louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02330861: Relationship Between Pressure and Flow Velocity on Coronary Physiology
Official title: Relationship Between Pressure and Flow Velocity on Coronary Physiology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Stenosis
Keywords: Coronary Circulation
Lead sponsor: Hyogo Medical University
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 0
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: Subjects are patients who are planned to do percutaneous coronary intervention for coronary stenosis in the left circumflex artery without other stenosis in the left ascending artery and the right coronary artery, or a patient with normal coronary artery. Immediately after coronary angiography or percutaneous coronary intervention, the investigators will evaluate for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary pressure and flow velocity with Combowire in each coronary segment. Also, they will assess coronary morphology by View It in each coronary segment.

Detailed description: Combowire (Volcano Therapeutics Inc., CA, USA) is a 0.014 inch pressure/Doppler sensor-tipped-guidewire which can measure coronary pressure and flow velocity.

View It (Terumo Co., Japan) is a guide catheter with intravascular ultrasound which can measure coronary morphology such as vessel diamter.

Eligibility criteria: Inclusion Criteria:

* A patient who are planned to do percutaneous coronary intervention for stenosis in the left circumflex artery without any lesions in other coronary arteries
* Or a patient who is performed coronary angiography without significant stenosis lesion in 3-coronary vessel

Exclusion Criteria:

* A patient with coronary stenosis with LAD
* Hemodialysis
* Acute coronary syndrome
* Congestive heart failure
* A patient with shock vitals

Primary outcomes:
measure: Wave intensity
timeFrame: Immediately after coronary angiography or percutaneous coronary intervention
Secondary outcomes:
measure: Coronary pressure
timeFrame: Immediately after coronary angiography or percutaneous coronary intervention
measure: Flow velocity
timeFrame: Immediately after coronary angiography or percutaneous coronary intervention
measure: Vessel diameter
timeFrame: Immediately after coronary angiography or percutaneous coronary intervention
Other outcomes:
Locations:
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
Study officials:
References:
Clinical trial NCT02642861: Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis
Official title: Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Liver Cirrhosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: - Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Detailed description: Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.

- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis and has frequent muscle cramps

Exclusion Criteria:

* Allergy to cyclobenzaprine
* Encephalopathy.
* Receiving antidepressant drugs

Primary outcomes:
measure: Number of muscle cramps
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university - faculty of medicine
Study officials:
affiliation: liver diseases dept.- Tanta university hospital
name: Sherief M. Abd-Elsalam, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: liver diseases dept.- Tanta university hospital
name: Walaa A. Elkhalawany, Consultant
role: STUDY_DIRECTOR
References:
Clinical trial NCT02276261: The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Lead sponsor: Bridgeport Hospital
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.


Eligibility criteria: Inclusion Criteria:

* Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy
* Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital
* Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital
* Age 18 or older
* Able to give informed consent to participate in the research study

Exclusion Criteria:

* Age less than 18
* Unable to give informed consent
* Patients undergoing radical hysterectomy
* Patients receiving vaginal cuff radiation within the study period
* Patients undergoing concomitant pelvic floor or vaginal suspension procedure

Primary outcomes:
measure: Vaginal length
timeFrame: 1-3 weeks postop
Secondary outcomes:
measure: Vaginal length
timeFrame: 3-4 months postop
measure: Cuff closure time
timeFrame: intra-op
Other outcomes:
measure: Complications
timeFrame: Up to 4 months post-op
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT04572061: Emergency Coronary Artery Bypass Graft in Acute Myocardial Infarction
Official title: Emergency Coronary Artery Bypass Graft in Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: CABG
Lead sponsor: Saud Al Babtain Cardiac Center
Sponsor class: OTHER_GOV
First posted: 2020-10-01
Enrollment: 109
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients admitted at Saud Al Babtain Cardiac Center with post cardiogenic shock who underwent CABG.

Brief summary: A retrospective study investigating the early outcome of emergency CABG post MI in patients who were operated at Saud Al Babtain Cardiac Center.

Detailed description: A retrospective study of surgical patients who underwent Coronary Artery Bypass Graft for Acute Myocardial Infarction between December 2013 and February 2018 determining outcomes on morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* Patients with post cardiogenic shock who underwent CABG
* =/\> 17 years old

Exclusion Criteria:

* Patients other than post cardiogenic shock who underwent CABG or any cardiac surgeries
* \<17 years old

Primary outcomes:
measure: STEMI and Emergency CABG
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Saud Al Babtain Cardiac Center
Study officials:
affiliation: Saud Al Babtain Cardiac Center
name: Ahmed Attiea, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01717261: Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: breast cancer
early breast cancer
partial breast irradiation
preoperative radiation
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 10
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.


Eligibility criteria: Inclusion Criteria:

* Female aged 60 years or older.
* Invasive ductal carcinoma.
* Unifocal disease.
* Tumors less than 2cm.
* No clinical evidence of nodal disease.
* Estrogen receptor status (ER) positive.
* Her2 negative.

Exclusion Criteria:

* Age less than 60 years.
* BRCA 1 and/or BRCA 2 mutation.
* Tumour histology limited to lobular carcinoma only.
* Neoadjuvant hormonal manipulation or chemotherapy.
* More than one primary tumour in different quadrants of the same breast.
* Inability to view tumor on imaging.

Primary outcomes:
measure: Acute toxicity
timeFrame: 6 months
Secondary outcomes:
measure: Chronic toxicity
timeFrame: 2 years
measure: Cosmetic outcome
timeFrame: 5 years
Other outcomes:
measure: Ipsilateral breast cancer recurrence
timeFrame: 5 years
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemon Hospital
name: Michael Yassa, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06226961: Effects of Dynamic Cupping on Shoulder Active Range of Motion of Senior Male Handball Athletes
Official title: Immediate Effects of Dynamic Cupping on Shoulder Active Range of Motion of Senior Male Handball Athletes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University Fernando Pessoa
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to to verify the immediate effects of dynamic cupping on shoulder active range of motion (AROM) of senior male handball athletes.

Detailed description: After completing the questionnaire, 80 senior male handball athletes will be randomly divided into two designated groups, Intervention Group (IG; n = 40) (dynamic cupping therapy) and Control Group (CG; n = 40) (no intervention).

Shoulder AROM (flexion, extension, abduction, adduction, horizontal adduction, horizontal abduction, internal rotation and external rotation movements) will be assessed in both control and intervention groups before (M0) and after (M1) intervention.

Eligibility criteria: Inclusion Criteria:

* Healthy senior handball athletes in competition with at least three training sessions per week.

Exclusion Criteria:

* history of injury, fracture or surgical intervention in the upper limb in the last six months before the study;
* vestibular, neurological or cardiorespiratory diseases;
* reported pain in the upper limb or spine
* presence of contraindication for cupping (deep venous thrombosis, with active infection or open wound.

Primary outcomes:
measure: active movements of the shoulder
timeFrame: [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior Saúde Fernando Pessoa
Study officials:
References:
Clinical trial NCT06306261: Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
Official title: Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 150 patients affected by UC under the standard of care protocols at OSR, will be subjected to a questionnaire each 30 days about their habits.

Brief summary: The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.

Detailed description: This is a prospective, single-center observational study involving patients with an established diagnosis of UC who are currently receiving standard care and eligible for advanced therapies at the San Raffaele Hospital (OSR).

The estimated sample size for the 1-year project is 150 UC patients eligible for advanced therapy.

This study aims to understand the relationship between environmental factors, dietary composition, and altered intestinal permeability that contribute to flares in UC patients by leveraging Internet-Of-Things (IoT) technologies.

These subjects will be asked to answer a series of questions about feelings and thoughts via the mobile app each month.

The mobile app was developed and designed following the open source ResearchKit framework.

The questionnaire based on the Perceived Stress Scale (PSS) will be created thanks to the collaboration between the gastroenterologist and psychologists of the San Raffaele Hospital (OSR). The PSS is a classic stress assessment tool.

Finally, all this data will be integrated thanks to the bioinformatic tool based on machine learning. All analyzes will be performed and stored in a dedicated cloud service (https://www.heroku.com/), which will make the project feasible and easy to manage.

Eligibility criteria: Inclusion Criteria:

- Patients in whom the ulcerative colitis has been diagnosed and eligible for advanced therapies Patients will be asked to sign an informed consensus before filling out the questionnaire.

Exclusion Criteria:

- Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus.

Primary outcomes:
measure: to evaluate mental stress/health as an impacting factor on UC progression
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT05302661: Effect of Re-education on Rebleeding Rate After Endoscopic Treatment in Liver Cirrhosis
Official title: Effect of Re-education on Rebleeding Rate After Endoscopic Treatment of Esophageal and/or Gastric Varices in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Esophageal Varices Bleeding
Gastric Variceal Bleeding
Bleeding
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis

Detailed description: After receiving esophageal variceal ligation and （or） gastric fundus variceal sclerotherapy, patients with outside hospitalthe rate of bleeding due to liver cirrhosis shall be re-educated outside the hospital, including diet, drugs, anticoagulation of portal vein thrombosis,regular endoscopic treatment, reexamination , nutrition, etc. The patients were divided into the first treatment group and the more thanonce treatment group according to whether they had received endoscopic treatment in the past

Eligibility criteria: Inclusion Criteria:

* Esophageal and / or gastric varices ；
* liver cirrhosis ；
* patients receiving endoscopic treatment (esophagogastric variceal sclerosis and/or ligation) ；
* All subjects or their guardians must sign the subject consent form before entering the test

Exclusion Criteria:

* Patients with mental illness, severe hearing loss and unable to take care of themselves ;
* ASA score ≥ grade IV at discharge ;
* Hepatic encephalopathy ≥ stage II;
* Patients with liver cancer;
* Pregnant and lactating women;
* Patients who cannot sign informed consent

Primary outcomes:
measure: rebleeding
timeFrame: 2 yeas
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanjing Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060861: Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis
Official title: Safety, Efficacy and Immunogenicity of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ChAdOx1 nCoV-19 Vaccine
Keywords: safety
efficacy
immunogenicity
COVID-19 vaccine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 18 years and older vaccinated by 2 doses of ChAdOx1 nCoV-19 vaccine

Brief summary: Since the beginning of COVID-19 pandemic, a safe and effective vaccine against infection and development of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is needed control of the wide spread of COVID-19 and reduce death rates throughout the world. Many clinical trials investigated the immunogenicity of different proposed vaccine including the first distributed vaccine; the ChAdOx1 nCoV-19 vaccine and there is a need to analyze the results of published clinical trials.


Eligibility criteria: Inclusion Criteria:

* Participant who received 2 doses of ChAdOx1 nCoV-19 vaccine

Exclusion Criteria:

* non vaccinated person

Primary outcomes:
measure: To evaluate the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Aliae AR Mohamed-Hussein
Study officials:
References:
Clinical trial NCT00421161: Olive Oil With Omega 3 to Treat Stasis Dermatitis
Official title: Phase 1 and 2 Study on the Efficacy and Side Effects of Olive Oil and Omega 3 Local Treatment in Stasis Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dermatitis
Keywords: olive oil
stasis dermatitis
Patients with stasis dermatitis for at least six months.
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Olive oil and Omega 3 have many anti inflammatory effects that may be beneficial in the inflammation and edema of chronic stasis dermatitis. The olive oil contains many mono unsaturated fatty acids and anti oxidants that may add to the well being of a diseased skin by improving cell membrane homeostasis.

Detailed description: Patients with chronic stasis dermatitis due to venous insufficiency will be treated with the study cream and as control we will use "Venoroutone" . Patients will be followed weekly at the clinic of the vascular surgery at Assaf Harofeh MC.

Eligibility criteria: Inclusion Criteria:

* Patints with stasis dermatitis for 6 months at least

Exclusion Criteria:

* skin ulceration or infection

Primary outcomes:
measure: improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement,
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofe MC
state: Beer Yaacov
city: Zerifin
country: Israel
facility: Clinic of vascular surgery, Assaf Harofe MC
city: Zerifin
country: Israel
facility: Clinic of Vascular Surgery
Study officials:
affiliation: Assaf Harofe MC
name: Arie Bass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sapino S, Carlotti ME, Peira E, Gallarate M. Hemp-seed and olive oils: their stability against oxidation and use in O/W emulsions. J Cosmet Sci. 2005 Jul-Aug;56(4):227-51.
Clinical trial NCT01371461: Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
Official title: Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects of 18 years or more diagnosed with depression or in a depressed state, who are considered appropriate to prescribe paroxetine tablet according to the prescribing information

Brief summary: Overall improvement, severities and changes of specific clinical symptoms were surveyed in outpatients with depression or in a depressed state to evaluate the efficacy and safety of PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a constant dose.


Eligibility criteria: Inclusion Criteria:

* Subjects who is 18 years or more
* Subjects diagnosed with depression or in a depressed state

Exclusion Criteria:

* Subjects who have been treated with paroxetine prior to this investigation
* Subjects with hypersensitivity to paroxetine
* Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in subjects taking pimozide

Primary outcomes:
measure: Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
timeFrame: 12 weeks
measure: Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II)
timeFrame: 12 weeks
measure: Efficacy evaluation based on overall improvement
timeFrame: 12 weeks
measure: Efficacy evaluation based on severities of specific symptoms
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: