louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05222360: Improvement of Body Image Flexibility in High School Female Athletes Doing Educational About Nutrition and Body Image
Official title: Improvement of Body Image Flexibility in High School Female Athletes Undergoing Three Educational Sessions About Nutrition and Body Image
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Image
Nutrition, Healthy
Lead sponsor: Rocky Mountain Sports Medicine
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 49
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These are athletes at local high schools who identify as female. The demographic area is primarily socioeconomically middle class.

Brief summary: Evaluation of increase in body flexibility in female high school athletes undergoing education on nutrition and body image

Detailed description: This study was a prospective cohort design. Female high school athletes were asked to participate in three educational sessions about nutrition, body image flexibility, and RED-S (relative energy deficiency in sport). Pre and post-tests were done with a validated tool measuring body image flexibility.

Eligibility criteria: Inclusion Criteria:

* identify as female
* athlete at local high school
* willing to fill out survey at beginning and end of sessions
* willing to provide consent

Exclusion Criteria:

* none

Primary outcomes:
measure: BI-AAQ Scores
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Parker
country: United States
facility: Rocky Mountain Sports Medicine
state: Colorado
Study officials:
affiliation: Rocky Mountain Sports Medicine
name: Kathryn Vidlock, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04931160: B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
Official title: B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sjogren's Syndrome
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Sjögren patients
* Non-Sjögren controls (retrospective)
Primary purpose: OTHER

Brief summary: The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

Detailed description: The formation of this patient is single-center prospective intervention. It consists of collecting data from patients suspected of pSS from standardized biological clinical data and imaging examination and additional pathology.

* Sjögren patients will be followed at inclusion, 2y, 3y, 4y, 6y, 8y and 10 years. Blood, fluid, sells and urine samples will be collected at inclusion, 4y et 10y.
* Non-Sjögren controls will be followed at inclusion and 4y and samples will be collected at the same visits.

Eligibility criteria: Inclusion Criteria:

* Major patient
* Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...)
* Patient affiliated with Social Security
* Patient who has signed written informed consent

Exclusion Criteria:

* Refusal to participate
* Pregnant and lactating woman

Primary outcomes:
measure: Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)
timeFrame: Inclusion
Secondary outcomes:
measure: Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure
timeFrame: 10 years
measure: Number of patients with rheumatological manifestations
timeFrame: 10 years
measure: Number of patients with dermatological manifestations
timeFrame: 10 years
measure: Description diagnostic performance of new tests
timeFrame: 10 years
measure: Disease evolution criteria
timeFrame: 10 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU Brest
name: Valérie Devauchelle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01960660: A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
Official title: A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparative Bioavailability
Keywords: Fish Oil
EPA
DHA
Omega-Score
Lipemic Index
ethyl esters
triglycerides
phospholipids
Lead sponsor: Nordic Pharma, USA
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2013-10-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques.

The purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage.


Eligibility criteria: Inclusion Criteria:

* Participant is fluent in English
* Participant understands the study requirements and is willing to comply with the protocol
* Participant is willing to provide written informed consent
* Participant is 18 years of age or older

Exclusion Criteria:

* Unwilling or unable to provide written consent
* Participant has taken omega-3 supplements in the last 3 months
* Participants consumes fish on a regular basis (more than 1 serving per week)
* Females who are pregnant or breastfeeding
* Participant has an allergy to fish or seafood
* Participant has been diagnosed with any medical illness or conditions
* Participant has a history of drug dependence or substance abuse (excluding nicotine)
* Participant is taking cholesterol or triglyceride lowering medications or supplements (statins, niacin, carnitine, fibrates)
* Individual has difficulty giving multiple blood samples

Primary outcomes:
measure: Omega-Score
timeFrame: Change from Baseline in Omega-Score at 28 days
Secondary outcomes:
measure: Lipemic IndexTM
timeFrame: Change from Baseline in Lipemic Index at 28 days
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasource Diagnostics Inc
state: Ontario
Study officials:
affiliation: Nutrasource Diagnostics
name: Maggie D Laidlaw, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutrasource Diagnostics
name: Carla Cockerline, M.Sc
role: STUDY_DIRECTOR
References:
citation: Laidlaw M, Cockerline CA, Rowe WJ. A randomized clinical trial to determine the efficacy of manufacturers' recommended doses of omega-3 fatty acids from different sources in facilitating cardiovascular disease risk reduction. Lipids Health Dis. 2014 Jun 21;13:99. doi: 10.1186/1476-511X-13-99.
Clinical trial NCT03427060: Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
Official title: CONSENT II: Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Lead sponsor: AKARI Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.

Detailed description: Coversin, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5 convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in patients with PNH and proven resistance to eculizumab due to C5 polymorphisms. Patients will be treated with Coversin by daily subcutaneous injection for 6 months in order to determine the safety and efficacy of the drug in these circumstances. If satisfactory control of the PNH is achieved, and at the discretion of the Principal Investigator (PI), patients will have the option of remaining on Coversin and being entered into the long term follow-up study.

Eligibility criteria: Inclusion Criteria:

1. Patients with known PNH.
2. Aged 18 and above. No upper age limit.
3. Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.
4. Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.
5. Resistance to eculizumab (Soliris®).
6. Voluntary written informed consent.
7. Willing to self-inject Coversin daily.
8. Willing to receive appropriate prophylaxis against Neisseria infection.
9. Willing to avoid prohibited medications for duration of study.

Exclusion Criteria:

1. Subjects with body weight \<50 kg (110 lb) or \>100 kg (220 lb).
2. Pregnancy or breast feeding (females).
3. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
4. Unresolved Neisseria meningitidis infection.
5. Patients who have not received adequate immunization against Neisseria meningitides.
6. Impaired hepatic function.
7. Patients with impaired renal function.
8. Failure to satisfy the Principal Investigator (PI) of fitness to participate for any other reason.

Primary outcomes:
measure: Measurement of Serum Lactate Dehydrogenase (LDH)
timeFrame: Baseline to Day 186
Secondary outcomes:
measure: Percentage Change in Haemoglobin (Hb) Compared to Screening
timeFrame: Baseline to Day 186
measure: Number of Packed Red Blood Cells (PRBC) Transfusions
timeFrame: Baseline to Day 180
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT00180960: Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia
Official title: Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colon Tumors
Rectum Tumors
Appendix Tumors
Peritoneum Tumors
Endocrine Tumors
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan.

This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.


Eligibility criteria: Inclusion Criteria:

* Peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum (mesothelioma and serous tumors), or endocrine tumors.
* No extra-abdominal metastases
* Good general status (American Society of Anesthesiologists Physical Status score \[ASA\] 1 or 2)
* Signed consent

Exclusion Criteria:

* Tumor seedings coming from other origins
* Huge peritoneal carcinomatosis (peritoneal score \> 25, except for pseudomyxomas)
* Peritoneal carcinomatosis progressing rapidly
* Presence of extra-abdominal metastases
* Patients presenting contraindications to the use of oxaliplatin or irinotecan

Primary outcomes:
measure: To study overall survival
Secondary outcomes:
measure: To study mortality-morbidity
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Dominique Elias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01379560: A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Age-related Macular Degeneration
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo Pharmaceuticals, Inc.
First posted: 2011-06-23
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacodynamics of ocular blood flow measurements with multiple drop unoprostone isopropyl administration versus placebo in subjects with dry age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years at screening
* Ametropy ≤ 3 diopters
* Clear ocular media
* Visual acuity in the study eye \> 20/40

Exclusion Criteria:

* Presence of any ocular condition in the study eye (other than AMD) that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study
* Blood donation during the previous 3 weeks
* Current smoker or a history of smoking within 5 years of enrollment
* Treatment with protocol-specified prohibited concomitant medications
* Prior exposure to Rescula (unoprostone isopropyl) and or a known sensitivity to any of the components of the study medication (e.g. benzalkonium chloride)

Primary outcomes:
measure: Change in choroidal blood flow
timeFrame: In total 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02563860: Pharmacological Treatment of Rett Syndrome With Statins
Official title: Pharmacological Treatment of Rett Syndrome With 3-Hydroxy-3 Methylglutaryl-coenzyme A Reductase Inhibitor-Lovastatin (Mevacor)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rett Syndrome
Keywords: Treatment trial
Lovastatin
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Rett Syndrome Research Trust
First posted: 2015-09-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.

Detailed description: Excess neuronal cholesterol plays a role in the pathophysiology of Rett syndrome(RTT) and the investigators hypothesise that inhibition of cholesterol synthesis in the CNS will reduce neuronal cholesterol and lead to improvement in Rett syndrome related symptoms.

Goal: To determine the optimal dosing regiment of Lovastatin for patients with RTT and to identify the most appropriate primary outcome measure for the subsequent Phase 3 study.

Phase 2, dose escalation study.

Primary outcome: Gait speed Secondary outcomes: respiratory function, cognition, EEG (encephalopathy), Rett syndrome severity scale, neurodevelopmental assessment (QOL)

20 ambulatory female patients with genetically confirmed.

Eligibility criteria: Inclusion Criteria:

* Females patients,
* Genetically confirmed RTT,
* Ambulatory.

Exclusion Criteria:

* Presence of co morbid non-Rett related disease,
* History of adverse reaction/hypersensitivity to statins,
* Levels of aspartate-amino trans-ferase (AST), alanine-amino transferase (ALT) or creatine kinase (CK) triple the normal values,
* Active liver disease,
* Concomitant use of strong CYP3A4 inhibitors,
* Condition predis-posing to renal failure secondary to rhabdomyolysis (scoliosis surgery within 6 months),
* Oral contraceptives use.

Primary outcomes:
measure: Gait Velocity as Measured by GAITRite System
timeFrame: During final week of treatment, week 32
Secondary outcomes:
measure: Visual Memory Novelty Score as Assessed by TobiiTX 300 Eyetracking System
timeFrame: final week of treatment, Week 32
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Aleksandra Djukic, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04261660: Vascular Endothelial Growth Factor Levels in Patients Undergoing Embryo Transfer
Official title: Vascular Endothelial Growth Factor Levels in Patients Undergoing Embryo Transfer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reproductive Techniques
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients undergoing ovum pickup and embryo transfer as part of assited reproductive technologies

Brief summary: Assessing the relationship between the VEGF levels in blood and the IVF protocol

Detailed description: The investigators are assessing the VEGF levels in the blood in IVF patients undergoing different protocols

Eligibility criteria: Inclusion Criteria:

Patients undergoing IVF -

Exclusion Criteria:

* Women with any malignancy
* Patients request to be withdrawn

Primary outcomes:
measure: vascular endothelial growth factor LEVELS
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Carmel Medical Center
name: Ido Feferkorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06987760: Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones
Official title: Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ureter Injury
Urolithiasis; Lower Urinary Tract
Efficacy, Self
Keywords: Urolithiasis
Ratio of Endoscope-Sheath Diameter
Flexible ureteroscope
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Fuyang District, Hangzhou City
name: The Central Hospital of Lishui City
First posted: 2025-05-23
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.
Primary purpose: TREATMENT

Brief summary: Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.

Detailed description: Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.

Eligibility criteria: Inclusion Criteria:

- 1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy.

2.Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.

Exclusion Criteria:

* 1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.

  2.Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones.

  6.Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm.

  8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.

Primary outcomes:
measure: Success rate of ureteral access sheath insertion
timeFrame: From enrollment to completion of surgery
Secondary outcomes:
measure: The condition of ureter injury
timeFrame: 24 hours
measure: Stone clearance rate
timeFrame: up to 8 weeks.
measure: Operation time
timeFrame: 24 hours
measure: The incidence of surgical complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: