cyrilzakka/clinical-trials huggingface dataset:
Vektor vMap™ Clinical Validation Study

This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™).


Eligibility Criteria:
Inclusion Criteria:

1. Patient has one of the following clinical arrhythmia/pacing types:

   * Atrial pacing
   * Atrial fibrillation
   * Ventricular pacing
   * Premature ventricular complex
   * Ventricular tachycardia
   * Ventricular fibrillation
   * Focal atrial tachycardia
   * Premature atrial complex
   * Atrioventricular reentrant tachycardia
2. Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.
3. Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
4. Patient has undergone a successful ablation procedure.
5. Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
6. Patient was between 22 and 100 years of age at time of EP study and ablation procedure.

Exclusion Criteria:

Patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset.
Sleep, Pain and Stress in Adolescents With Persistent Pain

The main aim is the gain information of sleep structures in adolescents with persistent pain. Also to study simple interventions to support their sleep and pain management. The main aim of this study is to test the efficacy and feasibility of suggestive presleep relaxation technique in improving sleep quality and sleep-related emotional memory processing.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 15-17 years with persistent (\> 3months) pain reporting average pain intensity over 3/10 on the Numerical Rating Scale (NRS).

Exclusion Criteria:

* ongoing medication for sleep or pain.
EUS-guided Laser Ablation in Pancreatic Adenocarcinoma

This study evaluates the possibility of performing local therapy for PDAC using laser ablation of the tumor under ultrasonography (EUS) guidance.

Safety of the procedure as well as post procedural quality of life will be also evaluated.

Pancreatic adenocarcinoma (PDAC) is projected to be the second cause of cancer death in Western societies within a decade. Management include chemotherapy and/or radiation therapy, while resectable disease is possible only in 15% of cases.

Despite these therapeutic approaches, the survival rate of unresectable pancreatic cancer remains disappointing. Recently, there is a growing interest in the development of alternative therapeutic approaches, which can work in parallel with standard chemoradiation therapy. These methods include intra-lesion injection/instillation of antitumoral agents performed through a laparoscopic approach, or percutaneously or under endoscopic ultrasound (EUS) guidance and tumor volume reduction procedures using ablative techniques.

In this context laser ablation has been reported to be effective in inducing coagulative necrosis of the tumour in absence of major adverse events. However, the available studies on the matter are limited by small sample size, lack of extended follow up and informations about the possibility to ablate the entire tumour mass.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of pancreatic ductal adenocarcinoma
* Unresectable advanced, non-metastatic Stage III tumor
* Stable disease without regression or progression after 6 months of chemotherapeutic treatment
* Locally progressive disease after chemiotherapy, without evidence of metastases
* Age \>18 and \<80 years
* Willing to be followed up c/o the Fondazione Policlinico A. Gemelli University Hospital
* Signed informed consent

Exclusion Criteria:

* Stage I, Stage II, Stage IV disease
* Absolute contraindications to general anesthesia or deep sedation
* Absolute contraindications to perform digestive endoscopy
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
* Use of anticoagulants that cannot be discontinued
* International Normalized Ratio (INR) \>1.5 or platelet count \<50.000
* Pregnancy or lactation
* Unable to sigh informed consent
pBFS Guided Precision Neuromodulation Treatment for ASD

This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.

Autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. Using the developed technique, personalized brain functional sectors (pBFS), we could precisely identify individualized brain function networks based on the resting-state functional MRI scan. A tailored dorsal lateral prefrontal cortex (DLPFC) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (DMPFC) region situated within the social network will be selected as intervention targets.

The participants will be equally randomized to the following three groups, active iTBS to the left DLPFC, active iTBS to the left DMPFC, and sham iTBS to either the left DLPFC or left DMPFC at a ratio of 2:2:1:1. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions.

Eligibility Criteria:
Inclusion Criteria:

* 6-30 years old
* Have the diagnosis of autism spectrum disorder
* ADOS-2 score is higher than the ASD cut-offs
* Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
* Participant's parents or other legal guardians give informed consent

Exclusion Criteria:

* Current or history of psychotic disorders, such as schizophrenia, bipolar disorder
* Severe self-injury or suicidal behavior presented in the last 1 year
* Severe visual, auditory, or motor disability that interferes with any study procedure
* Current, history or family history of epilepsy
* Known severe physical diseases, such as congenital heart defects, traumatic brain injury
* Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
* Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
* Currently participating in other clinical trials
MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning

Many patients with brain tumors require surgery. Some patients have brain tumors near important parts of the brain. These brain areas have roles in language or motor function. Avoiding these motor and language areas helps to prevent neurological deficits. The investigators are studying the parts of the brain involved in motor and language. Patients usually get functional MRI (fMRI) or resting-state fMRI (rs-fMRI) for gray matter mapping and diffusion tensor imaging (DTI) or diffusion spectrum imaging (DSI) for white matter mapping. These special MRI sequences are used to plan surgery. Patients are scheduled to have imaging to help plan for possible surgery.

Some patients may require stimulation during surgery to motor and language areas. In patients who require stimulation as part of their standard of care, the investigators will compare the investigators imaging results with the stimulation results. The purpose of this study is to improve MRI mapping of the motor and language pathways in the brain.

The scans are necessary stimulation for this protocol are part of the standard of care. In other words, these tests are done as part of the best possible care even if they did not join this study. The investigators are studying new techniques for analyzing the MRI data. These new techniques may give the doctor a better view of where the brain tumor is located relative to important parts of the brain.

The investigators will only perform the test sequences that are necessary for mapping the tumor. Most patients will require both fMRI and DTI. Some patients may only require fMRI or DTI. The investigators may also ask to perform optional sequences during the scan. Multi-echo is an modified form of fMRI. DSI is a modified form of DTI. These optional sequences are for research only. The patient would not get these sequences if they do not enroll in this study.


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary brain tumor (enhancing mass lesion ± nonenhancing abnormality), known or suspected, located near (\< 2 cm) any portion of the motor cortex, motor pathway, language cortex, or language pathway as determined on anatomical images;
* Planned resection of the tumor;
* fMRI and/or DTI required for preoperative imaging as part of the standard of care
* Patient and/or guardian is able to provide written informed consent prior to study registration
* Age ≥ 18 years old

Exclusion Criteria:

* Unable to tolerate MRI and/or perform fMRI tasks (e.g., severe claustrophobia or pacemaker or aneurysm clip that precludes MRI scan)
* Pregnant or nursing female
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis

In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.


Eligibility Criteria:
Inclusion Criteria:

* 20-45' degrees of cobb's angle in the neuromuscular disease

Exclusion Criteria:

* patient's who had spinal surgery
* less than 20 degree or more than 45 degree of cobb's angle
* acute lumbar pain
BMS-184476 in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-184476 in treating patients who have advanced solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended phase II dose, and safety of BMS-184476 in patients with advanced solid tumors. II. Determine the pharmacokinetic profile of BMS-184476 and its metabolites in these patients. III. Determine preliminary evidence of antitumor activity of BMS-184476 in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive BMS-184476 IV over 1 hour. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. In the second part of the study, patients receive BMS-184476 IV over 1 hour weekly. Cohorts of 3-6 patients are treated at escalating doses of BMS-184476. The maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity. Patients are followed every 4 weeks until toxicity is resolved.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumors refractory to conventional anticancer therapy, or for which no effective therapy exists Measurable or evaluable disease No active brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No uncontrolled or significant cardiovascular disease No myocardial infarction within past 6 months No congestive heart failure (with or without therapy) No history of atrial or ventricular arrhythmias No history of second or third degree heart block Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious uncontrolled medical disorder or active infection No known hypersensitivity to drugs containing Cremophor EL No concurrent neurologic toxicity No dementia or altered mental status

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas, mitomycin, or carboplatin) Prior taxane therapy allowed No other concurrent chemotherapy Endocrine therapy: At least 1 week since prior steroid therapy No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior wide field radiotherapy (involving at least 30% of the bone marrow) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental anticancer medications
Radiofrequency Non-ablation in the Treatment of Women With Urinary Stress Incontinence: Study Pilot

Pilot study, case series conducted in women with a clinical diagnosis of urinary incontinence and were treated with radiofrequency technique for capacitive transfer non ablative in external urethral meatus. All participants did an hour Pad Test. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Tonederm® brand device with capacitive transfer method using non-ablative handle with electrode in the region of the external urethral meatro and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration of 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.


Eligibility Criteria:
Inclusion Criteria:

* The target audience was made up of women aged between 18 and 65 years with a diagnosis of stress urinary incontinence, referred for physical therapy and who had Pad Test positive criteria by International Continence Society

Exclusion Criteria:

* Were excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of copper and pregnant women
Motion Sickness on Astrolabe's Vessel

Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions Astrolabe, sometimes there is a risk of very significant dehydration. A special unit specialized in the fundamental study of the vestibular system (inner ear), sensory organ at the base of visual-vestibular conflict inducing this syndrome, also provides medical support for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly present. The goal of the study is to assess the frequency of occurrence of this sea sickness syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality traits, anxiety / stress) without changing habits on board for those on board taking a antinaupathique treatment given by the ship's doctor. This study will be done in collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER specialized in extreme environments (Belgium). The ultimate goal will be to provide the best recommendations and the best treatment regimen to alleviate as best as possible the symptoms of people on board of the Astrolabe so scientists on board can perform their work.

Background: The objectives were to assess the prevalence, severity, medication taken and to look for predictive factors, in order to better identify characteristics of passengers at risk of motion sickness during transport scientists travelling from Hobart in Tasmania to the French polar stations in Antarctica.

Methods: Two hundred and thirty-nine passengers were surveyed over 4 years with 4 round trips per year using Motion Sickness Susceptibility Questionnaire (MSSQ), Simulator Sickness Questionnaire (SSQ), state-trait anxiety test (STAI-Trait and STAI-State), and general parameters (age, gender, number of trips, jet-lag, direction of the trip), medication, calculation of the distance of each passenger's cabin to the Centre of Gravity (CoG.).

Eligibility Criteria:
Inclusion Criteria:

* participant aged of 18 or older but younger than 70 who received their medical ability to travel to Terre Adélie or making a research cruise aboard the Astrolabe
* particpant signing the informed consent.

Exclusion Criteria:

* none
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis

A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18-65 years of age at time of consent
* Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
* At randomization, moderate to severe psoriasis as defined by:
* PASI score of 12 or greater and,
* IGA score of 3 or greater and,
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
* Female patients may be included according to the following:

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment.

• Male subjects must agree to comply with two highly effective contraceptive methods

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis)
* Ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
* Previous treatment with IL-17 or IL17R blocking agents, including secukinumab
* Any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of CJM112 or secukinumab
* Evidence of active tuberculosis at screening
* Active systemic infections (other than common cold)
* Pregnant or nursing (lactating) women
Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality

To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal administration of Nitroglycerin. Aim of this prospective research study is to investigate equivalence on image quality after sublingual or transdermal Nitroglycerin administration (H0).

Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Scheduled cCTA with contrast.
2. Able to comprehend and sign the consent form.

Exclusion Criteria:

1. Known hypersensitivity to glyceryl trinitrate, and related organic nitrates.
2. Acute circulatory failure associated with marked hypotension (shock).
3. Conditions associated with elevated intracranial pressure, cerebral haemorrhage and head trauma.
4. Closed-angle glaucoma.
5. Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®), tadalafil (Cialis), or vardenafil (Levitra) within the last 24 hours
6. Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
7. Critical aortic stenosis
8. Systolic blood pressure \< 90 mmHg
9. Pregnant or lactating female; premenopausal women with a positive urine pregnancy test.
10. Age under 18
11. Unwilling or unable to inform consent.
Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors

This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).

Patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pNET) were randomized to either BEZ235 or everolimus. The study was planned to include 140 patients, with 70 patients in the BEZ235 treatment group and 70 patients in the everolimus treatment group. An interim analysis was conducted on 62 randomized patients. The study was terminated as the BEZ235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.

Eligibility Criteria:
Inclusion Criteria:

* Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor
* Progressive disease within the last 12 months
* Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT

Exclusion Criteria:

* Prior treatment with mTOR or PI3K inhibitors
* Patients with more than 2 prior systemic treatment regimens
* Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4 weeks

Other protocol-defined inclusion/exclusion criteria may apply
Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)

The purpose of this study is to describe the postoperative outcomes after laparoscopic transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of our experiences from the previous study to optimize the postoperative outcomes.


Eligibility Criteria:
Inclusion criteria:

1. Patient between 25-80 years old.
2. Diagnosed as Cancer Renis
3. Can read and understand Danish
4. No cardiac disease lead to close cardiologic observations
5. Any T, any N any M stadia.

Exclusion criteria:

1. Mentally sick patient
2. Dement
3. Living alone
4. Cardiac problem
5. Per operative bleeding with the need to blood transfusion
6. Operation time at afternoon