bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs).
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess and compare the safety and effectiveness of Autologous Bone
      Marrow-Derived MSCs (AutoBM-MSCs) in one group(group A) of SCI who are unlikely to be able to
      walk independently without treatment after 1 year of SCI, in the other group (group B) to
      assess the second group of Wharton Jelly derived mesenchymal stem cells ( WJ-MSCs) in the
      treatment of acute and subacute spinal cord injury (SCI) patients.
    

Detailed description: 
      The study will be directed by the Cell Therapy Center (CTC) in Jordan, where 20 SCI patients
      meeting the inclusion criteria will be recruited and divided according to the type of injury
      into two groups; Group A for patients with complete transection of the spinal cord, and Group
      B for SCI without a total transaction,10 patients will receive (AutoBM-MSCs)and the other 10
      patients with acute and subacute spinal cord injury will receive(WJ-MSCs) by a specialized
      spine surgeon into the spinal medulla. The outcomes and improvements will be assessed using
      the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and the Spinal Cord
      Independence Measure (SCIM) version III, in addition to blood tests, MRI, and somatosensory
      evoked potential (SSEP).
    

Intervention name(s): Collection and expansion of BM-MSC; VI-SCI evaluation and patients' follow up
Intervention type(s): Biological; Diagnostic Test
Intervention description(s): MSCs collection from patients owns marrow using a volume of 20 ml of bone marrow obtained from iliac crest of SCI patients under local anesthesia. Manipulations of blood and bone marrow are to be done according to Good Laboratory Practice (GLP) using the gradient sedimentation method.; At 6, and 12 months post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
The (ASIA)/(ISNCSCI) score will be repeated every 3 months to evaluate any motor or neurological changes
The Spinal Cord Independence Measure (SCIM III) score will be repeated every 3 months to evaluate the effect on daily activities.
Blood samples will be withdrawn from patients at 3 months interval for biomarkers detection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with complete transection of the spinal cord. Each group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal cord injuries; Mesenchymal Stem Cells; Allogenic; Bone marrow derived Mesenchymal stem cells; American Spinal Injury Association Impairment Scale
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
Condition: Cardiac Catheterization; Retina; Embolism
MeSH terms: Embolism
Study type: Interventional

Summary: 
      Retinal emboli is a common phenomenon in cardiac catheterization. In this study the
      investigators evaluate the incidence of retinal emboli post diagnostic and therapeutic
      cardiac catheterization over 300 patients. The incidence was 6.3% and had no clinical sequel
      on visual acuity and visual field.
    

Detailed description: 
      Background and Purpose Cardiac catheterization may cause retinal embolization, a risk factor
      for cerebrovascular emboli and stroke. We describe the incidence of clinically silent and
      apparent retinal emboli following diagnostic and interventional coronary catheterization and
      associated risk factors.

      Methods Three hundred selected patients attending a tertiary referral center for diagnostic
      and therapeutic cardiac catheterization were studied. Direct retinal examination and
      examination of the visual field and acuity were done before and after catheterization by a
      retinal specialist.
    

Intervention name(s): diagnostic cardiac catheterization; therapeutic cardiac catheterization
Intervention type(s): Procedure; Procedure
Intervention description(s): coronary intervention: angiography; cardiac catheterization: angioplasty
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Catheter; coronary artery disease; embolus; stroke; retinal emboli
Cognitive-Behavioral Therapy in Veterans With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This is a study comparing the benefits of two types of individual psychotherapy
      (cognitive-behavioral therapy for psychosis and supportive therapy) in symptomatic Veteran
      outpatients diagnosed with schizophrenia or schizoaffective disorder. Treatment lasted
      approximately 6 months, with outcome data on symptoms, functioning, and distress levels
      collected at baseline, post-treatment, and 6 months post -treatment follow-up.
    

Detailed description: 
      This is a randomized controlled trial comparing 6 months of participation in one of two
      active treatments, cognitive-behavioral therapy for psychosis or supportive therapy in
      symptomatic Veterans diagnosed with schizophrenia or schizoaffective disorder who are still
      symptomatic. Assessments of clinical status and social functioning were obtained at baseline,
      end of treatment, and 6 month follow-up. We hypothesized that participation in the
      cognitive-behavioral therapy would lead to greater reductions in symptoms and distress about
      symptoms, and more improvements in social functioning.
    

Intervention name(s): Supportive Therapy (ST); Cognitive Behavioral Therapy for Psychosis (CBTp)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery; approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: clinical trials; psychotherapy
Normal Human Plasma Level of iNOS Study
Condition: Normal Human Plasma Level of iNOS
Study type: Observational

Summary: 
      The discovery that inducible nitric oxide synthase (iNOS) circulates in people who are
      developing the sepsis pathology has provided an opportunity to develop a first-in-class
      diagnostic test for the onset of sepsis. This study is designed to determine the normal human
      plasma level of circulating iNOS as the initial reference level against which hospitalized
      patients at risk for the development of sepsis can be compared to ascertain if the patient is
      at risk for becoming septic based upon an elevated level of plasma iNOS.
    

Detailed description: 
      Infections in intensive care units (ICUs) and other hospital settings can be caused by
      different types of organisms, such as bacteria and fungi. Yearly, these infections cause at
      least 2 million patients in the USA to enter the early stages of the sepsis pathology
      (pre-sepsis) which will lead to more than 750,000 cases of sepsis that can deteriorate into
      life-threatening severe sepsis with organ dysfunction and septic shock with multiple organ
      failure and result in more than 250,000 deaths per year. At present, an accurate clinical lab
      test to predict the onset of the sepsis pathology does not exist. Thus, there is a large
      unmet clinical lab need for a test that can aid physicians in assessing the risk their
      hospitalized patients have for developing the sepsis pathology. A reliable test for
      predicting very early the onset of sepsis would be a major medical breakthrough. However, a
      reference level for normal healthy individuals is needed against which plasma levels can be
      compared for increased (or decreased) levels of iNOS.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Reference values will be obtained from 100 plasma samples obtained from healthy normal
        humans collected prospectively under an IRB approved protocol and informed consent after
        blood donation for use in research. The 100 normal human plasma samples will be assayed
        using the PliNOSa test.
      
Biospecimen description: 
      heparinized plasma samples
    
Keywords: reference range; plasma; inducible nitric oxide synthase; iNOS; healthy adults
HIV Vaccine Trial in Thai Adults
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether immunizations with an integrated
      combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in
      healthy Thai volunteers.
    

Detailed description: 
      A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts
      to control the HIV pandemic. In this phase III efficacy trial, a 'prime-boost' vaccine
      strategy is evaluated for prevention of infection and amelioration of disease course.
      ALVAC-HIV (vCP1521) from sanofi pasteur is given as the 'prime' vaccine at months 0, 1, 3 and
      6; AIDSVAX gp120 B/E from VaxGen is given as the 'boost' at months 3 and 6. This regimen will
      be given to 8,000 adult Thai subjects, while another 8,000 will be given placebos in a
      double-blinded, randomized manner. Following the completion of each subjects immunization
      phase, he/she will be followed for 3 years with clinic visits every 6 months with HIV
      testing, pre- and post-test counseling. Subjects who become HIV infected will be counseled,
      referred to HIV treatment facilities for management according to national guidelines, and
      offered enrollment in a protocol for extended follow-up.
    

Intervention name(s): ALVAC-HIV vCP1521 + AIDSVAX; ALVAC Placebo + AIDSVAX Placebo
Intervention type(s): Biological; Other
Intervention description(s): Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL; ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Other intervention name(s): ALVAC-HIV (vCP1521) >106 CCID50 per 1 mL dose; AIDSVAX® B/E; Bivalent HIV gp120 vaccine subtype B (MN), and E (A244); ALVAC carrier lyophilized product without virus; Aluminum hydroxide adjuvant
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity
The Clinical Difference Between the Nonfatal Patients and the Fatal Patients With Severe COVID-19
Condition: Coronavirus Disease 2019; Character of the Severe Patients
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019
      (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to
      compare the clinical information (laboratory and radiologic characteristics)of nonfatal
      participants and fatal cases. The investigators wish figure out the clinical character of the
      fatal participants. The result may help the physician to find the fatal patients with
      COVID-19 more easily. The fatal patients with COVID-19 could be treated early.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The patients with Coronavirus Disease 2019
A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074
Condition: Healthy; HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the
      antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in
      HIV-infected and HIV-uninfected individuals.
    

Detailed description: 
      In preclinical studies carried out in humanized mice and non-human primates, 10-1074 alone or
      in combination with other neutralizing antibodies led to protection from HIV or simian/human
      immunodeficiency virus (SHIV) infection and also to sustained suppression of HIV plasma
      viremia. The aims of this protocol are to evaluate the safety, tolerability and
      pharmacokinetics profile of 10-1074 in both HIV-infected and HIV-uninfected individuals, and
      its antiretroviral activity in HIV-infected individuals.
    

Intervention name(s): 3 mg/kg, single dose IV administration of 10-1074; 10 mg/kg, single dose IV administration of 10-1074; 30 mg/kg, single dose IV administration of 10-1074
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 mg/kg, single dose IV administration of 10-1074; 10 mg/kg, single dose IV administration of 10-1074; 30 mg/kg, single dose IV administration of 10-1074
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; 10-1074; Monoclonal Antibody
Epiretinal Proliferation in Eyes With Full Thickness Macular Hole
Condition: Macular Disease
MeSH terms: Retinal Perforations
Study type: Observational

Summary: 
      We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes
      with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was
      detected and detection of EP was correlated to the visual improvement.
    

Detailed description: 
      We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes
      with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was
      detected and detection of EP was correlated to the visual improvement.
    

Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The eyes with macular hole
      
Keywords: idiopathic macular hole
Divided Attention Steering Simulator Alertness Test
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Driving simulator programmes are used under a wide range of conditions, and a correlation of
      driving performance and real accident risks in patients with obstructive sleep apnoea
      syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided
      Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until today
      there are no reference levels with regards to sex and age in existence. To define the
      boundaries of normality age and sex reference values are to be generated and compared to
      values of patients with OSAS.

      50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will
      perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as
      well. A better differentiation of pathologic driving performance and response times of OSAS
      patients should be possible with new reference levels.
    

Detailed description: 
      The DASS programme records several data, including mean and absloute errors and standard
      deviations from centre and curve.

      Additionally the response time to a randomly appearing target number is recorded (divided
      attention).

      The standard deviation (curve) is the difference between the steering angle and the road
      angle. Standard deviation (centre) is the standard deviation of the centre of the car from
      the centre of the road.

      Steering performance is quantified as the standard deviation of the error from a theoretical
      perfect path.

      The secondary task of the divided attention test is to respond to a randomly appearing target
      number at the sides of the monitor while trying to keep the car in the centre of the road.

      Average Reaction time is the average time (in seconds) it takes the subject to respond to the
      target numbers.
    

Intervention name(s): Divided Attention Steering Simulator (DASS)
Intervention type(s): Other
Intervention description(s): Half-hour divided attention test with steering wheel after 5 to 10 minutes of practice. Completion of three questionnaires (ESS, Young, Berlin Questionnaire).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: alertness test; sleepiness; vigilance; Sleep Apnea, Obstructive
Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs
Condition: Myofascial Pain Syndrome
MeSH terms: Shoulder Pain; Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will
      explore muscle contractility characteristics, the occurrence of post-intervention muscle
      soreness and the effect of dry needling on muscle contractile characteristics and clinical
      outcomes.
    


Intervention name(s): Dry needling
Intervention type(s): Procedure
Intervention description(s): Insertion of acupuncture needle into a myofascial trigger point.
Other intervention name(s): Acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: TP; Myofascial pain
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      A 12-week clinical research study to evaluate the tolerability, efficacy and safety of
      ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS
      in the United States.
    


Intervention name(s): ropinirole
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: RLS; Restless Legs Syndrome
Steps for PRosTAte Cancer Health and Survival (SPaRTACuS): Pilot Study of a Walking Intervention to Improve Health and Quality of Life in Prostate Cancer Patients
Condition: Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether sustainable daily physical activity is
      effective in improving biological indicators of health and self-reported quality of life in
      men with prostate cancer.
    

Detailed description: 
      Living with prostate cancer is a unique challenge faced by millions of men across the globe.
      Existing research has indicated many potential methods of attenuating prostate cancer
      progression and preserving patients' quality of life, but is lacking in definitive
      conclusions regarding the effectiveness of these methods in practice. This study seeks to
      further investigate the impact of post-diagnosis physical activity on biological indicators
      of health and self-reported quality of life in a cohort of men with prostate cancer in
      Sweden. Participants are randomized to either a walking intervention group, which encourages
      walking 10,000 steps per day for one year, or to a standard-or-care control group, and
      followed for 11 weeks.
    

Intervention name(s): Walking Intervention; Standard of Care
Intervention type(s): Behavioral; Other
Intervention description(s): Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention. Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse. Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day. This journal is submitted to investigators at the end of the intervention period.; Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prostate Cancer
Comparative Bioavailability Study of Lisinopril Tablets, 10 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets
      and IPR Pharmaceuticals, Inc. Zestril (R).
    

Detailed description: 
      To compare the bioavailability of Par and IPR (Zestril(R)), Lisinopril 10 mg Tablets under
      fasting conditions.
    

Intervention name(s): Lisinopril; Zestril
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 10 mg, single dose; Tablets, 10 mg, single dose
Other intervention name(s): Zestril; lisinopril
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; lisinopril; fasting
A Study in Healthy Volunteers to Compare the Profiles of DA-3880 and EU Sourced ARANESP® (Amgen)
Condition: Symptomatic Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to determine whether the test product and the reference
      product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a
      single intravenous dose and as a single subcutaneous dose of each of the formulations. The
      study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.
    


Intervention name(s): DA3880; Aranesp
Intervention type(s): Drug; Drug
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function
Condition: Healthy
Study type: Interventional

Summary: 
      This study will evaluate the physiological and pathophysiological determinants of pregnancy
      and feeding method on the maternal cardiovascular system. This includes non-invasive
      measurements.
    


Intervention name(s): Breastfeeding; Bottlefeeding
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Breastfeeding; Bottlefeeding
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Healthy women during pregnancy and in the postpartum period