bioihbjkbjnl/mcl2 huggingface dataset:
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Condition: Familial Adenomatous Polyposis
MeSH terms: Adenoma; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Study type: Interventional

Summary: 
      Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the
      formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually,
      all patients with FAP will develop colorectal cancer on average by the 5th decade of life if
      prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer
      surveillance of the remaining colorectum or ileum.

      Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which
      selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2
      (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the
      rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with
      significant comorbidity including renal and gastric toxicity and increased risk of vascular
      events. Therefore, identification of a chemopreventive agent that would have similar efficacy
      but less toxicity would enhance our ability to treat these patients. Therefore the following
      specific aim has been proposed:To determine in a randomized, double-blinded,
      placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal
      adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients
      with FAP.
    

Detailed description: 
      Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or
      placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor
      questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.
    

Intervention name(s): Calcumin (Curcumin); Risk Factor Questionnaire; Blood samples; Biopsies (Sigmoidoscopy); Biopsies (Upper endoscopy)
Intervention type(s): Drug; Other; Other; Other; Other
Intervention description(s): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).; Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.; Three tubes of blood at visits 0, 4 and 12 months.; Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.; Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.
Other intervention name(s): Curcumin
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Familial Adenomatous Polyposis (FAP); Curcumin; Colorectal polyps; Duodenal polyps
Bile Leak After Liver Surgery
Condition: Bile Leak; Hepatic Resection; Liver Resection; Hepatectomy; Biliary Fistula
MeSH terms: Biliary Fistula; Fistula
Study type: Observational [Patient Registry]

Summary: 
      The definition of biliary fistula is heterogeneous and the more accepted is that proposed by
      the ISGLS. We devised a precise definition of post-resectional biliary fistula and a
      well-established policy both for its disclosure and management.Aim was the validation of our
      definition, and management of biliary fistula after hepatic resection in a large prospective
      cohort of patients and its comparison with that of the International Study Group of Liver
      Surgery (ISGLS).
    

Detailed description: 
      Data on abdominal drains and on clinical, pathological and short-term outcome were reviewed
      in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012.
      Drains were maintained at least 7 days, and the bilirubin levels were measured in POD3, 5,
      and 7. Drains were removed if the bilirubin level in POD7 was inferior than in POD5, and less
      than 10 mg/dl. Statistical analysis on prognostic factors for biliary fistula was performed.
    

Intervention name(s): Hepatic resection
Intervention type(s): Procedure
Other intervention name(s): Liver resection; Hepatectomy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The records of 475 consecutive patients who were submitted to hepatectomy between 2004-2012
        were reviewed.
Comparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair
Condition: Bilateral Inguinal Hernia Repair
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with
      dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under
      direct visualization will be compared it to a standard anesthetic technique (control)
      following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are
      hypothesizing that the bilateral TAP block and preperitoneal instillation of local
      anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction
      and post-operative pain control when compared to a standard anesthetic technique (no regional
      technique).
    


Intervention name(s): Transversus abdominis plane block (TAP BLOCK); Instillation of surgical site with local anesthetic.; Opioid IV medications (Control)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Ultrasound guided TAP block with local anesthetics and dexamethasone.; Instillation of surgical site with local anesthetics and dexamethasone.; Standard anesthetic technique.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ultrasound guided; Bilateral Transversus abdominis Plane Block; Dexamethasone; Preperitoneal Instillation; Local Analgesic; Efficacy; Total Extraperitoneal Bilateral Inguinal hernia repair
Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse
Condition: Cocaine Dependent; Alcohol Dependent
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus
      placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and
      treatment outcome study to examine the effects of guanfacine on brief exposure to stress,
      drug cues and neutral situations on cocaine/alcohol craving, mood and neurobiological
      reactivity in a sample of cocaine and/or alcohol dependent individuals. Guanfacine will be
      beneficial for reduction in stress and drug cue induced craving and related arousal. In a
      sample of 60 cocaine and/or alcohol dependent men and women, we propose to examine (a)
      differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal
      (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery
      and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine/alcohol
      abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as
      measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment
      attendance. Hypothesis 1: Guanfacine will decrease stress-induced cocaine craving, negative
      emotions and related arousal in the laboratory as compared to placebo. Hypothesis 2a: As
      compared to the PLA group, the GFC group will show significant reductions in protracted
      withdrawal symptoms as measured by the CSSA/CIWA during the 9-week treatment period.

      Hypothesis 2b: As compared to the PLA group, a higher percentage of the GFC patients will
      remain abstinent during the 9-week treatment period with a higher percent of negative cocaine
      urines and alcohol-free days.

      Hypothesis 2c: The GFC group will show greater adherence to treatment as measured by the days
      in treatment as compared to the Pla group.
    


Intervention name(s): Guanfacine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.5mg BID; placebo
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy of an Automatic Toothbrush
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The objective of this study is to compare the efficacy in terms of bacterial plaque removal,
      in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles,
      compared with the electric toothbrush of similar shape but with silicone bristles, with the
      manual toothbrush, and with a negative control (no brushing) in a group of volunteer
      students.

      Primary endpoint: difference in "full mouth plaque score" between before and after brushing.

      Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0
      indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.

      Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5
      treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric
      toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2
      minutes, no brushing), carried out in a single session and spaced one week apart.
    


Intervention name(s): Automatic toothbrush with nylon bristle; Automatic toothbrush with silicone bristle; Manual toothbrush used for 2 minutes; Manual toothbrush used for 45 seconds
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch; The automatic toothbrush with silicone bristles will be used for 10 seconds; A conventional manual toothbrush will be used for 2 minutes; A conventional manual toothbrush will be used for 45 seconds
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
SPI-1005 for the Treatment of Patients With Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels
      of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.
    

Detailed description: 
      Study participants will be randomized to SPI-1005 or placebo in this double-blind study to
      evaluate both safety and efficacy of the investigational treatment. Participants, aged 18-75
      years, with probable or definite Meniere's disease will undergo baseline testing to assess
      severity of sensorineural hearing loss, tinnitus and vertigo. During the study, and 28 days
      after completion of treatment, participants will be evaluated for safety (adverse events,
      physical examinations, vital signs and clinical laboratory testing (CBC,serum chemistry).
      Trough plasma levels of ebselen and its major metabolite will be determined using liquid
      chromatography-mass spectrometry (LCMS) at specified visits. Additionally, plasma will be
      analyzed for selenium at the corresponding visits. The effect of SPI-1005 on hearing and
      balance will be evaluated. Tinnitus (TFI) and vertigo (VSS) will be evaluated at baseline,
      during and study treatment.
    

Intervention name(s): 200mg SPI-1005 BID; 400mg SPI-1005 BID; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Active: low dose; Active: high dose; Placebo Comparator
Other intervention name(s): ebselen; ebselen
Intervention MeSH terms: Ebselen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniere's disease; Hearing Loss; Vertigo; Tinnitus; Ebselen; Pharmacokinetics; Safety; Efficacy; Speech
Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
Condition: Acellular Pertussis; Haemophilus Influenzae Type b; Tetanus; Poliomyelitis; Diphtheria; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Influenza, Human; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the safety and reactogenicity of a booster dose of
      Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age
      who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within
      their first six months of lives.
    


Intervention name(s): Infanrix-IPV+Hib™
Intervention type(s): Biological
Intervention description(s): Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: booster; Infanrix-IPV+HibTM; DTPa-IPV/Hib; Vietnamese toddlers
A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      An increase in dietary protein intake has been shown to blunt the increase in intrahepatic
      fat induced by high fat feeding in healthy individuals. The purpose of this study is to
      determine if a protein supplementation decreases intrahepatic fat in obese patients with
      non-alcoholic fatty liver disease.
    

Detailed description: 
      12 obese patients will be be treated with a dietary whey protein supplementation over 4
      weeks. Their intrahepatic fat content, glucose tolerance, and body weight will be evaluated
      before and after 4 weeks of supplementation.
    

Intervention name(s): ProWHEY 94 CFM, SponserR
Intervention type(s): Dietary Supplement
Intervention description(s): 3 times 20g per day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intrahepatic fat; obesity; body fat; impaired glucose tolerance
Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
Condition: Health Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, two period crossover study to evaluate the effect of food
      on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
    


Intervention name(s): CTP-543
Intervention type(s): Drug
Intervention description(s): For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CTP-543
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of
      10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon
      review of the safety and PK data, it may be decided to expand the current cohort size and/or
      dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4
      cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher
      dose if deemed safe.
    

Detailed description: 
      This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of
      10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon
      review of the safety and PK data, it may be decided to expand the current cohort size and/or
      dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4
      cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher
      dose if deemed safe.

      Double-blind dosing will occur in cohorts 1 through 4. In these cohorts, 8 subjects will
      receive HU6 and 2 will receive matching placebo. Doses will escalate and may be modified
      based on results of safety and pharmacokinetic evaluation conducted after each cohort.
    

Intervention name(s): HU6
Intervention type(s): Drug
Intervention description(s): HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study will be conducted in one phase: a single dose, dose escalation phase in up to 4 cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib
      (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic
      Arthritis
    


Intervention name(s): Celecoxib; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): Celecoxib 50 mg or 100 mg PO BID for 6 weeks; Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
Intervention MeSH terms: Celecoxib; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis
Women of Color and Asthma Control
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The proposed randomized controlled trial will evaluate an innovative intervention in 420
      African American women with asthma. It will be the first to use a highly tailored, telephone
      counseling approach to address both specific cultural factors affecting asthma and the
      influence of female sex and gender on control.
    

Detailed description: 
      Research and practice efforts in asthma continue to overlook one of the most vulnerable
      subgroups of Americans, minority women. Women of color, especially African Americans, bear a
      significantly disproportionate burden of asthma among adults. However, no rigorous trial of
      an intervention to assist them with their particular challenges can be located. The proposed
      randomized controlled trial will evaluate an innovative intervention in 420 African American
      women with asthma. It will be the first to address both specific cultural factors affecting
      asthma and the influence of female sex and gender on control. It will use a highly tailored,
      telephone counseling approach designed to foster partnership with the clinician, resolution
      of specific asthma management problems, and identification of important contributing
      influences often misunderstood or ignored by women themselves as well as the health care
      system. It will attend closely to the role of allergy in asthma management as patients in the
      African American population have been shown to be at greater risk for allergic asthma.

      Data will be collected at baseline, 12, and 24 months by telephone interview and from medical
      records. The hypotheses of the research are that women in the intervention group when
      compared to the control group will:

        -  Use emergency department services for asthma less frequently and need urgent care in a
           physician's office less often;

        -  Be hospitalized for asthma less frequently.

        -  Experience fewer symptoms of asthma;

        -  Have higher levels of asthma-related quality of life

      The intervention aims to reduce the burden of asthma as carried by a large subgroup of the
      adult population. It employs state of the art asthma management strategies and creative means
      to reach and help patients at high risk of asthma exacerbations and health care use.
    

Intervention name(s): Telephone counseling intervention
Intervention type(s): Behavioral
Intervention description(s): self-regulation telephone counseling program for African American women with asthma
Other intervention name(s): Women Breathe Free
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Asthma
Lifeline-NET (Narrative Exposure Therapy): A Short-term Treatment for Traumatized Refugees and Asylum Seekers
Condition: Trauma Treatment; Lifeline NET; Modification of Narrative Exposure Therapy
Study type: Interventional

Summary: 
      Evaluation of a short version of Narrative Exposure Therapy
    


Intervention name(s): Lifeline NET
Intervention type(s): Behavioral
Intervention description(s): Short Version of Narrative Exposure Therapy
Other intervention name(s): LL-NET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Validation of the Spanish Version of the Neck Disability Index
Condition: Neck Pain; Cervicalgia
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      The primary purpose of this study is to adapt the Neck Disability Index (NDI)and the Cervical
      Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the
      correlation between intensity of cervical pain, degree of disability, and quality of life; to
      determine the correlation between the NDI, CCS6 and the Northwick Park Neck Pain
      Questionnaire; and to determine factors that predict the chronification of disability.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who visit their physician for cervicalgia, with or without referred pain
      
Keywords: Neck pain; Cervicalgia; Quality of life; Disability