louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06484660: Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula
Official title: Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated Complex Perianal Fistula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fistula Perianal
Keywords: Perianal Fistula
Mucosal Advancement Flap
Minimally Invasive Approach
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
Collaborators: name: Fundació d'investigació Sanitària de les Illes Balears
First posted: 2024-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery.

The main question it aims to answer is:

- Does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery?

Researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time.

Quality of life and global morbidity will also be analyzed.

Participants will:

* Undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique.
* Attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.


Eligibility criteria: Inclusion Criteria:

* Age older than 18.
* Present with a complex perianal fistula not surgically treated with curative intention.
* Present only one main fistulous tract.
* Mucosal advancement flap as the chosen technique for the treatment of the fistula.
* Patient has given informed consent to participate in the study.

Exclusion Criteria:

* Non-cryptoglandular internal fistulous orifice (IFO).
* Extrasphincteric fistula.
* Coexistence of anal fissure.
* Coexistence of hemorrhoids tributary to surgery.
* Coexistence of anal or rectal prolapse.
* Coexistence of inflammatory bowel disease.
* Coexistence of anal or colorrectal cancer.

Primary outcomes:
measure: Healing rate
timeFrame: six months
Secondary outcomes:
measure: Postoperative pain
timeFrame: one week
measure: Global morbidity
timeFrame: one month
measure: Quality of life score
timeFrame: six months
measure: Fecal incontinence
timeFrame: six months
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Illes Balears
Study officials:
References:
Clinical trial NCT00005460: Predictors of Cardiovascular Disease in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Cerebrovascular Accident
Coronary Disease
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795 men and women aged 75 years or older at the time of a comprehensive examination conducted between 1984 and 1987.

Detailed description: BACKGROUND:

The study was needed because evidence in 1991 suggested that cardiovascular risk factors which had been identified by studies of middle-aged populations did not have the same predictive value in the elderly; especially the "oldest old" aged 75 and above.

DESIGN NARRATIVE:

The study analyzed data that had been collected over the years. At the time of the analysis, mortality follow-up was complete for over 99 percent of subjects, and incident morbidity information was available for myocardial infarction, coronary bypass surgery and stroke. The database included measurements which allowed: 1) prospective analyses of the effects of putative cardiovascular risk factors on disease incidence in the elderly, 2) prospective analyses of the impact of change in risk factors on events in the elderly, 3) exploration of risk factors not classically associated with cardiovascular events in younger populations but which may be important in the very old, and, 4) cross-sectional description of putative risk factors in an aged population.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Langer RD, Criqui MH, Barrett-Connor EL, Klauber MR, Ganiats TG. Blood pressure change and survival after age 75. Hypertension. 1993 Oct;22(4):551-9. doi: 10.1161/01.hyp.22.4.551.
Clinical trial NCT05555160: Application of Intracavity Electrocardiogram Positioning Technique in PICC
Official title: Application of Intracavity Electrocardiogram Positioning Technique in Catheterization of Valvular PICC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Requiring Peripherally Inserted Central Venous Catheters
Lead sponsor: Shandong Branden Med.Device Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2022-09-26
Enrollment: 3051
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a prospective, multicenter, randomized controlled study. The study aimed to exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on the positioning accuracy of catheter tip and exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on catheterization complications.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old who need PICC catheterization for the first time according to the doctor's advice;
* No serious cardiovascular diseases before catheterization, such as atrial fibrillation, pulmonary heart disease and other P wave abnormalities, serious heart block, etc.;
* patients who did not participate in other clinical studies;
* Patients who voluntarily participated in the clinical study, signed informed consent and cooperated with clinical follow-up

Exclusion Criteria:

* patients with local malformation or scar formation;
* Patients with infection or damage at the puncture site;
* patients with tumor compression of blood vessels;
* Patients with confirmed or suspected catheter-related infection, bacteremia and septicemia
* Patients diagnosed or suspected to be allergic to silicone material
* Patients with a history of radiotherapy at the pre-intubation site
* Patients with a history of venous thrombosis, trauma or vascular surgery
* Patients with superior vena cava syndrome
* Patients with poor medical behavior
* Patients with severe peripheral vascular edema
* High-flow fluid infusion, patients requiring hemodialysis, pacemaker installation, crutches, or patients who may undergo A-V fistula

Primary outcomes:
measure: Accuracy of tip determination
timeFrame: Immediately after surgery
Secondary outcomes:
measure: incidence of PICC-related complications
timeFrame: After the operation to 180 days
measure: success rate of one catheterization
timeFrame: Immediately after surgery
measure: rate of convenient
timeFrame: Immediately after surgery
measure: rate of unplanned extubation
timeFrame: After the operation to 180 days
measure: Retention duration
timeFrame: After the operation to 180 days
measure: Medical costs resulting from complications
timeFrame: After the operation to 180 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03380260: Investigating Neural Processing of Social Stimuli
Official title: Investigating Neural Processing of Social Stimuli: Investigating a Neurobehavioral Mechanism of Paranoia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary goal of the present study is to test whether neural activity in brain regions associated with processing threat and social stimuli may underlie paranoid thinking.

Detailed description: Paranoia is a prominent symptom of psychosis that occurs in several other diagnoses, as well as the general population, and that is associated with significant distress and impairment. Previous research suggests that increased baseline activity of the amygdala and related neural circuits may serve as a mechanism for paranoid ideation. This exploratory study will use a paranoia induction procedure in healthy individuals who vary in pre-existing levels of paranoid ideation to test whether increases in self-reported paranoia are accompanied by increases in resting cerebral blood flow (CBF), decreased stimulus-driven neural activity in social processing networks, and increased behavioral perceptions of untrustworthiness.

Participants will be randomly assigned to participate in a paranoia induction procedure or a control condition and will then complete neuroimaging and behavioral assessments.

Eligibility criteria: Inclusion Criteria:

* between the ages of 18 and 55

Exclusion Criteria:

* current psychiatric diagnosis
* current use of psychotropic medications
* history of head trauma with loss of consciousness for more than 15 minutes
* presence of neurological or neurodegenerative disorder
* sensory impairments that preclude assessment
* presence of intellectual disability
* contraindications for MRI (e.g., metallic implants or pregnancy)

Primary outcomes:
measure: Resting cerebral blood flow (CBF)
timeFrame: CBF measurements will be obtained during the study visit and will last approximately 9 minutes.
Secondary outcomes:
measure: Amount of Neural Activity
timeFrame: Measurements will be obtained during the study visit and will last approximately 25 minutes.
measure: Ratings of Trustworthiness
timeFrame: Data will be obtained during the study visit and will last approximately 12 minutes.
measure: Self-reported paranoid ideation
timeFrame: Data will be obtained during the study visit and will last approximately 5 minutes.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Advanced Research Imaging Center, The University of Texas Southwestern Medical School
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Amy Pinkham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05289960: Lung Ultrasound Score and Weaning Outcome
Official title: Lung Ultrasound Score for Prediction of Weaning Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Ultrasound Score
Acute Respiratory Failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU.

Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.

Detailed description: Methods: A prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.

Eligibility criteria: Inclusion Criteria:

- 1. Patients age \> 18 years

2. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.

Exclusion Criteria:

* 1. Patients \< or =18 years 2. Patients with left ventricular failure

  3. Right ventricular failure

  4. Pulmonary hypertension

  5. Aortic valve disease

  6. Hyperthyroidism

  7. Tracheostomy

Primary outcomes:
measure: Extubation success
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: farouk faris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04842760: PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
Official title: PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Disorder
Heparin-induced Thrombocytopenia
Platelet Activation
Platelet Aggregation
Keywords: Platelet Disorder
Heparin-induced Thrombocytopenia
ImageStream cytometer
Platelet activation
Platelet aggregation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT.

Brief summary: Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia \[HIT\]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach.

This study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.


Eligibility criteria: Inclusion Criteria:

* male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT

Exclusion Criteria:

* minor patients
* patients who have opposed the use of their personal data for research work.

Primary outcomes:
measure: Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis
timeFrame: 12 months
measure: Concordance between ImageStream cytometer and reference laboratory tests for HIT diagnosis
timeFrame: 12 months
Secondary outcomes:
measure: Characterization of platelet morphology with ImageStream
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05447260: A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
Official title: A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis: a Multicenter, Prospective, Single-arm Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myelofibrosis
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, single-arm study to assess safety and efficacy of Ruxolitinib in myelofibrosis (MF) based on a new prognostic stratification.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged ≥18 years with a diagnosis of primary or secondary MF by World Health Organization and International Working Group for Myeloproliferative Neoplasms Research and Treat- ment (IWG-MRT) criteria;
2. Received ruxolitinib treatment for ≥3 months.

Exclusion Criteria:

1. Malignant tumors with other progression or myelofibrosis secondary to other diseases;
2. Exclude myelofibrosis patients after splenectomy;
3. Patients with poor compliance with case follow-up or lost to follow-up.

Primary outcomes:
measure: The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline.
timeFrame: From Week 0 through Week 24
Secondary outcomes:
measure: The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.
timeFrame: From Week 0 through Week 24
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT06089460: Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources
Official title: Longitudinal Examination of Metabolic and Behavioral Correlates of Various Protein Food Sources
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this three-arm, pilot, randomized controlled trial is to examine the metabolic and behavioral impacts of consuming a diet characterized by protein from red meat, a meat analogue, or beans/legumes.


Eligibility criteria: Inclusion Criteria:

* 18-55 years of age
* Willingness to consume any of the three protein sources
* Willingness to stop consumption of any pre- or pro-biotic supplements
* Willingness to follow a meal plan for four weeks

Exclusion Criteria:

* Medical condition which precludes consumption of specific foods or whole food groups

Primary outcomes:
measure: Body weight
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary outcomes:
measure: Fasting lipid panels (i.e., total cholesterol, HDL, LDL, VLDL, triglycerides)
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Fasting blood glucose
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Yale Food Addiction Scale
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Skin carotenoids
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Blood pressure
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Dietary patterns (3-day diet records)
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Behavioral Activation Scale Reward Responsiveness
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Ad-Libitum Ultra-Processed Food Consumption
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
measure: Sensitivity to Punishment and Reward Questionnaire (Reward Questions)
timeFrame: Baseline (week 0), T1 (week 4), T2 (week 8)
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT00546676: Ketek in CAP / AECB in Ambulatory Adult Patients
Official title: A Canadian Multicenter, Prospective, Open Label, Non-Comparative Study of the Effectiveness and Safety of Oral Telithromycin, 800mg Once Daily in the Treatment of Either Community Acquired Pneumonia or Acute Exacerbation of Chronic Bronchitis in Ambulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community Acquired Pneumonia (CAP)
Acute Exacerbation of Chronic Bronchitis (AECB)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 174
Sex: ALL
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: To determine the clinical effectiveness of telithromycin in the treatment of either CAP or AECB in a large population of ambulatory adult patients in a community-based setting.


Eligibility criteria: Inclusion Criteria:

Male or female subjects greater than or equal to 18 years who fulfill the clinical diagnostic criteria for outpatient treatment of one of the two following community acquired respiratory tract infections (CARTIs):

* CAP: a new pulmonary infiltrate confirmed by chest X-ray and at least 3 of the following signs or symptoms of infection: fever greater than or equal to 38C, cough, chest pain, sputum production, rales, dyspnea, malaise and/or headache; OR
* ECB: documented medical history of chronic bronchitis in subjects over the age of 40 and presenting an FEV1 \<80% of the predicted value in the last 36 months and at least 2 of the following clinical symptoms: increased sputum purulence, increased dyspnea and/or increased sputum production.

Exclusion Criteria:

* Subjects with a confirmed cardiogenic syncope, ventricular tachyarrythmia or Torsades de Pointes while taking a medicinal product with QT- prolonging potential, such as a macrolide or quinolone antibiotic, or other non-antibiotic suspected of prolonging the QT interval;
* Pregnancy or lactation;
* Hypersensitivity to macrolides;
* Concomitant treatment with terfenadine, ergot alkaloid derivatives, astemizole or pimozide;
* Myasthenia gravis;
* Antibiotic treatment in the 30 days prior to study entry;
* Treatment with any investigational product in the 30 days prior to study entry and/or a previous participation in this study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the clinical effectiveness of telithromycin treatment as determined by the clinical cure rates based on the resolution of infection-related signs and symptoms for CAP and AECB.
Secondary outcomes:
measure: Evaluate speed of symptom resolution,define the safety of telithromycin,& assess health economic parameters
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Margaret Mississian
role: STUDY_DIRECTOR
References: