bioihbjkbjnl/mcl2 huggingface dataset:
Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients
Condition: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie Syndrome
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis I; Syndrome
Intervention: Aldurazyme; Aldurazyme; placebo
Intervention description: Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks; 0.58 mg/kg Aldurazyme every week for 208 weeks; Placebo for 26 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Healthy volunteers: No

Summary:

      This study is being conducted to collect additional long-term efficacy and safety data of
      Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled
      in the Phase 3 Double-Blind Study will be enrolled in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient or patient's legal guardian must provide written informed consent prior to
             any protocol-related procedures being performed.

          -  The patient must have successfully completed Study ALID-003-99 (who received 21 of 26
             consecutive weekly infusions).

          -  The patient has not experienced any safety issues that would contraindicate
             participation in the Extension study.

          -  A female patient of childbearing potential must have a negative pregnancy test at
             entry

        Exclusion Criteria:

          -  The patient is pregnant or lactating.

          -  The patient has received an investigational drug within 30 days prior to the study
             enrollment.

          -  The patient has a medical condition, serious intercurrent illness, or other
             extenuating circumstance that may significantly interfere with study compliance
             including all prescribed evaluations and follow-up activities
Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
Condition: Corneal Ulcer; Fungal Keratitis
MeSH terms: Corneal Ulcer; Keratitis; Ulcer
Intervention: Intrastromal voriconazole; Natamycin
Intervention description: Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.; Subjects will receive topical 5% natamycin drops hourly for 3 days.
Intervention MeSH terms: Voriconazole; Natamycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: cornea; ulcer; fungal; keratitis

Summary:

      Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical
      trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers.
      There is currently little evidence to guide the treatment of fungal keratitis beyond topical
      anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used
      as well. This study will provide evidence to guide the treatment of fungal keratitis in the
      future. The purpose of this study is to determine differences in microbiological cure for
      3-day repeat cultures between different antifungal treatments. For this study, there will be
      1:1 randomization to one of these two treatment groups: 1) topical natamycin plus
      intrastromal voriconazole injection or 2) topical natamycin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe corneal ulcer that is smear positive for filamentous fungus

          -  Pinhole visual acuity worse than 20/70 in affected eye

          -  Basic understanding of the study as determined by the physician

          -  Commitment to return for follow up visits

        Exclusion Criteria:

          -  Gram stain positive for bacteria or evidence of other concomitant infection (i.e.
             herpes, acanthamoeba)

          -  Impending or frank perforation at recruitment

          -  Involvement of sclera at presentation

          -  Non-infectious or autoimmune keratitis

          -  History of corneal transplantation or recent intraocular surgery

          -  No light perception in the affected eye

          -  Pinhole visual acuity worse than 20/200 in the unaffected eye

          -  Pregnant women

          -  Participants who are decisionally and/or cognitively impaired
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: pazopanib
Intervention description: 800 mg daily dosing continously until progression
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal cell carcinoma; pazopanib; anti-angiogenic therapy; open label

Summary:

      This is an open-label, international, multi-center study designed to provide access to
      pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study
      (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once
      daily. The study treatment will continue until subjects experience disease progression,
      unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is
      to evaluate the safety and tolerability of pazopanib for the treatment of renal cell
      carcinoma. The secondary objectives of the study are to assess response rate (defined as
      complete response or partial response), progression-free survival, and overall survival.
      Response rates will be collected per investigator assessment (no central review). Subjects
      will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.
    

Eligibility criteria:

        Inclusion criteria:

          -  Progressed from VEG105192 study treatment

          -  Patient's VEG105192 was placebo

          -  Baseline has good organ function

        Exclusion criteria:

          -  No brain metastasis
Laser Acupuncture for Postpartum Weight Retention
Condition: Postpartum Weight Retention
MeSH terms: Body Weight; Gestational Weight Gain
Intervention: laser acupuncture; sham laser acupuncture
Intervention description: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total.; Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 66.0
Sex: Female
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Laser acupuncture; Postpartum weight retention; Obesity

Summary:

      Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention.

      Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided
      into laser acupuncture and control group. A single-blind clinical trial will be conducted and
      the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After
      about 3 weeks of treatment, the differences of the subjects' body weight, body mass index,
      and waist circumference will be analyzed with ANOVA between laser acupuncture and control
      group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postpartum duration of <1 month;

          -  body mass index (BMI) > 25;

          -  age > 20 years;

          -  did not use any other medications for weight loss during the study period; and

          -  provided informed consent.

        Exclusion Criteria:

          -  presence of a pacemaker;

          -  history of seizure or epilepsy;

          -  taking immunosuppressant medication;

          -  cancer;

          -  infectious disease of the skin;

          -  taking medications for weight loss, including Chinese herbal preparations, during the
             study period;

          -  receiving other treatment, including supplements, herbs, and medications for weight
             gain prior to entering the study;

          -  comorbidities (hypothyroidism, renal disease, etc.) that the physician believes would
             affect the findings;

          -  unable to undergo LAT due to other medical conditions; and

          -  lack of informed consent.
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
Condition: Surgery
Intervention: Neostigmine+glycopyrrolate; Sugammadex
Intervention description: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate; At the conclusion of surgery neuromuscular blockade reversed with sugammadex
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuromuscular blockade; sugammadex; SUG; neostigmine; NEO/GLYCO; 17-207

Summary:

      The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate
      and sugammadex) to see if one drug improves patient comfort regarding the return of muscle
      strength after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients age 18 years of age or greater who are capable of giving consent

          -  Undergoing surgical procedures of expected length 6 </= hours requiring NMB

        Exclusion Criteria:

          -  Pregnancy

          -  History of documented anaphylaxis or contraindication to any of the study medications

          -  Active coronary disease with a positive cardiac stress test

          -  History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 <
             50% of predicted

          -  Serum Creatinine >/= 2.0 mg/dL

          -  Severe hepatic dysfunction accompanied by coagulopathy

               -  Definition:

               -  Known liver Disease AND

               -  INR > 1.5 (except for patients on anticoagulants) AND

               -  Platelet count <100,00/ul without other obvious cause

          -  Chronic sustained release opioid for > 2 weeks duration pre op (in the 30 days prior
             to surgery)

          -  Use of toremifene

          -  Significant cognitive impairment or documented psychologic impairment

          -  Myasthenia gravis or other neuromuscular disease

          -  Patients who are not eligible for standard anesthetic induction, eg, those needing
             rapid sequence induction or awake fiberoptic bronchial intubation.

          -  American Society of Anesthesiologists (ASA) Status > 3
Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Low Dose Asenapine maleate transdermal patch; High Dose Asenapine maleate transdermal patch; Placebo
Intervention description: The study will evaluate low dose Asenapine maleate transdermal patch; The study will evaluate high dose Asenapine maleate transdermal patch; The study will evaluate placebo transdermal patch.
Intervention MeSH terms: Asenapine; Maleic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 617.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo
      transdermal patch in subjects diagnosed with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current diagnosis of schizophrenia.

          -  Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of the
             following PANSS items at Screening and at Baseline: conceptual disorganization
             delusions; hallucinatory behavior; unusual thought content.

          -  Subjects must be able to wear a transdermal patch for 24 hours.

        Exclusion Criteria:

          -  Subject has been diagnosed with schizophrenia less than 6 months prior to Screening
             Visit.

          -  Subject has received within 90 days of Screening Visit: electroconvulsive therapy;
             transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation
             treatments

          -  Subject has experienced acute depressive symptoms within 30 days prior to Screening
             Visit that requires treatment with an antidepressant, as determined by the
             Investigator.

          -  Currently taking clozapine for the treatment of schizophrenia.

          -  Has hypothyroidism or hyperthyroidism.

          -  Subject is currently being treated with insulin for diabetes.

          -  Subject has epilepsy or history of seizures.

          -  Positive urine pregnancy test.
Study in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Intervention: Quetiapine; Risperidone
Intervention description: Oral administration; Oral administration
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizoaffective psychosis; Schizophreniformic psychosis; Pilot study; Quetiapine Prolong; Risperidone

Summary:

      This pilot trial in Finland is designed to evaluate in a randomized fashion change of
      agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or
      Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first
      visits on days 1, 2, 4 or 5 and 7 ± 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the opinion of the Investigator, requirement for treatment for an acute episode of
             schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to
             DSM-IV diagnostic criteria), Positive and Negative Symptoms Scale (PANSS) ≥ 65, CGI ≥
             4

        Exclusion Criteria:

          -  Pregnancy or lactation

          -  In-patients/hospitalized > 7 days before enrollment

          -  Known intolerance or lack of response to quetiapine fumarate or risperidone, as judged
             by the investigator
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Condition: Pain
Intervention: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Intervention description: capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily
Intervention MeSH terms: Naltrexone; Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic pain; joint pain; back pain; diabetic peripheral neuropathy; post herpetic neuralgia; ALO-01; Embeda; Chronic Non-Malignant Pain

Summary:

      Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered
      for up to 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject 18-70 years of age

          -  Subject agrees to refrain from taking any opioid medications other than study
             medication during study period.

          -  History of chronic moderate to severe pain caused by a nonmalignant condition for at
             least 3 months prior to baseline

        Exclusion Criteria:

          -  Subject has a documented history of allergic reaction or clinically significant
             intolerance to morphine or other opioids, such that treatment with morphine is
             contraindicated.

          -  Subject is pregnant or breast-feeding.

          -  Subject is receiving chemotherapy, or has an active malignancy of any type or has been
             diagnosed with cancer within the past three years (excluding squamous or basal cell
             carcinoma of the skin).

          -  Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic
             abuse/dependence/misuse within five years prior to the Baseline Visit.

          -  Subject has a Body Mass Index (BMI)>45kg/m2.
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Condition: Bunionectomy; Pain; Postoperative Pain; Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: CG5503 IR; Morphine; Placebo
Intervention description: 75mg IR 4 - 6 hourly Total: 72 hours; Morphine 30 mg IR 4 - 6 hourly Total: 72 hours; Placebo; 4 - 6 hourly; Total: 72 hours
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 291.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid; Central acting analgesic; CG5503 IR; Postoperative pain; Bunionectomy; Morphine; Placebo

Summary:

      The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose
      application of oral application of CG5503 IR 75mg compared to placebo and to assess safety
      and tolerability of CG5503 IR 75mg in subjects following bunionectomy.

      This trial was performed based on a previously performed double-blind, placebo-controlled,
      multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75
      and 100 mg) published under PMID: 18851776.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 18 and 80 years of age;

          -  Scheduled to undergo primary unilateral first metatarsal bunionectomy;

          -  Anesthesiological and surgical procedures performed according to protocol;

          -  Moderate or severe baseline pain following bunionectomy on a VRS within 9 hours of
             termination of the continuous popliteal sciatic block or systemic analgesia;

          -  Pain following bunionectomy of at least 4 on an 11-point NRS within 9 hours of
             termination of the continuous popliteal sciatic block or systemic analgesia; American
             Society of Anesthesiologists (ASA) classification I-III.

        Exclusion Criteria:

          -  History of seizure disorder;

          -  History of alcohol, medication or drug dependency, unstable psychological personality
             requiring intermittent or permanent treatment; severely impaired renal function,
             moderately or severely impaired hepatic function;

          -  Contraindications to, or history of allergy or hypersensitivity to CG5503, oxycodone,
             morphine, fentanyl hydrocodone, acetaminophen, heparin, or any compound planned to be
             used during the anesthesia, or their excipients;

          -  Pre-operative use within 12h prior to surgery or peri-operative use of non- steroidal
             anti-inflammatory drugs (NSAIDs);

          -  Treated regularly with opioid analgesic or NSAIDs within 30 days prior to screening;
A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)
Condition: Post-Operative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Comparator: MK0517; Comparator: ondansetron
Intervention description: a single administration of 40 mg MK0517 by IV immediately prior to surgery; a single administration of 4 mg ondansetron by IV immediately prior to surgery
Intervention MeSH terms: Ondansetron; Aprepitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A new intravenous medication is being tested for the prevention of the nausea and vomiting
      that occurs after surgery. This new medication is being compared to another intravenous
      medication that is already available to patients for this indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open abdominal surgery requiring 24 hour hospital stay

          -  General anesthesia

          -  Post-operative opioids

          -  ASA status of I-III

        Exclusion Criteria:

          -  Patient exhibits evidence of any clinically significant respiratory, metabolic,
             hepatic, renal dysfunction, or cardiovascular condition or congestive heart failure
             (CHF)

          -  Morbid obesity

          -  Patient is mentally incapacitated or has a significant emotional or psychiatric
             disorder