bioihbjkbjnl/mcl2 huggingface dataset:
Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The study goes on 24 months, with recruiting, treatment and follow period for all patients.
      The first day for each patient will be the first cellular administration. 3 doses will be
      administrated every 3 months from first dose.

      When the clinical trial finishes, it will be done a completed check of all obtained
      parameters.
    

Detailed description: 
      It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective
      follow-up of a cohort of patients with chronic spinal cord injury (SCI) .10 patients will be
      included with this injury.

      Primary objective: Analyze the possible clinical efficacy of administration of main adult
      mesenchymal autologous cells expanded "in vitro" in patients with incomplete and chronically
      established SCI.

      Secondary objectives: Confirm the safety of treatment, and study possible changes in the
      cerebrospinal fluid (CSF) levels (Brain-derived neurotrophic factor (BDNF), glial cell
      line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), ciliary neurotrophic
      factor (CNTF), Nerve Growth Factor 3 and 4(NT3 and NT4) after subarachnoid administration of
      BMMC.
    

Intervention name(s): Adult Autologous Mesenchymal Bone Marrow Cell
Intervention type(s): Biological
Intervention description(s): Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Analyze clinical efficacy of subarachnoid administration of; autologous BMSC expanded "in vitro"
Mechanisms Behind Antidiabetic Effects by Gastric By-pass
Condition: Diabetes Mellitus Typ 2 and Obesity
Study type: Interventional

Summary: 
      The aim of the study is to develop new strategies in treatment of continuous increasing
      number of patients with type 2 diabetes by understanding how bariatric surgery cures or
      improves this condition.
    


Intervention name(s): Modifast; Normal diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day; normal diet 2 weeks before gastric by-pass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients
Condition: Stroke; Complementary
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness and reliability of acupuncture
      treatment in patients experiencing impaired sleep quality after a stroke. Additionally, the
      goal is to reduce the need for multiple medications and/or high-dose drug usage in the
      treatment of these complications in patients
    

Detailed description: 
      The aim of this study is to evaluate the effect of acupuncture therapy on sleep quality in
      patients experiencing insomnia in the early post-stroke period. In this prospective,
      randomized controlled, single-blind study, 70 ischemic stroke patients undergoing inpatient
      rehabilitation were included. Participants were randomly divided into two groups: the
      acupuncture group receiving acupuncture therapy and standard rehabilitation program. The
      control group receiving only the standard rehabilitation program. The acupuncture group
      received acupuncture treatment twice a week for 4 weeks. Sleep quality was evaluated using
      the Pittsburgh Sleep Quality Index (PSQI). The PSQI scores were assessed three times at
      baseline, at the 4th week, and at the 8th week. The results of the study indicated that the
      acupuncture group demonstrated a significant improvement in sleep quality compared to the
      control group. Significant differences were observed between the baseline PSQI scores and the
      PSQI scores at the 4th week in both the acupuncture and control groups (p: 0.000 and p:
      0.008). The change between baseline and 8th-week PSQI scores was also significant (p: 0.000
      and p: 0.000). However, in the acupuncture group, the decrease in PSQI scores was
      significantly greater compared to the control group. The addition of acupuncture therapy to
      standard treatment resulted in a significant improvement in sleep quality. Additionally, the
      baseline PSQI scores were found to be correlated with the severity of depression.This study
      suggests that acupuncture therapy can be an effective intervention for improving sleep
      quality in patients with early post-stroke insomnia.
    

Intervention name(s): Acupuncture treatment
Intervention type(s): Other
Intervention description(s): Acupuncture treatment with needles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acupuncture; sleep medicine; stroke
Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
Condition: Brain Injuries; Craniocerebral Trauma
MeSH terms: Brain Injuries; Craniocerebral Trauma; Emergencies; Wounds and Injuries
Study type: Observational

Summary: 
      The objectives of the study are to document device performance with respect to the primary
      and secondary endpoints.
    

Detailed description: 
      The purpose of the current study is proposed to prospectively validate the BrainScope Ahead®
      M-100 device design, performance, and labeling with respect to the device's target intended
      use and indications for use:

        -  Primary Endpoint:

             -  Structural Injury Assessment

             -  There are four co-primary endpoints in this study: two sets of sensitivity and
                specificity to divide the data into three classes.

             -  Using a BrainScope classification algorithm, the Ahead® M100 will identify subjects
                showing sensitivities among 3 classes: Green-normal, nonhead injured
                controls,Yellow-head injured subjects who do not exhibit brain electrical activity
                that is consistent with a structural brain injury observable on CT or for whom CT
                was not deemed necessary,Red-head injured subjects who exhibit brain electrical
                activity consistent with a structural brain injury observable by CT.

        -  Secondary Endpoint:

             -  Functional Injury Assessment

             -  There are two co-secondary endpoints for the secondary objective, the sensitivity
                and specificity to split Yellow from the primary endpoint into two sub groups
                depending on degree of brain functional impairment observable by an evaluation of
                the clinical findings on a clinical charter used as the assessment of truth.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who enter the ED at hospitals that are participating as clinical sites for this
        study
      
Keywords: Head Injury; Head Trauma; TBI (Traumatic Brain Injury); Emergency Department
The Association Between Pain Catastrophizing Scale Score and Postspinal Headache
Condition: Pain; Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Observational

Summary: 
      This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and
      Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.
    

Detailed description: 
      This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and
      Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Patients
      were asked to fill the questionnaire booklet including Pain Catastrophizing Scale, Beck
      Depression Inventory and Beck Anxiety Inventory before elective cesarean section in
      preoperative room in operating theater. In postoperative second and fourth day, patients will
      call by phone and be asked to have headache or any complaints. The intensity of headache will
      evaluate by using visual analog scale. Age, gender, and visual analog scale scores will be
      recorded.
    

Intervention name(s): urgent or elective cesarean section
Intervention type(s): Procedure
Intervention description(s): a kind of surgical procedure to deliver a baby
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women with pregnancy whose planned to undergo urgent or elective cesarean section
      
Keywords: Pain Catastrophizing Scale
Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
Condition: Acne Scars - Mixed Atrophic and Hypertrophic; Acne
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This single-center, clinical trial consists of a one autologous fat grafting treatment
      followed by 3-month and 6-month post-treatment visits in order to assess the efficacy of fat
      grafting when used by men and women with facial acne scars.
    

Detailed description: 
      This investigation, pilot study will evaluate the safety and efficacy of autologous fat
      grafting for the treatment of acne scarring. Overall assessment of clinical outcome and
      safety will be based clinic visits and evaluation of pre- and post- procedural photos. In
      conjunction with standard and close-up photography, we will also be using 3D imaging,
      cross-polarized imaging, UV imaging, high-resolution ultrasonography, optical coherence
      tomography, transepidermal water loss measurements, and/or BTC 2000 measurements.
      Additionally, we will be utilizing 0.33 mm skin biopsies to assess histological and genetic
      changes that occur below the skin surface as a result of this treatment. The subject's
      assessment of satisfaction will be characterized using a non-parametric assessment scale at
      each follow-up period.
    

Intervention name(s): Fat Grafting
Intervention type(s): Procedure
Intervention description(s): This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
Condition: Epilepsy; Cysticercosis
MeSH terms: Cysticercosis; Taeniasis; Neurocysticercosis; Epilepsy
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the
      severity and duration of epilepsy due to neurocysticercosis.

      II. Determine the effect of a short course of albendazole on Taenia solium cysts present in
      the brain.

      III. Determine the natural regression of cerebral T. solium cysts in patients given placebo
      and their response to treatment at the end of the study.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to
      receive either albendazole and dexamethasone or placebo.

      Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1
      year. Albendazole and dexamethasone or placebo only is administered orally once daily on days
      5-15.

      Patients are asked to maintain a diary. Patients are followed on day 15 and 30, then every 3
      months for 3 years.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): albendazole; dexamethasone; phenytoin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Albendazole; Dexamethasone; Phenytoin
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: cysticercosis; epilepsy; immunologic disorders and infectious disorders; neurologic and psychiatric disorders; parasitic infection; rare disease; seizures
Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
Condition: Stroke; Proprioceptive Disorders; Balance; Distorted
MeSH terms: Stroke; Somatosensory Disorders
Study type: Interventional

Summary: 
      To determine the combined effects of proprioceptive neuromuscular facilitation and electrical
      muscle stimulation on spasticity and hand function in stroke patients.
    

Detailed description: 
      It will be a randomized controlled trial. The stroke patients aged between 30-70 years will
      be included in this study. Participants will be selected with non-probability convenience
      sampling technique. Participants will be randomly allocated into two groups by lottery method
      i.e experimental group and control group. The experimental group will receive proprioceptive
      neuromuscular technique (contract relax-10 repetition) (5-min) and electrical muscle
      stimulation(10 min) as 15 min session 3 times a week for four weeks while the control group
      will receive only conventional therapy. The outcome measure will be calculated by modified
      barthel index, modified ashworth scale and wolf motor function test.
    

Intervention name(s): experimental group; control group
Intervention type(s): Other; Other
Intervention description(s): Patients will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS; Patients will receive conventional therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients will be allocated to two groups by randomization. Patients in Group A will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique & EMS patients in Group B will receive conventional therapy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Proprioceptive Disorders; Balance; Distorted
Study of MOC31-PE in Antigen Positive Carcinomas
Condition: Carcinoma
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Immunotoxins (ITs), monoclonal antibodies conjugated to plant or bacterial toxins, have been
      extensively investigated for their possible use as anti-tumor agents although not in
      carcinoma patients with minimal residual disease. Various ITs have been tested in early
      clinical trials and recent studies demonstrate anti-tumor activity of IT treatment in
      patients with glioblastoma and different solid tumors. Systemic treatment with immunotoxins
      directed against carefully selected epithelial cell surface molecules may have a potential
      for eradicating also dormant metastatic tumor cells, as their action is independent of cell
      proliferation. The effector moieties of the IT used here, the Pseudomonas exotoxin A (PE),
      inhibits protein synthesis in eukaryotic cells by catalytic inactivation (ribosylation) of
      elongation factor 2 in the ribosome complex.
    


Intervention name(s): MOC31-PE
Intervention type(s): Drug
Intervention description(s): Immunotoxines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDT and DLT
Noninvasive Imaging of Heart Failure: A Pilot Study
Condition: MRI; Acquired Heart Disease; Myocardial Fibrosis
MeSH terms: Heart Failure; Heart Diseases; Fibrosis
Study type: Observational

Summary: 
      Background:

      - Heart failure is a common cardiovascular disorder whose incidence increases with age,
      affecting up to 10% of people older than 65 years of age. As the population ages, the
      prevalence and cost of heart failure will continue to rise. Researchers are interested in
      using noninvasive imaging methods to better understand the symptoms and effects of heart
      failure.

      Objectives:

      - To conduct a noninvasive comparative imaging study of individuals with heart failure.

      Eligibility:

      - Individuals at least 18 years of age who have been diagnosed with heart failure (with at
      least mild symptoms and slight limitations on physical activity).

      Design:

        -  This study will last approximately 2 years and will require four visits to the National
           Institutes of Health Clinical Center, with one screening visit and three study visits.

        -  Participants will be screened with a full medical history and physical examination, as
           well as blood and urine samples.

        -  Participants will have the following tests during each study visit:

        -  Physical examination

        -  Blood and urine samples

        -  Cardiac magnetic resonance imaging

        -  Cardiac computerized tomography to study the blood vessels in and leading to the heart

        -  Echocardiogram to evaluate heart function

        -  Electrocardiogram to measure heart electrical activity

        -  The three study visits will take place 1 year apart. Participants will also receive
           follow-up phone calls 6 months after the first and second visits.

        -  No treatment will be provided as part of this protocol.
    

Detailed description: 
      More than 9% of American men and close to 5% of women ages 60 to 79 years report a diagnosis
      of heart failure, where above the age of 80 years these figures increase to 13.8% and 12.2%,
      respectively. Projection into the middle part of this century suggests that, as the
      population ages, the prevalence and cost of heart failure will continue to rise. The primary
      aim of this proposal is to investigate noninvasive imaging methods for quantifying diffuse
      myocardial fibrosis with cardiac magnetic resonance imaging (CMR) in heart failure patients.
      The secondary aims are to investigate the association between diffuse fibrosis detected by
      CMR with left ventricular function, and examine the utility of multi-detector CT (MDCT) in
      detecting diffusion myocardial fibrosis.
    

Observational model: Case-Control
Time perspective: Prospective
Keywords: Heart Failure; MRI; Ultrasound; Fibrosis; Biomarker
Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study is being conducted to learn more about the role of diet and exercise in regulating
      plasma triglyceride (fat) metabolism. The investigators will examine the effect of acute (24
      hour) changes in energy intake and expenditure on fat metabolism the following day.
    

Detailed description: 
      Excess body fat and a sedentary lifestyle are associated with increased plasma triglyceride
      (TG) and apolipoprotein B-100 (apoB-100) concentrations, which are important risk factors for
      the development of cardiovascular disease.

      Weight loss and endurance exercise improve plasma lipid and lipoprotein concentrations.
      However, the mechanisms responsible for this effect are largely unknown, and much uncertainty
      remains regarding the independent roles of dietary energy intake, exercise energy
      expenditure, and net energy balance in controlling plasma TG concentrations.

      The main goal of this project, therefore, is to investigate the mechanisms by which acute
      alterations in energy balance, induced by diet and/or physical activity (endurance exercise),
      regulate very-low density lipoprotein (VLDL) metabolism.

      Subjects will be asked to perform 3 separate trials. One of these will always be an "energy
      balance" trial that will act as the control trial for the other 2 trials they perform.
      Subjects will therefore be randomized to 2 different study arms.
    

Intervention name(s): Positive energy balance; Energy balance with exercise; Negative energy balance; Negative energy balance with exercise; Energy balance
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.; Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.; Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.; Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial; Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fat metabolism; exercise; liver; lipoproteins; triglycerides
Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia
Condition: Hernias, Diaphragmatic, Congenital
MeSH terms: Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic
Study type: Interventional

Summary: 
      Congenital diaphragmatic hernia (CDH) is a life-threatening condition with long-term
      complications including respiratory tract infections, respiratory muscle weakness, and
      abnormal lung functions. This study, therefore, has been designed to ascertain the effect of
      chest resistance exercise and chest expansion exercise on respiratory muscle strength, lung
      function, and chest mobility in children with post-operative CDH.
    

Detailed description: 
      With the advances in surgical and neonatal treatment, the survival rates in children with CDH
      have been improved in the last decades. The surviving children may suffer from long-term
      complications such as impairments in lung growth (lung hypoplasia), cardiovascular disorders,
      pulmonary hypertension, gastrointestinal problems, and recurrent occurrence of lower
      respiratory tract infection. One of the physical therapy techniques used to treat chest
      disorders via encouraging the normal alignment of respiratory muscles with respiratory rhythm
      is chest resistance exercise through applying resistance to the sternal and coastal areas .
    

Intervention name(s): chest resistance exercise; chest expansion exercises
Intervention type(s): Other; Other
Intervention description(s): lung function.; thoracic excursion
Other intervention name(s): respiratory muscle strength; POWER breath KH2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment