Kornimate/medical-research-clean huggingface dataset:
incidence of malignant peripheral nerve sheath tumor (mpnst) development in participants with neurofibromatosis type 1 (nf1) receiving and not receiving medical therapies directed at plexiform neurofibromas (pn)

Conditions: Neurofibromatosis 1; Peripheral Nerve Neoplasms, Malignant

Summary: background: nf1 is a genetic syndrome. tumors appear early in life. many people with nf1 develop pn. these tumors can become an aggressive cancer called mpnst. people with mpnst may benefit from treatment with a mek inhibitor (meki). researchers want to learn if there is an increased risk of mpnst formation from meki treatment in people with nf1. to do this, they will review data that has been collected in nih nf1 studies. objective: to describe the characteristics of people who have taken part in nf1 studies at nih and to compare the risk of mpnst formation in those treated with meki or other pn-directed treatment. eligibility: people with nf1 who were seen at nih from jan. 1, 1998, to jan. 1, 2020. design: participants medical records will be reviewed. participants who opted out of future use of their data will not be included. demographic data, like sex, race, and date of birth, will be collected. data about meki and non-meki treatments will be collected. clinical data, such as surgery and treatment details, will be collected. the differences between all participants who were seen at nih for any nf1 related study will be compared. participants will be put into 4 groups: history of meki therapy treatment with tumor directed therapy other than meki treatment with both meki and non-meki tumor directed therapies no tumor directed medical therapy participants with nf1 who were treated for pn with either a meki treatment or a non-meki treatment will also be compared. the study will last for 3 to 6 months.

study description: this is a retrospective review that includes all patients with nf1 enrolled on natural history and treatment trials at the national cancer institute (nci) from 1/1/1998 to 1/1/2020, excluding patients referred for treatment of mpnst. objective: to describe the clinical and demographic characteristics of nf1 study participants who come for evaluation at the nci and to compare the risk of mpnst formation in patients treated with mek 1/2 inhibitor (meki) or other pn-directed treatment. study population: all participants with nf1 seen at the nih from 1/1/1998 to 1/1/2020 description of sites/facilities conducting research: this is a single site study initiated by the pediatric oncology branch at the national cancer institute study duration: data abstraction to completion of data analyses will take 3-6 months.

Eligibility criteria:
* inclusion criteria: * all participants seen at the nih from 1/1/1998 to 1/1/2020 with a clinical or laboratory diagnosis of nf1 * participants beyond the neonatal period (4 weeks). exclusion criteria: -all participants seen at the nih from 1/1/1998 to 1/1/2020 with a clinical or laboratory diagnosis of nf1 who opted out of future use.

Keywords: retrospective review natural history genetic tumor predisposition syndrome
comparative study of gene-activated bone substitute and xenogenic bone matrix in alveolar ridge augmentation

Conditions: Alveolar Bone Loss; Alveolar Ridge Pathology &#X7C; Gingiva &#X7C; Dental

Summary: the study aim is to compare the effectiveness of two bone substitutes, the gene-activated bone substitute based on octacalcium phosphate and plasmid dna encoding vegfa gene and xemogenic deproteinized bone matrix, mixed with shredded autobone in vertical and horizontal augmentation of alveolar ridge before dental implantation

an open-label randomized controlled clinical trial, two cohort. patients who met the inclusion criteria is planned to be enrolled into the trial. on enrollment, all patients will have screening, a set of clinical examination, instrumental investigations and laboratory tests, including dental ct of the affected jaw with the assessment of alveolar ridge width and height. all patients enrolled in the study will be subjected to guided bone regeneration surgery of the upper or lower jaw with the use of investigational bone substitutes mixed with shredded autobone harvested during the surgery. if the height of alveolar ridge needs to be augmented, the non-resorbed systems for granular material fixation will be used. the clinical study results will be evaluated at the time points of 1, 2, 10, 30, 90, and 180 days with clinical examination, instrumental investigations and laboratory tests. a control dental ct will be carried out before dental implantation for the primary outcome measure, at 180 days after surgery. the clinical trial completion date is the day of the second surgery, a dental implant placement. during the procedure, trephine biopsy samples will be harvested from the bone grafting area addressing the secondary outcome measure.

Eligibility criteria:
inclusion criteria: * partial or full edentulism; * alveolar ridge atrophy and defects preventing from dental implant placement; * obtained voluntary informed consent for participation in the clinical study exclusion criteria: * disability or unwillingness to give a voluntary informed consent or follow requirements of the clinical trial; * plaque index (pi) score \> 15%; * gingival sulcus bleeding index (sbi) \> 10% * decompensated chronic diseases; * alcohol addiction; * a history of drug addiction; * a history of medication with drugs affecting bone tissue metabolism; * participation in other clinical trials (or the administration of investigational products) within 3 months prior to the study; * conditions limiting study compliance (e.g., dementia, psycho-neurological diseases, drug addiction, and alcoholism); * pregnancy or lactation

Keywords: alveolar ridge atrophy bone grafting gene-activated matrix dental implants
efficacy and mechanism of acupuncture for chronic sciatica using fmri

Conditions: Chronic Sciatica

Summary: this research is planned to build a basis about the efficacy and mechanism of acupuncture on pain and emotional disorder in patients with chronic sciatica using fmri.

clinical research to assess the effect of acupuncture for chronic sciatica on pain and emotional disorder will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. sixty eight subjects would be collected and divided into two groups(experimental and placebo, 34 subjects each). experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) and placebo group will undergo with sham acupuncture treatment (acupuncture without skin penetration + electroacupuncture without electrical stimulation) twice a week, for 4 weeks. the effect on parameters related with pain and emotional disorder will be assessed at 1(baseline: just before the beginning of treatment) and 5(primary end point: 1 week after the end of treatment) weeks. functional magnetic resonance imaging will be also conducted for 52 subjects(experimental and placebo, 20 among 34 subjects each + normal control 12 subjects) at 1 and 5 weeks to seek machanism of acupuncture.

Eligibility criteria:
inclusion criteria: * adults 19 years of age or more and 70 years of age or less * clinical diagnosis of chronic sciatica (pain lasting 3 months or more) * 40mm or more of 100mm vas for bothersomeness due to sciatica * volunteers through announcements and advertisements with written informed consent exclusion criteria: * spinal surgery within the past 6 months * diagnosis of specific severe diseases resulting in sciatica: malignant tumor, spinal infection, inflammatory sponlylitis * progressive neurological deficit or severe neurological signs * other chronic diseases which could disturb the effect of treatments and the results of the study: cardiovascular diseases, autoimmune diseases, renal diseases, diabetic neuropathy, dementia, epilepsy * inadequate or insafe for the treatment of acupuncture/ electroacupuncture: hemorrhagic diseases, medication of anticoagulant, serious diabetes mellitus vulnerable to infections, serious cardiovascular diseases/ pacemaker, metal materials interior of the body * currently or might be pregnant * severe mental illness * currently participating other clinical trials * experience of acupuncture or electroacupuncture treatment, or taking medicines which might affect the symptom of pain such as corticosteroids, narcotics, nsaids or considered to be inadequate by the investigators within the past week (but they could be included only after going through 2 weeks of wash out period.) * difficulty of writing informed consent * inadeguate or insafe for mri scanning: claustrophobia, metal materials interor of the body * other inadequate subjects assessed by the study investigators

Keywords: acupuncture sciatica mri, functional
special survey for patients with type 1 or type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in japan. the aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.


Eligibility criteria:
inclusion criteria: * patients with no treatment history of insulin aspart (novorapid®)
remotely delivered cognitive multisensory rehabilitation for sensory and motor recovery after spinal cord injury

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Summary: so far, therapies have limited success in functional recovery in adults with chronic sci. by introducing remote cognitive multisensory rehabilitation (cmr), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic sci are anticipated. the results will inform and justify a large scale federally funded clinical trial.


Eligibility criteria:
inclusion criteria: * 18-75 years old, with an incomplete or complete sci/d of ≥ 3months, medically stable. * be recruited from hospitals within the minnesota regional spinal cord injury model system (mn regional scims), healthpartners neuroscience center, minneapolis va healthcare system, duluth, and in the community. exclusion criteria: * adults with mri contra-indications (stabilizing hardware is typically mri safe); * adults with uncontrolled seizure disorder; * adults with cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent them from following directions or from learning; * adults with with ventilator dependency; * adults with other major medical complications * pregnant women
identification and treatment response prediction of antipsychotic-related metabolic syndrome

Conditions: Metabolic Syndrome X

Summary: the investigators developed an easy identification model to identify metabolic syndrome in patients with schizophrenia or schizoaffective disorder who received treatment of clozapine, olanzapine, or risperidone. the accuracy of the investigators' models showed well. in the study, the investigators aim to (1) to examine whether the developed identification models can be generalized to patients taking other antipsychotics or patients with other diagnoses; (2) to develop an easy risk score and validate it; (3) to switch antipsychotics to amisulpride or aripiprazole for those with metabolic syndrome, and compare the changes of metabolic parameters including adiponectin, and analyze their association with genetic variants, demography, and clinical variables; (4) to establish models using artificial neural network and statistic method to predict metabolic response after a switch to amisulpride or aripiprazole; (5) to investigate the effect of antipsychotics on adiponectin gene expression and secretion during the differentiation process of 3t3l1 adipocytes.


Eligibility criteria:
stage i for identification of metabolic syndrome: inclusion criteria: * a diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, mood disorders, or anxiety disorders based on dsm-iv-tr criteria. * age at least 20 years old. * the current antipsychotic drugs have been used for at least 3 months before evaluation. * psychiatrically stable with clinical global impression of severity scale (cgi-s) not greater than 5 exclusion criteria: * severe uncontrolled medical illnesses, including cardiovascular, hepatic, renal and metabolic diseases (eg. cancer, poor-control hypertension, diabetes mellitus, and other metabolic diseases). * organic mental or neurological disorder, substance abuse or dependence (alcohol, amphetamine, heroin). * pregnant or breast-feeding women. * patients from yuli veterans hospital, who attended our previous study of identification model. stage ii for switch response: inclusion criteria: * the same as stage i criteria. * fulfill the metabolic syndrome criteria. exclusion criteria: * the same as stage i criteria except the 4th item. * treated with depot form of antipsychotics.

Keywords: antipsychotic agents metabolic syndrome x identification prediction
patient reported outcomes in chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: although the impact of disease and treatment related burden on health-related quality of life (hrqol) in patients with solid tumours has been well studied, with several clinical trials that included hrqol as an endpoint, the general understanding in patients with chronic myeloid leukaemia (cml) is lacking in comparison. the literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose. the main scope of this project is develop to an international validated questionnaire for the purpose of hrqol assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.

the development process will follow the international guidelines published by the eortc quality of life group (qlg). this process will follow three main phases. phase 1 of will deal with the review of the literature, identification of an item list and interviews with experts in the treatment of cml and cml patients (undergoing all possible treatments). in phase ii the identified issues from phase i will be worded and translated into possible items for the provisional questionnaire using existing eortc questionnaires and the eortc qlg item bank. in the phase iii the provisional cml questionnaire will be pre-tested by to a larger sample of cml patients (not the same patients involved in previous phases) and individual structured interviews will be conducted as well. these latter will identify questions that might be irrelevant or whether there will be additional issues not previously included. overall up to 480 patients will be enrolled in this study (up to 180 in phase i and up to 300 in phase iii).

Eligibility criteria:
inclusion criteria: * adult patients (18 years of age or older) * confirmed diagnosis of philadelphia chromosome positive cml * informed consent provided * patients enrolled in investigational treatment trials are eligible * ability to speak and read language of the questionnaire exclusion criteria: * freedom from overt cognitive impairment or major psychiatric conditions that may confound hrqol evaluation

Keywords: chronic myeloid leukemia quality of life symptoms patient-reported outcomes questionnaire
a clinical trial of vorinostat (mk0683, saha) in combination with fda approved cancer drugs in patients with advanced non-small cell lung cancer (nsclc)(0683-056)

Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer

Summary: this phase iii clinical trial which incorporates an initial phase ii component will determine the survival of advanced non-small cell lung cancer patients when treated with mk0683 and paclitaxel plus carboplatin


Eligibility criteria:
inclusion criteria: * males and females at least 18 years of age who have confirmed diagnosis of non-small cell lung cancer * patients with no systemic prior systemic treatment for lung cancer except patients at least 12 months from prior adjuvant therapy * adequate bone marrow,kidney and liver function * must be recovered and at least 4 weeks from major surgery or radiation * ecog (eastern cooperative oncology group) performance status of 0 or 1 * men and women must agree to use birth control during the study * women able to have children must have a negative pregnancy test 14 days before study enrollment exclusion criteria: * patients with prior treatment with other investigational agents less than 4 weeks before study enrollment * pregnant or nursing female patients * patients who are hiv positive * patients who have hepatitis a, b, or c * patients unable to take study medication by mouth * patients with untreated brain cancer * patient eligible for treatment with bevacizumab and for whom bevacizumab is available
study evaluation tazocin intervention

Conditions: Bacterial Infections

Summary: this is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of esbl producing e. coli or k. pneumoniae colonization and infection.


Eligibility criteria:
inclusion criteria: * all patients admitted or transferred to icu/pulmonary units * patients of either sex, 18 years of age or older exclusion criteria: - patients who stay in units less than 48 hours will not be enrolled.
carotid flow measurements in pregnant women

Conditions: Postspinal Hypotension; Pregnant Women Undergoing Cesarean Delivery

Summary: the goal of this observational study is to reveal the relation between carotid flow changes and post-spinal hypotension in pregnant women between the ages of 20-40. the main question it aims to answer is: do the carotid flow blood flow measurements and corrected flow time change before and after spinal anaesthesia related to postspinal hypotension? participants are already receiving spinal anaesthesia to receive a caesarean section. as part of their regular anaesthesia management protocol, they will answer questions about anaesthesia management. the participants will only examined by ultrasound twice.

in this study, doppler ultrasound measurements will be taken to evaluate the diameter and flow velocity of the left carotid artery in pregnant women aged 20-40 years, classified as asa 1-2 term and uncomplicated, upon their arrival at the operating room in the supine position. measurements will be performed three times at the cricoid level, before the carotid bifurcation, and directly from the arch to mitigate any errors due to the measurer. these measurements will be conducted by the same individual (b.c) and repeated three minutes after returning to the supine position post-spinal anaesthesia, with changes between the two measurements recorded. the spinal anaesthesia dose will be standardized with 10 mg of heavy bupivacaine and 10 mcg of fentanyl. hemodynamic data from the time patients enter the operating room until baby delivery will be recorded. hypotension during this period will be defined as (1) a decrease in systolic blood pressure \>30% or a decrease in mean arterial pressure (map) \>20% from baseline, or (2) systolic blood pressure \<90 mmhg or map \<65 mmhg. carotid flow measurements and the amount of crystalloid administered during spinal anaesthesia will be noted in hypotensive and non-hypotensive patients.

Eligibility criteria:
inclusion criteria: * "uncomplicated term pregnant women aged 20-40 years classified as asa 1-2. exclusion criteria: * those diagnosed with preeclampsia or eclampsia or with systolic blood pressure above 160 individuals with arrhythmia individuals with contraindications for spinal anesthesia individuals with ba mi over 40 those with a gestational age under 36 weeks or over 41 weeks individuals with chronic kidney insufficiency (grf under 60) those with carotid stenosis or a history of previous cerebrovascular events patients with placental anomalies those initially planned for expected delivery but later switched to cesarean after being taken to trauma. patients were taken to the operating room with an emergency cesarean decision in case of failed spinal anaesthesia, those who switched to general anaesthesia before delivery

Keywords: carotid blood flow corrected carotid flow time postspinal hypotension cesarean delivery
survey on gi and nutritional parameters among oagb patients from different countries

Conditions: Obesity

Summary: one anastomosis gastric bypass (oagb) surgery is a type of bariatric surgery (bs) which is gaining popularity worldwide and is considered to be a simple, safe and effective bariatric procedure in terms of weight loss and comorbidities resolution. however, only limited data exists on the nutritional and gastrointestinal (gi) consequences of this procedure. this study aimed to gain information on gi and nutritional parameters from a large sample of oagb patients living in 3 different countries. post-oagb patients across israel (n=277), spain (n=105) and portugal (n=111) were recruited to the study based on the time elapsed since surgery \[1-6 months (1-6m), 6-12 months (6-12m) and 1-5 years (1-5y) post-surgery\]. participants were asked to complete an anonymous survey delivered by surveymonkey®️ software which included data on demographics, comorbidities, anthropometrics, gi outcomes and satisfaction with the procedure.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * patients who underwent primary oagb in the last 5 years exclusion criteria: * patients who had undergone other bariatric surgery * current pregnancy * lacked capacity to consent

Keywords: bariatric surgery gastric bypass weight outcomes functional gastrointestinal disorders nutrition
prognostication of recovery in early disorders of consciousness after covid-19

Conditions: Covid19; Coma; Consciousness Disorder

Summary: the primary aim of this research proposal is to use multimodal metrics (e.g., clinical data and advanced neuroimaging) in the early (i.e., acute hospitalization) phase of recovery from covid-19-related disorders of consciousness to predict outcome at 3, 6, and 12 months post-hospitalization. we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.


Eligibility criteria:
inclusion criteria: 1. age 18 or older, 2. positive diagnosis of covid-19, 3. diagnosis of coma, vegetative state or minimally conscious state per glasgow coma scale (gcs) at time of enrollment (excluding confounders such as sedation) and 4. clinical team plan for an mri for clinical management. exclusion criteria: a subject with any of the following mri contraindications will not be eligible for this study: * electrical implants such as cardiac pacemakers or perfusion pumps * ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants * ferromagnetic objects such as jewelry or metal clips in clothing that cannnot be easily removed for scanning * pregnant volunteers