGX-011 may
      help flutamide and buserelin kill more tumor cells by making tumor cells more sensitive to
      the drugs. Giving flutamide and buserelin with OGX-011 before surgery may shrink the tumor so
      it can be removed during surgery.

      PURPOSE: Phase I trial to study the effectiveness of combining hormone therapy with OGX-011
      before radical prostatectomy in treating patients who have prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and recommended phase II dose of OGX-011 (clusterin
           antisense oligonucleotide) when administered with neoadjuvant hormonal therapy before
           radical prostatectomy in patients with adenocarcinoma of the prostate.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the pharmacokinetics of OGX-011 when this regimen is administered in these
           patients..

        -  Assess the effects of this regimen on pathologic complete response rates in these
           patients.

        -  Correlate plasma and/or prostate concentrations of OGX-011 with patient response or
           toxicity measures.

      OUTLINE: This is a dose-escalation study of OGX-011.

      Patients receive OGX-011 IV over 2 hours on days 1, 3, 5, 8, 15, 22, and 29; oral flutamide
      three times daily for 4 weeks; and buserelin subcutaneously on day 1.

      Cohorts of 3-6 patients (except for 1 patient at starting dose) receive escalating doses of
      OGX-011 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The
      recommended phase II dose is the dose preceding the MTD.

      Patients undergo radical prostatectomy and bilateral pelvic lymphadenectomy 1 week after the
      last dose of neoadjuvant therapy.

      Patients are followed at 7 days after surgery and then at 3 months.

      PROJECTED ACCRUAL: Approximately 25-33 patients will be accrued for this study.
    

Intervention name(s): buserelin; custirsen sodium; flutamide; conventional surgery; neoadjuvant therapy
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Flutamide; Buserelin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage III prostate cancer; stage II prostate cancer
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is testing if under the tongue olanzapine for schizophrenia, related psychosis,
      schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that
      is swallowed, in patients who are already gaining weight on olanzapine.
    


Intervention name(s): Sublingual orally disintegrating olanzapine (SODO); Oral olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): 5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.; 5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
Other intervention name(s): LY170053; Zydis; LY170053; Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days
Condition: Focus: Estrogen-free Oral Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate
      5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.
    


Intervention name(s): Ulipristal Acetate
Intervention type(s): Drug
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression
Condition: Stomach Neoplasm
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free
      survival rate (primary end-point) and response rate, toxicity, overall survival and biomarker
      assessment (secondary end-points) in patients with metastatic or recurrent gastric cancer
      with pS6 Ser 240/4 expression.

      Eligibility criteria include pathologically proven non-resectable adenocarcinoma of stomach
      with measurable disease who failed previous first-line palliative chemotherapy including
      fluoropyrimidine and platinum with high expression of pS6 Ser 240/4.

      Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted
      according to the observed clinical toxicities. Treatment will be continued until disease
      progression or patient's intolerability to the study drug.

      A study requires 40 assessable subjects to decide whether the proportion of patients who are
      free from progression at 4 months (16 weeks), P, is less than or equal to 0.1 or greater than
      or equal to 0.25 with a target error rate of 0.05 and β of 0.2. If the number of responses is
      7 or less, the hypothesis that P >= 0.250 is rejected with a target error rate of 0.200 and
      an actual error rate of 0.182. If the investigators assume that drop-out rate is 10%, total
      accrual patient will be 45.
    

Detailed description: 
      Methodology: Prospective, non blinded, open label, single center phase II study

      Criteria for evaluation: Assessment of response will be assessed radiologically according to
      RECIST criteria after completion of the two cycles. Evaluation will be by physical
      examination, chest X-ray, abdomen-pelvis CT scan Safety criteria: Physical examination, vital
      signs, performance status, CBC, serum chemistry, NCI CTC V.3.0
    

Intervention name(s): RAD001
Intervention type(s): Drug
Intervention description(s): RAD001 (everolimus) 10 mg daily, orally without interruption.
1 cycle is equal to 4-week treatment. Treatment will be continued unless disease progression or intolerability.
Other intervention name(s): everolimus
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pS6 Ser 240/4; RAD001 (everolimus); second-line treatment; advanced gastric cancer
Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject
      comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream
      can cause skin irritation after light exposure in people with healthy skin.
    


Intervention name(s): Delgocitinib cream; Delgocitinib cream vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Cream for topical application; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Other intervention name(s): LEO 124249 cream; LEO 124249 cream vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects will receive all treatments with treatments randomised over test fields.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
Condition: IgG Deficiency
MeSH terms: IgG Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13)
      in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the
      antibody response will be impaired in patients as compared with controls. In contrast, we
      postulate that the cellular immune response will be intact.
    

Detailed description: 
      Ten patients with Immunoglobulin G1 and/or Immunoglobulin G2 deficiency will be enrolled
      together with 10 age and sex- matched controls. Blood-samples will be drawn at base-line and
      after 1, 2 and 4 weeks post-vaccination. Serum will be analyzed for opsonophagocytic
      antibodies. Peripheral blood monocytic cells (PBMCs) will be isolated, frozen and later
      analyzed for all time-points simultaneously. PBMCs will be stimulated with vaccine-antigens
      for 3-5 days and cellular activation markers will be measured together with cytokines
      (Interferon-gamma, Interleukin (IL)-5, IL-13, IL-10, IL-17, IL-22). In addition, levels of
      antimicrobial peptides in nasal fluid will be measured at baseline and after 4 weeks
      post-vaccination.
    

Intervention name(s): Prevenar13
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Opsonophagocytic antibodies; Cellular immunity; Vaccine immunity; Antimicrobial peptides
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent
      of patients don't respond to current treatments. MBS2320, the drug being tested in this
      trial, represents a new approach to treating RA, with the potential not only to reduce levels
      of inflammation but to also directly prevent bone damage.The aim of this project is to test
      the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an
      existing treatment, methotrexate.
    

Detailed description: 
      Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation
      and cartilage and bone degradation, leading to joint destruction and progressive disability.

      The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with
      RA following chronic administration. In addition, the study aims to evaluate the effects of
      MBS2320 on measures of disease activity.
    

Intervention name(s): MBS2320; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): As described in the arm descriptions; As described in the arm descriptions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This 26-week extension study evaluates the efficacy and safety of certolizumab pegol
      administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects
      with active Crohn's disease who had no clinical response at Week 6 to induction therapy in
      the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical
      response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this
      extension study.
    

Detailed description: 
      This study is an open-label extension study which follows on from the 6-week double-blind
      main study C87037 (NCT00291668). All 'Week' numbers quoted are relative to the start of the
      double-blind main study. The first visit in this extension study is at Week 8, and the final
      efficacy assessment in this extension study, 26 weeks later, is at Week 34.
    

Intervention name(s): Certolizumab pegol; Certolizumab pegol; Certolizumab pegol
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.
Other intervention name(s): CDP870; Cimzia; CZP; CDP870; Cimzia; CZP; CDP870; Cimzia; CZP
Intervention MeSH terms: Certolizumab Pegol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease; CDP870; Certolizumab pegol; CZP
A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg
      daily) with placebo in the treatment of obesity following an intensive non-pharmacologic
      weight loss program.
    

Detailed description: 
      Although dietary modification coupled with increased exercise is the preferred treatment of
      obesity, these lifestyle changes alone are often insufficient in achieving and maintaining
      weight reduction in obese patients. Topiramate is not approved for the treatment of obesity.
      This double-blind, placebo controlled study will evaluate the effectiveness and safety of
      topiramate in maintaining weight loss achieved by an intensive non-drug weight reduction
      program. Enrolled patients will undergo run-in phase (8 weeks of intensive non-drug weight
      reduction therapy consisting of a low calorie diet, a behavioral modification program, and an
      exercise program). Those patients who achieve weight loss of >= 8% of enrollment body weight
      and meeting the eligibility criteria will be randomized to either 96mg or 192mg of
      topiramate, or placebo. After 8 weeks of dose titration, the patients will receive one year
      of treatment. Effectiveness will be assessed by body weight, Body Mass Index (BMI), number
      and proportion of 5%, 10% and 15% weight loss responders, number and proportion of patients
      who maintain 50%, 75%, and 100% of weight lost during run-in phase, waist and hip
      circumferences, fasting lipid profile, fasting plasma glucose, HbA1c, fasting insulin,
      two-hour glucose tolerance test, uric acid level, blood pressure, body composition,
      echocardiography, and Health Related Quality of Life scores. Safety evaluations (incidence of
      adverse events, electrocardiograms, vital signs, etc) will be performed throughout the study.
      The study hypothesis is that topiramate is more effective than placebo in maintaining weight
      reduction in obese patients following intensive non-drug weight reduction program. During the
      initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target
      doses (either 96mg or 192mg) daily by mouth and the doses will be maintained for one year.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity; Hypertension; Hyperlipidemia; Type 2 Diabetes; Life style modification
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
Condition: Cognition Disorders
MeSH terms: Cognition Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test whether an investigational drug called solanezumab can
      slow the progression of memory problems associated with brain amyloid (protein that forms
      plaques in the brains of people with Alzheimer Disease [AD]).
    

Detailed description: 
      The A4 study is a clinical trial for older individuals who have evidence of amyloid plaque
      build-up in their brains who may be at risk for memory loss and cognitive decline due to
      Alzheimer's disease. The A4 study will test an anti-amyloid investigational drug in older
      individuals who do not yet show symptoms of Alzheimer's disease cognitive impairment or
      dementia with the aim of slowing memory and cognitive decline. The A4 study will also test
      whether anti-amyloid treatment can delay the progression of AD related brain injury on
      imaging and other biomarkers.
    

Intervention name(s): Placebo; Solanezumab
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV; Administered IV
Other intervention name(s): LY2062430
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognition; Prevention
The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects
Condition: Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      The kidneys have numerous salt and water channels and play a major role in the regulation of
      sodium and water. We do not know how these channels work in certain water and sodium
      accumulating medical conditions.

      The purpose of this study is to identify and measure the activity in the water and sodium
      channels by measuring urine biomarkers/proteins in young healthy subjects.
    

Detailed description: 
      25 healthy subjects from age 18-45 are recruited.

      Subjects will be examined on three examination days. Four days prior to the examination days
      the subjects will consume a standard diet based on the amount of sodium and calories.

      On the examination day subjects are randomised to an infusion with either isotonic saline 23
      ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes.

      Renal function is measured by renal clearance of 51Cr-EDTA, urinary sodium, potassium and
      creatinine.

      Urinary NCC, NKCC and ENAC will be measured to evaluate the activity of sodium channels in
      the nephron.
    

Intervention name(s): isotonic saline 0,9 mg/ml; hypertonic saline 2,9 mg/ml; glucose 5%
Intervention type(s): Other; Other; Other
Intervention description(s): infusion, 23 ml/kg, during 50 minutes; infusion, 7 ml/kg, during 50 minutes; infusion, 23 ml/kg, during 50 minutes
Other intervention name(s): isotonic saline; hypertonic saline; glucose 5 %
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Nephrology; ENaC; NCC; NKCC; Sodium channels; renal biomarkers
Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery
Condition: Caesarean
Study type: Interventional
Phase: Phase 4

Summary: 
      Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.
    


Intervention name(s): ceftizoxime
Intervention type(s): Drug
Intervention description(s): ceftizoxime (cefizox) injection either after clamping the cord
Other intervention name(s): cefizox
Intervention MeSH terms: Ceftizoxime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ceftizoxime; Cesarean; post caesarean febrile morbidity