bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      The aim of this study is to describe the survival and relapses of patients with diagnosis of
      acute lymphoblastic leukemia at two tertiary level hospitals in the metropolitan area of the
      valley of Mexico
    

Detailed description: 
      Retrospective, observational study in patients with diagnosis of acute lymphoblastic
      leukemia, according to the criteria of the World Health Organization, from July, 2016, to
      October, 2020. The patients were cared for in the hematology department of the Hospital
      General de Mexico and in the hematology department of the Hospital Regional de Alta
      Especialidad Ixtapaluca. Relapse was considered in those cases with more than 5% of blasts in
      bone marrow and as relapse to the central nervous system with the presence of blasts in
      cerebrospinal fluid.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with first diagnosis of acute lymphoblastic leukemia
      
Keywords: Survival; Leukemia; Relapse; Retrospective study
Exercise and Glycemic Control in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional

Summary: 
      Hyperglycemia is an independent risk factor for the development of diabetic complications in
      type 2 diabetes. Exercise improves glycemic control, however, the role of exercise
      characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be
      elucidated.

      This study aims to assess the effect of several exercise characteristics on hyperglycemia in
      various subgroups of type 2 diabetes patiënts.
    


Intervention name(s): Exercise intervention; No exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): various exercise characteristics; No exercise control period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Glucose Monitoring System; Exercise
The Effectiveness of Calistenic Exercise Training in Adolescents
Condition: Adolescent Development
Study type: Interventional

Summary: 
      Objective: The aim of this study is to examine the effectiveness of calisthenic exercise
      training applied via video chat application on physical activity, physical fitness, quality
      of life and sleep, and anxiety and depression levels in adolescents during distance
      education. Material and methods: In our study, 38 adolescents were randomly divided into two
      equal groups as exercise training group and control group. Calisthenic exercise training was
      given to the exercise training group for eight weeks, three days a week, via video chat
      application and under the supervision of a physiotherapist. The control group was evaluated
      before and after the study period. Physical activity levels of individuals; International
      Physical Activity Scale, quality of life; Children's Quality of Life Scale, anxiety
      depression levels; Beck Anxiety Scale, Reynolds Depression Scale and sleep quality were
      evaluated with Pittsburg Sleep Quality Index.
    


Intervention name(s): calisthenic exercises
Intervention type(s): Other
Intervention description(s): these exercises are a kind of exercise for increasing cardiovascular endurance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled study
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Adolescent; Teleconference; exercise training; calisthenic exercise; physical activity
Stylet Use for McGrath Videolaryngoscope
Condition: Orotracheal Intubation
Study type: Interventional
Phase: Phase 4

Summary: 
      The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by
      some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious
      complications. We compared the intubation time and success rate whether or not use of stylet
      for endotracheal intubation with McGrath videolaryngoscope.
    


Intervention name(s): McGrath videolaryngoscope; McGrath videolaryngoscope with Intubating stylet (Mallinckrodt); rocuronium
Intervention type(s): Device; Device; Drug
Intervention description(s): without use of stylet; use of stylet; tracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope
Other intervention name(s): rocumeron
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Comparison of Cardiac Computed Tomography and Vasodilator Stress Magnetic Resonance Imaging Perfusion in Patients With Prior Equivocal Stress Test for Detection of Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Background:

        -  Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate
           further expensive testing.

        -  In patients with known or suspected coronary artery disease, both computed tomography
           (CT) and magnetic resonance imaging (MRI) have been shown to provide suitable results
           for detecting the disease. However, both types of scans have limitations in their
           usefulness, and it is not known whether one is preferable in either accuracy or
           cost-effectiveness.

      Objectives:

      - To determine the accuracy and cost-effectiveness of CT and MRI in subjects with a prior
      inconclusive heart stress test.

      Eligibility:

      - Patients 18 years of age and older who have had an inconclusive heart stress test within
      the past 90 days.

      Design:

        -  A blood test will be obtained prior to both heart tests. This will require less than a
           teaspoon of blood.

        -  A CT scan will be performed, accompanied by beta blocker medications (to slow heart
           rate) or nitroglycerin (to enlarge blood vessels) to improve picture quality, as needed.

        -  An MRI scan will be performed. Scans will be taken before, during, and after the patient
           receives vasodilators (to increase blood flow to the coronary arteries and detect
           blockages in heart blood vessels).

        -  Heart rate and function will be monitored with an electrocardiogram.
    

Detailed description: 
      Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate further
      expensive testing. We will do both cardiac computed tomography (CT) and stress cardiac
      magnetic resonance imaging (MRI) in patients who have an inconclusive noninvasive cardiac
      stress test. We will test whether MRI predicts significant coronary artery disease in a more
      cost-effective and accurate manner than CT, or vice versa.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This trial will involve the NIH Clinical Center and Suburban Hospital. Subjects with an
        equivocal stress study determined by a referring physician will be recruited from the
        surrounding community.
      
Keywords: Inconclusive Noninvasive Cardiac Stress Test; Cardiac Computed Tomography; Coronary Artery Disease; Atherosclerosis
Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia.
Condition: Apnoeic Oxygenation
MeSH terms: Apnea
Study type: Interventional

Summary: 
      Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction
      of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is
      effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in
      the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim
      of this study was to investigate the effectiveness of apnoeic oxygenation during airway
      management in children.

      This was a pilot randomised controlled trial. Patients were randomised to either receive
      apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome
      was the duration of safe apnoea, defined as a composite of the time to first event, either
      time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2
      observed during airway management. Secondary outcomes were number of patients whose SpO2
      dropped below 95% and number of patients whose SpO2 dropped below 92%.
    


Intervention name(s): Apnoeic oxygenation
Intervention type(s): Device
Intervention description(s): 3 L/min of oxygen by nasal cannula during as apnoeic oxygenation during airway management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Apnoeic oxygenation; Airway management; Oxygen insufflation; Paediatric general anaesthesia
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.
    


Intervention name(s): Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories); Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries
Condition: Gynecological Outpatient Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-center, randomized, double-blind, Propofol parallel-controlled phase
      III clinical study, with the primary objective of evaluating the efficacy of Ciprofol vs.
      Propofol for the induction of sedation/anesthesia in subjects undergoing gynecological
      outpatient surgeries and secondary objective of evaluating the safety of Ciprofol in subjects
      undergoing gynecological outpatient surgeries.
    


Intervention name(s): Ciprofol; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): intravenous bolus; intravenous bolus
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fasting Condition
Condition: Fasting State
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this
      study is to assess the bioequivalence between Test Product and the corresponding Reference
      Product under fasting condition in normal, healthy, adult, human subjects.
    

Detailed description: 
      Primary Objective of this pivotal study was to assess the bioequivalence between Test
      Product: Levocetirizine Dihydrochloride 5 mg Tablets of M/s Ipca Laboratories Limited, India
      and the corresponding Reference Product: Xyzal® (levocetirizine dihydrochloride) 5 mg Tablets
      of M/s UCB Inc.,USA, under fasting condition in normal, healthy, adult, human subjects in a
      randomized crossover study.

      Secondary Objective was to monitor the safety and tolerability of a single oral dose of
      Levocetirizine Dihydrochloride 5 mg Tablets in normal,healthy, adult, human subjects.

      The study was conducted with 28 healthy adult subjects. In each study period, a single 5 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Levocetirizine Dihydrochloride 5 mg Tablets
Intervention type(s): Drug
Intervention description(s): A single oral dose of Levocetirizine Dihydrochloride 5 mg Tablets
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma
Condition: Chronic Subdural Hematoma
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic
      subdural hematoma (CSDH).
    

Detailed description: 
      Study design:

      Multi-center, randomized, double-blind, placebo parallel controlled

      Subjects:

      Patients with chronic subdural hematoma (CSDH)

      Sample size:

      200, including an Atorvastatin-treated group of 100 patients and a control group of 100
      subjects.
    

Intervention name(s): Atorvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg (every evening orally) for 8 weeks; 20 mg (every evening orally) for 8 weeks
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic subdural hematoma; Atorvastatin; oral administration therapy
Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to identify the dose of linagliptin in paediatric
      patients.

      Other efficacy objectives include the comparison of the lowering effect of linagliptin low
      dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of
      treatment.

      Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD)
      and the PK/PD relationship of linagliptin in the paediatric population.
    


Intervention name(s): placebo; BI1356 low dose; BI1356 high dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): comparison of different dosages of drug (low vs high) vs placebo; comparison of different dosages of drug (low vs high) vs placebo; comparison of different dosages of drug (low vs high) vs placebo
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Condition: Blood Donation
MeSH terms: Syncope, Vasovagal
Study type: Interventional

Summary: 
      we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and
      white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation
    

Detailed description: 
      Vasovagal reaction is the most common type of blood donation reaction. The main cause of this
      reaction is the decrease of blood volume. Therefore, fluid supplement before blood donation
      has been proved to be effective in preventing the vagal reaction after blood donation. It was
      proved that isotonic (sugar & salt) drink intake before blood donation had a significant
      effect on reducing vasovagal reaction.

      However, in 2002, WHO recommended the new reduced osmolarity rehydration formula with better
      taste. Oral Rehydration Salt 3 has been produced according to WHO formula with standard
      ingredient and easy to prepare. In addition, in Guangdong culture, sugar water is regarded as
      a tonic, more easily accepted. So, the aim of our study was to compare the effects of 500 ml
      water with Oral Rehydration Salt 3, white granulated sugar and conventional recommended water
      intake prior to blood donation on blood donation reaction after whole blood donation, in
      order to understand the effect of different liquid supplement on blood donation reaction and
      the willingness of blood donation again.
    

Intervention name(s): Oral Rehydration Salts power (iii); water with white granulated sugar; water
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): Dissolve 2 packs of Oral Rehydration Salts Power (iii) (5.125g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.; Dissolve 2 packs of Taikoo white granulated sugar (5g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.; Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.
Other intervention name(s): Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      SRI's are considered first-line treatments for OCD, however many patients continue to have
      significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown
      that the glutamate neurological system is involved in OCD. This study will test the safety
      and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where
      the OCD has been un-responsive, or partially responsive to regular SRI treatment.
    


Intervention name(s): Topiramate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg - 400 mg/day x 12 weeks; 25 - 400 mg/day x 12 weeks
Other intervention name(s): Topomax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment Refractory Obsessive Compulsive Disorder
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
      tumor and cause less damage to normal tissue.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic
      body radiation therapy and to see how well it works in treating patients with prostate
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To escalate the dose of stereotactic body radiotherapy (SBRT) to a tumoricidal dose
           without exceeding the maximum tolerated dose in patients with organ-confined prostate
           cancer. (Phase I)

        -  To determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity
           occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol
           treatment as assessed by CTCAE v3.0. (Phase II)

      Secondary

        -  To determine the dose-limiting toxicity of SBRT in these patients. (Phase I)

        -  To determine the 2-year biochemical (PSA) control (freedom from PSA failure),
           disease-free and overall survival, local control, freedom from distant metastases, and
           the incidence of high-grade adverse events of any type in patients treated with this
           therapy in order to determine if the therapy is promising enough for further clinical
           investigation. (Phase II)

      OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II
      open-label study.

        -  Phase I: Patients undergo 5 treatments of stereotactic body radiotherapy (SBRT).

        -  Phase II: Patients undergo SBRT at the maximum tolerated dose as in phase I. After
           completion of study treatment, patients are followed at 1.5, 3, 6, 9, and 12 months,
           every 6 months for 5 years, and then once a year for years 5-10.

      PROJECTED ACCRUAL: A total of 97 patients will be accrued for this study.
    

Intervention name(s): stereotactic body radiation therapy (SBRT)- 45 Gy; stereotactic body radiation therapy (SBRT) - 47.5 Gy; stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1); stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)
Intervention type(s): Radiation; Radiation; Radiation; Radiation
Intervention description(s): Dose of SBRT - 45 Gray (Gy) in five fractions; Dose of SBRT - 47.5 Gray (Gy) in five fractions
Other intervention name(s): Dose of SBRT - 47.5 Gy in five fractions; Dose of SBRT - 50 Gray (Gy) in five fractions; Dose of SBRT - 50 Gray (Gy) in five fractions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.
Condition: Alcoholism; Depression
MeSH terms: Alcoholism; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study was to examine the influence of memantine, a noncompetitive NMDA
      receptor blocker, in depression co-morbid with long term alcohol heavy use comparing to
      SSRI-inhibitor, escitalopram. Second goal is to compare their influence to cognitive tasks
      and the third goal is to follow up alcohol-use with these two medicines.
    

Detailed description: 
      Context Depression is common clinical problem among alcoholics and its treatment has no
      standard and is controversy. Glutamate NMDA-receptors may mediate the effects of long term
      alcohol related depression and thus the NMDA-receptor modulator memantine could have effects
      on it.

      Objectives The preliminary aim of this study was to identify possible new treatment for
      depression of alcoholics and compare the efficacy of escitalopram and memantine in co-morbid
      depression of alcoholism.

      Design and setting Double-blind, randomized, naturalistic study, 26-week trial on alcohol
      dependent outpatients.

      Participants Eighty alcohol dependent depressive adults

      Intervention Subjects were randomized 1:1 to receive memantine or escitalopram 20 mg per day.
      During the study the patient received routine psychosocial treatment at A-Clinic. No
      concomitant intervention on alcohol consumption and no imposed treatment goals. The patients
      were met weekly in first month, then after 3 and 6 months.
    

Intervention name(s): Ebixa (memantine hydrochloride); Cipralex (escitalopram)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Memantine; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alcoholism; Depression; Efficacy study; Memantine; Escitalopram