bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease
Condition: Alzheimer´s Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune
      Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion
      compared with placebo in participants with mild to moderate Alzheimer's disease (AD).
    

Detailed description: 
      Study visits: Each participant will be tested at the investigational site, and if qualified,
      will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18
      months). The first three infusions must be done at the site, but if the infusions are well
      tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or
      other suitable location. Each participant must return to the site every 3 months for
      evaluation of cognition as well as blood tests and scans of the brain.
    

Intervention name(s): Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg; Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg; Placebo solution: Human Albumin 0.25% - 4 mL/kg; Placebo solution: Human Albumin 0.25% - 2 mL/kg
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 400 mg/kg bodyweight every 2 weeks for 70 weeks; 200 mg/kg bodyweight every 2 weeks for 70 weeks; Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks; Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks
Other intervention name(s): Gammagard Liquid; KIOVIG; Gammagard Liquid
Intervention MeSH terms: Pharmaceutical Solutions; Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer´s; Dementia; Dementia of Alzheimer Type; Immunoglobulins; Gammaglobulins; Immune Globulin Intravenous (IGIV); Intravenous Immune Globulin (IVIG); Antibodies; Amyloid; Immunotherapy
A Study of the Effect of Multiple Doses of Rifampin on the Single Dose Pharmacokinetics of RO5424802
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, open-label, 3-period, fixed-sequence study will evaluate the effect of
      multiple oral doses of rifampin on the pharmacokinetics of a single oral dose of RO5424802 in
      healthy volunteers. Subjects will receive a single dose of RO5424802 on Days 1 and 17 and
      rifampin daily from Days 8 to Day 20.
    


Intervention name(s): RO5424802; rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Single dose without (Day 1) and with (Day 17) co-administration of rifampin; Multiple doses Days 8-16 and Days 17-20
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effects of Arzoxifene on Bone Mass and the Uterus
Condition: Postmenopausal Bone Loss
MeSH terms: Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are to determine:

        -  The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in
           postmenopausal women.

        -  The effects of arzoxifene on the uterus (womb) in postmenopausal women.

        -  The effects of arzoxifene on blood tests that measure changes in bone rebuilding in
           postmenopausal women with low bone density.

        -  The effects of arzoxifene on blood lipids (fats) and other blood markers of heart
           disease risk.

        -  The safety of arzoxifene and any side effects that might be associated with its use.
    


Intervention name(s): Arzoxifene; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
Condition: Central Airway Stenosis
MeSH terms: Constriction, Pathologic
Study type: Observational

Summary: 
      Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the
      lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds).
      Airflow in the lungs during the respiration cycle creates vibrations that propagate through
      the lung tissue; these vibrations are affected by the structural properties of the lungs and
      may vary in space, time and frequency. Moreover, any structural alteration, such as a
      bronchial obstruction or space occupying infiltration, is reflected in a corresponding
      modification of the vibration response.

      As obstructions that occur in airways alter airflow, the VRI may provide additional lung
      function information prior to treatment for airway obstruction and during follow-up.
      Moreover, the VRI may provide the physician immediate evaluation of the improvement of air
      flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a
      non-invasive, radiation free procedure which is simple and doesn't require the level of
      patient effort required for lung function test and other evaluation.
    


Intervention name(s): Vibration Response Imaging
Intervention type(s): Other
Intervention description(s): 12 seconds of recording lung sounds
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in the age range of 18-85 and consisting of both male and females, who present to
        the clinic with airway obstruction and who are designated to undergo intervention.
      
Keywords: central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment
Effect of Hemifacial Spasm on Intraocular Pressure Measurement
Condition: Hemifacial Spasm; Intraocular Pressure
MeSH terms: Hemifacial Spasm; Spasm
Study type: Observational

Summary: 
      Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly
      selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure
      measurements using Goldmann Applanation Tonometer and non-contact tonometer. An interval of
      15 minutes was maintained between Goldmann Applanation Tonometer and non-contact tonometer
      measurements. Intraocular pressure measurements were performed before (during hemifacial
      spasm) and 2 weeks after Botox injections in Hemifacial spasm patients and in healthy
      volunteers without Botox injections. All the measurements with Goldmann Applanation Tonometer
      were carried out by a single physician while those with the non-contact tonometer were done
      by another physician who was masked to the results of the Goldmann Applanation Tonometer. All
      measurements were taken between 10:00 and 11:00 a.m.
    


Intervention name(s): effect of hemifacial spasm on intraocular pressure
Intervention type(s): Other
Intervention description(s): To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Twenty-four consecutive patients with Hemifacial spasm (study group) and twenty-five
        age-matched and gender-matched healthy volunteers (control group) will be prospectively
        included in the study. Intraocular pressure measurements will be performed before and 2
        weeks after Botox injections in patients with HFS (involved and uninvolved eyes of HFS
        both) and in healthy volunteers without Botox injections.
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Condition: Foetal Growth Problem; Small for Gestational Age
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety
      of somatropin in children born small for gestational age (SGA) in Japan.

      In the main period, subjects will receive either active treatment for 104 weeks (two dosing
      regimens) or no treatment for 52 weeks followed by an extension period where subjects who
      received active treatment for 104 weeks (two years) will continue with the same treatment for
      further 156 weeks (three years) while those subjects who received no treatment for 52 weeks
      (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In
      total, subjects participate in trial for 260 weeks (five years).

      Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension
      period is registered as GHLIQUID-1517.
    


Intervention name(s): somatropin; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): 0.033 mg/kg/day of NN-220 for s.c. injection in cartridge; 0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
Condition: Lung Cancer; Precancerous Condition; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Precancerous Conditions; Tobacco Use Disorder
Study type: Interventional

Summary: 
      RATIONALE: Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the
      lungs.

      PURPOSE: This clinical trial is studying the side effects and best dose of calcitriol in
      preventing lung cancer in current smokers and former smokers at high risk of lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To establish the safety of calcitriol in patients at high risk of lung cancer.

        -  To determine the dose-limiting toxicities of calcitriol in these patients.

      OUTLINE: Patients receive oral calcitriol on day 1. Courses repeat every 2 weeks for 3 months
      in absence of unacceptable toxicity.

      Patients undergo blood collection periodically for pharmacokinetic and molecular analysis.

      After completion of study therapy, patients are followed periodically.
    

Intervention name(s): calcitriol; laboratory biomarker analysis; pharmacological study
Intervention type(s): Drug; Other; Other
Intervention description(s): Oral; Correlative Study; Correlative Study
Intervention MeSH terms: Calcitriol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: lung cancer; tobacco use disorder; squamous lung dysplasia
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
Condition: Hepatitis C Infection
MeSH terms: Infections; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined
      with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically
      infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is
      safe, well tolerated, and efficacious
    


Intervention name(s): Daclatasvir; Daclatasvir; Placebo; Peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 10 mg, daily, 24-48 weeks; Tablets, Oral, 60 mg, daily, 24-48 weeks; Tablets, Oral, 0 mg, daily, 48 weeks; Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks; Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other intervention name(s): Pegasys®; Copegus®
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Respiratory Outcome at Adolescence of Very Low Birthweight Infants
Condition: Premature Baby 26 to 32 Weeks; Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Birth Weight
Study type: Interventional

Summary: 
      EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be
      evaluated in very low birth weight and term infants, born in 1997 and included in the French
      EPIPAGE cohort.
    

Detailed description: 
      EPIPAGEADO is a multicenter observational study:- to evaluate respiratory symptoms and lung
      function at adolescence in very low birthweight (VLBW) children, to identify perinatal risk
      factors for persistent symptoms or impaired lung function tests at adolescence, to assess the
      exercise tolerance in VLBW children and to search for genetic susceptibility markers
      associated to impaired lung function.

      The main criteria for analysis will be the forced expiratory volume in one seconde (FEV1) The
      study duration will be 36 months the number of centers will be 4 centers in France
      (Paris-Necker, Nantes, Lille, Rouen) The number of patients to be included will be 400,
      including 260 VLBW children without BPD, 40 VLBW children with BPD, 100 control children with
      birth at term.
    

Intervention name(s): Prevention and follow-up of the patients pulmonary parameters
Intervention type(s): Other
Intervention description(s): Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.
Other intervention name(s): Prevention and follow-up pulmonary parameters
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Low birthweight; Bronchopulmonary dysplasia; Lung development; Airway obstruction; Asthma
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3, multicenter, open-label study of chronic, intermittent use of study drug (DBF)
      is designed to evaluate the safety and tolerability of the buccal formulation of diazepam in
      children, adolescents and adults with intermittent, stereotypic episodes of frequent seizure
      activity (eg, seizure clusters) that are distinct from the subject's usual seizure pattern.
    

Detailed description: 
      The Primary objective of the study is to assess the safety and tolerability of DBF (study
      drug) administered a minimum of 3 times to subjects with epilepsy for the treatment of
      seizures over a minimum 6-month period.

      Secondary objectives:

        -  To evaluate the usability of study drug as assessed by the ability of
           caregivers/subjects to administer study drug based on the Instructions for Use (IFU).

        -  To evaluate the Quality of Life (QoL) of the subjects during the study drug treatment
           period as assessed by use of age-appropriate epilepsy scales over a minimum 6-month
           period.
    

Intervention name(s): Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category
Intervention type(s): Drug
Intervention description(s): The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff.
Other intervention name(s): DBF, Diazepam Buccal Film (Aquestive Therapeutics)
Intervention MeSH terms: Diazepam
Intervention model: Single Group Assignment
Intervention model description: The study population was male or female pediatric, adolescent, and adult subjects with a clinical diagnosis of epilepsy and with bouts of increased seizure activity, frequent breakthrough seizures, seizure clusters, or cluster seizures and who were on chronic, intermittent use of rescue medication (eg, Diastat AcuDial or other benzodiazepine).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizure
Effect of the HIV Protease Inhibitors Atazanavir and Lopinavir/Ritonavir on Cardiovascular Disease Risk Factors
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      HIV protease inhibitors (PIs) are a class of antiretroviral drugs used to inhibit viral
      replication. They do so by interfering with a key step in the replication process. Some HIV
      PIs have been associated with an increased risk of adverse cardiovascular side effects.
      Further study is needed, however, to assess the full extent of effect of newer HIV PIs,
      including atazanavir and lopinavir/ritonavir, on cardiovascular disease risk. This study will
      compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular
      disease risk factors in healthy people without HIV.
    

Detailed description: 
      Antiretroviral therapy for HIV, particularly with the use of PIs, is associated with an
      increased risk of heart attack. Specific cardiovascular side effects seen with the use of
      some PIs include insulin resistance, abnormal blood lipid levels, and endothelial dysfunction
      (abnormalities in the cells that line the inner surface of blood vessels). Past studies have
      shown that treatment with indinavir, an older PI, results in significant endothelial
      dysfunction, which may be the main cause for the increase in cardiovascular risk. Indinavir
      is now seldom used in clinical practice, and the newer PIs atazanavir and combination
      lopinavir/ritonavir now account for nearly 70% of total PI use in the United States. It is
      not known what effect these new PIs have on endothelial dysfunction. This study will compare
      the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular disease
      risk factors, including abnormal glucose metabolism and endothelial dysfunction, in healthy
      people without HIV.

      Participation in this study will last 4 weeks. All participants will undergo initial
      assessments that will include various vascular and metabolic evaluations. Body weight,
      height, basal heart rate, and systolic and diastolic blood pressure will also be measured.
      Participants will then be assigned randomly to receive 4 weeks of treatment with 400 mg of
      atazanavir per day plus placebo, 400 mg/100 mg of lopinavir/ritonavir twice per day plus
      placebo, or placebos for both drugs per day. Upon completing the 4 weeks of treatment,
      participants will repeat the initial assessments.
    

Intervention name(s): Atazanavir; Lopinavir/ritonavir; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg of atazanavir (two 200-mg capsules) per day for 4 weeks; 400 mg/100 mg of lopinavir/ritonavir (three soft-gel capsules, each containing 133.3 mg lopinavir and 33.3 mg ritonavir) twice per day with food for 4 weeks; Daily dose of placebo for 4 weeks
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
Condition: Awareness, Anesthesia; Recall Phenomenon; Inhalation; Gas
MeSH terms: Intraoperative Awareness
Study type: Interventional
Phase: Phase 4

Summary: 
      Awareness during general anesthesia - that has an incidence between 0.1% and 0.9% of cases
      and may be more in elderly - remains a concern for anesthesiologists. Awareness experiences
      range from isolated auditory perceptions to reports of a patient being fully awake,
      immobilized, and in pain. The isolated forearm technique allows assessment of consciousness
      of the external world (connected consciousness) through a verbal command to move the hand (of
      a tourniquet-isolated arm) during intended general anesthesia.
    

Detailed description: 
      Objective: To compare inhalational induction versus intravenous induction regarding awareness
      during laryngoscopy and intubation in elderly patients undergoing day case elective surgery.
    

Intervention name(s): Sevoflurane; TIVA
Intervention type(s): Drug; Drug
Intervention description(s): IFT response, hemodynamics and BIS value were recorded during intubation period. Then the data acquisition was stopped and the isolated forearm cuff deflated. IFT values were noted by two independent observers; IFT response, hemodynamics and BIS value were recorded during intubation period. Then the data acquisition was stopped and the isolated forearm cuff deflated. IFT values were noted by two independent observers
Other intervention name(s): Inhalational induction; Total Intravenous induction
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventions: Patients were randomized into either Group A (who received inhalational induction) and Group B (who received total intravenous induction followed by maintenance infusion).
Main outcome measure: IFT response was recorded at laryngoscopy and intubation to identify awareness at this stressful timepoint.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: TIVA; Isoflurane; old age
A Study of the Relative Bioavailability of ASC41 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy
      subjects after single and multiple oral dosing.
    

Detailed description: 
      The purpose of this study was to evaluate the tolerability, safety pharmacokinetics and
      pharmacodynamic (biomarkers) of ASC41 tables in a randomized, double-blind,
      placebo-controlled single- and multiple-dose phase I clinical trial in healthy subjects the
      study. The effects of ASC41 on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) will be
      observed after repeated administration of ASC41 in healthy subjects.
    

Intervention name(s): ASC41; ASC41 placebo
Intervention type(s): Drug; Drug
Intervention description(s): ASC41,1mg/table;5mg/table; ASC41 placebo,1mg/table;5mg/table
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment