bioihbjkbjnl/mcl2 huggingface dataset:
Arterial Access for Coronary Intervention in Myocardial Infarction
Condition: Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Reperfusion
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the radial and femoral access for percutaneous
      interventions in the acute phase of the ST elevation acute myocardial infarction in terms of
      efficacy and security.
    

Detailed description: 
      Some groups have previously used the radial artery as the access route in the procedures of
      percutaneous coronary revascularization, with good results. The advantages of the radial
      compared with femoral access are related to a lower incidence of vascular complications. The
      radial access has also inconveniences such as a less predictable anatomy which can make the
      procedure difficult and prolong the time required.The patients with ST elevation myocardial
      infarction have an increased risk of vascular complications after interventional procedures
      because previous antithrombotic or thrombolytic therapy.On the other hand, the time and
      success of the procedure are significant prognostic issues.In this sitting, the radial
      approach might reduce vascular complications and increase other cardiovascular events when
      comparing with the classical femoral access. For this reason, the purpose of the study is to
      compare both arterial access in terms of efficacy and security and to quantify the
      consequences of the advantages and drawbacks of both.
    

Intervention name(s): Coronary angioplasty
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transradial access; Femoral access; Femoral vs radial access
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Condition: Menopause
Study type: Observational

Summary: 
      The purpose of this study is to estimate the prevalence of Vasomotor Symptoms (VMS) and
      prevalence of moderate to severe VMS in peri-menopausal women and post-menopausal women aged
      40-65 in East Asia (China, South Korea and Taiwan) and the proportion of the following
      subpopulations: Hormone Replacement Therapy (HRT)-eligible and willing to take HRT;
      HRT-eligible and HRT-averse (i.e. not willing to take HRT); HRT-ineligible due to
      contra-indications/high-risk; and HRT-stoppers.

      The study will also assess Health Related Quality of Life (HRQoL) and VMS related
      productivity loss among perimenopausal and post-menopausal women with moderate-to-severe
      MR-VMS and the respondents' attitudes toward prescription treatments.
    

Detailed description: 
      The study will recruit women of 40-65 years old from an established consumer panel in China,
      South Korea, and Taiwan.

      Women who meet the inclusion criteria for Part I will be recruited to sign the informed
      consent form (ICF) and participate in Part I of the survey.

      Based on the information collected in Part I of the survey, peri- and post-menopausal women
      who meet the inclusion criteria for Part II will be directed to Part II of the survey. The
      survey will be terminated for women who do not meet the inclusion criteria for Part II.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This is a cross-sectional survey study evaluating prevalence, severity and associated factors in women with moderate-to-severe menopause-related vasomotor symptoms (MR-VMS).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea
        and Taiwan)
      
Keywords: peri-menopausal; hormone replacement therapy; menopause; VMS; post-menopausal; menopausal; Vasomotor Symptoms; HRT
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered
      as a single SC or IV dose.
    

Detailed description: 
      This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered
      as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe
      psoriasis (Part B).
    

Intervention name(s): 700 mg IV; 350 mg SC; Placebo; 140 mg SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).; single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures
Condition: Ankle Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Observational

Summary: 
      The purpose of this study is to use a novel load monitoring technology to correlate limb
      loading to ankle fracture outcomes. This study will collect continuous limb loading data and
      will provide the first objective insight into how limb loading directs fracture healing.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who present to the University of Utah emergency department with ankle fractures.
Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
Condition: Obesity; Binge Eating
MeSH terms: Obesity; Weight Loss; Bulimia; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This controlled study will test the effectiveness of a stepped-care approach to a standard
      behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The
      major question is whether the stepped-care approach, which begins with behavioral weight loss
      and then follows a decision tree for additional interventions based on early treatment
      response is superior to standard behavioral treatment.
    

Detailed description: 
      The stepped-care arm of this study included an obesity medication intervention. At the start
      of the study, the active medication was sibutramine and was compared to a placebo control. On
      10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the
      market in light of clinical trial data pointing to an increased risk for stroke and
      myocardial infarction. In response to this event, the investigators submitted an IRB
      amendment to change the active obesity medication from sibutramine to Orlistat. The IRB
      amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer
      Robert Kuczmarski to enact this change.
    

Intervention name(s): Behavioral Weight Loss; Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy; Placebo; Sibutramine/Orlistat
Intervention type(s): Behavioral; Behavioral; Drug; Drug
Intervention description(s): weekly individual sessions for 6 months; weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months; One pill daily; Sibutramine 15 mg daily or Orlistat 120mg TID
Intervention MeSH terms: Orlistat; Sibutramine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Experimental; Comparator
Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
Condition: Locally Advanced Solid Tumor; Metastatic Solid Tumor; Breast Cancer; Non Small Cell Lung Cancer; Melanoma; Colorectal Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This research trial is testing a combination of two experimental drugs, MSC1936369B
      (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and
      SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR)
      inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary
      purpose of the study is to determine the maximum tolerated dose of the drug combination.
    


Intervention name(s): MSC1936369B (pimasertib); SAR245409 (PI3K and mTOR inhibitor); MSC1936369B (pimasertib); SAR245409 (PI3K and mTOR inhibitor)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): MSC1936369B (pimasertib) single dose capsule was administered at dose of 15 milligram (mg), 30 mg, 60 mg, 90 mg orally in successive 21-day cycles.Dose escalation was proceeded until Maximum Tolerated Dose (MTD) was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohorts enrolled subjects with Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Melanoma, and Colorectal Cancer.; SAR245409 (PI3K and mTOR inhibitor) capsule was administered orally at a dose of 30 mg, 50 mg, 70 mg and 90 mg in successive 21-day cycles. Dose escalation was proceeded until MTD was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohort enrolled subjects with Breast Cancer, NSCLC, Melanoma, and Colorectal Cancer.; MSC1936369B (pimasertib) capsule was administered twice daily orally at a dose of 60 mg and 45 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of MSC1936369B (pimasertib) was combined with a lower dose of SAR245409 (PI3K and mTOR inhibitor).; SAR245409 (PI3K and mTOR inhibitor) was administered twice daily orally at a dose of 30 mg and 50 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of SAR245409 (PI3K and mTOR inhibitor) was combined with a lower dose of MSC1936369B (pimasertib).
Other intervention name(s): Pimasertib; PI3K and mTOR inhibitor; pimasertib; PI3K and mTOR inhibitor
Intervention MeSH terms: Niacinamide; Sirolimus; MTOR Inhibitors; Temsirolimus; Elafin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MEK inhibitor (Pimasertib); PI3K/mTOR Inhibitor; Solid Tumor; Phase I
A Home Visit Program and Perceived Care Burden
Condition: Burden
MeSH terms: Caregiver Burden
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of a home visit program provided to the
      caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial
      was used. The sample consisted of 30 participants in the intervention group and 30
      participants in the control group. A home visit program including education and counseling
      was applied to participants in the intervention group.
    

Detailed description: 
      The aim of this study was to determine the effect of a home visit program provided to the
      caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial
      was used. The sample consisted of 30 participants in the intervention group and 30
      participants in the control group. A home visit program including education and counseling
      was applied to participants in the intervention group. A total of five home visits over three
      months were performed. Data were collected by a personal information form, and the Zarit
      Caregiver Burden Scale (ZCBS).
    

Intervention name(s): A home visit program
Intervention type(s): Other
Intervention description(s): A home visit program including education and counseling was applied. A total of five home visits over three months were performed.
Other intervention name(s): standard education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; burden; caregiver; education; home visit
A Comparison of Hearing Aid Fitting Methods
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      This investigation will compare hearing aid fitting methods between self-fitting and
      clinician fitting approaches by using a standardized questionnaire to evaluate subjective
      hearing aid benefit.
    

Detailed description: 
      Participants will be fit with hearing aids using two different fitting methods (fitting A and
      fitting B). The order of the fitting will be randomized such that half of the participants
      will start out with fitting A and half of the participants will start out with fitting B. All
      participants will undergo baseline speech testing and answer a questionnaire about their
      experiences in daily life without hearing aids. All participants will use devices for a
      period of 1-2 weeks in their daily lives. After this first home trial, participants will
      return to the clinic where they will answer questionnaires regarding their experience with
      the devices. They will also perform aided speech testing. They will then be given devices
      with the second fitting method and will wear devices for a period of 1-2 weeks in their daily
      lives. Following the second home trial, all participants will return to the clinic to answer
      the same questionnaire that was given after home trial #1, and complete aided speech testing.
      The results for each of the two fitting methods will be analyzed.
    

Intervention name(s): Experimental hearing aid
Intervention type(s): Device
Intervention description(s): This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a prospective, repeated measures, within-subject, cross over design. Subjects will be assigned in random order to the two fitting methods. Subjects will be blinded as to which fitting method they are using during the home trials.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability, Immunogenicity, and Pharmacodynamics (PD) of GSK2800528 in Healthy Subjects.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal
      antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted
      in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of groups of 12
      subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will consist of a
      group of 9 subjects, all on active treatment (adalimumab).
    


Intervention name(s): GSK2800528, solution for injection; Placebo (0.9% w/v Sodium Chloride), solution for injection; Adalimumab, solution for injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug will be administered at 3 different dose levels by subcutaneous injection.; Subcutaneous injection of. 0.8 mL solution will be administered; Subcutaneous injection of 0.8 mL solution will be administered (40mg)
Intervention MeSH terms: Adalimumab; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: monoclonal antibody; healthy volunteer; TNF alpha
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to evaluate the safety and efficacy of filgotinib
      during induction and maintenance treatment of moderately to severely active Crohn's disease
      (CD) in participants who are biologic-naive and biologic-experienced.

      Participants who complete the study, or do not meet protocol response or remission criteria
      at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study
      GS-US-419-3896).
    


Intervention name(s): Filgotinib; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Filgotinib tablets administered orally once daily.; Placebo administered orally once daily.
Other intervention name(s): GS-6034; GLPG0634
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacogenetics of Ace Inhibitor-Associated Angioedema
Condition: Hypertension; Diabetes Type 2
MeSH terms: Hypertension; Angioedema; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4
      inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people
      receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure
      medicine. Understanding how these drugs interact in healthy people will help us learn their
      potential effects in people who have diabetes.
    

Detailed description: 
      To test the hypothesis that DPPIV inhibition with sitagliptin potentiates the vasodilator
      response to substance P in the presence of ACE inhibition with enalaprilat and to BNP and
      GLP-1 even in the presence of ACE inhibition. The aim promises to provide important new data
      regarding the mechanism of action of DPPIV inhibitors and interactive effects of these two
      drug classes used in a growing population of diabetic patients.
    

Intervention name(s): Sitagliptin (DPP4 inhibitor); Substance P,; bradykinin; enalaprilat (ACE inhibitor); Glucagon-like peptide 1; brain natriuretic peptide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 200 mg (DPP4 inhibitor) or matching placebo will be given one hour prior to intra-arterial infusions; Substance P intra-brachial artery (2,4,8 pmol/min); bradykinin intra-brachial artery (23.6, 47.2, and 94.3 pmol/min); intra-brachial artery(0.33 µg/min per 100 mL forearm volume); intra-brachial artery (0.45-3.60 pmol/min); Intra-brachial artery (0.90, 1.80 and 3.6 pmol/min)
Other intervention name(s): Januvia; vasotec; GLP-1; nesiritide
Intervention MeSH terms: Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors; Enalaprilat; Natriuretic Peptide, Brain; Bradykinin; Glucagon; Glucagon-Like Peptide 1; Angiotensin-Converting Enzyme Inhibitors; Substance P; Neurokinin A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: DPPIV inhibitors; ACE inhibitors; Bradykinin; glucagon-like peptide (GLP-1); BNP; diabetes; hypertension
Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell
      administration in treatment of ischemic damages of cardiovascular system with control group,
      who will receive the placebo.
    

Detailed description: 
      The CIHF trial will enroll 105 patients with randomization into active and placebo therapy
      with 2:1 ratio.

      Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded
      fashion, labelled CardioCell to determine the early myocardial uptake and retention of IMP.

      The primary research question of this project is to check if the administration of CardioCell
      could improve the clinical outcomes in patients with CIHF. There are several secondary
      questions, defined by secondary endpoints in each cohort, e.g.: if the investigated treatment
      is possible to administered, if the investigated treatment and way of CardioCell
      administration is safe, if it is possible to define any selected subgroup in which the
      treatment results are significantly different than in whole group.
    

Intervention name(s): CardioCell; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Patients randomized to the active treatment group will receive transcoronary or trans-bypass graft administration of 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin).
Injection will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties.; Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.
Other intervention name(s): CardioCell administration; Placebo administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The CIHF trial will enroll 105 patients with randomization into active and placebo therapy with 2:1 ratio.
Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early myocardial uptake and retention of IMP.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
n-Acetylcysteine and Cocaine
Condition: Cocaine Abuse; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine
      as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study
      will be conducted in which the subjective, physiological and reinforcing effects of cocaine
      are evaluated during maintenance on placebo and n-acetylcysteine.
    


Intervention name(s): Cocaine; n-Acetylcysteine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and n-acetylcysteine.
Intervention MeSH terms: Acetylcysteine; Cocaine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science