bioihbjkbjnl/mcl2 huggingface dataset:
Sprint Interval Training on the Endurance, Strength and Velocity Capacities of Healthy Sedentary Subjects
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      The present study aims to analyse first, the acute effects generated by a single bout of
      Sprint Interval Training (SIT) and, secondly, the effects of a long-term intervention on
      sedentary participants.
    

Detailed description: 
      The main goal is to determine the optimal dose of high-intensity exercise that enhances the
      best physiological adaptations.

      The cumulative effects of SIT, will be assessed by a series of measures placed throughout the
      time-course (before, after the 1st , the 2nd and the 3rd block of SIT). Those measures
      consist of physiological measurements (VO2max), neuromuscular capacities (force-velocity
      profile) the autonomic nervous system responses (heart rate variability) and blood markers
      (lactate, Creatine phosphoKinase (CK), cytokinases, µRNA). Acute effects will be measured in
      the familiarisation sessions (after short (8 sprints) and long (14 sprints) sets) by
      performing a battery of neuromuscular, perceptual, and autonomic nervous system tests before
      and after the single session of SIT.
    

Intervention name(s): Sprint Interval Training
Intervention type(s): Other
Intervention description(s): The Sprint Interval Training (SIT) training consists of 3 successive blocks of 5 training sessions each. The sessions are 24 to 48 hours apart.
. One block lasts two weeks. After the end of one block, the following block begins the day after.
The Sprint Interval Training lasts 6 weeks.
Each session consists of a series of sprints, the number of which varies from 8 to 14. Thus a session will last from 30 to 45 min approximately
So, the time frame of this study is Baseline, Block 1, Block 2 and Block 3 (Not in day or week or month)
Intervention model: Single Group Assignment
Intervention model description: Sedentary participants
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sprint Interval Training; VO2max; acute fatigue; chronic fatigue; force-velocity profile
Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate efficacy, safety and tolerability of BI 1356 versus placebo
    


Intervention name(s): linagliptin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): active; placebo
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Testing the Effects of an Algorithm for Neuropathic Pain on Patient and System Outcomes
Condition: Pain
MeSH terms: Neuralgia
Study type: Observational

Summary: 
      The overall purpose of this project is to improve nurse skills regarding neuropathic pain
      (NP) assessment, treatment and referral practices through implementation of an evidence-based
      algorithm and to improve selected patient outcomes as a result of algorithm use.
    

Detailed description: 
      Neuropathic pain (NP) is defined as pain that arises from injury, disease or dysfunction of
      the central or peripheral nervous system. For the patient focused phase of the project NP
      treatment will be guided via the Peripheral Neuropathy Treatment Algorithm. Patients will
      receive algorithm-specific treatment for 12 weeks.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cancer patients experiencing NP from a variety of causes
The Sun Protective Effect of Melatonin
Condition: Sunburn
MeSH terms: Sunburn
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the sun protective effect of melatonin, when used as
      a cream applied before sun exposure.

      Sun exposure induces erythema as indication of an inflammatory reaction in the skin. It is
      proven that the amount of free radicals in the skin are increased by UV exposure.
      Furthermore, it is known that melatonin is a potent antioxidant. It is hypothesized that
      melatonin can be protective against the UV induced release of free radicals by acting as a
      radical scavenger and thereby protect against UV-induced cellular damage.
    

Detailed description: 
      This study investigates the sun protective effect of melatonin when used as a creme applied
      before sun exposure.

      The study is a randomized, placebo-controlled, double-blinded study conducted on healthy
      volunteers. The volunteers will have 5 squares of 8 cm*8 cm on their backs, which each will
      be randomized to receive one of following: melatonin cream 0,5%; melatonin cream 2,5%;
      melatonin cream 12,5%; placebo cream (vehicle) and no treatment.

      After randomization and received treatment the volunteers will be exposed to strong midday
      sun (UV-index of approximately 9) for 40 minutes.

      The outcomes parameters (degree of erythema and pain sensation) are measured at baseline and
      1,4,8 and 24 hours post exposure.
    

Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Melatonin; Sunburn; Erythema; Sunlight; Ultraviolet rays
Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis
Condition: Interstitial Cystitis, Bladder Pain Syndrome, Quality of Life
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders
Study type: Observational

Summary: 
      The aim of our study was to evaluate whether there is a higher prevalence of
      anxiety-depressive disorders in women with interstitial cystitis than in women with chronic
      non-neoplastic pain with or without fibromyalgia, to examine possible correlations between
      urological and psychiatric symptoms, analyze how urological symptoms affect psychological
      dimension, and how specific stress or trauma can contribute to the onset of interstitial
      cystitis.
    

Detailed description: 
      The survey included 69 patients, 42 patients had a diagnosis of Bladder Pain
      Syndrome/Interstitial Cystitis while 27 of them had chronic non-neoplastic pain. The
      comparison of the total values of the PHQ-9 between the two groups, 1 versus 2, in relation
      to final score of PHQ-9, the average PHQ-9 score was 10.3 in group 1, therefore a value
      greater than 9, considered as major depression (score between 10 and 14); the average score
      of PHQ-9 was 6.9 in group 2, as in sub-threshold depression (between 5-9). Correlation
      between PHQ-9 and BPI was also evaluated, the relation was significant only in interstitial
      cystitis with regard to the following spheres: daily life, work activity, pleasure of life,
      mood, sleep quality, pain intensity, and urinary symptoms. Based on these data, when PHQ-9
      score increases, and depressive symptoms worsen, there is interference with daily life and
      work activity, pleasure of living, mood, quality of sleep, perception of intensity of pain
      and urinary symptoms. Patients who had onset of psychiatric symptoms following diagnosis
      (both interstitial cystitis and other painful syndromes) had an average PHQ-9 score of 11.7
      compared to the score of 8.3 of patients without onset of psychiatric symptoms after
      diagnosis (p = 0.0464), so it may be that depressive symptoms starting after the diagnosis of
      pain syndrome are more severe. Women who undergo psychiatric-psychological consultation and
      therapy have an average O'Leary score 20.4 compared to 25.8 in those who are not under
      psychiatric consultation (p = 0.0418). This emphasizes how psychosocial support can improve
      perception of pain and urinary symptoms.
    

Intervention name(s): chronic non-neoplastic pain
Intervention type(s): Other
Intervention description(s): comparison of questionnaires scores
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group 1: patients with an existing diagnosis of BPS/IC. We confirmed presence of BPS/IC by
        reviewing medical record.

        Group 2: patients with chronic non-neoplastic pain, suffering from fibromyalgia or other
        types of chronic pain (chronic arthralgia or lower back pain).
Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The study aims to determine the effects of upper limb sensorimotor training as compared to
      task oriented raining in subjects with cerebral palsy. The study will target the upperlimb
      functions using multiple outcomes and will find the changes in subjects undergoing
      sensorimotor or task oriented training.
    

Detailed description: 
      The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2
      groups; interventional and control. The interventional group will be recieving sensorimotor
      training comprising of sensory activities and motor activities. The control group will be
      having motor activities in the form of task oriented training. The duration of intervention
      would be 40 minutes in each group, 3 days a week, for 8 weeks.
    

Intervention name(s): Sensory training; Motor training; Conventional exercises
Intervention type(s): Other; Other; Other
Intervention description(s): sensory training includes superficial sensory and deep sensory activities i.e. play with dough, painting with finger, recognizing objects with blocked vision, recognizing the drawn figure on palm, oint compression, bearing the weight on the paretic hand, leaning on the paretic side, walking with hand, rolling the heavy objects, dough squeezing etc.; Motor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc.; stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Tolerability of Oral Proglumide for NASH
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open labelled Phase I/II clinical trial, designed to evaluate the safety and
      efficacy of an oral cholecystokinin (CCK) receptor antagonist, proglumide, at escalating
      doses in subjects with NASH.

      An extended use protocol has been approved for subjects completing this study that show
      benefit or are at risk of Liver disease progression to continue on Proglumide at 1200 mg /
      day for an additional 3-9 months. Subjects in the extended protocol will have telephone
      visits monthly and in the research unit every 3 months for safety lab tests and research
      blood for fibrosis analysis.
    

Detailed description: 
      This is a Phase 1single ascending dose study in 18 patients with ultrasound evidence of fatty
      liver disease AND increased hepatic transaminases. Proglumide will be using the single
      ascending dose study design in a Phase 1 fashion to determine the recommended Phase 2 dose
      (RP2D). Dose levels of proglumide will be: 400mg BID (twice daily); 400 mg TID (three times
      daily); 800 mg BID (twice daily).

      Six patients will be enrolled in each cohort starting with the lowest dose of 400mg po BID
      (Twice daily)for 12 weeks.

      Patients will be monitored for safety and toxicity by laboratory blood testing, physical
      examinations. Blood level for proglumide will be done at before proglumide at screening or
      baseline, week 2 and then week 4 and week 12.

      Safety and toxicity will be monitored using the Common Terminology Criteria for Adverse
      Events v 5 and 'efficacy 'of the treatment will be evaluated by assessment of liver enzymes
      and fibroscan. The Phase 1 study design, we will follow the dose escalation scheme, where the
      dose increases after 6 subjects if a drug limiting toxicity (DLT) does not occur.
    

Intervention name(s): Proglumide
Intervention type(s): Drug
Intervention description(s): oral CCK receptor antagonist
Other intervention name(s): Milid
Intervention MeSH terms: Proglumide
Intervention model: Sequential Assignment
Intervention model description: open labelled sequential Phase I ascending dose study
Masking: None (Open Label)
Primary purpose: Other
Keywords: NASH
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study
Condition: Chagas' Disease
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the effect of food on the absorption of the drug as well as safety and
      tolerability in adults suffering from chronic Chagas' disease In addition pharmacokinetics of
      the drug following 120 and 240 mg single doses will be assessed
    

Detailed description: 
      Primary objective was to evaluate the effect of various food compositions on the PK of
      nifurtimox after a single oral dose (120 mg) administered under 3 types of fed conditions
      (low fat, dairy products, and high calorie and high fat), as well as fasted conditions, to
      assess relative bioavailability. It was chosen to allow a direct inter-study comparison of PK
      data obtained in previous studies.

      A secondary objective of the study was to assess the relative bioavailability of 2 different
      dose levels of nifurtimox, given as a single oral dose, in a second group of patients.The
      second treatment group addressed a biopharmaceutical aspect for which no study data have been
      obtained to date. In order to assess the relationship between dose and exposure (linearity of
      PK), an analysis of the dose range of 120 mg to 240 mg was chosen to close the knowledge gap
      for this dose range.
    

Intervention name(s): Nifurtimox (Lampit, BAYA2502)
Intervention type(s): Drug
Intervention description(s): Oral Intake of 4 x 30 mg nufurtimox tablets for treatment A-D; Oral Intake of 8 x 30 mg nufurtimox tablets for treatment E.
Intervention MeSH terms: Nifurtimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect; Dose proportionality
To Evaluate the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing
      Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 （JAK2）inhibitor and can be used to
      treat JAK2 target-related diseases. This study is a randomized, open-label, single-center,
      two-cycle, two-crossover Phase I clinical trial evaluating the effect of food on the
      pharmacokinetics of TQ05105 tablets in healthy adult subjects. Pharmacokinetic effects and
      safety after oral administration of TQ05105 tablets.
    


Intervention name(s): TQ05105 Tablets
Intervention type(s): Drug
Intervention description(s): TQ05105 tablet is a novel JAK2 inhibitor.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Adolescents With Migraine: What's Stress Got To Do With It?
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Observational

Summary: 
      The overall objective of this proposal is to better define the relationship between perceived
      stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of
      the study: those with migraines (cases) and those without migraines or headaches (controls).
      Each arm will answer several of the same questionnaires and have hair cortisol samples taken
      multiple times over the course of 12 weeks.
    

Detailed description: 
      The overall objective of this proposal is to better define the relationship between perceived
      stress, hair cortisol, and migraine in adolescents. Although adolescents most frequently
      report stress as their migraine trigger, stress measurement and treatment are usually beyond
      the scope of routine clinical care. Hair cortisol levels may identify stressed adolescents
      who need structured stress management, as well as provide objective evidence for the medical
      community, migraineurs (i.e. individuals who experience migraines), and their families, who
      may be reluctant to accept stress as a migraine factor. The rationale for this research is
      that scientific validation of an association between stress and migraine will inform future
      prevention studies in the headache field and potentially identify a stress biomarker for
      migraine.

      This prospective study will enroll 67 adolescents (aged 13-17) with migraine and 33
      adolescents without migraine for 12 weeks with the following aims:

      Aim 1: Measure the relationship between hair cortisol concentration and perceived stress in
      adolescents with and without migraine.

      Hypothesis: The association between hair cortisol and perceived stress (3 month averages)
      will be a positive in both adolescents with and without migraine.

      Aim 2: Measure the relationship between migraine frequency with perceived stress and hair
      cortisol concentration in adolescents with migraine.

      Hypothesis: The association between migraine frequency with (a) perceived stress and (b) hair
      cortisol will be positive in adolescents with migraines.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The population to be sampled is adolescents (13-17 years old) with migraines, both male and
        female. Migraines are common in the pediatric population with a prevalence as high as 10%
        in children 5-14 years old,1 and 28% in adolescents 15-19 years old (Split W, 1999).
      
Biospecimen description: 
      Hair samples for cortisol.
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
Condition: Macular Edema; Diabetic Macular Edema; Neovascular Age-related Macular Degeneration; Retinal Vein Occlusions
MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration; Retinal Vein Occlusion; Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of LKA651 in patients with macular edema from
      diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal
      vein occlusions (RVO)
    


Intervention name(s): LKA651; Sham Comparator
Intervention type(s): Drug; Other
Intervention description(s): Interventional
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Macular Edema; Diabetic Macular Edema (DME); Neovascular age-related Macular Degeneration(AMD); Retinal Vein Occlusions (RVO)
The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
Condition: Overweight; Diabetes Mellitus; Obesity
MeSH terms: Obesity; Diabetes Mellitus; Overweight
Study type: Interventional

Summary: 
      It is well known that steam onion have benefit effects on controlling the blood sugar,
      triacylglycerol (TG) and total cholesterol (TC). In this study, the jeju steam onion examined
      whether it has beneficial effects on reducing body fat of overweight or obesity subjects.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial was conducted to verify the
      effects of jeju steam onion. Fifty-six healthy male and female subjects aged 20-65 years with
      normal body weight [25.0 kg/㎡ ≤ body mass index (BMI) < 30.0 kg/㎡] were recruited. The basic
      framework of the present study was based on a previous study. A 12-week (at each visit;
      screening, 6-week, 12-week), placebo-controlled, randomized study was conducted with
      overweight subjects (25.0 kg/㎡ ≤ BMI < 30 kg/㎡). Subjects participants were divided into two
      group: either Jeju steaming onion or matching placebo (the baked barley powder).
      Randomization was achieved by computer generated block randomization (placebo : test = 1 :
      1).
    

Intervention name(s): baked barley powder; jeju steam onion
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The baked barley was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The baked barley powder capsule had approximately 900 mg/day, 336 mg of baked barley and 564 mg of nondigestible maltodextrin.; The jeju steam onion was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The jeju steam onion capsule had approximately 900 mg/day, 336 mg of jeju steam onion powder and 564 mg of nondigestible maltodextrin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: overweight; body fat; diabetic,; obersity; diabetes mellitus; DM; glycemic
Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS
      following oral administration of single rising doses from 50 mg to 350 mg in healthy male
      subjects of Japanese and Caucasian origin. This was the first administration of this
      substance to subjects of Japanese origin.
    


Intervention name(s): BIBR 1048 MS; Placebo of BIBR 1048 MS
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment