louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06041685: Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia
Official title: Effect of Local Warming for Arterial Catheterization in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 126
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better arterial catheterization. Since an increase in body temperature can cause peripheral vasodilation, we aimed to determine if local warming of the radial artery (RA) catheterization site could improve the success rate of catheterization in pediatric patients.

Detailed description: This randomized, controlled study enrolls 126 pediatric patients aged ≤ 2 years who were scheduled for heart surgery. They are randomized into non-warming (C) and warming (W) groups. After induction, the baseline artery ultrasonography images are collected. In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. The primary outcome is the first-attempt success rate. The secondary outcomes included the ID and CSA of the artery and overall complications.

Eligibility criteria: Inclusion Criteria:

* aged ≤ 2 years
* cardiac surgery with peripheral artery catheterization

Exclusion Criteria:

* unstable vital signs
* pre-existing arterial catheter (exception of umbilical artery catheterization)

Primary outcomes:
measure: first-attempt success rate of arterial catheterization
timeFrame: baseline, imediate after arterial catheterization
Secondary outcomes:
measure: internal diameter (ID) and cross-sectional area (CSA)
timeFrame: baseline, imediate after arterial catheterization in the non-warming group, or warming group
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyungnam
Study officials:
affiliation: Pusan National University
name: Hee Young Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christen S, Delachaux A, Dischl B, Golay S, Liaudet L, Feihl F, Waeber B. Dose-dependent vasodilatory effects of acetylcholine and local warming on skin microcirculation. J Cardiovasc Pharmacol. 2004 Dec;44(6):659-64. doi: 10.1097/00005344-200412000-00006.
citation: Al-Hakim R, Hedge JC, Jahangiri Y, Kaufman JA, Galuppo R, Farsad K. Palmar Warming for Radial Artery Vasodilation to Facilitate Transradial Access: A Randomized Controlled Trial. J Vasc Interv Radiol. 2019 Mar;30(3):421-424. doi: 10.1016/j.jvir.2018.10.021.
citation: Barcroft H, Edholm OG. The effect of temperature on blood flow and deep temperature in the human forearm. J Physiol. 1943 Jun 30;102(1):5-20. doi: 10.1113/jphysiol.1943.sp004009. No abstract available.
Clinical trial NCT06278285: Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery
Official title: Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Normalizing weight gain and preventing the redistribution of body fat is a major health issue, and could help prevent the onset of various symptoms of metabolic syndrome. Above all, it is important to understand the mechanisms by which these different treatments affect adipose tissue. To this end, the investigators will first study the impact of GLP-1 analogues on adipose tissue. The main objective is to show that subjects treated with a GLP-1 agonist have a significant change in their oxytocin levels compared with subjects not treated with a GLP-1 agonist.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age.
* Patient able to read and understand the information/consent leaflet.
* Patient with BMI \> 35 with at least one comorbidity. Or BMI \> 40
* Indication for digestive surgery validated in a multidisciplinary consultation meeting and prior agreement accepted by the CPAM.
* Membership of a social security scheme
* Patient's signed informed consent
* For subjects in the GLP-1 analogue group: GLP-1 analogue taken for at least 3 months.
* For non-GLP-1 analogue group: never taken GLP-1 analogues.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Vulnerable patients (under guardianship)
* Patients deprived of liberty

Primary outcomes:
measure: Rate of oxytocin
timeFrame: one time (before surgery)
Secondary outcomes:
measure: Fibrosis rate
timeFrame: At surgery
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
state: Alpes-maritimes
Study officials:
affiliation: Clinique Parc Impérial, Service de Chirurgie Digestive
name: Iannelli Antonio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01253356: ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
Official title: A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
Lead sponsor: Datascope Corp.
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction \< or = 30%)

Exclusion Criteria:

* Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score \> or = 5 Pregnancy Inability to provide informed consent

Primary outcomes:
measure: Safety
timeFrame: 30 days
Secondary outcomes:
measure: Efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
Study officials:
affiliation: Erasmus Medical Center
name: Don Poldermans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173056: The Factors Predicting Change of Peritoneal Transport Characters in Peritoneal Dialysate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Fibrosis
Keywords: Peritoneal dialysis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular matrix (ECM) deposition is the most possible causes leading to PF. ECM are mainly synthesized from HPFB and human peritoneal mesothelial cells (HPMC). In the PF process, there is decrement in the quantity of HPMC, loss of permeability for lower molecules, and eventually ultrafiltration failure. This phenomena will result in technique failure.

High glucose content of the dialysate and peritonitis have been claimed as major stimulants to the development of PF. In each episode of peritonitis, the number of HPMC will decrease. On the other hand, ECM production will be reinforced by the inflammatory cytokines secreted by the white cells or HPMC per se. High glucose dialysate will induce the above process with more chronic stimulation, and PF followed by technique failure is inevitable.

Peritoneal fibrosis is definitively diagnosed with peritoneal biopsy, but this is inconvenient for most patients. Besides, pathology changes will be noted only after a substantial loss of peritoneal function. The peritoneal equilibration test (PET) is usually used as the index of peritoneal function. However, in the chronic process, PET change is also slow and is unable to be a parameter for treatment outcome. In this study, the factors predicting PET change will be searched, and they could be an index for evaluation and even a marker of preventing or treating PF.

In this project, peritoneal dialysis (PD) dialysate will be collected during an annual PET in each PD patient in the National Taiwan University Hospital (NTUH). Some cytokines that will be measured include vasculoendothelial growth factor, hyaluronan, transforming growth factor-β, procollagen, and cancer antigen-125. The same test and measurement will be performed during PET in the next year. The factors which affect PET results will be analyzed such as cytokines, glucose exposure, peritonitis incidence, PD duration, gender, age. The investigators will try to find a convenient acute reactive marker for preventing or treating PF to monitor the PET change clinically.


Eligibility criteria: Inclusion Criteria:

* All PD patients

Exclusion Criteria:

* Peritonitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine, NTUH
name: Jenq-Wen Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06865456: Predictors of Survival of DKD Patients in Assiut University Hospital
Official title: Predictors of Survival of DKD Patients in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Disease(CKD)
Keywords: diabetic nephropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diabetic patients with chronic kideny disease stage 4,5

Brief summary: In recent years, the global prevalence of diabetes has risen significantly. According to the 9th edition of the International Diabetes Federation Atlas, an estimated 463 million adults were living with diabetes in 2019, representing approximately 9.3% of the population, with an average annual increase of 51%.

Diabetes is associated with multiple complications that can significantly impact patient outcomes . In 2019 alone, around 4.2 million deaths were attributed to diabetes and its complications, accounting for approximately 11.3% of all global deaths .

In diabetic patients, several factors influence renal survival, including glycemic control, blood pressure management, lifestyle interventions, and pharmacological therapies such as renin-angiotensin-aldosterone system (RAAS) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists(9). Early detection of kidney dysfunction through biomarkers like estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR) plays a pivotal role in improving renal outcomes.

This study aims to evaluate the factors affecting Patients survival in diabetic patients, identify early predictors of renal function decline, and assess the effectiveness of current therapeutic strategies.


Eligibility criteria: Inclusion Criteria:

* ● Patients age \> 18 years old

  * Both sex
  * diabetic patients with HbA1c level \>6.5( Type 1 and 2)
  * Diabetic patients with CKD 4, 5 )
  * HD Pt

Exclusion Criteria:

* ● Chronic kidney diseases stage 1,2, and 3.

  * Acute kidney injury.
  * Patients with any other causes of CKD autoimmune disease

Primary outcomes:
measure: incidence of CKD in diabetic patients
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04455256: Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss
Official title: Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pregnancy Loss
Endoplasmic Reticulum Stress
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Loss of 3 or more pregnancy between the ages of 18 and 45 and women who have given at least 1 healthy birth in the same age group.

Brief summary: To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.


Eligibility criteria: Inclusion Criteria:

* with three or more miscarriages before 20 th week of gestation
* had no chronic or acute inflammatory disease
* used no steroids, anti-inflammatory, or antioxidant medications

Exclusion Criteria:

* had inflammatory diseases
* had systemic disease
* Anatomical abnormalities, infectious, endocrine, or genetic etiologies

Primary outcomes:
measure: Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT00910156: Indirect Laryngoscopy for Nasal Intubation
Official title: Indirect Versus Direct Laryngoscopy for Routine Nasotracheal Intubation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation, Intratracheal
Lead sponsor: General Hospital Linz
Sponsor class: OTHER
First posted: 2009-05-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: Comparison of ease and convenience of nasotracheal intubation with the use of the two indirect laryngoscopes, Airtraq or Glidescope, versus the traditionally used Macintosh laryngoscope.


Eligibility criteria: Inclusion Criteria:

* nasotracheal intubation

Exclusion Criteria:

* anticipated difficult airway
* risk factors for gastric aspiration
* history of bleeding
* relevant allergy

Primary outcomes:
measure: Intubation Difficulty Scale (IDS)
Secondary outcomes:
measure: Posture of the intubator
Other outcomes:
Locations:
city: Linz
country: Austria
facility: General Hospital Linz
Study officials:
References:
Clinical trial NCT04863456: Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
Official title: Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pituitary Adenoma
Keywords: pituitary adenoma
treatment strategy
Hypothalamus
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)

Detailed description: There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.

Eligibility criteria: Inclusion Criteria:

* Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement
* Informed consent

Exclusion Criteria:

* No follow-up possible
* Emergency surgery without informed consent

Primary outcomes:
measure: Change of QoL (Quality of Life, EQ-5D) for the first surgery
timeFrame: baseline (before the first surgery), 2 years after the first surgery
measure: Change of QoL (Quality of Life, EQ-5D) for the second intervention
timeFrame: baseline (before the second intervention), 3 months after the second intervention
Secondary outcomes:
measure: Change of Visual Acuity statue
timeFrame: baseline (before the first surgery), 2 years after the first surgery
measure: Change of Visual Field statue
timeFrame: baseline (before the first surgery), 2 years after the first surgery
measure: Change of Hormone Replacement Therapy
timeFrame: baseline (before the first surgery), 2 years after the first surgery
measure: Extent of resection
timeFrame: baseline (before the first surgery), 2 years after the first surgery
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology
name: Tao Huang, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00889356: Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
Official title: Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Candidiasis
Bacterial Vaginosis
Lead sponsor: Zodiac Produtos Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
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, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.


Eligibility criteria: Inclusion Criteria:

* Mixed-type vaginosis
* Bacterial vaginosis
* Candidiasis

Exclusion Criteria:

* Pregnancy
* Vaginal bleeding
* History of recurrent vaginosis

Primary outcomes:
measure: Efficacy based on cure rate evaluated by clinical and laboratory criteria.
timeFrame: 7 days
Secondary outcomes:
measure: Tolerability based on adverse events reports and patient's information
timeFrame: 7 days
measure: Safety based on adverse events reports and laboratory criterion
timeFrame: 7 days
Other outcomes:
Locations:
city: Jundiaí
country: Brazil
facility: Vox Femina
state: SP
Study officials:
affiliation: CRM Regional Council of Medicine
name: Rogerio Bonassi Machado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06288256: Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery
Official title: Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spine Pathology
Elective Spine Surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: undergoing elective spine surgery

Brief summary: Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.

To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.

This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation

Exclusion Criteria:

* Severe psychiatric condition interfering with study participation Any major cardiac, pulmonary, renal, infectious, hepatic condition that interferes with study participation
* Polytrauma
* Prolonged hospitalization (\>10days)
* Pregnancy
* Known surgery cancellation within study period

Primary outcomes:
measure: Current Opioid Misuse Measure (COMM) Score
timeFrame: Up to 12 months post-operatively
Secondary outcomes:
measure: Numerical Rating Scale (NRS) Score
timeFrame: Up to 12 months post-operatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Spine Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Chinwe Nwaneshiudu
role: PRINCIPAL_INVESTIGATOR
References: