bioihbjkbjnl/mcl2 huggingface dataset:
Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -
Condition: Pneumonia; Lung Abscess; Peritonitis
MeSH terms: Pneumonia; Abscess; Peritonitis; Lung Abscess
Study type: Observational

Summary: 
      The purpose of the survey is to study the followings under practical use, regarding the
      safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and
      UNASYN-S KIT for intravenous use (UNASYN).

        1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse
           Drug Reaction)

        2. Incidence status of adverse drug reactions

        3. Factors that may affect the safety and effectiveness
    

Detailed description: 
      Implemented as a Special Investigation by a central registration system. Secondary data
      collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.
    

Intervention name(s): Sulbactam Sodium/Ampicillin Sodium
Intervention type(s): Drug
Intervention description(s): Intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection or drip infusion. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)).
Kit for intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection after dissolved in an accompanying reconstitution diluent. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)).
Other intervention name(s): UNASYN-S
Intervention MeSH terms: Ampicillin; Sulbactam
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with the following disease who received high doses of UNASYN (exceeding 6 g per
        day) from the first dosing date or the second dosing date.

          1. Pneumonia

          2. Lung Abscess

          3. Peritonitis
      
Keywords: UNASYN-S; High Dose
Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care
Condition: Malaria; Diarrhea; Acute Respiratory Infection
MeSH terms: Respiratory Tract Infections; Diarrhea
Study type: Interventional

Summary: 
      Under the World Health Organization's (WHO) integrated community case management (iCCM) Rapid
      Access Expansion Program (RAcE), World Vision Niger and Canada supported the Niger Ministry
      of Public Health to implement iCCM in four health districts in Niger in 2013. Community
      health workers (CHWs), known as Relais Communautaire (RCom), were deployed in their
      communities to diagnose and treat children under five years of age presenting with diarrhea,
      malaria and pneumonia and refer children with severe illness to the higher-level facilities.
      Two of the districts piloted RCom using smartphones equipped with an application to support
      quality case management and provide good timely clinical data. A two-arm cluster randomized
      trial assessed the impact of use of the mHealth application mainly on quality of care (QoC),
      but also on motivation, retention and supervision
    


Intervention name(s): mHealth Intervention for Quality of Care
Intervention type(s): Other
Intervention description(s): Does use of a specially equipped smartphone make a difference in the diagnosis and treatment by RCom of malaria, pneumonia and diarrhea in children aged 2 to 59 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effects of Different Doses of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection
Condition: Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion Injury
MeSH terms: Reperfusion Injury; Aortic Dissection; Ischemia; Wounds and Injuries
Study type: Observational

Summary: 
      Aortic dissection is the most common aortic disease leading to death. Among them, patients
      with Stanford type A dissection (TAAD) are prone to dissection rupture in the early stage,
      and their condition deteriorates rapidly. They need immediate surgical treatment after
      admission.In this study, the detection data of biomarkers of nervous system Ischemia /
      Reperfusion (I/R)injury in patients with Stanford type A dissection were retrospectively
      analyzed, and the effects of different doses of adrenaline on biomarkers of nervous system
      I/R injury were evaluated by statistical methods.The information of 132 patients with
      Stanford type A aortic dissection who underwent sun's operation in the Department of
      cardiovascular surgery of the first medical center of the PLA General Hospital from January
      2012 to January 2019 was retrospectively analyzed.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The TAAD patients aged 18-75 years old
A Booster Dose of Ad5-EBOV in Healthy Adults After Primary Immunization
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14
      outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious
      outbreak was considered to be a new epidemic strain, with GP homology of the gene was only
      97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine
      was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry
      products which could be stored at 4℃.

      In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical
      trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe
      and robustly immunogenic. One shot of the high dose vaccine could mount glycoprotein-specific
      humoral and T-cell response against Ebola virus in 14 days. The investigators intent to
      evaluate the safety and immunogenicity of a booster dose of the recombinant Ebola adenovirus
      vector vaccine (Ad5-EBOV) in healthy adults after primary immunization in this add in study.
      The investigators expect that the boosting immunization with a same vaccine for primary
      immunization is possible and could confer a longer-lived protection when needed.

      The phase I trial has been unblind 28 days after the primary vaccination, but all the
      subjects are still kept blind as well as the laboratory staffs. Therefore, this booster
      vaccination trial will be conduct in single blind.
    


Intervention name(s): 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV); 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV); placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): one dose, 4×10^10vp/1ml per dose; two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Safety; immunogenicity; Ebola vaccine; boosting
Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders
Condition: Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Developmental Disabilities
Study type: Observational

Summary: 
      Hippotherapy is every program of horseback riding meant to treat people with physiological,
      mental, social, cognitive or behavioral problems. The purpose of the current research is to
      evaluate the efficacy of hippotherapy for children with developmental disabilities. The
      hypothesis is that children with developmental disabilities who are treated with hippotherapy
      will show better outcomes than children with the same problems who are not treated with
      hippotherapy.
    

Detailed description: 
      Hippotherapy is every program of horseback riding meant to treat people with physiological,
      mental, social, cognitive or behavioral problems. Most studies that tested hippotherapy were
      uncontrolled and focused on motor problems, such as cerebral palsy. Today, hippotherapy is
      used for various developmental problems such as Attention deficit / Hyperactivity disorder
      (ADHD) and Autism spectrum disorder (ASD), without clear information about its efficacy for
      these populations.

      The purpose of the current research is to evaluate the efficacy of 6 months of hippotherapy
      for children with developmental disabilities. The hypothesis is that children with
      developmental disabilities who are treated with hippotherapy for 6 months will show better
      outcomes than children with the same problems who are not treated with hippotherapy.

      Assessment:

        -  BRIEF questionnaire

        -  Stony Brook Questionnaire

      All questionnaires will be applied at the beginning of the study and after 6 months.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hippotherapy subjects will be taken from horseback riding farms. Control subjects will be
        taken from a tertiary care clinic.
      
Keywords: ADHD; ASD
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Condition: HIV Infection; HIV-1 Infection; Mycobacterium Avium Complex (MAC)
MeSH terms: Infections; Communicable Diseases; Mycobacterium avium-intracellulare Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to
      characterize the pharmacokinetic properties of maraviroc alone and when administered with
      rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to
      the literature.
    


Intervention name(s): Rifabutin; Maraviroc
Intervention type(s): Drug; Drug
Intervention description(s): Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days; Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days
Other intervention name(s): Mycobutin, RFB; Celsentri, MVC
Intervention MeSH terms: Maraviroc; Rifabutin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy volunteers
Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Disease Progression
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients
      with prostate cancer.

      PURPOSE: This randomized clinical trial is studying how well diet works in altering disease
      progression in patients with prostate cancer on active surveillance.
    

Detailed description: 
      CALGB 70807 is a randomized, phase III clinical trial designed to test this practical,
      diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS
      will be randomized either to an intervention of centralized, telephone-based dietary
      counseling and structured dietary education or to a comparison control condition in which
      they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease
      progression, incidence of treatment, and health-related quality of life.

      OBJECTIVES:

      Primary

        -  To determine if a telephone-based dietary intervention compared to no intervention will
           decrease clinical progression in AS patients.

      Secondary

        -  To compare the incidence of active treatment (surgery, irradiation, local ablation, or
           androgen deprivation) in AS patients receiving dietary intervention compared to no
           intervention.

        -  To compare prostate cancer-related anxiety in AS patients receiving dietary intervention
           compared to no intervention.

        -  To compare health-related quality of life in AS patients receiving dietary intervention
           compared to no intervention.

      OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs
      > 70 years), race (black or african american vs other), and baseline prostate biopsy (0-12
      months before registration vs > 12-24 months before registration). Patients are randomized to
      1 of 2 treatment arms. Please see the arms section for more information.
    

Intervention name(s): dietary education and counseling; prostate cancer foundation booklet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; adenocarcinoma of the prostate
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease
Condition: Healthy Subjects; Pharmacokinetics of ASP8232; Pharmacodynamics of ASP8232; Chronic Kidney Disease (CKD); Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study consists of two parts.

      Part 1 evaluates the effect of renal impairment on the PK and PD of a single dose of ASP8232.
      In addition, the safety and tolerability will be assessed.

      Part 2 evaluates the PK, PD, and safety and tolerability of multiple doses of ASP8232
      compared with placebo in Type 2 Diabetes Mellitus (T2DM) subjects with Chronic Kidney Disease
      (CKD).
    

Detailed description: 
      This is a two-part study. Part 1 compares the pharmacokinetics (PK), pharmacodynamics (PD)
      and safety and tolerability of ASP8232 in healthy subjects with subjects with different
      degrees of renal impairment; Part 2 is a multiple-dose, placebo-controlled study to evaluate
      the PK, PD and safety and tolerability of multiple doses of ASP8232 in T2DM subjects with
      CKD.

      Part 1:

      Subjects reside in the clinic for 9 days, receiving a single oral dose of ASP8232 on Day 1
      under fasted conditions followed by a 168-hours blood and urine PK/PD sampling period.
      Subjects are discharged on Day 8 and return to the clinic on Days 10, 12, 14, 21, 28, and 42
      for the collection of blood PK/PD samples. An End of Study Visit (ESV) takes place after the
      last PK sample is collected on Day 56.

      Part 2:

      Subjects are admitted to the clinic on Day -2 in order to collect PD urine samples before
      dosing begins on Day 1. Subjects receive multiple oral doses of ASP8232 or placebo for 28
      days. They are discharged on Day 8 and return to the clinic on Days 14 and 21, and Days 27 to
      29 for blood PK/PD and urine PD samples. An ESV takes place 14 to 28 days after the last
      PK/PD sample is collected.
    

Intervention name(s): ASP8232; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ASP8232; Multiple doses; Phase 1; Single dose
Outcomes of Laparoscopic Sleeve Gastrectomy
Condition: Bariatric Surgery Candidate; Laparoscopic Sleeve Gastrectomy; Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The aim of this study is to assess 5 year long-term outcomes of laparoscopic sleeve
      gastrectomy emphasizing weight loss and modification of comorbidities such as type 2 diabetes
      mellitus, hypertension and gastroesophageal reflux disease from a developing country, Turkey.
      Prospectively-collected patient data will retrospectively reviewed. To measure the efficacy
      of the procedure, we will calculate the excess weight loss percentage (EWL %). Effective
      weight loss after LSG will accepted as more than 50%. The changes in the status of the type 2
      diabetes mellitus, hypertension, gastroesophageal reflux disease will be observed.
    


Intervention name(s): Laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Each procedure will be completed with laparoscopy with five trocars. A 36F bougie will used to calibrate the volume of the remnant stomach. Linear gastrectomy will begin 2 cm proximal of the pylor and will continue until the gastroesophageal junction. According to the intraoperative decision and experience of the surgeon, endoscopic clips would be used to ensure hemostasis of the stapler line.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in
      treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of Prolonged Release (PR) OROS
      methylphenidate in fixed dosage as compared to placebo, and the effectiveness of flexible
      dosage Prolonged Release (PR) OROS methylphenidate in Swedish adult male prison inmates with
      attention-deficit hyperactivity disorder (ADHD). An initial randomised, double-blind,
      placebo-controlled parallel group trial for 5 weeks is followed by an open-label extension
      for maximum 47 weeks, comprising altogether 52 weeks of treatment. A follow-up is carried out
      12 and 36 months post-study, respectively.
    

Intervention name(s): PR OROS Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PR OROS Methylphenidate given orally once daily for 5 weeks. The dosage was as follows: 36 mg per day from day 1-3, 54 mg per day from day 4-7 and 72 mg per day from day 8 until end of 5th week.; Sugar pill
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; Prison; Treatment; Randomized; Double-Blind; Placebo Control; Parallel Assignment; Efficacy Study
Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The study aims to determine if a popular dextrose candy alternative yields a similar glycemic
      curve compared to the standard oral Dextrose solution used in the Oral Glucose Tolerance
      Test.
    


Intervention name(s): Candy Glucose Tolerance Test
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will use a popular dextrose candy alternative to help assess glycemic response.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
Condition: Healthy Volunteers
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for
      treatment of depressed facial acne scars
    


Intervention name(s): Restylane Lidocaine; No-treatment control
Intervention type(s): Device; Other
Intervention description(s): Hyaluronic acid based filler; No-treatment control
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the humoral immune responses to three different dose
      schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously
      in healthy participants between 2 and <18 years of age living in dengue endemic countries.
    

Detailed description: 
      The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV) which
      was administered in 3 different dosing schedules to participants aged from 2 to 17 years
      resident in dengue endemic countries. This study looked at the titers of antibodies to dengue
      fever elicited in people who received TDV.

      The study randomized 1800 healthy participants. Participants were randomly assigned to one of
      the four treatment groups in a 1:2:5:1 ratio-which remained undisclosed to the participant
      and study doctor during the study (unless there was an urgent medical need):

        -  Group 1 - TDV 0.5 mL subcutaneous (SC) injection Days 1 and 91

        -  Group 2 - TDV 0.5 mL SC injection Day 1

        -  Group 3 - TDV 0.5 mL SC injection Days 1 and 365

        -  Group 4 - Placebo (dummy SC) - this is a liquid that looks like the study drug but has
           no active ingredient

      A total of 600 participants were planned to be randomly included in immunogenicity analyses
      (approximately 100 participants planned in each of Group 1 and Group 4, and 200 participants
      planned in each of Group 2 and Group 3).

      In order to keep the treatment arms undisclosed to the participant and the doctor,
      participants received a placebo injection at any study visit where TDV was not being
      administered (Days 1 and/or 91 and/or 365).

      Participants were asked to record any symptoms that may be related to the vaccine or the
      injection site in a diary card for 28 days after each vaccination.

      This multi-center trial was conducted in Asia and Latin America. Participants were followed
      for 48 months with 10 protocol-scheduled visits for participants included in the planned
      immunogenicity subset of approximately 600 subjects and 7 protocol-scheduled visits for
      subjects not included in the immunogenicity subset.
    

Intervention name(s): Takeda's Tetravalent Dengue Vaccine Candidate (TDV); TDV Placebo
Intervention type(s): Biological; Biological
Intervention description(s): TDV subcutaneous injection; Placebo-matching vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drug therapy