bioihbjkbjnl/mcl2 huggingface dataset:
Effects of the TNF-alpha Inhibiton on Hemodynamic Parameters in Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Resistant hypertension (RH) is characterized by high blood pressure (BP) in spite of
      concurrent use of three or more antihypertensive agents of different classes, combined at
      optimal doses. Currently it has been largely discussed the influence of inflammation in RH.
      The BP variation promotes increased expression of pro-inflammatory cytokines, such as tumor
      necrosis factor-alpha, interleukins 1 and 6. It was showed that treatment with TNF-α
      inhibitor improves BP and endothelial function, and reduces arterial stiffness in patients
      with rheumatoid arthritis. Recently, it was demonstrated that TNF-α levels are increased in
      RH subjects compared to normotensives. This study aims to assess whether the acute inhibition
      of TNF-α changes hemodynamic parameters, such as mean BP levels in RH.
    

Detailed description: 
      This crossover, double-blind study will include 12 resistant hypertensive subjects -
      regularly followed at the Outpatient Resistant Hypertension Clinic/UNICAMP - which will
      randomized assigned to (1) saline infusion followed by infliximab infusion (TNF-α inhibitor,
      3 mg/kg) and (2) infliximab followed by saline, for two hours and washout of the 40-day
      period between both infusions. It is expected that the TNF-α inhibition regulates hemodynamic
      parameters, such as mean BP, cardiac Output, total peripheral resistance, which may allow a
      better rational approach for the RH treatment.
    

Intervention name(s): Infliximab; Saline
Intervention type(s): Biological; Other
Intervention description(s): Monoclonal antibody biologic drug that inhibits tumour necrosis factor alpha (TNF-α), 3 mg/kg for 2 hours (250mL); Saline for 2 hours (250mL)
Other intervention name(s): Tumour necrosis factor alpha (TNF-α) inhibitor
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: blood pressure; inflammation; tumor Necrosis Factor-alpha
Clinical Benefits of B-Flow Ultrasound
Condition: Evidence of Liver Transplantation; Arterial Occlusive Diseases; Hypertension; Pregnancy, High Risk; Pregnancy
MeSH terms: Hypertension; Arterial Occlusive Diseases
Study type: Interventional

Summary: 
      The goals of this study are to evaluate the efficacy of the B-flow capability on the LOGIQ E9
      system in three clinical focus areas.

        1. Liver transplant patients: Improved real-time visualization of liver vessels is needed
           to improve diagnosis and assessment following stenting or angioplasty.

        2. Renal artery disease: Improved real-time visualization of the renal arteries would
           enable a more rapid and accurate assessment of renal artery disease (stenosis,
           dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal artery
           interventions.

        3. Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta
           perfusion and assay for potential ischemia.
    


Intervention name(s): GE LOGIQ E9 Ultrasound System
Intervention type(s): Device
Intervention description(s): Subjects will have an ultrasound exam using the GE LOGIQ E9 Ultrasound System which has computer software that combines the color-flow image and B-mode image to produce the new "B-Flow" method of ultrasound.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ultrasound; Ultrasonography; Liver transplantation; Arterial Occlusive Diseases; Hypertension; Pregnancy, High Risk; Pregnancy
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
Condition: Kidney Transplantation
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to validate an MRI method to detect renal fibrosis in patients
      after kidney transplantation (KT).
    

Detailed description: 
      The hypothesis underlying this proposal is that qMT reliably detects development of allograft
      fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool
      fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years
      after living donor KT. The bound pool fraction will also be compared to renal blood flow,
      oxygenation, and function, and the ability of qMT to provide consistent assessments of
      fibrosis tested at different magnetic field strengths. Two specific aims will test the
      hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of
      fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human
      kidney allografts is reproducible at 1.5 T and 3.0 T.
    

Intervention name(s): MRI 1.5T and 3.0T
Intervention type(s): Other
Intervention description(s): Magnetic Resonance Imaging for Renal Fibrosis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, unblinded, Parallel, imaging study
Masking: None (Open Label)
Primary purpose: Basic Science
Multicenter Selective Lymphadenectomy Trial (MSLT)
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their
      melanoma. If the melanoma meets study requirements, the subject is randomized to receive
      either (1) no further surgical procedures as part of the study or (2) a Selective
      Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then
      followed for 10 years.
    


Intervention name(s): Sentinel Lymph Node Dissection; Complete Lymph Node Dissection; Wide Excision
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Subject has wide excision and sentinel lymph node dissection for primary melanoma.; Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.; Subject has wide excision only for primary melanoma.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLND; Sentinel; Melanoma; Surgical
Financial Incentives to Improve Medication Adherence
Condition: Schizophrenia; Schizo Affective Disorder; Bipolar Disorder; Depression
MeSH terms: Schizophrenia; Bipolar Disorder; Mood Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Medication adherence is a challenge in all of medicine and is associated with multiple
      negative outcomes. Strategies to better measure and enhance adherence to medication are
      urgent and necessary to minimize unwanted health outcomes, hospitalizations, poorer quality
      of life and excessive costs for individuals, insurers and caregivers. Recently, behavioral
      economics-based approaches have emerged as a promising tool to address this unmet need, but
      its effectiveness in oral antipsychotic treatment remains to be assessed. For this project,
      investigators will use an app that offers financial incentives to increase compliance for
      patients with chronic diseases. Investigators intend to enroll 25 patients in a pilot project
      to assess feasibility of offering financial incentives to improve medication adherence in
      severe mental illness.
    


Intervention name(s): Wellth - Financial Incentives
Intervention type(s): Other
Intervention description(s): Patients who are willing to participate will be offered financial incentives for medication adherence through an app (Wellth) over 10 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: financial incentives; medication adherence; severe mental illness
To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Alkotinib Capsules in Healthy Subjects
Condition: NSCLC
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of food to Alkotinib Capsules in healthy subjects
    

Detailed description: 
      Alkotinib is an insulin receptor tyrosine kinase inhibitor that selectively inhibits
      anaplastic lymphoma Kinase and proto-oncogene protein ROS1。Alkotinib is expected to be used
      in the treatment of ALK positive and ROS1 positive metastatic non-small cell lung Cancer and
      other cancers include patients with non-small cell lung cancer who are resistant to treatment
      with the first generation ALK inhibitor, such as kezotinib。
    

Intervention name(s): Alkotinib（300mg)
Intervention type(s): Drug
Intervention description(s): 1. First empty stomach, after the meal.2. After eating first, after fasting.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject was randomly given Alkotinib capsules on an empty stomach or after a meal, and the cleaning period between the two dosages was set as 14 days. The actual dosing time was subject to the original clinical records. After admission to the ward on day -1 (1 day before drug administration), subjects will eat light dinner A 1:1 ratio was randomly assigned to 2 sequences (1=AB, 2=BA). Each subject was subject to two cycles of trials, and the study drug was taken once on an empty stomach or after meal according to the dosing sequence in the randomization table.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Alkotinib
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers
Condition: Anaphylaxis
MeSH terms: Anaphylaxis
Study type: Interventional
Phase: Phase 4

Summary: 
      Food allergy affects up to 2% of adults and 8% of children in the United Kingdom (UK), and is
      a major public health issue. It is the commonest cause of life-threatening allergic reactions
      (anaphylaxis), which can be fatal. Adrenaline (epinephrine) auto-injector (AAI) devices are
      the first-line treatment for anaphylaxis, yet in a UK survey, over 80% of 245 teenagers
      experiencing anaphylaxis did not use their AAI. Delays in, or lack of adrenaline
      (epinephrine) administration during anaphylaxis are risk factors for fatal anaphylaxis.

      In 2010, a coroner's investigation into the death of a food-allergic teenager in the UK
      raised several questions around AAI safety and efficacy, since the teenager died despite
      administering her auto-injector device. This prompted a review by the Medicines and
      Healthcare products Regulatory Agency (MHRA) in 2014 into the clinical and quality
      considerations of AAIs. Two recommendations which came from the review was that companies
      'should be encouraged to develop a 0.5mg [dose] AAI.' In the UK currently only Emerade, one
      of the three companies selling AAIs, manufactures a 0.5mg (500mcg) version. Emerade also has
      a longer needle length (23mm) compared to other AAIs (typically 15mm).

      The investigators plan to formally assess the pharmacokinetics (PK) and pharmacodynamics (PD)
      of self-injection with intramuscular adrenaline (epinephrine) in teenagers at risk of
      anaphylaxis due to food allergy, and have been prescribed AAI.

        1. The investigators will compare self-injection with 300mcg vs 500mcg in teenagers of body
           weight >40kg. In a 40kg person, an adrenaline dose of 300mcg results in an effective
           UNDER-dosing of 30% by body weight.

        2. The investigators will also assess the impact of needle length on injection, by
           comparing two different devices, both of which deliver 300mcg, but one via a 15mm needle
           and the other with a 23mm needle.
    


Intervention name(s): Epipen 0.3mg; Emerade 300mcg; Emerade 500mcg
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Epipen 0.3mg auto-injector; Emerade 300mcg auto-injector; Emerade 500mcg auto-injector
Other intervention name(s): Epinephrine; Epinephrine; Epinephrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Research of Serum Procalcitonin, ESR, CRP And Leukocyte Levels in Fertile Missed Abortion Cases
Condition: Abortion, Missed
MeSH terms: Abortion, Missed
Study type: Observational

Summary: 
      Aim: The serum procalcitonin, erythrocyte sedimentation rate, c-reactive protein and
      leukocyte values will be compared between fertile missed abortion diagnosed pregnants and
      fertile normal pregnants to determine the presence of subclinical infection in the etiology
      of missed abortion
    

Detailed description: 
      The study group will consist of 30 fertile, under 35 years old women having for the first
      time missed abortus diagnosis in the Obstetrics Department of Obstetrics and Gynecology of
      Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine. As control
      group, 30 cases with the same trimester, fertile, and under 35 years old who had referred to
      Obstetrics clinic, who had no systemic disease, will be included in the study. Blood samples
      will be collected at the time of diagnosis of the patients with missed abortion and in normal
      pregnancy in the week of 20th gestational week and will send to Biochemistry laboratory to
      examine procalcitonin, erythrocyte sedimentation rate, c-reactive protein and leukocyte
      values in their sera. The age, weight, gestational week, gravida (number), parity (number),
      abortus (number), body mass index, systemic diseases, blood group, smoking information,
      binary test results, and results of genetic analysis will be collected in both groups. The
      pathology results of the missed abortion group will also be collected. The results will
      statistically be compared in the SPSS 13.0 program in both groups.
    

Intervention name(s): study
Intervention type(s): Diagnostic Test
Intervention description(s): procalcitonin, sedimentation, CRP, leukocyte identification
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        60 pregnant women
      
Biospecimen description: 
      Blood Serum, abortion materials
    
Keywords: Missed abortion; Procalcitonin; Erythrocyte sedimentation rate (ESR); C-reactive protein (CRP); Leukocyte (WBC)
Study of Fast-track Surgery in Hernia Repair and Laparoscopic Cholecystectomy
Condition: Surgical Training
Study type: Interventional

Summary: 
      All Danish trainees in surgery in a two-year period asked for participation when enrolled in
      the formal five-year training program for specialty in surgery. The participants are
      randomized for either educational intervention or control (without intervention). The
      intervention group receive a skills-lab course in hernia repair followed by an opportunity to
      perform 20 groin hernia repairs in their departments within 4-8 weeks. Their performance will
      be video recorded three times during the intervention and as follow-up at end of the first
      year of training. After termination of the hernia training program a similar program for
      laparoscopic cholecystectomies are made. Each participant receive both intervention. The
      control group are video recorded at start of their first year and at end. All videos are
      blindly assessed with a validated rating scale of operative performance. The purpose is to
      assess if a fast-track program improves technical skills and if a change is sustained.
      Furthermore we want to compare outcome in similar training programs in open and laparoscopic
      skills.
    


Intervention name(s): Fast-track training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Surgery; Training
Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the feasibility of applying neuromuscular
      electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and
      whether the electrical stimulation improve pain, function and muscle strength.
    


Intervention name(s): Rehabilitation exercises; Electrical Stimulation
Intervention type(s): Other; Device
Other intervention name(s): Neuromuscular Electrical Stimulation (NMES)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Low back pain; stabilization exercises; neuromuscular electrical stimulation
Perception, Cognition, and Gait in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The investigators are examining how aspects of daily function are perceived in persons with
      PD and in those who interact with them on a regular basis. If eligible, participants will
      receive a set of online questionnaires by email. The questionnaires will take about 1 hour to
      complete, and can be done at the participant's convenience. The investigators are looking for
      volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and
      proficient English speakers). If a spouse, family member, significant other or other close
      associate is available (age 18 or older, proficient English speakers), the investigators will
      send them questionnaires as well. There is no monetary or other compensation for this study.
      For more information, please contact the Vision and Cognition Laboratory at
      vcognition@gmail.com or 617-358-1377.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants are accepted regardless of location, community, clinic, etc.
      
Keywords: Parkinson's Disease; Online Study; Quality of Life; Activities of Daily Living; Perception; Cognition; Gait
Lifestyle Education and Nutrition Demonstration
Condition: Chronic Disease
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven
      track record of engaging patients in healthy living and eating through education, live
      cooking demonstrations / hands-on cooking classes, exercise and stress management programs.

      As a result of the Community Health Needs Assessment, we are collaborating with Cleveland
      Clinic Community Outreach and 12th District Representative, John E. Barnes, Jr., to extend
      our expertise to the community of Warrensville Heights, Ohio.
    

Detailed description: 
      The City of Warrensville Heights and The Cleveland Clinic are combining efforts to address
      the paucity of fresh and nutritious foods accessible to seniors in the Warrensville Heights
      community through a new program at the city's Civic and Senior Center. This program will
      combine healthy lifestyle education with nutrition demonstration using recipes that can be
      prepared in a blender. These recipes have been designed to be simple, delicious and easy to
      eat, and include smoothies, soups and even a few desserts! Our ultimate goal is to use both
      education and demonstration to promote a mindset change regarding community members'
      abilities to eat healthy.

      The population in the Warrensville Heights community is aging, and there is a high prevalence
      of chronic diseases including hypertension, diabetes, obesity and kidney disease. A recent
      Community Health Needs Assessment (CHNA) identified engagement and participation in the
      promotion and maintenance of a healthy lifestyle as a major area for improvement. Currently
      there is very limited access to healthy foods in the immediate community of Warrensville
      Heights, and in many cases, the transportation costs required for residents to access those
      healthy foods is often financially unfeasible. It is clear from this CHNA that both access to
      and education about healthy food options is sorely needed in this community.

      The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven
      track record of engaging patients in healthy living and eating through education, live
      cooking demonstrations / hands-on cooking classes, exercise and stress management programs.
      In response to the CHNA and in collaboration with 12th District Representative, John E.
      Barnes, Jr., the BLENDS study will extend our expertise to the Warrensville Heights
      community.
    

Intervention name(s): Lifestyle Education and Cooking Demonstration
Intervention type(s): Other
Intervention description(s): Participants will receive an interactive cooking demonstration as well as healthy lifestyle education
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lifestyle; Nutrition; Cooking
Pharmacokinetic Study in Healthy Volunteers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I open, randomized cross-over pharmacokinetic study.
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa,
      3-OMD and ODM-104 after repeated doses of levodopa, carbidopa and ODM-104: an open,
      randomized, multicenter study with crossover design in healthy males and females.
    

Intervention name(s): levodopa, carbidopa, ODM-104; levodopa, carbidopa, entacapone
Intervention type(s): Drug; Drug
Other intervention name(s): Sinemet; Stalevo
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment