cyrilzakka/clinical-trials huggingface dataset:
Phase II Study Evaluating a Combination of Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy With High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.

The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.

This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cerebral lymphoma B cell refractory or relapsed within 12 months after first-line chemotherapy with high-dose methotrexate (1.5 g / m²) and high dose cytarabine (2g / m²) and / or radiotherapy or autologous, or patient with an indication against these treatments.

Refractory disease is defined by the absence of objective response to treatment or relapse within 3 months of it. A relapse is defined as disease progression after obtaining a complete or partial response.

* Age greater than or equal to 18 years
* Performance Index less than 4
* Illness measured by CT or MRI
* Hematologic adequate: neutrophils\> 1.5 x 106 / L, platelets\> 100x106 / L
* Adequate hepatic function: ALT / AST and bilirubin less than the upper limit of the normal laboratory
* Adequate renal function: creatinine clearance greater than 60 ml / min
* adequate cardiac function measured by ejection fraction of the left ventricle\> 50% by echocardiography
* Informed consent signed
* Negative pregnancy test for women of childbearing age
* Able to understand the arrangements for monitoring the study and to comply
* Corticosteroids are only accepted during the first cycle

Exclusion Criteria:

* Patients with immunosuppression from any cause (HIV, history of transplantation, immunosuppressive treatments ...)
* Prior treatment MYOCET ® or other anthracycline
* Active infection
* Surgery large (more than 3 days hospitalization) within 28 days before enrollment in the study, except for a diagnostic neurosurgical
* Hypersensitivity to any component of the treatment
* Contraindications to the administration of MYOCET ® and / or dexamethasone Participation in a clinical trial within 4 weeks prior to study entry
Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families

This trial develops a patient-driven self-navigated web-based family outreach program for cancer prevention in high-risk families. Creating the family outreach program may help to improve the way in which genetic test results are communicated within families and increase the number of at-risk relatives who become aware of their risks.

PRIMARY OBJECTIVES:

I. To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG).

II. The long-term goals of this program are expected to include, but are not limited to the following:

IIa. To enable families with inherited cancer susceptibility and/or at increased familial risk of cancer to provide personal and family history of neoplasia through a convenient and self-directed program.

IIb. To enable communication of possible inherited cancer susceptibility with and among family members through the web-based portal.

IIc. To facilitate genetic testing, screening and prevention strategies in those at risk.

IId. Establish high-risk cohort for optional participation in research and clinical trials.

OUTLINE:

Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow-up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have been diagnosed with a hereditary cancer-causing mutation. Individuals may be identified through clinical testing as patients at MD Anderson or patients whose mutation was identified at an outside institution who contact the registry
* Individuals that have clinical suspicion for syndromic cancer susceptibility, but in whom mutational testing has been nondiagnostic (depending on condition in question, nondiagnostic testing may be as little as 10%, as in familial adenomatous polyposis \[FAP\], or as high as 70% in suspected hereditary diffuse gastric cancer or HDGC)
* At-risk family members of individuals with a cancer causing mutation or of individuals with nondiagnostic testing notwithstanding presence of likely syndromic cancer. Such patients will in most cases not be MD Anderson patients. Note: The enrollment, consenting, and evaluation process anticipates and addresses this.

Exclusion Criteria:

* Index patients who test negative for a cancer causing mutation, except for those agreeing to provide family history (FH) that is informative for at-risk individuals when no other source of such information is available
* Patients who are unwilling or are unable to provide informed consent
Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

Prevenar 13 is safe for administration to Filipinos.

Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.

Eligibility Criteria:
Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine
Training in Exercise Activities and Motion for Growth

To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.

This is a non-randomized pilot study to evaluate the safety and feasibility of an exercise program in hospitalized infants with single ventricle physiology. Following the Norwood procedure, the intervention will be administered for up to 21 days or until discharge, whichever comes first. Data will be collected daily during hospitalization and at a follow-up visit at 3 months of age. Sources of data will include medical record review. Twenty subjects will be enrolled at three Pediatric Heart Network study sites (Utah Primary Children's Hospital, Children's Hospital of Philadelphia and Texas Children's Hospital). Subjects will be recruited following Institutional Review Board (IRB) approval at each institution and parental/legal guardian consent.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized infants with SV physiology
* \>37 weeks gestation
* \<30 days of age
* Hemodynamically stable (as defined by the attending physician) after surgical or interventional palliation with closed sternum
* Parent or guardian willing to comply with protocol and provide written informed consent

Exclusion Criteria:

* Intrauterine growth restriction
* Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan or Turner syndromes)
* Unstable hemodynamics as defined by the attending physician
* Non-cardiac diagnosis associated with growth failure
* Severe neurologic injury resulting from stroke or intracranial hemorrhage confirmed by head CT/ MRI or cranial ultrasound
* Anticipated discharge within 14 days of screening
Determination of Reference Values for Diluted Russell's Viper Venom Time (dRVVT) Specific to Pregnant Women (GRAPL)

Pregnancy is associated with significant changes in several aspects of haemostasis, especially an imbalance between procoagulant and anticoagulant factors. These changes contribute to creating a state of hypercoagulability, mainly at the end of pregnancy and during the post-partum period, protecting pregnant women from delivery haemorrhage, but exposing them to a major thromboembolic risk.

Vascular diseases of pregnancy (VDP) are obstetric diseases which are linked to an ischaemic origin associated with placental thrombosis. These include pre-eclampsia, retroplacental haematoma, intrauterine growth retardation and even foetal death in utero. A number of risk factors have been identified for these VDPs, some of which have extremely serious consequences, the main one being antiphospholipid syndrome (APS).

The diagnosis of VDP in a current or previous pregnancy requires close monitoring and joint management by an obstetrician, haemostasis physician, internist and medical biologist, particularly in terms of pre, peri- and post-partum anticoagulation in patients at increased risk of thromboembolism.

The aim of treating APS during pregnancy is : to reduce the occurrence of maternal arterial or venous thrombotic complications in one hand and in the other hand to reduce the occurrence of obstetric complications, which are responsible of a significant morbimortality rate. The detection of a possible APS during pregnancy will therefore determine the specific management of patients.

The latest guidelines from the Groupe Français d'Etude sur l'Hémostase et la Thrombose (GFHT) in 2022 recommended a diluted Russell's viper venom time (dRVVT) and an activated partial thromboplastin time (APTT) measured using a sensitive reagent such as silica (SCT) should be used to assess the presence of LA.

Please remove all personal pronouns. For example, please change "we" to "the investigators" and "you" to "participants." The "Control + Find" function (Ctrl+F) can be used to locate personal pronouns throughout the record.

Eligibility Criteria:
Inclusion Criteria:

Control group :

* patients with normal pregnancies at the HCL.
* Affiliation to a social security regime

Case group :

* Patients followed at the HCL who had an increased dRVVT ratio during pregnancy, investigated as part of the development of VDP during pregnancy.
* Affiliation to a social security regime

Exclusion Criteria:

* History of thromboembolic disease
* History of autoimmune disease
* History of VDP
Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis

The purpose of this study is to determine whether nabilone (Cesamet) when used as an adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over gabapentin alone for the management of neuropathic pain in MS.

Neuropathic pain syndromes, which occur due to damage to central and/or peripheral nerve axons, are often more difficult to manage and are commonly refractory to the conventional analgesia approach described by the World Health Organization, including NSAIDs and narcotic agents. These pain syndromes are often described by symptoms of burning, stabbing, crawling, shock-like, numbness and/or tingling, and can be quite concerning to the patient, especially when there is an inadequate response to treatment. It has been estimated that the prevalence of chronic pain in MS ranges anywhere from 30-90%, placing it as the second worst disease-induced symptom experienced by this patient population.

The pathophysiologic causes of this pain syndrome are complex and multifaceted, with no one specific link attributed to the pain response. Due to the complexity of neuropathic pain - which is only partially understood at best - it may be necessary in many cases to treat the source of the pain with more than one agent in order to address the many different contributors to this pain process. More thorough review of how the currently available agents for NPP work together would provide clinicians with safety and efficacy data which would aid in providing optimal pain management.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18-65 years old with clinically definite RRMS
* EDSS of \< 6.5
* Current treatment with gabapentin that is not effective at a stabilized dose of (\>1800mg/day) for at least 1 month.
* Visual Analogue Scale score for NPP symptoms \> 5; pain present for at least 3 months
* Negative serum pregnancy test for all females of childbearing age; not currently breastfeeding
* No history of alcohol or substance abuse
* No history of non-psychotic emotional disorders
* No significant hepatic or renal insufficiency
* No significant cardiovascular disease or hypertension
* No known hypersensitivity and/or allergy to nabilone or its derivatives
* No current use of cannabinoid or related products
Quality of Preanesthesia Teleconsultation : a Randomized Controlled Trial.

Since the publication of the law " Hôpital, Patients, Santé, Territoire " of 2009 in France, the development of telemedicine is a public health issue. It is also a government priority registered in the government investment plan of 2017-2018.

The quality of preanesthesia teleconsultation at home, through video-conference, has never been tested in practice.The aim of this study is to evaluate the quality of preanesthesia teleconsultations through video-conference, compared with traditional preanesthesia consultations. The quality is established by the assessment of the primary outcome : the risks related to difficult intubation, in patients undergoing ambulatory surgery at the Surgical Center Emile Galle. Our research hypothesis is that there is no difference between the quality of preanesthesia teleconsultations through video-conference, and the quality of traditional preanesthesia consultations. Secondary objectives are to identify satisfaction and preoperative anxiety of patients regarding teleconsultation, to identify satisfaction of practioners regarding teleconsultation, to evaluate the quality (based on the assessment of secondary outcomes) of preanesthesia teleconsultations compared with traditional preanesthesia consultations, and to evaluate the technical viability of generalising preanesthesia teleconsultation.


Eligibility Criteria:
Inclusion Criteria:

* Patient with social security affiliation.
* Informed consent from patient
* Patient with an ambulatory surgery programmed in the surgical center Emile Galle (CHRU de Nancy)
* Patient with technology equipments, which are compatible with the plateform of video-conference :
* smartphones, touch pads, computer
* web-browser ( chrome or internet explorer)
* Webcam and microphone
* Printer

Exclusion Criteria:

* Patients covered by Articles L. 1121-5 to L. 1121-8, L1122-2 and L. 1122-1-2 of the french public health code. (Persons especially protected by Act)
* Patients refusing to participate to the study, or refusing the randomization for the group allocation.
* Preanesthesia consultation for a programmed surgery in an hospital other than the surgical center of Emile Galle.
Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial

The purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile compared with standard drops of phenylephrine 1.67% and tropicamide 0.33%, which is routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit.

A pilot prospective randomized crossover clinical trial is conducted for assessing the mydriatic efficacy and safety of microdrops (6-7 μL) compared with standard drops (28-34 μL) for retinopathy of prematurity screening. A random number table was used to allocate participants into either a) receiving standard drop on their first and microdrop on their second screening examination a week later, or b) receiving microdrop first and standard drop a week later. The mydriatic agent contains phenylephrine 1.67% and tropicamide 0.33%, which derives from compounding the commercial phenylephrine 5% with the commercial tropicamide 0.5% in volume ratio 1:2.

Eligibility Criteria:
Inclusion Criteria:

Preterm infants undergoing screening for ROP, i.e.

* with gestational age (GA) \< 32 weeks and/or birth weight (BW) \< 1501 grams
* infants of greater GA and BW with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc.

Exclusion Criteria:

* Unstable clinical condition
* Suspicion of cardiovascular disease
* Severe congenital anomalies
* Clinical syndromes
* Traumatic apoptosis of the corneal epithelium
* Corneal ulcer
* Anatomical variations of the anterior segment
Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors

This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer, ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who consent to provide tumor biopsies while participating in the study.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of any solid tumor
* Incurable cancer, with disease progression following at least 1 therapy with no further standard treatment available in the opinion of the investigator.
* At least 1 evaluable lesion per RECIST criteria

Exclusion Criteria:

* Clinically unstable primary or metastatic CNS tumors
* Subjects with known diabetes
* QTc interval greater than 470 ms.
Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

This clinical trial studies optical imaging in assessing activity during surgery in patients with brain tumors. New procedures, such as optical spectroscopy, may help doctors maximally remove brain tumors and minimize damage to normal brain.

PRIMARY OBJECTIVES:

I. To develop the instrumentation to achieve real time processing and display of intraoperative 2-dimensional optical imaging and spectroscopy (i2DOS) maps in the operating arena.

II. To examine the timing and spatial involvement of human cortex intraoperatively to different stimuli using i2DOS.

OUTLINE: Patients undergo i2DOS.

Eligibility Criteria:
Inclusion Criteria:

* Neurosurgical patient population in the City of Hope brain and spinal tumor neurosurgical programs that have been diagnosed with a brain tumor.
* Only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study.
* We do intend to enroll subjects with potentially terminal brain tumors. Due to the potential benefit of intraoperative mapping, we are not planning to exclude these subjects.
* Patients with any type of brain tumor will be eligible for participation.
* All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* There are no exclusion criteria except for individuals without a brain tumor and the location of the craniotomy. If the exposed area of brain is not compatible with peripheral stimuli or volitional activity the subject cannot be enrolled.
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Aqueous Urea Concentration May be Related to Cataract Development

cataracts could be cured with eye drops. Some studies reported that in chronic renal failure, the occurrence of cataract is rare and the mechanism is unknown. The aim of this research is to describe correlation between urea concentration in the serum and aqueous humor and development of age related cataract.

The study was conducted in the departments of Ophthalmology and internal medicine,

Asyut University hospitals, Egypt. Three groups of subjects were included:

patients with age related cortical cataracts who are otherwise healthy (cases) and two control groups; first systemically healthy subjects with ocular problems other than cataract and a second control group of patients with impaired renal functions and are not on dialysis treatment and thus have elevated serum urea levels. Slit lamp examination was performed to evaluate crystalline lens for opacities. Measurement of serum urea was done for all study subjects. Aqueous humor urea concentration was done only for the group of patients who are planned to have intraocular surgery. For that purpose, 0.1 ml of aqueous humor will be aspirated at the start of routine intraocular surgery.

Eligibility Criteria:
Inclusion Criteria:

* Senile Cortical cataract.

Exclusion Criteria:

* Senile Nuclear cataract.
* Congenital cataract
* Traumatic cataract
Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.

This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* proved cerebral infarction by CT or MRI.
* no cerebrovascular disease before
* signed informed consent form

Exclusion Criteria:

* serious body and intracranial lesions (tumor, infection, etc.)
* patients repeated cerebral infarction attacks
* multi-foci of cerebral infarction
* history of drug dependence and mental disease
* disturbance of consciousness and non-compliance patients
* subjects who are HIV positive
* pregnant or lactation
* donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive
* subjects/ donor: alcoholism, drug addicts or mental disease
Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

The current project will aid patients with motor impairment to reduce the need for homecare. Specifically the aim is to develop and implement a robotic exoskeleton and brain computer interface to assist and eventually perform arm and hand movement in patients with the progressive neurodegenerative disease ALS. This proposal brings together state-of-the-art robotic technology, EEG-based brain computer interface (BCI) know-how, clinical expertise, patient perspective and industrial partners to develop and implement a robotic arm/hand device that will adapt, with increasing brain-computer control, based on the need of the patient. In short the BCI will measure electroencephalography (EEG) from the surface of the scalp and recognize signature EEG as the patient intents to move. As the patient loses muscle power the BCI robotic-device will gradually take over and support motor activity, even when the patient is totally paralyzed. As the device supports hand/arm function only, the investigators aim to address ADLs associated to hand function, specifically eating activities.


Eligibility Criteria:
Inclusion Criteria:

* ALS according to the latest revision of El Escorial Criteria (Ludorph et al. 2015)
* Loss of muscle force or fine motor skills in a hand

Exclusion Criteria:

* Other severe Neurological or Psychiatric disease
* Drug or Alcohol dependency
* Pregnancy
* Severe cognitive disturbances found to impede with study completion