bioihbjkbjnl/mcl2 huggingface dataset:
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
Condition: Dupuytren's Contracture
MeSH terms: Dupuytren Contracture; Contracture
Intervention: collagenase clostridium histolyticum; Placebo
Intervention description: Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.; Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 308.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the
      United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal
      (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at
      least one finger, other than the thumb, that was at least 20° as measured by finger
      goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or
      placebo.

      This study was designed to be part of the larger clinical program, for adult patients with
      Dupuytren's contracture with a palpable cord, where the data from 2 pivotal
      Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7
      non-pivotal studies were evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity
             of at least one finger, other than the thumb, that had a contracture at least 20°, but
             not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had
             never been treated with AA4500.

          -  Had a positive "table top test," defined as the inability to simultaneously place the
             affected finger(s) and palm flat against a table top.

          -  Judged to be in good health.

        Exclusion Criteria:

          -  Had a chronic muscular, neurological, or neuromuscular disorder that affected the
             hands.

          -  Had received a treatment for Dupuytren's contracture, including surgery (fasciectomy
             or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil
             and/or interferon on the selected primary joint within 90 days before the first dose
             of study drug.

          -  Had a known recent history of stroke, bleeding, a disease process that affected the
             hands, or other medical condition, which in the investigator's opinion, would make the
             subject unsuitable for enrollment in the study.
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Prenatal Vitamin; Cholecalciferol (Vitamin D3); Cholecalciferol (Vitamin D3)
Intervention description: Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery; Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery; Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 192.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research study is to compare the effects of higher dose vitamin D with
      commonly recommended dose in pregnant women to see which is better in achieving and/or
      maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well
      as improving growth in the infant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are within the ages of 18-45 years

          -  In good general health

          -  12 weeks pregnant (based on last menstrual period)

        Exclusion Criteria:

          -  Mothers with preexisting type I or type II diabetes

          -  Mothers with preexisting hypertension

          -  Mothers with preexisting parathyroid disease or uncontrolled thyroid disease

          -  Mothers with multiple fetuses (e.g., twins, triplets, etc.)
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Condition: Anxiety; Depression
MeSH terms: Depression
Intervention: Cognitive Behaviour Therapy (CBT); Usual Cardiac Care (UCC)
Intervention description: Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.; Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: health anxiety

Summary:

      About 30% of patients survive a cardiac arrest, and the majority of these receive an
      implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD).
      While ICD therapy offers survival benefit over drug therapy, there remain significant quality
      of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD
      shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating
      ICD therapy. The aims of the current study are:

        1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with
           receiving an ICD for secondary prevention of SCD,

        2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e.,
           anti-tachycardia pace terminations and shocks); and

        3. to explore if the psychosocial intervention results in less need for appropriate ICD
           therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients from either Toronto General hospital or St. Michael's Hospital who have
             coronary heart disease,

          -  Receiving their first ICD implant for secondary prevention of SCD or for primary
             prevention of SCD and their underlying heart disease was hypertrophic cardiomyopathy.

        Exclusion Criteria:

          -  Not able to read or understand English;

          -  Evidence of psychosis, dementia or cognitive impairment as documented in the patients'
             hospital records;

          -  Receiving an ICD for primary prevention of ICD.
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
Condition: Thrombosis, Venous
MeSH terms: Thrombosis; Venous Thrombosis; Thrombophlebitis
Intervention: Fondaparinux 2.5mg or placebo
Intervention description: Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 3002.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: superficial vein thrombosis; superficial thrombophlebitis; fondaparinux; deep vein thrombosis; venous thromboembolism treatment; thrombosis

Summary:

      To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of
      acute (recent) superficial thrombophlebitis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long
             diagnosed by compression ultrasound.

        Exclusion criteria:

          -  Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,

          -  deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism
             within last 6 months, treatment for cancer during last 6 months,

          -  anticoagulant medication for more than 48 hours prior to inclusion,

          -  need for oral non-steroidal anti-inflammatory drugs during the study, significant
             bleeding event during past month,

          -  major surgery within last 3 months, low platelet count (below 100×109/L),

          -  kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing
             potential not using reliable contraceptive method
A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Abilify MyCite®
Intervention description: Combination product of aripiprazole tablet embedded with sensor and wearable patch.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To compare inpatient psychiatric hospitalization rates while participants are on oral
      standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be willing and able to give written informed consent, adhere to
             trial procedures and able to read and understand English.

          -  Male and female participants 18 to 65 years of age.

          -  Participants must possess a smartphone and is familiar with its use and is willing to
             download and interact with the Abilify MyCite® app. Participants with a smartphone,
             that is not compatible with the Abilify MyCite® app will be offered a loaner phone for
             the trial period.

          -  Clinical diagnosis of schizophrenia and able to ingest oral medication.

          -  Positive and Negative Syndrome Scale (PANSS) total score between 60-90.

          -  Participants currently prescribed oral atypical antipsychotic medication including
             aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.

          -  Participants are required to have had an inpatient hospitalization for schizophrenia
             within the last 48 months prior to entering the trial.

          -  Skin on the anterior chest just above the lower edge of the rib cage that is free of
             any dermatological problems.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who are pregnant.

          -  Sexually active males or women of childbearing potential (WOCBP) who do not agree to
             practice 2 different methods of birth control or remain abstinent during the trial and
             for 30 days after the last dose of Abilify MyCite®.

          -  Any participants who participated in another clinical trial within 30 days of
             enrollment.

          -  Participants who are currently being treated with an LAI antipsychotic or have been
             treated with an LAI in the retrospective 6-month phase.

          -  Participants with a current DSM-5 diagnosis other than schizophrenia.

          -  Participants with a known allergy to adhesive tape or any pertinent components of the
             patch or aripiprazole tablet embedded with an IEM sensor.
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
Condition: Nephrolithiasis
MeSH terms: Nephrolithiasis; Kidney Calculi
Intervention: Ketorolac Oral Tablet [Toradol]; Acetaminophen; Oxycodone Acetaminophen
Intervention description: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.; Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.; Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine; Acetaminophen, hydrocodone drug combination; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be an open label, prospective study of approximately 112 subjects undergoing either ureteroscopy or percutaneous nephrolithotomy. Patients who are eligible and choose to undergo ureteroscopy or percutaneous nephrolithotomy will then be asked if they would like to participate in the study and informed consent will be obtained. Patients will then be randomized to control (opioid analgesia) or non-opioid analgesia groups, and given this medication at discharge.
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain Outcomes; Ureteroscopy; Percutaneous Nephrolithotomy; Opioids

Summary:

      There are two options for postoperative pain management: opioid and non-opioid analgesia.
      Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous
      nephrolithotomy by randomly administering opioid and non-opioid analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and Women age>18 years old

          -  Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous
             nephrolithotomy.

          -  Uncomplicated ureteroscopy or percutaneous nephrolithotomy

        Exclusion Criteria:

          -  Pregnant/Breastfeeding/Possibly Pregnant Patients

          -  Pediatric Patients

          -  Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen

          -  Significant Renal Disease

          -  Peptic Ulcer Disease

          -  Chronic Pain and recovering opiate use

          -  Inability to complete questionnaires

          -  Non-mobile patients

          -  Patients on methadone
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine transdermal patch; Placebo transdermal patch
Intervention description: Buprenorphine transdermal patch applied for 7-day wear.; Placebo to match buprenorphine transdermal patch 10 or 20.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: osteoarthritis; opioid; transdermal

Summary:

      The original objective of this study was to assess the safety and efficacy of the
      buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal
      system in subjects with moderate to severe osteoarthritis pain. However, this study was
      terminated early with only 35% of the planned sample size, therefore the primary objective is
      changed to focus on the safety evaluations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year
             currently adequately treated with short acting opioids.

          -  taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks
             for control of their osteoarthritis pain.

        Exclusion Criteria:

          -  requiring frequent analgesic therapy for chronic condition(s), other than
             osteoarthritis of the hip, knee, or spine.

          -  scheduled for surgery of the disease site (e.g., major joint replacement surgery), or
             any other major surgery that would fall within the study period.

        Other protocol-specific exclusion/inclusion criteria may apply.
Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: QIVc; TIV1c; TIV2c
Intervention description: Novartis Investigational Quadrivalent Vaccine; Licensed Influenza Vaccine; Novartis Investigational Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2680.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Influenza; Influenza vaccine; Novartis; Adults

Summary:

      Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and
      above.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ages 18 years and older.

          2. Individuals who give written informed consent, who can comply with study procedures,
             and who are available for follow-up.

        Exclusion Criteria:

          1. Individuals recently vaccinated against influenza

          2. Subjects with contraindications to receive influenza vaccine

          3. Please contact the site for additional eligibility criteria
A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: indacaterol and glycopyrronium (QVA149); glycopyrronium (NVA237); indacaterol (QAB149); tiotropium; placebo
Intervention description: Capsules for inhalation delivered via SDDPI.; Capsules for inhalation delivered via SDDPI.; Capsules for inhalation delivered via SDDPI.; Capsules for inhalation delivered via HandiHaler® device.; Placebo to match capsules for inhalation delivered via SDDPI.
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2144.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QVA149, COPD, combination bronchodilator, indacaterol, glycopyrronium bromide

Summary:

      The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in
      patients with moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥40 yrs

          -  Smoking history of at least 10 pack years

          -  Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for
             Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)

          -  Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and
             post-bronchodilator FEV1/FVC (forced vital capacity) <70%

        Exclusion Criteria:

          -  Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for inhaled anticholinergic agents and β2 agonists

          -  Other protocol-defined inclusion/exclusion criteria may apply
Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
Condition: Graft Versus Host Disease; Recurrent Adult Acute Lymphoblastic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Graft vs Host Disease
Intervention: prednisone; methylprednisolone; questionnaire administration
Intervention description: immunosuppressive drug; immunosuppressive drug; Ancillary studies
Intervention MeSH terms: Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying low-dose prednisone or methylprednisolone to see
      how well they work compared with standard-dose prednisone or methylprednisolone in treating
      patients with newly diagnosed acute graft-versus-host disease (GVHD). Glucocorticoids, such
      as prednisone or methylprednisolone at a starting dose of 2 mg/kg/day are standard treatment
      for acute graft-versus-host disease caused by a donor stem cell transplant. It is not yet
      known whether low-dose glucocorticoids are more effective than standard-dose glucocorticoids
      in treating acute graft-versus-host-disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with newly diagnosed acute GVHD (>= grade IIa) for whom, in the judgment of
             the attending physician, initial treatment with systemic glucocorticoids is indicated

          -  Patient or guardian able and willing to provide informed consent

        Exclusion Criteria:

          -  Hallmarks of chronic GVHD

          -  GVHD after donor lymphocyte infusion (DLI)

          -  Patient unwilling to remain in Seattle under the care of the Fred Hutchinson Cancer
             Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA) through day 42 after the
             start of treatment for GVHD

          -  Uncontrolled infection or other underlying comorbidity (i.e. severe psychiatric
             illness) that precludes the use of "standard-dose" prednisone

          -  Recent diagnosis of recurrent or progressive malignancy that precludes the use of
             "standard-dose" prednisone

          -  Any prior systemic therapy for acute GVHD (Patients may receive up to 2 doses of
             low-dose prednisone prior to randomization; low-dose prednisone is defined as 0.5
             mg/kg/dose for patients who present with grade IIa GVHD and 1 mg/kg/dose for those who
             present with grade IIb-IV GVHD)

          -  Enrollment on Blood and Marrow Transplant Clinical Trials Network (BMT-CTN) trial 0802