louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04791098: Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital
Official title: Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplantation
Keywords: Immunization Coverage
Transplant Recipient
Transplantation, Kidney
Infectious Disease Medicine
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.

Detailed description: The main objective of this study is to impove vaccine coverage before kidney transplantation.

Enrollment was based on the waiting list for a kidney transplant. Patients newly listed are invited to participate by the transplant team (nephrology department) ; for those that are already registered, a notification letter is sent to their home.

All patients included must :

* complete a health questionnaire
* take a blood test at day 0 : viral, bacterial and parasitic serologies, QuantiFERON-TB
* take a chest X-ray and dental panoramic Patients randomized in interventional group will be seen in specific infectious diseases consultation at Clermont Ferrand Hospital. A letter of recommendations is sent to nephrologist for patients randomized in group control.

The primary study endpoint (immunization coverage) is evaluated at 6 months.

Eligibility criteria: Inclusion Criteria:

* Patient over 18
* On the waiting list for kidney transplantation at Clermont-Ferrand
* Free and informed consent
* Affiliation to a social security system

Exclusion Criteria:

* Patient under 18
* Protected adults (individuals under guardianship by court order
* Pregnant and nursing women
* Prior graft (solid organs or hematopoietic stem cells)
* Absence of consent

Primary outcomes:
measure: Vaccination coverage
timeFrame: Month 6
Secondary outcomes:
measure: Infectious complications
timeFrame: within the 6 months of the transplantation
measure: Mortality
timeFrame: Month 6
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Olivier Lesens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277198: Role of Flexible Cystoscopy in Laparoscopic Stone Surgery
Official title: The Role of Flexible Cystoscopy in Laparoscopic Stone Surgery: a Single Surgeon Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Calculi; Ureteral Calculi
Keywords: kidney calculi
ureteral calculi
cystoscopes
laparoscopes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 71 patients with complex renal stones and large or impacted ureter stones. All the patients underwent laparoscopic pyelolithotomies with concomitant calyceal stone removal or ureterolithotomy using a flexible cystoscopy or not.

Brief summary: Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.

Detailed description: Previous trials to increase stone clearance rates have been recently reached using flexible equipment in laparoscopic surgery, however, it is not clear whether using flexible equipment is really helpful in performing pyelolithotomies and the clearance rates using flexible equipment varies 71% to 100%. Therefore, authors plan to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.

Eligibility criteria: Inclusion Criteria:

* patients with complex renal stones and large or impacted ureter stones
* patients who underwent laparoscopic pyelolithotomies with concomitant calyceal stone removal or ureterolithotomy using a flexible cystoscopy or not

Exclusion Criteria:

* active infection, uncontrolled bleeding tendency, previous abdominal surgery

Primary outcomes:
measure: the presence of residual stones
timeFrame: intravenous pyelogram at 12 weeks postoperatively
Secondary outcomes:
measure: stone numbers and sizes, surgical approach, insertion of a DJ ureteral catheter, and use of a flexible cystoscopy, etc
timeFrame: Retrospective review of data
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sung Yong Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06897098: Regeneration of Knee and Ankle Cartilage From Autologous Cartilage Mini-grafts (From the Patient's Own Cells)
Official title: Autologous Cartilage Implantation: Safety Study for Focal Chondral Lesions in the Knee and the Ankle : Open Cohort, Small Sample Size With 12 Months Follow-Up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cartilage Repair
Keywords: Cartilage repair
Lead sponsor: Vanarix SA
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle.

Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). A small cartilage biopsy (\~50 to 150 mg according to lesion size to be treated) is collected from a minimal weight bearing zone of the patient's articulation. Chondrocytes are extracted from the biopsy and expanded in culture. Our patented, standardized methodology then allows expanded cells to recover their capacity of producing hyaline matrix and to form cartilage mini-grafts (Cartibeads). These grafts are beads of 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.

Autologous Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 12 months for assessment of study endpoints, with safety being the primary outcome.


Eligibility criteria: Key inclusion criteria:

* Cartilage focal lesion(s) ≥ 1.5 cm2 and ≤ 10 cm2
* ICRS grade 3 or 4
* Pain for 3 months or more
* Aged over 18 years

Key exclusion criteria

* Inability to undergo MRI
* Cartilage specific surgery within 12 months from baseline
* Cartilage therapeutic injection within 3 months from baseline
* Radiologically apparent degenerative joint disease (K\&L grade \>1)
* Chronic inflammatory arthritis and/or infectious arthritis

Primary outcomes:
measure: Safety
timeFrame: From enrolment to the end of follow-up at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ente Ospedaliero Cantonale (EOC)
state: Ticino
city: Geneva
country: Switzerland
facility: Center for Sports Medicine and Exercise, Hirslanden Clinique La Colline
city: Geneva
country: Switzerland
facility: Geneva University Hospitals (HUG)
Study officials:
References:
Clinical trial NCT04451798: Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic
Official title: JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Impella
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Jena University Hospital
First posted: 2020-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 91
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device


Eligibility criteria: Inclusion Criteria:

* Cardiogenic shock following acute MI or acute heart failure with

  * systolic BP \< 90 mm Hg over \> 30 min or inotropes for support of cardiac output and BP with
  * signs of left heart failure and pulmonary congestion
  * and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or serum lactate \>2 mmol/l

Exclusion Criteria:

Primary outcomes:
measure: Hemodynamic Parameters due to PA catheterisation
timeFrame: Day 1
measure: Echocardiographic Parameters of left and right heart function
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University of Jena
Study officials:
affiliation: Universityhospital Jena
name: Sven Möbius-Winkler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01005498: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Official title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes
Keywords: Low carbohydrate diet. Dietary treatment of diabetes mellitus.
Diabetes mellitus type 2 and dietary treatment.
Lead sponsor: Vårdcentralen Lyckorna
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus type 2

Exclusion Criteria:

* Severe psychiatric disease or difficulties in understanding Swedish language.

Primary outcomes:
measure: Laboratory findings and body composition
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Motala
country: Sweden
facility: Vårdcentralen Lyckorna
state: Östergötland
Study officials:
affiliation: Vårdcentralen Lyckorna
name: Hans G Guldbrand
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.
citation: Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
citation: Guldbrand H, Dizdar B, Bunjaku B, Lindstrom T, Bachrach-Lindstrom M, Fredrikson M, Ostgren CJ, Nystrom FH. In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss. Diabetologia. 2012 Aug;55(8):2118-27. doi: 10.1007/s00125-012-2567-4. Epub 2012 May 6.
Clinical trial NCT00043498: Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children
Official title: Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Development
Keywords: Pollutants
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-08-12
Enrollment: 727
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study enrolled 727 African American and Latino (Dominican) mothers and their children. The African American and Latino (Dominican) women were initially enrolled into the parent CCCEH study during pregnancy. Caucasian women are not included because a central purpose of the research is to evaluate health outcomes in a high risk, minority population.

Brief summary: A molecular epidemiologic study of African American and Hispanic mothers and newborns to investigate the role of common urban pollutants on procarcinogenic and developmental damage.

Detailed description: The major objective of the proposed research is to study the impact of early-life exposures to common urban pollutants on neurobehavioral development and asthma in a sample of children living in three low-income, minority communities of New York City (Central Harlem, Washington Heights and the South Bronx). Using a molecular epidemiologic approach with monitoring, biomarkers, and clinical assessments at serial time points, we will extend our study of African-American and Latina urban mothers and children in order to follow the cohort through child age 11 years to assess the longer-term impact of exposures on child health and developmental outcomes.

Eligibility criteria: Enrollment eligibility was restricted to nonsmoking pregnant women 18-35 years of age who self-identified as either African American or Dominican and who had resided in northern Manhattan or the South Bronx in New York City for at least 1 year before pregnancy. Women were excluded if they used illicit drugs, had diabetes, hypertension, or known HIV, or had their first prenatal visit after the 20th week of pregnancy.

Primary outcomes:
measure: Neurobehavioral development
timeFrame: 1 to 12 years
measure: Asthma
timeFrame: 2-12 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University, 722 W 168th St, 12th Floor
state: New York
Study officials:
affiliation: Columbia University
name: Frederica P Perera, DrPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Widen EM, Whyatt RM, Hoepner LA, Ramirez-Carvey J, Oberfield SE, Hassoun A, Perera FP, Gallagher D, Rundle AG. Excessive gestational weight gain is associated with long-term body fat and weight retention at 7 y postpartum in African American and Dominican mothers with underweight, normal, and overweight prepregnancy BMI. Am J Clin Nutr. 2015 Dec;102(6):1460-7. doi: 10.3945/ajcn.115.116939. Epub 2015 Oct 21.
Clinical trial NCT01650298: Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
Official title: Pilot Study: Tailored Anticoagulation for Noncontinuous AF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).


Eligibility criteria: Inclusion Criteria:

* Patient has a St Jude Medial device that is compatible with Merlin.net (remote monitoring)
* Patient has history of atrial fibrillation (non-continuous)
* Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation
* Patient is willing to complete a questionnaire

Exclusion Criteria:

* Patient is in atrial fibrillation all of the time
* Patient has a history of stroke or blood clot
* Patient is on warfarin or coumadin
* Patient cannot be taken off of his blood thinner medication due to another medical condition
* Patient is not capable of sending a remote device transmission to doctor once a week

Primary outcomes:
measure: Total Cumulative Days on Anticoagulation
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jeffrey Goodman, MD
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Research Institute
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Corvallis
country: United States
facility: Samaritan Heart and Vascular Institute
state: Oregon
city: Philadelphia
country: United States
facility: Jefferson Heart Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: San Antonio
country: United States
facility: STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio
state: Texas
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Peter Zimetbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410098: Bikram Yoga and Asthma
Official title: The Influence of Bikram Yoga (39 Degree Celsius Heat and 60% Humidity) on Basic Lung Function Tests,Bronchial Challenges and Pulmonary-Heart Endurance in Young Asthmatic Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthmatics
Keywords: asthma
yoga
heat
humidity
bikram
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cold and dry air induce exercise induced asthma. Yoga training may improve lung function tests. Bikram Yoga (heat 39 degree Celsius and humidity 60%)training may improve both lung function tests and bronchial hyperreactivity (to exercise and adenosine 5'monophosphate).

Detailed description: 15 young adults with exercise induced asthma and 10 healthy young adults will participate in 2 months taining of Bikram Yoga in Tel Aviv. They will perform sessions of 90 minutes training at least 5 times a week. Lung function tests, bronchial challenges (exercise and AMP) and progressive exercise test will be performed before and after the 2 month training at Hadassah University Hospital in Jerusalem in the asthmatic patients. Healthy adults will perform only lung function tsts and progressive exercise before and after training.

Eligibility criteria: Inclusion Criteria:

* controlled asthma
* age 18-30 years

Exclusion Criteria:

* heart,
* hypertension,
* kidney disease,
* chronic lung disease,
* oxygen dependence

Primary outcomes:
measure: prevent exercise induced asthma and improve lung function tests
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Avraham AVITAL, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02607098: Understanding Adaptive Challenges Associated With Male-factor Infertility
Official title: Understanding Adaptive Challenges Associated With Male-factor Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male-factor Infertility
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit a convenience sample of 10 men and their partners seeking consultation from a fertility urologist following the detection of male-factor infertility.

Brief summary: The purpose of this study is to understand the experience of men and their partners when diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills they use to adapt to this diagnosis.


Eligibility criteria: Inclusion criteria:

Men:

* in a partnered relationship with a female
* have been trying without success to conceive a pregnancy
* have been referred due to suspected or diagnosed male-factor infertility
* have the ability to read and write English

Female Partner:

* 18 to 40 years of age
* ability to read and write English

Exclusion criteria:

* living children, either biological or adoptive
* history of vasectomy

Primary outcomes:
measure: Feasibility, as measured by the percentage of eligible subjects agreed to participate
timeFrame: 6 months
measure: Feasibility, as measured by retention percentage
timeFrame: 6 months
Secondary outcomes:
measure: Change in level of global infertility stress, as measured by questionnaire
timeFrame: Baseline, 6 months
measure: Change in quality of life, as measured by questionnaire
timeFrame: Baseline, 6 months
measure: Change in level of global infertility stress, as measured by questionnaire
timeFrame: Pre and post significant event, up to 7 months
measure: Change in quality of life, as measured by questionnaire
timeFrame: Pre and post significant event, up to 7 months
measure: Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire
timeFrame: 3 months
measure: Concordance between men and partners with respect to quality of life, as measured by questionnaire
timeFrame: 3 months
measure: Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire
timeFrame: 6 months
measure: Concordance between men and partners with respect to quality of life, as measured by questionnaire
timeFrame: 6 months
measure: Feasibility, as measured by percentage of participants who used text messaging to complete their study questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Newcastle Fertility Centre
state: England
Study officials:
affiliation: Duke University
name: Eleanor Stevenson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: