bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
Condition: Coronary Artery Disease; Edema
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac
      surgery patients. Systemic inflammatory response initiated by CPB through releasing of
      several mediators lead to altered endothelial integrity and in consequence the leakage of
      proteins and fluids from the intravascular to the interstitial compartment is occurred.
      Increased capillary permeability and decreased colloid osmotic pressure were shown to play a
      key role for fluid shift and increasing of extravascular water. Further tissue edema can
      result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to
      adverse outcomes.

      Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid
      shift from the intracellular and the interstitial spaces of tissue into the intravascular
      compartment.

      The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6%
      hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass
      grafting with cardiopulmonary bypass.
    


Intervention name(s): 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5; 0.9% NaCl
Intervention type(s): Drug; Drug
Other intervention name(s): HyperHAES; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Organ dysfunction; Hypertonic solution; Extravascular water; Cardiopulmonary Bypass
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333
      in healthy volunteers and the antiviral activity in HCV infected subjects.
    

Detailed description: 
      Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV
      genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and
      pharmacokinetics of ABT-333.
    

Intervention name(s): ABT-333; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, see arms for intervention description; Capsule, see arms for intervention description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Trial of Standard Chemotherapy With Metformin (vs Placebo) in Women With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the addition of metformin to standard
      chemotherapy improves progression free survival in women with metastatic breast cancer.
    

Detailed description: 
      A double blind Phase II randomized study of metformin versus (vs) placebo in non-diabetic
      women on first to fourth line chemotherapy with anthracycline, taxane, platinum, capecitabine
      or vinorelbine based regimens for metastatic or unresectable locally advanced breast cancer
      (BC). Patients were randomized to receive metformin 850 mg tablets or placebo once daily for
      two days as ramp-up, followed by one tablet twice a day for the duration of the study.
      Randomization was stratified by line of chemotherapy (1st, 2nd, 3rd and 4th line) and hormone
      receptor status (ER and/or PgR positive versus both negative). All patients were required to
      have measureable or non-measureable, but evaluable metastases at study entry. Metformin or
      placebo was to be continued until disease progression, even if chemotherapy was changed or
      stopped prior to disease progression. Recruitment took place at five sites in Ontario,
      Canada: Mount Sinai Hospital, Princess Margaret Cancer Centre, St. Michael's Hospital,
      Toronto and London Regional Cancer Centre, London.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).
Number of cycles: Until progression or unacceptable toxicity develops.; Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).
Number of cycles: until progression or unacceptable toxicity develops.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metastatic Breast Cancer; Metformin
The Effect of PinnoThin on Satiety and Food Intake
Condition: Obesity
Study type: Interventional

Summary: 
      Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1),
      PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans.
      Therefore, the objective of this study is to investigate whether PinnoThin leads to an
      increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed
      during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy
      intake during an ad libitum lunch?
    


Intervention name(s): PinnoThin
Intervention type(s): Dietary Supplement
Intervention description(s): 6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor
Condition: Malignant Solid Neoplasm
Study type: Interventional

Summary: 
      This trial studies how well pharmacist-led transitions of care works in the outpatient
      oncology infusion center for patients with solid tumor. Having a pharmacist in the outpatient
      oncology infusion center may help to identify and correct medical related problems and
      improve overall patient and staff satisfaction. Patients receiving education may benefit from
      gaining a better understanding of their antineoplastic therapy. Understanding the side
      effects associated with the therapy may also help patients better be prepared to manage any
      adverse effects they may experience.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To demonstrate the effectiveness of a clinical oncology pharmacist in the outpatient
      infusion center through education, and the identification and correction of medication
      related problem (MRP)s.

      SECONDARY OBJECTIVE:

      I. To evaluate overall patient and staff satisfaction with the added clinical oncology
      pharmacy education.

      EXPLORATORY OBJECTIVE:

      I. Estimate the cost avoidance utilizing the pharmacy services provided in the prospective
      trial.

      OUTLINE:

      PHASE I: Patients' medical records are reviewed.

      PHASE II: Patients receive pharmacist-led education on antineoplastic therapies including
      what to expect during infusion, general drug facts, common adverse effects, side effect
      management, and when to contact provider.

      After completion of study, patients are followed up periodically.
    

Intervention name(s): Medical Chart Review; Educational Intervention; Survey Administration
Intervention type(s): Other; Other; Other
Intervention description(s): Review of medical chart; Receive pharmacist-led education; Ancillary studies
Other intervention name(s): Chart Review; Education for Intervention; Intervention by Education; Intervention through Education; Educational
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Adherence to Lumefantrine-Artemether
Condition: Malaria, Uncomplicated
MeSH terms: Malaria
Study type: Observational

Summary: 
      This is a study of how well caregivers of children with malaria adhere to the recommended
      regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group
      receiving directly observed treatment in hospital or to a group treated at home by the
      routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic,
      pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and
      are used to evaluate drug adherence.
    


Intervention name(s): artemether-lumefantrine
Intervention type(s): Drug
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Observational model: Defined Population
Time perspective: Prospective
Keywords: malaria; artemether-lumefantrine; co-artem; Tanzania; adherence
A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at how a new study medicine called NNC0194-0499 behaves in the body of
      Chinese men. Three different dose levels will be tested. Participant will get only one of the
      three different dose levels of NNC0194-0499. Which dose participant will get will be decided
      by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the
      medicine has not yet been approved by the health authorities. Participant will get 1 or 2
      injections of the study medicine. It will be injected with a needle into a skin fold on
      stomach. The study will last for a maximum of 64 days. Participant will not be able to take
      part in the study if the study doctor considers there is a risk for participant's health.
    


Intervention name(s): NNC0194-0499; NNC0194-0499; NC0194-0499
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.; Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.; Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer
Condition: Recurrent Tongue Cancer
MeSH terms: Tongue Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      recurrent tongue cancer.
    

Detailed description: 
      By enrolling patients with recurrent tongue cancer adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of the
      combined therapy using cryosurgery and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Percutaneous ablation under CT or ultrasound guidance; Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): Argon-helium cryosurgical system
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tongue cancer; cryosurgery; NK immunotherapy
GSK1521498 Alcohol Interaction Study
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the safety and tolerability of GSK1521498 in combination
      with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you
      have been given these together. The study will also determine whether GSK1521498 will have an
      effect on alcohol liking and consumption.
    

Detailed description: 
      The study is to test a new drug which may be used for treating alcohol addiction. The drug
      works by inhibiting the effects of messenger molecules called opioids. These opioids are
      naturally produced within the human body, and are involved in controlling how much alcohol we
      drink and the pleasure we get from drinking alcohol. We believe that GSK1521498 might be
      effective in the treatment of alcohol addiction because it is well known that drugs working
      on similar binding sites in the brain reduce the pleasure we get from drinking alcohol. As
      alcohol can effect the way that a drug is metabolised in the body, The investigators need to
      determine that it is safe to take GSK1521498 in combination with alcohol. and to determine
      the amount of GSK1521498 and alcohol in your blood after you have been given these together.
      The study will also determine whether GSK1521498 will have an effect on alcohol liking and
      consumption.
    

Intervention name(s): GSK1521498; Placebo
Intervention type(s): Drug; Other
Intervention description(s): GSK1521498 20 mg administered with alcohol to determine PK/PD interactions; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; mu-opioid receptors; Addiction; Pharmacodynamics; Alcohol
A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      This descriptive study will evaluate the safety and immunogenicity of different formulations
      of the WRAIR dengue vaccine compared to a placebo.
    

Detailed description: 
      Subjects will be randomized into one of three groups. One group will receive a placebo
      vaccine and the other two will receive different dengue vaccine formations. Each subject will
      receive two doses six months apart. All subjects will have 11 venipunctures during 11 visits
      (i.e., screening plus 10 study visits) over a period of nine months.
    

Intervention name(s): T-DEN F17; T-DEN F-19; Placebo Comparator
Intervention type(s): Biological; Biological; Other
Intervention description(s): A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.; A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.; A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
Other intervention name(s): T-DEN vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Blood Flow Restriction and Recovery in Soccer Players
Condition: Resistance Training; Recovery
Study type: Interventional

Summary: 
      The objective is to evaluate the effects of blood flow restriction training on the
      post-competition recovery of professional and semi-professional soccer players. Randomized
      crossover clinical trial, with two intervention groups: Experimental group I will carry out a
      recovery training based on the use of the blood flow restriction (BFR) on day 1
      post-competition. On the other hand, the Experimental II group will perform the same recovery
      training without the use of BFR. After 1 month the groups will cross their intervention and
      make the recovery with the opposite method to the initial one. The study will be carried out
      during the 2021-2022 season, from first regional to third division of Spanish soccer, with
      soccer teams from the Mallorca Island. Before the competition, the countermovement jump (CMJ)
      will be evaluated and repeated at 0, 24, and 72 h after the competition. The levels of muscle
      soreness (DOMS) will be evaluated pre-post-competition 0, 24, 48 and 72h later. The same
      procedure will be carried out to evaluate muscle fatigue, sleep quality, and stress through a
      questionnaire that athletes will fill out pre, 0, 24, 48 and 72h after the game.
      Sociodemographic and anthropometric data will be collected before starting the study.
    

Detailed description: 
      W-UP:

      The warm-up will consist of 5 minutes running slow, 5 minutes mobility, and 5 minutes of
      running exercises. In addition, the warm-up will contain a familiarization with the jump
      test.
    

Intervention name(s): Blood flow restriction recovery; Active recovery
Intervention type(s): Device; Other
Intervention description(s): Soccer players included in experimental group I will carry out this program for 1 week setting the blood pressure to ~ 60% of limb occlusion pressure (LOP). After a month they will carry out the program without restriction of blood flow. Which will consist of a warm-up part with continuous running (5 min), 6 sprints from box to box of the field at 60-70% of a maximum repetition, and an activation part in the form of rounds with the ball.; Soccer players included in experimental group II will carry out this program for 1 week. After a month they will carry out the program with blood flow restriction. Which will consist of a warm-up part with continuous running (5 min), 6 sprints from box to box of the field at 60-70% of a maximum repetition, and an activation part in the form of rounds with the ball.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Soccer; Blood Flow Restriction; Performance; Active recovery
Drug Interaction Study With a Potential Alzheimer's Disease Compound
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics
      of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and
      dextromethorphan
    


Intervention name(s): Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan); BMS-708163; BMS-708163 + Cooperstown Cocktail
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day; Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days; Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 Days
Intervention MeSH terms: Vitamin K; Midazolam; Dextromethorphan; Caffeine; Omeprazole; Warfarin; BMS 708163
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
Condition: Arthroplasties, Replacement, Knee
Study type: Interventional

Summary: 
      This is a prospective, non-randomized, longitudinal study of the clinical outcomes of
      participants that receive the Stryker Triathlon® Total Knee System for Total Knee
      Arthroplasty implanted using ShapeMatch® Cutting Guides.

      Health status and functional outcome measures will be recorded to quantify functional status
      of subjects before surgery and at each follow-up interval. This sub-study involved the
      assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and
      post-operatively. An assessment of post-operative patient outcomes compared to pre-operative
      status was also analysed.
    

Detailed description: 
      Protocol Attached in documentation.
    

Intervention name(s): ShapeMatch Cutting Guides with Triathlon
Intervention type(s): Device
Intervention description(s): All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis
Condition: IPF
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung.
      The estimated prevalence is 30-80/100,000 in the United States with incidence estimates
      clearly rising. A major challenge in the care of patients with IPF is determining prognosis.
      The natural history of IPF is usually one of inexorable decline in lung function, ultimately
      resulting in death from respiratory failure. However, longitudinal physiologic decline in IPF
      is heterogeneous and difficult to predict in individual patients. While some patients with
      IPF may remain stable for years, in others the disease may progress rapidly over a relatively
      short time. We hypothesize that peripheral blood biomarkers based on extracellular matrix and
      matrix-modifying molecules will improve prognostication in patients with IPF.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes subjects with IPF identified via the University of Michigan
        Interstitial Lung Disease Clinical-Radiologic-Pathologic Conference. The investigators will
        only enroll subjects in whom an IPF diagnosis is firmly established.
      
Biospecimen description: 
      Peripheral blood plasma obtained from individuals at 6-month intervals for up to 2 years
    
Keywords: Idiopathic Pulmonary Fibrosis; Biomarkers; Forced Vital Capacity; Diffusion Capacity for Carbon Monoxide; Prognosis