bioihbjkbjnl/mcl2 huggingface dataset:
S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
Condition: Adult Meningioma
MeSH terms: Meningioma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor
      cells from dividing so they stop growing or die.

      PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with
      unresectable benign meningioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the partial and complete response rates in patients with unresectable benign
           meningioma treated with hydroxyurea.

        -  Assess the quantitative and qualitative toxic effects of this drug in this patient
           population.

      OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.
    

Intervention name(s): hydroxyurea
Intervention type(s): Drug
Intervention description(s): 20 mg/kg/day PO
Intervention MeSH terms: Hydroxyurea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult grade I meningioma
A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to characterize the pharmacodynamic profile, safety and
      tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus
    


Intervention name(s): ONO-5129
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial
Condition: Early Feeding; Bowel Anastomosis
Study type: Interventional

Summary: 
      Purpose:

      To determine the safety and efficacy of early enteral feeding after distal (ileum-colon)
      elective bowel anastomoses in children.

      Methods:

      Controlled randomized trial including all pediatric patients with distal elective bowel
      anastomosis, excluding non-elective and high risk patients. VARIABLES:

      Demographic characteristics, operative time, anastomosis placement,

      Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to
      full diet intake, post-operative stay. Safety variables: mild and persistent vomiting,
      persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or
      dehiscence, reoperation and death. At the end of surgery were randomized to:

        1. Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good
           abdominal conditions (once the post operative ileus had solved), oral fluids and diet
           was started.

        2. Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the
           patients were discharged. Statistics: Descriptive statistics for global description.
           Student's t test for quantitative variables and Chi square test for qualitative
           variables, a p-value less than 0.05 was considered statistically significant.
    


Intervention name(s): Early feeding; 5 day fasting
Intervention type(s): Other; Other
Intervention description(s): after 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated.; Obligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Early feeding; Bowel anastomosis; Children
A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects
Condition: Metabolics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the
      effects the drug has on the body
    


Intervention name(s): Placebo; BMS-986036
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aims of this study are to learn how lanadelumab moves through a child's body and if
      the children have any medical problems from lanadelumab. Other aims are to learn if
      prophylactic treatment with lanadelumab reduces the number and severity of HAE attacks in
      children, how lanadelumab affects the child's body, and if the children develop antibodies to
      lanadelumab.

      The study doctors will treat acute HAE attacks according to their standard practice.

      Participants will receive lanadelumab for up to 52 weeks. When they start treatment,
      participants will visit their clinic every week for the first 4 weeks. Then, they will visit
      their clinic every 4 weeks during treatment.
    

Detailed description: 
      This study will consists of 52-week treatment period and a 2 or 4-weeks follow-up period
      (depending on the treatment schedule). 52-week treatment period comprises of a 26-week
      treatment period A (Day 0 to Day 182) and a 26-week treatment period B (Day 183 to Day 364).
      Participants who complete treatment period A will immediately continue into treatment period
      B.
    

Intervention name(s): Lanadelumab
Intervention type(s): Drug
Intervention description(s): Participants will receive 150 mg dose of lanadelumab every 2 or 4 weeks, depending on the participants age, over the 52-week treatment period.
Other intervention name(s): TAK-743; DX-2930; SHP643
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lanadelumab
A New Glucose Meter With Alternative Site Testing
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of the study was to evaluate the performance of the blood glucose monitoring
      system when used with samples taken from the palm and forearm for alternative site testing
      (AST).
    

Detailed description: 
      The blood glucose monitoring system may be used for alternative site testing. The blood
      glucose results obtained by subjects with samples taken from the palm and forearm were
      compared with fingerstick capillary blood glucose results obtained from subjects by an HCP.
      Product labeling was evaluated for comprehension of performing alternative site testing as
      well as for additional meter features. User feedback about the system and its features was
      obtained.
    

Intervention name(s): Apollo Blood Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.
Other intervention name(s): Commercial name is CONTOUR® USB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to See if Platelet Transfusion Stop or Lessen the Effect of the Drug on Platelets
Condition: Inhibition on Platelet Aggregation
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to see if platelet transfusion stop or lessen the effect of the drug on platelets
    

Detailed description: 
      A open label, randomized, crossover and potential parallel, single dose study of ticagrelor
      180 mg and acetylsalicylic acid (ASA) in healthy volunteers followed by autologous in vivo
      platelet transfusion to determine the effects of platelet supplementation on the
      reversibility of platelet inhibition
    

Intervention name(s): Ticagrelor; Clopidogrel; ASA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral single loading dose 180ng; Oral single loading dose 600mg; 81mg once daily from day -2 up to platelet transfusion
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1 Safety ,; pharmacodynamic,; Ticagrelor,; Clopidogrel,; Platelets
Mucinex® for Treatment of Filamentary Keratitis
Condition: Filamentary Keratitis
MeSH terms: Keratitis
Study type: Interventional

Summary: 
      It is a pilot study aimed to determine if oral Mucinex® is effective in reducing the amount
      of corneal filaments and improving symptomology in subjects with filamentary keratitis.
    

Detailed description: 
      The study is aimed to determine if oral administration of Mucinex® is effective in reducing
      the amount of corneal filaments and improving symptomology in subjects with filamentary
      keratitis. Subjects will be instructed to take 600 mg tablets of extended release Mucinex®
      twice a day (total dose is 1.2 g/day) for 4 weeks.
    

Intervention name(s): Mucinex®
Intervention type(s): Drug
Intervention description(s): Mucinex®
Other intervention name(s): Guaifenesin
Intervention MeSH terms: Guaifenesin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Forearm Immobilization, Metabolic Health, and Nutrition
Condition: Healthy
Study type: Interventional

Summary: 
      The present study will investigate the impact of dietary branched chain amino acid
      restriction on muscle atrophy, insulin sensitivity and muscle protein synthesis following
      short-term forearm immobilization
    

Detailed description: 
      Twenty-four healthy young volunteers will undergo 2 days of forearm immobilization in
      combination with either a branched chain amino acid restricted diet or a control diet. Before
      and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined
      with repeated blood and muscle sampling under insulin clamp conditions, in order to measure
      insulin sensitivity and muscle protein synthesis in the fasted and fed state.
    

Intervention name(s): Forearm immobilization
Intervention type(s): Behavioral
Intervention description(s): Two days of forearm immobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Physical Activity Levels of Hypertensive and Healthy Individuals Under Social Isolation During the COVID-19 Pandemic
Condition: Hypertension; Social Isolation; COVID
MeSH terms: COVID-19
Study type: Observational

Summary: 
      COVID-19 is an emergency situation which broke out from China in 2020. Health commitees and
      goverment set some rules and limit people's freedom to leave from their houses and it is
      called as 'social isolation'.Staying at home and disease bring about sedentary lifestyle,
      anxiety and depression and changed eating habits of all person. Hypertension is an important
      cardiovasculary risk factor and physical activity, stress managament are very important for
      disease control. In that study we aimed to assess hypertensive and healthy person's anxiety
      level, physical activity and qualit of life level during COVID-19 social isolation.
    

Detailed description: 
      COVID-19 is an emergency situation which broke out from China in 2020. Health commitees and
      goverment set some rules and limit people's freedom to leave from their houses and it is
      called as 'social isolation'. With social isolation people were restricted to go outside from
      house and with that they had to stay at home. Staying at home and disease bring about
      sedentary lifestyle, anxiety and depression and changed eating habits of all person. It was
      very dangerous especially chronically ill persons. Physical activity and exercise are
      keystones for managing cardiovasculary disease risk factors. Hypertension is important risk
      factor all around the world. Disease control is important to prevent complications. In that
      study, we aimed to assess hypertensive and healhty individuals' physical activity, anxiety,
      healthy lifestyle habits and quality of life with changed life condition during COVID-19
      social isolation.
    

Intervention name(s): Questionnaires
Intervention type(s): Behavioral
Intervention description(s): Questionnaires: Physical therapists ask questions these assess quality of life, anxiety and depression, physical activity level.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy population: Being adult and absence of any chronic disease and willing to
        participate to study

        Hypertensive Population: Diagnosed with hypertension, being adult and willing to
        participate study
      
Keywords: physical activity; hypertensive; anxiety; quality of life
Efficacy of Naltrexone Treatment as Augmentation to SSRI in OCD Patients
Condition: Obsessive Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Assessing the efficacy of Naltrexone as augmentation to SSRI in patients with OCD
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational

Summary: 
      Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.
    

Detailed description: 
      Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma
      whose are treated with cytoreductive therapy and stem cell transplant.
    

Intervention name(s): zoledronic acid
Intervention type(s): Drug
Intervention description(s): zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years
Intervention MeSH terms: Zoledronic Acid
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with multiple myeloma previously untreated
      
Keywords: multiple myeloma; stem cell transplant; zoledronic acid
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
Condition: Small for Gestational Age (SGA)
Study type: Observational

Summary: 
      The objective of this surveillance is to collect Safety and Effectiveness information for
      Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
    

Detailed description: 
      All the patients whom an investigator prescribes Genotropin should be registered
      consecutively until the number of subjects reaches target number in order to extract patients
      enrolled into the investigation at random.
    

Intervention name(s): Somatropin
Intervention type(s): Drug
Intervention description(s): 0.23 mg to 0.48 mg/kg/week
Other intervention name(s): Genotropin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        -  A patients who is diagnosed for SGA. (SGA is defined as birth weight and/or length at
             least 2 standard deviations (SDs) below the mean for gestational age (<or=-2 SD)).

          -  A patient who is SGA and older than 3 years.

          -  A patient who has persistent short stature (i.e., remaining at least 2.5 SD below the
             mean for chronologic age).
      
Keywords: Genotropin; Somatropin; Long Term Follow-Up; Special Investigation; Small for Gestational Age; SGA
Next Steps: a Community-led Solution to Address Childhood Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of Next Steps pilot intervention is to develop and test a new program designed to
      help low-income multiethnic families with overweight or obese children achieve long-term
      maintenance of healthful behaviors following completion of Hennepin County Medical Center's
      (HCMC) 16-week intensive obesity management course (Taking Steps Together (TST)).
    

Detailed description: 
      Next Steps is a community based pilot intervention study conducted in collaboration between
      community leaders, the University of Minnesota, Hennepin County Medical Center (HCMC) and The
      Family Partnership. The study collaborators will develop and test a new program designed to
      help low-income multiethnic families with overweight or obese children achieve long-term
      maintenance of healthful behaviors following completion of HCMC's 16-week intensive obesity
      management course (Taking Steps Together (TST)). Next Steps, the focus of this study, will
      comprise a network of parent-led, community-based health maintenance programs that will be
      offered to TST graduate families.

      Project Aims:

      Aim 1: Establish a core parent leadership group and health maintenance program network that
      is self-sustaining and can serve the community for years to come.

      Aim 2: Test the feasibility, acceptability and sustainability of the Next Steps programs.

      Aim 3: Assess the impact of the Next Steps programs on helping participant families sustain
      or improve healthful behaviors and achieve or maintain healthy body mass index (BMI).
    

Intervention name(s): Nutrition/physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): Nutrition/physical activity intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Radio-frequency in Patients With Myofascial Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the potential clinical benefits of Monopolar Capacitive
      Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial chronic neck
      pain.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled trial. Setting: University community.

      Patients with myofascial chronic neck pain with active MTrP in one upper trapezius muscle
      were involved. The patients were randomly divided into two groups: a radiofrequency group
      (RFG), who (14 patients) received 8 sessions of a monopolar capacitive resistive
      radiofrequency (MCRRF) application over the upper trapezius muscle and ten patients received
      8 sessions of placebo radiofrequency (PG) over the same muscle. Main outcome measures: Visual
      analog scale (VAS), neck disability index (NDI) and cervical range of motion (pre-treatment,
      immediately post-first session treatment and post-treatment.
    

Intervention name(s): Radiofrequency
Intervention type(s): Other
Intervention description(s): The equipment used, 35-mm diameter CAP and 30-mm diameter RES movable electrode was used on the affected site, and a planar electrode was used as a return electrode on the abdomen. The electricity was administered in the following manner: cream was applied to the site with the severest pain and its adjacent area, and the electrical output was increased by moving the movable electrode within the patient´s tolerance level, while monitoring the skin temperature tolerable to the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Different Tools Inserted Nasal Endotracheal Tube
Condition: Intubation, Nasotracheal Intubation
Study type: Interventional

Summary: 
      Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial
      surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal
      intubation, limited information presents in NTI. The aim of the study is to compare the
      efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.
    


Intervention name(s): Macintosh Laryngoscope; Pentax Airway scope; Glidescope
Intervention type(s): Device; Device; Device
Intervention description(s): the device is to assist nasotracheal intubation; the device is to assist the nasotracheal tube into trachea; the device is to assist the nasotracheal tube into trachea
Other intervention name(s): Macintoish laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Macintosh laryngoscope, Pentax, Glidescope
Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo and tocilizumab controlled phase II
      trial in RA patients to evaluate the initial efficacy, safety, pharmacokinetic,
      pharmacodynamic characteristics, and immunogenicity of VDJ001 in RA patients.
    

Detailed description: 
      After screening, eligible subjects were randomly assigned in a 1:1:1:1 ratio to VDJ001 4
      mg/kg group, VDJ001 6 mg/kg group, placebo group, and tocilizumab group to receive trial drug
      or control drug every 4 weeks. The treatment course was 12 weeks (D1, W4, W8 administration,
      followed up to W12).
    

Intervention name(s): Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
Intervention type(s): Biological
Intervention description(s): The drug was administered once every 4 weeks.
Other intervention name(s): Tocilizumab Injection; placebo control
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment