louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02000531: Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population
Official title: Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small-cell lung cancer (NSCLC)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).


Eligibility criteria: Inclusion Criteria:

* Participant in ENSURE trial
* Disease progression during first-line treatment

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
timeFrame: within 3 years, 9 months (data cut-off December 2014)
Secondary outcomes:
measure: Participants With Adverse Events
timeFrame: start of second-line treatment to data cut-off in December 2014 (within 12 months)
Other outcomes:
Locations:
city: Beijing
country: China
city: Changchun
country: China
city: Chongqing
country: China
city: ChongQing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shantou
country: China
city: Wuhan
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02261831: Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood
Official title: Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bacterial
gut
type 2 diabetes.
16S rDNA gene
intestinal crypt
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 99
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.

Detailed description: Experimental evidence suggests that bacterial translocation from gut to tissue could be an initial step leading to diabetes. To test this hypothesis, a bacterial component that is highly conserved between different species of bacteria, the 16S rDNA gene will be analysed both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and control.

Eligibility criteria: Inclusion Criteria:

* Between 35 and 75 years old
* Colonoscopy and biopsies required

Diabetes population:

* Type 2 diabetes

Obese population:

* Android obesity

Exclusion Criteria:

* Inflammatory bowel disease
* Colonic cancer
* Bariatric surgery
* Previous administration of antibiotic (within 15 days)
* Pregnancy

Primary outcomes:
measure: rDNA comparison between cases and controls
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: CHU Toulouse
name: Jacques AMAR, MD PhD
role: STUDY_DIRECTOR
affiliation: CHU Toulouse
name: Jacques Moreau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670331: Psychological Preparation Prior to Bariatric Surgery
Official title: Psychological Preparation Prior to Bariatric Surgery: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Psychological Disorders
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Is it feasible to perform a randomized controlled trial to assess whether or not psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial to the investigators patients?

Detailed description: This is a feasibility study, assessing how possible it would be to perform a randomized controlled trial to see if preoperative psychological or mental health problems impacts on length of stay, short and long term health outcomes, weight loss, and if preoperative counseling has any effect.

Eligibility criteria: Inclusion Criteria:

* New referrals to the Sheffield Teaching Hospital Bariatric service

Exclusion Criteria:

* Non-English speakers
* Patients that are not fit for bariatric surgery
* Patients that have already seen the bariatric psychologist

Primary outcomes:
measure: Are there increased scores in the BAROS psychometric tests in patients that undergo psychological preparation prior to bariatric surgery, than in those that do not at 12 months?
timeFrame: 12 months
Secondary outcomes:
measure: Are there increased scores in the PHQ-9 psychometric tests in patients that undergo psychological preparation prior to bariatric surgery, than in those that do not at 12 months?
timeFrame: 12 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Corinne E Owers, MB/ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Adam Saradjian, DClinPsy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04877431: A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease
Official title: Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Teduglutide (Revestive®) in Adult and Pediatric Patients With Short Bowel Syndrome in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult and pediatric participants who are treated with teduglutide according to approved indications.

Brief summary: The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).

This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant's medical records will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.


Eligibility criteria: Inclusion Criteria:

* Adult participants (greater than or equal to \[\>=\] 18 years) or pediatric (\>= 1 year and less than \[\<\] 18) with a diagnosis of SBS who are dependent on parenteral support.
* Have received at least one dose of teduglutide according to approved indications.
* Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria:

- Not Applicable.

Primary outcomes:
measure: Number of Participants With Adverse Events of Special Interest (AESI)
timeFrame: Up to 24 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at Week 12 and 24
timeFrame: Week 12 and 24
measure: Change From Baseline in Weekly Parenteral Support Volume at Week 12 and 24
timeFrame: Baseline, Week 12 and 24
measure: Change From Baseline in Number of Days per Week of Parenteral Support at Week 12 and 24
timeFrame: Baseline, Week 12 and 24
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: IC Projects
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01289431: Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis
Official title: Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Conjunctivitis, Allergic
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 236
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.


Eligibility criteria: Inclusion Criteria:

* positive history of ocular allergies and a positive skin test reaction
* positive bilateral CAC reaction

Exclusion Criteria:

* have known contraindications or sensitivities to the use of any of the study medications(s) or their components.
* have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.
* had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;
* a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
* the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.
* use of any disallowed medications during the period indicated prior to Visit 1 and during the study.
* have planned surgery during the trial period or within 30 days after.
* have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1

Primary outcomes:
measure: Ocular Itching
timeFrame: 8 hours
measure: Conjunctival Redness
timeFrame: 8 hours
Secondary outcomes:
measure: Ciliary Redness
timeFrame: 8 hours
measure: Episcleral Redness
timeFrame: 8 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Rabia Ozden, OD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02524431: The Changes Within the Cells of the Drainage System of the Eye in Patients With Glaucoma
Official title: The Changes of Mitochondrial Dynamics and the Molecular Mechanisms in the Trabecular Meshwork of Patients With Glaucoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glaucoma
Keywords: Mitochondria
trabeculectomy
trabecular meshwork
Glaucoma surgery
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2015-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to try to identify the cause of damage to the drainage system of the eye (the trabecular meshwork). Damage to this system may cause elevation in the pressure within the eye and thereby damage to the optic nerve and the vision.

Detailed description: During a routine trabeculectomy surgery, a corneo-scleral block that includes TM tissue will be collected at the operating room. This tissue is routinely removed during every trabeculectomy surgery. The tissue will be stored immediately in normal saline at 4 degrees Celsius, and walked directly to the Jefferson Center for Translational Medicine at Thomas Jefferson University by the Wills eye glaucoma research fellow. TM tissue will be identified using light microscope base on TM cell pigmentation. The ocular tissue will be fixed and placed in pre-cooled fixative on ice for 1 hour. The lengths of mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.

Eligibility criteria: Inclusion Criteria:

* Minimum 2-year diagnosis of POAG
* Moderate to advanced stage of the disease
* DDLS stages 5 through 10 with visual field loss
* Age between 21 and 80 years
* Planned trabeculectomy with or without concomitant cataract surgery

Exclusion Criteria:

* Age ≤ 20 years old
* Any other type of glaucoma other than POAG
* Patients who had undergone selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)
* Patients with history of ocular trauma
* Patients with previous eye surgery will be excluded both from the study and the control groups

Primary outcomes:
measure: 3-D EM tomography for mitochondria obtained from sample tissue
timeFrame: 1 year
Secondary outcomes:
measure: Gene expression of Drp1
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: George Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00293631: Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy
Official title: A Randomized, Parallel-Group, Double-Blind, Single-Dose Study Evaluating the Efficacy and Safety of Intravenous Lornoxicam (8 mg and 16 mg) Compared to Intravenous Placebo and Ketorolac 30 mg in Management of Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bunionectomy
Orthopedic Surgery
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.


Eligibility criteria: Inclusion Criteria:

* Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic.
* Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications.
* Subjects are in generally good health with no uncontrolled chronic illnesses or diseases.

Exclusion Criteria:

* Subjects who are pregnant.
* Subjects who have significant obesity.
* Subjects with medically significant heart, liver, kidney, lung or endocrine disease.
* Subjects with active viral disease, i.e. hepatitis, HIV.

Primary outcomes:
measure: The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy)
measure: To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.
Secondary outcomes:
measure: To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
Study officials:
affiliation: Advanced Clinical Research Institute
name: Michael P. DeMicco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01448031: A Healthy Female and Male Volunteers Aspirin Study
Official title: A Phase I, Open-label, Randomized, Two Way Crossover Pharmacokinetic Study Comparing the Bioavailability of Acetylsalicylic Acid (ASA) After 5 Days Repeated Once Daily Administration of a Fixed Dose Combination Capsule of ASA 81 mg/Esomeprazole 20 mg and ASA 80 mg (European Aspirin Reference Product)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Acetyl Salicylic Acid
Bioavailability
Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.

Detailed description: A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product).

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 20 to 50 years inclusive.
* Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive.
* Females must be of non-childbearing potential or be of childbearing potential but have a negative serum hCG pregnancy test during screening and on admission.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator.
* History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.

Primary outcomes:
measure: pharmacokinetic profile of acetylsalicylic acid (ASA) and salicylic acid (SA) in terms of area under curve (AUC), maximum concentration at steady state (Css,max), time to reach maximum concentration (tmax) and terminal half- time (t1/2).
timeFrame: Day 5
Secondary outcomes:
measure: Description of the safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, safety labs
timeFrame: Pre-dose up to 7 day after last dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
state: UK
Study officials:
affiliation: BioKinetic Europe Ltd,14 Great Victoria Street,Belfast, N.Ireland,United Kingdom BT2 7BA
name: Ronnie Beboso
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Pepparedsleden 1 431 83 Molndal Sweden
name: Tore Lind
role: STUDY_DIRECTOR
References:
Clinical trial NCT03114631: Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
Official title: Single-center Trial Evaluating the Safety and Efficacy of MUC-1/WT-1 Peptide or Tumor Lysate-pulsed Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dendritic Cells
Pancreatic Neoplasms
Keywords: dendritic cells, pancreatic cancer, immunotherapy
Lead sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
Sponsor class: OTHER
Collaborators: name: Belarusian State Medical University
First posted: 2017-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer

Detailed description: The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.

Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.

The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).

Eligibility criteria: Inclusion Criteria:

* histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
* HLA-A2 expression by tumor cells;
* WT-1/MUC-1 expression by tumor cells.

Exclusion Criteria:

* refuse of patient to participate in the trial;
* pregnancy/lactation;
* intercurrent severe chronic diseases;
* HIV, Hepatites B/C;
* active tuberculosis;
* alcohol use disorder/drug addiction.

Primary outcomes:
measure: Number of Participants with PR or CR at 1 year
timeFrame: 1 year
measure: Number of Participants Who Survived at 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Antigen-specific immune response
timeFrame: 1 year
measure: Circulating tumor cells count
timeFrame: 1 year
measure: Immune response
timeFrame: 1 year
measure: Number of Participants Who Survived at 2 Years
timeFrame: 2 years
measure: Number of Participants Who Survived at 3 Years or more
timeFrame: 3 years
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Minsk City Clinical Oncologic Dispensary
Study officials:
affiliation: Belarussian State Medical University, Minsk, Belarus
name: Alexander V. Prokharau, Prof.
role: STUDY_DIRECTOR
affiliation: The Republican Research and Practical Center for Epidemiology and Microbiology
name: Andrei Y Hancharou, Dr.
role: STUDY_DIRECTOR
References: