bioihbjkbjnl/mcl2 huggingface dataset:
Study of Fat Malabsorption by Lipiblock Versus Xenical
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is a chronic condition with fat-rich diets playing a major role in its etiology.
      Pharmacological therapy has been proposed for weight loss and maintenance. This study aims to
      study the intestinal lipase blockade by partial inhibition of fat absorption after treatment
      with two commercials formulations of Orlistat.
    

Detailed description: 
      The overweight and obesity epidemic affects approximately 1.6 millions of people worldwide.
      Obesity is a chronic condition, associated with premature death, co-morbidities, risk factors
      for main cardiac disease, stigmatization and significant economic costs. The causes of
      obesity are complex and include the interplay of environmental, social, economic and genetic
      factors. Besides fat-rich diets also play a significant role in the etiology of obesity.
      Correct diet orientation associated with physical exercise usually did not lead to expected
      result in weight loss and maintenance. Pharmacological therapy has been proposed as an
      adjunct to achieve the ideal weight. Orlistat acts in reduction of lipids absorption by
      inhibition of gastric and pancreatic lipases in gastrointestinal tract leading to sustained
      weight loss. This is a double blind study, randomized, of 2 weeks. The aim of this study was
      evaluate the intestinal lipase blockade by decrease of fat absorption of fecal fat after
      treatment with two commercials formulations of Orlistat in obese patients.
    

Intervention name(s): Orlistat
Intervention type(s): Drug
Intervention description(s): Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
Other intervention name(s): Xenical; Lipiblock; Tetrahydrolipstatin
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Intestinal lipase; Orlistat; fecal fat; obesity
Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The investigators hypothesize that cardiovascular and metabolic alterations due to obesity
      already manifest at childhood age.

      To identify these alterations and risk factors, the investigators have established a cohort
      of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of
      cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity
      and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally
      after 5, 7 and 9 years.

      In addition, the investigators will assess the effects of increased physical activity and
      exercise on cardiovascular function.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese children from our out-patient department in Leipzig, Germany Lean children
        community-based from Leipzig
      
Biospecimen description: 
      Serum samples, samples from oral glucose tolerance tests (oGTT), EDTA/DNA samples, primary
      cells (endothelial progenitor cells), peripheral blood mononuclear cells), urine
    
Keywords: endothelial function; children; obesity; cardiovascular dysfunction; carotid intima media thickness; blood pressure; oral glucose tolerance test
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure
      the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after
      eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take
      olaparib capsules daily and study assessments will be recorded for 6 months (minimum).
      Treatment can continue for as long as the patient is benefitting. Throughout the study
      patients will be monitored for any side effects.
    


Intervention name(s): Olaparib; Dietary Fasted; Dietary standard; Dietary High Fat
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): 400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.; Allocated breakfast prior to dosing with 400mg olaparib capsules; Allocated breakfast prior to dosing with 400mg olaparib capsules; Allocated breakfast prior to dosing with 400mg olaparib capsules
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: oncology, cancer, tumour, neoplasm, anticancer drug, food effect, area under the curve, pharmacokinetics, olaparib, solid tumour, metabolites, drug availability
Retrospective Examination of Electroencephalography Signals of Individuals With Different Eating Disorders
Condition: Anorexia Nervosa; Bulimia Nervosa
MeSH terms: Anorexia; Bulimia; Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa
Study type: Observational

Summary: 
      The aim of this study was to investigate the difference between electroencephalography (EEG)
      data and current psychological status of individuals diagnosed with anorexia nervosa (AN) and
      bulimia nervosa (BN).
    

Detailed description: 
      The data used in this study were obtained from individuals aged 18 and younger with eating
      disorders who applied to Üsküdar University NP Istanbul Brain Hospital. Two different
      diagnostic groups, Anorexia Nervosa and Bulimia Nervosa, were included in the study.
      Demographic information, secondary diagnosis status, Beck Depression Inventory (BDI), Beck
      Anxiety Inventory (BAI), Eating Attitude Test - 40 (EAT-40) scores and EEG data were used to
      investigate the differences between eating disorders. Comparison of neurological differences
      between individuals with AN and BN was done retrospectively.

      This information, which will be obtained for AN and BN, which are diseases in which severe
      deterioration in behavior and perception are seen, can give advice to experts in planning
      treatment and rehabilitation processes.
    

Intervention name(s): No interventions - retrospective data collection
Intervention type(s): Other
Intervention description(s): The differences between the two diagnoses were investigated by using the scale results and EEG data in the patient files.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Individuals aged 18 years or younger with AN and BN who were administered scales of
        depression, anxiety and eating attitudes
      
Keywords: eating disorders; electroencephalography; depression
Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery
Condition: Opioid Use, Unspecified
Study type: Interventional

Summary: 
      This is a randomized controlled trial assessing the utility of an educational video on pain
      management after a cesarean section to reduce opioid use. The educational video will be shown
      during the patient's postpartum stay and the amount of opioid and adjunct medications will be
      assessed in those who watched the video compared to those who received the standard of care
      discharge instructions without the video. Participants will be contacted 7 and 14 days after
      cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on
      their overall pain management and to determine how many opioid tablets have been used.
    


Intervention name(s): Educational video; Standard of care; Ibuprofen; Oxycodone
Intervention type(s): Other; Other; Drug; Drug
Intervention description(s): An educational video on pain management after cesarean section. The educational video was put together by two general obstetrician-gynecologists, two maternal fetal medicine specialists, and a palliative care physician.; The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.; Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.; Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.
Other intervention name(s): Advil
Intervention MeSH terms: Ibuprofen; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
Condition: Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether LNG/EE is effective in the treatment of
      menstrual cycle related symptoms.
    


Intervention name(s): Levonorgestrel/Ethinyl Estradiol
Intervention type(s): Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Levonorgestrel; ethinyl estradiol; premenstrual syndrome; menstrual cycle related symptoms
A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles)
      vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated
      with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be
      cross-reactive against multiple HIV-1 stains. Also, to determine whether boosting with the
      vaccine orally or rectally will help induce mucosal antibody responses.

      Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine.
      Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal
      surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV
      p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against
      HIV-1.
    

Detailed description: 
      Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine.
      Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal
      surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV
      p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against
      HIV-1.

      Volunteers receive HIV p17/p24:Ty-VLP vaccine or placebo by IM injection (with or without
      alum adjuvant) at months 0, 2, and 6, and then either by mouth or rectal enema at months 10
      and 11. Volunteers who receive oral vaccine boosting will receive concurrent omeprazole to
      decrease stomach acid.
    

Intervention name(s): HIV p17/p24:Ty-VLP; Aluminum hydroxide
Intervention type(s): Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Recombinant Proteins; HIV-1; AIDS Vaccines; HIV Core Protein p24; p24-VLP vaccine; Gene Products, gag; HIV Seronegativity; HIV Preventive Vaccine
Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal Cancer
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This prospective, multicenter, single arm clinical trial was designed to evaluate the
      efficacy and safety of Vemurafenib in combination with Irinotecan and Cetuximab in the
      treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      To evaluate the Overall Response Rate (ORR) of v-raf murine sarcoma viral oncogene homolog B
      (BRAF) V600E mutant metastatic colorectal cancer patients treated with Vemurafenib in
      combination with Irinotecan and Cetuximab (VIC regimen).

      SECONDARY OBJECTIVES:

      To evaluate the Progression Free Survival (PFS), Overall Survival (OS), safety and toxicity
      of VIC regimen in the treatment of BRAF V600E mutant colon cancer.

      EXPLORATORY OBJECTIVES:

      Mechanism of primary and secondary resistance to VIC regimen in the treatment of BRAF V600E
      mutant colon cancer.

      OUTLINE:

      Patients receive Cetuximab and Irinotecan intravenously on day 1 and Vemurafenib orally (PO)
      twice daily (BID) on days 1 to 14. Courses are repeated every 2 weeks in the absence of
      disease progression or unacceptable toxicity.
    

Intervention name(s): Cetuximab; Irinotecan; Vemurafenib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Route of administration: Intravenous; Route of administration: Intravenous; Route of administration: Oral
Other intervention name(s): C225; Erbitux; CPT-11; Camptothecin-11; Camptosar; Zelboraf
Intervention MeSH terms: Irinotecan; Camptothecin; Cetuximab; Vemurafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation
Condition: Bowel Preparation; Sodium Picosulfate and Magnesium Citrate; Polyethylene Glycol With Ascorbic Acid
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the efficacy depending on the order of the sequential
      combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic
      acid for bowel preparation.

      The investigators designed this study as a phase II prospective randomized parallel arm
      clinical trial. 71 participant will be enrolled in each group (142 in total).

      The primary outcome is the efficacy of bowel preparation. secondary outcomes are
      tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.
    


Intervention name(s): sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid
Intervention type(s): Drug
Intervention description(s): sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.
There is a difference in the order of intake between two group
Other intervention name(s): Picosolution; Coolprep
Intervention MeSH terms: Ascorbic Acid; Magnesium citrate; Picosulfate sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer
Condition: Advanced or Metastatic Breast Cancer; Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose
      (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced
      breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients
      with metastatic or locally advanced and unresectable triple negative breast cancer, to
      evaluate the efficacy of combined dinaciclib and pembrolizumab.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. Define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of dinaciclib

      SECONDARY OBJECTIVE:

      I. Evaluation of the preliminary efficacy of this combination using RECIST 1.1 and irRECIST.

      EXPLORATORY OBJECTIVE:

      I. Characterizing and correlating PDL-1 and MYC overexpression with clinical response.

      OUTLINE:

      This is an open-label phase Ib trial of weekly dinaciclib in combination pembrolizumab in
      participants with advanced triple negative breast cancer. Participants will undergo a single
      needle biopsy of a site of active disease prior to initiating treatment of Pembrolizumab and
      dinaciclib in 21 day cycles. The dose of dinaciclib will be escalated following a toxicity
      probability interval (TPI) design where dose-limiting toxicities (DLT) observed during the
      first cycle will be used to determine whether additional participants should be enrolled at
      the same, higher, or lower dose level. Treatment will continue until disease progression,
      intolerable toxicity, or participant withdraws consent. In the event of a complete response
      (CR), participants may elect to hold dinaciclib treatment and continue with pembrolizumab
      alone. At the time of radiographic disease progression, dinaciclib can be resumed at the same
      dose as at the time of discontinuation. Participants will be followed for 30 days after the
      last dose of treatment.
    

Intervention name(s): Dinaciclib; Pembrolizumab
Intervention type(s): Drug; Drug
Intervention description(s): Given IV; Given IV
Other intervention name(s): SCH727965; Keytruda
Intervention MeSH terms: Pembrolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ANG-3070 in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food
      effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

      This study is comprised of 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple
      ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each
      cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6
      subjects receiving active ANG-3070)
    

Detailed description: 
      This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food
      effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

      Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6
      subjects receiving active ANG-3070). The study design employs sentinel dosing with 2 subjects
      (1 placebo, 1 active treatment) at least 24 hours prior to remainder of cohort for dose
      cohort 1.

      SAD cohorts are defined as follows, with the FE crossover occurring for participants in
      cohort A3 on Day 15 and in cohort D1 on Day 5:

      A1 ANG-3070 50 mg (n=6) / Placebo (n=2) A2 ANG-3070 100 mg (n=6) / Placebo (n=2) A3 ANG-3070
      200 mg (n=6) / Placebo (n=2) A3 Day 15ANG-3070 200mg (n=6) / Placebo (n=2) A4 ANG-3070 400 mg
      (n=6) / Placebo (n=2) A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) D1 Day 1 ANG-3070 600 mg
      Single Dose (n=6) / Placebo (n=2) D1 Day 5 (ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2)

      MAD cohorts will receive drug or placebo twice daily for 14 consecutive days (Day 1 to Day
      14) or drug or placebo once daily for 14 consecutive days (Day 1 to Day 14) as follows:

      B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2) B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2) B3
      ANG-3070 250 mg BID (n=6) / Placebo (n=2) B4 ANG-3070 500 mg BID (n=6) / Placebo (n=2) C1
      ANG-3070 400 mg QD (n=6) / Placebo (n=2) C2 ANG-3070 600 mg QD (n=6) / Placebo (n=2)
    

Intervention name(s): ANG3070; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.; ANG-3070 placebo capsules visually match the drug product.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery
Condition: Colorectal Disorders; Colorectal Surgery
Study type: Interventional

Summary: 
      The aim of this study is to provide conclusive clinical evidence as to whether or not the
      preoperative administration of oral carbohydrate-rich solutions is effective on the outcomes
      of patients undergoing colorectal surgery.
    

Detailed description: 
      Preoperative oral carbohydrate loading is an issue that has been investigated extensively in
      terms of its fundamental and biochemically apparent effects and potential benefits. Most
      commonly, proponents of the application advocate that it may be beneficial for improving
      patient outcomes and for decreasing complication rate by attenuating postoperative insulin
      resistance. To date, however, no study with a sufficient sample size has been able to
      demonstrate that it has a marked value in clinical practice. Almost all of the clinical
      benefits ascribed to the application have been based on subjective well-being, which can also
      be provided with non specific simple beverages. A study conducted to show whether or not the
      application has direct influence on patient outcome, therefore, could significantly
      contribute insights on this topic. The present study was planned to consist of three study
      arms, namely: 1.Study group, which will be given high-carbohydrate beverage (Nutricia preOp®,
      Numico, Zoetermeer, The Netherlands) 2. Placebo group, which will be given flavored water,
      and 3. Control group (surgery after overnight fast). The revised power analysis shows that an
      accrual of 74 patients in each group would allow detecting a 15% difference in the rate of
      complications with 80% power at the 5% level of significance (two tailed). We hope we will
      have recruited at least 220 subjects at the end of a two-year course. Once the data recording
      is complete, this study will be the largest one ever conducted to investigate this topic.
    

Intervention name(s): commercially available high-carbohydrate beverage; flavored water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 800 ml before the day of surgery, and additional 400 ml two hours prior to surgery; will be given in doses equal to those of high-carbohydrate beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preoperative care; colorectal surgery; carbohydrate; fasting