louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06829446: Recurrent Persistent Atrial Fibrillation:In-situ Ablation Vs Extensive Ablation
Official title: A Randomized Control Study of Repeat In-situ Ablation Versus Extensive Ablation for Patients with Recurrent Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Persistent Atrial Fibrillation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Jinshan Hospital Affiliated to Fudan University
name: Tongji University
First posted: 2025-02-17
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, randomized parallel control clinical trial, to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.

Detailed description: This is an open label, randomized parallel control clinical trial. Patients with recurrent persistent atrial fibrillation are 1:1 randomized into EXT group(Extra-PV extensive ablation) and IN-SITU group(Repeat same PVI and linear ablation as the first procedure). Postoperative recurrence rate and other indicators are analyzed to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older; 2) Diagnosed as recurrent PerAF according to the latest clinical guidelines; 3) Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment; 4) the first ablation procedure was PVI and linear ablation; 5) consented to receive radiofrequency catheter ablation.

Exclusion Criteria:

* 1) Recurrent atrial flutter/atrial tachycardia; 2) The first ablation procedure included extra-PV substrate ablation; 3) The first low voltage area\>30%; 4) Serious complications during the first procedure; 5) The first ablation was paroxysmal atrial fibrillation. 6) Uncontrolled congestive heart failure; 7) History of severe valve disease and/or prosthetic valve replacement; 8) Left atrial thrombus confirmed by preoperative esophageal ultrasound; 9) Severe congenital heart disease; 10) Severe lung disease; 11) Left atrial diameter ≥60mm; 12) Contraindications for cardiac catheterization; 13) Myocardial infarction or stroke within 6 months; 14) Contrast agent allergy; 15) The use of anticoagulant drugs is contraindicated; 16) Have performed any cardiac surgery within 2 months;17) life expectancy is less than one year, including factors such as physical inability to tolerate ablation or unstable disease conditions.

Primary outcomes:
measure: Freedom from any documented AF/AT episode
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from any documented AF episode
timeFrame: 12 months
measure: Any documented AT episode
timeFrame: 12 months
measure: Periprocedural complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References:
Clinical trial NCT01147146: The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery
Official title: The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: transurethral surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 64
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: The effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery.


Eligibility criteria: Inclusion Criteria:

* male patients (ASA physical status I and II) aged over 65 yrs and scheduled elective transurethral surgery

Exclusion Criteria:

* cardiovascular, renal, liver disease, or cerebrovascular disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Anesthesiology & Pain Medicine, Severance Hospital
name: Jeong-Yeon Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05246046: Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler
Official title: Pharmacokinetic Study to Compare Tiotropium Easyhaler® Product Variants and Spiriva® 18 µg Capsules Administered Via HandiHaler® in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.


Eligibility criteria: Main inclusion criteria:

1. Healthy male and female
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. FEV1 at least 80% of the predicted value measured at screening
6. Written informed consent obtained

Main exclusion criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
2. Any condition requiring regular concomitant treatment.
3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject.
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose.
5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness.
6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Primary outcomes:
measure: Peak tiotropium concentration in plasma (Cmax)
timeFrame: between 0-72 hours after dosing
measure: Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)
timeFrame: between 0-30 minutes after dosing
measure: Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)
timeFrame: between 0-72 hours after dosing
Secondary outcomes:
measure: Time to reach peak concentration in plasma (tmax)
timeFrame: between 0-72 hours after dosing
Other outcomes:
measure: Adverse events
timeFrame: throughout the study, an average 7 weeks
Locations:
city: Espoo
country: Finland
facility: Clinical Pharmacology Unit, Orion Corporation
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Corporation Clinical Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02783846: The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial
Official title: The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loss of Consciousness
Keywords: Propofol
Dexmedetomidine
Dose
Bispectral index monitor
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 73
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: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.

Detailed description: It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* Aged 18-65 years
* Body Mass Index 18.0～24.5 kg/m2
* Without hearing impairment

Exclusion Criteria:

* Bradycardia
* Atrioventricular block
* Neurologic disorder and recent use of psychoactive medication
* Allergic to the drugs

Primary outcomes:
measure: The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness
timeFrame: To infuse dexmedetomidine and saline completely ten minutes after
Secondary outcomes:
measure: The bispectral index values when patients loss of consciousness
timeFrame: To infuse dexmedetomidine and saline completely ten minutes after
Other outcomes:
Locations:
Study officials:
References:
citation: Gu Y, Yang F, Zhang Y, Zheng J, Wang J, Li B, Ma T, Cui X, Lu K, Ma H. The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Apr 25;20(1):96. doi: 10.1186/s12871-020-01013-x.
Clinical trial NCT01018446: Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling
Official title: Determination of Optimal Busulfan Dose Using Pharmacokinetic Modeling in Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Hematopoietic stem cell transplantation with busulfan based conditioning
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 30
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the investigators plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.

Detailed description: Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study we plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.

Eligibility criteria: Inclusion Criteria:

1. Hematopoietic stem cell transplantation with busulfan based conditioning
2. Age: no limits.
3. Performance status: ECOG 0-2.
4. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
5. Patients must lack any active viral infections or active fungal infection.
6. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
7. Patients (or one of parents if patients age \< 19) should sign informed consent.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.

Primary outcomes:
measure: To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation.
timeFrame: For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation
Secondary outcomes:
measure: To evaluate survival, toxicities, engraftment rate of patients received optimal dose of busulfan.
timeFrame: 1, 3, 6 and 12 months after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Daehangno, Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06063746: Compassionate Use of Vidutolimod
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-10-03
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide Compassionate Use of Vidutolimob

Detailed description: Compassionate use is only available to patients who transitioned from a previous vidutolimod (CMP-001) study.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02041546: Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome
Official title: Zekai Tahir Burak Maternity Teaching Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meconium Aspiration Syndrome
Keywords: Lung lavage,
Surfactant,
Duration of mechanical
ventilation
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 30
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.


Eligibility criteria: Inclusion Criteria:

* Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled.

Exclusion Criteria:

* Congenital cardiac anomalies
* Major congenital anomalies
* Hemodynamically unstable infants

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Complications
timeFrame: up to 4 weeks
measure: Duration of Hospital Stay
timeFrame: Up to 8 weeks or till discharge
measure: Mortality
timeFrame: Up to 3 months or till discharge
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
References:
citation: Arayici S, Sari FN, Kadioglu Simsek G, Yarci E, Alyamac Dizdar E, Uras N, Canpolat FE, Oguz SS. Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome. J Trop Pediatr. 2019 Oct 1;65(5):491-497. doi: 10.1093/tropej/fmy081.
Clinical trial NCT02102646: MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
Official title: MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Metabolic Syndrome
Hypogonadism
Fatty Liver
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution.

Detailed description: This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate regardless of assignment to either orchiectomy or triptorelin.

Eligibility criteria: Inclusion Criteria:

* Eligible for inclusion are patients who are included in the already ongoing Randomised trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29)

Exclusion Criteria:

* Implanted devices or foreign metallic bodies incompatible with Magnetic Resonance Imaging.
* claustrophobia
* Severe Psychiatric disease

Primary outcomes:
measure: Change in hepatic fat content
timeFrame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Secondary outcomes:
measure: Change in visceral/subcutaneous fat mass
timeFrame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
measure: Correlation between Hepatic fat content and baseline androgen status
timeFrame: Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy)
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Department of Urology, Herlev Hospital, Denmark
name: Peter B Østergren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122169: Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery
Official title: Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaginal Delivery
Surgical Site Infection
Keywords: Chlorhexidine-alcohol
Povidone-iodine
Perineal infection
Surgical site infection
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 4140
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multi-center, randomized, controlled trial study to find whether use of chlorhexidine-alcohol or povidone-iodine for pre-vaginal delivery skin prep is superior to reduce postpartum infection in pregnant women with vaginal delivery. The primary outcome is the episiotomy site infection.


Eligibility criteria: Inclusion Criteria:

* Women with singleton pregnancy
* Women who will undergo vaginal delivery after 37+0/7 weeks of gestation

Exclusion Criteria:

* Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish
* Women with any infection at perineum (before vaginal delivery)

Primary outcomes:
measure: Number of participant with episiotomy site infection
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04793269: Characteristics of Long COVID-19 Syndrome
Official title: Long COVID Syndrom: Charakterisierung Eines Neuen Krankheitsbildes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Long COVID Syndrome
Keywords: long COVID
post COVID
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with long COVID syndrome

Brief summary: Characterization of patients with long COVID syndrome including symptoms, medical history and persistent organ damage.

Detailed description: Some people are very hesitant to recover from a COVID-19 infection and present persistent symptoms. The participants still suffer after the acute phase of the infection from shortness of breath, coughing, chest pain or fatigue. Therefore, a special interdisciplinary consultation was built. The consulatation is not only addressed to people who have been hospitalized due to COVID-19, but also to those with mild symptoms during infection. During the consultation hours, personal health data are collected that serves as the basis for this research project.

Eligibility criteria: Inclusion Criteria:

* Long COVID syndrome
* age \>= 18 years
* Informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Dyspnea
timeFrame: once through study completion, an average of 6 months.
measure: self-addressed Quality of life
timeFrame: once through study completion, an average of 6 months
measure: Thoracic pain
timeFrame: once through study completion, an average of 6 months
measure: Medical history
timeFrame: once through study completion, an average of 6 months
measure: Fibrosis
timeFrame: once through study completion, an average of 6 months
measure: Myocardial damage
timeFrame: once through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Pulmonology
name: Christian F Clarenbach, MD
role: STUDY_CHAIR
References: