louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04255940: 2019-nCoV Outbreak and Cardiovascular Diseases
Official title: Impact of a Novel Coronavirus (2019-nCoV) Outbreak on Public Anxiety and Cardiovascular Disease Risk in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Death; Major Adverse Cardiovascular Events
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting emergency department.

Brief summary: Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.

Detailed description: This survey aims to assess whether the public anxiety from a novel coronavirus (2019-nCoV) outbreak increases cardiovascular disease risk in China. Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.

Eligibility criteria: Inclusion Criteria:

* Patients visiting emergency department.

Exclusion Criteria:

-

Primary outcomes:
measure: Cardiovascular Death
timeFrame: 3 months
Secondary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 3 months
measure: Times From symptom onset to hospital arrival
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
Other outcomes:
Locations:
city: Binzhou
country: China
facility: Affiliated Hospital of Binzhou Medical Universty
state: Shandong
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong University Qilu Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: First Hospital Affiliated with Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Jining Hospital of Traditional Chinese Medicine
state: Shandong
city: Qihe
country: China
facility: Qihe People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University Medical College
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Zibo
country: China
facility: Central Hospital of Zibo
state: Shandong
Study officials:
References:
Clinical trial NCT01392040: Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy
Official title: Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulated Patients
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the conditions for the patients inclusion are: to take oral anticoagulant therapy for at least 2 years; to be in stable conditions for at last 3 months

Brief summary: The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy.


Eligibility criteria: Inclusion Criteria:

* to take oral anticoagulant therapy for at least 2 years
* to be in stable conditions for at last 3 months

Exclusion Criteria:

* patients who need to perform surgery
* patients who interrupt therapy

Primary outcomes:
measure: Time spent in therapeutic range of INR by the patients
timeFrame: 6 months
Secondary outcomes:
measure: Thrombotic and bleeding events
timeFrame: 6 months
Other outcomes:
Locations:
city: Macerata
country: Italy
facility: Hospital of Macerata
Study officials:
affiliation: University Of Perugia
name: Michela Basileo, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Alfonso Iorio, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04541940: TeleRehabilitation Following ACL Reconstruction
Official title: TeleRehabilitation Following ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.

The purpose of the proposed study is to evaluate telerehabilitation vs. in-person rehabilitation following ACL reconstruction. Objectives include assess return to sport and patient reported functional outcomes.


Eligibility criteria: Inclusion Criteria:

* Scheduled for ACL reconstruction
* Age 18-40
* Ability to comply with a standardized postoperative protocol
* Willing and able to provide consent

Exclusion Criteria:

* Pregnant patient
* Age \>40 years, or \< 18
* Previous knee surgery
* Unable to speak English or perform informed consent

Primary outcomes:
measure: RTS (Return to Sport)
timeFrame: up to 1 year post-op
Secondary outcomes:
measure: ACL-RSI Questionnaire Score
timeFrame: up to 1 year post-op
measure: Visual Analogue Scale (VAS) Score
timeFrame: up to 1 year post-op
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: up to 1 year post-op
measure: International Knee Documentation Committee (IKDC) Score
timeFrame: up to 1 year post-op
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: kirk.campbell@nyulangone.org
name: Kirk Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02961140: Different Anesthetic Managements of Esophageal Resection and Reconstruction
Official title: The Effects of Different Anesthetic Managements on Inflammation, Oxidative Injuries, and Major Organ Complications: a Prospective Investigations on Esophageal Reconstruction and Intraoperative Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Esophagus Cancer
Postoperative Complications
Keywords: Outcome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2016-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.

Detailed description: Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. Excessive fluid administration may result in pulmonary complication, while extremely hypovolemia may lead to shock, circulatory dysfunction, and renal damage. Little is known about fluid status will have impact on anastomotic leakage. Goal-directed fluid therapy has shown to benefit perioperative outcome in major abdominal surgery. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as esophageal cancer
* Scheduled for minimally invasive esophageal resection and reconstruction

Exclusion Criteria:

* End-stage organ dysfunction, including heart failure, hepatic failure, renal failure
* Arrhythmia
* Pregnancy

Primary outcomes:
measure: Incidence of postoperative complication
timeFrame: 1 month
Secondary outcomes:
measure: Intraoperative hemodynamic stability
timeFrame: 1 day
measure: Length of stay
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Ya-jung Cheng, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036840: Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penicillin Allergy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 513
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of allergy to penicillin who required antibiotic prophylaxis prior to/during surgery.

Brief summary: The proposed research project will retrospectively review the anesthetic records over the past 5 years and identify patients who present with a history of penicillin allergy or allergy to an antibiotic in the penicillin family. The reason for that history and the facts on which that allergy are noted will be determined. Additionally, the choice of antibiotic prophylaxis will be recorded and any adverse effect to that antibiotic noted. We will also note whether appropriate timing of the antibiotic is achieved.


Eligibility criteria: Inclusion Criteria:

* Patients that are labeled as penicillin or penicillin family allergic.

Exclusion Criteria:

* As neurosurgical patients routinely receive vancomycin at NCH for surgical prophylaxis, they will be excluded from the study.

Primary outcomes:
measure: Number of Subjects With Antibiotic Related Adverse Event
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03838640: Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery
Official title: Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Assess Feasibility of the New Application
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Identification and preservation of internal carotid artery during endoscopic nasopharyngectomy in cases of malignancy is a main difficulty of this kind of surgery, especially when anatomy is distorted by previous radiation. Intraoperative navigation based on preoperative imaging cannot remain precise throughout the process of resection. We aim to check a feasibility of internal carotid artery localization with the help of transnasal ultrasonic scanning. The most appropriate for this method existing device is an echocardiography system with pediatric transesophageal transducer.

We plan to use it in 20 patients undergoing elective surgery for inflammatory sino-nasal disease. After initiatioin of general anesthesia and local decongestion, transducer will be placed transnasally to nasopharynx in order to scan a parapharyngeal space.


Eligibility criteria: Inclusion Criteria:

Indication for endoscopic nose and paranasal sinuses surgery

Exclusion Criteria:

Previous nasopharyngeal surgery

Primary outcomes:
measure: distance from nasopharynx surface to a closest wall of internal carotid arter
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT03291340: Determining the Impact of Shunting and CerebroVascular Reactivity on 7T MRI (DISCoVeR 7T MRI)
Official title: A Pilot Cross-sectional Cohort Study of Right-to-left-shunt, Cerebrovascular Reactivity, Ischemic Infarct Burden on High Resolution MRI, and Cognitive Impairment in Elderly Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only subjects that are enrolled in the NACC longitudinal cohort (Protocol 068200) will be eligible for this study. Subjects must also agree to participate in the ADCC high-resolution MRI sub-study to be eligible.

Brief summary: The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess cerebrovascular reactivity (CVR) in the elderly.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 60 years of age.
2. Fluent in English.
3. Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal, Mild Cognitive Impairment, or probable/possible Alzheimer's disease.
4. Has consented to participate in the ADCC high-resolution MRI sub-study.
5. NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.
6. Women: post-menopausal or surgically sterile.
7. Willing and able to complete all required study procedures.
8. Completed 6 grades of education.
9. Geriatric Depression scale less than 6 (assessed within 6 months at the NACC longitudinal visit).

Exclusion Criteria:

1. Prior clinically symptomatic ischemic or hemorrhagic stroke.
2. Inability to tolerate or contraindication to TCD study in the opinion of an investigator or treating physician.
3. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Primary outcomes:
measure: Presence of right-to-left shunt on TCD
timeFrame: Baseline
measure: Presence of cerebrovascular reactivity on TCD
timeFrame: Baseline
Secondary outcomes:
measure: Volume of ischemic injury
timeFrame: Baseline
measure: Location of ischemic injury
timeFrame: Baseline
measure: Presence of cognitive impairment
timeFrame: Baseline
measure: Type of cognitive impairment
timeFrame: Baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01421940: The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rectal Cancer
Keywords: Udenafil
rectal cancer
penile rehabilitation
total mesorectal excision
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.


Eligibility criteria: Inclusion Criteria:

* Age : 20-65
* Rectal cancer within 15cm from anal verge
* Patients with more than 5 points decreased IIEF-5 after operation
* Patients with sexual activity

Exclusion Criteria:

* Preoperative IIEF-5 : ≤14
* Recent MI, CVA, nitrate medication
* Severe cardiovascular disease, psychiatric disease
* Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
* Renal dysfunction (Cr ≥2mg/dl)

Primary outcomes:
measure: Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
timeFrame: Baseline, 12weeks, 24 weeks
Secondary outcomes:
measure: Change from baseline in SEP Q2,Q3 and GEQ
timeFrame: baseline, 12weeks, and 24 weeks
measure: Number of patients with adverse events during 24 weeks of the study
timeFrame: Baseline through 24 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
Study officials:
References:
citation: Park SY, Choi GS, Park JS, Kim HJ, Park JA, Choi JI. Efficacy and safety of udenafil for the treatment of erectile dysfunction after total mesorectal excision of rectal cancer: a randomized, double-blind, placebo-controlled trial. Surgery. 2015 Jan;157(1):64-71. doi: 10.1016/j.surg.2014.07.007.
Clinical trial NCT02118740: Bone Marrow Collection in Healthy Volunteers (iCell)
Official title: Bone Marrow Collection in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injury
Keywords: Autologous Stem Cells
Spinal Cord Injury
Preclinical
Lead sponsor: Amarna Stem Cells BV
Sponsor class: INDUSTRY
Collaborators: name: Neuroplast
First posted: 2014-04-21
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young healthy volunteers

Brief summary: This is a observational study in which healthy found volunteers are recruited to donate 50 ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only for animal studies and after completion of the preclinical program, the intention of AMARCELL is to treat humans with a traumatic Spinal cord injury.

Detailed description: Coded anonymized patient data

Eligibility criteria: Inclusion Criteria:

* Men in the age range of 21-30 years and/or women in the age range of 21-30 years and taking birth control medication to prevent pregnancy
* Written informed consent
* Healthy as concluded by the answers given to questions in a short health questionnaire

Exclusion Criteria:

* Pregnancy or lactation period
* Volunteers who are unable to comply with the rules of this project. Important is if the volunteer can not follow the schedule of the appointments.
* Abuse of alcohol, medicines or illicit drugs.
* Legally protected people

Primary outcomes:
measure: Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL
timeFrame: 3 days
Secondary outcomes:
measure: Absence of contamination with infectious agents especially bacteria and pseudomonas
timeFrame: 3 days
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MUMC
state: Limburg
Study officials:
affiliation: University Maastricht
name: Harry Steinbusch, Prof.dr.
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Gerard Bos, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822340: Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
Official title: A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Growth Hormone Deficiency
Keywords: AGHD
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-04-02
Enrollment: 72
Sex: ALL
Minimum age (years): 23
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.

Detailed description: * To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment
* To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)

Eligibility criteria: Inclusion Criteria:

* GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009);
* r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening.
* Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
* Female patients must have a negative serum pregnancy test at inclusion.
* Confirmed to be negative for anti r-hGH antibodies at the time of screening.
* Willing and able to provide written informed consent prior to performing any study procedures.

Exclusion Criteria:

* Patients with childhood onset of GHD treated with r-hGH before the age of 18.
* Current antitumor therapy.
* Subjects presenting with any clinically significant ECG abnormality.
* Evidence of intracranial hypertension.
* Significant hepatic dysfunction (persistent elevation of alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \>1.5 x upper limit of normal).
* Pregnancy and breastfeeding;

Primary outcomes:
measure: Change of IGF-I levels in function of time, and dose strengths
timeFrame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
Secondary outcomes:
measure: IGF-I SDS; changes to baseline in IGF-I SDS
timeFrame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Hanmi Pharmaceutical
Study officials:
References: