bioihbjkbjnl/mcl2 huggingface dataset:
Prostate Cancer Screening in Men With Germline BRCA2 Mutations
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to determine the incidence of prostate cancer in men with the
      BRCa2 gene mutation as an independent indicator for prostate cancer screening.
    

Detailed description: 
      This is a cohort screening study to prospectively identify the incidence of prostate cancer
      in a population of BRCA2 carriers. All men identified to have a BRCA2 mutation as part of the
      Yale Cancer Genetic Counseling Program will be approached and offered participation in the
      study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing.

      Standard of care screening at the Yale Cancer Center for men with a normal prostate cancer
      risk consists of a PSA test and prostate physical examination beginning at age 50 years and
      if either is abnormal an MRI of the prostate followed by Fusion-targeted biopsy of the
      prostate is performed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be identified because of their BRCA2 mutation that places them at
        increased risk for developing prostate cancer. Because this is a pre-selected high-risk
        population, and our goal is to establish the incidence of cancer and association of risk
        factors with developing disease, all men ≥30 years of age, able to give informed consent,
        and with at least a 5-10 year life expectancy will have PSA testing, prostate examination,
        Pelvic MRI, and Artemis fusion prostate biopsy.

        Men identified to have prostate cancer will be treated according to current standards of
        care. Treatment for prostate cancer at the Yale Cancer Center is largely based on clinical
        risk; options include, but are not limited to, active surveillance for appropriate men with
        low risk disease, treatment with curative intent for men with localized intermediate and
        high risk prostate cancer, and systemic therapy for men with metastatic disease.
ARIXTRA Local Study For Registration In China.
Condition: Thromboembolism; Knee Replacement; Hip Replacement
MeSH terms: Thromboembolism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a local registration study in China to compare the safety and efficacy of ARIXTRA to
      Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of
      components.
    


Intervention name(s): ARIXTRA infusion; Enoxaparine infusion
Intervention type(s): Drug; Drug
Other intervention name(s): ARIXTRA infusion
Intervention MeSH terms: Enoxaparin; PENTA; Fondaparinux
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: ARIXTRA; prevention of DVT
Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured
      vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will
      be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a
      blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of
      volunteers will be followed up to 3 years in order to evaluate the duration of immunity
      following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and
      randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a
      sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive
      volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25,
      and 1:50).
    


Intervention name(s): Cell-Cultured Smallpox Vaccine compared to Dryvax®
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Smallpox; Smallpox Vaccine; Vaccinia
Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia
Condition: Postoperative Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus
      anterior block and erector spinae block and control group. during anaesthesia:total
      intraoperative fentanyl required will be recorded. After surgery, all patients will be
      connected to PCA device containing morphine solution, the amount of morphine consumed during
      the first 24 hours will be recorded.
    

Detailed description: 
      90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus
      anterior block (SAB) and erector spinae block (ESB) and control group. During anaesthesia:
      total intraoperative fentanyl required will be recorded. After surgery, all patients will be
      connected to PCA device containing morphine solution, the amount of morphine consumed during
      the first 24 hours will be recorded. Other secondary outcomes are: numerical rating scales
      and postoperative pulmonary functions.
    

Intervention name(s): Serratus anterior block (SAB); Erector spinae block; Saline (as a placebo); Bupivacaine
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%; Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%; Patients will receive a sham block with 20 ml saline (as a placebo); bupivacaine
Other intervention name(s): SAB group; ESB group
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Serratus anterior block; Erector spinae block; Postoperative analgesia
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Gastrectomy
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug
      candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,
      and placebo-controlled study.
    

Detailed description: 
      VVZ-149 is a dual antagonist of GlyT2 and 5HT2A. GlyT2 blockage increases inhibitory synaptic
      transmission by glycine in the spinal cord, resulting in a reduction of pain transmissions to
      the brain. 5HT2A blockage decreases descending serotonergic facilitatory modulation on pain
      transmission by the brain and reduces nociceptor activation in peripheral nerves, which are
      primary sources of pain in post-surgical pain. VVZ-149 has been shown to have comparable
      efficacy to morphine in well controlled (blind, complete randomization with a positive
      control) animal studies using rat models of post-operative pain and formalin-induced pain.
      The PK/PD study in animals indicates that therapeutic plasma concentration in human subjects
      will be 600-1,900 ng/ml. A clinical Phase 1 study performed in healthy subjects has shown no
      clinically significant adverse events up to a plasma concentration level of 3,261 ng/ml other
      than brief symptoms of mild nausea or dizziness, and mild somnolence when the plasma exposure
      level is more than 2,000 ng/ml.
    

Intervention name(s): VVZ-149 injections; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Colorless, transparent liquid in water for injection; water for injection
Other intervention name(s): VVZ-149 injection; water for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer
Condition: Circulatory Function; Laparoscopic Radical Cystectomy for Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Observational

Summary: 
      To optimize the perioperative management of patients undergoing laparoscopic radical
      cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain
      Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the
      use of transthoracic echocardiography(TTE).
    

Detailed description: 
      Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence
      perioperative circulatory function, resulting in a series of pathophysiological changes. BNP
      is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are
      dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume
      and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory
      function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and
      steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and
      influence cardiac function.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who undergo laparoscopic radical cystectomy for bladder cancer in Renji Hospital
      
Keywords: brain natriuretic peptide; pneumoperitoneum; Trendelenburg; circulatory function; laparoscopic radical cystectomy for bladder cancer; central venous pressure; stroke volume variation; transthoracic echocardiography
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The study will assess the safety, tolerability and feasibility of Lacrima investigational
      medical device vs. sham device in adult patients with chronic Insomnia
    


Intervention name(s): Lacrima Medical Device and sham comparator
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia, medical device, sleep latency
MIST3: Active Patient Safety Reporting
Condition: Safety Issues
Study type: Observational

Summary: 
      This study will seek to describe and understand adverse events (AE) severity ratings.
    

Detailed description: 
      Using an explanatory mixed methods design, three different quantitative methods 1. severity
      ratings based on a series of questions, 2. severity rating based on severity terms, and 3.
      severity based on definitions will be used to conduct a feasibility study on understanding
      adverse event reporting system.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of all patients at the Parker University Wellness clinic will be
        invited to participate in the study.
      
Keywords: Adverse event; Electronic reporting system; Chiropractic; Spinal manipulation
Immune Responses After Human Subject Challenge With Sand Fly Bites
Condition: Healthy
Study type: Observational

Summary: 
      Sand flies can carry the infection leishmaniasis (a parasite). The purpose of this study is
      to evaluate the human immune response to uninfected laboratory raised sand fly bites and
      select from the immune response to sand fly saliva, possible substances to use for a future
      vaccine to protect against the parasite leishmaniasis.
    

Detailed description: 
      Based on travel history and possible exposure, subjects were entered into one of 2 arms, Ph.
      dubosqui or Lu. lutzomyia controlled sand fly repeated feedings. At baseline a pheresis was
      done to collect baseline cells. Subjects received sand fly bites on a q2 week schedule for 2
      months followed by a q2 months schedule for one year. They had an option to extend for a late
      recall feeding at 18 months, when a skin biopsy was performed 48 hours after sand fly bites.
      Currently the study is fully enrolled and all human subject contact is complete. We
      (laboratory at NIAID) are studying the humoral, cellular immune responses using blood
      samples, and cytokine expression in the skin biopsy samples.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female military health care beneficiaries in good health, age 18-50
      
Biospecimen description: 
      Plasma and white blood cells will be retained.
    
Keywords: Sandfly; leishmaniasis; immune response; individuals age 18-50
Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
Condition: Non-suicidal Self-injury
MeSH terms: Self-Injurious Behavior
Study type: Interventional

Summary: 
      In this proposed study, Text messages are used to intervene in the NSSI behavior of
      adolescents, and the efficacy of this intervention method is evaluated, as well as the
      internal mechanism of adolescents' NSSI behavior is discussed.
    

Detailed description: 
      In this proposed study, the investigators will evaluate the effect of text message
      intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110
      adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the
      participants will be randomized to the intervention group (55 cases) or the control group 55
      cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at
      baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect
      of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of
      Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety,
      and hopelessness 3) The use of emotion regulation strategies and coping styles. A
      semi-structured quantitative interview will be conducted among adolescents from the SMS group
      to get the attitude and experiences feedback about the text message.
    

Intervention name(s): SMS intervention
Intervention type(s): Other
Intervention description(s): SMS intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Feasibility of Community-based Test and Treat Strategies Among Men Who Have Sex With Men and Transgender Women to Increase the Uptake of HIV Testing and Treatment Services in Thailand
Condition: HIV Test and Treat
Study type: Observational [Patient Registry]

Summary: 
      HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants
      Same-day result HIV testing along with pre-test and post-test counseling, including risk
      reduction counseling, will be provided according to the standard practice at each study site
      at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can
      also access non-occupational post-exposure prophylaxis service and symptomatic STD service if
      these are available at study sites. HIV-positive participants will also receive risk
      reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.
    

Detailed description: 
      This study is a prospective observational cohort study that will enroll up to 6,000 Thai MSM
      and TG from drop-in centers in Bangkok, Chiang Mai, Chonburi and Songkhla. Each participant
      will have HIV testing at baseline and will be followed up for 18 months.

      HIV-negative participants will be asked to have HIV re-testing every 6 months. HIV-positive
      participants will have POC CD4 testing and ART initiation regardless of CD4 count will be
      offered. Those who accept ART will be followed up at week 2, week 4, month 2, month 3 and
      every 3 months thereafter. Those who deny ART will be followed up every 3 months.

      Uptake of HIV re-testing will be determined. Access to POC CD4 testing and acceptability of
      ART initiated at HIV diagnosis regardless of CD4 count along with ART adherence will also be
      determined.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1. SWING Drop-In Center, Bangkok, Thailand

          2. RSAT Drop-In Center, Bangkok, Thailand

          3. Chiang Mai Buddy Station, Northern Thailand

          4. SWING Drop-In Center, Pattaya, Chonburi, Eastern Thailand

          5. Sisters Drop-In Center, Pattaya, Chonburi, Eastern Thailand

          6. RSAT Drop-In Center, Songkhla, Southern Thailand
      
Keywords: 6,000 Thai MSM and TG from study sites in Bangkok, Chiang Mai, Chonburi and Songkhla
The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations
Condition: Pediatric ALL
Study type: Interventional

Summary: 
      The investigators developed a smartphone app that guides pediatric patients and their
      families through colonoscopy prep in an attempt to see if an app could improve the
      colonoscopy process.
    

Detailed description: 
      The investigators created a smartphone app designed for pediatric patients and their families
      that informs patients about their colonoscopy procedure, alerts them when to take their
      medications throughout the hours-long colonoscopy prep process and tells them when to arrive
      to the endoscopy suite. The investigators designed a study to determine if this app will
      yield improved colonoscopy cleanouts, better patient understanding of the procedure, fewer
      calls to the GI service and more punctual arrival times to the endoscopy suite compared to
      patients who receive written instructions that do not actively interact with the patient
      before, during or after their colonoscopy prep.
    

Intervention name(s): Smartphone App "SB Colonoscopy Prep"; Written Instruction
Intervention type(s): Device; Other
Intervention description(s): We created a smartphone app that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.; Written Instruction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were randomly assigned via block randomization to receive either written or software-based prep instructions.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Women are followed prospectively for 3 months, recording headaches, other symptoms, and
      menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan
      for 3 months.
    

Detailed description: 
      Women are followed prospectively for 3 months, recording headaches, other symptoms, and
      menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan
      for 3 months.
    

Intervention name(s): eletriptan
Intervention type(s): Drug
Intervention description(s): oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days
Other intervention name(s): Relpax
Intervention MeSH terms: Eletriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.
    


Intervention name(s): Bimekizumab
Intervention type(s): Drug
Intervention description(s): Bimekizumab will be administered subcutaneously in 2 different doses.
Other intervention name(s): UCB4940
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab
The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
Condition: Gastric Adenoma; Early Gastric Cancer
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc
      resection of superficial tumors in the gastrointestinal tract. ESD, however, is a
      time-consuming procedure that requires a high level of endoscopic skill to achieve a
      desirable oncologic outcome. Several procedure-related complications may occur after ESD.
      Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and
      patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are
      administered after ESD. In addition, ulcer protective agents such as rebamipide can be added
      to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for
      healing of iatrogenic ulcer.
    


Intervention name(s): Polaprezinc; Rebamipide
Intervention type(s): Drug; Drug
Intervention description(s): Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.; Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.
Intervention MeSH terms: Rebamipide; Polaprezinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PRC-4016 (Icosabutate) Phase I Drug-drug Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate the effect of PRC-4016 at steady state on the
      pharmacokinetics (PK) of cytochrome P450 (CYP) 3A substrates (midazolam, simvastatin), a
      CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female
      subjects.
    

Detailed description: 
      Day 1: Subject will receive single oral doses of 2.5 mg midazolam, 20 mg omeprazole and 50 mg
      flurbiprofen morning Day 2: Subject will receive a single oral dose of 40 mg simvastatin on
      the morning of Day 2. Day 4: Subjects will commence the multiple-dose regimen for PRC-4016
      (600 mg once daily) for 11 days. Day 12: Subjects will be given single oral doses of 2.5 mg
      midazolam, 20 mg omeprazole and 50 mg flurbiprofen co-administered with 600 mg PRC-4016.

      Day 13, subjects will be given a single oral dose of 40 mg simvastatin co-administered with
      600 mg PRC-4016.

      All subjects will return for a post-study visit 7 to 10 days after their final dose.
    

Intervention name(s): PRC-4016 (icosabutate)
Intervention type(s): Drug
Intervention description(s): Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under "Study description"
Other intervention name(s): Midazolam, omeprazole, flurbiprofen and simvastatin
Intervention MeSH terms: Flurbiprofen; Midazolam; Omeprazole; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Phase I drug-drug interaction