louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05719545: A Cohort of Patients Undergoing Percutaneous Coronary Intervention
Official title: A Longitudinal Cohort of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Myocardial Infarction
Unstable Angina
Lead sponsor: Jinan Central Hospital
Sponsor class: OTHER
Collaborators: name: Shandong First Medical University
First posted: 2023-02-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Brief summary: To investigate the risk factors involved in the occurrence and prognosis of the patients with acute coronary syndrome, patients undergoing percutaneous coronary intervention will be recruited and followed up for at least 2 years.

Detailed description: Patients with acute coronary syndrome undergoing percutaneous coronary intervention will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as diagnosis, medical history, laboratory test results, therapy methods, prognosis and follow-up information. The risk factors involved in the occurrence and prognosis of acute coronary syndrome will be investigated.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as acute coronary syndrome and needed to undergo percutaneous coronary intervention.
* \>18 years old.

Exclusion Criteria:

* With malignant tumors, acute infectious diseases and advanced liver diseases.
* Won't sign an inform consent.

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 2-year outcome and long-term outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
Study officials:
affiliation: Jinan Central Hospital
name: Guohao Su, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03872245: Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients
Official title: Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 20
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: Patients will be randomized into 2 groups:

* Group 1:Patients undergoing PENS T6, who also received Probiotics, during 10 weeks.
* Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics

Weight loss after 10 weeks of treatmente will be assessed.

Detailed description: Patients will be randomized into 2 groups:

* Group 1:Patients undergoing percutaneous electrical stimulation of dermatome T6 (PENS T6), who also received Probiotics (Adomelle 1 caps/12h), during 10 weeks.
* Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics

Weight loss after 10 weeks of treatmente will be assessed.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30 Kg/m2

Exclusion Criteria:

* Patients with pacemakers or implanted electrical devices.
* Pregnant women
* History of allergy to Probiotics

Primary outcomes:
measure: Weight loss
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Rey Juan Carlos
name: Carolina Llavero
role: STUDY_DIRECTOR
References:
Clinical trial NCT00507845: Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
Official title: Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-27
Enrollment: 271
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary:

* To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients

Secondary:

* To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.


Eligibility criteria: Inclusion Criteria:

* Outpatient
* Patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ACE inhibitors, AT2 blockers)(uncontrolled hypertension).

Exclusion Criteria:

* Already on fixed-dose combination treatment for hypertension
* Contraindication to angiotensin converting enzyme (ACE) inhibitors or CCB therapy
* Known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ACE or any of the excipients of ramipril felodipine.
* History of angioedema
* Unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke.
* Patients with AV block II or III
* Severely impaired hepatic function.
* Pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
* Pregnant and lactating mothers
* Patients on dialysis or haemofiltration.
* Patients with creatinine clearance \< 20ml/min
* Use of potassium sparing diuretics
* Severe hypertension (SBP ≥ 180 mmhg or DBP ≥ 110 mmhg)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Mean changes in Systolic Blood Pressure (SBP)
timeFrame: from baseline to Week 8
Secondary outcomes:
measure: Mean changes in Diastolic Blood Pressure (DBP)
timeFrame: from baseline to Week 8
measure: Percentage of responders with regard to DBP and SBP
timeFrame: comparison to baseline
measure: Adverse events
timeFrame: After treatment and at each follow-up visit
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi
name: Cristian von Schulz Hausmann, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03137745: Coagulation Profile of Patients Undergoing CRS(Cytoreductive Surgery) and Hyperthermic Intraperitoneal Chemotherapy
Official title: To Study the Changes in Coagulation Profile in Patients Undergoing CRS(CYTOREDUCTIVE SURGERY) and HIPEC(HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haematological Abnormality
Keywords: Thromboelastography, chemotherapy,hyperthermic
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: thromboelastography was done in 60 patients undergoing CRS with HIPEC in RGCI FROM MARCH2015- MARCH 2016

Brief summary: To study the changes in coagulation profile in patients undergoing cytoreductive surgery and Hyperthermic intraperitoneal chemotherapy. The objective of the study is to determine the utility of thromboelastography in comparison to standard coagulation tests in assessing the coagulopathy in patients undergoing CRS with HIPEC.

Detailed description: This is a prospective observational study conducted in 60 patients undergoing CRS with HIPEC in RGCIRC from march 2015- march2016 after taking permission from the institutional review board and informed written consent from the patients.

Arterial blood samples were collected before and after HIPEC and on first and second postoperative day for PT,APTT INR,TEG and ABG. Statistical analysis was done using chi square test and unpaired t- test for categorical and continuous variables. Pearson's correlation coefficient was calculated for analysing the correlation between the variables .P - value \<0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* ASA 1\&2
* Undergoing CRS with HIPEC

Exclusion Criteria:

* extremities of age
* patients with coagulopathy
* patients on anticoagulant preoperatively sever organ dysfunctions

Primary outcomes:
measure: comparison of thromboelastograph values with standard coagulation tests
timeFrame: 1.5 hours after HIPEC
Secondary outcomes:
measure: comparison of various thromboelastograph values with standard coagulation tests
timeFrame: 24hours and 48 hours after HIPEC
Other outcomes:
Locations:
Study officials:
References:
citation: Sheshadri DB, Chakravarthy MR. Anaesthetic Considerations in the Perioperative Management of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. Indian J Surg Oncol. 2016 Jun;7(2):236-43. doi: 10.1007/s13193-016-0508-2. Epub 2016 Feb 20.
citation: Korakianitis O, Daskalou T, Alevizos L, Stamou K, Mavroudis C, Iatrou C, Vogiatzaki T, Eleftheriadis S, Tentes AA. Lack of significant intraoperative coagulopathy in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) indicates that epidural anaesthesia is a safe option. Int J Hyperthermia. 2015;31(8):857-62. doi: 10.3109/02656736.2015.1075606. Epub 2015 Oct 8.
Clinical trial NCT01009645: The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination
Official title: The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccination
Keywords: education
vaccination
preventive service
Prevention & Control
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2009-11-09
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.


Eligibility criteria: Inclusion Criteria:

* Participant must have a scheduled appointment at least 6 weeks in advance in either the GIM or Geriatrics clinics at NMFF.
* Participant must be a patient of Northwestern Medical Faculty Foundation.
* Participant does not intend to receive the influenza vaccine.

Exclusion Criteria:

* Participant has a diagnosis of Alzheimer's Disease or Dementia
* Participant has received an influenza vaccination during either the last influenza season or the current.
* The scheduled visit is the participant's first time being seen by this doctor (appointment is to establish care in the clinic).

Primary outcomes:
measure: Influenza Vaccination
timeFrame: 1 week following randomization
Secondary outcomes:
measure: Recall Accuracy
timeFrame: 1 week following receipt of message
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation General Internal Medicine and Geriatric Clinics
state: Illinois
Study officials:
References:
Clinical trial NCT04611945: Westlake Sailing Cohort
Official title: Westlake Sailing Cohort: Dynamic Change of Human Microbiome During Sailing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbiome
Glucose Metabolism
Mood
Environment
Lead sponsor: Westlake University
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who will sail by Shenkuo, a scientific research ship, December 2020.

Brief summary: Little is known about the dynamic change of human microbiome in different body sites including skin, mouth and gut during sailing. The present study aims to reveal the change of human microbiome in response to the sailing environment in a 1-month period, and its implication for human health.

Detailed description: This study will recruit a number of participants who are going to sail for mariana trench from Shenzhen, China. Characteristics of the participants will be described by a series of index of stool, urine, skin microbiota and tongue coating. All the biospecimen will be collected before and during the voyage. Stool at the 2nd, the 4th and the 12th week after the voyage and blood sample at the baseline will also be collected. Participants' mood states, health-related quality of life, fatigue score and sleep quality will be investigated with questionnaires throughout the 1-month period. Participants are asked to record diseases and symptoms, if any, when sailing. All the data will be used to analyse how microbiota change and be involved in human health during a voyage.

Eligibility criteria: Inclusion Criteria:

* Willingness and capability to complete the study protocol

Exclusion Criteria:

* Inability or unwillingness to approved to provide informed consent.
* Women who are pregnant or lactating.

Primary outcomes:
measure: Gut microbial abundant change
timeFrame: Day 1, day 10, day 16, day 23, day 28
measure: Tongue coating microbial abundant change
timeFrame: Day 1, day 10, day 16, day 23, day 28
Secondary outcomes:
measure: Mood states change over 4 weeks
timeFrame: Day 1, day 10, day 16, day 23, day 30
measure: Health-related quality of life change over the one-month sailing
timeFrame: Day 1, day 30
measure: Sleep quality change over the one-month sailing
timeFrame: Day 1, day 30
measure: Short-chain fatty acids change
timeFrame: Day 1, day 10, day 16, day 23, day 28
measure: Weight change
timeFrame: Day 1, day 10, day 16, day 23, day 28
measure: Blood pressure change
timeFrame: Day 1, day 10, day 16, day 23, day 28
measure: Fatigue score change
timeFrame: Day 1, day 10, day 16, day 23, day 30
measure: Skin microbial abundant change
timeFrame: Day 1, day 10, day 16, day 23, day 28
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00762645: Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)
Official title: A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Angle-closure Glaucoma
Keywords: IOP lowering efficacy
CACG
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 30
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: The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Chronic Angle Closure Glaucoma (CACG)
* 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
* Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
* Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
* Peripheral anterior synechiae (PAS)

Exclusion Criteria:

* Traumatic damage of the anterior chamber angle
* History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
* Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
* Visual Acuity ≥ 1.0
* Contact lenses wearer

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
timeFrame: 4PM at Week 12 Visit
Secondary outcomes:
measure: Number of Patients With Peripheral Anterior Synechiae (PAS)
timeFrame: Week 12 Visit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00644345: T-Wave Alternans (TWA) Reproducibility in CAD Patients
Official title: Reproducibility of T Wave Alternans Testing in Patients With Ischemic Heart Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Microvolt T wave alternans
reproducibility
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease enrolled in a cardiac rehabilitation program.

Brief summary: Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its clinical performance compares favorably with that of other non-invasive risk stratifiers and invasive electophysiologic studies. The purpose of the present study is to define the reproducibility of MTWA testing.

Detailed description: The study will be performed in the Cardiac Rehabilitation Center at Assaf Harofeh Medical Center. Patients with coronary artery disease will be eligible to enroll.

Patient will undergo an exercise test on a stationary bicycle. TWA will be measured at heart rate of 105 and 115 BPM. The test will be repeated one week later in the same fashion. The patient will continue follow-up in the rehabilitation center as dictated by the rehabilitation program. Patients will be kept on their regular medications and there will be no change of the medications from the first TWA measurement to the second.

Eligibility criteria: Inclusion Criteria:

1. Patients enrolled in the cardiac rehabilitation center program
2. Patients with CAD
3. Age \>18 and \< 80 YO
4. Patients with a pacemaker or defibrillator with normal AV conduction

Exclusion Criteria:

1. Patients with chronic AF
2. Patients with multiple APB's or PVC's
3. Patients who are unable to increase their heart rate to 115 BPM and don't have a pacemaker.
4. Patients who are unable to exercise on a bicycle.

Primary outcomes:
measure: Reproducibility of TWA test results
timeFrame: 1 week
Secondary outcomes:
measure: Ventricular arrhythmias during exercise
timeFrame: 1 week
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Therese Fuchs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00281645: Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
Official title: A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Lead sponsor: DOV Pharmaceutical, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-25
Enrollment: 1250
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: The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400 mg BID for up to one year in patients with moderate to severe chronic low back pain.

The secondary objectives are to compare the long-term safety of bicifadine to standard of care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not tolerate bicifadine 400 mg BID.

Detailed description: There are two ways by which subjects could enter this study.

Subjects who completed 12 weeks of treatment in two other double blind clinical studies of bicifadine (Studies 020 and 021, both in the United States) could roll over into this study.

Also, de novo subjects (that is, subjects who had not previously received bicifadine) could enroll in this study.

Eligibility criteria: Main Inclusion Criteria:

* Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
* Patients must have required on average daily analgesics for the treatment of low back pain over the past 3 months prior to screening.

Main Exclusion Criteria:

* Patients may not have moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity) or weakness in the lower extremities.
* Patients must not have had epidural corticosteroid injections in the lower back within 1 month prior to baseline.
* Patients may not have an unstable medical condition.

Primary outcomes:
measure: Adverse Events
measure: Clinical Labs
measure: Vital Signs
measure: ECGs
Secondary outcomes:
measure: Pain Severity Rating (VAS)
measure: Short-Form McGill Pain Questionnaire (SF-MPQ)
measure: Roland-Morris Disability Questionnaire (RDQ)
measure: Short-Form 36 (SF-36) Health Survey
measure: Patient Withdrawal Checklist
Other outcomes:
Locations:
Study officials:
References: