bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Neoplasms
MeSH terms: Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of
      recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way
      of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil
      (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of
      angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease
      the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar)
      can improve the sensitivity to chemoradiation via selectively inhibiting the migration of
      endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular
      remodeling and normalization of the tumor vasculature, which will effectively aid the
      delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with
      chemoradiotherapy will be a promising way of treatment for NPC. In this study, the
      first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with
      recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group
      (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a
      control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including
      progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse
      effects rate and quality of life. This research will provide more evidences of evidence-based
      medicine for the safety and tolerability of endostar and the clinical application of endostar
      in NPC treatment.
    


Intervention name(s): endostar; intensity modulated radiation; cisplatin
Intervention type(s): Drug; Radiation; Drug
Other intervention name(s): Human recombinant vascular endothelial inhibitor; DDP
Intervention MeSH terms: Cisplatin; Endostar protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glucose Metabolism and Sleep in People With Family History of Type 2 Diabetes.
Condition: Sleep; Insulin Resistance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when
      people sleep. However, it is still not known if differences in the amount of nighttime sleep
      have an effect on the carbohydrate metabolism of people who have a relative with type 2
      diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis
      that individual differences in habitual sleep duration may be related to differences in the
      carbohydrate metabolism of people who have a history of type 2 diabetes in their family.
    

Detailed description: 
      On two consecutive inpatient days, the participants in this study will undergo two different
      tests. The first test will determine how much insulin can their body produce in response to
      an intravenous glucose infusion over a period of several hours. The second test will
      determine how effective is the action of the sugar-processing hormone, insulin, in their body
      when it is infused intravenously together with glucose over a period of several hours.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy non-obese community-living men and women with a parent, sibling or grandparent who
        has type 2 diabetes
      
Keywords: short sleep duration; glucose clamp technique; insulin secretion; insulin action; lipid turnover; free fatty acids
Effect of Aerobic Exercises on Static & Dynamic Balance
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      To determine the effect of aerobic exercises on static & dynamic balance of children in Down
      syndrome. When a person has Down syndrome, they have an extra chromosome. In the body,
      chromosomes are discrete collections of genes. They control how a baby's body develops and
      works both throughout pregnancy and after birth. A newborn typically has 46 chromosomes. Down
      syndrome is a genetic disorder that affects physical and developmental growth and can cause
      minor to severe issues. Mental impairment, unusual facial features, an increased risk of
      cardiac defects, and digestive issues that can range in severity from mild to severe are all
      symptoms associated with the syndrome.
    

Detailed description: 
      This will be a randomized controlled trial. Total sample size of 20 will be divided into
      control and experimental groups. Control group will be given with the standard physical
      therapy intervention as a baseline treatment while experimental group will be given with the
      aerobic exercise along with baseline treatment. Pediatric balance test and the six-minute
      walk test will be used before and after the intervention. Data will be analyzed on SPSS 26.0
      and necessary analysis will be done after checking the normality of data.
    

Intervention name(s): Cycling; Balance Board
Intervention type(s): Device; Device
Intervention description(s): The experimental group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 8-week period; Control group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises (if required);
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a randomized control trial, used to compare the effect of aerobic exercises on static & dynamic balance in children with down's syndrome. Subjects with down syndrome meeting the predetermined inclusion & exclusion criteria will be divided into two groups using simple random sampling technique
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Down syndrome; aerobic exercises; Static & dynamic balance
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
Condition: Suspected or Documented Gram-negative Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Negative Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of
      imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single
      intravenous (IV) dose of MK-7655A (a fixed ratio combination of
      imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.
    


Intervention name(s): IMI/REL FDC
Intervention type(s): Drug
Intervention description(s): IMI/REL is supplied as a single fixed dose combination (FDC) vial; which is administered at a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).
Other intervention name(s): MK-7655A
Intervention MeSH terms: Relebactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
Condition: Streptococcal Infections; Pharyngitis
MeSH terms: Pharyngitis; Streptococcal Infections
Study type: Interventional

Summary: 
      The purpose of this study was to compare the microbiological effects of two different
      treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day
      daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource
      settings. This study was a prospective multi-center randomized active control treatment
      trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin
      treatment is at least as effective as the currently given IM BPG treatment.
    


Intervention name(s): Penicillin G, Benzathine; Amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg); 750 mg/QD
Other intervention name(s): Intramuscular Benzathine Penicillin G; Beta-lactam antibiotics; Amoxil®; Trimox®
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Penicillins; beta-Lactams; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: streptococcal pharyngitis; randomized clinical trial; amoxicillin; intramuscular benzathine penicillin G.
Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180
      administered as a single intravenous infusion in healthy volunteers, and (2) the safety,
      pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of
      APL018 in patients with CHD
    


Intervention name(s): APL180; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Apolipoprotein A-I,; Atherosclerosis,; HDL,; Inflammation,
Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
Condition: Atypical Endometrial Hyperplasia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will
      not be inferior to returning the endometrial tissue to a normal state than megestrol acetate
      or LNG-IUS alone in patients with endometrial atypical hyperplasia.
    

Detailed description: 
      After diagnosed of endometrial atypical hyperplasia (EAH) by hysteroscopy, patients will be
      enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood
      pressure, serum lipid level and side effects will be collected. Blood tests, including
      fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG,
      sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before
      treatment to evacuate their metabolic conditions.

      Patients are randomized to 1 of 3 treatment groups. Patients will receive MA (megestrol
      acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive LNG-IUS
      insertion on Arm II and MA 160 mg plus LNG-IUS insertion on Arm III. Then an hysteroscope
      will be used to evaluate the endometrial condition every 3 months, and the findings will be
      recorded. For patients with EAH, complete response (CR) is defined as the reversion of
      endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response
      (PR) is defined as regression to simple or complex hyperplasia without atypia; no response
      (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as
      the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR,
      NR or PD.

      After completion of study treatment, 2 months of maintenance treatment will be recommended
      for patients with CR, and participants will be followed up for 2 years.
    

Intervention name(s): Megestrol Acetate; Levonorgestrel-releasing Intrauterine System(LNG-IUS)
Intervention type(s): Drug; Device
Intervention description(s): At a dosage of 160 mg/day; Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
Other intervention name(s): Megace; Mirena Intrauterine Device; Mirena
Intervention MeSH terms: Megestrol; Megestrol Acetate; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levonorgestrel-releasing intrauterine system; megestrol acetate; Atypical Endometrial Hyperplasia
Methylphenidate Treatment for Cocaine Abuse and ADHD - 1
Condition: Attention Deficit Disorder With Hyperactivity; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Many cocaine dependent individuals are also diagnosed with Attention Deficit Hyperactivity
      Disorder (ADHD). Methylphenidate (Ritalin) is currently approved to treat individuals
      diagnosed with ADHD. The purpose of this study is to determine the effectiveness of
      methylphenidate in treating ADHD symptoms in cocaine dependent individuals.
    

Detailed description: 
      Methylphenidate (MPH) is commonly used to treat individuals diagnosed with ADHD. The purpose
      of this study is to determine the effectiveness of MPH in treating adult cocaine dependent
      individuals who are also diagnosed with ADHD.

      Participants in this 14-week, double-blind, placebo-controlled study will be randomly
      assigned to receive either sustained-release MPH or placebo. All participants will receive
      individual cognitive behavioral therapy. The trial will last 14 weeks. It will include a
      1-week placebo lead-in phase and a 2-week dose titration phase, followed by 11 weeks on a
      stable dose of MPH. During the titration phase, MPH will be given twice a day, starting at a
      dose of 10 mg/day. The dose will increase by 10 mg each day, until a final stable dose of 40
      mg/day is reached. At this time, sustained-release MPH will be given as two 20 mg doses (one
      in the morning and one in the afternoon). Depending on a participant's tolerance of MPH, the
      dose will be increased to a maximum of 60 mg/day (40 mg in the morning and 20 mg in the
      afternoon). Participants who are unable to tolerate a dose of at least 40 mg/day of MPH will
      be discontinued from the study. Assessments of ADHD symptoms will be completed at weekly
      study visits. In addition, drug use assessments will also be completed and will include
      self-reports and urine toxicology tests.
    

Intervention name(s): Methylphenidate; placebo
Intervention type(s): Drug; Other
Intervention description(s): placebo
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Cocaine dependence; treatment; methylphenidate
Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension
Condition: Spinal Anesthetic Toxicity; Hypotension Drug-Induced; Cesarean Section Complications
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 8
      mcg) in management of maternal hypotensive episode after spinal block during cesarean
      delivery.
    

Detailed description: 
      Maternal hypotension after spinal anesthesia is a common and serious complication during
      cesarean delivery. Despite all preventive measures, the incidence of hypotension is still
      around 20%. In these cases, maternal hypotension treatment is usually required using
      vasopressor boluses. One of the vasopressors commonly used during cesarean delivery is
      norepinephrine, especially recently.

      Although phenylephrine has long been the first choice for the prevention and treatment of
      maternal hypotension, its use may cause bradycardia and decreased maternal cardiac output.

      Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity;
      therefore, it does not cause significant cardiac depression like phenylephrine.
      Norepinephrine has been introduced for use during cesarean delivery with promising results.
      Several previous studies have investigated the efficacy of norepinephrine infusion in
      preventing maternal hypotension. A dose-response study investigated the best dose of
      Norepinephrine for the prevention of hypotension. In the dose-response study mentioned above,
      a dose of 6 mcg was reported as the best dose for prophylaxis against hypotension.

      There are very limited studies investigating the best bolus dose of norepinephrine for the
      treatment of maternal hypotensive episode, and the optimal dose recommendation is uncertain.
      In this study, researchers will investigate the efficacy and adverse effects of two bolus
      doses of norepinephrine (6 mcg and 8 mcg) in the management of a maternal hypotensive episode
      after subarachnoid block during cesarean delivery.
    

Intervention name(s): Noradrenaline Bitartrate; Bupivacaine Hydrochloride; Noradrenaline Bitartrate; Bupivacaine Hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.; Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL); An intravenous bolus of norepinephrine 8 mcg will be administered for management of maternal hypotension.; Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)
Other intervention name(s): Stenor; Marcaine Spinal Heavy; Stenor; Marcaine Spinal Heavy
Intervention MeSH terms: Norepinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dissemination of Colorectal Cancer Screening to Primary Care Physicians
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently
      repeated educational program, on increasing recommendations for colorectal cancer screening
      among primary care providers by comparison to a service-as-usual control. The study is a
      stratified randomized clinical trial of primary care physicians, stratified by distinct urban
      communities in the New York metropolitan area. The primary outcome is colorectal cancer
      screening recommendations measured via medical audit at 12-month followup after
      randomization.
    

Detailed description: 
      The purpose of the present study is to adapt and extend the use of academic detailing to the
      dissemination of colorectal cancer (CRC) screening findings and guidelines to primary care
      physicians practicing in selected geographic areas in New York City. Since improving
      implementation of cancer screening guidelines also involves compliance by patients in
      completing the recommended tests or examinations, we will also seek to assess knowledge,
      attitude and screening behaviors of patients visiting primary care practitioners in our
      sample. Our long-term goal is to reduce colorectal cancer mortality among ethnic and racial
      minorities, by influencing the screening behaviors of their primary care physicians.

      The specific aims of the study are as follows:

        -  Aim 1. To test the hypothesis that an intervention, multi-component academic detailing,
           will increase the rate of physician CRC screening at 3and 6month postrandomization,
           compared to the rate observed in a serviceasusual control.

        -  Aim 2. To develop models predicting which physician offices are most and least likely to
           adopt the intervention, and to generate hypotheses about tailoring the dissemination of
           CRC screening guidelines to different physician subgroups.

        -  Aim 3. To conduct cost-effectiveness analysis comparing the incremental societal costs
           and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the
           CRC intervention implemented in physicians' offices.
    

Intervention name(s): Academic Detailing
Intervention type(s): Behavioral
Intervention description(s): The academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also be customized to each physician, although the frequency of the detailing visits will be routinized across all participants to reduce cost and to maximize its potential for dissemination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colorectal cancer screening; primary care physicians; health disparities; stratified randomized clinical trial
Comparison of Two Application Techniques for LET Gel
Condition: Lacerations; Pain, Procedural; LET
MeSH terms: Pain, Procedural; Lacerations
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of anesthetic efficacy of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine
      (0.5%) topical gel (LET) applied three times for 10 minutes each time vs. once for 30 minutes
      prior to suturing simple lacerations in children aged 7-17 years.
    

Detailed description: 
      Randomized single-blinded clinical trial with convenience sampling of the anesthetic efficacy
      of a single 30-minute application vs three 10-minute applications of Lidocaine (4%),
      Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) prior to suturing simple
      lacerations in children aged 7-17 years seen in the Emergency Department.
    

Intervention name(s): LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Intervention type(s): Drug
Intervention description(s): Topical anesthetic
Other intervention name(s): LET
Intervention MeSH terms: Lidocaine; Epinephrine; Tetracaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded randomized study; patients are randomized to one of two groups
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment