louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01252706: Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: brief intervention
alcohol
nicotine
drug abuse
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Israel
First posted: 2010-12-03
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov) and to evaluate study Brief Intervention impact on reduction exposure, and its effect on newborn outcomes.

Detailed description: All pregnant women who will arrive to Poria (and third of pregnant who will arrive to Ichilov) ER, high risk, and follow-up clinic will be asked for alcohol exposure, smoking and psychoactive substance usage. Relevant women will be asked to participate in a brief intervention treatment for about 30 min by expert personal, and a follow-up by phone every 3 months during pregnancy and post deliver. In addition, through all the year, questionnaires about exposure will be given to all women who will have labor (about 3000 labors), and third of 10,000 expecting in Ichilov. We expect in the second half of the year, to have those who enrolled to the BI. New-born outcome of the BI group as compared to the non-BI group will be compared, as well as rate of alcohol/substance/nicotine abstinence and reduction.

Eligibility criteria: Inclusion Criteria:

* pregnant women who smoke cigarets, drink alcohol and or abuse any drugs

Exclusion Criteria:

* pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs

Primary outcomes:
measure: nicotine, alcohol and drug abstinence
timeFrame: during pregnancy until labor
Secondary outcomes:
measure: newborn weight of birth
timeFrame: at labor
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Poria Medical Center
Study officials:
References:
Clinical trial NCT01959906: Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.
Official title: Prognostic Value of a Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: Esophagectomy
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 923
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 923 consecutive pT3 patients operated between january 1990 and june 2013

Brief summary: A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and GE-Junction tumors.

Detailed description: From our prospectively build database 923 consecutive pT3 patients operated between january 1990 and june 2013 were selected. CRM status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery.

Kaplan-Meier survival curves were generated, and factors affecting survival were assessed by Cox regression multivariate analysis.

Eligibility criteria: Inclusion Criteria:

* pathologic T3 tumours of esophagus or GEJ

Exclusion Criteria:

* pT other than pT3
* R2 resections

Primary outcomes:
measure: overall survival
timeFrame: 5 years after esophagectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: University Hospital Leuven, dept. Thoracic Surgery
name: Philippe Nafteux, MD
role: STUDY_DIRECTOR
affiliation: Katholic University Leuven
name: Katrien Van de Steen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05070806: Plastic Surgery Training in Europe
Official title: Plastic Surgery Training in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plastic Surgery Training
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty-seven member countries of the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and Sweden) and Norway, Switzerland and the United Kingdom

Brief summary: Survey study to evaluate plastic surgery training in European countries.

Detailed description: National delegates of 30 European countries - the 27 member countries of the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and Sweden) and Norway, Switzerland and the United Kingdom were invited to complete a questionnaire on plastic surgery training.

Eligibility criteria: Inclusion Criteria:

* Countries of the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and Sweden) and Norway, Switzerland and the United Kingdom
* Countries must organise plastic surgery training

Exclusion Criteria:

* Countries other than member states of the European Union, Norway, Switzerland and United Kingdom
* Countries that do not provide plastic surgery training

Primary outcomes:
measure: Organisation of training
timeFrame: 2019-2020
measure: Scope of practical training curriculum
timeFrame: 2019-2020
measure: Scope of theoretical courses
timeFrame: 2019-2020
measure: Evaluation of trainees
timeFrame: 2019-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
Study officials:
References:
Clinical trial NCT06138106: Developing a Nutritional Supplement to Increase Collagen Synthesis in People
Official title: Developing a Nutritional Supplement to Increase Collagen Synthesis in People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dietary Supplements
Connective Tissue
Exercise
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether a natural product supplement can potentiate the increase in collagen synthesis following the ingestion of collagen protein. The investigators have developed a model of natural (GRAS certified) products that stimulate collagen synthesis, in vitro. The investigators will determine whether the natural product supplement can potentiate the collagen synthetic response to the ingestion of collagen protein. Basal and fed serum will be isolated and these samples will be used to treat human engineered ligaments.


Eligibility criteria: Inclusion Criteria:

* Young healthy adults (18-30 y)

Exclusion Criteria:

* Pregnancy
* Smoking
* Receiving any medication that may interfere with the study outcomes

Primary outcomes:
measure: Collagen protein synthesis
timeFrame: 7 days
Secondary outcomes:
measure: Strength of ligament constructs
timeFrame: 60 minutes post-exercise
measure: Collagen content of ligament constructs
timeFrame: 60 minutes post-exercise
Other outcomes:
Locations:
city: Davis
country: United States
facility: Hickey Laboratory
state: California
Study officials:
affiliation: University of California, Davis
name: Keith Baar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230906: Uremic Toxin Removal With a New High Flux Cellulose Triacetate Membrane
Official title: Uremic Toxin Removal With a New High Flux Cellulose Triacetate Membrane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemodialysis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Nissho Nipro Europe
First posted: 2005-10-03
Enrollment: 12
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: Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high flux cellulose triacetate membrane

Detailed description: Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high flux cellulose triacetate membrane

Eligibility criteria: Inclusion Criteria:

* Chronic haemodialysis patient
* Serum albumin \> 3.6 g/dl

Exclusion Criteria:

* \< 18 years

Primary outcomes:
measure: Concentration of uremic components after 3 weeks of haemodialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Van Holder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02063906: Prognostic Relevance of Biological Subtype in Breast Cancer
Official title: Prognostic Relevance of Biological Subtype Overrides That of TNM Staging in Breast Cancer: Discordance Between Stage and Biology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received curative surgery for stage I-III breast cancer between January 2004 and September 2008 and had available immunohistochemistry profiles.

Brief summary: Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. The aim of this study was to compare the prognostic relevance of the TNM staging system and intrinsic subtype in breast cancer patients who received curative surgery.

Detailed description: Identified patients who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008. Primary outcomes were recurrence-free survival (RFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* patients who received curative surgery
* stage I-III breast cancer
* between January 2004 and September 2008
* had available immunohistochemistry profiles.

exclusion Criteria:

* age \<18 years old
* microinvasive carcinoma of breast

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: 1 Year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Young-Hyuck Im, Pf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02516306: A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
Official title: A Phase 1/2 Prospective, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution, in Improving Distance Corrected Near Vision in Subjects With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Presbyopia
Keywords: Presbyopia
Vision
UNR844
Lead sponsor: Encore Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
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 EV06 Ophthalmic Solution is safe and effective in improving distance corrected near vision in people who have presbyopia.

Detailed description: Study subjects who were eligible for enrollment and had provided written informed consent were randomized in a 2:1 ratio to use of either EV06 Ophthalmic Solution or Placebo Ophthalmic Solution. For the first 7 days of study product administration (Period 1: Days 1-7), subjects applied 1 drop of their assigned study product to one eye twice per day. For the next 84 days (Period 2: Days 8 - 91), if there were no unanticipated and no significant adverse events observed in the treated eye, subjects applied 1 drop of their assigned study product to both eyes twice per day.

Eligibility criteria: Inclusion Criteria:

* 45 to 55 years of age
* Distance Corrected Near Visual Acuity worse than 20/40
* Best Corrected Distance Visual Acuity of 20/20 or better in each eye
* Willing and able to sign consent, following study instructions

Exclusion Criteria:

* Certain pupillary conditions
* Significant astigmatism, glaucoma, diabetes, cataracts, eye surgery, ocular trauma or accommodative issues
* contact lens wear within 3 days prior to and for duration of study
* use of prohibited medications
* participation in a clinical study within 30 days prior

Primary outcomes:
measure: Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit
timeFrame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center, Inc.
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
Study officials:
affiliation: Encore Vision, Inc.
name: Expert Clinical Project Lead Ophthalmology
role: STUDY_DIRECTOR
References:
Clinical trial NCT03998306: Probiotics in Children With Early Childhood Caries
Official title: Influence of the Probiotic Streptococcus Salivarius K12 on Dental Health in Children With Early Childhood Caries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dietary Supplement
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if probiotic lozenges taken once a day before bedtime for twelve weeks can decrease the numbers of Streptococcus mutans

Detailed description: Streptococcus salivarius is one of the commensal bacteria of the mouth and the main component of biofilm. Research indicates that some microorganisms present in plaque, which until recently were considered not to cause caries, including Streptococcus salivarius, present in the supragingival microbiome, can also cause tooth decay.

Eligibility criteria: Inclusion Criteria:

* generally healthy children aged 3-6;
* recognized caries of early childhood, dmf\> 1,
* lack of active caries and inflammation of the mouth
* CFU\> 105 / ml Streptococcus mutans
* a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.

Exclusion Criteria:

chronic diseases and chronically taken medicines in the past,

* planned change of residence during the year,
* age below 3 and above 6 years,
* healthy teeth, dmf = 0,
* CFU \<105 / ml Streptococcus mutans
* Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations
* no toothpaste with fluoride
* using xylitol
* lack of written consent of parents / legal guardians for participation in research.

Primary outcomes:
measure: Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Dorota Olczak-Kowalczyk
state: Warsaw, 18 Miodowa Saint
Study officials:
References:
Clinical trial NCT03015506: Measuring the Glycemic Index of Pulse Based Breads
Official title: Measuring the Glycemic Index of Pulse Based Breads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carbohydrate Intolerance
Lead sponsor: Glycemic Index Laboratories, Inc
Sponsor class: INDUSTRY
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2017-01-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine the glycemic index of 4 pulse-based breads in at least 10 normal healthy human volunteers. Participants will be studied in the morning on 6 separate days after overnight fasts. On the first and last days they will consume a test meal consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over 2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after white bread.


Eligibility criteria: Inclusion Criteria:

* participants in good health

Exclusion Criteria:

* known history of HIV
* known history of diabetes
* history of hepatitis within the last 3 months
* heart condition requiring hospitalization within 3 months
* use of medications or presence of any condition which in the opinion of the study physician, would increase the risk of harm to the subject or to others, or affect the results of the study.
* participants who cannot or will not comply with experimental procedures or the safety guidelines of Glycemic Index Laboratories, Inc.

Primary outcomes:
measure: Glycemic Index
timeFrame: 120 minutes
Secondary outcomes:
measure: Incremental area under the blood glucose response curve
timeFrame: 120 minutes
measure: Peak blood glucose concentration (Cmax)
timeFrame: 120 minutes
measure: Peak rise of blood glucose
timeFrame: 120 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06157606: Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy
Official title: Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Sleeve Gastrectomy
Weight Loss
Keywords: Sleeve Gastrectomy
Weight Loss
Prediction Model
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Shandong University
name: Jining First People's Hospital
First posted: 2023-12-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The population included patients with obesity who received sleeve gastrectomy between September 2017 and September 2024. All patients were followed up for at least 1 year.

Brief summary: This study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy.

Detailed description: Inadequate weight loss (IWL) is a major problem after sleeve gastrectomy, leading to the recurrence of obesity-related comorbidities and increased risk of revision surgery. It is important to identify the high-risk individuals for IWL before surgery so that clinicians can initiate more rigorous weight monitoring and management strategies. Therefore, this study aims to develop a prediction model using preoperative clinical and laboratory data to estimate the risk of IWL one year after sleeve gastrectomy, and then validate it using two separate datasets.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 27.5 kg/m2;
* 16 years ≤ age ≤ 70 years;
* Complete preoperative data and one-year follow-up information

Exclusion Criteria:

* Patients who did not undergo SG;
* Incomplete follow-up information;
* Patients with a history of pituitary or thyroid disease;
* Female patients who conceived within one year after surgery

Primary outcomes:
measure: Area under receiver operating characteristic curve (AUC) of the prediction model
timeFrame: 1 year
Secondary outcomes:
measure: Brier score of the prediction model
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yuntao Nie
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yuntao Nie, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Shandong University
name: Yinlu Ding, M.D.
role: STUDY_DIRECTOR
affiliation: Jining First People's Hospital
name: Ming Zhu, M.D.
role: STUDY_DIRECTOR
References: