bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Participants to Evaluate the Effects of Multiple Doses of JNJ-55308942 on Cytochrome P450 Substrate Activity and on the Pharmacokinetics of Levonorgestrel/Ethinyl Estradiol
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of JNJ-55308942: 1) high dose at steady
      state on the single dose pharmacokinetics of a cocktail containing selective probes of
      cytochrome P450 (CYP) enzymes (CYP3A, CYP2D6 and CYP2C19) in healthy adult participants (Part
      1); 2) high dose at steady state on the single dose pharmacokinetics of a combination oral
      contraceptive containing levonorgestrel and ethinyl estradiol in healthy female participants
      (Part 2); and 3) low dose at steady state on the single dose pharmacokinetics of a cocktail
      containing selective probes of CYP enzymes (CYP3A, CYP2D6 and CYP2C19) in healthy adult
      participants (Part 3).
    


Intervention name(s): JNJ-55308942 High Dose; JNJ-55308942 Low Dose; Levonorgestrel/Ethinyl Estradiol Fixed Dose combination (FDC); Drug Cocktail:Midazolam (2mg)/Omeprazole (20mg)/Dextromethorphan (30mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive high dose of JNJ-55308942 orally once daily.; Participants will receive low dose of JNJ-55308942 orally once daily.; Participants will receive 0.150 milligram (mg) levonorgestrel and 0.030 mg ethinyl estradiol FDC tablet orally.; Participants will receive single dose of drug cocktail consisting of midazolam (2 mg), dextromethorphan (30mg) and omeprazole (20 mg) orally.
Other intervention name(s): Microgynon 30
Intervention MeSH terms: Midazolam; Dextromethorphan; Omeprazole; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; JNJ-55308942; Estradiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Brentuximab Vedotin for Systemic Sclerosis
Condition: Diffuse Cutaneous Systemic Sclerosis; Scleroderma; dcSSc
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There is significant unmet need for effective treatment options for Diffuse Cutaneous
      Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of
      brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and
      targeted to the protein CD30 molecule expressed on activated immune cells There is evidence
      for CD30 involvement in SSc. This study represents the first step in determining safety and
      tolerability of brentuximab vedotin in SSc.
    

Detailed description: 
      This is a multicenter prospective double blind placebo controlled dose escalation safety
      clinical trial with brentuximab vedotin and stable background immunosuppressive therapy in
      adult individuals with Diffuse Cutaneous Systemic Sclerosis (dcSSc). Adult male and female
      participants with dcSSc will be recruited by a collaborative group of clinical sites in the
      United States. Participants who meet the eligibility criteria will be enrolled without regard
      to gender, race, or ethnicity.

      Eligible participants will be randomly assigned to study treatment, either brentuximab
      vedotin or placebo equivalent in a 6:2 ratio favoring brentuximab vedotin. Three dose cohorts
      are planned with 8 participants in each cohort, for a total of 24 participants who receive
      sufficient doses of the investigational medication to assess safety.

      The doses planned for each ascending dose cohort include 0.6mg/kg, 1.2 mg/kg, and 1.8 mg/kg
      brentuximab vedotin or placebo equivalent. All cohorts will receive intravenous
      administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.
      Following completion of treatment, participants will undergo follow-up visits at weeks 24,
      28, 36 and 48.
    

Intervention name(s): Brentuximab Vedotin; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.; Placebo control for blinding (masking), 0.95% normal saline.
Other intervention name(s): Adcetris®; Placebo for brentuximab vedotin
Intervention MeSH terms: Brentuximab Vedotin; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diffuse Cutaneous Systemic Sclerosis (dcSSc); Phase 1/2 clinical trial; dose escalation randomized trial; Brentuximab vedotin
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary study objective is to assess the feasibility of using the MindFrame System to
      safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients
      experiencing an ischemic stroke.
    

Detailed description: 
      The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely
      and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with
      acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it
      compares to other similar therapies. The events include but are not limited to symptomatic
      hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target
      vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments)
      arteries.
    

Intervention name(s): MindFrame System
Intervention type(s): Device
Intervention description(s): Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
Other intervention name(s): IRIIS System; Clot; Thrombus; Mechanical Thrombectomy; Ischemic Stroke; Intervention; Neurovascular
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Infarction; Stroke; Vascular Diseases; Central Nervous System Diseases; Penumbra; Functional Outcome; Aphasia; Hemiplegia; Left sided weakness; Right Sided weakness
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The study will include 60 patients after cardiac surgery. The first group will include 30
      patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed
      combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist
      of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of
      monotherapy.
    

Detailed description: 
      The patient signs an informed consent to participate in the study after tracheal
      extubation.The application of one or another method of influence is carried out by the method
      of random sampling (the envelope method). The drug Neodolpasse is used according to the
      following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a
      day with intervals between infusions about 12 hours. The second injection will be prescribed
      at VAS > 40 mm no earlier than 12 hours after the first. The first injection will begin
      immediately after tracheal extubation. Morphine analgesia controlled by the patient will
      begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the
      initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes;
      the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).
    

Intervention name(s): Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi); Analgesics
Intervention type(s): Drug; Drug
Intervention description(s): A decrease in the pain severity (VAS);opioid-sparing effect; A decrease in the pain severity (VAS)
Other intervention name(s): Fixed combination of Orfenadrine and Diclofenac; Patient-controlled analgesia (with Morphine)
Intervention MeSH terms: Diclofenac; Morphine; Analgesics; Analgesics, Non-Narcotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: analgesia, non-opioid, patient-controlled analgesia
Unrelated Donor Stem Cell Transplantation
Condition: Severe Aplastic Anemia; Paroxysmal Nocturnal Hemoglobinuria; Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Myeloproliferative Syndromes; Chronic Myelogenous Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Large Granulocytic Leukemia
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hemoglobinuria; Myelodysplastic Syndromes; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to provide an opportunity for patients with malignancies or bone
      marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic
      progenitor cell transplantation using cells from unrelated individuals or cord blood
      registries.
    

Detailed description: 
      same
    

Intervention name(s): Allogeneic transplantation
Intervention type(s): Procedure
Intervention description(s): Allogeneic transplantation with matched unrelated donors
Other intervention name(s): MUD transplant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transplant; Allogeneic; Allogeneic transplant; Unrelated donor transplant; MUD; HSCT; Stem cell transplant
Effect of Tesofensine on Weight Reduction in Patients With Obesity.
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose:

      To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine
      versus placebo in obese patients
    


Intervention name(s): Tesofensine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Validation of the Back Beliefs Questionnaire to the Turkish
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The Back Beliefs Questionnaire (BBQ) developed by Symonds et al. in 1996 is used to measure
      patient's attitudes and beliefs towards recovery and return-to-work; and expectations
      regarding the negative circumstances that could be created as a result of low back pain
      (LBP).The aim of this study was the translation to Turkish language, cross-cultural
      adaptation and assessment of reliability&validity of BBQ for the patients suffering from
      chronic LBP.
    

Detailed description: 
      Back Beliefs Questionnaire was translated and culturally adapted into Turkish regarding to
      the published guidelines. This observational cross-sectional study was performed with 110
      chronic low back pain patients. All participants were asked to complete Back Beliefs
      Questionnaire and also fill the socio-demographic data form and evaluation tools (Numeric
      rating scale-pain, Oswestry Disability Index, Fear Avoidance Beliefs Questionnaire, Hospital
      Anxiety and Depression Scale). Internal consistency was evaluated with Cronbach's alfa
      coefficient. Intraclass correlation coefficient was used to assess test-retest reliability.
      Structural validity was assessed by correlations with other tools.

      Back Beliefs Questionnaire had a good internal consistency (Cronbach alfa= 0.79) and an
      excellent test-retest reliability (Intraclass correlation coefficient = 0.84). A moderate
      correlation was determined between Back Beliefs Questionnaire and Fear Avoidance Beliefs
      Questionnaire. Correlations with Numeric rating scale-pain, Oswestry Disability Index,
      Hospital Anxiety and Depression Scale were fair.

      Turkish version of Back Beliefs Questionnaire is a valid and reliable questionnaire that can
      be used to evaluate beliefs about pain in patients with chronic low back pain.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who consulted to our Physical Medicine and Rehabilitation clinic during the period
        between June 2018 and April 2018; and volunteered to participate in this study were
        evaluated.
      
Keywords: low back pain; turkish language; pain beliefs; validity
Comparison of the Quality of Recovery After Cesarean Section Surgery
Condition: Postoperative Recovery; Abdominal Pain; Cesarean Section
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      Inadequate pain control after cesarean section surgery causes postpartum depression,
      persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether
      ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane
      (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid
      consumption after cesarean section surgery.
    


Intervention name(s): Transversalis Fascia Plane Block; Transversus Abdominis Plane Block
Intervention type(s): Procedure; Procedure
Intervention description(s): 40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally; 40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cesarean section surgery; postoperative recovery; postoperative pain; trasversalis fascia plane block; transversus abdominis plane block; obstetric quality of recovery 11 Turkish score; numeric rating scale
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to
      everolimus conversion at 10-14 weeks post transplantation improves renal allograft function
      without compromising efficacy compared to standard CNI treatment in de novo renal allograft
      recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen
      on evolution of cardiovascular parameters in de novo renal allograft recipients
    

Detailed description: 
      This was a 24-month, multi-center, randomized, open-label trial with two parallel arms in
      adult de novo renal allograft recipients. The study consisted of a run-in period from
      transplantation to Randomization and a treatment period from Randomization until Month 24. At
      baseline visit, patients were transplanted and entered the run-in period from transplantation
      (Baseline) to Randomization (week 10-14 post-transplantation). At Week 10-14, eligible
      patients were randomized into one of the 2 treatment arms: standard CNIs and Myfortic versus
      everolimus and Myfortic and entered the treatment period of the study from Randomization to
      Month 24. Patients in both arms received steroids as per center practice and in any caseat
      least 5 mg/Day. At Randomization, patients were stratified according to their renal allograft
      function and previous cardiovascular events. The main analysis was performed at Month 12 and
      the follow-up analysis was performed at Month 24.
    

Intervention name(s): Everolimus; Prograf or Neoral
Intervention type(s): Drug; Drug
Intervention description(s): Early CNI to everolimus conversion; Active CNI-based control (Prograf or Neoral)
Other intervention name(s): Certican, Zortress, RAD001; Tacrolimus or Cyclosporine
Intervention MeSH terms: Cyclosporine; Everolimus; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: de novo renal allograft recipients; renal allograft function; CNI-free regimen
The Clinical Diagnosis Meaning of MIF in Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      Macrophage migration inhibitory factor (MIF) is a pleiotropic cytokine that promote the
      inflammatory response.In animal studies, it has been found that MIF is released in the
      ischaemic heart, promoting glucose uptake and protecting the heart from ischaemia-reperfusion
      injury.The MIF concentration, influenced by age and myocardial ischemia, have different
      impact on myocardial functional recovery after ischemia.Therefore, the purpose of this
      experiment is to study the clinical significance of MIF in patients with coronary heart
      disease.
    

Detailed description: 
      MIF is a pleiotropic cytokine that promote the inflammatory response. MIF is expressed in
      several cell types,including monocytes/macrophages, vascular smooth muscle and
      cardiomyocytes, and is released on stimulation from pre-formed storage pools. A foreign study
      reported that MIF had demonstrated to offer protection from I/R-injury by activating
      adenosine monophosphate-activated protein kinase (AMPK) and inhibiting c-Jun Nterminal kinase
      (JNK)-induced apoptosis of cardiomyocytes. In addition, animal experiments showed that MIF
      was reduced in aged heart compared with young heart. Coronary heart disease is a chronic
      ischemic disease, in which MIF may play as a protective factor during the whole procedure.

      We observed individuals who will be taking coronary angiography during the hospitalization.
      Individuals will be assigned to coronary-artery-disease group, which included acute coronary
      syndromes and stable ischemic heart disease, or non-coronary-artery-disease group, according
      to coronary angiography. All participants will be extracted 3ml blood sample 5 minutes before
      coronary angiography. Coronary-artery-disease group will be taken another two blood samples,
      5 minutes after the opening of the balloon and 5 minutes after the stents have been
      implanted, respectively.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Second Hispital of Wenzhou Medical College outpatient and inpatient
      
Biospecimen description: 
      The biospecimen is blood that taken from cubital vein.
A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is a noninferiority comparison of the orthostatic tolerability of a
      dose of 12 mg extended-release (ER) OROS paliperidone with the current recommended initial
      titration dose (2 mg) of immediate-release (IR) risperidone in patients with schizophrenia.
      Other study objectives are 1) to compare the tolerability and safety of a clinically
      equivalent fixed dose of ER OROS paliperidone with the currently recommended dose of
      risperidone, 2) to compare the early tolerability of the 2 treatments with placebo, 3) to
      compare tolerability of the 2 treatments, using a population pharmacokinetic/pharmacodynamic
      (pop PK/PD) model, to 4) assess the relationship between genetic variability in drug
      metabolizing enzymes and interindividual variability in plasma exposure to paliperidone or
      risperidone within each treatment group.
    

Detailed description: 
      This is a randomized, double-blind, placebo- and active-controlled, parallel group, Phase 1.
      The study in patients with schizophrenia consists of a 1 week, open-label, placebo washout
      period (Days -7 to -1) and a 6 day double-blind treatment period during which patients will
      receive 1 of 3 treatments: placebo on Day 1 and ER OROS paliperidone (12 mg) on Days 2 to 6,
      ER OROS paliperidone (12 mg) on Days 1 to 6, or IR risperidone 2 mg on Day 1 and 4 mg on Days
      2 to 6. Safety and tolerability will be monitored throughout the study.. ER OROS paliperidone
      (12 mg, oral) on Days 2 to 6, ER OROS paliperidone (12 mg, oral) on Days 1 to 6, or IR
      risperidone (oral) 2 mg on Day 1 and 4 mg on Days 2 to 6
    

Intervention name(s): extended-release (ER) OROS paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Extended-release paliperidone; Schizophrenia, Mood disorders, Antipsychotic drugs; ER OROS paliperidone