louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01265680: Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery
Official title: Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Transfusion
Keywords: Blood Transfusion
Heart surgery
Erythropoietin
HRE
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients operated on at the European Hospital Heart surgery Division will be randomized to either single dose 80.000 UI of Human Recombinant Erythropoietin and intravenous iron or control.

Primary end point is the amount of transfused blood. Secondary end point is the Hemoglobin level in the patient on postoperative day four.

Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well

Detailed description: Growing evidence points out blood transfusion as a major determinant in medium and long term prognosis as regarding heart surgery population. Moreover blood has become a scarce resource, thus often delaying intervention due to lack of availability.

Previous studies at our Hospital have shown that high dose Human Recombinant Erythropoietin (HRE)effectively spares transfusions even when administered two days before surgery. The previous protocol was fragmented into 5 administration which proved to be unpractical even if effective.

After multidisciplinal discussion with nephrologists and transfusionists a new protocol was established: 80.000 UI in a single dose at time of arrival at the hospital. There are no exclusion criteria planned.

Our primary end point is the amount of transfused blood. Our secondary end point is the Hemoglobin level in the patient on postoperative day four.

Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well.

Eligibility criteria: Inclusion Criteria:

* All comers

Exclusion Criteria:

* None

Primary outcomes:
measure: Use of allogenic blood transfusions
timeFrame: In hospital stay (usually 5 to 8 days after operation)
Secondary outcomes:
measure: Hemoglobin level on postoperative day four.
timeFrame: Day 4 after operation
Other outcomes:
Locations:
city: Rome
country: Italy
facility: European Hospital
Study officials:
References:
Clinical trial NCT01309880: Evaluation of a New Silicone Hydrogel Contact Lens
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria:

* Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study care products.

Primary outcomes:
measure: Visual Acuity
timeFrame: Dispensing & 1-week follow up
Secondary outcomes:
measure: Slit Lamp Findings
timeFrame: 1 week
measure: Comfort
timeFrame: 1 Weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly Barna
role: STUDY_DIRECTOR
References:
Clinical trial NCT05156580: Tongzhou Cohort Study
Official title: Cardiovascular Risk in Elderly Obese Patients With Hypertension During Rapid Urbanization of Tongzhou District: A Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Hypertension
Keywords: Obesity
Hypertension
Cardiovascular risk
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongzhou Yongshun Community Health Service
First posted: 2021-12-14
Enrollment: 10750
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with hypertension in Tongzhou, China

Brief summary: The present study aimed to investigate the impact of obesity on long-term cardiovascular risk in elderly patients with hypertension.

Detailed description: Overweight status and obesity are important risk factors leading to hypertension, poor blood pressure control, and poor prognosis. However, the studies focused on elderly patients with hypertension are limited. Therefore, the aim of the present study was to evaluate the long-term impact of obesity on cardiovascular risk in elderly patients with hypertension.

Eligibility criteria: Inclusion Criteria:

* Ages of ≥ 60 years
* History of hypertension and treatment with anti-hypertension drugs for more than 4 weeks
* Availability for follow-up until 2026
* No major barriers to provide written consent

Exclusion Criteria:

* NA

Primary outcomes:
measure: Percentage of participants with major adverse cardiovascular events (MACEs)
timeFrame: 2021-2026
Secondary outcomes:
measure: Percentage of participants with all-cause death
timeFrame: 2021-2026
measure: Percentage of participants with MI
timeFrame: 2021-2026
measure: Percentage of participants with stroke
timeFrame: 2021-2026
measure: Percentage of participants undergoing coronary revascularization
timeFrame: 2021-2026
measure: Change in BP control rate
timeFrame: 2021-2026
measure: Change in SBP
timeFrame: 2021-2026
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: 2021-2026
measure: Change in low-density lipoprotein-cholesterol (LDL-c)
timeFrame: 2021-2026
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Rongchong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03768180: Infective Endocarditis After TAVR
Official title: INfecTive ENdocarditis After Transcatheter Aortic Valve Replacement (TAVR) a National SwEdish Study (INTENSE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Endocarditis of Aortic Valve
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 4600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that has under TAVR/TAVI in Sweden between 2008 and 2018

Brief summary: This study aims at studying the frequency of infective endocarditis after transcatheter aortic valve replacement/implantation

Detailed description: Since the start of transcatheter aortic valve implnatations/replacements (TAVR/TAVI) implantations in Sweden in 2008 all procedures have been added to a national database, which now contains 4500+ procedures. At the same time, all admissions to the hospital is also recorded with diagnosis in a separate database. We intend to make a nation-wide complete follow up of all TAVR/TAVI patients in swede that has received the diagnosis of infective endocarditis after the implantation. In addition data will also be collected from the national endocarditis database for detailed information of the cases.

Eligibility criteria: Inclusion Criteria:

All patients that has under TAVR/TAVI in Sweden between 2008 and 2018

Exclusion Criteria:

Patients unable to follow up due to emigration or missing social security number

Primary outcomes:
measure: Infective Endocarditis
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
Study officials:
References:
citation: Bjursten H, Rasmussen M, Nozohoor S, Gotberg M, Olaison L, Ruck A, Ragnarsson S. Infective endocarditis after transcatheter aortic valve implantation: a nationwide study. Eur Heart J. 2019 Oct 14;40(39):3263-3269. doi: 10.1093/eurheartj/ehz588.
Clinical trial NCT03900780: Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure
Official title: Preimplantion Genetic Testing for Aneuploidies (PGT-A) in Patients With Recurrent Implantation Failure: a Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Implantation Failure
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot RCT
Primary purpose: TREATMENT

Brief summary: Assessing whether Preimplantation Genetic Testing for Aneuploidy (PGT-A) can increase the ongoing pregnancy rate per transferred embryo and can decrease the time to pregnancy and miscarriage rate in patients with Recurrent Implantation Failure (RIF)


Eligibility criteria: Inclusion Criteria:

* Women with recurrent implantation failure (previous transfer of least 4 good quality embryos in at least 3 fresh or frozen cycles)
* BMI \< 35
* Normal hysteroscopy

Exclusion Criteria:

* thin endometrium in previous cycles (\<6mm), endometriosis ASRM score III-IV, premature ovarian failure (POF, Bologna criteria), abnormal karyotype, donor oocytes or embryos, PGT-M

Primary outcomes:
measure: OPR
timeFrame: at 20 weeks gestational age
Secondary outcomes:
measure: IR
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT06791980: Integrated Care Approach for Rheumatoid Arthritis Patients
Official title: Association Between Pro-inflammatory Cytokines and Depressive Symptoms in Patients with Rheumatoid Arthritis: Evaluating the Impact of an Integrated Care Approach
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this study is to learn about the long-term effects of integrated care approach in persons over the age of 20 who take part in integrated care approach to treat their rheumatoid arthritis (RA). The main question is to explore whether adding the integrated care approach into routine care can lower pro-inflammatory cytokines and depressive symptom in RA persons over age 20 when taken long-term to treat RA?


Eligibility criteria: Inclusion Criteria:

age of at least 20 years; willingness to participate in the survey; having the physician-diagnosed RA with the International Classification of Diseases, 9th Revision, Clinical Modification code of 714.0

Exclusion Criteria:

* having physician-based diagnosis of cognitive impairment and with the ability to express opinion

Primary outcomes:
measure: cytokines
timeFrame: From enrollment to the end of treatment at 12 weeks&#34;
Secondary outcomes:
measure: depressive symptom
timeFrame: From enrollment to the end of treatment at 12 weeks&#34;
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Dalin Tzuchi Hospital
Study officials:
References:
Clinical trial NCT02626780: Adipose-derived SVF for Treatment of Alopecia
Official title: Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: GID BIO, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF for the treatment of alopecia.


Eligibility criteria: Inclusion Criteria:

1. Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
2. Subjects will be in good health (ASA Class I-II) with a BMI \< 35. Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia without scarring or traumatic injury
3. Able and willing to make the required study visits.
4. Able and willing to give consent and follow study instructions.
5. Must speak, read and understand English

Exclusion Criteria:

1. History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
2. Allergic to lidocaine, epinephrine, valium or sodium phosphate
3. Individuals with a propensity for keloids
4. Individuals with diminished decision-making capacity will not be included in this research study
5. Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven, Marfarin). In addition, if any of the following medicines are used two (2) weeks prior to surgery the patient will be ineligible.
6. Use of concomitant treatments, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, interfollicular PRP injection and hair transplantation within the preceding 6 months.
7. All smokers and other tobacco users.

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (Safety)
timeFrame: 6 months
Secondary outcomes:
measure: Growth of New Hair
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Maxwell Aesthetics
state: Tennessee
city: San Antonio
country: United States
facility: Renew Associates
state: Texas
Study officials:
References:
Clinical trial NCT05681091: Effect of Perioperative Hypothermia on Postoperative Pain
Official title: The Effect of Perioperative Hypothermia on Postoperative Pain and Pain Sensitization With Laparoscopic Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients' age is during 18-70 years old

Brief summary: This study aims to observe the impact of perioperative body temperature on postoperative pain and pain sensitization for the patients with laparoscopic surgery. Based on this study the investigators aimed to explore the effect of perioperative hypothermia on postoperative pain.

Detailed description: This study aims to included surgery patients to observe the impact of perioperative body temperature on postoperative pain and pain sensitization for the patients with laparoscopic surgery. Body temperature and postoperative pain will be continuously assessed, and then association analysis will be performed.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years old
* American society of anesthesiologists I-III
* Patients who plan to laparoscopic surgery under general anesthesia
* Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

* the patient with chronic pain
* Patients with fever
* The patient is infected
* Severe vision, hearing, language impairment or other reasons unable to communicate with visitors
* Patients with known mental illness or lack of communication or cognitive impairment before operation;
* Long-term use of sedatives, antidepressants or alcoholism
* Artificial cooling and low temperature protection were taken during the operation

Primary outcomes:
measure: Patients' pain score after surgery
timeFrame: From ending of the surgery to 24 hours after anesthetic resuscitation
Secondary outcomes:
measure: Patients' pain score during postanesthesia care unit
timeFrame: From ending of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes after surgery
measure: Pressure pain threshold
timeFrame: From beginning of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing
name: Huang He, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03893591: A Prospective Study to Examine the Need to Adjust the Dose of Apixaban When Used in Atrial Fibrillation and Obesity
Official title: A Prospective Cohort Study to Examine the Need to Adjust the Dose of Anticoagulant Apixaban When Used in Patients With Atrial Fibrillation and Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulant
Apixaban
Obesity
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults

Brief summary: A prospective cohort study to determine whether a high body weight (BMI equal to or greater than 35 kg / m 2) has an effect on anticoagulant Apixaban level in the blood of patients with atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

- hospitalized Patients on Steady State level of Apixaban, based on the data given in the hospital ward . A level of Steady State is received within two days of treatment.

Exclusion Criteria:

* Anasarca
* acute renal failure

Primary outcomes:
measure: Anti Xa level of patients with atrial fibrillation and obesity while treatment of Apixaban.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
References:
Clinical trial NCT04423991: Identification of a Responsive Subpopulation to Hydroxychloroquine in COVID-19 Patients Using Machine Learning
Official title: Identification of a Responsive Subpopulation to Hydroxychloroquine in COVID-19 Patients Using Machine Learning: the IDENTIFY Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Coronavirus
Mortality
Lead sponsor: Dascena
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 290
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to assess the performance of a machine learning algorithm which identifies patients for whom hydroxychloroquine treatment is associated with predicted survival.

Detailed description: In a multi-center pragmatic clinical trial, COVID-19 positive patients admitted to 6 United States medical centers were enrolled between March 10 and June 4, 2020. A machine learning algorithm was used to determine which patients were suitable for treatment with hydroxychloroquine.

Eligibility criteria: Inclusion Criteria:

* Patient admitted to covered ward and tested positive for COVID-19
* Patient had COViage applied to electronic health record data within four hours of COVID-19 test

Exclusion Criteria:

* Patient not admitted to covered ward or tested negative for COVID-19
* Patient had COViage applied to electronic health record data greater than four hours after COVID-19 test

Primary outcomes:
measure: Mortality outcome
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Dascena
state: California
Study officials:
References:
Clinical trial NCT01583491: Evaluation of Platelet Rich Fibrin on Reduction of Periodontal Problems After Surgical Removal of Mandibular Third Molar
Official title: Evaluation of Platelet Rich Fibrin Efficacy on Reduction of Periodontal Problems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mastication Disorder
Keywords: platelet rich fibrin
mandibular third molar
periodontal problem
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the influence of platelet rich fibrin to reduction of periodontal problems after surgical removal of third molar.

Detailed description: After extraction or surgical removal of third molar, a deep bony pocket created behind the second molar specially in the mandible. For reduction of this problem, investigators, needed to acceleration tissue healing. For this purpose, investigators used platelet rich fibrin (autologous) and followed patient for 3 months.

Eligibility criteria: Inclusion Criteria:

* have 2 impacted third molars

Exclusion Criteria:

* periodontal disease
* history of periodontal surgery

Primary outcomes:
measure: Measurement of periodontal pocket depth at mid buccal, disto buccal and distolingual of mandibular second molar
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: