louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06193642: Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data
Official title: Increasing Knowledge on Osteogenesis Imperfecta by Collecting and Integrating Epidemiological Data, Genetic Information, and Functional Performance From Movement Analysis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteogenesis Imperfecta
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: interventional pilot study with the enrollment of patients affected by Osteogenesis Imperfecta

Detailed description: Subjects diagnosed with Osteogenesis Imperfecta will be undergoing, after collection of informed consent, to a series of assessments using sensor imaging and Gait-Analysis and collection of specific parameters

Eligibility criteria: Inclusion Criteria:

* Patients with Osteogenesis Imperfecta (clinical diagnosis) able to perform the gait-analysis movement data acquisition session, in the most complete instrumental configuration, i.e., with kinematics, dynamics and electromyography; it will naturally be evaluated which motor tasks are safely executable and which are not.
* All patients of both sexes will be included
* Patients in the age range: 8-60 will be included

Exclusion Criteria:

* Subjects who do not fit the inclusion criteria

Primary outcomes:
measure: Gait-Analysis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: quality of life questionnaires
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Colnaghi S, Rezzani C, Gnesi M, Manfrin M, Quaglieri S, Nuti D, Mandala M, Monti MC, Versino M. Validation of the Italian Version of the Dizziness Handicap Inventory, the Situational Vertigo Questionnaire, and the Activity-Specific Balance Confidence Scale for Peripheral and Central Vestibular Symptoms. Front Neurol. 2017 Oct 10;8:528. doi: 10.3389/fneur.2017.00528. eCollection 2017.
citation: Benedetti MG, Catani F, Leardini A, Pignotti E, Giannini S. Data management in gait analysis for clinical applications. Clin Biomech (Bristol). 1998 Apr;13(3):204-215. doi: 10.1016/s0268-0033(97)00041-7.
Clinical trial NCT00976742: Gene - Exercise Research Study
Official title: Impact of Common Genetic Polymorphisms on CV Disease Risk Factor Changes With Endurance Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease Risk Factors
Keywords: plasma lipoprotein lipids
body composition
glucose tolerance
inflammation markers
insulin sensitivity
coagulation markers
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: University of Maryland, Baltimore
First posted: 2009-09-14
Enrollment: 225
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that the degree to which older generally healthy but sedentary men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of highly-standardized endurance exercise training will be a function of common genetic variations in candidate genes.


Eligibility criteria: Inclusion Criteria:

* generally healthy
* free from CV disease
* ability to undergo exercise training

Exclusion Criteria:

* previous history of CV disease

Primary outcomes:
measure: Cardiovascular Disease Risk Factors
timeFrame: ~9 months
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland Dept of Kinesiology
state: Maryland
Study officials:
References:
citation: Halverstadt A, Phares DA, Wilund KR, Goldberg AP, Hagberg JM. Endurance exercise training raises high-density lipoprotein cholesterol and lowers small low-density lipoprotein and very low-density lipoprotein independent of body fat phenotypes in older men and women. Metabolism. 2007 Apr;56(4):444-50. doi: 10.1016/j.metabol.2006.10.019.
Clinical trial NCT01712542: Curcumin Bioavailability in Glioblastoma Patients
Official title: Measurement of Intratumoral Concentration of the Nontoxic Natural Compound Curcumin in Glioblastoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Harboring Glioblastoma That Will Undergo Surgery
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2012-10-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients harboring Glioblastoma

Brief summary: Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients.


Eligibility criteria: Inclusion Criteria:

* Patients harboring Glioblastoma
* Patient will undergo surgery

Exclusion Criteria:

* BMI \> 30
* Liver and Kidney Function so compromised that medication is prescribed

Primary outcomes:
measure: Concentration of Curcumin in Glioblastoma
timeFrame: At Tumor resection
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Neurosurgery, Johann Wolfgang Goethe-University
state: Hessen
Study officials:
affiliation: Goethe University
name: Stephan Duetzmann
role: PRINCIPAL_INVESTIGATOR
References:
citation: Senft C, Polacin M, Priester M, Seifert V, Kogel D, Weissenberger J. The nontoxic natural compound Curcumin exerts anti-proliferative, anti-migratory, and anti-invasive properties against malignant gliomas. BMC Cancer. 2010 Sep 14;10:491. doi: 10.1186/1471-2407-10-491.
Clinical trial NCT06696742: PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma
Official title: Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bladder (Urothelial, Transitional Cell) Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.

Detailed description: This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.

This study is divided into two parts. One is the patients with neoadjuvant therapy. After 3 cycles of neoadjuvant therapy, to observe whether the patients with Clostridium butyricum live tablets have better neoadjuvant therapy efficacy. The other was in patients with adjuvant therapy to see if adjuvant therapy combined with Clostridium butyricum could prolong the patient's prognosis.

Eligibility criteria: Inclusion Criteria:

For Neoadjuvant therapy:

* T2-T4aN0M0 bladder patients

For Adjuvant therapy:

* Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.

Exclusion Criteria:

* The researchers evaluated the patients who could not tolerate radical surgery;
* Previously received systemic chemotherapy or immunotherapy;
* There are active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of a large number of hormones and other immunosuppressants;
* Have had major surgery or major trauma within 28 days before joining the group;
* Vaccinated with live vaccine within 28 days before joining the group.

Primary outcomes:
measure: PFS
timeFrame: 3 years after surgery
Secondary outcomes:
measure: OS
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Qiang Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887742: Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient
Official title: Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemodialysis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haemodialysed patients from two nephrology centers.

Brief summary: Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient


Eligibility criteria: Inclusion Criteria:

* \>18
* patient under haemodialysis treatment
* patient not objecting to study

Exclusion Criteria:

* Patient with known cardiac arrythmias

Primary outcomes:
measure: Description of all the cardiologic abnormalities
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: AUB
city: Brest
country: France
facility: CHU Brest
Study officials:
affiliation: University Hospital, Brest
name: Yannick Le meur, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05897242: A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults
Official title: ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Nicotine Addiction
Nicotine Use Disorder
Nicotine Vaping
Vaping
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-06-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, this trial will evaluate a digital program for young adult e-cigarette users at all stages of readiness to quit called ACT on Vaping.

Detailed description: OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status.

ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.

Eligibility criteria: Inclusion Criteria:

* Age 18-30.
* Current weekly user of e-cigarette product(s).
* Owns an Android phone or iPhone.
* Has an email address.
* United States (US) resident, with a US mailing address.
* Willing to complete all study procedures.

Exclusion Criteria:

* Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation).
* Member of the same household as another research participant.

Primary outcomes:
measure: Overall Treatment Satisfaction Rating
timeFrame: At 3 months post-randomization
measure: Change in Readiness to Quit
timeFrame: From baseline to 3 months post-randomization
measure: Proportion of Participants With a 24-hour Quit Attempt
timeFrame: At 3 months post-randomization
measure: Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco
timeFrame: At 3 months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jaimee Heffner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02584842: Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy
Official title: Rivaroxaban for Thrombosis Prophylaxis in Endovenous Laser Ablation With and Without Miniphlebectomy: A Multicenter Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Venous Thrombosis
Thromboembolism
Bleeding
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age greater than 18 years, informed consent was given. EVLA of the GSV, ASV and/or SSV using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional EHIT prophylaxis with rivaroxaban.

Brief summary: The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.

Detailed description: Rivaroxaban is an orally active direct factor Xa inhibitor, that is used for thrombosis prophylaxis for example in the setting of orthopaedic surgery.

In the observed situation Rivaroxaban was applied in a dosage of 10mg daily during 5 days after endovenous laser ablation.

Eligibility criteria: Inclusion Criteria:

* Patients age greater than 18 years, informed consent was given.
* Endovenous Laser Ablation (EVLA) of the greater saphenous vein (GSV), autologous saphenous vein (ASV) and/or small saphenous vein (SSV) using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional Endothermal Heat Induced Thrombosis (EHIT) prophylaxis with rivaroxaban.

Exclusion Criteria:

Patients are ineligible if they had:

* an endovenous ablation technique other than EVLA,
* other veins than GSV, ASV or SSV treated with EVLA (i.e. perforators),
* postinterventional EHIT prophylaxis other than prophylactic dose of rivaroxaban or
* informed consent was not given.

Primary outcomes:
measure: Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation
timeFrame: within 6 weeks after endovenous laser ablation
Secondary outcomes:
measure: Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation.
timeFrame: within 6 weeks after endovenous laser ablation
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Luca Spinedi, MD, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uthoff H, Holtz D, Broz P, Staub D, Spinedi L. Rivaroxaban for thrombosis prophylaxis in endovenous laser ablation with and without phlebectomy. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):515-523. doi: 10.1016/j.jvsv.2016.12.002. Epub 2017 Feb 21.
Clinical trial NCT05764642: A Study of Renal Microvessel Imaging for Chronic Kidney Disease
Official title: Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Healthy
Chronic Kidney Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-03-10
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Definity is an ultrasound contrast agent currently approved by the FDA for use on the heart, liver, and urinary tract. This study will look at its effectiveness on the kidney.


Eligibility criteria: Inclusion Criteria:

- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.

Exclusion Criteria:

* Subjects lacking capacity to consent.
* Vulnerable subjects such as prisoners; pregnant women; nursing mother.
* Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
* Patients with high-risk cardiac diseases.

Primary outcomes:
measure: Renal cortex microvessel density
timeFrame: Baseline
measure: Renal cortex microvessel diameter
timeFrame: Baseline
measure: Renal blood flow velocity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shigao Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00716742: Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 1099
Sex: ALL
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: Patients can be either: (a) newly diagnosed and require, in the judgment of the treating physician, one of study agents as first-line treatment, (b) have an insufficiently controlled IOP on their current medication (any but not more than two in combination), and a treatment switch to one of study agents is an acceptable option.

Brief summary: To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
* Patient is having both eyes treated

Exclusion Criteria:

* Contraindications per product labelling will apply.
* Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.

Primary outcomes:
measure: Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
timeFrame: Baseline, 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Murfreesboro
country: United States
state: Tennessee
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02838342: Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Official title: Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).


Eligibility criteria: Inclusion Criteria:

* performance status ECOG-WHO ≤ 1
* histologically proved neuroendocrine tumor with Ki67 \< or = 10%, metastatic or locally advanced without surgery possibility
* at least one measurable lesion based on RECIST criteria version 1.1
* signed written informed consent

Exclusion Criteria:

* previous treatment with interferon or cyclophosphamide
* treatment by immunosuppressive drugs
* diabetes complicated by coronary artery disease or vasculopathy
* severe respiratory failure, chronic respiratory failure, COPD
* history of severe heart failure
* severe renal or hepatic impairment
* diabetes complicated with coronary artery disease or vasculopathy
* alcoholism unweaned
* uncontrolled epilepsy and/or achievement of the central nervous system functions
* history of severe depressive syndrome
* presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide
* decompensated liver cirrhosis
* severe myelosuppression
* psoriasis and sarcoidosis
* active disease condition or uncontrolled infection
* association with the yellow fever vaccine
* association with phenytoin in prophylaxis
* hypersensitivity against interferon or cyclophosphamide
* prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 3 years
* pregnancy, breast-feeding or absence of adequate contraception for fertile patients
* patients under guardianship, curatorship or under the protection of justice

Primary outcomes:
measure: rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
timeFrame: at 3 months of the association CMC and Interferon-alpha
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References: