louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00834548: Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols
Official title: Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Intermittent Claudication
Keywords: Magnetic resonance
whole body
angiography
hybrid protocol
MRI
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2009-02-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Study population: Patients with peripheral arterial disease

Brief summary: To compare to different approaches in whole-body magnetic resonance angiography of patients suffering peripheral arterial disease.

Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA procedure.

Detailed description: Patients suffering peripheral arterial disease must undergo imaging procedures before endovascular or surgical procedures.

WB-MRA is an imaging procedure that can visualise the arterial system. WB-MRA can be performed in different manners. On option is to start the scan in the head region and continue down the body to the feet (standard protocol). Another option is to use a hybrid protocol that first examines the head and lower leg followed by examination of the pelvic and upper leg region.

A comparison between the standard and hybrid protocols has not been performed in a 3T high magnetic field system, therefore we will perform such a study.

Eligibility criteria: Inclusion Criteria:

* Symptomatic lower extremity ischemia (claudication, ischemic wounds)
* Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

* Renal insufficiency (GFR \< 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease

Primary outcomes:
measure: Diagnostic quality of WB-MRA
Secondary outcomes:
measure: Signal to noise ratio
measure: Contrast to noise ratio
Other outcomes:
Locations:
city: Herlev Copenhagen
country: Denmark
facility: Copenhagen University Hospital Herlev
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Yousef W Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051948: TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
Official title: Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Neoplasms
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2003-01-22
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent ovarian cancer.


Eligibility criteria: Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
* Recurrent ovarian cancer or persistent disease following primary treatment
* At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one)
* At least 18 years of age

Exclusion Criteria

* Pregnant or lactating women
* History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which patient has been disease-free for at least 2 years
* Known leptomeningeal metastases or carcinomatous meningitis
* Having received whole pelvis radiation therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Santa Monica Hematology/Oncology Consultants
state: California
city: Skokie
country: United States
facility: Midwest Cancer Research Group, Inc.
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT04436848: LRRK2 G2385R Leucocyte and Urine Biomarker Study
Official title: Identifying Leucocyte and Urine Biomarkers in Parkinson's Patients With LRRK2 G2385R Gene Variant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: University of Dundee
name: Nextcea, Inc
name: Max Planck Institute of Biochemistry
First posted: 2020-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease attending the Neurology outpatient clinic, at University of Malaya Medical Centre, Kuala Lumpur, Malaysia.

Brief summary: Given the emerging evidence on LRRK2-related biomarkers, this project will focus on identifying leucocyte and urine biomarkers that are altered by the LRRK2 G2385R variant, and investigating the effects of LRRK2 kinase inhibitor (MLi-2) on these biomarkers, using immunoblotting and mass spectrometry.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's disease assigned by a movement disorder specialist according to clinical diagnostic criteria
* Age above 18 year-old
* Provision of a written informed consent

Exclusion Criteria:

- Physical or mental incapacity to complete study protocol

Primary outcomes:
measure: Identification of monocyte-based biomarkers for LRRK2 G2385R variant
timeFrame: Two years
measure: Identification of urine-based biomarkers for LRRK2 G2385R variant
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
Study officials:
affiliation: University of Malaya
name: Ai Huey Tan, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06271148: Career and Lifestyle Among Female Surgeons in Jordan
Official title: Career and Lifestyle Among Female Surgeons in Jordan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lifestyle
Lead sponsor: Mutah University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female in General Surgery practice

Brief summary: A study conducted to evaluate the female surgeons in Jordan from different lifestyle

Detailed description: A study conducted to evaluate the female surgeons in Jordan from different lifestyle challenges

Eligibility criteria: Inclusion Criteria:

* female General surgery practitioners Lives in Jordan

Exclusion Criteria:

* males Other surgical specialists Outside Jordan

Primary outcomes:
measure: Career and Lifestyle Among Female Surgeons in Jordan
timeFrame: 5 years
measure: Working Hours
timeFrame: 5 years
measure: Sex Bias
timeFrame: 5 years
measure: inadequate mentorship
timeFrame: 5 years
measure: having 30 days of leave
timeFrame: 5 years
measure: salary
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Al-Karak
country: Jordan
facility: Mutah University
Study officials:
affiliation: Mutah University
name: Mohammad Abu-Jeyyab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00633048: Study Evaluating the Safety and Tolerability of NSA-789
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ascending single-dose study
healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is the first time that NSA-789, a new compound being developed for schizophrenia, will be given to humans. Each healthy subject will receive a single dose, except for 8 subjects who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.


Eligibility criteria: Inclusion:

* Healthy men and women between 18 and 50 years old.
* Women must be of non-child-bearing potential (not able to have children).
* Must be of normal body weight.

Primary outcomes:
measure: Safety and tolerability from reported adverse events, scheduled physical examinations, vital signs, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results
timeFrame: 3 months
Secondary outcomes:
measure: pharmacokinetics
timeFrame: 3 months
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02927548: Evaluation of the Efficacy and Safety of Advantage® Strips in Women Stress Urinary Incontinence (SUI )
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 500
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient of CHU Nîmes

Brief summary: This is a single-center retrospective study that evaluates the effectiveness and long-term safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary incontinence in women on a population of 500 patients with a mean follow-up of 6 years.


Eligibility criteria: Inclusion Criteria:

* patient who received the laying of a strip ADVANTAGE between 1/1/2015 and 1/6/2012

Exclusion Criteria:

* no

Primary outcomes:
measure: Patient global improvement scale
timeFrame: 6 years
measure: Complications
timeFrame: 6 years
measure: Urinary symptom questionnaire
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06080048: A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
Official title: A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Sorriso Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).


Eligibility criteria: Key Inclusion Criteria:

* Male or females, of any ethnic origin.
* Established diagnosis of UC by standard criteria for \>3 months.
* Disease evaluable by sigmoidoscopy.
* Mildly to severely active UC as determined by central reader in combination with other assessments of disease

Key Exclusion Criteria:

* Any diagnosis of IBD except for UC.
* History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
* Concurrent use of any biologic drug.
* Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.

Primary outcomes:
measure: Treatment Emergent Adverse Events following oral dosing
timeFrame: Up to 6 weeks in Part 3 or at the time of study discontinuation
Secondary outcomes:
measure: SOR102 concentrations following oral dosing
timeFrame: Up to 6 weeks in Part 3 or at the time of study discontinuation
measure: Incidence of positive ADAs to SOR102
timeFrame: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation
measure: Incidence of positive neutralizing ADA
timeFrame: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine
city: Kyiv
country: Ukraine
facility: Arensia Exploratory Medicine
Study officials:
affiliation: Sorriso Pharmaceuticals
name: Carlos C Sattler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03214848: Evaluation of an Intervention to Increase Post-abortion LARC Uptake.
Official title: Evaluation of an Intervention to Increase Post-abortion LARC Uptake: A Randomized Controlled Trial of Educational and Financial Counseling Prior to Clinical Presentation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Abortion Contraception
Keywords: Long-acting reversible contraceptive
Post Abortion
Iintrauterine device
Contraceptive implant
LARC
IUD
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Woodruff Health Sciences Center Foundation
First posted: 2017-07-12
Enrollment: 1314
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized prospective study evaluating the impact of a brief contraceptive education intervention with optional referral for financial counseling on post abortion long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post abortion.

Detailed description: As repeat unintended pregnancy and abortion remain public health challenges, increasing long-acting reversible contraceptive (LARC), specifically intrauterine device (IUD) and contraceptive implant, use among women presenting for abortion care is a priority. Despite its efficacy and safety, LARC methods remain underutilized in the abortion setting.

This is a randomized prospective study evaluating the impact of a brief contraceptive education intervention with optional referral for financial counseling on post abortion long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post abortion.

Eligibility criteria: Inclusion Criteria:

* Women calling to schedule an appointment for an abortion and/or those who receive abortion services at the Atlanta Women's Center with fluency in English and able to provide informed consent
* 16 years and older

Exclusion Criteria:

-Younger than 16 years old

Primary outcomes:
measure: Proportion of Long-Acting Reversible Contraception (LARC) methods inserted immediately post abortion in the intervention and standard of care arms.
timeFrame: Immidiately post abortion (day of the procedure).
Secondary outcomes:
measure: Proportion of Long-Acting Reversible Contraception (LARC) methods used in the intervention and standard of care arms three months post abortion.
timeFrame: Three months post abortion.
measure: Cost-effectiveness analysis of the study intervention.
timeFrame: Three months post abortion.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Women's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Lisa Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00894348: Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangiopancreatography
Official title: EXEMPT: Prospective Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangio-pancreatography (ERCP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Stricture
Keywords: ERCP
Positive Biliary Brush Cytology
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing an ERCP for evaluation of biliary strictures

Brief summary: To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.

Detailed description: There are only 3 studies available that have tried to evaluate factors influencing the yield of brush cytology. Two of the 3 studied one parameter. The third study, which is also the largest, reported on 199 samples which the authors evaluated in a retrospect fashion. We plan to conduct a larger study assessing several other factors that have not been studied before. The study findings would help develop strategies to improve sensitivity of brush cytology specimens. This would ultimately result in more effective use of health care resources and improve patient outcomes.

Eligibility criteria: Inclusion Criteria:

* ERCP Patients

Exclusion Criteria:

* Non ERCP Patients

Primary outcomes:
measure: To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Staff Physician
name: Mansour Parsi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164448: The Effects of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
Keywords: dexmedetomidine
postoperative bowel movement
laparoscopic gastrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of intraoperative dexmedetomidine infusion on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
* gastric cancer patient undergoing laparoscopic gastrectomy

Exclusion Criteria:

* ASA physical status Ⅳ
* bradycardia (\< 60 bpm), arrhythmia
* uncompensated heart failure
* hepatic failure (Child-Pugh score B 이상)
* renal failure (eGFR MDRD \< 60 ml/min/1.73m2)

Primary outcomes:
measure: gas passing
timeFrame: up to 1 week
Secondary outcomes:
measure: sips of water time
timeFrame: up to 1 week
Other outcomes:
measure: soft diet time
timeFrame: up to 1 week
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,
Study officials:
References:
Clinical trial NCT00431548: Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)
Official title: Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Retina
Ocular Physiology
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several hypotheses including infectious damage of the retinal vasculature and altered retinal hemodynamics have been postulated. The latter would be compatible with the theory that the retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the retina is not possible and indirect methods have to be employed. The study objective was to investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with HIV.


Eligibility criteria: Inclusion Criteria:

Group 1 (Patients with HIV)

* Aged between 19 and 70 years, male and female
* HIV positive patients without HIV-related retinopathy with a CD4+ cell count  500 cells/mm3 stage A2, A3, B2, B3, C2 and C3.
* Best corrected visual acuity \>= 0.8
* Ametropy \< 6 dpt

Group 2 (Healthy control subjects)

* Aged between 19 and 70 years
* Age and sex matched to the subjects in the HIV group (group matched)
* Matched with regard to the smoking habits in the HIV group
* Best corrected visual acuity \>= 0.8
* Ametropy \< 6 dpt

Exclusion Criteria:

* Evidence of any other eye disease
* Diabetes mellitus
* Systemic hypertension (defined as SBP \> 150 mmHg or DBP \> 90 mmHg)
* Abuse of illegal drugs

Primary outcomes:
measure: Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Hans-Georg Eichler, MD
role: PRINCIPAL_INVESTIGATOR
References: