bioihbjkbjnl/mcl2 huggingface dataset:
Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
Condition: Alcohol Use; Smoking; Contraception; HIV
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with
      master's level mental health professionals within a juvenile justice setting; 2) determine
      acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment
      satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk
      of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).
    

Detailed description: 
      The overall objective of this study is to assess the feasibility and promise of an adapted
      CHOICES preconception intervention (CHOICES-TEEN) in reducing the risk of HIV,
      nicotine-exposed pregnancy (NEP), and alcohol-exposed pregnancy (AEP) in adolescent females
      on intensive community probation. The current study posits that a two-session CHOICES
      intervention adapted to target multiple bundled health risks-AEP, NEP, and HIV-will be
      feasible, acceptable, and promising in reducing these risks among females on community-based
      juvenile probation. This study will: Aim 1: Modify the efficacious CHOICES preconception
      intervention to target the prevention of HIV, AEP, and NEP. The result will be a two session
      individual intervention (CHOICES-TEEN) and accompanying therapy manual based on the
      Transtheoretical Model (TTM) and Motivational Interviewing. Aim 2: Conduct a one-arm
      feasibility trial with females in the juvenile justice system to assess the promise of
      CHOICES-TEEN. This pilot study will: 1) demonstrate the feasibility of delivering
      CHOICES-TEEN with master's level mental health professionals within a juvenile justice
      setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention,
      and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g.,
      reduction of risk of HIV, NEP, and AEP). This study will inform subsequent Stage II/III
      behavioral intervention studies and contribute to a missing, fundamental element in the
      knowledge base - further understanding of the feasibility of targeting bundled health risks
      in high-risk adolescents, and the potential promise of a gender-specific intervention for
      this population.
    

Intervention name(s): Choices-Teen
Intervention type(s): Behavioral
Intervention description(s): Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: alcohol-exposed pregnancy; nicotine-exposed pregnancy; tobacco-exposed pregnancy; alcohol; contraception; smoking; pregnancy; HIV; prevention
Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and
      garlic oil. This components showed synergistic enhancing effects in previous tests. In phase
      2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on
      above, this study is phase 3 test to prove efficacy and safety of PENNEL.
    


Intervention name(s): NISSEL; PENNEL
Intervention type(s): Drug; Drug
Intervention description(s): Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap; Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple Dose Healthy Volunteer Study of PF-03715455.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers
    

Detailed description: 
      Healthy volunteer PK study
    

Intervention name(s): PF-03715455; PF-03715455; PF-03715455; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-03715455 1.6 mg BID; PF-03715455 4mg BID; PF-03715455 10 mg BID; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Postmenopausal Hormone Therapy in Unstable Angina
Condition: Angina, Unstable; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Postmenopause
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Angina, Unstable
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if estrogen therapy in postmenopausal women with unstable angina reduces the
      incidence of ischemic episodes.
    

Detailed description: 
      BACKGROUND:

      Unstable angina is a frequent diagnosis in post-menopausal women and is associated with a
      significant risk of myocardial infarction and need for revascularization. The pathogenesis of
      unstable angina involves vasoconstriction superimposed on fixed disease, causing a temporary
      decrease in coronary blood flow. Recent catheterization studies in patients with
      atherosclerosis utilizing quantitative angiography and intracoronary doppler measurements of
      blood flow velocity suggest that endothelial dysfunction results in a paradoxical coronary
      vasoconstriction response to certain neurohumoral stimuli including acetylcholine,
      catecholamines, and serotonin with resultant myocardial ischemia. Therapeutic agents which
      prevent or limit this vasoconstriction may prevent recurrent ischemia and/or myocardial
      infarction in unstable angina patients. Recently, estrogen receptors were identified in the
      smooth muscle of post-mortem human coronary arteries. Work in animal models and studies in
      post-menopausal women suggest that intravenous estrogen acutely decreases coronary vascular
      resistance, increases coronary blood flow, and prevents the paradoxical response to
      acetylcholine in patients with endothelial dysfunction.

      DESIGN NARRATIVE:

      The randomized, double-blind, placebo-controlled, multi-center trial tested the hypothesis
      that intravenous estrogen followed by oral estrogen and the combination of intravenous and
      oral estrogen and progesterone in the routine management of unstable angina were beneficial
      compared with placebo in post-menopausal women. Subjects with rest angina and no
      contraindications to hormone therapy were randomized to receive intravenous followed by oral
      conjugated estrogen for 21 days, intravenous estrogen followed by oral conjugated estrogen
      plus medroxyprogesterone for 21 days or placebo. The primary end point was the number of
      ambulatory electrocardiographic ischemic events over the first 48 hours. Clinical events were
      also determined over six months of follow-up.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): estrogen replacement therapy; estrogens; progesterone; hormone replacement therapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Hormones; Progesterone; Estrogens
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
A Study to Investigate the Effects on Blood Pressure and Pulse Rate of a Single 100mg Dose of Sildenafil in Patients With Benign Prostatic Hyperplasia Who Are Being Treated With Doxazosin
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood
      pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (BPH).
      To investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg,
      and to investigate the safety and toleration of sildenafil 100 mg when co-administered with
      doxazosin.
    


Intervention name(s): placebo; sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): placebo by mouth as a single dose; sildenafil 100 mg by mouth as a single dose
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Volatile Organic Compounds in Staphylococcus Aureus Patients
Condition: Staphylococcus Aureus; Methicillin-resistant Staphylococcus Aureus; Nosocomial Disease
MeSH terms: Staphylococcal Infections
Study type: Observational

Summary: 
      The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus,
      which may predict the probability of bacterial organisms in the anterior nares, throat and
      respiratory tract, wounds, and anus and therefore be able to replace or supplement current
      active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists
      of:

        -  A collection apparatus for collection of volatile compounds from suspected infection
           sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate
           sample of room air.

        -  Analysis of the volatile organic compounds from suspected infection sites and room air
           by short acoustic wave gas chromatography.

        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order
           to predict the probability of Staphylococcus aureus infection and colonization.

      This study will test the hypothesis that we can identify the presence of MRSA by sampling the
      "head space" above culture media of anterior nare samples provided by patients with MRSA.
      Additionally, this study will test the hypothesis that we can identify the presence of MRSA
      by sampling air exhaled through the nostrils (nasal exhalant).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be selected upon suspicion of MRSA or MSSA infection or colonization.
        Increased concentration will be give to selection of persons from the following high risk
        groups:

          -  It has been documented that the patient has been previously discharged from a general
             acute care hospital within 30 days prior to the current hospital admission.

          -  The patient will be admitted to an intensive care unit or burn unit of the hospital.

          -  The patient receives inpatient dialysis treatment.

          -  The patient is being transferred from a skilled nursing facility
      
Keywords: Staphylococcus aureus; Methicillin-resistant staphylococcus aureus; Nosocomial disease; Electronic nose; Gas chromatography
Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic
      infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic
      efficacy and rescue tramadol consumption in inguinal hernia repairs.
    

Detailed description: 
      Currently, multimodal techniques are used in inguinal hernia repairs in addition to
      pharmacological and regional techniques for postoperative analgesia.TAP block is performed on
      the principle of hydrodissection of the fascia between the internal oblique and transversus
      abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic
      drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the
      T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional
      anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic
      drug is also used as pharmacological postoperative analgesia method in most clinics.
    

Intervention name(s): Transversus abdominis plane block; Local anesthetic infiltration; Intravenous dexketoprofen
Intervention type(s): Other; Other; Other
Intervention description(s): Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.; Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.; Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.
Intervention MeSH terms: Dexketoprofen trometamol; Anesthetics; Anesthetics, Local
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
Condition: ACL Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Researchers are trying to find out whether the use of low-intensity strength exercises during
      the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the
      outcomes after surgery to repair an injured ligament of the knee.
    


Intervention name(s): Exercise Blood Flow Restriction training; SHAM Exercise Blood Flow Restriction training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): While exercising, an Inflatable cuff, similar to a blood pressure cuff, is applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow; While exercising Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Vitamin D During Pregnancy
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of
      this vitamin for the proper development of the fetus, are a significant risk group. The
      purpose of this study is to examine which factors - education, knowledge from
      non-professional sources, recommendations from medical staff - influence the use of vitamin D
      among pregnant women in light of the lack of a clear health policy, and to help formulating
      guidelines for a new health policy with specific recommendations for vitamin D dosage in
      pregnancy.
    


Intervention name(s): completion of a questionnaire; Blood draw
Intervention type(s): Other; Other
Intervention description(s): Completion of a questionnaire; A subset of 100 women will have a blood test to measure Vitamin D levels
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We are recruiting either pregnant women or those who just gave birth (and still
        hospitalized) and a group of both family practice physicians and obstertricians.
      
Keywords: Pregnancy; Vitamin D
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo
      in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.
    


Intervention name(s): Comparator: Sitagliptin phosphate; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.; All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.
Other intervention name(s): GLUCOPHAGE®; GLUCOPHAGE®
Intervention MeSH terms: Sitagliptin Phosphate; Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial was to investigate safety and tolerability of multiple
      doses of BI 409306 in healthy young and elderly volunteers.

      The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple
      doses of BI 409306 in healthy young and elderly volunteers
    


Intervention name(s): BI 409306; BI 409306; BI 409306 Placebo; BI 409306; BI 409306
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): High dose film-coated tablet; High dose film-coated tablet; Placebo film-coated tablet; Low dose film-coated tablet; Medium dose film-coated tablet
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain
Condition: Acute Pain; Injection; Needle Phobia
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Acupressure is an ancient manual therapy which fingers are used to press key points on the
      body. These points are the same with acupuncture points but in contrast to acupuncture,
      acupressure uses gentle but firm pressure with fingers and hands. The purpose of this study
      is to investigate effect of acupressure onto GB30 poin for ventrogluteal intramuscular
      injection pain.The study was designed as a prospective, single-blind, crossover study. The
      study included 72 volunteer students attending Faculty of Health Sciences, Nursing
      Department.
    


Intervention name(s): Acupressure
Intervention type(s): Procedure
Intervention description(s): Acupressure was performed before the injection onto GB30 point
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
Condition: Smallpox
MeSH terms: Smallpox
Study type: Observational

Summary: 
      The purpose of this study is to provide long-term follow-up immunogenicity and safety data on
      participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04
      (NCT 00258947).

      Primary Objectives:

      Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years
      post-vaccination.

      Safety: To follow-up the long-term safety up to 5 years post-vaccination.
    

Detailed description: 
      None of the participants in this study will receive any vaccination as part of the study. All
      participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5
      year anniversaries of vaccination. Safety will be assessed for up to 5 years after
      vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT
      00258947).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04
        (NCT 00258947)
      
Keywords: Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus
Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      To generate real world evidence to compare clinical outcomes and patient health-related
      quality of life, resulting from catheter ablation therapy with clinical outcome and patient
      health-related quality of life resulting from drug therapy in China. An economic model will
      be constructed, and using the clinical events evidence collected in this study, and China
      long-term disease progression and local disease cost data to perform a cost-effectiveness
      evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF)
      patients.
    

Detailed description: 
      The evidence generated by this study is expected to help inform medical decision makers with
      the clinical and economic data of therapy for AF patients, and also provide policy decision
      makers with information that can be considered /used to allocate funds for AF ablation and
      permit patients to have access to appropriate treatment options for AF management.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A minimum of 300 subjects in the catheter ablation arm (150 paroxysmal AF patients and 150
        persistent AF patients) and 150 subjects in the drug treatment arm (75 paroxysmal AF
        patients and 75 persistent AF patients).
      
Keywords: Catheter Ablation versus Drug Therapy in AF in China
The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis
Condition: Hemodialysis
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of mandala on coping with fatigue,
      psychological well-being and stress in patients treated with hemodialysis
    

Detailed description: 
      The Effect of Mandala on Coping with Fatigue, Psychological Well-Being and Stress in Patients
      Treated with Hemodialysis
    

Intervention name(s): Mandala coloring page
Intervention type(s): Other
Intervention description(s): Mandala program will be applied three days a week (30 minutes) for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Fatigue; Psychological Well-Being; Stress