louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01107184: Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)
Official title: A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Remote ischemic conditioning
CABG surgery
Atrial fibrillation
Coronary Artery Bypass
Ischemic Preconditioning
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 191
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: Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Elective on-pump CABG surgery
* Informed consent

Exclusion Criteria:

* Prior cardiac surgery (Re-operations)
* Prior atrial fibrillation
* Use of class 1 or 3 anti arrhythmic medication or digoxin Use of intermittent aortic cross clamping during surgery
* Age \<18 years
* Left ventricular ejection fraction ≤30%
* Serious pulmonary disease (resting pO2 \<90% at room air)
* Renal failure (clearance \<30 ml/min as calculated using the Modification of Diet in Renal Disease formula)
* Liver failure
* Use of the sulfonylurea derivative glibenclamide (this drug is known to block any preconditioning stimulus

Primary outcomes:
measure: Post-operative atrial fibrillation
timeFrame: 72 hours
Secondary outcomes:
measure: Major cardiovascular and cerebrovascular events
timeFrame: 3 months, 6 months, 1 year
measure: Length of stay
timeFrame: 1 week on avarage
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Stef de Hert, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brevoord D, Hollmann MW, De Hert SG, van Dongen EH, Heijnen BG, de Bruin A, Tolenaar N, Schlack WS, Weber NC, Dijkgraaf MG, de Groot JR, de Mol BA, Driessen AH, Momeni M, Wouters P, Bouchez S, Hofland J, Luthen C, Meijer-Treschan TA, Pannen BH, Preckel B. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial). BMC Anesthesiol. 2011 May 23;11:11. doi: 10.1186/1471-2253-11-11.
Clinical trial NCT01330784: Assessment of the Therapeutic Utility of hMG-HP
Official title: Assessment of the Therapeutic Utility of hMG-HP Within a Protocol of Controlled Ovarian Hyperstimulation in IVF in Normoresponders Women Undergoing Downregulation With GnRH Antagonist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sterility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring SAU
First posted: 2011-04-07
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females affected by sterility able to undergo IVF

Brief summary: To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins


Eligibility criteria: Inclusion Criteria:

* Women aged 18-38 years
* Body mass index (BMI) between 18 and 30
* Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
* Testosterona, FSH (follicle-stimulating hormone) LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
* No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion Criteria:

* Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
* Data suggestive of possible ovarian failure
* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
* Important systemic disease
* Pregnancy or contraindication to pregnancy

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 30 days
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: 16 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT00826384: Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion
Official title: Phase 1,Single-blind, Randomized, Controlled Study to Evaluate the Safety and Effectivity of TACE Therapy of HCC(Hepatocellular Carcinoma) With Blocking Tumor Blood Temporarily and Enhancing Perfu
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
transcatheter arterial chemoembolization
overall survival
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 352
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: According to radiology imaging, the patients of HCC are divided into two groups(hypovascular tumor group and moderately vascular tumor group). Every group is divided into TACE therapy with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All objects are observed until the end event happening or in the group for 6 months.


Eligibility criteria: Inclusion Criteria:

* sign the written informed consent form provided.
* diagnosed clinically as HCC,need to take TACE.

Exclusion Criteria:

* have had an allergic reaction following iodine.
* have been in any TACE or radiotherapy or biotherapy within 30 days before the study.
* HCC of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus.

Primary outcomes:
measure: Overall survival
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
affiliation: Eastern hepatobilliary surgery hospital
name: Feng Shen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01217684: Test-retest Reliability of a Standard Protocol on the Biodex Dynamometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Test-retest Reliability
Validity
Biodex Medical Systems III Dynamometer
Experimental Measure of Knee Extension Strength
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: older adults

Brief summary: The purpose of the present study is to evaluate test-retest reliability of a standard protocol on the Biodex dynamometer in older adults.

In addition, the test-retest reliability and validity of an experimental measure of knee extension strength will be assessed in older adults.


Eligibility criteria: Inclusion Criteria:

* +65 years old
* able to perform a maximal strength test on a dynamometer

Exclusion Criteria:

* pathologies that prohibit a maximal strength test on a dynamometer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Faculty of Kinesiology and Rehabilitation Sciences
Study officials:
References:
Clinical trial NCT04682184: A Study of Continuous Heart Rate Monitoring in Healthy Participants
Official title: A Study to Investigate Continuous Heart Rate Monitoring Using a Chest-worn Biosensor on the Background of Drug-induced Positive and Negative Heart Rate Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study in healthy participants is to find out whether a heart rate monitor will accurately pick up changes in heart rate caused by 2 different medications (pseudoephedrine and metoprolol), on the background of daily activities. Participants will wear a patch heart rate and activity monitor on the chest for the entire study. The study will last about 36 days and may include up to seven visits to the study center.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females
* Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have history of sensitive skin or chronic skin conditions, like eczema
* Regularly use known drugs of abuse
* Are women who are pregnant or lactating
* Have known allergies to medications used in the study

Primary outcomes:
measure: The mean change in heart rate (HR)
timeFrame: Day 1: Hour 1, Hour 4 post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05182684: The Collection and Transmission of Electrocardiogram Using a Wearable Device
Official title: A Multi-center Clinical Trial to Explore the Status of Collection and Transmission of Electrocardiogram Using a Wearable Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device

Detailed description: The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male volunteers who can use an Android smartphone.
* The subjects who voluntarily agree to participate and give written informed consent.

Exclusion Criteria:

* The subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions.
* The subjects who are judged to be inappropriate for the clinical trials to participate.

Primary outcomes:
measure: The proportion of data collected
timeFrame: 6 hours
Secondary outcomes:
measure: The comparison of ventricular rate
timeFrame: 6 hours
measure: The comparison of abnormal events
timeFrame: 6 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Huh KY, Jeong SI, Yoo H, Piao M, Ryu H, Kim H, Yoon YR, Seong SJ, Lee S, Kim KH. Lessons from a multicenter clinical trial with an approved wearable electrocardiogram: issues and practical considerations. Transl Clin Pharmacol. 2022 Jun;30(2):87-98. doi: 10.12793/tcp.2022.30.e7. Epub 2022 May 24.
Clinical trial NCT06545084: Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)
Official title: Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Apical Periodontitis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 50
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: Dental Clinic population.

Brief summary: The purpose of the study is to evaluate peri-radicular healing after root-end surgery using Leukocyte and Platelet Rich Fibrin. The study population includes patients diagnosed with persistent periapical pathology and scheduled for Endodontic Microsurgery at the University of Pennsylvania School of Dental Medicine, Department of Endodontics. Patients undergoing routine endodontic microsurgery and who meet the inclusion criteria will be given the opportunity to opt in to receive L-PRF in the osteotomy site to promote bone formation. Healing will be assessed radiographically and clinically at six, twelve, eighteen, and twenty-four months.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study, including the follow-up visits.
3. Male or Female age \>18 years old.
4. In good general health (ASA 2 or less) with no contraindications for Endodontic Microsurgery.
5. Persistent endodontic periapical pathology Class A, B, or C according to the Kim and Kratchman classification (5)
6. Intact coronal restorations with no evidence of leakage or caries under the restoration.

Exclusion Criteria:

1. Minors.
2. Suspected root fractures.
3. ASA classification 3 or greater.
4. Periapical pathology Class D, E, or F according to the Kim and Kratchman classification (5).
5. Patients with history of Oral or IV Bisphosphonate use.
6. Patients may be excluded if their treatment team do not believe Endodontic microsurgery and L-PRF graft is in the patient's best interests.

Primary outcomes:
measure: Peri-radicular Healing
timeFrame: 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Dental Medicine
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00737984: Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination
Official title: Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Clinical Pregnancy Rate
Keywords: Infertility
Clinical pregnancy rate
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 9
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles

Detailed description: Endometrial sampling is performed using the standard technique in the outpatient department. Similarly, superovulation with gonadotrophins will be performed according to our standard practice.Endometrial sampling will be done in the follicular phase not later than day 10 of the cycle. Endometrial sampling will be performed using Pipelle sampling catheter. The Pipelle is inserted gently through the cervical canal into the uterine cavity and advanced slowly till just resistance felt by the operator. Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.

Eligibility criteria: Inclusion Criteria:

1. All women undergoing superovulation with gonadotrophins and intrauterine insemination.
2. All women with cervical factor, mild male factor and/or unexplained infertility.
3. At least one patent Fallopian tube.

Exclusion Criteria:

1. Bilateral tubal disease
2. Severe male factor infertility
3. Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions)
4. Women with positive cervical culture and/or acute vaginal infection

Primary outcomes:
measure: The rate of clinical pregnancy
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Togas Tulandi, MD, MHCM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
citation: Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
Clinical trial NCT01243684: A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis
Official title: Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spondylosis
Keywords: Spinal cord
cervical spondylosis
myelopathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis.

Detailed description: Diffusion tensor imaging (DTI) of the cervical spinal cord will be performed in patients with cervical spondylosis with varying degrees of symptoms and in healthy control subjects. Fibre tracking of main spinal tracts will be performed. Regions of interest will also be identified. Diffusion parameters will be extracted. This will allow quantification of degree of damage in of the spinal cord. The findings will be related to motor function measures and comprehensive clinical tests of sensory and motor function.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* Sufficiently cooperative
* Cognitively understands study and implications
* Signed informed consent
* Symptomatic cervical spondylosis

Exclusion Criteria:

* MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
* Previous pathology that would impact behavioural measures
* Anxiety and poor cooperation
* Previous neurological condition
* Pregnancy

Primary outcomes:
measure: DTI parameters in cervical spinal cord
timeFrame: 3 weeks
Secondary outcomes:
measure: Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital, Radiology B
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Antoine FEYDY, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01663584: Multi-disease Carrier Screening Test Validation
Official title: Collection of Blood Samples for Development of Multi-disease Carrier Testing
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spinal Muscular Atrophy (SMA)
Carrier Screening
Genetic Testing
Keywords: Spinal Muscular Atrophy (SMA)
Carrier Screening
Genetic Testing
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participation will be open to individuals who have tested positive for carrier status of a specific genetic disease or mutation and are able to provide documentation of their test results.

Brief summary: The purpose of this study is to collect blood samples to enable validation of genetic testing for diseases within a multi-disease carrier screening panel. Samples will be collected from adult women or men who have previously tested positive as carriers for various recessive conditions. These are healthy adults who carry a mutation that might place them at increased risk of having a child with a specific genetic disorder. Study participation will be open to adults that were previously tested as part of their routine medical care and where test results demonstrated positive carrier status for a specific genetic disease. Samples will be tested for the disease mutation for which the subjects provides documentation of prior testing.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Individuals who are carriers of an SMN1 deletion consistent with Spinal Muscular Atrophy carrier status and are able to provide documentation of carrier status determined from prior testing
* Able to provide a blood sample
* Pregnant women may be include in the study

Exclusion Criteria:

* Minors under the age of 18 years
* Individuals who are not carriers of a Spinal Muscular Atrophy mutation
* Individuals who are unable to provide documentation of Spinal Muscular Atrophy carrier status.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: Natera, Inc
state: California
Study officials:
References: