louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03006224: The Effects of Secondary Smoking During One Lung Ventilation
Official title: The Effects of Secondary Smoking to Intraoperative Arterial Oxygen Tension During One Lung Ventilation in Lobectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Oxygen Deficiencies
Keywords: secondary smoking
one lung ventilation
arterial oxygen tension
lobectomy
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 60
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.

Detailed description: Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be included in this study. These patients will be divided into 2 groups. Groups S which will be included non smoking and secondary smoking and group SS which will be included secondary smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative peak airway pressure will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3.

Exclusion Criteria:

* Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.

Primary outcomes:
measure: arterial oxygen tension
timeFrame: From beginning of Anesthesia to 1st day of surgery
measure: arterial carbon dioxide tension
timeFrame: From beginning of Anesthesia to 1st day of surgery
measure: intraoperative peak airway pressure
timeFrame: during intraoperative ventilation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05963724: Real-Time CAD for Colonic Neoplasia: A RCT
Official title: Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Neoplasms
Keywords: artificial intelligence
Lead sponsor: Riverside University Health System Medical Center
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 1100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Detailed description: Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

Eligibility criteria: Inclusion Criteria:

* Undergoing colonoscopy at RUHS
* Age \> 45 years
* No contraindications to colonoscopy

Exclusion Criteria:

* Prior history of subtotal colectomy

Primary outcomes:
measure: Adenoma Detection Rate
timeFrame: 1 year
Secondary outcomes:
measure: Adenomas Per Colon
timeFrame: 1 year
measure: Sessile Serrated Lesion Detection Rate
timeFrame: 1 year
measure: Sessile Serrated Lesions Per Colon
timeFrame: 1 year
measure: False Neoplasia Rate
timeFrame: 1 year
measure: Withdrawal Time
timeFrame: 1 year
Other outcomes:
Locations:
city: Moreno Valley
country: United States
facility: Riverside University Health System
state: California
Study officials:
References:
citation: Thiruvengadam NR, Cote GA, Gupta S, Rodrigues M, Schneider Y, Arain MA, Solaimani P, Serrao S, Kochman ML, Saumoy M. An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model. Gastroenterology. 2023 May;164(6):906-920. doi: 10.1053/j.gastro.2023.01.027. Epub 2023 Feb 2.
Clinical trial NCT04783324: The Effect of the E-Mobile Health Application on Postpartum Adaptation
Official title: The Effect of the E-Mobile Health Application for Pregnant Women Created Based on the Roy's Adaptation Model on Postpartum Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Period
Pregnant Women
Adaptation
Mobile Applications
Keywords: Mobile Applications
Postpartum Period
Adaptation
Randomized Controlled Trial
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of two groups: Experimental group and control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to determine the effect of the e-mobile health application on postpartum adaptation. The study will consist of two groups: Experimental group and control group.

Detailed description: This is a randomized controlled trial. A questionnaire and The Postpartum Self-Evaluation Questionnaire will be used to collect data. The main hypothesis of the research: Postpartum Self-Evaluation Questionnaire total mean score of women who use e-mobile health application created according to Roy's Adaptation Model is not different from the total mean score of women in the control group.

Research sample will consist of a total of 62 pregnant women, 31 in the experimental group and 31 in the control group. The data will be evaluated with the SPSS (Statistical Package of SocialSciences) 24.0 package program.

Eligibility criteria: Inclusion Criteria:

* Primiparous
* Being in the 32nd week of pregnancy and above
* Not getting any diagnosis that poses a risk for pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
* Speaking Turkish
* To be at least a primary school graduate
* Having a smart phone with Android operating system

Exclusion Criteria:

* Multiparous
* Being under 32 weeks of pregnancy
* Getting any diagnosis that poses a risk to pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
* Not speaking Turkish
* Having a smartphone with an operating system other than Android

Primary outcomes:
measure: Postpartum Adaptation
timeFrame: At postpartum tenth day (baseline) and last-interview at postpartum sixth week (change from baseline at sixth week)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Koru Hospital
Study officials:
affiliation: Gazi University
name: Şengül Yaman Sözbir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03492424: Ablative Therapy in the Management of Prostate Cancer
Official title: Ablative Therapy in the Management of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: prostate cancer
cryotherapy
focal therapy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
First posted: 2018-04-10
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are generally healthy men diagnosed with prostate cancer, undergoing focal therapy for treatment of prostate cancer.

Brief summary: The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.

Detailed description: Through the use of a pro- and retrospective registry, the investigators will collect information on patient characteristics including age, co-morbidities, imaging and biopsy information, and prior treatments. Information on treatment details will also be captured, including treatment time, anesthesia delivered, and length of stay, when applicable. Oncologic outcomes including PSA, post-treatment biopsy and imaging data, need for re-treatment, and survival outcomes will also be captured. Safety outcomes will be captured using the Clavien-Dindo classification scale, and additional specific GU complications will be recorded, which include urinary retention, urethral stricture, recto-urethral fistula, osteomyelitis, and urinary tract infection. Finally, the investigators will capture functional outcomes using health related quality of life questionnaires including the EPIC questionnaire, IIEF-5, MSHQ-EjD, and IPSS.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Undergoing focal therapy for primary or salvage treatment of prostate cancer, or
* Have received prior focal therapy

Exclusion Criteria:

* Clinically-evident metastatic disease
* Unable to fill out an English-language questionnaire

Primary outcomes:
measure: Prostate biopsy Gleason grade
timeFrame: 12 months
Secondary outcomes:
measure: Patient characteristics/demographics
timeFrame: 12 months
measure: MRI PI-RAD grade
timeFrame: 12 months
measure: Lab results - PSA level
timeFrame: 12 months
measure: Patient-reported quality of life: EPIC-26
timeFrame: 12 months
measure: Patient-reported quality of life: IIEF-5
timeFrame: 12 months
measure: Patient-reported quality of life: MSHQ-EjD
timeFrame: 12 months
measure: Patient-reported quality of life: IPSS
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Tim McClure, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03045224: PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up
Official title: Endovascular Treatment in Patients With Peripheral Artery Disease: Real Life Effectiveness Off the Road of Studies PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Efficacy/Long-term Effectiveness Endovascular Therapy in PAD
Keywords: PAD, PTA, mortality, morbidity, amputation rate, quality of life
Percutaneous transluminal angioplasty (PTA), Stenting, balloon angioplasty
Lead sponsor: Vascular Center Berlin
Sponsor class: OTHER
Collaborators: name: BVMed - The German Medical Technology Association
name: German Society for Angiology - Society for Vascular Medicine (DGA)
First posted: 2017-02-07
Enrollment: 1760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines were included in the registry. Presence of written informed consent for participating in the registry was mandatory. There were no exclusion criteria and no age restriction.

Brief summary: The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and follow-up patients with peripheral arterial disease undergoing endovascular peripheral intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and radiologists contributed actively to this registry.

Detailed description: The registry was created for the following purposes: evaluation of the clinical effectiveness, safety and quality of the endovascular therapy, and history of the disease after endovascular therapy. The resulting specific research questions were determination of the technical and clinical success of the procedure, monitoring of periinterventional complications, evaluation of vessel patency, amputation rate, mortality, and major adverse cardiac events during the follow-up. In addition, the quality of life after endovascular peripheral intervention over a period of two years was evaluated.

Eligibility criteria: Inclusion Criteria:

* peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines

Exclusion Criteria:

* no exclusion criteria and no age restriction

Primary outcomes:
measure: death of any cause
timeFrame: 2 years
measure: revascularization (TLR, TVR)
timeFrame: 2 years
Secondary outcomes:
measure: minor or major amputation
timeFrame: 2 years
measure: major adverse cardiac events and stroke
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02634424: PK Driven Prophylaxis for Hemophilia A
Official title: Interest of Preventive Personalized Treatment in Hemophilia A
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemophilia A
Keywords: Hemophilia A
Prophylaxy
Pharmacokinetic
Bayesian
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2015-12-18
Enrollment: 12
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven prophylaxis in current clinical practice

Detailed description: Starting from 3 pharmacokinetic (PK) points, data are entered in the PK calculator device, and treatment dose is adjusted following the results of PK values obtained and clinical bleeding data

Eligibility criteria: Inclusion Criteria:

* Male Patient
* Severe or moderately severe haemophilia A (FVIII = 2 %), preventively treated (processing) by ADVATE for at least 6 months,
* At last 6 years old,
* An informed consent must be signed by the patient or his legal representative for the patients minor.
* Affiliated to a national insurance scheme

Exclusion Criteria:

* Previous or actual treatment with FVIII inhibitors \> 0,6 UB at the selection
* Induction of immune tolerance
* Planned orthopedic surgery for the 18 next months
* Any other haemostatic pathology
* Any treatment interacting on the haemostasis
* Patient under guardianship
* Patient participating in another biomedical research

Primary outcomes:
measure: Joint Annual Bleeding Rate
timeFrame: during 6 months before (retrospectively) and up to 12 months after using of myPKFiT
Secondary outcomes:
measure: Total annual bleeding rate
timeFrame: during 6 months before (retrospectively) and up to 12 months after using of myPKFiT
measure: Quality of life
timeFrame: up to 12 months
measure: Joint function
timeFrame: up to 12 months
measure: Adherence to treatment estimated as the quantity of Facteur VIII consumed reported to the prescribed quantity.
timeFrame: up to 6 and 12 months
measure: Consumption of Factor VIII estimated by the Quantity of Facteur VIII consumed by thr patient.
timeFrame: during 6 months before (retrospectively) and up to 12 months after using of myPKFiT
measure: Hemorrhagic Risk Sport
timeFrame: up to 6 and 12 months
measure: Evolution between the annualized incidence of intercurrent events appeared or worsened under each treatment period (with and without myPKFit), globally, by System Organ ( SO) and Preferred Term ( PT) of the code MedDRA
timeFrame: during 6 months before (retrospectively) and up to 12 months after using of myPKFiT
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: AP-HP, Bicêtre Hospital
name: Thierry LAMBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04151524: Classification of Adenocarcinoma of the Esophagogastric Junction
Official title: Biologic Classification of Adenocarinoma of the Esophagus and Esophagogastric Junction (AEG) Using a Novel Data-driven System: Should it Replace or Compliment the Siewert Classification?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oesophagus Cancer
Barrett Esophagus
Siewert Type I Adenocarcinoma of Esophagogastric Junction
Siewert Type II Adenocarcinoma of Esophagogastric Junction
Siewert Type III Adenocarcinoma of Esophagogastric Junction
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 1658
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observational study

Brief summary: The Siewert classification of oesophageal cancer is the standard approach in anatomically subdividing cancer of the lower oesohagus.

Detailed description: Retrospective review of tumour biology, pathological staging and outcomes in the participants based on Siewert classification. The investigators to scrutinise this scoring system to evaluate if it is indeed appropriate.

Eligibility criteria: Inclusion Criteria:

* All patients

Exclusion Criteria:

-

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin 8
country: Ireland
facility: St. James's Hospital
state: IE
Study officials:
References:
Clinical trial NCT05317624: Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief
Official title: Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Shoulder Pain
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups will be included
Primary purpose: TREATMENT

Brief summary: Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears

Detailed description: The effect of injection of platelet rich plasma will be compared with effects of steroids injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in both groups.

30 patient in each group will be included

Eligibility criteria: Inclusion Criteria:

1. Patients with positive tests for rotator cuff pain
2. Patients with positive radiological (US or MRI) findings of partial rotator cuff tear

Exclusion Criteria:

1. Patient refusal
2. Age less than 20 years.
3. Infection at injection site.
4. Prior surgery on the shoulder joint area.
5. Presence of other associated pathology in the shoulder joint
6. Patients using antiplatelet drugs (aspirin).
7. Contraindications to the use of platelet concentrate
8. Contraindications to the steroids injection

Primary outcomes:
measure: Shoulder pain assesment
timeFrame: 4 months
Secondary outcomes:
measure: Assesment of rotator cuff tendon healing
timeFrame: 4 months
measure: Assesment the failure rate after shoulder joint injection
timeFrame: 4 months
measure: The reinjection rate recording
timeFrame: 4 months
measure: Assesment the rate of tear recurrence after shoulder joint injection
timeFrame: 4 months
measure: Simple shoulder assessment test
timeFrame: 4 months
Other outcomes:
measure: Measurement plasma C-Reactive Protein level
timeFrame: 4 months
measure: Measurement the fasting blood glucose level
timeFrame: one week
measure: Assesment the complications after shoulder joint injection
timeFrame: 4 months
measure: Measurement the serum cortisol level
timeFrame: one week
Locations:
city: Alexandria
country: Egypt
facility: Facility of medicine
Study officials:
affiliation: AlexandriaUniversity
name: Dorreya Fikry
role: PRINCIPAL_INVESTIGATOR
affiliation: AlexandriaUniversity
name: Tarek Sarhan
role: STUDY_DIRECTOR
References:
Clinical trial NCT06879834: Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Official title: Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy
Fundus photo
nonmydriatic camera
Artificail Intelligence
CheckEye
Fundus image
fundus photography
Lead sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy
Sponsor class: OTHER
Collaborators: name: CheckEye LLC
name: Oftacentro SA
First posted: 2025-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 participants were planed to include in study, 100 of them had diabetes mellitus and 100 participants were as a control group have risk factors for diabetes mellitus.

All participants were selected for the study based on the following inclusion and exclusion criteria

Brief summary: To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.

Detailed description: Operator took fundus images with a non-mydriatic fundus camera as per the Retina-AI CheckEye imaging protocol (an optic disc centered image and a fovea centered image for each eye).Thereafter, operator uploaded fundus images in the AI system for processing by the neural network.

Eligibility criteria: Inclusion Criteria:

1. Documented diagnosis of diabetes mellitus by definition.
2. Understanding of the Study and willingness and ability to sign informed consent
3. Patient age 18 or above
4. Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes

Exclusion Criteria:

-1. Patients under 18 years of age; 2. Failure to give informed consent; 3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.

4. A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.

Primary outcomes:
measure: The accuracy
timeFrame: Baseline
Secondary outcomes:
measure: The percent of invalid images
timeFrame: Baseline
measure: The percent of false positive detection of DR
timeFrame: Baseline
Other outcomes:
Locations:
city: Odessa
country: Ukraine
facility: The Filatov Institute of Eye Diseases and Tissue Therapy
Study officials:
affiliation: The Filatov Institute of Eye Diseases and Tissue Therapy
name: Andrii MD Korol, PhD
role: PRINCIPAL_INVESTIGATOR
References: