louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02246192: Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision
Official title: Application of PRGF (Plasma Rich in Growth Factors) to Reduce the Healing Time After Pilonidal Sinus Excision. A Randomized 5-years Prospective Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Hospital Quiron Sagrado Corazon
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 51
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. The investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.

Detailed description: prospective randomized control trial, comparing PRGF application vs daily local care(betadine +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications.

this study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.

Eligibility criteria: Inclusion Criteria:

* Patients among 13 and 65 years old
* Possibility of observation during the follow-up period
* Patients who have read and signed informed consent

Exclusion Criteria:

* Abscessed pilonidal sinus
* Recurrent pilonidal sinus
* Patients treated with immunosuppressive drugs or anticoagulants

Primary outcomes:
measure: healing time(days) of pilonidal sinus wound excision
timeFrame: 6 months
Secondary outcomes:
measure: postoperative pain
timeFrame: 1 month
Other outcomes:
measure: postoperative bleeding
timeFrame: 1 week
measure: surgical site infection rate
timeFrame: 1 month
measure: sinus recurrence rate
timeFrame: 4 years
measure: quality of life
timeFrame: 6 months
Locations:
Study officials:
affiliation: Quirón Sagrado Corazón Hospital, Seville, Spain
name: Juan Bellido Luque
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00415792: Comparison Between hCG and GnRH Agonist for Ovulation Induction in Patients With High Response to IVF Drugs
Official title: Administration of Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRH) Agonist for Ovulation Induction in Hyper-Responder Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Ovulation induction
hCG
GnRH agonist
hyper-responders
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: hCG and GnRH agonist can be used to induce final oocyte maturation and ovulation in IVF cycles. These two approaches will be compared in this study in terms of pregnancy rates and embryological data using patients with hyper-response to IVF drugs.

Detailed description: hCG is commonly used for the substitution of the endogenous LH surge to induce oocyte maturation and ovulation induction in ovarian hyperstimulation protocols for in vitro fertilization (IVF). However, hCG is related to the occurrence of the ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening complication and hyper-responding patients are particularly in high risk. An alternative to exogenous hCG is the administration of a GnRH agonist inducing an endogenous rise in both LH and FSH levels due to the initial flare effect.

Comparisons: Pregnancy rates and embryological data will be compared from hyper-responding patients receiving either GnRH agonist (Arvekap) or hCG (Pregnyl) for ovulatrion induction following a GnRH antagonist treatment cycle.

Eligibility criteria: Inclusion Criteria:

* Hyper-responder patients (\>20 oocytes retrieved)

Exclusion Criteria:

* Normal responders
* Poor responders
* PCOS

Primary outcomes:
measure: Ongoing pregnancy per embryo transfer
Secondary outcomes:
measure: Biochemical pregnancy per embryo transfer
measure: Clinical pregnancy per embryo transfer
measure: Embryological data
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia
Study officials:
affiliation: Eugonia
name: Tryfon Lainas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griesinger G, Diedrich K, Devroey P, Kolibianakis EM. GnRH agonist for triggering final oocyte maturation in the GnRH antagonist ovarian hyperstimulation protocol: a systematic review and meta-analysis. Hum Reprod Update. 2006 Mar-Apr;12(2):159-68. doi: 10.1093/humupd/dmi045. Epub 2005 Oct 27.
Clinical trial NCT04734392: Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Official title: Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PM Implantation After TAVR
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will comprise of patients referred to transcatheter aortic valve replacement. Patients will be prospectively and consecutively screened and enrolled at a tertiary high-volume center in Germany.

Brief summary: Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation follow TAVR-procedures.

Detailed description: Project objectives or hypothesis Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation following TAVR-procedures.

Patient profile and sample size The study cohort will comprise of patients referred to transcatheter aortic valve replacement. Patients will be prospectively and consecutively screened and enrolled at a tertiary high-volume center in Germany. TAVR will be performed according to a modified implantation technique regarding membranous septum length. Pacemaker rates will be analyzed and compared to a historical control. Taking into account a contemporary pacemaker rate of 15%, a reduction to 7% will require a sample size of 239 patients per group to achieve statistically significance (Chi-squared test, alpha 0.05, beta 0.80).

Regarding the prospective cohort, interims analysis will be performed after each 10 TAVR procedures. In case a signal towards worse outcomes with the modified implantation technique will be observed, the institutional safety and endpoint adjudication committee will stop further execution of the study.

Eligibility criteria: Inclusion Criteria:

* All patients referred to TAVR procedure due to severe aortic stenosis

Exclusion Criteria:

* PM-implantation before TAVR
* Valve-in-valve procedures

Primary outcomes:
measure: Pacemaker implantation rate
timeFrame: Day 5 after TAVR
Secondary outcomes:
measure: Extent of paravalvular leak
timeFrame: Day 5 after TAVR
measure: Number of patients alive
timeFrame: 30 days
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Ulm University
Study officials:
References:
Clinical trial NCT01125592: Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals
Official title: Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: assess the ability of the IonCleanse machine to remove heavy metals through the feet
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Makers of ionic foot baths claim that their machines can eliminate heavy metals from the body. Researchers at the Canadian College of Naturopathic Medicine are evaluating the ability of an ionic foot bath to help eliminate heavy metals from the body by rigorously testing the machine under controlled conditions. The machine will first be tested without feet under normal operating conditions and again after operation under normal conditions with foot immersion.


Eligibility criteria: Inclusion Criteria:

* Healthy Adults

Exclusion Criteria:

* A wearer of a pacemaker or any other battery operated or electrical implant
* Pregnant or nursing women
* On heartbeat regulating medication
* On blood thinners (anticoagulants)
* On any drug known to have chelating properties
* Have had an organ transplant or a metal joint implant
* On a medication the absence of which would mentally or physically incapacitate them, e.g., psychotic episodes, seizures, etc.

Primary outcomes:
measure: Change in heavy metal content in the water after a 30 minute IonCleanse footbath
timeFrame: 4 sessions, May 26 to June 17 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian College of Naturopathic Medicine
state: Ontario
Study officials:
References:
citation: Kennedy DA, Cooley K, Einarson TR, Seely D. Objective assessment of an ionic footbath (IonCleanse): testing its ability to remove potentially toxic elements from the body. J Environ Public Health. 2012;2012:258968. doi: 10.1155/2012/258968. Epub 2011 Nov 29.
Clinical trial NCT00922792: Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B
Official title: An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.


Eligibility criteria: Inclusion Criteria:

* Haemophilia A or B
* Bodyweight max 100 kg
* Body Mass Index (BMI) max 30 kg/m2
* Adequate venous access

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
* The receipt of any investigational product within 30 days prior to enrolment in this trial
* Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
* The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
* Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
* Known pseudo tumours
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Any major and/or orthopaedic surgery within one month prior to trial start
* Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
* Clinical signs of renal dysfunction
* Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
* Use of non-prescribed opiate substances

Primary outcomes:
measure: Frequency of adverse events
timeFrame: after 1 and 2 weeks after dosing
measure: Frequency of serious adverse events
timeFrame: after 1, 2 and 6-10 weeks after dosing
measure: Frequency of MESIs (Medical Event of Special Interest)
timeFrame: after 1, 2 and 6-10 weeks after dosing
measure: Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa
timeFrame: after 2 and 6-10 weeks after dosing
Secondary outcomes:
measure: Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½
timeFrame: from time of dosing up to 72 hours after the last dose
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04371692: Prevalence of COVID-19 Infection Among HCW in a French University Hospital
Official title: Prevalence of SARS-Cov2 Infection Among HCW in Lille University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Keywords: Prevalence
Health Care Workers
occupational exposure
environmental exposure
serological testing
RT-PCR
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Fondation Santé Roquette
First posted: 2020-05-01
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health Care workers with or without symptoms suggestive of a COVID-19 infection

Brief summary: The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.


Eligibility criteria: Inclusion Criteria:

- Health Care workers with or without symptoms suggestive of a COVID-19 infection

Exclusion Criteria:

* HCW working off-site at the CHU de Lille
* HCW on sick leave.
* HCW outside the Lille University Hospital temporarily coming as reinforcements in the context of the epidemic.

Primary outcomes:
measure: the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection
timeFrame: at 2 months
Secondary outcomes:
measure: the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection
timeFrame: once week during 2 months
measure: Occupational exposures associated with the SARS-Cov2 infection
timeFrame: once week during 2 months
measure: Environmental exposures associated with the SARS-Cov2 infection
timeFrame: once week during 2 months
measure: immunologic status of health Care Worker
timeFrame: once week during 2 months
measure: inflammatory biomarkers status of Health Care Worker
timeFrame: once week during 2 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Annie SOBASZEK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05628792: In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study
Official title: In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Vascular Tumor
Keywords: CT
Osteoid Osteoma
Ultra High Resolution CT
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective inclusion of all histologically proven Osteoid Osteoma referred to our department for CT imaging

Brief summary: To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a model.


Eligibility criteria: Inclusion Criteria:

* Proven osteoid osteoma
* Ultra High Resolution CT

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of cortical vessels
timeFrame: Retrospective review of all ultra high resolution CT of the precedent 2 years
measure: Number of nidus vessels
timeFrame: Retrospective review of all ultra high resolution CT of the precedent 2 years
Secondary outcomes:
measure: Confidence Score
timeFrame: Retrospective review of all ultra high resolution CT of the precedent 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03323892: Effect of Abstinence Duration on Embryo Development
Official title: Effect of Abstinence Duration on Embryo Development: a Prospective Sibling Oocyte Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Development
Keywords: preimplantation development
DNA fragmentation
abstinence duration
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective sibling oocyte study: both study arms will be applied to the oocytes of 1 patient
Primary purpose: DIAGNOSTIC

Brief summary: The aim the investigators study is to analyze the embryo development if oocytes of the participants are injected with sperm from a longer or shorter (2 hours) abstinence duration.

Detailed description: Participants undergoing an IVF treatment, are asked to respect an abstinence duration of 2-7 days. This is to obtain a sufficient number of motile sperm. A recent investigation, analyzed the quality (number and motility) of a sperm sample produced after an abstinence duration of 4 to 7 days, followed by a second sperm sample 2 hours later. The second sample (after 2 hours) was able to produce sperm cells with a higher motility. Not only has this short abstinence duration of 2 hours a positive effect on the motility, it will also reduce the sperm DNA damage, which again has a positive effect on embryo development. Because participants need gametes of high quality to obtain embryos with a high quality, the investigators want to investigate what the effect is of abstinence duration on embryo development.

Eligibility criteria: Inclusion Criteria:

* Patients planned for embryo development up to day 5
* at least 6 mature oocytes
* fresh ejaculates
* ICSI
* fresh embryo transfer or freeze all strategy
* all stimulation protocols
* concentration of \>1x10\^6 /ml sperm

Exclusion Criteria:

* IVF
* IVF versus ICSI patients
* chirurgical sperm
* acceptors of donor oocytes
* patients with PGD
* patients already enrolled in another study

Primary outcomes:
measure: Embryo development (blastocyst stage)
timeFrame: 1 year
measure: Embryo development (cleavage stage)
timeFrame: 1 year
Secondary outcomes:
measure: Fertilization
timeFrame: 1 year
measure: Utilization rate
timeFrame: 1 year
measure: Sperm quality
timeFrame: 1 year
measure: Sperm DNA fragmentation
timeFrame: 1 year
measure: Clinical Pregnancies
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Neelke De Munck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05383092: Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity
Official title: Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: pediatric cancers
exercise
insulin sensibility
metabolic syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized pilot study studying the parameters of two groups receiving physical activity management over a period of 6 months
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this study is to evaluate the evolution of the sensitivity to insulin, a hormone that acts on sugar in the body, as well as other metabolic, motor and nutritional elements of children with cancer, according to the practice of intense physical activities or stretching. In view of the scientific work on this subject, it is expect to observe that the practice of intense physical activities will improve the results of the children in the metabolic, motor and nutritional evaluations, compared to the stretching program.

Detailed description: The protocol consists of 6 months of intense physical activity and stretching programs for children with solid cancer or haematological disease, starting at diagnosis. Evaluations will be performed at the first, third and sixth month of the programs and then six and eighteen months after they are stopped. The physical activity sessions will take place in the hospital during hospitalizations or by videoconference when the children are at home. The sessions are adapted to the needs, desires and abilities of the children and will take place two to three times a week. They will be mediated by various activities such as soccer, rugby, darts, muscle strengthening. Inclusion lasts two years.

Eligibility criteria: Inclusion Criteria:

* age between 5 and 18 years old;
* have a solid cancer or hematological disease;
* be treated for the first time in pediatric oncology and hematology department;
* have an estimated life expectancy at diagnosis of more than 6 months.

Exclusion Criteria:

* present a physical and/or psychological impossibility to follow an adapted physical activity program;
* have a pre-existing heart disease that is not suitable for adapted physical activities;
* have a known type 1 diabetes
* have an obesity defined by a body mass index greater than or equal to the International Obesity Task Force 25 threshold

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: PASQUET Marlène
Study officials:
affiliation: University Hospital, Toulouse
name: Marlène PASQUET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: