louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05097170: Cerebral Oxygenation and Awareness During VT Ablation
Official title: Determining the Effect of Vital Parameters on Cerebral Oxygenation and Awareness During Ventricular Tachycardia Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Oxygenation
Keywords: cerebral oxygenation
ventricular tachycardia ablation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing VT ablation procedure

Brief summary: It is aimed to examine the effect of the decrease in blood pressure that occurs during the ventricular tachycardia ablation process on cerebral oxygenation and awareness.

Patient's age, cardiac measurements (ejection fraction-EF), basal vital values, procedure time (especially activation and pacing mapping), and localization of the arrhythmia, may affect the NIRS and BIS response to blood pressure drop. In addition to the effects of patients' demographic information, cardiac capacity and procedure time on NIRS and BIS values (downtrend and duration), correlations of these values with other monitoring parameters (ETCO2 and SpO2) intended to be displayed.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18
* Patients who will undergo VT ablation
* Patients who want to participate in the study

Exclusion Criteria:

* Patients whose baseline values could not be obtained before induction
* Patients with severe neurological or psychiatric illness
* Patients who do not want to participate in the study

Primary outcomes:
measure: Near Infrared Spectrometer
timeFrame: perioperative (ventricular tachycardia ablation)
Secondary outcomes:
measure: Bispectral Index
timeFrame: perioperative (ventricular tachycardia ablation)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Filiz Uzumcugil
Study officials:
References:
citation: Shivkumar K. Catheter Ablation of Ventricular Arrhythmias. N Engl J Med. 2019 Apr 18;380(16):1555-1564. doi: 10.1056/NEJMra1615244. No abstract available.
Clinical trial NCT03512470: Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal Aortic Pathology Using the "PREVENA" System
Official title: A Clinical Study, Spontaneous, Randomized and Controlled, on the Prevention of Surgical Wound Complications for Aneurysmal Thoracoabdominal Aortic Disease by Using the "PREVENA ™" Negative Topical Pressure System (TVAC STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toraco Abdominal Aneurysm
Keywords: surgical wound
Prevena System
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 100
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 patients will be randomized into two groups of 100 subjects each one. One arm will be randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while the other arm ("control group") will be randomized to treatment with standard medication with sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use.

The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed. The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. For each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).


Eligibility criteria: Inclusion Criteria:

* patients over 18 years;
* patients of any sex, race, age, who have accepted to participate in the study by signing the informed consent form of the study.
* patients with surgical wounds to treat thoracic-abdominal aortic pathology.

Exclusion Criteria:

* patients with established sepsis;
* patients with septic recurrence;
* patients with sensitivity to silver.

Primary outcomes:
measure: Reduction of surgical site infections
timeFrame: 14 days after surgery
Secondary outcomes:
measure: Reduction of adverse events
timeFrame: 12 month
measure: Reduction of adverse events
timeFrame: 12 month
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
citation: Cutting KF, White RJ. Criteria for identifying wound infection--revisited. Ostomy Wound Manage. 2005 Jan;51(1):28-34.
citation: Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.
Clinical trial NCT00297570: Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Leukemia, Myeloid, Philadelphia-Positive
Keywords: CML
Imatinib
Pegylated Interferon
Philadelphia Positive CML
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response after more than one year of imatinib therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.


Eligibility criteria: Inclusion Criteria:

* Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy.

Exclusion Criteria:

* Patients in imatinib study
* Patients with a history of intolerability to interferon.
* Patients with less than CCR or less than one year of imatinib therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Department of Hematology, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Izhar Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hardan I, Stanevsky A, Volchek Y, Tohami T, Amariglio N, Trakhtenbrot L, Koren-Michowitz M, Shimoni A, Nagler A. Treatment with interferon alpha prior to discontinuation of imatinib in patients with chronic myeloid leukemia. Cytokine. 2012 Feb;57(2):290-3. doi: 10.1016/j.cyto.2011.11.018. Epub 2011 Dec 13.
Clinical trial NCT00092170: An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)
Official title: A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia, Complicated Intra-Abdominal Infections, and Acute Pelvic Infections in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections
Pelvic Infections
Keywords: Intra-abdominal infections
Acute pelvic infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

Detailed description: The duration of treatment is 18 months.

Eligibility criteria: Inclusion Criteria:

* Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection

Exclusion Criteria:

* Immune problems
* Kidney problems

Primary outcomes:
measure: Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Yellin AE, Johnson J, Higareda I, Congeni BL, Arrieta AC, Fernsler D, West J, Gesser R. Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. Am J Surg. 2007 Sep;194(3):367-74. doi: 10.1016/j.amjsurg.2007.01.023.
Clinical trial NCT03281070: Anastomotic Leakage After Anterior Resection of Rectal Cancer
Official title: The Incidence and Risk Factors of Anastomotic Leakage After Anterior Resection of Rectal Cancer: a Multi-site Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: Anastomotic leakage
Anterior resection
Risk factors
Incidence
Rectal Cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer patients who underwent anterior resection with or without postoperative anastomotic leakage

Brief summary: Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior resection of rectal cancer. This complication compromises both short term and long term outcome of patients. The incidence of AL after anterior resection was approximately 6-11%. Although several risk factors for AL such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of AL did not meet a significant decrease. So far there is no multi-site observational study on incidence and risk factors of AL after anterior resection in China, therefore this study aims to work on this issue and provide evidence for clinical practice.


Eligibility criteria: Inclusion Criteria:

* adenocarcinoma of the rectum by biopsy
* single lesion
* anterior resection was performed
* anastomosis using circular stapler

Exclusion Criteria:

* history of colorectal cancer surgery
* emergency surgery because of bowel obstruction, bleeding or perforation
* colo-anal anastomosis
* subtotal colectomy
* total colectomy
* abdominal perineal resection
* Hartmann procedure
* pull out anastomosis

Primary outcomes:
measure: Anastomotic leakage
timeFrame: 14 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
References:
Clinical trial NCT00370370: Intravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Bevacizumab,
Triamcinolone
Age-related macular degeneration
Choroidal neovascular membrane
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab + triamcinolone acetonide in neovascular AMD.


Eligibility criteria: Inclusion Criteria:

* Cases of active neovascular AMD with visual acuity of 20/400- 20/40

Exclusion Criteria:

* History of glaucoma or ocular hypertension
* Disciform scar

Primary outcomes:
measure: visual acuity
Secondary outcomes:
measure: central macular thickness
measure: leakage in fluorescein angiography
measure: intraocular pressure
measure: anterior chamber reaction
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540670: A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Official title: A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

1. 45 - 80 years old (at time of informed consent).
2. Male or female (females of childbearing potential must use contraception).
3. Confirmed coronary artery disease.
4. All subjects must be receiving aspirin (75 - 325 mg).

Exclusion Criteria:

1. Unwilling or unable to provide informed consent.
2. History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder.
3. Recent trauma or major surgery.
4. Evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
5. History of intracranial bleeding or history of hemorrhagic retinopathy.
6. New York Heart Association class III or IV congestive heart failure.
7. Pregnant or lactating women.

Primary outcomes:
measure: Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG
timeFrame: 6 months
Secondary outcomes:
measure: Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
timeFrame: 6 months
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
state: Aichi
city: Ogaki
country: Japan
state: Gifu
city: Asahikawa
country: Japan
state: Hokkaido
city: Chitose
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Tomakomai
country: Japan
state: Hokkaido
city: Himeji
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Tsuchiura
country: Japan
state: Ibaraki
city: Kanazawa
country: Japan
state: Ishikawa
city: Yokohama
country: Japan
state: Kanagawa
city: Matsusaka
country: Japan
state: Mie
city: Tsu
country: Japan
state: Mie
city: Osakasayama
country: Japan
state: Osaka
city: Kitamoto
country: Japan
state: Saitama
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Tachikawa
country: Japan
state: Tokyo
city: Gifu
country: Japan
city: Kumamoto
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
Study officials:
affiliation: New Product Development, Clinical Research Center, Eisai Co., Ltd.
name: Masaru Takeuchi
role: STUDY_DIRECTOR
References:
Clinical trial NCT03098875: Heart Rate Variability Under Propofol and Sevoflurane
Official title: Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability


Eligibility criteria: Inclusion Criteria:

* ASA risk classification 1 or 2,
* scheduled for middle ear surgery, or cardiovascular ANS activity.

Exclusion Criteria:

* preoperative medications that interfere with the autonomic nervous system
* preoperative medications that interfere with the central nervous system

Primary outcomes:
measure: Spectral analysis of heart rate variability with a bispectral index of 25
timeFrame: During surgical procedure
measure: Spectral analysis of heart rate variability with a bispectral index of 55
timeFrame: During surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
References:
Clinical trial NCT06997575: Comparing Intravenous and Intramuscular Magnesium Sulphate for Preventing Seizure Recurrence in Women With Eclampsia
Official title: Frequency of Recurrence of Seizures With Intravenous Versus Intramuscular Magnesium Sulphate in Women With Eclampsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Eclampsia
Seizures
Pregnancy
Keywords: Magnesium sulphate
eclampsia
Seizures
intramuscular
intravenous
Lead sponsor: Nishtar Medical University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to learn whether the way we give magnesium sulphate-into a vein (intravenous, IV) versus into a muscle (intramuscular, IM)-affects how often women with eclampsia have repeat seizures.

The main question it aims to answer is:

1. Do women who receive IV magnesium sulphate have fewer recurrent seizures than those who receive IM magnesium sulphate?

Researchers will compare two groups of women with eclampsia: one group will receive a bolus and a continuous IV infusion of magnesium sulphate, and the other will receive a combined IV-plus-IM dosing regimen.

Participants will:

1. Be women aged 18-45 years diagnosed with eclampsia in the labour room.
2. Have their basic health information (age, gestation, parity, body mass index) recorded
3. Be randomly assigned (by sealed envelope) to receive either the IV regimen (4 g loading dose then 1 g/hour infusion) or the IM regimen (10 g loading dose with 4 g IV plus 6 g IM, then 2.5 g IM every 4 hours).
4. Continue treatment for 24 hours after their last seizure or delivery, whichever is later.
5. Be monitored in hospital for seizure recurrence.
6. Have any repeat seizure treated immediately with an extra IV dose of magnesium sulphate.


Eligibility criteria: Inclusion Criteria:

* Admitted in labor room due to eclampsia (new onset of grand mal seizure activity and/or unexplained coma during pregnancy)

Exclusion Criteria:

* Patients with intracranial bleeding (on CT-scan)
* Already received MgSO4, phenytoin and diazepam before attending the hospital

Primary outcomes:
measure: Seizure
timeFrame: Within 48 hours after the last dose of MgSO4
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Medical University & Hospital
state: Punjab
Study officials:
affiliation: Nishtar Medical University & Hospital Multan
name: Mehnaz Khakwani Professor, FCPS
role: STUDY_CHAIR
References:
citation: Saha PK, Kaur J, Goel P, Kataria S, Tandon R, Saha L. Safety and efficacy of low dose intramuscular magnesium sulphate (MgSO4) compared to intravenous regimen for treatment of eclampsia. J Obstet Gynaecol Res. 2017 Oct;43(10):1543-1549. doi: 10.1111/jog.13424. Epub 2017 Jul 16.
Clinical trial NCT05854875: Diabetes Remission After RYGBP and RYGBP With Fundus Resection
Official title: RYGBP vs RYGBP With Fundus Resection for Morbid Obese Patients With Type 2 Diabetes. Evaluation of the Gastric Fundus in Glycemic Control. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Morbid Obesity
Bariatric Surgery
Keywords: Gastric Fundus
Gastrointestinal Hormones
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with fundus resection. The main questions to answer are:

* Rate of diabetes remission and the role of the gastrointestinal hormones
* Whether fundus resection leads to improved glycemic control

Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile \[ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon\], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.


Eligibility criteria: Inclusion Criteria:

* morbid obesity (ΒΜΙ ≥ 40)
* type II diabetes mellitus (T2DM)
* duration of T2DM shorter than 8 years

Exclusion Criteria:

* pregnancy
* type 1 diabetes
* previous gastrointestinal surgeries
* alcohol consumption
* depression
* no compliance

Primary outcomes:
measure: Diabetes remission in both groups
timeFrame: At 6 months and 12 months postoperatively
measure: Change in fasting and postprandial glucose levels
timeFrame: At 6 months and 12 months postoperatively
measure: Change in insulin levels, fasting and postprandial
timeFrame: At 6 months and 12 months postoperatively
measure: Change in HOMA - IR
timeFrame: At 6 months and 12 months postoperatively
measure: Change in ghrelin levels
timeFrame: At 6 months and 12 months postoperatively
measure: Change in GLP-1 levels
timeFrame: At 6 months and 12 months postoperatively
measure: Change in PYY levels
timeFrame: At 6 months and 12 months postoperatively
measure: Change in glucagon levels
timeFrame: At 6 months and 12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University of Patras, University Hospital of Patras
state: Rio
Study officials:
References: