bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether brain anatomy impacts the efficacy
      of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation.
      TMS is used to stimulate different areas of the brain and it is well tolerated and generally
      a safe procedure. It has been studied by researchers for 20 plus years. This brain
      stimulation device and technique used in this study is an investigational device that has not
      been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device
      brochure can be found at: https://www.magstim.com/product/rapid-family/
    


Intervention name(s): intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle; intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle
Intervention type(s): Device; Device
Intervention description(s): repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head; repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: transcranial magnetic stimulation; non-invasive brain stimulation; magnetic resonance imaging
Yoga and Psychological and Physiological Health
Condition: Stress; Anxiety; Depression; Sleep; Physiological Stress
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's
      effects on health-related psychological and physiological variables. The study also aims to
      investigate whether an association exists between subjective (psychological) and objective
      (physiological) measures, with a particular focus on stress as the primary outcome.
    

Detailed description: 
      Stress and worry in everyday life are common features of Western society. Stress is a
      biological mechanism tapping the fight-or-flight-response via activation of the sympathetic
      nervous system. When exposed to stress during prolonged periods of time, the immune system is
      affected, leading to physiological as well as psychosocial problems. The consequences of
      untreated high stress can not only turn into reduced job capacity, and work roles conflicts,
      but also into cardiovascular disease, and mental illness such as an anxiety disorder or/and
      depression.

      One common and recommended strategy to manage stress is to exercise regularly. Yoga is an
      umbrella term for a wide variety of physical, mental, and spiritual practices with its roots
      in ancient India. Most previous research on the health effects of yoga has demonstrated
      benefits on psychological health factors including mental stress, anxiety, depression and
      sleep problems.

      The aim of the study is thus to investigate the effects of two types of yoga intervention on
      psychological and physiological health.
    

Intervention name(s): Yin yoga; YOMI
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Yin yoga 2 times per week for 5 weeks. Daily breathing assignments.; 30 minutes of psychoeducation combined with mindfulness practice followed by 60 minutes of Yin yoga allowing the psychological theme to be further explored, aided by verbal instructions of the yoga teacher. 2 times per week for 5 weeks.
Daily breathing assignments.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-group RCT with three arms during 5 weeks. Subjects were randomized to a control group, the Yin Yoga intervention group or the YOMI intervention group. YOMI intervention combines Yin yoga with psychoeducation and mindfulness practice.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: yoga; stress; anxiety; depression; sleep quality; physiological stress; biomarkers
Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)
Condition: Neuropathy, Diabetic; Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Observational

Summary: 
      MEDON aims to examine new methods for early detection and grading of diabetic peripheral
      neuropathy focusing on both small- and large nerve fibers. Furthermore, MEDON aims to
      describe differences between people with classic diabetic peripheral neuropathy and those
      with painful diabetic neuropathy.
    


Intervention name(s): Perception Threshold Tracking (PTT); Axon-flair mediated respons; Heart rate variability; Quantitative Sensory Testing (QST); Peripheral blood pressure and transcutaneous oxygen tension; Magnetic Resonance Imaging (MRI); Questionnaires; Corneal Confocal Microscopy /CCM)
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): low-current electrical stimulation of both large- and small nerve fibers.; Laser-doppler examination of small blood vessels in the peripheral skin.; 4 measurements of heart rate.; Seven tests measuring 13 parameters including heat- and cold-detection and pain thresholds, mechanical pain treshold, mechanical detection threshold, pressure pain treshold and vibration threshold.; Ankle/brachial index, toe/brachial index, TcpO2.; MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.; Questionnaires for detecting painful neuropathy; Confocal microscopy of the cornea measuring NBD, NFD, NFL
Other intervention name(s): Laser-doppler; Vagus TM; German Research Network on Neuropathic Pain (DFNS) standard protocol; Perimed 6000; PainDETECT, Douleur Neuropathique 4
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population include four well-defined groups of subjects:

          1. Patients with Type 1 diabetes and painful diabetic peripheral neuropathy (DPN).

          2. Patients with Type 1 diabetes and non-painful diabetic peripheral neuropathy (DPN)

          3. Patients with Type 1 diabetes and without diabetic peripheral neuropathy (VPT<15)
             (DPN).

          4. Healthy control subjects matched for age, BMI, and gender. Diabetes duration, HbA1c,
             insulin use, ethnicity, and co-morbidities will be matched between group 1, 2 and 3 to
             best ability.
      
Keywords: diabetes; neuropathy; early detection; small nerve fibers
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective
      medications that are approved and available for young children who are HIV+. The liquid form
      is reported to have a very nasty taste and presents difficulties for the children who must
      take the medication twice a day and for their parents who must enforce the medication
      regimen. The children are often well into their teens before they weigh enough to be able to
      take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now
      available. However, it is not known if the liquid and tablet act the same in children. The
      purpose of this study is to switch children from the baseline treatment with the liquid to
      the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will
      compare children pre-switch and post-switch in terms of how well their HIV is controlled .
      Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children
      currently well managed with a medications including liquid Kaletra will be invited to switch
      from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a
      satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At
      the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the
      parent and/or child will complete the satisfaction survey. In addition, at the switch and 1
      month post switch, a day will be spent in clinic with 5 blood draws to see how much of the
      drug is in the blood stream at different times after the medicine is taken.
    


Intervention name(s): Low dose Kaletra tablets
Intervention type(s): Drug
Intervention description(s): Lopinavir/Ritonavir tablets 100mg/25mg
Other intervention name(s): lopinavir/ritonavir 100mg/25mg
Intervention MeSH terms: Ritonavir; Lopinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Kaletra; treatment Experienced
Analgesic Effects of Intravenous Paracetamol on Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether intravenous paracetamol is effective in
      treating labor pain.
    


Intervention name(s): Acetaminophen; Meperidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Soluble Phosphate in Humans
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The study was conducted to investigate the effect of soluble phosphate in combination with
      different calcium doses on calcium and phosphorus metabolism and further physiological
      parameters in healthy subjects. The main aim of the study is to investigate the influence of
      a soluble phosphate supplementation on the fasting blood phosphate concentration and the
      dependency of an additional calcium intake.
    


Intervention name(s): P1000/Ca0; P1000/Ca500; P1000/Ca1000; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]; 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]; 22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]; all participants consume two weeks before intervention the beverage without phosphate and calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: soluble phosphate; phosphorus metabolism; calcium metabolism; bone metabolism; human study
A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate one-way interaction of calcium carbonate, omeprazole, or rifampin on
      ACP-196.
    

Detailed description: 
      This is a 3-part study. Each part will be conducted as an open-label, 2-period,
      fixed-sequence study. All the study parts will be conducted concurrently and the participants
      will receive the study treatment in all the parts after an overnight fast. In each part, 24
      healthy, non-tobacco using, men and women will be enrolled, to ensure 22 participants
      complete each part. Each participant will participate in only one study part. In Part 1, a
      single oral dose of ACP-196 100 mg capsule will be administered on Day 1 of Period 1
      (Treatment A), and a single oral dose of calcium carbonate 1 g tablets will be coadministered
      with a single oral dose of ACP-196 100 mg on Day 1 of Period 2 (Treatment B). In Part 2, a
      single oral dose of ACP-196 100 mg capsule will be administered on Day 1 pf Period 1
      (Treatment C) and oral doses of omeprazole 40 mg capsules once daily (QD) for 5 consecutive
      days with a single oral dose of ACP-196 100 mg capsule coadministered on Day 5 of Period 2
      (Treatment D). In Part 3, a single oral dose of ACP-196 will be administered on Day 1 of
      Period 1 (Treatment E) and oral dose of rifampin 600 mg capsule QD for 9 consecutive days
      with a single oral dose of ACP-196 100 mg capsule coadministered on Day 1 and Day 9.
      Participants will be screened within 28 days before the dose. There will be no washout
      between the dose in Period 1 and the first dose in Period 2. Participants will be contacted
      approximately 14 days after the last dose of study drug for adverse events.
    

Intervention name(s): ACP-196; Calcium carbonate; Omeprazole; Rifampin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 in Part 1, Part 2, and Part 3; and on Day 1 of Period 2 in Part 1, Day 5 of Period 2 in Part 2, and Day 1 and Day 9 of Period 2 in Part 3.; Participants will receive a single oral dose of calcium carbonate 1 g tablet on Day 1 of Period 2 in Part 1.; Participants will receive multiple oral doses of omeprazole 40 mg capsules QD for 5 consecutive days in Period 2 of Part 2.; Participants will receive multiple oral doses of rifampin 600 mg capsule QD for 9 consecutive days in Period 2 of Part 3.
Other intervention name(s): Acalabrutinib
Intervention MeSH terms: Rifampin; Acalabrutinib; Omeprazole; Calcium Carbonate; Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acalabrutinib; ACP-196; Healthy participants; Pharmacokinetics; PK; Safety
Bioequivalence Study of Lu AF35700
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical
      formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
    


Intervention name(s): Lu AF35700 5 mg clinical formulation; Lu AF35700 5 mg commercial formulation; Lu AF35700 10 mg clinical formulation; Lu AF35700 10 mg commercial formulation; Lu AF35700 20 mg clinical formulation; Lu AF35700 20 mg commercial formulation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lu AF35700 tablets 5 mg oral single dose; Lu AF35700 tablets 5 mg oral single dose; Lu AF35700 tablets 10 mg oral single dose; Lu AF35700 tablets 10 mg oral single dose; Lu AF35700 tablets 20 mg oral single dose; Lu AF35700 tablets 20 mg oral single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Observational

Summary: 
      Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary
      stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral
      endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is,
      in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary
      status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of
      abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia
      endothelium-dependent brachial artery dilation.
    

Detailed description: 
      Coronary microcirculation, non invasively assessed with trans-thoracic echo-doppler (coronary
      blood flow before and after cold pressure testing), and biochemical markers of endothelial
      dysfunction will also be measured. Correlations between peripheral and coronary endothelial
      functions will be checked. The measurements will be performed and validated in two other
      groups

        -  30 patients with overweight but free of diabetes, matched with the patients with
           diabetes for age, gender and body mass index

        -  30 control subjects.Reproducibility of the methods will be assessed in 10 patients of
           the three groups of subjects.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  type 2 diabetes

          -  overweight free of diabetes

          -  control
      
Biospecimen description: 
      whole blood, serum
    
Keywords: Type 2 diabetes; silent myocardial ischemia; endothelial function
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
Condition: Nasal Continuous Positive Airway Pressure,; Preterm Infants,; Surfactant Treatment,; Respiratory Distress Syndrome,; Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Premature Birth
Study type: Observational

Summary: 
      We hypothesis a period of early NCPAP before surfactant treatment is effective for treating
      RDS and preventing BPD in very premature infants.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        inborn infants at 26-32 weeks gestation with RDS, whom received NCPAP as the initial
        treatment, followed by surfactant treatment within 24 h after birth
Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how well tolerated and safe AZD5069 is at different
      dose levels in healthy male and/or females. The study will also investigate how quickly
      AZD5069 is absorbed into and cleared by the body.
    


Intervention name(s): AZD5069; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of oral solution.; Single dose of oral solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteer; Single ascending dose; Safety; Tolerability; Healthy volunteer study
Brain Control of Bimanual (Both Hands) Movements
Condition: Healthy
Study type: Observational

Summary: 
      This study will use magnetic resonance imaging (MRI) to investigate how the brain controls
      bimanual movements (movements of both hands).

      Healthy normal volunteers between 21 and 65 years of age may be eligible for this study.

      Participants will have a medical history, physical and neurological examinations, and will
      complete a questionnaire before and after testing. The study consists of two parts: 1) finger
      movement training and 2) magnetic resonance imaging, as follows:

      Part 1 - Finger movement training

      Participants will train to do three different finger movements using the index finger of both
      hands. The fingers will be taped to a device that measures their movement. The movements are:

        -  Lifting and dropping the index fingers of each hand repetitively and in synchrony
           (starting and stopping at the same time). The amplitude of finger movements is the same
           for both hands.

        -  Lifting and dropping the index fingers of each hand repetitively and in synchrony, but
           with a different amplitude for each hand.

        -  Lifting and dropping of the index finger of each hand repetitively, but each with a
           different amplitude and not in synchrony.

      Part 2 - Magnetic resonance imaging

      Participants will perform the trained movements during MRI scanning. This diagnostic
      procedure uses a magnetic field and radio waves to produce images of brain structure and
      activity. For MRI, the subject lies on a stretcher that is moved into the scanner-a cylinder
      containing a strong magnet. Earplugs are worn to protect the ears from loud thumping noises
      that occur with electrical switching of radio frequency circuits. Scanning time varies from
      20 minutes to 2 hours, with most examinations lasting 1 to 1 1/2 hours. The subject can
      communicate with the staff person conducting the test at all times during the scan.
    

Detailed description: 
      OBJECTIVE: The present study is aimed to clarify which structure or network of structures are
      responsible for the temporal linkage in bimanual co-ordination in healthy humans.

      STUDY POPULATION: Healthy normal volunteers.

      DESIGN:

      fMRI: Anatomical MRI and fMRI sequences are performed to obtain blood-oxygenation
      level-dependent (BOLD) imaging of brain activation during which movement performance will be
      measured with respect to movement synchrony, movement speed and amplitude.

      Multi-channel EEG recording performed while motor performance is monitored.

      OUTCOME MEASURES:

      fMRI: BOLD will be obtained using baseline correction.

      EEG: band-power and inter-regional coherence will be calculated using baseline correction.
    

Keywords: fMRI; Voluntary Movement; Healthy Volunteer; HV; Normal Control
Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, randomised, double blind, two-way crossover study, to investigate
      the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder
      GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to
      improve the physical stability of inhaled dry powder formulations. Male and female patients
      with mild/moderate asthma will be randomised to determine which order they receive a single
      inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will
      be a wash-out period of at least 5 days between doses.
    


Intervention name(s): GW685698X; GW685698X containing magnesium stearate
Intervention type(s): Drug; Drug
Intervention description(s): GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS; GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Asthmatic Patients