louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02269930: Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
Official title: An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif.

The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

- Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and Day -1

Key Exclusion Criteria:

* History or positive test result at Screening for human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\])
* History of premalignant and malignant disease including solid tumors and hematologic malignancies
* Known allergy to any interferon or any component of BIIB017
* Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h)
timeFrame: 2 weeks
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of BIIB017 and Rebif
timeFrame: 2 weeks
measure: Number of participants experiencing Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Up to 4 weeks following treatment period
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Research Site
state: Indiana
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B. COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):380-8. doi: 10.1111/bcp.12968. Epub 2016 May 29.
Clinical trial NCT05252130: Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
Official title: Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pathology
Lead sponsor: Innova Smart Technologies (Pvt.) Ltd
Sponsor class: OTHER
Collaborators: name: Rehman Medical Institute - RMI
name: NOABIO LLC
First posted: 2022-02-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope

Detailed description: The enrolled population will include adults with a history of heart and lung complications. The enhanced sound quality of the electronic stethoscope and its non-inferiority to the traditional/conventional 3M Littmann stethoscope will be assessed through auscultation examination of every patient by a health professional (consultant, medical resident, and house officer) with both the electronic stethoscope and 3M Littmann/traditional/conventional stethoscope

Eligibility criteria: Inclusion Criteria:

* Ages: 18 years or older (male and female)
* Hospital admitted or Out Patient Department
* Written consent provided

Exclusion Criteria:

* Age \<18
* ICU admitted
* Written consent not provided

Primary outcomes:
measure: Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III.
timeFrame: 1 month
measure: The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.
timeFrame: 1 month
Secondary outcomes:
measure: Difference in performance between subgroups of doctors based on clinical experience.
timeFrame: 1 month
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute - RMI
state: KP
Study officials:
References:
Clinical trial NCT06543030: Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
Official title: Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics of Assuit university hospital.

Brief summary: Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Detailed description: To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.

Eligibility criteria: Inclusion Criteria:

* Patients with Hepatocellular carcinoma of BCLC (Barcelona Clinic Liver Cancer) stage B
* Also for BCLC stage A patients, in whom ablative therapy has technical limitations.
* Downsizing tumor for resection or transplantation.

Exclusion Criteria:

* Factors related to liver cirrhosis:

  * Decompensated cirrhosis (Child-Pugh B and C, score \>8), including jaundice, clinical hepatic encephalopathy, and refractory ascites and/ or hepatorenal syndrome
  * Impaired portal-vein blood flow (portal-vein thrombus, hepatofugal blood flow)
* Factors related to HCC:

  * Extensive tumor involving the entirety of both lobes of the liver
  * Malignant portal vein thrombosis
  * Extra-hepatic metastases
* Impaired renal function:

  * Creatinine ≥2 mg/dl or creatinine clearance \<30 ml/min
* Factors related to procedure (Radial artery access):

  * Existing AV (arteriovenous) fistula or graft
  * Pervious major surgery to forearm or wrist
  * Vasculitis
  * Pervious access failure
  * Skin infection or compromised integrity
  * Artery size \<2mm
  * Intolerance of hyperextended wrist positioning
  * Severe vasospasm
  * Vessel tortuosity
  * Radial loops
  * Absent or occluded radial artery
  * Atherosclerotic or calcific PAD (peripheral artery disease)
  * Coagulopathy INR\>1.5 platelets count \<50.000/mmc

Primary outcomes:
measure: To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospitals
Study officials:
References:
Clinical trial NCT04884230: Oversewing Staple Line of The Gastric Remnant
Official title: Oversewing Staple Line of the Gastric Remnant in Gastric Bypass Reduces Postoperative Bleeding.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Bypass
Obesity
Keywords: Obesity
Lead sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients older than 18 years, body mass index (BMI) \> 30kg/m2 with or without comorbidities that underwent RYGB or one anastomosis gastric bypass (OAGB).

Brief summary: Background: Roux-en-Y gastric bypass (RYGB) is a surgery with low rate complications. However, it is not exempt from them, and 1-6% suffer complications such as postoperative bleeding. Many intraoperative techniques have been evaluated to reduce postoperative bleeding, like the oversewing or reinforcement of the staple line. This study aims to evaluate the rate of postoperative bleeding in the oversewing of the staple line of the gastric remnant group versus the stapling only group.

Methods: This is a 2-center, case-control study. The investigators randomly selected two groups who underwent RYGB or OAGB: group A (n=225) with oversewing from 2019-2020 and group B (n=225) with stapling only between the period of 2017-2018; both groups with similar demographic characteristics.

Detailed description: This case-control study was conducted in the International Unit of Bariatric and Metabolic Surgery of "Clinica La Sagrada Familia" located in Maracaibo, Venezuela, and in "Grupo Medico Santa Paula" Caracas, Venezuela. All procedures were performed by a single experienced bariatric surgeon during the period 2017-2020. The Ethics committees of Clinica "La Sagrada Familia" and "Grupo Medico Santa Paula" approved this study. The investigators selected 225 patients (group A) from the period 2019-2020 where the stapling line of the gastric remnant was oversewn and another group of 225 patients (group B) from the period of 2017-2018 with stapling alone.

Eligibility criteria: Inclusion Criteria:

* Our inclusion criteria were patients older than 18 years, body mass index (BMI) \> 30kg/m2 with or without comorbidities that underwent RYGB or one anastomosis gastric bypass (OAGB).

Exclusion Criteria:

* We exclude from our study any patient with psychiatric disorder, open surgery history, history of previous bariatric surgery, non-controlled comorbidity at the moment of surgery, and patients under the age of 18

Primary outcomes:
measure: Reduce bleeding
timeFrame: Through study completion, 6 month average
Secondary outcomes:
Other outcomes:
Locations:
city: MAracaibo
country: Venezuela
facility: CCSF
state: Zulia
Study officials:
References:
Clinical trial NCT06305130: Prognostic Value of Performance Scores in Patients Undergoing Surgery for Upper Tract Urothelial Carcinoma
Official title: Prognostic Value of Eastern Cooperative Oncology Group Performance Status and American Society of Anesthesiologists Score in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Transitional Cell (RENI)
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 2515
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: Patients diagnosed with UTUC and underwent RNU between 1988 and 2023, and a total of 2515 eligible patients were included in the final analysis.

Brief summary: Aim: to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.

Methods: multicentered cohort study

Detailed description: Background:

The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score and the American Society of Anesthesiologists (ASA) score are essential tools for the assessment of patients with various malignancies. However, doubts have arisen regarding their prognostic utility due to conflicting findings in limited studies. This study aims to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.

Materials and Methods:

This multicentered cohort study enrolled patients who underwent RNU with curative intentat sixteen institutes in Taiwan from 1988 to 2023. Univariable and multivariable regression analyses were used to determine the impact of ECOG-PS scores and ASA scores on survival outcomes and postoperative complications. Patients were categorized based on ECOG-PS scores (0-1 vs. 2-4) and ASA scores (1-2 vs.3-4) according to prior literature.

Eligibility criteria: Inclusion Criteria:

* All patients received UTUC surgery and follow-up in sixteen institutions across Taiwan

Exclusion Criteria:

* Treatment not aimed at curative intent
* Incomplete data

Primary outcomes:
measure: Overall survival
timeFrame: 1988 to 2023
measure: Cancer-specific survival
timeFrame: 1988 to 2023
measure: Disease-free survival
timeFrame: 1988 to 2023
measure: Bladder recurrence-free survival
timeFrame: 1988 to 2023
Secondary outcomes:
measure: Number of patients with major postoperative complication
timeFrame: 1988 to 2023
measure: Number of patients with postoperative renal failure
timeFrame: 1988 to 2023
Other outcomes:
Locations:
Study officials:
affiliation: Department of Urology, Kaohsiung Medical University, Kaohsiung, Taiwan
name: Hsin-Chih Yeh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793230: Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy
Official title: Predictive Value of Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dacryocystitis; Chronic
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes fifty patients with chronic epiphora due to chronic nasal duct obstruction seeking for treatment by endoscopic intranasal dacryocystorhinostomy. Their age ranged from (20-70) years from both genders. They were selected from patients attending the Ophthalmology and Ear Nose Throat (ENT) clinics, at Al-Azhar University Hospital. Their referring ophthalmologist diagnosed all of the patients with lacrimal obstruction.

Brief summary: During dacryocystorhinostomy (DCR), the lacrimal sac wall biopsy is not routinely performed, but it is recommended if there is a suspicion of underlying disease other than preoperatively or intraoperatively chronic inflammation. We aimed to evaluate the utility of the histopathology examination of fifty patients in AlAzhar Hospitals to put recommendation for histopathology examination of such cases.

Detailed description: Most of patient with epiphora have different causes of nasolacrimal duct obstruction . This study aims to examine how important routine lacrimal sac biopsy is during endoscopic dacryocystorhinostomy surgery.

The study included 50 patients with chronic unilateral epiphora. All patients underwent endoscopic dacryocystorhinostomy with nasolacrimal duct biopsy. Histopathologic analysis was performed for each specimen to assess the nature of the pathology.

Eligibility criteria: Inclusion Criteria:

- Male and female patients with chronic lacrimal duct obstruction attended the outpatient clinic of the hospital for treatment during the study period.

Exclusion Criteria:

* Patients refusing the biopsy
* Patients asked for histopathology in private laboratories

Primary outcomes:
measure: Microscopic examination using Hematoxylin and Eosin stains with special stain
timeFrame: fourteen days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Azhar faculty of medicine
Study officials:
affiliation: Al-Azhar University
name: Ibrahim El-dsoky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06916130: A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A
Official title: A Randomized, Open-label, Multiple Oral-dose, 2x2 Crossover Clinical Trial to Compare the Safety, Pharmacokinetic, and Pharmacodynamic Characteristics of a AD-120 and AD-120A in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Gastroesophageal Reflux Disease (GERD)
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.

Detailed description: The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 and equal to or less than 50 in healthy volunteers at the time of screening visit
* Negative result from Serum Helicobacter pylori antibody at the time of screening visit

Exclusion Criteria:

* Patients with trouble performing pH monitor catheter

Primary outcomes:
measure: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
timeFrame: AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
measure: The time of peak concentration after single dose
timeFrame: Tmax: from pre-dose to 24 hours of 1st administration
measure: Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring
timeFrame: 24 hours before 1st administration to 24 hours after repeated administration (7days)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04186130: Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
Official title: Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spina Bifida
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Purpose: In order to verify the hypothesis that the composition of intestinal microbiota in children with spina bifida is different from that of normal control, prospective comparative analysis would be performed.

Background of the study:

Spina bifida is a congenital neurological disorder, causing neurogenic bowel. It has been known that the intestinal microbiota in spinal cord injury patient was different than that of control. Changes in intestinal motility, mucous secretion, immune surveillance, and epithelial barrier permeability are possible causes of this change. As spina bifida is also related with neurogenic bowel, the investigators hypothesized that the intestinal microbiota in spina bifida is different from that of normal control.

Patients total 30 patients and 10 controls Inclusion for patients

Patients who meet following conditions:

1) Children over 3 years old and under 12 years old who have been diagnosed with spinal bifida with spinal MRI Exclusion for patients and controls

1) Children with known inflammatory bowel disease or cloacal anomaly

Statistical analysis Statistical processing for fecal samples is aimed at alpha or beta diversity using bioinformatics, and the Kruskal-Wallis test is used to compare similarities or differences between each fecal sample. Prior to statistical analysis, the relative abundance of the detected microorganisms is analyzed first, and microorganisms having a distribution less than 0.1% are excluded from the analysis, and the remaining microorganisms are analyzed in the 'genus' step.


Eligibility criteria: Inclusion Criteria:

* 1. Children aged 3-12 years, diagnosed with spina bifida in spinal MRI.

Exclusion Criteria:

* 1. The patient has an inflammatory intestinal disease known in the colon or has a cloacal anomaly.

Primary outcomes:
measure: the alpha or beta diversity of intestinal microbiota composition in children with spina bifida is different from that of normal control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01495130: Transrectal Ultrasound (TRUS) in Finding Tumors During Robotic-Assisted Laparoscopic Surgery
Official title: Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-19
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery

Detailed description: PRIMARY OBJECTIVES: I. To assess the feasibility and limitations of using a mechanically-manipulated transrectal ultrasound (TRUS) probe for TRUS evaluation during a da Vinci robotic-assisted laparoscopic prostatectomy (RALP). II. To collect TRUS evaluation data during RALP to guide us in deciding whether and how the mechanical manipulation of the TRUS probe will allow sufficient clarity of ultrasound imaging. OUTLINE: Patients undergo TRUS during RALP. After the completion of study treatment, patients are followed up at 7 days.

Eligibility criteria: Inclusion Criteria:

* Undergoing Robotic Assisted Laparoscopic Prostatectomy

Exclusion Criteria:

* Known or discovered rectal pathology
* Bleeding hemorrhoids
* Rectal stenosis
* Any prior rectal surgeries
* Prior rectal radiation
* Any known rectal disease

Primary outcomes:
measure: Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.
timeFrame: 7 days post-RALP
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Osamu Ukimura
role: PRINCIPAL_INVESTIGATOR
References: