bioihbjkbjnl/mcl2 huggingface dataset:
Strength Training in Walking Tolerance in Intermittent Claudication Patients
Condition: Peripheral Arterial Disease; Hypertension; Diabetes
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
Intervention: Walking Training; Strength Training
Intervention description: The Walking Training program was performed using a treadmill. In each session, patients performed fifteen 2-min bouts of exercise followed by a 2-min rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds of each exercise bout.; The strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-min interval between sets and exercises.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: peripheral arterial disease; exercise; resistance training; cardiac rehabilitation

Summary:

      Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in
      patients with intermittent claudication (IC), suggesting that strength training (ST) could
      improve exercise performance in these patients.

      Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with
      walking training (WT) effects.

      Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for
      12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of
      whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2
      minutes of resting.

      Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic
      window and knee extension strength
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fontaine stage II peripheral arterial disease(14)

          -  Symptoms of intermittent claudication for at least 6 months

          -  Ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs

          -  Reduction of ABI after treadmill test

          -  Exercise tolerance limited by intermittent claudication

        Exclusion Criteria:

          -  Presence of chronic lung disease

          -  Inability to obtain ABI measurement due to noncompressible vessels

          -  Exercise tolerance limited by factors other than claudication (e.g., dyspnea or
             orthopedic problems)

          -  Poorly controlled blood pressure

          -  Presence of electrocardiogram response suggestive of myocardial ischemia during the
             exercise test

          -  History of revascularization in the previous year
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: MK0518 (raltegravir); Comparator: KALETRA™ (lopinavir (+) ritonavir ); Comparator: placebo; Comparator: placebo
Intervention description: MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment; KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.; MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment; KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.
Intervention MeSH terms: Ritonavir; Lopinavir; Raltegravir Potassium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 352.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment experienced

Summary:

      The purpose of this study is to investigate the efficacy, safety, and tolerability of an
      investigational treatment for patients with HIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is at least 18 years of age

          -  Patient is Human Immunodeficiency Virus (HIV) positive

          -  Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50
             copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen

          -  Patient has been on a KALETRA based regimen for at least 3 months without a change in
             background antiretroviral therapy

          -  Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on
             the KALETRA based regimen

        Exclusion Criteria:

          -  Patient is or plans to become pregnant, or nursing a child

          -  Patient plans to donate eggs or impregnate/donate sperm

          -  Patient is receiving Stavudine (d4T) as a component of the background antiretroviral
             therapy

          -  Patient is currently receiving a second protease inhibitor in addition to KALETRA

          -  Patient is currently receiving, or has received in the past twelve weeks, treatment
             for the management of elevated lipids

          -  Patient has used another experimental HIV-integrase inhibitor

          -  Patient has a current (active) diagnosis of acute hepatitis due to any cause

          -  Patient has used systemic immunosuppressive therapy within one month prior to
             treatment in this study
A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
Condition: Gastrointestinal Stromal Tumor
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: Placebo; SU011248
Intervention description: 50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.; 50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Intervention MeSH terms: Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal
      stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to
      imatinib treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation
             or combined modality treatment with curative intent

          -  Failed Gleevec treatment or intolerant to Gleevec therapy

        Key Exclusion Criteria:

          -  Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or
             investigational agent since the last dose of Gleevec
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Exenatide; Exenatide matching placebo
Intervention description: 2 mg weekly suspension injection; Once weekly Placebo injection
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 464.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Exenatide; Diabetes drug; Treatment efficacy; Placebo; Metabolism; Cardiovascilar metabolic

Summary:

      Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel
      group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added
      to titrated basal insulin glargine with or without metformin to placebo added to titrated
      basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus
      (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the
      28-week treatment period.
    

Eligibility criteria:

        Inclusion criteria:

          -  Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)

          -  Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).

          -  Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1
             (Screening)

          -  Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least
             6 weeks prior to Screening, in combination with diet and exercise alone or in
             combination with:

               1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1

               2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
                  (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the
                  Screening visit

        Exclusion criteria:

          -  Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)

          -  History of, or currently have, acute or chronic pancreatitis, or have triglyceride
             concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1

          -  Positive serological test for hepatitis B or hepatitis C
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Intervention: turoctocog alfa
Intervention description: Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Male
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe, and North and South America. The trial consists of a
      main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog
      alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial
      investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding
      episodes during surgical procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects with the diagnosis of severe (FVIII less than or equal to 1%)
             haemophilia A from age 12 (except for Israel where the age limit will be 18 for the
             first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg

          -  Documented history of at least 150 exposure days to any other FVIII products
             (prevention or treatment of bleeds)

          -  No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor
             should be measured regularly for at least the last 8 years or since the first
             treatment of haemophilia A

          -  No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by
             a Central Laboratory at the time of screening)

        Exclusion Criteria:

          -  Congenital or acquired coagulation disorders other than haemophilia A

          -  Creatinine levels 50% above normal level (as defined by central laboratory range)

          -  Known or suspected allergy to trial product (N8) or related products
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
Condition: Refractory Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: Eculizumab; Placebo
Intervention description: Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26; Placebo
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myasthenia Gravis; Eculizumab; safety; efficacy

Summary:

      The purpose of this study is to determine if eculizumab is safe and effective for the
      treatment of refractory generalized Myasthenia Gravis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female patients ≥18 years old

          -  Diagnosis of MG made by the following tests:

               1. Positive serologic test for anti-AChR Abs as confirmed at screening, and

               2. One of the following:

                    1. History of abnormal neuromuscular transmission test demonstrated by
                       single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or

                    2. History of positive anticholinesterase test, e.g. edrophonium chloride test,
                       or

                    3. Subject has demonstrated improvement in MG signs on oral cholinesterase
                       inhibitors, as assessed by the treating physician.

          -  MGFA Clinical Classification Class II to IV at screening.

          -  MG-ADL total score must be ≥6 at screening and Randomization (Day 1).

          -  Subjects who have:

               1. Failed treatment with at least two immunosuppressive agents. Or,

               2. Failed treatment with at least one immunosuppressive agent and require chronic
                  plasma exchange or IVIg

        Key Exclusion Criteria:

          -  History of thymoma or other neoplasms of the thymus

          -  History of thymectomy within 12 months prior to screening

          -  MGFA Class I or MG crisis at screening (MGFA Class V)

          -  Use of rituximab within 6 months prior to screening

          -  Use of IVIg or PE within 4 weeks prior to Randomization (Day 1)
Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone; Paliperidone extended-release (ER)

Summary:

      The purpose of this study is to explore the efficacy of flexibly dosed paliperidone
      extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms
      of emotional instability, detachment from reality, often with delusions and hallucinations,
      and withdrawal into the self) who were previously unsuccessfully treated with other oral
      antipsychotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant diagnosed with schizophrenia

          -  Participant's previous treatment of schizophrenia is considered unsuccessful

          -  Participant is healthy on the basis of a physical examination and vital signs

          -  Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active,
             agree to practice an effective method of birth control before entry and throughout the
             study

          -  Be willing and able to fill out self-administered questionnaires

        Exclusion Criteria:

          -  Have used clozapine or Risperdal CONSTA during the last month, or have received any
             other conventional drug used to treat psychosis during the last 3 months

          -  Judged to be at high risk for adverse events, violence or self-harm

          -  Inability to swallow the study medication whole with the aid of water

          -  Pregnant or breast-feeding female

          -  History or current symptoms of tardive dyskinesia (involuntary movements of the facial
             muscles and tongue)
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate; Placebo-matching telotristat etiprate
Intervention description: Telotristat etiprate tablets.; Placebo-matching telotristat etiprate tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to confirm that at least 1 or more doses of telotristat
      etiprate compared to placebo is effective in reducing the number of daily bowel movements
      (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the
      trial in patients not adequately controlled by current SSA therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor

          -  Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements
             per day during the Run-in period

          -  Currently receiving stable-dose somatostatin analog (SSA) therapy

          -  Minimum dose of long-acting release (LAR) or depot SSA therapy

               -  Octreotide LAR at 30 mg every 4 weeks

               -  Lanreotide Depot at 120 mg every 4 weeks

               -  Patients who cannot tolerate SSA therapy at a level indicated above will be
                  allowed to enter at their highest tolerated dose

          -  Ability and willingness to provide written informed consent

        Exclusion Criteria:

          -  Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome

          -  Karnofsky Performance status ≤60%

          -  Treatment with any tumor directed therapy, including interferon, chemotherapy,
             mechanistic target of rapamycin (mTOR) inhibitors <4 weeks prior to Screening, or
             hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking <12
             weeks prior to Screening

          -  History of short bowel syndrome (SBS)

          -  Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would
             compromise patient safety or the outcome of the study

          -  Previous exposure to telotristat etiprate
Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Ibandronate; Zoledronate
Intervention description: Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.; Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
Intervention MeSH terms: Ibandronic Acid; Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, open-label trial will randomize participants with multiple myeloma to a
      regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity,
      measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an
      absolute value of 30 milliliters per minute (mL/min) or lower.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)

          -  Indication for biphosphonate therapy

        Exclusion Criteria:

          -  Previous therapy with ibandronate or zoledronate within the past 12 months

          -  Renal insufficiency with serum creatinine >3.0 mg/dL or >265 micromoles per liter
             (µmol/L) or CrCl <30 mL/min

          -  Hypersensitivity to ibandronate, zoledronate, or other biphosphonates

          -  Presence of secondary malignomas, apart from basaliomas and cervical carcinoma in situ

          -  Severe accompanying illness with organ impairment

          -  Osteonecrosis of the jaw at the start of the study

          -  Life expectancy ≤12 months