bioihbjkbjnl/mcl2 huggingface dataset:
Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
Condition: Breast Cancer; Lung Cancer; Ovarian Cancer
MeSH terms: Breast Neoplasms; Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines may make the body build an immune response to tumor cells.
      Colony-stimulating factors such as sargramostim increase the number of immune cells found in
      bone marrow or peripheral blood.

      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in
      treating patients who have stage III or stage IV cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety of serial intradermal or subcutaneous vaccinations of
      HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres
      with adjuvant sargramostim (GM-CSF) in patients with stage III or IV HER-2 expressing
      cancers. II. Determine whether cytotoxic T lymphocytes (CTL) specific for the HER-2 protein
      can be elicited in patients with HLA-A2 by immunization with this regimen. III. Determine
      which route of immunization, intradermal or subcutaneous, is more effective in generating
      HER-2 specific CTL in these patients on this regimen. IV. Determine the extent to which
      escalated dose of PLG peptide affects the immune response in these patients on this regimen.

      OUTLINE: Patients undergo leukapheresis prior to study and after final vaccination. Patients
      are sequentially entered into one of three treatment arms: Arm I: Patients receive an
      intradermal vaccination of HER-2 derived p369-377 peptide incorporated into
      polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF). Arm II:
      Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated
      into PLG microspheres with adjuvant GM-CSF. Arm III: Patients receive a higher dose of
      subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres
      with adjuvant GM-CSF. Treatment repeats every 4 weeks for up to 6 courses in the absence of
      unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 15 patients (5 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): HER-2/neu peptide vaccine; sargramostim
Intervention type(s): Biological; Biological
Intervention MeSH terms: Sargramostim
Primary purpose: Treatment
Keywords: stage IV breast cancer; stage IIIA breast cancer; stage III non-small cell lung cancer; stage IIIB breast cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung
The Role of Endothelin in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123,
      an investigational compound which is not approved by the FDA.
    

Detailed description: 
      Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare
      the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.
    

Intervention name(s): BQ-123
Intervention type(s): Drug
Intervention description(s): 6-120 µg/min
Intervention MeSH terms: cyclo(Trp-Asp-Pro-Val-Leu)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary pulmonary hypertension; secondary pulmonary hypertension due to left heart failure; secondary pulmonary hypertension due to other causes; patients without pulmonary disease or pulmonary hypertension
IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery
Condition: Pain; Obesity
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve
      quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of
      intraoperative systemic lidocaine decrease postoperative opioid consumption and improve
      quality of recovery after laparoscopic gastric bypass surgery.

      This study has the potential to confirm an opioid sparing strategy for morbid obese patients
      undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea
      and the increased risk of postoperative hypoxemia make the development of opioid sparing
      techniques in this patient population warranted.
    


Intervention name(s): Lidocaine Infusion; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period; Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Other intervention name(s): Placebo infusion
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Gastric Surgery; Pain; Recovery; Laparoscopic Surgery
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
Condition: Physical Function; Pain; Hernia; Wound Infection; Postoperative Complication; Recurrence
MeSH terms: Wound Infection; Hernia; Recurrence; Postoperative Complications; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE
      Mesh, and to compare it with the traditional Lichtenstein procedure performed with
      polypropylene mesh.
    


Intervention name(s): polypropylene mesh; Infinit® PTFE mesh (WL Gore)
Intervention type(s): Device; Device
Intervention description(s): A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.; A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: shrinkage; postoperative pain and discomfort
An Investigation of Tumor Necrosis Factor (TNF)-Alpha in Asthma Using Biopsy Explants and Primary Bronchial Epithelial Cell Cultures
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      We have developed in vitro systems including primary epithelial cell cultures and explant
      cultures of bronchial tissues to study the interaction between the bronchial mucosa and
      allergens. This approach involves culturing bronchial biopsies under optimal conditions and
      stimulate them with allergens thus enabling us to perform a dynamic study without the need of
      performing several bronchoscopies and will allow the testing of unapproved substances, which
      could, otherwise, not be delivered, in vivo.

      We wish to apply these ex vivo bronchial culture systems to assess cytokine release in
      moderately severe asthmatics and evaluate the effects of blocking TNF-alpha signalling using
      anti TNF-alpha monoclonal antibodies.
    

Detailed description: 
      Volunteers with moderately severe asthma will be recruited and carefully characterized in
      terms of lung function, asthma symptom scores, medication usage and allergen sensitivity (by
      blood and skin tests). If suitable, they will then be asked to withdraw their corticosteroids
      for a week with careful monitoring of the symptoms and peak flows before undergoing
      fibreoptic bronchoscopy as was carried out in the previous explant study. Bronchial brushings
      and biopsies will be carried out as per standard technique used in University medicine.
      Primary epithelial cell cultures will be established from bronchial brushings and will be
      used for optimising the dose of anti TNF-alpha required for inhibition of TNF-alpha induced
      responses. The biopsies will be placed in either culture medium alone, allergen extract or
      allergen extract plus anti TNF-alpha antibody and cultured for 24 hours. The biopsies will
      then be either snap frozen in liquid nitrogen for analysis of cytokines or processed for
      immunohistochemical analysis. The supernatants from each study will be recovered and analysed
      for cytokine (IL-5, IL-8, IL-13, MIP 1 alpha and RANTES) release by ELISA.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Biospecimen description: 
      -  bronchial brushings and biopsies

        -  Blood
    
Keywords: Asthma; TNF alpha; epithelial cell culture
Learning Theory to Improve Obesity Treatment
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to optimize an obesity treatment program targeting overweight
      8-12 year old children using "Cue Exposure Training".
    

Detailed description: 
      The goal of the Cue Exposure program is to train children to resist cues to eat unhealthy
      foods. Through a series of experimental studies, the investigators will evaluate how many
      weekly treatment visits there should be, whether children should be exposed to a single food
      or multiple foods during treatment, whether to use partial reinforcement or not, whether
      visits should be daily or weekly, and whether the exposures should be in single or multiple
      contexts. The investigators will be recruiting parent-child dyads in the San Diego community
      to participate in 8 to 16 weekly or daily treatment sessions either in their home, community
      center, or our lab, depending on the treatment arm. Parents and children will complete
      baseline and post-treatment assessments consisting of collecting psychophysiological data,
      completing laboratory tasks, and completing questionnaires. The investigators will be
      evaluating which treatment condition reduces overeating (as measured by our laboratory
      tasks).
    

Intervention name(s): Single food Cue Exposure Treatment; Multiple food Cue Exposure Treatment; Partial Reinforcement - Enhanced Cue Exposure Treatment; Partial Reinforcement -Consistent Cue Exposure Treatment
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.; Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.; Subjects will take random additional tastes of the food during cue exposure treatment.; Subjects will consistently take the same tastes of the food during cue exposure treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; overweight; overweight children; overweight parents; overeating; eating in the absence of hunger; families with overweight child; body mass index; BMI; weight; childhood obesity; treatment; cue exposure treatment; cravings; habituation to food cues; psychophysiological response to food cues; intervention; experiments; family based treatment; behavioral treatment
A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this placebo-controlled study is to evaluate the safety, tolerability and
      pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy
      adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis
      and treatment in the event of exposure to chemical nerve agents (as employed during chemical
      warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion
      of either HuBChE or normal saline placebo. The volunteers will remain in the study for 90
      (+/- 7) days. For the first 3 days following dose administration, they will remain at the
      clinical trial site as an inpatient and will be closely monitored for patient safety.
      Afterwards, they will return to the trial site (at pre-determined intervals) as an outpatient
      for a further 8 visits, where patient safety will be assessed.
    


Intervention name(s): Human butyrylcholinesterase (HuBChE) derived from human plasma; Placebo: Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular administration; Intramuscular administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chemical Warfare Agents; Chemical Nerve Agent Intoxication; Chemical Terrorism
Influence of OATP1B1 and CYP2C9 Genotypes on the Pharmacokinetics of Bosentan Before and During Clarithromycin
Condition: Drug Interactions
Study type: Observational

Summary: 
      The aim of the present study is to assess the impact of the OATP1B1 genotype (SLCO1B1*15 vs.
      wild type; ~2% SLCO1B1*15 haplotypes in Caucasian population) and the CYP2C9 genotype (*2 and
      *3 allele vs. wild type; ~5% poor metabolisers in Caucasian population) on the
      pharmacokinetics of bosentan and the impact of CYP3A4-inhibition by clarithromycin on steady
      state bosentan which is a CYP3A4 inducer itself.

      This study will focus on differential effects of genotypes and co-medication on the
      pharmacokinetics of bosentan at the metabolic and transport level. Participants will be
      genotyped for CYP2C9 (inclusion criterion), OATP1B1 (inclusion criterion), and CYP3A5 (no
      inclusion criterion).
    


Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): Administration of bosentan: 1 x 125 mg p.o. on day 1, 2 x 125 mg p.o. on day 2-14
Administration of clarithromycin: 2 x 500 mg p.o. on day 11-14
Other intervention name(s): Tracleer
Intervention MeSH terms: Bosentan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects
      
Keywords: steady state; bosentan; clarithromycin
Laser Acupuncture for Pain Prevention in Neonates
Condition: Pain
Study type: Interventional

Summary: 
      Pain prevention and/or therapy in neonates is still a challenge. It is widely accepted that
      early pain experience can have a tremendous impact on the pain memory. We want to investigate
      if a simple, fast method, that is nearly devoid of side effects can lead to a significant
      alleviation of pain sensation in neonates. Acupuncture has been shown to be effective in
      various painful conditions. Trials on acupuncture in children are rare. Trials on acupuncture
      in neonates are lacking so far. Our hypothesis is that neonates in the active laser group
      experience less pain than those in the placebo group.
    


Intervention name(s): active laser acupuncture; placebo laser acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): low level laser acupuncture, 830 nm, 30 mW, 0,3 J per acupoint, 2 points per neonate (Hegu and Shen Men). Overall 30 seconds of treatment; placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.
Other intervention name(s): Modulas Handy 2/99, schwamedico, Ehringshausen, Germany; placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pain prevention; neonatal pain; laser acupuncture; complementary and alternative medicine
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and tolerability of once-daily versus twice-daily
      dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
    


Intervention name(s): CTP-543; CTP-543 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CTP-543 administered as 8 mg tablet.; Administered as tablets to aid treatment masking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      A clinical trial to assess the effect of celecoxib 200 milligrams (mg) once daily and 400
      milligrams (mg) once daily compared to diclofenac three times daily in the treatment of
      Ankylosing Spondylitis (AS) for 12 weeks. This will be used to confirm the results of a prior
      6 week trial.
    


Intervention name(s): Celecoxib 200 milligrams; Celecoxib 400 milligrams; diclofenac 50 milligrams
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Celecoxib 200 milligrams once a day; Celecoxib 400 milligrams once a day; diclofenac 50 milligrams three times a day
Intervention MeSH terms: Celecoxib; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ankylosing Spondylitis; Celecoxib; Diclofenac
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 4

Summary: 
      Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and
      women. The most important disease associated with oncogenic HPV infection is cervical cancer,
      currently the second leading cause of cancer-related death among women globally. The current
      study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15
      years of age.
    


Intervention name(s): Cervarix; Engerix-B
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccine; Healthy adolescents; Cervical cancer; Safety; Immunogenicity; Cervarix
Effect of Estradiol Pretreatment on Antagonist ICSI Cycles
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      Depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the
      gradual follicle stimulating hormone (FSH) elevation that occurs during the late luteal
      phase, the aim of this work is to study the effect of estradiol pretreatment on follicular
      synchronization and intracytoplasmic sperm injection (ICSI) outcome in antagonist cycles
    

Detailed description: 
      Gonadotropin-releasing hormone antagonist (GnRH-ant) cycles are characterized by higher
      patient acceptability with more attention being directed to the potential effect of steroid
      pretreatment to program antagonist protocol cycles, as marked size discrepancies of growing
      follicles reflect incoordinated maturation of follicular-oocyte complexes and complicates
      clinical criteria for human chorionic gonadotropin (hCG) administration. This phenomenon is
      associated with fewer mature oocytes and resulting embryos, which limits sufficient embryo
      selection for embryo transfer. Indeed, the large number of available embryos represented an
      important prognostic factor of invitro-fertilization (IVF) outcome, particularly in poor
      prognosis patients, possibly by increasing the probability that at least one good-quality
      embryo will be selected for embryo transfer. During COH, a better understanding of follicular
      development has resulted in the improvement of strategies for ovarian stimulation. This
      approach represents a potential and more physiological alternative to GnRH agonist or oral
      contraceptive pills pre-treatment in a trial to synchronize multi-follicular development and
      improve controlled ovarian hyperstimulation (COH) results. The present study is a randomized
      controlled trial that investigated whether E2 pre-treatment during the luteal phase affects
      developmental characteristics of growing follicles during COH. It depended on the hypothesis
      that growth asynchrony of antral follicles is a consequence of the gradual FSH elevation that
      occurs during the late luteal phase, thus testing for detection of the effect of luteal
      estradiol on follicular synchronization and its effect on ICSI outcome.
    

Intervention name(s): Estradiol Valerate 4mg
Intervention type(s): Drug
Intervention description(s): Estradiol valerate 2 mg (two tablet once daily) started 5 days before expected menses (or 7 days after ovulation of previous cycle). After start of menses, estradiol pretreatment was stopped and controlled ovarian stimulation started.
Other intervention name(s): Progynova
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pangenomic Study During Alcoholic Cirrhosis
Condition: Alcoholic Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis
Study type: Observational

Summary: 
      Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC
      could be linked with multiple functional region of genome.

      The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to
      perform some genetic link studies with pathologies without clear hereditary disposition.

      In this study, the investigators will identify predictives genetic polymorphism of HCC.
    


Intervention name(s): DNA extraction
Intervention type(s): Genetic
Intervention description(s): DNA extraction of blood sample for DNAship analysis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        2 groups with 2 subgroups:

          -  patient with HCC

          -  HCC with Child A

          -  HCC with Child B/C

          -  patient without HCC

          -  Child A without HCC

          -  Child B/C without HCC
      
Biospecimen description: 
      2 blood samples of 5ml for DNA extraction