louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01311050: A Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
Official title: A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 46
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic Colorectal Cancer

Brief summary: A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

Detailed description: A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed Metastatic Colorectal Cancer

Exclusion Criteria:

* Patients with diagnosis other than Metastatic Colorectal Cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: Shouki Bazarbashi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elshenawy MA, Badran A, Aljubran A, Alzahrani A, Rauf MS, Eldali A, Bazarbashi S. Survival benefit of surgical resection after first-line triplet chemotherapy and bevacizumab in patients with initially unresectable metastatic colorectal cancer. World J Surg Oncol. 2020 Jul 8;18(1):163. doi: 10.1186/s12957-020-01930-8.
citation: Bazarbashi S, Aljubran A, Alzahrani A, Mohieldin A, Soudy H, Shoukri M. Phase I/II trial of capecitabine, oxaliplatin, and irinotecan in combination with bevacizumab in first line treatment of metastatic colorectal cancer. Cancer Med. 2015 Oct;4(10):1505-13. doi: 10.1002/cam4.497. Epub 2015 Jul 24.
Clinical trial NCT00997750: Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome
Official title: Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: ACS
Acute Coronary Syndrome
NSAID
Lornoxicam
Xefocam
Lead sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Sponsor class: OTHER_GOV
First posted: 2009-10-19
Enrollment: 85
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: The purpose of this study is to determine whether nonsteroidal antiinflammatory drug lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients with Acute Coronary Syndrome without persistent ST-segment elevation.

Detailed description: Nonsteroidal Antiinflammatory drugs (NSAIDs) are the most frequently prescribed drugs in the world. There are a lot of controversial information published during recent years about NSAID cardiosafety. It is still unclear do NSAIDs develop cardioprotective or cardiotoxic effects in acute and chronic heart disease patients. Aim of the study was to investigate safety and efficacy of Lornoxicam, nonselective COX-inhibitor, in patients with acute coronary syndrome without ST-segment elevation (NSTEACS) and to evaluate the influence of Lornoxicam on C-reactive protein (CRP) and IL-6, IL-10 levels.

Eligibility criteria: Inclusion Criteria:

1. Unstable angina verified during first 48 hours after admitting to the hospital or
2. Acute Miocardial infarction without St-segment elevation verified during first 48 hours after admitting to the hospital

Exclusion Criteria:

1. High risk of bleeding of any location
2. Any kind of acute and active inflammatory process (excluding acute coronary syndrome)
3. Aspirin or NSAID Intolerability
4. No informed consent
5. Acute peptic stomach or duodenum ulcer
6. Acute or chronic renal failure (serum creatinin \>300 mmol/l)
7. Acute cerebrovascular bleeding

Primary outcomes:
measure: All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)
timeFrame: six months
Secondary outcomes:
measure: Noncardiovascular death, Gastrointestinal bleeding
timeFrame: six months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Presidential Department Of Russian Federation
Study officials:
affiliation: Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation
name: Alexei K Gruzdev, Prof
role: STUDY_CHAIR
References:
citation: Lomakin N.V., Gruzdev A.K. Cardiovascular risks of cyclooxygenase inhibitors (data review). Kardiol serdecno-sosud hir #1:28-36, 2009 (http://www.mediasphera.ru/journals/cardsurg/530/eng/8095/)
Clinical trial NCT05831150: Discovering Patterns in Experiences of Patients in Esophageal Cancer Clinical Research
Official title: Investigating Factors Affecting Clinical Trial Participation Rates in Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Cancer
Keywords: esophageal cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are actively considering involvement in an observational esophageal cancer clinical trial, but have not yet completed enrollment and registration.

Brief summary: Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.

This study will investigate the safety and efficacy of esophageal cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future esophageal cancer research.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of esophageal cancer
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Inability to perform regular electronic reporting

Primary outcomes:
measure: Rate of patients who decide to enroll in a clinical research.
timeFrame: 3 months
measure: Number of study participants who remain in clinical research until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Kim HJ, Bains MS. Randomized clinical trials in esophageal cancer. Surg Oncol Clin N Am. 2002 Jan;11(1):89-109, viii. doi: 10.1016/s1055-3207(03)00076-0.
citation: Harada K, Rogers JE, Iwatsuki M, Yamashita K, Baba H, Ajani JA. Recent advances in treating oesophageal cancer. F1000Res. 2020 Oct 1;9:F1000 Faculty Rev-1189. doi: 10.12688/f1000research.22926.1. eCollection 2020.
citation: Zhou N, Hofstetter WL. Prognostic and therapeutic molecular markers in the clinical management of esophageal cancer. Expert Rev Mol Diagn. 2020 Apr;20(4):401-411. doi: 10.1080/14737159.2020.1731307. Epub 2020 Feb 24.
Clinical trial NCT04468750: Kinesiotaping Effect Glenohumeral Shoulder Subluxation
Official title: The Effect of Kinesiotaping on Glenohumeral Shoulder Subluxation in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Subluxation, Glenohumeral
Lead sponsor: Ankara Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
First posted: 2020-07-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a quasi-experimental, single-subject AB design.
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily life activities in Turkish hemiplegic patients.


Eligibility criteria: Inclusion Criteria:

* (1) 18 to 90 years of age, (2) stroke onset within one year, (3) shoulder subluxation in the involved upper extremity and (4) being oriented and cooperative.

Exclusion Criteria:

* (1) global aphasia, (2) malignancy, (3) previous shoulder pain or surgery, (4) other neuromuscular disorders and (5) severe cardiopulmonary disease that affects daily life activities.

Primary outcomes:
measure: Subluxation degree by physical examination
timeFrame: 0-3weeks
measure: Subluxation degree by radiograph
timeFrame: 0-3weeks
measure: physical examination
timeFrame: 0-3weeks
Secondary outcomes:
measure: Evaluation of the pain of the shoulder
timeFrame: 0-3weeks
measure: Evaluation of Daily life activities
timeFrame: 0-3weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Physical Medicine and Rehabilitation Education and Research Hospital
name: Halil Ucan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06693050: AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study
Official title: AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diagnostic Test
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.

Brief summary: The purpose of this study is to verify performance claims for method comparison for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer in whole blood (WB) and plasma (PL).


Eligibility criteria: Inclusion Criteria:

* Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
* Subjects must be 18 years of age or older.
* Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.

Exclusion Criteria:

* Subjects known to be pregnant or breast-feeding.
* Subjects previously enrolled in the study.
* Subject, who has withdrawn consent.

Primary outcomes:
measure: Slope, R
timeFrame: 5 month
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospiltal Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Ùbeda
country: Spain
facility: Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz
Study officials:
References:
Clinical trial NCT06764550: Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease
Official title: Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease - Caratterizzazione Dei Meccanismi Molecolari e Del Microbiota Nella Malattia Diverticolare Del Colon
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diverticular Disease of Colon
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were recruited from the endoscopy room.

Brief summary: The pathogenesis of diverticular disease is likely multifactorial in origin. This project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

Detailed description: The pathogenesis of diverticular disease is likely multifactorial in origin. Some studies have demonstrated the role of genetic factors, while others have highlighted the role of environmental factors. The present project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 years.
* Belonging to one of the following groups:

  1. Patients with diverticula of the colon without symptoms.
  2. Patients symptomatic for diverticular disease.
  3. Subjects undergoing colonoscopy for colorectal cancer prevention or follow-up of previous polypectomies, asymptomatic for digestive symptoms.
* Obtaining informed consent.

Exclusion Criteria:

* Acute complicated diverticulitis (bleeding, perforation)
* Previous colon surgery
* Antibiotics or laxatives within the past 90 days
* Pregnancy and/or lactation
* Systemic and psychiatric disorders
* Asthma, food allergies and other allergic-type disorders
* Possible diseases leading to intestinal bacterial contamination (diabetes, blind loop syndrome, rheumatologic diseases).

Primary outcomes:
measure: Assess the interaction between host factors and gut microbiota
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria Raffaella Barbaro, Biologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357550: Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
Official title: Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketone Body Metabolism
Brain Metabolism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion.

Hypotheses

1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.
2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.
3. Altered oxygen consumption during hyperketonemia in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI 20-30 kg/m2

Exclusion Criteria:

* smoking
* alcohol abuse
* severe comorbidity
* blood donation 6 month prior
* claustrophobia

Primary outcomes:
measure: Glucose metabolism in brain, CMR
timeFrame: t=240-360 minutes
Secondary outcomes:
measure: Stress metabolism
timeFrame: 0-360 minutes
measure: Oxygen use
timeFrame: T=150-200 minutes
measure: cerebral blood flow
timeFrame: t=180-250 minutes
measure: Intramuscular signaling
timeFrame: t= 260 minutes
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University / Aarhus University Hospital
name: Mads Svart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauritzen ES, Svart MV, Voss T, Moller N, Bjerre M. Impact of Acutely Increased Endogenous- and Exogenous Ketone Bodies on FGF21 Levels in Humans. Endocr Res. 2021 Feb;46(1):20-27. doi: 10.1080/07435800.2020.1831015. Epub 2020 Oct 19.
citation: Lauritsen KM, Sondergaard E, Svart M, Moller N, Gormsen LC. Ketone Body Infusion Increases Circulating Erythropoietin and Bone Marrow Glucose Uptake. Diabetes Care. 2018 Dec;41(12):e152-e154. doi: 10.2337/dc18-1421. Epub 2018 Oct 16. No abstract available.
Clinical trial NCT00352950: Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer
Official title: An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Oncology
Non-Small Cell Lung Cancer
Keywords: NSCLC, Lung cancer
Panitumumab
Sirolimus
mTOR
Monoclonal antibody
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC


Eligibility criteria: Inclusion Criteria:

* Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer
* Received only one prior treatment (not including radiation)
* Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines
* Life expectancy of ≥ 4 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal and hepatic function
* Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN Exclusion Criteria:
* Brain metastases requiring treatment
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
* Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
* Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EGFr tyrosine kinase inhibitors
* Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
* Prior therapy with sirolimus, sirolimus analogs
* Immunosuppressive agents within 28 days before enrollment

Primary outcomes:
measure: safety within the first 3 weeks
Secondary outcomes:
measure: pharmacodynamic analysis of mTOR
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03392350: Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
Official title: Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Behavior and Behavior Mechanisms
Hypertension
Hypercholesterolemia
Lead sponsor: Reengineering Healthcare Inc.
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 267
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One Control group one Intervention arm. The intervention group are the only subjects receiving a body scan consultation and behavioral intervention.
Primary purpose: PREVENTION

Brief summary: We evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to beneficial lifestyle behaviors, as well as possibly reduced risk of disease.

Detailed description: We initially enrolled 267 volunteer asymptomatic adults consisting of firefighters/police workers (n= 173), active military personnel (n= 57) and community college staff (n= 37). Subjects were randomized either to an intervention group or to usual care. The intervention group received The RENEW™ Program (www.therenewprogram.net) of lifestyle intervention as described below. A whole body CT scan was performed using a multidetector CT scan on all participants at baseline with the results discussed by a physician only in the intervention group, and after 2 years of follow-up a repeat scan was performed with a detailed evaluation of the results discussed by a physician with all participants (in part as a motivation to complete thestudy). This study was carried out in accordance with the recommendations of the Western Institutional Review Board with written informed consent from all subjects. All subjects gavewritten informed consent in accordance with the Declaration of Helsinki. The protocol wasapproved by the Western Institutional Review Board.

Eligibility criteria: Inclusion Criteria:

Men or women aged 35 and over who provide informed consent to participate including the baseline, interim, and follow-up clinic visits, as well as willingness to participate in the on-line intervention (if selected to be in that group) -

Exclusion Criteria:

Known cardiovascular disease, cancer, or any life-threatening or debilitating illness, including psychiatric illnesses, or significant difficulty with the English language that would preclude successful participation in the program

-

Primary outcomes:
measure: Progression of Coronary Artery Calcium
timeFrame: 2 years
Secondary outcomes:
measure: Epicardial and Thoracic fat volume (in cm3)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: