bioihbjkbjnl/mcl2 huggingface dataset:
Thermal Stimulation for Stroke Patients
Condition: Stroke; Upper Limb Paresis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      Sensory and/or motor deficits in upper limb following stroke often have negative impacts on
      their daily living. Thermal stimulation with hot and cold pack alternatively incorporated
      into conventional rehabilitation has been reported and proved to be effective for upper limb
      functional recovery after stroke. However, whether hot- and cold-water stimulation
      alternatively based on thermal stimulation also has the effect still remains unknown. The aim
      of present study is to investigate the facilitated effect of hot and cold water stimulation
      alternatively on upper limb after stroke.
    

Detailed description: 
      Stroke patients from department of rehabilitation in Tzu Chi general hospital will be
      recruited and randomized into two groups, one for experimental group and the other for
      control group. In addition to receiving routine standard rehabilitation for both groups, the
      experimental group will receive additional hot- and cold-water stimulation alternatively for
      five times one session, consecutive four sessions a set, one set for 30 minutes a day and
      five sets a week for six weeks. The control group will be given ergometer exercises with the
      similar duration as experimental group. Both groups will be evaluated at baseline before TS
      and every two weeks till six weeks after TS, then at 3, 6 and 12 months for follow-up. A
      variety of evaluations used in the present study include Semmes-Weinstein monofilaments for
      sensory functions; Brunnstrom's stage, Fugl-Meyer Assessment Scale and Motricity Index were
      used for upper limb motor control and strength; Box and block test for hand dexterity. The
      modified Motor Assessment Scale and Barthel Index are utilized for evaluating general motor
      functions and daily activity performance, respectively. The modified Ashworth scale is used
      for change of muscle tone of upper limb.
    

Intervention name(s): thermal stimulation; control group ergometer exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The heat and cold-water will be added to the thermal group for 30-40minutes a session daily,five sessions a week for six weeks.; The control group will be given ergometer exercises with the similar duration as experimental group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; follow up; upper limb; rehabilitation
Vitamin D Half-life in Pregnancy and Lactation
Condition: Pregnancy; Lactation
Study type: Interventional

Summary: 
      This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in
      non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months
      post-partum in women who are exclusively breast-feeding.
    


Intervention name(s): Oral dose of stable isotope labeled 25(OH)D3
Intervention type(s): Other
Intervention description(s): At each measurement, women are given an oral dose of stable isotope labelled 25(OH)D3. Blood and urine samples are collected at baseline and on day 21 post-dose. Additional blood samples are collected post-dose on days 6,9,24,27 and 30.
Intervention MeSH terms: Calcifediol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vitamin D; Africa
Relation Between Complication in Repeated Cesarean Sections, Newborn Outcome and Surgical Characteristics and Maternal Information
Condition: Women Who Had at Lease One Cesarean Section in the Past
Study type: Observational

Summary: 
      To examine the relation between complication in Repeated Cesarean Sections and Newborn
      Outcome compared to number of repeated cesarean section and reasonf or surgery and personal
      medical information to the mother
    


Intervention name(s): compare complication
Intervention type(s): Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All women who underwent a cesarean section at Rambam Medical Center who had at least one
        cesarean section in the past
Chemical Ice Packs for Cooling Hyperthermic Patients
Condition: Heat Stroke, Heat Exhaustion
MeSH terms: Heat Stroke; Heat Exhaustion
Study type: Interventional

Summary: 
      A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are
      used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.

      The ability of these to cool a person has never been quantified, the efficiency and extent of
      cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of
      this study is to determine whether strategically placed chemical ice packs will provide
      benefit to individuals subjected to heat stress.
    


Intervention name(s): Chemical Cold Pack
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, randomized, placebo-controlled, five-period crossover study to
      examine the likability of a repeated administration of immediate release methylphenidate
      hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses
      are as follows:

        -  Hypothesis 1: the subjective feelings of detection and likeability will be greater for
           periods of IR-MPH administration than after OROS-MPH administration irregardless of
           sequence;

        -  Hypothesis 2: the greater ratings of feelings of detection and likeability will be
           associated with the periods of most rapid change in plasma d-MPH and not with the
           magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in
           which they coincide), and

        -  Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions
           in which IR-MPH is the second condition.
    

Detailed description: 
      The main goal of this study is to assess whether the abuse liability potential of delayed,
      repeated administrations of different formulations of MPH is moderated by the oral delivery
      system in which a delivery system with slower onset may be safer than one with more rapid
      early release. To this end, the investigators will compare repeated administration of orally
      administered, therapeutic doses of a short (IR-MPH) and a long-acting formulation of MPH
      (OROS-MPH) in the following areas:

        1. pharmacokinetic profile of MPH assessing rate of onset of MPH action (indexed through
           change in plasma level) and

        2. abuse liability (indexed through detection and likeability).

      The investigators will test all combinations of initial administration and then delayed
      (repeated) administration of the two formulations: IR-MPH to IR-MPH; IR-MPH to OROS-MPH;
      OROS-MPH to IR-MPH; OROS-MPH to OROS-MPH, and placebo to placebo.
    

Intervention name(s): OROS-Methylphenidate; Immediate Release Methylphenidate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules; Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules; Placebo will be administered during the first part of the day, and again during the second part of the day.
Other intervention name(s): Concerta; OROS MPH; IR MPH; Ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: healthy volunteers
A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-845
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-845.
    

Detailed description: 
      A phase 1 clinical trial to evaluate pharmacokinetics and safety in male after administration
      of CKD-845 and D309.
    

Intervention name(s): D309; CKD-845
Intervention type(s): Drug; Drug
Intervention description(s): D309(Testosterone) 1 vial, Once, IM injection; CKD-845(Testosterone) 1 vial, Once, IM injection
Other intervention name(s): Reference Drug; Test Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CKD-845
Effect of Passive Smoking on Oxidative Stress and Dental Caries in Children
Condition: Oxidative Stress; Dental Caries; Passive Smoking
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      The purpose of the present study was to determine the effect of passive smoking on oxidative
      stress and dental caries in children.A total of 180 children were included to the study as
      follows; 90 children exposed to passive smoking, and 90 children in the control group
      (unexposed controls). Also demographic data were recorded (age, gender, parental education
      levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family
      income). Dental examination of children were performed and caries prevalence of the patients
      were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine
      levels' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant
      status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained
      data parameters of the two groups were evaluated and comparison was performed.
    


Intervention name(s): taking saliva samples to determine oxidative stress markers TAS and TOS
Intervention type(s): Diagnostic Test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children, referring for dental examination to the Department of Pediatric Dentistry of
        Kirikkale University, were selected.
Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate that a 3 months physical exercise programme
      improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized
      since at least 6 months under prednisone and/or azathioprine.
    

Detailed description: 
      Three centers randomized simple blind clinical trial whose objective is to assess the
      efficacy on QoL improvement, and the tolerance of physical exercise over a period of 3 months
      in patients with generalized MG who have been stabilized since at least 6 months.

      During the 3 months pre-inclusion phase, the characteristics of MG will be collected.
      Physical activity and performance will be assessed monthly.

      MGQOL15 will be assessed at inclusion.

      Patients will be randomized in either intervention arm or control arm.

      The intervention arm will consist of three sessions exercise per week during three months.
      The daily exercise will be performed on a rowing machine that will be adapted to the
      patient's own physical ability.

      Physical activity will be measured with the help of an actimeter.

      Once a month, MG evolution and tolerance to exercise will be assessed and MG treatment dose
      will be collected.

      Exercise will be interrupted in case of MG exacerbation.

      Quality of life and psychological status will be assessed at 3, 6 and 9 months.

      Plasma levels of pro and anti-inflammatory cytokines will be measured at 3, 6 and 9 months in
      order to assess the effects of exercise on immune response.

      Patients enrolled in the control arm will benefit from the same follow-up but will not have
      exercise.
    

Intervention name(s): Physical exercise programme using a rowing machine
Intervention type(s): Behavioral
Intervention description(s): 3 sessions per week of individualized physical training using a rowing machine during 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myasthenia gravis; physical exercise; quality of life; muscular performance; fatigability
A Proof of Concept Study to Evaluate CN-105 in ICH Patients
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, open-label phase 2a trial of CN-105 in patients with supratentorial
      intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of
      symptom onset. Eligible participants (approximately 60) will receive CN-105 administered
      intravenously (IV) for a 30-minute infusion every 6 hours for up to a maximum of 3 days (13
      doses) or until discharge (if earlier than 3 days). Participants will be monitored daily
      throughout the Treatment phase of the study (up to a maximum of 5 days) and will receive
      standard-of-care treatment for the duration of the study. Additional protocol assessments
      will be required during the Treatment phase. After discharge from the hospital, participants
      will enter a 3-month Follow-up phase, with a clinic visit at 30 days and a follow-up
      telephone interview with telephone-validated Modified Rankin Scale (mRS) at 90 days after
      first dose of study agent.

      Funding Source - FDA OOPD
    


Intervention name(s): CN-105
Intervention type(s): Drug
Intervention description(s): Patients with supratentorial intracerebral hemorrhage (ICH) will be evaluated for eligibility within 12 hours of symptom onset. Eligible participants will receive CN-105 administered intravenously (IV) for a 30 -minute infusion every 6 hours for up to a maximum of 3 days (13 doses) or until discharge (if earlier than 3 days)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
Condition: Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to show that the incidence of sternal wound infections at day 30
      after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard
      antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.
    


Intervention name(s): Daptomycin; Cefuroxime
Intervention type(s): Drug; Drug
Intervention description(s): one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis; 1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine
Other intervention name(s): Cubicin
Intervention MeSH terms: Daptomycin; Cefuroxime; Cefuroxime axetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prophylaxis; Antibiotic; Sternotomy; Heart-Lung Machine
Comparison of the Effects of Vapocoolant Spray and EMLA Cream on Pain During Needle Electromyography
Condition: Electrodiagnosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effects of vapocoolant spray and topical
      lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle
      electromyography.
    

Detailed description: 
      The study was conducted on patients with patients that underwent needle EMGs in the lower
      extremity between July and August 2011 at the university hospital. The patients were divided
      into a total of three groups by random assignment: a control group that did not receive
      pretreatment, a group that received ethyl chloride vapocoolant spray and a group that
      received topical anesthetic cream (EMLA cream®).The patients with spray group, they were
      sprayed with ethyl chloride vapocoolant spray for 5 seconds from a distance of 30 cm just
      before the needle EMG, and patients with EMLA cream, they received an application of topical
      anesthetic cream on the needle electrode insertion site 60 minutes before the needle EMG. The
      37-mm monopolar needle electrode was vertically inserted into the medial head of the
      gastrocnemius muscle in all patients.

      To assess the degree of pain for each group, patients were asked to indicate their level of
      pain on a 100 mm VAS (0, no pain; 100, worst intolerable pain) after the needle EMG in the
      gastrocnemius muscle.

      In both experimental groups, a 5-point Likert scale was used to evaluate patient satisfaction
      with the pain reduction method used and their willingness to use the same analgesic method in
      another EMG.
    

Intervention name(s): vapocoolant spray; topical anesthetic cream
Intervention type(s): Device; Drug
Intervention description(s): spray for 5 seconds from a distance of 30 cm just before the needle EMG; application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG
Other intervention name(s): Ethyl chloride spray; EMLA® (Eutectic Mixture of Local Anesthetics)
Intervention MeSH terms: Anesthetics; Ethyl Chloride; Lidocaine, Prilocaine Drug Combination; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury
Condition: Postoperative Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      The aim of this study is to investigate the changes in renal regional oxygen saturation
      (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the
      occurrence of postoperative AKI.
    

Detailed description: 
      Postoperative acute kidney injury (AKI) is a severe complication after liver resection and
      contributes to increased morbidity and mortality.

      Advanced age reduces renal autoregulatory capacity due to physiological and functional
      changes, thus render the elderly to suffer postoperative AKI and probably the consequent
      chronic kidney disease. Thus, it is essential to identify those patients at high risk to
      develop postoperative AKI to optimize perioperative prevention and protection strategies.

      Despite the multiple risk factors and potential mechanisms that have been identified, the
      diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for
      early identification of postoperative AKI. It is of great interest to develop target
      strategies for close motoring of renal function.

      This study is a prospective cohort study to investigate the associations between
      intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators
      intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI.
      Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during
      the surgical process. The principal clinical outcome of the study is postoperative AKI,
      defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a
      1.5-fold increase from preoperative baseline within seven days after surgery, according to
      the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.
    

Intervention name(s): Near-infrared spectroscopy
Intervention type(s): Device
Intervention description(s): Before the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients older than 60 years who intend to receive elective hepatectomy surgeries
      
Keywords: liver resection; elderly; renal oxygen saturation; near-infrared spectroscopy
Trial of Rifaximin in the Treatment of Tropical Enteropathy
Condition: Tropical Enteropathy
MeSH terms: Intestinal Diseases; Sprue, Tropical
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether rifaximin is effective in the treatment of
      tropical enteropathy in a population of African children at high risk for this disease.
    


Intervention name(s): Rifaximin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg of rifaxin for 7 consecutive days, twice daily; twice daily for 7 consecutive days
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis
Condition: Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of
      smoked and vaporized cannabis. Careful analysis of different cannabis administration methods
      on these parameters is required to determine the level and duration of biological cannabinoid
      exposure and associated subjective, cardiovascular and cognitive effects. In the present
      study the investigators evaluated the detection of cannabinoids in whole blood, oral fluid,
      and urine, as well as the acute pharmacodynamics associated with smoked and vaporized
      cannabis among individuals who were not regular cannabis users. The outcomes of the study
      will extend scientific knowledge about the behavioral pharmacology and toxicology of smoked
      and vaporized cannabis administration and can inform policies regarding clinical, workplace
      and roadside drug testing programs.
    


Intervention name(s): Cannabis
Intervention type(s): Drug
Intervention description(s): Inhaled cannabis
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Cannabis; Toxicology; Intoxication
Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold
Condition: Vocal Cord Dysfunction
MeSH terms: Vocal Cord Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is carried out to explore the short-term and long-term efficacy of the functional
      collagen scaffold in guiding laryngeal soft tissue regeneration.
    


Intervention name(s): Autologous fat transplantation; Functional collagen scaffold transplantation
Intervention type(s): Biological; Biological
Intervention description(s): Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.; Injectable collagen scaffold combined with adipose derived stem cells that are isolated from abdominal adipose tissue will be injected into vocal cord beneath mucous under surgery microscope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment