bioihbjkbjnl/mcl2 huggingface dataset:
Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
Condition: Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional

Summary: 
      RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's
      cancer cells, may stimulate the immune system in different ways and stop cancer cells from
      growing.

      PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to
      see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluation of feasibility of dendritic cell (DC)-based vaccination program using
           autologous tumor cells and/or lysates in patients with indolent B cell lymphomas or
           multiple myeloma as an adjuvant therapy to induce immune response in remission after
           cytoreductive treatment.

        -  Evaluation of the immune response of patients treated with this regimen.

        -  Evaluation the progression-free survival of patients treated this regimen.

        -  Evaluate the adverse events of this regimen in these patients.

      OUTLINE: Patients receive intranodal (under ultrasound guidance) or subcutaneous vaccinations
      of adjuvant electrofusion hybrids of autologous dendritic cells (DC) with autologous lymphoma
      cells, electrofusion hybrids of allogeneic DC with autologous lymphoma cells, and/or
      autologous DC pulsed with autologous tumor lysate cells in weeks 0, 2, 4, 8, 12, 18, 26, and
      50.
    

Intervention name(s): autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine; autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine; autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dendritic cell vaccine; tumor cell lysate; lymphoma
Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The research protocol aim is to compare diagnostic tools for the proper evaluation of patient
      with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl
      carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE),
      a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation
      of patients with positive fecal occult blood as compared to colonoscopy, which is considered
      the best evaluation method. Colonoscopy involves the direct visualization of the colon using
      a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves
      additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in
      this protocol.

      Additional aims of this study are: to determine the localization, number, size and pathologic
      characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the
      patient preference between both studies.

      This study is limited to those patients 50 years or older who are at average risk for colon
      cancer and who had a positive fecal occult blood screening test.
    


Intervention name(s): Double-contrast Barium enema, colonoscopy
Intervention type(s): Procedure
Intervention description(s): This is a blinded cohort study comparing double contrast barium enema (DCBE) and colonoscopy in detecting polyps and/or cancer in patients with positive FOBT. Initial evaluation consisted of complete clinical history and physical examination. A DCBE and a colonoscopy were performed in all patients. All polyps identified during colonoscopy were removed and classified by histology. Sensitivity and specificity of DCBE for polyp and/or cancer detection was determined. Tolerability and grade of satisfaction with study procedures was assessed.
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Colon polyps; Fecal occult blood test; Double contrast barium enema; Colonoscopy
Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin
    


Intervention name(s): Vicks Cough Syrup for Chesty Coughs; Robitussin Extra Strength Chest Congestion; Organ-I- NR tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water; Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water; Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
Condition: Fertility Disorders; Early Pregnancy
Study type: Observational

Summary: 
      In this study physiological data is measured using wearable sensors as well as hormonal and
      ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically
      healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were
      recruited to generate reliable data on changes of the measured physiological parameters in a
      healthy menstrual cycle, as well as to evaluate physiological changes associated with early
      pregnancy.

      All pregnancies beginning during the study period are to be monitored to their natural end,
      in order to evaluate how the same nine physiological parameters are changing during
      pregnancy, how strong the variations of the parameters during pregnancy are, and whether they
      could be associated with early onsets of pregnancy complications such as premature birth or
      pre-eclampsia. This will be highly valuable to develop study protocols for the specific
      evaluation of the screening potential of pregnancy complications.
    


Intervention name(s): Ava
Intervention type(s): Device
Intervention description(s): Ava is a fertility monitoring bracelet that collects various physiological parameters
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In this study we want to conduct measurements of physiological data as well as hormonal and
        ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically
        healthy women with a regular cycle, who aim for a spontaneous pregnancy. We choose these
        women to generate reliable data on changes of the measured physiological parameters in a
        healthy menstrual cycle, as well as to evaluate physiological changes associated with the
        initiation of pregnancy.

        We want to continue measurements in all pregnancies beginning during the study period to
        evaluate how the same nine physiological parameters are changing during pregnancy, how
        strong the variations of the parameters during pregnancy are, and whether they could be
        associated with early onsets of pregnancy complications such as premature birth or
        preeclampsia. This will be highly valuable to develop study protocols for the specific
        evaluation of the screening potential of one of the pregnancy complications.
Cardiac Safety Evaluation of P03277
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled
      and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.

      The primary objective is to assess the cardiac safety after administration of P03277 to 48
      healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg
      (supra-clinical dose) by evaluating the QT and QTc intervals.
    

Detailed description: 
      Each subjects will be administered with 4 products (P03277 at the 2 different doses, placebo
      and moxifloxacin) in a 4*4 cross over sequence balanced for first order carry over effect.
      Twelve subjects will be assigned to each sequence (6 males and 6 females). The volunteers
      will be enrolled sequentially by cohort of 8 subjects.

      ECG measurements will be compared with ECG parameters collected after administration of
      placebo (Nacl 0.9%). The test sensitivity will be assessed using a positive control
      (moxifloxacin 400 mg per os) known to induce delays in QT intervals.
    

Intervention name(s): P03277 0.1 mmol/kg; Moxifloxacin 400mg; NaCl 0.9%; P03277 0.3 mmol/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single intravenous bolus injection at 2 mL/sec; One tablet per os; Single intravenous bolus injection at 2 mL/sec; Single intravenous bolus injection at 2 mL/sec
Other intervention name(s): Gadopiclenol; Gadopiclenol
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Williams design for a 4*4 cross over
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Gadolinium-based contrast agent; Cardiac safety; ECG; Gadopiclenol
Behavioral Neurocardiac Training and Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This randomized controlled trial will examine whether behavioral neurocardiac training with
      heart rate variability biofeedback (BNT) augments reduction in ambulatory daytime and 24-hour
      SBP, DBP and PP, in comparison to an active control intervention (AC, autogenic relaxation
      training), among subjects diagnosed with hypertension, and following adjustment for
      medications. In addition, the independent association between the BNT and AC interventions on
      vagal-heart rate modulation and baroreflex sensitivity will be evaluated during a
      standardized assessment protocol of mental stress testing. This study extends a previous
      trial conducted at the UHN, in which we reported that the biofeedback intervention
      independently augments vagal-heart rate modulation, while reducing symptoms of stress and
      depressed mood, among subjects diagnosed with cardiovascular disease. Exploratory features of
      this trial will examine the association between ambulatory blood pressure, vagal-heart rate
      modulation, baroreflex sensitivity, and markers of inflammatory activity.
    


Intervention name(s): Behavioral neurocardiac training; Autogenic relaxation training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 training sessions scheduled over 8 weeks; 6 training sessions scheduled over 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hypertension; Biofeedback; Relaxation training
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Condition: Candidiasis, Esophageal; HIV Infections
MeSH terms: Infections; Candidiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety, toleration, and efficacy of fluconazole oral suspension in the
      treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.
    

Detailed description: 
      Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks.
      Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of
      symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of
      treatment. Patients undergo follow-up at 2 weeks post-treatment.
    

Intervention name(s): Fluconazole
Intervention type(s): Drug
Intervention MeSH terms: Fluconazole
Primary purpose: Treatment
Keywords: Esophagitis; Fluconazole; Acquired Immunodeficiency Syndrome; Candidiasis; Immunocompromised Host
Remediation of Auditory Recognition in Schizophrenia With tDCS
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether transcranial direct current stimulation
      (tDCS), when combined with different forms of computer based training, improves the ability
      to discriminate small differences between sounds in people diagnosed with schizophrenia or
      schizoaffective disorder.
    

Detailed description: 
      This study uses an experimental procedure called transcranial direct current stimulation
      (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with
      schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This
      study is being done to see if an experimental computer training program, when combined with
      tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed
      through electrodes placed on the head that is able to stimulate the brain. By stimulating the
      brain, the investigators believe that the functioning of the brain can be altered. This study
      will test whether such stimulation of the brain, when done with computer training, can
      improve hearing ability and if this improvement helps in other ways, like detecting changes
      in someone's tone of voice or understanding other people's emotions better. The data being
      collected aims to better understand how the brain processes sounds and how tDCS affects the
      brain.
    

Intervention name(s): Active Transcranial direct current stimulation (tDCS); Sham Transcranial direct current stimulation (tDCS); Auditory Remediation; Control computer activities
Intervention type(s): Device; Device; Behavioral; Behavioral
Intervention description(s): Active tDCS, where an extremely weak electric current passes through the brain; Sham (inactive or placebo) tDCS; Computer program designed to improve discrimination between sounds; Computer program (e.g. games), which are not designed to improve discrimination between sounds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.
Condition: Obstructive Jaundice; Periampullary Tumour
MeSH terms: Jaundice; Jaundice, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of
      their jaundice with transpapillary stenting at endoscopic retrograde
      cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.

      Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative
      stenting in patients with obstructive jaundice due to periampullary tumour obstruction.
    

Detailed description: 
      Patients who present with obstructive jaundice and have a periampullary tumor and where the
      patient seems to be in good condition for surgical resection are offered the opportunity to
      become randomized to either endoscopic drainage with self expanding metallic or plastic
      stents. Before randomization they are informed about the study details and have to give their
      consent to participate. The metallic as well as plastic stents are standard commercially
      available stents. Within four weeks after stent placement the patient will be operated and
      the following parameters will be evaluated: quality of life, clinical symptoms and lab tests.
      At the operation the surgeon will make an evaluation of the inflammatory reaction in the area
      of the bile ducts. A culture from the bile is sampled close to the area where the anastomosis
      will be sutured. A tissue sample is also taken from the bile ducts to evaluate inflammation.
      A Lymph node is also sampled for the same reason. The surgeon also evaluates the difficulty
      with which the stent had to be removed. Postoperative complications are monitored in line
      with the regular routines at the clinic.
    

Intervention name(s): Plastic stent (7-10Fr); Self Expanding Metal Stent
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effect of Virtual Reality Glasses on Labor Pain
Condition: Labor Pain; Anxiety
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There are different medicinal and non medicinal methods to control labor pain. Today, much
      attention has been on non medicinal methods because of limitations and complications of
      medical procedures. Virtual reality is a new and promising method of diversion of mind that
      may have an impact on labor pain. This study was conducted to determine the effect of virtual
      reality on the first stage of labor pain.
    


Intervention name(s): three-dimensional glasses(manufactor Vuzix,wrap 920); usual care
Intervention type(s): Device; Other
Intervention description(s): The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.; Women in Control group did not use the glasses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Labor pain; Virtual reality; the first stage of labor; Pain relief; Simulator
Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      To explore whether serial changes of data in body composition of patients with sepsis can
      help clinician to monitor prognosis.
    

Detailed description: 
      The investigators will use the random number generator to divide the patients into two
      groups, the control group (with no nutritional intervention) and the intervention group (with
      nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the
      intervention group will be given to the dietitians for adjusting the diet formula according
      to the patient's body composition.The patients in control group also will undergo
      Bio-electrical Impedance Analysis (BIA) assessment, but not disclosed to the dietitian. The
      diet formula will be adjusted on the discretion of the dietitian caring for the septic
      patients based on clinical judgement.
    

Intervention name(s): Nutritional intervention
Intervention type(s): Dietary Supplement
Intervention description(s): In the intervention group, the body composition data (of day 1, 3, 8) will be given to the dietitians for adjusting the diet formula. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement. The policy adopted by the dietary treatment guidelines for sepsis is to adjust the dietary concentration when there is too much extracellular water under the premise of gastrointestinal tolerance. When the skeletal muscle mass loss is too fast, the dietitians will increase the protein intake by 1.2g/kg of body weight. For patients with acute renal failure and excess extracellular water accumulation and muscle loss, the dietitians will adjust the protein, sodium, potassium, calcium and phosphorus content in the formula. The dietitians will give appropriate nutrition prescriptions based on clinical signs, disease diagnosis and biochemical values.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: sepsis; body composition; Nutritional intervention
Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and the optimal way of
      administration of autologous mesenchymal bone marrow stem cells (MSC) compering intravenous
      injection and intrathecal injection vs. placebo, in active-progressive Multiple Sclerosis
      patients.
    

Detailed description: 
      Mesenchymal stem cells (MSC) induce immune-modulatory and neurotrophic effects and were shown
      to have an acceptable safety profile for clinical applications. We aimed to evaluate the
      safety and efficacy of MSC transplantation in active progressive MS and investigate possible
      neuroprotective effects.

      Methods: This single-center double-blind crossover trial enrolled 48 patients with
      progressive MS (expanded disability status scale (EDSS) range: 3.5-6.5, mean: 5.6+/-0.8).
      Patients were randomised into three groups and treated intrathecally (IT) or intravenously
      (IV) with autologous MSCs (1x106/Kg) or placebo. At 6-months, treatment groups were crossed
      over and patients re-treated with either MSC or placebo. During the 2-months run-in period
      and the 12-months after treatment, participants were followed using EDSS, 25-foot timed
      walking, 9-hole peg test, neurocognitive tests, quantitative magnetic resonance imaging
      (MRI), functional MRI, optic coherence tomography (OCT), visual evoked potentials (VEP), and
      dynamic visual tests.
    

Intervention name(s): Mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): A culture of purified MSCs was prepared under aseptic conditions, and cultured for 4 weeks, until they reached confluency, and were then harvested. After sterility was confirmed, the cells resuspended in normal saline at a concentration of 10 × 106/mL to 15 × 106/mL.
Other intervention name(s): Autologous MSC
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients were randomised into three groups and treated intrathecally (IT) or intravenously (IV) with autologous MSCs or placebo. At 6-months, treatment groups were crossed over and patients re-treated with either MSC or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis (MS); Stem Cells
The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, Randomized, Double-blind, Parallel group, Sing-dose study to compare the
      Pharmacokinetics and Safety of CMAB008 and Remicade in healthy subjects.
    


Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): 100mg/vial
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Biological: CMAB008 Biological: Remicade
Masking: Double (Participant, Investigator)
Primary purpose: Other