bioihbjkbjnl/mcl2 huggingface dataset:
MASCT-I in Patients With Metastatic or Recurrent Solid Tumors Who Failed Standard Therapy.
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of MASCT-I in patients
      with metastatic or recurrent solid tumors who failed standard therapy.
    

Detailed description: 
      The study is divided into two stages. The first stage is divided into two groups, both of
      which adopted 3+3 design. The first group is given MASCT-I by administration method 1, and
      the second group is given by method 2. One of the administration method will be used in the
      second stage according to DLT and adverse events found in the first stage.
    

Intervention name(s): MASCT-I injection
Intervention type(s): Biological
Intervention description(s): The final products of MASCT-I technology are dendritic cells (DC) and effector T cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline,
      Boostrix®) and HPV vaccine (Merck & Co., Inc., Gardasil®) when administered concomitantly
      with MenACWY are comparable to responses elicited by these vaccines when given alone.
    


Intervention name(s): Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine; MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): All three vaccines were administered concomitantly. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.; All three vaccines were administered concomitantly. MenACWY-CRM contains diphtheria-like toxoid as carrier for the capsular polysaccharides. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
Reduced Diphtheria Toxoid,Acellular Pertussis Vaccine(Tdap) is Boostrix®.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: meningitis; human papillomavirus; tetanus; diptheria; pertussis
A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous
      danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on
      the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.
    


Intervention name(s): danoprevir; danoprevir; placebo; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single iv infusion; single oral dose; single iv infusion; oral doses
Intervention MeSH terms: Ritonavir; Lactams
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Non-invasive Mechanical Ventilation After Cardiac Surgery
Condition: Heart; Dysfunction Postoperative, Cardiac Surgery
Study type: Interventional

Summary: 
      Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac
      patients but more studies are necessary to clarify its respiratory and hemodynamic effects.
      Therefore, the investigators objective was to study its effects in the oxygenation index
      (PaO2/FiO2) and in hemodynamic variables in this group of patients.
    

Detailed description: 
      -  Postoperative cardiac surgery patients having a Swan-Ganz catheter and showing a
           PaO2/FiO2 between 150 and 300 (with FIO2 0.31), one hour after extubation, were
           included.

        -  Then, the patients were randomized into two groups: control and intervention group.
           Intervention group used NIV with a bi-level positive airway pressure (an inspiratory
           pressure to generate a tidal volume of 6ml/kg and an expiratory pressure of 7cmH2O) with
           a FIO2 0.4. Control group used oxygen by Venturi mask(FIO2 0.4) in order to keep a good
           oxygenation.

        -  In both groups measurements were done in basal situation, one and three hours after
           beginning the treatment and one hour after stop the treatment (FiO2 0.31).

        -  Variables studied included: PaO2/FiO2, PaO2, PaCO2, heart rate (HR), mean arterial
           pressure (MAP), pulmonary capillary wedge pressure (PCWP) and cardiac output (CO).
    

Intervention name(s): VPAP II®
Intervention type(s): Device
Intervention description(s): VPAP group:inspiratory pressure to generate 6ml/kg of weight and expiratory pressure of 7cmH2O plus oxygen therapy (FIO2=40%) during three hours.
Other intervention name(s): VPAP II -STA (Resmed®)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cardiac surgery; Non-invasive ventilation
Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This single center case control study will assess differences in bone structure between women
      and men with longstanding type 1 diabetes (diabetes duration>/= 25 years) and healthy
      controls.
    

Detailed description: 
      Based on a cross-sectional approach the investigators aim to assess microstructural,
      biomechanical and densitometric bone characteristics in patients with longstanding type 1
      diabetes and age- and sex-matches controls. The investigators examine whether the presence of
      microvascular disease and/or poor diabetic control is associated with an altered bone
      microarchitecture and whether any such effect is independent of bone mineral density.
      Furthermore, the investigators aim to look into the relationship between an altered bone
      microarchitecture and advanced glycation end product (AGE) formation as well as biochemical
      markers of bone formation and bone turnover. The study aims to identify type 1 diabetic
      patients with high fracture risk by assessing the discriminatory power of parameters of
      cortical and trabecular microstructure measured via high resolution peripheral quantitative
      computed tomography (HR-pQCT) of the distal radius and tibia and high resolution quantitative
      computed tomography (HR-QCT) of the proximal femur and tibia with and without adjustment for
      bone density.
    

Intervention name(s): Biochemical Tests; Osteodensitometry; Clinical Tests; HR-QCT; HR-pQCT
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): The investigators will perform blood tests in every participant.; The investigators will perform an osteodensitometry in every participant.; The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant.; The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.; The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.
Other intervention name(s): dual energy x-ray absorptiometry (DXA scan)
Intervention model: Single Group Assignment
Intervention model description: Identical diagnostic procedures will be performed in participants with type 1 diabetes and age- and sex-matched controls.
Masking: None (Open Label)
Primary purpose: Diagnostic
Weight Loss Effect on Circulating Liver Enzymes
Condition: Visceral Fat; Liver Dysfunction
MeSH terms: Liver Diseases; Weight Loss
Study type: Interventional

Summary: 
      To investigate weight loss effect with mild calorie restriction on circulating levels of
      liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral
      fat area (VFA) at L4 ≥ 100 cm²].
    

Detailed description: 
      A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight
      subjects with high VFA. The participants divided into two groups: 12-week mild calorie
      restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The
      randomization was according to computer-generated block randomization (placebo:test = 1:1).
      Before and after intervention period, venous blood samples were obtained from the subjects,
      and biochemical parameters including circulating liver enzymes were measured.
    

Intervention name(s): Control group; Weight loss group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The participants who included in control group did not receive any treatment.; The participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High visceral fat; Liver enzymes; Aminotransferase; Mild calorie restriction
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
Condition: Acute Migraine Headache
MeSH terms: Migraine Disorders; Emergencies; Headache
Study type: Interventional

Summary: 
      ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR
      imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is
      improvement in pain scales between the groups.
    


Intervention name(s): prochlorperazine and benadryl IV; Imitrex SubQ, saline IV
Intervention type(s): Drug; Drug
Intervention description(s): prochlorperazine and benadryl IV, saline subQ; Imitrex SubQ, saline IV
Intervention MeSH terms: Diphenhydramine; Prochlorperazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine; Emergency; imitrex; prochlorperazine; Acute Migraine Headache in the Emergency Department
A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of paliperidone extended-release
      (ER; designed to slowly release a drug in the body over an extended period of time) tablets
      in participants with schizophrenia (psychiatric disorder with symptoms of emotional
      instability, detachment from reality, often with delusions [a false belief held in the face
      of strong differing evidence, especially as a symptom of psychiatric disorder] and
      hallucinations [imagining things], and withdrawal into the self) who were not satisfied with
      other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute
      psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine,
      quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone
      ER tablets will also be assessed.
    

Detailed description: 
      This is an open label (all people know the identity of the intervention), prospective (study
      following participants forward in time), non-randomized (the study drug is not assigned by
      chance, participants may choose which group they want to be in, or they may be assigned to
      the groups by the researchers), single-arm (getting one dose of medicine) and multi-center
      (when more than one hospital or medical school team work on a medical research study) study
      designed to determine the efficacy, tolerability and safety of flexible dosage of
      paliperidone ER tablets in treatment of participants with schizophrenia not satisfied with
      other prior antipsychotics. The duration of the study will be 12 weeks. All participants will
      be given paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets
      depending on Investigator's discretion once daily for 12 weeks; initial dose for paliperidone
      ER will be 6 mg/day. The primary objective will be to evaluate the efficacy of treatment with
      paliperidone ER using Positive and Negative Symptom Scale (PANSS) total scores. Participants
      safety and tolerability will be monitored throughout the study.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone extended-release tablets
Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine
Condition: Allergies
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      This is a non-interventional retrospective data collection study from children aged from 2 to
      12 years old diagnosed with an allergy and who received a treatment consisting of an
      H1-antihistamine. The period of last taken medication will be observed to evaluate the global
      satisfaction of the parents and physician for this last treatment.
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care
      
Keywords: Pediatric; Allergies; Antihistamines; Non-interventional
Drug Drug Interaction Study for EYP001 With Entecavir
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, open-label, three subsequent dosing periods study to
      evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD),
      safety, and tolerability of a single dose of EYP100a combined with ETV in healthy men and
      women dosed in the morning under fasted conditions.
    

Detailed description: 
      This is a Phase 1, single-center, open-label, three consecutive dosing periods study to
      evaluate the drug-drug interaction, PK, safety, tolerability and PD of a single dose of
      EYP100a combined with ETV in healthy men and women. Sixteen (16) adult male and female
      healthy participants 18 to 60 years of age inclusive are planned to participate in the study.
      Women of childbearing potential will be eligible to participate if she is non pregnant or non
      lactating and willing to use adequate contraception.

      All participants in the study will be monitored for safety after administration of the last
      dose of investigational product and with a follow up visit. The DDI, PK, PD, safety and
      tolerability of EYP001a and ETV will be assessed based on plasma-concentration profiles of
      EYP001a and ETV, FXR related PD markers and the types and frequency of treatment-emergent
      adverse events (TEAEs) reported, concomitant medication usage, and changes from baseline in
      physical examination (PE), vital signs, electrocardiogram (ECG), and standard clinical
      laboratory tests.
    

Intervention name(s): EYP001; Entecavir 1 MG
Intervention type(s): Drug; Drug
Intervention description(s): EYP001 self administered capsules, morning, with non carbonated water; Entecavir self administered tablets, morning, with non carbonated water
Other intervention name(s): EYP001a; ETV
Intervention MeSH terms: Entecavir
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic
      hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the
      liver.

      Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.

      The major interest of this marker is that it can be measured by a simple blood test instead
      of a liver biopsy.
    

Detailed description: 
      - Studying intra lymphocyte and blood cccDNA: before inclusions, D0 then each month during
      the first three months each three months during treatment and follow-up.

      - Viral kinetics:Before inclusions, at D0, then monthly till the end of treatment and
      follow-up: Evolution of quantitative viraemia in serum Evolution of quantitative viraemia in
      circulating lymphocytes Evolution of quantitative viraemia in total blood

      - Studying viral genotypes
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic hepatitis B infection and treated with adefovir dipivoxil and peg
        interferon alpha 2a.
      
Keywords: Chronic hepatitis B; CCC DNA kinetics; Total HBV DNA kinetics; Adefovir-Dipovixil; Peg interferon alpha 2a
Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)
Condition: Dilated Cardiomyopathy; Heart Failure
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with
      chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is
      (1) on repetitive administration of cell therapy that would allow for long-lasting
      improvements in heart function and outcome in this patient population. In parallel, the
      investigators aim to (2) develop a standardized patient-specific stem cell product that could
      be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for
      therapeutic application when clinically indicated. By using a unique multimodality imaging
      platform, the goal of this project is also to (3) define standardized clinical criteria that
      would serve as a guideline for evaluation of the effects of stem cell therapy in future
      clinical trials and everyday clinical settings. Finally, to improve the clinical
      implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery
      technique that could be used to treat both left and right and ventricular failure and could
      be implemented in a standardized fashion designed for a widespread clinical use.
    


Intervention name(s): Stem cell therapy
Intervention type(s): Biological
Intervention description(s): Bone marrow cells will be mobilized into peripheral blood by daily subcutaneous injections of G-CSF (10 µg/kg daily) and collected by leukapheresis. Positive immunomagnetic selection of CD34+ cells will be performed. Electroanatomic mapping of the left ventricle will be performed using the Biosense NOGA system (Biosense-Webster®, Diamond Bar, CA). The target area for cell delivery will be defined as the myocardial segments with unipolar voltage potentials ≥8.3 mV, bipolar amplitudes >1.9 mV, and linear shortening <6%. Intramyocardial delivery of cell suspension will be performed with the MyoStar (BiosenseWebster®, Diamond Bar, CA) injection catheter. Each patient will receive 20 injections (0.3 mL each; total volume of 6 mL). All the procedures will be repeated 6 months after baseline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PET Study of Repeated ASN51 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label, dose escalation, PET study to investigate the brain occupancy
      of O-GlcNAcase, and the PD response in PBMCs, after repeated doses of ASN51 in healthy
      subjects.
    

Detailed description: 
      The clinical data from the first-in-human single- and multiple-ascending dose study of ASN51
      (ASN51-101), and the adaptive-design PET study of O-GlcNAcase brain ASN51 occupancy after
      single oral doses (ASN51-102), showed acceptable safety, tolerability and PK. However, to
      date, no assessment of RO after multiple doses of ASN51 and at plasma concentrations below
      the EC50 have been done. Hence, the purpose of this study is to assess brain O-GlcNAcase RO
      using PET following repeated doses of ASN51. The study will also characterise the PBMC
      response (including the effect of food), and further assess the safety, tolerability, PK, and
      PK/RO relationship, after repeated ASN51 doses.

      The results of this study will be used to select doses for subsequent studies in patients.
    

Intervention name(s): ASN51
Intervention type(s): Drug
Intervention description(s): ASN51 formulation for oral capsule
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a phase 1, open-label, dose escalation, PET study to investigate the brain occupancy of O-GlcNAcase, and the PD response in PBMCs, after repeated doses of ASN51 in healthy subjects. Enrolment of up to 12 healthy subjects is planned, in up to 2 groups (Groups 1 and 2). Each group will consist of up to 6 subjects.
Masking: None (Open Label)
Primary purpose: Other
The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      the aim of the study is to assess the effect of intralipid as regard efficiency in decreasing
      myocardial ischemia , given during preconditioning in off pump coronary artery
      revascularization
    


Intervention name(s): Intralipid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intralipid is given as a preconditioning drug during off bump coronary artery bypass grafting surgery to measure efficacy in decreasing post operative ischemia; normal saline is given in same volume to normal saline group over the same duration
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention