bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
Condition: Tetanus; Diphtheria; Pertussis; Whooping Cough
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to describe the safety and immunogenicity of repeat
      administration of Adacel vaccine approximately 10 years following initial administration of
      the vaccine. Antibody levels prior to revaccination will also be used to characterize
      antibody persistence following initial vaccination 10 years earlier.

      Primary Objectives:

        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine
           to those induced by Td Adsorbed vaccine.

        -  To compare booster response rates against tetanus and diphtheria induced by Adacel
           vaccine to those induced by Td Adsorbed vaccine.

        -  To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by
           Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants.

      Secondary Objectives:

        -  To describe the rates of immediate reactions, solicited reactions, unsolicited adverse
           events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td
           Adsorbed vaccine.

        -  To describe booster response rates for pertussis antigens following revaccination with
           Adacel vaccine.
    

Detailed description: 
      Healthy adults < 65 years of age who received Adacel vaccine 10 years previously will be
      randomized to receive either Adacel or TENIVAC (Td Adsorbed) vaccine. They will be assessed
      for immunogenicity at baseline and post-vaccination. Safety data will be collected for 6
      months following vaccination.
    

Intervention name(s): Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine; Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Adacel®; TENIVAC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adacel vaccine; Tetanus; Diphtheria; whooping cough
The Value of Amniopatch in Preterm Premature Rupture of Membranes
Condition: Preterm Premature Rupture of Membrane
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional

Summary: 
      A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34
      weeks of gestational age. Participants were randomized equally into 2 groups. Group I in
      which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen
      plasma in addition to the routine management used in the control group. Group II were treated
      with routine management including antibiotics and corticosteroids
    

Detailed description: 
      All patients were started on a regimen of hospital bed rest and received antibiotic
      prophylaxis consisting of ampicillin 2g IV every 6hours for 48 hours, followed by
      erythromycin 250mg every 6hours for 5days . Antenatal corticosteroids were given in the form
      of dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses.

      Fifty to two hundred ml of normal saline was infused to create an adequate pocket in which
      the infusion needle can be stabilized. After injection of normal saline, alternate infusions
      of 20 mL of platelets, normal saline (which does not contain Calcium, needed for the clotting
      process), and 20 mL of (FFP). The infused substances were warmed to a temperature of 37°c.
      Avoiding contact between the blood products prevents clotting in the lines.

      During infusion, the fetal heart rate as well as the accumulation of amniotic fluid was
      monitored by ultrasound. Usually a total of around 60-80 mL of platelets, 100-150 mL of FFP
      and 100-150 mL of amnioinfusion fluid was used throughout the procedure
    

Intervention name(s): Antibiotics; Corticosteroid; Amniopatch
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days; dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses; a total of around 60-80 mL of platelets, 100-150 mL of FFP and 100-150 mL of amnioinfusion fluid was used throughout the procedure
Other intervention name(s): ampicillin erythromycin; Dexamethasone
Intervention MeSH terms: Anti-Bacterial Agents; Erythromycin; Ampicillin; Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers
Condition: Hepatitis C; Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      The investigators aim to determine the prevalence of hepatitis C in the adult children of
      female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C
      testing was either not available or was not standard of care. Because of this, participants'
      children may be unaware of participants' risk of hepatitis C.
    


Intervention name(s): Eligibility Screening; HCV test
Intervention type(s): Other; Diagnostic Test
Intervention description(s): Investigators will call eligible mothers to screen for the possibility that eligible mothers may have passed HCV on to adult children. Investigators will consent these mothers to contact the adult child(ren), as the child(ren) must be informed of the mother's HCV status, if not already known.; Adult children will be invited to Penn or a Penn affiliate to have labwork, testing HCV antibody and HCV quant. If the quant comes back positive, investigators will also test genotype and fibrosure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult children of women born between 1945-1965 who have or have had hepatitis C Women born
        between 1945-1965 who have or have had hepatitis C

        Investigators will only be recruiting subjects who are black or white as hepatitis C is
        most common in these two populations. Using these populations maximizes the
        generalizability of our results. HCV is not only significantly less common among Asian
        women and women of other races, but these women also represent a minority of the patient
        population at Penn.
Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
Condition: Advanced Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in
      absence and presence of prior administration of proton pump inhibitor Omeprazole. The
      increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect
      the absorption process of SHR6390.
    


Intervention name(s): SHR6390、Omeprazole
Intervention type(s): Drug
Intervention description(s): SHR6390 tablet single dose、Omeprazol single dose.
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Intervention model description: The study is a single-center, open, single-dose, Fixed-sequence clinical trial.
Masking: None (Open Label)
Primary purpose: Basic Science
FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging
Condition: Fever
MeSH terms: Fever
Study type: Observational

Summary: 
      In this study, the investigators will prospectively assess fever rates and other associated
      vaccine adverse events in 6-23 month old patients during days 0-7 after administration of
      trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine
      (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine
      (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The
      investigators hypothesize that fever rates will be significantly higher during the 0-1 days
      after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal
      conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered
      non-concomitantly.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        6-23 months old visiting study sites
Tolerance and Safety of a Ketone-Promoting Food Ingredient
Condition: Tolerance
Study type: Interventional

Summary: 
      The objective of this study is to capture information on tolerance and safety of a
      ketone-promoting food ingredient in healthy adults.
    


Intervention name(s): Ketone- Promoting Food Ingredient #1; Ketone- Promoting Food Ingredient #2; Ketone Free Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Novel proprietary food ingredient (#1) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.; Previously characterized proprietary food ingredient (#2) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.; Beverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive Disorder
Condition: Major Depressive Disorder Patients
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to evaluate the safety and plasma concentration changes of
      quetiapine after multiple oral administration of FK949E (extended-release formulation of
      quetiapine) in elderly patients with major depressive disorder (MDD).
    


Intervention name(s): FK949E
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): extended release formulation of quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Antipsychotic; FK949E; Quetiapine; Elderly
Palifermin DDI (Drug Drug Interaction)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Paliferim interacts with Heparin.
    

Detailed description: 
      Heparin has been shown to modulate binding of palifermin to the KGF receptor. Therefore, as
      part of a post-marketing regulatory commitment with the Food and Drug Administration (FDA),
      the purpose of this study is to characterize the potential pharmacokinetic and
      pharmacodynamic drug-drug interaction between a continuous IV infusion of heparin and an IV
      bolus injection of palifermin. If an interaction is observed during co-administration, it is
      expected that the outcome would be modulation of clearance of palifermin or a change in
      heparin activity. Although not commonly conducted, the literature describes heparin drug-drug
      interaction studies conducted in healthy subjects using both subcutaneous (Grimaudo et
      al,1988; Kroon et al, 1992) and intravenous (Caplain at al, 1999; Noveck & Hubbard, 2004;
      Spowart et al, 1988) formulations. Based on these experiences, it is appropriate to
      investigate heparin drug-drug interactions in healthy subjects.

      In this study, subjects will receive a single 60 mcg/kg dose of palifermin either as
      monotherapy or in conjunction with a continuous heparin infusion. The 60 mcg/kg dose of
      palifermin explored in this study is identical to the current recommended daily dosage for
      patients with hematologic malignancies who were undergoing autologous PBPC transplantation
      after receiving total body irradiation and high-dose chemotherapy: 3 consecutive days
      administered in two cycles with a 5-day non-dosing interval.
    

Intervention name(s): Palifermin; Heparin
Intervention type(s): Drug; Drug
Other intervention name(s): Kepivance
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Palifermin; drug interaction
Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase
Condition: Kidney Transplantation
Study type: Interventional

Summary: 
      LOVED stands for the Living Organ Video Educated Donors (LOVED) program. It is a culturally
      tailored program for African Americans to reduce the disparity of low rates of living kidney
      donation. It is a mobile health delivered platform that does not require transplant center
      visits, thus increasing the reach of the program compared to center-based program to enhance
      living kidney donation. The purpose of LOVED is to give education and encouragement to those
      who need a kidney transplant and teach about the process of living donation to be better
      educated when approaching others about donating a kidney. The ultimate goal of the program is
      to increase the number of living kidney donor transplants, especially among African Americans
      in South Carolina. The program was created to educate those in need of a kidney about the
      donor process, to dispel myths about living donation, discuss who can be asked to donate and
      develop and practice skills to start asking others for a living kidney donation. The program
      is designed to be completed using a tablet computer and is made up of weekly video education
      clips, resources, short quizzes to reinforce the learning points and weekly video chat
      sessions with others who need a kidney led by a "navigator" who was once a living donor
      kidney recipient. The video clips are made up of stories and brief educational messages from
      transplant center staff, physicians, former donors and recipients. The video chat sessions
      were designed to solve and address individual issues for those enrolled in the program and to
      give a sense of community as they continue on their journey to find a kidney. This randomized
      control trial uses groups of 6-9 participants in each LOVED group that lasts 8-weeks each. A
      total of 60 participants will be recruited with 30 assigned to LOVED and 30 assigned to a
      standard care groups. This program is funded by a grant from the National Institute of Health
      and was developed at the Medical University of South Carolina.
    


Intervention name(s): LOVED Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Exploratory Study to Investigate the Effect of Dapagliflozin and Exenatide Combined on Body Weight
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      Obesity is a medical condition which increases the risk of other diseases, such as type 2
      diabetes and cardiovascular disease. Obesity-related risk factors for the development of
      other metabolic diseases include unstable glucose levels and high blood pressure.
      Dapagliflozin and exenatide are both approved worldwide for treatment of patients with Type 2
      Diabetes. Dapagliflozin works by lowering glucose levels by inhibiting the renal reabsorption
      of glucose and thereby promoting its urinary excretion and energy loss and thereby reduction
      in body fat. Exenatide exhibits many of the same glucose-lowering actions of that of a
      naturally occurring hormone and leads to weight loss mainly via reduced energy intake, most
      likely via a central effect on appetite regulation. The purpose of this exploratory study is
      to investigate if a combination treatment with dapagliflozin and exenatide have a synergistic
      effect on weight loss in non-diabetic obese subjects. Subjects will be treated for 24 weeks
      with either active combination treatment or placebo (non-active treatment). Neither study
      personnel nor subjects will know what treatment is given. All subjects completing the 24-week
      double-blind study and who are willing and eligible will be offered to enter a 28-week
      open-label extension study. All subjects entering the extension study will receive unblinded
      active study treatment for an additional 28 weeks. Thus the total treatment period for
      subjects entering the extension study will be 52 weeks.
    


Intervention name(s): Dapagliflozin; Exenatide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral use; Powder and solvent for suspension for injection, prolonged release suspension. Subcutaneous use.; Oral and Subcutaneous use.
Other intervention name(s): Forxiga®; BYDUERON®; BYETTA®
Intervention MeSH terms: Dapagliflozin; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Dapagliflozin; Exenatide; Combination treatment; Type 2 diabetes
Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving sorafenib together with docetaxel may kill more tumor cells.

      PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how
      well it works in treating patients with metastatic androgen-independent prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the proportion of patients achieving a 50% reduction in serum PSA from
           baseline in patients with androgen-independent prostate cancer (AIPC) receiving
           sorafenib tosylate and docetaxel.

      Secondary

        -  To estimate the progression-free survival of patients with AIPC.

        -  To quantify the number and percent of patients who have stable disease at 6 months of
           therapy (failure to progress).

        -  To estimate median time to progression for all patients.

        -  To estimate the objective response rate of patients with AIPC treated with this regimen.

        -  To measure the percentage of patients surviving at 2 years.

        -  To determine the toxicities and estimate toxicity rates for patients treated with this
           regimen.

        -  To measure changes in tumor vasculature in response to therapy in selected patients with
           dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary objectives
           to these measurement changes.

        -  To measure changes in serum HMGB1 in response to therapy and correlate primary and
           secondary objectives with these changes.

        -  To measure changes in serum cathepsin D in response to therapy and correlate primary and
           secondary objectives with these changes.

      OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV
      on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral
      sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in
      the absence of disease progression or unacceptable toxicity.

      Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels
      before and after therapy.
    

Intervention name(s): docetaxel; sorafenib tosylate
Intervention type(s): Drug; Drug
Other intervention name(s): Taxotere; Nexavar
Intervention MeSH terms: Docetaxel; Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer
LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current
      clinical practice setting.
    

Detailed description: 
      This observational study will evaluate the effect of Lotronex® as used in the current
      clinical practice setting on symptom relief, specifically, improvement in bowel habits and
      IBS pain. Patients planning to initiate commercially available LOTRONEX® therapy will be
      consented for study participation. Patients will complete study questionnaires related to
      bowel symptoms, prior therapies, quality of life, productivity loss and treatment outcome.
      Investigators will also be asked to complete questionnaires related to the patient's disease
      characteristics, patient progress on study medication and treatment outcome.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women ≥ 18 years of age with severe diarrhea-predominant IBS, who have chronic IBS symptoms
        lasting 6 months or longer and who have not responded adequately to other IBS therapy will
        be eligible to enroll in the study.
      
Keywords: Diarrhea; IBS; Irritable Bowel Syndrome
Alfuzosin for Treating Acute Urinary Retention
Condition: Acute Urinary Retention
MeSH terms: Urinary Retention
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the
      return to successful voiding after removal of the catheter following a first episode of acute
      urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).
    


Intervention name(s): Alfuzosin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily; Once daily
Intervention MeSH terms: Alfuzosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Benefits of Assistive Listening Device for Speech Intelligibility
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe
      sensorineural hearing loss, using an assistive listening device and hearing aid, and compared
      to speech intelligibility in noise using hearing aids alone.
    


Intervention name(s): Roger microphone; Phonak Audeo hearing aid
Intervention type(s): Device; Device
Intervention description(s): Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.; Commercially available receiver-in-canal hearing aid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other