bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the possible effect of using dual-tDCS applied
      during conventional physical therapy on lower limb function in stroke patients.
    

Detailed description: 
      Recently dual-tDCS applied before the conventional physical therapy show positive effect of
      lower limb performance. However to explore the time during which dual-tDCS can be combined
      with physical therapy to maximize motor performance is required. Results from the present
      study with be compared with our previous study that used dual-tDCS applied before physical
      therapy.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Dual Active/sham tDCS will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy. Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 2 weeks. The two experiments will be performed in random order for each subject.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Amlodipine for Myocardial Iron in Thalassemia
Condition: Thalassemia
MeSH terms: Thalassemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Children with thalassemia may have high iron levels after receiving blood transfusions. These
      high iron levels can have damaging effects on the body, especially the heart. Conventionally
      only chelation therapy was given for prevention of iron buildup in the heart. However,
      current research has shown that another drug, amlodipine, also helps to slow down the
      deposition of iron in the heart. This study is designed to see if patients receiving
      amlodipine along with their regular chelation therapy have a slower rate of iron buildup in
      the heart when compared with patients who are receiving chelation only.
    

Detailed description: 
      Null Hypothesis There is no difference between the efficacy of chelation plus amlodipine
      therapy and chelation therapy alone in retarding the rate of myocardial iron deposition in
      thalassemia patients with iron overload and a constant transfusion need.

      Alternate Hypothesis Chelation plus amlodipine therapy is more efficacious than chelation
      therapy alone in retarding the rate of myocardial iron deposition in thalassemia patients
      with iron overload and a constant transfusion need.

      The aim of the investigators study is to determine if amlodipine, an L-type specific calcium
      channel blocker, in addition to the standard aggressive chelation therapy, can retard the
      deposition of iron in the myocardium of thalassemia patients with significant myocardial iron
      load with or without cardiomyopathy.
    

Intervention name(s): Standard Chelation; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): This will comprise of standard chelation drugs (Deferasirox or Deferoxamine or Combination of Deferoxamine and Deferiprone).The dosage and drug used will depend on ferritin levels and individual requirement, as determined by the treating hematologist and will be in accordance with the Iron chelation guidelines from Pakistan Thalassemia Society.; doses of 0.2 to 0.25 mg/kg/day PO would be given during this trial
Other intervention name(s): Asunra or Kelfer or Desferal; L-type calcium channel blocker
Intervention MeSH terms: Amlodipine; Calcium Channel Blockers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Thalassemia; Amlodipine; Chelation; T2*; MRI; Myocardial Iron
Relationship Between Hamstring Length and Gluteus Maximums in Mechanical Low Back Pain
Condition: Mechanical Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The aim of this study was to determine the correlation between hamstring length and gluteus
      maximus strength with and without normalization in patients with mechanical low back pain
    

Detailed description: 
      seventy-three patients diagnosed as mechanical low back pain. Firstly, gluteus maximus (GM)
      strength was measured isometrically as a force (kg) and then converted to torque (Nm). GM
      strength was normalized for body weight and height using the following formula: % (body
      weight × h) = torque (N × m) ×100 / body weight (N) × h (m), then assessment of hamstring
      length flexibility using the active knee extension method.

      Data was collected and the correlation was determined.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  Male and female patients

          -  Age ranged from 18-40 years

          -  Body mass index ranged from 25-30 kg/m2
Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare three consistency lots of ProQuad to each other as well as to M-M-R
      II and Varivax, administered concomitantly at different injection sites, with respect to
      immunogenicity, safety, and tolerability.
    


Intervention name(s): Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: Varivax; Comparator: M-M-R II
Intervention type(s): Biological; Biological; Biological
Intervention description(s): A Single 0.5 mL subcutaneous injection at Day 0; A Single 0.5 mL subcutaneous injection at Day 0; A Single 0.5 mL subcutaneous injection at Day 0
Other intervention name(s): ProQuad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
Condition: Psoriasis; Inflammation
MeSH terms: Psoriasis; Inflammation
Study type: Observational

Summary: 
      This is a prospective longitudinal observational pilot study of psoriasis patients on
      continuous standard-of-care systemic therapeutics to determine the level of change in
      established (plasma/serum) and investigative (cellular) biomarkers that are associated with
      increased risk of CVD events.

      The final endpoint of the proposed study will be a ranking of the examined biomarkers based
      upon an integrated assessment of biomarker behavior over time.

      Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI,
      skin biopsies, and clinical improvement.
    


Intervention name(s): Methotrexate; Ustekinumab; Etanercept; Adalimumab; Acitretin; UVB Excimer Laser; Narrowband UVB
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other; Other
Intervention description(s): Subjects will receive Methotrexate as detailed in the "Group" description.; Subjects will receive Ustekinumab as detailed in the "Group" description.; Subjects will receive Etanercept as detailed in the "Group" description.; Subjects will receive Adalimumab as detailed in the "Group" description.; Subjects will receive Acitretin as detailed in the "Group" description.; Subjects will receive UVB Excimer Laser therapy as detailed in the "Group" description.; Subjects will receive Narrowband UVB as detailed in the "Group" description.
Intervention MeSH terms: Adalimumab; Etanercept; Methotrexate; Ustekinumab; Acitretin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Psoriasis patients
      
Biospecimen description: 
      Skin biopsies and blood samples will be collected
    
Keywords: psoriasis, comparative effects, inflammation
A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label, Phase II study of intravenous (IV) SHR-1210 at 200mg,q2w
      in combination with Apatinib at two dose levels in subjects with locally advanced or
      metastatic non-small cell lung cancer (NSCLC).

      The study is composed of two parts. Part 1 of the study will determine the safety
      ,tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib.

      Part 2 includes a randomized comparison of Apatinib 250mg/d or 500mg/d plus SHR-1210 .

      Subject's tumors will be screened at baseline for EGFR mutations, EML4-ALK translocation, and
      PD-L1 expression.But positive tumor PD-L1 expression will not be required for enrollment.
    

Detailed description: 
      SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a
      new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase
      inhibitor (TKI). A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in
      Apatinib phase II study in patients with NSCLC.
    

Intervention name(s): SHR-1210; Apatinib
Intervention type(s): Biological; Drug
Intervention description(s): SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg; Apatinib tablet will be administered orally,once daily until progression
Other intervention name(s): Apatinib Mesylate
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SHR-1210; Apatinib; NSCLC
A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia
Condition: Agitation
MeSH terms: Psychomotor Agitation; Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of Intramuscular
      Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared
      with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of
      study (72 hours after first dosing) from baseline.
    

Detailed description: 
      Secondary Outcome Measures:

      To evaluate the change of Agitation Calmness Evaluation Scale(ACES), Clinical Global
      Impression(CGI, including CGI-S and CGI-I),PANSS total scores,Brief Psychiatric Rating
      Scale(BPRS) total scores and every item of PANSS-EC from baseline to the end of study (Time
      Frame: 72 hours) [ Designated as safety issue: No ]

      To evaluate the change of patients' main complain, physical examination, lab and ECG tests,
      AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from
      baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: Yes ]
    

Intervention name(s): Intramuscular Haloperidol; Intramuscular Levosulpiride
Intervention type(s): Drug; Drug
Intervention description(s): 1ml：5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days.; 2ml：50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days.
Other intervention name(s): Intramuscular Haloperidol parenteral solution; Intramuscular Levosulpiride parenteral solution
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Sulpiride; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Agitation; Schizophrenia; Randomized; Blind; Parallel; Intramuscular Haloperidol; Controlled; Multicenter; Clinical Trial; Efficacy; Safety; Intramuscular Levosulpiride; Chinese; PANSS-EC; ACES; CGI; BPRS; PANSS; RSESE; BAS
A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)
Condition: Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of
      participants already receiving cytotoxic therapy. Additional blood and urine samples will be
      collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing,
      respectively.
    


Intervention name(s): Biomarker sample collection before and after dosing with cytotoxic agent(s); Biomarker sample collection before and after dosing with cytotoxic agent(s)
Intervention type(s): Other; Other
Intervention description(s): Participants will have blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s).; A second group of participants will have blood and urine samples collected at Visit 1 (there is no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Resistance Exercise in Healthy Men
Condition: Single Bout of Resistance Type Exercise; Standardized Diet
Study type: Interventional

Summary: 
      In the present study, the effects of age and dietary intake will be assessed on myocellular
      characteristics during 72 hours after a resistance type exercise session.
    


Intervention name(s): Adhere to a specific standardized diet for 4 days
Intervention type(s): Behavioral
Intervention description(s): 24 h before the start of the intervention all subjects will adhere to a standardized diet for 4 days. Young subjects are randomly allocated to either a low protein diet, regular protein diet or high protein diet group. All elderly subjects will adhere to a regular protein diet comparable to the regular protein diet of the young subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: ALS (Amyotrophic Lateral Sclerosis)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a study of transplantation of Astrocytes derived from human embryonic stem cells, in
      patients with Amyotrophic Lateral Sclerosis (ALS).

      There will be no change in the routine ALS treatment of the patients enrolled into the study.
      Treatment will be administered in addition to the appropriate standard of care treatment.

      The study hypothesis is that transplantation of Astrocyte(AstroRx) cells can compensate for
      the malfunctioning of patients' own astrocytes by restoring physiological capabilities like
      the reuptake of excessive glutamate, reducing oxidative stress, reducing other toxic
      compounds, as well as by secreting different neuroprotective factors
    


Intervention name(s): AstroRx
Intervention type(s): Biological
Intervention description(s): Astrocytes derived from human embryonic stem cells
Intervention model: Sequential Assignment
Intervention model description: Dose-escalating, four subject-groups clinical study; a single treatment administration of AstroRx, administered in an escalating low, medium and high dose or two consecutive administrations of the medium dose separated by an interval. AstroRx will be administered by intrathecal (spinal) injection to subjects with ALS at the early disease stage.
Masking: None (Open Label)
Primary purpose: Treatment
Mitigating ACEs in Pediatric Primary Care
Condition: Violence; Parenting
Study type: Interventional

Summary: 
      The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting
      intervention in pediatric primary care.
    

Detailed description: 
      The goal of the project is to affect policy and practice related to Adverse Childhood
      Experiences (ACEs) screening and intervention in pediatric primary care. First, the
      investigators will develop and test a new ACEs screening tool that is brief, has a pediatric
      perspective, builds on parents' strengths, and measures parenting-related ACEs that can be
      treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal
      punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration,
      mental illness). A research assistant will invite approximately 1000 parents to complete the
      survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior
      problems that the investigators hypothesize will be associated with elevated parenting
      scores. The second part of the project will be to recruit English and Spanish-speaking
      parents for a randomized controlled trial (RCT) to determine if educational interventions can
      help educate parents about ACEs and decrease parenting-related ACE scores two months
      post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to
      participate in the study. Parents in the intervention group will receive 1) a copy of the
      Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely
      multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will
      receive routine primary care. Follow up data will be obtained 2 months after enrollment.
    

Intervention name(s): Play Nicely Program
Intervention type(s): Behavioral
Intervention description(s): Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis
Study type: Observational [Patient Registry]

Summary: 
      Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the
      prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in
      Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it
      in other rheumatologic diseases.
    

Detailed description: 
      Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the
      prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in
      Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it
      in other rheumatologic diseases.

      This study aims at detecting the prevalence of subclinical HCV infection in different
      rheumatologic disease groups in Egypt.

      Consecutive patients with different rheumatologic diseases from seven- geographically
      different- rheumatology departments were prospectively studied. None of the patients was
      known to have previous HCV infection. Patients' serum samples were screened for the presence
      of anti-HCV antibodies. Patients with positive serology were further evaluated for the
      presence of HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)
    

Intervention name(s): HCV RT-PCR
Intervention type(s): Diagnostic Test
Intervention description(s): HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All rheumatologic and other muscloskeletal diseased patients attending Rheumatology clinic
        Assuit university hospital
      
Biospecimen description: 
      Patients' serum samples were screened for the presence of anti-HCV antibodies. All Patients
      were further evaluated for the presence of HCV ribonucleic acid by reverse transcriptase
      polymerase chain reaction (RT-PCR)
Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The primary objective of this study is to determine if Australian patients with schizophrenia
      treated with paliperidone palmitate under conditions of continuous monitoring of outcomes
      over a 12-month period achieve relapse rates comparable to published literature.
    

Detailed description: 
      This study involves the establishment of PEARL, an Australian Quality Use of Medicine
      clinical registry designed to collect clinical and social data on up to 300 patients with
      schizophrenia for a 12-month period after initiating treatment with intramuscular (IM)
      injections of paliperidone palmitate as part of their routine clinical care. Continuous
      feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment
      in PEARL should be considered only after the clinical decision to prescribe IM paliperidone
      palmitate has already been made because the treating physician has determined that this
      treatment is the best option for the patient. Observational Study - No investigational drug
      administered
    

Intervention name(s): paliperidone palmitate
Intervention type(s): Drug
Intervention description(s): Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
Intervention MeSH terms: Paliperidone Palmitate
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Australian patients with schizophrenia will be enrolled in the registry
      
Keywords: schizophrenia; paliperidone palmitate; INVEGA SUSTENNA; registries; quality of healthcare