cyrilzakka/clinical-trials huggingface dataset:
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY

This is a prospective, observational study on approximately 70-100 Real World participants affected by LGS, DS, or TSC treated with Epidyolex® as prescribed in the summary of product characteristics. The eligible participants are expected to participate in the study for a duration of 52 weeks of treatment.

This observational study evaluates a Real-World population of children and adult participants affected by LGS, DS, and TSC and the effect of therapy with Epidyolex® administered according to clinical practice on epileptic symptoms. The study will assess specific scales, questionnaires, and the satisfaction of the caregivers and the participants/tutors.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, and minor patients ≥ 2 years old diagnosed with LGS, DS or TSC.
* Clinical decision, taken by the physician, to initiate Epidyolex®
* Adult participants, parents or legal representatives must be willing and able to give informed consent/assent for participation in the study.

Exclusion Criteria:

* Participants currently using or have used recreational, medicinal cannabis, or cannabinoid-based products within the three months prior to study entry and are unwilling to abstain from these products for the duration of the study.
* Any reason, according to Investigator's judgment, able to compromise compliance with procedures outlined in the study There will not be any other specific exclusion criteria; however, contraindications, special warnings, and precautions for use as detailed in the Summary of Product Characteristics (SmPC) (particularly related to raising of aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and total bilirubin) will have to be considered by the treating physician.
A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors

This research aims to evaluate the absorption and elimination profile of a bioactive compound PEITC in the matrix of Nutri-jelly - a novel edible nutritious gel. Thus, the investigators conducted a pharmacokinetic study in 12 head and neck cancer survivors. After consumed a serving of Nutri-jelly containing 20 mg PEITC, plasma levels of PEITC at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by liquid chromatography-mass spectrometry (LC-MS/MS). Non-compartmental pharmacokinetic analysis was performed.

β-phenylethyl isothiocyanate (PEITC) is a phytochemical found in cruciferous vegetables with anti-cancer properties in vitro and in vivo. However, its pharmacokinetic profile in cancer survivors were unknown. A pharmacokinetic study was conducted in head and neck cancer survivors to evaluate the absorption and elimination profile of PEITC in the matrix of Nutri-jelly - a novel edible nutritious gel. Twelve head and neck cancer survivors consumed a serving of Nutri-jelly containing 20 mg PEITC. Plasma levels of PEITC at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by LC-MS/MS. Non-compartmental pharmacokinetic analysis was performed. Pharmacokinetic parameters including Cmax, Tmax, half-life, clearance were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age 20 or above
* Diagnosed with Head and neck cancer
* Completed radiation or chemotherapy since at least 4 weeks ago
* normal physical exam
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* Life expectancy \> 3 months
* Normal kidney function evidenced by serum creatinine, blood urea nitrogen (BUN), no kidney stone, no history of renal dialysis
* Normal liver function evidenced by serum bilirubin, aspartate transaminase (AST), alanine amino transferase (ALT)
* not pregnant or breastfeeding
* no psychiatric symptoms
* normal vital sign and normal blood chemistry including complete blood count CBC)
* provide voluntary inform consent

Exclusion Criteria:

* unable to communicate
* reject to take Nutri-jelly
* unable to refrain from vegetable intake for 3 days prior to the test
* take paracetamol during 2 days prior to the test
* body weight less than 35 kg or higher than 65 kg
* oral infection such as Candidiasis interfering with normal oral intake
Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).


Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent;
2. Normal nasal exam;
3. History of perennial allergic rhinitis;
4. Allergy to perennial allergen documented by allergy testing;
5. Age 12 years and older;
6. Must follow instructions;
7. Must make required study visits;
8. Negative pregnancy test and adequate birth control methods for females of childbearing potential;
9. Refrain from certain allergy medications during the study;
10. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Nasal disorders;
2. Use of substances that affect the nasal septum;
3. Exposure to industrial metal plating solutions;
4. Uncontrolled, severe, or unstable diseases;
5. Hypersensitivity to the study drug or nasal spray components;
6. Relative of site staff with access to the protocol;
7. Participation in another investigational study within 30 days or at the same time as this study;
8. Medical Monitor decision;
9. Other protocol-defined exclusion criteria may apply.
Intervention to Improve HIV Self-care Among People Who Inject Drugs

This study will implement a pilot randomized controlled trial (RCT, N=70) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among substance using HIV+ PWID sub-optimally engaged in HIV care.

Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). All participants will receive substance use treatment referral information if interested. Participants will be randomized to one of two treatment arms. Participants in both arms will receive a mobile application-facilitated incentivized directly observed therapy (iDOT) intervention. Participants in the control arm will receive iDOT alone. Participants in the intervention arm will receive iDOT in combination with the iSTRIVE intervention. After randomization, participants in the iSTRIVE intervention group will attend 6 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, cognitive restructuring, and assertive communication skills. Participants in the iSTRIVE intervention arm will also receive texts messages containing customized compassionate self-statements to enhance HIV-related self-care. All participants will be compensated for every research visit and adherence to the iDOT protocol.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* HIV virally unsuppressed (\>20 copies/mL) in past year or no past-year HIV viral load result
* Drug use behavior endorsed in past 6 months
* Able to provide informed consent
* 18 years or older
* English speaking

Exclusion Criteria:

* HIV negative
* Denying drug use in past 6 months
COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study

The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialization and quality of strut apposition to the vessel wall.

Background: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis.

Methods: Patients with complex bifurcation lesions with involvement of a significant side branch requiring a stent are randomized into two treatment arms. The first group of 20 patients (group I) is treated with the AXXESS Biolimus A9 Bifurcation Stent System (Devax, Inc, Lake Forest CA), where additional everolimus-eluting Xience V stents (Abbott Vascular, Santa Clara, CA) are implanted into the distal main branch and the side branch as required. The second group of 20 patients (group II) is treated with the culotte technique using everolimus-eluting Xience V stents. Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography (with QCA using dedicated software) and OCT (of both main vessel and side branch) is performed.

Assessment of Results:

1. EP: stent strut coverage and stent strut apposition, assessed with OCT at 9 months.
2. EP: restenosis, restenosis at SB ostium, MACE, stent thrombosis.

Eligibility Criteria:
Inclusion Criteria:

1. Patient older than 18 years
2. Written informed consent available
3. Patient eligible for percutaneous coronary intervention
4. Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1))
5. Target reference vessel diameter measured by QCA: 2-4 mm
6. Target lesion stenosis measured by QCA: \> 70% - \< 100%
7. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations

Exclusion Criteria:

1. Left ventricular ejection fraction of \< 30%
2. Impaired renal function (serum creatinine \> 2.0 mg/dl)
3. Previous and/or planned brachytherapy of target vessel
4. Lesion of the left main trunk \> 50%, unprotected
5. Known allergies to antiplatelet, anticoagulation therapy, contrast media or everolimus
6. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
7. Patients with a life expectancy of less than one year
8. Patient currently enrolled in other investigational device or drug trial
9. Patient not able or willing to adhere to follow-up visits
10. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study
11. Patient not able or willing to adhere to follow-up visits
12. Patients who previously participated in this study
EFFORT Further Extension Study

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who completed EFFORT extension study.
2. Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA \<9 Log copies/mL and ALT ≥2×ULN.
3. Patients who are willing to participate in the further extension study.
4. Patient is willing and able to comply with the study drug regimen and all other study requirements.
5. Patients must give written informed consent before any assessment is performed.

Exclusion Criteria:

1. Poor compliance judged by investigators
Waist Circumference Measurements in Schizophrenic Patients

The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients with MS have an increased incidence of DM, coronary heart disease and increased mortality from cardiovascular diseases. Central adiposity is highly correlated with the presence of hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD than either BMI or waist-to-hip ratio. However, currently there is no standard location for the measurement of WC.

Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males and females.

2. To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.


Eligibility Criteria:
Inclusion Criteria:

* • Patients with schizophrenia or schizoaffective disorder (DSM-IV 295) age 18 till 65 years old.

  * Body weight change less than 1 kg in previous one month before index date.

Exclusion Criteria:

* • Patients with a previous hyperlipidemia diagnosis or antilipemic prescription during the preceding 30 days.

  * Patients received any anti-hypertensives or oral hypoglycemic agents.
  * Pregnant or breast-feeding women.
The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia

Antiangiogenic drugs, such as bevacizumab, are a new treatment strategy in Hereditary Hemorrhagic Telangiectasia (HHT). Its systemic administration in patients with HHT improves liver damage-related symptoms and epistaxis (cases reported and on-going study-ClinicalTrials.gov Identifier #NCT00843440-). To limit the systemic adverse effects of bevacizumab and to ease administration, a local administration seems suitable.

A clinical case recently showed the benefits of bevacizumab nasal spray in these patients. Its results were confirmed in a characterization study on bevacizumab transport through porcine nasal mucosa (in press).

It seems necessary to assess the tolerance and efficacy of bevacizumab nasal spray in humans for the treatment of epistaxis in HHT with a prospective phase 1 study.

The primary objective of the study is to evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.

This phase-1, randomized, double-blind, placebo-controlled, monocentric study is to be carried out sequentially (dose escalation) on 5 groups of 8 patients. Each group is made up of 6 verum and 2 placebos.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients who give voluntary, informed consent and sign a consent form.
* Patients affiliated with the French universal health care system.
* Patients treated for HHT, that has been confirmed clinically (presence of at lease 3 Curaçao criteria) and/or by molecular biology.
* Patients who fill out epistaxis tally sheets completely in the three months before inclusion.
* Patients who present severe epistaxis averaging over 30 minutes in the three months before inclusion ((duration M1 + duration M2 + duration M3) / 3).
* Patients whose number of red blood cell transfusions in the six months before inclusion is known.
* Patients who have not undergone nasal surgery in the three months before inclusion.

Exclusion Criteria:

* Pregnant women or women who could become pregnant during the study.
* Patients not affiliated with the French universal health care system.
* Patients who are protected adults according to the terms of the law (French public health laws).
* Refusal to give consent.
* Patients whose HHT diagnosis has not be confirmed clinically and/or by molecular biology.
* Infectious episode.
* Patients presenting unchecked hypertension at the time of inclusion (systolic BP \> 150 mmHg and/or diastolic BP \> 100 mmHg) with or without treatment. -Patients with hypertension can be included, once blood pressure levels have been controlled by appropriate medical treatment.
* Participation in another therapeutic trial in the 28 days before inclusion. Patients who have already being treated with bevacizumab by intravenous infusion.
* A known hypersensitivity to the active substance or one of its excipients.A known hypersensitivity to products containing Chinese hamster ovarian (CHO) cells or to other human or humanized recombinant antibodies.
Activity Monitoring and Counseling in a Geriatric Population

The goal of the study is to determine if a Fitbit, a kind of accelerometer, provides feedback to subjects combined with an activity counseling program will result in an increase in physical activity of at least 20%.


Eligibility Criteria:
Inclusion criteria

* Volunteers from the public including subjects in the independent living section of Assisted Living Facilities between the ages of 65 and 85.
* Those over 85 may participate with their personal physician's consent.
* BMI 25-40 kg/m2 OR a waist circumference 88 cm or greater in women or 102 cm or greater in men
* Sedentary (no more than 30 minutes of vigorous or 90 minutes of moderate activity per week)
* Complete a Timed Get Up and Go test in \<= 20 seconds
* If walking is done with an assistive device, the subject must have no history of falling with the use of said device)
* Subjects will complete the Physical Activity Readiness Questionnaire - Revised (PARQ-R) which is as follows:

  1. Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?
  2. Do you feel pain in your chest when you do physical activity?
  3. In the past month, have you had chest pain when you were not doing physical activity?
  4. Do you lose your balance because of dizziness, or do you ever lose consciousness?
  5. Do you have a bone or joint problem that could be made worse by a change in your physical activity?
  6. Is your doctor currently prescribing drugs (for example, water pills) for your blood pressure or heart condition?
  7. Do you know of any other reason why you should not do physical activity? Subjects who respond "yes" to any of the above questions will require written permission from their physician to participate in this study.

Exclusion criteria:

* Significant cognitive impairment (score on Mini-Cog less than 3).
* Diabetics on medication
* Subjects who should not participate in an exercise program will not be eligible for the study.
* Angina or a history of myocardial infarction
* Cancer (other than non-melanoma skin cancer) will not be eligible.
* Uncompensated liver disease
* Uncompensated thyroid disease
* Severe osteoporosis
* Any medical condition which might lead to weight loss or weight gain
* Patients on the following medications: antidepressants (those on bupropion and stable doses of selective serotonin re-uptake inhibitors (SSRIs) and trazodone will be included), antipsychotics, topiramate, orlistat, or phentermine (Patients on statins will be eligible if no change in their medication is planned over the next 6 months)
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.

This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). SIM1803-1A is a drug that blocks the actions of these NTRK/ ROS1 /ALK genes in cancer cells and can therefore be used to treat cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists；Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion；Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month；Adequate hematologic, hepatic, and renal function；Signed informed consent form；

Exclusion Criteria:

* Any contraindications as listed in the local approved product information；Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible；Pregnancy or lactation；Clinically significant active cardiovascular disease or history of myocardial infarction；Participation in an investigational program with interventions outside of routine clinical practice；Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition；Active uncontrolled systemic bacterial, viral, or fungal infection；Current treatment with a strong CYP3A4 inhibitor or inducer；
A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease

Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body weight) hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation.

Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo:

1. brief medical history and vital signs,
2. full pulmonary function tests,
3. proton MRI,
4. spin-density and/or diffusion weighted Helium-3 MRI.

Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) will be performed according to ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.

Eligibility Criteria:
Inclusion Criteria:

* Subjects male and female aged 18-75 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, lymphangioleiomyomatosis (LAM) and Bronchiolitis obliterans organizing pneumonia (BOOP)
* Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
* Subject must be able to perform a breathhold for 16s.
* Subject is judged to be in otherwise stable health on the basis of medical history
* Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume in one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
* FEV1 \>25% predicted
* Forced Vital Capacity (FVC) \> 25% predicted and \>0.5Liters

Exclusion Criteria:

* Subject with a contraindication to Magnetic Resonance Imaging (i.e. ferrous implants, cardiac pacemakers). This will be determined through a screening form.
* Subject has a daytime room air oxygen saturation \<90% while lying supine.
* Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.
* Subject previously injured by a metallic object that was not removed.
* In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
* Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)