bioihbjkbjnl/mcl2 huggingface dataset:
Behavioral and Recovery Support for 30 Day Post-Discharge Care
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study will provide behavioral and mental health support to a select group of
      participants to supplement the hospital-provided discharge and recovery plans, based on
      clinical guidance and dedicated post-hospitalization behavioral protocols, with the goals of
      reducing readmission rates and costs.
    

Detailed description: 
      This study was designed to provide support to a select group of participants by supplementing
      the hospital-provided discharge instructions. Laguna integrated clinical guidance and
      dedicated post-hospitalization Laguna recovery protocols, with the aims of improving health
      outcomes, reducing health costs, and reducing readmission rates within 30 days
      post-discharge.

      Participants in the intervention group received support from Laguna Health via phone, video,
      text, or web chat. Laguna provided contextual support to remove recovery barriers to these
      intervention participants.
    

Intervention name(s): Laguna Coach Intervention Group
Intervention type(s): Behavioral
Intervention description(s): Behavioral and mental support was delivered through personal interactions with Laguna Coaches via phone, video, or web chat. Behavioral and mental support was individualized to best match each patient's needs and strengths. Support was provided to participants through human interactions over approximately 30 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were assigned upon consent randomly to an intervention or control group. The intervention group received support from Laguna Coaches for 30 days, the control group did not receive any support from Laguna coaches.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Readmissions; Cardiovascular; Post-Discharge; Behavioral Health; Readmission Cost; 30 Day Readmission; Heart Failure; Care Management; Barriers to Care; Contextualizing Healthcare
Nudges for Statin Prescribing in Primary Care
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the effect of nudges to clinicians, patients, or
      both to initiate statin prescriptions for patients that meet national guidelines.
    

Detailed description: 
      Cardiovascular disease (CVD) is the leading cause of mortality in the United States. Statins
      have been demonstrated to be an effective tool for reducing the risk of CVD-related events
      and mortality, but statins are often not prescribed for patients that meet evidence-based
      guidelines. In this study, the investigators will evaluate nudges to clinicians, patients, or
      both to initiate statin prescriptions for patients that meet the United States Preventive
      Task Force guidelines, patients with clinical atherosclerotic cardiovascular disease (ASCVD)
      condition, and patients with a history of familial hyperlipidemia. In partnership with the
      health system, this will be conducted as a 4-arm factorial, cluster randomized trial to
      evaluate the effect of the interventions.
    

Intervention name(s): Clinician Nudge; Patient Nudge
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Active choice intervention in the electronic health record and peer comparison messaging on performance; Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The four-arm factorial trial will randomly assign primary care practices to one of the following arms for the intervention:
Control
Clinician nudge using an active choice prompt in the electronic health record at the time of the patient visit and a monthly peer comparison message on statin prescribing performance relative to peer clinicians at Penn Medicine delivered through the electronic health record
Patient nudge using a text message sent 72 hours prior to their primary care clinician appointment that informs them of their eligibility for a statin, the risks and benefits, and asking them to discuss the role of starting a statin with their clinician
Both clinician nudge and patient nudges
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Statin
Chlorhexidine Gluconate Versus Povidone Iodine at Cesarean Delivery: a Randomized Controlled Trial
Condition: Pregnancy; Cesarean Section
Study type: Interventional

Summary: 
      Currently there are no published studies comparing the efficacy of Chloraprep and
      povidone-iodine in decreasing postoperative- wound infection in cesarean sections. However,
      there have been studies involving other types of surgery that have compared the efficacy of
      different types of preoperative cleansing agents in preventing postoperative wound infection.
      These studies have shown that controversy exists over which antiseptic skin preparation is
      the most effective for preventing postoperative surgical wound infections. The standard of
      care at Los Angeles County Hospital for preoperative skin antiseptic in cesarean sections is
      povidone- iodine 10% (betadine), however many other hospitals have made the transition to
      using Chloraprep. In an attempt to improve on the current standard of care, we propose a
      quality improvement prospective randomized study to compare the difference in postoperative
      wound complications with the use of povidone- iodine and Chloraprep as a preoperative
      antiseptic in cesarean sections. We hypothesize that Chloraprep will be better than Betadine
      at reducing the incidence of positive bacterial cultures following cesarean sections.
    


Intervention name(s): Chlorhexidine Gluconate; Povidone Iodine
Intervention type(s): Other; Other
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cesarean delivery; chlorhexidine; iodine; skin disinfectant
Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia
Condition: Hyperammonemia
MeSH terms: Liver Cirrhosis; Hyperammonemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study was to evaluate the safety, tolerability, and pharmacokinetic
      characteristics of TNP-2092 Capsules in liver cirrhosis patients with hyperammonemia; and to
      preliminarily observe the effects of the study drug on blood ammonia and hepatic
      encephalopathy related clinical symptoms and signs, neuropsychological indicators, and
      quality of life in liver cirrhosis patients with hyperammonemia.
    


Intervention name(s): TNP-2092 placebo capsules; TNP-2092 capsules
Intervention type(s): Drug; Drug
Intervention description(s): TNP-2092 placebo capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.; TNP-2092 capsules will be orally administered 30 min after breakfast and dinner for 14 consecutive days, and last dose will be administered 30 min after breakfast on the morning of D15.
Other intervention name(s): rifaquizinone
Intervention MeSH terms: Rifamycins
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Role of GIP and GLP-2 in Postprandial Splanchnic Blood Flow Distribution and Metabolism
Condition: Blood Flow
Study type: Interventional

Summary: 
      This project will describe the mechanisms of action and the relative contributions of GIP and
      GLP-2 to changes in gastrointestinal blood flow induced by oral glucose, exogenous GIP and
      GLP-2 infusions, and endogenous GIP and GLP-2 with the use of two novel receptor antagonists
      GIP(3-30)NH2 and GLP-2(3-33) in healthy individuals.
    

Detailed description: 
      Each participant will attend eight independent randomised experimental days in the
      MRI-scanner with intravenous infusion (hormone/placebo), subcutaneous injection
      (hormon/placebo) and oral ingestion (glucose/water). On experimental day A-C, an intravenous
      infusion of saline, GIP(3-30)NH2, or GLP-2(3-33), respectively, starts at time point -20
      minutes. On experimental day D-F, the same infusions are combined with an oral glucose
      tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0
      minutes. On experimental days G-H, a subcutaneous injection of either GIP or GLP-2 at time
      point 0 minutes is performed (positive control) during saline infusion and oral water
      ingestion.

      MRI measurements are repeatedly performed and blood samples are drawn to be analysed for
      endocrine responses from the intestines, pancreas, and bones.
    

Intervention name(s): GIPR antagonist / study tool; GLP-2R antagonist / study tool; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Selective antagonist of the GIPR, GIP(3-30)NH2; Selective antagonist of the GLP-2R, GLP-2(3-33); Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single blind, placebo controlled, randomized, crossover study
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Gut hormones; GIP; GLP-2; Physiology
Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by
      ileocolonoscopy.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
      treat people who have Crohn's disease. This study will look at mucosal healing in people who
      take vedolizumab.

      The study will enroll approximately 100 patients and will be conducted in 2 Parts. Part A
      will consist of a 26-week treatment period and all participants will receive vedolizumab 300
      mg intravenously (IV) on Day 1 and at Weeks 2, 6, 14 and 22. Part B will consist of a 26-week
      extension treatment period and all participants will receive vedolizumab 300 mg IV at Weeks
      30, 38, and 46.

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study is approximately 70 weeks for Parts A, B and 18-Week Follow-up combined. Participants
      will make multiple visits to the clinic. All participants included in the study will also
      have a 6 month safety follow-up telephone call following his/her last dose of study drug.
    

Intervention name(s): Vedolizumab
Intervention type(s): Drug
Intervention description(s): Vedolizumab intravenous injection
Other intervention name(s): MLN0002
Intervention MeSH terms: Vedolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD
Condition: COPD; Hypercapnic Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      15 COPD patients will be surveyed in this prospective randomized crossover pilot study
      concerning non invasive ventilation. Patients will be treated over 2 nights in randomized
      order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography
      (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by
      evaluating the PSG and pCO2 values over night.

      Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on
      pCO2 values over night.
    


Intervention name(s): BIPAP ST; Airtrap
Intervention type(s): Device; Device
Intervention description(s): non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.; Addional to the individally titrated BiPAP ventilation parameters the function "AirTrap Control" is added.
AirTrap Control helps to prevent dynamic hyperinflation and makes it possible for VENTImotion 2 to automatically regulate to the best frequency and expiration time.
Other intervention name(s): Ventimotion 2; Ventimotion 2, Weinmann
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; NIV; Airtrapping; Ventimotion2
Comparison of Carotid Peak Systolic Velocity Variation With Aortic Peak Systolic Velocity Variation in Pediatric Non-Cardiac Surgery
Condition: Anesthesia, General; Anesthesia, Endotracheal; Mechanical Ventilation; Fluid Responsiveness
MeSH terms: Systolic Murmurs
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether carotid Doppler peak systolic velocity can
      be an easy to measure possible surrogate for echocardiographic measurement of aortic peak
      systolic velocity variation which is an index of fluid responsiveness in mechanically
      ventilated children intra-operatively.
    


Intervention name(s): Measurement of aortic and carotid Doppler peak systolic velocity variation
Intervention type(s): Other
Intervention description(s): Aortic peak systolic velocity variation to be measured by echocardiography from apical five chamber and suprasternal windows alongwith carotid peak systolic velocity variation by Doppler ultrasound simultaneously at intermittent time points intermittently.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients consenting for inclusion
      
Keywords: Fluid Responsiveness; Pediatric surgery; General endotracheal anaesthesia
Correlation OF Hemodynamics in Pulmonary Hypertension With Perfusion Lung Scans
Condition: Pulmonary Arterial Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Observational

Summary: 
      The goal of our study is to correlate data from non-invasive tests such as perfusion lung
      scans with hemodynamic measurements from right heart catherizations.
    

Detailed description: 
      Data collected from PAH patients who have had non-invasive Ventilation/Perfusion testing,
      Echocardiography, Chest CT Scan, Pulmonary Function Testing and the correlation of those
      results to the hemodynamic parameters Right Heart Catherization results and the various
      biomarkers.
    

Intervention name(s): Pulmonary Arterial Hypertension - Lung Perfusion Scans
Intervention type(s): Other
Intervention description(s): Correlation of data from non-invasive tests such as lung perfusion scans with hemodynamic measurements
Other intervention name(s): Pulmonary Arterial Hypertension
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pulmonary Arterial Hypertension
      
Keywords: PAH; V/Q SCAN;RHC;Echo;CT Scans; Angiography;PFTs
Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The objective of this cross over study is to access if continuous glucose monitoring (CGMS)
      with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only
      retrospective analysis of glucose values is able to improve course of glucose with special
      regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired
      hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access
      satisfaction with CGMS during both conditions
    

Detailed description: 
      The objective of this cross over study is to access if continuous glucose monitoring (CGMS)
      with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only
      retrospective analysis of glucose values is able to improve course of glucose with special
      regard to time spent in hypoglycemic glucose ranges. The second objective is to access
      satisfaction with CGMS during both conditions.

      This study is conducted in an inpatient setting with type 1 diabetic patients. Partisans are
      asked to have twice a continuous glucose measurement with the GlucoDay System (Menarini
      Diagnostics). Each measurement period is limited to maximal 48 hours. In one condition the
      have real time access to current glucose values and alerts are given if glucose is dropping
      below 70 mg/dl or exceeding 180 mg/dl. During the other condition the participants are blind
      against their current glucose values and no alerts are given. Glucose course is
      retrospectively analyzed.

      The order of these two conditions is randomized.

      Expected outcome:

      The primary outcome variable is the daily time spent in hypoglycemic range in type 1 diabetic
      patients with and without impaired hypoglycemia awareness or a history of severe
      hypoglycemia. Additionally the patients will also complete questionnaire about satisfaction
      with CGMS, diabetes related distress, treatment satisfaction, depressive and anxiety symptoms
      which belongs to the secondary variables.

      Inclusion criteria:

        -  Type 1 diabetes

        -  Age > 18 years

        -  Informed consent

      Exclusion criteria:

        -  Diagnosis and/or treatment of a current psychiatric disease

        -  Severe late complications
    

Intervention name(s): Real time access to current glucose values during CGMS
Intervention type(s): Device
Intervention description(s): One arm gets real time access to current measured glucose values and hypoglycemic or hyperglycemic alerts are elicited, The second arm get´s a retrospective analysis of glucose values
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; glucose excursion; hypoglycemia awareness; continuous glucose monitoring
Effect of Niaspan on Cholesterol in Men
Condition: HDL Cholesterol
Study type: Observational

Summary: 
      To determine whether 8 weeks of Niaspan treatment increases cholesterol efflux in male
      subjects with low HDL-C cholesterol when compared to no treatment.

      To determine whether 8 weeks of Niaspan treatment increases fecal cholesterol excretion when
      compared to no treatment.

      To determine whether 8 weeks of Niaspan treatment increases the rate of global reverse
      cholesterol transport when compared to no treatment.
    

Detailed description: 
      This will be a single center, open-label, randomized, mechanism of action study consisting of
      8 weeks of active treatment preceded by a screening phase from one to 8 weeks and a baseline
      measurement of parameters of reverse cholesterol transport for 10 days. The population for
      this trial is 15 non-diabetic men aged 18-70 years. Ten subjects will be low HDL-C male
      volunteers who will receive aspirin and Niaspan and five subjects will be low HDL-C male
      volunteers who will receive only aspirin.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study will include a total of 15 subjects, non-diabetic men with low HDL-C, defined as <40
        mg/dL. Subjects will be aged 18 to 70 years and have a BMI between 18.5-40 kg/m2.
      
Biospecimen description: 
      Stool, urine, and blood samples will be taken and analyzed as part of the study.
    
Keywords: HDL; RCT; Cholesterol
Investigating the Physiology of Targeted Theta-burst Neuromodulation
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This research seeks to study the physiological effects of theta-burst transcranial magnetic
      stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.
    


Intervention name(s): theta-burst TMS; sham theta-burst TMS
Intervention type(s): Device; Device
Intervention description(s): This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.; This protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Phase 1 Study Investigating Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if treatment with HTL0009936 will lead to changes in neural activity, measured
      using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and
      working memory, learning and executive functioning.
    


Intervention name(s): HTL0009936; HTL0009936 matching placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence
Condition: Quality of Life; Sexual Dysfunction
Study type: Interventional

Summary: 
      The investigators think that the two techniques of TOT (inside-out and outside-in) procedures
      both statistically improve the sexual functions, psychosocial state and quality of life after
      the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12
      were statistically more increase in inside-out group than the outside-in group.
    


Intervention name(s): transobturator tape
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)