bioihbjkbjnl/mcl2 huggingface dataset:
Functional Significance of Complexity Measures in the Sensory-motor Behavior
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The main objective of this study is to compare between groups the level of complexity of the
      estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.
    

Detailed description: 
      The secondary objectives of this study are to compare the level of complexity of the
      estimated sensorimotor performance using the(A) mono-fractal exhibitors (the αDFA values) and
      the (B) coefficient of variation (CV) between groups.
    

Intervention name(s): Wrist anesthesia; Blinding mask; Anti-noise helmet; Tapping test
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Prior to the tapping test, regional anesthesia is performed in the form of sensory blocks distal to the wrist: injection of ropivacaine 7.5mg / ml is carried out successively in contact with three nerves (ulnar, median and radial) with a volume of 2 ml for nerve, for a total of 45mg.; Patients will don a mask that prevents them from seeing during the tapping test.; Patients will don a helmet that prevents them from hearing during the tapping test.; Subjects will be placed at a table in a sitting position where they will perform a rhythmic finger tapping test. The seat height is adjusted so that the front dominant arm rests comfortably on the table. Subjects will be equipped with headphones to receive auditory signals during a first synchronized phase of tapping.
After the last auditory signal, participants will continue the tapping task by themselves as directed: "after the metronome stops,continue tapping the prescribed tempo as accurately and consistently as possible throughout the test." The movements of the index finger will be measured by a single-axis accelerometer (15 × 15 mm) attached to the nail.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
High Tone Pelvic Floor Dysfunction
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Observational

Summary: 
      Dyspareunia, or painful intercourse, is one of the most commonly reported complaints in
      postmenopausal women. One common cause of dyspareunia is vaginal atrophy (VVA), which occurs
      in >50% of postmenopausal women. At the time of menopause, a lack of estrogen thins the
      vaginal mucosa and lessons lubrication, making sex painful. Some women with vaginal atrophy
      will also have high tone pelvic floor dysfunction (HTPFD) (also known as levator spasm).
      Successful treatment of the sexual pain requires treatment of both vaginal atrophy and HTPFD.

      How often vaginal atrophy and HTPFD coexist has not been studied. In fact, the prevalence of
      HTPFD is unknown. This is most likely due to the fact that many clinicians are unaware of its
      existence or how to diagnose or treat it. Also, sexual symptoms tend to be underreported due
      to embarrassment or hesitation to seek care. HTPFD frequently coexists with other conditions
      that cause pain like vaginal atrophy, endometriosis or interstitial cystitis. Treatment
      includes treating both conditions. If only one is treated, then sexual pain is likely to
      continue. There are several available treatments for HTPFD that have been studied including
      physical therapy, botox and intravaginal diazepam.

      This is an area where clinicians may be under treating a condition and limiting the
      possibility of restoring normal sexual function to many women. Treating only vaginal atrophy
      without appropriate evaluation and treatment of HTPFD leaves a cohort of women still
      struggling with sexual pain. With a better understanding of the relationship between HTPFD
      and vaginal atrophy, the investigators hope to bring awareness concerning the importance of
      treating both in restoring normal sexual function.
    

Detailed description: 
      This is a retrospective chart review that will be performed to identify all female patients
      in the electronic medical records with a diagnosis of vulvovaginal atrophy (VVA).

      The records of these patients with VVA will be examined for demographics, symptoms, answers
      to standardized questionnaires ( e.g. Female Sexual Function Index - FSFI - that is routinely
      assessed during clinical evaluation), work-up, diagnosis, and/or treatment of high tone
      pelvic floor dysfunction (HTPFD). Symptoms of HTPFD include but are not limited to pelvic
      pressure or pain, and dyspareunia. These data will then undergo statistical analysis.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): None, there is no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        >/= 18 -90 years of age female any ethnic background
Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, single dose, 3-period crossover PK study. This
      study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1,
      subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects will
      be administered Treatment A, B, or C according to the randomization schedule.

        -  Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state

        -  Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state

        -  Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state
    

Detailed description: 
      Subjects will be confined to the Clinical Research Unit (CRU) from the time of Check-in (Day
      -1) to Day 10. Predose blood and urine samples will be obtained prior to each ACY-1215
      administration. Following administration of ACY-1215 in each period, blood and urine samples
      will be collected at specified timepoints or intervals through 24 hours postdose for the
      determination of the PK of a single oral dose of ACY-1215. Subjects will be discharged from
      the CRU on Day 10, following the completion of the last PK collection and successful
      completion and evaluation of discharge safety tests. Subjects will return to the clinic for a
      Follow-up visit 5 to 7 days after the last dose of ACY-1215 (Days 14 to 16) for additional
      safety evaluations.
    

Intervention name(s): ACY-1215
Intervention type(s): Drug
Intervention MeSH terms: Ricolinostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: relative bioavailability; food-effect
A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration
Condition: Chronic Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study that will investigate the safety, tolerability and
      pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind,
      placebo controlled, randomized study design. The influence of food on the pharmacokinetics of
      HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.
    


Intervention name(s): HRS-2261 tablet、placebo; HRS-2261 tablet、placebo
Intervention type(s): Drug; Drug
Intervention description(s): HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.; HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: HRS-2261 compared with placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Coenzyme A and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia
Condition: Hyperlipoproteinemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the lipid lowering effects and clinical safety of a
      natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in
      Chinese patients with moderate dyslipidemia.
    

Detailed description: 
      Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay
      of medical therapy for cardiovascular event prevention, evidence from clinical trials
      supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol
      (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate
      is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining
      with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα
      activation. However, safety of coadministration of statin with fenofibrate has been a great
      concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA)
      functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm
      to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal
      studies have proved its lipid-lowering effects. In a previous multicenter study we conducted
      in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in
      hypertriglyceridemia patients without increasing adverse effects when compared with placebo.
      So, the present study was performed to further investigate the lipid-lowing effects and
      safety of CoA capsule by comparing with fenofibrate.
    

Intervention name(s): Coenzyme A; Fenofibrate 200mg
Intervention type(s): Drug; Drug
Intervention description(s): Coenzyme A 400mg per day; Fenofibrate 200mg per day
Other intervention name(s): Coenzyme A group; Fenofibrate group
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording
Condition: Sugammadex; Motor Evoked Potentials
Study type: Interventional

Summary: 
      Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during
      surgery without or with minimal neuromuscular blockade (NMB) because of its potential
      interference with signal interpretation.The feasibility of TcMEP interpretation was assessed
      during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record
      of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse
      NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by
      sugammadex on intraoperative TceMEP recording.
    


Intervention name(s): Sugammadex; Saline
Intervention type(s): Drug; Drug
Intervention description(s): The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.; The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
rTMS Treatment in Patients With General Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study will compare the change detected by a standardized rating scale (Hamilton Anxiety
      Rating Scale) scores in the active treatment group as compared to sham (placebo) group after
      6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to
      improvement of core symptoms in patients with GAD.
    


Intervention name(s): Repetitive transcranial magnetic stimulation; placebo sham
Intervention type(s): Device; Device
Intervention description(s): 6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.; Sham treatment will mimic active treatment mentioned above.
Other intervention name(s): rTMS machine (MagPro, Medtronic).; rTMS machine (MagPro, Medtronic).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates
Condition: Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases
Study type: Interventional

Summary: 
      An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on
      growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr.
      Cipto Mangunkusumo Hospital.
    

Detailed description: 
      Preterm neonates were recruited via random sampling and divided into two groups (intervention
      group and control group). A written informed consent was obtained from the parents or
      guardians.

      Before the intervention, physical examination was performed to ensure the neonates had normal
      vital signs, were healthy and did not present with congenital abnormalities.

      In the intervention group, TKS was performed with specific baby oil for 15 minutes, three
      times a day, for 10 days. After 10 days, TKS was applied once daily by the mother or
      caregiver. TKS implementation at home was supervised by the investigator or nurse through
      phone call. The TKS were documented by the mother or caregiver in the diary card, which
      should be brought during the next visit when the neonate was 11-14 days old. In addition to
      TKS, history of illness and nutrition which was confirmed through history taking during
      hospital or home visit, was also recorded. The participants who did not go the hospital were
      home visited by the investigator or nurse.

      Anthropometric measurement by investigator and trained nurses and Dubowitz examination was
      performed by investigator in a warm and quiet place in the neonatal unit, mother-baby unit,
      outpatient clinic or participants' home while the neonate was fully alert.

      At 3 months of age, infant development was assessed by the investigator using the Capute
      scales (Developmental Quotient of Clinical Adaptive Test [DQ CAT], Clinical Linguistic
      Adaptive Milestone Scale [DQ CLAMS]) and the Full Scale Developmental Quotient (FS DQ) score.
      The Clinical Linguistic Adaptive Milestone Scale (CLAMS) score was based on the parent's
      report of language skill attainment. The Clinical Adaptive Test (CAT) score was based on the
      child's performance according to the listed items.
    

Intervention name(s): Tactile-kinesthetic Stimulation; Placebo
Intervention type(s): Procedure; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: preterm; growth; development; premature birth; infant; massage; weight gain
A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine
      agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or
      dopamine agonists, patients notice that their PD medications wear off sooner than when they
      first started taking them. This "wearing off" is characterized by the return of symptoms
      (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an
      hour. When a patient's PD symptoms have returned, the patient is said to be in the "off"
      state. When the patient takes another dose of medication, and his/her PD symptoms improve or
      resolve, the patient is said to be in the "on" state. Antagonism of adenosine Type 2a
      receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that
      A2a receptor antagonism can lead to improvement in the function of PD participants taking a
      stable dose of L-dopa, as measured by a reduction in "off" time.
    


Intervention name(s): Preladenant 2 mg tablet; Preladenant 5 mg tablet; Preladenant 10 mg tablet; Placebo to Preladenant Tablet; Rasagiline 1 mg capsule; Placebo to Rasagiline capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): one 2 mg tablet orally twice daily; one 5 mg tablet orally twice daily; one 10 mg tablet orally twice daily; one tablet orally twice daily; one 1 mg capsule orally in AM; one capsule orally in AM
Other intervention name(s): SCH 420814; SCH 420814; SCH 420814; Azilect
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Idiopathic Parkinson Disease; Idiopathic Parkinson's Disease
Oral Immunotherapy for Peanut Allergy (PMIT)
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects
      who have peanut allergy less allergic and induce changes in their immune system.
    

Detailed description: 
      Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food
      allergies it tends to be more persistent and also its prevalence seems to be rising.
      Currently there is no proven treatment other than strict avoidance. We are attempting to
      decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut
      using peanut oral mucosal immunotherapy (OIT). We are also studying the effect of peanut OIT
      on the peanut specific immune response to determine if tolerance to peanut protein will
      develop. Children ages 1 to 18 with peanut allergy will be randomized to peanut OIT or
      placebo. Subjects will undergo a modified rush immunotherapy on the first day and then
      increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent
      to about 13 peanuts). Doses will be taken daily at home except for dose increases which will
      be done on the research unit. Subjects will undergo a double-blind, placebo-controlled food
      challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to
      open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects
      will then complete at least 36 months of peanut OIT therapy after which once skin prick (<5
      mm) and IgE (<15 kU/L) criteria are met, they will then complete the end of study DBPCFC.
      Dosing will continue up to a maximum of 60 months after which even if criteria are not met,
      the subject will undergo the end of study DBPCFC. Outcome variables of interest include
      response to DBPCFC, skin prick testing, peanut specific IgE, and adverse events. These
      results will be compared between the start and end of peanut OIT using appropriate
      statistical analysis.
    

Intervention name(s): Peanut OIT; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Defatted peanut flour ingested daily as oral mucosal immunotherapy; Oat flour matched by weight and consistency that is ingested daily as a placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Peanut allergy
Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.
Condition: Low Back Pain; Neck Pain; Muscular Atrophy
MeSH terms: Muscular Atrophy; Back Pain; Low Back Pain; Neck Pain
Study type: Interventional

Summary: 
      The purpose of this project is to investigate the occurrence of neck and back pain in a
      population of commercial helicopter pilots, and investigate factors related to the profession
      that can cause these problems. The project has a biological approach assessing the supporting
      and stabilizing muscles (multifidus) in pilots with chronic back and neck ailments. Pilots
      with low back problems are invited to a controlled intervention trial to investigate whether
      one can achieve improved spinal health with a rigid training régime. Primary trial outcome is
      improved neck and back multifidus muscles pathology and function as assessed by the extent of
      fat infiltration -as visualized on MRI - and the volume and ability of the lumbar multifidus
      muscles to contract as shown with ultrasound. The perceived effect on spinal health with sick
      leave frequency is also evaluated.
    


Intervention name(s): Low back exercises 1; Low back exercise 2
Intervention type(s): Other; Other
Intervention description(s): Excentric / concentric extension type exercises; Traditional low back training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment