bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 After an Intravenous and an Oral Dose
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study.
      This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion,
      and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of
      blood, urine, and feces.

      Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day
      screening period, two dosing periods (approximately 8 days each) and a follow up visit.

      The subjects will be admitted to the clinical unit on Day 1 of the first treatment period and
      remain in the unit for up to approximately 16 days through the end of the second treatment
      period.

      On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single
      therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is <1%
      of the administered dose in all subjects, Period 2 dosing will begin (approximately 8 days
      after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic oral
      solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during both
      the periods. The subject may be discharged from the unit as early as Day 8 of Period 2.
      Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge
      from the unit.
    


Intervention name(s): GSK1322322 1000 mg containing radioactive 14C-GSK1322322; GSK1322322 1200 mg containing radioactive 14C-GSK1322322
Intervention type(s): Drug; Drug
Intervention description(s): GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.; GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mass balance; radiolabel; oral; IV; GSK1322322; healthy volunteer; antibiotic
A Study of Patients With Chronic Kidney Disease to Assess the Safety of a Single Dose of COR-001
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,
      pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo
      administered subcutaneously to patients with moderate-to-severe chronic kidney disease and
      persistent inflammation.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,
      pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo
      administered subcutaneously to patients with moderate-to-severe chronic kidney disease (CKD)
      and persistent inflammation (defined as a persistently elevated serum CRP (C-Reactive
      Protein) level). The primary objective is to evaluate the safety of a single dose of the
      study drug delivered subcutaneously. Four CKD patients will be randomized to the study drug
      or placebo within each dosing cohort in a ratio of 3:1. The dosing cohorts are 5 mg, 15 mg,
      50 mg, and 100 mg. Each patient will be given 1 dose of the study drug and then be followed
      for 12 weeks for primary safety, pharmacokinetic and pharmacodynamic assessments. Next,
      patients will continue to be followed for an additional 20 weeks (32 weeks observation in
      total) for safety and anti-drug antibody assessments.

      Prior to dose escalation (i.e., higher total dose than studied in the preceding cohorts),
      there will be a formal safety review and the data will have been determined to be acceptable
      by a Data Safety Monitoring Board (DSMB) which will include at least one nephrologist. The
      safety review required for dose escalation will include at least 21 days of treatment data
      from the preceding cohort(s). The DSMB will also meet to review data concerning an SAE
      (Serious Adverse Event) that is suspected to be study drug related

      The investigative team (other than an un-blinded research pharmacist or equivalent) will be
      blinded to the treatment assignment.
    

Intervention name(s): COR-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anti-inflammatory therapy; Sterile water with a final buffer of 25 mM Histidine, 8.5% (w/v) trehalose and 0.05% PS80
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled - 4 cohorts of 4 patients each with a dosing regimen of 3:1 (active:placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO
      15197
    

Detailed description: 
      This study assesses the system accuracy the blood glucose monitoring systems for personal use
      GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.
    

Intervention name(s): Glucometer Test; blood glucose measurement, laboratory reference device
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): measurement of the blood glucose concentration using the blood glucose monitor for personal use; measurement of the blood glucose concentration using a laboratory reference device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
PK Study of IV Formulation of GW856553
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy
      volunteers.
    

Detailed description: 
      The aims of this study are to evaluate the safety and tolerability of single intravenous (IV)
      doses of GW856553 in healthy adult subjects and to investigate the relationship between PK
      and PD markers within the first few hours following administration of study drug to support
      progression of this formulation into a patient population.

      Subjects in Cohort 1 (n=4) will receive a single 1mg IV dose (given as a 15 minute infusion)
      of GW856553. Safety, tolerability and PK exposures will be reviewed, and in an optional
      cohort (Cohort 2) (n=4), the dose may be adjusted upward or downward based on data from
      Cohort 1. Based on the results from Cohort 1 (and Cohort 2 if required), Cohort 3 (n=12) will
      be dosed appropriately to receive a single IV 15 minute infusion of GW856553.

      After a one week washout, Cohort 3 subjects will receive a single oral dose of 15mg GW856553.
      Access to both IV and oral PK in the same individuals will permit calculation of absolute
      bioavailability for the oral dose. Subjects will be resident in the research unit from the
      morning prior to dosing until after the last PK blood sample is collected at 24 hours after
      the dose of study drug (excluding any washout period).
    

Intervention name(s): losmapimod 1 mg; losmapimod; losmapimod 15 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV infusion; IV infusion (dose to be determined based on PK from first dose); oral, two 7.5 mg tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers; IV formulation study
Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this trial are to investigate the efficacy and safety of six weeks of
      treatment with OLT1177 Gel in subjects with moderate to severe pain associated with
      osteoarthritis of the knee following cessation of pain therapy.
    


Intervention name(s): Placebo Gel; OLT1177 Gel
Intervention type(s): Drug; Drug
Intervention description(s): 6 mL of Placebo Gel administered TID for 6 weeks; 6 mL of OLT1177 Gel (5%) administered TID for 6 weeks
Intervention MeSH terms: Dapansutrile
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical
      study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of
      SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the
      safety, tolerability, and pharmacokinetic profile.
    

Detailed description: 
      This is a single and multiple ascending dose study to assess the safety, tolerability and
      pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The
      study will be conducted under double-blind conditions.

      The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral
      administration of single or multiple ascending doses and estimate the maximum tolerated dose
      of SUVN-911, if possible.

      The secondary objectives are to evaluate the single and repeat dose plasma and urine
      pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending
      doses in healthy male subjects.
    

Intervention name(s): SUVN-911; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: subjects randomized to drug or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SUVN-911; Depression; single dose; multiple dose; alpha4 beta2 receptor; first in human; safety; pharmacokinetics; tolerability
MyoStrain CMR Testing of Ischemia With Low Levels of Stress
Condition: Coronary Artery Disease; Myocardial Ischemia; Myocardial Dysfunction
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Observational

Summary: 
      This prospective, observational study evaluates the accuracy of stress testing with the
      MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients
      with suspected coronary artery disease using low levels of stress.
    

Detailed description: 
      This prospective, single center study evaluates the MyoStrain SENC CMR Imaging System for the
      detection of myocardial ischemia and viability during conventional Cardiac Magnetic Resonance
      (CMR) wall motion stress testing. Patients with known or suspected coronary artery disease
      and scheduled for cardiac catheterization will be consented for inclusion in the study and
      evaluated during stress testing with low dose Dobutamine as the stressor agent. Data obtained
      with the MyoStrain SENC CMR Imaging System will be for observational purposes and will not be
      used to alter patient management.
    

Intervention name(s): MyoStrain
Intervention type(s): Diagnostic Test
Intervention description(s): Prior to cardiac catheterization, patients will be stress testing with low dose Dobutamine to evaluate wall motion, segmental, and global myocardial strain at rest and under stress to determine the accuracy of detecting ischemia and viability of myocardial tissue.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with known or suspected coronary artery disease scheduled for cardiac
        catheterization.
      
Keywords: Strain
Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate safety and effectiveness of the peripheral
      mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF
      levels, immunological profile and brain functional connectivity changes in patients with
      Parkinson's disease.
    

Detailed description: 
      Patients will be submitted to 8 sessions of peripheral mechanical stimulation of the feet or
      sham stimulation along 4 weeks.

      Evaluations will be performed before and after the first session, after the forth and the
      eighth session.
    

Intervention name(s): Mechanical Peripheral Stimulation (GONDOLA)
Intervention type(s): Device
Other intervention name(s): GONDOLA equipment (Ecker Technologies Sagl, Switzerland)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest
Condition: Out-Of-Hospital Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Interventional

Summary: 
      To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3
      different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.
    


Intervention name(s): Target Temperature Management of 34°C; Target Temperature Management of 32°C; Target Temperature Management of 33°C
Intervention type(s): Device; Device; Device
Intervention description(s): In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.; In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.; In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Target Temperature Management; Cooling comatose survivors from OHCA; Good neurological outcome at modified Rankin Score (mRS) ≤ 3
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of multiple oral doses
      of ABT-450/ritonavir/ABT-267 and ABT-333 when co-administered under non-fasting conditions in
      healthy Chinese adult participants.
    


Intervention name(s): ABT-450/r/ABT-267; ABT-333
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Tablet
Other intervention name(s): Paritaprevir/Ritonavir/Ombitasvir; Dasabuvir
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteer
Guided Tissue Regeneration With a Periodontal Dressing
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test
      and a control side will be selected by means of a computer-generated randomization list. Test
      sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will
      receive no periodontal dressing. After 14 days the periodontal dressing will be removed and
      the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters
      will be recorded.
    


Intervention name(s): periodontal dressing (coe-pak); Guided Tissue Regeneration
Intervention type(s): Procedure; Procedure
Intervention description(s): Guided tissue regeneration and periodontal dressing; Regeneration of lost periodontal tissues
Other intervention name(s): GTR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
Condition: Life Threatening Diseases
MeSH terms: Rare Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening
      rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine
      kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that
      specific disease.
    


Intervention name(s): Imatinib mesylate
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma; leiomyosarcoma; angiosarcoma; synovial sarcoma; myelodysplastic syndrome/HES; CMML; multiple myeloma; embryonal rhabdomyosarcoma; endometrial sarcoma; adenoid cystic carcinoma; fibromatosis; ductal invasive breast carcinoma; chondrosarcoma; pleural tumor; brenner tumor; ewing sarcoma; round cell tumor; seminoma; thymic carcinoma; malignant melanoma; fibrosarcoma breast; dermatofibrosarcoma protuberans; DFSP; ovarian stromal tumor; osteosarcoma; chorioideal melanoma; hemangiopericytoma; myelofibrosis; liposarcoma; SCLC; small cell lung carcinoma; hypereosinophilic syndrome; chronic myelo-monocytic leukemia; neurofibrosarcoma; mesothelioma; malignant mesenchymoma; malignant schwannoma; mast cell leukemia / mastocytosis; renal cell carcinoma; malignant histocytoma; chordoma
Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of gastric pH changes due to
      famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in
      healthy participants.
    


Intervention name(s): BMS-986256; Famotidine
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
Condition: Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State
MeSH terms: Mania; Bipolar Disorder; Psychotic Disorders; Mental Disorders; Affective Disorders, Psychotic
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of the study is to assess the efficacy of Quetiapine extended release
      600mg per day either as monotherapy or combined therapy in the treatment of patients with
      mania associated to Bipolar disorder. This trial will also assess the life quality and
      productivity loss improvement for patients from baseline to day 21.
    


Intervention name(s): Quetiapine 600mg
Intervention type(s): Drug
Intervention description(s): 300 mg quetiapine fumarate tablets for oral use.
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State
Influence of Dietary Nitrate on Time Trial Performance in Swiss Paracycling Athletes
Condition: Exercise Nutritional Physiology
Study type: Interventional

Summary: 
      The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time
      trial performance in Swiss paracycling athletes compared to the ingestion of a placebo
      supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will
      be investigated in spinal cord injured and non-injured athletes.
    

Detailed description: 
      The influence of dietary nitrate on performance will be tested performing a time trial on a
      handbike. The time trial will be the same as in the Paralympics 2016 in Rio. The subjects
      perform three trials and receive another supplement for each trial: beetroot juice with 6mmol
      nitrate, 6mmol sodium nitrate or plain water (placebo supplement). The time to complete the
      time trial will be the main outcome parameter.
    

Intervention name(s): beetroot juice; sodium nitrate; water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 6mmol nitrate; 6mmol sodium nitrate; plain water
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Injection Regimen Trial of PEG-rhG-CSF During Breast Cancer Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Febrile Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to try to find a better injection regimen (including time and
      dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN
      in breast cancer patients who receive chemotherapy.
    


Intervention name(s): Day 7 regimen; Day 3 regimen
Intervention type(s): Drug; Drug
Intervention description(s): patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.; patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PEG-rhG-CSF; Bone marrow suppression; Febrile neutropenia; Breast cancer; Chemotherapy