bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
Condition: Fasting
Study type: Interventional

Summary: 
      The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21
      levels in humans.
    


Intervention name(s): oral fructose challenge
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Study for Patients With Hypertension Associated With Dyslipidemia
Condition: Hypertension; Dyslipidemia
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of DWJ1276
    


Intervention name(s): DWJ1276; Olmesartan; Rosuvastatin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Olmesartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Stress Ball Use on Anxiety
Condition: Stress; Anxiety; Hemodialysis Complication
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Stress management in dialysis patients plays a key role in reducing these negativities and in
      maintaining both physical and mental well-being. In dialysis patients, on the other hand, the
      effectiveness of stress ball use on comfort and stress was evaluated, and no study was found
      that evaluated its effect on anxiety.
    

Detailed description: 
      Stress ball is one of the non-pharmacological methods used to distract individuals when they
      consciously focus on a stimulus. With the squeezing of the ball, the nerves in the hands are
      stimulated and stimuli are sent to the limbic region of the brain, and these stimuli provide
      an acupressure effect. At the same time, it is the easiest and cheapest method that allows
      the mind to get away from stress and maintain the mental well-being of the person.
    

Intervention name(s): Stress ball use
Intervention type(s): Other
Intervention description(s): They were asked to use the ball for at least 10 minutes during the dialysis treatment and when they felt stressed or unwell at home/work. Patients with arteriovenous fistula or arteriovenous graft were instructed to use the stress ball with the other hand, where there was no vascular access.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
30-Days Post-Operative Complications in Bariatric Surgery
Condition: Bariatric Surgery
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and
      laparoscopic Roux-en-Y gastric bypass (LRYGB)
    

Detailed description: 
      Obesity is one of the most challenging chronic diseases in the western world as well as in
      Pakistan. Half of the people in this world consider themselves overweight or obese. Obesity
      is one of the most challenging chronic diseases in the western world as well as in Pakistan .
      Half of the people in this world consider themselves overweight or obese. Obesity is
      challenging to control by medical therapy and drug treatment. The most effective way to treat
      obesity is bariatric surgery. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a "gold
      standard" bariatric surgical procedure. Recently there is much attention gained by
      laparoscopic sleeve gastrectomy (LSG). Therefore, we decided to conduct this comparative
      study to compare the early post-op complications of LSG with LRYGB technique in patients
      undergoing bariatric surgery.
    

Intervention name(s): Comparison of two Techniques of bariatric surgery
Intervention type(s): Procedure
Intervention description(s): We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bariatric surgery; Laparoscopic Roux-en-Y gastric bypass; Laparoscopic sleeve gastrectomy
Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
Condition: Pre-eclampsia; Hypertension, Pregnancy-Induced; Pregnancy, High-Risk
MeSH terms: Pre-Eclampsia; Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Introduction:

      Hypertensive disorders during pregnancy are an important issue in global public health. It is
      current the leading cause of maternal mortality in Brazil.

      Objective:

      To assess the effect of physical exercise using stationary bicycle through blood pressure and
      heart rate measurements, incidence of pre-eclampsia and quality of life survey in pregnant
      women with chronic high blood pressure, previous preeclampsia pregnancies or both factors
      associated comparing to a group with no intervention. Verify the type of births, maternal and
      perinatal outcomes in both groups. Methodology: This randomized clinical trial enrolled
      pregnant women presenting chronic hih blood pressure, previous pre-eclampsia experience or
      both. Women from 12 to 20 gestational weeks were selected from the prenatal outpatient clinic
      and randomly allocated to the study or non-interventional group. Women at the study group
      performed physical exercise using stationary bicycle (horizontal bench model) during 20
      minutes, once a week. The heart rate was maintained at 20% above resting heart rate and up to
      140 bpm. Blood pressure and heart rate measurements were evaluated before and after exercise.
      The non-intervention group followed regular prenatal routine with weekly returns for heart
      rate and blood pressure measurements. Both groups fulfilled the quality of life survey (SF-36
      questionnaire) at three times: between 12 and 20 weeks; 28 and 32 weeks and 36 and 41 weeks
      of gestation. After that data of parturition will be analyzed to compare the incidence of
      pre-eclampsia, types of birth, maternal and perinatal outcomes.
    

Detailed description: 
      Significance was assumed as p<.5%.
    

Intervention name(s): Exercise using stationary bicycle
Intervention type(s): Other
Intervention description(s): Before exercise, blood pressure and heart rate are measured in the sitting position.
Exercise is realized using stationary bicycle (horizontal bench mode) once at week, during 20 minutes under physiotherapist supervision.
The heart rate was maintained at 20% above resting heart rate and up to 140 bpm.
After exercise is performed a leg stretching and a low back stretching. The blood pressure and heart rate are measured in the sitting position.
Other intervention name(s): incidence of pre-eclampsia; types of birth; perinatal outcomes; blood pressure; heart rate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnant women; Pre-eclampsia; Exercise; Hypertension, Pregnancy-Induced; Parturition
Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis
      Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of
      trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

      Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce
      postoperative pain scores when compared to conventional postoperative pain control with local
      infiltration of trochar insertion sites.
    

Detailed description: 
      The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis
      Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of
      trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

      Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce
      postoperative pain scores when compared to conventional postoperative pain control with local
      infiltration of trochar insertion sites.
    

Intervention name(s): TAP Block; Local infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia; 20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
Condition: Anxiety Disorders; Major Depression; Stress Disorders; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Common mental illness, such as anxiety disorders and depression, is the main
      cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be
      effective in alleviating target symptoms of these disorders, but its effect on sick leave
      rates has not been sufficiently addressed. The investigators have developed an intervention
      called return to work (RTW), which is based in cognitive behavioral theory, that has a
      primary aim of helping sick-listed patients with common mental illness return to work. This
      new treatment has not been evaluated in a randomized controlled trial.

      Aims: The aim of this study is to investigate the effect of CBT and RTW for common mental
      illness in a randomized controlled trial conducted in primary care. Participants will be
      randomized to diagnosis specific CBT (n=70), RTW (n=70), or a combination of the two
      treatments (n=70). Main outcomes are days of sick leave and clinician severity rating of
      psychiatric symptoms. This study could contribute to new knowledge regarding how to best
      treat patients on sick leave with common mental illness.
    


Intervention name(s): Cognitive behavior therapy; Return to work
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.; Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      High fat diets are associated with impaired endothelial function and increased cardiovascular
      disease risk amongst our population. These negative effects are likely caused by triglyceride
      induced suppression of nitric oxide, which is produced from the endothelium, and/or an
      increase in oxidative stress.

      Interestingly, previous studies have found that some beverages that are high in polyphenols
      and antioxidants may suppress the impairment in endothelial function observed following high
      fat meals/diets. Typically, these studies have investigated the ingestion of red wine, orange
      juice or green tea on outcome measures (typically flow mediated dilatation (FMD) of the
      brachial artery). Despite this previous research, no study has compared the effects of
      different beverages on endothelial outcomes following a high-fat meal within the same
      participants.
    


Intervention name(s): Water; Red Wine; Green Tea; Orange Juice
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 250 ml; 250 ml; 250 ml; 250 ml
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: antioxidants; polyphenols; flow-mediated dilatation
A Mechanistic Evaluation of the Interactions Between Thermoceptive and Pruriceptive Sensory Processing
Condition: Itch; Thermal Stimulation; Histamine; Cowhage; Serotonine
Study type: Interventional

Summary: 
      The purpose of this human experimental study is to evaluate the pattern of itch intensity
      over time in response to strong, short-term heat stimulation in two different models of
      histamine and cowhage-induced itch. Moreover, the purpose is to evaluate the effect of mild
      pre-heating of the skin in human experimental models of histamine, cowhage and serotonin.
      Finally, we want to investigate the effect of short-term intense heat stimulation on
      previously anesthetized skin.
    


Intervention name(s): Lidocaine; Histamine; Cowhage; Heat stimulation; Pre-heating; Serotonin
Intervention type(s): Drug; Other; Other; Other; Other; Other
Intervention description(s): Lidocaine intradermal injection; Skin Prick Test with Histamine; Manually skin insertion of cowhage spicules; Short heat stimulation; Mild skin pre-heating; Serotonin electrophoresis
Intervention MeSH terms: Lidocaine; Serotonin; Histamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the single-dose pharmacokinetics of the
      investigational drug PL 3100 following oral administration to healthy volunteers and to
      compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
    


Intervention name(s): Naproxen; PL 3100
Intervention type(s): Drug; Drug
Intervention description(s): Single orally administered dose of 500 mg naproxen; Single orally administered dose of PL 3100 (500 mg naproxen)
Other intervention name(s): Naproxen-PC
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fluid Balance During Closure of Atrial Septal Defect
Condition: Heart Defects,Congenital; Heart Septal Defects, Atrial
MeSH terms: Heart Septal Defects; Heart Defects, Congenital; Heart Septal Defects, Atrial; Congenital Abnormalities
Study type: Observational

Summary: 
      This project will evaluate fluid balance and oedema formation in children with the same
      congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with
      the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization.
      The investigators will measure interstitial colloid osmotic pressure, distribution of
      proteins and cytokines. The study hypothesis is that "Oedema developed during heart surgery
      is caused by reduced colloid osmotic pressure gradient through the capillary membrane".
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with Atrial Septal Defect scheduled for interventional closure with device or
        surgical repair
      
Biospecimen description: 
      Interstitial fluid Serum
    
Keywords: Heart Septal Defects, Atrial; Oedema formation
Self-Weighing Instruction Feasibility Study
Condition: Weight Loss; Body Weight
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Scant data have been reported on the effects of weight self-monitoring during weight control.
      The purpose of this pilot project was to consider the questions: Is it possible to assign
      participants to engage in daily weight self-monitoring, and are there differential effects on
      mood of daily versus weekly weighing?
    

Detailed description: 
      This study tested the feasibility of assigning participants to daily or weekly weighing,
      monitored adherence to weighing instructions, and tracked additional behavioral and
      psychosocial indicators over a period of six months. It was hypothesized that there would be
      no differences in mood or adherence between daily versus weekly weighing conditions.
      Knowledge about the benefits of frequent self-weighing may shape public health
      recommendations for regular weighing as a weight reduction or obesity prevention strategy.
    

Intervention name(s): weighing frequency instructions and tips
Intervention type(s): Behavioral
Intervention description(s): Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: self monitoring; self weighing; weight tracking; psychosocial outcomes; feasibility
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by
      intravenous infusion (iv) and subcutaneous (sc) injection.
    


Intervention name(s): CDP6038; CDP6038; CDP6038; Placebo; Placebo; Placebo
Intervention type(s): Biological; Biological; Biological; Other; Other; Other
Intervention description(s): 100 mg/mL solution for injection Single infusion over 60 minutes; 100 mg/mL solution for injection Single infusion over 120 minutes; 100 mg/mL solution for injection Single sc injection; 0.9% sodium chloride for injection Single infusion over 60 minutes; 0.9% sodium chloride for injection Single infusion over 120 minutes; 0.9% sodium chloride for injection Single sc injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: CDP6038; single-dose; pharmacokinetics; healthy subjects
Heat Wrap Device Safety With Age and Body Fat
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      This study is designed to compare the safety, as measured by skin findings and adverse
      events, of two different heat devices in elderly, overweight, and elderly and overweight
      subjects.
    

Detailed description: 
      Safety measurements
    

Intervention name(s): thermal therapy; marketed heatwrap
Intervention type(s): Device; Device
Intervention description(s): heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day; heatwrap, topical, one time application, 8 hour duration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: heat; device; safety; performance; heatwrap; elderly; overweight
A Split-Blind Clinical Investigation to Compare the Performance and Safety of Inion GTR™ Biodegradable Membrane System to Resorbable Bilayer Bio-Gide®-Membrane of Geistlich Biomaterials in Enhancing Bone Regeneration After Removal of Wisdom Teeth.
Condition: Bone Regeneration Following Wisdom Teeth Extraction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate by histology and histomorphometry, thirty human
      osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of
      implantation. This study is part of a splitting-blind clinical investigation to compare the
      performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer
      Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of
      wisdom teeth.

      The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson &
      Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an
      INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer
      Bio-Gide®-membrane.

      This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of
      Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation.

      This study was conducted in accordance with the requirements of the FDA (Department of health
      and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of
      April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory
      Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.

        -  Trial with medical device
    


Intervention name(s): guided bone regeneration
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment