louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02319811: Cryopreserved Human Meniscus Transplantation
Official title: Meniscus Transplantation in Symptomatic Patients Under Fifty Years of Age: Survivorship Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Cincinnati Sportsmedicine Research and Education Foundation
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 76
Sex: ALL
Minimum age (years): 14
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minimum age: 14 Years Maximum age: 49 Years Gender: Both Accepts Healthy Volunteers: No Patients post-meniscectomy, symptomatic with activities, early cartilage degeneration in affected tibiofemoral compartment.

Brief summary: The purpose of this study is to determine the long-term survivorship and clinical outcomes of all cryopreserved meniscus transplants performed by Dr. Frank Noyes.

Detailed description: All patients receiving cryopreserved meniscus transplants will be followed at 1, 2, 5, 10, and 15 years postoperatively. Study examination will include comprehensive knee examination by Dr. Noyes, x-rays, and potentially MRI. Patients will complete the following forms of the Cincinnati Knee Rating System: Symptom Rating Form, Sports Activity and Function Form, and Occupational Rating Form. All patient identification will be kept confidential. Patient data will be entered into the Knee Registry database according to their unique study number by the clinical research assistant.

Eligibility criteria: Inclusion Criteria:

* Patient post-meniscectomy
* Patient symptomatic with activities
* Patient has early articular cartilage degeneration in affected tibiofemoral compartment
* Patient understands goals of operation, willing to undergo lengthy rehabilitation

Exclusion Criteria:

* Patient has no symptoms with activities
* Patient has advanced degeneration in affected tibiofemoral compartment or other compartments
* Patient is obese (BMI \> 30)
* Patient has uncorrected lower limb axial malalignment or knee ligament deficiency
* Patient has active infection
* Patient has pre-existing knee arthrofibrosis or lower limb muscular atrophy
* Patient has symptomatic patellofemoral articular cartilage deterioration
* Patient is unwilling to undergo lengthy rehabilitation after surgery

Primary outcomes:
measure: Survivorship analysis
timeFrame: 15 years postoperatively
Secondary outcomes:
measure: Cincinnati Knee Rating System
timeFrame: 15 years postoperatively
measure: International Knee Documentations Committee
timeFrame: 15 years postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: President, Noyes Knee Institute
name: Frank R Noyes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06533111: Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
Official title: Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Post-operative Complications
Keywords: Intraoperative anesthesia handoffs
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-08-01
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The non-cardiac adult operating rooms at Memorial Hermann Hospital are split into 2 floors, Sarofim 2 and Sarofim 3. These floors will be the unit of clustering. One floor will be randomized to the intervention arm and the other to the control arm. Every 4 weeks both floors will be re-randomized again to either arm for a total of 18 weeks.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the impact of a semi-structured intraoperative anesthesia handoff tool on patient outcomes and to assess the validity of the 5-Factor Perceived Shared Mental Model Scale (5-PSMMS) in a healthcare setting and whether the perception of Shared Mental Model (SMM) mediates the effect of the intraoperative handoff tool on postoperative outcomes


Eligibility criteria: Inclusion Criteria:

* Undergoing non-cardiac surgery in the main operating rooms (e.g. not the endoscopy suite or labor and delivery ward)
* Undergoing at least one permanent (e.g. end of shift) anesthesia clinician handoff

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status 6 (organ donors)

Primary outcomes:
measure: Number of participants that show post-operative complications that have been associated with intraoperative handoffs
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Number of participants that die after surgery
timeFrame: 30 days after surgery
measure: Hospital length of stay
timeFrame: At time of discharge or 30 days whichever comes first
measure: Number of participants that show peri-operative complications that have been associated with intraoperative handoffs
timeFrame: At time of discharge or 30 days whichever comes first
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Aubrey Samost-Williams, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463811: Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM
Official title: Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROM
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 42
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted on 42 healthy pregnant with preterm PROM women they will be investigated for lactate concentration in vaginal fluid and observed for latency period till onset of spontaneous labor

Brief summary: The present study is aimed to assess whether lactate determination in vaginal fluid is associated with and can predict onset of labor for women with suspected preterm prelabor rupture of membranes (PPROMs).

Detailed description: Study design: Prospective observational cohort

Eligibility criteria: Inclusion Criteria:

* Age 25-35 years old
* BMI 25-30
* Singleton pregnancy in presentation with a history of suspected PPROM
* A live fetus with gestational age between 26+0 weeks and 34+0 weeks

Exclusion Criteria:

* Abruption placenta
* Medical disorders and hypertensive disorders of pregnancy
* Intrauterine fetal death
* Known or suspected fetal anomalies
* Signs of infection (Fever, increase total leucocytic count)
* Multiple pregnancy.
* Regular uterine contractions.
* History of cervical insufficiency

Primary outcomes:
measure: Time from examination to spontaneous onset of labor
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams
Study officials:
affiliation: Ainshams university
name: Ahmed Khairy, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01645111: An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
Official title: An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neuromuscular Scoliosis
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. As the investigators currently have projects underway which include those patients having scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing scoliosis surgery for neuromuscular disease.

Detailed description: This would basically be an observational study without a significant change in our current practice. There would be no change in the standard and usual anesthetic care including premedication, anesthetic induction, intraoperative anesthetic management, and intraoperative monitoring. Our usual anesthetic routine includes:

1. Intravenous or oral premedication with midazolam
2. Inhalational or intravenous induction based on the preference of the patient
3. Facilitation of endotracheal intubation with a dose of rocuronium with placement of intraoperative monitors including an arterial cannula
4. Maintenance anesthesia to include desflurane titrated to maintain the bispectral index at 40-60, fentanyl 2-4 µg/kg followed by a remifentanil infusion to maintain the mean arterial pressure at 55-65 mmHg.
5. Tranexamic acid to limit intraoperative bleeding
6. As needed, agent to control blood pressure to maintain the MAP at 55-65 mmHg if remifentanil in doses up to 0.3 µg/kg/min are ineffective.

As needed, clevidipine will be started at 1 µg/kg/min and titrated up in 1 µg/kg/min every 1-2 minutes to achieve an MAP at 55-65mmHg. Vital signs including heart rate will be recorded every 1 minute until the target MAP is achieved and then at 15 minute increments after that.

Eligibility criteria: Inclusion Criteria:

* Spinal fusion for neuromuscular scoliosis.

Exclusion Criteria:

* Allergy to dihydropyridine calcium channel antagonists
* Allergy to soy or eggs
* Non-neuromuscular causes of scoliosis
* Disorders of lipid metabolism (clevidipine is in a lipid base)

Primary outcomes:
measure: Time to Achieve Target MAP
timeFrame: First 30 minutes of infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745211: 755nm Alex Laser for Treatment of Stretch Marks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Striae
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.


Eligibility criteria: Inclusion Criteria

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted striae and wishes to undergo laser treatments to remove or improve them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.

Primary outcomes:
measure: Photographic Evaluation of Striae Clearance
timeFrame: Follow Up Between 1 and 3 Months Post Last Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT04613011: Effect of Double Tourniquet Technique on Ultrasonographic View of Forearm Veins
Official title: Effect of Double Tourniquet Technique on Width and Compressibility of Superficial Veins of Forearm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Superficial Forearm Veins Compressibility and Width
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Vein compressibility will be assessed after light pressure applied with the ultrasound probe. Vein compressibility will be graded as 3 (100% compressed), 2 (50-100 compressed), and 1 (less than 50% compressed). After baseline measurements were taken, a proximal tourniquet will be applied to mid-arm. Repeated measurements of depth, width, and compressibility will be taken one minute after the tourniquet was applied. Same measurements will be repeated again with second tourniquet applied 1 cm distal to the first tournique.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged 18-60 years will participate in the study

Exclusion Criteria:

* patients with dialysis shunts, previous mastectomy on the examined side, fracture , skin lesion , burn or edema on the examined side

Primary outcomes:
measure: Superficial forearm vein width and compressibility under ultrasonography
timeFrame: 1 minute after application of one proximal tourniquet
measure: Superficial forearm vein width and compressibility under ultrasonography
timeFrame: 1 minute after application of two proximal tourniquet 1 cm apart
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Lecturer of anesthesia and ICU sohag university
name: Bahaa M Refaie, MD
role: STUDY_CHAIR
affiliation: Consultant of anesthesia and ICU at Elhelal insurance hospital sohag
name: Hosam eldeen M Marie, MD
role: STUDY_DIRECTOR
affiliation: Lecturer of anesthesia and ICU sohag university
name: Mohammed A Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04180111: Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism
Official title: Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus
Lead sponsor: Intuor Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 101
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty three (23) Subjects 18 years and older and will be enrolled from one clinical. Subjects will be chosen from patients who are being examined for a corneal cross-linking procedure.

Brief summary: The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Detailed description: This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, at least 18 years of age
* Subject has a clear understanding and agrees to all the conditions of the informed consent form

Exclusion Criteria:

* • Subject has undergone ocular surgery within the last 3 months

  * Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
  * Pregnant or nursing women
  * Those who have had corneal surgery including corneal laser surgery
  * Microphthalmos
  * Buphthalmos
  * Severe Dry eyes
  * Lid squeezers - blepharospasm
  * Nystagmus
  * corneal or conjunctival infection.

Primary outcomes:
measure: IOP measurement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Eye Consultants
state: Arizona
Study officials:
References:
Clinical trial NCT06781411: Unity Cures Future (UCF) Biobank
Official title: Unity Cures Future (UCF) Biobank for Translational & Biomedical Research At UCF College of Medicine and Burnett School of Biomedical Sciences with Identifiable Human Tissue.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tissue Banking
Keywords: tissue
donate
surgery
biobank
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will donate unwanted human tissue as a result of surgery.

Brief summary: Research scientists of the University of Central Florida College of Medicine (COM) and Burnett School of Biomedical Sciences (BSBS) conduct laboratory studies in biomedical and translational medical research for the purpose of understanding human disease and developing innovative methods for diagnosing, measuring, or treating disease or disease symptoms. The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology.

Detailed description: The goal of this human tissue repository protocol is to aggregate resources and streamline the acquisition of human tissue. It is optimal for the advancement of biomedical and translational medical research that the human tissue be received under one protocol by the College of Medicine's the Clinical \& Aerospace Health Research team and transferred to the COM/BSBS research scientists for laboratory testing.

This aggregation of efforts and resources through a human tissue repository protocol allows for:

1. Improvements in biomedical and translational medical research by availability of viable human tissues.
2. Reduced recruitment and enrollment burden on the Clinical \& Aerospace Health Research team and the participants via pooled recruitment. Further, participants will only need to provide one informed consent. Received human tissue may be used for multiple protocols.
3. Improved data for analysis as participants will complete an online case report form containing basic demographic data; planned location and date of upcoming surgery or procedure; diagnosis; name of surgeon/doctor for the planned surgery or procedure; type of surgery or procedure; medical data; medical history; and surgery history.

Eligibility criteria: Inclusion Criteria:

1. be able to read and understand English
2. scheduled for a surgery or procedure that will result in the removal of human tissue.

Exclusion Criteria:

1. Pregnant
2. unable to provide an informed consent
3. unable to understand or read in English
4. minors (ages under 18)
5. prisoners

Primary outcomes:
measure: Receipt of donated human tissue for research
timeFrame: 50 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT00897611: Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma
Official title: Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Grade Glioma
Keywords: adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
recurrent adult brain tumor
adult glioblastoma
adult gliosarcoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: North American Brain Tumor Consortium
First posted: 2009-05-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: RATIONALE: Studying levels of tumor DNA in the samples of blood from patients with cancer may help doctors find out whether the cancer has grown and how much.

PURPOSE: This laboratory study is comparing levels of tumor DNA with MRI and CT scan findings to measure cancer growth in patients with grade III or grade IV malignant glioma.

Detailed description: OBJECTIVES:

* Correlate changes in the level of serum tumor-specific DNA over time with changes in brain tumor size as measured by serial MRI or CT scans in patients with grade III-IV malignant gliomas.

OUTLINE: This is a multicenter study.

Blood samples are collected from patients at baseline and every 2 months thereafter. Tumor and nontumor plasma is extracted. Plasma samples are analyzed by polymerase chain reaction (PCR) to assess the p16_ink4a, p73, and O \^6-MGMT gene promoter methylation profile. Quantitative realtime PCR is performed on samples with tumor-specific DNA to determine the plasma concentrations of each methylated tumor-specific gene and the total plasma tumor-specific DNA concentration. Patients also undergo MRI or CT scans every 2 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed malignant brain tumor

  * One of the following grade III or IV supratentorial gliomas:

    * Anaplastic astrocytoma
    * Anaplastic oligodendroglioma
    * Glioblastoma multiforme
* Newly diagnosed or recurrent disease
* Planning to undergo anticancer therapy on a New Approaches to Brain Tumor Therapy (NABTT) Consortium clinical trial

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Total plasma glioma-specific DNA concentration
timeFrame: every 2 months until death
measure: Tumor size
timeFrame: every 2 months until death
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Stuart A. Grossman, MD
role: STUDY_CHAIR
affiliation: Vanderbilt-Ingram Cancer Center
name: Kyle Weaver, MD
role: PRINCIPAL_INVESTIGATOR
References: