louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06093009: The Significance of Postoperative Muscle Wasting in Pancreatic Cancer
Official title: National Cheng Kung University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 208
Sex: ALL
Minimum age (years): 20
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 Years and older (Adult, Older Adult ).

Brief summary: To assess the impact of preoperative sarcopenia and postoperative skeletal muscle wasting on the outcomes of patients with resectable pancreatic cancer who underwent pancreatectomy.

Detailed description: Previous studies have revealed that sarcopenia, defined as generalized loss of skeletal muscle mass, is a poor prognostic factor following surgery. However, research focusing on postoperative muscle wasting and its influence on the prognosis of resectable pancreatic cancer (PC) is limited. Investigators retrospectively reviewed 208 patients who underwent pancreatectomy for PC at the National Cheng Kung University Hospital (NCKUH) between June 2002 and April 2020. Clinical information regarding patient characteristics, pathological parameters, and biochemical features was collected from all patients using electronic medical records (EMRs) under an IRB-approved protocol (B-ER-110-420) at NCKUH. Preoperative psoas major area and the degree of muscle reduction at 3 months postoperatively were calculated using computed tomography to define sarcopenia and drastic muscle wasting. Patients were assigned to two groups based on sarcopenia or drastic muscle wasting, and compared for postoperative morbidity, disease free survival (DFS), and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pancreatic cancer
* Must be able to undergo pancreatectomy
* Must be able to undergo pre- and post-operative abdominal computed tomography scan

Exclusion Criteria:

* Unresectable pancreatic cancer

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
measure: Disease-free survival
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT01519609: Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy
Official title: Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Bowel prep
Safety
Efficacy
Lead sponsor: Randers Regional Hospital
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home.


Eligibility criteria: Inclusion Criteria:

* Patients suspected of colorectal cancer scheduled for colonoscopy

Exclusion Criteria:

* Patients with previous colorectal surgery
* Colonis Stenosis
* ASA \> 2

Primary outcomes:
measure: Degree of bowel cleansing
timeFrame: 1 Day of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Regions Hospital
Study officials:
affiliation: unaffilated
name: thorbjorn sommer, ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT07026409: This Study Will Assess the Etiology, Potential Risk Factors, and Seizure Types in Patients Over 50 With Epileptic Seizure Disorder, Using Laboratory Tests, EEG, and Neuroimaging Findings.
Official title: Study of Epilepsy and Seizure in Elderly Patients in Sohag University Hospitals.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epilepsy
Keywords: Epilepsy,Elderly,Seizure,EEG.
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include all consecutive patients aged 50 years and older who are admitted to the inpatient Neuropsychiatry Department or attend the Epilepsy Specialized Outpatient Clinic at Sohag University Hospital with epilepsy or new-onset epileptic .

Brief summary: This study underscores the importance of studying the etiology, clinical characteristics, and types of epilepsy in the elderly to improve diagnosis and management in our community.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of epilepsy and epileptic seizures will be clinically established based on patient history, following the Glossary of Descriptive Terminology for Ictal Semiology by the International League Against Epilepsy (ILAE) Task Force on Classification and Terminology, as well as the Operational Classification of Seizure Types (ILAE, 2017).

Exclusion Criteria:

* • Inability to determine the onset of epilepsy or epileptic seizures, or a history of seizures occurring before the age of 50.

  * Metabolic disturbances such as hypoglycemia, uremia, or electrolyte imbalances.
  * Patients who refuse to participate in the study.

Primary outcomes:
measure: Risk factors of epilepsy in elderly
timeFrame: Baseline
measure: Etiology of epilepsy in elderly
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine Sohag University
Study officials:
References:
Clinical trial NCT03494309: Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures
Official title: Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fractures
Keywords: Mandibular Subcondylar Fractures
Mouth Opening
Open Reduction and Internal Fixation
Closed Reduction with External Fixation
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with mandibular sub-condylar fractures underwent either either open reduction with internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to CREF.


Eligibility criteria: Inclusion Criteria:

* Age 16-60 years
* Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.

Exclusion Criteria:

* Bilateral MCFs
* MCF with mid-facial fractures
* Insufficient bilateral dentition
* Medically unfit for surgery
* Old healed mandibular fractures
* History of previous mandibular surgery for the same indication

Primary outcomes:
measure: Mouth Opening
timeFrame: 6 months
measure: Occlusion
timeFrame: 6 months
Secondary outcomes:
measure: Complications
timeFrame: 6 months
measure: Cost-Effectiveness
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04275609: The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
Official title: The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disease
Keywords: Endoscopic Report
Artificial Intelligence
Gastrointestinal Disease
Writing Efficiency
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.

Detailed description: Digestive endoscopy permits early detection of gastrointestinal diseases and improving the patients' quality of life. However, writing endoscopic report takes a lot of manpower and time, reducing the efficiency of endoscopy. Our center has developed a structured diagnostic report generation system for digestive endoscopy, which can generates the report by artificial intelligence. Here, we compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* patients aged between 18 and 80 years；
* patients undergoing gastroscopy and colonoscopy examination with anesthesia；
* patients able to give informed consent

Exclusion Criteria:

* patients with the contraindications to endoscopic examination;
* a history of gastrointestinal cancers;
* allergic to anaesthetics in previous medical history;
* the endoscopic procedure cannot be completed due to stenosis, obstruction, solid food or complications of anaesthesia.

Primary outcomes:
measure: The time spent writing reports
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00851409: A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
Official title: An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated "rhC1INH" Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency ("HAE")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Genetic Disorders
Hereditary Angioedema
Lead sponsor: Pharming Technologies B.V.
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 25
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: Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").


Eligibility criteria: Inclusion Criteria:

* Aged at least 18 years
* Signed informed consent
* Comfirmed diagnosis of HAE with baseline plasma level of functional C1INH activity of less than 50% of normal, and/or proven HAE ,mutation in C1INH gene.

Exclusion Criteria:

* A history of anaphylaxis or severe allergy (i.e. requiring medication) to food, proteins and/or drugs.
* A history of allergic reactions to C1INH products or rabbit protein.
* Any reported SAE related to study drug administration (withdrawal criterium)
* Elevated IgE against rabbit dander (\>0.35 kU/L; ImmunoCap assay; Phadia)
* A diagnosis of acquired C1INH deficiency.
* Woman of child bearing potential, pregnancy or breast-feeding
* previous treatment within the last 3 months with plasma-derived C1INH
* Any clinically significant abnormality in the routine haematology, biochemistry and urinalysis
* Any condition or treatment that in the opinion of the investigator might interfere with the evaluation of the study objectives.
* Any changes since screening that would exclude subject based on above exclusion criteria.

Primary outcomes:
measure: HAE Attacks/Week
timeFrame: 8 weeks
Secondary outcomes:
measure: The Evaluation of Pharmacokinetic/ Pharmacodynamic ("PK/PD")Parameters.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: For information on sites, please contact Pharming Technologies
city: Târgu-Mureş
country: Romania
facility: Emergency County Hospital, Internal Medicin Clinica, Allergology-Immunology Department
Study officials:
affiliation: COO Pharming
name: Bruno Giannetti, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03210909: Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
Official title: Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Decompensation, Acute
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-07-07
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
* Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.

Exclusion Criteria:

* History of chronic illness
* Chronic headaches
* Recurrent dizziness
* Personal or family history of heart disease
* Personal history of bleeding diathesis

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
timeFrame: Up to 8 days
measure: Percent of Total Radioactivity Recovered in All Excreta (% total)
timeFrame: Up to 8 days
measure: Half-Life (T-HALF)
timeFrame: Up to 8 days
measure: Total Body Clearance (CLT)
timeFrame: Up to 8 days
measure: Volume of Distribution during Terminal Elimination Phase (Vz/F)
timeFrame: Up to 8 days
measure: Time to Maximum Observed Concentration (Tmax)
timeFrame: Up to 8 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 8 days
measure: Results of electrocardiogram tests (ECGs)
timeFrame: Up to 8 days
measure: Results of vital sign measurements
timeFrame: Up to 8 days
measure: Results of clinical laboratory tests
timeFrame: Up to 8 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06346509: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants
Official title: A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study of PORT-77 Administered Orally to Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Adult Participants
Lead sponsor: Portal Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* All healthy adult participants must be willing and able to follow protocol-specified assessments.
* Healthy based on no clinically significant medical history, physical examination, laboratory profiles, vital signs, and Electrocardiograms (ECGs), as deemed by the Principal Investigator (PI) or designee.

Exclusion Criteria:-

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
* Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
* Participation in another clinical study within 60 days or within 10 half-lives (if known), prior to the first dosing, whichever is longer, or previous participation in another PORT 77 study or study part.

Primary outcomes:
measure: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)
timeFrame: Day 8
measure: Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II)
timeFrame: Day 21
Secondary outcomes:
measure: Plasma concentration of a single-dose of PORT-77 (Part I)
timeFrame: Day 8
measure: Plasma concentration of the steady-state of PORT-77 (Part II)
timeFrame: Day 21
measure: Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)
timeFrame: Day 4
measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)
timeFrame: Day 8
measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part II)
timeFrame: Day 21
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Portal Therapeutics
name: Portal Therapeutics, Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04098809: Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
Official title: Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is designed to assess the effect of catheter size on postoperative catheter pain, urinary continence, urinary flow rates, post void residuals, International Prostate Symptom Scores (IPSS), and Quality of Life (QoL) score, as well as long term complications after robotic assisted laparoscopic prostatectomy.

Detailed description: Subjects identified to receive a robotic assisted laparoscopic prostatectomy.were randomized to either a 16 French or 20 French catheter at the completion of the prostatectomy. All prostatectomies were performed by one of three surgeons at the investigator's institution. Preoperative demographics and operative data were recorded for each group. Catheters remained in place for 7-14 days. Subjects were asked on postoperative day 7 to report their catheter-related pain and amount of opioid medication used. Urinary symptoms and quality of life scores and pads per day were recorded at 6 weeks and 12 weeks post-operatively.

Eligibility criteria: Inclusion Criteria:

* Identified as candidate for robotic assisted laparoscopic prostatectomy

Exclusion Criteria:

* Having filled a prescription for opioid medication in last 2 months.
* Known latex allergy
* Known pre-operatively that catheter placement will exceed 14 days
* History of pelvic radiation
* Significant deviation from normal operative protocol

Primary outcomes:
measure: Catheter Related Pain: Visual Analog Score Rating
timeFrame: post-op day 5-7
Secondary outcomes:
measure: Urinary Symptoms
timeFrame: week 6
measure: Quality of Life Score
timeFrame: Week 6
measure: Urinary Symptoms
timeFrame: week 12
measure: Quality of Life Score
timeFrame: Week 12
measure: Opioid Use
timeFrame: after discharge until post-op day 7
measure: Home Opioid Use in Standard Morphine Equivalency
timeFrame: after discharge until post-op day 7
measure: Number of Incontinence Pads Used
timeFrame: week 6
measure: Patient Reported Number of Pads Used Per Day.
timeFrame: Week 12
measure: Number of Participants Experiencing Bladder Neck Contracture
timeFrame: week 12
measure: Number of Participants Experiencing Bladder Neck Contracture
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: John Corman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06891209: Exploration of HRQOL and Urinary Outcomes Following Partial Cystectomy
Official title: Exploration of HRQOL and Urinary Outcomes Following Partial Cystectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Currently living partial cystectomy patients in Mayo Urology's cystectomy registry and patients undergoing radical or partial cystectomy.

Brief summary: This study explores and compares health-related quality of life and urinary outcomes in postoperative partial cystectomy and matched radical cystectomy patients.

Detailed description: PRIMARY OBJECTIVES:

I. Explore and compare urinary outcomes in postoperative partial cystectomy patients and matched radical cystectomy patients through patient-filled questionnaires.

II. Explore and compare health related quality of life in postoperative partial cystectomy and matched radical cystectomy patients using patient-filled questionnaires.

III. Explore the relationship of patient-specific characteristics, ranging from demographic characteristics and clinicopathologic characteristics, on variation in HRQOL and urinary outcomes among the partial cystectomy and radical cystectomy cohorts.

OUTLINE: This is an observational study.

Patients complete questionnaires and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Currently living partial cystectomy patients in Mayo Urology's cystectomy registry and patients undergoing radical or partial cystectomy
* Matched 2:1 living radical cystectomy to partial cystectomy patients
* Either urothelial or non-urothelial histology

Exclusion Criteria:

* Partial cystectomy patients that underwent subsequent radical cystectomy

Primary outcomes:
measure: Health-related quality of life - EORTC QLQ-C30
timeFrame: Up to 1 year
measure: Self-reported urinary outcomes
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vidit Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: