bioihbjkbjnl/mcl2 huggingface dataset:
Transfer of Neural Energy Between Humans
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to determine whether visual evoked potentials generated in one
      human brain by photostimulation can generate a correlated EEG signal in the brain of another
      human subject who is located at a distance and who is not visually stimulated.
    

Detailed description: 
      This study will attempt to replicate findings suggesting that visual evoked potentials
      generated in one human brain (Subject A) by photostimulation can generate a correlated EEG
      signal in the brain of another human subject (subject B) who is located at a distance (14.5
      meters) and who is not visually stimulated.

      This project will occur in three stages. First we will identify pairs of subjects who have
      cross-correlated evoked potentials during photostimulation to Subject A at the p < .01 level
      of significance. If no pairs can be identified we will continue to enroll and test up to 50
      pairs of subjects. If pairs of subjects that demonstrate the phenomenon cannot be identified
      using this p value by the end of the project time line we will reject the hypothesis that
      remote transfer of neural energy occurs and report failure to replicate the original study.
      If we detect greater than or equal to 5 pairs of subjects who meet the criteria we will
      attempt to replicate in those pairs using a higher criteria of p < .001. If
      Grinberg-Zylberbaum et al's experiment can be replicated at both stages, the project team
      will go to stage 3 to investigate the same phenomenon in the identified pairs of human
      subjects using functional magnetic resonance imaging (fMRI) as a second independent
      neurophysiological measure of transfer of information between two human brains. We will
      record fMRIs (occipital, temporal, frontal and parietal) in the remote individual while their
      counterpart, located in a separate chamber, is receiving light stimulation in an on-off
      pattern. We will determine if there are statistically significant differences in digitized
      fMRI during lights on vs. lights off conditions. The main outcome measures for this project
      will be the binary (yes-no) output from statistical analysis using cross-correlational and
      z-score testing for the detection of a transferred evoked signal (in both EEG and fMRI
      experiments) in Subject B. Appropriate controls will be used. If replicated, this study will
      provide a useful technology and method to quantitatively investigate the characteristics and
      neural mechanisms of remote effects of "mental events." Such experimental methods will assist
      in the investigation of basic mechanisms involved in "mind-body" medicine.
    

Observational model: Defined Population
Time perspective: Cross-Sectional
Diet and Omega-3 Intervention Trial on Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very
      long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of
      atherosclerosis in a high risk population. A total of 563 elderly men were included and
      randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice
      and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3
      capsules and dietary advice.

      The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media
      thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.
    

Detailed description: 
      The basis for recruitment was a follow up of subjects participating in the Oslo Diet and Anti
      Smoking Study (1972-1977) characterised as hypercholesterolemic in 1972.

      Measurements of the outcome variables were performed at baseline and after 36 m; blood
      sampling also after 6 and 18 m.

      In addition to the main outcome variables, a biobank was established for future analyses.

      Clinical events were also recorded.
    

Intervention name(s): No dietary counseling and omega-3 capsules; Omega-3 capsules and dietary counseling; Dietary counseling, placebo capsules for omega-3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Omega-3 2.4 g/day; Omega-3 2.4 g/day and Mediterranean-like diet; Mediterranean-like diet
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pilot Study of OXP001 and Brufen in Healthy Subjects
Condition: NSAID Related Gastric Irritation
Study type: Interventional
Phase: Phase 1

Summary: 
      Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the
      study drug) which it is proposed will have less of the side effects than are currently
      reported with standard prescription strength Ibuprofen.

      This study will compare the study drug to an already marketed formulation of prescription
      strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body
      and also by performing a specialist procedure called an endoscopy (or more specifically a
      gastroscopy). The safety and tolerability of the study drug will also be assessed.

      The study will involve approximately 44 healthy male and female subjects. Subjects will be
      randomly assigned to receive either the study drug or reference product for 8 days. On Day 1,
      subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will
      receive 800 mg ibuprofen three times a day.
    


Intervention name(s): OXP001; Ibuprofen
Intervention type(s): Drug; Drug
Other intervention name(s): Brufen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      This study is aimed at evaluating single short spinal technique as a form of labour analgesia
      in a setting where more expensive and labor intensive techniques are not feasible.The study
      will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl
      vs intrathecal morphine+bupivacaine) through a randomized control trial.

      The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl
      or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients
      experiencing normal labour.
    


Intervention name(s): Intrathecal morphine with fentanyl; Intrathecal morphine with bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min.
The fetus was monitored with an ultrasonic aided fetal Doppler until delivery; Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min.
The fetus was monitored with an ultrasonic aided fetal Doppler until delivery
Other intervention name(s): Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong; Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong; Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong; sesorcaine 0.5%, Ampoule 4ml, Astrazeneca
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Labour analgesia; Intrathecal morphine; Bupivacaine; Fentanyl
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of
      concept study will investigate the efficacy and safety of RG7314 in adult participants with
      ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral
      doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety
      review, the study may proceed to Stage II. In Stage II of the study, additional participants
      will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks.
      After an independent safety review, Stage III will be started wherein additional participants
      will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12
      weeks. During Stage III, safety will be reviewed by independent safety review twice and if no
      safety signal is observed, then additional participants will be randomized in 1:1:1 either to
      receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in
      Stage IV.
    


Intervention name(s): Placebo; RG7314
Intervention type(s): Drug; Drug
Intervention description(s): Placebo will be administered in different stages of the study for 12 weeks.; RG7314 will be administered orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability
Condition: Scapholunate Ligament Partial Tears
Study type: Observational

Summary: 
      The purpose of this study is to investigate scapholunate ligament partial tears regarding
      tear localization, extrinsic ligament accompaniment in stable wrist and accordingly to
      scrutinize conservative treatment response.
    

Detailed description: 
      Patients admitted with radial sided wrist pain without carpal instability were
      retrospectively evaluated. Scapholunate interosseous ligament (SLIOL) tear localization,
      grade of injury and associated extrinsic ligament injuries were examined on MRI. Patients
      treated conservatively and recalled at their first year for re-evaluation.
    

Intervention name(s): Conservative Treatment (splint)
Intervention type(s): Procedure
Intervention description(s): splint 6 weeks
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        109 of 311 patients admitted with radial sided wrist pain had SLL and/or extrinsic ligament
        injury on MRI, 49,5% (n:55) were female, 50,5% (n:56) male with mean age 34 ± 10 (age
        range, 12-67 years).
      
Keywords: Scapholunate interosseous ligament, Extrinsic wrist ligaments, Carpal instability, MRI of wrist, Wrist ligamentous injury,
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
Condition: Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Anidulafungin is a medicine being developed for treatment of adults with certain kinds of
      fungal infections. This study is evaluating anidulafungin in children and adolescents who
      have fever and a low white blood cell count (neutropenia).
    

Detailed description: 
      Anidulafungin is an investigational drug being developed as an intravenous treatment for
      esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an
      antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and
      other filamentous fungi.
    

Intervention name(s): Anidulafungin
Intervention type(s): Drug
Intervention MeSH terms: Anidulafungin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neutropenia; fever; febrile neutropenia
Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

Summary: 
      The objective of this before-after non-randomized trial study is to evaluate the efficacy of
      ultrasound therapy in combination with manual therapy in the management of systemic sclerosis
      patients with IDU. The main questions it intends to answer are:

      • Is this combination of treatments effective in these patients in terms of improvement in
      hand functional ability, pain relief, injury healing, and quality of life?

      Participants will receive rehabilitation treatment consisting of a combination of manual
      therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water
      immersion. The researchers will compare the group of participants, called the treatment
      group, with a control group to see if:

      • Is the combined treatment of ultrasound therapy and manual therapy more effective in these
      patients than manual therapy alone?
    


Intervention name(s): combination ultrasound therapy and manual therapy; manual therapy
Intervention type(s): Other; Other
Intervention description(s): The proposed manual therapy lasted 90 minutes and involved a combination of three different techniques: McMennel manipulation, connective tissue massage and mobilization technique of pumping. Patients in the treatment group also received a treatment with US (I-Tech medical device certified UT2 CE0476) in combination with manual therapy. Dipping technique was applied with a frequency of 1 MHz, intensity of 1W/cm2, duty cycle of 60% and a duration of 15 minutes per session.; manual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rehabilitation; skin ulcer; ultrasound therapy; disability
A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      We are testing the hypothesis that subjects in the treatment group will experience fewer
      fasting induced headaches as compared to those in the placebo group.In our clinical
      experience, we estimate that approximately 25% of our headache population experiences
      fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28
      million in the United States alone, we estimate that approximately 7 million will experience
      hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a
      variety of ways to modify care in order to address that trigger. The simplest is to avoid
      that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use
      for a short time to help prevent menstrually related migraines. A short course of treatment
      can often avoid the initiation of the migraine and improve quality of life. Knowing that a
      longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing
      headache through a known trigger, suggests the need to study this with fasting induced
      migraines, as well.
    


Intervention name(s): Frovatriptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast; Inert tab identical in appearance to Frovatriptan
Other intervention name(s): Frova
Intervention MeSH terms: Frovatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Explorative Assessment of Biomarkers in Overweight and Obese Subjects
Condition: Prediabetes
MeSH terms: Overweight; Prediabetic State; Glucose Intolerance
Study type: Observational

Summary: 
      The rationale for this trial is to apply a simple and minimally strenuous pre-screening
      approach prior to performing more extensive trial-specific screening and
      baseline-characterization activities in the resulting pre-selected population of subjects.
    

Detailed description: 
      The pre-screening assessments are designed to characterize the metabolic risk profile /
      prediabetic status in an unselected population of overweight and obese volunteers, aiming to
      pre-select high risk and prediabetic subjects as a target population who may specifically
      profit from primary diabetes intervention (prevention) strategies.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Generally healthy or Type 2 Diabetes mellitus
      
Biospecimen description: 
      Blood samples
Inspiratory Muscle Training in Ehlers Danlos Patients
Condition: Ehlers Danlos
Study type: Interventional

Summary: 
      Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients
    


Intervention name(s): Threshold inspiratory muscle training
Intervention type(s): Device
Intervention description(s): Inspiratory muscle training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of JNJ-440 in healthy
      and Chronic Hepatitis B (CHB) participants after single and multiple doses; and to evaluate
      the pharmacokinetic (PK) of JNJ-440 in healthy participants and in CHB participants following
      single and multiple dose regimens, administered alone (healthy participants and CHB
      participants).
    


Intervention name(s): JNJ-440; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-440 will be administered as oral tablets in Parts 1, 2 and 3. JNJ-440 may be provided as oral solution in a cohort in Part 1.; Matching placebo as oral tablets will be administered in Parts 1, 2 and 3.
Other intervention name(s): JNJ-64530440 or ALS-003440
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: First in Human; Healthy Volunteers; Hepatitis B Virus; JNJ-64530440
EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)
Condition: Endoscopic Hemostasis; Colonic Polyps
MeSH terms: Colonic Polyps
Study type: Observational

Summary: 
      Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment
      techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common
      complication following EMR. Several endoscopic hemostasis methods are currently in use.
      EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was
      previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic
      application remains unknown. This study has been designed to observe the effect of rebleeding
      prevention after EMR.
    


Intervention name(s): EndoClot
Intervention type(s): Device
Intervention description(s): EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive cases of colorectal mucosal and submucosal lesions with intented EMR treatment
      
Keywords: Endoscopic Hemostasis; EndoClot Absorbable Polysaccharide Hemostat; Colonic Polyps
Predictors of Chronic Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the
      lower back for at least three months with no known causes. The CNSLBP prevalence is estimated
      of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the
      patients and the society. Whereas a specific pathology has not been identified for CNSLBP,
      mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to
      the pain and disability.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic non-specific LBP were recruited from five hospitals in Ahvaz, Iran.
      
Keywords: Chronic low back pain; disability; endurance
A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation
Condition: Healthy; Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional
Phase: Phase 1

Summary: 
      A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN)
      mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability,
      pharmacokinetics, and pharmacodynamics
    

Detailed description: 
      This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK
      and PD of intravenously administered AL001 in Healthy Volunteers and FTD-GRN mutation
      carriers.
    

Intervention name(s): AL001; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Active dose of AL001; Saline solution administered as a single infusion as palcebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment