bioihbjkbjnl/mcl2 huggingface dataset:
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor
      cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer
      cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether
      bortezomib is more effective with or without docetaxel in treating patients with advanced
      non-small cell lung cancer.

      PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without
      docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the tumor response rates (complete and partial response) in patients with
           relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with
           vs without docetaxel.

      Secondary

        -  Compare time to progression in patients treated with these regimens.

        -  Compare the overall and 1-year survival of patients treated with these regimens.

        -  Compare the safety and tolerability of these regimens in these patients.

        -  Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.

        -  Compare the quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.

        -  Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm
           I.

      In both arms, courses repeat every 21 days in the absence of disease progression or
      unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses
      beyond confirmation of CR.

      Quality of life is assessed on day 1 of each treatment course (before drug administration)
      and at 30 days after the completion of study treatment.

      Patients are followed at 30 days and then every 3 months for survival.

      PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued
      for this study within 1 year.
    

Intervention name(s): bortezomib; docetaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel; Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer
Exercise and Body Composition in Juvenile Idiopathic Arthritis
Condition: Arthritis, Juvenile
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      This research is being done to see if resistance exercise (RE) is safe and has a positive
      effect on children and young adults with juvenile idiopathic arthritis (JIA).

      JIA is an inflammatory autoimmune disease that can cause severe impairment and disability.
      JIA can cause bone loss and decreased muscle strength. The medications used to treat JIA can
      also have negative effects on growth and development, strength, and ability to function. RE
      is performing movements in a slow and controlled fashion (i.e., no speeding up or using force
      in the lifting and lowering of the weight) to lessen force on the joints and tissues. This
      study will be using Ren-Ex exercise equipment to perform RE.

      Currently the American College of Rheumatology recommends exercise for patients with
      arthritis. This exercise includes range of motion exercise to protect joint mobility as well
      as low resistance and aerobic exercise (AE) to protect muscle mass, bone health, and fitness.
      However, a recent study showed no major differences in functionality or quality of life
      between patients who performed AE and those who did not perform AE. There is a need for more
      data on the impact of RE on children with JIA. Children and young adults aged 10 to 21 with
      juvenile idiopathic arthritis may join.
    


Intervention name(s): Ren-Ex Machine; Dual-Emission X-ray Absorptiometry (DEXA) scan; Biodex dynamometer; Sub-maximal test; Quality of life questionnaires
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): The exercise is performed once per week with individualized instruction using moderate resistance on Ren-Ex Machines, ultra-low-friction equipment to minimize force on joints.; To study body composition; To study muscle strength; To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.
Other intervention name(s): Isokinetic strength testing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Control and participant groups.
Primary purpose: Supportive Care
Coload Optimization Guided by Inferior Vena Cava Collapsibility Index
Condition: Adverse Effect
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the optimal coload guided by inferior vena cava
      collapsibility index in parturients with prophylactic norepinephrine infusion undergoing
      cesarean section.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended
      for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential
      substitute drug for phenylephrine, norepinephrine has gradually been used in parturients
      undergoing cesarean section. There's some evidence that prophylactic infusion of
      norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension
      in parturients undergoing cesarean section. However, our study (NCT03997500) had been shown
      that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic
      norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery,
      suggesting that more prudent fluid management is required. The ideal dose of coload and
      coload is still unknown. Thus, the purpose of this study is to investigate the optimal coload
      guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean
      section.
    

Intervention name(s): 4 ml/kg group; 8 ml/kg group; 12 ml/kg group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.; 8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.; 12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.
Other intervention name(s): Crystalloid; Crystalloid; Crystalloid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coload; Inferior vena cava collapsibility index; Norepinephrine; Cesarean section; Dose-finding
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active
      comparator in severely depressed patients
    

Detailed description: 
      Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are
      selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults.
      This study is designed to evaluate the safety and efficacy of escitalopram and an active
      comparator in severely depressed patients.
    

Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major Depressive Disorder
Oxytocin Buffers Stress Response in Individuals With Impaired Coping Abilities
Condition: Coping Skills; Oxytocin; Stress
Study type: Interventional

Summary: 
      This study investigated, if people with impaired coping abilities benefit from intranasal
      oxytocin application.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The study drug levetiracetam is FDA approved as an add-on medication in the treatment of
      partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an
      "open-label" trial, which means that all participating patients will receive active study
      drug.

      The Jefferson Headache Center has developed this clinical study to evaluate the safety and
      effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual
      disturbances).

      In addition, the study site will be performing a procedure called Transcranial Magnetic
      Stimulation (TMS). This procedure measures brain activity because it is thought that people
      with migraine experience periods of cortical hyperexcitability or over-activity in the brain.
      This information may help physicians in the future determine which preventive medications
      will work for which patients.
    


Intervention name(s): levetiracetam; Transcranial Magnetic Stimulation
Intervention type(s): Drug; Procedure
Intervention description(s): Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg)
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
Condition: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to compare treatment methods and outcomes of patients diagnosed
      with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
    

Detailed description: 
      This is a prospective multicenter observational study in a Consortium of collaborating
      institutions investigating how often older and medically infirm patients who are diagnosed
      with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated
      with induction chemotherapy undergo allogeneic HCT. Investigators will look at the rate of
      undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients
      compared to younger and relatively healthier patients. Investigators will also compare the
      characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT. A
      number of outcomes will be assessed including mortality, morbidity, and quality of life
      (QOL). Baseline information will be collected on different domains of QOL, geriatric
      assessment, health status measures, AML features, and socioeconomic status. Information will
      help physicians and patients to decide on best treatment choices for AML and high-risk MDS in
      older and medically infirm patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include non-M3 AML (including first relapsed and primary
        refractory AML) and high-risk MDS, MPN, and MF adult patients considered for chemotherapy
        at FHCRC and the Seattle Cancer Care Alliance Network and other Core institutions (Stanford
        School of Medicine, Cleveland Clinic, Northwestern University, University of Utah,
        University of Pennsylvania, Washington University in St. Louis, Roswell Park Cancer
        Institute, Hackensack University, University of Maryland, and Duke University).
A Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose trial in
      healthy subjects, randomized to ZP7570 or placebo within each cohort.
    

Detailed description: 
      Sixty-four subjects are planned to be studied in eight cohorts in this first-in human trial.
      Eight subjects will be allocated to the to eight dose levels. The entire observation period
      comprise 28 days starting with a 96 hours in-house stay, where discharge is planned for Day
      5, followed by five outpatient visits and an End of Trial Visit at Day 28. A blinded
      evaluation of each cohort will be performed by a Trial Safety Group to determine whether the
      trial will progress to the next dose level based on the stopping rules specified in protocol.
    

Intervention name(s): Dual GLP-1/GLP-2 Receptor agonists
Intervention type(s): Drug
Intervention description(s): Eight ascending doses of ZP7570
Other intervention name(s): ZP7570
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dual GLP-1R/GLP-2 Receptor agonist
A Case Series on Incidentally Detected Gallbladder Malignancy
Condition: Gallbladder Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      A retrospective analysis of data, using the Hospital records of all the patients who
      underwent cholecystectomy for benign conditions at Osmania General Hospital in a year (2019).
    

Detailed description: 
      A retrospective analysis of hospital records of patients who underwent Cholecystectomy in a
      year duration (2019) for any benign condition, diagnosed and confirmed histopathologically as
      Gallbladder Malignancy.

      There are a total of one hundred and eighty patients who underwent cholecystectomy at our
      hospital (Osmania General Hospital) in 2019, out of which seven patients' histopathological
      diagnosis was gall bladder malignancy. We reviewed all the case's history, cross-checked the
      histopathological slides, and confirmed the diagnosis. To avoid the bias of covid-19 pandemic
      in surgical practice we confined the patient records to the pre-pandemic period of one-year
      duration (2019).

      A total of 180 patients underwent cholecystectomy for various benign conditions in one year,
      out of which seven patients confirmed histopathologically with Gallbladder malignancy.

      Total no of patients : 180 Diagnosed with malignancy : 7 percentage 3.8%

      Among these seven, three patients converted from laparoscopic to open procedure for
      difficulty with resection, two patients are posted for surgery considering empyema of gall
      bladder preoperatively, one patient in view of gall bladder perforation, and for two patients
      preoperative diagnosis was gall bladder polyp.

      Converted from Lap to Open: 3 Pre-op GB Polyp : 2 Perforated GB : 1 Empyema GB : 2

      Only one patient is 40 years old and others are more than 50 years, and two of them are
      males.

      Total : 7 100% Males : 2 28.5% Females : 5 71.5%

      Out of a total of 180 patients who underwent cholecystectomy, 117 are females and 63 are
      males

      Total : 180 Males : 63 Females : 117

      Out of 180, the age distribution is as follows

      Age. Percentage 20 - 29 0 30 - 39 0 40 - 49 0.005 >50. 99.99

      It implies that the malignancy rate increases with an increase in the patient's age more than
      50years and also with gender (Females > males).
    

Intervention name(s): Cholecystectomy, extended cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Cholecystectomy and histopathological evaluation
Other intervention name(s): Histopathological evaluation of the specimen
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the patients who underwent cholecystectomy for benign conditions like gall stones,
        polyps,. Etc,.
      
Keywords: Gallbladder,; Polyp; Gallstones; Malignancy; Perforation
Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade
Condition: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use; Neuromuscular Blockade
Study type: Interventional

Summary: 
      It is well known that magnesium enhances the effect of neuromuscular blocking agents such as
      rocuronium. However, it is not known how much magnesium can reduce neuromuscular blocking
      agents in maintaining deep neuromuscular blockade. Through this study, the investigators will
      quantitatively analyze the rocuronium saving effect of magnesium.
    

Detailed description: 
      It is well known that magnesium potentiate the effect of neuromuscular blocking agents. It
      prolonged the duration of rocuronium and reduces the onset time of rocuronium. Magnesium acts
      on motor end plate, where magnesium reduces the release of prejunctional acetylcholine,
      thereby decreasing the muscle membrane excitability. However, the quantitative rocuronium
      saving effect of magnesium is not clear. This study's hypothesis is that magnesium would
      reduce the amount of rocuronium. And the investigators want to evaluate how much magnesium
      can reduce the amount of rocuronium. Secondary outcome is the effects of magnesium on
      recovery time, postoperative pain, nausea and vomiting.
    

Intervention name(s): Magnesium Sulfate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion; Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Magnesium
Sun Protection Factor Assay (SPF Assay 205/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code:Z09-054)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in
      participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will
      reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.
    


Intervention name(s): MK-0893; Metformin; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg and 100 mg tablets; 500 mg metformin tablets; Placebo tablets matching MK-0893; Placebo tablets matching metformin
Other intervention name(s): Glucophage; Glucophage XR; Glumetza; Fortamet; Riomet
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Therapeutic Uses; Pharmacologic Actions; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Metformin
Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole
Condition: Dyspepsia; Emergency; Pain
MeSH terms: Emergencies; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immediate synergistic effect on the relief of
      severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of
      oral antacid and antispasmodic agent (the conventional treatment).
    

Detailed description: 
      Acid-related dyspepsia is common among the population. Number of these patients may have so
      severe symptoms that can lead them to the emergency department. Mixtures of antacid and
      antispasmodic were widely used over decades to relieve this acute pain with moderate, yet
      questionable, improvement in pain score. Proton pump inhibitors (PPIs), the novel
      acid-lowering agents, are undoubtedly effective to reduce acid secretion and control
      dyspeptic symptoms in short-term and long-term duration. To our knowledge, no previous study
      was conducted to evaluate the efficacy of such agents on immediate pain relief in patients
      with severe dyspeptic symptoms in emergency care. Clinically, they are frequently used to
      treat this circumstance in an unofficial manner since intravenous proton pump inhibitor alone
      is not yet considered as a well-approved indication to alleviate such condition.
      Pantoprazole, a proton pump inhibitor, reaches its peak serum concentration within one hour
      and its acid-lowering effect occurred within first hour following a single intravenous
      infusion. Thus, it theoretically has rapid onset and prolonged action on acid reduction. Our
      primary aim of the study is to evaluate the immediate effect of intravenous pantoprazole in
      addition to the combination of oral antacid and antispasmodic agent (the conventional
      regimen) on the relief of severe acid-related dyspeptic pain.
    

Intervention name(s): Normal saline; Pantoprazole; Oral antacid; Hyoscine butylbromide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 ml of 0.9% sodium chloride solution; 80 mg of intravenous pantoprazole; 30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide); 20 mg of intravenous hyoscine butylbromide
Other intervention name(s): Controloc (Protonix); Antacid; Buscopan
Intervention MeSH terms: Scopolamine; Pantoprazole; Anti-Ulcer Agents; Antacids; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dyspepsia; Emergency treatment; Pantoprazole; Antacid; Pain measurement