bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease; Cognitive Impairment
MeSH terms: Alzheimer Disease
Intervention: Sodium oligo-mannurarate 600mg; Sodium oligo-mannurarate 900mg; Placebo
Intervention description: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks; sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks; simulant of sodium oligo-mannurarate capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is
      effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine
      the best therapeutic dose of sodium oligo-mannurarate capsule.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least primarily educated.

          -  Accord with Probable Alzheimer disease of National Institute of Neurological and
             Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders
             Association(NINCDS-ADRDA)'s Criteria.

          -  10 points ≤ Minimum Mean-Square Error(MMSE) ≤ 24 points.

          -  Hachinski ischemia scale <4 points.

          -  Hamilton depression scale ≤10 points.

          -  Should have stable accompanying person, or at least contact 2 hours per day, 4 days
             per week with accompanying person. The accompanying person should help the patient
             throughout the trial.

          -  Signed the information consent form.

        Exclusion Criteria:

          -  Have been in other clinical trials within 30 days before this trial' start.

          -  women during pregnancy or lactation.

          -  Dementia caused by other diseases.

          -  previous nervous system diseases.

          -  Abnormal laboratory results.

          -  Uncontrolled hypertension.

          -  Unstable or serious diseases of heart, lung, liver, kidney and blood.

          -  Visual or auditory handicap.

          -  Significant focal lesions revealed by electronic computer X-ray tomography(CT) or
             magnetic resonance imaging(MRI) in one year before enrollment.

          -  Alcohol abuse or drug abuse.

          -  psychotic, including patients with serious depression.

          -  Patients being in drug therapy of Alzheimer disease which cannot be stopped.

          -  In treatment of heparin, Polysaccharide sulfate, mannose ester 3 weeks before the
             recruitment.

          -  Investigator consider the patient cannot finish this trial for any reason.

          -  Relatives or employees of the investigators, staff of the investigate centers,
             contract research organization and sponsor.
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ORM-12741; ORM-12741; Placebo for ORM-12741
Intervention description: 60mg twice a day; 200mg twice a day; Placebo twice a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether ORM-12741 is safe and effective in the
      treatment of Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained from the patient and legally acceptable representative, if
             required

          -  Informed consent obtained from the caregiver

          -  Males and and females between 55-90 years

          -  Diagnosis of probable Alzheimer's disease, history of progressive cognitive
             deterioration

          -  Brain imaging consistent with Alzheimer's disease

          -  Mini-mental state examination score 12-21

          -  Treated with donepezil, rivastigmine or galantamine

          -  At least mild level of behavioral symptoms

        Exclusion Criteria:

          -  Other types of dementias

          -  Modified Hachinski Ischemia Score > 4

          -  Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a
             max of 3 nights/week) within 2 months

          -  Changes in antidepressant dosing within 2 months

          -  Use of other psychotropic agents

          -  Myocardial infarction within the past 2 years

          -  Malignancy within the past 5 years

          -  Suicidal ideation, risk of suicide

          -  History of alcoholism or drug abuse within 5 years

          -  Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal,
             neurological or psychiatric disorder or any other major concurrent illness

          -  Specific findings in brain imaging

          -  Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical
             examination; orthostatic hypotension

          -  Blood donation or participation in a drug study within 60 days

          -  Previous AD immunotherapy treatment

          -  Patient cannot complete the computerised cognitive training

          -  Patients who reside in a skilled nursing facility

          -  Patients who are not able to swallow capsules
Trial of IRE in Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Intervention: IRE Device
Intervention description: For use in ablating soft tissue
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, single-center phase I study.
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: intraoperative use of IRE; 18-489

Summary:

      The purpose of this study is to test any good and bad side effects of surgery using IRE to
      treat cancer of the bile duct.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Capable of providing written and oral informed consent in English

          -  Locally advanced disease based on preoperative work-up demonstrating that the tumor is
             unresectable due to portal vein, hepatic artery, and/or bile duct involvement,
             insufficient hypertrophy response of the future liver remnant after portal vein
             embolization, or patients not able to tolerate major liver surgery

          -  Found to be unresectable intraoperatively based on vascular, biliary, or lymph node
             (N2) involvement upon exploratory laparotomy

          -  Patients will be assessed for chemotherapy prior to treatment with IRE, but given the
             common problem of recurrent cholangitis, some patients will not be candidates for
             chemotherapy until after IRE is performed.

        Exclusion Criteria:

          -  Locally advanced PHC eligible and accepted for liver transplantation evaluation

          -  PHC with > 5 cm extension along the common hepatic duct or common bile duct on
             preoperative imaging or intraoperative ultrasound

          -  Metastases to peritoneum, liver or other organs confirmed by percutaneous biopsy,
             staging laparoscopy or intraoperative frozen section

          -  Lymph node metastases beyond N2 stations, confirmed by intraoperative frozen sections
             or radiographic diagnosis

          -  History of cardiac disease:

               -  Congestive heart failure (NYHA class >2)

               -  Active Coronary Artery Disease (defined as myocardial infarction within 6 months
                  prior to screening)

               -  Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers
                  are permitted)

          -  Any implanted stimulation device (defined as implantable cardiac device and a
             pacemaker)

          -  Uncontrolled hypertension (blood pressure must be ≤160/95 mmHg at the time of
             screening on a stable antihypertensive regimen)

          -  Uncontrolled infections (> grade 2 NCI-CTC, version 3.0)

          -  Epilepsy

          -  Both narrowing (sclerosis) of the main portal vein and a reduced diameter of either
             the common hepatic artery, celiac trunk or superior mesenteric artery of >50%
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: temozolomide; protein expression analysis; reverse transcriptase-polymerase chain reaction; diagnostic laboratory biomarker analysis; immunoenzyme technique
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent adult brain tumor; adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult subependymal giant cell astrocytoma; adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult anaplastic oligodendroglioma; adult oligodendroglioma; adult brain stem glioma; adult mixed glioma; adult pineal gland astrocytoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients
      with recurrent glioblastoma multiforme or other malignant glioma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically diagnosed glioblastoma multiforme or other malignant glioma

               -  Recurrent disease

          -  Must have received prior temozolomide

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 60-100%

          -  Granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  SGOT ≤ 2.5 times upper limit of normal (ULN)

          -  Creatinine ≤ 2 times ULN

          -  Bilirubin ≤ 2 times ULN

          -  No other active malignancy except for cervical carcinoma in situ or basal cell
             carcinoma of the skin

          -  No serious medical or psychiatric illness that, in the opinion of the investigator,
             would preclude study treatment

          -  No medical condition that precludes swallowing pills

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: CS-1008 (humanized anti-DR5 antibody); gemcitabine
Intervention description: CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.; Gemcitabine - 1000mg/meter sq
Intervention MeSH terms: Gemcitabine; Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic cancer; chemotherapy naive; unresectable or metastatic pancreatic cancer; CS1008; Gemcitabine; Gemzar

Summary:

      Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to
      subjects with previously untreated and unresectable (unable to be surgically removed) or
      metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed resectable or metastatic pancreatic cancer;
             not previously treated with chemotherapy; measurable disease; 18 years of age or older

        Exclusion Criteria:

          -  Anticipation of need for major surgery or radiation therapy during the study

          -  Heart Disease exclusions: myocardial infarction or unstable angina within the past 6
             months; severe or unstable angina pectoris within the past 6 months; coronary or
             peripheral artery bypass graft within the past 6 mo., etc.

          -  Clinically significant active infection or history of HIV

          -  Partial or complete bowel obstruction

          -  Poorly controlled psychiatric illness
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
Condition: Diabetes Mellitus, Type 2; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Diabetes Mellitus, Type 2
Intervention: Circadin; Placebo
Intervention description: 2 mg prolonged-release melatonin
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Healthy volunteers: No
Keywords: melatonin; insomnia; diabetes; sleep

Summary:

      Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and
      suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on
      glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetic patients with proven presence of the disease who complained of insomnia.

        Exclusion Criteria:

          -  Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis; Medial Compartment Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: ABT-981; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 35 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Synovitis; Knee; Pain

Summary:

      A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study
      to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of
      ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3

          2. Body Mass Index (BMI) 18-34 kg/m2

          3. One or more clinical signs and symptoms of active inflammation in the index knee

        Exclusion Criteria:

          1. History of allergic reaction to any constituents of the study drug, or to any
             Immunoglobulin G (IgG)-containing product

          2. History of anaphylactic reaction to any agent

          3. Significant trauma or surgery to the index knee

          4. Severe knee malalignment

          5. Any uncontrolled medical illness or an unstable treatment or therapy
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Intervention: nesiritide; milrinone; placebo
Intervention description: Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted; Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted; Placebo bolus on CPB, then placebo infusion
Intervention MeSH terms: Milrinone; Natriuretic Peptide, Brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Healthy volunteers: No
Keywords: Fontan Operation; Cardiopulmonary Bypass; Heart Defects, Congenital; Milrinone; Natriuretic peptide, brain

Summary:

      The staged surgical pathway to treat children with single ventricle heart defects culminates
      with the Fontan operation. In this procedure, systemic venous return is rerouted directly to
      the pulmonary arteries, which serves to separate the systemic and pulmonary circulations.
      Although mortality following the Fontan operation is now uncommon, early postoperative
      morbidity including prolonged postoperative chest tube drainage and hospitalization remains
      significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory
      therapies in the perioperative period is unknown and practice varies widely between centers.

      The investigators will propose a single-center, randomized, double-blind, phase II clinical
      trial in children undergoing Fontan surgery. The investigators plan to compare the effects of
      perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical
      course and neurohumoral profile. The investigators hypothesize that, when compared to the
      milrinone and placebo groups, the nesiritide group will have more days alive and out of the
      hospital within the first 30 days after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing an elective, primary Fontan operation at Children's Hospital
             Boston.

        Exclusion Criteria:

          -  Revision surgery for failing Fontan circulation.

          -  Preoperative serum creatinine > 1.5 mg/dL or chronic dialysis.

          -  The attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a
             compelling indication to initiate either nesiritide or milrinone outside of the
             confines of the study.
Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
Condition: Male Pattern Hair Loss; Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Bimatoprost; Placebo
Intervention description: Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
Intervention MeSH terms: Bimatoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: male pattern hair loss; androgenetic alopecia; bimatoprost

Summary:

      The purpose of this study is to determine the effect of bimatoprost solution on scalp hair
      growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment
      of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is
      not approved for the treatment of scalp hair loss and its use in this study is considered
      investigational which means it is still being tested in research studies.

      Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.

          2. Subject's hair color must have adequate contrast against scalp color to allow hair
             counting on macrophotography.

          3. Good health with normal blood tests for hematological, renal, and liver function.

          4. Able to return to Duke for study visits.

        Exclusion Criteria:

          1. ECOG >1.

          2. Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12
             months or oral dutasteride in the past 24 months.

          3. Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6
             months and any in the past month.

          4. Taken any chemotherapy in the past 2 years.

          5. Used any over-the-counter (OTC) preparation that purports to help hair growth in the
             past four months.

          6. Used prostaglandins of any type in the past or currently.

          7. Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair
             transplants, or scalp reductions.

          8. Any skin abnormalities in the target area that would effect hair growth.

          9. Any history of glaucoma or elevated intraocular pressure (IOP).

         10. Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must
             be in remission.
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: PF-04447943; Placebo
Intervention description: tablets, 25 mg every 12 hours for 12 wks; matching placebo tablets, every 12 hours for 12 wks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; PF-04447943; efficacy; safety; plasma concentrations

Summary:

      The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on
      cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and
      tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in
      the plasma over the course of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate Alzheimer's disease (MMSE 14-26)

          -  Good general health (such controlled conditions as Type 2 diabetes and hypertension
             allowed)

        Exclusion Criteria:

          -  Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or
             memantine within 12 weeks of the start of the study

          -  Significant cardiovascular disease in the past 6 months

          -  Illness other than Alzheimer's disease that could contribute to cognitive impairment

          -  History of stroke or seizure disorder