bioihbjkbjnl/mcl2 huggingface dataset:
Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients
Condition: Renal Failure
MeSH terms: Hepatitis B; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled
      and this could improve seroconversion rate of hepatitis B vaccination.

      In this study, the investigators aimed to compare seroconversion rates and immune response
      rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B
      surface antigen (HBsAg) vaccine given to predialysis CKD patients.
    

Detailed description: 
      In an open, randomized clinical trial, the investigators compared seroconversion rates in 51
      predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses
      or 20 μg 3 doses of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0,
      1, 6 months respectively.
    

Intervention name(s): four doses of Euvax B vaccine; 20 μg (1 ml) three doses of Euvax B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 40 μg (2 ml) four doses of Euvax B vaccine; 20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
Other intervention name(s): Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
Intervention MeSH terms: Aluminum Hydroxide; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: predialysed; chronic; renal failure patients
Vaccine Enriched, Autologous, Activated T-Cells Directed to Tumor in Patients With Relapsed/Refractory Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The researchers will investigate if modified T-cells from a patients own system can be
      utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.
    

Detailed description: 
      The rate of progression free survival at one (1) year is < 20% for patients with stage IV
      metastatic melanoma, despite aggressive cytotoxic chemotherapy regimens and newly approved
      immunomodulatory and targeted therapy. Immunotherapy seems to hold the most promise for
      achieving prolonged survival or even cure, therefore,efforts have focused on several
      different approaches. Such approaches have used tumor vaccination, adoptive transfer of tumor
      infiltrating lymphocytes, and even monoclonal antibodies, unconjugated or conjugated to
      cytokines, toxins, or radionucleotides.

      The tumor-associated antigen GD2 has been noted on the surface of several tumors, most
      notably neuroblastoma, but is expressed on melanoma as well. Clinical studies have shown
      activity of a GD2-specific chimeric T-cell receptor expressed on activated, autologous,
      T-cells in patients with neuroblastoma. It is the investigators intention to enrich
      peripheral blood mononuclear cells (PBMC) of patients with stage IV metastatic melanoma with
      vaccine-specific T-cells through pre-harvest/ phlebotomy vaccination with common, well
      understood vaccines. The investigators will then modify the T-cells to attack the GD2
      antigen. These tumor redirected, vaccine specific, activated T-cells will then be infused
      into the patient following revaccination with the common vaccines. The Investigators will
      monitor expansion of the modified T-cells through serial polymerase chain reaction (PCR)
      assays following vaccination.

      The Investigators then intend to re-vaccinate with the selected vaccines one month following
      infusion and monitor for expansion of the modified T-cells.
    

Intervention name(s): tvs-CTL Vaccine
Intervention type(s): Biological
Intervention description(s): autologous, 14g2a.zeta chimeric receptor transduced, activated T-cells, enriched for vaccine specific cytotoxic T-lymphocytes (tvs-CTL)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; metastatic; relapsed; refractory
Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new
      short-acting human soluble insulin, Julphar Insulin R, and the already approved reference
      insulin, Huminsulin® Normal. The trial participants received both study treatments on two
      separate dosing days.
    

Detailed description: 
      The daily injection of insulin is a necessity for many patients with diabetes mellitus in
      order to treat hyperglycemia. Julphar Insulin R and Huminsulin® Normal are both soluble
      insulins intended for subcutaneous administration and consist of a neutral solution
      containing recombinant human insulin as the active ingredient. The new insulin, Julphar
      Insulin R is biosimilar to Huminsulin® Normal. Demonstration of bioequivalence from a PK and
      PD perspective of the two insulins are necessary to achieve market approval for Julphar
      Insulin R.
    

Intervention name(s): Julphar Insulin R (soluble human insulin, biosimilar); Huminsulin® Normal (soluble human insulin, reference)
Intervention type(s): Drug; Drug
Intervention description(s): investigational insulin, Julphar Insulin R (soluble human insulin); marketed product, Huminsulin® Normal (soluble human insulin
Other intervention name(s): Julphar Insulin R; Huminsulin® Normal
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: soluble human insulin, biosimilar
Differential Lung Ventilation vs. CPAP
Condition: One Lung Ventilation; Continuous Positive Airway Pressure; Differential Lung Ventilation
Study type: Interventional

Summary: 
      In this study we compared the efficacy of continuous positive airway pressure (CPAP) to
      differential lung ventilation, in terms of patient's oxygenation, during video assisted
      thoracoscopic lung resection.
    

Detailed description: 
      Background: One Lung Ventilation (OLV) is the technique used during lung resection surgery in
      order to facilitate optimal surgical conditions. OLV may result in hypoxemia due to the shunt
      created. Several techniques are used to overcome the hypoxemia, one of which is continuous
      positive airway pressure (CPAP) to the non-dependent lung. Another technique is ventilating
      the non-dependent lung with a minimal volume, thus creating differential lung ventilation
      (DLV). In this study we compared the efficacy of CPAP to DLV during video assisted
      thoracoscopic lung resection.

      Patients and Method: This is a prospective study of 30 adult patients undergoing elective
      video assisted thoracoscopic lung lobectomy. Each patient was ventilated in four modes: two
      lung ventilation, OLV, OLV+CPAP and OLV+DLV. Fifteen patients were ventilated with CPAP first
      and DLV next, and the other 15 were ventilated with DLV first and then CPAP. Five minutes
      separated each mode, during which the non-dependent lung was open to room air. We measured
      the patient's arterial blood gas during each mode of ventilation. The surgeons, who were
      blinded to the ventilation technique, were asked to assess the surgical conditions at each
      stage.
    

Intervention name(s): cpap
Intervention type(s): Device
Intervention description(s): application of cpap to the non-dependent lung, during one lung ventilation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: prospective randomized controlled crossover study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: one lung ventilation; continuous positive airway pressure; differential lung ventilation
Autophagy Maintains Vascular Function Through a Novel Glycolysis-linked Pathway Regulating eNOS
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Interventional

Summary: 
      Aging is inevitable and is the primary risk factor for developing cardiovascular disease. The
      molecular mechanisms that drive vascular dysfunction in the context of aging are incompletely
      understood. The overall hypothesis is that the age-related decline in endothelial cell (EC)
      autophagy leads to arterial dysfunction. This study will determine whether physiological
      shear-stress affects autophagosome formation and nitrous oxide (NO) generation in ECs.
    

Detailed description: 
      It is hypothesized that genetic autophagy suppression prevents shear-stress induced
      purinergic signaling to endothelial nitrous oxide synthase (eNOS) and this pathway will be
      evaluated in primary arterial ECs obtained from older adult (> 60 years) and adult (18-30
      years) subjects before and following rhythmic handgrip exercise that elevates brachial artery
      shear-rate similarly in both groups. ECs will be used to quantify markers of EC autophagy,
      eNOS activation, and NO generation. The study will also determine whether exercise-training
      attenuates the aging-associated decline in EC autophagy, and whether intact autophagy is
      required for training-induced vascular improvements. To evaluate this potential, it will be
      determined whether one-limb rhythmic handgrip exercise training by older adult (> 60 y) human
      subjects is sufficient to elevate basal and shear-induced EC autophagy initiation, eNOS
      activation, and NO generation vs. the contralateral sedentary limb. Results from this work
      have tremendous potential to reveal a new therapeutic target and approach for restoring /
      maintaining vascular function in the aging population.
    

Intervention name(s): Rhythmic Handgrip Exercise; Chronic Exercise Training
Intervention type(s): Other; Other
Intervention description(s): 60 minute rhythmic handgrip exercise; Handgrip exercise training consisting of three 60-minute training sessions per week for eight weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Aging; Endothelial Cell Autophagy
Effect of Cognitive Behavioral Therapy in OCD Highlighted by Neuropsychological Tests and MRI: Pathophysiology and Treatment Outcome Predictors
Condition: Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      OCD patients are assessed before and after treatment using diagnostic tools, rating scales
      neuropsychological assessment and functional and structural MR-scans.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        OCD patients from the primary care clinics in middle Jutland, Denmark
      
Biospecimen description: 
      Full blood
    
Keywords: Psychological tests; Magnetic Resonance Imaging; Cognitive therapy
The Effects of Breakfast on Brain Function
Condition: Healthy
Study type: Interventional

Summary: 
      To test cognitive abilities of 8-11 year old children under conditions of fasting or
      receiving a full school breakfast.
    


Intervention name(s): USDA School Breakfast
Intervention type(s): Dietary Supplement
Intervention description(s): Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: School Breakfast; Diet; Nutrition; Brain Function; Cognition; USDA; Healthy Children
Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Condition: Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This phase 4 study will explore, in the context of the present French clinical practice, the
      impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for
      etiologic determination of the cognitive and functional impairment, but in whom:

        1. lumbar puncture was not feasible for medical conditions

        2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating
           physicians

        3. lumbar puncture (LP) was refused by the patient
    

Detailed description: 
      It will be conducted in an outpatient setting at the tertiary memory clinics (CMRR) in France
      in patients with a preliminary diagnosis based on the completion of a prior, full diagnostic
      workup, not more than 12 months previously - which could include, but will not be limited to
      brain imaging if needed (magnetic resonance imaging (MRI) or computed tomography (CT)),
      neuropsychological evaluation including a Mini-Mental Status Examination (MMSE), CSF
      examination and other examinations according to "Haute Autorité de santé" (HAS, National
      Authority of Health, France) Recommendations - and in whom:

        1. lumbar puncture was not feasible for medical conditions

        2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating
           physicians

        3. lumbar puncture (LP) was refused by the patient

      For all subjects the study will comprise 3 outpatient clinic visits to record information on
      previous work ups and to perform the FBB Positron Emission Tomography (PET) scan (Visit 1:
      screening/ baseline, Visit 2: PET scan, Visit 3: subject informed on the FBB PET scan
      result).

      At Visit 1, the initial diagnosis based on previous work up will be collected and rated on a
      five-point Likert confidence scale by the Physician.

      At Visit 2, the FBB PET scan will be performed. Adverse events will be reported during the
      exam and up to 7 days after the PET procedure.

      At Visit 3, based on the amyloid PET scan results, change of diagnosis will be collected, in
      addition to physician confidence.
    

Intervention name(s): Neuraceq (florbetaben 18F); PET
Intervention type(s): Drug; Procedure
Intervention description(s): Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.; A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
Other intervention name(s): FBB; Positron Emission Tomography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: CSF; Alzheimer's Disease (AD) and related dementia; HAS recommendations
Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy
Condition: Mammary Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      patients undergoing modified radical mastectomy were divided into two groups. patients in
      catheter group were placed a catheter with open technique by the surgeon in the pectoral
      area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml
      %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in
      iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog
      pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and
      compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.
    

Detailed description: 
      patients undergoing modified radical mastectomy were divided into two groups by computer.
      patients in catheter group were placed a catheter under clavipectoral fascia in the
      neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis
      lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula. solution included
      10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given
      via the catheter for postoperative analgesia at the end of surgery. patients in iv analgesia
      group were given 100 mg tramadol iv 30 minutes before extubation. Patients in both groups
      were given dexketoprofen 50 mg iv if the VAS score was over 4. VAS scores, rescue analgesic
      requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24
      hours and 90 days after surgery.
    

Intervention name(s): catheter; iv analgesia
Intervention type(s): Device; Drug
Intervention description(s): catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis; patients were given 100 ml of tramadol 30 minutes before extubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: postoperative analgsia; peripheral block catheter; modified radical mastectomy
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain
      relief in migraine patients. However, despite the number of CES studies done, many have been
      open label, single blinded, or have utilized a small group of patients.
    

Detailed description: 
      This study will evaluate the efficacy of the Fisher Wallace Cranial Stimulator in persons
      with chronic migraine who have not achieved satisfactory pain control on their current
      medications.
    

Intervention name(s): Cranial Electrostimulator; Sham Device
Intervention type(s): Device; Device
Intervention description(s): participant wears active cranial electrostimulation device for 20 minutes daily for 28 days; participant wears sham device for 20 minutes daily for 28 days
Other intervention name(s): Fisher Wallace Cranial Electrostimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Removal of impacted lower third molar is considered as the most common surgical procedure
      carried out in the oral and maxillofacial Clinics. The surgical removal of the impacted
      mandibular third molar is usually associated with pain, swelling and inability to open the
      mouth. Those symptoms reach the maximum intensity between the third to fifth hours
      postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then,
      they gradually diminished until the 7th day postoperatively
    

Detailed description: 
      Removal of impacted lower third molar is considered as the most common surgical procedure
      carried out in the oral and maxillofacial Clinics. The surgical removal of the impacted
      mandibular third molar is usually associated with pain, swelling and inability to open the
      mouth. Those symptoms reach the maximum intensity between the third to fifth hours
      postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then,
      they gradually diminished until the 7th day postoperatively.

      Kinesio taping (KT), also termed ''elastic therapeutic bandage,'' is a popular technique used
      for the management of postoperative lymphedema after maxillofacial surgery. KT is an elastic
      therapeutic tape invented by Dr Kase in the 1970s. KT originated from sports medicine and is
      primarily used to support damaged soft tissues (muscles and joints), helping to reduce pain.
      KT is considered to regulate the blood and lymph flow and also to remove the congestion of
      lymphatic fluid or hemorrhage and, thus, has achieved popularity in the control of
      lymphedema.

      Many studies had evaluate the KT technique in reducing the morbidity after surgical removal
      of third molar. There is a lack of adequate evidence regarding effects of KT techniques
      versus placebo and the effectiveness of KT with that of other methods and medical agents.
    

Intervention name(s): Kinesio taping; Wound Tape
Intervention type(s): Device; Device
Intervention description(s): skin colored Kinesio-Tex Gold tape, 50 mm _ 5 m (Kinesio Holding Corp, Albuquerque, NM) tapped in technique described by Gozluklu et al in 2020; skin colored wound tape tapped in technique described by Gozluklu et al in 2020
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impacted third molar; Kinesio taping; swelling
OTO-313 in Subjects With Unilateral Subjective Tinnitus
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral
      tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral
      tinnitus.
    


Intervention name(s): OTO-313; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intratympanic injection; Single intratympanic injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intratympanic injection; IT injection; gacyclidine; tinnitus
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Condition: Needlestick Injuries
MeSH terms: Needlestick Injuries
Study type: Interventional

Summary: 
      The aim of the study is to find a simple method for pain reduction that can be used in
      clinical practice when administering digital nerve block with a single subcutaneous
      injection. It will be investigated whether a smaller volume of lidocaine can decrease pain
      during injection.
    

Detailed description: 
      Healthy volunteers will receive a single subcutaneous injection digital nerve block at the
      base of each ring finger. 2ml 1% lidocaine in one of the fingers, and 1 ml 2% lidocaine in
      the other. After each injection, the subject will be asked to evaluate the pain on a visual
      analog scale (0-100 mm). Additionally the sensibility will be tested with a Semmes-Weinstein
      monofilament, to evaluate if the different methods achieve desired anesthetic effect.
    

Intervention name(s): 2 ml 1% Lidocaine; 1 ml 2% Lidocaine
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Injections; Lidocaine; Pain; Healthy volunteers