louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02447367: Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers
Official title: Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: LUTS
Benign Prostatic Hyperplasia
Overactive Bladder
Keywords: α1-blockers
antimuscarinic agent
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 54
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Detailed description: A randomized, open-label, single dose, two-way crossover study

Eligibility criteria: Inclusion Criteria:

* 19\~45 years healthy male
* Body weight is over 55kg, BMI measurement 18.0kg/m\^2\~ 27.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
* Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

* History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* Sitting SBP\>150mmHg or \<100mmHg, sitting DBP\>100mmHg or \<60mmHg, after 3 minutes break
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
* Donated blood within 60 days prior to the first administration day in this study.

Primary outcomes:
measure: AUClast, Cmax, AUCinf
timeFrame: 192 hours
Secondary outcomes:
measure: Tmax
timeFrame: 192 hours
measure: t1/2
timeFrame: 192 hours
measure: CL/F
timeFrame: 192 hours
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital(SNUH)
name: Kyung-sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04997967: Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis
Official title: Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Conscious Sedation Failure During Procedure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.

Detailed description: This randomized controlled trial was carried out on 96 patients undergoing urgent ERCP for severe cholangitis. Patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. Demographic data, ERCP duration, recovery time, heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation, Ramsey Sedation Scale (RSS), pain Numerical Rating Scale (NRS), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded

Eligibility criteria: Inclusion Criteria:

* Severe acute cholangitis of either sex
* Aged between 21-70 years
* Undergoing urgent therapeutic ERCP for severe cholangitis with American Society of Anaesthesiologist (ASA) Grade II - III.

Exclusion Criteria:

* Patients who had ASA physical status Grade VI,
* Baseline SpO2 \<90%,
* Patients who had difficulty in communication,
* Patients allergic to the studied medications,
* Morbidly obese patients,
* Patients with chronic obstructive pulmonary disease,
* Complicated airway,
* Pregnant patients.

Primary outcomes:
measure: Efficacy of ketofol in sedation
timeFrame: 24 hours
Secondary outcomes:
measure: Impact of ketofol on hemodynamics
timeFrame: 24 hours
measure: Impact of ketofol on oxygen saturation
timeFrame: 24 hours
measure: Impact of ketofol on hemodynamics
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: faculty of medicine
name: Haidi Ramadan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02223767: TMS Augmented Exposure Therapy
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Height Phobics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phobia
Keywords: TMS
virtual reality (VR)
Exposure therapy
TMS augmentations of exposure therapy
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the beneficial effects of prefrontal brain stimulation (with a facilitating TMS protocol) before exposure therapy in acrophobic patients. The two exposure sessions were realized in virtual reality. Before and after therapy, the phobic symptoms were measured on a subjective, behavioral and physiological level. The placebo-controlled single blinded study includes 50 phobic patients, which were randomized into verum or sham TMS.


Eligibility criteria: Inclusion Criteria:

Criteria for a simple phobia: specific heights

Exclusion Criteria:

Objective tinnitus Involvement in psychiatric treatments Clinically relevant psychiatric comorbidity Clinically relevant unstable internal or neurological comorbidity History of or evidence of significant brain malformation or neoplasm, head injury Cerebral vascular events Neurodegenerative disorder affecting the brain or prior brain surgery Metal objects in and around body that can not be removed Pregnancy Alcohol or drug abuse history of seizures

Primary outcomes:
measure: Subjective Anxiety Symptoms
timeFrame: 4 weeks
measure: Subjective Anxiety in Height Situation (BAT), Differences From Pre (Baseline) to Post Therapy (Week 4)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University hospital
Study officials:
affiliation: University of Würzburg
name: Martin J. Herrmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06764667: Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor
Official title: Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Donor Nephrectomy
Perioperative Pain Management
Keywords: Quadratus lumborum block
Spinal anesthesia adjuvant
Laparoscopic donor nephrectomy
Perioperative pain management
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Cipto Mangunkusumo Hospital, Jakarta, Indonesia
First posted: 2025-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to compare the effectiveness of spinal anesthesia adjuvant and quadratus lumborum block on the opioid requirement and perioperative pain on patients undergoing laparoscopic kidney transplant donor.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65 years undergoing laparoscopic donor nephrectomy
* Patients with BMI ≤ 35 kg/m2
* Patients with American Society of Anesthesiology (ASA) physical status 1-2
* Patients who are willing to participate in this study

Exclusion Criteria:

* Cardiovascular disease (uncontrolled stage 2 hypertension, heart failure, arrhytmia)
* Recent onset cerebrovascular diseasae of \< 3 months
* Infection on spinal site
* Coagulopathy
* Elevated intracranial pressure
* Severe renal or liver dysfunction
* Valvular heart disease or atrioventricular block

Primary outcomes:
measure: Postoperative pain
timeFrame: Hour 2, 6, 12, and 24
measure: Opioid requirement
timeFrame: Hour 2, 6, 12, and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUP dr. Cipto Mangunkusumo
state: Jakarta
Study officials:
References:
Clinical trial NCT04978467: SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke
Official title: Feasibility of Using Maestro Hand Exoskeleton in Post-stroke Hand Rehabilitation to Improve Joint Coordination
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: Soft Robotics
Robotic Exoskeleton
Neurologic Rehabilitation
Physical Medicine and Rehabilitation
Rehabilitation Exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will experience all controller conditions.
Primary purpose: TREATMENT

Brief summary: The research team will develop a novel training tool to improve finger joint coordination, to address the unmet need in the current rehabilitation, thereby enhancing hand function and contributing to improved independence and quality of life for Veterans with stroke.

Detailed description: The research team will determine feasibility of training using CA and TA controllers in subacute stroke. Specifically, we will examine if joint coordination improves over a training session. The investigators will compare the extent of improvement for each controller and impairment severity.

Eligibility criteria: Inclusion Criteria:

* Adult Veterans with a stroke 1-6 months ago
* Ability to move fingers (Chedoke-McMaster Hand Section Stage 2-4)

Exclusion Criteria:

* Inability to follow 2-step commands
* Severe muscle tone prohibiting proper placement of the fingers (Modified Ashworth Scale, MAS=5 out of 5)
* Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment

Primary outcomes:
measure: change in finger joint torque assistance
timeFrame: from the 1st half to the 2nd half of the 1-hour training session
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Na Jin Seo, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03324867: The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery.
Official title: The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Decline
Heart Diseases
Delirium
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 316
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. Postoperative Cognitive Dysfunction (POCD) may last a prolonged period of time while Postoperative Delirium (POD) is a more acute disturbance in attention, awareness and cognition. The cause of POCD and POD are not fully understood, however some of the pathophysiology of POCD is similar to that of Alzheimer's disease (AD).

Insulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. Clinical trials further demonstrated that insulin given via the nose (intranasal) improves memory performance of patients with AD or cognitive impairment suggests that intranasal insulin also could be a therapeutic option for POCD and POD.

This study is designed to examine the effect intranasal insulin on POCD and POD. The goal is to investigate whether administration of intranasal insulin during and after heart surgery improves cognitive function postoperatively.


Eligibility criteria: Inclusion Criteria:

• elective open heart surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* inability to provide informed consent
* allergy to insulin
* pregnancy
* mother tongue other than English or French
* visual or hearing impairment interfering with the ability to complete cognitive tests.

Primary outcomes:
measure: Confusion Assessment method for the ICU
timeFrame: an average of 5 days
measure: Rey Auditory Verbal Leaning
timeFrame: up to 12 month
measure: Rey-Osterrieth Complex Figure Test:
timeFrame: up to 12 month
Secondary outcomes:
measure: Stropp Test
timeFrame: up to 12 month
measure: Trail Making Test
timeFrame: up to 12 month
measure: Tower of London test
timeFrame: up to 12 month
measure: Symbol Digit Modalities Test
timeFrame: up to 12 month
measure: Boston Naming Test
timeFrame: up to 12 month
measure: Clock Drawing Test
timeFrame: up to 12 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04510467: Mental Health Consequences of COVID19 Infection in the French RMD Cohort
Official title: Mental Health Consequences of COVID19 Infection in the French Rheumatic Musculoskeletal Diseases (RMD) Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Systemic Autoimmune Disease
Inflammatory Rheumatism
Auto Inflammatory Diseases
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
First posted: 2020-08-12
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the French RMD covid19 cohort (ClinicalTrials.gov Identifier: NCT04353609) including patients from hospitals in the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners (rheumatologists, internists with mixed hospital and private practice activities) caring for patients with inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases.

Brief summary: this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.


Eligibility criteria: Inclusion Criteria:

Patient case:

* Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
* With confirmed COVID-19 infection (at least one month prior to study inclusion)
* Study information given to the patient
* Patient affiliated to social security

Patient control:

* Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
* Not having had a confirmed COVID-19 infection
* Study information given to the patient
* Patient affiliated to social security

Exclusion Criteria:

* Opposition to participation in the study by the patient and/or his legal representative
* Adult patient not able to understand the implications and rules of the study
* Protected adults under guardianship or curatorship

Primary outcomes:
measure: Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID
timeFrame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
Secondary outcomes:
measure: Severity of PTSD depending on whether or not autoimmune patients have experienced COVID
timeFrame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Eric Hachulla, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06918067: Comparison of Urinary Flow Study
Official title: Comparison of Urinary Flow Speed Using 14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter Versus 14 Fr Coloplast Micro Zone Luja Female Catheter in Female Patients Using Intermittent Catheters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Retention
Keywords: catheter
intermittent catheterization
bladder
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to compare the urinary flow speed of two different female catheters in patients that use intermittent catheters to empty their bladder. The "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" will be compared to the "14 Fr Coloplast Micro Zone Luja Female Catheter." Participants will have one study visit that should take about an hour and will also receive a follow-up telephone call about one week after the visit.

Detailed description: The purpose of this crossover study is to compare the urinary flow speed of two different female catheters manufactured by Coloplast, the "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" vs "14 Fr Coloplast Micro Zone Luja Female Catheter" in patients that use intermittent catheters to empty their bladder. Patients will be randomly assigned to group A or group B using a closed-envelope randomization method. Group A will self catheter with Luja, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with SpeediCath. Group B will self catheter with SpeediCath, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with Luja. Outcomes will be measured with office uroflow device.

Eligibility criteria: Inclusion Criteria:

* Female
* Regular use of intermittent catheters to empty bladder, for at least 1 month before enrolment
* Age 18 years or older
* Required to adhere to the intervention procedure and not participate in any other clinical studies throughout the duration of this study

Exclusion Criteria:

* Severe urinary tract abnormalities (e.g. excessive production of urinary mucus/sediments/debris)
* Hypersensitive to the ingredients in the catheters being tested
* Recent surgery, within 3 months
* Currently being treated for urinary tract infection
* Being pregnant or breastfeeding
* Non-English speaking

Primary outcomes:
measure: Urinary flow duration
timeFrame: Day 1
Secondary outcomes:
measure: Total Urine Volume
timeFrame: Day 1
measure: Peak Flow Rate
timeFrame: Day 1
measure: Time to Peak Flow
timeFrame: Day 1
measure: Mean Flow
timeFrame: Day 1
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Women's Center for Pelvic Health (Mercy)
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Kennelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01473667: Superficial Cervical Plexus Block for Pacemaker Insertion
Official title: Superficial Cervical Plexus Block for Pacemaker Insertion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pacemaker Insertion
Regional Block
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.


Eligibility criteria: Inclusion Criteria:

* Age 18-100 years old
* Registered patients at Mayo Clinic in Florida scheduled to undergo primary insertion of pacemaker

Exclusion Criteria:

* Emergency placement of pacemaker
* Sub-pectoral placement of pacemaker
* Patients with history of chronic pain
* Patients with anatomical abnormality or disruption to the pacemaker insertion site or site of block placement
* Patients with allergy to local anesthetic

Primary outcomes:
measure: To decrease opioid requirements after Pacemaker insertion
timeFrame: first 24 hrs post pacemaker insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Christopher Robards, MD
role: PRINCIPAL_INVESTIGATOR
References: