bioihbjkbjnl/mcl2 huggingface dataset:
Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit.
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often
      intubated and sedated which makes self-evaluation of pain impossible.

      Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be
      measured by quantitative pupillometry.

      Several studies in ICU showed a significant relationship between pupillary diameter variation
      and pain.

      The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of
      pain essentially used in operating room.

      The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients
      in sedated patients under mechanical ventilation during the mobilization plus toilet
      (described in literature as not painful procedure) and tracheal suctioning (described as a
      painful procedure)
    

Detailed description: 
      Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain
      Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator
      (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure,
      respiratory rate) iv) Nociception level index (NOL-index).

      The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and
      tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes
      after the procedures.

      The procedures are:

        -  A mobilization and toilet of the patient: a priori, not a very painful procedure. The
           pain will be evaluated every 5 minutes during the toilet.

        -  Tracheal suctioning: a procedure known to be painful. The painful will be evaluated just
           at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from
           the endotracheal intubation).
    

Intervention name(s): Systemic pain assessment
Intervention type(s): Other
Intervention description(s): Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception Level Index (NOL) index.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pain; intensive care; sedated; ventilated; NOL ICU; pupillometry
Shortened Depression Assessment Study
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      Participants will be asked to fill out an online questionnaire about their demographics
      information and all 42 items from the Depression Anxiety Stress Scale (DASS-42). A series of
      machine learning techniques will be applied to the dataset to develop a shortened assessment
      using the most important demographics and DASS-42 items from the original questionnaire, to
      predict depression levels indicated by DASS-42.
    

Detailed description: 
      Clinical depression affects 5-10% of the world population each year and is a serious mental
      health issue globally. There are many traditional psychological scales that assess levels of
      depression in adults, where their items are often redundant in the information they carry,
      and their scoring is not necessarily linear to the item scores. Thus, machine learning
      techniques can help find the redundancy in the items, as well as the nonlinear relationship
      between the item scores and the final prediction. Using the Depression Anxiety Stress Scale
      42 (DASS-42) as the basis, participants will be asked to fill out an online questionnaire
      about their demographics information (age, gender, country of residence, race, etc.) and all
      42 items of DASS-42 to provide a dataset for this study. Feature selection techniques such as
      MRMR and Gini feature importance were applied to identify the most important features in the
      dataset. Then, using machine learning methods such as Logistic Regression, XGBoost, and
      Ensemble models, models will be fitted on the most important features to develop a shortened
      depression scale (7-9 items consisting of demographics items and DASS items) that accurately
      predicted the levels of depression (as measured by the AUC, ROC and F1 scores.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants from all countries worldwide are eligible
      
Keywords: Depression Moderate; Depression Severe; Survey Methodology
MethaCholine Bronchoprovocation Study (MeCIS)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to evaluate the methacholine challenge test as an accurate
      indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares
      methacholine challenge test results from asthma patients to those from people who do not have
      asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid
      will be compared to results on high dose inhaled corticosteroids. Both males and females with
      stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will
      be between 12 and 69 years of age.
    

Detailed description: 
      The study consists of two phases. The first phase is a cross-sectional, case-control study
      measuring the sensitivity and specificity of methacholine challenge testing for
      differentiating asthmatic participants from non-asthmatic controls. The second phase is a
      cross-over, randomized, double-masked trial designed to evaluate the impact of high dose
      versus low dose inhaled corticosteroids (ICS) on bronchial hyperreactivity (BHR) in
      asthmatics.
    

Intervention name(s): fluticasone
Intervention type(s): Drug
Intervention description(s): Inhaled corticosteroid approved for treatment of asthma
Other intervention name(s): Flovent diskus
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Normal Controls
CHARGE: Controlling Hunger and ReGulating Eating
Condition: Binge-Eating Disorder; Overweight; Obesity
MeSH terms: Overweight; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      The objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a
      novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to
      evaluate the efficacy of both treatments on reduction of binge eating and weight loss among
      120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid
      overweight/obesity (OW/OB).
    

Detailed description: 
      The investigators have developed a new model for the treatment of obesity, called Regulation
      of Cues (ROC), which is based on Schachter's Externality Theory. This study will compare ROC
      with Cognitive Behavior Therapy for individuals with Binge Eating Disorder. The investigators
      will recruit and randomize 120 male and female Veterans with BED and subclinical BED with
      comorbid overweight/obesity, provide 5 months of treatment and follow participants for
      6-months post-treatment. Participants will complete assessments at baseline, mid-treatment
      (week 9), post-treatment (week 20), and 6-month follow-up (week 44). This study will be the
      first to contribute to a body of literature developing treatments for BED and
      overweight/obesity in the Veterans Affairs (VA) and/or military health care systems.
    

Intervention name(s): Regulation of Cues (ROC); Cognitive Behavior Therapy (CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger, satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs.; Participants are taught to identify problems in eating, thinking, and mood patterns that served to trigger binge episodes through self-monitoring and to gradually develop alternative patterns aimed at facilitating healthy, binge-free eating patterns. Participants are taught to eat a healthy variety of foods and reducing the avoidance of "forbidden" foods that are typically consumed during a binge.
Other intervention name(s): ROC; CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Binge Eating; Overeating; Body Mass Index; Weight; Treatment; Intervention; Behavioral Treatment
Urdu Version of Maastricht Upper Extremity Questionnaire Reliability Validity Study.
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Observational

Summary: 
      In this study, the examiners will investigate the reliability and validity of Mastrict Upper
      Extremity scale in Urdu language in Pakistani patients with Carpal tunnel syndrome.
    

Detailed description: 
      The objective of this study is to translate as well as culturally adapt the Mastrict Upper
      Extrimity scale (MUEQ) into Urdu language and to test its reliability and validity in
      patients with Carpal Tunnel Syndrome. This cross-sectional survey will use convenience
      sampling technique to enroll the participants on a pre-defined criteria.

      The outcomes of this study will help in finding the reliability and validity of MUEQ in
      patients with CTS. The reliability of this scale will be examined using internal consistency
      and test-retest methods. The internal consistency will be checked by Cronbach's alpha value.
      The test-retest reliability will be analyzed using an interclass correlation with patients.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani computer user's population with complaint of arm, neck, shoulder (CANS) was
        included in this study.
Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia
Condition: Hypothyroxinemia
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical
      trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first
      month of age is conducted.
    

Detailed description: 
      A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth
      weight less than 1500g are randomized into thyroxine treatment or un-treatment group.
    

Intervention name(s): thyroxine
Intervention type(s): Drug
Intervention description(s): thyroxine at the dose of 5 μg/kg-wt /day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: very low birth weight infant; hypothyroxinemia; outcomes
Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
Condition: Obesity; Diet Modification; Nutrient; Excess
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The present study was designed to evaluate the impact of a nutritionally balanced
      conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in
      Taiwanese obese subjects. Various parameters like anthropometric (body weight, body fat,
      waist circumference), lipid profile (TC, LDL-c and TG), cardiovascular risk factors, glycemic
      and oxidative markers as well as renal and hepatic markers were evaluated.
    

Detailed description: 
      The present study was designed to evaluate the impact of a nutritionally balanced
      conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric
      restriction in Taiwanese obese subjects. Obese subjects (BMI>27; n=50, male 23, female 27)
      were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by
      balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular
      meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men
      and 1200 kcal/day for women.
    

Intervention name(s): Meal replacement diet
Intervention type(s): Dietary Supplement
Intervention description(s): Obese subjects were requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.
Intervention model: Single Group Assignment
Intervention model description: To evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meal replacement; calorie restriction; body weight
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
Condition: Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine whether the new centrally active analgesic and MS
      Continus® are effective in the treatment of painful diabetic polyneuropathy.
    


Intervention name(s): GRT6005; MS Continus®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days; 60 mg, capsule, once daily; liquid formulation and capsule, once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: analgesic; diabetes mellitus; chronic neuropathic pain; painful polyneuropathy caused by diabetes mellitus type I or II
An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the
      pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant
      administration of bardoxolone methyl with digoxin or rosuvastatin.
    

Detailed description: 
      Subjects in Cohort 1 will receive a single dose of digoxin (0.5 mg) on Study Day 1, an
      initial dose of bardoxolone methyl (60 mg) and a single dose of digoxin (0.5 mg) on Study Day
      10, and once daily doses of bardoxolone methyl (20 mg) on Study Days 11 through 14. Subjects
      in Cohort 2 will receive a single dose of rosuvastatin (20 mg) on Study Day 1, an initial
      dose of bardoxolone methyl (60 mg) and a single dose of rosuvastatin (20 mg) on Study Day 10,
      and once daily doses of bardoxolone methyl (20 mg) on Study Days 11 through 14. All doses
      will be given in the morning under fasting conditions. Bardoxolone methyl and the probe
      substrates (digoxin, rosuvastatin) will be dosed at the same time. Confinement will begin on
      Study Day -1 (Study Day before the first dosing day) and end after the collection of the 216
      hour blood samples and scheduled study procedures on Study Day 19.

      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Digoxin; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Oral, Day 1 and Day 10; Oral, Day 1 and Day 10
Intervention MeSH terms: Digoxin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Use of Bioelectrical Stimulation in the Treatment of Post-prostatectomy Erectile Dysfunction
Condition: Erectile Dysfunction Following Radical Prostatectomy
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Erectile dysfunction (ED) affects up to 20% of men and is a growing problem with advancing
      age. There are many causes that contribute to ED, including the concomitant use of
      prescription drugs for health problems, including hypertension, or diseases such as diabetes.
      causes an up-regulation or increased local tissue expression of these proteins. This study
      follows the demonstration of the effectiveness of using BES in the treatment of ED. The aim
      of this study will be to examine the potentially additive effect of adding a third arm to the
      previous protocol to include the addition of 4 new target proteins to VEGF, including
      endothelial nitric oxide (eNOS), stromal-derived factor 1 (SDF-1), insulin-like growth factor
      (IGF) and follistatin.
    

Detailed description: 
      For this randomized clinical trial, 10 patients from a private Urology clinic will be
      selected. Each patient will serve as their own two-month documentation control using the
      validated IIEF-5 and EHS questionnaires. The intervention period will last 8 weeks. And 6
      months of follow-up after the end of treatment to see how long the benefit lasts without
      continued treatment. The assessment will be carried out before the intervention period
      (pre-intervention) and after the intervention period (post-intervention and follow-up) for
      all participants. All patients who, after medical consultation, are diagnosed with erectile
      dysfunction and who meet the inclusion criteria will be included in the study.

      Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument
      will be completed by a blind researcher and the technique will be applied by a
      physiotherapist trained in the area.

      Erectile dysfunction (ED) was defined as the inability to achieve and/or maintain sufficient
      penile erection for satisfactory sexual performance 11 for at least 6 months, accompanied by
      an IIEF5 questionnaire score of less than 22 points.

      The patients were in the supine position, in a lithotomy position. They will undergo
      trichotomy at the site of placement of the self-adhesive surface electrodes. Each patient
      will have their own pair of electrodes that will be used until the end of therapy, and they
      will be discarded after the end of the sessions. The intervention will consist of the
      application of low intensity transcutaneous penile electrical stimulation for 45 minutes
      using frequency.
    

Intervention name(s): IG1
Intervention type(s): Device
Intervention description(s): application of low intensity transcutaneous penile electrical stimulation for 45 minutes using frequency.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk
Condition: Maternal Obesity Syndrome
MeSH terms: Obesity, Maternal
Study type: Interventional

Summary: 
      Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies
      suggest that childbearing is an important contributor to the development of obesity in many
      women and that breastfeeding may be protective.

      Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy
      homeostasis and are biological neuroendocrine signals that potentially affect body weight and
      adiposity/
    

Detailed description: 
      Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk.

      This study evaluated whether fasting or postprandial ghrelin or PYY is different between
      lactating and nonlactating postpartum women matched for age, body weight, and adiposity.

      Eligibility Criteria: Healthy females, 18+ years old, non-smokers, no major food allergies,
      first-time mom, currently pregnant or within 1 month of giving birth.
    

Intervention name(s): cross-sectional
Intervention type(s): Other
Intervention description(s): Monitoring two recently discovered appetite hormones called "ghrelin" and "neuropeptide YY (PYY)." This study evaluated whether fasting or postprandial ghrelin or PYY is different btween lactating and nonlactating postpartum women matched for age, body weight, and adiposity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human milk, Ghrelin,PYY and maternal obesity.
Study of Coffee Mannooligosaccharides for Weight Management
Condition: Obesity
Study type: Interventional

Summary: 
      The goal of this study is to establish the role of coffee mannooligosaccharides (MOS),
      provided in a beverage format, on body weight regulation. Overweight and obese men and women
      will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to
      consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will
      provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and
      safe. In the first phase, subjects will be counseled once monthly on a nutrition-related
      topic on an individual basis. They will be asked to maintain their regular eating and
      exercise habits for the duration of the 12 week period. An 8-week washout period will follow
      during which time they will not be required to consume the beverages. The second phase of the
      study will be a weight loss phase. For this phase, subjects will be re-randomized and may
      consume the alternate or the same beverage as the first phase, depending on the outcome of
      randomization. During this phase, they will undergo group counseling on a weekly basis.
      Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of
      approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each
      phase. This study will allow us to determine whether MOS helps maintain body weight and
      prevent weight gain (first phase) and whether it helps to stimulate weight loss (second
      phase). The results will allow us to find ways in which overweight and obese individuals can
      incorporate beverages in their diets that will help promote weight loss.
    


Intervention name(s): Coffee mannooligosaccharide; Coffee mannooligosaccharides
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 beverages daily providing either 4 g of coffee mannooligosaccharide or placebo.; Subjects consume 2 beverages daily providing 4 g of coffee mannooligosaccharides or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Body composition; Weight loss; Weight management; Beverages; Diet