bioihbjkbjnl/mcl2 huggingface dataset:
EEG and EMG Studies of Hand Dystonia
Condition: Focal Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Observational

Summary: 
      This study will examine how the brain operates during execution and control of voluntary
      movement and what goes wrong with these processes in disease. It will use
      electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal
      subjects and in patients with focal hand dystonia. In dystonia, involuntary muscle movements,
      or spasms, cause uncontrolled twisting and repetitive movement or abnormal postures. Focal
      dystonia involves just one region of the body, such as the hand, neck or face.

      EEG measures the electrical activity of the brain. The activity is recorded using wire
      electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures
      electrical activity from muscles. It uses wire electrodes placed on the skin over the
      muscles.

      Adult healthy normal volunteers and patients with focal hand dystonia may be eligible for
      this study. Patients will be selected from NINDS's dystonia patient database.

      Participants will sit in a semi-reclining chair in a darkened room and be asked to move
      either their right index finger, right foot, or the angle of their mouth on the right side at
      a rate of one movement every 10 seconds. Brain and muscle activity will be measured during
      this task with EEG and EMG recordings.
    

Detailed description: 
      Objective

        -  To find and quantify EEG/MEG correlates of cortical center-surround organization and
           intracortical inhibition.

        -  To compare these between healthy volunteers and focal hand dystonia (FHD) patients.

      Study Population

      - Healthy volunteers and FHD patients.

      Design

      - The study has two separate arms aiming to examine the same question. In the first one
      subjects perform a 4-choice contingence negative variation (CNT) type motor task while
      multi-channel EEG and EMG are recorded. In the second arm somatosensory evoked potentials
      (SEPs) or fields (SEFs) are recorded to median nerve stimulation.

      Outcome Measures

      - First arm: EEG band-power difference between "center" and "surround". Second arm: number,
      amplitude, and power of high frequency oscillations (HFOs) component of SEPs/SEFs.
    

Keywords: Cortex; Inhibition; Motor Control; Event-Related Synchronization; Event-Related Desynchronization; Focal Hand Dystonia; Focal Dystonia; Dystonia; Hand; Healthy Volunteer; HV
The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm
Condition: Cytokine Storm; Cytokines
MeSH terms: Cytokine Release Syndrome
Study type: Interventional

Summary: 
      The trial was designed to assess the effect of daily dose of 300 mg omega-3 supplements for 2
      months on the selected interleukins levels in uninfected people with Covid-19.
    

Detailed description: 
      Omega-3 Fatty Acids (Omega-3) are long poly unsaturated fatty acids that can be found in
      plants and fish, its refer to a group composed of three type of fatty acids called:
      Eicosapentaenoic acid (EPA), Alpha-linoleic acid (ALA), and Docosahexaenoic acid (DHA) . The
      health promoting effect of n-3FA may be due to immune modulating and anti-inflammatory
      actions . The anti-inflammatory properties of n-3FA are used for treatment of the
      inflammatory diseases such as irritable bowel syndrome, rheumatoid arthritis, eczema, and
      psoriasis . Many studies reported a significant reduction in the risk of cancers in breast,
      prostate, ovaries with supplementation of n-3FA (Larsson et al. 2004) .However, high-doses
      omega-3 supplements such as 1000 mg/day are widely spread in community pharmacies in Jordan .
      Currently , community pharmacy around the world are facing the challenge of increased demand
      for care of uninfected people with Covid -19. Accordingly , the current randomized clinical
      trial was designed to evaluate the effect of daily 300 mg of omega 3-FA supplements on the
      immune health status of uninfected people with Covid-19 as a part of as a part of preventive
      health care .

      Therefore , this RCT aims to assess whether regular daily dose of regular daily dose of omega
      3-FA (300 mg) for 2 months supplementation against COVID-19 infection as a part of preventive
      treatment protocol in uninfected Jordanian peoples. The investigators hypothesize that the
      regular dose of omega 3-FA (300 mg) /day for 2 months will significantly change immune
      responses compared with the control group.
    

Intervention name(s): 300 mg of omega3-FA
Intervention type(s): Dietary Supplement
Intervention description(s): The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.
Baseline and follow-up serum levels of IL-1,IL-6, and TNF will be measured.
Other intervention name(s): n-3FA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Covid-19; IL-1 beta; IL-6; TNF alpha; Omega-3; n-3FA; uninfected
Tympanostomy Tube Placement in Children in the Office (Inova Study)
Condition: Otitis Media
MeSH terms: Otitis Media
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS
      for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
    


Intervention name(s): Tube Delivery System (TDS)
Intervention type(s): Device
Intervention description(s): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Other intervention name(s): Tula TDS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Sleep Variability in Youth
Condition: Sleep Variability
Study type: Interventional

Summary: 
      Daily sleep variability is prevalent in the young populations, yet its effects remain less
      clear. The experimental study aims to examine the impacts of intraindividual daily sleep
      variability on sleep characteristics, cardiometabolic regulations and daytime functioning in
      college students.
    


Intervention name(s): Irregular sleep
Intervention type(s): Behavioral
Intervention description(s): Experimental-induced sleep variability
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude
Condition: Altitude Hypoxia
MeSH terms: Altitude Sickness; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating the effect of acetazolamide on maximal
      exercise performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of acetazolamide intake on the maximal exercise performance in lowlanders older than 40 years
      travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be
      transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there
      for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at
      760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

      An interim analysis will be carried out when 80 participants will have completed the study or
      after the first year. The Peto's method will be used and the trial will be stopped when
      pre-specified futility boundaries were crossed.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: healthy participants older than 40 years; exercise performance; prevention; acetazolamide
Prevention of Post Sexual Assault Stress
Condition: Drug Use; Drug Abuse; Posttraumatic Stress Disorder
MeSH terms: Substance-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate whether a brief intervention in video format, that
      includes education about reactions to assault and modeling of adaptive coping strategies,
      designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of
      sexual assault at the time of receipt of post assault medical care is associated with better
      post-assault outcomes as compared to a comparable length video that includes pleasant imagery
      and relaxation instruction or standard care.
    

Detailed description: 
      Post assault outcomes include coping behaviors and PTSD symptoms.
    

Intervention name(s): PPRS; PIRI
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.; Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rape; Secondary prevention; Intervention
Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects
Condition: Liver Cirrhosis
MeSH terms: Liver Diseases; Liver Cirrhosis
Study type: Observational

Summary: 
      The elimination of the carbohydrate galactose is used in daily clinical work with liver
      patients as a quantitative measure of metabolic liver function, as the liver test "The
      Galactose Elimination Capacity", GEC. We are working to develop a PET/CT scanning procedure
      for providing 3D images of the hepatic galactose elimination and measurement of regional
      values. This may be used for example for planning resection or stereotactic radiotherapy of a
      patient with malignant tumor in the liver. Will the patient be able to tolerate removal of
      the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6
      healthy human subjects. Direct measurements of the hepatic galactose elimination (successive
      constant iv infusions of galactose in increasing doses with measurements of blood
      concentrations of galactose in blood from an artery and a liver vein, and measurements of
      liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements
      after iv injection of a 18F-labelled galactose analog, FDGal.

      Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose
      elimination kinetics by the two methods, including estimation of a factor ("lumped constant")
      for recalculating PET/CT data to data for natural galactose.

      Besides possible practical clinical importance, the project elucidates basic problems
      concerning liver metabolism using PET.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are out-patients recruited from Department of Hepatology, Aarhus University
        Hospital Healthy subjects are recruited via add in a local newspaper
      
Keywords: Galactose; PET/CT; Liver physiology; Liver pathophysiology
A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent
      subjects with asthma.
    

Detailed description: 
      Interleukin-13 (IL-13) is a pleiotropic cytokine that promotes inflammation, airways
      hyper-responsiveness (directly and through recruitment and activation of inflammatory cells),
      mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE)
      synthesis and mast cell activation.Tralokinumab (CAT-354) is a human immunoglobulin G4 (IgG4)
      anti-IL-13 monoclonal antibody that has been shown to potently and specifically neutralize
      IL-13 in preclinical models.This study will evaluate the PK profile of a single dose of
      tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with
      asthma to be compared with the PK data from completed studies in adults.
    

Intervention name(s): Tralokinumab 300 mg
Intervention type(s): Biological
Intervention description(s): Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Other intervention name(s): CAT-354
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tralokinumab; CAT-354; Asthma
Comparison of Efficacy and Safety of Prandilin and NovoRapid in Newly Diagnosed Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effect of the rapid-acting insulin analogues (RAIAs) NovoRapid (aspart) and
      Prandilin (lispro) on glycemic variations by Continuous glucose monitoring system (CGMS) in
      continuous subcutaneous insulin infusion (CSII) with metformin intensive therapy in newly
      diagnosed type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      The study was designed as a single blind randomized control trial. A total of 110 newly type
      2 diabetic diagnosed patients with hemoglobin A1c (HbA1c%) above 9% were hospitalized, and
      were randomly divided into two groups: NovoRapid group (group Asp) and Prandilin group (group
      Lis) in CSII, combined with metformin therapy. Treatments were maintained for 2-3 weeks after
      the glycaemic target was reached. To complete the assessment of general information, fasting
      C-peptide (C-P0), 2-h postprandial C-peptide (C-P2h), fasting insulin (Ins0), 2-h
      postprandial insulin (Ins2h), HbA1c% and fructosamine on the baseline and endpoint. 4 days
      continuous glucose monitoring (CGM) was performed on after three days stable glucose.
    

Intervention name(s): aspart insulin or lipro insulin
Intervention type(s): Drug
Intervention description(s): After completing OGTTS, enrolled subjects (new diagnosed T2DM) were randomly assigned into two groups: NovoRapid group (group Asp, Novo Nordisk, Bagsvaerd, Denmark) and Prandilin group (group Lis, Gan & Lee pharmaceuticals, Beijing, China) in CSII, combined with metformin (Bristol-Myers Squibb, USA) therapy. During insulin intensive therapy, every patient general use 1.5g metformin per day. If the patient is unable to tolerate the side effects of metformin, such as diarrhea, nausea, vomiting, allergies, etc., the daily dose of metformin is reduced to 1.0g. If the patients are still unable to tolerate the daily 1.0g of metformin, exit from this study.
Intervention MeSH terms: Insulin; Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Rapid-acting insulin analogues; Continuous glucose monitoring system (CGMS); Continuous subcutaneous insulin infusion (CSII)
A Study of LY3410738 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety and tolerability of LY3410738 and to
      look at the amount of the study drug, LY3410738, that gets into the blood stream and how long
      it takes the body to get rid of it when given in healthy adult participants. For each
      participant, the total duration of the study will be 53 days, including screening.
    


Intervention name(s): LY3410738; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a
      substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or
      lycopene before surgery may be an effective treatment for prostate cancer.

      PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of
      lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on
           intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients
           with localized prostate cancer.

        -  Compare the effects of these nutritional supplements on increases in plasma levels and
           tissue levels of these agents in these patients.

        -  Compare the effects of these nutritional supplements on changes in surrogate markers of
           disease progression (e.g., prostate-specific antigen levels) in these patients.

        -  Compare the effects of these nutritional supplements on changes in serum steroid
           hormones, estradiol, and free testosterone in these patients.

        -  Compare the magnitude of these changes in patients treated with these nutritional
           supplements vs patients in the control group.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial
      neoplasia. Patients are randomized to 1 of 7 treatment groups.

      PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
    

Intervention name(s): Lycopene; Multivitamin; Soy isoflavones
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily administration as outlined in treatment arm(s); Daily administration as outlined in treatment arm(s); Daily administration as outlined in treatment arm(s)
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
Lutein Influence on Macula of Persons Issued From Amd Parents
Condition: Persons Issued From Amd Parents
Study type: Interventional
Phase: Phase 3

Summary: 
      Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina
      (named macula) and is the leading cause of blindness in industrialized countries. There is
      growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin)
      of dietary origin, which specifically accumulate in the macula, where they form the macular
      pigment. A first step towards the demonstration of a preventive effect of macular pigment for
      AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on
      their plasma and retinal concentrations.
    

Detailed description: 
      The objective of this study is to estimate the efficiency of a nutritonal supplementation
      with lutein and zeaxanthin to increase their plasma concentration and the density of macular
      pigment, in subjects at high genetic risk for AMD (1st generation stemming from parent
      affected by DMLA). This study is a multicentric, double blind, randomized clinical trial of
      supplementation versus placebo
    

Intervention name(s): Nutrof Total; Placebo Nutrof total
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules 2 times per day during 6 month; 2 capsules 2 times per day during 6 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: AMD; food supplementation; macular pigments; luthéine; zéaxanthine; visual acuity; prevention; genetique risk
Demonstration of the "SPECT/CT System With CZT Detectors" Imaging Performance in a Clinical Setting
Condition: Cancer
Study type: Interventional

Summary: 
      The primary purpose of the study is to obtain sample clinical images that are evaluated by
      physicians in support of regulatory submissions. Additionally, the study will provide data
      for current and future product development and it will provide clinical images and data for
      marketing use.
    


Intervention name(s): Discovery NM/CT 670 CZT Imaging Scan
Intervention type(s): Device
Intervention description(s): At a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pain During Vaccine Administration
Condition: Infant, Newborn, Pain
Study type: Interventional

Summary: 
      Many painful interventions that cause pain and stress are applied to preterm babies in the
      neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of
      acute interventional pain; Non-pharmacological methods including behavioral, psychological
      and environmental regulations should be used.

      In the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex
      can make the preterm baby feel safe and calm. In the literature, there are many studies aimed
      at reducing pain in preterm newborns. However, no study has been found on the effect of
      grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to
      preterm infants.

      This study was planned to examine the effect of grasping reflex on pain and crying duration
      in preterm infants with hepatitis B vaccine.
    


Intervention name(s): Palmar grasp reflex
Intervention type(s): Behavioral
Intervention description(s): The reflex can be stimulated by moving an object distally across the palm. In the study, at the beginning of the vaccine administration, the right hand of the infant will be moved distally along the palm with the researcher's index finger, thus providing reflex stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care