bioihbjkbjnl/mcl2 huggingface dataset:
Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study will compare one- and two-component treatments in women with post-traumatic stress
      disorder (PTSD).
    

Detailed description: 
      PTSD is a debilitating and often chronic anxiety disorder with serious psychiatric
      comorbidity. The most common trauma associated with PTSD among women is childhood abuse. PTSD
      related to childhood abuse may cause problems with emotion regulation and interpersonal
      functioning. This study will address three domains of PTSD related to childhood abuse:
      emotion management problems, interpersonal problems, and PTSD symptoms.

      Participants in this study will be randomly assigned to 16 sessions of one of three
      treatments: Skills Training for Affective and Interpersonal Regulation (STAIR), which focuses
      on helping individuals strengthen and build skills in managing feelings and improving
      interpersonal relationships; Modified Prolonged Exposure (MPE), which focuses on developing
      narratives of abuse history and completing an "emotional processing" of the trauma in a safe
      environment; and a combination of STAIR and MPE. Dropout rates and adverse effects will be
      measured.
    

Intervention name(s): Psychotherapy treatment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Condition: Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects
      with Opioid-Induced Constipation
    


Intervention name(s): TD-1211; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules; Capsules
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Opioid induced constipation; OIC; Constipation; Opioid side effects; morphine induced constipation
A Phase 1-2 Study of CF102 in Patients With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer.
      Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily
      basis. Treatment will be assessed for adverse effects and for effects on the tumor.
    

Detailed description: 
      This is a multicenter, open-label, non-randomized, dose-escalation study, to be conducted in
      2 phases: a dose-escalation phase, to determine the MTD of CF102 and to evaluate its
      safety/tolerability, PK, pharmacodynamic, and preliminary clinical activity; and a
      dose-confirmation phase, which will be a cohort expansion at or below the MTD (ie, the RP2D)
      of CF102. Subjects will be treated with oral doses of CF102 in consecutive, 28-day cycles.
      The initial dose of CF102 will be 1 mg twice daily (BID), with subsequent escalations to 5
      and 25 mg BID, unless limited by toxicity. Subjects will be evaluated weekly for the first
      cycle, every 2 weeks for Cycles 2 and 3, and at the end of each subsequent cycle, up to 6
      cycles of CF102 treatment. Subjects will return for a follow-up visit 28 days after
      completion of the last dose of study drug.
    

Intervention name(s): CF102
Intervention type(s): Drug
Intervention description(s): CF102 capsules twice daily by mouth
Other intervention name(s): 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide; Cl-IB-MECA
Intervention MeSH terms: Adenosine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Study Arms: CF102 (1, 5, and 25 mg BID) in 28-day cycles.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Hepatoma; HCC
OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate that treatment with OXN PR tablets is non
      inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with
      postoperative pain after knee arthroplasty based on average pain intensity scores.
    


Intervention name(s): Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets; Oxycodone
Intervention type(s): Drug; Drug
Intervention description(s): Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg; Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)
Intervention MeSH terms: Oxycodone; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxycodone; Naloxone; Postoperative pain; Arthroplasty; Efficacy
A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients
Condition: End-Stage Renal Disease; Malnutrition
MeSH terms: Kidney Failure, Chronic; Malnutrition
Study type: Interventional

Summary: 
      The study proposes that addition of high protein plant based diet will improve serum albumin
      as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Dialysis. Patient
      will be provided additional food items to help improve their nutritional status.
    

Detailed description: 
      The purpose of this study is to improve the albumin and nutritional status of patient with
      ESRD on dialysis. Serum albumin is a marker to show how well the patient's overall nutrition
      is. When albumin level drops it signifies poor outcome in dialysis patients both in terms of
      complications as well as mortality. Our goal on dialysis is to improve serum albumin level as
      close to normal as possible. This study intends to also improve phosphorus level by adding
      high protein sources which are plant based. In this study we intend to add certain plant
      based food items which are high in protein content. Studies have shown that these particular
      food items considerably increase serum albumin level but at the same time they are safe as
      they do not increase the phosphorous levels in kidney patients. Patients will be provided the
      additional food items and all their nutritional parameters will be monitored at baseline and
      during the study period of one month
    

Intervention name(s): Plant based high protein food items
Intervention type(s): Dietary Supplement
Intervention description(s): Patients will add high protein plant based food items to their diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS
Condition: Atypical Hemolytic Uremic Syndrome
MeSH terms: Hemolytic-Uremic Syndrome; Atypical Hemolytic Uremic Syndrome; Syndrome; Hemolysis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether eculizumab is safe and effective in the
      treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic
      Syndrome (aHUS).
    


Intervention name(s): Eculizumab
Intervention type(s): Drug
Intervention description(s): All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Intervention MeSH terms: Eculizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aHUS
Controling Mean Arterial Pressure Using a Closed-Loop System for Vasopressor Titration
Condition: Cardiac Surgery
Study type: Interventional

Summary: 
      The investigators have developed an automated vasopressor controller to improve the titration
      of vasopressor in order to maintain mean arterial pressure (MAP) within a narrow range and
      have recently shown the controller was effective in both the operating room and intensive
      care unit. The controller has been used recently in a case series of three patients
      undergoing cardiac surgery and in five patients after cardiac surgery.

      The investigators want to compare now a manual to a closed-loop titration of vasopressor
      infusion in patients admitted in the Intensive Care unit after cardiac surgery
    

Detailed description: 
      Perioperative hypotension and arterial pressure variability have been shown to negatively
      impact patient outcomes, increasing risk of stroke, kidney injury, and myocardial injury
      among others.

      Vasopressors are usually used to rapidly correct hypotension. Vasopressor infusions are
      typically administered by standard infusion pump with the rate adjusted by anesthesiologists
      to reach a predefined target mean arterial pressure (MAP); this requires frequent changes in
      the infusion rate because of the almost constantly changing hemodynamic status of such
      patients. Because it is infeasible for human providers to pay constant attention and make
      second-to-second changes, management is often suboptimal (i.e. large amounts of time are
      spent in hypotension below the target, or well above the target with the vasopressor drip
      still running).

      The investigators have developed an automated closed-loop vasopressor (CLV) controller to
      improve the titration of vasopressor (e.g:noradrenaline) in order to maintain MAP within a
      narrow range in the perioperative setting. The investigators have published engineering,
      animal and most recently, pilot,studies or case series with promising results.

      In this randomized controlled trial, the investigators will compare time spent in hypotension
      defined as a mean arterial pressure < 65 mmHg. They tested the hypothesis that the automated
      system will allow patients to spent less time during the postoperative period with a MAP < 65
      mmHg. This is thus a superiority study over a two hours study period
    

Intervention name(s): Computer guided vasopressor infusion; Manual control of vasopressor infusion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): automated titration of vasopressor infusion to maintain a mean arterial pressure > 65mmHg; manual adjustments of noradrenaline infusion
Intervention MeSH terms: Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled superiority trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients
Condition: Melanoma Stage III or IV
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as
      such they are able to direct the immune system specifically against cancer cells. Currently
      DCs are used in clinical vaccination studies and immunological and clinical responses have
      been observed. For inducing anti-tumor immunity, the DCs have to be loaded with tumor antigen
      (i.e. molecular structures that are presented by the tumor, that are recognized by the immune
      system). Currently most studies use tumor peptides (small protein fragments) for this
      purpose. This approach has several disadvantages: only patients with a certain HLA-type can
      be treated and the immune response that is induced by the vaccine is limited to the used
      peptides. These disadvantages do not exist when the DCs present antigen which is endogenously
      processed, for example after RNA transfection. For this reason we investigate the
      immunogenicity of DCs that are pulsed with peptides or transfected with mRNA encoding
      melanoma associated antigens in stage III and IV melanoma patients.
    


Intervention name(s): autologous dendritic cell vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic cells; Melanoma; Vaccine; Immunotherapy; RNA; Peptides
The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of
      sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.
    

Detailed description: 
      Anesthetic agents vary in their relative hypnotic potency. Recent studies demonstrated that
      equi-minimum alveolar concentration of various volatile anesthetic agents may produce
      different spectral entropy or bispectral index values. However, there is no study that
      demonstrate the difference between analgesic potency of volatile anesthetics. The aim of this
      clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and
      desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia was maintained with sevoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).; Anesthesia was maintained with desflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Other intervention name(s): SEVO; DES
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
MRI Biomarkers and Exercise
Condition: Cerebrovascular Circulation
Study type: Observational

Summary: 
      The overall goal of observational study is to examine the age-related and habitual exercise
      training status-related differences in structural and functional changes in the human brain,
      detected by magnetic resonance (MR) imaging.
    

Detailed description: 
      Normal aging reduces cerebral blood flow, brain volume, and cognitive function, thereby
      increasing the risk of dementia or Alzheimer's disease. Aging is associated with increased
      white matter hyperintensities (WMH) and appears to alter functional connectivity within the
      brain both of which associated with cognitive function (references). Observational studies
      suggest that regular physical activity is associated with improved cognitive function and
      higher cerebral blood flow 1,2. However, it is unknown if aging or exercise training status
      alters the structural and functional biomarkers that are predictive of cognitive decline.
      Thus, the overall goal of this project is to examine the age-related and exercise training
      status-related differences in structural and functional changes in the brain, detected by
      magnetic resonance (MR) imaging.

        1. To determine if white matter hyperintensities on MRI scans of the brain are altered by
           aging and exercise training status.

        2. To determine the interaction of aging and habitual physical activity on functional
           connectivity in the brain.
    

Intervention name(s): MRI
Intervention type(s): Device
Intervention description(s): Participants will undergo an MRI scan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects for this study will include healthy young adults (18-35 years old), sedentary
        older adults (55-75 years old), and healthy exercise trained older adults (55-75 years
        old). Both men and women will be eligible to participate in this study.
      
Keywords: Aging; White Matter Hyperintensity Volume; Default Mode Network Connectivity; Cognitive Function; Cardiorespiratory Fitness; Magnetic Resonance Imaging
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following
      single ascending intravenous (IV) dose administration in healthy subjects (Part 1) and
      multiple ascending IV dose administrations in subjects with prodromal or mild Alzheimer's
      disease (AD) (Part 2).
    


Intervention name(s): JNJ-63733657; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously.; Subjects will receive matching placebo intravenously.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Detection of Circulating Tumor Cells (CTCs) in Patients With Lung Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
Condition: Neoplastic Cells, Circulating
MeSH terms: Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time
      biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in
      lung cancer could play an important role in diagnosis, predicting the risk for tumor
      recurrence, and providing novel target therapy biomarkers. In view of these facts, the
      investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting
      human tumor cells of lung cancer in normal peripheral blood after cryosurgery with or without
      dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also
      compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)
      method.
    

Detailed description: 
      1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately
      17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients
      with lung cancer and healthy volunteers. The blood of the healthy volunteers will be used to
      evaluate the sensitivity and specificity and as negative control cells. To avoid
      contamination with skin cells, 2 mL blood will be discarded before the study samples will be
      taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for
      20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood
      cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear
      cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis
      of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in
      phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR.
      Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to
      choose an adequate therapy.
    

Intervention name(s): Flow cytometry (FCM); RT-PCR
Intervention type(s): Other; Other
Intervention description(s): Use FCM to test PBMCs/CTCs from volunteers/patients.; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ⅱ,Ⅲ,Ⅳ stage lung cancer come to Fuda Hospital for treatment.
      
Keywords: Lung Neoplasms; Circulating Tumor Cells
The Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum RC15_0421
Condition: Beta-lactamase Extended Spectrum, E. Coli, Elderly, Mortality, Risk Factor
MeSH terms: Bacteremia
Study type: Observational

Summary: 
      In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes.
      E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia.
      In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public
      health, causing increased mortality, particularly in the elderly, and an increase in the
      average hospital stay. However, few studies have specifically concerned with the criteria
      associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally,
      improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E.
      coli has importance in terms of public health and is a prerequisite to the development of
      preventive strategies and to improve the short-term prognosis.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All data concerning blood cultures analyzed in the bacteriology department of University
        Hospital of Nantes are stored digitally, particularly E. coli ESBL. Thus, the extraction of
        these data will allow the retrospective inclusion of patients and enhance the feasibility
        of the study.
Pharmacokinetics and Safety Study of Single and Multiple Oral Doses Prodarsan™ in Patients With Cockayne Syndrome
Condition: Cockayne Syndrome
MeSH terms: Cockayne Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is to compare the exposure of orally administered Prodarsan to the intravenous
      dosed Osmitrol (10% solution) in Cockayne Syndrome (CS) patients. Also the pharmacokinetics
      of single and multiple orally dosed Prodarsan will be evaluated and compared to intravenous
      dose of Osmitrol in CS patients.
    


Intervention name(s): Prodarsan
Intervention type(s): Drug
Intervention description(s): Prodarsan TID, oral solution, 6-8 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cockayne Syndrome; Ageing; pediatrics; Pharmacokinetics; Prodarsan; Dwarfism; Genetic disease, inborn; DNA Repair-Deficiency Disorders; Tolerability; Safety
A Study of Single Dose RO6811135 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers.
      Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135
      or placebo subcutaneously.
    


Intervention name(s): RO6811135; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single ascending doses sc; single doses sc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)