bioihbjkbjnl/mcl2 huggingface dataset:
Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.
Condition: Interstitial Lung Disease; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the clinical features and long-term outcome of
      anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and
      assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated
      ANCA-positive idiopathic interstitial pneumonia.
    

Detailed description: 
      ILD patients with serum ANCA-positivity were enrolled in this study.

        1. Baseline data collection:

             1. Demographics information (age, gender)

             2. Clinical course

             3. Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing
                fingers, mechanics hand)

             4. Laboratory findings (blood and urine routine, liver and renal function tests,
                erythrocyte sedimentation rate, C reactive protein)

             5. Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP),
                Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)

             6. Systemic manifestation if diagnosed as systemic vasculitis

             7. Pulmonary function tests (ventilation and diffusion capacity test)

             8. Chest high-resolution computed tomography (HRCT)

        2. Treatment: treatment will be given according to the experience of each pulmonologist.

        3. Follow-up:

             1. Patients were followed up at least once a year and basic laboratory tests,
                serologic autoantibodies, pulmonary function test and chest HRCT were evaluated
                routinely

             2. Follow-up end point was April 2019.

        4. Outcome
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Interstitial lung disease patients with anti-neutrophil cytoplasmic antibody.
      
Biospecimen description: 
      serum
    
Keywords: Interstitial Lung Disease; Anti-Neutrophil Cytoplasmic Antibody; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Benfotiamine in Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of benfotiamine supplementation in
      patients with diabetic nephropathy, and to determine whether it will slow down the
      progression to end-stage renal disease (ESRD).
    

Detailed description: 
      There is a worldwide increase in prevalence in type 2 diabetes mellitus, which is being
      paralleled by an increasing number of patients reaching dialysis because of diabetic
      nephropathy. Much of the fivefold increase in patients receiving dialysis treatment that
      occurred over the past two decades is attributable to type 2 diabetes and diabetic
      nephropathy. Diabetes is now the leading cause of end-stage renal disease (ESRD), with more
      than 40% of all new cases of ESRD occurring in patients with diabetes.

      Benfotiamine has been shown to reduce diabetic nephropathy and retinopathy in animal
      experimental models. We hypothesize that benfothiamine supplementation in patients with
      diabetic nephropathy will ameliorate the effects of both albuminuria/proteinuria and
      hyperglycaemia on oxidative stress and advanced glycation end-products (AGEs) accumulation in
      renal tissue, and thereby decrease inflammatory responses and fibrotic responses, causing
      slowing down of progression to ESRD as a consequence.

      Intervention:

      The intervention duration is 12 weeks for each group.

        -  Group A: Benfotiamine (300 mg) 3x 1 film coated tablet daily (900 mg daily dose
           benfotiamine)

        -  Group B: Placebo 3x 1 film coated tablet daily
    

Intervention name(s): Benfotiamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.; 3x 1 film coated tablet daily. Duration: 12 weeks.
Other intervention name(s): Milgamma® mono 300, Wörwag Pharma GmbH & Co. KG; A11DA05; Placebo, Wörwag Pharma GmbH & Co. KG
Intervention MeSH terms: Benphothiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Benfotiamine; Diabetes; Nephropathy
Sleep Apnea : Diagnosis and Monitoring
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational [Patient Registry]

Summary: 
      This prospective study aims to evaluate a new medical screening method to detect and
      discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to
      propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea
      syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography
      (PSG), the gold standard reference method of sleep apnea diagnosis.
    

Detailed description: 
      The objective of this study is to dertermine the performance of the ApneaBand, a new
      non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.

      40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep
      stages and the occurency of apnea-hypopnea sleep events through four sensors including
      oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and
      tri-axial accelerometer (movements).

      Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography
      and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will
      be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second
      night.
    

Intervention name(s): ApneaBand
Intervention type(s): Device
Intervention description(s): Mesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Patients with OSA and not treated for that

          -  Non apneic subjects or unknown apneic subjects wishing to explore their sleep

          -  Different skin tones from Fitzpatrick's phototypes I to VI.
      
Keywords: Sleep apnea diagnosis; Sleep apnea monitoring
A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers
Condition: Torsades de Pointes
MeSH terms: Torsades de Pointes
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Determine whether VI-0521 has an effect on the electrical activity of the heart in
           healthy subjects.

        -  Find out how much VI-0521 is in the blood and any potential side effects on ECG's of
           healthy subjects after taking the study drugs.
    

Detailed description: 
      This three-arm, parallel group, double-blind, active- and placebo-controlled study comparing
      VI-0521 at a potential therapeutic dose of PHEN/TPM 7.5/46 and PHEN/TPM 22.5/138 , a
      supra-therapeutic dose, with placebo. A single oral dose of 400 mg moxifloxacin is included
      as a positive control in terms of the effect on cardiac repolarization. The three treatment
      regimens are defined as follows:

      Group 1: 56 subjects to receive active study drug (VI-0521) at steady state, PHEN/TPM 7.5/46
      (a potential therapeutic dose), escalating to PHEN/TPM 22.5/138 (a supra-therapeutic dose);

      Group 2: 28 subjects to receive placebo preceded by a single oral dose of moxifloxacin on Day
      2;

      Group 3: 28 subjects to receive placebo followed by a single oral dose of moxifloxacin on Day
      24;

      A total of 112 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be
      randomized.Subjects will check into the clinical research unit (CRU) on Day -1. Day 1 will be
      a baseline electrocardiogram (ECG) profile day (all groups). Active dosing for Group 1 with
      VI-0521 will commence on Day 2. VI-0521 dose will escalate every 2-3 days until steady-state
      is achieved on Day 10 for the therapeutic dose PHEN/TPM 7.5/46. A full ECG assessment day
      will be performed (all groups, blinded); enabling the comparison of VI 0521 PHEN/TPM 7.5/46
      with the placebo (pooled Groups 2 and 3).Subsequently, VI-0521 doses will be escalated until
      subjects in Group 1 reach a dose of 22.5/138, and then continue at this dose level until Day
      22. On Day 22, when the active group has reached a steady state for the supratherapeutic dose
      level, another ECG assessment day will be performed (all groups, blinded); enabling a
      comparison of supratherapeutic VI-0521 with placebo (pooled Groups 2 and 3). Groups 2 and 3
      will receive VI-0521 placebo on Days 2 to 22.
    

Intervention name(s): VI-0521
Intervention type(s): Drug
Intervention description(s): PHEN/TPM 7.5/46 mg (a potential therapeutic dose) PHEN/TPM 22.5/138 mg (a supra-therapeutic dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: TQT, QTc
Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
Condition: Moderate-to-Severe Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and efficacy of a single dose level of
      KB003 in subjects with inadequately controlled asthma.
    


Intervention name(s): Anti-GM-CSF Monoclonal Antibody 400mg; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Anti-GM-CSF Monoclonal Antibody 400mg; Normal Saline
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; GM-CSF; Moderate-to-Severe Asthma
Regulation of Retinal Bloodflow Pressure
Condition: Retinal Bloodflow
Study type: Observational

Summary: 
      Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance
      to changes in perfusion pressure. In the eye, several studies have reported that retinal
      blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale
      studies have shown that reduced ocular perfusion pressure is an important risk factor for the
      prevalence, the incidence and the progression of primary open angle glaucoma. There is also
      evidence that autoregulation is impaired in patients with primary open angle glaucoma.

      To gain more insight into these phenomena in humans is the primary goal of the present study.

      The present study aims to investigate the pressure/flow relationship as a measure for retinal
      blood flow autoregulation during an experimental increase in intraocular pressure by the use
      of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        16 healthy subjects
      
Keywords: Retinal Bloodflow Pressure
Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen
      sodium) in adolescents for the acute treatment of migraine.
    

Detailed description: 
      This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen
      sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.
    

Intervention name(s): Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Intervention type(s): Drug
Intervention description(s): Combination Tablet of Treximet(sumatriptan/naproxen sodium)
Other intervention name(s): Combination Product (sumatriptan succinate / naproxen sodium)
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Long-term Safety; Migraine; Adolescent Migraine Headache; sumatriptan succinate; naproxen sodium
First-in-Human Single Ascending and Multiple Dose of GLPG0555
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)
      and multiple (MD) oral dose of GLPG0555 compared to placebo.

      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple
      oral administration will be evaluated, and, if applicable, the maximum tolerated dose
      determined.
    


Intervention name(s): GLPG0555; placebo; GLPG0555; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single ascending doses, oral solution; single dose, oral solution; multiple dose, oral solution, 7 or 14 days; multiple dose, oral solution, 7 or 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics
Cycled Testosterone Replacement Study
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether testosterone (male hormone) therapy is
      effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing
      in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body
      composition, muscle metabolism, muscle strength, and bone metabolism.
    

Detailed description: 
      Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing
      age regardless of their level of physical activity. A 12-yr longitudinal study in healthy
      sedentary older men showed a correlation between loss of muscle cross-sectional area and
      muscle strength of the thigh, quadriceps, and flexor muscles. Once weakened, older
      individuals are prone to falls that prevent independent living and diminish the quality of
      life. There is a need to develop therapies to counteract losses in skeletal muscle strength
      with aging. Studies show that exercise and testosterone administration increase skeletal
      muscle mass and strength in older men. However, the increase in muscle strength by
      testosterone in older men has not been consistent in all studies. Androgens increase muscle
      mass by either increasing muscle protein synthesis or inhibiting muscle protein breakdown.
      This proposal will investigate the hypothesis that cyclic testosterone administration
      (monthly on/off cycles) will preferentially increase muscle protein synthesis and result in a
      consistent and greater improvement in muscle strength than continuous testosterone
      administration.
    

Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Weekly im injections of 100 mg testosterone enanthate.; Weekly IM injections of sesame oil.
Other intervention name(s): Testosterone Enanthate; Sesame Oil
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Low Normal Testosterone; Male; Aging
Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects
Condition: Sleep; Stress; Mood
Study type: Interventional

Summary: 
      The purpose of this placebo-controlled, double-blind study is to determine the effects of a
      commercially available (i.e. dietary supplement) Hemp Oil Extract product on various markers
      of physical and mental stress resilience, and perceived recovery from normal daily physical &
      mental stress. Secondary purposes are to collect information on perceived appetite, mood,
      feelings of wellbeing, sleep quality, body composition and safety information via standard
      clinical chemistry panels of sera and plasma.
    


Intervention name(s): Hemp arm
Intervention type(s): Dietary Supplement
Intervention description(s): Hemp oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Clinical Evaluation of Ultrasonic Hydration Monitor for Infants
Condition: Diarrhea; Dehydration
MeSH terms: Dehydration; Diarrhea
Study type: Observational

Summary: 
      Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration
      status in newborns and infants by means of ultrasound velocity measurements through muscle
      tissues. Changes of tissue hydration will be followed during first days of life in newborns
      and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical
      dehydration symptoms will be used as controls.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborns from 1 to 7 days Small children from 1 month to 3 years old
      
Keywords: Dehydration; Hydration; Muscle composition; Diarrhea; Pediatrics; Neonatology; Ultrasound
Behavioral and Cognitive Therapies for Auditory Hallucination Management
Condition: Chronic Psychosis
MeSH terms: Hallucinations; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The present study wants to evaluate the efficacy of a short psychoeducational type group
      intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory
      Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.
    


Intervention name(s): Behavioral and Cognitive Therapies
Intervention type(s): Behavioral
Intervention description(s): Group intervention of 6 weekly sessions of one hour and 30 minutes based on the psychoeducational therapeutic principles and CBT type 3 wave "Accept Voices" applied to HAV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral and Cognitive Therapies
Effect of Exercise on Chocolate Addiction
Condition: Acute Exercise and Addictive Behavior
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The study will use stress inducing tasks to determine if there are significant improvements
      in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate
      abusers following rest and a bout of high intensity interval exercise.
    

Detailed description: 
      The purpose of this research study is to investigate whether a single high intensity interval
      exercise (HIIE) bout, following two stress-inducing tasks, reduces addictive behavior to
      chocolate. Volunteers must complete the consent form before being able to participate in two
      days of testing (exercise day and control day) which will be presented in randomized order.
      The two days will be separated by a one to 7 day washout period. Subjects will be required to
      submit a three day chocolate diary then abstain from chocolate on the 4th day. They will also
      be asked to record everything they eat and drink on the day before and the morning of the
      study and list three types of chocolate they crave most. Two stress-inducing tasks will be
      performed on both days followed by completion of either 26 minutes of HIIE or seated resting
      condition followed by the completion of two mood and craving questionnaires. They will
      finally be asked to complete a task that measures the amount of attention they pay to
      chocolate. Statistical analyses will be conducted to determine the effect of either
      exercising or not on addictive behaviors to chocolate.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Exercise will be performed on a stationary bicycle ergometer.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Probiotics and Nutritional Status on Exercise-Induced Symptoms, and Endurance Performance in Ultra-Endurance Athletes
Condition: Ultra-endurance Athletes With Gastrointestinal Symptoms
Study type: Interventional

Summary: 
      Ultra-endurance athletes have been commonly endured extreme conditions during races and
      training sessions, resulting in exercise-associated clinical symptoms, including
      gastrointestinal symptoms, dehydration, and elevated oxidative stress. Although these
      alterations adversely affect sports performance and well-being, there is no certain treatment
      or consensus on alleviating the exercise-associated clinical symptoms in ultra-endurance
      athletes. The objective of this study is to determine the effects of oral rehydration salts
      supplemented with Lactobacillus Rhamnosus GG on exercise-induced gastrointestinal problems,
      dehydration and oxidative stress in ultra-endurance athletes. Additionally, we aimed to
      assess the exercise-induced alterations in oxidative stress determined by applying an acute
      strenuous exercise protocol ((a cycle ergometer (45 min at 65%VO2max) immediately followed by
      a treadmill test (75% VO2max to exhaustion)) before and after the supplementation period.
    


Intervention name(s): Oral Rehydration Salts supplemented with L. Rhamnosus GG; Oral Rehydration Salts only
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides; A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ultra-endurance athletes with at least one gastrointestinal symptoms will be administered oral rehydration salts supplemented with L. Rhamnosus GG or oral rehydration salts only for 4 weeks
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: signs and symptoms, digestive; Probiotics; Oral rehydration therapy; Gastrointestinal Microbiome