bioihbjkbjnl/mcl2 huggingface dataset:
Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all
      around the world, however optimal graft source for ACLR still remains controversial. Although
      Quadriceps tendon (QT) is the least used and least studied autograft, it could be an
      appropriate and good alternative for ACLR. If investigaters use the same surgical technique,
      and exert the same rehabilitation methods they may have better results than hamstring tendon
      (HT) autografts.
    

Detailed description: 
      Investigators enrolled 36 patient and randomized them to different group (HT, QT). at the
      first evaluation examination findings noted, PROMs (patient reported outcome measurements)
      questioned, thigh circumference measured, flexor and extensor thigh muscle strength recorded
      with help of Humac CYBEX Norm (CSMI, 2004) device. After these examinations and preparations
      all patients operated by the same surgeon who is familiar with both technique. The same
      surgical technique and fixation method used for both groups. At 1st year follow-up all
      evaluations PROMs (İKDC,lysholm,VAS) and measurements repeated. Back to the sports rates and
      postoperative complications compared between HT-QT.
    

Intervention name(s): anterior cruciate ligament recontruction
Intervention type(s): Procedure
Intervention description(s): Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate equivalent blood glucose control in patients with
      type 1 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin
      and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human
      insulin.
    


Intervention name(s): VIAject™; Regular Human Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Dosage as individually required; Dosage as individually required
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin; Diabetes Mellitus type I; Juvenile diabetes
Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation; Radiofrequency Ablation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Curative catheter ablation has been established as an effective therapeutic option for atrial
      fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However,
      standard ablative approaches targeting the pulmonary veins (PVs) are associated with a
      success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of
      catheter ablation of AF isolating the posterior left atrium including all PVs (called Box
      Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6
      months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs,
      with a single procedure success rate of 87% (40/46). This study provided new evidence
      supporting the hypothesis that the posterior wall is of high importance for the maintenance
      of AF. The aim of the investigators study is to determine the efficacy of two different
      approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment
      of chronic AF.
    


Intervention name(s): usual PV ablation; Box isolation of pulmonary veins
Intervention type(s): Procedure; Procedure
Intervention description(s): usual PV ablation, per above; as above
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Psychological Mechanisms Linking Food Insecurity and Obesity
Condition: Obesity; Psychological
MeSH terms: Obesity
Study type: Observational

Summary: 
      The current pilot study will examine emergent hypotheses by investigating the role of
      psychological mechanisms in the relationship between food insecurity and obesity. This
      objective will be achieved via a cross-sectional, observational pilot study collecting
      quantitative and qualitative data.
    

Detailed description: 
      This pilot study will investigate an emergent risk factor for obesity: food insecurity, which
      is defined as the limited or uncertain availability of nutritionally adequate and safe foods.
      While paradoxically linked, numerous studies have shown a significant association between
      food insecurity and obesity. Moreover, recent narrative works have developed new, untested
      hypotheses linking food insecurity and obesity positing the causal role of psychological
      mechanisms. Given this, this mixed method pilot study will collect new psychological data in
      a sample of food secure and food insecure adults with and without obesity to examine the
      connections between food insecurity, body weight, and psychological constructs. The
      overarching objective of the study is to gather pilot data to identify potentially new
      intervention targets that will be used in future studies to more rigorously investigate the
      relationship between food insecurity and obesity.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The target study sample will be 56 food secure and food insecure women and men aged 18 to
        49 years with a BMI of 20.0 kg/m2 or greater.
      
Keywords: Food Insecurity
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Condition: Obesity, Childhood; Neural Development
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in
      individuals with obesity.
    

Detailed description: 
      Adolescents are the highest consumers of sugar sweetened beverages (SSB) potentially because
      their developing brains are most susceptible to the rewarding neural effects of sugar
      consumption. Thus, we specifically target this population (adolescents) to understand neural
      mechanisms involved in excess sugar consumption which predisposes to the development of
      obesity, prediabetes, and type 2 diabetes.
    

Intervention name(s): Liraglutide
Intervention type(s): Drug
Intervention description(s): Liraglutide will be supplied in the following package sizes containing disposable, pre-filled, multidose pens. Each individual pen delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg (6 mg/mL, 3 mL). Liraglutide will be self-administered daily for 12 weeks under the following regimen: 0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, 3.0mg until week 12.
Other intervention name(s): Glucagon-like peptide 1
Intervention MeSH terms: Liraglutide; Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 15 control and 30 obese subjects
Masking: Single (Participant)
Primary purpose: Treatment
Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.
    

Detailed description: 
      One of the most serious complications of treatment in patients with hemophilia A or
      hemophilia B is the development of an inhibitor, which is an antibody that neutralizes the
      factor VIII or IX coagulant activity. Up to one fourth of patients with severe hemophilia A
      develop an inhibitor but at present it is not possible to predict which patients will develop
      such antibody. The ability to predict an inhibitor development at an individual level would
      greatly improve therapeutic approach to this serious problem
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with Severe Hemophilia A and a positive inhibitor
      
Biospecimen description: 
      Serum and Plasma
    
Keywords: Inhibitors
Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
Condition: Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency
MeSH terms: Tricuspid Valve Insufficiency
Study type: Observational

Summary: 
      The purpose of this study is to gather clinical information on the hemodynamic performance of
      the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.
    

Detailed description: 
      The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or
      reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and
      Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial
      size and right ventricular function. Additionally, this study will characterize the patient
      population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency.
      Health status and adverse events (AE) will be assessed.
    

Intervention name(s): Contour 3D® implant for tricuspid valve repair; Tri-Ad® implant for tricuspid valve repair
Intervention type(s): Device; Device
Intervention description(s): Tricuspid annuloplasty ring; Tricuspid annuloplasty ring
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subject population includes patients indicated for a TV repair procedure concomitant to
        left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour
        3D® or Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with
        primary TV regurgitation will not be included in this study. Implantation with the Contour
        3D® or Tri-Ad® ring will occur in conjunction with another concomitant surgical repair
        procedure
Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to
      healthy older adults. Balance is a key element of function that allows individuals to
      maintain posture and respond to perturbations, and poor balance control, a risk factor for
      falls, has been noted in those with knee OA. There is a lack of research guiding treatment
      for balance deficits in knee OA, with interventions aimed at improving balance deficits in
      those with knee OA having mixed results. Targeted dynamic balance interventions in other
      patient populations have been shown to significantly improve dynamic balance control and
      physical function. If results similar to such populations can be achieved, such a program may
      produce a significant reduction in functional disability in the knee OA population and
      improve quality of life. The purpose of this study is to examine the effect of a 10-week
      targeted dynamic balance intervention on dynamic balance and physical function in people with
      knee OA. This will be a randomized controlled trial (RCT).
    


Intervention name(s): Targeted dynamic balance training
Intervention type(s): Other
Intervention description(s): Participants in this study group will complete dynamic balance training exercises four times per week, for ten weeks. Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete. Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: balance; knee; osteoarthritis; physical function
Effects of E-Cigarette Flavors on Adults TCORS 2.0
Condition: Nicotine Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at the effects of flavors when administered with nicotine in e-cigarettes in
      younger and older adult cigarette smokers.
    

Detailed description: 
      This study looks at the effects of flavors when administered with nicotine in e-cigarettes in
      younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit
      smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and
      complete questionnaires. This will be followed by a two-week period where participants are
      asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes
      provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward
      (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18
      mg/ml) following acute tobacco abstinence.
    

Intervention name(s): Nicotine; Flavor
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine level (6 or 18 mg); Flavor of e-juice (tobacco, menthol, strawberry)
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The study is designed as a prospective, observational study to assess the effect of
      adalimumab on health-related quality of life (QoL) and work productivity in patients with
      rheumatoid arthritis (RA) in Korea.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Korea
      
Keywords: Rheumatoid Arthritis; Work productivity; patient-reported QoL(Quality of Life)
Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2
      essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline.
      Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril +
      placebo. Subjects will be uptitrated over a 6 week period until target blood pressure
      (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of
      subjects who achieve target blood pressure after 6 weeks of treatment.
    


Intervention name(s): carvedilol controlled release/lisinopril; lisinopril + placebo
Intervention type(s): Drug; Drug
Intervention description(s): carvedilol CR + lisinopril given as separate pills; lisinopril plus placebo to match carvedilol CR
Intervention MeSH terms: Carvedilol; Lisinopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: target blood pressure; hypertension; COREG CR; carvedilol CR; Stage 1 or 2 essential hypertension; lisinopril
Exercise and Therapeutic Learning Among Women With PTSD
Condition: PTSD
Study type: Interventional

Summary: 
      This study aims to test whether aerobic exercise performed after fear extinction learning
      improves the consolidation and subsequent recall of the learned safety memories (i.e., fear
      extinction memories) among adult women with PTSD related to interpersonal violence exposure,
      and whether this effect is mediated by the ability of exercise to increase acute levels of
      Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB). Participants can expect
      to be on study for up to 90 days, participating in 4 study stages: Day 1 of Assessments, Day
      2 of Fear Learning, Day 3 of Fear Extinction (and activity), and Day 4 of Recall of Fear
      Extinction.
    


Intervention name(s): Day 1 Assessments; Day 2 Fear Learning; Day 3 Fear Extinction; Moderate Intensity Exercise; Low Intensity Exercise; Day 4 Recall of Fear Extinction
Intervention type(s): Other; Other; Other; Behavioral; Behavioral; Other
Intervention description(s): Structured clinical interview to assess trauma history and mental health diagnoses, as well as a screening EKG to assess safety to engage in exercise testing (lasts 3-4 hours); Participants undergo a standard fear conditioning procedure, in which they learn that one of two geometric shapes (circles or triangles) predict the occurrence of a noxious stimulus (mild electrotactile stimulation). Day 2 lasts about 1 hour.; Participants undergo a fear extinction procedure, in which participants learn that the geometric shapes no longer predict a noxious stimulus (i.e., safety learning). Blood samples will be drawn immediately before exercise, and immediately following.; The moderate-intensity aerobic exercise session will consist of a 5 minute warm-up of light intensity activity (40-60% maximum heart rate; MHR) on a treadmill followed by walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes on Day 3; Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for the full duration of 30 minutes.; During Day 4, recall of the fear extinction memory is tested. Visits on Day 4 occur ~24 hours following Day 3, and lasts about 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: women; exercise; mental health
Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy
      with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal
      dosage of combination chemotherapy.
    

Detailed description: 
      Open label single arm phase II study of cisplatin and irinotecan in patients with advanced
      gastric carcinoma not previously treated with palliative chemotherapy. 40 Patients will be
      enrolled in this local trial. The primary objective of this study is to determine the
      response rate of the treatment.Schedule for this study is as follows: 8 cycles/14 days of
      irinotecan 125 mg/m2 on Day 1 and cisplatin 50 mg/m2 on Day2. This study will also include
      genotype investigations of UGT1A1 and ERCC1 expression in order to assess determinants of
      efficacy and toxicity of the treatment with cisplatin and irinotecan in the study population.
    

Intervention name(s): irinotecan and cisplatin
Intervention type(s): Drug
Intervention description(s): irinotecan 125 mg/m2 will be administered as an intravenous (IV) infusion over half a hour on Days 1; Cisplatin 60 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day.
14 days as a cycle, up to 8 cycles.
Other intervention name(s): CAMPT
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced gastric cancer; irinotecan; cisplatin
VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational

Summary: 
      Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS)
      is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap
      fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined
      with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS.
      Fractional flow reserve (FFR) is an established index of the physiological significance of a
      coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable
      clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional
      severity of CAD. Few studies reported relevance between two tests. Aim of this study was to
      investigate whether the geometry and composition of lesions were different under FFR
      criteria.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who underwent coronary angiography for the diagnostic purposes because of clinical
        angina pectoris. Patient who underwent simultaneous virtual histology-intravascular
        ultrasound (VH-IVUS)and fractional flow reserve (FFR) measurement at the time of coronary
        angiography would be enrolled consecutively.
      
Keywords: coronary atherosclerosis; virtual histology intravascular ultrasound; fractional flow reserve