louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06183346: Global Evaluation of Cholecystectomy Knowledge and Outcomes, Indonesia
Official title: Global Evaluation of Cholecystectomy Knowledge and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystectomy
Keywords: surgery
cholecystectomy
robotic
audit
international
multicentre
prospective
observational
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 92
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: Consecutive patients undergoing cholecystectomy, between 31st July - 19th November 2023, with follow-up at 30-day and one-year postoperatively

Brief summary: GECKO is a prospective, international, multicentre, observational cohort study delivered by GlobalSurg Collaborative. This will be on consecutive patients undergoing cholecystectomy, between 31st July 2023 to 19th November 2023, with follow-up at 30-day and one-year postoperatively. Mini-teams of up to five collaborators per 14-day data collection period will prospectively collect data at each participating centre.

The primary aim is to define the global variation in compliance to pre-, intra-, and post-operative audit standards. The subjects will be observed and interviewed during pre-surgery hospitalization up to one-year post-surgery.

Detailed description: Audit Standards include:

1. Pre-operative

   * Interventional radiology service
   * Risk Stratification (Tokyo Guidelines).
   * Timing of surgery
2. Intraoperative

   * Critical Safety View (CVS)
   * Intraoperative imaging
   * Bailout Procedures
   * Antibiotic use
   * Use of drains
   * Bile Duct Injury (BDI)
3. Postoperative

   * 30-day readmission
   * Critical Care

Eligibility criteria: Inclusion Criteria:

* All adult patients (greater than or including 18 years of age)
* Undergo primary cholecystectomy (as the main procedure)
* Any open, laparoscopic, robotic approaches are eligible
* Elective, delayed and emergency cholecystectomy

Exclusion Criteria:

* Cholecystectomy as a part of another surgical procedure (Whipple's, bariatric, transplant)
* Patients with Mirizzi syndrome
* Patients returning to theatre and requiring a cholecystectomy for whatever indication
* Known gallbladder malignancy: Gallbladder cancer diagnosed preoperatively

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days after the surgery
measure: 1-year mortality
timeFrame: 1 year after the surgery
Secondary outcomes:
measure: Critical care admission
timeFrame: 24 hours after the surgery
measure: 30-day readmission
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: RSUP Prof. Ngoerah
state: Bali
city: Jimbaran
country: Indonesia
facility: RS Universitas Udayana
state: Bali
Study officials:
References:
Clinical trial NCT05988346: Ghrelin and Diastolic Heart Function
Official title: Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Obesity, Abdominal
Diastolic Dysfunction
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The authors will enroll T2DM obese patients, according to the evidence or not of LV diastolic dysfunction, and then divided in three groups. The LV diastolic dysfunction was characterized as indicated by international recommendations, by the values of E/E' ratio (18). Thus, the patients without LV diastolic dysfunction (E/E'\<9) were characterized as group 1. Those with LV diastolic dysfunction (E/E'\>9), were divided in two groups, in accordance with the E/E' values: group 2 (the patients with 9\<E/E'\<13), and group 3 (the patients with E/E'\>13).

Obesity will be diagnosed as body mass index (BMI) \> 30 (15). All enrolled patients will have T2DM according to international guidelines diagnostic criteria: evidence of fasting plasma glucose of ≥7.0 mmol/L (126 mg/dL; impaired fasting glucose \[IFG\]), a 2-hour glucose of ≥11.1 mmol/L during a 75 g oral glucose tolerance test (GTT) (\>200 mg/dL; impaired glucose tolerance \[IGT\]), or a plasma hemoglobin (Hb) A1c of ≥48 mmol/mol (≥6.5%), (16).

Brief summary: In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in the current study authors will investigate ghrelin expression in T2DM obese patients after abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of follow-up.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of T2DM obese patients;
* T2DM obese patients under anti-diabetic full medical therapy and glycemic control.

Exclusion Criteria:

* clinical diagnosis of type 1 diabetes;
* T2DM patients in poor glycemic control (HbA1c values of \>7%);
* chronic neurological disorders;
* heart failure and coronary heart disease or depression of left ventricular ejection fraction (LVEF \<55%);
* severe anemia;
* thyroid dysfunction;
* kidney failure;
* uncontrolled blood pressure (blood pressure \> 140/90 mmHg on two occasions 2 weeks apart);
* inflammatory chronic disease;
* neoplastic disease.

Primary outcomes:
measure: normalization of LV diastolic dysfunction
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Celestino Sardu
Study officials:
References:
Clinical trial NCT01239446: Hybrid SPECT/CTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients.
Official title: Hybrid Single-Photon Emission Computed Tomography/Computed Tomography Coronary Angiography for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients After Mediastinal Irradiation for Hodgkin Lymphoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hodgkin Lymphoma Treated With Mediastinal Irradiation
Keywords: Hodgkin lymphoma
mediastinal irradiation
Coronary Artery Disease
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia and proximal coronary segments, or causes diffuse microvascular damage. Younger patients and those exposed to high radiation doses (\> 35 Gy) have a higher risk for developing premature CAD and likely may benefit from coronary assessment.

A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the specificity and mainly PPV of CTCA.

The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who have received radiotherapy to the mediastinum in order to allow an early diagnosis of hemodynamically significant CAD that will need further therapeutic interventions.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic HL patients without evidence of disease and without prior history of CAD that underwent mediastinal irradiation due to HL

Exclusion Criteria:

* Known CAD (these patients will be excluded from the imaging study, but will be analyzed as separate control group)
* active HL or other active malignancy
* chronic renal failure
* pregnant/ nursing women
* previous allergic reaction to iodine contrast media

Primary outcomes:
measure: Extent of coronary artery plaques and number of perfusion defects in patients enrolled.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
Study officials:
References:
Clinical trial NCT02083146: C1q/TNF-related Proteins in Coronary Artery Disease
Official title: C1q/TNF-related Proteins in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease (CAD)
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 362
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects with stable angina or a history of acute coronary syndrome who visited for a department of cardiology in Korea Univ. Guro hospital were enrolled using predefined inclusion and exclusion criteria.

Brief summary: Now, adipose tissue is established as an active endocrine organ that controls systemic energy homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in metabolism and inflammation. The investigators tried to clarify the relationship between CTRP family and coronary artery disease (CAD) in Korean men and women.

Detailed description: Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). Adiponectin is the insulin-sensitizing adipokine with anti-inflammatory and anti-atherogenic properties. Hypoadiponectinemia has been associated with an increased risk of coronary artery disease (CAD) in several though not all studies. Recently, a new family of secreted proteins, C1q/TNF-related protein (CTRP), was cloned on the basis of sequence homology with adiponectin. This family of adiponectin paralogs might have pivotal implications in energy homeostasis and obesity-related inflammation. Each CTRP family member has its own unique tissue expression profile and function in regulating glucose and/or fat metabolism. In the present study, we evaluated the role of CTRP in patients with CAD and investigated whether CTRP family is significantly associated with CAD prevalence after adjustment for well-known CAD risk factors.

Eligibility criteria: Inclusion Criteria:

* 20\<age\<80
* History of stable angina, unstable angina, or acute myocardial infarction

Exclusion Criteria:

* a history of diabetes
* stage 2 hypertension
* malignancy
* severe renal or hepatic disease

Primary outcomes:
measure: serum concentration of CTRP-1,3, or 9 in the subjects with/without CAD
timeFrame: at enrollment
Secondary outcomes:
measure: The relationships of serum CTRPs/adiponectin levels with cardiometabolic risk profiles
timeFrame: at enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Guro Hospital
Study officials:
affiliation: medica7@gmail.com
name: Kyung Mook Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04321746: The Effect of Ketamine on Postoperative Cognitive Dysfunction.
Official title: The Effect of Ketamine on Postoperative Cognitive Dysfunction in Geriatric Patients Undergoing Orthopaedic Surgery Under Spinal Anaesthesia, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Available evidence suggests that there is no significant difference in the incidence of postoperative cognitive dysfunction POCD when general anaesthesia and regional anaesthesia are compared\[13, 14\]. To the knowledge of the investigators , no studies are examining the effects of ketamine on cognitive outcomes in the setting of spinal anesthesia.

Thus, the purpose of this study was to compare the cognitive status, as assessed by the SPMSQ, of elderly patients undergoing orthopaedic surgery under spinal anaesthesia before and after ketamine administration. The authors hypothesized that patients receiving ketamine would exhibit better cognitive performance.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for orthopaedic surgery under spinal anaesthesia.
* ASA physical status I to II.

Exclusion Criteria:

* Patients with a history of psychosis, schizophrenia, nephropathy, uncontrolled blood pressure, uncontrolled hepatic disorders, or allergy to ketamine.
* Patients With moderate to severe depression according to Yesavage abbreviated Geriatric Depression Scale,
* Patients presented with postoperative delirium or required medications other than study drugs.
* Ketamine administration is contraindicated.

Primary outcomes:
measure: postoperative cognitive dysfunction
timeFrame: first postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
Clinical trial NCT05565846: NTX-001 to Repair Peripheral Nerve Transection(s)
Official title: An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves
Lead sponsor: Neuraptive Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-04
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned.

Detailed description: For this expanded access program, there is a case-by-case internal review process conducted by Neuraptive after the respective investigator provides a prospective case narrative for enrollment consideration.

Allowed Sunderland Classifications are IV degree (Seddon's Class II) and V degree (Seddon's Class III). If the case is approved, the investigator can move forward.

Patients who are between twelve (12) and eighty (80) years of age and has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and require surgical treatment. All peripheral nerve repairs including gap repairs (autografts) will be considered for enrollment.

Eligibility criteria: Inclusion:

1. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and requires surgical treatment.

Exclusion:

1. Patients whose nerve repair will occur greater than 48 hours after nerve transection.
2. Patients requiring repair of the intracranial portion of any nerve.
3. Patients requiring a nerve repair involving an allograft or conduit.
4. Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).
5. Patients who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow-up due to significant muscle atrophy or other morbidity.
6. The patient has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
7. The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health Orthopedic Institute
state: Florida
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT03722446: Epidural Catheter Thread Between Two Different Vendors
Official title: A Head-to-head Comparison of Catheter Thread Between Two Epidural Kit Vendors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 257
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different epidural pain management kits vendors

Detailed description: The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different pain management kits. In order to improve patient care, if there is a difference in the time to thread epidurals with one kit over the other, we would like to use the kit with decreased time to thread in the future.

Eligibility criteria: Inclusion Criteria: women in labor

-

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Participants Who Experienced a Successful Thread at First Pass
timeFrame: within 60min of first attempt at placement
Secondary outcomes:
measure: Time to Thread Epidural Catheter
timeFrame: within 60min of first attempt at placement
measure: Incidence of Unintended Dural Punctures
timeFrame: within 60min of first attempt at placement
measure: Incidence of Paresthesia
timeFrame: within 60min of first attempt at placement
measure: Incidence of Epidural Intravascular Cannulations
timeFrame: within 60min of first attempt at placement
measure: Epidural Needle Manipulations Needed to Successfully Advance
timeFrame: within 60min of first attempt at placement
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: von Voitlander Women's Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Carlo Pancaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pancaro C, Purtell J, LaBuda D, Saager L, Klumpner TT, Dubovoy T, Rajala B, Singh S, Cassidy R, Vahabzadeh C, Maxwell S, Manica V, Eckmann DM, Mhyre JM, Engoren MC. Difficulty in Advancing Flexible Epidural Catheters When Establishing Labor Analgesia: An Observational Open-Label Randomized Trial. Anesth Analg. 2021 Jul 1;133(1):151-159. doi: 10.1213/ANE.0000000000005526.
Clinical trial NCT02600546: Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With SD-OCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Repeatability & Reproducibility
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeing eye doctor for routine or follow-up care

Brief summary: Evaluate the repeatability and reproducibility of the RTVue-XR for measuring the total corneal thickness (pachymetry), the epithelial thickness, and the stromal thickness mapping in normal subjects and corneal patients.


Eligibility criteria: Inclusion Criteria:

* Able and willing to provide consent.
* Able and willing to complete required exams
* History of refractive surgery, contact lens, dry eye or keratoconus for corneal patients

Exclusion Criteria:

* Unable to complete required exams
* History of refractive surgery, contact lens, dry eye or keratoconus for normal patients

Primary outcomes:
measure: epithelial thickness
timeFrame: Day 1
Secondary outcomes:
measure: Stromal thickness
timeFrame: Day 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT00935246: Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Official title: Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Continuous Antidepressant Abuse
Adverse Reaction to Drug
Keywords: Genomic devices
Prediction of Escitalopram Response
Depressed Patients
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2009-07-08
Enrollment: 202
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning).

Detailed description: The purposes of this study are:

1. To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning)
2. To improve the success rate of escitalopram treatment response for depressed patients

Eligibility criteria: Inclusion Criteria:

1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Primary outcomes:
measure: antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: biological value at 0 week and 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References: