bioihbjkbjnl/mcl2 huggingface dataset:
Masked Faces in Parkinson Disease: Mechanism and Treatment
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effectiveness of high intensity respiratory
      muscle strength training in treating blunted facial expression in people with Parkinson
      disease.
    

Detailed description: 
      Facial expressions are complex signals that last only a few minutes and are important for
      communicating intention, motivation, and emotional states. In humans, a variety of
      neurological and psychiatric conditions alter the tendency to use facial signals. One of the
      main symptoms of Parkinson disease (PD) is diminished facial expressivity or "masked facies,"
      which refers to the expressionless appearance of individuals with the disorder.

      Unfortunately, little progress has been made over the years regarding the basis of "masked
      faces" or strategies that might improve facial expressivity among individuals with PD. This
      is unfortunate because the particular symptom can have significant medical and social
      consequences ranging from misdiagnosis of depression to the misattribution of negative
      emotional states and motivation by family members and healthcare providers.

      The goal of this trial is to study the effectiveness of a novel, behavioral treatment
      approach-high intensity respiratory muscle strength training (MST)-for blunting of facial
      expressions in people with PD. The MST device, a mouthpiece that the participant uses to
      inspire against resistance, may improve the strength and mobility of muscles around the mouth
      that are involved in forming facial expressions.

      Study participation includes screening, baseline evaluations, 4 weeks of behavioral
      intervention, immediate post-treatment followup, and a 3-month follow-up. Participants will
      be randomly assigned to take part in high intensity respiratory MST, or a Sham MST.
      Participation in the study will last for approximately 5 months.
    

Intervention name(s): Respiratory muscle strength training
Intervention type(s): Behavioral
Intervention description(s): The Muscle Stength Training (MST)device is a mouthpiece that the participant uses to inspire against controlled resistance; Intervention involves use of this device for breathing exercises over 4 week period, 5 days a week, approximately 20 minutes/day.
Other intervention name(s): Respiratory Training; Inspiratory Training; Expiratory Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; PD; masked faces; diminished facial expressivity; diminished facial expression; high intensity respiratory muscle strength training; MST
Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients
Condition: Severe Sepsis
MeSH terms: Sepsis
Study type: Observational

Summary: 
      This is a mono-centre trial performed at the medical ICU at the Medical University Graz.
      There will be a study visit (V1) and a follow-up assessment (V2). In the study visit (V1)
      arterial blood glucose values will be monitored and subcutaneous sampling of interstitial
      fluid (ISF) with microdialysis for glucose determination and with microperfusion for
      cytokine-measurement will be performed. The study visit will last for 26 hours starting with
      the insertion of two catheters in the abdominal subcutaneous tissue (one microdialysis- and
      one microperfusion catheter). The primary hypothesis of the study is: Interstitial fluid
      glucose concentration profiles correlates to the arterial blood glucose concentration profile
      in patients with severe sepsis in the medical ICU.
    


Intervention name(s): microdialysis; microperfusion
Intervention type(s): Procedure; Procedure
Observational model: Defined Population
Time perspective: Prospective
Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to investigate the safety and tolerability of the partial A1 agonist
      BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single
      dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study
      is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of
      standard therapy for heart failure, particularly ß-blocker treatment.
    


Intervention name(s): Placebo (treatment 1); BAY1067197 (treatment 2)
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of placebo tablets; Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The study evaluates the effects of two commercially available weight loss programs, the TSFL
      and the MEDD programs, each compared to a self-directed control diet, on changes in body
      weight over a 16-week weight loss phase, in apparently healthy overweight and obese men and
      women.
    


Intervention name(s): Take Shape For Life Program; Medifast Direct Program; Self-directed Control
Intervention type(s): Other; Other; Other
Intervention description(s): The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 & 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.; The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 & 2 & 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.; The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development and Feasibility of Psycho-Educational Weight Reduction Program for Young Adults
Condition: Emotional Eating; Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The main aim of the study was to assess the efficacy of psycho-educational weight reduction
      program for reducing emotional eating and obesity
    

Detailed description: 
      All participants who provide written informed consent will go through a screening process to
      evaluate their eligibility for study entrance after being briefed about the study and any
      potential risks. Individuals who met the eligibility requirements will then be randomly
      assigned to the control group and the experimental group.
    

Intervention name(s): Psycho-educational weight reduction program
Intervention type(s): Behavioral
Intervention description(s): This program provides behavioral technique in order to minimize level of emotional eating and level of obesity
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two groups i-e control and experimental. The experimental group was provided with treatment while the control group was only provided with behavioral relaxing techniques.
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Psycho-educational weight reduction program
Integrative Cognitive-Affective Therapy for Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to test a newly developed individual psychotherapy treatment for
      binge eating disorder in adults. This treatment is a type of individual psychotherapy called
      Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their
      behaviors, feelings, thoughts about themselves, and relationships. This new treatment is
      being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help
      (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework
      assignments along with sessions with a therapist. The primary hypothesis of this
      investigation is that ICAT will be associated with greater reductions in binge eating at end
      of treatment and follow-up compared to CBTgsh.
    


Intervention name(s): Integrative Cognitive-Affective Therapy; CBT-Guided Self Help
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships; CBT-Guided Self Help focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Binge Eating Disorder; Binge Eating; Eating Disorders; Obesity; Psychotherapy; Cognitive Behavioral Therapy
Study of Chlorhexidine Gluconate as a Preoperative Antisepsis
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone
      iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver,
      hepatobiliary, small or large bowel, stomach) is effective.
    


Intervention name(s): Povidone-Iodine; Chlorhexidine gluconate
Intervention type(s): Drug; Drug
Intervention description(s): 7.5% povidone iodine soaping 10% povidone iodine painting; 4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
Other intervention name(s): 7.5% POVICLEAN BRUSH (SUNGKWANG PHARM); 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM); 4% HEXICLEN BRUSH (SUNGKWANG PHARM); 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM)
Intervention MeSH terms: Iodine; Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: surgical site infection; chlorhexidine gluconate; povidone iodine
Botswana TDF/FTC Oral HIV Prophylaxis Trial
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral
      medicines) was safe for sexually-active young adults in Botswana without HIV infection and
      whether it reduced their risk of getting an HIV infection.
    

Detailed description: 
      Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without
      HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with
      free male and female condoms, repeated individualized risk-reduction counseling, diagnosis
      and treatment of sexually transmitted diseases, and women will be provided with a choice of
      effective family planning methods. In addition, volunteers were randomized to receive either
      Tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day.
      Volunteers were seen monthly for at least 12 months to monitor for side effects and
      toxicities and to test their HIV status. Persons who become HIV infected during the trial
      received ongoing supportive counseling, CD4 and viral load monitoring, education about HIV
      infection/disease, and access to HIV care including free antiretrovirals when clinically
      indicated. Volunteer safety was monitored by a local ethics committee, Centers for Disease
      Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring
      board
    

Intervention name(s): Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Other intervention name(s): Truvada; Placebo
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV incidence; HIV prevention; Tenofovir; Emtricitabine; Botswana; HIV seronegativity
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to test if dexamethasone, an anti-inflammatory medication
      approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue
      around the blood vessel wall at the time of an angioplasty or atherectomy.
    

Detailed description: 
      This is an investigator-initiated, single-arm, external pilot study to assess the safety and
      feasibility of perivascular administration of dexamethasone following endovascular
      superficial femoral and popliteal artery angioplasty or atherectomy.

      Although dexamethasone is approved by the FDA for injection into blood, skin or joints, it
      has not been approved by the FDA for injection around blood vessels. The investigators want
      to find out if this procedure helps prevent re-narrowing of the blood vessel after
      angioplasty or atherectomy. The dexamethasone will be injected with a Bullfrog®
      Micro-Infusion catheter, which is an FDA-approved device for injecting medications into
      tissues around the blood vessel wall. The Bullfrog® Micro-Infusion catheter is similar to
      other balloon tipped catheters except that it contains a microneedle covered by a fold of
      semi-rigid balloon. Once the balloon is inflated, the microneedle is uncovered and a
      medication can be injected into the tissue around the blood vessel.
    

Intervention name(s): Administration of dexamethasone to SFA/popliteal adventitia
Intervention type(s): Procedure
Intervention description(s): Following a balloon angioplasty or atherectomy of a stenotic TASC II A, B, or C lesion in the superficial femoral or popliteal artery, a Bullfrog Micro-Infusion Catheter will be used to infuse 0.96 mg dexamethasone per cm arterial lesion.
Other intervention name(s): angioplasty; atherectomy; TASC II A, B, C lesion; dexamethasone; superficial femoral artery; popliteal artery
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Arterial Disease; Femoral popliteal lesions
Pediatric Virtual Visits as a Strategy for Access to Care During the COVID-19 Pandemic in a Pediatric Hospital
Condition: Telehealth
MeSH terms: COVID-19
Study type: Observational

Summary: 
      In this study we will describe the factors associated with missed virtual visit appointments
      in an academic children´s hospital during the covid-19 pandemic and we will develop a
      predictive model that serves as the basis for improving the Telehealth Program.
    

Detailed description: 
      Pediatric visits are a fundamental axis of health policies because actions to promote and
      protect health have a maximum effect on children. Due to the COVID-19 pandemic a marked
      decrease in pediatric visits was observed in scheduled and on-call visits. This fact can be
      explained by the restriction on people's circulation necessary to contain COVID-19
      dissemination. In this context, the population that attends the Hospital General de Niños
      Pedro de Elizalde was especially affected, since 91% of the patients attending the
      institution live in another district.

      In order to overcome this barrier in access to care, we decided to implement a Telehealth
      Program that uses virtual visits as a tool for access to care. Little is known about the
      effects that these programs can have on patients with exclusive public health coverage.
      Although virtual visits could be a solution for access to care in an oversaturated system,
      there is the possibility that virtual visits could not be carried out and that a significant
      proportion will be lost, increasing inequity and difficulties in access to health.

      Due to the relevance of the topic and the little information available, we propose in this
      study to estimate the proportion of virtual visits appointments lost. On the other hand,
      considering the possibility of avoiding the loss of virtual visits appointments, we propose
      to describe the factors associated with missed appointments and develop a predictive model
      that serves as the basis for improving the Telehealth Program.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All scheduled virtual visit appointments between August 1 2020 and 31 december 2020 will be
        included. The sample will be randomized to allocate a generation cohort (two-thirds of the
        sample) and a validation cohort (one third of the sample).
      
Keywords: Telehealth; Children; COVID-19; virtual visit; Lost appointments
Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper
      airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the
      only technological advancements shown to increase adherence is heated humidification, now
      considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique
      technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to
      deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to
      conventional humidification in reducing side effects, condensation and titrated pressure as
      well as increasing total sleep time. However, improved humidity delivery has not lead to
      significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.

      A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a
      single blind, randomized, parallel-arm trial to determine whether the the use of heated
      humidification will impact therapy adherence.
    


Intervention name(s): ICON Auto CPAP™ with Thermosmart heated tube; ICON Auto CPAP™ without Thermosmart heated tube
Intervention type(s): Device; Device
Intervention description(s): ICON Auto CPAP™ with heated humidification and the use of a heated tube; ICON Auto CPAP™ without heated humidification or the use of a heated tube.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Humidification; Continuous Positive Airway Pressure; ICON; ThermoSmart
Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain
Condition: Lumbar Sciatic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and
      safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in
      lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).
    


Intervention name(s): Dextralgen; Meloxicam
Intervention type(s): Drug; Drug
Intervention description(s): Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.; Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lumbar sciatic pain; moderate to severe lumbar sciatic pain within the last three days
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to investigate the efficacy and safety of liraglutide in subjects with type 2
      diabetes and moderate renal impairment.

      The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin
      regimen.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.; Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SpO2 System Accuracy Testing With Different Sensors
Condition: Pulse Oximetry
Study type: Interventional

Summary: 
      A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and
      modules.
    

Detailed description: 
      The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2
      monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold
      reference.
    

Intervention name(s): Pulse oximetry
Intervention type(s): Device
Intervention description(s): Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other