bioihbjkbjnl/mcl2 huggingface dataset:
Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
Condition: Hemiplegia, Spastic
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of rhythmic auditory cueing with
      bilateral arm training on upper limb functions in stroke patients.
    

Detailed description: 
      Arm and hand movement problems are major contributors to disability in patients after stroke.
      In fact, only 5% of adults regain full arm function after stroke, and 20% regain no
      functional use. Hence, alternative strategies are needed to reduce the long-term disability
      and functional impairment from upper limb hemiparesis.

      To solve problems concerning upper limb dysfunction related to stroke, various treatment
      methods have been used in several previous studies. Rhythmic auditory stimulation has been
      reported as an effective intervention for improving movement in the affected extremities of
      stroke patients.

      To the best of our knowledge, no mentioned previous studies evaluating the effect of rhythmic
      auditory cueing with bilateral arm training using functional exercises on upper extremity
      impairment in patients with stroke in Egypt are reported. So, this study aims to determine
      the effect of rhythmic auditory cueing with bilateral arm training on upper limb functions in
      patients with stroke.
    

Intervention name(s): Rhythmic Auditory Cueing; Bilateral arm training; Conventional physical therapy program
Intervention type(s): Other; Other; Other
Intervention description(s): Patients will perform the same movement sequence in time with the metronome beat. The frequency of the rhythmic auditory stimulation will be matched to the participant"s preferred movement speed, which will be assessed prior to the start of the trial, and participants typically started moving after they had heard the metronome beat two to three times. Participants will be given sufficient practice trials to ensure full understanding before the actual recording of data, and will be given 3-minutes break between trials.
On the 3rd and 5th week, the rhythm frequency was increased by 5%.; Training will consist of 20 minutes of bilateral arm training In each session, patients will be seated comfortably at a table in the following limb positions: ankles in neutral dorsiflexion, knees and hips placed at 90°, shoulders in 0° flexion, elbows in 60° flexion, and wrists in neutral position of flexion/extension; Scapular mobilization. Thoracic spine mobilization. Mechanical assisted (active and passive) exercises. Therapeutic positioning as weight bearing on the paretic arm. Opening and closing closed fist. Strengthening exercise. Stretching of spastic muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle Toning
Condition: Fat Necrosis; Muscle Stimulation
MeSH terms: Necrosis; Fat Necrosis
Study type: Interventional

Summary: 
      Open-label, baseline-controlled, multi-center study evaluating an electrical muscle
      stimulation system for circumferential reduction and muscle toning. The study will enroll up
      to 100 subjects desiring circumferential reduction and muscle toning. Each subject will
      receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2,
      30- and 90-days post treatment. Measurement outcomes will be compared to baseline.
    


Intervention name(s): Accufit
Intervention type(s): Device
Intervention description(s): Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow through the muscles in order to activate the muscle. The Accufit Electrical Muscle Stimulation device is an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms of interferential and biphasic for muscle stimulation. The Accufit system is indicated for relaxation of muscles, muscle re-education, reduction of pain and increased local blood circulation.
Muscle stimulation technology has been around for many decades and has been shown to be safe and effective for a variety of clinical applications. The foundational basis for the technology revolves around electrical current flowing through the muscle can be used to activate the muscle.
Other intervention name(s): ME Sys*STIM 240
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing the Atraumatic Technique in Ophthalmic Patients
Condition: Intravenous Cannula Regional Ophthalmic Anesthesia
Study type: Interventional

Summary: 
      This study is conducted to determine the efficacy of the cannula atraumatic technique as an
      alternative to the traditional needle penetrating technique to minimize the incidence of
      accidental globe penetration and/ or perforation, as the plastic part of the cannula is blunt
      and is difficult to perforate the normal globe being marble-like in consistency.
    

Detailed description: 
      A prospective comparative single blinded randomized controlled clinical study was held in the
      operating theatre at Research institute of ophthalmology, on adult patients with age group
      between 18- 80 years of both sexes undergoing anterior, posterior segment or plastic
      surgeries. two techniques were used in comparison: the atraumatic technique, using a 20 or
      22-gauge cannula advanced in the inferior-temporal peribulbar space after local infiltration.
      The skin and the conjunctiva will be pierced by the cannula and advanced for only 0.5 cm,
      then the cannula will be advanced blindly. Supplementation using the other sites (medial
      canthus and superior nasal) as needed.
    

Intervention name(s): Cannula plastic part while applying peribulbar block; traditional technique
Intervention type(s): Device; Procedure
Intervention description(s): Using the cannula and introducing it peribulbar to apply regional ophthalmic anesthesia avoiding by this causing trauma to the globe, as the normal globe consistency is marble-like, the cannula can't puncture except in case of presence of staphyloma, so the cannula will either curve around it or will be kinked causing failure of the technique.; the patients are going to receive the local anesthetic standard of care technique by using 23- or 24-gauge needle introduced through the skin extra-conal and local anesthetic solution will be injected with volume AND concentration according to the surgery going to be done
Other intervention name(s): Atraumatic peribulbar technique; needle traumatic peribulbar anesthesia
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study of ANAVEX2-73 in Patients With Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized,
      placebo-controlled study.

      7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients
      with RTT 18 years or older. A voluntary option will be offered for all patients who meet the
      exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.
    

Detailed description: 
      This Phase 2 safety, tolerability and efficacy study is designed as a double-blind,
      randomized, placebo-controlled study.

      This is a 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of
      patients with RTT 18 years or older. A voluntary option will be offered for all patients who
      meet the exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.
    

Intervention name(s): ANAVEX2-73; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid oral solution; Liquid oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 31 participants: 6 PK open-label followed by 25 double-blind, randomized, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia
Condition: Pain; Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Determine whether opioid (morphine) treatment results in better management of
      pain than treatment with tricyclic antidepressant (nortriptyline).

      II. Assess the effects the two treatments have on affective and cognitive functions.

      III. Determine whether the presence of psychiatric comorbidity, particularly depression, can
      predict the outcome of the two treatments.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, crossover study. Patients are
      stratified by the duration of pain (greater than 1 year or no greater than 1 year) and the
      presence or absence of major depression.

      Patients are randomized into 6 treatment order groups. Patients start with nortriptyline,
      morphine, or placebo, taken orally every day. If patients are unable to tolerate
      nortriptyline or morphine, they will receive desipramine or methadone instead.

      A drug titration period lasting 3 weeks is ensued for administration of the first drug
      treatment. The goal of this titration period is to gradually increase the dose of the drug to
      obtain maximal analgesic efficacy. Drug dosage is maintained for a period of 3 weeks. The
      drug dosage is tapered off and followed by a drug free period of 1 week.
    

Intervention name(s): desipramine; methadone; morphine; nortriptyline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Morphine; Methadone; Nortriptyline; Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: disease-related problem/condition; herpes zoster infection; herpesvirus infection; immunologic disorders and infectious disorders; pain; rare disease; viral infection
Agouti-related Peptide (AgRP) in Healthy Mothers and Mothers With Preeclampsia and Their Offspring
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The study is focused on the investigation of possible associations between plasma/serum
      levels of agouti related peptide (AgRP) and its genetic background in healthy women with
      physiological pregnancy (non-preeclamptic) and women with preeclampsia, in the postpartum
      period, and in their offspring.
    

Detailed description: 
      The study is focused on investigation of possible genotype-phenotype interactions of
      agouti-related peptide (AgRP) in postpartum non-preeclamptic women and preeclamptic women and
      in their offspring.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients of the Masaryk university afilliated hospital, Clinic of Obstetrics and
        Gynecology,hospitalized due to preeclampsia or healthy women with uncomplicated conception,
        pregnancy and delivery that came to give birth at the Clinic. Along with the mothers, their
        offspring in included in the study. The study population originated from a static region of
        the Czech Republic - South Moravia.
      
Biospecimen description: 
      whole blood, umbilical blood
    
Keywords: preeclampsia; agouti-related peptide; intrauterine growth; birth weight; Intrauterine growth restriction due to preeclampsia
Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration
Condition: Left Ventricular Dysfunction
MeSH terms: Myocardial Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluative pilot study for safety and feasibility with administration of autologous bone bone
      marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo
      the ischemic lesion.
    


Intervention name(s): PCI
Intervention type(s): Device
Intervention description(s): Stent implantation after acute myocardial infarction
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: left ventricular dysfunction; myocardial infarction; left ventricular dysfunction (LVDF) after acute myocardial infarction
Study of Aolanti Weikang Tablets in Healthy Volunteers
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple doses
      escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers
    

Detailed description: 
      This is a single-center, randomized, doule blind, placebo-controlled, multiple dose
      escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets
      in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat
      Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD
      is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level,
      subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1
      ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up
      for 14 days. No intrapatient dose-escalation is permitted.
    

Intervention name(s): Aolanti Weikang tablets; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Hand Strength and Spasticity in Hemiplegic Patients
Condition: Neurological Rehabilitation; Stroke; Upper Extremity Problem
MeSH terms: Muscle Spasticity
Study type: Observational

Summary: 
      The aim in this study is to evaluate spasticity and hand grip strength with a finger hand
      robot in the Turkish population.
    

Detailed description: 
      Spasticity has been defined as "irregular sensorimotor control resulting from upper motor
      neuron lesion manifesting as intermittent or sustained involuntary activation of muscles".

      The commonly used tools in the evaluation of spasticity are subjective clinical scales,
      including Ashworth Scale (AS), Modified AS (MAS), Tardieu Scale (TS), Modified TS (MTS), and
      Tone Assessment Scale (TAS). Current scales are based on the clinician's perception of the
      patient assessing spasticity through their perceptions, experience, and training over the
      years. An objective measure of spasticity is required, and the development of robot-based
      systems for this purpose can help clinicians objectify their assessment.

      It has been widely shown that robotic systems can be useful in the rehabilitation of adults
      and children with brain damage. In addition, these systems can be used to assess upper
      extremity function during treatment.

      The aim in this study is to evaluate spasticity and hand grip strength with a finger hand
      robot in the Turkish population.
    

Intervention name(s): Assessment of Hand Strength and Spasticity
Intervention type(s): Other
Intervention description(s): Assessment of Hand Strength and Spasticity
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        250 hemiplegia patients and 50 healthy controls aged between 40-85 years who applied to our
        clinic will be included in the study.
      
Keywords: Hemiplegia; Spasticity; Hand Grip Strength; Finger-Hand Robot
KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel
      group study to evaluate the safety and immunogenicity of KBP-COVID-19 plus CPG adjuvant
      vaccine in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-85
      years).
    

Detailed description: 
      Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization.

      Approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for
      Part A and 90 eligible healthy seronegative adults ages 50-85 years will be enrolled for Part
      B.

      Sentinel dosing (three subjects in each group) will be utilized in this FIH study. Sentinel
      cohorts will be used for the following groups:

      Part A (18-49 years) low dose Part B (50-85 years) low dose Part A (18-49 years) high dose
      Part B (50-85 years) high dose

      Overall, subjects will be randomized in a 1:1:1 ratio to receive study vaccine or placebo by
      IM injection on Days 1 and 22.

      All study visits will be conducted at the clinical sites on an outpatient basis. Subjects
      will participate in the study for approximately 1 year from the first dose.
    

Intervention name(s): Low Dose of KBP-COVID-19; High Dose of KBP-COVID-19; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Low Dose of KBP-COVID-19 and adjuvant; High Dose of KBP-COVID-19 and adjuvant; Buffered saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Covid19 Vaccine
Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)
Condition: Meniscus Lesion
MeSH terms: Fractures, Stress
Study type: Interventional

Summary: 
      This study will compare meniscal healing augmented or without augmentation with bone marrow
      stimulation techniques The assessments will include validated, disease specific, patient
      oriented outcome measures, second look arthroscopy during second step ACL reconstruction.
      Results of this study will help ascertain whether microfractures improve meniscal healing
      rates.
    

Detailed description: 
      The role of meniscal in the knee integrity is pivotal and lack or partial role of the
      meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular
      procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of
      inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in
      the 60-80% range for isolated repairs. This rate is greater when performed with ACL
      reconstruction. We believe that augmentation with bone marrow stimulation techniques will
      induce more complete and possibly faster healing.
    

Intervention name(s): with microfractures; without microfractures
Intervention type(s): Procedure; Procedure
Intervention description(s): following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively; standard procedure meniscal repair without augmentation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: meniscus repair; bone marrow stimulation
AVACEN Hand Heating on Fasting Blood Glucose
Condition: Hyperglycemia; Hypertension
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN
      device on fasting blood glucose. The AVACEN device creates negative pressure around the hand
      while heating the palm. Two sham devices, one providing heat but no vacuum and one providing
      neither heat nor vacuum were also used. Each subject was tested while using each of these
      three devices on separate visits. Subjects arrived in the morning following an overnight
      fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal
      ratings were measured before and throughout the 30 minutes that the device was used.
    


Intervention name(s): AVACEN 100; AVACEN 100 Heat Only; AVACEN Sham
Intervention type(s): Device; Device; Device
Intervention description(s): AVACEN 100 pulls a -30mmHg vacuum around hand from wrist down and applies heat (108 farenheit) to the palm and will be applied for 30 minutes; AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes; AVACEN 100 neither heats nor pulls a vacuum to hand
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
LD-FUD for Gastric Cancer With Bone Marrow Metastasis and DIC
Condition: Gastric Cancer; Bone Marrow Metastasis; Disseminated Intravascular Coagulation
MeSH terms: Neoplasm Metastasis; Stomach Neoplasms; Disseminated Intravascular Coagulation
Study type: Interventional
Phase: Phase 2

Summary: 
      A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC
      has been described. Few patients have been treated properly due to the lack of standard care.
      We designed this phase II study to evaluate a dose-dense regimen for this kind of highly
      aggressive gastric cancer (HAGC).
    

Detailed description: 
      5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel
      25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.
    

Intervention name(s): 5-fluorouracil; Docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): 200mg/square metre/day civ D1-D21; 25mg/square metre ivdrip D1, D8, D15
Other intervention name(s): 5-Fu; D
Intervention MeSH terms: Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 5-fluorouracil; docetaxel