louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02515721: PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
Official title: Probe-based Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia,Intraepithelial Neoplasia,and Carcinoma:A Multicenter,Randomized,Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnostic Yield of Gastric Neoplasia
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Tongji Hospital
name: Zhejiang University
First posted: 2015-08-05
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80;
* patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;
* agree to give written informed consent.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia;
* Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), impaired renal function (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
* Inability to provide informed consent

Primary outcomes:
measure: the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer
timeFrame: 12 months
Secondary outcomes:
measure: the biopsy number needed for diagnosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Endoscopic unit of Qilu Hospital Shandong University
state: Shandong
Study officials:
References:
citation: Zuo XL, Li Z, Li CQ, Zheng YY, Xu LD, Chen J, Lin R, Song J, Yu CH, Yue M, Zhou Q, Liu ZY, Li YQ. Probe-based endomicroscopy for in vivo detection of gastric intestinal metaplasia and neoplasia: a multicenter randomized controlled trial. Endoscopy. 2017 Nov;49(11):1033-1042. doi: 10.1055/s-0043-115382. Epub 2017 Jul 28.
Clinical trial NCT03722121: Is the Distance of Patients From Rouen University Hospital Influencing the Time Between Colectomy and First Chemotherapy Cure for Colon Cancer?
Official title: Is the Distance of Patients From Rouen University Hospital Influencing the Time Between Colectomy and First Chemotherapy Cure for Colon Cancer?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Colon
Colectomy
Chemotherapy
Keywords: distance
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient having a cancer colon and hospitalized for colectomy: malignant tumor colon, in situ colon carcinoma or tumor with unpredictable or unknown evolution of the colon

Brief summary: This project has for objective to demonstrate that the increase of the distance "Patient home - center of treatment" may be associated with significant, other noticeable, noted events. This distance may also be available in the Rouen University Hospital. The study of the association in this distance and the delay in initiating chemotherapy after surgery in patients treated at the CHU correspond to a pilot study prior to the completion of the analysis at the regional scale.


Eligibility criteria: Inclusion Criteria:

- Patients who had colectomy for colon cancer and at least one chemotherapy treatment at CHU Rouen, between 2009 and the first half of 2015.

Exclusion Criteria:

* Patients who died in hospital before receiving a chemotherapy treatment
* Patients with a CIM code of metastasis during the stay of the colectomy or the first chemotherapy treatment
* Patients who received a chemotherapy treatment before colectomy
* Patients who have undergone several colectomies.

Primary outcomes:
measure: distance "home of patients - treatment center"
timeFrame: At the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT01965821: Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
Official title: Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: tracheal cuff pressure
continuous control
microaspiration
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflations and overinflations frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal cuff pressure.


Eligibility criteria: Inclusion Criteria: :

* Patients intubated in the ICU with a high volume / low pressure PVC-cuffed tracheal tube
* Predicted duration of mechanical ventilation \> or = 48h
* Age \> or = 18 years
* signed informed consent

Exclusion Criteria:

* Contraindication for semirecumbent position
* Contraindication for enteral nutrition
* Pregnancy
* refuse to participate to the study

Primary outcomes:
measure: percentage of recording time spent with cuff overinflation or underinflation
timeFrame: 48 hours
Secondary outcomes:
measure: Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lille
country: France
facility: ICU, Salengro Hospital, University Hospital of Lille
state: Nord
Study officials:
affiliation: University Hospital of Lille
name: Saad NSEIR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rouze A, De Jonckheere J, Zerimech F, Labreuche J, Parmentier-Decrucq E, Voisin B, Jaillette E, Maboudou P, Balduyck M, Nseir S. Efficiency of an electronic device in controlling tracheal cuff pressure in critically ill patients: a randomized controlled crossover study. Ann Intensive Care. 2016 Dec;6(1):93. doi: 10.1186/s13613-016-0200-2. Epub 2016 Oct 4.
Clinical trial NCT01315821: Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
Official title: Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Necrotizing Enterocolitis
Very Low Birth Weight Infants
Keywords: Saccharomyces boulardii
necrotizing enterocolitis
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Detailed description: The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Eligibility criteria: Inclusion Criteria:

* Very low birth weight infants \< 1500 gr

Exclusion Criteria:

* Genetic anomalies
* Not willing to participate
* Allergy to S. boulardii components

Primary outcomes:
measure: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants
timeFrame: up to 6 months
Secondary outcomes:
measure: Effect of Saccharomyces boulardii on culture proved sepsis
timeFrame: 6 months
measure: Effect of Saccharomyces boulardii on weight gain
timeFrame: up to 6 months
measure: Effect of Saccharomyces boulardii on length of hospital stay
timeFrame: up to 6 months
measure: Effect of Saccharomyces boulardii on mortality
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Gamze Demirel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Clinical trial NCT01328821: Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499
Official title: A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose, Safety, Tolerability, Pharmacokinetics, and Relative Bioavailability Study of CTP-499 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Nephropathy
Keywords: Safety
Tolerability
Pharmacokinetics
Healthy volunteers
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-04-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.

Detailed description: This is a double-blind, single ascending dose administration study of four doses of CTP-499. Following dosing safety and tolerability will be assessed. Blood and urine samples will be taken for pharmacokinetics (PK) and bioavailability. Safety assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, and physical examination findings.

The plasma concentration time data for CTP-499 and its metabolites will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analysis. The primary pharmacokinetics parameters are: Cmax, Tmax, T1/2, AUClast and AUCinf for plasma; relative bioavailability; and Ae and CLr for urine.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* ages 18 to 55 years old
* nonsmokers
* BMI of 18 to 30 kg/m2

Exclusion Criteria:

* Significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders of drug hypersensitivity
* Systolic Blood pressure \< 90 or \> 140, diastolic bp \> 90

Primary outcomes:
measure: To assess safety and tolerability of CTP-499
timeFrame: 5 days
Secondary outcomes:
measure: To assess Pharmacokinetics, Pharmacodynamics and relative bioavailability
timeFrame: 2 days
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Frontage
state: New Jersey
Study officials:
affiliation: Frontage Clinical Services
name: Gregory Tracey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913621: The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
Official title: The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations: A Novel Intervention for Children at Risk for Aspiration-Associated Complications (Aim 3)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Feeding Difficulties
Gastrostomy
Aspiration
Keywords: blenderized
bile acid
gastrostomy
aspiration
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 138
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring gastrostomy tube feeds for feeding difficulties

Brief summary: Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.


Eligibility criteria: Inclusion Criteria:

* receive at least 80% of their nutritional needs via gastrostomy
* receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula
* receive their bolus feeds within 30 minutes or less.

Exclusion Criteria:

* have undergone anti-reflux surger
* receive post-pyloric feeds
* receive regular daily prophylactic antibiotics.

Primary outcomes:
measure: total hospitalization and emergency room visits rates
timeFrame: 6 months
Secondary outcomes:
measure: differences in pulmonary, gastrointestinal or ICU admission rates
timeFrame: 6 months
measure: differences in bile acid concentrations
timeFrame: 6 months
measure: correlations between microbial abundance and diversity and hospitalization and emergency room visit rates
timeFrame: 6 months
measure: differences in metagenomic patterns between diets
timeFrame: 6 months
measure: correlations between admission rates by diet type and short chain fatty acid concentrations
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01131221: S8947-9800-9911-0016A Vitamin D Insufficiency in Determining Prognosis in Patients With Newly Diagnosed Follicular Lymphoma
Official title: Vitamin D Insufficiency and Follicular Lymphoma Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-26
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients enrolled in S8947-9800-9911-0016 consenting to banking

Brief summary: RATIONALE: Studying samples of serum from patients with cancer in the laboratory may help doctors identify and learn more biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying vitamin D insufficiency in determining prognosis in patients with newly diagnosed follicular lymphoma.

Detailed description: OBJECTIVES:

* To evaluate the role of pre-treatment serum 25(OH)D with regard to progression-free survival and objective response among patients with newly diagnosed follicular lymphoma, within the context of a uniformly treated and evaluated Phase III clinical trial in the modern therapeutic era.

OUTLINE: This is a multicenter study.

Pre-treatment serum samples are analyzed for 25(OH)D levels to determine vitamin D sufficiency or insufficiency.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Newly diagnosed CD20+ follicular lymphoma
* Enrolled on clinical trial SWOG-S0016, SWOG-9800, or SWOG-9911
* Pre-treatment serum available through SWOG-8947

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Progression-free survival
timeFrame: retrospective
Secondary outcomes:
measure: Objective response (confirmed and unconfirmed complete and partial responses)
timeFrame: retrospective
Other outcomes:
Locations:
Study officials:
affiliation: James P. Wilmot Cancer Center
name: Jonathan W. Friedberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01926821: Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer During Radiation or Chemoradiation Therapy
Official title: The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cervical Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy

1. Primary endpoint : Quality of life
2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan

Detailed description: Study design Prospective randomized controlled trial

Study period Protocol registration approval date - may/31/2016

Study drug Sonifilan(Sizofiran)

Study population

1. Cervical cancer FIGO stage IA2-IVA patients will be participated.
2. Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
3. age 20-75 year

Treatment Fron the day of radiation therapy started, Sonifilan 20mg, 1amp IM/week for 8weeks

Concurrent therapy Chemo \& radiation therapy

1. Cisplatin 40mg/m2, day 1, 8, 15, 2, 29, 36
2. External whole pelvic irradiation 3000-3500 cGy / 6 fractions in high dose rate

Assessment

1. Pre-study assessment (within 4weeks before participation) a medical history b informed consent c ID number assignment d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI e basic information collect
2. On-study assessment (during study) a complication check b life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI

3. Post-study assessment (1week after study finished) a MRI b PAP smear c HPV test d life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI

4 Follow-up assessment (every 3 month for 1 year) a Pelvic exam b PAP smear c HPV test d MRI (if needed) e PET (if needed) f life quality assessment - fill out EORTC QOQ-C30, CX24, SF-36, FSFI 93, 6, 12, 24 month after study finished)

Eligibility criteria: Inclusion Criteria:

* Cervical cancer FIGO stage IA2 - IVA
* Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma
* GOG performance status 0-2

Exclusion Criteria:

* past radiation therapy history
* Neuroendocrine carcinoma
* concurrent other cancer
* uncontrolled medical disease
* ulcerative disease history
* current pregnancy and lactation

Primary outcomes:
measure: Quality of life
timeFrame: 3 year
Secondary outcomes:
measure: Complications of drug, treatment effects
timeFrame: 3 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: JongHyeokKim
Study officials:
affiliation: Asan Medical Cneter
name: jongHyeok Kim, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06201221: Single-port Laparoscopy in Children and Adolescents
Official title: Advantages of Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents: A Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Ovarian Tumors
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
Collaborators: name: Quanzhou First Hospital
name: First Affiliated Hospital of Fujian Medical University
First posted: 2024-01-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged ≤18 years and pathologically diagnosed with BOT were collected from the electronic medical records of six gynecological oncology medical centers in Fujian, China between January 2019 and January 2023.

Brief summary: To compare the safety evaluation, efficacy evaluation, long-term aesthetics and psychological satisfaction of single-port and multiport laparoscopy for children and adolescents with BOT in China.


Eligibility criteria: Inclusion Criteria:

* Patients ≤18 years old
* Postoperative pathological diagnosis confirmed benign ovarian tumor
* Multi-hole laparoscopic or single-hole laparoscopic surgery
* Medical records and pathological data were complete and available

Exclusion Criteria:

* Patients with malignant pathological diagnosis
* Patients undergoing open surgery
* Incomplete medical records or pathological data

Primary outcomes:
measure: Operation duration
timeFrame: 3 hours
Secondary outcomes:
measure: The Visual Analog Scale (VAS) score
timeFrame: 24 hours after surgery
measure: 5-point Likert scale
timeFrame: 1 month and 1 year after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Maternal and Child Health Hospital
state: Fujian
Study officials:
affiliation: Fujian Maternity and Child Health Hospital
name: Pengming Sun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: