bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to identify the best dose of V81444 to use in future trials
      in patients with Parkinson's disease. The study will also explore the effects of V81444 on
      brain activity and blood flow with tests of mental ability ("cognitive function tests"). It
      will also check how safe V81444 is and how well it is tolerated after dosing.
    

Detailed description: 
      In this Phase I, single-centre, open-label, adaptive, single-dose study at multiple dose
      levels, the relationship between dose and plasma concentration of orally administered V81444
      to brain A2A RO was investigated in 6 healthy male volunteers. In addition, the effects of
      V81444 on regional brain activity and perfusion during tests of cognitive function, and the
      safety and tolerability of V81444 were assessed. For each subject, the study consisted of a
      screening visit, a baseline visit, a treatment period, and a safety follow-up visit. The dose
      of V81444 and timing of scans performed were defined in the protocol for the first 2 subjects
      only. The dose, nature and timings of assessments for subsequent subjects were determined
      based on review of emerging receptor binding, pharmacokinetic (PK), pharmacodynamic (PD) and
      safety information.

      In each treatment period, subjects were admitted to the unit on the day before dosing (Day
      -1), received a single oral dose of V81444 on Day 1 and, subject to satisfactory medical
      review, were discharged a minimum of 12 h after dosing. Overall, 3 doses of V81444 were
      assessed (250 mg, 50 mg, and 100 mg), with 2 subjects included at each dose level. PD
      assessments were performed at baseline and after each dose of V81444 using PET (with the A2A
      radioligand, to measure brain A2A RO, as well as MRI techniques to investigate the effects of
      V81444 on regional brain activity and perfusion during cognitive function tests. PK
      parameters were assessed by assay of V81444 concentration in plasma. Safety and tolerability
      were assessed by monitoring physical examination findings, adverse events (AEs), vital signs,
      12 lead electrocardiogram (ECG) and clinical laboratory safety tests.
    

Intervention name(s): V81444
Intervention type(s): Drug
Intervention description(s): Single oral dose of V81444
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Phase IV O2 Consumption Study in COPD Patients.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects
      with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after
      administration of Symbicort pMDI 160/4.5 μg.
    

Detailed description: 
      Patients with moderate/severe COPD are known to have static hyperinflation and to develop
      dynamic hyperinflation during exercise. Treatment with inhaled long-acting beta agonists and
      combination of the long-acting beta agonist (LABA), formoterol and the inhaled
      corticosteroid, budesonide has been shown to improve IC and decrease lung hyperinflation. In
      a similar previous pilot single centre study with budesonide/formoterol (Symbicort®) the
      analysis of cardiac outcomes demonstrated a decrease in maximum volume of oxygen (VO2)
      compared to placebo. Findings suggested that the use of Symbicort can decrease the cost of
      breathing and therefore reduce the cardiac demand experienced by COPD patients with
      hyperinflation at rest. The aim of this study is to investigate whether Symbicort therapy can
      decrease resting VO2 by decreasing static lung hyperinflation in subjects with COPD and to
      evaluate changes in cardiac function.
    

Intervention name(s): Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol; Matching Placebo pMDI 160/4.5 μg
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints; Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Respiratory; COPD; O2 Consumption
Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and
      tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4
      weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone
      regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are
      randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time.
      All patients are followed through 144 weeks after initiation of antiviral therapy. The
      primary objective are to compare the proportion of patient who achieve undetectable plasma
      HIV-1RNA<50 copies/ml at week 48. The previous reports demonstrated that the standard doses
      of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis
      patients who receiving rifampicin even though plasma levels are somewhat reduced by
      rifampicin. However, there have been not been a randomized control trial to compare these two
      regimens. Thus, this trial will provide the efficacy data between these two regimens.
    


Intervention name(s): efavirenz; nevirapine
Intervention type(s): Drug; Drug
Intervention description(s): efavirenz 600 mg/day + stavudine + lamivudine; nevirapine 400 mg/day + stavudine +lamivudine
Intervention MeSH terms: Efavirenz; Nevirapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; tuberculosis; efavirenz; nevirapine; rifampicin; co-infected HIV and tuberculosis patients
Cognitive Behavioral Therapy for the Treatment of Depression-Related Insomnia
Condition: Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating
      insomnia symptoms that are secondary to depression. This study will also determine how long
      the benefits of CBT will last and how the recurrence of insomnia is associated with the onset
      of new depressive episodes.
    

Detailed description: 
      Insomnia, characterized by an inability to initiate and maintain sleep, is a defining feature
      of mood disorders such as depression. CBT has been found to be an effective treatment for
      depression-related insomnia. This study will determine the effectiveness of CBT in treating
      insomnia that is secondary to depression. In addition, this study will assess the
      relationship between insomnia and depression, since previous studies have shown that insomnia
      may not only be a symptom of depression but may also indicate the onset of a depressive
      episode.

      Participants will be randomly assigned to receive weekly sessions of either CBT or clinician
      monitoring for 8 weeks. Participants in both groups will meet with a therapist at selected
      visits, but only CBT participants will receive actual therapy. All participants will have 13
      study visits; four will be overnight visits in a sleep lab. On Visit 1, participants will
      complete questionnaires about their sleep quality and symptoms of depression. Participants
      will also undergo a physical exam and will begin a daily sleep diary. Visits 2, 3, 12, and 13
      will be overnight visits in the sleep lab. During these visits, participants will have
      electrodes placed on their bodies and a polysomnograph will be used to monitor their sleep.
      Participants will meet with their therapist on Visits 4 to 11. Participants' sleep diaries,
      depression scales, and sleep scales will be used for assessment. After the intervention part
      of the study is complete, participants will have monthly follow-up visits for up to 2 years.
      During the follow-up visits, participants will complete questionnaires about their sleep
      quality and symptoms of depression.
    

Intervention name(s): Cognitive behavioral therapy (CBT) for insomnia; Clinician monitoring
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Depression; Insomnia
Ovarian Reserve in Patients With Psoriasis
Condition: Psoriasis; Anti Mullerian Hormone; Ovarian Reserve
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive
      years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This
      study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian
      reserve) in women with and without psoriasis.
    

Detailed description: 
      Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive
      years. Almost 75% of patients are diagnosed before the age of 40. There is also increased
      evidence on autoimmune disease and their link to premature ovarian failure.Ovarian reserve is
      important for the reproductive period. The measurements of serum hormones including follicle
      stimulating hormone (FSH),luteinizing hormone (LH),prolactin (PRL), estradiol (E2) and
      anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The
      investigators aim is to measure ovarian reserve parameters in patients newly diagnosed with
      psoriasis and to compare them to healthy controls. Serum FSH,LH,E2,PRL and AMH will be
      measured on the 3rd day of the cycle.The serum hormone levels will be compared between women
      with psoriasis and women without psoriasis
    

Intervention name(s): Hormone panel
Intervention type(s): Other
Intervention description(s): Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH,LH,PRL,E2 and AMH hormone levels.
Intervention MeSH terms: Hormones
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be reproductive age women diagnosed with psoriasis. The control
        population will be aged and BMI matched women without psoriasis.
      
Biospecimen description: 
      Blood samples for the measurement of serum FSH,LH,E2,PRL and AMH
    
Keywords: psoriasis; Anti mullerian hormone; ovarian reserve; antral follicle count
Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma
Condition: Vitamin D Deficiency; Primary Open-angle Glaucoma; High Myopia; Vitamin D Receptor Polymorphisms
MeSH terms: Glaucoma; Myopia; Glaucoma, Open-Angle; Vitamin D Deficiency
Study type: Observational

Summary: 
      Vitamin D deficiency is known to be significantly associated with high myopia. This study
      investigated the vitamin D status in patients with high myopia and primary open-angle
      glaucoma, in order to understand the relationship between high myopia and the development of
      primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia
      patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a,
      25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D
      receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment
      length polymorphism technique.
    


Intervention name(s): Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay
Intervention type(s): Other
Other intervention name(s): Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique
Intervention MeSH terms: Vitamin D; Dihydroxycholecalciferols
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary open-angle glaucoma patients, high myopia patients and age-matched people in the
        Han population
      
Biospecimen description: 
      blood
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
Condition: Growth
Study type: Interventional

Summary: 
      The primary objective of the clinical trial is to compare growth in infants (expressed as
      weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants
      consuming a commercially available EHF.
    


Intervention name(s): Extensively hydrolyzed whey infant formula; Extensively hydrolyzed casein infant formula
Intervention type(s): Other; Other
Intervention description(s): New hydrolyzed infant formula.; Commercially available infant formula.
Other intervention name(s): Baby Formula; Baby Formula
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
The Correlation Between B-type Natriuretic Peptide (BNP) and Global End Diastolic Volume
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be
      correlated with global end diastolic volume (GEDV) as measured by transpulmonary
      thermodilution technique (PiCCO). The rationale is that some animal studies have proven that
      BNP is released from ventricular myocardium in response to physical expansion. Such physical
      expansion can be measured by GEDV. If the hypothesis can be confirmed with our study, the
      serum level BNP can be used to monitor volume status of critically ill patient, instead of
      the invasive monitoring system.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        critically ill patients who required hemodynamic monitoring using PiCCO
      
Keywords: B-type natriuretic peptide; global end diastolic volume
Effect of TRO19622 in the Treatment of Patients With Chemotherapy Induced Peripheral Neuropathy
Condition: Chemotherapy-Induced Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores
      after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia
      scores.
    

Detailed description: 
      Chemotherapy Induced Peripheral Neuropathy represents a frequent and invalidating side effect
      that requires treatment. Current treatment options are multiple, but none have yet
      demonstrated efficacy in double-blind clinical trials .

      This study will provide information useful to determine the potential of TRO19622 to relieve
      both pain and dysesthesia which are the most common symptoms experienced by patients with
      peripheral neuropathy following taxane chemotherapy.

      At the start of the study, patients will be randomized to one of two groups : TRO19622 (330
      mg QD or placebo once a day).

      Each treatment will be administered for 6 weeks. Additionally, patients will have the option
      to continue treatment for another 6 weeks duration.

      Treatment will be administered under double-blind conditions. The product under evaluation
      will be administered to patients receiving the standard of care for CIPN.
    

Intervention name(s): Olesoxime (TRO19622); Placebo Control
Intervention type(s): Drug; Drug
Intervention description(s): 2 capsules of TRO19622 (330 mg) once day with the noon meal; Placebo Control 2 capsules once day with the noon meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chemotherapy Induced Peripheral Neuropathy; TR019622; Trophos
Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA)
      from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude
      decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is
      a surrogate marker for waking reactions (arousal) which eventually will contribute to assess
      sleep disruption and resulting performance deterioration. Arousal and performance
      deterioration and its possible improvement under continuous positive airway pressure (CPAP)
      therapy will be determined in this study.
    

Detailed description: 
      Patients from the sleep laboratory with verified obstructive sleep apnea syndrome (OSAS) will
      be asked to participate in this study.

      A device is used to determine autonomic arousal over night (SOMNOcheck micro). The Somnocheck
      micro records oxygen saturation as well as pulse frequency and breathing, and calculates an
      autonomic arousal index (AAI). Somnocheck measurements will take place in two nights
      (baseline and with CPAP) and parallel to a standard polysomnography (PSG). The PSG provides
      data to analyze the arousal frequency according to ASDA rules, which will then be compared to
      the AAI.

      Performance is determined twice (prior and after CPAP therapy) by the use of a steering
      simulator programme (DASS). Differences in arousal will be correlated with differences in
      performance (deviation from the road, reaction time). The subjects are also asked to fill out
      the Epworth Sleepiness Scale (ESS) twice, prior and after therapy. Aim is to compare
      Somnocheck and PSG measurements and daytime sleepiness with DASS and ESS.
    

Intervention name(s): Somnocheck micro
Intervention type(s): Device
Intervention description(s): Study nights in sleep lab with standard polysomnography plus Somnocheck micro. The Somnocheck micro is a device with pulse oxymetry and nasal cannula, which can be worn like a wristwatch. It records information about sleep disordered breathing, oxygen saturation, and pulse wave.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Arousal detection; Pulse Wave Amplitude; Obstructive Sleep Apnea; Daytime sleepiness; Cardiorespiratory risk
Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
Condition: Cerebrovascular Accident; Stroke, Acute; Cerebral Stroke
MeSH terms: Stroke; Ischemic Stroke; Fabry Disease
Study type: Observational

Summary: 
      More than one million people in Europe suffer from a stroke every day. Normally older people
      have a stroke, but also a significant number of younger people between 18 and 55 years.
      Usually, these can only be explained for a minority by the classical risk factors such as
      diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of
      the younger stroke patients the etiology can be an undiagnosed genetic disease, e.g. Fabry
      disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The
      purpose of this study is to determine in a large number of young stroke patients, how many
      strokes were caused by Fabry disease and what risk factors might be able to predict this
      disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with acute ischemic cerebrovascular event of any ischemic etiology
      
Biospecimen description: 
      Fabry diagnostic will be done centrally: blood samples will be stored for analysis of
      a-galactosidase in blood, Gb3 as well as lyso-Gb3. In all cases direct analysis of the gene
      will be done, especially in females where due to the Lyonisation effect a-galactosidase
      activity might be normal in blood although the patient might suffer from Fabry disease.
    
Keywords: Cerebrovascular Accident; Cerebrovascular Accident, Acute; Fabry Disease; Fabry´s Disease; Anderson-Fabry Disease; CVA (Cerebrovascular Accident); Stroke, Acute; Cerebral Stroke