bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Intensive Chiropractic Care to Usual Care for Adults With Spinal Cord Injuries.
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      To determine the effects of chiropractic care on spasticity, functional outcomes and quality
      of life in Spinal Cord Injuries in adults.
    


Intervention name(s): Sham intervention; Chiropractic Care; Physical therapy intervention
Intervention type(s): Other; Other; Other
Intervention description(s): The participant's head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust.; A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.; The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Spinal Cord Injuries children, where Conventional Therapy will be provided according to the respective needs of the individual patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Research
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of three analgesia techniques on
      pain relief and functional recovery after knee replacement: continuous femoral nerve block vs
      single-injection femoral nerve block with intravenous patient controlled analgesia vs
      intravenous patient controlled analgesia.
    

Detailed description: 
      Primary Outcome Measures:

        -  Incidence of patients with significant pain on movement on day 1 post surgery

        -  Range of knee flexion

      Secondary Outcome Measures:

        -  Pain intensity (rest/movement)

        -  Functional recovery

        -  Knee Injury and Osteoarthritis Score

        -  Side effects/ Adverse outcomes

        -  SF12 Quality of Life Questionnaire

        -  Length of stay
    

Intervention name(s): Continuous Femoral Nerve Block
Intervention type(s): Procedure
Intervention description(s): 20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.
Other intervention name(s): Bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Replacement; Analgesia; Analgesics; Nerve blocks; Recovery of functions; Post operative analgesia
Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
Condition: Nasal Fracture
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study is perfored to investigate the efficacy of preoperative lidocaine spray and
      lidocaine-bupivacaine mixture-soaked nasal packing for acute postoperative pain after nasal
      closed reduction surgery.
    

Detailed description: 
      To investigate the treatment of postoperative pain after nasal closed reduction surgery, we
      plan to investigate the effect of preoperative lidocaine spray and lidocaine-bupivacaine
      mixture-soaked nasal packing for the patinets undergoing nasal closed reduction under general
      aensthesia, compaing to the control group (normal saline spray and normal saline-soaked nasal
      packing).
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing
Other intervention name(s): bupivacaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA (Tenecteplase, Metalyse®) With Accelerated Infusion of Rt-PA (Alteplase, Actilyse®) in Asian Patients With Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial was to compare the efficacy and safety of a single bolus of
      TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian
      patients.
    

Detailed description: 
      This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study
      to compare the efficacy and safety of TNK-tPA (tenecteplase, Metalyse®) with that of
      accelerated rt-PA (alteplase, Actilyse®) in Asian patients with AMI. The primary endpoint
      (TIMI 3 Flow) and the secondary endpoint (TIMI frame count) were evaluated in a blinded
      manner in the core laboratory.

      Patients eligible for the trial who met all inclusion and exclusion criteria and who gave
      their informed consent were randomized to one of two treatment groups (i.e. TNK-tPA or
      accelerated rt-PA).

      The study period totaled 30-37 days and included baseline, randomisation, study drug
      administration, in-hospital follow-up and thirty-day follow-up.

      Coronary angiography was performed at 90 minutes after the start of study drug
      administration. 12-lead electrocardiograms (ECGs) were obtained before randomization, between
      60 to 75 minutes and 180 ± 15 minutes after the start of study drug administration, and at
      hospital discharge.

      If the patient showed rapid and progressive hemodynamic deterioration before 90 minutes,
      rescue PTCA or other appropriate interventions should be performed at the discretion of the
      treating physician.

      Following the analysis of TIMI flow and frame count at each study center, the results were
      carefully recorded on the CRFs. This data was stored on a compact disk or a film and labeled
      with the subject's study I.D. number. It was then sent with the summary worksheets and ECGs
      to the Angiographic Core Laboratory located at the Leuven Coordinating Center (LCC) of the
      University Hospital Gasthuisberg (Leuven, Belgium) for central evaluations.

      Study Hypothesis:

      The null hypothesis tested was that there was no difference between the two treatment groups:
      TNK-tPA (Tenecteplase, Metalyse®) and accelerated rt-PA (Actilyse®), against the alternative
      that there was a difference.

      Comparison(s):

      The primary endpoint of the study was TIMI 3 flow at 90 minutes after start of thrombolytic
      therapy, angiograms were evaluated in a blinded manner in a core laboratory.
    

Intervention name(s): TNK-tPA; rt-PA
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tenecteplase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Food Effect Study for PF-06372865
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed to investigate the effect of high fat food on the
      pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.
    


Intervention name(s): PF-06372865; PF-06372865
Intervention type(s): Drug; Drug
Intervention description(s): 7.5 mg as 3 x 2.5 mg tablets single dose; 7.5 mg as 3 x 2.5 mg tablets single dose
Intervention MeSH terms: PF-06372865
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population
Condition: Balance; Cerebellum
Study type: Interventional

Summary: 
      The cerebellum is involved in regulating balance and walking and plays a crucial role in the
      locomotor adaptation and learning processes. This study aims to investigate the association
      between balance and the integrity of the cerebellar white matter tracts in a healthy
      population. Healthy participants will undergo four weeks of balance training. The
      investigators will analyze changes in the microstructural integrity of the cerebellar white
      matter tract before and after four weeks of balance training.
    

Detailed description: 
      The cerebellum is involved in regulating balance and walking and plays a crucial role in the
      locomotor adaptation and learning processes. The cerebellum's intermediate zone, which
      receives afferent stimuli from the sensorimotor cortex (via the cortico-ponto-cerebellar
      tract) and peripheral muscles (via the dorsal spinocerebellar tract), contributes to
      maintaining body posture and regulating walking. Proprioceptive information from the
      peripheral muscles passes through the dorsal spinocerebellar tract, enters the ipsilateral
      cerebellar hemisphere via the inferior cerebellar peduncle, and finally projects to the
      contralateral motor cortex through the cerebello-thalamo-cortical pathways.

      Diffusion tensor imaging (DTI) enables microstructural evaluation of the white matter tracts.
      Both diffusion tensor tractography, to determine the structural connectivity of the whole
      tract, and DTI-derived parameters, to determine the microstructural organization, can
      represent the integrity of the cerebellar white matter tracts.

      The investigators will evaluate the motor-related white matter tracts, including the
      corticospinal tract, the cortico-ponto-cerebellar tract, the dorsal spinocerebellar tract,
      and the dentato-rubro-thalamo-cortical tract. Healthy participants will perform the four
      weeks of balance training, and DTI will be acquired before and after exercise. The
      investigators will analyze the DTI-derived parameters of the relevant white matter tracts and
      analyze the longitudinal changes. The investigators hypothesized that the four weeks of
      balance training would enhance the integrity of the cerebellar white matter tracts.
    

Intervention name(s): Balance and Proprioceptive Training
Intervention type(s): Behavioral
Intervention description(s): Step-by-step training (5 levels)
30 minute per training
3 times per week
Four weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Balance; Cerebellum; White matter tract; Diffusion Tensor Imaging
Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
Condition: Fibromyalgia; Chronic Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the mean number of stimulation (high
      definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a
      clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS)
      for pain. These data will be important in defining the optimal number of sessions for future
      fibromyalgia subjects in Phase III trials.
    


Intervention name(s): High Definition transcranial Direct Current Stimulation
Intervention type(s): Device
Other intervention name(s): 4X1 low-intensity direct current stimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transcranial stimulation; direct current
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
Condition: Hypertension
MeSH terms: Hypertension; Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg
      Tablets Under Fed Conditions.
    


Intervention name(s): Eplerenone 50 mg Tablets Sandoz Inc., USA; Inspra 50 mg Tablets GD Searle LLC, USA
Intervention type(s): Drug; Drug
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Home Based Assessments on Participants With DMD
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      This study is designed to evaluate the feasibility, wearability and participant satisfaction
      of novel outcome assessment tools in DMD patients which are performed in the home
      environment.
    

Detailed description: 
      This is a low interventional feasibility study to evaluate the use of:

        1. An FDA 510(k) cleared Class II wearable medical device designed to collect medical
           grade, clinical quality biometric, physiological and other electronic clinician outcome
           assessments data in a clinical trial setting, and;

        2. The Duchenne Video Assessment (DVA) tool to evaluate the quality of movement in patients
           with Duchenne Muscular Dystrophy (DMD)

      This study will provide data on suitability of these tools in future clinical trials.
    

Intervention name(s): Wearable Device; Duchenne Video Assessment (DVA)
Intervention type(s): Device; Other
Intervention description(s): The wearable device used in this study is an FDA 510(k) cleared Class II medical device designed to collect medical grade, clinical quality biometric, physiological and other electronic clinician outcome assessments data in a clinical trial setting. The system processes raw data into recognizable clinical metrics including vital signs, activity and posture classifications, surface electromyography (sEMG), and sleep metrics. The sensors are multi-modal, multilocation, rechargeable and reusable.; The DVA is a standardized tool that documents and assesses compensatory movement strategies as a marker of quality of movement.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately twenty ambulatory males aged 4 to <13 years with DMD will be recruited. Of
        these, approximately 10 participants will be considered Early Ambulatory and 10 will be
        considered Late Ambulatory. Early ambulatory is defined as able to get off the floor
        without assistance or use of furniture.

        Approximately twenty healthy, age-matched controls will be recruited.
      
Keywords: duchenne; muscular dystrophy; DMD
Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers
Condition: Lower Limb Ulcer
MeSH terms: Ulcer
Study type: Observational

Summary: 
      The aim of this prospective study is to assess the utility of treatment of leg ulcers using a
      skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous
      oxygen pressure in the distal region of the wound.

      This is a multi-centre study on 60 patients who have a lower limb ulcer.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be patients with "difficult" lower limb ulcers, whose wounds have
        not responded to directed healing for more than 6 months or who have a wound > 10 cm².
Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess multiple ascending doses of AR882 in healthy adult males.
    


Intervention name(s): Cohort 1: AR882 or placebo; Cohort 2: AR882 or placebo; Cohort 3: AR882 or placebo; Cohort 4: AR882 or placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AR882 or matching placebo administered once daily for 10 days; AR882 or matching placebo administered once daily for 10 days.; AR882 or matching placebo administered once daily for 10 days; AR882 or matching placebo administered once daily for 10 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects
Condition: Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple
      dose levels of GLY-230 in healthy and diabetic subjects
    


Intervention name(s): GLY-230; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 125, 250 0r 375 mg bid for 14 days; No drug administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Carbohydrate Availability and microRNA Expression
Condition: Glycogen Depletion
Study type: Interventional

Summary: 
      This investigation will examine the impact of skeletal muscle glycogen stores on skeletal
      muscle and circulating microRNA expression and exogenous carbohydrate oxidation.

      Primary Objective Determine the influence of carbohydrate availability (e.g., glycogen
      depletion and repletion) on skeletal muscle microRNA expression, and if changes in
      circulating microRNA are reflective of changes in skeletal muscle microRNA.

      Secondary Objective Determine how initiation of exercise with adequate or low glycogen stores
      effects exogenous carbohydrate efficiency.
    

Detailed description: 
      Twelve, normal weight, healthy, physically active men and women will complete a glycogen
      depletion protocol, cycling at various intensities until failure. Participants will then
      consume a carbohydrate (CHO: 1 g/kg/hr) or an energy free control (CON) beverage matched for
      taste and color during the first 3-hr post glycogen depletion. For the remainder of the day
      participants will consume a diet designed to adequately (6.0 g CHO/kg/d) or inadequately (1.2
      g CHO/kg/d) replenish glycogen stores. The following day participants will to complete 80-min
      of steady-state (~60% VO2peak) cycle ergometry consuming carbohydrate at a rate of 1.8 g/min
      enriched with a stable isotope of carbon to determine exogenous carbohydrate efficiency when
      glycogen stores are low or adequate at the onset of exercise.

      Following a minimum 7-d washout period volunteers will return to the laboratory to complete
      the second arm of the investigation. To ensure glycogen stores are similar between volunteers
      on testing day, 48-hrs prior to testing all volunteers will complete a glycogen depletion
      protocol and then consume a diet providing 6.0 g/kg/d carbohydrate to replenish glycogen
      stores.
    

Intervention name(s): Adequate Carbohydrate; Low Carbohydrate
Intervention type(s): Other; Other
Intervention description(s): During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion; During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.
For the day participants will consume a diet of 1.2 g/kg/d carbohydrate following glycogen depletion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: microRNA, carbohydrate oxidation
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD
      and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of
      RGZ in healthy subjects.
    


Intervention name(s): Rosiglitazone maleate; Atazanavir Sulphate; Atazanavir Sulphate + Rosiglitazone maleate; Atazanavir Sulphate + Ritonavir; Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, RGZ 4 mg, once daily, 1 day.; Capsules, Oral, ATV 400 mg, once daily, 5 days.; Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.; Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.; Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
Other intervention name(s): Reyataz; Reyataz; Reyataz; Reyataz
Intervention MeSH terms: Rosiglitazone; Ritonavir; Atazanavir Sulfate; Maleic acid
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: HIV
Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In the present study researchers aim to investigate the effectiveness of an intervention
      combining emotion regulation and mindfulness skills in a single 10-week program. A total of
      75 individuals with major depressive disorder (MDD) diagnosis in complete or partial
      remission participated in this randomized controlled trial (RCT) comparing an intervention
      including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program.
      After treatment, participants were followed for a 1-year period. Researchers results indicate
      that ER+M was not more effective than the treatment used with the control group in preventing
      depression relapse. Participants allocated to the ER+M group showed a significant decrease on
      global psychiatric symptoms, whereas those in the control group did not. Further studies are
      needed in order to better determine the combined effects of mindfulness and behavioral
      activation.
    


Intervention name(s): Emotion Regulation and Mindfulness skills
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment