louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03045562: Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI
Official title: Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: STEMI - ST Elevation Myocardial Infarction
Lead sponsor: Green Valley Group of China
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 536
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: To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI

Detailed description: This is a prospective, randomized, double-blind and controlled study.536 subjects of STEMI who underwent primary PCI within the first 12 hours will be enrolled.all patients were assigned to receive 300mg of asprin and ≥300mg of clopidogrel as loading dose,and following 100mg and 75mg once daily respectively.Patients were assigned to receive Salvianolate injection or 0.9% sodium chloride injection in catherter room setting,and following similar medicine once daily respectively for 7 days.Myocardial circulation perfusion will be checked with mmediate coronary angiography parameters,ECG,echocardiographic，CK-MB.The major adverse cardiovascular events will be observed.

Eligibility criteria: Inclusion Criteria:

1. Informed consent must be obtained prior to any study procedure.
2. Age\>18 years.
3. Subjects of STEMI who underwent primary PCI within the first 12 hours.

Exclusion Criteria:

1. Allergic to Salvianolate injection
2. Mechanical complications
3. History of severe renal or hepatic insufficiency
4. Pregnant or breastfeeding women
5. Pool compliance,greater risks result from the study

Primary outcomes:
measure: TIMI flow grade
timeFrame: an average of 2 hours
measure: TIMI myocardial perfusion grade
timeFrame: an average of 2 hours
Secondary outcomes:
measure: ST-segment resolution
timeFrame: up to 90 minutes
measure: myocardial contrast echocardiograph
timeFrame: up to 7 days
measure: creatine kinase isoenzyme
timeFrame: up to 48 hours
measure: major adverse cardiovascular events
timeFrame: an average of 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Junbo Ge, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04357262: Resiliency in Total Joint Arthroplasty
Official title: Resiliency in Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Hip Arthroplasty
Total Knee Arthroplasty
Patient Reported Outcomes
Resilience
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators primary objective is to determine how does participation in StreaMD affect patient reported outcomes after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)?

Detailed description: Osteoarthritis is a leading cause of disability in the US. By conservative estimates, about 54 million adults in the US have doctor-diagnosed arthritis. The number of people expected to have arthritis by the year 2040 is more than 78 million. Total joint arthroplasty is considered the treatment of choice for end-stage osteoarthritis. Currently, more than 1 million hip and knee replacements are performed each year in the US. By 2030, primary THR is projected to grow 171% and primary TKR is projected to grow by up to 189%, for a projected 635,000 and 1.28 million procedures, respectively. The incidence of pre-operative psychological distress in this group of patients is reported between 30% and 60% and preoperative psychological distress is associated with poorer pain and functional outcomes after surgery. Resilience, characterized by an ability to bounce back or recover from stress, is increasingly recognized as a psychometric property affecting many outcomes' domains including outcomes after TJA. Better resilience could improve patients overall satisfaction with the procedure.

Eligibility criteria: Inclusion Criteria:

* All patients aged 18 and older who are receiving a total hip or knee replacement.

Exclusion Criteria:

* Patients enrolled in the MyMobility study
* Patients who do not have cell phones with text messaging capability
* Non-English speaking patients

Primary outcomes:
measure: Patient Reported Outcome Score (PROMIS) following THA or TKA
timeFrame: Follow Up Visits up to 2-Years
measure: Patient Reported Outcome Score (HOOS Jr.) following THA or TKA
timeFrame: Follow Up Visits up to 2-Years
measure: Patient Reported Outcome Score (KOOS Jr.) following THA or TKA
timeFrame: Follow Up Visits up to 2-Years
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah
name: Jeremy Gililland, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786562: The Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.
Official title: The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Obesity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal administration of morphine in abdominoplastic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominoplasty under spinal anesthesia
* American Society of Anesthesiologists (ASA) class I and II.

Exclusion Criteria:

* allergy to local anesthetics
* bleeding diatheses
* local infection or sepsis

Primary outcomes:
measure: postoperative nausea and vomiting
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative pain and puririts.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT04544462: ANXA5 M2 Haplotyping in IVF Patients and Embryos
Official title: ANXA5 M2 Haplotyping in IVF Patients and Embryos
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Miscarriage, Recurrent
Pregnancy Complications
Lead sponsor: Genomic Prediction Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 500
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: All couples above the age of 18 seeking infertility treatment at IVF centers

Brief summary: This study aims to characterize the association between history of pregnancy complications and M2 carrier status in IVF patients and the utility of M2 haplotype preimplantation genetic testing (PGT) in embryos produced by carrier couples. Participants in this study will be screened for the M2 variant. History of pregnancy complications and miscarriages will be studied in order to determine potential associations with M2 carrier-ship.

Detailed description: Patients consenting to participation in the study will receive a saliva collection kit for M2 testing. Genomic Prediction Clinical Laboratory will perform testing and issue a report per routine clinical procedures. Upon completion of issuing a report, the patients' medical records will be obtained from the IVF Center providing care to the patient. Information obtained may include: history of miscarriage, embryo transfer outcomes, preeclampsia, small for gestation age baby, or thrombophilia disorders.

In addition to obtaining records related to history of pregnancy complications, carrier couples will be offered the use of preimplantation genetic testing for M2 carrier status (PGT-M2) in their embryos. Patients electing to perform PGT-M2 will receive PGT-A according to standard clinical practice, along with M2 carrier status.

A total of 500 patients will complete the study and may be recruited from any IVF clinic in the United States. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by each clinic.

Eligibility criteria: Inclusion Criteria:

* All couples above the age of 18

Exclusion Criteria:

* Any case where biological parental DNA is unavailable.

Primary outcomes:
measure: M2 Haplotype frequency
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: North Brunswick
country: United States
facility: Genomic Prediction Clinical Laboratory
state: New Jersey
Study officials:
References:
Clinical trial NCT04865562: Hormones and Decision Making
Official title: Hormones and Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyssocial Behavior
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: An investigation of the neuropsychological processes underlying ethical decision making.

Detailed description: This study will investigate the influence of reward sensitivity on cheating behavior via experimental manipulation of reward sensitivity using testosterone.

Eligibility criteria: Inclusion Criteria:

* males between 18 and 25

Exclusion Criteria:

* recruitment will be limited to male participants between 18 and 25 years who have no current conditions that would preclude the use of testosterone. Specific exclusion criteria are:
* women of all ages
* males younger than 18 years and older than 25 years
* self-report discomfort with ingestion of testosterone for the purpose of this study
* body mass index lower than 18 or higher than 27
* prior diagnosis of major depression, posttraumatic stress disorder, phobia, anxiety disorder, or other psychiatric conditions
* first-degree relatives diagnosed with a psychiatric disorder
* presence of a medical condition that would preclude the use of testosterone
* use of medications that would preclude the use of testosterone
* consumption of more than 5 cigarettes a day
* current use of testosterone enhancing products, such as gels, creams, and injections

Primary outcomes:
measure: Measure of ethical behavior - Cheating rate defined as the Average number of 'heads' coin flips participants claim to have obtained
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Robert Josephs
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Robert A Josephs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00839462: Efficacy of Dexpanthenol in Thermic Erythema
Official title: Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erythema
Keywords: Thermal Erythema
Dexpanthenol
Erythema
Efficacy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Phototype: I to IV according to Fitzpatrick scale

Exclusion Criteria:

* Pregnant or nursing women
* Subjects registered as being in exclusion period in the French Health Minister file of subjects
* Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

Primary outcomes:
measure: Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
timeFrame: 2 min, 5 min, 10 min, 15 min
Secondary outcomes:
measure: Skin temperature
timeFrame: 2 min, 5 min, 10 min
measure: Evaluation of the cooling/soothing effect (scores) after first and second application
timeFrame: 2 min, 5min, 10 min, 15 min
measure: Evaluation of the foam covering properties after first application
timeFrame: 2 min, 5 min, 10 min, 15 min
measure: Incidence of adverse events
timeFrame: FPFV - LPLV
Other outcomes:
Locations:
city: Villeurbanne
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04966962: Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
Official title: Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: bladder cancer
metabolomics
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
name: The Seventh Affiliated Hospital of Sun Yat-sen University
First posted: 2021-07-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with bladder cancer or benign. disease of urinary system will be enrolled.

Brief summary: Metabolomics is a complementary approach for identifying perturbed metabolic pathways. The goal of this study is to establish and validate an early diagnostic model for bladder cancer by metabolomics.

Detailed description: Early diagnosis and life-long surveillance are clinically important to improve the long-term survival of bladder cancer patients. Currently, a noninvasive biomarker that is as sensitive and specific as cystoscopy in detecting bladder cancer is lacking. Metabolomics are small organic molecules (below 2000 mass units) that are products of complex pathways. This is a prospective study aims to create an early diagnostic model based on serum and urine metabolomics. Commonly employed metabolomics analytical platforms include nuclear magnetic resonance spectroscopy (NMR), gas chromatography mass spectrometry (GC-MS), and liquid chromatography mass spectrometry （LC-MS）. The diagnostic model will be made to distinguish bladder cancer and benign disease of the urinary system.

Eligibility criteria: Inclusion Criteria:

Bladder cancer group:

1. Any male or female patient aged 18 or older
2. Able to provide serum and urine specimen before treatment
3. Diagnosis with incident or recurrent bladder cancer

Control group

1. Any male or female patient aged 18 or older
2. Able to provide serum and urine specimen before treatment
3. Diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.

Exclusion Criteria:

1. Kidney and liver dysfunction.
2. Incomplete clinical information and laboratory test result
3. Tumor-related treatment was received preoperatively
4. Preoperative routine examination and medical history indicate a history of diabetes, hyperlipidemia and other metabolic diseases or other malignant tumors

Primary outcomes:
measure: Sensitivity
timeFrame: 1 year
measure: Specificity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04921462: Silastic Sheet Usefulness Following Septoplasty
Official title: Silastic Sheet Usefulness Following Septoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septoplasty
Keywords: Intranasal splint
Silastic sheet
quilting suture
NOSE score
Lead sponsor: King Abdulaziz Medical City
Sponsor class: OTHER_GOV
First posted: 2021-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique.

Methods:

A single center randomized controlled trial, including adult above the age of 18. A total of 50 participants who underwent septoplasty were enrolled and randomly assigned into two groups, Silastic group (n=25), and quilting group (n=25). Nasal obstruction severity was assessed by using an Arabic validated version of NOSE score, preoperatively then 3 days, one week and one month postoperatively. Post-operative complications were assessed at outpatient clinic 1 week and 1 month postoperatively. Pain was assessed by a 10-point numerical scales via phone call on the 3rd day postoperative.


Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.

Exclusion Criteria:

* 1. Concomitant procedure other than septoplasty. 2. Previous history of septal or nasal surgery. 3. Presence of nasal polyps, chronic sinusitis or other regional pathology. 4. Bleeding disorders or anticoagulation therapy.

Primary outcomes:
measure: Change in NOSE score 1 month postoperatively
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Validated NOSE score
timeFrame: NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively
measure: complications
timeFrame: 1 month
measure: postoperative pain
timeFrame: at 3 days postoperative
measure: general satisfaction questionnaire
timeFrame: at 1 month postoperative
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
Study officials:
References:
Clinical trial NCT00410891: Topical Antibiotics and Intravitreous Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intravitreous
Injections
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-12-13
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluation of efficacy of topical preoperative antibiotics in patients undergoing intravitreous injections.


Eligibility criteria: Inclusion Criteria:

* intravitreous injection

Exclusion Criteria:

* antibiotic use

Primary outcomes:
measure: Positive Culture
timeFrame: Study day 1, assessed following administration of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Christopher Ta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04295291: Quality of Cardiopulmonary Resuscitation Pre- and Intra Hospital
Official title: Quality of Cardiopulmonary Resuscitation Pre- and Intra Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Death
Cardiac Arrest
Cardiac Arrhythmia
Cardiac Disease
Keywords: Cardiopulmonary resuscitation
Defibrillation
Ventilation
Quality
Mortality
Morbidity
Lead sponsor: Ostfold University College
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with cardiac arrest, treated with cardio-pumonary resusciation and the use of a defirbillator with USB memory stick installed (all 71 in the current hospital)

Brief summary: The survival after intrahospital cardiac arrest has been reported to 15%. In Norway this varies between 16 and 23%.). Many factors are associated with survival after cardiac arrest, both intra- and prehospital. Recent studies have not included information about individual patient factors and the outcome after cardiopulmonary resuscitation (CPR). In the current hospital, we are able to record patient specific information related to a cardiac arrest/CPR situation, and thereby be able to assess patient-related factors associated with both detection, treatment and outcome of CPR.

Detailed description: Several factors have been associated with survival, e.g. to monitor hands-off time(Odds ratio, OR, for 2.48, 95% KI 1.11-5.56, p=.03), monthly assessment of all cardiac arrest cases (OR 6.9, 95% KI 1.41-33.92), and includin av local coordinator for CPR (OR 2.93, 95% KI 1.08-7.94, p=.03), as well as depth of compressions. Nevertheless, information about cardiac arrests and CPR have not been assessed in relation to patient specific information. In the current hospital, we are able to record the CPR sequence, and see this in relation to other patient- and case- specific information such as initial cardiac rythm, time to first compression, hands-off time, quality of CPR, and factors affecting the treatment and outcome.

The hospital has 71 registered defibrillators used in CPR. The current study will both gather retrospective data- not seen in relation to patient specific information, and prospective data related to specific patients.

Eligibility criteria: Inclusion Criteria:

* cardiac arrest (all reasons)
* a defibrillator has been used
* over 18 years
* cardiopulmonary resuscitation has been conducted

Exclusion Criteria: N/A

Primary outcomes:
measure: Mortality
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: