bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Simtuzumab; Simtuzumab placebo
Intervention description: 125 mg/mL single-dose vials administered subcutaneously once a week; Simtuzumab placebo single-dose vials administered subcutaneously once a week
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 544.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Idiopathic; Pulmonary; Fibrosis; IPF

Summary:

      The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on
      progression-free survival (PFS) as determined by either a categorical decline in forced vital
      capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of
      participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified
      level in serum at baseline.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female subjects from 45 to 85 years of age

          -  Definite IPF within 3 years prior to screening

          -  Be able to walk at least 50 meters

        Key Exclusion Criteria:

          -  Significant diseases other than IPF

          -  Obstructive lung disease

          -  Aortic aneurysm greater than or equal to 3.5 cm in diameter

          -  Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to
             randomization are not permitted.

               -  N-acetylcysteine is permitted provided the individual has been on a stable dose
                  for > 4 weeks prior to screening

               -  Concomitant use of pirfenidone or nintedanib must be in accordance with the
                  approved prescribing instructions in the country where the site is located

          -  Individuals actively listed for lung transplant are excluded. However individuals at
             transplant centers with long waiting times (greater than 1 year) may be permitted to
             enter the study after discussion with Medical Monitor.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Blood sample
Intervention description: Blood sample will be collected at Month 48, Month 60 and Month 72
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes Zoster; vaccine; safety; immunogenicity

Summary:

      The subjects included in this study are subjects that participated in study NCT00434577.
      These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and
      Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for
      safety and immunogenicity.

      This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and
      safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.

      The study visits will be scheduled at approximately one year intervals after the first visit
      in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be
      taken from all subjects at each visit. Information on safety and the occurrence of HZ will
      also be collected during these visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  Previous participation in study NCT00434577 as a member of the intermediate dose
             active vaccine group

          -  Written informed consent obtained from the subject

        Exclusion Criteria:

          -  Having participated in another study at any time after NCT00434577 study end in which
             the subject was exposed to an investigational or non-investigational product or;
             concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first blood draw

          -  Having received a vaccine containing some vaccine components, any time after study end
             of study NCT00434577

          -  Having received a vaccine against HZ any time after study end of study NCT00434577

          -  Subject who did not receive a complete vaccination course of 2 doses of the
             intermediate dose active vaccine in study NCT00434577
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo (linagliptin); Placebo (linagliptin); Sitagliptin; Placebo (sitagliptin); Placebo (sitagliptin); Linagliptin
Intervention description: once daily for 28 days; once daily for 28 days; 100 mg once daily for 28 days; once daily for 28 days; once daily for 28 days; 5mg once daily for 28 days
Intervention MeSH terms: Sitagliptin Phosphate; Linagliptin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control
      and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic
      control.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male and female patients with a diagnosis of type 2 diabetes mellitus and previously
             treated with not more than one drug

          -  Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

        Exclusion criteria:

          -  Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior
             to informed consent

          -  Impaired hepatic function

          -  Renal insufficiency with a creatinine clearance < 50 mL/min

          -  Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues,
             insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months
             prior to informed consent.
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium; Placebo; GSK573179
Intervention description: long-acting muscarinic receptor antagonist; 18mcg once-daily; Inactive/ excipients only; GSK573179 investigational drug
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Dose ranging; Chronic Bronchitis; Long-acting muscarinic antagonist; cross-over; COPD; Emphysema; Chronic Obstructive Pulmonary Disease (COPD); anticholinergic

Summary:

      The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared
      with placebo in subjects with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated written informed consent prior to study participation

          -  Males or females of non-childbearing potential

          -  40 to 80 years of age

          -  COPD diagnosis

          -  10 pack-years history or greater of cigarette smoking

          -  Post-bronchodilator FEV1/FVC ratio of 0.70 or less

          -  Post-bronchodilator FEV1 of 35 to 70% of predicted normal

        Exclusion Criteria:

          -  Asthma

          -  Other significant respiratory disorders besides COPD, including alpha-1 deficiency

          -  Previous lung resection surgery

          -  Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of
             screening

          -  Hospitalization for COPD or pneumonia within 3 months of screening

          -  Any significant disease that would put subject at risk through study participation

          -  BMI greater than 35

          -  Pacemaker

          -  Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or
             C)

          -  Cancer

          -  Allergy or hypersensitivity to anticholinergics or inhaler excipients

          -  Diseases that would contra-indicate the use of anticholinergics

          -  Use of oral corticosteroids within 6 weeks of screening

          -  Use of long-acting beta-agonists within 48 hours of screening

          -  Use of tiotropium within 14 days of screening

          -  Use of theophyllines or anti-leukotrienes within 48 hours of screening

          -  Use of short-acting bronchodilators within 4 to 6 hours of screening

          -  Use of investigational medicines within 30 days of screening

          -  Use of high dose inhaled corticosteroids

          -  Use of long-term oxygen therapy, CPAP or NIPPV

          -  Previous use of GSK573719
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
Condition: Neoplasms
MeSH terms: Endocrine Gland Neoplasms
Intervention: bevacizumab [Avastin]; 5 FU; Streptozotocin; Xeloda
Intervention description: 7.5mg/kg iv on day 1 every 3 weeks; 400mg/m2/day iv on days 1-5 every 6 weeks; 500mg/m2/day iv on days 1-5 every 6 weeks; 1000mg/m2 po bid on days 1-14 every 3 weeks
Intervention MeSH terms: Bevacizumab; Streptozocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the efficacy and safety of two systemic treatments including
      Avastin in patients with previously-untreated progressive locally advanced/metastatic
      well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm
      1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin
      500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks.
      Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po
      bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated
      with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or
      unacceptable toxicity. The anticipated time on study treatment is until disease progression
      or unacceptable toxicity, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic
             endocrine tumors;

          -  no previous anti-cancer therapy, other than surgery;

          -  progressive metastatic disease;

          -  >=1 measurable lesion.

        Exclusion Criteria:

          -  abnormal cardiac function, with history of ischemic heart disease in past 6 months
             and/or abnormal 12 lead ECG;

          -  patients with known bleeding disorders;

          -  unstable systemic disease;

          -  chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;

          -  previous history of malignancy (other than successfully treated basal and squamous
             cell cancer of the skin, and/or in situ cancer of the cervix).
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin lispro; recombinant human hyaluronidase PH20; Insulin aspart; Insulin glulisine; Insulin glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin Lispro; Insulin glulisine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 1 diabetes

Summary:

      The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human
      hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for
      the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged ≥18 years

          -  Type 1 Diabetes Mellitus (T1DM) treated with insulin for ≥12 months

          -  Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m^2).

          -  Hemoglobin A1C (HbA1C) level 6.7% to 8.2%, inclusive

          -  Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)

          -  Willingness to use twice daily (BID) insulin glargine as basal insulin for the
             duration of the study

          -  Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose
             monitoring (CGM) during the study

        Exclusion Criteria:

          -  Known or suspected allergy to any component of any of the study drugs

          -  Use of pramlintide within 30 days of Screening

          -  Use of drugs during the study or within 30 days of Screening (such as corticosteroids
             or antimetabolites) that could interfere with the interpretation of study results or
             are known to cause clinically relevant interference with insulin action, glucose
             utilization, or recovery from hypoglycemia

          -  Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or
             hypoglycemic unawareness, as judged by the Investigator
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: PF-04457845; Placebo
Intervention description: Study medication will be administered at 4mg by mouth daily for four weeks.; Sugar pill
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Cannabis dependence is associated with changes in the brain's cannabinoid system. When
      cannabis dependent individuals try to quit using cannabis, some of them experience problems
      that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the
      problems related to quitting cannabis may facilitate abstinence. One way to do this is by
      harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids.
      One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the
      problems related to quitting cannabis use will be reduced by increasing the brain levels of
      anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will
      be less likely to relapse. Brain anandamide levels will be increased by blocking the
      breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of
      a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied
      in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent
      subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The
      trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient
      treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis
      use and urinary THC-COOH levels will be measured during the entire study. The treatment phase
      will be followed by a safety follow up phase of 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male

          2. Ages 18-55 (inclusive)

          3. Cannabis Dependence

        Exclusion Criteria:

          1. Allergies or intolerance to FAAH-Inhibitors

          2. Current significant medical or other comorbidities
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil 2.5 mg; Tadalafil 5 mg; Placebo
Intervention description: oral, daily; oral, daily; oral, daily
Intervention MeSH terms: Tadalafil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the
      efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an
      open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese
      men with signs and symptoms of benign prostatic hyperplasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at
             least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS)
             greater than or equal to 13 at Visit 2.

          -  Agree not to use any other approved or experimental pharmacologic BPH, erectile
             dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the
             study.

          -  Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any
             other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.

        Exclusion Criteria:

          -  Prostate specific antigen (PSA) score beyond acceptable range defined for study at
             Visit 1.

          -  History of urinary retention or lower urinary tract (bladder) stones within 6 months
             of Visit 1.

          -  History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit
             1.

          -  Clinical evidence of prostate cancer at Visit 1.

          -  Clinical evidence of any of the bladder or urinary tract conditions, which may affect
             lower urinary tract symptom at Visit 1.

          -  History of cardiac conditions, including Angina requiring certain treatment with
             nitrates, unstable angina defined for study, positive cardiac stress test before
             starting the study.

          -  History of significant central nervous system (CNS) injuries (including stroke or
             spinal cord injury) within 6 months of Visit 1.

          -  Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens,
             luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic
             steroids at Visit 1.
Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Application of topical vitamin d3 (Top-D); Application of Aloe vera gel
Intervention description: Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days; aloe vera gel will be applied
Dosage: 1 gram Duration: 120 days Frequency: Daily
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: assignment
Masking: Double (Participant, Investigator)
Enrollment: 550.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      After obtaining the approval from the IRB of University of Dammam and informed consent from
      550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency
      were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical
      examination was performed to rule out any diseases and complete blood picture, serum calcium,
      phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be
      done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and
      ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The
      participants were divided into two groups of 350 in study arm and 200 in control arm. All
      participants were instructed not to change their dietary habits and life style till the study
      was over. The study group of women were instructed to apply to apply Top-D (Proniosomal
      Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram
      of Aloe vera gel. The participants had no knowledge to which group they belong. A second
      blood sample was taken at the end of 4 months and the data was entered in the data base and
      analyzed using SPSS Inc version 19.
    

Eligibility criteria:

        Inclusion Criteria:

        all men and women with vitamin D insufficiency and deficiency Must be able to apple the
        topical vitamin D3 Must be willing to sign and informed consent

        Exclusion Criteria:

          -  Those who have normal 25OHD levels