louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06127420: Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices
Official title: Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices in Patients Referred to Angiography
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A all-comer population of patients with suspected coronary artery disease referred to invasive angiography at Zhongshan Hospital.

Brief summary: The objective of the Zhongshan Hospital CONCORDE Registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physiological indices in an all-comers population of patients with suspected coronary artery disease referred to invasive coronary angiography in order to further inform patients and health care providers about which technologies are most effective and efficient in the diagnosis and management of coronary artery diseases.

Detailed description: CONCORDE registry offers a comprehensive pressure and/or flow measurements, as well as angiography-derived functional assessment of coronary. Patient treatment was at the operator's discretion at the time of the invasive procedure. A standardized data collection sheet was used and data were extracted from electrical medical history according to standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data.

Eligibility criteria: Inclusion Criteria:

* suspected coronary artery disease
* referred to invasive coronary angiography

Exclusion Criteria:

* hemodynamic instability

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 5 years
Secondary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 5 years
measure: Individual components of MACE and TVF
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Chenguang Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT04570020: Scleral Lens Fitting Using Wide-Field OCT
Official title: Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Keratoconus
Irregular; Contour of Cornea
Keywords: Keratoconus (KCN)
Irregular Cornea
Optical Coherence Tomography (OCT)
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2020-09-30
Enrollment: 258
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: Male and female subjects meeting the eye criteria listed above.

Brief summary: The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.


Eligibility criteria: Inclusion Criteria:

* Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders

Exclusion Criteria:

* Inability to maintain stable fixation for OCT imaging
* Inability to commit to required visits to complete the study
* Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome

Primary outcomes:
measure: Apical Clearance
timeFrame: 5 years
measure: Limbal Clearance
timeFrame: 5 years
measure: Conjunctival Compression
timeFrame: 5 years
measure: Lens Edge Lift
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University, Casey Eye Institute
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01773720: Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis
Official title: Evaluation of Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis During Off-pump Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Index
Keywords: cardiac index
coronary artery bypass
uncalibrated pulse contour analysis
hemodynamic monitoring
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease, ranked ASA II-III and scheduled for elective off-pump coronary artery bypass grafting

Brief summary: The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass grafting.

Detailed description: Using contemporary statistical method the cardiac index values obtained via uncalibrated pulse contour analysis with Pro AQT system will be compared with traditional transpulmonary thermodilution technique (Pulsion, Germany).

Eligibility criteria: Inclusion Criteria:

* elective off-pump coronary artery bypass grafting

Exclusion Criteria:

* age \< 18 and \> 80 years,
* preoperative ejection fraction \< 0.35,
* severe cardiac valve dysfunction or peripheral vascular disease,
* constant atrial fibrillation,
* simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.),
* transfer to cardiopulmonary bypass.

Primary outcomes:
measure: Validity of cardiac index measurement
timeFrame: Up to 24 hrs post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Dep. of Anesthesiology, Northern SMU
Study officials:
affiliation: Northern State Medical Univercity
name: Mikhail Y Kirov, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Smetkin AA, Hussain A, Kuzkov VV, Bjertnaes LJ, Kirov MY. Validation of cardiac output monitoring based on uncalibrated pulse contour analysis vs transpulmonary thermodilution during off-pump coronary artery bypass grafting. Br J Anaesth. 2014 Jun;112(6):1024-31. doi: 10.1093/bja/aet489. Epub 2014 Feb 13.
Clinical trial NCT02349620: Effect of Platelet-rich Factor on Implant Stability and Bone Resorption in the Lower Posterior Mandible
Official title: Platelet-rich Factot in Implant Dentistry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osseointegrated Dental Implantation
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 30
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: The main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants.

Detailed description: Dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. Implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. In one side PRF will be instilled after surface treatment with PRF before implant placement, while no PRF was added in other side to serve as control group. All implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. Bone height was measured on medial \& distal side on standardized IOPA x-rays.

Eligibility criteria: Inclusion Criteria:

* patients who have 1 or 2 missing teeth in both side of posterior mandible

  * adequate bone quantity and quality at the implant site
  * the implant sites with at least 3 months of healing after extraction,
  * patients well motivated for implant therapy and maintaining good oral hygiene
  * the implant sites with width and length to installation of an implant of 4.5 mm x 11.5 mm.
  * Patients who gave written informed consent

Exclusion Criteria:

* • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome

  * infection around the implant site
  * history of bruxism/parafunctional habits
  * patients with history of any bleeding disorder or on anti-coagulant therapy.
  * pregnant patients

Primary outcomes:
measure: implant loss
timeFrame: 6 months
Secondary outcomes:
measure: ISQ analysis
timeFrame: 3 months
measure: bone height (mm)
timeFrame: 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz university of medical sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Reza Tabrizi, DMD
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: Touba karagah, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06811220: The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
Official title: The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Paclitaxel-induced peripheral neuropathy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is evaluation of the potential neuroprotective effect of oral hesperidin and diosmin in reducing paclitaxel- induced peripheral neuropathy in the treatment of breast cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Female patients over 18 years of age with pathologically confirmed breast cancer.
2. Breast cancer patients candidate for chemotherapy and will receive paclitaxel.
3. Patients having an eastern cooperative oncology group (ECOG) score more than 2

Exclusion Criteria:

1. Patients with signs and symptoms of clinical neuropathy at baseline.
2. Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
4. Patients who have previously received chemotherapy.
5. Hepatic impaired patients.
6. Patient with history of allergy to hesperidin.
7. Patients with history of allergy to diosmin.
8. Renal impaired patients.
9. Patient inadherent to paclitaxel.
10. Patients inadherent to the administered hesperidin and diosmin during the study period.

Primary outcomes:
measure: Changes in serum levels of the following biomarker:Nerve growth factor (NGF)
timeFrame: 3 months
measure: Changes in serum levels of the following biomarker :Malondialdehyde (MDA).
timeFrame: 3 months
measure: Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β).
timeFrame: 3 months
measure: Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) .
timeFrame: 3 months
Secondary outcomes:
measure: A- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria assessed.
timeFrame: at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).
measure: B- Measurement of the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire assessed.
timeFrame: at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02049320: Remifentanil for Sedation of Patients With Traumatic Brain Injury (TBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering a traumatic brain injury who were sedated in the PICU using remifentanil.

Brief summary: This is a descriptive retrospective study designed to measure the efficacy of remifentanil sedation and the ability to perform frequent neurological examinations of patients with traumatic brain injuries.


Eligibility criteria: Inclusion Criteria:

* Patients previously admitted to the hospital presenting with traumatic brain injury (TBI)
* Patients who have undergone sedation after presenting with TBI

Exclusion Criteria:

* None

Primary outcomes:
measure: Depth of Sedation
timeFrame: Every 24 hrs until discharged from the PICU, up to 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT01141920: Comparison of Two Counseling Induction Strategies
Official title: Comparison of Two Different Counseling Schedules on Treatment Response of New Admissions to Methadone Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methadone
Drug Use Disorders
Keywords: treatment retention
methadone maintenance
treatment induction
Retention in methadone maintenance treatment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-11
Enrollment: 120
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: New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on methadone and randomly assigned to one of two induction conditions: 1) routine stepped care, or 2) low threshold stepped care. All participants will continue with routine stepped care in month 4. Treatment retention is the primary outcome measure, while drug use (measured via weekly urinalysis testing) is the major secondary outcome.

Detailed description: This randomized clinical trial will evaluate two induction strategies for helping out-of-treatment opioid abusers transition to methadone maintenance treatment. All study participants (n = 120) will be new admissions to the Addiction Treatment Services at Hopkins Bayview (ATS), stabilized on 80 mg of methadone, and randomly assigned to one of two study conditions. The experimental induction condition will receive low threshold stepped care (LTSC) for the first 3-month of treatment that reduces the counseling demands of maintenance treatment (i.e., one counseling session / month). This condition will be compared to routine stepped care (RSC) for the first 3-months, which provides escalating intensity of counseling schedules contingent on drug use or poor adherence. RSC is routine treatment at ATS. All participants will receive routine stepped care following the 3-month induction phase, and will have the opportunity to remain in treatment at ATS following study participation. Participation is for 4-months. Retention is the primary outcome. Participants will also submit urine samples weekly on a random schedule each month. We hypothesize that LTSC participants will exhibit better retention than RSC participants, and that both conditions will exhibit reductions in drug use compared to baseline.

Eligibility criteria: Inclusion Criteria:

* New admissions to methadone maintenance

Exclusion Criteria:

* Pregnant
* Acute medical or psychiatric condition

Primary outcomes:
measure: treatment retention
timeFrame: 120 days
Secondary outcomes:
measure: Drug use
timeFrame: weekly observation for 120 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Addiction Treatment Services -- Hopkins Bayview
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael S Kidorf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03468920: Preoperative IV Versus Oral Acetaminophen
Official title: Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will use a randomized, double-blind, placebo controlled design with two arms.
Primary purpose: TREATMENT

Brief summary: The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.

Detailed description: This study will use a randomized, double-blind, controlled design with two arms:

Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively

120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia

Exclusion Criteria:

* Allergy to Acetaminophen
* Lactose intolerance or lactose allergy (placebo capsules contain lactose)
* Hepatic disease
* Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
* Pregnant
* Weight less than 50kg
* Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse
* Emergent or on-call procedures
* Inpatient surgery

Primary outcomes:
measure: Patient Reported Pain
timeFrame: through study visit, less than 24 hours
Secondary outcomes:
measure: Number of Participants Who Received Opioid Administration in PACU
timeFrame: through study visit, less than 24 hours
measure: Number of Participants Who Experienced Postoperative Nausea and Vomiting
timeFrame: through study visit, less than 24 hours
measure: Length of Stay
timeFrame: through study visit, less than 24 hours
measure: Patient Satisfaction
timeFrame: up to 2 days after surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth, Bethesda Butler Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT01825720: Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Disease
Keywords: GIK, valvular heart surgery, lactate
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 106
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: PREVENTION

Brief summary: Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an adjuvant therapy in patients with myocardial infarction or in the patients undergoing valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known to prevent excretion of lactate and to increase the extraction of lactate after reperfusion with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury of myocardium after CPB, to improve myocardial contractility, insulin resistance and hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.


Eligibility criteria: Inclusion Criteria:

* patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:

  1. congestive heart failure
  2. infective endocarditis
  3. redo valvular surgery
  4. surgery combined with coronary bypass graft
  5. multiple valvular surgery
  6. expected CPB duration longer than 2 hr 7\> preoperative serum creatinine over 1.4 mg/dl 8\> preoperative hemoglobin level less than 12 mg/dl 9\> left ventricular ejection fraction less than 40%

Exclusion Criteria:

1. emergency surgery
2. hemodynamic instability before surgery (mean arterial pressure \< 60 mmHg, heart rate \>100 /min
3. need for pharmacological or mechanical assist for hemodynamic stability before surgery
4. baseline blood lactate level more than 2 mmol/l
5. on steroid or NSAID
6. hepatic dysfunction

Primary outcomes:
measure: perioperative blood lactate level
timeFrame: change of blood lactate level for 10 time points (before induction of anesthesia, immediately after induction of anesthesia, pre-CPB, 15 min after CPB, ACC off, post-CPB, sternum closure, ICU admission, 3 h after ICU admission, POD 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
Study officials:
References:
citation: Roh GU, Shim JK, Song JW, Kang HM, Kwak YL. Effect of glucose-insulin-potassium on hyperlactataemia in patients undergoing valvular heart surgery: A randomised controlled study. Eur J Anaesthesiol. 2015 Aug;32(8):555-62. doi: 10.1097/EJA.0000000000000250.