bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Inhalation of Low Dose CO2 on Exercise Performance at High Altitude
Condition: High Altitude; Inhalation; Gas; Acute Mountain Sickness
MeSH terms: Respiratory Aspiration; Altitude Sickness
Study type: Interventional

Summary: 
      High altitude (>2400 m) is associated with decreased atmosphere pressure leading to hypoxia
      which in turn impairs exercise capacity and causes acute mountain sickness (AMS). It is noted
      that adding CO2 might be beneficial to improve hypoxia and exercise performance at high
      altitude. However, no device is currently available that can supply a constant low dose of
      CO2 during free movement at high altitude. We have recently invented a portable device which
      is small and light enough for supplement of low dose CO2 during field exercise at high
      altitude.
    

Detailed description: 
      Objective: To determine whether the supplement of low-dose CO2 by the novel device could
      improve exercise performance at high altitude.

      Methods: The lowlanders (<500m) who have no history of travelling to high altitude (>1000m) a
      year before the study will be recruited. And the subjects who are high-altitude residents and
      have not left high altitude over the last twelve months will also be recruited for the study.
      Subjects will be randomly and blindly given either CO2 mixed with air or air alone during
      endurance shuttle walking test (ESWT). Blood gases will be measured before and after
      inhalation of CO2. ESWT time, ventilation per minute (VE), blood oxygen saturation (SPO2),
      and end-tidal CO2 concentration (ETCO2) will be measured during exercise and will be compared
      during inhalation of CO2 and during inhalation of ambient air.
    

Intervention name(s): Exercise under inhalation CO2; Exercise under inhalation ambient air
Intervention type(s): Drug; Other
Intervention description(s): Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2; Participants perform shuttle walk test at high altitude while inhaling ambient air
Other intervention name(s): inhalation of low dose CO2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: High altitude; Exercise performance; CO2 inhalation
Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Condition: Kidney Transplantation, Mannitol
MeSH terms: Delayed Graft Function
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study we want to evaluate the effect of mannitol on postoperative renal biomarkers in
      patient receiving cadaveric renal transplantation. Furthermore we want to evaluate the effect
      of mannitol on perioperative redox status in patients receiving renal transplantation using
      the oxidation-reduction potentials assessed with the RedoxSYS®system.

      We are planning to perform a double-blind randomized controlled trial. In the study, mannitol
      20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9%
      in the dose of 5 ml / kg / BW. Patients will be randomized to receive either the mannitol or
      NaCl. The follow-up of the study is 24 hours. The following biomarkers will be determined
      befor induction of anesthesia and 24 hours after administration of study medication: CCL2,
      CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and
      IL 18.

      Furthermore we want to perform sORP and cORP before induction of anesthesia, just before
      bolus of mannitol, 5 min after bolus of mannitol and after operation in anesthetic recovery
      room.

      Data will be collected, compared and published at the end of the study. It is planned to
      include a total of 34 patients in the study.
    


Intervention name(s): Mannitol
Intervention type(s): Drug
Intervention description(s): In the study, mannitol 20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9% in the dose of 5 ml / kg / BW. The study medication will be administered immediately before organ reperfusion. The follow-up of the study is 24 hours.
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate long-term safety of growth hormone replacement in adult patients with growth
      hormone deficiency
    


Intervention name(s): Somatropin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Family-Based Weight Loss Intervention for Youth With Intellectual Disability
Condition: Obesity
MeSH terms: Intellectual Disability; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial is twofold. First, to examine the efficacy of
      a 24-session, 6-month family-based behavioral intervention (FBBI) - as compared to a waitlist
      FBBI group, which later receives the same FBBI - that targets weight loss in
      adolescents/young adults with intellectual disability aged 14-22 years. Second, to examine
      the efficacy of a 12-session, 6-month Maintenance intervention that targets maintenance of
      weight loss in the same population of adolescents/young adults with intellectual disability.
      The Maintenance condition follows the completion of each FBBI group and involves a
      re-randomization to either the Maintenance intervention or no further intervention. Primary
      outcome measures include body weight and Body Mass Index (BMI). Secondary outcome measures
      include physical activity/sedentary behavior (measured via accelerometry), dietary patterns
      (3-Day Food Records), and self-efficacy (brief questionnaire). Hypotheses are that: (1)
      participants in the FBBI condition will lose more weight (and reduced BMI) than participants
      in the waitlist treatment condition, and that (2) participants in the Maintenance condition
      will maintain weight lost (and reductions in BMI) or experience less weight regain, as
      compared with participants who receive no further intervention following FBBI.
    


Intervention name(s): Family Based Behavioral Intervention; Maintenance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family Based Behavioral Intervention (FBBI) is a 24-session lifestyle intervention designed to: (1) educate adolescent/young adult participants and their parents in principles of good nutrition and physical activity, and (2) train parents to implement lifestyle changes at home to facilitate weight loss in their child by monitoring diet and physical activity behaviors, setting goals, providing support and reinforcement, and assessing and making changes to the home environment.; The Maintenance condition in this study is a 12-session intervention designed to extend FBBI and continue to teach adolescent/young adult participants and their parents to continue practicing lifestyle behaviors, generalize healthful behaviors to new environments, find additional social and community supports, and prevent and manage relapse.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss, nutrition, physical activity, lifestyle, intellectual disability, adolescence, families
A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of SCULPTRA Measured by Three Dimensional Digital Surface Imaging
Condition: Mid Facial Contour Deficiencies
Study type: Observational

Summary: 
      -  Measure the mid-facial volumetric correction from SCULPTRA treatment, using
           three-dimensional digital surface imaging

        -  Determine the mean change from baseline in facial contour deficiency as measured by the
           Dermik Nasolabial Photo-numeric Scale

        -  Correlate volumetric correction with clinical improvement as measured by the Dermik
           Nasolabial Photo-numeric Scale

        -  Correlate the mean volumetric change in mid-facial treatment area with the amount of
           product used

        -  Evaluate subject and investigator global assessment of improvement and subject treatment
           satisfaction at the end of treatment

        -  Obtain photographs pre- and post-treatment for the purpose of providing a subject visual
           aid during the course of treatment

        -  Collect safety data
    


Intervention name(s): DL6049 (injectable poly-L-lactic acid)
Intervention type(s): Device
Intervention description(s): Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
Other intervention name(s): Sculptra
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with signs of facial contour deficiencies in the area of the nasolabial folds
        [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial
        Photo-numeric Scale.
Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
Condition: Chronic Kidney Disease; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
Study type: Interventional

Summary: 
      Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have
      demonstrated that integrated pre-dialysis care may slow the decline in renal function
      (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early
      intervention especially in high risk groups like Diabetic may also improve outcome of these
      patients in primary health care setting resulting in delay of CKD progression.
    

Detailed description: 
      We conducted a 12-month longitudinal study at district A (control) and B (intervention) at
      Kamphaeng Phet Province, Thailand. Diabetic patients with eGFR ≥ 60 ml/min/1.73m2 were
      recruited from both districts. Patients in district A (control group) received standard CKD
      care according to NKF-K/DOQI guidelines1 whereas those in district B (intervention) received,
      in addition to the standard care, educational activities provided by nutritionist, pharmacist
      and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse,
      health care officers and village health volunteers. During each hospital visit of both groups
      clinical data were assessed. All laboratory parameters were collected every 3 months, and LDL
      and HbA1C every 6 months. The primary end point was rate of eGFR decline. Secondary outcomes
      were random urine albumin to creatinine ratio (ACR), blood pressure, waist circumference,
      HbA1C and LDL .
    

Intervention name(s): Community-based Integrated CKD Care
Intervention type(s): Behavioral
Intervention description(s): Patients received, in addition to the standard care, educational activities provided by nutritionist, pharmacist and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse, health care officers and village health volunteers
Other intervention name(s): Multidisciplnary clinic + home visit team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chronic Kidney Disease; Diabetic Nephropathy; Integrated Chronic Kidney Disease Care
Fluoride Varnish for Treatment of White Spot Lesions
Condition: White Spot Lesions
MeSH terms: Exanthema
Study type: Interventional

Summary: 
      Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that
      can occur around the edge of fixed orthodontic brackets.
    

Detailed description: 
      To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in
      reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.
    

Intervention name(s): Vanish Varnish; Pediagel
Intervention type(s): Device; Device
Intervention description(s): 5% sodium fluoride varnish with tricalcium phosphate; 1.23% Acidulated Phosphate Fluoride Gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: white spot lesions; fixed orthodontic brackets; fluoride varnish; fluoride gel
18432-Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. Formulation number SR15-40-Z12-006.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and
      Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.
    

Detailed description: 
      The primary objective is to investigate the safety, tolerability, and pharmacokinetics of
      multiple doses of GCC-4401C in healthy male subjects.

      Forty-six subjects are planned for enrollment. The study consists of five cohorts (10 mg, 20
      mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort. In the 20 mg cohort, six
      additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in
      open-label fashion. Within each of the five cohorts, six subjects will be randomized to
      GCC-4401C and two subjects will be randomized to placebo.

      The secondary objectives of this study are

        -  To characterize the single dose safety, tolerability, and PK after oral administration
           of GCC-4401C in healthy male subjects.

        -  To characterize the multiple dose pharmacodynamics after oral administration of
           GCC-4401C in healthy male subjects.

        -  To determine an appropriate dose range and dosing regimen of oral GCC-4401C for
           subsequent clinical trials.

        -  To compare the PK and PD of GCC-4401C with an active rivaroxaban (Xarelto®)group at 20
           mg in healthy male subjects.
    

Intervention name(s): GCC-4401C; Rivaroxaban; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease.
The dose selection for this clinical study was based on the safety, Pharmacokinetics and Pharmacodynamics results of the single dose study.
GCC-4401C was well tolerated in the single ascending dose study up to the highest single oral dose administered of 80 mg from 2.5 mg in 48 subjects.
The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort.
In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion.; Rivaroxaban (Xarelto®) 20 mg tablets for oral administration IMP, placebo and comparator will be administered the same time points. The comparator will be administered open-label 30 minutes after a standard breakfast.; GCC-4401C matching placebo(Capsule): Strength is not applicable. GCC-4401C and placebo will be administered double-blind after a 10 hours fast.
Other intervention name(s): Nokxaban; Xarelto; GCC-4401C matching placebo
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Anti-coagulant; Coagulation factor Xa inhibitor
A First-in-Human Study of Single and Multiple Doses of anle138b in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and blood levels of orally
      administered anle138b in healthy subjects.
    

Detailed description: 
      This is a single-centre, study of double-blind, randomised, placebo-controlled single
      ascending doses (SAD) and multiple ascending doses (MAD) of anle138b in healthy subjects in
      study Parts 1 and 2. In study Part 3 the effect of food (FES) on the safety and PK of
      anle138b in healthy subjects is examined.

      In the SAD cohorts, subjects will be randomly assigned to receive a single oral dose of
      active investigational medicinal product (IMP) or matching placebo in a sequential escalating
      manner with sufficient time planned between dose groups to allow interim review of the data.

      In the MAD cohorts, subjects will be randomly assigned to receive oral doses of active IMP or
      matching placebo once daily (QD) for 7 days, in a sequential escalating manner with
      sufficient time planned between dose groups to allow interim review of the data.

      In the FES, the effect of food on the safety and PK of anle138b is explored by administering
      a single dose of IMP after a high-fat breakfast. Subjects will be randomly assigned to one of
      2 treatment sequence to receive anle138b in the fed or fasted state over 2 periods.
    

Intervention name(s): anle138b; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule containing excipient and anle138b; matching placebo capsule containing excipient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anle138b; alpha-Synuclein; Oligomer modulator; Parkinson Disease; Multiple System Atrophy; Neurodegenerative diseases; Alzheimer Disease; Tauopathies; Amyloid
A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to see if St. John's wort helps people with irritable bowel
      syndrome, otherwise known as "IBS". St. John's wort is a herbal supplement derived from the
      St. John's wort plant. It has been shown to be helpful in several medical conditions such as
      depression as well as other pain syndromes.
    

Detailed description: 
      Eligibility criteria:

        1. Established diagnosis of IBS

        2. 18-70 years of age

      4) U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6)
      Able to participate in all aspects of the study

      You will be asked to do the following:

        -  Undergo a screening interview and physical examination

        -  Take a urine pregnancy test (if applicable)

        -  Take a study pill twice daily for 12 weeks(3 months)

        -  Complete daily symptom diaries and bi-weekly questionnaires for 12 weeks.

        -  Complete a questionnaire at 6 months after the active phase of the study is over.
    

Intervention name(s): St. John's wort; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day; Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Other intervention name(s): Latin name: Hypericum perforatum L.; Common name: St. John's Wort
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Efficacy and Safety of Thunderbeat in Thyroid Surgery
Condition: Thyroid
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat
      device to that with the harmonic scalpel.
    

Detailed description: 
      Thunderbeat instrument combines an advanced bipolar clamp to the existing ultrasonic cutter.
      In the animal study with pig, the result of Thunderbeat shows fast abalation rate and same
      thermal conductivity. There has been reported a significant reduction in operative time and
      same complications with Thunderbeat in gynecology patient who underwent laparoscopic
      hysterectomy with lymph node dissection. Comparison of the utilization of this new device,
      however, with the Harmonic scalpel in thyroidectomy has not been performed in any study. The
      objective of this study is to compare the results of thyroidectomy using the Thunderbeat to
      that with the Harmonic scalpel device in respect to hemostasis, operative time and
      perioperative complications. All patients undergoing a thyroidectomy in our endocrine surgery
      department are randomized into those operated with Thunderbeat (Group A) and those with
      Harmonic scalpel (Group B).
    

Intervention name(s): Thunderbeat (Group A); Harmonic (Group B)
Intervention type(s): Device; Device
Intervention description(s): hemostatic device utilized intraoperatively; hemostatic device utilized intraoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thyroidectomy; Thunderbeat
Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single Ascending Dose (SAD; Part A) and Multiple Ascending Dose (MAD; Part B) Phase 1 Study
      of LB-102 N-Methyl amisulpride) in healthy volunteers. The primary objective is to evaluate
      the safety and the tolerability of a single oral dose (SAD) and multiple oral doses (MAD) of
      LB-102 as compared to placebo. The secondary objectives are to evaluate the pharmacokinetics
      (PK) and pharmacodynamics (PD) of LB-102.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate
      the safety, tolerability, and pharmacokinetics of LB-102 in healthy subjects. The study will
      consist of two parts: Part A - Single Ascending Dose and Part B - Multiple Ascending Doses.
      There will be 5 cohorts in Part A and 3 Cohorts in Part B of this study. Each cohort consists
      of 8 subjects, with 6 subjects assigned to LB-102 and 2 subjects assigned to placebo.

      In Parts A and B, eligible subjects will be randomized on Day 1 (pre-dose) to placebo (n=2)
      or LB-102 (n=6). Eligible subjects will receive 1 dose on Day 1 (Part A) or 13 doses on Days
      1-7 (Part B) of placebo or LB-102.
    

Intervention name(s): LB-102
Intervention type(s): Drug
Intervention description(s): (N-Methyl amisulpride)
Other intervention name(s): Active Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment