louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05599750: Suture Repair vs Mesh Repair for Incisional Hernia
Official title: A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques.

The main question it aims to answer are:

• Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.

Detailed description: This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.

Eligibility criteria: Inclusion Criteria:

* Adults \>18 years old.
* Anticipated hernia defect 2-6cm in width
* Non-emergent case
* CDC class I
* Patients who previously underwent primary ventral hernia repair without the use of mesh
* Incisional hernia

Exclusion Criteria:

* Emergent cases
* Patients \< 18 years old
* Patients who are pregnant
* Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed.
* Ventral hernia \<2cm or \> 6 cm in width
* Primary hernia
* CDC wound class II-IV

Primary outcomes:
measure: Hernia specific quality of life
timeFrame: 1 year
Secondary outcomes:
measure: Hernia specific quality of life
timeFrame: 5 years
measure: PROMIS-3a-Pain Intensity scores
timeFrame: 5 years
measure: Recurrence
timeFrame: 5 years
measure: Complications
timeFrame: 5 years
measure: Overall quality of life
timeFrame: 5 years
measure: Cost effectiveness
timeFrame: 5 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: The Cleveland Clinic
name: Clayton Petro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03121950: Movement and Music Intervention for Individuals With Dementia
Official title: Movement and Music Intervention for Individuals With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia With Lewy Bodies
Dementia
Keywords: dementia
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 21
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be placed in one of two groups. One group will participate 2 times a week in a dance class. The other group will listen to live music once a week.
Primary purpose: TREATMENT

Brief summary: The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition.

Detailed description: Dementia impacts 5%-7% of individuals \>60 years old. It impacts the person's ability to perform work, care for him/herself and ultimately leads to physical disability. There is a high caregiver burden associated with dementia and many individuals require care in a long-term care facility. There is some emerging evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia. The study aims to recruit individuals with a diagnosis of dementia. Once enrolled participants will undergo assessment of walking, balance and cognition and then be asked to participate either in a dance class or to listen to live music. After 6 weeks and again at the end of the study (after 12 weeks) participants will undergo assessments of walking, balance and cognition.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of dementia
* Mini-Mental State Examination score \> 9
* Age \> 60 years
* Able to follow simple instructions

Exclusion Criteria:

* Unable to walk 10 feet unassisted
* Presence of orthopedic disorder that impacts walking
* Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury

Primary outcomes:
measure: Timed up and go Cognitive
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Score on the Montreal Cognitive Assessment
timeFrame: 12 weeks
Other outcomes:
measure: Change in Score on the Caregiver Burden Scale
timeFrame: 12 weeks
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Deb Kegelmeyer, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004350: Evaluation of Fanconi Syndrome and Cystinosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystinosis
Fanconi Syndrome
Keywords: Fanconi syndrome
cystinosis
rare disease
renal and genitourinary disorders
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of California, San Diego
First posted: 1999-10-19
Enrollment: 12
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Classify renal tubular defects using clinical and biochemical findings in patients with Fanconi syndrome and cystinosis.

Detailed description: PROTOCOL OUTLINE:

Patients receive a clinical and biochemical evaluation, including a psychometric assessment and molecular, renal, and thyroid studies.

Eligibility criteria: * Inherited renal tubular defects, i.e., Fanconi syndrome
* Fanconi syndrome due to cystinosis eligible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Jerry A. Schneider
role: STUDY_CHAIR
References:
Clinical trial NCT02139150: Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy
Official title: Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Histologically-confirmed Malignancies
Keywords: FLT PET Imaging
3'deoxy-3' [18F] fluorothymidine ([18F] FLT)
CT
scans
14-050
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if PET/CT scans that use a radioactive substance called \[18F\] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive substances are used with PET/CT scans to "see" cancer cells, and are also called radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard clinical scan and is commonly used. The investigators would like to know if there is any evidence of early treatment response by obtaining FLTPET/ CT scans before and after treatment.

Detailed description: This protocol is an "umbrella" or "companion" protocol to be used in conjunction with other protocols that are evaluating treatment response in solid or hematologic malignancies. The aim of this protocol is to determine if PET imaging with the proliferation marker 18FFLT can monitor changes in FLT uptake parameters, in particular changes in the standardized uptake value (SUV), within tumor target lesions.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically-confirmed (confirmation done at MSKCC) malignancies.
* Patients who have consented to a therapeutic protocol for the treatment of their cancer.
* Patients must be ≥ 18 years old.

Exclusion Criteria:

* Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
* Women who are pregnant or breast-feeding.

Primary outcomes:
measure: change from pre- to posttreatment
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schöder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01407250: PhysioGlove Versus Clinic Electrocardiogram Comparison
Official title: Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Normal ECG
Patients With Pathological ECG
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult male and female patients

Brief summary: Comparison of the quality of the outpatient clinic electrocardiogram performed on patients sent to a cardiology consultation with a standard cable and the PhysioGlove-ES electrocardiograms performed in the cardiology clinic.

Detailed description: The correct performance of a 12 lead electrocardiogram depends on the correct placement of the electrocardiogram electrodes in internationally agreed upon anatomic locations on the patient's limbs and chest. This process requires specific training and diligence on the part of the electrocardiogram performer. The literature points towards a progressive quality degradation of the electrocardiogram performance probably due to the delegation of it's performance to lesser trained individuals. This study is attempting to ascertain the quality of the electrocardiogram recordings performed in non-specialized out patient clinics.

For this purpose we will compare outpatient electrocardiograms of patients referred to a cardiological consultation with electrocardiogram's acquired using a conventional electrocardiogram cable as well as the PhysioGlove-ES by the well training cardiology clinic personnel.

Eligibility criteria: Inclusion Criteria: all consenting male and female patients age 18-95 -

Exclusion Criteria:

1. All patients using shirt-sizes under small mand over extra-large
2. all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -

Primary outcomes:
measure: Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms
timeFrame: Each patient will be tested once while visiting the cardiology consultation clinic. No further patient follow-up is planed. Data collection and evaluation is estimated at 6-9 months from study initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Natanya
country: Israel
facility: Clalit- Cardiology consult clinic
Study officials:
References:
Clinical trial NCT06889350: Pharmacokinetics and Safety of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
Official title: A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applies

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
Secondary outcomes:
measure: AUC∞ of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: AUCt/AUC∞ of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: Tmax of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: VZ/F of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: CL/F of Teneligliptin and Empagliflozin
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT04569955: Knowledge and Perception of Clinical Trial Participation in Breast Cancer Patients in Egypt
Official title: Knowledge and Perception of Clinical Trial Participation in Breast Cancer Female Patients in Egypt, a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Clinical Trials
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 300
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Egyptian female Breast cancer patients

Brief summary: * Clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. Beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation.
* This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries.


Eligibility criteria: Inclusion Criteria:

* Female breast cancer patients

Exclusion Criteria:

* Patients who refuse participation

Primary outcomes:
measure: The percentage of breast cancer patients who accept to participate in clinical trials
timeFrame: 1 year
Secondary outcomes:
measure: The barriers for participation in clinical trials
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university, faculty of medicine
state: Select
Study officials:
affiliation: Ain shams university, faculty of medicine
name: Hagar Elghazawy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03859050: Alveolar Macrophage Programming Following Endotoxin Exposure
Official title: Alveolar Macrophage Programming Following Endotoxin Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ARDS, Human
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The histologic hallmarks of lung inflammation include accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).


Eligibility criteria: Inclusion Criteria:

1. Written, informed consent
2. Age 18-50

Exclusion Criteria:

1. Current or recent illness (past 2 weeks)
2. Presence or prior history of cardiac, pulmonary or systemic disease
3. Bleeding disorder, use of systemic anticoagulants or antiplatelet therapy
4. American Society of Anesthesiology (ASA) class 2 or greater
5. Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants)
6. Use of any inhaled substance, including tobacco, marijuana, e-cigarrettes, cocaine, methamphetamines, or toxic vapors in the past 3 months or greater than 10 pack-year smoking history
7. Alcohol use disorder or greater than 7 drinks/week for women or greater than 14 drinks/week for men in the past 3 months
8. Allergy or prior adverse reaction to lidocaine, midazolam or fentanyl
9. Abnormal spirometry or electrocardiogram at time of screening
10. Pregnant (based on urine pregnancy test) or breast feeding

Primary outcomes:
measure: Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
Clinical trial NCT03476850: Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy
Official title: Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Donor
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic assisted donor nephrectomy
* Patients that have elected to have a nerve block
* 18 years of age or older
* Patients of ASA status I - III

Exclusion Criteria:

* Chronic pain or narcotic usage during the preceding 30 days
* Infection at or near the intended needle insertion site
* Complex or altered abdominal wall anatomy
* Weight \<45kg

Primary outcomes:
measure: Average Pain Score
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Total Cumulative Opioids
timeFrame: 72 hours
measure: Number of Participants With Nausea or Emesis Requiring Antiemetic Medication
timeFrame: 24 hours
measure: Number of Participants With Block Related Complications
timeFrame: 24 hours
measure: Length of Stay in Post Anesthesia Care Unit (PACU)
timeFrame: 24 hours
measure: Length of Hospital Stay
timeFrame: 3 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT03913650: The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery
Official title: Preoperative Peripheral Nerve Blocks Attenuate Intraoperative Surgical Stress and Postoperative Pain in Patients Undergoing Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Change; Circulatory
Surgical Injury
Keywords: peripheral nerve block
IL-6
post-operative pain
limb surgery
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Municipal Hsiaokang Hospital
First posted: 2019-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain

Detailed description: In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours

Eligibility criteria: Inclusion Criteria:

* diagnosis of limb fracture
* must receiving orthopedic surgery

Exclusion Criteria:

* With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine

Primary outcomes:
measure: peak pain intensity in the postoperative care unit
timeFrame: 2 hours
Secondary outcomes:
measure: change of perioperative IL-6 level
timeFrame: up to 6 hours
Other outcomes:
measure: changes of perioperative hemodynamic parameter
timeFrame: up to 3 hours
measure: changes of perioperative hemodynamic parameter
timeFrame: up to 3 hours
Locations:
city: Kaohsiung
country: Taiwan
facility: I-Cheng Lu
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Siaogang Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: I-Cheng Lu, MD, PHD
role: STUDY_CHAIR
References: