louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00757484: Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery
Official title: Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urogynecology
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 528
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gynecologic patients

Brief summary: The purpose of this study is to establish normal postoperative changes in blood pressure in women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also, to establish if there is a difference in normal postoperative blood pressure changes between elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient postoperative care.


Eligibility criteria: Inclusion Criteria:

* Women who underwent scheduled gynecologic surgery requiring inpatient postoperative care between January 2007 - January 2008

Exclusion Criteria:

* Women who experienced myocardial infarction, cardiac arrest or failure, pulmonary embolism, infection requiring intravenous antibiotics, intra- or postoperative hemorrhage requiring blood transfusion, renal failure

Primary outcomes:
measure: Percentage of Participants Who Underwent Gynecologic Surgery
timeFrame: January 2007 to January 2008
Secondary outcomes:
measure: Percentage of Women With Asymptomatic Hypotension
timeFrame: 1 year
measure: Percentage of Participants Undergoing Different Types of Anesthesia
timeFrame: January 2007 to January 2008
measure: Surgical Time
timeFrame: January 2007 to January 2008
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Erin Duecy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165784: Comparison of Techniques in Determining Femoral Veins Location
Official title: Comparison of the Accuracy Between Technique V and Arterial Palpation Techniques in Determining the Location of the Femoral Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Keywords: arterial palpation technique
femoral access
femoral vein
V tecnique
vascular access
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to determine the accuracy of the V technique in predicting the location of the femoral vein compared to the technique of palpating the femoral artery with the use of USGss as a standard in determining the exact location of the femoral vein.

Detailed description: One hundred and fifteen subjects were allocated into two large groups, V tecnique group and palpation tecnique group. Researchers will perform the V technique on the patient's inguinal area. This technique was performed using the researcher's contralateral hand. After the V technique is performed, the next researcher will perform the technique of palpating the femoral artery pulse at the exact location as the V technique. This technique is done by palpating the femoral artery pulsation using the examiner's index and middle fingers along the inguinal ligament; the location of the femoral vein is at 1 cm. medial to the femoral artery 2 cm inferior to the inguinal ligament. This location is marked "y" with a UV marker. researchers will compare the accuracy of both techniques in determining the exact location of femoral veins.

Eligibility criteria: Inclusion Criteria:

* patients aged 18-65 years
* body mass index (BMI) of 18-25 kg/m2

Exclusion Criteria:

* could not lie supine
* had congenital or acquired abnormalities in the pelvic and inguinal region
* had a history of previous femoral vein puncture
* allergic to USG gel

Primary outcomes:
measure: prediction of femoral vein location
timeFrame: intra procedural
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Aida Rosita R Tantri, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02992184: PoC-HCV Genedrive Viral Detection Assay Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: HCV
Genedrive
Point of Care
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: EPISTEM
First posted: 2016-12-14
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-treatment cohort: 228 HCV patients samples

* Age \> 18 years old.
* Patients with positive HCV RNA.
* Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
* Patients have given a written consent that their blood samples will be further used for research.

Control samples : 189 controls

* Age \> 18 years old.
* Participants were tested negative for anti-HCV antibody
* Heparinized plasma samples are available
* Participants have given a written consent that their blood samples will be further used for research

Brief summary: The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.


Eligibility criteria: Inclusion Criteria:

Criteria for case

* Age \> 18 years old.
* Patients with positive HCV RNA.
* Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
* Patients have given a written consent that their blood samples will be further used for research.

Criteria for control

* Age \> 18 years old.
* Participants were tested negative for anti-HCV antibody
* Heparinized plasma samples are available
* Participants have given a written consent that their blood samples will be further used for research

Exclusion Criteria:

-

Primary outcomes:
measure: Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).
timeFrame: pre-treatment
Secondary outcomes:
measure: Diagnostic algorithm optimization
timeFrame: Pre-treatment
measure: Factors associated with false-positive of false-negative results
timeFrame: Pre-treatment
measure: Assess the inter-examiner reproducibility of the PoC assay.
timeFrame: Pre-treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Llibre A, Shimakawa Y, Mottez E, Ainsworth S, Buivan TP, Firth R, Harrison E, Rosenberg AR, Meritet JF, Fontanet A, Castan P, Madejon A, Laverick M, Glass A, Viana R, Pol S, McClure CP, Irving WL, Miele G, Albert ML, Duffy D. Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus. Gut. 2018 Nov;67(11):2017-2024. doi: 10.1136/gutjnl-2017-315783. Epub 2018 Apr 3.
Clinical trial NCT01611584: A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
Official title: A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Lung Cancer in Normal and Malignant Tumors
Keywords: ALA
Florescence
Lung cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2012-06-05
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: DIAGNOSTIC

Brief summary: The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria Patients (12 total patients with lung cancer) meeting eligibility criteria will be enrolled.
* Preoperative diagnosis of either presumed or documented non-small cell lung cancer.
* Tumor judged to be suitable for surgical resection based on preoperative evaluation of radiographic studies, pulmonary function tests, performance status and clinical judgment of surgeons at DHMC (Erkmen, Nugent)
* Age ≥ 18 years old.
* Population representative of our usual referral pattern including minority populations, women and those who are financially disadvantaged.
* Subjects capable of giving informed consent

Exclusion Criteria:

* Pregnant Women
* Women who are breast feeding
* History of cutaneous photosensitivity
* Porphyria, hypersensitivity to porphyrins, photodermatosis
* Exfoliative dermatitis
* History of liver disease within the last 12 months
* Inability to comply with photosensitivity precautions associated with the study
* Inability to give informed consent
* AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the past 2 months
* Plasma creatinine in excess of 180 umol/L
* Women who are breast feeding
* History of cutaneous photosensitivity
* Porphyria, hypersensitivity to porphyrins, photodermatosis
* Exfoliative dermatitis
* History of liver disease within the last 12 months
* Inability to comply with photosensitivity precautions associated with the study

Primary outcomes:
measure: ALA-induced fluorescence- lung cancer
timeFrame: Participants will be followed for duration of the hospital stay, and up to 3 weeks after
Secondary outcomes:
measure: Determine Feasibility of fluorescence
timeFrame: Participants will be followed for the duration of their hospital study and up to 3 weeks after
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Cherie P Erkmen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05070884: Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer Treatment Planning
Official title: Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Medical University of Gdansk
name: Medical School University of Zagreb
name: Medical University of Vienna
name: Hacettepe University Hospital
name: Alexander Fleming Institute
name: Ain Shams University
First posted: 2021-10-07
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with chemotherapy prior to surgery

Brief summary: RadioVal will develop and implement interoperable solutions for clinical deployment of the radiomics tools, including information, training, and communication packages for clinicians and patients, as well as standard operating procedures for the integration of radiomics in clinical oncology. With this study, we will clinically validate these solutions, by looking at their reliability for precise breast cancer diagnosis, treatment recommendation and prognosis estimate, treatment response, evaluation of residual disease and outcome prediction.


Eligibility criteria: Inclusion Criteria:

* Females ≥ 18 years up to 85 years old
* Individuals referred to hospitals for diagnosis of breast cancer
* Availability of radiological images: 2D mammography or 2D synthetic digital tomosynthesis, ultrasound, or magnetic resonance
* Availability of pathological report (surgical specimen)
* Availability of (Neoadjuvant) treatment allocation (scheme, duration, benefit)
* Availability of treatment response

Exclusion Criteria:

* Patient with incomplete or low-quality data (radiological, pathological or clinical)

Primary outcomes:
measure: Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness)
timeFrame: Baseline and after neoadjuvant treatment (4-6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Alexander Fleming
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Zagreb
country: Croatia
facility: University of Zagreb School of Medicine
city: El Cairo
country: Egypt
facility: Ain Shams University
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe de Valencia
city: Stockholm
country: Sweden
facility: Karolinska Institute
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT04231084: Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide
Official title: Acute Hemodynamic Comparison of Inhaled Nitric Oxide and Inhaled Epoprostenol in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.


Eligibility criteria: Inclusion Criteria:

* mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU
* Classified as WHO group I-III pulmonary hypertension

Exclusion Criteria:

* WHO group IV and V pulmonary hypertension
* Patients who are on baseline pulmonary vasodilator medications
* Severe aortic or mitral valve disease
* Patients who are pregnant
* Left ventricular ejection fraction of \<35%
* Patients who are hospitalized as inpatients at the time of RHC
* Patients with systolic blood pressure \<90mmHg or mean arterial pressure of \< 60mmHg

Primary outcomes:
measure: Change in mean pulmonary artery pressure
timeFrame: Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Aaron B Waxman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192684: Obesity, Sleep Apnea, and Insulin Resistance
Official title: Interfacing Adiposity, Sleep Apnea, and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
insulin sensitivity
cardiovascular risk
positive airway pressure therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.


Eligibility criteria: Inclusion Criteria:

* Healthy Individuals
* Age 30-70 years old
* BMI- 25-40 kg/m2
* Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography

Exclusion Criteria:

* Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer.
* Must not have previously received treatment for OSA, including CPAP.
* Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity.
* Pregnancy/lactation is also an exclusion.

Primary outcomes:
measure: Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Gerald M Reaven, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu A, Kim SH, Ariel D, Abbasi F, Lamendola C, Cardell J, Xu S, Patel S, Tomasso V, Mojaddidi H, Grove K, Tsao PS, Kushida CA, Reaven GM. Does enhanced insulin sensitivity improve sleep measures in patients with obstructive sleep apnea: a randomized, placebo-controlled pilot study. Sleep Med. 2016 Jun;22:57-60. doi: 10.1016/j.sleep.2016.06.005. Epub 2016 Jun 21.
Clinical trial NCT05869084: Assessment of Bronchial Obstruction in Adolescents With HIV
Official title: Assessment of Bronchial Obstruction in Adolescents With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: antiretrovirals
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 21
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In children, data from the literature find a higher prevalence of asthma in the population treated for HIV. Bronchial hyperreactivity, indicative of chronic inflammation and bronchial obstruction, is also present.

Screening for early peripheral obstruction could therefore make it possible to initiate appropriate anti-inflammatory treatment, if necessary, and early preventive management.

Detailed description: In adults chronically infected with HIV, there is an increased prevalence impaired respiratory function, with a greater occurrence of COPD than in the uninfected population. In children, data from the literature find a prevalence of greater atopy in the HIV-infected pediatric population. Furthermore, a bronchial hyperreactivity or even peripheral bronchial obstruction, indicative of a local chronic inflammation has been found in young adolescents treated since the birth for HIV infection in utero. Screening for early peripheral obstruction in HIV-infected adolescents could therefore make it possible to initiate, if necessary, a anti-inflammatory treatment, and early management to prevent the occurrence of impaired respiratory function in adulthood For this this single-center prospective study chose to perform respiratory function explorations with forced oscillometry with the Endpoint main factor of the peripheral obstruction the R5HZ parameter expressed in % predicted. Patients from 11 to 25 years to whom it was proposed added to that to answer a questionnaire of respiratory quality of life

Eligibility criteria: Inclusion Criteria:

* Children over 11 and Under 25-year-old infected with HIV and on antiretrovirals and followed up at Robert Debré hospital for this pathology
* Consent of the holders of parental authority and Patients informed and not objecting to participate in research Exclusion Criteria : •
* Age ≤ 11 years old
* Not treated for HIV
* Patients under guardianship / curatorship

Primary outcomes:
measure: Resistance measured by forced oscillometry (5hZ)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Veronique HOUDOUIN, PhD
role: PRINCIPAL_INVESTIGATOR
References: