bioihbjkbjnl/mcl2 huggingface dataset:
Non-invasive Cardiac Output Monitor in Young Adults
Condition: Fluid Overload; Hypovolemia
MeSH terms: Hypovolemia
Study type: Observational

Summary: 
      The investigators would like to study cardiac output, stroke volume, and fluid responsiveness
      on young adult pediatric patients undergoing anesthesia and surgery with the use of the
      NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable
      trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with
      routine monitoring will provide a better assessment of intra-operative status.
    

Detailed description: 
      This study will involve measurements of cardiac output, stroke volume, and fluid
      responsiveness (change in stroke volume of ≥ 10%) obtained via passive leg raise (PLR) before
      and after anesthesia induction.
    

Intervention name(s): NICOM
Intervention type(s): Device
Intervention description(s): Use of NICOM and PLR to obtain patient fluid status
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18-30 years of age having surgery at Riley or University Hospital
      
Keywords: cardiac monitoring, Cheetah Medical, passive leg raises
A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI)
      in the bodies of healthy adult participants when taken as a combination formulation, and when
      ATV is administered as an oral powder at the same time as COBI administered as an oral
      tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
    


Intervention name(s): Atazanavir/Cobicistat; Reyataz Atazanavir; Cobicistat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days
Other intervention name(s): ATV/COBI; REYATAZ (ATV); COBI
Intervention MeSH terms: Atazanavir Sulfate; Cobicistat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Participants
In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Observational

Summary: 
      Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal
      evaluation that permits non-invasive imaging of corneal structures on the cellular level.
      Precise anatomic characterization of corneal structures, including corneal nerves, can be
      rapidly performed with high resolution.
    

Detailed description: 
      Evaluation of the corneal nerve layer with IVCM provides a method of direct visualization of
      peripheral small fiber nerves and a quantifiable assessment of nerve abnormalities in a low
      risk, non-invasive manner. Therefore, our goal is to develop a non-invasive diagnostic
      protocol as a quantitative tool for the evaluation of DPN. The protocol and the tool we seek
      to develop could ultimately be used in large-scale clinical trials and in clinical practice
      to assess DPN severity and progression.

      We hypothesize that in vivo confocal imaging of the corneal nerve layer is a clinically
      viable method to assess and quantify systemic peripheral nerve health. We emphasize that this
      imaging method can be used in both humans and animal models to provide quantifiable,
      longitudinal data on the same live individual to advance our understanding of the development
      and progression of DPN, and to evaluate treatment effectiveness.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjes\cts with diabetes with none, mild or severe neuropathy
      
Biospecimen description: 
      Skin biopsy from leg
Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women
Condition: Skin Laxity; Skin Fold
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This goal of this clinical trial is to study the efficacy of collagen supplement on skin
      moisture and elasticity in middle-aged women of 30-50 years old.

      Participants will be assigned two products with and without collagen supplement and use for 2
      months, twice a day.

      Researchers will compare the two groups whether there are siginificant improvement of skin
      moisture and elasticity for participants via skin measurement and anaysis system.
    

Detailed description: 
      This is a two arms, randomized, double-blind controlled trial. Study product plus collagen
      supplement and placebo product but without collagen will be randomly assigned to 70 eligible
      participants who will be enrolled at two study sites in Shanghai. Participants need to use
      the assigned product one bottle (25ml) each time, twice a day and visit the study site for
      three times (baseline day, day 30 and day 60) during the 2-month study. For each visit, the
      primary outcomes (skin hydration and skin elasticity) and secondary outcomes (skin barrier,
      lines/wrinkles, and facial glow,etc.) will be measured with professional equiment and imaging
      system and recorded to data management system. At the end of the study, the study data will
      exported and analyzed to validate the assumption that the collagen could improve skin
      moisture content and elasticity in middle-aged women of 30-50 years old.
    

Intervention name(s): WonderLab Collagen Tripeptide Drink; Ordinary Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): the participant in this arm will use the assigned product 25ml one time, twice a day.; the participant in this arm will use the assigned product 25ml one time, twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Collagen; skin hydration; skin elasticity; anti-aging
Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
Condition: Diphtheria; Tetanus; Polio; Pertussis; Haemophilus Influenzae Type B
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The present clinical study will assess the immunogenicity and reactogenicity of the
      subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine
      (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age
      schedule followed by a booster vaccination during the second year of life with the aim to
      cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus,
      pertussis, poliomyelitis and Hib vaccines.

      WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks
      of age) will be also assessed in infants born to HBsAg seronegative mothers.

      To assess the safety of Pentaxim.
    

Detailed description: 
      Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one
      of the two study groups as follows:

      Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and
      the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.

      Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B
      vaccines at 6, 10 and 14 weeks of age.

      All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19
      months of age.
    

Intervention name(s): Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine; Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): PENTAXIM™; PENTAXIM™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pentaxim
Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia
Condition: Schizophrenia
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to exploratively evaluate the efficacy and safety of
      transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience
      persistent auditory verbal hallucinations after adequate antipsychotics therapy for over
      three months.
    


Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): 2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
Other intervention name(s): YDT-201N
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Refractory auditory hallucination; tDCS
Combined Treatment for Patients With Comorbid Substance Use Disorders and Post-traumatic Stress Disorder (PTSD): an Integration of Cognitive-behavioral Treatment (CBT) and Trauma-focused Structured Writing Therapy
Condition: Substance-Related Disorders; Stress Disorders, Post-Traumatic
MeSH terms: Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized controlled trial comparing two treatments for patients with
      comorbid substance use disorder (SUD) and post-traumatic stress disorder (PTSD) conducted
      within two different routine clinical settings for the treatment of SUD, namely (a) a
      day-care and inpatient setting and (b) an outpatient setting. Participants will be randomly
      assigned to either (1) a combination of cognitive-behavioral treatment (CBT) for SUD and
      trauma-focused structured writing therapy, or (2) CBT for SUD alone. Randomization will take
      place separately for each setting. It is expected that the combined treatment is
      significantly more effective in reducing symptoms of SUD as well as PTSD than CBT for SUD
      alone. Outcome measures will be assessed at pre-treatment, post-treatment as well as 3
      months, 6 months and 12 months follow-up.
    


Intervention name(s): CBT for SUD; Structured writing therapy for PTSD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.; Patients progress through three stages, in which instructions for writing and feedback by therapists are successively aimed at achieving trauma processing, cognitive restructuring and social sharing of a traumatic event.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Evaluation Analysis and Kinetics Registry
Condition: Atrial Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      In a cohort of patients electively treated for atrial arrhythmia with IV sotalol (initiation
      or dose escalation), this study will describe patient characteristics, short-term safety and
      efficacy, electrocardiographic monitoring, and PK and PD parameters (in a subset) associated
      with IV dosing approach.
    

Detailed description: 
      Antiarrhythmic drug therapy plays a vital role in the achievement of rhythm control in
      patients with atrial arrhythmias. Class III antiarrhythmic drugs are frequently used in these
      patients. However, these drugs are associated with a nontrivial risk of QT interval
      prolongation and associated risk of life-threatening ventricular arrhythmias. In this
      setting, initiation and dose titration of these drugs is often performed on an inpatient
      basis for the first five oral doses, typically requiring hospitalization for two days or
      longer.

      The availability of sotalol in intravenous (IV) form, recently approved for initiation or
      dose increase among patients with atrial arrhythmias, affords an opportunity to shorten
      hospitalization for these patients. This approach was approved based on translational science
      research that used computer-based simulation modeling to predict sotalol concentrations.
      There remain knowledge gaps regarding the use of IV sotalol in these patients, specifically
      around real-world outcomes, as well as pharmacodynamic and pharmacokinetic profiles in
      patients. The purpose of this registry is to collect data among patients and centers using IV
      sotalol loading for initiation or dose titration in the treatment of atrial arrhythmias, in
      order to fill the above knowledge gaps.
    

Intervention name(s): Sotalol Injection
Intervention type(s): Drug
Intervention description(s): Standard of care IV sotalol infusion for atrial arrhythmias
Intervention MeSH terms: Sotalol
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        This registry study will enroll adult patients 18 years and older electively treated for
        atrial arrhythmia with standard of care IV sotalol (initiation or dose escalation). During
        their elective hospitalization the patient is not planned to receive any other
        intervention. The registry allows retrospective and prospective enrollment. Patients will
        be excluded if they are undergoing treatment for active concomitant ventricular
        arrhythmias, intolerant to class III antiarrhythmic therapy, not meeting standard criteria
        to receive elective IV sotalol, or if key data elements not available (retrospective
        enrolled patients only). Approximately 150 patients will be enrolled and for about 20
        patients PK/PD data will be collected.
      
Keywords: Atrial Arrhythmia; Sotalol
Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)
Condition: Poor Quality Sleep
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind intervention study, with four parallel branches
      depending on the product consumed, to analyze the efficacy of different types of milks on the
      improvement of sleep quality.
    

Detailed description: 
      The duration of the study will be 90 days (12 weeks). Each day they will have to consume the
      product under investigation. The subjects who meet the selection criteria will be randomly
      distributed in each of the study groups (A, B, C or D, depending on the group in which they
      have been randomized). Each day the subjects will have to fill in a diary on sleep quality
      and concomitant medication.

      They will make a total of two visits to the research laboratory and the tests preestablished
      in the protocol will be performed. Subsequently, a statistical analysis will be performed
      with the variables measured in the study to obtain the results.
    

Intervention name(s): Control Product; Experimental Product: 250; Experimental Product: 250 + TRP; Experimental Product: 600
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Lactose-free skimmed milk; Lactose-free skimmed milk enriched with 250 mg aswaghanda; Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan; Lactose-free skimmed milk enriched with 600 mg aswaghanda
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Ashwagandha extract; tryptophan
Safety and Efficacy of Longterm HPN With Two Lipid Emulsions
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 4

Summary: 
      It is the purpose of this trial to provide evidence for safety and efficacy of long term home
      parenteral nutrition with either Lipofundin MCT or Lipoplus in patients with proven
      insufficient enteral resorption.
    

Detailed description: 
      Long term parenteral nutrition is indicated in the home care setting of patients who are
      unable to completely cover their daily caloric requirements by oral/enteral nutrition due to
      e.g. pre existing malnutrition or compromised intestinal absorption.

      An appropriate nutritional supplementation ensuring the provision of patients basic
      requirement of amino acids, glucose, lipids, micronutrients and electrolytes is therefore
      required to stop weight loss, increase quality of life and to reduce unfavorable consequences
      of malnutrition in those patients.

      Major causes for malnutrition and compromised intestinal absorption are malignant processes.
      Tumor cachexia, weight loss due to insufficient nutrition of < 60 -80 % of the calculated
      substrate need for > 14 days, antineoplastic therapy and surgical intervention are
      consequences of the malignant disease and lead to catabolic processes.
    

Intervention name(s): Lipoplus; Lipofundin MCT
Intervention type(s): Drug; Drug
Intervention description(s): i.v. fat emulsion for parenteral nutrition; i.V. fat emulsion for parenteral nutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: HPN; lipid emulsion; long term; insufficient enteral resorption capacity
Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of theophylline in treating patients who
      have in situ, stage I, or stage II chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate in asymptomatic patients with stage 0, I, or II
      B-cell chronic lymphocytic leukemia treated with theophylline. II. Determine the toxicity of
      this treatment in these patients.

      OUTLINE: Patients receive oral theophylline daily. Daily treatment continues for a maximum of
      6 months in the absence of disease progression or unacceptable toxicity. Patients are
      followed every 4 months for 1 year.

      PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study over approximately
      10 months.
    

Intervention name(s): theophylline
Intervention type(s): Drug
Intervention MeSH terms: Theophylline
Primary purpose: Treatment
Keywords: stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; B-cell chronic lymphocytic leukemia
Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
Condition: Sprain; Strain; Acute Soft Tissue Injury
MeSH terms: Wounds and Injuries; Soft Tissue Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting
      of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment
      of acute musculoskeletal pain.
    

Detailed description: 
      The primary objective of this study is to determine the efficacy and safety of ketoprofen 10%
      cream compared to placebo as a three-times-per-day topical application in improving the
      patient assessment of pain when used to treat mild to moderate acute soft tissue injury of
      the upper and lower extremities over a 7-day period.
    

Intervention name(s): Topical Ketoprofen 10% Cream; Topical Placebo Cream
Intervention type(s): Drug; Drug
Intervention description(s): Topical Administration; Topical Administration
Other intervention name(s): Ketotransdel (TDLP-110); Placebo; Vehicle
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sprain; Strain; Pain; Ankle Pain; Shoulder Pain; Elbow Pain; Tennis Elbow; Knee pain; Wrist Pain; Hand Pain; Muscle, Bone and Cartilage Disorders
Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      In 2010 there was published new European recommendations for assessment of adult and elderly
      men and women, who want to start with physical activity and/or participate in endurance
      contests. In this study we want to test if a group of people with positive score on a
      self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have
      more undetected heart diseases than a control group with no reported or detected risk
      factors.
    

Detailed description: 
      Forty senior athletes between 35 to approximately 80 yrs old with a positive score will be
      included in one group, and another forty seniors without positive score in a control group.
      Each of them will be tested with an cardiorespiratory exercise test (CPET) with ECG and
      examined with echocardiography together with an usual medical examination and blood tests
      (cholesterol and HbA1c-glucose). Some with symptoms of arrhythmias will be examined by
      24-hours Holter-monitoring.

      The main purpose of the study is to assess if men and women with a positive score on the
      questionnaire og NORRISK-screening (risk calculator for coronary heart disease) have more
      detectable heart diseases than the control group.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Observational study without any intervention described under intervention type
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Senior men and women < 35 yrs participating in long-enurance competitions. 40 persons in a
        group with positive score and one group without.
      
Keywords: Heart Screening; Master Athletes; Cardiovascular Disease