bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Efficacy and Safety of Risperidone in the Prevention of Relapse in Children and Adolescents With Conduct and Other Disruptive Behavior Disorders
Condition: Attention Deficit and Disruptive Behavior Disorders
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of risperidone as maintenance
      therapy to prevent symptoms of relapse in children and adolescents with conduct and other
      disruptive behavior disorders, who initially responded well to treatment.
    

Detailed description: 
      This is a randomized, double-blind study to compare an oral formulation of risperidone with
      placebo when taken daily over 24 weeks by children and adolescents with conduct and other
      disruptive behavior disorders. Patients who do not respond to treatment after an initial
      6-week open-label phase, or do not show continued response after 12 weeks, must leave the
      trial and will not enter into the 24-week double-blind phase. The principal measure of
      efficacy is the time to symptom relapse. Relapse is assessed by changes in following
      measures: the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF), a
      measure of symptoms of conduct and other disruptive behavior disorders and Clinical Global
      Impression-Severity of Illness (CGI-Severity), and a measure of overall severity of illness.
      Efficacy assessment also includes Clinical Global Impression-Change (CGI-C), an assessment of
      improvement, and Visual Analogue Scale for the most troublesome symptom (VAS-MS), which is a
      scale ranging from not troublesome to extremely troublesome, and Children's Global Assessment
      Scale (C-GAS), which is an assessment of overall functioning. Safety evaluations include
      incidence of adverse events, physical examinations, laboratory tests (biochemistry,
      hematology, and urinalysis), and electrocardiograms (ECGs). The study hypothesis is that
      daily treatment with an oral formulation of risperidone, compared with placebo, will result
      in a clinically significant difference in time to relapse, and is well tolerated by children
      and adolescents with conduct and other disruptive behavior disorders. Oral risperidone
      solution (1milligram[mg]/milliliter [ml]), daily for 36 weeks. Patients weighing at least 50
      kilograms start at 0.5 ml/day and may increase up to.1.5 ml/day. Patients under 50kg start at
      0.25ml/day and may increase to 0.75ml/day (maximum).
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Child; adolescent; disruptive behavior disorders; risperidone; antipsychotropic agents
Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who
      have extensive-stage small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the complete and overall response rate to paclitaxel in patients
      with previously untreated extensive stage small cell lung cancer. II. Determine the overall
      and progression free survival of these patients in response to this treatment regimen. III.
      Determine the toxicity of this treatment regimen in this patient population.

      OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours weekly for
      6 consecutive weeks. Treatment continues every 8 weeks for 4 courses in the absence of
      disease progression or unacceptable toxicity. Patients are followed every 2 months for 1
      year, then every 3 months for 2 years, and then annually for 2 years.
    

Intervention name(s): paclitaxel
Intervention type(s): Drug
Intervention description(s): 150 mg/sq m IV over 3 hours weekly for 6 weeks per cycle
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a single-center, open label and single-dose clinical trail, to explore the body mass
      balance and identify the major metabolites in Chinese adult male healthy volunteers after a
      single oral dose of [14C]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and
      observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
    

Detailed description: 
      In order to determine the optimal time point for sample collection, this study will be
      divided into two stages: the first stage, two volunteers will be enrolled, the volunteers
      should stop collecting the corresponding samples by the investigators based on radioactive
      test results, safety results combined with the actual comprehensive situation. And in the
      second stage sample collection time for another four volunteers will be determined and
      adjusted according to the results of the first stage.
    

Intervention name(s): [14C]Sulfatinib
Intervention type(s): Drug
Intervention description(s): 300 mg Sulfatinib with 100 µCi [14C]
Other intervention name(s): 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib
Intervention model: Single Group Assignment
Intervention model description: This is single centre, open label, single dose study
Masking: None (Open Label)
Primary purpose: Other
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the safety and feasibility of a decision support
      system aimed at reducing glucose variability in T1DM patient using an insulin pump.
    

Detailed description: 
      The overall aim of this proposed research is to demonstrate the safety and feasibility of a
      decision support system aimed at reducing glucose variability in T1DM patient using an
      insulin pump. The system will be deployed on our portable medical application platform (DiAs)
      and will include insulin pump treatment parameters optimization and an exercise risk warning
      system, capable of predicting hypoglycemia at the onset of physical activity and advising on
      mitigating alteration of treatment.

      A second phase of the trial will enroll additional users of insulin pumps, and subjects who
      treat their T1DM with the use of multiple daily injections (MDI) of insulin. MDI users should
      be administering the Lantus (glargine) dose at approximately the same time each day and use
      only one basal rate per day. MDI users will also use MySugr app to count carbohydrates for
      all meals that require insulin treatment.
    

Intervention name(s): Decision Support System; Usual Care
Intervention type(s): Device; Other
Intervention description(s): The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump or MDI. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements:
An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
A smart bolus calculator based on CGM glucose measurements and insulin sensitivity estimation.; During the Control study admission, DiAs will be programmed with the home insulin dosing parameters. The study subject will use the home basal/bolus MDI or continuous subcutaneous insulin infusion (CSII) insulin regimen via the home insulin pens or pump and determine the amount of insulin to give for the entire admission per the subject's home carb counting parameters and as calculated by the DiAs meal screen.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus (T1DM); Artificial Pancreas Project (APP); Diabetes Assistant (DiAs); Insulin Pump; Continuous Glucose Monitor; Exercise; Glucose Variability; Decision Support System; Multiple Daily Injections (MDI)
Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
Condition: Defecatory Disorders After Left Colonic or Rectal Resection
MeSH terms: Diverticulum; Diverticular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve
      or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA
      preservation could improve patient's quality of life reducing incontinence and/or
      constipation rate.
    


Intervention name(s): Inferior Mesenteric Artery Preservation; Inferior Mesenteric Artery Ligation
Intervention type(s): Procedure; Procedure
Intervention description(s): Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.; Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Other intervention name(s): IMA-P; IMA-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Labor Induction After Failed Induction With Dinoprostone.
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional

Summary: 
      Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours
      from the beginning of labor induction. Women with a BISHOP score of less than 5 will be
      randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with
      a 2nd dinoprostone insert.
    

Detailed description: 
      Nulliparous women with obstetric indications for induction of labor who were induced with a
      dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor
      induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the
      study and sign informed consent. The eligible women will be randomized to 1 of 2 groups.
      Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.
      Relevant demographic and medical information will be gathered from the patients' electronic
      files.
    

Intervention name(s): Dinoprostone; Cervical ripening balloon.
Intervention type(s): Drug; Device
Intervention description(s): Dinoprostone vaginal insert.; Double lumen cervical ripening balloon.
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen
Condition: Allograft
Study type: Interventional

Summary: 
      Traditionally known for their role in haemostasis, platelets have also an immune role.

      Platelets play a key role in immune mediator secretion, and interact with innate and adaptive
      immune cells, contributing to the fight against pathogens, as viruses.

      Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of
      the induced immune depression. Platelets activation for patients is not determined during the
      post-graft period, and platelet induced inflammation following a CMV infection is not
      described.
    

Detailed description: 
      The descriptive present study will determine if platelet activation is altered during the
      post-graft follow-up (day 30 to 90).

      The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus)
      antigen.

      The study will also focus on inflammatory response variation, focusing on the cytokines
      release during the same post-graft follow-up (spontaneously and after CMV antigen
      stimulation).

      This preliminary study could lead to a better understanding of the immune-modulator role of
      inflammation, controlled by the platelets, particularly in the initiation of the
      Graft-versus-host disease in this kind of population.
    

Intervention name(s): Blood samples
Intervention type(s): Other
Intervention description(s): Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Allograft; Cytomegalovirus; Platelets; Hematopoietic stem cells; Graft Versus Host Disease (GVH); Hemostasis; Adaptive immunity; Innate immunity; Post graft follow up
Effect of DHEA on Skin Aging in Postmenopausal Women
Condition: Skin Aging; Quality of Life
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the response of skin parameters related to skin
      aging to the local action of DHEA in postmenopausal women.
    

Detailed description: 
      Humans, along with the others primates, are unique among animal species in having adrenals
      that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone(DHEA)and
      especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the
      adrenals during aging results in a dramatic fall in the formation of androgens and estrogens
      in peripheral target tissues, a situation that has been proposed to be associated with
      age-related diseases including skin atrophy, insulin resistance and obesity. Moreover, much
      attention has been given to the benefits of DHEA administered to postmenopausal women,
      especially on the bone, skin, vagina and well being after oral as well as percutaneous
      administration of the precursor steroid.

      Therefore this study proposes to study the effect of 0.3% DHEA cream during a period of 12
      months administered twice daily to postmenopausal women. During the study several biological
      and clinical parameters will be evaluated. In summary, these include blood steroid levels,
      distribution of hormonal receptors in the skin, sebaceous gland activity, skin hydration,
      skin wrinkles and finally skin genomic evaluation.

      Subjects will be evaluated at specific time intervals for the above mentioned parameters as
      well as tolerability and adverse reactions.
    

Intervention name(s): Dehydroepiandrosterone; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 3.0 ml of 0.3% DHEA cream applied on the skin twice daily.; 3.0 ml of placebo cream applied on the skin twice daily.
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin aging; Menopausal symptoms
Reducing Asthma Disparities Through School-Based Telemedicine for Rural Children
Condition: Asthma; Quality of Life; Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The overall goal of this proposal is to examine the efficacy of a school-based asthma
      telemedicine intervention in a predominately minority, low-income rural pediatric population.
    

Detailed description: 
      A total of 1110 subjects will be enrolled in this research study. Five hundred forty (540)
      subjects will be between the ages of 7-14 years. The remaining 540 subjects will be comprised
      of the primary caregiver of the participants. Thirty (30) school nurse/s providing care to
      the 270 intervention participants will also be enrolled in the study. To test our hypotheses,
      the investigators will conduct a cluster randomized trial with 540 children, ages 7-14 years
      and their parent/guardian(s), to address the following specific aims:

      Specific Aim 1: Examine the efficacy of a school-based asthma telemedicine intervention in
      improving asthma-related health outcomes in an intervention group compared to children
      receiving usual care.

      Specific Aim 2: Determine the effects of a school-based asthma telemedicine intervention on
      asthma self-management skills of intervention caregivers and participants compared to a usual
      care group. The investigators will compare changes in asthma self-efficacy, quality of life,
      and knowledge between groups.

      Specific Aim 3: Determine the cost of the intervention in relation to health outcomes.
    

Intervention name(s): Asthma Education Sessions; Asthma Health Assessment via Telemonitoring; Provider Treatment Prompt; School Absenteeism; Prescription Filling Profile
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Comprehensive asthma education sessions delivered via telemedicine.; Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.; A treatment prompt will be mailed to the primary care provider at baseline and 3 months.; Absenteeism before and after the intervention will be compared in the intervention group and also will be compared to absentee rates of the usual care group.; Study personnel will monitor participants' prescription profiles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pediatric Asthma; Low-income; Arkansas Delta Region
DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn what effects digoxin (DIG) may have on human breast
      cancer tissue.
    

Detailed description: 
      Breast cancer cells grow in a low oxygen environment called hypoxia. The body normally
      controls the amount of oxygen in cells with what is known as Hypoxia-inducible factor
      (HIF)-1. HIF-1 helps cancer cells grow in low oxygen environments; therefore, if this
      function can be blocked, it may make it harder for breast cancer cells to grow. Digoxin is a
      drug that has been shown to block HIF-1 in lab studies. The investigators want to learn if it
      blocks HIF-1 in human breast cancer tissue. This will be done by comparing the tumor tissue
      from the original diagnostic biopsy to tissue that is taken at the time of surgery. The
      investigators will also be comparing tumor tissue of patients who are not randomized to take
      digoxin.
    

Intervention name(s): Digoxin
Intervention type(s): Drug
Intervention description(s): Digoxin once daily for 2 weeks prior to definitive breast surgery.
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Digoxin
PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how low and high does of brexpiprazole binds to
      certain receptors in the brain. This will be determined by PET scans taken pre-dose and
      post-dose.
    


Intervention name(s): Brexpiprazole 1mg to 4mg
Intervention type(s): Drug
Other intervention name(s): Brexpiprazole
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
Condition: Cesarean Section Complications; Wound Breakdown; Wound Infection; Satisfaction; Surgical Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Surgical Wound Dehiscence; Wounds and Injuries; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be an open label pilot randomized controlled clinical trial. Women undergoing
      cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine
      gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).
    

Detailed description: 
      Subjects requiring cesarean delivery and without exclusion criteria will be informed by the
      obstetrical team about the study and asked for permission to contact the study personnel.
      Written informed consent will be obtained by person-to-person contact. The research staff
      will be responsible for the informed consent.

      Subjects who agree to participate in the study will be randomized to one of the two groups
      below in a 1/1 allocation:

        -  Standard Wound Care: Wound dressing and care as per our current practice. Compression
           dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively.
           Dressing will be removed after 24 hours from surgery completion and subjects will have
           an absorption pad with overlying garments for the remaining postoperative days until
           standard postoperative visit for wound check.

        -  CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's
           instructions (Appendix A) intraoperatively. The dressing will be in place until the
           postoperative clinic visit on postoperative day 7.

      The remainder of the subjects' care will be similar for both arms and will follow current
      standard clinical practice at the University of Texas Medical Branch (UTMB).
    

Intervention name(s): ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG); Standard Wound Care
Intervention type(s): Combination Product; Other
Intervention description(s): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7; Wound care will be administered as standard protocol in our institution
Other intervention name(s): Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfection
Intervention MeSH terms: Disinfectants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label randomized control trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cesarean; Wound care; Wound complication; Surgical site infection