louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03740711: Early LA Venting During Venoaterial ECMO Support
Official title: Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support (EVOLVE-ECMO Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock
Extracorporeal Membrane Oxygenation Support
Refractory Pulmonary Edema
Keywords: Cardiogenic shock
Extracorporeal Membrane Oxygenation Support
Left atrial venting
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled test
Primary purpose: TREATMENT

Brief summary: The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting would result in a significant reduction in failure of weaning ECMO support in refractory CS.


Eligibility criteria: Inclusion Criteria:

* Subject was \> 18 years of age.
* Subjects who underwent successful VA-ECMO support
* Subjects with refractory cardiogenic shock who had pulmonary edema confirmed by chest X ray or lung sonogram.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* subject was \<80 years of age
* Pregnant and/or lactate women
* Subjects who underwent VA-ECMO after recent open heart surgery
* Subjects who underwent VA-ECMO after non-cardiogenic arrest(trauma, hypothermia, submersion, drug overdose, asphyxia, intracranial hemorrhage etc)
* Severe bleeding tendency
* Terminal malignancy
* Known severe irreversible brain damage
* Subject was unable to provide written informed consent or participate.

Primary outcomes:
measure: weaning rate of VA-ECMO
timeFrame: during index admission
Secondary outcomes:
measure: In hospital mortality
timeFrame: during index admission
measure: Adverse outcome due to LA venting
timeFrame: during index admission
measure: Free days for mechanical ventilation
timeFrame: during index admission
measure: Success rate to heart transplantation
timeFrame: during index admission
measure: rate of improving for pulmonary edema
timeFrame: during index admission
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01675011: Embozene Microspheres for Uterine Fibroid Embolization (UFE)
Official title: Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Fibroids
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 4
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.


Eligibility criteria: Inclusion Criteria:

* Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form.
* Pre-menopausal women age 30-50 years at time of enrollment
* Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.

Exclusion Criteria:

* Patient has a history of pelvic malignancy
* Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure
* Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts).
* Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
* Patient has evidence of current or recent pelvic inflammatory disease or uterine infection.
* Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents.
* Patients unable to comply with the follow-up requirements of the study.

Primary outcomes:
measure: Primary Endpoint
timeFrame: 12 Months post study procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New Hyde Park
country: United States
facility: North Shore LIJ Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01742611: Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Official title: ASP1585 Phase 3 Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Renal Insufficiency
Hyperphosphatemia
Keywords: CKD
Not on dialysis
ASP1585
Bixalomer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.


Eligibility criteria: Inclusion Criteria:

* Patients who completed study 1585-CL-0101 or new patients who meet following criteria
* Chronic kidney disease patients (eGFR \< 60 mL/min/1.73 m2)
* Serum phosphorus measurement ≧4.6 mg/dl, \<9.0 mg/dl
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention

Primary outcomes:
measure: Time-course changes in serum phosphorus levels
timeFrame: During 48 week treatment
Secondary outcomes:
measure: Achievement rate of the target range of serum phosphorus level
timeFrame: During 48 week treatment
measure: Time to achieve the target range of serum phosphorus level
timeFrame: During 48 week treatment
measure: Time-course changes in serum calcium levels
timeFrame: During 48 week treatment
measure: Time-course changes in serum intact PTH (parathyroid hormone) levels
timeFrame: During 48 week treatment
measure: Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
timeFrame: During 48 week treatment
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05827211: The Usefulness of Antibiotics in Smokers Receiving Dental Implants
Official title: Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Therapy
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: This randomized clinical trial will compare the usefulness of pre- and postoperative antibiotics while strict asepsis will be followed during periodontal surgery in smokers diagnosed with Stage III Grade C Generalized Periodontitis.

Material and Methods: Two groups of 40 consecutive patients each with fully or partially edentulous jaws will be enrolled. Antibiotics group (GrAB+): will receive oral doxycycline 200 mg, 1 h pre-operatively and 100 mg g for 9 days post-operatively. Non-antibiotics group (GrAB- ): will receive a placebo (no antibiotics). Bacterial samples will be taken from the peri-oral skin before and at the end of the surgery. In 12 patients in each group, samples will also be taken from the nares. A visual analogue scale will evaluate symptoms of infection/ inflammation by both the patient and the periodontist at suture removal.


Eligibility criteria: Inclusion Criteria:

* smoker
* in need of dental implant therapy
* above 18 years of age

Exclusion Criteria:

* allergy to doxycycline,
* need for endocarditis prophylaxis,
* any systemic or local immunodeficiency,
* uncontrolled diabetes mellitus,
* previous radiation therapy in the head and neck area

Primary outcomes:
measure: Rate of post-operative infection
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ramallah
country: Palestinian Territory, occupied
facility: Mahmoud Abu-Ta'a
Study officials:
affiliation: Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)
name: Mahmoud Abu-Ta'a
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01143311: Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of the Skin
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to analyze the differential expression of the miR transcriptome in the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each biopsy and the miRNA profiles will be characterized using a dedicated miR array.


Eligibility criteria: Inclusion Criteria:

* patient older than 40th, suffering of a C-SCC
* letter of consent signed by the patient
* to be registered to social security

Exclusion Criteria:

* Pregnant women or breastfeeding.
* Small C-SCC (size \< 6mm)
* Allergy to Xylocaine
* All vulnerable (minor, adult guardianship...)

Primary outcomes:
measure: miRNAs
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
name: Thierry Passeron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563693: Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)
Official title: Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cheyne Stokes Respiration
Keywords: heart failure
cheyne stokes respiration
adaptive servo ventilator
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2007-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life.

Detailed description: Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.

Several patients with chronic heart failure also has Cheyne Stokes respiration pattern. Earlier studies have shown that this respiration pattern improves with Adaptive servo ventilator. We wish to investigate wether this leads to improved cardiac function.

Eligibility criteria: Inclusion Criteria:

* Ejection fraction \<40%
* NYHA class III-IV
* Optimized therapy with drugs
* Cheyne stokes respiration pattern \> 25% while sleeping
* Age \< 85 years
* clinical stability the last month before inclusion.

Exclusion Criteria:

* CABG less then 6 months ago
* PCI treatment less then 3 months ago
* Unstable angina pectoris
* Acute coronary syndrome less then 3 months ago
* Stroke less then 6 weeks ago
* Thoracal myopathy
* Advanced COPD

Primary outcomes:
measure: Ejection fraction (measured with echocardiography) and inflammatory markers
timeFrame: 3 months
Secondary outcomes:
measure: 6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias
timeFrame: 3 months
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Sykehuset ostfold Fredrikstad
Study officials:
affiliation: University of Oslo
name: Arild Hetland, cardiologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01381393: BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Administered in Korean Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: osteoporosis
ibandronate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 659
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated ibandronate with postmenopausal osteoporosis in Korea

Brief summary: This is an open label, multi-centre, non-interventional post-marketing surveillance.

Detailed description: This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ibandronate administered in Korean patients according to the prescribing information.

Eligibility criteria: Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

1. Subjects diagnosed with osteoporosis in postmenopausal women.
2. Subjects who the investigator believes that they can and will comply with the requirements of the protocol
3. Subjects with no experience of treatment using ibandronate.
4. Subjects who are administered of ibandronate in normal prescription use

Exclusion Criteria:

Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate following the locally approved Prescribing Information.

The following criteria should be checked at the time of study entry.

According to contraindication on the prescribing information, ibandronate should not be administered to the following patients:

1. Patients with known hypersensitivity to ibandronate or to any of its excipients
2. Uncorrected hypocalcemia
3. Inability to stand or sit upright for at least 60 minutes

Primary outcomes:
measure: The number of adverse event after ibandronate administration
timeFrame: 6 months
Secondary outcomes:
measure: The number of unexpected adverse events after ibandronate administration
timeFrame: 6 months
measure: The number of serious adverse events after ibandronate administration
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04282993: Wearable Devices for Secondary Prevention of Ischemic Stroke
Official title: Wearable Devices for Secondary Prevention of Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Atrial Fibrillation
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. The aim of this study is to evaluate the feasibility of an approach based on the use of wearable devices for the identification and reduction of risk factors in patients with previous history of ischemic stroke or transient ischemic attack.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal 50 years
* Recent transient ischemic attack or minor stroke

Exclusion Criteria:

* Patients with significant cognitive impairment
* Patients dependent in the instrumental activities of daily life
* Patients not able to respect the frequency of monitoring program
* Patients with history of atrial fibrillation

Primary outcomes:
measure: Compliance of patients to at-home follow-up by means of wearable devices
timeFrame: 1 month
Secondary outcomes:
measure: Atrial fibrillation Detection Rate
timeFrame: 1 month
measure: Prevalence of Recurrent Stroke or Transient Ischemic Attack
timeFrame: 1 month
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
state: RM
Study officials:
affiliation: Campus Bio-Medico University
name: Vincenzo Di Lazzaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06990893: Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial
Official title: Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sufentanil
Morphine
Validity
Safety
Oliceridine
Keywords: Sufentanil
Safety
Morphine
oliceridine
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 90
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: Objective: To compare the application of oxelidine in postoperative analgesia after orthopedic lumbar spine surgery with morphine or sufentanil, and to explore the efficacy and safety of postoperative analgesia.

Method: Researchers included 90 patients with American Society of Anesthesiologists (ASA) physical conditions I and III, aged 18 to 65 years, who were scheduled to undergo orthopedic lumbar general anesthesia surgery at an appropriate time. The patients were randomly divided into 3 groups, with 30 cases in each group: The oxeridine group (Group A), where a loading dose of 1.5mg of oxeridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01mg/kg-1.h-1 was connected. Oxeridine was mixed with normal saline to 100ml at a rate of 2ml/h. Morphine group (Group M), a loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03mg.kg-1.h-1 morphine was connected with normal saline to 100ml at a rate of 2ml/h. Sufentanil group (Group S), a 4u loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was combined with normal saline to 100ml at a rate of 2ml/h.The resting and exercise VAS pain scores of the three groups of patients at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation and adverse reactions within 48 hours were recorded.


Eligibility criteria: Inclusion Criteria:

* Lumbar spine surgery with ASA grades I-III
* Aged 18-65 years
* Ethically, the patient voluntarily accepted this trial and signed the informed consent form

Exclusion Criteria:

* Severe respiratory and circulatory system diseases
* Nervous system disease
* Mental and psychological disorders
* Abnormal liver and kidney functions
* Participated in another drug clinical research within the past 30 days

Primary outcomes:
measure: The VAS pain scores at rest and during exercise of the three groups of patients after the operation
timeFrame: at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Hospital Anesthesiology
state: Anhui
Study officials:
References:
Clinical trial NCT04561193: Investigation of Subsequent and Co-infections Associated With SARS-CoV-2 (COVID-19)
Official title: Investigation of Subsequent and Co-infections Associated With SARS-CoV-2 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with positive COVID-19 PCR test admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020.

Brief summary: Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals

Detailed description: Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals (Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas) between February 1 and April 30, 2020. All study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020
* \>18 years old
* Positive SARS-CoV-2 (COVID-19) PCR test

Exclusion Criteria:

* Outpatient or emergency department visit
* Not admitted to an inpatient or observation status for \>24 hours

Primary outcomes:
measure: Prevalence of subsequent and co-infections
timeFrame: Feb 2020 - April 2020
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Feb 2020 - April 2020
measure: Hospital length of stay (LOS)
timeFrame: Feb 2020 - April 2020
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Matthew Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References: