louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02176109: Metabolism Des LAM
Official title: Rôle Pronostique Des métabolismes du Stress Oxydatif et du Fer Dans Les Leucémies Aiguës Myéloblastiques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron
Acute Myeloid Leukemia
Diagnosis
Oxydative Stress
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: de novo acute myeloid leukemic patient from 18 years to 99 years. promyelocytic leukemia excluded

Brief summary: In this study, the investigators study the prognostic role of oxidative stress metabolism and iron in Acute myeloid leukemia.

Detailed description: Primary goal of this study is to Evaluate the characteristics of regulatory networks of iron and redox balance in leukemic cells, to study the correlations between the prognosis of AML patients (in terms of response to induction chemotherapy and survival i) and metabolism of these markers. Secondary ones areto assess the impact of induction therapy on markers of oxidative stress and to correlate biological iron and redox metabolism with the molecular status of patients (eg Flt3/IDH/CEBPA/NPM...).

Eligibility criteria are patients at diagnostic of de novo acute myeloid leukemia (promyelocytic excluded) aged from 18 to 100 years.

Eligibility criteria: Inclusion Criteria:

de novo acute myeloid leukemic patient from 18 years to 99 years at diagnosis

Exclusion Criteria:

age under 18 years promelocytic leukemia secondary leukemia

Primary outcomes:
measure: overall survival Event-free survival Response to induction chemotherapy, overalll survival, event-free survival
timeFrame: five years after the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
state: Isere
Study officials:
References:
Clinical trial NCT01260909: Real-Time MV/kV Image Guided Radiation Therapy
Official title: Real-Time MV/kV Image Guided Radiation Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2010-12-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prostate cancer patients at Stanford University

Brief summary: In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. A tumor target may change its position during the dose delivery process. The goal of this project is develop a real-time imaging strategy to monitor the tumor position during dose delivery and evaluate its potential clinical impact.


Eligibility criteria: Inclusion Criteria:

* The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.

Exclusion Criteria:

* The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.

Primary outcomes:
measure: To verify improved tumor targeting accuracy using IMRT (intensity modulated radiation therapy) and VMAT (volumetric modulated radiation therapy)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Lei Xing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04013009: Laparotomy Closure Techniques: do Surgeons Follow the Latest Guidelines? Results of a Questionnaire.
Official title: Laparotomy Closure Techniques: do Surgeons Follow the Latest Guidelines? Results of a Questionnaire.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Laparotomy Closure Technique
Keywords: incisional hernia
prevention
laparotomy closure
quality improvement
survey
guideline
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2019-07-09
Enrollment: 402
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgeons in the Netherlands

Brief summary: Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.

Detailed description: Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.

All members of the Dutch Surgical Society were invited to participate in a 24-question online survey on techniques and materials used for abdominal wall closure after midline laparotomy. Subgroup analysis based on surgical subspecialty, hospital and experience was performed.

Eligibility criteria: Inclusion Criteria:

* surgeon in the Netherlands

Exclusion Criteria:

* not practicing surgery
* not practicing in the Netherlands

Primary outcomes:
measure: opinions on and current technique used for laparotomy closure
timeFrame: July till August 2016 at survey completion; snapshot measurement
measure: knowledge of incisional hernia development
timeFrame: July till August 2016 at survey completion; ; snapshot measurement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VieCuri Medical Centre
name: Arthur Bloemen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00038909: Study Evaluating ReFacto in Hemophilia A
Official title: Factor VIII Mutation Testing Program in Previously Untreated Patients (PUPs) With Hemophilia A Participating in ReFacto® Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-07
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To identify the causative mutations in previously untreated patients with hemophilia A enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using two established hemophilia mutation testing laboratories (one in Europe and one in North America).


Eligibility criteria: Inclusion Criteria:

* Patients who were or are enrolled in Study CTN 93-R833-0XX/C9741-28, and have been treated with ReFacto® during this study are eligible for participation.
* The patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed.
* A blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories.

Exclusion Criteria:

* Any condition which, in the investigator's opinion, places the patient at undue risk.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02525809: Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.

The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).

This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.

Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.


Eligibility criteria: Inclusion Criteria:

* patients older men or women 60-75 years
* with a primary or secondary osteoarthritis or osteonecrosis
* having a functional disorder requiring the installation of a total hip prosthesis of primary

Exclusion Criteria:

* patients aged 76 years or more
* protected adults
* resumption of PTH
* cephalic prosthesis recovery or intermediate
* resumption of cupules
* primary or secondary malignant tumor of the hip

Primary outcomes:
measure: Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)
timeFrame: change over baseline and 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05751109: Comparison of IPACK and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty
Official title: Comparison of Infiltration Between the Popliteal Artery and the Capsule of the Knee (IPACK) Block and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 people

Brief summary: To compare the efficacy and complications of IPACK and adductor canal block combination and epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia.

Detailed description: Between 15.08.2022 and 15.04.2023, the patients who will be operated on for knee surgery under spinal anesthesia, older than 18 years of age were included in the study. Demographic characteristics of the patients, comorbidities, ASA scores, mobilization time, amount of postoperative analgesic use, and postoperative pain scores of the 1. 8. 24. hours will be observed. The vas score at the 3rd month was learned over the phone.

Eligibility criteria: Inclusion Criteria:

* Those who consented to participate in the study
* Patients over the age of 18 who will be operated on due to knee pathology
* Patients to be operated under spinal anesthesia
* Disease that will limit cooperation

Exclusion Criteria:

* Patients under the age of 18
* Patients to be operated under general anesthesia
* Disease that will cause limited cooperation

Primary outcomes:
measure: Visual Analogue Scale (VAS) evaluation for postoperative pain
timeFrame: 8. Hour
Secondary outcomes:
measure: Visual Analogue Scale (VAS) evaluation for postoperative pain
timeFrame: 1. Hour
measure: Visual Analogue Scale (VAS) evaluation for postoperative pain
timeFrame: 24. Hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Onur Karaoglu
state: Kağıthane
city: İstanbul
country: Turkey
facility: Rasim Onur Karaoglu
state: Kağıthane
Study officials:
References:
Clinical trial NCT03499509: Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
Official title: Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-04-17
Enrollment: 67
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Scientific Premise of this study is that the high level of obesity displayed by African American (AA) women is due to the ability to secrete large amounts of insulin when sugary foods are consumed. When AA women eat a diet rich in starchy or sugary food (a "high-glycemic" diet that stimulates insulin secretion), the food that is eaten is stored as fat rather than being burned as fuel. The investigators previous research has suggested that AA women have an easier time losing weight and keeping it off when eating a low-glycemic diet. The proposed study will be the first randomized clinical trial to test the effect of high and low glycemic diets for weight loss and weight-loss-maintenance in obese AA women.


Eligibility criteria: Inclusion Criteria:

* BMI 30-45 kg/m2
* Sedentary to moderately active (\<2 hours/wk of moderate, structured, intentional exercise.
* Normal menstrual cycle

Exclusion Criteria:

* History of eating disorder
* daily use of tobacco (\>1 pack/wk)
* change in weight greater than 5 pounds in previous 3 months
* presence of any condition (e.g. PCOS) or use of any medication (e.g. glucocorticoid) deemed by the project physician to interfere with study outcomes
* applicants will be screened with a standard oral glucose tolerance test. If a participant's 2 hour glucose if \>200, they will not be able to enroll in the study.

Primary outcomes:
measure: Total Energy Expenditure
timeFrame: Baseline, Week 13
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Barbara Gower, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03948009: TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation
Official title: TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: First or Second Uretral Stenosis
Diagnosed With Uretral Fibroscopy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men between 18 and 80 First or second uretral stenosis, diagnosed with uretral fibroscopy

Not multiple, strength or long stenosis No previous surgery of the urethra

Brief summary: Urethral stenosis has a recurrent character. The clean intermittent self-catheterization can be proposed for repeat stenosis. This study seeks to explore the tolerance of clean intermittent self-catheterization in the evolution of urethral stenosis after urethrotomy.


Eligibility criteria: Inclusion criteria:

* Men between 18 and 80
* First or second uretral stenosis, diagnosed with uretral fibroscopy

Exclusion criteria:

* Not multiple, strength or long stenosis
* No previous surgery of the urethra
* Refusal to participate to the study
* Inability to perform self-catheterization

Primary outcomes:
measure: Number of patient which continue clean intermittent self-catheterization.
timeFrame: 18 months
Secondary outcomes:
measure: Comparaison of uroflowmetry
timeFrame: 18 months
measure: Comparaison of Urinary Score Profile (USP)
timeFrame: 18 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Thibault TRICARD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06793709: A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy
Official title: Post-marketing Observational Study of Tasfygo Tablet 35 mg to Evaluate the Safety of Tasfygo in Patients With Unresectable Biliary Tract Cancer With FGFR2 Fusion Gene Positivity Who Progressed After Chemotherapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Biliary Tract Cancer
Keywords: Tasfygo
FGFR2 fusion
Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with FGFR2 fusion positive unresectable biliary tract cancer with prior chemotherapy who will receive Tasfygo tablet as per daily practice and package insert will be enrolled.

Brief summary: The primary purpose of this study is to investigate the safety of Tasfygo.


Eligibility criteria: Inclusion Criteria:

1. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.

Exclusion Criteria:

Not applicable.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: Up to 1 year
Secondary outcomes:
measure: Percentage of Participants With Best Overall Response (BOR) Based on Physician's Assessment
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05173207: Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients
Official title: A Preliminary Investigation of Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Diseases
Cardiovascular Diseases
Keywords: Dysphagia
Extubation
Respiratory-swallow coordination
Swallow
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 individuals undergoing cardiothoracic surgery will be enrolled in this study.

Brief summary: Dysphagia (swallowing impairment) is a common complication of cardiothoracic surgery (CS). Although alterations in respiratory-swallow coordination is a known underlying pathophysiologic mechanism of dysphagia in multiple patient populations, no group has examined respiratory-swallow physiology in CS patients. The proposed study will examine respiratory-swallow physiology in CS patients and determine its association with unsafe swallowing and inferior health-related outcomes.

Detailed description: The proposed study will examine respiratory-swallow physiology in cardiothoracic surgical patients and determine its association with unsafe swallowing and inferior health-related outcomes. Participation will involve a single postoperative research exam of approximately 60-90 minute duration. Participants will be seated upright and positioned for simultaneous instrumental imaging of swallow physiology, nasal airflow monitoring, and respiratory inductance plethysmography testing.

Eligibility criteria: Inclusion criteria:

* Adults over 18 years of age who have undergone cardiothoracic surgery at UF Health
* No allergies to barium
* Not pregnant
* Willing to participate in study

Exclusion criteria:

* Individuals 18 years of age or younger
* Allergies to barium
* Pregnant
* Not willing to participate in study

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily K Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References: