bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 3

Summary: 
      The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled,
      multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus
      matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including
      patients with primary peritoneal and/or fallopian tube cancer)
    

Detailed description: 
      The OReO study will investigate the efficacy and safety of Olaparib maintenance re-treatment
      in patients with relapsed non-mucinous EOC, who have had disease progression following
      maintenance therapy with a Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerisation
      inhibitor (PARPi) and a complete or partial radiological response to subsequent treatment
      with platinum-based chemotherapy or may have no evidence of disease (if optimal cytoreductive
      surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125. Patients
      will be enrolled on the basis of their breast cancer susceptibility gene (BRCA1, BRCA2)
      status into one of two cohorts (BRCA1/2 [+ve] and BRCA1/2 [-ve]). The BRCA1/2 (+ve) and
      BRCA1/2 (-ve) cohorts will be randomised separately. Within each cohort, patients will be
      randomised by prospective allocation in a 2:1 ratio (Olaparib: matching placebo).
    

Intervention name(s): Active Comparator: Olaparib tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Olaparib
300mg Olaparib tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.; Placebo
300mg placebo tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.
Other intervention name(s): Olaparib tablets
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: polymerisation inhibitor (PARPi); PARPi re-treatment; BRCA1/2 (+ve); BRCA1/2 (-ve); Olaparib; ovarian cancer; progression free survival (PFS)
Effects of Berries on Post-meal Blood Sugar
Condition: Blood Glucose, Postprandial; Blood Insulin, Postprandial; Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether berries are effective in lowering blood
      glucose and insulin responses to meals containing starch or sucrose.
    

Detailed description: 
      Berries are rich sources of various polyphenols which may be beneficial in the regulation of
      blood glucose. In vitro and animal studies have shown that polyphenols and polyphenol-rich
      extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates
      and thereby suppress postprandial glycemia. However, current evidence on the effects of
      berries on postprandial glycemic responses in humans is limited.

      The purpose of this study is to investigate the effects of berries on postprandial glycemic
      responses (blood glucose and insulin) to starch or sucrose in healthy subjects. It consists
      of five substudies each of which includes 2-4 meals with different berry species typically
      consumed in Finland and a reference meal without berries. The following combinations of
      carbohydrates and berries are studied:

        -  Studies 1-2: white wheat bread (starch) is consumed with several berry species

        -  Study 3: white wheat bread or rye bread is consumed with a mixture of berries

        -  Study 4: sugar (sucrose) is consumed with berries and berry nectars

        -  Study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries
           and berry nectar.
    

Intervention name(s): Berries; No berries
Intervention type(s): Other; Other
Intervention description(s): Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).; Meals containing starch (bread) or sucrose are consumed without berries.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Berries; Starch; Sucrose; Glucose; Insulin; Postprandial
Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of filibuvir on the pharmacokinetics of
      ethinyloestradiol [EE] and levonorgestrel [LN], to assess the safety and tolerability of 600
      mg BID of filibuvir in healthy women and to investigate the pharmacokinetics of 600 mg BID of
      filibuvir in healthy women.
    

Detailed description: 
      To investigate the effects of multiple oral doses of filibuvir on the steady state
      pharmacokinetics of oral contraceptive steroids in healthy female subjects.
    

Intervention name(s): filibuvir + Oral Contraceptives
Intervention type(s): Drug
Intervention description(s): This is an open-label, fixed sequence study to investigate the effect of filibuvir (600 mg BID on the pharmacokinetics of oral contraceptives steroids. Sixteen subjects who have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1 will be enrolled into the study. The study will be conducted over two 28 day menstrual cycles and Day 1 of each period is defined as the first day of dosing OC in each cycle. During the first cycle (Period 1), the subjects will receive OC QD for 21 days and filibuvir BID on Days 22 through 28. During the second cycle (Period 2) the subjects will receive OC QD and filibuvir BID for 21 days. The dosing of filibuvir will start in Period 1 (Days 22 - 28).
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral
Intervention model: Crossover Assignment
Masking: None (Open Label)
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Condition: Gastric Carcinoma
MeSH terms: Carcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor
      receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The
      investigators' phase I study has shown that the drug's toxicity is manageable and the maximum
      tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib
      can improve progression free survival compared with placebo in patients with metastatic
      gastric carcinoma who failed two lines of chemotherapy.
    

Detailed description: 
      Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have
      been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is
      still unsatisfied for their toxicity and limitation in prolonging survival. Based on the
      promising results of apatinib in the phase I study, this clinical trial has been designed to
      evaluate whether apatinib can improve progression free survival in patients with metastatic
      gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will
      be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg
      qd, one group patients will receive apatinib 425mg bid, and the other group will receive
      placebo.
    

Intervention name(s): apatinib tablet
Intervention type(s): Drug
Intervention description(s): A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Progress free survival; Toxicity; Response rate; Overall survival; Quality of live
A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of AZD1656 after single
      ascending oral doses in healthy male subjects
    


Intervention name(s): AZD1656; AZD1656
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation to achieve maximum tolerated dose; Oral single dose
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pharmacokinetics; pharmacodynamics; AZD1656; safety; tolerability; Healthy Volunteers
A Study to Investigate the Effects of Imatinib on Pulmonary Vascular Dysfunction in a Human Model of Lung Injury
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, double-blind, placebo-controlled clinical study of imatinib (as
      mesilate) in healthy subjects exposed inhaled lipopolysaccharide. During the study, eight
      oral doses of imatinib, or placebo, will each be taken 12 hours apart, before subjects are
      exposed to nebulized lipopolysaccharide (LPS). Four hours after LPS exposure, a
      bronchoalveolar lavage (BAL) will be undertaken, and BAL fluid (BALF collected. Once study
      assessments are completed, a follow-up visit will be conducted approximately 7 days after the
      last dose of imatinib.

      The primary objective of the study is to investigate the effect of imatinib on LPS-induced
      pulmonary vascular dysfunction. The primary endpoints of this study are:

        1. Change in the number of neutrophils in BALF 6 hours after the LPS challenge in subjects
           exposed to imatinib compared with placebo.

        2. Change in concentration of total protein in BALF 6 hours after the LPS challenge in
           subjects exposed to imatinib compared with placebo
    


Intervention name(s): Imatinib; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Over-encapsulated 100 mg imatinib mesilate tablets; Matching placebo oral capsule
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Iron Supplements on the Growth of Enteric Pathogens
Condition: Iron-deficiency; Iron Deficiency Anaemia Due to Dietary Causes; Iron Deficiency Anemia Treatment; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      Iron supplementation is a common approach to address iron deficiency with recommendations for
      women of childbearing age, particularly those at risk of iron deficiency. Because of its
      considerably higher absorption, ferrous sulphate is the common iron compound used in iron
      supplements. However, concerns about iron supplements arise from the knowledge that a large
      portion of the supplement consumed is not absorbed. This unabsorbed iron travels to the colon
      and, in preclinical studies, has been shown to promote the growth of enteric pathogens at the
      expense of beneficial commensal bacteria and increase infection risk, including the clinical
      incidence of diarrhea. The objective of this study is to compare the effects of iron as
      ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and
      virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool
      samples will be collected from women of reproductive age following ingestion of an iron
      supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric
      pathogens, and outcome measures will be determined following in vitro fecal fermentation.
    


Intervention name(s): Ferrous sulfate; Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron); 2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Dietary Supplement: FeSO4 Dietary Supplement: Ao iron
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare the efficacy (in terms of event-free survival and overall
      survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see
      program in patient with radically operated renal cell carcinoma.
    

Detailed description: 
      For pts with non-metastatic RCC, no standard adjuvant treatment exists. Immunotherapy (IT)
      using IFN and/or IL2 is effective in metastatic disease setting. Low and chronically repeated
      doses of IL2 plus IFN induce a persistent stimulation of the immune system with no relevant
      toxicity.

      Surgically treated RCC pts were randomized to the following arms: A) low-dose IT; B) control
      arm. IT consisted of a 4-week cycle of s.c. IL2 (5 days/wk, 1 million UI/sqm bid d 1,2 and 1
      million UI/sqm x 1 d 3,4,5) + IFN (1,8 million UI/sqm d 3,5 of each week). Cycles were
      repeated every 4 months for the first 2 years and every 6 months for the remaining 3 years.
      Each patient received 12 cycles in 5 years. Inclusion criteria were as follows: histological
      diagnosis of RCC, age <75 yrs, radical or partial nephrectomy within the past 3 months, pT1
      (diameter of T > 2,5 cm), T2, T3 a-b-c; pN0-pN3, M0; good cardiac and renal function and no
      autoimmune disease.
    

Intervention name(s): Interferon Alfa-2a; Interleukin-2
Intervention type(s): Drug; Drug
Intervention description(s): Interferon Alfa-2a in combination with Interleukin; Interferon Alfa-2a in combination with Interleukin
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Interleukin-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carcinoma, Renal Cell; Low-dose Interleukin; Adjuvant Immunotherapy
Preconditioning Volatile Anesthesia in Liver Surgery
Condition: Anesthesia
Study type: Observational

Summary: 
      The purpose of this study is to compare the impact and outcome of continuous volatile
      anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in
      liver surgery.
    

Detailed description: 
      Comparing the impact and outcome of continuous volatile anesthesia to continuous intravenous
      anesthesia and to preconditioning volatile anesthesia in liver surgery.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients were included undergoing any type of liver resection with inflow
        occlusion for benign as well as malign diseases between January first, 2005 and December
        31, 2007 in a single tertiary care center
      
Keywords: Liver resection; Continuous volatile anesthesia; Continuous intravenous anesthesia; Preconditioning volatile anesthesia; Comparing three groups of anesthesia during the liver surgery according to their benefit on liver and outcome.
Lung Deposition Via Different Inhalation Devices
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the deposition of budesonide to the lung after
      inhalation with 5 different devices and to relate the findings to in vitro properties of
      inhaled budesonide.
    


Intervention name(s): Pulmicort pMDI HFA; Budesonide pMDI HFA; Pulmicort Repulses; Pulmicort Turbohaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations; Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations; Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations; Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inhalation; lung deposition
The Effect of Different Videolaryngoscopes on Intubation Success in Difficult Airway Patients
Condition: Mallampati Score, Difficult Intubation, Videolaryngoscope
Study type: Observational [Patient Registry]

Summary: 
      Mallampati score > 3 generally indicate difficult airway and difficult intubation. Most
      anesthesiologist usually use this score system to predict difficult airway management.
      Different laryngoscopes may be useful in management of difficult airway. This study designed
      to compare different videolaryngoscopes in intubation success in patient of Mallampati
      score>3.
    


Intervention name(s): intubation time
Intervention type(s): Other
Intervention description(s): intubation attempt number and intubation time
Other intervention name(s): intubation attempt
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who has mallampati score >3
Measurement of Gastric Emptying During and After COLOKIT® Intake
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      Ultra-sound study to assess changes in intragastric volume after bowel preparation.
    


Intervention name(s): Sodium phosphate
Intervention type(s): Drug
Intervention description(s): 32 tablets
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Condition: Recurrent Malignant Pleural Effusion.
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to analyze and compare radiological lung expansion after talc
      pleurodesis performed either by videothoracoscopy or chest tube and correlate it with
      clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of
      life and survival.
    

Detailed description: 
      Talc pleurodesis is the most popular method to control symptoms of recurrent malignant
      pleural effusion. The intrapleural talc delivery may be by videothoracoscopy and talc
      poudrage or talc slurry thought a chest tube and the best method is still controversial.
      Although the lung expansion is a key criteria for success of the procedure, its
      characteristics are poorly studied.

      Patients were enrolled into two groups: videothoracoscopic talc poudrage (VT) and talc slurry
      through a chest tube (DT). Lung expansion was evaluated through chest CT scans obtained
      obtained in the first 7 days and 1, 3 and 6 months after pleurodesis. All examinations were
      revised by two independent observers. Clinical efficacy (considered as lack of new procedures
      during follow up), complications, drainage duration, hospital stay and quality of life
      (general and specific questionnaires) were also analyzed.
    

Intervention name(s): Videothoracoscopic talc poudrage (VT).; Talc slurry through a chest tube (DT).
Intervention type(s): Procedure; Procedure
Intervention description(s): Videothoracoscopic talc poudrage; Talc slurry through a chest tube
Other intervention name(s): Videothoracoscopic talc poudrage; Talc slurry through a chest tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pleural Effusion.; Talc.; Pleurodesis.; Quality of Life.; Thoracoscopy.
Prepulse Inhibition of Startle in Cocaine Dependence - 7
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Cocaine-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of chronic cocaine use on the acoustic
      startle response and on gating of this response in humans.
    

Detailed description: 
      The objective of this study is to assess the effects of chronic cocaine use on the acoustic
      startle response and on gating of this response in humans.
    

Intervention name(s): Amantadine
Intervention type(s): Drug
Intervention MeSH terms: Amantadine
Masking: Double
Primary purpose: Diagnostic
Keywords: cocaine dependence
SBRT in 4 Fractions for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is
      to study early and late side effects of hypofractionated accelerated RT for prostate cancer
      with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered
      in 5 alternative days.
    


Intervention name(s): SBRT
Intervention type(s): Other
Intervention description(s): hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment