cyrilzakka/clinical-trials huggingface dataset:
AIMN Multicenter Study: 18 F-FDG PET-CT With or Without Contrast Medium in the Staging and Radiation of Lung Cancer?

Accurate staging of patients with non-small cell cancer (NSCLC) is of fundamental importance both for the correct choice of treatment plan and for prognosis. Numerous studies have demonstrated the added value of co-registration of functional PET images and anatomical CT images using hybrid PET-CT tomographs and the consequent benefits on the choice of treatment in patients with NSCLC. Currently in most PET centers CT is performed with a "low dose" technique and is used exclusively as a transmissive source for attenuation correction and anatomical localization. The availability of new generation hybrid tomographs allows for "diagnostic" CT examinations (contrast CT) to be performed with a standard dose of radiation and with the use of intravenous and/or oral iodinated contrast medium (contrast medium). Little data is currently available on the added value of a PET-CT scan performed in a single session compared to PET-CT performed independently and, generally, subsequently to CT scan.

The objective of the study is to evaluate the ability to correctly define the accuracy in localizing and characterizing lung "lesions" in patients with confirmed NSCLC, in the staging or restaging phase, through the use of: PET-CT "low-dose" and PET contrast CT.

The effects of the two procedures on the patient's quality of life and on the costs incurred by the patient and the healthcare service will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologically proven NSCLC, undergoing staging or restaging;
* plasma creatinine normal;

Exclusion Criteria:

* patients with lung microcytoma;
* pregnant women
Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery Diseases in Sohag Hospital University.

One of the most common medical approaches to the treatment of coronary artery disease (CAD) is the percutaneous coronary intervention (PCI) which became frequent due to high efﬁciency and safety of this procedure. Modern-day advances in pharmacotherapy and the device innovations over the last thirty years enhanced the benign outcomes of patients with unstable or multivessel CAD, and multiple co-morbidities, treated by PCI .

In-stent restenosis (ISR) is a recognized complication following percutaneous coronary intervention in which the luminal diameter is narrowed through neointimal hyperplasia and vessel remodeling. Although rates of ISR have decreased in most recent years owing to newer generation drug-eluting stents, thinner struts, and better intravascular imaging modalities, ISR remains a prevalent dilemma that proves to be challenging to manage. Several factors have been proposed to contribute to ISR formation, including mechanical stent characteristics, technical factors during the coronary intervention, and biological aspects of drug-eluting stents .identiﬁcation of risk factors and mechanisms underlying ISR is necessary for understanding the process, the risk stratiﬁcation, and optimal treatment development. Restenosis, as a physiological response to mechanical damage, involves two mechanisms which are neointimal hyperplasia and vessel remodeling \[3\]. Several factors such as age, diabetes mellitus, hypertension, stenting of small coronary arteries, and ﬁnal total length of stents have been shown to be associated with an elevated risk of restenosis.


Eligibility Criteria:
Inclusion Criteria:

* patients with CAD

Exclusion Criteria:

* PATIENTS WITHOUT OTHER HEALTH PROBLEMS
MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)

Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic colorectal cancer.

This Phase Ib/II study investigated the anti-tumor activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male participants affected by PIK3CA-mutated, neuroblastoma-Kristen-rat sarcoma virus (N-K-RAS) wild-type, and BRAF wild-type metastatic colorectal cancer.

MEN1611 is a potent, selective class I phosphoinositide 3-kinase (PI3K) inhibitor. The maximum tolerated dose of MEN1611 given as single agent was assessed in a Phase I trial in participants with advanced solid tumors.

This Phase Ib/II started with a dose confirmation part (Step 1) to identify the recommended phase 2 dose of MEN1611 given in combination with cetuximab.

The study continued with a cohort expansion (Step 2) to explore the anti-tumor activity of the selected MEN1611 dose level combined with cetuximab with further assessment of safety and tolerability.

Eligibility Criteria:
Main Inclusion Criteria:

* Histological documentation of adenocarcinoma of the colon or rectum.
* Progression or recurrence following prior irinotecan, oxaliplatin, 5-fluorouracil (5-FU) and anti-epidermal growth factor receptor (EGFR) containing regimens for metastatic disease.
* Best response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria to the last anti-EGFR containing regimen of partial response or stable disease for at least 4 months.
* Measurable disease according to RECIST criteria.
* N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated.
* Eastern Cooperative Oncology Group performance status of 0 or 1.

Main Exclusion Criteria:

* Previous treatment with PI3K inhibitor.
* Brain metastases, unless treated \>4 weeks before screening visit and only if clinically stable and not receiving corticosteroids.
* National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≥2 diarrhea.
* History of significant, uncontrolled or active cardiovascular disease.
* Known active or uncontrolled pulmonary dysfunction.
* Uncontrolled diabetes mellitus (glycated hemoglobin \>7%) and fasting plasma glucose \>126 milligrams/deciliter.
* Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus.
* Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.
Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children

Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol.

The objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included in the study.

Children who meet the inclusion criteria will be alternately distributed in two groups:

Group 1:

Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.

Group 2:

Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation.

Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with acute bronchiolitis.

Exclusion Criteria:

* Children with congenital heart disease or
* chronic lung diseases
3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions

The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were treated for calcified femoropopliteal lesions (de novo, single or multiple, mono- or bilateral) between December 1, 2016 and December 31, 2020 at the Clinique Rhône-Durance, Avignon, France

This study is a non-interventional, retrospective, descriptive, single-centre study of adult male and female patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions, in order to assess the long-term clinical effects of this treatment.

The study will be conducted at the Clinique Rhône-Durance. Data on the management of all adult patients with calcified femoropopliteal lesions treated with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 will be collected and recorded for analysis.

Eligibility Criteria:
Inclusion Criteria:

* treated for femoropopliteal lesions with Jetstream atherectomy in combination with a Ranger paclitaxel-eluting balloon (Drug Coated Balloon (DCB)) between 1 December 2016 and 31 December 2020.
* Informed and not opposed to the use of their data in this study.

Exclusion Criteria:

* None.
Co-transplantation of MSC in the Setting of Allo-HSCT

Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged \<65 years
* Willing to transplant
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of MSCs.
Trial of Cannabis for Essential Tremor

This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.

Essential tremor (ET) is the most common neurological movement disorder, affecting up to 1% of the population and up to 5% of individuals over the age of 65. ET is characterized by often disabling tremors that occur when an individual moves. The tremors most commonly affect the hands, head, voice, and legs in order of frequency, leading to impairment in activities of daily living and morbidity. No pharmacological agent has been developed for ET, though existing agents such as propranolol and primidone are used off-label to reduce tremor amplitude. Deep brain stimulation surgery is often reserved for only individuals with the most severe tremors. Patients with ET have long reported tremor benefits with the use of cannabis, though no controlled trials have been conducted. The investigators plan to conduct the first double-blind, placebo-control clinical trial of cannabis in an oral capsule. Various validated tremor rating methods will be used to quantify tremor severity, while looking at tolerability and safety.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ET by a Movement Disorder Neurologist
* Stable dose of tremor medication for a period of at least 6 weeks prior to screening
* Tremor in the arms
* Tremor(s) is/are moderately severe (amplitude of at least 1cm)

Exclusion Criteria:

* Significant non-ET related abnormal findings on neurological exam
* Tremor at rest, or other features suggestive of Parkinson disease
* Diagnosis of dementia
* Pregnant or nursing
* Childbearing potential and unable or unwilling to use contraception during course of the trial
* On medications known to interact with the study drug
* Current or prior history of alcohol or substance abuse
* Recent exposure to primidone (within the past 21 days) or benzodiazepines (such as Valium, Ativan or Klonopin), ketoconazole, ritonavir, clarithromycin, rifampin, carbamazepine, St. Johns Wort, digoxin or other medications known to affect your liver enzymes (within the past 7 days).
* Unwilling to abstain from consuming grapefruits, grapefruit juice or grapefruit containing products.
* Taking medications such as warfarin, cyclosporine, and amphotericin B that are highly protein-bound
* Do not wish to take a cannabis-derived agent
* Allergy or sensitivity to sorbitol, xylitol, stevia or other natural sweeteners
* Allergy or sensitivity to cannabis
* Used cannabis or a cannabis-derived product (such as CBD oil) within the past 4 weeks or plan to use it during this research study.
* Diagnosis of a psychiatric disorder (e.g., mania, bipolar depressive disorder, schizophrenia, schizoaffective disorder, or other major psychiatric disorder)
* Current or prior history of suicidal thoughts and/or behavior
* Active medical problem affecting the immune system, liver, gastrointestinal tract, lungs, heart, endocrine system (such as diabetes and/or thyroid), and/or a blood clotting disorder
* Current infection
* Reduced kidney function (GFR \<60)
Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).

Patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. These symptoms are called Behavioural- and Psychological Symptoms in Dementia (BPSD), and are difficult to treat. Antipsychotic and antidepressant medication is in use, despite its lack of clinical evidence.

We will discontinue antipsychotics in one group of 12 patients and antidepressants in one group of 12 patients. Patients should have dementia of Alzheimer- or vascular origin. They should live in Nursing Homes and have no other psychiatric disease for which they receive psychotropic drug. They will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. The study period is 24 weeks. The questionnaires are filled in by the patients and the nurses at the nursing homes.

This is an open labelled study with no control group. Based on the results of this study, we will design a RCT study with placebo-controlled group.

Eligibility Criteria:
Inclusion Criteria:

* Vascular- or Alzheimer Dementia
* Nursing Homes resident for 3 months or more
* Given antipsychotics or antidepressants for 3 months or more
* Clinical Dementia rating 1, 2 or 3

Exclusion Criteria:

* Dementia of other origin
* Psychiatric disease
* Life expectancy less than 3 months
* Acute infection last 10 days
* Unstable Diabetes Mellitus
* Terminal disease
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

Primary Outcome Measures:

Decrease in rate of serum PSA rise

Secondary Outcome Measures:

Adherence to treatment regimens

Quality of life as assessed by FACT-P at baseline and at 12 months of treatment

Modulation of serum testosterone,isoflavone metabolites, and cholesterol

Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

* Pretreatment evaluation included a complete medical history, physical examination (including digital rectal examination), serum PSA, free/total testosterone, lipids, serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of life (Functional Assessment of Cancer Treatment-Prostate, FACT-P questionnaire).
* Whole blood will be obtained prior to initiation of the study to assess for DNA polymorphism.
* Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment.
* Medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Raising serum PSA profile after previous definitive therapy (e.g., radical prostatectomy or external beam radiation therapy).
* Life expectancy of at least one year and performance status of \<2 of Zubrod scale.

Exclusion Criteria:

* Metastatic or locally recurrent disease demonstrated on bone scan, computed tomography or transrectal ultrasound, or be clinically symptomatic at the time of enrollment
* No androgen deprivation therapy (ADT) or chemotherapy within 12 months of entry into the study.
* Known allergic reaction to milk or soy products were excluded.
Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.

Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects will perform two tests for binaural integration (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds perception.

Cochlear implantation is the most efficient method to restore hearing in deaf patients. However, about 2/3 of patients have some residual hearing and these patients usually combine two types of auditory information (electrical and acoustical). It is important to know how the brain is processing during two distinct stimulations and how it is related to the auditory level of performance.

Patients and controls will undergo a positron emission tomography scan brain imaging session during a simplified voice/non-voice discrimination task. For each tasks and brain imaging sessions, patients will be stimulated either with the non-implanted ear (acoustical stimulation), the cochlear implant (electrical stimulation) and using both modalities in a binaural condition.

Eligibility Criteria:
Inclusion Criteria:

* cochlear implantation\>3 months
* signature of informed consent
* affiliation to social service.

Exclusion Criteria:

* associated neurological disorder
* protected subjects
* epilepsy episodes
* psychotropic medication
* pregnancy
Online Memory Intervention for Individuals with Traumatic Brain Injury

This study will examine the behavioural and neurophysiological efficacy and feasibility of an online spatial navigation intervention for improving memory and brain health in individuals who have sustained moderate-severe traumatic brain injury.

The memory impairments associated with moderate to severe traumatic brain injury can be debilitating to younger and older adults, and can prevent a person's return to work, school and social life. The "hippocampus" is a ubiquitously compromised memory brain structure in moderate-severe TBI. Unfortunately, not only does the hippocampus sustain the damage at the time of injury, but researchers have identified that it shows continued atrophy in the months and years following injury. The investigators has developed a promising behavioural intervention for arresting this shrinkage, enhancing the integrity of the hippocampus - and improving memory function. It entails engagement in novel, continuous and challenging allocentric spatial navigation, that is, learning new routes of cities, and making a map in one's head of those routes for 1 hour/day, 5 days per week for a period of 16 weeks. N=87 participants will be randomized to either the intervention group or an active control group that will watch 3 TedTalk videos per day, 5 days a week for the same duration. An MRI scan and cognitive measures focusing on memory and spatial navigation will be conducted before and after participation.

Eligibility Criteria:
Inclusion Criteria:

* acute care diagnosis of m-sTBI
* PTA of 24 hours or more and/or lowest GCS \<13
* positive CT or MRI; (4) between 18 to 55 years of age
* fluency in English; (6) competency to provide informed consent or availability of a legal decision maker
* basic computer skills (use of internet/email, mouse and arrow keys)
* functional use of at least one upper extremity for computer use
* resident of Greater Toronto Area (to facilitate access to the MRI).

Exclusion Criteria:

* neurological disorder other than TBI (e.g., dementia, stroke)
* diagnosis of a neurodevelopmental disorder
* TBI sustained before age 18
* systemic comorbidities (e.g., lupus, diabetes)
* current diagnosis of aphasia
* presence of metal inside the body (e.g., surgical clips, pacemaker) leading to ineligibility for an MRI.
MelaFind Evaluations for Patients With Multiple Nevi

We have added objectives 4-6 to our updated study:

Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient.

Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify "signature" lesions.

Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity.

Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics.

Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion.

Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.


Eligibility Criteria:
Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria:

Inclusion Criteria:

* The lesion is pigmented (i.e., melanin, keratin, blood)
* The diameter of the pigmented area is not \< 2 mm, and not \> 22 mm
* The lesion is accessible to the MelaFind
* The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form;

Cutaneous lesions that meet any of the following exclusion criteria will not be accepted:

Exclusion Criteria:

* The patient has a known allergy to isopropyl alcohol
* The lesion has been previously biopsied, excised, or traumatized
* The skin is not intact (e.g., open sores, ulcers, bleeding)
* The lesion is within 1 cm of the eye
* The lesion is on mucosal surfaces (e.g., lips, genitals)
* The lesion is on palmar hands
* The lesion is on plantar feet
* The lesion is on or under nails
* The lesion is located on or in an area of visible scarring
* The lesion contains foreign matter (e.g., tattoo, splinter, marker)