louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04932057: The Investigation of Acute Effects of Action Observation Training on Upper Extremity Functionality, Reaction Time and Cognitive Functions in Right-handed Healthy Subjects
Official title: The Investigation of Acute Effects of Action Observation Training on Upper Extremity Functionality, Reaction Time and Cognitive Functions in Right-handed Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Right-handed Healthy Adults
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
First posted: 2021-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the acute effects of action observation training on upper extremity functionality, reaction times, and cognitive functions in right-handed healthy subjects.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* willingness

Exclusion Criteria:

* any kind of neurological or musculoskeletal problems
* sight problems
* pain in the upper limb
* left handedness

Primary outcomes:
measure: Change in upper extremity functionality
timeFrame: The outcome will be assessed at baseline and immediately after the intervention.
measure: Change in upper extremity dexterity
timeFrame: The outcome will be assessed at baseline and immediately after the intervention.
measure: Change in cognitive functions
timeFrame: The outcome will be assessed at baseline and immediately after the intervention.
measure: Change in cognitive functions
timeFrame: The outcome will be assessed at baseline and immediately after the intervention.
measure: Change in reaction time
timeFrame: The outcome will be assessed at baseline and immediately after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
Study officials:
References:
citation: Emuk Y, Kahraman T, Sengul Y. The acute effects of action observation training on upper extremity functions, cognitive processes and reaction times: a randomized controlled trial. J Comp Eff Res. 2022 Sep;11(13):987-998. doi: 10.2217/cer-2022-0079. Epub 2022 Jun 30.
Clinical trial NCT01206257: The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)
Official title: This is an International, Prospective, Non-interventional Study, Company Sponsored, Multi-center Study. Patients Undergo Coronary Angiography or PCI Procedure With Ultravist. The Primary Objective is to Evaluate the Safety and Tolerability.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angiocardiography
Keywords: Survey
Angiography
ADR
Image quality
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-21
Enrollment: 17513
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled

Brief summary: This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity


Eligibility criteria: Inclusion Criteria:

* Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study

Exclusion Criteria:

* Patients who are or are suspected in pregnancy or nursery
* Patients with the contraindications for Ultravist
* Patients with the contraindications for cardiac catheterization

Primary outcomes:
measure: Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
timeFrame: 12 months
Secondary outcomes:
measure: Estimation of the image quality of Ultravist®
timeFrame: 12 months
Other outcomes:
Locations:
city: Many Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03632057: Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
Official title: Shock Efficacy, a Randomized Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Arrythmia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 779
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: This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.

Detailed description: The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.

Eligibility criteria: Inclusion Criteria:

* Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks

  * Subjects who are willing to be registered on the Merlin.net remote follow-up program
  * Subject ≥18 years
  * Subjects with life expectancy of at least 1 year
  * Subjects who agree to comply with the follow-up program included in this protocol

Exclusion Criteria:

* • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months

  * Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
  * Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
  * Functional NYHA Class IV
  * Subjects who are participating in another ICD or CRT-D study
  * Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
  * Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)

Primary outcomes:
measure: Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
state: Andalucia
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
Study officials:
name: Ignacio Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
name: Javier Alzueta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03343548: Epidural Magnesium Sulfate for Post-thoracotomy Pain Control
Official title: The Effect of Adjuvant Epidural Magnesium Sulfate to Bupivacaine and Morphine on Post-thoracotomy Pain Control: A Randomized Double Blind Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: National Research Institute of Tuberculosis and Lung Disease, Iran
Sponsor class: OTHER_GOV
First posted: 2017-11-17
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain after thoracotomy is very severe and may cause pulmonary complications. Thoracic epidural analgesia has greatly decreased the pain experience and its consequences. However, new ways of decreasing post-operative opioid drugs consumption is an important issue of research. We aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled in a randomized double blind trial. Patients randomly will be allocated in two groups. Bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients at the end of operation. Patients in group I will be received epidural magnesium sulfate (50 mg) and patients in Group II will be received normal saline as an adjuvant. Visual analog scale (VAS) score and the amount of morphine consumption will be measured during 24 hours post-operation.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical statuses I-III
* Undergoing thoracotomy

Exclusion Criteria:

* Known hypersensitivity to magnesium sulfate
* Renal failure
* Hepatic dysfunction
* Severe obesity
* Psychotic or neurologic diseases
* Currently taking opioid or calcium channel blocker
* AV block degree II or III
* Refused to participate in trial

Primary outcomes:
measure: severity of post-thoracotomy pain
timeFrame: 24 hours after thoracotomy
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shadi Baniasadi
Study officials:
References:
Clinical trial NCT05340348: Patientheque in Patients With a Psychosis .
Official title: Formation of a Patientheque in Patients With a Beginner Psychosis .
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia Prodromal
Schizophrenia, Childhood
Schizophrenia
Keywords: Schizophrenia
Patient library
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric interventional study with minimal risks and constraints
Primary purpose: BASIC_SCIENCE

Brief summary: Establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.

Detailed description: The constitution of this patient library will include results of clinical tests carried out in current practice, neurocognitive tests, blood samples, audio recordings, clinical follow-up, urine samples, fecal samples, brain imaging, EEG.

Eligibility criteria: Inclusion Criteria:

* Major and or minor aged 15 to 30 assessed within the CEVUP (Consultation for the Assessment of Psychological Vulnerability) and cared for at the psychiatry center as part of a first psychotic episode (Diagnosis CIM 10: F20 -F29 first hospitalization). These patients are referred by care and medico-social partners (general practitioners, school doctors, school nurses, educators, addictologists, psychiatrists
* "At risk" status for psychotic disorder (GRD, APS, BLIPS group) or psychosis threshold during the CAARMS test (psychometric scale for the assessment of psychotic symptoms)
* Consent of the patient or his legal guardian

Exclusion Criteria:

* History of psychosis for more than one year
* "Not at risk" status for psychotic disorder on the CAARMS (psychometric scale for the assessment of psychotic symptomatology)
* IQ\<70 (WAIS)
* Neurological disorder or other health problem that may explain the disorders
* Refusal to participate - History of psychosis for more than one year

Primary outcomes:
measure: CAARMS (Comprehensive assessment of at-risk mental states) score.
timeFrame: 5 years
Secondary outcomes:
measure: CAARMS sub-assemblies
timeFrame: 5 years
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
affiliation: CHRU BREST
name: Michel WALTER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01133548: Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
Official title: A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypogonadism
Keywords: testosterone, hypogonadal, males
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

Detailed description: To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

Eligibility criteria: Inclusion Criteria

1. Hypogonadal males
2. Screening testosterone \<300 ng/dL

Exclusion Criteria

1. Smokers
2. Previous history of or current or suspected prostate or breast cancer

Primary outcomes:
measure: Maximum Plasma Concentration observed (Cmax)
timeFrame: Up to 24 days
measure: Area Under the Plasma Concentration-time Curve (AUC)
timeFrame: Up to 24 days
measure: Time of Cmax (Tmax)
timeFrame: Up to 24 days
measure: Average Plasma Concentration observed (Cav)
timeFrame: Up to 24 days
Secondary outcomes:
measure: Application site evaluation based on the clinical evaluation of skin reactions grading scale
timeFrame: 24 days
measure: Adverse events
timeFrame: 24 days
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Michael miller, PharmD
role: STUDY_DIRECTOR
References:
citation: Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011 Jul;8(7):2079-89. doi: 10.1111/j.1743-6109.2011.02265.x. Epub 2011 Apr 14.
Clinical trial NCT04193748: Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
Official title: Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Lichen Planus
Keywords: pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 42
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: This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus

Detailed description: Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).

Eligibility criteria: Inclusion Criteria:

* The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent

Exclusion Criteria:

* Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Sign score
timeFrame: 4 weeks
measure: OHIP-14 questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Oral Medicine and Periodontology Department
city: Giza
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT05198648: Trigeminal Nerve Cardiac Reflex During Resection of Cerebellopontine Angle Tumors and Postoperative Myocardial Injury
Official title: Trigeminal Nerve Cardiac Reflex During Resection of Cerebellopontine Angle Tumors and Postoperative Myocardial Injury: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Injury
Trigeminal Cardiac Reflex
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged more than 18 years old with American Society of Anesthesiology status I to III who will be scheduled to receive elective skull base tumor surgery under general anesthesia. Patients with trigeminal cardiac reflex during surgery will be included in the exposure group while patients without trigeminal cardiac reflex during surgery will be included in the non-exposure group.

Brief summary: Myocardial injury after noncardiac surgery is significantly related to postoperative 30-day mortality. Trigeminal cardiac reflex is one of the main causes of perioperative cardiac emergency. Therefore, the investigators' aim is to test the hypothesis that trigeminal cardiac reflex associates postoperative myocardial damage in participants undergoing skull base tumor surgery. The investigators will observe the association between trigeminal cardiac reflex and myocardial injury by measuring the concentration of plasma high sensitivity cardiac troponin (hs-cTnT) in participants after skull base tumor surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective skull base tumor surgery.
* Age ≥ 18 years old.
* ASA class I to III.
* All those who sign the informed consent form.

Exclusion Criteria:

* Patients with severe heart disease (including patients with preoperative heart rate \< 50 beats / min, severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation, patients with myocardial ischemia \< 6 months, heart failure, myocarditis, pericarditis or cardiomyopathy).
* Patients unable to complete preoperative cardiac assessment.
* Patients with chronic kidney disease.

Primary outcomes:
measure: The incidence of postoperative myocardial injury
timeFrame: Postoperative 1 day.
Secondary outcomes:
measure: The duration time of trigeminal cardiac reflex during skull base tumor surgery.
timeFrame: The whole skull base tumor surgery procedure.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital
name: florapym766@163.com Peng, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04917848: A Study of a Telemedicine Program for Older Adults With Cancer
Official title: Tele-Geriatric Oncology Program: Geriatric Assessment Via Telemedicine for Older Adults With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Geriatric Oncology Program
Geriatric Assessment
Telemedicine
Tele-Geriatric Oncology Program
21-200
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 124
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out if a telemedicine program for older adults in cancer treatment is a practical way to understand and meet these participants' unique needs. Telemedicine is the use of secure video technology on a desktop computer, laptop, smartphone, or tablet to provide and receive healthcare from a distance. The telemedicine program used in this study is called a tele-geriatric oncology program. It involves the participant and a study nurse meeting by videoconferencing during 2-6 telemedicine visits. As part of the program, the participant and the study nurse will discuss the participant's symptoms and aging-related needs.


Eligibility criteria: Inclusion Criteria:

* Age 70 or older
* Gastrointestinal or gynecological cancer.
* Receiving or about to receive medical cancer treatment (e.g., chemotherapy, immunotherapy, targeted therapy, biological agents)

Exclusion Criteria:

* Inability of the patient or caregiver to read or comprehend English
* No internet connection at home
* No electronic device with videoconferencing capability

Primary outcomes:
measure: Feasibility of Tele-Geriatric Oncology Program
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Beatriz Korc-Grodzicki, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: