louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00168506: Panic Disorder and Cardiac Risk
Official title: Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Panic Disorder
Keywords: panic disorder
cardiac risk
Lead sponsor: Baker Heart Research Institute
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2005-09-15
Enrollment: 50
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: The reason for increased cardiac mortality in panic disorder has not been precisely identified, but possibly is due to chronic activation of the cardiac stimulant (sympathetic) nerves, which may predispose the individual with panic disorder to disorders of cardiac rhythm and coronary artery spasm. The uniqueness of this study lies in its comprehensive evaluation of a psychobiological approach to the treatment of panic disorder using change in biological, behavioural and psychological variables as criteria for efficacy. 50 patients aged between 18 and 60 years will be recruited; both males and females. They will be treated with either cognitive behavioural therapy (CBT) or SSRI (selective serotonin re-uptake inhibitor) antidepressants or a combination of both.

This project will firstly compare individuals with panic disorder who demonstrate abnormal brain transmitter (noradrenaline, serotonin) with those who demonstrate normal activity of these neurotransmitters, on interoceptive accuracy for changes in sympathetic nervous system arousal. It is predicted that individuals who demonstrate abnormal activity of these neurotransmitters will also demonstrate enhanced interoceptive ability to detect changes in arousal levels. Secondly, this project will evaluate the effects of a psychobiological treatment approach to panic disorder involving a combination of CBT and SSRI. This approach will be compared to the effects of both these interventions alone on a comprehensive array of measures related to panic disorder. It is predicted that the combined approach will be the most effective intervention on behavioural, psychological and biological variables, and cardiac risk. We will also be able to assess whether changes in panic disorder severity are associated with changes in interoceptive accuracy.


Eligibility criteria: Inclusion Criteria:

* Panic disorder

Exclusion Criteria:

* Comorbid heart disease
* Comorbid significant psychiatric illness
* Significant suicide risk
* HIV/AIDS hepatitis B/c

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker Heart Research Institute
state: Victoria
Study officials:
affiliation: Baker Heart Research Insitute
name: Murray A Esler, MBBS Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06632106: HAIC in Combination with Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors for Advanced HCC
Official title: In Which Tumor Burden Range Does Advanced Hepatocellular Carcinoma Patients Benefit More from Hepatic Arterial Infusion Chemotherapy Plus Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors Than Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors? a Multi-center, Retrospective, Propensity Score Matching Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatic Arterial Infusion Chemotherapy
Tyrosine Kinase Inhibitor
Immune Checkpoint Inhibitors
Hepatocellular Carcinoma (HCC)
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced HCC with PVTT who received HAIC in combination with TKIs and ICIs under real-world practice conditions.

Brief summary: The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).


Eligibility criteria: Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
5. HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
6. Received at least 2 cycles of HAIC or ICIs treatments；
7. Has repeated measurable intrahepatic lesions;
8. Child-Pugh class A or B.

Exclusion Criteria:

1. Patients who took systemic anti-tumor treatments before the combination therapy;
2. With other malignant tumors;
3. Unable to meet criteria of combination timeframe described above.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: Up to approximately 2 years
measure: Objective response rate(ORR) per RESCIST 1.1
timeFrame: Up to approximately 2 years
measure: ORR of PVTT
timeFrame: Up to approximately 2 years
measure: Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The first hospital of China medical university
state: Liaoning
Study officials:
References:
Clinical trial NCT02187406: Ankle Athletic Taping Fatigue After a Standard Tennis Warm up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Keywords: athletic tape
tennis
warm-up exercise
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Identify, quantify and compare the fatigue caused in two ankle athletic tapes after the completion of a tennis warm-up.


Eligibility criteria: Inclusion Criteria:

* There have been no ankle injury in the last 6 months (defined as any problem ankle injury that limited normal activity for more than 48 hours).
* Not having any neurological, circulatory or degenerative disease or to upset the balance in the lower limbs.
* Not having had any fractures or have undergone surgery on the lower limbs.
* No experience pain in the ankle at the time of the study.

Exclusion Criteria:

* Allergy to any of the materials used bandage
* Suffer an injury before taking the last measurement that prevented them from developing their sport normally.

Primary outcomes:
measure: Change in the Goniometry of the active range of movement
timeFrame: participants will be followed for the duration of a standard tennis Warm up, an expected average of 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
affiliation: San Pablo CEU University
name: Francisco García-Muro San José, MSc, PT
role: STUDY_DIRECTOR
affiliation: San Pablo CEU University
name: Serafín Álvarez Álvarez, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: San Pablo CEU University
name: Luis Fernández Rosa, Phd, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00799006: A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
Official title: A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Keywords: Single Ascending Dose Study in Overweight subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of approximately 27 to 35 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.
timeFrame: 4 days/dose group
measure: The single dose pharmacokinetics of PF-04620110 will be assessed
timeFrame: 4 days/dose group
Secondary outcomes:
measure: Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures
timeFrame: 1 day/dose group
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05974306: Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System
Official title: Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System: a Prospective Randomized Clinical Trial (VASCO)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Arrhythmias, Cardiac
Lead sponsor: Policlinico Casilino ASL RMB
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Vasco trial is a no profit, multicenter, international, prospective, randomized study designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and left ventricle ejection fraction (LVEF)\> 40% .The study will enroll about 331 patients (221 in the ILR group and 110 in the in-hospital follow-up group).


Eligibility criteria: Inclusion Criteria:

* Patients with heart failure, LVEF\> 40% who report episodes of palpitations.
* Over 18 years of age
* Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion Criteria:

* Subject who is, or is expected to be unavailable for follow-up
* Pregnancy
* Medical contraindications for ILR implantation
* Patients with PMK / ICD or with Indication for ICD / PMK implantation
* Cardiovascular events / myocardial revascularization in the previous three months
* Patients already on oral anticoagulant treatment
* Patients who do not want to use the telemonitoring system
* Presence of other recognized indications to ILR (Unexplained syncope, cryptogenic stroke/TIA, Transient loss of consciousness and recurrent falls)

Primary outcomes:
measure: Evaluate the benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and LVEF> 40% in the detection of significant clinical events.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03141606: Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response
Official title: Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Atrial Volume
Lead sponsor: Ospedale Borgo Trento - Verona
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 230
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 implanted with cardiac resynchronization therapy defirbillator devices and who meet the inclusion and exclusion criteria

Brief summary: Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset


Eligibility criteria: Inclusion Criteria:

* Patient with left ventricular ejection fraction ≤ 35%, II, III or IV NYHA Class, even if optimal medical therapy.
* Patients with standard indication to CRT according current guideline, sinus rhythm at implantation, LBBB and QRS duration \>= 120 ms
* Patients who will undergo to a new CRT-defibrillator system implantation
* Patients who are able to understand and sign the informed consent
* Patients who are able to attend all required follow-up visits at the study centerfor 24 months

Exclusion Criteria:

* Age \< 18 years
* Women who are pregnant or who are planning to become pregnant
* Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the 90 days preceding the implantation
* Patients with organic mitral valve disease
* Patients with prosthetic heart valves
* Patients who will undergo to upgrading from other devices (PM or ICD) to CRT, heart transplantation, patients with CRT devices

Primary outcomes:
measure: Cardiac remodelling
timeFrame: 6 months
measure: CRT Predictor Index
timeFrame: 6 months
Secondary outcomes:
measure: Clinical benefit
timeFrame: 12 months
measure: Cardiac remodelling
timeFrame: 6 months
measure: Atrial arrhythmias
timeFrame: 24 months
measure: Ventricular arrhythmias
timeFrame: 24 months
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: G. Panico Hospital
state: Italy/Lecce
city: Verona
country: Italy
facility: Borgo Trento Hospital
Study officials:
References:
Clinical trial NCT01347606: Secured Thyroidectomy With Intraoperative Methylene Blue Using
Official title: Prospective Randomized Technical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid
Keywords: thyroid
secure
surgery
methylene
blue
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2011-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: thyroidectomy indicated patients

Brief summary: Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using.

Detailed description: Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using. In the operation when thyroid lobes manipulated to medially, methylene blue will be sprayed to this area. Dying patternes of tissues (thyroid tissue, oparathyroid tissues, arteries, venules and neural structures) will ensure to identification the tissues.

Eligibility criteria: Inclusion Criteria:

* Thyroidectomy indicated patients

Exclusion Criteria:

* Recurrent disease
* Additional disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: erhan aysan, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03262506: Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults
Official title: Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is evidence that computerized cognitive training can improve cognition in healthy older adults and in people at risk of developing dementia, although an effective model to implement the training in the daily life of people and to ensure engagement is missing. This project studies the adherence, engagement and progress on computerized cognitive training exercises that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte and Brasilia) received licenses to perform the exercises on line and were followed by a team of psychologists. We will evaluate adherence, engagement and progress on the computerized cognitive training exercises of those subjects.


Eligibility criteria: Inclusion Criteria:

* To be an associate of ASASTEL, or the spouse of an associate,
* To have access to the internet at home and proficiency on accessing and navigating the internet,
* Availability to be evaluated and followed by the professional team.

Exclusion Criteria:

* Any medical condition that precludes performing the computerized training exercises,
* Score below 27 points in the Mini Mental State Examination (MEEM),
* Moderated or advanced dementia.

Primary outcomes:
measure: Training adherence
timeFrame: 1 year
Secondary outcomes:
measure: Individual gains on the computerized exercises
timeFrame: 1 year
measure: Motivation with the computerized training exercise
timeFrame: 1 year
measure: Training adherence (dichotomic variable)
timeFrame: 1 year
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: RJ
Study officials:
References:
Clinical trial NCT01369706: Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Official title: Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromagnetic Interference
Keywords: electromagnetic interference
hand-held metal detector
pacemaker
cardioverter-defibrillator
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 388
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: Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. airport controls.

The objective was to determine the safety of screening procedures for ferrous materials with regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for routine pacemaker or cardioverter defibrillator control
* appropriate PM/ICD function

Exclusion Criteria:

* atrial or ventricular sensing abnormalities that could not be avoided by reprogramming of device parameters
* low battery status of the device such as elective replacement indicator (ERI)
* intrinsic heart rate \> 120 beats per minute (bpm)

Primary outcomes:
measure: Electromagnetic Interference
timeFrame: time during exposure to hand-held metal detector (2x 30 sec)
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Athens
country: Greece
facility: Cardiology Department, Hospital "Henry Dunant"
Study officials:
affiliation: Deutsches Herzzentrum München
name: Clemens Jilek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum München
name: Christof Kolb, MD
role: STUDY_CHAIR
References:
citation: Jilek C, Tzeis S, Vrazic H, Semmler V, Andrikopoulos G, Reents T, Fichtner S, Ammar S, Rassias I, Theodorakis G, Weber S, Hessling G, Deisenhofer I, Kolb C. Safety of screening procedures with hand-held metal detectors among patients with implanted cardiac rhythm devices: a cross-sectional analysis. Ann Intern Med. 2011 Nov 1;155(9):587-92. doi: 10.7326/0003-4819-155-9-201111010-00005.
Clinical trial NCT03742206: Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder
Official title: Comparison of Parasacral Transcutaneous Electrical Stimulation With Transcutaneous Posterior Tibial Nerve Stimulation in Women With Overactive Bladder: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Urinary Urge Incontinence
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 68
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: Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women.

Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.

Detailed description: Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed

Main outcome: to measure changes in urinary urgency and quality of life.

Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of overactive bladder with or without the presence of urinary incontinence.
* Understand the instruments used in the research.

Exclusion Criteria:

* Urinary tract infection
* Neurological disease
* Other previous treatment in the last four weeks

Primary outcomes:
measure: Efficacy of treatment in quality of life
timeFrame: six weeks
Secondary outcomes:
measure: Severity of urinary incontinence
timeFrame: six weeks
measure: Severity of overactive bladder symptoms
timeFrame: six weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Suzana Mallmann
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: José Geraldo Lopes Ramos
role: PRINCIPAL_INVESTIGATOR
References: