louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05215470: CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy
Official title: CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Renal Cancer Metastatic
Keywords: Renal Cancer
Nivolumab
Ipilimumab
Immunotherapy
molecular profiling
Lead sponsor: Hospital das Clínicas de Ribeirão Preto
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2022-01-31
Enrollment: 100
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: The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).

Detailed description: One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School.

Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment.

Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival).

Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization.

Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination.

Eligibility criteria: Inclusion Criteria:

* Renal cell carcinoma patient: histological confirmed clear cell tumor;
* First-line metastatic treatment;
* Stage IV with at least one measured lesion;
* Fresh-frozen primary tumor tissue available;
* No previous immunotherapy or tyrosine kinase inhibitor treatment;
* All International Metastatic RCC Database Consortium (IMDC) Risk Score;
* Karnofsky Performance Scale (KPS) \>=70;
* \>=18 years old.

Exclusion Criteria:

* History of a known or suspected autoimmune disease;
* Any condition requiring systemic treatment with corticosteroids;
* Creatinine clearance \< 40mL/min;
* Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) \> 5 x ULN;
* Pregnant women.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto - USP
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Leandro Machado Colli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02116270: Accelerated Immunosenescence and Chronic Kidney Disease
Official title: Accelerated Immunosenescence and Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: Renal Failure
Dialysis
Biological Aging
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent T lymphocytes.

Detailed description: The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation. Kidney disease is associated with a decrease in adaptive immunity as evidenced by the decrease in vaccine response and increased susceptibility to infections, similar to those observed in the elderly population.

However, data on aging of the immune system in chronic kidney disease remains incomplete. Furthermore, the determinants of immunosenescence are not also not known. It is possible that "uremic" factors help explain the phenotypic and functional changes of lymphocytes, as antigenic stimuli associated with repeated bio-compatible materials used in dialysis contact.

The purpose of this study is to describe the phenotypes of the immune system of renal and analyze the determinants of these changes.

Eligibility criteria: Inclusion Criteria:

* Patient able to understand the reason of the study
* Patient not opposed to the conservation of biological samples for scientific research

Exclusion Criteria:

* Patient suffering from psychotic illness
* Any history of immunosuppressive therapy (except steroids up to 5mg/day)
* History of cancer (except skin cancer) or treated hematological malignancy
* Infectious episode required hospitalization not older 3 months
* Hepatitis B or C infection
* HIV infection, active or inactive
* For dialysis patients: renal failure on dialysis for less than 3 months and/or have benefited from two techniques for renal replacement therapy in the last 6 months

Primary outcomes:
measure: Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes)
timeFrame: 6 months
Secondary outcomes:
measure: Telomerase Activity of T lymphocytes
timeFrame: 6 months
measure: Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes
timeFrame: 6 months
measure: Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes
timeFrame: 6 months
measure: T-cell receptor excision circle (TREC) level in PBMC.
timeFrame: 6 months
measure: Telomere length in T lymphocytes
timeFrame: 6 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service de néphrologie, CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Jamal BAMOULID, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03853070: Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
Official title: Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysm
Arteriovenous Malformations
Arterio-venous Fistula
Lead sponsor: Kaneka Corporation
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
First posted: 2019-02-25
Enrollment: 100
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: All patients with an aneurysm, arteriovenous malformation, or arteriovenous fistula and eligible for endovascular treatment with ED Coil and ED Detach Generator v4.

Brief summary: This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.


Eligibility criteria: Inclusion Criteria:

* Patients are over 18 years of age.
* Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)
* The patient, or his/her representative, has agreed to the informed consent.

Exclusion Criteria:

* The patient, or his/her representative, is unwilling or unable to agree to the informed consent.

Primary outcomes:
measure: Performance Measure
timeFrame: At 6 months
measure: Performance Measure
timeFrame: At 12 months
measure: Safety Measure - Assessment of Adverse Events
timeFrame: During 12 months
measure: Technical Measure
timeFrame: At embolization procedure, an average of 1 week
measure: Technical Measure
timeFrame: At embolization procedure, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA Atwerp
state: Antwerp
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT03429270: T-DOC® 5 Fr Pediatric Clinical Investigation
Official title: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urge
Lead sponsor: Laborie Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 28
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects


Eligibility criteria: Inclusion Criteria:

* Male and Female (Children and infants, 12 years of age and younger)
* Subjects who are scheduled and normally indicated for urodynamics testing, for any medically necessary reason as per the physician.

Exclusion Criteria:

* Subjects who suffer from bladder infections (not including subjects with asymptomatic bacteruria)
* Subjects with urethral strictures
* Subjects who require the use of a suprapubic catheter

Primary outcomes:
measure: The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).
timeFrame: 2 months
measure: The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Effective in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System - UVA - Pediatric Urology Clinic
state: Virginia
city: Morgantown
country: United States
facility: J.W. Ruby Memorial Hospital and WVU Medicine Children's
state: Virginia
Study officials:
References:
Clinical trial NCT06113770: Clinical Evaluation of Polymethyl Methacrylate CAD/CAM Crowns Versus Prefabricated Zirconia Crowns in Primary Molars
Official title: Clinical Evaluation of Polymethyl Methacrylate CAD/CAM Crowns Versus Prefabricated Zirconia Crowns in Primary Molars
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caries of Infancy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 17
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: , in this studythe investigator will compare between ready-made zirconia crowns and Computer-aided design and Computer-aided manufacturing (CAD/CAM) polymethyl methacrylate (PMMA) crowns to overcome the disadvantages of ready-made zirconia crowns.


Eligibility criteria: A- Inclusion Criteria:

1. Primary molars indicated for crown restoration (pulp treated molars indicated for crown
2. Co-operative child (Frankel scale +ve and ++ve)
3. The age ranged from 4 to 8 years regardless of sex or socioeconomic background.

B- Exclusion Criteria:-

1. Badly decayed non-restorable tooth indicated for extraction.
2. Patients with parafunctional habits like bruxism.
3. Systemic diseases with oral manifestation or blood diseases.

Primary outcomes:
measure: Gingival condition
timeFrame: in 6 months
Secondary outcomes:
measure: gingival bleeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzharU
Study officials:
affiliation: Al-Azhar University
name: Adel S Rehab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00863070: Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy
Official title: Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Exstrophy
Keywords: Bladder exstrophy
Abnormal gait
anatomy
urinary bladder disease
urogenital abnormalities
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bladder exstrophy patients receiving follow-up services at Connecticutcmc Urology clinic.

Brief summary: The purpose of this study is to determine whether patients who have undergone exstrophy closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This study is a descriptive analysis of the study cohort's gait patterns and pelvic structure.

Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent closure demonstrate gait abnormalities.

Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) demonstrate gait abnormalities compared with a reference population.

Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) will have below normal functional survey scores.


Eligibility criteria: Inclusion Criteria:

1. Subject was seen at CCMC for bladder exstrophy between January 2002 and December 2010.
2. Subject is four years of age or older at time of enrollment.
3. Subject has the ability to walk.
4. Subject has not had gait testing performed.
5. Subject provides Informed Consent and HIPAA Authorization.

Exclusion Criteria:

1. Subject was not seen at CCMC for bladder exstrophy between January 2002 and December 2010.
2. Subject under four years of age at time of enrollment.
3. Subject does not have the ability to walk.
4. Subject had prior gait testing performed.
5. Subject not willing to provide Informed Consent and HIPAA Authorization.

Primary outcomes:
measure: Gait Testing and Analysis
timeFrame: 2 Weeks
Secondary outcomes:
measure: Demographic Data:age;GA at birth; Prenatal DX;closure age;Pelvic osteotomies;Perioperative and late complications;Successful initial closure;Continence; Additional surgeries w/age
timeFrame: 2 weeks
measure: Pediatric Outcomes Data Collection Instrument (PODCI)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Center for Motion Analysis
state: Connecticut
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Katherine W Herbst, M.Sc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00131170: Paravertebral Block for Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-08-17
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

Detailed description: Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain (\[VAS\] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.

Eligibility criteria: Inclusion Criteria:

* Breast surgery

Exclusion Criteria:

* Infections
* Coagulation disorder
* Allergy

Primary outcomes:
measure: Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively
timeFrame: 2 days
Secondary outcomes:
measure: Dosage of analgesic
timeFrame: 1 day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept of Anesthesiology, Aarhus University Hospital
Study officials:
affiliation: Dept anesthesiology, Arhus University Hospital
name: Palle Carlsson, MD Dr Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03433170: Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction
Official title: Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 42
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial comparing reconstruction of anterior cruciate ligament (ACL) with autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. It is intended to specially evaluate if by using only the semitendinosus (ST) tendon, the strength of the limb for hamstrings is affected different compared to using both gracilis and ST.

Detailed description: Data checks programmed by a third party after inclusion of participant number 10, 20, 30 and 42. This includes source data verification.

Simple size calculations estimating a difference of 50% in strength improvement between both groups at the six months follow-up visit. 80% power and 5% alpha error.

Strength measured with dynamometer, laxity with ACL laxity tester and function with 3 scores: IKDC, Tegner-Lysholm and KOOS.

Missing data will be minimized by double checking when registering data. It might be necessary to increase sample size to 50 patients of intermediate analysis show it is necessary to find an statistically significant difference.

Trial could be stopped early if one intervention shows to be better in the intermediate analysis. These analysis will be conducted after the first 16 and 32 participants have been included.

Eligibility criteria: Inclusion Criteria:

* Patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. They should be at least 16 years old.

Exclusion Criteria:

* Multiligament injuries. Re-ruptures of the ACL.

Primary outcomes:
measure: Hamstrings Strength
timeFrame: 6 months
Secondary outcomes:
measure: Anterior cruciate ligament rerupture
timeFrame: 24 months
measure: ACL laxity
timeFrame: 24 months
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
state: Valle
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Juan P Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02880670: Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects
Official title: Pharmacokinetics and Metabolism of [14C] BMS-986142 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis
Keywords: Rheumatoid
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-dose, study in healthy males. The primary objective is to assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose of radiolabeled BMS-986142 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
* Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.

Exclusion Criteria:

* History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
* Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
* History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
* Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.

Primary outcomes:
measure: The primary endpoint is PK parameters that will be determined from plasma concentration versus time
timeFrame: Day 1 to Day 13
measure: Urinary/fecal/bile (if applicable) TRA (Total radioactivity) recovery data
timeFrame: Day 1 to Day 13
Secondary outcomes:
measure: Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests.
timeFrame: Day 1 to Day 13
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: