Kornimate/medical-research-clean huggingface dataset:
identification by microarrays of the risks of metastatic relapse, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (nsclc).

* a first blood sample will be taken during the week before the operation. a second blood sample will be taken 4 to 8 weeks after the operation. and in case of relapse, a third sample will be taken. these samples are going to be stored in the collection of biological resources of angers. * concerning the biopsy of the resected nslcl, it will be sent to the collection of biological resources of angers for conservation directly next to the surgery.

Eligibility criteria:
inclusion criteria: * major subject * subject who received resection with primary non-small cell lung cancer at the university hospital of angers and whose tumor samples will be stored in collection of biological resources of university hospital of angers * a written inform consent. exclusion criteria: * under 18 year old; * pregnant or nursing women; * deprived of liberty; * age under curatorship or guardianship; * unable to consent person; * about not carrying a non-small cell lung cancer.

Keywords: non-small cell lung cancer, adjuvant chemo-therapy, dna chip
study to evaluate real-world pharmacoeconomics and resistance mechanisms of panitumumab in metastatic colorectal cancer patients

Conditions: Colorectal Cancer Metastatic

Summary: this is a phase iv multicenter trial to evaluate real-world health outcomes, economic impact and resistance mechanisms of panitumumab in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mcrc). this study will address two anticipated issues surrounding personalized medicine and treatment with panitumumab. first, it will enable to assess the economic impact of panitumumab in a real-life setting (heor study). second, it will identify new blood-based mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic colorectal cancer (blood study). the primary objective is to collect information on quality of life and health care resource utilization by patients diagnosed with metastatic colorectal cancer. the secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. the blood biomarker study objective is to determine blood-based biomarkers of response or resistance to panitumumab. patients with a mutated kras gene will be treated with standard-of-care (soc) and will participate to the heor study only. patients with a non-mutated (wild type) kras gene will be treated with panitumumab and will participate to the heor study and to the blood biomarker study. during the course of the study, data will be collected on quality of life and work productivity. patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation. for patients participating to the blood study (patients with a wild type kras), blood samples will be collected before patients start their treatment, at every treatment and when they discontinue their treatment.


Eligibility criteria:
inclusion criteria: * patients with a histologically confirmed diagnosis of mcrc. * immunohistochemical evidence of egfr expression. * ecog performance status of 0, 1 or 2. * patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens * patients with a wt kras scheduled to receive panitumumab as a single agent for the third-line treatment of mcrc or patients with a mt kras scheduled to receive soc for third-line treatment of mcrc. * signed and dated irb-approved informed consent document. * ability to read and understand english or french. * 18 years of age or older. exclusion criteria: * acquired immunodeficiency syndrome (aids-related illnesses) or known hiv disease.
effect of covid-19 on mental health in syrian and turkish maintenance hemodialysis patients: cost-hd study

Conditions: Depression; Hemodialysis

Summary: sars-cov infection first has begun at wuhan, china, and then became a pandemic. the first covid-19 case has been reported on march 11, 2020, in turkey. people older than 65 years old have been locked down on march 21 and people younger than 20 years old locked down at april 03. a total lockdown has been done a few times lasting for 3 or 4 days, especially at weekends. renal replacement modalities have been affected in different ways during the pandemic. patients with kidney transplantation and patients performing home hemodialysis or peritoneal dialysis have been advised to perform self-isolation at homes. however, center hemodialysis patients continued to come dialysis centers obligatorily. syrian civil war has been continuing since 2011, and turkey has accepted millions of syrian people in a position called temporary protection. there are many syrian center hemodialysis patients both in turkey and in our unit. the investigators do not know if pandemic affected syrian patients different than turkish ones. the aim of this study is to compare beck depression scores of turkish and syrian patients undergoing hemodialysis during the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * hemodialysis history of more than three months exclusion criteria: * patients who can not speak turkish or arabic, * not volunteer to fill the form * history of hospitalization for any reason during the pandemic time, * history of covid-19 before the questionnaire (beck depression inventory)

Keywords: hemodialysis depression
diffuse gastric and esophagogastric junction cancer s-1 trial

Conditions: Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

Summary: the purpose of this study is to evaluate the safety and efficacy of s-1 and cisplatin compared to 5-fu and cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

this is an open-label, international, phase 3 study evaluating the efficacy and safety of the s-1/cisplatin regimen versus the 5-fu/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. patients will be randomly assigned to s-1/cisplatin (experimental regimen, arm a) or 5-fu/cisplatin (control regimen, arm b).

Eligibility criteria:
inclusion criteria: * has given written informed consent. * histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction. * no prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago. * life expectancy of at least 3 months. * able to take medications orally. * eastern cooperative oncology group performance status 0 to 1. * adequate organ function (bone marrow, kidney and liver). exclusion criteria: * certain type(s) of non-measurable lesion(s), if the only one(s). * certain serious illness or medical condition(s). * lost greater than or equal to 10% of body weight in the 3 months proceeding signing the informed consent form. * treatment with drugs interacting with s-1, 5-fu, or cisplatin. * pregnant or lactating female. * known hypersensitivity to fluoropyrimidines or cisplatin. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: gastric cancer , s-1, phase 3
safety and efficacy of nitric oxide gel in promoting hair growth in male human subjects with androgenetic alopecia

Conditions: Alopecia Androgenica

Summary: preclinical studies showed the nitric oxide (no) gel significantly promoted hair follicle formation and growth in both rat and mouse models. the no gel induced major physiological, developmental, and structural changes in the skin of mammals to increase the number of hair follicles, follicle stem cell development and regeneration as well as hair shaft elongation, and accelerated hair growth rate. based on our animal model findings, the investigators hypothesize that the nitric oxide releasing gel could be used as a medical treatment for hair growth in humans. the objective of this trial is to evaluate the safety and efficacy of this no gel (xn-001), in comparison with a placebo gel in subjects in a 24-week treatment schedule.


Eligibility criteria:
inclusion criteria: 1. male subjects \>= 20 and \<= 65 years of age. 2. subjects with hair loss caused by androgenetic alopecia. 3. subjects who are healthy without any serious diseases that require hospitalization during the study period. 4. subjects who are capable of understanding and having signed the informed consent form after detailed description of the treatment procedures and potential risks and benefits. exclusion criteria: 1. subjects who received any treatment for hair loss within 6 months or finasteride within 12 months 2. subjects with diagnosis of cancer and is still on active therapies. 3. subjects with diagnosis of an active disease and is still under regular treatment for this disease 4. subjects with hair loss caused by a known chronic disease. 5. subjects who are on vasodilators or other medication with pharmacological actions that may lead to excessive formation of nitric oxide or may accentuate drug effects due to excessive formation of nitric oxide. 6. subjects with thyroid disease. 7. subjects iron-deficiency anemia. 8. subjects with skin diseases of the scalp, including severe seborrhoeic dermatitis, psoriasis, lichenoid eruption, tinea capitis, or other scalp infections or infestations 9. subjects with any known allergic reaction to any ingredient in the 2 gel preparations. 10. subjects who have been enrolled into any clinical study in the preceding 6 months prior to randomization. 11. subjects who have taken medications that are known to induce hypotrichosis or hypertrichosis.
register of blood stem cell transplantation

Conditions: Hematologic Malignancies

Summary: register of patients with blood stem cell transplantations (autologous, allogen).

documenting the success rate in terms of complication rate, disease response, survival rate, engraftment, and details of transplantation settings, for example donor and conditioning data, remission status before transplantation. it's a register of patients who have one or more autologous and / or allogenic blood stem cell transplants due to an existing indication for performing myeloablative / non-myeloablative high-dose chemotherapy. the inclusion occurs at our center during preparation for blood stem cell transplantation. the written consent will be obtained separately in the context of the information on blood stem cell transplantation. participation is voluntary and consent can be revoked at any time. this involves no additional effort for the patient and has no influence on his treatment. it may be necessary in the course of contacting the patient at home, as long as the data is incomplete. this is also explicitly explained. a copy of the declaration of consent is given to the patient.

Eligibility criteria:
inclusion criteria: * signed ic * patients eligible for stem cell transplantation exclusion criteria: * unable to consent to study participation

Keywords: autologous & allogenic blood stem cell transplantations
a study of ro4917523 in pediatric patients with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: this randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of ro4917523 in pediatric patients with fragile x syndrome. patients will be randomized to receive one of 2 dose levels of ro4917523 or placebo orally daily for 12 weeks.


Eligibility criteria:
inclusion criteria: * children and adolescents, 5 to 13 years of age * diagnosis of fragile x syndrome based on prior dna testing confirming fragile x mental retardation 1 (fmr1) full mutation and qualifying scores on the abc and cgi-s exclusion criteria: * previous treatment with another mglu5 receptor antagonist within the prior 3 months * participation in a clinical trial involving an investigational drug (unapproved) or non-drug treatment within the prior 6 weeks or 5 times the half-life (whichever is longer) before the start of this study * any uncontrolled, unstable clinically significant psychiatric condition other than fragile x syndrome * history of suicidal behavior * other protocol defined inclusion/exclusion criteria may apply
neural links between ocd and anorexia

Conditions: Anorexia Nervosa; Obsessive-compulsive Disorder

Summary: individuals with anorexia nervosa (an) have long been observed to demonstrate symptoms in common with obsessive-compulsive disorder (ocd), in particular, an obsessive fear of normal weight leading to dangerous food restriction, as well as many compulsive rituals about food. both an and ocd are seriously handicapping and often resistant to conventional therapies. given that the two conditions often co-occur and are associated with still unknown genetic risk factors, the aim of this project is to identify their shared and distinct patterns of brain activity. the investigators propose to use functional magnetic resonance imaging to compare brain response among adolescents with an, ocd, and age-matched healthy individuals. specifically, this study will investigate function of distinct brain circuits related to core aspects of these related disorders. the investigators use three tasks related to set shifting, global vs. local processing, and reward. based on evidence of deficits in cognitive flexibility and ability to change behavior, the investigators hypothesize that adolescents with an and with ocd will show hypoactivity of frontostriatal circuitry during cognitive tasks, and adolescents with an will show hyperactivity in limbic regions in a reward task. this study is the first to directly compare brain activation patterns using functional neuroimaging in an and ocd. the goal is to determine how abnormal brain activity relates to symptom formation, what accounts for shared characteristics amongst these disorders, and whether deficits in specific circuitry underlie their unique defining features. the study of shared and unique elements of functional brain circuitry reflects a new, emerging approach to the classification of psychiatric illness, one based on identifying unique combinations of biological risk factors that link related conditions. this approach is widely believed to be a critical step forward in developing more brain-relevant targeted strategies for preventative interventions.


Eligibility criteria:
inclusion criteria: * female * age 12-19 * anorexia nervosa diagnosis or obsessive-compulsive diagnosis or no psychiatric disorder exclusion criteria: * any contraindication for mri (orthodontia, vascular stent, metallic ear tubes, metal implants, piercings, etc.) * neurological disorder, psychiatric disorder, or any major sensory deficit not associated with eating disorders or ocd (blindness, head trauma, bipolar disorder, seizure disorder, etc.) * pregnancy * below 85% of ideal body weight
very low birth weight preterm infant bundled care in the nicu

Conditions: Preterm Infants

Summary: the purpose of this study is to explore the impact of bundling nursing care activities on the overall health of very low birthweight (vlbw) preterm infants who receive bundled care in a level iv neonatal intensive care unit (nicu). the study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.

preterm infants' growth and developmental outcomes vary with illness severity and degree of neurological insult and unpredictable variations in outcomes exist even among healthy preterm infants. the variations in preterm infants' outcomes have led to the supposition that the neonatal intensive care unit (nicu) environment may negatively impact the health and development of these infants and significant research has been devoted to examination of light, noise, and caregiving interventions. consequently, many nicus have implemented neuroprotective strategies to reduce over simulation, promote sleep and facilitate brain development in high-risk infants including the grouping of care activities around a single caregiving event described as "clustering" or "bundling care". yet, the number and type of caregiving activities that are included in bundled care and the timeframe between bundled care events has not been systematically studied. the inclusion and exclusion of certain care activities in any individual care event is often dictated by the infant's treatment plan or needs, but some activities like diapering may be optional. understanding the impact of when to include optional, yet stress provoking interventions, will allow us to minimize overall environmental stress in hospitalized very low birthweight (vlbw) infants. therefore, given the lack of data around bundled care, the investigators aim to explore through a randomized controlled design the impact of bundling diaper care activities on overall health of vlbw preterm infants. the investigators will include a focus on skin health because it is important to understand the benefits of decreased infant stress and any potential skin health trade-offs associated with longer versus shorter time between diapering care. findings from this study will allow us to better understand the relationship between neonatal skin health while providing developmentally appropriate bundled care.

Eligibility criteria:
inclusion criteria: 1. must be participating in the intensive care nursery standard 3-hour bundled care 2. must wear a breathable diaper 3. must be ≤ 32 weeks gestation at birth and weigh ≤ 1500g at birth. 4. infants are expected to remain hospitalized for at least 4 weeks exclusion criteria: 1. neonatal abstinence syndrome 2. humidified incubator 3. diaper rash 4. pre-existing or genetic skin conditions 5. use of barrier creams 6. severe illness requiring 1:1 nursing care: e.g. minimal stimulation protocol, high frequency ventilation, vasopressor drug support, or body cooling.
neotech ram cannula versus conventional binasal prong continuous positive airway pressure (cpap) to treat respiratory distress in low birth weight neonates

Conditions: Respiratory Distress Syndrome, Newborn; Continuous Positive Airway Pressure; Low Birth Weight Infants

Summary: the purpose of this study is to determine if the ram cannula is as effective as conventional binasal prongs to deliver cpap to low birth weight infants with respiratory distress.


Eligibility criteria:
inclusion criteria: * low birth weight infant * currently on continuous positive aireway pressure of 5-7 cm water pressure * receiving continuous positive airway pressure support for \> 24 hrs prior to enrollment * fraction of inspired oxygen requirement of 23-50% exclusion criteria: * fraction of inspired oxygen \> 50% * congenital defects of head, pulmonary or cardiovascular systems * chromosomal abnormalities/genetic syndromes * invasive surgical procedure within 24 hrs prior to enrollment * enrollment in separate clinical trial that has ongoing data collection

Keywords: nasal cannula
spinocerebellar ataxia type 27b natural history study (sca27b-nhs)

Conditions: Spinocerebellar Ataxia Type 27B

Summary: this international, multi-center, multi-modal, and prospective observational cohort study aims to validate trial outcomes for capturing disease progression in spinocerebellar ataxia type 27b (sca27b), with combined multi-modal capture of clinical outcome assessments, digital-motor assessments, and molecular biomarkers.

the investigators will perform an international, multi-center, multi-modal, and registry-based standardized prospective natural history study (nhs) in spinocerebellar ataxia type 27b (sca27b), including the presymptomatic phase of the disease (i.e. presymptomatic subjects at risk for sca27b). participants will be assessed annually. clinical data, including clinician-reported outcomes and patient-focused outcomes, will be entered into a clinical database customized to the requirements of this specific study (sca27b registry; www.ataxia-registries.org). digital-motor outcomes comprise digital gait assessment by wearable sensors, and digital assessment of upper limb movements by q-motor. at all study visits, participants will be asked to donate biosamples; and participants can elect to participate in sampling of blood, urine, csf, and/or a skin biopsy. based on this multimodal protocol, the study aims to determine the most sensitive, comprehensive, and reliable outcome measures for future therapeutic trials in sca27b.

Eligibility criteria:
inclusion criteria: * sca27b: genetic diagnosis of ≥250 uninterrupted gaa repeat expansions in fgf14 * sca27b risk subject: asymptomatic first-degree relative of sca27b participant with known or unknown carrier status * unrelated healthy controls: no signs or history of neurological or psychiatric disease and * written informed consent and * participants are willing and able to comply with study procedures exclusion criteria: * sca27b: missing informed consent * sca27b risk subjects: missing informed consent * unrelated healthy controls: missing informed consent, or concurrent neurological, orthopedic, or other diseases interfering with the motor assessments

Keywords: ataxia sca27b fgf14 natural history study outcome validation
benefits of nigella sativa in children with beta thalassemia major

Conditions: Nigella Sativa With Beta Thalassemia Major

Summary: evaluate the therapeutic effects health benefits, and immunological effect of nigella sativa in children with beta thalassemia major.

study will be carried on children patients with β- thalassemia major attending the hematology unit of pediatric department at tanta university hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. then evaluate the therapeutic effects health benefits, and immunological effect of nigella sativa in children with beta thalassemia major. evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of nigella sativa in those patient.

Eligibility criteria:
inclusion criteria: * thalassemia with iron overload exclusion criteria: * thalassemia complicated with diabetes mellitus or hepatitis * patients who discontinue treatment