bioihbjkbjnl/mcl2 huggingface dataset:
Prostate Cancer Education in African American Men
Condition: Prostate Cancer Screening Decision
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates the efficacy of a tailored telephone intervention to promote informed
      decision making about prostate cancer testing among predominantly immigrant black men.
    

Detailed description: 
      African American and African-Caribbean men have the greatest prostate cancer incidence and
      mortality rate. Professional organizations provide conflicting recommendations regarding
      prostate cancer testing but generally agree that men learn about the risks and benefits of
      testing and share in decisions about testing based on their personal preferences. This study
      was designed to assess the effects of a decision support intervention on men's knowledge
      about prostate cancer testing, participation in medical decisions about testing, decision
      conflict related to testing, and the congruence between prostate cancer testing intentions
      and behaviors. A randomized controlled trial was conducted. Participants were randomized into
      one of two conditions: (a) tailored telephone education about prostate cancer testing
      (intervention group) or (b) tailored telephone education about national guidelines for fruit
      and vegetable consumption (attention control group).
    

Intervention name(s): Prostate Cancer Screening Education; Fruit and Vegetable Intake Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): tailored telephone education on prostate cancer testing; tailored telephone education about fruit and vegetable consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: prostate-specific antigen (146-154); prostate-specific antigen (154-163)
Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients
Condition: Hypotension; Obstetrical Complication of Anesthesia; Complications; Cesarean Section
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be
      used to treat hypotension but lead to lower fetal pH as well. This study is to compare the
      effects of norepinephrine and ephedrine on hypotension in parturients.
    

Detailed description: 
      Spinal anesthesia is an accepted technique in elective cesarean sections. However,
      hypotension, resulted from sympathectomy is a common problem, especially in pregnant women.
      Prevention of this complication by sympathomimetic agents is of potential clinical
      significance. Ephedrine could be used to treat hypotension but lead to lower fetal pH, which
      may be related to worse fetal outcome.Norepinephrine could improve the hypotension to the
      same extent as phenylephrine. In this study, we tend to compare the effects of norepinephrine
      and ephedrine on hypotension in parturients and on fetal acid status.
    

Intervention name(s): Norepinephrine; Ephedrine
Intervention type(s): Drug; Drug
Intervention description(s): norepinephrine injection; Ephedrine injection
Other intervention name(s): vasoactive agents; vasoactive agents
Intervention MeSH terms: Norepinephrine; Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: norepinephrine; ephedrine
The Young Adult and Pediatric Bipolar Study
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine the safety and effectiveness of extended-release carbamazepine in the treatment of
      children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
    


Intervention name(s): Extended-Release Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose
Condition: Unspecified Disorder of Nose and Nasal Sinuses
MeSH terms: Nose Diseases
Study type: Interventional

Summary: 
      Investigation of the immediate effect on subjective relief of symptoms by Proponent - Nasal -
      Spray after a one time administration (following a single dose administration in each
      nostril) in an open, not randomised, non-blinded single centre observation study on 40
      volunteers between 18-75 years of age with an unspecific discomfort in the nose such as
      enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or
      feeling of a dry nose.
    

Detailed description: 
      By regularisation of environment of nasal mucosa and the following restitution and
      improvement of the ciliary function the efficacy of mucociliary clearance can be remarkably
      enhanced, pathogens from the environment can be physically removed and a bacterial or viral
      infection may be prevented on this way.

      Such an optimizing effect may be reached by the administration of an equilibrated saline
      solution with an optimal composition regarding osmolality, pH-value and buffer substance.

      In addition it would be very advantageous to support the efficacy of the local unspecific and
      specific immune mechanisms in the nasal respiratory mucosa (NALT) without any negative
      effects on the optimized mucociliary clearance.

      As demonstrated recently in airway mucosa sodium propionate is able to interact with
      macrophages, the interleukin system and other factors of the TNF receptor family.

      Sodium propionate could therefore have an ancillary effect on the genuine immune mechanisms
      of nasal respiratory mucosa. On this way the primary effect of administration of saline
      solution is supported.
    

Intervention name(s): Proponent Nasal Spray
Intervention type(s): Other
Intervention description(s): The medical device consists of a Saline solution containing sodium propionate which is administered as single dose
Intervention model: Single Group Assignment
Intervention model description: Every participant of the study will specify at the beginning of the investigation his subjective starting situation concerning the nasal discomfort.The participant records his/ her personal impression on the change of severity of the general symptoms or selected individual symptoms of unspecific nasal discomfort following the single administration of "Proponent Nasal Spray". Every Patient serves as his own control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nose Saline Solution Irrigation Nasal Spray; Sodium propionate Locke-Ringer Solution
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a
      pregabalin controlled release tablet following either a low, medium, or high-fat evening meal
      as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the
      safety and tolerability of a single dose of a pregabalin controlled release tablet following
      a low, medium, or high fat evening meal as compared to a single dose of the pregabalin
      immediate release capsule.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a
      pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR
      capsule
    

Intervention name(s): Pregabalin controlled release, 330 mg, low-fat; Pregabalin controlled release, 330 mg, medium-fat; Pregabalin controlled release, 330 mg, high-fat; Pregabalin immediate release, 300 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal; A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal; A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal; A single oral dose of 300 mg immediate release capsule administered following a medium-fat evening meal
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      This study seeks to provide evidence of the effectiveness and obtain patient reported
      outcomes (PRO) and work productivity data of the interferon-free regimen of paritaprevir
      (PTV)/ritonavir (r) + ombitasvir (OBV), +/- dasabuvir (DSV), +/- ribavirin (RBV) in chronic
      hepatitis C virus infected patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic Hepatitis C (CHC)
      
Keywords: Chronic Hepatitis C; Dasabuvir; Paritaprevir/r/Ombitasvir; Observational Study; Quality of Life; Fibrosis; Cirrhosis; Work Ability
Asthma Severity in Children and Environmental Agents
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study measures residential exposures (indoor allergens, mold, nitrogen dioxide,
      nicotine) and relates exposure levels to daily symptoms (wheeze, persistent cough, chest
      tightness, shortness of breath) and medication use, in a population of children with
      physician diagnosed asthma, followed for 12 months.
    


Time perspective: Prospective
Keywords: asthma; indoor allergens
Efficacy Study of T Cell Vaccination in HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The hallmark of HIV infection and AIDS is the continuous attrition of CD4 T cells. One of the
      mechanisms that may account for the CD4 attrition , is autoimmunity against the CD4 T cells,
      caused by autologous immune cells. Vaccination against autoimmune reactive T cells has been
      successfully tried in animal models of autoimmune diseases and is now being tried in patients
      with Multiple Sclerosis. The purpose of the present study is to test this hypothesis in HIV
      infection. We will vaccinate HIV infected patients in whom specific autoimmune reactivity
      against CD4 is present , with their own CD4 reactive T cells. Following that, we shall study
      the patients and find out if the T cell vaccination caused a rise in CD4 T cell levels, and
      whether it influenced HIV viral load, as well as HIV and CD4 specific immunity.
    

Detailed description: 
      The study will be based on forty HIV infected patients, receiving anti retroviral treatment
      (HAART), with CD4 levels between 150-350 and HIV plasma viral load < 5000, for at least 12
      months and despite continuous anti-retroviral treatment. The patients will be randomly
      divided into two groups, one that will get the T cell vaccination, and the other that will
      serve as controls. The T cell vaccine will be prepared from autologous T cells that responded
      by specific proliferation to recombinant CD4, further expanded in vitro by IL-2, and then
      fixed by glutaraldehyde. Each vaccine portion will consist of 10,000 such cells suspended in
      saline and given subcutaneously every three months during the first year of the trial. The
      outcome measures will be CD4 levels, specific immunity to HIV antigens, immune activation
      profile and HIV plasma viral loads, determined sequentially during the 24 months of the
      trial. These outcome measures will be compared between the experimental and the control
      groups, to determine if this mode of treatment is effective in influencing CD4 levels as an
      additional mode of treatment during HIV infection.
    

Intervention name(s): T cell vaccination; T cell vaccination
Intervention type(s): Biological; Biological
Intervention description(s): Approximately 10-20 million glutaraldehyde fixed CD4 responsive autologous T cells in 1-2 ml, per vaccine injection.; Approximately 10-20 million autologous CD4 reactive T cells per each vaccine injection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; CD4 T cell level; CD4 autoimmunity; Viral load; T cell vaccination; HIV Therapeutic Vaccine
Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
Condition: Gastric Cancer; Precancerous Condition
MeSH terms: Stomach Neoplasms; Precancerous Conditions; Gastritis, Hypertrophic
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them.

      PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with
      Ménétrier disease at high risk of developing stomach cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate clinical and biochemical parameter response in patients with Ménétrier disease
           at high risk of developing gastric cancer treated with cetuximab.

      OUTLINE: This is a non-randomized study.

      Patients receive cetuximab IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks in
      the absence of disease progression or unacceptable toxicity.

      Patients complete a quality of life questionnaire at baseline and during week 4.

      PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
    

Intervention name(s): Cetuximab
Intervention type(s): Biological
Other intervention name(s): C225
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; giant hypertrophic gastritis
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and
      tamsulosin, phase I study in healthy volunteers was designed.
    

Detailed description: 
      During each of the two periods of a randomized, double-blind, placebo-controlled, crossover
      study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg
      of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for
      24 hours after SK3530 or placebo.
    

Intervention name(s): SK3530
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: SK3530; tamsulosin; hemodynamic interaction; safety
Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40
      mg lurasidone in healthy Chinese subjects.

      To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone
      in healthy Chinese subjects.
    

Detailed description: 
      Single oral administration of 40 mg study drug lurasidone or placebo after the over 350 kcal
      breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral
      administration of 40 mg study drug lurasidone or placebo, once daily between Day 4 and Day 8.
    

Intervention name(s): 40mg lurasidone; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: pharmacokinetic; lurasidone; multiple dose
Vitamin K Injections for the Treatment of Painful Menstruation
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the feasibility and effectiveness of vitamin K
      injections into certain body parts for the treatment of painful menstruation.
    

Detailed description: 
      Painful menstruation, also known as dysmenorrhea, is a common problem affecting a significant
      percentage of women. In the United States and Europe, nonsteroidal anti-inflammatory drugs
      (NSAIDs) and oral contraceptives are the most commonly prescribed treatments for this
      condition. However, in China, oral contraceptives are not commonly prescribed for unmarried
      women. Acu-injection, a procedure involving the injection of vitamin K into acupuncture
      points, has become standard treatment for dysmenorrhea at many Chinese health care
      facilities. This trial will assess the willingness of young Chinese women to participate in
      an acu-injection trial, explore the utility of pain measurements after injection, and
      determine the effectiveness of the injections. This study will also help in planning larger
      acu-injection clinical trials.

      This study will last for five menstrual cycles. Participants will be randomly assigned to one
      of three groups. Group 1 participants will receive a vitamin K3 injection in an acupuncture
      point of both legs and a saline injection in the right buttock. Group 2 participants will
      receive a saline injection in an acupuncture point of both legs and a saline injection in the
      right buttock. Group 3 participants will receive a saline injection in a pseudo-acupuncture
      point of both legs and a vitamin K3 injection in the right buttock. Injections will be
      administered one time during the first 2 days of the first menstrual cycle for participants
      who are experiencing menstrual pain. Participants will record their level of menstrual pain
      before injection and at 2, 5, 30 and 60 minutes after the injections. Participants who do not
      respond to or are not satisfied with the acu-injection treatment will be offered either
      Chinese herbal medicine or NSAIDs within 1 hour of the injection. After the injection visit,
      participants will be asked to complete questionnaires about any menstrual pain or side
      effects they may be experiencing for five subsequent menstrual cycles.
    

Intervention name(s): Acupuncture point injection of vitamin K
Intervention type(s): Procedure
Intervention MeSH terms: Vitamin K
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Dysmenorrhea; Acupuncture; Vitamin K; Medicine, Chinese Traditional; Women; Menstruation; Pain, Menstrual; China
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Condition: HIV Infections
MeSH terms: Infections; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist
      INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not
      currently on a HAART regimen and have not received any antiretroviral agents for 3 months
      prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered
      orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead
      electrocardiograms, physical examinations and virologic assessments, including viral load,
      viral tropism and CD4+ cell count determinations will be performed at the Screening visit and
      at regularly scheduled visits throughout the study. A blood sample will also be obtained and
      stored to potentially determine the genotype of the CCR5 receptor.

      The primary objectives are:

        1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered
           orally, once daily, as monotherapy for 14 days;

        2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered
           orally, once daily, as monotherapy for 14 days;

        3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when
           administered orally, once daily, as monotherapy for 14 days
    


Intervention name(s): INCB009471; INCB009471; Placebo comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100mg SR (sustained release) orally once daily; 300mg SR (sustained release) orally once daily; Orally once daily
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV-infection; viral load; CCR5; viral tropism; HIV-1 infection; Treatment Naive