louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00187876: Evaluation of Biocleanse Allografts For ACL Reconstruction
Official title: Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Tear
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.

Detailed description: The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.

You are being asked to volunteer in a research study. The purpose of this study is to compare the different ways of cleaning allograft tendons used to replace the main ligament in the knee. The anterior cruciate ligament (ACL) is the main ligament in the knee that your doctor will replace in your surgery. The allograft tendons come from other people who have donated a tendon from the front of the knee after they died.

The three ways of cleaning the tendons that will be used in this study are BioCleanse, irradiation, and aseptic. Aseptic uses clean conditions when preparing the tissue for surgery, sometimes with a chemical bath. BioCleanse is a way of cleaning the tendon physically and chemically, while irradiation uses gamma rays. The goal is to clean the tendons to make them safer for the patients without weakening the tendon when put in the knee.

Eligibility criteria: Inclusion Criteria:

* ACL reconstruction

Exclusion Criteria:

* none

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Form
timeFrame: 24 month period
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Orthopedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Peter A. Indelicato, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04974476: Onsite vs. Virtual Group Fitness in Overweight/Obese Women
Official title: A Comparison of Onsite vs. Virtual Fitness Program on Anthropometric Measures, Aerobic Fitness, and Vascular Markers of Cardiac Risk Markers in Overweight/Obese Premenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Exercise Program
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.


Eligibility criteria: Inclusion Criteria:

* Premenopausal adult females over the age of 18 and under the age of 45 with a BMI greater than or equal to 25 and a waist circumference greater than or equal to 35 inches.
* No medical contraindications to participation in an exercise program including major medical illnesses (i.e. cardiovascular disease, stroke, cancer, etc.)
* Ability to provide informed consent
* Willingness and ability to participate in an interval training in-person group fitness exercise program 3x/week for 12 weeks

Exclusion Criteria:

* Adults unable to consent or mini-mental score less than 18.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Post-menopausal women
* Do not speak English
* Prisoners
* Subjects on medicines (serum glucose, insulin, weight loss medicines, beta-blockers) and having any medical pre-conditions that would interfere with one's capacity to exercise.
* Answer "Yes" to any of the questions on the Pre-Activity Screening Questionnaire (PASQ)

Primary outcomes:
measure: Pulse Wave Velocity (PWV)
timeFrame: Up to 12 weeks
measure: Pulse Wave Analysis Augmentation Index (AIx)
timeFrame: Up to 12 weeks
measure: Pulse Wave Analysis Mean Arterial Pressure (MAP)
timeFrame: Up to 12 weeks
measure: Visceral Adipose Tissue (VAT) content
timeFrame: Up to 12 weeks
measure: Total Adiposity
timeFrame: Up to 12 weeks
measure: Aerobic Fitness
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Arlette C Perry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04854473: Collection of Electrophysiological Data During Colon Resection
Official title: Data Collection Study - Recording Electro-physiological Signals From Intact (to be Resected, Pathological) and Ischemic Bowel Tissue During Open Colonic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open/ Laparoscopic/ Robotic Resection of the Colon
Keywords: Exero
anastomotic leak
impedance
ischemia
colon
bowel
Lead sponsor: Exero Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery.
3. Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out.

Exclusion Criteria:

1. Subject has gastroparesis.
2. Subject has significant multisystem (autonomic) diseases.
3. Subject has a body mass Index greater than 35 kg/m2
4. Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
5. Subject has significant cardiac arrhythmia or ectopy.
6. Obstructing lesion and pre obstruction bowel dilatation
7. Subject has an existing implanted electrical stimulator (e.g., pacemaker.
8. Subject requires chronic anticoagulant therapy
9. Subject is currently enrolled in other potentially confounding research.
10. Pregnancy
11. Current alcohol abuse
12. Subject poses a significant general anesthesia risk
13. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.

Primary outcomes:
measure: Functionality of signal measurement
timeFrame: 10 minutes
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Nir Wasserberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102073: Validation of Romanian Version of Radner Reading Charts
Official title: Validation of Romanian Version of Radner Reading Charts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Keywords: Reading speed
Lead sponsor: Opera CRO, a TIGERMED Group Company
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy patients

Brief summary: Interventional, parallel groups, single center trial with a prospective design

Detailed description: The "Radner Reading Charts" have been developed on the basis of the concept of "sentence optotypes" for the standardized examination of reading acuity and reading speed. Print sizes are logarithmically scaled (LogRAD) to permit statistical analysis, and the results obtained can be compared to other logarithmically scaled vision systems (e.g., LogMAR). To guarantee accurate, reproducible and standardized measurements of reading acuity and reading speed at every viewing distance, "sentence optotypes" have been created to minimize the variations between the test items and to keep the geometric proportions as constant as possible at all distances. Through interdisciplinary cooperation, a series of test sentences were developed that are highly comparable in terms of the number of words (14 words), as well as the word length, number of syllables, position of words, lexical difficulty and syntactical complexity. The most similar sentences were statistically selected for the Radner Reading Charts.

Eligibility criteria: Inclusion Criteria:

* Men or women aged ≥18 years
* Visual acuity ≥ 20/20 Snellen in each eye
* Average daily reading time for students 5-7 hours and for non-students 0,5-2 hours
* Willingness to provide signed informed consent

Exclusion Criteria:

* Ocular pathologies that can influence the study results
* Alcohol ingestion
* Concomitant medication that can influence visual acuity

Primary outcomes:
measure: Reading speed
timeFrame: 2-4 months postsurgery
Secondary outcomes:
measure: Reading errors
timeFrame: 2-4 months postsurgery
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Opera Contract Research Organization Srl
state: Timis
Study officials:
affiliation: OPERA CRO
name: Serban Rosu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00383773: Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Retinal Vein Occlusion
Keywords: retinal vein occlusion
rTPA
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-10-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about 71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.

Detailed description: Patients with Central Retinal Vein Occlusion less than 6 month duration and reduction of vision to 6/21 will go OCT and FANG examinations.

Patient will be operated vitrectomy, and a branch retinal vein will be punctured by small needle and rTPA 200mcg/ml will be injected to the vein.

Eligibility criteria: Inclusion Criteria:

* crvo less than 6 month
* Visual Acuity less than 6/21
* No prior eye surgery except cataract.

Exclusion Criteria:

* Retinal/iris neovascularization

Primary outcomes:
measure: Visual acuity
measure: Amount of macular edema.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Michael halpert
role: STUDY_CHAIR
References:
Clinical trial NCT02974231: Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer
Official title: Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine

Brief summary: The objective is to report outcomes,including grade ≥2 overall late rectal and urinary toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)


Eligibility criteria: Inclusion Criteria:

Consecutive patients from June 2000 to December 2010 with

* untreated histologically confirmed adenocarcinoma of the prostate
* stage T1c-T4 N0 M0 according to the 1992 American Joint Committee on Cancer staging system

Exclusion Criteria:

* Patients with positive pelvic lymphadenectomy or radiological positives nodes

Primary outcomes:
measure: grade≥ 2 overall late rectal 5 years after the end of radiotherapy
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03087331: An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
Official title: An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective, pre post, pilot cohort study to be conducted in patients with chronic pain, which is defined as pain that lasts beyond 3 months. To accomplish the primary and secondary objectives of the study, three phrases will be designed and completed during three months

Detailed description: This study will evaluate the effectiveness of community-based pharmacist interventions on the quality of life of patients with chronic pain as determined by self-reported pain levels using an established scoring system. Participating pharmacists will enroll chronic pain patients from their normal practice to receive a consultation, which consists of an assessment of their current pain, a medication review, and education about their condition. Based on the information provided by the patient, the pharmacist will prepare a care plan, contact the patient's prescriber, and, in conjunction with the prescriber, implement the plan to help relieve their pain. Follow-up assessments will be done after 2 weeks, and 3 months.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or older
2. Baseline average pain intensity using Brief Pain Inventory is 6 or higher
3. Ambulatory and able to attend the intervention
4. Complaining of pain for 3 months or longer

Exclusion Criteria:

1. Patients with malignant or cancer pain
2. Patients who are unable to communicate in English
3. Non-ambulatory and unable to attend the intervention at the participating site
4. Unable to give informed consent.

Primary outcomes:
measure: Pain intensity change
timeFrame: baseline, 2 weeks follow-up, 3 months follow-up
Secondary outcomes:
measure: Pain interference
timeFrame: baseline, 2 weeks follow-up, 3 months follow-up
measure: Quality of life change
timeFrame: baseline, 3 months follow-up
Other outcomes:
measure: patient adherence
timeFrame: 2 weeks follow-up and 3 months follow-up
Locations:
city: Kitchener
country: Canada
facility: The PharmaShoppe
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Feng Chang
role: STUDY_DIRECTOR
References:
Clinical trial NCT04387331: The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
Official title: The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fuchs Endothelial Corneal Dystrophy
Pseudophakic Bullous Keratopathy
Chemical Burn of Cornea
Posterior Polymorphous Corneal Dystrophy
Keywords: Descemet Membrane Endothelial Keratoplasty
DMEK
Fuchs Endothelial Corneal Dystrophy
Pseudophakic Bullous Keratopathy
Chemical Burn of Cornea
Posterior Polymorphous Corneal Dystrophy
Postoperative Head Position
Corneal Transplantation
Head Tracking Sensor
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Institut für Angewandte Trainingswissenschaft
First posted: 2020-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Descemet Membrane Endothelial Keratoplasty during the study are offered to participate.

Brief summary: This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.

Detailed description: After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome.

In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing DMEK

Exclusion Criteria:

* no specific exclusion criteria

Primary outcomes:
measure: Corneal Endothelial Cell Density
timeFrame: three months after surgery
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: prior to surgery, three and six months after surgery
measure: Central Corneal Thickness
timeFrame: prior to surgery, three and six months after surgery
measure: Number of Re-Bubblings
timeFrame: six months after surgery
measure: Corneal Endothelial Density
timeFrame: six months after surgery
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig University Hospital, Department of Ophthalmology
state: Sachsen
Study officials:
affiliation: University of Leipzig
name: Peter Wiedemann, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01741831: A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
Official title: Regulatory Post Marketing Surveillance of Prezista 400mg Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immune Deficiency Syndrome
Keywords: Acquired Immune Deficiency Syndrome
AIDS
TMC114
Darunavir
Prezista
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with darunavir for treatment of AIDS.

Brief summary: The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.

Detailed description: This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients who are prescribed with darunavir for treatment of Acquired Immune Deficiency Syndrome (AIDS)

Exclusion Criteria:

* Known hypersensitivity to Prezista
* Prezista coadministered with medicinal products that are highly dependent on CYP3A for clearance

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: Up to 30 days from end of treatment
Secondary outcomes:
measure: Number of patients with viral load
timeFrame: Screening, Week 12, Week 24
measure: Number of patients with CD4 T-cell count
timeFrame: Screening, Week 12, Week 24
Other outcomes:
Locations:
city: Dae-Gu
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06573931: Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty
Official title: Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Erector Spinae Plane Block
Fascia Iliaca Block
Lumbar Plexus Block
Analgesia
Total Hip Arthroplasty
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare lumbar erector spinae plane block, fascia iliaca block, and lumbar plexus block for postoperative analgesia for hip surgery.

Detailed description: Approximately 500,000 hip arthroplasties are performed each year in the United States. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia and reduce the side effects of opioids, namely sedation, nausea, and vomiting. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.

Lumbar erector spinae plane block (LESPB) was reported to lead to effective postoperative analgesia in hip and proximal femoral surgery.

The fascia iliaca block (FIB) is an established and effective technique, especially when US guidance and proximal approaches are used.

lumbar plexus block (LPB) could be safe because of the targeted somatic nerve block in the psoas region which prevents dispensable sympathetic block even in cardiovascular-compromised patients.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Undergoing total hip arthroplasty under spinal anesthesia.

Exclusion Criteria:

* Obesity (Body Mass Index \> 30 kg/m2).
* Allergy to any drug used in the study.
* Contraindications to spinal anesthesia (such as Thrombocytopenia (platelets \<100,000/mCL) and coagulopathy (INR \>1.4 or insufficient time since stopping systemic anticoagulation)).
* Epilepsy.
* Psychiatric disease.
* Pre-existing neurologic deficits or neuropathies.
* Pregnancy.
* Pre-existing alcohol/opioid use disorder.
* Previously diagnosed with chronic pain.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total morphine consumption in the 1st 24h
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: