louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05546320: Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale
Official title: COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patent Foramen Ovale
Migraine
Keywords: Migraine
Patent Foramen Ovale
Medication therapy
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 ；
2. Diagnosed migraine by ICHD-3
3. History of migraine longer than 1 year
4. TCD/TTE/TEE diagnosed patent foramen ovale
5. Willing to participant and agree to follow-ups

Exclusion Criteria:

1. Migraine caused by other reason
2. Had TIA/stroke history
3. Hypersensitive or hyposensitive to the study drug
4. With a history of anticoagulation or anti-platelet drug intake 3 month before randomization.
5. With a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.

Primary outcomes:
measure: Responder rate
timeFrame: From baseline period to 3-month treatment period
measure: Treatment safety
timeFrame: From baseline period to 3-month treatment period
Secondary outcomes:
measure: Migraine days change per month
timeFrame: From baseline period to 3-month treatment period
measure: Number of migraine attacks change per month
timeFrame: From baseline period to 3-month treatment period
measure: Percentage of migraine change
timeFrame: From baseline period to 3-month treatment period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiangbin Pan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00933920: Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension
Official title: A Randomized, Single-blind, Parallel Group, Multiple Oral Dose Study to Evaluate the Effect of a Light Meal on the Pharmacokinetics and Pharmacodynamics of Aliskiren Using Market 300 mg Tablet Formulation in Subjects With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Aliskiren,
hypertension,
renin-angiotensin-aldosterone system,
pharmacokinetics,
pharmacodynamics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension
* Patients who are eligible and able to participate in the study

Exclusion criteria:

* Severe hypertension
* Secondary form of hypertension.
* Type 1 or type 2 diabetes mellitus
* Serum potassium out side laboratory reference range
* Any history of hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.
timeFrame: 28 Days
Secondary outcomes:
measure: Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal
timeFrame: 28 Days
measure: Assess safety and tolerability of aliskiren when given with and without light meal
timeFrame: 28 days
measure: Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal
timeFrame: 28 days
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: Novartis Investigator Site
city: Hyderabaad
country: India
facility: Novartis Investigative Site
city: Hyderabaad
country: India
facility: Novartis Investigator Site
city: Mangalore
country: India
facility: Novartis Investigator Site
city: New Delhi
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00651820: Effect of Collagenase on Healing and Scarring
Official title: A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scarring
Impaired Wound Healing
Keywords: wound healing
scarring
collagenase
Santyl
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.


Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Willing to attend all required study visits

Exclusion Criteria:

1. Known hypersensitivity to Clostridial collagenase
2. Anticoagulants (blood thinners, including aspirin) within two weeks
3. Congenital skin disorder which affects keratinocytes, elastin, or collagen
4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure
5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
6. At risk of keloid or hypertrophic scar formation
7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
8. Any skin disorder which causes delayed healing
9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
10. Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs

Primary outcomes:
measure: Time to Complete Wound Closure Collagenase Santyl and Vehicle
timeFrame: 21 days
Secondary outcomes:
measure: Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle
timeFrame: 9 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Healthpoint
name: Herbert B Slade, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04507620: Effect of Cervical Immobilization on Optic Nerve Sheath Diameter
Official title: Effect of Cervical Neck Collar and Head Blocks Strapped on the Backboard on Optic Nerve Sheath Diameter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optic Nerve Sheath Diameter
Point of Care Ultrasound
Keywords: cervical immobilization
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective study will be done on 100 medical students, emergency medicine and traumatology residents and assistant lecturers ,Tanta university faculty of medicine, healthy volunteers during a period of 6 months.

Brief summary: Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

Detailed description: Two cervical immobilization devices will be used in this study named cervical neck collar and head blocks strapped on the backboard and optic nerve diameter will be measured using point of care ultrasound and compare the effect of each type of cervical immobilisation on optic nerve sheath diameter.

Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers aged more than 18 years

Exclusion Criteria:

* Hx of stroke

  * Inability to consent,
  * Inability to lay flat on a bed or table for 15 min in duration,
  * History of glaucoma, globe injury, lens implant,
  * Recent refractive surgery (within the past 60 days).
  * Uncontrolled hypertension

Primary outcomes:
measure: Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Mohamed Elbahnasawy
state: Gharbia
Study officials:
References:
Clinical trial NCT05768620: Active Navigation Training
Official title: Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Spatial Navigation
Keywords: virtual reality
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Proof-of-concept trial
Primary purpose: PREVENTION

Brief summary: Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of mild cognitive impairment
* absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996)
* age ≥ 60

Exclusion Criteria:

* the presence of acute stroke/transient ischemic attack;
* the presence of other concomitants severe neurological/psychiatric diseases;
* history of traumatic brain injury with loss of consciousness;
* physical/functional deficits that could affect the use of immersive virtual reality;
* severe visual deficiency;
* the presence of recurrent vertigo.

Primary outcomes:
measure: Change in Corsi supra-span test
timeFrame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
measure: Change in Manikin Test
timeFrame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary outcomes:
measure: Trail-making test part A and B
timeFrame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
measure: Raccontino (6 Dicembre) (immediate-delayed-forgetting)
timeFrame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
measure: Mini-mental state examination
timeFrame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
measure: Digit span forward
timeFrame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
measure: Corsi Block Tapping
timeFrame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Cosimo Tuena
state: Lombardia
Study officials:
References:
Clinical trial NCT00489320: An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).
Official title: An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Vascular Disease
Arterial Occlusive Disease
Arteriosclerosis
Atherosclerosis
Keywords: Coronary disease
Arteries
Atherosclerosis
Arteriosclerosis
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 7759
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is, they have been approved for use in the general population.

Detailed description: The D.E.S.cover Registry is a prospective, multi-center, observational study. Consecutive patients undergoing PCI procedures will be asked to consent to participate in this study. For these patients, baseline, clinical and angiographic characteristics, as well as certain procedural and clinical events will be recorded using standardized case report forms. Outcomes will be assessed during hospitalization and at one, six and twelve months after discharge. Depending on results from the first year of follow-up, the study may be extended with an additional one or two years of follow-up.

The strategy for achieving the scientific objectives of the Registry is to document actual, real-world PCI practice and outcomes. Accordingly, the D.E.S.cover Registry does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the D.E.S.cover Registry database.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients undergoing percutaneous coronary intervention at an enrolling center by study investigators

Exclusion Criteria:

* Patient refusal or inability to provide written informed consent and/or HIPAA authorization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: David O Williams
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams DO, Abbott JD, Kip KE; DEScover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the DEScover Registry. Circulation. 2006 Nov 14;114(20):2154-62. doi: 10.1161/CIRCULATIONAHA.106.667915. Epub 2006 Oct 23.
Clinical trial NCT04212520: Predictive Value of Non-fasting Blood Lipid Levels for Cardiovascular Events in Community Population(PICC Study)
Official title: Predictive Value of Non-fasting Blood Lipid Levels for Cardiovascular and Cerebrovascular Events in Community Population(PICC Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lipid
Keywords: non-fasting lipid
cardiovascular and cerebrovascular events
major adverse cardiovascular events
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes subjects who living in community, of any race or ethnicity, 18 or older years of age, and have provided written informed consent.

Brief summary: Numerous studies have shown that non-fasting blood lipid levels are closely related to the occurrence of cardiovascular and cerebrovascular events, but it is still unclear in the Chinese population. The purpose of the study is to investigate the association between non-fasting blood lipid levels and adverse outcomes in Chinese community population.

Detailed description: Study population includes subjects who living in community, of any race or ethnicity, 18 or older years of age, and have provided written informed consent to provide biological sample at one or more study visits. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of a composite of major adverse cardiovascular events will be investigated during follow-up.

Eligibility criteria: Inclusion Criteria:

•≥18 years old;

* Signed informed consent;
* Life expectancy is greater than 1 year.

Exclusion Criteria:

* mental disorder;
* is not willing to participate in the clinical study;
* suffered with other disease to quite the trial;
* violated the protocol.

Primary outcomes:
measure: All-cause mortality
timeFrame: Through study completion, an average of 1 years
measure: Cardiovascular Mortality
timeFrame: Through study completion, an average of 1 years
measure: Cardiovascular and cerebrovascular diseases
timeFrame: Through study completion, an average of 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Feng Ying-qing, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03533920: Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Official title: A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma


Eligibility criteria: Inclusion Criteria:

* Over 19 years
* Diagnosis of HCC
* Unresectable asymtomatic uninodular or multinodular tumor.
* Subject who maintain clinically normal hepatopetal flow without main portal vein closure
* At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less.
* ECOG Performance Status of 0 or 1.
* Child-Pugh class A or B
* Life expectancy of at least 6 months.

Exclusion Criteria:

* Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
* Hepatic resection, liver transplantation or Percutaneous local treatment
* Previously received HCC related medical procedure
* Previously treated with anthracyclines
* Only measurable disease is within an area of the liver previously subjected to radiotherapy.
* Child Pugh C
* Active gastrointestinal bleeding within 6 months from screening.
* Total bilirubin \> 3mg/dL
* WBC \< 3,000cells/mm3
* Platelet \< 50,000mm3
* Serum creatinine \> 2mg/dL
* INR\> 1.4
* ALT and AST \> 5 times UNL
* Diffuse HCC defined as \>50% tumour involvement of the whole liver.

Primary outcomes:
measure: Objective Response Rate by independent evaluator
timeFrame: 4 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
References:
Clinical trial NCT04768920: Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)
Official title: Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Substance Use
Substance Dependence
Keywords: Telehealth
Motivational interviewing
Cognitive behavioral therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via telehealth (Teletx) to help improve substance use and other related outcomes in SUD patients who are not receiving SUD care. We will examine feasibility and acceptability of these pilot psychosocial programs in a total of n=50 participants. The goal is to refine the programs to improve acceptability and feasibility and collect preliminary data for a future fully powered randomized controlled trial (RCT) in the future.

In addition to study sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.


Eligibility criteria: Inclusion Criteria:

* Outpatient care at Michigan Medicine in past year
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month
* Have a Smart phone, tablet or another Wi-Fi or data-enabled device (e.g. with a camera)

Exclusion Criteria:

* Inability to speak or understand English
* Conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content
* Prior alcohol withdrawal seizures or delirium tremens (DTs). Those who are at-risk of complicated withdrawal (e.g., seizures, DTs) require greater medical attention and will be excluded and referred to their clinician for medical management.

Primary outcomes:
measure: Feasibility of the intervention (engagement)
timeFrame: 8 weeks
measure: Tele-Tx Intervention acceptability
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
measure: Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)
timeFrame: baseline, 8 weeks post-baseline
measure: Change in Alcohol Consumption
timeFrame: baseline, 8 weeks post baseline
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Allison Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: