louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02450643: Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Official title: Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow's Milk Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 83
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.


Eligibility criteria: Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to \<4 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
* Immunodeficiency
* Receiving free amino acid formula
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial.

Primary outcomes:
measure: allergic reaction
timeFrame: 2 hours post-DBPCFC
Secondary outcomes:
measure: stool characteristics
timeFrame: 1 week
measure: formula intake
timeFrame: 1 week
measure: adverse events
timeFrame: 1 week
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Atria Clinical Research
state: Arkansas
city: Mission Viejo
country: United States
facility: Allergy and Asthma Associates of Southern California
state: California
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Savannah
country: United States
facility: AeroAllergy
state: Georgia
city: New York
country: United States
facility: Mt. Sinai
state: New York
city: Newburgh
country: United States
facility: ENT & Allergy Associates
state: New York
city: Chardon
country: United States
facility: Allergy and Sinus Relief Center/Great Lakes Medical research
state: Ohio
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
Study officials:
affiliation: Mt. Sinai
name: Anna Nowak-Wegrzyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05686343: Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks
Official title: Hemodynamically Important PDA in Newborns Under 32 Weeks: Clinical and Echocardiographic Findings and Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patent Ductus Arteriosus After Premature Birth
Keywords: Cardiology
Newborn
Diseases
Congenital Heart Defects
Patent Ductus Arteriosus
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborns \< 32 weeks

Brief summary: To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.


Eligibility criteria: Inclusion Criteria:

* Born at less than 32 weeks newborns

Exclusion Criteria:

* Congenital heart disease
* Syndromic and/or major congenital anomaly

Primary outcomes:
measure: Diameter of PDA
timeFrame: 1 year
measure: Velosity of PDA
timeFrame: 1 year
measure: Left ventricule expansion
timeFrame: 1 year
measure: Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Özlem Bayram
Study officials:
affiliation: Ankara University
name: Özlem Bayram
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00425243: Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
Official title: Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5 mg Compared to Placebo, When Both Are Administered Over a Long-Term Period "as Needed", in Patients With Chronic Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: primary insomnia
chronic insomnia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 1025
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia.

Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.


Eligibility criteria: Inclusion Criteria:

* patients with chronic primary insomnia

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.
Secondary outcomes:
measure: Main secondary variables are the Clinical Global Impression (CGI) improvement item and to items 2, 3, and 4 of the PGI scale at week 12.
Other outcomes:
Locations:
city: Malvern
country: United States
facility: Sanofi-Aventis
state: Pennsylvania
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Krystal AD, Erman M, Zammit GK, Soubrane C, Roth T; ZOLONG Study Group. Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sleep. 2008 Jan;31(1):79-90. doi: 10.1093/sleep/31.1.79.
Clinical trial NCT04776343: Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity
Official title: Prospective, Randomized Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Macular Edema
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 88
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Verify the reliability of VA measured every week at home, by the patient using a TC, compared to the reliability of VA also measured by the patient using a TC but every 2 month at the hospital, during standard DME follow-up visits


Eligibility criteria: Inclusion Criteria:

Will be included in the study, patients with all of the following criteria:

* aged ≥ 25 years old (the minimum age is set at 25 years old in order to include patient with controlled diabetes);
* diagnosed with DME;
* followed and treated by anti-VEGF IVT in the ophthalmology debarment at Hopital Saint Joseph Marseille;
* having a VA score ≥ 20/100;
* able to understand the study and to use a TC;
* having an internet access at home;
* having given free and informed written consent;
* being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

Will not be included in the study, patients with one of the following criteria:

* treated for another pathology that DME;
* already participating to another research study;
* pregnant or breastfeeding woman;
* subject to a measure for the protection of justice.

Primary outcomes:
measure: Rate of patients with VA evolution in the two groups
timeFrame: 36 months
Secondary outcomes:
measure: Variation of the VA measured using ETDRS scale on TC for the patients followed at home
timeFrame: 36 months
measure: Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital
timeFrame: 36 months
measure: Number of follow-up and injection visits for each patient according to their group
timeFrame: 36 months
measure: Average time between the follow-up visit and the IVT (if performed)
timeFrame: 36 months
measure: Variations in foveolar thickness and maximum central retinal thickness on OCT
timeFrame: 36 months
measure: Change in quality of life for patients in group 1 compared to group 2
timeFrame: 36 months
measure: Change in the total cost per patient for patient in group 1 compared to group 2.
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph Marseille
Study officials:
References:
Clinical trial NCT02708043: Laryngeal Mask Airway for Adenoidectomies (LMAA)
Official title: The Use of Laryngeal Mask Airway for Adenoidectomies: An Experience of 814 Paediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adenoidectomy Surgery
Flexible-Laryngeal Mask Airway
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 814
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The current study retrospectively assesses laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.


Eligibility criteria: Inclusion Criteria:

* 1-16 years of age
* ASA I-II
* Scheduled for elective adenoidectomy under general anesthesia with F-LMA between June 2012 and November 2015.

Exclusion Criteria:

* Emergency
* Extreme obesity
* Sign of clinical significant infection.

Primary outcomes:
measure: The incidence of failed LMA (0=failed, 1=good)
timeFrame: 3 year
Secondary outcomes:
measure: Surgeon satisfaction level (0=bad, 1=same, 2=good)
timeFrame: 3 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06553443: Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Official title: Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Arteriovenous Fistula
Arteriovenous Fistula Stenosis
Dialysis Access Malfunction
Keywords: drug-coated balloon
access circuit patency
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore Clinical Research Institute
name: Boston Scientific Corporation
First posted: 2024-08-14
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

Detailed description: This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type.

The primary outcome measure is 6-month access circuit patency.

Eligibility criteria: Inclusion Criteria:

1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
3. Less than 30% residual stenosis after angioplasty.
4. ≥ 21 years old
5. Informed and valid consent given.

Exclusion Criteria:

1. Thrombosed AVFs
2. Haemodynamically significant central vein stenosis
3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
4. Contraindication to antiplatelet therapy
5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
6. Allergy / contraindication to paclitaxel.
7. Acute infection over proposed puncture site.
8. Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study.
9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
10. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.

Primary outcomes:
measure: Access circuit primary patency
timeFrame: 6 months
Secondary outcomes:
measure: Access access circuit patency
timeFrame: 12 months
measure: Access circuit assisted primary patency
timeFrame: 6 and 12 months
measure: Access circuit secondary patency
timeFrame: 6 and 12 months
measure: Procedural complication
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months and 5 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT03651843: Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis
Official title: Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy, High Risk
Keywords: high risk
pregnant women
occupational hazard
occupational risk
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have just given birth in maternity hospitals in the Lille metropolis and who worked during their pregnancy

Brief summary: In ten years, the labor force has grown by 1.4 million people according to French national institute for statistical and economic studies. This increase is partly due to the increased presence of women in the labor market. Thus, the majority of some 800,000 annual births come from working women. However, some women in professional activity may be exposed to occupational risks, which may have effects on the develop-ment of the fetus during pregnancy. France benefits from protective legislative measures against pregnant women. Recommendations already exist.

But with medical desertification, pregnant women may have more difficulty contacting their occupational doctor or treating physician and to access information about the risks to her work-related pregnancy.

It seems to us important to be able to better quantify the information needs of women in this problem.


Eligibility criteria: Inclusion Criteria:

* working during their pregnancy (at least 2 months, including the beginning of pregnancy
* having given birth during the period of inclusion
* in a hospital or clinic of Lille metropolis volunteer to participate in the study

Exclusion Criteria:

* minor women
* unemployed
* student
* guardianship
* work abroad
* change of employer during pregnancy
* inability to answer the questionnaire

Primary outcomes:
measure: percentage of women who thought they had occupational exposures at risk for their baby during pregnancy
timeFrame: At childbirth
Secondary outcomes:
measure: adaptation or not of the workstation in case of exposure to a professional risk
timeFrame: at childbirth
measure: percentage of women with a score of at least 5 out of 10
timeFrame: at childbirth
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Sophie Fantoni, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06605443: Precision Medicine for L/GCMN and Melanoma 2
Official title: Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma (Skin Cancer)
Nevi and Melanomas
Congenital Melanocytic Nevus
Keywords: Volatilomics
Breath analyzer
Skin patch
Melanoma
L/GCMN
Liquid biopsy
cfDNA
Non-invasive diagnostics
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2024-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population (over 18 years of age) diagnosed with melanoma that are currently being treated at the Hospital Clinic de Barcelona or that are admitted before or at the time of the enrolment in the study.

Brief summary: The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.

Detailed description: This is a unicentric national prospective observational study aimed at evaluating the use of two devices (skin patch and breath analyzer) for the non or minimally invasive diagnosis of metastatic melanoma with a total duration of 24 months. The study will be based on the obtention of different patterns of volatile organic compounds using the aforementioned devices for melanoma patients with and without metastasis. The results will be compared with the standard procedures for the detection of metastatic melanoma (standard imaging techniques such as PET, MRI, etc.) and correlated with standard prognostic biomarkers (cfDNA mutations in BRAF, NRAS, etc.) obtained using liquid biopsy.

Eligibility criteria: Inclusion Criteria:

* Be over 18 years old
* Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)

Exclusion Criteria:

* Not signing the informed consent form
* Present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles

Primary outcomes:
measure: Early identification of metastases
timeFrame: 24 months
Secondary outcomes:
measure: Follow-up of high-risk melanoma patients
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona (Dermatology service)
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
Study officials:
References:
Clinical trial NCT04812743: Colorectal Health Research Champions
Official title: Colorectal Health Research Champions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of Colon
Cancer of Rectum
Keywords: Prevention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 91
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the Colorectal Health Research Champions program is to provide accurate and reliable colorectal health cancer information that they can share within their communities to encourage cancer prevention, screening, and early detection, as well as the importance of participating in research.


Eligibility criteria: Inclusion Criteria:

the individual is \> 30 years of age

* They are literate
* They are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research.

To participate in a chat hosted by the CHRC the inclusion criteria is:

* adult of any gender
* over 30 years of age.

Exclusion Criteria for chat hosted by the CHRC:

-Those \< 30 years of age

Primary outcomes:
measure: Increase in participants knowledge and intentions related to colorectal cancer screening.
timeFrame: 4 months
measure: Increase in knowledge and intentions related to biospecimen donation and clinical trial participation.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Vanessa B Sheppard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527643: Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects
Official title: Single-Centre, Randomised, Balanced, Double- Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 50 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
* Body Mass Index (BMI) between 19.0-30.0 kg/m\^2
* Glycohemoglobin (HbA1c) within laboratory normal range
* Non-smokers

Exclusion Criteria:

* The receipt of any investigational drug within the last 3 months prior to this trial.
* Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)
* HIV (human immunodeficiency virus), Hepatitis B or C positive
* Subjects with a first-degree relative with diabetes mellitus
* A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions

Primary outcomes:
measure: Area under the insulin aspart curve in the interval from 0-16 hours
measure: Cmax, maximum insulin aspart concentration
Secondary outcomes:
measure: tmax, time to maximum insulin aspart concentration
measure: Area under the insulin aspart curve
measure: Mean residence time (MRT)
measure: t½, terminal half-life
measure: Incidence of hypoglycaemic events
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: