bioihbjkbjnl/mcl2 huggingface dataset:
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult
      male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and
      alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects
      after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0
      g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses
    

Detailed description: 
      Blood samples for determining plasma concentrations of ETX2514 and sulbactam will be
      collected within 5 minutes prior to and at 1.0, 2.0, 2.5, 2.95, 3.05, 3.25, 3.5, 4.0, 5.0 and
      6.0 hours after start of the third dose (last dose) administered on Day 2.

      Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in
      the outpatient bronchoscopy suite at 1.0, 2.5, 3.25, 4.0, or 6.0 hours after start of the
      infusion of the third dose of ETX2514 and sulbactam (6 subjects per timepoint) on Day 2.

      Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory
      tests, ECG, physical examination, and vital sign monitoring.
    

Intervention name(s): ETX2514 and sulbactam
Intervention type(s): Drug
Intervention description(s): Each subject will receive three doses of of ETX2514 1.0 g and sulbactam 1.0 g via intravenous (IV) infusion administered every 6 hours with each drug infused over 3 hours
Intervention MeSH terms: Sulbactam; Durlobactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetic; Bronchoalveolar Lavage; Epithelial Lining Fluid; Alveolar Macrophage; Gram-negative bacterium; Acinetobacter baumannii
Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine
      compared to placebo in patients with schizophrenia after receiving treatment for up to 6
      weeks.
    


Intervention name(s): Quetiapine Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Schizophrenic disorder
Effect of Dexmedetomidine on the Inflammatory Response After One-lung Ventilation
Condition: Lung Cancer
Study type: Interventional

Summary: 
      The postoperative inflammatory response is significant in lung resection surgery because of
      major operation and one-lung ventilation. Dexmedetomidine has been shown to reduce
      pro-inflammatory cytokine levels and improve clinical outcomes. The aim of this study was to
      determine the effects of dexmedetomidine on inflammatory responses after lung resection
      surgery.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): The study drug for each group was administered from the time immediately after induction of anesthesia until the end of the surgery.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography.
Condition: Fluid Resuscitation; Electrical Cardiometry; Transthoracic Echocardiography; Shock
Study type: Observational

Summary: 
      The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC)
      for the noninvasive determination of fluid responsiveness in critically ill shocked patients
      and agreement of EC compared to transthoracic echocardiography (TTE)
    

Detailed description: 
      Electrical cardiometry (EC), based on thoracic electrical bioimpedance, can measure SV
      continuously and non-invasively. The EC"s working principle of estimation of SV is to utilize
      changes in thoracic electrical impedance, which is mainly influenced by erythrocyte
      orientation and peak flow velocity in the ascending aorta throughout the cardiac cycle.

      Electrical cardiometry (EC) has been validated to monitor SV and other hemodynamic parameters
      non-invasively compared to different techniques such as thermodilution technique,
      transesophageal Doppler echocardiography and cardiac catheterization including critically ill
      patients, intra-operative settings, in pregnant women, in children with congenital heart
      diseases, even in obese children
    

Intervention name(s): Assessment of fluid responsiveness by electrical cardiometry
Intervention type(s): Device
Intervention description(s): Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotropic, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3).
Transthoracic echocardiography (TTE) measurements will be performed equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and VTI measured in LVOT from apical 5 chamber view (by pulsed wave Doppler).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged from 25 to 55 years old were intubated, with clinical criteria of shock (mean
        arterial pressure (MAP) ≤ 65 mmHg).
Virtual Reality- Working Memory Retraining
Condition: Alcohol Use Disorder; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      This study will establish the acceptability and feasibility of enrolling and retaining heavy
      drinking Veterans with mild traumatic brain injury (mTBI) in an 8-week, randomized cross-over
      design trial of active VR working memory retraining (WMR). This study will also seek to
      establish the efficacy of active VR-WMR to increase performance in executive function.
    

Detailed description: 
      The investigators will employ a physically active VR working memory retraining (VR-WMR)
      regimen utilizing components of Blue Goji VR Active Gaming. The synthesis of physical
      activity and an enriched VR environment is expected to yield superior working memory training
      stemming from greater neurological activation. This enhanced working memory training task
      will result in greater motivation to engage and complete a training regimen, thus fostering
      greater improvements in executive function than traditional working memory training tasks;
      ultimately resulting in increased self-control over alcohol use and other high-risk
      behaviors.
    

Intervention name(s): VR-WMR-Only; Exercise-only; Active VR-WMR
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will spend up to 30 minutes in a VR-WMR environment during each training session.; Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.; Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.
Other intervention name(s): Virtual Reality-Working Memory Retraining; Recumbent bicycle; Active Virtual Reality-Working Memory Retraining
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: We will use an 8-week, randomized cross--over design trial of active VR-WMR.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Alcohol Use Disorder; Traumatic Brain Injury; Working Memory Training; Virtual Reality; Physical Exercise
Glutathione and Function in HIV Patients
Condition: HIV Infection; Erythrocyte Glutathione Deficiency
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      We have recently reported that older patients with HIV are deficient in glutathione (GSH) due
      to decreased availability of cysteine and glycine, and that oral supplementation with
      cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and
      improves (but does not fully normalize) concentrations of red-cell GSH. We also found that
      when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with
      an increase in intracellular GSH concentrations. These older HIV patients also had
      significant increases in muscle strength with improvement of GSH levels.The current proposal
      in older HIV patients will investigate study if cysteine and glycine supplementation for a
      duration of 12 weeks will result in changes in : (a) GSH levels; (b) body
      composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial
      energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and
      glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months,
      GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests
      will be measured for a further 2 months to determine the effects of washout.
    

Detailed description: 
      Detailed data are not as yet available
    

Intervention name(s): GlyNAC (combination of glycine and n-acetylcysteine)
Intervention type(s): Dietary Supplement
Intervention description(s): HIV patients will be studied before and after receiving GlyNAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine; Glycine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will test whether damage of the heart nerves appears in patients before they
      develop diabetes.
    

Detailed description: 
      Patients who have mild abnormalities of blood sugar, high blood pressure, abnormal lipids
      and/or obesity can have a condition called metabolic syndrome. These patients are at high
      risk for diabetes and Cardiac Autonomic Neuropathy (CAN). Subjects with diagnosed metabolic
      syndrome will be expected to participate in the Metabolic Fitness Program which is a
      University of Michigan diet exercise program located in the Cardiology department at Domino
      Farms in Ann Arbor. Time required for this program and the study is 6 months. Clinic visits
      will involve Cardiac autonomic testing (CAN) procedures, PET scans and labs which will
      measure pre and post program intervention.
    

Intervention name(s): Exercise and Diet (Metabolic Fitness Program)
Intervention type(s): Behavioral
Intervention description(s): 6 month program of diet and exercise training and support.
Other intervention name(s): Metabolic Fitness Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Metabolic; Syndrome; CAN
Single Ascending Dose Study of MEDI1341 in Healthy Volunteers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of single ascending intravenous doses of MEDI1341 or placebo in up to 48
      healthy volunteers, aged 18 to 65 years. The study will include up to 6 planned cohorts; each
      cohort will comprise 8 participants.

      Each participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo
      and will undergo scheduled assessments over a period of 13 weeks.

      The main aim of the study is to assess the safety and tolerability of single doses of
      MEDI1341 in healthy volunteers.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study of single ascending intravenous
      doses of MEDI1341 in male and nonfertile female healthy volunteers, aged 18 to 65 years.

      The study will include up to 6 planned cohorts; each cohort will comprise 8 participants.
      Within each cohort, 6 participants will be randomized to receive MEDI1341 and 2 will be
      randomized to receive placebo. A Safety Review Committee will review data from each cohort
      before progression to the next higher dose cohort occurs. On Day 1, each randomized
      participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and
      will undergo scheduled safety, pharmacokinetic, pharmacodynamic, and immunogenicity
      assessments. Additional study assessments will occur on Days 2, 4, 8, 15, 22, 29, 43, 57, and
      92.
    

Intervention name(s): MEDI1341; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.; Participants will receive IV infusion of placebo matched to MEDI1341.
Other intervention name(s): TAK-341
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to one of two groups within a cohort of 8 participants (N=6 MEDI1341; N=2 placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; Immunogenicity
A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)
Condition: Migraine; Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo
      for preventing migraines in participants with episodic migraine. After a 28-day Screening
      period during which baseline number of monthly migraine days was assessed, participants were
      randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who
      completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2
      weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the
      initial randomization. In the Run-out Period, participants who received placebo in the
      Treatment Period continued to receive placebo and participants who received MK-6096 in the
      Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested
      in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as
      measured by the mean change from baseline in monthly migraine days averaged over the 12- week
      treatment period.
    


Intervention name(s): MK-6096; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily; Placebo, 2 tablets, orally, once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
ALTO-300 in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to collect biologically-based data for defining predictors and
      correlates of the effects of ALTO-300.
    


Intervention name(s): ALTO-300 PO tablet
Intervention type(s): Drug
Intervention description(s): One tablet daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Condition: Multiple Sclerosis, Chronic Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to determine if lipoic acid can protect the brain and slow
      disability in secondary progressive multiple sclerosis.
    

Detailed description: 
      There are no approved medications that are neuroprotective or able to slow disability
      accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will
      determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to
      placebo in reducing injury to the brain and reducing disability progression in SPMS.
      Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and
      disability will be measured by neurological status and quality of life.
    

Intervention name(s): lipoic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.; The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
Other intervention name(s): alpha lipoic acid
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Multiple sclerosis, chronic progressive; Neuroprotective agents; Magnetic resonance imaging; Optical coherence tomography; Gait; Thioctic acid; Alpha-lipoic acid
Effectiveness to Weight Loss in Sedentary and Overweight People Using a Smartphone Application.
Condition: Healthy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years
      selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the
      effects of the addition of an ICT tool developed for the Smartphone application and a
      Smartband in support of behavioral and educational recommendations to reduce weight.
    

Detailed description: 
      -  Objetive: To develop and validate an application for the use in Smartphone in which the
           management of a SmartBand is included and evaluate the effect of adding this tool of
           information and communication technology (ICT), to a standardized intervention reduce
           weight, reduce sedestation time, increase physical activity and decrease total caloric
           intake in obese and sedentary subjects.

        -  Design and setting: A clinical of two parallel group, multicenter, randomized, aimed at
           assessing the effects of adding an ICT tool (intervention) to support behavioral and
           educational recommendations (control) in physical activity and weigh loss. Population:
           700 obese and sedentary subjects will be included, 20 to 65 aged, selected by random
           sampling in 5 centers.

        -  Measurements and intervention: physical and sedeentary acivity will be assessed with an
           accelometer and IPAQ and Marshall Questionnaires, the nutrition by a food frequency and
           adherence to the Mediterranean diet survey and weight loss with body mass index and
           waist circumference. Vascular function with a wrist-worn tonometer (blood pressure,
           augmentation index and pulse rate) will be evaluated and also the Cardio Ankle Vascular
           Index and carotid intima media thickness. The advice on nutrition (plate method) and
           exercise will be common to both groups. The intervention group will be added a training
           for 3 months in use of ICT tool described, designed to foment a healthy and low-calorie
           diet and increased physical acivity and decreased sedentary.
    

Intervention name(s): Intervention group; Control: Lifestyle counseling
Intervention type(s): Other; Other
Intervention description(s): Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition; Conseling on physical activity and nutrition (intervention)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical activity; Food Habits; Information and communiation Technology; Health education
A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.
Condition: Rare Diseases
MeSH terms: Rare Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo controlled and double-blinded study to evaluate the
      pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of
      emapalumab in adult healthy Japanese subjects.
    

Detailed description: 
      This is a randomized, placebo-controlled and double-blinded study to evaluate the PK, PD and
      safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects, performed
      in Japan. The subjects, 8 in total, will be randomized to receive either emapalumab or
      matching placebo in a 3:1 ratio (emapalumab: placebo).
    

Intervention name(s): NI-0501; Saline
Intervention type(s): Drug; Drug
Intervention description(s): emapalumab single i.v infusion (1 mg/kg); Saline single i.v infusion
Other intervention name(s): Gamifant; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Other
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
Condition: Her2-Positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the
      anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin)
      concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The
      study will also test the safety of this therapy.
    

Detailed description: 
      Subjects will receive 6 months of T-FEC chemotherapy concomitant with trastuzumab and
      pertuzumab before surgery. Subsequently, subjects will undergo surgery to remove any cancer
      from the breast and axillary lymph nodes that may have survived the chemotherapy. It is
      expected that the majority of women will have no viable cancer left in the breast or lymph
      nodes by the time all chemotherapy is completed.
    

Intervention name(s): Pertuzumab; Trastuzumab; Paclitaxel; 5-fluorouracil; Epirubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total); For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).; Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).; Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).; Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).; Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Other intervention name(s): Perjeta; Herceptin; Taxol; 5-FU; Ellence; Cytoxan
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Fluorouracil; Trastuzumab; Epirubicin; Pertuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment