louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00139451: Nutrients and Hormones: Effects in Boys With Disordered Growth
Official title: Nutrients and Hormones: Effects in Boys With Disordered Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constitutional Growth Delay
Nutrition Disorders
Growth Disorders
Keywords: GH
Delayed Growth
Energy Expenditure
Puberty
Nutrition
Short Stature
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-08-31
Enrollment: 20
Sex: MALE
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those given GH plus added nutritional supplements for one year.

Detailed description: Two groups of boys 7-10 years old who are very short and below average in weight but otherwise healthy will be studied. One group will be observed initially for 6 months and then receive GH injections every day for the subsequent 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then receive GH injections plus the supplement every day for the next 12 months. We will compare how well boys grow in height, weight and the changes in body composition. We will compare diet and energy usage using the doubly labeled water technique. A battery of hormonal and nutritional tests will be performed, as well as body composition assessment.

Eligibility criteria: Inclusion Criteria:

* Boys 7-10 years old who are very short and below average in weight but otherwise healthy.
* Delay in skeletal maturation \> 1 year.

Exclusion Criteria:

* Growth hormone deficiency
* Chronic illness
* Participation in high endurance athletics

Primary outcomes:
measure: Change in height, weight, and body composition
timeFrame: 6month, 12month, 18month
Secondary outcomes:
measure: Changes in total energy expenditure
timeFrame: 6month, 12month
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Nelly Mauras, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01344551: Effects of Cocoa Flavanols on Human Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neural Degeneration
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.

Detailed description: This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.

Eligibility criteria: Inclusion Criteria:

* Aged 62 - 75 years
* A signed consent form

Exclusion Criteria:

* Blood pressure \> 160/90 mmHg
* Haemoglobin (anaemia marker) \< 125 g/l
* Gamma GT (liver enzymes) \> 80 IU/l
* Had suffered a myocardial infarction or stroke in the previous 12 months
* Suffers from any gastrointestinal/stomach disorder
* Suffers from any blood-clotting disorder
* On medication for hypertension
* Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
* Depression or major mental illness
* Any dietary restrictions or on a weight reducing diet
* Drinking more than 21 units per week
* On any medication affecting blood clotting
* Smoking
* Vegans

Primary outcomes:
measure: Executive function - attention
timeFrame: change from baseline to 2 hours
Secondary outcomes:
measure: Blood pressure
timeFrame: change from baseline to 2 hours
measure: Plasma flavanols
timeFrame: change from baseline to 2 hours
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Reading
name: Laurie Butler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01846351: Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes
Official title: Visual and Anatomic Outcomes of Intravitreal Anti-VEGF Therapy for Exudative Age-related Macular Degeneration With Concurrent Significant Epiretinal Membrane.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Age Related Macular Degeneration
Keywords: choroidal neovascularization
epiretinal membrane
anti-VEGF
Lead sponsor: New England Retina Associates
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 58
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age-related macular degeneration

Brief summary: Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.

Detailed description: Gass in 1987 described three cases of epiretinal membrane (ERM) associated with wet macular degeneration. Since then we have seen that is not rare to find the coexistence of these entities. An ERM may produce intrinsic disorganization of the outer retina leading to persistent increased macular thickness and/or edema. This persistent edema may affect the effectiveness in the treatment of exudative age-related macular degeneration (eAMD). Therefore, this study was designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.

Eligibility criteria: Inclusion Criteria:

* Significant epiretinal membrane
* Anti-VEGF treatment for age-related macular degeneration

Exclusion Criteria:

* Uveitis
* Macular disorders
* Diabetic retinopathy
* Vascular occlusions

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 12 months
measure: Central macular thickness
timeFrame: 12 months
measure: Fluorescein angiogram
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New England Retina Associates
name: Nauman A Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Retina Associates
name: Peter E Liggett, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00541151: MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
Official title: Long-Term Effectiveness Trial for AMS Sling Systems
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Urinary Incontinence in Women
Keywords: Stress urinary incontinence in Women
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 188
Sex: FEMALE
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: Females 18 years or older who have confirmed SUI

Brief summary: Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.

Detailed description: This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires.

Eligibility criteria: Inclusion Criteria:

* Females 18 years or older who have confirmed SUI defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise.

Exclusion Criteria:

* Unwilling or unable to sign ICF
* Unable to understand the study or has a history of non-compliance with medical devices
* Contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses
* Pelvic prolapse greater than grade 3
* Is, in the investigator's opinion, otherwise unsuitable for the study

Primary outcomes:
measure: Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of procedural variables of the implantation,outcomes,and long-term safety.These outcomes will be measured via questionnaires, procedural data, and report of adverse events.
timeFrame: 2 years
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: McKay Urology Research
state: North Carolina
Study officials:
affiliation: McKay Urology Research
name: Michael Kennelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04724551: The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula
Official title: The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Neoplasm
Keywords: Pancreatic fistula
Neutrophil-to-Lymphocyte Ratio
Pancreatoduodenectomy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3 cohorts, which were as follows: the set of 451 patients was randomly sampled following a ratio 2:1 into a training (n=301) and a validation (n=150) cohort to respectively determine and validate the accuracy, best timing, and cut-off for the surrogate markers, then validated in an external cohort (n=197).

Brief summary: There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.

Detailed description: From January 1, 2012 to December 31, 2020, consecutive patients underwent PD performed at Institut Paoli-Calmettes for various pathologies. Data were entered prospectively into a clinical database (NCT02871336).

The cohort was split into 3 groups:

* a training cohort ;
* an internal validation cohort (Paoli Calmettes institute);
* an external validation cohort (Rennes Pontchaillou Hospital).

Eligibility criteria: Inclusion Criteria:

* Patients who underwent pancreatoduodenectomy

Exclusion Criteria:

* Total pancreatectomy
* Enucleation

Primary outcomes:
measure: Incidence of clinically relevant pancreatic fistula
timeFrame: at hospital discharge assessed up to 30 days
Secondary outcomes:
measure: Biological markers
timeFrame: Postoperative day one and three
Other outcomes:
Locations:
Study officials:
affiliation: Institut Paoli-Calmettes- (IPC)
name: Olivier Turrini, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06915051: The Relationship Between Umbilical Cord Coiling Index and Fetal Cardiac Functions.
Official title: Evaluation of the Relationship Between Umbilical Cord Coiling Index and Fetal Cardiac Functions.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Umbilical Cord Coiling Index and Fetal Cardiac Functions
Keywords: Umbilical cord coiling index
fetal cardiac functions
umbilical cord
fetal circulation
Lead sponsor: Sanliurfa Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton uncomplicated pregnancies between 20-24 weeks seeking routine antenatal care will be included.

Brief summary: The maximum efficiency of umbilical cord blood flow depends on a specific number of coils. With modern ultrasound techniques, investigators can now detect cord abnormalities even before birth. In recent years, there has been a renewed interest in the umbilical cord, and several articles have been published regarding the number of coils.In this study, the relationship between the umbilical cord coiling index and fetal cardiac functions was evaluated.


Eligibility criteria: Inclusion Criteria:

-Singleton uncomplicated pregnancies between 20-24 weeks seeking routine antenatal care.

Exclusion Criteria:

* Multiple pregnancy
* Preterm rupture of membranes
* Chorioamnionitis
* Placental abruption
* Severe fetal growth restriction
* Congenital anomalies of the fetus
* Preeclampsia
* Oligohydramnios
* Maternal diabetes.

Primary outcomes:
measure: The correlation between the fetal umbilical cord coiling number and the concurrently performed fetal echocardiography findings.
timeFrame: The correlation between the fetal umbilical cord coiling index and the echocardiographic findings of the fetus within the first hour will be investigated.
Secondary outcomes:
Other outcomes:
Locations:
city: Sanliurfa
country: Turkey
facility: Sanliurfa Education and Research Hospital
Study officials:
References:
Clinical trial NCT05204251: Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt
Official title: Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Liver Disease
Keywords: Chronic liver disease
TIPS
Quality of life
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Advanced Chronic Liver Disease who underwent a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement at the University Hospital of Strasbourg

Brief summary: Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites.

One of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).

The indications for placing TIPS take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites.

TIPS placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life.

Very few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales.

The main objective of this study is to evaluate the quality of life of patients who have undergone TIPS using a validated and standardised quality of life questionnaire (the SF-36 questionnaire).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients referred to the TIPS service between January 2012 and October 2020 at the University Hospitals of Strasbourg, with a follow-up period of at least 1 month
* Subjects who have not expressed any opposition to the use of their medical data for research purposes
* For subjects invited to fill in the questionnaires: subject having expressed his/her agreement with the use of his/her medical data in the framework of the current study

Exclusion Criteria:

* Diseased patient
* Liver transplant patient following TIPS
* Pregnancy
* Patient in a vulnerable situation
* Patient under court protection, guardianship or trusteeship
* Difficulties in understanding the questionnaire
* Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under legal protection

Primary outcomes:
measure: Mental component of quality of Life of the
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02027051: Etude génétique Des Arméniens
Official title: Etude génétique Des Arméniens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: population genetics
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-01-03
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Descends of individuals originating from Armenia.

Brief summary: This study aims at better understanding the genetic structure of the Armenians, an old population whose genetics has not been the subject of many studies. We will study 500 individuals whom grandparents originate from different regions of Armenia. Each individual will be genotyped using a large panel of genetic markers. Principal component analysis will be used to analyze the genetic structure of this population.


Eligibility criteria: Inclusion Criteria:

* Four grand-parents originating from Armenia

Exclusion Criteria:

* One or more grand-parents not originating from Armenia

Primary outcomes:
measure: Genome wide genotyping of individuals
timeFrame: 3 months following inclusion
Secondary outcomes:
measure: Principal component analysis of genotypes
timeFrame: Three months after completion of individual genotypes
Other outcomes:
measure: Genetic structure
timeFrame: One month after principal component analysis of individuals
Locations:
city: Paris
country: France
facility: Hovnanian
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Emmanuelle Genin, Researcher
role: STUDY_DIRECTOR
References:
Clinical trial NCT00762151: A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Official title: Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Plaque
Keywords: Dental Plaque
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.

Detailed description: The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.

Eligibility criteria: Inclusion Criteria:

* Must be between ages 18 to 65 years inclusive
* Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present
* Must give written informed consent
* Be in good general health
* Must discontinue oral hygiene for 24-hours after initial appointment
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental visits/procedures
* Advanced periodontal disease
* 5 or more decayed, untreated dental sites
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of drugs that can affect salivary flow
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff
* Pregnant or breastfeeding
* Participation in another clinical study in the month preceding this study
* Allergic to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* History of allergic reaction to any anti-inflammatory agents

Primary outcomes:
measure: Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
timeFrame: Baseline (time zero), 24 hour time point
Secondary outcomes:
Other outcomes:
Locations:
city: Cedar Knolls
country: United States
facility: Concordia Research Laboratories
state: New Jersey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03189251: HFCS, Apple Juice, Excess Free Fructose & asthma-the FHS-OS
Official title: Moderate Intake of High Fructose Corn Syrup Sweetened Soft Drinks, Fruit Drinks and Apple Juice Increases Asthma Risk - the Framingham Offspring Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: DeChristopher, Luanne R.
Sponsor class: INDIV
Collaborators: name: Jaime Uribarri, M.D.
name: Katherine L. Tucker, Ph.D.
First posted: 2017-06-16
Enrollment: 2657
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the Framingham Heart Study (Offspring) cohort

Brief summary: Perform an exploratory analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.


Eligibility criteria: Inclusion Criteria:

* Participants in the FHS Offspring who answered questions in the FFQ about soft drinks, fruit drinks and fruit juice consumption; Participants with non-missing data for the exposures and potentially confounding variables of interest.

Exclusion Criteria:

* Extreme energy intake on food frequency questionnaire (defined as ≤600 kcal/day or ≥4800 kcal/day)

Primary outcomes:
measure: Asthma
timeFrame: Exams 3 - 7, 17 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: