louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06242522: Fertility and Pregnancy After Avelumab Treatment
Official title: Fertility and Pregnancy After Avelumab Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Trophoblastic Tumours
Immune Checkpoint Inhibitors
Keywords: Immune checkpoint inhibitors
Gestational trophoblastic tumours
Young women
Childbearing age
Pregnancy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective and retrospective cohort
Primary purpose: OTHER

Brief summary: Immune checkpoint inhibitors (ICIs), such as anti-PD-1/PD-L1 agents, initially evaluated in advanced non-curative pathologies, are now being evaluated in adjuvant or even neoadjuvant curative treatment conditions. This paradigm shift is leading to the treatment of young women, particularly in the context of gestational trophoblastic tumours. Given the potential autoimmune side-effects affecting endocrine functions, as well as their impact on maternal-foetal tolerance mechanisms, accurate assessment of post-ICT fertility is necessary. In the coming years, treatment with anti-PD-L1 (avelumab) could become a cornerstone of the therapeutic strategy for patients with gestational trophoblastic tumours.

However, these patients are often young and of childbearing age, so safety of use in terms of fertility and successful pregnancies is an essential factor in the widespread use of immunotherapy as a treatment option. Some studies have reported the possibility of conceiving after avelumab treatment, but no cohort has been reported. This study aims to explore fertility and the course of potential pregnancy in 50 patients treated with anti-PD-L1 (avelumab) over the last 5 years in several French centres.


Eligibility criteria: * Inclusion Criteria :

  * Patient aged over 18 years
  * Have received AVELUMAB treatment for GTT in the TROPHIMMUN or TROPHAMET trials, or have received AVELUMAB outside the trial for gestational trophoblastic tumour.
  * Did not object to participating in the study
* Exclusion Criteria :

  * Patient who has died
  * Patient who has had a hysterectomy

Primary outcomes:
measure: Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud
Study officials:
References:
Clinical trial NCT01184222: Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache
Official title: EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HEADACHE
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* migraine patient with medication overuse headache by non specific analgesics according to the ICHD-II diagnostic criteria
* failure of outpatient withdrawal
* Signature of informed consent.
* Affiliation to French national health and pensions organization

Exclusion Criteria:

* pregnancy (positive pregnancy test at pre-study) and breast-feeding
* patients with medication overuse headache by specific antimigraine treatment (triptans or/and ergot derivatives) according to the ICHD-II diagnostic criteria
* previous surgical treatment targeting great occipital nerves

Primary outcomes:
measure: Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham)
timeFrame: 14 days
Secondary outcomes:
measure: number of headache days during the 14 days withdrawal period
timeFrame: 14 days
measure: maximal intensity and duration of rebound headache
timeFrame: 14 days
measure: rescue medication used
timeFrame: 14 days
measure: withdrawal facility perceived by the patient
timeFrame: 14 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Neurology department - La timone
city: Nice
country: France
facility: Neurosurvery department
city: Paris
country: France
facility: Headache Emergency Center
city: Toulouse
country: France
facility: Neurology department - CHU Rangueil
Study officials:
affiliation: Neurosurgery depatment - CHU Pasteur, Nice
name: FONTAINE Denys, PhD
role: STUDY_CHAIR
affiliation: Neurosurgery department
name: LANTERI-MINET Michet, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01765322: The Effect of Laser-assisted Zona Thinning on the Implantation Rate in the Women of Advanced Age
Official title: Center of Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Urogenital Diseases
Lead sponsor: Shanxi Provincial Maternity and Children's Hospital
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether laser-assisted zona thinning improve the implantation rate of the women of advanced age in the first IVF/ICSI cycles

Detailed description: Registry procedures：

1. It's required to sign an informed consent form prior to the recruitment of all patients.
2. Data collection and entry need double check and supervision.

The outcome measures:

the implantation rate per embryo transfer miscarriage live birth

Eligibility criteria: Inclusion Criteria:

* Age: 35y ≤age≤46y
* Basal FSH value: FSH≤10IU/L
* Day-3 embryos transferred in the fresh IVF/ICSI cycles
* the number of embryos available to be transferred on Day-3: ≥one embryo

Exclusion Criteria:

* cycles with thawed/warmed embryos biopsied for PGD/PGS.
* cycles with oocyte donation transfer.
* the maximum number of previous unsuccessful IVF attempts: ≥ 3 cycles(transfer cycles)
* any cycles with the risk of OHSS, fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation, and other acute maternal problems.
* One or both spouses have an abnormal karyotype (including polymorphism)

Primary outcomes:
measure: The implantation rate
timeFrame: 30 days
Secondary outcomes:
measure: The miscarriage
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Maternal and Children Health Care Hospital
state: Shaanxi
Study officials:
affiliation: Maternal and Children Health Care Hospital
name: Wenhao Shi, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT05172622: Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects
Official title: A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic of JP-2266 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 80
Sex: MALE
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: Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

Detailed description: A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

Eligibility criteria: Inclusion Criteria:

* Healthy male Caucasian subject aged 18 to 50 years inclusive
* Body Mass Index (BMI) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening
* Signing a written informed consent prior to selection;

Exclusion Criteria:

* Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;

Primary outcomes:
measure: The evaluation of the number of adverse events and the number and percentage of subjects
timeFrame: up to Day 10
measure: Assessment of PK parameter: Maximum plasma concentration (Cmax)
timeFrame: up to 72hours of each period
measure: The evaluation of the number of adverse events and the number and percentage of subjects
timeFrame: up to Day 19
Secondary outcomes:
Other outcomes:
Locations:
city: Gières
country: France
facility: OPTIMED clinical research
Study officials:
References:
Clinical trial NCT02219022: Progressive Resistance Exercise in Rheumatoid Arthritis
Official title: Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Progressive resistance exercise
Pain
Functional capacity
Quality of life
Muscle strength
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients will be randomized into two groups. Experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical treatment. Patients will be evaluated at baseline, after 6, 12 and 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis according to American College of Rheumatology 2010
* Both genders
* Age between 18 and 65 years
* Functional class I, II and III
* Stable medication within the three months preceding the study
* Haven't done any kind of regular exercise (two or more times per Week) for at least three months before study start
* Have agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Participating in another type of study
* Have difficulty understanding the evaluation tools with fibromyalgia
* Joint deformities that make impossible do the exercises
* Other musculoskeletal diseases
* Other diseases that contraindicate exercises.

Primary outcomes:
measure: Change in pain - Visual analogue scale
timeFrame: baseline, 6, 12 and 24 weeks
Secondary outcomes:
measure: Change in function capacity - Health Assessment questionaire
timeFrame: Baseline, after 6, 12 and 24 weeks
measure: Change in quality of life - Short form 36
timeFrame: baseline, after 6, 12 and 24 weeks
measure: Change in strength - 1 maximum repetition
timeFrame: baseline, after 6, 12 and 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT04984122: Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure
Official title: Influence of General and Local Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedure, Gynecologic Surgical
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 248
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The loop electrosurgical excision procedure (LEEP) is a modified cervical conization that is performed with an electrosurgical loop. It may be performed under local anesthesia (LA) or under general anesthesia (GA), and practice patterns differ widely. In some countries, specific guidelines for the choice of anesthesia during LEEP are provided, whereas, in other countries, the choice of anesthesia is not specified. LEEP under LA is more economical, obviating the need for anesthesia staff, equipment, and operating room fees. However, LEEP under LA may be more difficult to perform, may be more difficult to learn, may lead to inferior surgical results, and may result in more pain and patient dissatisfaction. This study aimed to compare loop electrosurgical excision procedures under local anesthesia vs general anesthesia regarding patients' satisfaction, histopathologic results, and short-term morbidity


Eligibility criteria: Inclusion Criteria:

Patients were \> 21 years old; were not pregnant

The patient had one of the following indications for LEEP:

1. histologyproven, persistent, low-grade squamous intraepithelial lesion (LGSIL);
2. a histology-proven high-grade squamous intraepithelial lesion (HGSIL);
3. discrepancies between cytological reports and colposcopic impressions;
4. investigation for unsatisfactory colposcopy;
5. microinvasion or adenocarcinoma in situ on cervical punch biopsy.

Exclusion Criteria:

Patients with cervical or vaginal infection; Patients with an abnormal menstrual cycle; who were taking anticoagulants, Patients with a coagulation defect Patients with mental incapacity Patients with previous hysterectomy with removal of the cervix Patients with a history of cervical cancer.

Primary outcomes:
measure: visual analog scale 1
timeFrame: up to 1 hour after the procedure
Secondary outcomes:
measure: visual analog scale 2
timeFrame: up to 2 hour after the procedure
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Education and Research Hospital
city: Muğla
country: Turkey
facility: Kemal Gungorduk
Study officials:
References:
Clinical trial NCT02949622: Multimodal Intervention Program for Patients With Metabolic Syndrome
Official title: Development and Validation of a Multimodal Intervention Program for Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Metabolic syndrome
Mediterranean diet
Stress
quality of life
psychological factors
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen de las Nieves
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2016-10-31
Enrollment: 136
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to identify the psychological, emotional and lifestyle variables that can have an influence on the different components of metabolic syndrome (MetS) and develop a program for change lifestyle in this patients.


Eligibility criteria: Inclusion Criteria:

* Between 25 and 65 years age
* Waist circumference \>88 cm for women and \>102 cm for men
* Blood pressure: systolic ≥ 130 mmHg and diastolic ≥ 85 mmHg
* Fasting glucose level ≥ 110mg/dL
* Triglycerides: ≥ 150 mg/dL
* HDL cholesterol ≤40 mg/dL in men and ≤50 mg/DL in women

Exclusion Criteria:

* Osteoarthritis,
* Active inflammatory diseases,
* Severe psychiatric disorders and/or significant cognitive impairment assessed using the Mini-Mental State Examination.

Primary outcomes:
measure: Weight
timeFrame: 2 minutes
measure: Waist circumference
timeFrame: 2 minutes
measure: Blood pressure
timeFrame: 15 minutes
measure: Lipid profile
timeFrame: 3 minutes
measure: Glycemic profile (fasting glucose)
timeFrame: 3 minutes
Secondary outcomes:
measure: State-Trait Anger Expression Inventory-2 - STAXI-2
timeFrame: 5 minutes
measure: Perceived Stress Scale -PSS
timeFrame: 5 minutes
measure: Assertiveness Inventory
timeFrame: 5 minutes
measure: Medical Outcomes Study 12-Item Short Form - SF-12
timeFrame: 5 minutes
measure: Mediterranean-diet scale
timeFrame: 5 minutes
measure: Fagerström Test for Nicotine Dependence
timeFrame: 5 minutes
Other outcomes:
measure: Mini Mental State Examination - MMSE
timeFrame: 5 minutes
measure: Mini International Neuropsychiatric Interview - MINI
timeFrame: 30 minutes
measure: Height
timeFrame: 2 minutes
Locations:
city: Granada
country: Spain
facility: Jaqueline Garcia da Silva
Study officials:
References:
citation: Garcia-Silva J, Borrego IRS, Navarrete NN, Peralta-Ramirez MI, Aguila FJ, Caballo VE. Efficacy of cognitive-behavioural therapy for lifestyle modification in metabolic syndrome: a randomised controlled trial with a 18-months follow-up. Psychol Health. 2024 Jan-Feb;39(2):195-215. doi: 10.1080/08870446.2022.2055023. Epub 2022 Mar 28.
Clinical trial NCT01756222: Bicuspid Aortic Valve (BAV) Registry
Official title: Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bicuspid Aortic Valve
Keywords: Bicuspid Aortic Valve Disease
Bicuspid Aortic Valve
BAV
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary clinic

Brief summary: The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.

Detailed description: The purpose of this registry is to gather information on patients with bicuspid aortic valve disease. The data collected in the registry will be used to assess patterns of aortic dilation, responses to medical therapy based on serial imaging and to assess for potential genetic markers of this disease

Eligibility criteria: Inclusion Criteria:

* Any patient over the age of 18 who is able/willing to give informed consent with the diagnosis of bicuspid aortic valve disease, a family history of this disease or an ascending aortic aneurysm that is idiopathic can be included in the registry.

Exclusion Criteria:

* Patients unable or unwilling to give informed consent.

Primary outcomes:
measure: Characterizing patients with bicuspid aortic valve disease
timeFrame: 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Univeristy of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Bo Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05944822: Pro-inflammatory Cytokines in Case of Essure®
Official title: Study of Pro-inflammatory Cytokines in Case of Essure® Contraceptive Implants
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Disease
Keywords: contraceptive implants
pro-inflammatory cytokines
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study focuses on patients who underwent surgery to remove the Essure® contraceptive implant and on control patients who underwent benign gynecological laparoscopic surgery.

Brief summary: It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.

The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.

Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.

The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.


Eligibility criteria: Inclusion Criteria:

* women over 18
* intervention between January 2021 and November 2022
* person having expressed his non-opposition

Essure group : patient who underwent removal of the Essure® contraceptive implant

Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis

Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis

Exclusion Criteria:

* inability to understand the information given
* person deprived of liberty
* person under guardianship

Primary outcomes:
measure: cytokine IL10 in peritoneal fluid
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
Study officials:
References: