bioihbjkbjnl/mcl2 huggingface dataset:
Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of piritrexim in treating patients with
      advanced cancer of the urinary tract that has not responded to previous treatment.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the antineoplastic activity of piritrexim and its effect on the
      survival of patients with advanced urothelial carcinoma previously treated with systemic
      cytotoxic chemotherapy. II. Evaluate the toxicity of piritrexim in these patients.

      OUTLINE: Patients receive piritrexim by mouth 3 times daily, 5 days a week, for 3 weeks
      followed by 1 week of rest. Patients with responding or stable disease continue treatment
      every 4 weeks until unacceptable toxicity or progression intervenes.

      PROJECTED ACCRUAL: A maximum of 40 patients will be entered over 5-6 months if at least 1
      response is observed in the first 14 evaluable patients.
    

Intervention name(s): piritrexim
Intervention type(s): Drug
Intervention MeSH terms: Piritrexim
Primary purpose: Treatment
Keywords: recurrent bladder cancer; transitional cell carcinoma of the bladder; squamous cell carcinoma of the bladder; adenocarcinoma of the bladder; recurrent urethral cancer; recurrent transitional cell cancer of the renal pelvis and ureter
Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an
      additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and
      no more adverse events than patients receiving non-protocolized pain management.
    


Intervention name(s): Hydromorphone; Nonprotocolized
Intervention type(s): Drug; Drug
Intervention description(s): Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes; An IV opioid the type and dose of which will be determined by the treating clinician
Other intervention name(s): Dilaudid; Usual Care
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Pain, Emergency Department, ED, Hydromorphone, Dilaudid Protocolized Nonprotocolized Usual Care
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This research study is being done to examine how meditation and the relaxation response (RR)
      may change brain activity in attention-deficit/hyperactivity disorder (ADHD).
    


Intervention name(s): Meditation/Relaxation Response Training
Intervention type(s): Behavioral
Intervention description(s): 1 hour weekly sessions with 20 min daily home practice for 6 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Macronutrients on Satiety and Gut Hormone Responses
Condition: Eating Behavior
Study type: Interventional

Summary: 
      This study is part of a research theme aiming at elucidating the physiological mechanisms of
      action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure
      induces pronounced and sustained weight loss, but the physiological mechanisms of action are
      not completely clear. Neither mechanical restriction of food intake nor malabsorption, are
      the main contributing factors. The enhanced postprandial responses of gut hormones (e.g.
      GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a
      changed physiological set point for appetite and metabolism.

      Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be
      able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of
      the anorectic gut hormones. The higher functions of the brain will respond to these strong
      neuroendocrine signals by ensuing satiety and fullness.
    

Detailed description: 
      Ten healthy volunteers, aged 18 to 65 years will be recruited. Each subject will be studied
      on six occasions one week apart. On each visit, a baseline serum sample will be drawn from
      each subject. In a randomized way all subjects will receive the following meals in their
      successive weekly visits: Option 1 High protein mixed meal in capsules that break down in the
      stomach, Option 2 High protein mixed meal in capsules that break down in the distal small
      bowel, Option 3 High fat mixed meal in capsules that break down in the stomach, Option 4 High
      fat mixed meal in capsules that break down in the distal small bowel, Option 5 High CHD mixed
      meal in capsules that break down in the stomach, Option 6 High CHD mixed meal in capsules
      that break down in the distal small bowel. On the same day, all subjects will be offered
      standard ad libitum meal to measure their food consumption. After 3 hours (i.e. at 12:00)
      another blood sample will be drawn. All subjects will be asked to rate their appetite on a
      Visual Analogue Scale (VAS). Upon VAS completion the subjects will be allowed to go home.
    

Intervention name(s): Protein stomach; Protein distal small intestine; CHO stomach; CHO distal small intestine; Fat stomach; Fat distal small intestine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): encapsulated protein stomach; encapsulated protein distal small intestine; encapsulated CHO stomach; encapsulated CHO distal small intestine; encapsulated Fat stomach; encapsulated Fat distal small intestine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
Condition: Myelodysplastic Syndromes; Beta-Thalassemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Thalassemia; beta-Thalassemia; Iron Overload; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and efficacy of deferasirox in transfusion dependent
      Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
    


Intervention name(s): deferasirox
Intervention type(s): Drug
Other intervention name(s): ICL670
Intervention MeSH terms: Deferasirox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myelodysplastic Syndromes; beta-Thalassemia; Iron Overload; Iron Chelating Agents; deferasirox
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional

Summary: 
      To study the effects of crocin supplement in patients with type 2 diabetes, 50 patients will
      be randomly allocated to placebo group and 2 tablets of crocin for 12 weeks. At the first and
      the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and
      anthropometric factors will be assessed and compared between groups.
    


Intervention name(s): crocin; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 tablets crocin per day; 2 tablets placebo per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures
Condition: Clavicle Fracture
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      This is a prospective, level II evidence comparison between two cohorts. This study is
      designed to compare the percutaneous versus open approach for plate fixation of diaphyseal
      clavicle fractures. This study includes questionnaires and measurements that will collect
      data on incision-related numbness, union rates, overall outcomes, complication rates of the
      two methods, infection rates, and overall satisfaction. The surgical procedure, all
      radiographs and follow-up visits to a minimum of one year are the principle investigators
      (PI's) standard of care for this injury. Measurements and questionnaires are related to the
      study.
    


Intervention name(s): xrays
Intervention type(s): Other
Intervention description(s): xrays from 2 week postop to 5 year postop
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated surgically for diaphysial clavicle fracture.
      
Keywords: Clavicle Fractures; Numbness; Percutaneous plate fixation; open plate fixation; incision related numbness; union rates; subjective; questionnaire based outcomes; Diaphyseal
PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to
      insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM
      patients in a euglycemic clamp setting.

      To characterize the within-subject variability in the metabolic activity (pharmacodynamic
      [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp
      setting.

      Secondary Objectives:

      To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a
      euglycemic clamp setting.

      To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a
      euglycemic clamp setting.

      To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a
      euglycemic clamp setting.
    

Detailed description: 
      The maximum study duration per patient is approximately 9 weeks (screening of 3 to 28 Days,
      treatment period of 2 days [Periods 1 and 2], washout period of 5 to 19 days [between
      treatment period], and end-of-study visit of 7 to 14 days after study drug administration in
      Period 2).
    

Intervention name(s): Technosphere Insulin SAR439065 Afrezza®
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: dry powder
Route of administration: oral inhalation
Other intervention name(s): Afrezza®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of SPSIPB on Postoperative Pain and Analgesic Consumption in Patients Undergoing VATS
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and
      its effect on opioid consumption in patients undergoing video-assisted thoracoscopic surgery
      (VATS).
    

Detailed description: 
      There were two randomized groups: Group S (SPSIPB) (n=12), Group C (no block) (n=12). All
      patients had standard general anesthesia. Group S had serratus posterior superior intercostal
      plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) at the end of the
      surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS)
      was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery.
      Total tramadol consumption was calculated using patient-controlled analgesia (PCA) device.
    

Intervention name(s): Serratus posterior superior intercostal plane block (SPSIPB)
Intervention type(s): Other
Intervention description(s): Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: serratus posterior superior intercostal plane block; video assisted thoracoscopic surgery; postoperative pain; regional anesthesia
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of
      Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult
      subjects.

      Secondary Objective:

      Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in
      healthy adult subjects.
    

Detailed description: 
      The maximal total study duration per subject is 5 weeks and 1 day.
    

Intervention name(s): Z0063; Gaviscon
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: chewable tablets
Route of administration: oral; Pharmaceutical form: chewable tablets
Route of administration: oral
Intervention MeSH terms: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity
Condition: Obesity
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purposes of this study are to compare the effects of Topiramate and placebo on abdominal
      visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12
      months of continued treatment in male patients with abdominal obesity.
    

Detailed description: 
      Topiramate is not approved for the treatment of obesity. This study is a 6-month randomized,
      double-blind placebo-controlled study, followed by a 6-month open-label extension study to
      evaluate the effect of Topiramate on abdominal visceral fat accumulation, a clinical
      surrogate known to be associated with the complications of obesity such as increased
      incidence of Type 2 diabetes mellitus, hypertension, and dyslipidemia, and their associated
      morbidities. Patients will be randomized to receive either daily Topiramate or placebo.
      Effectiveness will be measured by multiple parameters such as abdominal visceral fat
      (assessed by computed tomography), total and subcutaneous abdominal fat, body composition,
      body weight, body mass index, glucose tolerance, lipid profile, blood pressure, Topiramate
      plasma concentration, or 24 hours energy expenditure (selected patients). Safety evaluation
      (adverse events, vital signs, 12-lead ECG, clinical laboratory tests) will be conducted
      throughout the study. The study hypothesis is that Topiramate is effective in reducing
      abdominal visceral fat in male patients and well tolerated. After the initial 12-week
      titration phase, patients will receive either Topiramate (200mg twice daily or the maximum
      dose tolerated) or placebo by mouth for 6-months. Then, patients will receive Topiramate
      (200mg twice daily or the maximum tolerated dose) for 6-months during the open-label phase.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity; Abdominal Obesity; Visceral Fat; Subcutaneous Fat; Dislipidemia; Hypertension; Type 2 Diabetes Mellitus
Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This is a randomized controlled behavioral intervention trial to assess the efficacy of
      investigating program of Reablement-Instrumental Activities of Daily Living (RE-IADL) on
      schizophrenia patients at immediately and long-term.
    

Detailed description: 
      Subjects will be randomized to intervention group and control group. The outcome measures
      include the Canadian Occupational Performance Measure, Instrumental Activities of Daily
      Living-3 Dimensions, Activities of Daily Living Rating Scale III, Frenchay Activities Index,
      Lawton Instrumental Activities of Daily Living, Mini Mental State Examination-2nd edition,
      Behavior Rating Inventory of Executive Function adult version, Allen Cognitive Level
      Screen-6th, Participation Measure-3 Domains, 4 Dimensions, Personal and Social Performance
      scale, Work Behavior Inventory, Schizophrenia-Quality of Life questionnaire, Beck Depression
      Inventory-II, and Functioning Scale of the Disability Evaluation System.
    

Intervention name(s): RE-IADL; General community rehabilitation
Intervention type(s): Other; Other
Intervention description(s): RE-IADL program is to conduct trainings related to instrumental activities of daily living. For example,using communication appliance, moving in community, financial management, health care, housework, prepare meals and clear ,and shopping.; General community rehabilitation contains the activities in psychiatric rehabilitation center.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: reablement; instrumental activities of daily living
rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis
Condition: Peripheral Vestibular Disorders
MeSH terms: Vestibular Diseases; Dizziness
Study type: Interventional

Summary: 
      Falling is one of the most common consequences of vestibular dizziness. Most of patients with
      vestibular dysfunction suffer from balance disorders, postural instability and vertigo that
      may lead to life threating complications as fractures and brain injuries. Non invasive brain
      stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been
      investigated as therapeutic interventions for various neurological disorders like motor
      deficits and balance disorders after various neurological deficits. To investigate the effect
      of repetitive transcranial magnetic stimulation (rTMS) added to supervised vestibular
      rehabilitation program on balance and postural stability in patients with vestibular
      dizziness
    

Detailed description: 
      The subjects of both genders with age 40 to 65 will be allocated randomly into two equal
      groups A and B. Group A Outcomes measure will include : Berg balance scale, computerized
      dynamic posturography (CDP) . Assessment will be done before and after treatment sessions.
    

Intervention name(s): rTMS group; placebo rTMS group
Intervention type(s): Device; Device
Intervention description(s): Twenty five randomly assigned patients with peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises; Twenty five randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.
Other intervention name(s): repetitive transcranial magnetic stimulation; placebo rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation
Condition: Liver Failure; Mesenchymal Stem Cells
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Liver Failure; Hepatic Insufficiency
Study type: Observational

Summary: 
      The study aimed to investigate the short-term efficacy and long-term prognosis of liver
      failure patients caused by hepatitis B after single transplantation with autologous marrow
      mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited
      and received the same medical treatments, among whom some patients underwent single
      transplantation with autologous MMSCs and other patients with matched age, gender and
      biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL),
      prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A
      total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs
      suspension were slowly transfused into the liver through the proper hepatic artery by
      interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in
      translation group were compared with those in control group. In 3 ~ 48 months of follow-up,
      differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and
      mortality between two groups were compared.
    

Detailed description: 
      A total of 527 patients with chronic hepatitis B induced liver failure were recruited from
      May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver
      failure were based on previously described criteria. All patients received the same medical
      treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene
      phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained
      before study. Among these patients, 53 received transplantation with autologous MMSCs. The
      day of surgery served as the first day of observation. And 105 patients with matched age,
      gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Liver failure patients with HBV infection
      
Keywords: short-term effects; long-term follow-up; liver failure patients; autologous MSCs transplantation