louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03014206: Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
Official title: PREVENAR13(REGISTRIED) SUSPENSION LIQUID FOR INJECTION DRUG USE INVESTIGATION - ADULTS AGED 65 YEARS OR OLDER
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Not Younger Than 65 Years
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 696
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Geriatric patients vaccinated with this product (adult not younger than 65 years)

Brief summary: This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older).

1. To confirm the use in actual clinical settings
2. To confirm the occurrence of adverse events

Detailed description: This study is a multicenter open-label cohort conducted in patients vaccinated with the Product; for which, case report forms will be recorded based on data presented in medical records obtained from day-to-day clinical treatment and diagnosis. "Pneumococcal vaccine health study diary" will be implemented to collect accurate safety data; to which, vaccine recipients will be asked directly to cooperate.

Eligibility criteria: Inclusion Criteria:

1. Geriatric patients vaccinated with this product (adult not younger than 65 years)
2. Consent of vaccine recipients \[Vaccine recipient (or his/her legally acceptable representative) must sign and date the consent form warranting that the relevant information concerning this Study was appropriately communicated to the recipient\].

Exclusion Criteria:

None

Primary outcomes:
measure: Number of Participants With Adverse Reactions
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00467506: Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Official title: Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Neoplasms
Keywords: Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2007-04-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)


Eligibility criteria: Inclusion Criteria:

* 18 -75 years
* Karnofsky ≥ 70%
* Histological diagnosis of medullary thyroid carcinoma
* Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years
* Normal liver and renal functions
* Granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3
* No immunization
* Consent form signed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: hôpital du Cluzeau
city: Lyon
country: France
facility: CHU
city: Marseille
country: France
facility: Hôpital de la timone
city: Nantes
country: France
facility: CHU
city: Rouen
country: France
facility: CHU
city: Saint Cloud
country: France
facility: Centre René Huguenin
city: Saint Herblain
country: France
facility: Centre René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Centre Claudius Régaud
Study officials:
affiliation: Nantes University Hospital
name: Francoise Bodere, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00678106: Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
Official title: A Phase 1, Open Label, Single Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Dalbavancin In Hospitalized Adolescents, Aged 12 Through 17 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Keywords: dalbavancin adolescent subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points. Safety labs will also be checked on a regular basis to assess the safety of dalbavancin.


Eligibility criteria: Inclusion Criteria:

* 12 to 17 year old adolescents hospitalized for the treatment of bacterial infections.

Exclusion Criteria:

* Patients being treated with vancomycin.
* Patients with liver and kidney failure.
* Pregnant female subjects.

Primary outcomes:
measure: Pharmacokinetic Plasma - Cmax, Tmax, AUClast, AUCinf, AUC(48) (as data permit), t1/2 (as data permit), CL, Vss. Urine - Ae48, Ae48% and CLR.
timeFrame: 56 days
Secondary outcomes:
measure: Safety assessments: adverse event monitoring; clinical laboratory tests (hematology, serum chemistry, and urinalysis); ECGs; blood pressure and pulse rate determinations; weight and physical examination.
timeFrame: 56 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03796299: Expression of MCM5 in Urine in Patients With Urothelial Cancers
Official title: Expression of MCM5 in Urine in Patients With Urothelial Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: bladder cancer
biomarker
urothelial cancer
cystoscopy
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients qualified for surgery due to bladder or upper urinary tract tumors and controls.

Brief summary: In patients with non-muscle-invasive bladder cancer, the development and introduction to the clinical practice of an adequately accurate biomarker may allow to limit the indications for performing control cystoscopy. Thus, it will reduce the discomfort and stress of patients, the risk of complications of the invasive procedure and probably significantly reduce the costs incurred by healthcare systems.

The aim of the present study is to determine the usefulness of the determination of MCM5 protein expression in the urine of patients with urinary bladder or upper urinary tract cancer.


Eligibility criteria: Inclusion Criteria:

* age \>18 years,
* written consent to participate in the study,
* ability to void and collect \>50ml of urine,
* recurrent bladder cancer confirmed by cystoscopy (group 1) or upper urinary tract tumor confirmed by imaging studies (group 2) or no history of urological/gynecological cancers (controls)

Exclusion Criteria:

* urinary tracy infection,
* nephrolithiasis

Primary outcomes:
measure: Expression of MCM-5 in the urine
timeFrame: Within 48 hours after subject enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Dept. of Urology
Study officials:
References:
citation: Bialek L, Czerwinska K, Fus L, Krajewski W, Sadowska A, Radziszewski P, Dobruch J, Kryst P, Poletajew S. MCM5 urine expression (ADXBLADDER) is a reliable biomarker of high-risk non- muscle-invasive bladder cancer recurrence: A prospective matched case-control study. Cancer Biomark. 2021;30(2):139-143. doi: 10.3233/CBM-200316.
Clinical trial NCT01254799: Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)
Official title: Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only".


Eligibility criteria: Inclusion Criteria:

1. Women under DMPA contraception for at least one month.
2. Accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients.
3. Women's ability to keep an accurate menstrual diary for the study.

Exclusion Criteria:

1. Lactating women for the fear of the effect of tetracycline on the breast-fed infant.
2. Patients with already diagnosed local gynecological abnormality.
3. Women receiving treatment for bleeding within the last one month.

Primary outcomes:
measure: Stoppage of bleeding within 7 days
timeFrame: 7 days from starting of tretment
Secondary outcomes:
measure: Number of days needed to stop a current attack of bleeding
timeFrame: 1 month
measure: Next bleeding free interval
timeFrame: 3 month
measure: Uterine bleeding patterns in the next 3 months after treatment
timeFrame: 3 months
measure: Women satisfaction with the treatment she received
timeFrame: 3 months
measure: Side effects encountered during treatment
timeFrame: 5 days
measure: Discontinuation of the DMPA and its reason
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Assiut University
name: Hany Abdel-Aleem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Omar M Shaaban, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mahmoud Abdel=Aleem, MD
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Assiut University
name: Gehian N Fetih, PH.D
role: STUDY_CHAIR
References:
citation: Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Fetih GN. Doxycycline in the treatment of bleeding with DMPA: a double-blinded randomized controlled trial. Contraception. 2012 Sep;86(3):224-30. doi: 10.1016/j.contraception.2012.01.003. Epub 2012 Feb 9.
Clinical trial NCT06989099: Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.
Official title: Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 50
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: MD Anderson Cancer Center

Brief summary: To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.

Detailed description: Primary Objectives

- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND.

Secondary Objectives

* Estimate the proportion of participants who have lymphedema that persists at 2 years after ILR surgeries.
* Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR.
* Evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.

Eligibility criteria: Inclusion Criteria:

1. Participants diagnosed with IBC.
2. Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
3. Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
4. Female subjects at least 18 years old and capable of providing consent to participate.
5. Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.

Exclusion Criteria:

1. Patients known to be pregnant or breast-feeding.
2. Patients with known or suspected iodine or ICG hypersensitivity.
3. Patients unable to remain stationary for one hour.
4. Active cellulitis.
5. Subjects with a preoperative clinical lymphedema diagnosis.
6. Subjects undergoing bilateral ALND.
7. Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
8. Patients with BMI \>45kg/m2.

Primary outcomes:
measure: Freedom from lymphedema (FFL)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mark Schaverien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04837599: Artificial Intelligence Performance in Colonoscopy in Daily Practice
Official title: Artificial Intelligence Performance in Colonoscopy in Daily Practice: Randomised, Comparative Study of Pentax i10 Colonoscopes With or Without Endocuff Combined With Discovery™ or Without
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Adenoma
Keywords: artificial intelligence
Lead sponsor: Gastroenterologie Baden-Wettingen
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2021-04-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional device, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI).

The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).

Detailed description: From August 2021 through August 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. Time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. Furthermore dosage of sedatives and over all satisfaction is traced.

1. endpoint is time gain in the different phase of the colonoscopy
2. endpoint is adenoma detection rate (ADR)

Eligibility criteria: Inclusion Criteria:

* all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria:

* none

Primary outcomes:
measure: Endoscopy time
timeFrame: within 45 minutes of examination
Secondary outcomes:
measure: polyp and adenoma detetction rate PDR and ADR
timeFrame: within 45 minutes of examination
Other outcomes:
measure: Medication dosage
timeFrame: withn 45 minutes of examination
Locations:
city: Wettingen
country: Switzerland
facility: Martin Geyer
state: Aargau
Study officials:
References:
Clinical trial NCT00598299: Comparison of the Effects on Promoting Corneal Epithelial Wound Healing Between Human Auto-Serum and Cord Blood Serum
Official title: Department of Ophthalmology, National Taiwan University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Injuries
Keywords: corneal epithelium
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: heahty adult volunteers and donated cord blood

Brief summary: Human serum eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. However, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. The purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. Primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, MTS assay and Boyden chamber migration assay in response to human serum and umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared between human serum and umbilical cord serum with ELISA kits.

Detailed description: Human serum eye drops have been successfully used clinically in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. However, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. The purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. Primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, MTS assay and Boyden chamber migration assay in response to human serum and umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared between human serum and umbilical cord serum with ELISA kits.

Eligibility criteria: Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

unhealthy volunteers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Fung-Rong Hu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05897099: Comprehensive HIV and Harm Prevention Via Telehealth
Official title: Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-06-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.


Eligibility criteria: Inclusion Criteria:

* age 18 or older
* able to speak English or Spanish
* willing and able to sign informed consent, provide locator information and medical records release
* non-reactive result on rapid HIV test
* use of SSP to exchange syringes 2 times in the past 3 months
* planning to stay in the area for 12 months

Exclusion Criteria:

* reactive HIV test
* currently on medications for opioid use disorder (MOUD) by urine drug screen
* currently on PrEP by self-report
* Principal or site investigator discretion
* currently in prison or jail
* current enrollment in Clinical Trials Network 121
* receipt of tele-harm reduction in previous 3 months
* signs or symptoms of acute HIV infection

Primary outcomes:
measure: HIV prevention via pre-exposure prophylaxis (PrEP)
timeFrame: up to 12 months
measure: HIV prevention via medications for opioid use disorder
timeFrame: up to 12 months
Secondary outcomes:
measure: syringe coverage
timeFrame: up to 12 months
measure: PrEP Adherence
timeFrame: up to 12 months
measure: Engagement in HCV treatment
timeFrame: Up to 12 months
measure: HCV cure
timeFrame: up to 12 months
measure: treatment of sexually transmitted infections
timeFrame: up to 12 months
measure: time to harm
timeFrame: up to 12 months
measure: number of harms
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: IDEA Miami
state: Florida
city: Miami
country: United States
facility: IDEA Syringe Services Program
state: Florida
Study officials:
affiliation: University of Miami
name: Hansel Tookes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Tyler Bartholomew, PhD
role: PRINCIPAL_INVESTIGATOR
References: