louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00479518: Prognostic Value of Cardiac and Renal Markers in Ischemic Stroke and Transient Ischemic Attack
Official title: Prognostic Value of Cardiac and Renal Markers in the Acute Phase of Ischemic Stroke or Transient Ischemic Attack :Albuminuria-Brain Natriuretic Peptide-Cystatine C in Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: stroke
transient ischemic attack
albuminuria
BNP
Cystatin C
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2007-05-28
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Ischemic stroke or TIA

Brief summary: Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome, recurrence of cardiovascular events or vascular death.Until now, no reliable predictive biological marker could be identified in the acute phase of stroke.We hypothese that, in the acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide, BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular events or vascular death. We want to assess which one of these markers has the best prognosis value , in a prospective study of 300 stroke patients followed during 3 years.

Detailed description: Patients with ischemic stroke or TIA will be included in the 48 hours following the onset of symptoms, in 3 university hospitals.For each patient will be collected

* 1 blood sample for the BNP measure in pg/ml
* 1 blood sample for the Cystatin C measure in mg/l
* 2 urinary samples to measure the albumine/creatinine ratio, at inclusion and 5 days after the inclusion, and to study the variation of albuminuria in micrograms/min.

The clinical follow-up will be organized during 3 years. The following events will be notified: poor outcome (defined with the Barthel and Rankin scores), recurrence of cardiovascular or cerebrovascular events, vascular death.

After adjustment on the main clinical prognosis factors, we want to determine wich one of these markers has the best prognosis significance and allows to identify in the acute phase the "high-risk" patients, in order to intensify individual treatment and secondary prevention.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke or TIA in the first 48 hours following the onset of symptoms

Exclusion Criteria:

* Patient unable to give an informed consent
* Urinary sample impossible to collect

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Service de Neurologie / Hopital LAENNEC
city: Rennes
country: France
facility: Service de neurologie / CHU Pontchaillou
city: Tours
country: France
facility: Service de Neurologie / CHRU de Tours
Study officials:
affiliation: Service de Neurologie / CHRU de Tours
name: BONNAUD Isabelle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01956513: Contribution of MRI in the Evaluation of Apparent Diffusion Coefficient and Prediction of Response to Neoadjuvant Chemotherapy in Breast Cancer
Official title: Etude ADC Apport de l'IRM Dans l'évaluation du Coefficient de Diffusion Apparent et prédiction de la réponse à la chimiothérapie néoadjuvante Dans le Cancer du Sein
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Assess the Variation of Apparent Diffusion Coefficient
Keywords: ADC
breast cancer
complete pathological response
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the study is to assess the sensitivity and the specificity of the variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant chemotherapy or after modification of the treatment sequence, the pathological response at the end of chemotherapy


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years.
* Patient suffering from a breast tumor, regardless of the stage and size
* Patient requiring neoadjuvant chemotherapy
* Patient has the ability to undergo 18F-FDG-PET at baseline, at end of cycle 1 and at the end of neoadjuvant treatment before surgery
* Compulsory affiliation to a social security system.
* Obtaining informed consent in writing, signed and dated.

Exclusion Criteria:

* Patient with cognitive or psychiatric disorders.
* Patient deprived of liberty by a court or administrative.
* Patient with signs against the achievement of MRI, mammography and ultrasound
* Patient metastatic
* Patient with prior chemotherapy, radiotherapy and hormone therapy for her breast cancer
* Pregnant women, current lactation
* Patient suffering from uncontrolled diabetes (\> 11 mmol / L)

Primary outcomes:
measure: Variation of apparent diffusion coefficient before / after a cycle of neoadjuvant chemotherapy or before / after modification of the treatment sequence and correlated with histologic response
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Jean Perrin
name: Anne BAILLY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05176613: Effects of High Frequency rTMS Combined Motor Learning on Upper Limb Motor Function in Subacute Stroke
Official title: Effects of High Frequency Repetitive Transcranial Magnetic Stimulation Combined Motor Learning on Motor Function and Grip Force for Upper Limbs and Activities of Daily Living in Sub-acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Hemiplegia
Lead sponsor: Chungnam National University Sejong Hospital
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to present the effect of a program combining high frequency repetitive transcranial magnetic stimulation with motor learning on upper limb motor function and grip strength and activities of daily motion in patients with subacute stroke.

Purpose : This study was to investigate the effects of high frequency repetitive transcranial magnetic stimulation combined with motor learning effects motor function and grip force for upper limbs and activities of daily living of subacute stroke patients.

Subjects : Thirty individuals with subacute stroke, satisfying the selection criteria, were selected for this study. Subject were randomly allocated into 14 high frequency repetitive transcarnial magnetic stimulation+motor learning group(experimental group), 16 sham repetitive transcranial magnetic stimulation+motor learning group(control group).

Intervention : 12 sessions, 3d/wk, 4week Studies : upper limb functional assessment(FMA-U/L, BBT), hand grip force assessment(disital hand dynamometer), activities daily of living assessment(K-MBI) Evaluation : 1)pre test 2)post test


Eligibility criteria: Inclusion Criteria:

* Hemiplegia from stroke
* Factors within six months of onset
* Found to have subcortex damage through diagnoses of magnetic resonance imaging(MRI)
* Had motor defects on the damaged upper extremities
* Korean version Mini mental state examination(MMSE-K) score greater than 24 points

Exclusion Criteria:

* Permanent damage such as heart vein
* Upper limb fractures
* Neurological damage such as Parkinson's, multiple sclerosis
* Other reasons limiting upper limb movement
* Epilepsy or family history of epilepsy
* wearing a metal tube in skull or pacemaker
* The lesion at occipital lobe

Primary outcomes:
measure: Fugl Meyer Assessment - Upper Limb(FMA-U/L)
timeFrame: Change from baseline at the end of four weeks intervention
Secondary outcomes:
measure: Box and Block Test(BBT)
timeFrame: Change from baseline at the end of four weeks intervention
measure: Digital hand dynamometer
timeFrame: Change from baseline at the end of four weeks intervention
measure: Korean version of the Modified Barthel Index(K-MBI)
timeFrame: Change from baseline at the end of four weeks intervention
Other outcomes:
Locations:
Study officials:
affiliation: Chungnam National University Hospital
name: JungWoo Shim, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213213: Using Sugar Water to Relieve Pain in Infants
Official title: Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Infant, Newborn
Diabetes
Keywords: sucrose
analgesia
pain
neonates
diabetes
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-21
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.

We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.


Eligibility criteria: Inclusion Criteria:

* healthy newborn infants ≥36 weeks gestation
* infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent)and infants born to mothers without diabetes

Exclusion Criteria:

* Admission to the neonatal intensive care unit
* plan to undergo circumcision during the study period
* major congenital or neurological anomalies
* clinical diagnosis of birth asphyxia or seizures
* receiving analgesics or sedatives

Primary outcomes:
measure: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
Secondary outcomes:
measure: (effectiveness):
measure: - Effectiveness of sucrose for repeated heel lances
measure: - Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture
measure: - Effectiveness of sucrose in decreasing pain response during Vitamin K injection
measure: - Determination of relationship between painful procedures and infant response during routine care procedures
measure: (safety):
measure: - Incidence of vomiting during administration of sucrose
measure: - Oxygen saturation during administration of sucrose
measure: - Serum Glucose concentrations in infants of diabetic mothers
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taddio A, Shah V, Hancock R, Smith RW, Stephens D, Atenafu E, Beyene J, Koren G, Stevens B, Katz J. Effectiveness of sucrose analgesia in newborns undergoing painful medical procedures. CMAJ. 2008 Jul 1;179(1):37-43. doi: 10.1503/cmaj.071734.
Clinical trial NCT03868813: An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)
Official title: An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be a total of two 2 groups - one group comprising of 10 health experts and another group 2comprising of 10 patient/caregiver dyads (20 people). There is no treatment or intervention offered, only the interview questionnaire will differ based on the group.

Brief summary: This protocol involves a qualitative study of the needs/preferences of people with diabetes and health coaches regarding a telehealth coaching platform for glycemic control in people with diabetes.


Eligibility criteria: Inclusion Criteria:

Health Coaches Group:

(i) age between 18 and 80 years (ii) fluent in English (iii) work in or carry expertise in physical activity, nutrition/diet or health behavior.

People with Diabetes Group (Patient/Caregiver Dyads):

(i) age between 18 and 80 years (ii) fluent in English (iii) have Type-II diabetes.

Exclusion Criteria:

None

Primary outcomes:
measure: Users' Expectation from a Health Coaching System
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT04412213: Correlation of Family History, Age at Onset & Severity of Stuttering
Official title: Correlation of Family History, Age at Onset and Severity of Stuttering in School-age Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stuttering, Childhood
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 stuttering childern, age between 7 and 15 years, with an IQ =80 or more

Brief summary: The aim of this study is to Detect the influence of the family history of stuttering (distance of relative) on the onset and severity of stuttering in children in these families. Also to explore developmental differences among young stutterers.


Eligibility criteria: Inclusion Criteria:

* 1-Age: from 7 to 15 years old. 2-Gender: both sexes will be included in the study. 3-The participants are diagnosed as stutterers by an expert phoniatrician. 4-Children will be accepted only if full information is provided concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, and the age of onset of stuttering manifestations. 5-Mentality: IQ is 80 or more

Exclusion Criteria:

* 1-Age below 7 years or above 15 years. 2-Failure to provide full information concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, or age of onset of stuttering manifestations.. 3- IQ less than 80

Primary outcomes:
measure: assess the correlation between family history, age of onset and severity of stuttering
timeFrame: year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yairi E, Ambrose N. Onset of stuttering in preschool children: selected factors. J Speech Hear Res. 1992 Aug;35(4):782-8. doi: 10.1044/jshr.3504.782.
citation: Buck SM, Lees R, Cook F. The influence of family history of stuttering on the onset of stuttering in young children. Folia Phoniatr Logop. 2002 May-Jun;54(3):117-24. doi: 10.1159/000063407.
Clinical trial NCT05059613: Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
Official title: Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Mucositis
Quality of Life
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

Detailed description: Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China.

Eligibility criteria: Inclusion Criteria:

* Karnofsky score ≥80 ,newly diagnosed NPC without distant metastasis, confirmed by pathology without any other malignant disease history ,no any other anti-cancer treatment for NPC previously ,received radiotherapy and chemotherapy at our Cancer Center

Exclusion Criteria:

* any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease

Primary outcomes:
measure: the incidence of Radiation Therapy Oncology Group grade 3 mucositis
timeFrame: one month
measure: the variaty of immune index
timeFrame: one month
measure: the variaty of immune index
timeFrame: one month
measure: the variaty of immune index
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
Study officials:
affiliation: Jiangxi Provincial Cancer Hospital
name: Chunling Jiang, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04589013: Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer
Official title: Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients meeting the inclusion criteria will be selected in each of the centers (Lille CHU, Lille Centre Oscar Lambret, Valenciennes Clinique Teissier, Roubaix CH) by the onco-pneumologists and included in the study, after collecting the consent, at the start of treatment with pembrolizumab + chemotherapy in first line.

Brief summary: This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.


Eligibility criteria: Inclusion Criteria:

* 18 years at time of diagnosis
* Affiliation to a social insurance
* Obtaining the patient's non opposition
* Patients with non-small cell lung carcinoma, confirmed by anatomopathological, metastatic or locally advanced unresectable, not eligible for local curative treatment
* Cellular or tissue FFPE available
* Indication of treatment with pembrolizumab + first line chemotherapy in multidisciplinary consultation meeting
* No mutation of the EGFR gene, no rearrangement of ALK and ROS,
* At least one measurable tumor according to RECIST criteria

Exclusion Criteria:

* Tissue or cellular FFPE not available
* Systemic anti-neoplastic or immunotherapy previously received except neoadjuvant or adjuvant treatment completed 6 months or more

Primary outcomes:
measure: The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year.
timeFrame: At 1 year
Secondary outcomes:
measure: Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test.
timeFrame: At 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Clcc Oscar Lambret Lille
city: Lille
country: France
facility: Hop Calmette Chu Lille
city: Roubaix
country: France
facility: CH Victor Provot
city: Valenciennes
country: France
facility: Clinique Teissier
Study officials:
affiliation: University Hospital, Lille
name: Sarah Humez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02135913: Roles of Vitamin D and HDL in Obese Children
Official title: Roles of Vitamin D and HDL in Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Vitamin D Deficiency
Low HDL
Keywords: Obese
Children
Vitamin D deficiency
Low HDL
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 1
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study to determine the association between Vitamin D deficiency in obese children and low high density lipoprotein (HDL) and dysfunctional HDL.

Detailed description: Subjects will be identified through the Department of Pediatric - High Body Mass Index (BMI) Clinic by Dr. Aurelia Radulescu during standard of care visit. Dr. Radulescu will determine if the subject meets study eligibility requirements.

Visit 1 (Baseline/Screening): Consent/assent will be obtained, medical history, demographic information along with height and weight will be collection. Clinical Laboratory testing, although not part of this study, will include the following standard of care tests. The results of Vitamin D and Lipid profile testing will be shared with Dr. Li by Dr. Radulescu.

* Lipid profile
* Vitamin D
* AST/ALT
* Hb A1C
* Glucose
* CBS w/diff
* TSH
* BUN, Creatine
* UA

Subjects will be placed on standard of care Vitamin D supplementation for 12 weeks.

Visit 2 (3 month visit) End of Study: Subjects will return to the BMI clinic at month 3 for follow-up and additional clinical laboratory testing (see visit 1 for a description of testing to be performed) in order to assess their response to Vitamin D supplementation. Subjects with previously reported abnormal Lipid values will have a Lipid profile repeated at this visit. Month 3 visit will be the End of Study visit.

Eligibility criteria: Inclusion Criteria:

* Obese children
* Vitamin D deficiency
* Low HDL

Exclusion Criteria:

* HIV
* Hepatitis A
* Hepatitis B
* Hepatitis C
* Non-English speaking

Primary outcomes:
measure: Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation
timeFrame: up to 24 months
Secondary outcomes:
measure: Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Xiang An-Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: