louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03110445: Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus
Official title: Monocentric Open Label Phase I Immunotherapy Trial of Breast Cancer Patients With a Non-replicating Recombinant Vaccinia Virus Expressing Cancer/Testis Antigens and Cluster of Differentiation Antigen 80 (CD80)-CD40L Costimulatory Molecules.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Breast Carcinoma
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 0
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: Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA expressing tumors.


Eligibility criteria: Inclusion Criteria:

* Surgically treated M0 patients with solid tumors
* Tumor expressing at least one of the vaccine targeted antigens Melanoma-associated antigen (MAGE)-A1, -A2,
* A3, -A4, -A6, -A10, -A12 or New York (NY) esophageal squamous cell carcinoma-1 (ESO-1) (NY-ESO-1) (by real-time quantitative PCR (RT-qPCR))
* Patient expressing the targeted Human Leukocyte Antigen (HLA) restriction (A0201 /A0101/ B3501)
* 4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy.
* Karnofsky over 70%
* No other concomitant malignancy

Exclusion Criteria:

* History of anaphylaxis or severe allergic reaction
* Severe heart, lung, kidney, liver or psychiatric condition
* Concurrent immunosuppressive therapy or impaired immune system

Primary outcomes:
measure: number of adverse Events
timeFrame: 2 years
measure: number of serious adverse Events
timeFrame: 2 years
Secondary outcomes:
measure: Evolution of Immune reactivity to the CTA
timeFrame: 18 months
measure: Disease free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Basel - Dept of Biomedicine
name: Paul ZAJAC, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital of Basel - Dept of Surgery
name: Walter WEBER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06824545: Incidence & Clinical Significance of Osteolysis Following PEEK Suture Anchor Use in Hand & Wrist Surgery
Official title: Incidence & Clinical Significance of Osteolysis Following PEEK Suture Anchor Use in Hand & Wrist Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteolysis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 2014 \& 2024 who were billed for one of the following CPT codes: 25310, 25320, 25447, 26480, 26540, 226541, 26542, and 26545.

Brief summary: This prospective observational study evaluates the incidence \& clinical significance of osteolysis following polyetheretherketone (PEEK) suture anchor use in hand \& wrist surgery. Building on a pilot study, it focuses on patients undergoing hand \& wrist surgeries with suture anchor implantation over the past 10 years. Patients are grouped by anchor composition: PEEK, metallic, or bioabsorbable. We hypothesize that PEEK anchors will show significantly greater osteolysis than metallic or bioabsorbable anchors. Furthermore, among all patients with osteolysis, we expect no statistically significant differences in patient-reported outcomes (PROs), post-op complications, or revision surgery rates, regardless of anchor type. Lastly, for patients with ulnar collateral ligament (UCL) thumb injuries, we hypothesize that osteolysis presence will not correlate with increased UCL laxity upon valgus stress testing compared to the nonoperative thumb.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 - 99 years-old
* History of hand and/or wrist surgery with suture anchor fixation over the 10-year period between January 1, 2014 and January 1, 2024.
* Possess an en face and/or tangential radiograph of the suture anchor tunnels from either the intra-operative or immediately post-operative (within 14 days) period.

Exclusion Criteria:

* Systematic inflammatory / autoimmune disease or immune-modulatory drug use.
* History of revision surgery of the body part of interest.

Primary outcomes:
measure: Rates of Osteolysis
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01321645: Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Official title: Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Azadirachta Indica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Homoeopathy
Homeopathy
Azadirachta Indica
Lead sponsor: Miglani, Anjali
Sponsor class: INDIV
Collaborators: name: Department of Indian Systems of Medicine and Homeopathy
First posted: 2011-03-23
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study,efficacy of Azadirachta Indica will be studied in the treatment of Acne vulgaris


Eligibility criteria: Inclusion Criteria:

* Males and females between 12 to 25 years of age
* Presence of inflammatory and non-inflammatory lesions
* Able to follow-up according to protocol
* Patients not taking any medication for treatment of Acne in preceding one month.

Exclusion Criteria:

* Acne Conglobata
* Pregnant or Breast feeding females or females having intention of becoming pregnant
* Significant systemic disease
* Any drug/ alcohol addiction
* History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome

Primary outcomes:
measure: percent change in acne lesion counts from the Baseline
timeFrame: 6 months
Secondary outcomes:
measure: change in quality of life of subjects from baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
state: Delhi
Study officials:
affiliation: Department of Indian Systems of Medicine and Homeopathy
name: Anjali Miglani, BHMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03249545: Late Effect of Ablation on Premature Ventricular Complex Ablation
Official title: Late Effect of Ablation on Premature Ventricular Complex Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Ventricular Complex
Electrophysiology
Ablation
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 30
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: Individuals having premature complexes and matching ablation indications are included and selection will be based on above mentioned criteria

Brief summary: Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally acutely abolition of PVC at the time of ablation accepted as successful ablation. However in some patients this effect occurs lately. In this study investigators sought late effect of ablation

Detailed description: On tissue level ablation lesion deepens and enlarges by time following the procedure. Based on this, investigators aimed to seek patients who has no acute success but late success. This phenomenon occurs in some patients. Investigators investigate the characteristics of those patients on both procedural and clinical aspects. Investigators enroll patients applied during prespecified dates

Eligibility criteria: Inclusion Criteria:

Patients who had both of the criteria below

* Presence of premature ventricular complex requiring ablation
* Successfully abolition of premature ventricular complex hours after the procedure

Exclusion Criteria:

Patients who had either of below mentioned criteria

* Abolition of premature ventricular complex during the procedure
* Unsuccessful procedure

Primary outcomes:
measure: Success
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkiye Yuksek Ihtisas Training and Research Hospital
Study officials:
References:
Clinical trial NCT00370747: Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
Official title: Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 162
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: The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome


Eligibility criteria: Inclusion Criteria:

* Male/female at least 18 years of age
* Agree to avoid disallowed medications
* Have a diagnosis of dry eye

Exclusion Criteria:

* Have chronic systemic inflammation
* Have active seasonal ocular allergies

Primary outcomes:
measure: Ocular signs and Symptoms
timeFrame: 90 days
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 90 days
Other outcomes:
Locations:
city: Irvine
country: United States
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Ralph Bianca, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00966147: Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy
Official title: Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radical Cystectomy
Perioperative Complications
Hemodynamic Monitoring
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-08-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine whether increasing cardiac output by a combination of intravenous fluids and inotropic drugs can reduce mortality and morbidity in radical cystectomy operations.


Eligibility criteria: Inclusion Criteria:

* Adults (\>18yo) scheduled for elective radical cystectomy and ileal conduit formation

Exclusion Criteria:

* Creatinine level above 200 mcg/dl
* single functioning kidney
* s/p kidney transplant
* heart rhythm other than sinus
* known allergy to lithium chloride
* chronic lithium therapy
* weight below 40 kg
* mental or language problems that precludes obtaining informed consent

Primary outcomes:
measure: Mortality
timeFrame: Hospital stay
Secondary outcomes:
measure: Morbidity
timeFrame: Hospital stay
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
Clinical trial NCT03020147: Low Birth Weight Follow-up
Official title: Follow-up of Low Birth Weight Cohort of 2008-2013
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Specific Effects of Vaccine
Bacillus-Calmette-Guerin
Low Birth Weight
Maternal Immunisation
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 1258
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who participated in the low birth weight trial between 2008 and 2013.

Brief summary: The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. The study assistants will ask about the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar status of both child and parents will be checked.


Eligibility criteria: Inclusion Criteria:

* Participation during the low birth weight BCG trial between 2008 and 2013.

Exclusion Criteria:

* Not living in the Bandim Health Project's study area.

Primary outcomes:
measure: mortality differences between group who received early BCG and late BCG
timeFrame: up to 8 years of age
measure: mortality by parental scar status
timeFrame: up to 8 years of age
Secondary outcomes:
measure: hospitalization rate between early BCG and late BCG group
timeFrame: last two weeks
measure: consultation rate between early BCG and late BCG group
timeFrame: last two weeks
measure: medication use between early BCG and late BCG group
timeFrame: last two weeks
Other outcomes:
measure: hospitalization based on parental scar status
timeFrame: last two weeks
measure: consultations based on parental scar status
timeFrame: last two weeks
measure: medication use based on parental scar status
timeFrame: last two weeks
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
state: Bissau Codex
Study officials:
References:
citation: Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
citation: Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
Clinical trial NCT03209947: ULnar Nerve ECHographic Observation (ULNECHO)
Official title: ULnar Nerve ECHographic Observation (ULNECHO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulnar Neuropathies
Keywords: Ulnar Neuropathies
Ultrasound
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a population of asymptomatic subjects

Detailed description: 100 elbows from 50 patients will be included, from a population of asymptomatic subjects, in order to measure the frequency of ulnar nerve which surface is \>8,3 mm².

The measures will be realized centered on the epicondyle : 2 cm higher, and 2 cm lower with 2 echographs (ESAOTE) and 2 observers. An inter and intra observer study will also be realized to determine the reproducibility and reliability of the measurements.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 -to 80 years or older
* Patient without any current or previous pathology on the ulnar nerve
* Patients would be able to consent

Exclusion Criteria:

* Patient under administrative supervision or legal guardianship

Primary outcomes:
measure: Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound
timeFrame: 1 day
Secondary outcomes:
measure: Correlation ulnar nerve surface measure of by two doctors
timeFrame: 1 day
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT01041547: Vascular Function, Insulin Sensitivity, and Vitamin D
Official title: Vitamin D, Vascular Function, and Insulin Sensitivity in Adults [The VIVID Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Sensitivity
Flow-mediated Dilation
Arterial Stiffness
Keywords: Insulin sensitivity
Vascular function
Flow-mediated dilation
Arterial stiffness
Glucose tolerance
Hypertension
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-12-31
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Healthy adults with BMI below 32
* Both males and females
* Ages 19-60 years
* Race: African Americans, White Hispanics, European Americans

Brief summary: The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in African Americans (AA) and White Hispanics (WH) is responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and European Americans (EA), as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA and WH relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D.

Acronyms: African American (AA), European American (EA), White Hispanics (WH), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).


Eligibility criteria: Inclusion Criteria:

* African American (AA), White Hispanic (WH), and European American (EA) race
* Ages 19-60 years
* Negative urine pregnancy test
* No evidence of diabetes
* Not on medications that can affect vascular functioning or insulin sensitivity

Exclusion Criteria:

* BMI \> 32 kg/m2
* Diabetes or any chronic diseases
* Use of medication(s) known to influence body composition, vascular function, or glucose metabolism
* Regular smoking
* Regular use of illegal drugs and pregnancy

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Cross sectional study: at first study visit
Secondary outcomes:
measure: Vascular function
timeFrame: Cross sectional study: at second study visit, within 2 weeks of first study visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ambika Ashraf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez JA, Gower BA, Calhoun DA, Judd SE, Dong Y, Dudenbostel T, Scholl J, Ashraf AP. Serum 25-hydroxyvitamin D and Ethnic Differences in Arterial Stiffness and Endothelial Function. J Clin Med Res. 2012 Jun;4(3):197-205. doi: 10.4021/jocmr965w. Epub 2012 May 15.
Clinical trial NCT04266847: Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients
Official title: Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract Senile
Keywords: unilateral cataract
binocular functional vision
Multifocal Intraocular Lenses
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.

Detailed description: The subjects are the patients who underwent monocular IOL implantation before and present mild cataract in the fellow eye.Compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and IOLs implantation)on the fellow eye. The type of IOLs maybe according to the patients preference and the eyes condition.The subjects will be divided into three groups according to the type of the IOLs，including monofocal group,bifocal group,and trifocal group.

Eligibility criteria: Inclusion Criteria:

* Patients who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye
* Regular corneal topography and corneal astigmatism ≤ 0.75 Diopter

Exclusion Criteria:

* Pregnant or nursing women
* In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
* In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR after surgery (amblyopia, strabismus, keratoconus, etc.)
* Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
* Patients using systemic or ocular medication that affect visual acuity.
* Patients with history of ocular trauma or prior ocular surgery including refractive procedures
* Patients participating in other clinical trials during the study.

Primary outcomes:
measure: binocular visual acuity
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Binocular Contrast sensitivity
timeFrame: 3 months postoperatively
measure: Binocular Defocus Curve
timeFrame: 3 months postoperatively
measure: stereopsis
timeFrame: 3 months postoperatively
measure: Fusion function
timeFrame: 3 months postoperatively
measure: Subjective visual quality
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qi Hong, PhD，MD
role: STUDY_DIRECTOR
References: