louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01050413: Evaluation of Thymidine Kinase Activity in the Serum of Patients With Solid Tumors
Official title: Evaluation of Serum Thymidine Kinase Activity in Diagnosis,Prognosis and Monitoring of Treatment in Patients With Solid Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Tumors
Keywords: Thymidine Kinase 1 activity
diagnosis
prognosis
follow-up
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from oncology department and patients visiting outpatient, daycare oncology clinic

Brief summary: This study aimed to evaluate serum thymidine kinase 1 (TK1) activity as a marker for solid tumors and more specifically in: preoperative testing for prediction of disease recurrence and survival; follow-up after surgical removal of the original tumor for early detection of disease recurrence and in monitoring therapy as a surrogate marker of tumor response.

Detailed description: Thymidine kinase 1 (TK1) is a metabolic enzyme catalyzing the ATP-dependent phosphorylation of thymidine to thymidine monophosphate followed by its utilization in DNA synthesis. It has been demonstrated that activity of TK1 in the serum of cancer patients corresponds to the amount of dividing tumor cells. Several clinical investigations clearly showed that abnormal TK1 levels indicate tumor growth. In breast cancer, serum TK1 was shown to predict increased risk of recurrence following surgery and may be a good marker for monitoring the response to therapy. The measurements of TK1 were useful as a prognostic and monitoring factor in patients with NSCLC. Unfortunately, all previously used assays measuring TK1 activity showed relatively low analytical sensitivity. Recently, the novel high sensitive non-radioactive TK1 assay (DiviTum) has been developed. With this assay tumour growth may be detected at an earlier stage of disease and smaller amounts of residual disease may be detected during and after therapy.

Eligibility criteria: Inclusion Criteria:

* patients with colon, breast, prostate and lung cancer before and during treatment

Exclusion Criteria:

* pregnant women;
* patients with generalized CMV and HZV infections;
* patients with severe rheumatoid arthritis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT02735018: Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions
Official title: Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Response to Epinephrine
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.


Eligibility criteria: Inclusion Criteria:

* Class I patients according to the American Society of Anesthesiology (ASA),
* Indication for third molars extraction,
* Similar degree of complexity, according to the classification of Pell and Gregory.

Exclusion Criteria:

* Patients with systemic conditions,
* Patients with known allergy to any component of the anesthetic solution.

Primary outcomes:
measure: Heart rate
timeFrame: 20 minutes
measure: Blood pressure
timeFrame: 20 minutes
measure: Arterial oxygen saturation, measured with a pulse oximeter device
timeFrame: 20 minutes
measure: Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive
timeFrame: 20 minutes
measure: Pain, evaluated using a visual analogue scale
timeFrame: After procedure, about 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01737918: Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa
Official title: Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Surgical Treatment of Urge Incontinence
Keywords: urge urinary incontinence, cesa, vasa, TOT, solifenacin
Lead sponsor: Klinikum der Universität Köln
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.

Detailed description: It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.

Eligibility criteria: Inclusion Criteria:

* prior vasa or cesa operation as part of the URGE I study
* stress urinary incontinence
* mixed urinary incontinence

Exclusion Criteria:

* previous urogynecological surgery
* avulsion of cesa or vasa tape
* pregnancy
* neurologic/psychological reasons for incontinence
* body weight \>100kg
* syndrome of dry overactive bladder

Primary outcomes:
measure: cure of incontinence
timeFrame: 3 months
Secondary outcomes:
measure: improvement of urge symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln
state: NRW
city: Köln
country: Germany
facility: Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln
state: NRW
Study officials:
affiliation: Study Supervisor
name: Wolfram H Jager, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104518: Evaluation of Different G6PD Testing Platforms
Official title: Evaluation of a Point-of-care G6PD Diagnostic Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glucose-6-Phosphate Dehydrogenase Deficiency
Keywords: glucose-6-phosphate dehydrogenase
point-of-care diagnostic testing
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Eijkman Institute for Molecular Biology
First posted: 2014-04-04
Enrollment: 700
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll up to 700 volunteers from the SW Sumba region in Indonesia. The SW Sumba region is inland, and isolated from other nearby villages. The general population of SW Sumba are substance farmers.

Brief summary: In this study the investigators propose to evaluate the performance of several G6PD testing platforms.

Detailed description: In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.

Eligibility criteria: Inclusion Criteria:

* Subjects must be at least five years of age
* Patient / parental consent
* Patient willing to allow donated sample to be used in future research

Exclusion Criteria:

* Patients with severe malaria or other severe illness
* Patients who received a blood transfusion in the last three months
* Patients unwilling to allow donated blood to be used in future research

Primary outcomes:
measure: Determine concordance between point-of-care tests and spectrophotometric gold standard
timeFrame: Six months
Secondary outcomes:
measure: Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard
timeFrame: Six months
measure: Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard
timeFrame: Six months
measure: Determine concordance between point-of-care G6PD tests and the florescent spot test
timeFrame: Six months
measure: Define the G6PD-normal and deficient profiles in the SW Sumba population.
timeFrame: Six months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Eijkman Institute for Molecular Biology
Study officials:
affiliation: Eijkman Institute for Molecular Biology
name: Ari Winasti Satyagraha, PhD
role: STUDY_CHAIR
affiliation: Eijkman Oxford Clinical Research Unit, Indonesia
name: Kevin Baird, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01103518: Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
Official title: Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Amenorrhea
Dysmenorrhea
Menstruation Disturbances
Hyperandrogenism
Keywords: Menstrual irregularity
Menstruation disturbances
Hyperandrogenism
Lead sponsor: Fundação Educacional Serra dos Órgãos
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.


Eligibility criteria: Inclusion Criteria:

* Female subject
* Premenopausal subject
* 18 years or older
* Medical history of irregular menses lasting at least 3 months
* Signature of informed consent

Exclusion Criteria:

* Pregnancy
* Use of hormonal contraceptives within 3 months of screening
* Primary bilateral oophorectomy
* Chemotherapy and / or radiotherapy within 6 months of screening
* Hysterectomy
* Myotonic dystrophy
* Galactosemia
* Galactorrhea
* History of tuberculosis or schistosomiasis
* Elevated prolactin / other significant laboratory alterations
* Diabetes
* Premature ovarian deficiency
* Sensitivity to any component of the drug formula

Primary outcomes:
measure: Regular Menstruation
timeFrame: Treatment month 3
Secondary outcomes:
measure: Menstrual flow
timeFrame: Treatment months 3
measure: Menstrual colic
timeFrame: Treatment month 3
measure: Global self evaluation scores
timeFrame: Treatment month 6
measure: Willingness to continue treatment
timeFrame: Treatment month 6
measure: Safety
timeFrame: Treatment and follow-up period
measure: Menstrual Flow
timeFrame: Treatment month 4
measure: Menstrual Flow
timeFrame: Treatment month 5
measure: Menstrual Colic
timeFrame: Treatment month 4
measure: Menstrual Colic
timeFrame: Treatment month 5
Other outcomes:
Locations:
city: Teresópolis
country: Brazil
facility: Hospital das Clínicas de Teresópolis
state: Rio de Janeiro
Study officials:
affiliation: Fundação Educacional Serra dos Órgãos
name: Carlos RB Gama, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundação Educacional Serra dos Órgãos
name: Carlos P Nunes, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02927418: Strength Training for Injury Prevention
Official title: Strength Training for Injury Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore the effects of a strength \& conditioning (S \& C) program on risk factors for injury (Y-balance and Functional Movement Screen scores), as well as parent reported injury occurrence in 12-16 year old male and female athletes. Forty girls and 40 boys aged 12-16 will be recruited; half will participate in supervised S \& C sessions 2-3x/week while the other half will continue with their regular sports and activities. Risk factors for injury and performance indices (20 m sprint and multiple jump test) will be assessed before and after the 4 month study. Injury occurrence will be recorded via bi-weekly phone calls to the parent and athlete.


Eligibility criteria: Inclusion Criteria:

* Athletes between 12 and 16 years of age, actively participating in organized sport

Exclusion Criteria:

* Any condition or injury that will place the athlete at risk during testing or training

Primary outcomes:
measure: Y-balance score
timeFrame: 4 months
Secondary outcomes:
measure: 20 metre sprint
timeFrame: 4 months
measure: Multiple Jump test
timeFrame: 4 months
measure: Functional Movement Screen score
timeFrame: 4 months
measure: Self-reported injury rates
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Joanne Parsons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00570518: Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study
Official title: DRUID Work Package 2 - Epidemiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevalence of Psychoactive Substances in Road Traffic
Psychoactive Substances in Accident Involved Drivers
Relative Risk Estimation of Accident Involvement for Impaired Drivers
Keywords: driving under the influence
psychoactive substances
roadside surveys
hospital surveys
accident involvement risk estimation
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Hospital District of Helsinki and Uusimaa
name: European Commission
First posted: 2007-12-11
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: drivers of motorised vehicles and bicycles in general road traffic or drivers of motorised vehicles and bicycles, injured or killed in road traffic accidents

Brief summary: The main purpose of the study is to determine the accident risk when driving under the influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the prevalence of psychoactive substances in road traffic and to obtain information on the role of these substances in road traffic accident causations.

For the purposes of the study, drivers of motorised vehicles are randomly stopped and interviewed and breath alcohol is recorded. Also, an oral fluid sample is taken and psychoactive substances are investigated in the laboratory. For cases, drivers injured in traffic accidents are asked to participate to the study. A whole blood sample and, if possible, an oral fluid sample is taken and psychoactive substances are determined in the laboratory. Also, people diseased in road traffic accident are included in the study. The information required for these subjects are taken from a register database.

The study is part of an EU-project DRUID. Altogether 13 European countries take part to the study.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* driver of a motorised vehicle or bicycle
* is willing to participate to the study (not applicable to the diseased drivers; information obtained from a register database)

Exclusion Criteria:

* 17 or younger
* not the driver of a motorised vehicle or bicycle
* does not want to participate (not applicable to the diseased drivers; information obtained from a register database)

Primary outcomes:
measure: relative risk estimation of accident involvement for drivers impaired by psychoactive substances
timeFrame: three years
Secondary outcomes:
measure: prevalence of psychoactive substances in the general driving population
timeFrame: three years
measure: prevalence of psychoactive substances among accident involved drivers
timeFrame: three years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Public Health Institute
Study officials:
affiliation: National Public Health Institute
name: Pirjo Lillsunde, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05223218: Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study
Official title: Investigating the Diagnostic Potential of Tear Proteins in Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Melanoma
Keywords: Preventative Screening
Protein Biomarkers
Lacrimal Tear Fluid
Non-invasive
Tear Collection
CLIA Laboratory
Affordable
Proteomics
Metabolomics
Protein Microarray
ELISA assay
Lead sponsor: Namida Lab
Sponsor class: INDUSTRY
Collaborators: name: Arkansas Urology
name: CARTI
First posted: 2022-02-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population presented in the inclusion criteria will be recruited at multiple cancer centers and clinical sites.

Brief summary: This Pilot Study is to investigate the tear proteins in a multitude of cancer types and indulge in biomarker discovery to manufacture simple, accurate, and novel tear-based diagnostic tests.

Detailed description: The Pilot Study is an observational study to investigate the diagnostic potential of tear proteins for Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon cancer. In this pilot study, we use lacrimal gland fluid (tears) as a liquid biopsy source for investigating the protein repertoire and conducting biomarker discovery studies with a goal to develop new tear-based tests that can detect crucial cancer-related biomarkers in the pan-cancer types.

Proteomic studies on tears have shown to express between 500-1500 proteins with \~35% overlap with serum proteome. The easy accessibility of tear fluid with minimal post-processing procedures and better access to lower molecular weight proteins make tears an ideal source to identify commonly associated cancer biomarkers.

Additionally, the results from this study will aid in improving our understanding of the cancer types and commonalities that exist between them.

Eligibility criteria: Inclusion Criteria:

* 18-100 years of age
* Presenting for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)
* Presenting for the evaluation of a palpable lump or mass
* Presenting with a mass may be pre or post-biopsy/diagnostic as long as there is a portion of the mass remaining.
* Have been diagnosed but have not received treatment

Exclusion Criteria:

* Less than 18 years of age OR more than 100 years of age
* Concurrent eye infection or trauma
* Acute conjunctivitis

Primary outcomes:
measure: Identify Cancer-related Biomarkers
timeFrame: Dec 2023
Secondary outcomes:
measure: Tear Protein Concentrations
timeFrame: Dec 2023
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Namida Lab
state: Arkansas
Study officials:
affiliation: Namida Lab Inc
name: Prashanth Ravishankar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06614218: MIMS® Retrospective Chart Review
Official title: Minimally Invasive Micro Sclerostomy (MIMS®) Retrospective Chart Review
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Open Angle Glaucoma
Keywords: Polypharmacy
Intraocular Pressure
MIMS
Minimally Invasive Glaucoma Surgery
MIGS
MTMT
Trabeculectomy
Sclerostomy
Lead sponsor: Sanoculis Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of subjects of Armenian descent that were treated with the MIMS® Device as a standalone procedure between 27 Sep 2023 and 30 April 2024.

Brief summary: This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and May 2025.


Eligibility criteria: Inclusion Criteria:

1. Eye treated with MIMS® Device as a standalone procedure
2. MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024

Primary outcomes:
measure: Change in IOP from medicated baseline at 12 months post-MIMS® surgery
timeFrame: Medicated baseline at 12 months post-MIMS® surgery
measure: Change in the number of topical IOP-lowering medications from medicated baseline at 12 months post-MIMS® surgery
timeFrame: Medicated baseline at 12 months post-MIMS® surgery
measure: Success rate at 12 months post-MIMS® surgery
timeFrame: 12 months post-MIMS® surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S. Malayan Eye Center
Study officials:
References: