bioihbjkbjnl/mcl2 huggingface dataset:
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates through standard practice. Investigators assume
      that the RCT provides the reference standard treatment effect estimate and that failure to
      replicate RCT findings is indicative of the inadequacy of the healthcare claims data for
      replication for a range of possible reasons and does not provide information on the validity
      of the original RCT finding.
    

Intervention name(s): Dabigatran; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Dabigatran dispensing claim is used as the exposure group; Warfarin dispensing claim is used as the reference group
Intervention MeSH terms: Warfarin; Dabigatran
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score-matched, retrospective
        cohort study design comparing dabigatran to warfarin users. The patients will be required
        to have continuous enrollment during a baseline period of 180 days before initiation of
        dabigatran to warfarin (index date). We will restrict the analyses to patients with a
        diagnosis of proximal DVT or PE.
Forearm Position in Subpectoral Biceps Tenodesis
Condition: Biceps Tendon Disorder
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The investigators aimed to compare two different forearm positions, extension-pronation (EP)
      or neutral, for fixation of the long head of the biceps tendon (LHB) in biceps tenodesis.
    

Detailed description: 
      Long head of biceps pathologies have been regarded as a source of anterior shoulder pain and
      disability. Tenodesis is preferable surgical choice for especially young patients to to
      eliminate anterior shoulder pain. The optimal position of the elbow and forearm during
      tenodesis is a debated topic. The investigators aimed to evaluate pain and strength loss
      after biceps tenodesis fixed at extension-pronation (EP) and neutral positions. The
      investigators aimed to find the most appropriate and anatomical arm position that gives
      better clinical and functional results.
    

Intervention name(s): Fixation while forearm in extension-pronation position
Intervention type(s): Procedure
Intervention description(s): Fixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biceps; tenodesis; forearm; shoulder arthroscopy; position
Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis
      with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging
      (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation
      therapy. Full inclusion/exclusion criteria are available. History and physical examination,
      and laboratory and imaging analyses will be done within 14 days prior to registration. The
      three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid,
      three times per week for 8 weeks. Subjects will also have co-administration of the
      chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9
      to 18 participants will be enrolled in this Phase I study.
    


Intervention name(s): Gemcitabine and Erlotinib; Intravenous Vitamin C
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day); 50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Cancer
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia, Europe and North America. The purpose of the trial is to
      evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in
      previously untreated children with haemophilia A.
    


Intervention name(s): turoctocog alfa
Intervention type(s): Drug
Intervention description(s): Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of HM10560A in Healthy Male Subject
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Study Design

             -  Randomized, Double-blind, Placebo-controlled, escalating single-dose design.

             -  Four ascending dose cohorts.

             -  In each cohort, subjects will be randomized to receive a single dose of HM10560A or
                placebo (negative control).

        -  Objectives

             -  The primary objective of the study is to assess the safety and tolerability of
                single escalating subcutaneous doses of HM10560A in healthy male subjects.
    

Detailed description: 
      The secondary objectives of the study are as follows:

        -  To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous
           dose of HM10560A.
    

Intervention name(s): HM10560A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneously administrate at 0 hour on Day 1; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy
Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting
Condition: Type 1 Diabetes; Autoimmune Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This is a pilot, interventional clinical trial to assess the effectiveness and safety of
      artificial pancreas (AP) using the ARG algorithm closed-loop system in a monitored 3-day
      period outpatient study. Once the safety of the device has been validated in the open-loop
      first 3-day period (continuous subcutaneous insulin infusion (CSII) plus continuous glucose
      monitoring (CGM)) the investigators will move the study to the second 3-day closed-loop
      period, without carbohydrate (CHO) counting.
    


Intervention name(s): Non-hybrid closed-loop system with ARG algorithm
Intervention type(s): Device
Intervention description(s): To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: diabetes technology; T1DM; artificial pancreas; closed-loop
Latina Adolescent Depression Treatment Study
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      Despite experiencing higher rates of depressive symptoms and similar rates of Major
      Depressive Disorder (MDD), Latina (female) adolescents in the U.S. are significantly less
      likely than their non-Latina White peers to receive treatment for MDD. The purpose of this
      study is to identify facilitators of and barriers to depression treatment engagement among
      Latina adolescents across patient-, family-, and healthcare provider-levels from the
      perspectives of these individuals. Latina adolescent-parent dyads and healthcare providers
      will be recruited from community and healthcare settings. Separate individual semi-structured
      interviews will be conducted with Latina adolescents (n=12) and their parents (n=12). Two
      focus groups will be conducted with primary care providers (n=6) and mental health providers
      (n=6) who frequently care for Latina youth. Qualitative content analysis will be used to
      analyze the transcripts to determine common themes in facilitators and barriers across
      stakeholder groups.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Latina adolescent young women experiencing depression and their parents will be recruited
        from community and integrated primary care settings. Healthcare providers will be recruited
        from an integrated primary care clinic.
      
Keywords: Hispanic Americans, Adolescent
Modulating Effects of Lisinopril on Sildenafil Activity in Pulmonary Arterial Hypertension(PAH)( MELISSA)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Observational

Summary: 
      Patients with pulmonary arterial hypertension(PAH) suffer from chronic shortness of breath,
      and have impaired survival related to progressive right ventricular failure. Abnormal
      vasoreactivity to nitric oxide(NO) plays a role in the pathophysiology of PAH.
      Phosphodiesterase Type 5 Inhibitor (PDE5 inhibitors) sildenafil have been shown to be
      beneficial in PAH, but extent of benefit is variable.
    

Detailed description: 
      The broad aim of this investigation is to determine whether the modulating effect of
      angiotensin converting enzyme inhibition on vascular smooth muscle responsiveness to the
      nitric oxide pathway that we have observed in an animal model of Congestive Heart
      Failure(CHF) can be exploited in humans with PAH. Furthermore, we have identified a group of
      genes TAO kinase I, IL-10, Rho kinase, Raf1, bile acid coenzyme A and Fmr1 that are modulated
      by long-acting angiotensin-converting enzyme inhibitor (ACEI) in our animal model, and
      therefore may also be modulated by ACEI in patients with PAH
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be currently diagnosed with Pulmonary Arterial Hypertension (PAH).
        Lisinopril versus placebo will be added to participants already recieving a stable dose of
        Sildenafil.
      
Keywords: Pulmonary Arterial Hypertension (PAH)
Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol is intended to compare the effects of both a solid (tablet) and liquid oral
      dosage form of LX4211 in subjects with type 2 diabetes mellitus.
    


Intervention name(s): 300 mg LX4211 (150 mg tablets); 300 mg LX4211 (50 mg tablets); 300 mg LX4211 (liquid)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of two 150 mg tablets LX4211; Single oral dose of six 50 mg tablets LX4211; Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Project ALIVE (A Lifestyle Intervention Via Email)
Condition: Inactivity
Study type: Interventional

Summary: 
      The objective of this study is to test the effectiveness of an email-based diet and physical
      activity intervention on increasing physical activity and fruit and vegetable consumption and
      decreasing intake of saturated and trans fats and added sugars.
    


Intervention name(s): ALIVE
Intervention type(s): Behavioral
Intervention description(s): ALIVE email-based behavioral program based on the participants selected intervention - physical activity, fats/sugars or fruits/vegetabls
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Plant Stanol Ester Beverage and Ileostoma Patients
Condition: Ileostoma
Study type: Interventional

Summary: 
      We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and
      LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects
      are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester
      beverage with or without a fatty acid preparation in a random order for one week period after
      a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids,
      sterols and fecal sterols and variables of cholesterol metabolism will be examined
      accordingly.
    


Intervention name(s): Plant stanolester and fatty acid
Intervention type(s): Dietary Supplement
Intervention description(s): Plant stanol ester 2gr/day and fatty acid in a beverage compared to plant stanol ester 2gr /day and placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cholesterol; Plant stanolester; Beverage; Ileostoma; Serum cholesterol level; serum LDL-cholesterol level; Intestinal cholesterol absorption efficiency
Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy
Condition: Periapical Abscess
MeSH terms: Periapical Abscess
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The trial is to test the resolution of pain, swelling and other signs of periapical infection
      and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as
      root canal irrigant in Pulpectomy treatment for children.
    

Detailed description: 
      To compare the effectiveness of neem leaf extract with that of Chlorhexidine gluconate when
      used as an intracanal irrigant in primary molar teeth indicated for pulpectomy treatment.

      P: children with primary necrotic molars indicated for pulpectomy I: Neem leaf extract
      (alcoholic solution). C: 2% chlorhexidine gluconate. O: Pain and swelling resolution. T:Over
      12 months. S: Randomised controlled trial.
    

Intervention name(s): Neem leaf extract; Chlorhexidine gluconate
Intervention type(s): Drug; Drug
Intervention description(s): A natural irrigant solution act as anti-inflammatory and anti bacterial; 2%chlorhexidine gluconate , anti bacterial root canal irrigant solution
Other intervention name(s): Gluconate-Chex 2%
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Image Fusion in the OR
Condition: Laparoscopic Cholecystectomy; Liver Ablation
Study type: Interventional

Summary: 
      The objective of this study is to test the technical feasibility of LapAR visualization
      system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this
      tool.
    

Detailed description: 
      Surgeons use real-time video generated by a laparoscope to visualize the operative field when
      performing laparoscopic procedures. An inability to see beneath organ surfaces is a
      limitation of the current visualization technology. Surgeons additionally use laparoscopic
      ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound
      image with the video of the operative field. This process is difficult, subjective, and
      variable with expertise, and discourages the use of ultrasound.

      We have developed a method to combine live laparoscopic video and laparoscopic ultrasound
      images to present fused multimodality images on a single display, eliminating the need for
      mental image correlation. Specifically, the image fusion method, called laparoscopic
      augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required
      by surgeons. For ablations, we further track the needle and overlay its path on the AR view
      for precise needle placement. This study is designed to test this minimal-risk capability in
      patients referred for relevant laparoscopic procedures.
    

Intervention name(s): LapAR
Intervention type(s): Device
Intervention description(s): LapAR system will map (transform) the live LUS image in the reference frame of the laparoscopic camera, and fuse it with the live laparoscopic video in real time. For thermal ablations that involve a needle, we also track the needle and overlay its path on the AR view.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Laparoscopic Ultrasound
Do Videos That Aim to Optimize Expectations Alter the Effectivess of PMR?
Condition: Experimental Group 1 (Video Personal Expert); Experimental Group 2 (Video Factual Expert); Control Group
Study type: Interventional

Summary: 
      The study's aim is to determine whether a short video aiming to optimize expectations
      regarding the effectiveness of progressive muscle relaxation (PMR) ist able to improve the
      actual effectiveness of PMR in comparison with a neutral (no video) control group.
    


Intervention name(s): Progressive Muscle Relaxation (PMR)
Intervention type(s): Behavioral
Intervention description(s): All groups undergo a PMR session, but they differ regarding the treatment before the PMR session. Two groups watch a video before undergoing PMR, the control group reads a text before undergoing PMR.
Progressive muscle relaxation (PMR) is a technique for learning to monitor and control the state of muscular tension. It was developed by American physician Edmund Jacobson in the early 1920s.
The technique involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Oxygen Therapy on Atelectasis
Condition: Atelectasis; Cesarean Section; Hypotension
MeSH terms: Pulmonary Atelectasis; Hypotension
Study type: Observational [Patient Registry]

Summary: 
      In pregnancy, cephalal shift of the diaphragm caused by the enlarged uterus reduces the
      functional residual capacity and may increase the closure volume and predispose the pregnant
      woman to airway closure, leading to atelectasis. The development of atelectasis due to
      dermatomes retained in spinal anesthesia and intraoperative supine position may increase
      further. Oxygen therapy to be applied may also lead to absorption atelectasis by causing
      hyperoxia. The aim of our study is to evaluate the effect of oxygen support on the lungs in
      cesarean section operations under spinal anesthesia by lung ultrasound score and oxygen
      reserve index.
    


Intervention name(s): lung ultrasound score
Intervention type(s): Diagnostic Test
Intervention description(s): determination of atelectasis by lung ultrasound score
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        parturients who underwent cesarean section under spinal anesthesia
      
Keywords: Atelectasis; lung ultrasound; oxygen reserve index; cesarean section
Effects of Cervical Stabilization Exercise in Violinists With Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to examine the influence of a 6-week cervical stabilization
      exercise program in university violin players with chronic nonspecific neck pain.
    


Intervention name(s): Cervical stabilization exercise
Intervention type(s): Other
Intervention description(s): The participants followed instructional videos and performed the cervical stabilization exercise program at home for 20 minutes/day, 3 days/week, for 6 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical stabilization exercise
Bioequivalence Study of Torrent Pharmaceutical Limited's Isosorbide Mononitrate 120 mg ER Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER
      Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA
      under fed condition. Dosing periods were separated by a washout period of 8 days.

      Study Design:

      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects
    


Intervention name(s): Torrent's Isosorbide Mononitrate 120 mg ER Tablets
Intervention type(s): Drug
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate