louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01874795: Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure
Official title: Effect of Ganglionar Transcutaneous Electrical Nerve Stimulation on Central Arterial Pressure in Healthy Young Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Chagas Disease
Keywords: Autonomic Nervous System
Neuromodulation
Exercise
Pulmonary oxygen kinetics
Oxygen uptake
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients.

Detailed description: A Crossover Randomized Controlled Study will be developed with 3 groups: Healthy Older, Ischemic Heart Failure and Chagas Disease. This individuals will be randomized in two groups: TENS and placebo (same stimulus without electrical output) with 48 hrs between the interventions.

Eligibility criteria: Inclusion Criteria:

* Ischemic and Chagas disease previously diagnosticated
* Age above 40 years old

Exclusion Criteria:

* No vascular disease
* No recent surgery
* No recent infections

Primary outcomes:
measure: tonometry
timeFrame: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks
Secondary outcomes:
measure: Cardiorespiratory Evaluation
timeFrame: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University of Brasilia
state: DF
Study officials:
affiliation: University of Brasilia
name: Gerson C junior, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Federal of Rio Grande do Sul
name: Gaspar R Chiappa, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cipriano G Jr, de Camargo Carvalho AC, Bernardelli GF, Tayar Peres PA. Short-term transcutaneous electrical nerve stimulation after cardiac surgery: effect on pain, pulmonary function and electrical muscle activity. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):539-43. doi: 10.1510/icvts.2007.168542. Epub 2008 Apr 16.
citation: Chiappa GR, Borghi-Silva A, Ferreira LF, Carrascosa C, Oliveira CC, Maia J, Gimenes AC, Queiroga F Jr, Berton D, Ferreira EM, Nery LE, Neder JA. Kinetics of muscle deoxygenation are accelerated at the onset of heavy-intensity exercise in patients with COPD: relationship to central cardiovascular dynamics. J Appl Physiol (1985). 2008 May;104(5):1341-50. doi: 10.1152/japplphysiol.01364.2007. Epub 2008 Mar 20.
citation: Vieira PJ, Ribeiro JP, Cipriano G Jr, Umpierre D, Cahalin LP, Moraes RS, Chiappa GR. Effect of transcutaneous electrical nerve stimulation on muscle metaboreflex in healthy young and older subjects. Eur J Appl Physiol. 2012 Apr;112(4):1327-34. doi: 10.1007/s00421-011-2084-z. Epub 2011 Jul 28.
Clinical trial NCT03172195: Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
Official title: Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colitis, Ulcerative
Keywords: ulcerative colitis
inflammation
immunosuppressive drugs
herpesvirus
qPCR
colonic mucosa
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score \>6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Voluntary to participate to the study
* Flare-up of ulcerative colitis with Mayo score \>6
* Ability to receive steroid or anti-TNF therapy
* Agree the rectosigmoidoscopy and the therapies

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Disagree the rectosigmoidoscopy or the therapies
* Participation to the evaluation of a new therapy
* Colectomy (partial or total)
* Contraindication of steroid or anti-TNF therapy
* Anticoagulant drugs

Primary outcomes:
measure: Number of patients with different viral load in the colonic mucosa
timeFrame: day 1
Secondary outcomes:
measure: Correlation of the different viral loads with the Mayo endoscopic score
timeFrame: Day 1
measure: Correlation of the different viral loads with the steroid treatment response
timeFrame: up to 24 months
measure: Correlation of the different viral loads with the anti-TNF treatment response
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Xavier Roblin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172595: FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma
Official title: 18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioma, Malignant
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Centre, Singapore
name: National Neuroscience Institute Singapore
name: Duke-NUS Graduate Medical School
First posted: 2023-12-15
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the performance characteristics of O-(2-\[18F\]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of \[18F\]FET-PET in delineating disease. The main question\[s\] it aims to answer are:

* whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression
* whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.


Eligibility criteria: Inclusion Criteria:

* Men or Women, aged 21 years or older at time of screening
* Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour
* With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field
* Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry
* Subject must consent to undergo all study procedures

Exclusion Criteria:

* Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17
* Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.
* Proven cerebral metastases
* IDH-mutated gliomas
* Pregnancy/ breast-feeding

Primary outcomes:
measure: Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT01421095: Ovarian Reserve Testing in Female Young Adult Cancer Survivors
Official title: Ovarian Reserve Testing in Female Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Infertility
Keywords: Fertility
adolescent
young adult
cancer survivors
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products.

Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.

Detailed description: Same as brief summary

Eligibility criteria: Inclusion Criteria:

* Postmenarchal
* Cancer diagnosis
* Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy
* A minimum of 1 year since completion of gonoadotoxic therapy
* Intact uterus
* At least one ovary

Exclusion Criteria:

* Estrogen receptor positive cancers

Primary outcomes:
measure: Return of menses
timeFrame: 3 months
Secondary outcomes:
measure: Blood levels of FSH
timeFrame: 3 months
measure: Blood levels of estradiol
timeFrame: 3 months
measure: Blood levels of AMH
timeFrame: 3 months
measure: Blood levels of inhibin B
timeFrame: 3 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
affiliation: UC San Diego
name: H. Irene Su, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905514: ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients
Official title: ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nonadherence to immunosuppression is a leading cause of late graft rejection, chronic rejection and graft failure and it is regarded as a preventable cause of graft loss after solid organ transplantation. The purpose of this study is to evaluate whether mobile application for drug medication can enhance the drug adherence rate.


Eligibility criteria: Inclusion Criteria:

* 1 year after kidney transplantation
* out-patient follow up in Seoul National University Hospital
* using android smartphone
* taking Prograf as a main immunosuppressant
* 15-70 years

Exclusion Criteria:

* patients who cannot use medication event monitoring system
* multiorgan transplant
* immunosuppression medication change within 4 weeks of randomization
* caregiver management of the medication regimen
* pregnancy
* patients who can not use mobile application

Primary outcomes:
measure: adherence rate
timeFrame: up to 6 months
Secondary outcomes:
measure: biopsy proven acute rejection rate
timeFrame: up to 6 months
Other outcomes:
measure: renal function
timeFrame: up to 6 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jongwon Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
Clinical trial NCT02867514: Effect of the Transcranial Direct Current Stimulation (tDCS) on Dependent Smoking People
Official title: Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Abuse Smoke
Keywords: tobacco
craving
tDCS
attentional tasks
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2016-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also evaluated 1 month post-treatment.

Detailed description: Tobacco is the second leading cause of death worldwide. It is currently responsible for the death of one in 10 adults (about 5 million deaths per year) and it is the fourth disease risk factor in the world. Many methods to quit smoking are available but in all cases, relapse is a common phenomena. The main risk factor for relapse is craving. So, acting on the craving seems essential to modulate tobacco consumption. Many functional neuroimaging studies have established a neuroanatomical substrate for craving process, in particularly dorsolateral prefrontal cortex (DLPFC), accessible par neuromodulation.

Eligibility criteria: Inclusion Criteria:

* Fagerström score ≥ 5
* Q-MAT score ≥ 6
* smoking subjects from 10 to 30 cigarettes a day
* right-handed subjects
* w/o severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
* Hamilton Depression Rating Scale-17 score \<18

Exclusion Criteria:

* pregnancy and/or lactation
* presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)

Primary outcomes:
measure: change from baseline in craving evaluated by item 1 of Fagerström test
timeFrame: baseline, day 10 and 1 month post-ttt
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Emmanuel Haffen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03881514: Mode of Delivery on Newborn Hearing Test
Official title: The Effect of Mode of Delivery on Automated Auditory Brainstem Response (AABR) Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss, Neonatal
Keywords: Newborn Hearing Screening
Automated Auditory Brainstem Response
Mode Of Delivery
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who gave birth in our hospital and who had a hearing test in their newborns will form the study group.

Brief summary: Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. The effect of the type of delivery to hearing screening is not yet clear. The first automated mode of delivery of babies born in Turkey auditory brainstem response (SAD's), the authors aimed to evaluate the effects of the test results and false positive rate.

newborns were evaluated with brainstem response test. The AABR test was performed before patients were discharged. Perinatal and neonatal variables and AABR test results were recorded retrospectively.


Eligibility criteria: Inclusion Criteria:

* records of birth process and
* pregnancy test results of newborns.

Exclusion Criteria:

* newborn;
* She was in a neonatal intensive care,
* congenital / chromosomal anomaly,
* undergoing congenital cmv infection,
* facial / ear deformity,
* families with hearing problems,
* those with hyperbiliromyemia,
* \<12 hours after delivery,
* maternal infection,
* dm,
* recurrent abortion,
* smoking,
* plesanta previa,

Primary outcomes:
measure: newborn hearing screening results
timeFrame: 1 week after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT06454214: 3D Structural Imaging of Human Breast Tissues
Official title: 3D Structural Imaging of Human Breast Tissues
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Human Breast Tissues
Keywords: breast tumor
tumor assessment
tumor microenvironment
digital pathology
3D pathology
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This research project aims to recruit 100 subjects and acquire three-dimensional images of the breast tissues. After reconstructing these images, the study will explore the diverse three-dimensional structures of tumor tissues and compare them with the structures of normal breast tissues.

Brief summary: This project aims to develop an advanced ex vivo medical microscopic imaging technology. By developing breast tissue staining techniques, acquiring microscopic images, and performing structural reconstruction, we seek to observe the 3D structure of breast tissue. This includes examining cell distribution, mammary ducts, and blood vessel distribution, to explore the different biological characteristics between normal breast tissue and various types of cancerous tissues.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and above.
* Patients clinically diagnosed with breast cancer.

Exclusion Criteria:

* Patients unable to provide consent (e.g., inability to speak, inability to communicate in Chinese, etc.).
* Patients for whom a definitive pathological diagnosis cannot be established.
* Patients suitable only for biopsy and not for surgical excision.
* Excised tissue showing severe radiation-induced changes under pathological examination.
* Tumor specimens smaller than 1 cm.
* Patients with ductal carcinoma in situ (DCIS).

Primary outcomes:
measure: Accuracy dependency on staining dye selection
timeFrame: 3 years
Secondary outcomes:
measure: Comparison between 3D pathology vs. FFPE on breast cancer samples with a focus on image contrast
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: