Kornimate/medical-research-clean huggingface dataset:
study of the capacity of the mri spectroscopy to define the tumor area enriched in glioblastoma stem cells. proof of concept study

Conditions: Glioblastoma

Summary: this is a prospective biomedical study of interventional type which includes 16 patients on 52 months (24 months of inclusion and 28 months of follow up). this pilot study, combining a metabolic imaging approach (proton magnetic resonance spectroscopy = 1hmrsi) and a biological one, will be performed in patients harbouring a glioblastoma (gbm)to determine whether mri markers of aggressiveness (cni2) are associated with specific biological patterns as regards to gbmsc (gbm contains tumor stem cell). in the first part of the study, patients with radiological criteria of gbm amenable to surgical resection will be included ; pre-operative multimodal mri scans will be done and all data acquired (including h1mrs and dti data) will be integrated in the image-guided surgical device (ie neuronavigation system) to be used intraoperatively. during tumor resection, tissue samples will be individualized, based on their multimodal imaging characteristics and sent to the radiobiology laboratory inserm for biological analysis. after surgery, patient will be treated by the standard radio-chemotherapy stupp protocol and will be followed according to standard practices; multimodal mri will be performed every 2 months during the first year and then every 3 months until progression.


Eligibility criteria:
inclusion criteria: first part of the study (surgery and imagery): 1. surgical indication for patients who present radiological criteria of glioblastoma. 2. patient who are ≥18 years old 3. patient must have performance status between 0 and 2 on the ecog performance scale 4. life expectancy ≥ 3 months 5. patient affiliated to social security regimen 6. patient has voluntarily agreed to participate by giving written informed consent for the first part of the study. second part of the study (treatment and biology): 1. histologically confirmed glioblastoma 2. patient must have performance status between 0 and 2 on the ecog performance scale or 3 only is due to motor deficit. 3. life expectancy ≥ 3 months 4. patient affiliated to social security regimen 5. patient has voluntarily agreed to participate by giving written informed consent for the second part of the study. exclusion criteria: first part of the study (surgery and imagery): 1. patients who are not allowed to perform an mri 2. spectroscopic exam whose results are not contributive 3. pregnant or nursing patient, 4. patients under law protection 5. patient who presents conditions that would interfere with cooperation with the requirements of the trial. 6. patient who presents medical, severe or chronic biological or psychiatric conditions not allowing his enrolment in the study, according to the investigator's opinion second part of the study (treatment and biology): 1.biological material received in the lab more than 48 hours after surgery.

Keywords: glioblastoma spectroscopy mri glioma stem cells surgery radioresistance
the clinical efficacy and safety of drug-coated balloon

Conditions: Coronary Heart Disease; Angioplasty, Balloon

Summary: drug-coated balloon (dcb) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. treating in-stent restenosis (isr) with the dcb has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. dcb has shown promising results for the treatment of isr. currently, dcb has a class i indication to treat isr recommended by european society of cardiology (esc) guidelines. in addition, some interventional cardiologist has also applied dcb in de novo lesions in their clinical practice. although some small sample size rcts and observational studies have suggested that the clinical prognosis of dcb in primary large vessels is non-inferior to drug-eluting stent (des), there is no large-scale rct or cohort studies to compare the clinical effects of dcb and des. despite several theoretical benefits of dcb, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion. some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis\ 0.91. however, such proposed technique and criteria have not been evaluated in the real-world clinical practice. this current study is designed to investigate the efficacy and safety of dcb in the real world and exploring the optimal procedural configurations.


Eligibility criteria:
inclusion criteria: 1. patients who received pci with one or more drug-coated balloons (dcb) 2. patients who did not received drug-eluting stent implantation exclusion criteria: 1. currently participating in another trial or participants unable to comply to follow-up

Keywords: drug-coated balloons de-novo all-comers in-stent stenosis
bridging the gap by transitional care

Conditions: Diabetes Mellitus Type 2

Summary: the purpose of the study is to evaluate patient adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management

it is a prospective, randomized, controlled study. patients randomized in a 1:1 ratio to pharmacist counseling or standard of therapy prior to discharge. standard therapy: nurses distribute a education pamphlet on diabetes. pharmacist counseling includes but is not limited to: * reviewing and explaining their medications (dosing, side effects, route) * reviewing symptoms and complications of hyper and hypoglycemia * defining glycemic \& non-glycemic goal levels * explaining the importance of compliance with medications \& appointments * educating on the basics of nutrition and physical activity

Eligibility criteria:
inclusion criteria: * males or females * 18 to 85 years of age * historical diagnosis of type 2 diabetes mellitus greater than one year * hba1c concentration ≥ 8% * discharged from general medicine unit of john h. stroger jr, hospital of cook county * patient with provider and prescriptions filled within cchs exclusion criteria: * type 1 diabetes mellitus * pregnancy * major illness or debility, that prohibits the subject from participating in the study * history of any hemoglobinopathy that may affect determination of hba1c * non-english speaking patients

Keywords: adherence with discharge diabetes medications diabeted mellitus type 2 greater than one year patient with provider and prescriptions filled within cchs
survey on the place of community pharmacists in the detection of cannabis use: a student's point of view

Conditions: Cannabis Use

Summary: the objective of this survey will be to evaluate the perception by the students (except for medical students, pharmacies) of community pharmacists concerning the management of cannabis consumption. we want to see if the student population perceives the pharmacist as the public health actor of choice, and if they would more easily turn to him or to another health professional (doctor, nurse) in case they need. discussing possible problematic consumption or for a simple search for information. it will be assessed whether the pharmacist seems to be a good candidate and an element of choice when young adults want to take an intelligence approach to cannabis consumption.

this observational and transversal study will be conducted as a survey using the redcap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (chu clermont-ferrand). students of the auvergne rhone alpes region will be contacted by email thanks to the student associations and scholarity departments. answer to the survey will be done online via the following link https://redcap.chu-clermontferrand.fr/surveys/?s=jmrf9flrjp.

Eligibility criteria:
inclusion criteria: - student following a university path in the auvergne rhone alpes region exclusion criteria: * medical student * pharmacy student * age \< 18-year * other than student

Keywords: cannabis community pharmacy prevention students
efficacy, acceptability and cost-effectiveness of long lasting insecticide nets (llin) in the prevention of kala azar

Conditions: Visceral Leishmaniasis; Kala Azar

Summary: a cluster-randomized vector control trial in bihar, india, and neighboring nepal, will test the efficacy of long-lasting impregnated bednets (llins, permanets) for reducing visceral leishmaniasis incidence. the intervention unit is the village (400-1000 people). the study is designed to detect a 50% reduction in leishmania donovani incidence in intervention compared to control clusters over 2 years. 24 clusters (selected as high incidence during previous years) will be randomly allocated to intervention or control. following health education, and with informed consent, all households in intervention villages will receive free permanets (from september 2006). net usage will be monitored and new nets provided if required. control villages will not be given untreated nets, as - although commonly used in this region - their effectiveness against sandflies has not been proven. pre-intervention infection status of villagers (\>2 yrs) will be evaluated serologically from finger-prick blood (and past/current disease status noted). incident infections will be recorded by 3-monthly active search for clinical cases, and by annual serological diagnoses to detect subclinical infections. all villagers (\>2yrs) will be leishmanin skin tested at the end of the trial for further subclinical infection detection, and sera from a sub-sample will be tested for antibodies to sandfly saliva antigens (a measure of sandfly exposure). all clinical cases will be given free treatment. free permanets will be provided to control villages after the trial. complementary studies involve entomological surveillance by light traps in a sample of houses and social/economic questionnaire surveys. the entomological surveys will test whether community-wide use of llins provides any mass effect, which could protect those in the community who fail to use llin for any reason.


Eligibility criteria:
inclusion criteria (clusters): 1. at least have seen 1 case per year in each of the last 3 years 2. an average of at least 1% incidence rate over the period of past 3 years. exclusion criteria (clusters): 1. minimum 500 people 2. maximum 2000 people 3. distance between clusters 2000 meters (distance between borders) 4. houses in tola/ward not sprayed (ddt, other) in 2006 5. accessibility

Keywords: leishmania donovani cluster-randomised control trial long lasting impregnated nets bednets sandflies
hangzhou hospital staff cohort

Conditions: Diabetes Mellitus; Cardiovascular Diseases; Metabolic Syndrome

Summary: the hangzhou hospital staff cohort (hhsc) is a prospective cohort study among staffs from three hospitals located in hangzhou, china, including the hangzhou first people's hospital, hangzhou women's hospital, and hangzhou red cross hospital. participants recruitment and baseline survey including anthropometric, lifestyle and clinical measurement, as well as biological samples collection are initiated in january 2021. recruited hospital staff are followed up every year during the medical examination organized by their employer. the primary aim of the hhsc study is to investigate the prospective associations of diet, physical activities, sleep, and other lifestyle factors with the long-term metabolic health of the hospital staffs. the secondary aim of the hhsc study is to integrate multi-omics data including genomics, metabolomics, proteomics and microbiome by a machine learning algorithm, to probe into the complex mediating roles of gene, metabolism and gut microbiota linking lifestyle factors with metabolic health.


Eligibility criteria:
inclusion criteria: * participants aged 18 years or older * serving staffs of designated hospitals exclusion criteria: * participants with cancer * participants with other serious medical disorders
transcutaneous non-invasive vagus nerve stimulation (t-vns) in the treatment of schizophrenia

Conditions: Schizophrenia

Summary: randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-vns), applied at the left auricle, in schizophrenia. study hypothesis: t-vns may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.


Eligibility criteria:
inclusion criteria: * diagnosis of a schizophrenic disorder (f20 according to icd-10),duration of disease ≥ 12 months * appliance of the t-vns® medical device according to the manual exclusion criteria: * improvent of the panss score within the period of 2 - 4 weeks from screening to the baseline * pregnancy * bronchial asthhma in medical history * clinically relevant internistic, neurological or psychiatric diseases * abuse of drugs or alcohol until 4 weeks to enrollment * traumatic brain injury in medical history as well as invasive and non-invasive methods of treatment (e.g. tumor surgery (gammma knife surgery)) * indication of structural impairment of the basal ganglia or the brain stem * malformations of the pinna * further circumstances that at the discretion of the investigator will not allow to include the subject into the clinical study

Keywords: schizophrenic disorders psychosis psychotic dementia delusional delusions hallucinations residual-type schizophrenia illusions split mind mental health disorder schizoid paranoid-type schizophrenia disorganized-type schizophrenia undifferentiated-type schizophrenia catatonic-type schizophrenia mental illness tardive dyskinesia neuroleptic malignant syndrome nms antipsychotics atypical antipsychotics psychosocial treatments rehabilitation
rheopheresis blood filtration study for the treatment of dry age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: amd is a progressive disease of the retina which is nourished by a network of tiny blood vessels. there is evidence to suggest that the flow of nutrients to the retina is impaired in patients with amd. rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.


Eligibility criteria:
* age 50-85 * diagnosis of dry amd * bcva between 20/32 and 20/125 in at least one eye * numerous large plaques (soft drusen) * no history of hiv, hepatitis b or c * elevation of certain blood factors, such as total cholesterol, fibrinogen, and iga

Keywords: dry amd age-related macular degeneration rheopheresis
genetic and functional analysis of aplasia cutis congenital (acc)

Conditions: Aplasia Cutis Congenita

Summary: the goal of this research study is to identify genes and regulatory elements on chromosomes that cause acc. the investigators also study tissue samples from patients to learn about the processes that lead to this disorder.

aplasia cutis congenita (acc) or congenital scalp defect is a very rare disorder that affects bone and skin. the definition for acc is the localized absence of (normal) skin at the time of birth (congenital). the skin appears thinner and the underlying structures are visible. we study mostly the isolated form of acc with the lesion often being at the vertex of the skull (at or close to the top of the skull). the bone underlying the lesion is sometimes thinner as well. for this study we will: * send out study participation kits and consent by phone * collect a saliva sample from eligible individuals * obtain information regarding acc * document disorder with photos and doctor's letters * if patients undergo surgery for acc we ask to obtain some tissue that would otherwise be discarded * isolate dna from the saliva sample * perform genetic analyses of the dna with the most up-to-date methods available to identify genetic variations * study in the laboratory why the genetic variations cause the disorder

Eligibility criteria:
inclusion criteria: * acc; unaffected individuals only if part of a participating acc family exclusion criteria: * no acc unaffected individuals only as part of a participating acc family

Keywords: aplasia cutis congenita bone osteoblast osteoclast skin
gene therapy in patients with mucopolysaccharidosis disease

Conditions: Mucopolysaccharidosis Type VI

Summary: this study investigated the safety and efficacy of gene therapy approaches for mucopolysaccharidosis type vi disease caused by the deficiency of arylsulfatase b (arsb) enzyme. the aim of the study is to evaluate the safety and efficacy of the treatment.

mucopolysaccharidosis type vi disease is involved in lysosomal storage disorder. the mps vi disease is characterized by growth retardation, corneal clouding, cardiac valve disease, organomegaly, skeletal dysplasia, without central nervous system involvement.

Eligibility criteria:
inclusion criteria: 1. documented biochemical and molecular diagnosis of mps vi. testing for homozygous or compound heterozygous disease-causing mutations of the arsb gene must have been performed by an accredited laboratory. 2. subjects must be of 4 years of age or older. 3. subjects should have received ert for at least 12 months before enrolment and should continue to receive ert until 7-14 days before imp administration. 4. documented informed consent; willingness to adhere to protocol and to participate to long-term follow-up, as evidenced by written informed consent. exclusion criteria: 1. subjects unable or unwilling to meet requirements of the study. 2. participation in a clinical study with an investigational drug in the 6 months prior to enrolment in this trial. 3. subjects unable to perform the 6mwt. 4. history of severe anaphylactoid reaction to naglazyme in subjects receiving ert that could affect the safety (severe reaction is meant to be a respiratory impairment event that is life-threatening). 5. presence of tracheostomy or need of ventilatory assistance. 6. subjects with evidence of progressive myelomalacia that is considered severe enough to require neck surgery in the first six months after enrolment. 7. values of ast or alt above the upper limit of normal range at baseline 2 (at -5days) evaluations. 8. co-existence of chronic diseases or clinically relevant abnormal baseline laboratory values; infections with hepatitis b, c, or hiv (baseline 1). 9. systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs within 2 months prior to imp administration. 10. female individuals of childbearing age who are pregnant or nursing or unwilling to use effective contraception for at least one year post-imp administration. 11. fertile male individuals who are unwilling to use male barrier contraceptives such as condom. 12. any other condition that would not allow the subject to complete follow-up examinations during the course of the study and that, in the opinion of the investigator, would make the subject unsuitable for the study. 13. presence of serum nab to aav8 above the limit of detection of the assay (screening and baseline 1). 14. presence of serum antibodies anti-arsb above the upper limit of detection of the assay (antibodies anti-arsb level \>31250 or declared positive at the value of serum dilution 1.10 according to the performed assay) at screening and baseline 1.

Keywords: mpsvi
study evaluating astra tech implant system, osseospeed™ implants in the upper jaw in women with osteoporosis

Conditions: Postmenopausal Osteoporosis; Osteopenia; Jaw, Edentulous, Partially

Summary: the overall objective of the study is to compare treatment with the astra tech implant system, osseospeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. the hypothesis is that there will be no difference in marginal bone level alterations between the two groups.


Eligibility criteria:
inclusion criteria: * provision of informed consent * postmenopausal women aged 60 years and over * in need of 2-8 implants in maxilla * a history of edentulism in the area of implant treatment of at least 6 months. * a bone mineral density (bmd) value suitable either for group a or group b: * group a (osteoporosis/osteopenia): bmd at least 2 standard deviations (sd) below mean peak bone density of young adults for the spine and total hip (t-score = -2 sd or less). absolute values (g/cm2) will be used. * group b (control): bmd not more than 1 standard deviation below mean peak bone density of young adults for the spine and total hip (t-score = -1 sd or more). absolute values (g/cm2) will be used. exclusion criteria: * unlikely to be able to comply with study procedures, as judged by the investigator. * untreated, uncontrolled caries and/or periodontal disease * known or suspected current malignancy * history of chemotherapy within 5 years prior to surgery * history of radiation in the head and neck region * history of other metabolic bone diseases, e.g. paget's disease, hyperparathyroidism, fibrous dysplasia or osteomalacia * a medical history that makes implant insertion unfavourable * need for systemic corticosteroids * current or previous use of intravenous bisphosphonates (esp. zoledronic acid) * current or previous use of oral bisphosphonates * history of bone grafting and/or sinus lift in the planned implant area * current need for bone grafting and/or sinus lift in the planned implant area * present alcohol and/or drug abuse * involvement in the planning and conduct of the study (applies to both astra tech ab staff or staff at the study site) * previous enrolment in the present study. * participation in a clinical study during the last 6 months.
neurotomy of optic nerve in non-arthritic anterior ischemic optic neuropathy

Conditions: Non Arthritic Anterior Ischemic Optic Neuropathy

Summary: non-arthritic anterior ischemic optic neuropathy is the most common cause of sudden visual loss due to optic nerve involvement in patients above 50 years old. as this problem can be considered as a sclera out let syndrome an there is no effective and successful treatment for it, we decided to do a neurotomy procedure and relax the involved optic nerve in order to achieve acceptable treating outcome.


Eligibility criteria:
inclusion criteria: * patients with non-arthritic anterior ischemic optic nerve exclusion criteria: * visual acuity more than 20/200 * other intra occular operations * passing more than 4 weeks of the problem * arthritic anterior ischemic optic nerve * age under 50 years * consumption of previous pharmaceutical treatment

Keywords: non arthritic ischemic optic neuropathy anterior ischemic optic neuropathy optic nerve neurotomy
use of blood flow restriction (bfr) therapy in post-operative rehabilitation following distal biceps tendon repair

Conditions: Bicep Tendon Rupture

Summary: the goal of this investigation is to determine if using bfr during postoperative therapy would lead to increased and expedited strength gains. additionally, the investigators would like to determine if bfr is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. the study will also look at patient reported outcomes metrics and pain scores to determine if bfr has a significant impact on the patient experience surrounding distal biceps tear and surgical repair


Eligibility criteria:
inclusion criteria: * age 18-80 * undergoing distal biceps tendon repair exclusion criteria: * revision biceps tendon repair, * irrepairable tendon injury, * biceps repairs with biologic augmentation, * patients with concomitant neurovascular injury, * inability to tolerate bfr treatment, * unable to complete full course of physical therapy, * peripheral vascular disease, * history of venous thromboembolism (vte)

Keywords: blood flow restriction rehabilitation physical therapy