bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of HIV Risk Reduction Program Among African American Men
Condition: Sexually Transmitted Diseases; HIV
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test the effectiveness of a brief clinic-based program designed to promote
      the correct use of condoms among young African-American men newly diagnosed with a sexually
      transmitted disease.
    

Detailed description: 
      Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread
      through unprotected sexual intercourse. STDs are a major health concern, especially among
      young ethnic minorities in the United States. The rate of STDs is significantly greater in
      urban areas where ethnic minorities, particularly African-American males, are commonly
      represented. Despite this knowledge, safe sexual practices, including correct condom use, are
      not the norm among minority males. It is believed that educational outreach designed to
      motivate and inform on the correct use of condoms will be effective in encouraging safer sex
      practices. This study will test the effectiveness of a brief clinic-based program designed to
      promote the correct use of condoms among young African-American men newly diagnosed with an
      STD.

      Participants in this single blind study will be randomly assigned to an experimental or
      control group. Upon being diagnosed with an STD, men in both groups will receive standard of
      care follow-up treatment. Men in the experimental group will also receive a one-on-one
      educational session on condom use. The educational session will be led by a health educator
      and will last about 30 minutes, depending on the existing skills and learning abilities of
      the participants. Using information provided by the participants on past experience with
      condoms, the health educator will attempt to correct misunderstandings about and problems
      with condom use. Upon enrollment, all men will respond to a series of pre-recorded questions
      and will be required to demonstrate their ability to apply condoms to a penile model. The
      same questions and procedure will be repeated 3 months later.
    

Intervention name(s): Focus on the Future; Control standard of care treatment
Intervention type(s): Behavioral; Other
Intervention description(s): Focus on the Future is an educational program designed to promote proper condom use.; Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: African American; Men; Sexually Transmitted Diseases; Condoms
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Condition: Pituitary Tumor; Pain
MeSH terms: Pituitary Neoplasms; Pituitary Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, double-blind, placebo-controlled intervention trial involving 100 treated
      subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects
      will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in
      the standard post-operative medication arm.
    

Detailed description: 
      Post-operative pain control is a common concern patients have when they consider undergoing a
      surgical procedure. Although effective for treating acute pain, opioid analgesics are also
      associated with dose-dependent adverse effects, including constipation, nausea and vomiting,
      altered mental status, and respiratory depression, all of which have been shown to increase
      patient length of stay. The use of non-opioid analgesics with different mechanisms of actions
      for acute pain control via a multi-modal approach is efficacious in reducing opioid
      consumption, decreasing the incidence of adverse effects, improving patient satisfaction and
      recovery time, and decreasing hospital costs.Certain minimally invasive procedures may afford
      many patients the opportunity to achieve adequate post-operative pain control with minimal to
      no requirement of opioid analgesics, thereby sparing the patient known adverse effects that
      can increase length of stay and costs. The ENTS approach for resection of pituitary tumors is
      the standard surgical procedure for these lesions, and is associated with pain that is more
      easily managed post-operatively, making it an ideal procedure for an opioid-sparing
      post-operative pain regimen. Anecdotally, the investigators note that in the investigator's
      post-operative pituitary patient population that post-operative pain can frequently be
      adequately managed with scheduled non-opioid analgesics, often without requiring breakthrough
      opioid doses. Another safe and effective non-opioid analgesic that is widely used in
      multi-modal pain management for moderate pain is IV Caldolor (ibuprofen). After literature
      review, the investigators were unable to find a study that had attempted to use an
      opioid-sparing analgesic regimen for post-operative pain control following ENTS approach for
      resection of pituitary tumors.
    

Intervention name(s): IV Caldolor; IV Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV Caldolor (IV ibuprofen) intraoperatively and postoperatively; IV Placebo intraoperatively and postoperatively
Other intervention name(s): IV ibuprofen; Opioid Sparing group; Standard treatment group
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Headache
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of antihistamine (Clemastin) on
      migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as
      on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate
      the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages
      than previously investigated. As this has never been done before it is unknown how a lower
      dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying
      symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.

      Our three hypotheses are:

        1. Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of
           migraine in migraine patients.

        2. Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and
           tryptase after PACAP38-infusion.

        3. PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.
    

Detailed description: 
      The purpose of this study is to determine the effects of antihistamine (Clemastin) on
      migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as
      on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate
      the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages
      than previously investigated. As this has never been done before it is unknown how a lower
      dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying
      symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
    

Intervention name(s): PACAP38
Intervention type(s): Drug
Intervention description(s): Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.
Other intervention name(s): Pituitary Adenylate Cyclase Activating Peptide 38
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is:

        -  To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to
           the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering
           from a manic episode according to DSM IV TR (American Psychiatric Association [APA]
           2000) and treated for a 3-month period.

      The secondary objectives are:

        -  To evaluate the clinical and biological safety of the association valproate-amisulpride
           to the association valproate-haloperidol;

        -  To assess the patient status 3 weeks and 3 months after inclusion; and

        -  To assess patient satisfaction at 3 months.
    


Intervention name(s): Amisulpride
Intervention type(s): Drug
Intervention MeSH terms: Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
Condition: Neurogenic Lower Urinary Tract Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to evaluate efficacy and safety of naftopidil in patient with
      neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.
    


Intervention name(s): Naftofidil; Tamsulosin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Naftopidil; safety
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
Condition: Measles; Varicella; Mumps; Rubella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3b study is being conducted for the purpose of registration of the GSK208136
      vaccine in Korea.
    


Intervention name(s): PriorixTM; VarilrixTM; Priorix-Tetra®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subcutaneous administration in left upper arm; Subcutaneous administration in right upper arm; Subcutaneous injection in left upper arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: second year of life; one-dose schedule; varicella; rubella; measles; mumps
Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients
Condition: Critical Illness; Septic Shock; SIRS
MeSH terms: Shock, Septic; Critical Illness
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in
      preventing invasion of gastrointestinal bacteria.
    

Detailed description: 
      Systemic Inflammatory Response Syndrome (SIRS), sepsis, septic shock and concomitant
      multiorgan failure are major causes of morbidity and mortality in intensive care units.
      During SIRS and septic shock the role of the gut seems to be uncertain. As it serves as an
      intestinal barrier which allows the symbiotic relationship between man and enteric bacteria,
      increased gut permeability during critical illness is accused to promote sepsis. Brush border
      enzymes have the ability to detoxify lipopolysaccharides and prevent bacterial invasion
      across the gut mucosal barrier. A reduced brush border enzyme function could contribute to
      the gastrointestinal intolerance in critically ill patients, which is frequently observed.
      The aim of this study is to assess the influence of SIRS and septic shock on brush border
      enzyme morphology and function in men.
    

Intervention name(s): Gastroscopy
Intervention type(s): Procedure
Intervention description(s): When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Active Commuting To Improve Well-being and Health in Everyday Life
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim of present randomized controlled trial is to evaluate the health effects of physical
      activity in transport and leisure time domains of everyday life and to develop durable
      physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle
      routine, in overweight individuals.

      Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical
      activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4:
      a non-intervention control group
    


Intervention name(s): Physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetics of Atorvastatin With Tipranavir/Ritonavir and the Effect of Antacid on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effects of combined tipranavir and ritonavir treatment (at
      steady-state) on the single-dose pharmacokinetics of atorvastatin, the effects of single-dose
      atorvastatin on the steady-state pharmacokinetics of tipranavir, and the effects of antacid
      on the pharmacokinetics of tipranavir
    


Intervention name(s): Tipranavir; Ritonavir; Atorvastatin; Maalox
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aluminum Hydroxide; Magnesium Hydroxide; Simethicone
Intervention MeSH terms: Ritonavir; Tipranavir; Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers
Condition: Healthy Volunteers; Anti-Bacterial Agents; Methicillin-Resistant Staphylococcus Aureus; Methicillin-Sensitive Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin®
      SAL200 following single and multiple ascending doses in healthy male volunteers after
      continuous intravenous infusion over 60 minutes.
    

Detailed description: 
      -  Forty subjects will be randomly assigned to receive either N-Rephasin® SAL200 injection
           or a placebo administered by a 60-min intravenous infusion. Within each group, 8
           subjects (6 active and 2 placebo) will receive a single dose of 6 mg/kg, followed by
           multiple ascending dose of 3, 6, 9, and 12 mg/kg/day. The clinical trial will be
           performed in sequence from the lowest level, and the progress of the next dose level
           will be determined based on the safety results in the previous dose level.

        -  Examinations by interview, physical examinations, and screening tests such as clinical
           laboratory tests and allergenicity will be conducted in volunteers within 4 weeks
           (-28~-2d) from the previous day ot this clinical trial (-1d) to select subjects who are
           judged eligible for the study.

        -  Eligible subjects will be called in the afternoon (-1d) to examine the allergenicity in
           the clinical center of Seoul National Unviersity Hospital.

        -  Allergen-free subjects will be hospitalized on -1d and assigned with each subject
           number. All subjects are advised to fast from 10:00 p.m. overnight to the next morning,
           except drinking water. In the morning (09:00 a.m.) on 1d, subjects in each group will be
           given N-Rephasin® SAL200 injection or a placebo administered by a 60-min intravenous
           infusion, After that, the clinical trial will be conducted according to the designated
           schedule.

        -  All subjects receiving at least one dose will undergo a post-study visit test after a
           certain period of time. Immunogenicity testing will be performed until approximately 50
           days after treatment.
    

Intervention name(s): N-Rephasin® SAL200; INT200-Placebo
Intervention type(s): Biological; Other
Intervention description(s): continuous intravenous infusion over 60 minutes; Formulation buffer except active ingredient for continuous intravenous infusion over 60 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methicillin-Resistant Staphylococcus Aureus; Methicillin-Sensitive Staphylococcus Aureus; N-Rephasin SAL200
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than
      expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels.
      the one-hour glucola test is currently used to screen pregnant patients for gestational
      diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour
      later. We wish to compare 7-day continuous glucose monitoring to the one-hour glucola test,
      and determine which one correlates better with adverse pregnancy outcomes as well as which
      one more accurately identifies patients at risk for adverse pregnancy outcomes.
    

Detailed description: 
      All pregnant patients without pre-existing diabetes will be eligible for the study. Interest
      in participation will be determined at their initial prenatal visit. Those that are
      interested will be consented. Between 24-28 weeks of gestation, the recommended period of
      glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be
      inserted superficially under the skin. The patient will be instructed on how to wear and care
      for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of
      the device, and downloading of the data. She will perform the routine glucola test sometime
      between days 2 to 7 . Finger stick blood glucoses will be checked by the patient 2 times
      daily during the 7 days of wearing the CGMS. Results of CGMS will not be available to the
      patient or her physician until after completion of the pregnancy. The patient will be treated
      routinely, based on the results of the routine glucola test.
    

Intervention name(s): The Seven Continuous Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of a Dexmedetomidine on Quality of Recovery 40 and Postoperative Nausea and Vomiting in Breast Cancer Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine
      was reported to a reduced PONV due to opioid-sparing effect. It is not clear if
      dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study:
      intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than
      placebo for reducing of PONV and improve postoperative quality of recovery score within 48
      postoperative hours.
    

Detailed description: 
      This study was approved by the Institutional Review Board of Severance Hospital, Yonsei
      University Health System. After written informed consent was obtained from all patients, aged
      20-75 years with ASA physical status class I-II who were scheduled breast cancer surgery
      under general anaesthesia were enrolled in this study All the patients were randomly assigned
      to receive dexmedetomidine or placebo during surgery. The primary outcome was quality of
      recovery determined by QOR-40 in the first 24h after surgery.The secondary outcome measure
      was PONV assessed by visual analogue scale every 6 hours within 48 postoperative hours.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery; Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention