bioihbjkbjnl/mcl2 huggingface dataset:
First Time in Human Study With GSK1325756
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single, oral ascending doses, and repeat oral doses of GSK1325756
      administered to healthy adult male volunteers. This study is the First Time in Human study
      for GSK1325756.
    

Detailed description: 
      This study will evaluate the safety, tolerability, pharmacokinetics(PK) and pharmacodynamics
      (PD) of single and repeat oral doses of GSK1325756 in healthy, male volunteer subjects,
      including the assessment of the effect of GSK1325756 on ex vivo 'C-X-C Motif Ligand 1'
      (CXCL1)-induced 'Cluster of Differentiation 11b' (CD11b) cell surface expression on
      peripheral blood neutrophils. Selective antagonism of the interaction between 'C-X-C Receptor
      Type 2' (CXCR2) and its various chemokine ligands provides a potential strategy for reducing
      the underlying inflammation that contributes to the progression of Chronic Obstructive
      Pulmonary Disease (COPD). This study is the first administration of GSK1325756 to humans and
      will be conducted in four cohorts.

      Cohorts 1 and 2 will comprise of a double-blind, placebo-controlled, single dose escalation
      of GSK132576 in healthy adult males in two interlocking cohorts.

      The data generated from this single dose escalation component of the study (safety,
      tolerability, and where applicable, PK profile, and, if available, PD data) will enable
      decisions regarding progression from one to dose the next higher dose later within Cohorts 1
      and 2. This data will also be reviewed in decisions regarding study progression to repeat
      dosing in Cohorts 3 and 4, and the most suitable doses of GSK1325756 that should be selected
      for these repeat dose cohorts.
    

Intervention name(s): GSK1325756; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Drug will be orally administered in varying amounts over varying time periods as detailed in the 'arms' section.; Placebo will be orally administered to at least 4 subjects in each treatment period of each cohort. In each sequence in each cohort, all subjects will receive one dose of placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; CXCR2 inhibitor
Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an 18-week, double-blind, multicenter study with gradual conversion from previous
      antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial
      epilepsy.
    

Detailed description: 
      This is an 18-week, double-blind, randomized, historical control, multicenter study with
      gradual conversion to monotherapy in subjects with partial onset seizures who are not well
      controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week
      titration period, 6-week taper or conversion period, and a 10-week monotherapy period. This
      study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by
      Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion
      Pharmaceuticals Inc.
    

Intervention name(s): Eslicarbazepine acetate 1600 mg; Eslicarbazepine acetate 1200 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1600 mg once per day; 1200 once per day
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seizures; Epilepsy; Anticonvulsant; Monotherapy; Historical control
X-Chromosome Inactivation Status and Premature Ovarian Failure
Condition: Premature Ovarian Failure
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Observational

Summary: 
      Women who are affected with premature ovarian failure will exhibit skewed X-chromosome
      inactivation patterns compared to women with normal menstrual function (as defined by being
      pregnant), indicating a possible X-chromosome defect.
    

Detailed description: 
      Premature ovarian failure (POF) affects approximately 1% of women. For most women a cause is
      not found, but structural abnormalities of the X-chromosome commonly lead to POF, suggesting
      genes on the X-chromosome are necessary for normal ovarian function. It is known that certain
      gene mutations on the X-chromosome can lead to changes in the normal random pattern of
      X-chromosome inactivation in females.

      We propose to study X-inactivation patterns in a cohort of women with idiopathic POF, and
      compare their pattern to a mean age-matched cohort of women with normal menstrual function.

      We hypothesize that some women with POF will show skewed X-inactivation, suggesting a
      mutation on the X-chromosome as the etiology of their POF.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population will include women diagnosed with POF through clinics. Women diagnosed
        with POF may also inquire about this study through the Clinical Trials website.
      
Biospecimen description: 
      DNA that is extracted from the blood specimen
    
Keywords: Premature Ovarian Failure; X-Chromosome Inactivation
Serum Pepsinogen After H. Pylori Eradication
Condition: Helicobacter Pylori Eradication
Study type: Observational

Summary: 
      Helicobacter pylori has been recognized as a major pathogen in gastric carcinogenesis.
      Current guidelines recommend the H. pylori "test-and-treat" strategy for the purpose of
      primary and secondary gastric cancer prevention. Considering the "point of no return" theory,
      however, H. pylori eradication cannot reduce the risk of gastric cancer in subjects with
      gastric atrophy and intestinal metaplasia. The intragastric hypoacidic environment is
      associated with the risk of intestinal-type gastric cancer development. Recently, the
      secretory ability of the stomach can be measured using the serum pepsinogen (PG) assay.
    

Detailed description: 
      This study aimed to evaluate the change of serum PGs after H. pylori eradication success and
      identify the optimal timing of eradication.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        H. pylori-infected subjects who underwent an upper gastrointestinal endoscopy were enrolled
        in this study at a single, tertiary-care, academic medical center.
      
Biospecimen description: 
      Biospecimen would be obtained for urease test (commercial name: CLOtest).
Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Menstrual low back pain (LBP) is one of the common complaints among women. Menstrual LBP may
      be attributed to the spinal instability resulting from ligament laxity due to hormonal
      change. The purpose of this study was to investigate the effect of functional lumbar
      stabilization exercises on pain, disability and kinesiophobia in women with menstrual LBP.
    

Detailed description: 
      Pain intensity using Numeric Pain Scale (NPS), Oswestry disability index (ODI), Roland-Morris
      questionnaire (RMQ) and Tampa scale of kinesiophobia (TSK) were collected at base line and at
      the end of treatment (after three months) in both groups.
    

Intervention name(s): Lumbar stabilization exercises
Intervention type(s): Behavioral
Intervention description(s): The functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively.
Other intervention name(s): Trunk stabilization exercice, Stability exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stabilization exercises, Pain, Disability, Menstruation
A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state concentrations of
      JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in
      healthy female participants.
    

Detailed description: 
      This is a Phase 1 and open-label study. The study consists of Screening Phase (less than or
      equal to (<=) 28 days before Day 1), Treatment Phase (Day 1 up to Day 78) and Follow up Phase
      (10 to 14 days after last study drug intake or, if an adverse event occurs, 30 to 35 days
      after last study drug intake). Treatment phase will consist of three Oral Contraceptive (OC)
      cycles (each cycle consists of 21 days of ethinylestradiol/norethindrone followed by 7
      pill-free days). The duration of the treatment phase, including the OC-free period of Cycles
      I and II, will be 78 days. Blood samples will be collected for measurement of pharmacokinetic
      (Pk) parameters. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Ethinylestradiol; Norethindrone; JNJ-63623872
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 35 microgram (mcg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.; Participants will receive 1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.; Participants will receive 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test) during third OC cycle under fed conditions.
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy; JNJ-63623872; Ethinylestradiol; Norethindrone
Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites
Condition: Ascites; Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 2

Summary: 
      To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis
      with ascites and exploring the dosage-effect relations of the drug.
    

Detailed description: 
      Tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of
      water reabsorption by renal collecting ducts without corresponding increase in electrolyte
      excretion. It has been confirmed that tolvaptan is able to increase urine volume without any
      adverse effects on renal functions.
    

Intervention name(s): Tolvaptan; Tolvaptan; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, 15 mg, Qd, for 7 days; tablet, 30 mg, Qd, 7 days; tablet, 30 mg, Qd, 7days.
Other intervention name(s): SAMSCA; SAMSCA; blank tablet
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PPROM Erythromycin Versus Azithromycin
Condition: Preterm Premature Rupture of Membranes
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Observational

Summary: 
      Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or
      azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in
      stomach upset in some patients, causing them to stop taking the medication. Therefore,
      azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach
      upset is not seen or greatly reduced. The goal of this study is to see if there is a
      difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in
      prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The
      working hypothesis is that there is no difference in the clinical effectiveness between
      antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging
      latency in PPROM.
    

Detailed description: 
      The current standard regimen for PPROM patients between the gestational age of 24 0/7 and 32
      0/7 weeks, is to administer ampicillin 2gm IV every 6hours for 48hrs followed by amoxicillin
      250mg orally every 8 hours for 5 days, with erythromycin 250mg IV for 48hours followed by
      500mg orally every 8hours for 5 days. Our study design would be a prospective randomized
      trial. Consented, eligible women will be randomized to receive ampicillin as above plus
      either azithromycin 1 gm orally at enrollment or erythromycin 250mg IV every 6 hours for
      48hours followed by 500mg orally every 8hours for 5 days. Those who are unable to tolerate
      the 1gm of azithromycin within the first 30 minutes of administration, a 1000mg powder
      suspension will be given. In conjunction with standard protocol, a course of steroids for
      fetal lung maturity will be administered upon the treating staff's discretion, and all Group
      B Beta Streptococcus positive patients will be treated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with the diagnosis of PPROM will be enrolled in this protocol.
      
Keywords: Preterm Premature Rupture of Membranes; Erythromycin; Azithromycin
Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
Condition: Amyotrophic Lateral Sclerosis; Neurodegenerative Disease; Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Sclerosis
Study type: Observational

Summary: 
      New technologies are giving people with motor disabilities alternative communication and
      control channels. The investigators are interested in using the Cyberlink Control System as a
      hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS).
      The goal of this project is to determine whether this device is a practical and realistic
      means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye
      movements.

      The benefit of this study may be of substantial value to many people with severe motor
      impairment. Additionally, it is hoped that some of the study subjects may benefit by
      incorporating hands-free computer use into their daily lives.

      This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily
      communication compared to the standard manual letter board.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ALS clinic patients at MDA/ALS Center of Hope.
      
Keywords: Amyotrophic Lateral Sclerosis; Cerebrospinal Fluid; Neurodegenerative Disease; Motor Neuron Disease; Autonomic Nervous System; Neurodegenerative Diseases; Movement Disorders
Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain
Condition: Sarcopenia; Chronic Lower Back Pain
MeSH terms: Sarcopenia; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      To study the prevalence of sarcopenia in a pre-retirement group with chronic lower back pain
      and factors associated between sarcopenia and chronic lower back pain in the pre-retirement
      group.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population included 164 people aged 50 - 59 years.
Airway Inflammation in Congenital Diaphragmatic Hernia Patients
Condition: Congenital Diaphragmatic Hernia
MeSH terms: Hernias, Diaphragmatic, Congenital; Inflammation; Hernia; Hernia, Diaphragmatic
Study type: Interventional

Summary: 
      We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway
      inflammation as a first step to characterize the reported bronchodilator responsiveness.
      Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to
      document the amount and type of inflammation present. Another ancillary non-invasive measure
      of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective
      of this study is to determine if CDH patients have any evidence of airway inflammation. The
      hypothesis of this study is that children with CDH do not have evidence of airway
      inflammation associated with bronchodilator responsiveness. Based on this information,
      treatment for CDH patients will hopefully be more accurate and appropriate for their specific
      needs.
    


Intervention name(s): Hypersaline; Bronchodilator Response
Intervention type(s): Drug; Drug
Intervention description(s): Subject will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer. Sputum production (with cough) will be attempted post inhalation. A maximum of 3 hypertonic saline inhalations will be attempted if inhalation does not generate a productive cough. If sputum induction is not successful and the FEV1 falls <10%, the concentration of inhaled hypertonic saline will increase from 3 to 4%. If 5 mls of 4% hypertonic saline inhaled for 7 minutes does not produce a productive cough we will proceed to 5%. If 5 mls of 5% hypertonic saline inhaled for 7 minutes does not produce a productive cough the test is complete and the sample is labelled 'no sputum collected'. If FEV1 falls >10%, the previous step will be repeated.; A bronchodilator (Salbutamol 200 mcg or 2 puffs inhaled via spacer device) will be administered to all subjects in the pulmonary function laboratory. 15 minutes after administration of the bronchodilator spirometry will be repeated. This is performed routinely in CDH clinic and is not an additional test for this study.
Intervention MeSH terms: Bronchodilator Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Congenital Diaphragmatic Hernia; Airway Inflammation; Asthma; Hypersaline; Pediatrics
Effect of Midazolam on White-coat Hypertensive Dental Patients
Condition: Transient Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Intravenous sedation was used for dealing with transient hypertension, so-called white-coat
      hypertension, before dental treatment. Midazolam used as a sedative also has antianxiety
      effect, and the mechanism is guessed that it minimizes patients' stress, resulting in the
      stability of blood pressure. The purpose of this randomized controlled trial (RCT) is to
      evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in
      white-coat hypertensive dental patients.
    


Intervention name(s): Midazolam; Normal Saline Solution (NSS)
Intervention type(s): Drug; Drug
Intervention description(s): Investigators select subject from patients for whom the doctor has ordered intravenous sedation. Inclusion criteria is SBP>=140mmHg or DBP>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes. Informed consent is obtained from the patient.
Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment.
Investigators take venous line on the upper limb and inject the drug (midazolam at dose of 0.02mg/kg) intravenously. Investigators measure blood pressure, heart rate, and oxygen saturation every 2 minutes until 10 minutes after drug administration.
10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again.
Investigators inject an additional sedative agent and the dental treatment is started.; Investigators select subject from patients for whom the doctor has ordered intravenous sedation. Inclusion criteria is SBP>=140mmHg or DBP>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes. Informed consent is obtained from the patient.
Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment.
Investigators take venous line on the upper limb and inject the drug (saline solution at dose of 0.004ml/kg) intravenously. Investigators measure blood pressure, heart rate, and oxygen saturation every 2 minutes until 10 minutes after drug administration.
10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again.
Investigators inject an additional sedative agent and the dental treatment is started.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Intravenous sedation; Midazolam; Dental treatment; White-coat hypertension; STAI; Dental patients; Transient hypertension