louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02844712: Negative Predictive Value of Drug Provocation Tests to Beta-lactams
Official title: Negative Predictive Value of Drug Provocation Tests to Beta-lactams
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Drug Hypersensitivity
Keywords: Drug hypersensitivity
Betalactam
Drug provocation test
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 750
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.


Eligibility criteria: Inclusion Criteria:

* Elderly patients with at least 5 years at the time of consultation for allergy suspected allergy to beta-lactam antibiotics in the University Hospital of Montpellier and with a negative provocation test to a betalactam
* The patient or the patient's legal representatives are not their opposition to participate in this study
* The patient must be affiliated or beneficiary in a health insurance system

Exclusion Criteria:

* The patient is exclusion period determined by a previous study
* The patient is under judicial protection, guardianship or curatorship
* The patient or the patient's legal representatives do not read fluently the French language

Primary outcomes:
measure: Negative predictive value of drug provocation tests to betalactams
timeFrame: one day
Secondary outcomes:
measure: The types of reactions upon reexposure to a negatively tested betalactam
timeFrame: one day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier
Study officials:
References:
Clinical trial NCT05163912: Virtual Physical Activity for Type 1 Diabetes
Official title: A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Exercise
Adolescent
Video games
Self-management
Social support
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Robert E. Leet and Clara Guthrie Patterson Trust
First posted: 2021-12-20
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A virtual group of teens with type 1 diabetes, led by young adults with type 1 diabetes, will play active videogames and discuss activity and health. This study will evaluate the program for feasibility and user satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age of 14-19 years
* Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
* Inadequate moderate-to-vigorous physical activity levels (defined as ≤3 days per week achieving ≥60min daily, which is ≤50% of the recommended 7 days per week)
* English literacy
* Own a continuous glucose monitor (Dexcom G4, G5, G6 \[San Diego, CA\], Abbott Freestyle Libre 2, 14-day \[Chicago, IL\], Medtronic Guardian 3, Enlite \[Dublin, Ireland\]) with enough supplies for 6 weeks (when available, we will provide these to those who do not own them, in which case they will be considered to meet this criteria).
* Access to television or computer with HDMI or USB port.
* Under regular care by a healthcare provider (defined as attending at least one appointment in the past year, plus access to verified 24hr phone number to reach the provider's team for insulin dose adjustments if assistance is needed)

Exclusion Criteria:

• A condition or disability besides type 1 diabetes that would preclude participation in group moderate-to-vigorous physical activity (e.g., cerebral palsy, current pregnancy)

Primary outcomes:
measure: Adherence
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT05258812: Cytopenias in Hospitalized Patients of Corona Virus Infection(COVID-19) During First and Other Waves
Official title: Cytopenias in Hospitalized Patients of COVID-19 During First and Other Waves
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Keywords: COVID-19
Cytopenia
Thrombocytopenia
Anemia
Leucopenia
Lead sponsor: Fatima Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 202
Sex: ALL
Minimum age (years): 10
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 Positive Hospitalized patients, of all genders and all age group.

Brief summary: Demographic, Clinical and laboratory data as well as outcome of total 202 COVID-19 patients who were Polymerase Chain Reaction (PCR) positive and admitted in Fatima memorial Hospital, Lahore, Pakistan, was collected during first and other waves. Data of First wave is from May 2020 to July 2020, second wave from early November to Mid December 2020 and third wave from Mid march to June 2021. Investigator analyzed the data on basis of Systemic immune inflammatory index (SII) as well hematological parameters of First Wave were compared to other waves of COVID-19.


Eligibility criteria: Inclusion Criteria:

* COVID-19 Positive Hospitalized patients
* All genders

Exclusion Criteria:

* Patients with Known hematological disorders
* Patients with known chronic Liver Disease

Primary outcomes:
measure: Cytopenias in Hospitalized Patients of COVID-19 During First and Other waves
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima memorial Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT01505712: Biomarkers in Tissue Samples From Patients With Hodgkin Lymphoma Enrolled on ECOG-2496 Clinical Trial
Official title: Outcome Prediction in Hodgkin Lymphoma by Low-Density Gene Expression Profiling of Formalin Fixed Paraffin Embedded Tissues: A Correlative Study of Inter-Group Trial E2496
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-06
Enrollment: 393
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients who participated in E2496 and provided samples for research.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with Hodgkin lymphoma enrolled on ECOG-2496 clinical trial.

Detailed description: OBJECTIVES:

* To explore the predictive power of a gene expression-based multi-gene predictor in classical Hodgkin lymphoma (cHL) with the potential to change clinical practice by basing treatment decisions on biological markers.

OUTLINE: Archived tissue samples are analyzed for gene expression profile using NanoString technology. Results are then compared with patients' treatment outcomes, including failure-free survival and overall survival.

PROJECTED ACCRUAL: A total of 306 patients from ECOG-2496 (training cohort) and 87 patients treated with ABVD in other trials (validation cohort) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Training cohort: Patients diagnosed with locally extensive and advanced stage classical Hodgkin lymphoma (cHL) and treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) or mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone (Stanford V)

  * Pretreatment formalin-fixed, paraffin-embedded tissue (FFPET) from patients enrolled on the randomized phase III ECOG-2496 clinical trial
* Validation cohort: Patients with advanced-stage cHL treated with ABVD at the British Columbia Cancer Agency (BCCA)

  * Pretreatment FFPET available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Potential of gene expression profiling in changing treatment decision in cHL
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: British Columbia Cancer Agency
name: Randall D. Gascoyne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00859612: Renal Osteodystrophy: A Fresh Approach
Official title: Renal Osteodystrophy: A Fresh Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Osteodystrophy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from dialysis clinics

Brief summary: There are two major goals of this project:

1. Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
2. Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older;
* Chronic maintenance dialysis of at least 3 months' duration;
* Mental competence;
* Willingness to participate in the study;
* Calcidiol levels within normal range.

Exclusion Criteria:

* Pregnancy;
* Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
* Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
* Chronic alcoholism and/or drug addiction;
* Participation in a study of an investigational drug during the past 90 days;
* Allergy to tetracycline.
* Planning to move out of the area within 2 years of the study;
* On active transplant list;
* Treatment within last 6 months with drugs that may affect bone metabolism (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics).
* Calcidiol level below the normal range. The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.

Primary outcomes:
measure: Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
timeFrame: 4 years
Secondary outcomes:
measure: Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.
timeFrame: 4 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Hartmut H Malluche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00108212: Effect of Diet on Men and Women With Genetic Alterations Associated With Abnormal Blood Tests
Official title: Clinical Implications of Genetic Alterations in TG Rich Lipoproteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Keywords: Diet
triglyceride
inflammation
Genetic polymorphism
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate different diets and the effects of blood measures or inflammation and endothelial function in association with genetics tending to abnormal blood test levels.


Eligibility criteria: Inclusion Criteria:

* Polymorphism in Apo C3 promoter and normal controls.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References:
Clinical trial NCT04412512: VATS Versus Thoracotomy for Pulmonary Hydatid Disease
Official title: VATS Versus Thoracotomy for Pulmonary Hydatid Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hydatid Cyst
Keywords: pulmonary hydatid cyst
video-assisted thoracic surgery
thoracotomy
Lead sponsor: Hassan II University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 134
Sex: ALL
Minimum age (years): 6
Maximum age (years): 81
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study the effect of a treatment and evaluate outcome postoperative
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary Hydatid Cyst.

Disease : pulmonary hydatid cyst.

Intervention:

* Group 1 : VATS approach.
* Group 2 : thoracotomy approach.

Detailed description: After being informed about the study and the approach, all patients giving written informed consent to determine eligibility for study entry.

Eligibility criteria: Inclusion Criteria:

- all patients underwent surgery for pulmonary hydatid cyst

Exclusion Criteria:

* none

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Casablanca
country: Morocco
facility: Hassan II University
Study officials:
affiliation: Hassan II University
name: sara WAGUAF
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03957512: Livet Skal Leves (A Life to Live)
Official title: Heart Defects in Infants- Detection, Rescue and Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 3000
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: National population

Brief summary: The overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (CHDs) in order to reduce death and complications

Detailed description: The project is designed as retrospective cohort study based on nationwide registry data of children born 2004-16. The project group has extensive experience of similar research, and includes representatives from different fields and levels of health care.

The results will provide a solid fundament for improvement of today's clinical practice, including development of knowledge-based routines in neonatal medicine and planning of health care services. Implementation is given particular attention, and will be managed in an interdisciplinary setting. The project will be of major relevance for the patients and their families as well as medical professionals at all levels of health care.

Eligibility criteria: Inclusion Criteria:

* Fetuses with severe CHDs who were identified by antenatal ultrasound screening, and where the pregnancy was terminated
* Children with severe congenital heart defects born in Norway 2004-18

Exclusion Criteria:

* Lack of parental consent

Primary outcomes:
measure: Mortality
timeFrame: 0-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital/University of Oslo
name: Henrik Holmstrøm, Dr Med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02103712: Long Term Outcome of Hypospadias Repair
Official title: Long Term Outcome of Hypospadias Repair: A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypospadias
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 170
Sex: MALE
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypospadias

Brief summary: Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy in 250. The opening of the urethra is located on the undersurface of the penis rather than the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe cases. Although the most commonly practised corrective operation ( TIP procedure) gives generally good results, recently published evidence points to a possible long term risk of stenosis ( narrowing of the reconstructed urethra). This comparative study will combine clinical assessment with non invasive measurements of urinary flow to assess the functional outcome of a large series of patients who have undergone hypospadias surgery . The study is primarily designed to answer this question : does a modification of the standard operation which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow and a decreased risk of stenosis? This has not been previously studied . The findings of our study could make an important contribution to improvements in the surgical treatment of boys born with hypospadias.


Eligibility criteria: Inclusion Criteria:

- 1 Patients with hypospadias who have been treated one of the following two surgical proceduresStandard Tubularised Incised Plate (TIP) operation (Group A) or Tubularised Incised Plate (TIP) procedure incorporating a free graft of preputial skin (in a layer of foreskin) into the urethral reconstruction (Group B ) 2 The study will be confined to primary operations. Patients in whom either of the techniques was used for a secondary or 'redo' procedure will be excluded from the study.

3 The study will be confined to boys over 3 years of age who are potty trained and able to pass urine for the non invasive flow rate test .

Exclusion Criteria:

- 1 Patients whose hypospadias was corrected using some technique other than 'standard' or 'grafted' TIP repair.

2 "Redo" cases 3 Boys under 3 years at the time of the study or patients who do not have full bladder control for some other reason.

Primary outcomes:
measure: Does a modification of the standard TIP hypospadias operation which incorporates a skin graft into the reconstructed urethra result in improved urinary flow and a (presumed)decrease in the long term risk of stenosis?
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT06044012: Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula
Official title: Double Layer of Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Large Oro-antral Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oro-Antral Communication
Keywords: Oro-Antral Fistula
Buccal pad of fat
Myomucosal Flap
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oroantral fistula (OAF) is a pathological communication between the oral cavity and the maxillary sinus. A variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. To increase the success rates of OAF closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity.


Eligibility criteria: Inclusion Criteria:

* Large Oro-antral Fistula
* Recent or previously failed closure of oro-antral Fistula

Exclusion Criteria:

* Immuno-supressed patients
* fistulae smaller than 5 mm in size

Primary outcomes:
measure: Healing
timeFrame: 6 months
Secondary outcomes:
measure: infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University
Study officials:
References:
Clinical trial NCT06779812: Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC
Official title: Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC. Parallel, Randomized, and Double-Blind Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain After Carpal Tunnel Surgery
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A (Experimental): Real auriculotherapy + standard medical care Group B (Control): Sham auriculotherapy + standard medical care
Primary purpose: OTHER

Brief summary: Auriculotherapy shows promising potential for pain management in patients with carpal tunnel syndrome (CTS). Studies have demonstrated encouraging results in pain reduction and improvement in quality of life. However, further research is required to strengthen these findings and fully integrate auriculotherapy into standard treatment protocols for CTS.

this prospective, double-blind comparative study aims to evaluate the effectiveness of auricular acupuncture in managing postoperative pain following outpatient carpal tunnel surgery


Eligibility criteria: Inclusion Criteria:

* Subjects aged over 20 years
* Patients with carpal tunnel syndrome scheduled for endoscopic surgery
* Patients who have never undergone auriculotherapy sessions before
* No participation in another clinical study

Exclusion Criteria:

* Patients under 20 years of age
* Unable to undergo medical follow-up for the study
* Legally protected adult subjects, under guardianship or curatorship

Primary outcomes:
measure: Evaluation of Postoperative Pain After Carpal Tunnel Surgery From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions
timeFrame: day1 to day 3
Secondary outcomes:
measure: Evaluation of the Effects of Real or Sham Auriculotherapy Sessions on Analgesic Consumption
timeFrame: Follow-up Logbook from Day 1 to Day 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Benkessou
city: Paris
country: France
facility: Bizet Clinic
Study officials:
References: