Kornimate/medical-research-clean huggingface dataset:
comparing clinical benefits of gamma knife and microvascular decompression for trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression

a randomized prospective study conducted in the neurosciences hospital, baghdad, from january 2016 to january 2018, patients had either gkr treatment or treated with mvd. the pain evaluated pre- and post-operatively using the barrow neurological institute pain intensity scale (bnipi), visual analog scale (vas) and brief pain inventory facial (bpi-facial) scoring systems. in gkr procedure, the trigeminal root entry zone targeted with a radiation dose of 80 gy. mvd was performed using retro-sigmoid approach. follow-up period for two years

Eligibility criteria:
inclusion criteria: * primary idiopathic trigeminal neuralgia exclusion criteria: * secondary trigeminal neuralgia

Keywords: trigeminal neuralgia, treatment
stand if you can: a standing intervention in long term care

Conditions: Frailty; Sedentary Behavior; Physical Disability

Summary: it is currently unknown if reducing sitting time, an activity that is highly prevalent in frail older adults living in long term care (ltc) facilities, is associated with an improvement in physical capacity such as walking speed. simple tasks such as walking speed is associated with important outcomes for residents in ltc such as autonomy and hospitalization. the investigators hypothesize that standing an additional 100 minutes per week for 5 months will result in a clinically meaningful improvement in walking speed (0.1m/sec) in ltc residents compared to residents receiving a sitting social activity.

ltc facilities from moncton and fredericton will be recruited, with half of the ltc facilities randomized as the intervention and half as the control group. the investigators are aiming to enrol half of the ltc in fredericton and half in moncton. a total of 88 residents (44 in the control group, 44 in the intervention group) will be enrolled in the program.

Eligibility criteria:
inclusion criteria: * resident at one of the selected ltc facilities; * able to provide consent or have a power of attorney agree on behalf of a resident to participate in the study; * able to walk for ten meters, with or without a walking aid; the main outcome is walking speed performed for a distance of 10 meters. therefore, we want everyone who participates in the study to be able to complete the test at baseline. this way we can answer the main research question, while adhering to our sample size calculation. exclusion criteria: * if identified by staff at the facility as too high risk for falling by participating in the intervention.

Keywords: long term care physical function
a study to demonstrate the effect of regn5713-5715 on reducing ocular allergy signs and symptoms in adult participants with birch pollen allergy

Conditions: Allergic Conjunctivitis

Summary: this study is researching 2 experimental drugs, regn5713 and regn5715, which are called regn5713-5715 when mixed together (called "study drug") to reduce eye allergy signs and symptoms due to birch tree pollen allergy. the aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. a placebo looks like a treatment but does not contain any real medicine. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).


Eligibility criteria:
key inclusion criteria: 1. documented or participant-reported history of moderate to severe birch pollen allergy for at least 2 years with bothersome ocular symptoms during the birch season 2. positive spt to birch allergen extract, as described in the protocol 3. positive allergen specific immunoglobulin e (sige) tests for birch and bet v 1 (≥0.7 kua/l) at screening visit 1 4. must be able to complete birch screening cacs and meet the criteria, as described in the protocol key exclusion criteria: 1. participation in a prior clinical study and received either regn5713-5714-5715, regn5713-5715, or regn5715 antibodies, as described in the protocol 2. inability to complete or termination of the screening or confirmatory cacs due to a safety concern (eg, anaphylaxis) per principal investigator (pi) judgement 3. significant and/or severe allergies causing symptoms that are expected to coincide or potentially interfere with the study cac assessments, as assessed by the investigator, as described in the protocol 4. persistent chronic or recurring acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1, as described in the protocol 5. the presence of an active ocular infection (bacterial, viral, or fungal) or diagnosis by a physician within 30 days prior to screening visit 1, as described in the protocol note: other protocol defined inclusion/exclusion criteria apply.

Keywords: birch pollen allergy ocular allergy symptoms ocular allergy signs
physiological concept of insulin therapy in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of the study was to evaluate the safety and efficacy of biphasic insulin aspart 30 (novomix® 30) when switching to a modern premix insulin analogue treatment compared to previous insulin regimen in routine clinical practice in the slovak republic.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes
an open-label safety, pharmacokinetic, and efficacy study of miglustat for the treatment of cln3 disease

Conditions: Batten Disease

Summary: this is an open label study in approximately 6 subjects in 2 centers to assess the safety, pk, and efficacy of the maximum tolerable dose (mtd) of oral miglustat (100 mg once daily \[qd\] to 200 mg 3 times daily \[tid\]) in subjects ≥ 17 years of age with cln3 disease over a period of 104 weeks.


Eligibility criteria:
inclusion criteria: individuals 1. have provided informed consents (tch and nih) by subject or parent/legal guardian/legally authorized representative (as appropriate). 2. are males or females ≥ 17 years of age at the time of screening 3. have genetically confirmed diagnosis of syndromic cln3 disease with either: a. two pathogenic mutations in the cln3 gene, or b. one confirmed pathogenic and one variant of unknown significance, or 2 variants of unknown significance, plus secondary confirmation with evidence of characteristic inclusions on electron microscopy and characteristic clinical course. there is no restriction on the specific cln3 mutations for eligibility to enroll in the study. the mutations will be recorded in the electronic case report form (ecrf) for potential use in determining if cln3 genotype is associated with tolerability and/or effectiveness of bbdf-101 therapy. 4. male and female participants must use a highly effective method of contraception and must continue for the duration of the trial (and for 30 days after the end of treatment). 5. are able to complete study assessments (subject or caregiver) and return to the clinic as scheduled exclusion criteria individuals 1. have a medical condition that in the opinion of the pi would interfere with the safety assessments or increase the subject's risk of aes 2. use of any therapy (approved, off-label, or unapproved) intended to modify the course of any neuronal ceroid lipofuscinosis disease, including but not limited to flupirtine or flupirtine derivatives, cerliponase alfa (brineura) 3. have, in the opinion of the pi, a clinically significant abnormality in their clinical laboratory values (hematology, chemistry, or urinalysis) at screening that would preclude their participation in the study

Keywords: batten disease cln3 treatment miglustat safety
automated ventilator controlled weaning vs daily spontaneous breathing trial in difficult to wean icu patients

Conditions: Mechanical Ventilation; Weaning

Summary: this study will compare drager smart care (sc), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (sbt) weaning protocol. the study is designed to determine if automated ventilator controlled weaning can reduce total duration of intubation following mechanical ventilation in icu patients requiring prolonged mechanical ventilation (\>72 hours).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * intubated with endotracheal tube * requiring mechanical ventilation for \> 72 hours * meets weaning criteria: improvement or resolution of the underlying process that precipitated need for mechanical ventilation, pao2 ≥ 60 mm hg on peep and fio2 requirements of ≤ 8 cm h2o and fio2 ≤ 0.50, stable oxygenation: peep and fio2 requirements not increased in the past 24 hrs, ability to initiate an inspiratory effort and trigger the ventilator, subject enrollment approved by the primary service attending physician exclusion criteria: * pregnancy * patients with tracheostomy or planned tracheostomy prior to attempt to extubate * patients with known airway patency issues that are anticipated to delay extubation. * patients with neurological injury in whom care is likely to be withdrawn * patients with cervical spinal cord injury. * prospective subject or surrogate consenter does not fully understand the implications of the study because of a language barrier.

Keywords: smartcare spontaneous breathing trials mechanical ventilation weaning patients requiring prolonged mechanical ventilation (>72 hours)
optimization with a gamma camera of the individualized patient dosimetry in radioiodine therapy of thyroid diseases

Conditions: Hyperthyroidism

Summary: this is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " moti " (mobile therapy imager)) for patients with hyperthyroidism (graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131i treatment is indicated. its aim is to assess the feasibility of using this ambulatory gamma camera (moti) in the clinic in this patient population. 20 patients will be included in the study.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patient with hyperthyroidism (graves' disease, toxic nodular goiter (tng) or toxic multi hetero nodular goiter (gmhnt)) relevant to an indication for 131i treatment. 3. patient with no risk of iodine saturation. 4. patient able to maintain a sitting position in an armchair for 10 minutes with chin raised and held by a "chin rest" with head in extension. 5. who index ≤ 1. 6. for non-menopausal patients, use of an effective contraceptive method at the start of the clinical investigation and throughout the clinical investigation, and a negative pregnancy test before administration of the tracer activity and the 131i therapeutic activity. 7. patient signed informed consent prior to inclusion in the clinical investigation and prior to any specific procedure for the clinical investigation. 8. patient affiliated to a social security scheme in france. exclusion criteria: 1. absence of clinical or biological hyperthyroidism. 2. patient with a contraindication to 131i treatment. 3. existence of one or more nodule(s) associated with hyperthyroidism at risk of malignancy according to eu-tirads and bethesda criteria if cytopuncture performed. 4. active orbithopathy associated with graves' disease. 5. contrast-enhanced examination performed within the two months prior to inclusion. 6. use of iodised products for skin disinfection (betadine) in the 4 weeks prior to inclusion. 7. treatment with amiodarone and derivatives in the 18 months prior to inclusion. (ioduria test to rule out iodine saturation). 8. pregnant or breast-feeding woman. 9. patient planning pregnancy within 6 months of 131i treatment. 10. any psychological, family, geographical or sociological condition that makes it impossible to comply with the medical monitoring and/or procedures set out in the clinical investigation protocol. 11. any co-existing medical condition which, in the opinion of the investigator, could constitute a risk by participating in this study. 12. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Keywords: hyperthyroidism 131i treatment thyroid scintigraphy gamma camera
time study for biometry measurements with the lenstar and intraocularlens (iol) master 500

Conditions: Pseudoaphakia

Summary: the objectives of this study are to determine the time needed to complete a full set of measurements (total ophthalmic exam, subject data entry and acquisition of the measurement) by each test device, the lenstar 900 version i4 and iol master 500.

this is an open-label study randomized by sequence. each eligible subject who signs a consent form and fulfills all inclusion/exclusion criteria will undergo ophthalmic measurements by the two test products: a. haag-streit lenstar version i4 b. zeiss iol master 500 the order of measurements for the iol master 500 and the haag-streit lenstar version i4 will he randomized. the two possible sequences will be balanced (approximately 22 eyes each: ab,ba). one eye of each subject will be measured. time needed to complete testing will be measured utilizing a stop-watch. total time needed to complete all measurements of the study eye using each of the test products to capture a complete ophthalmic exam with the devices standard operating settings set to automatic measurement and analysis will be calculated by the following start and stop points: first timed measurement: measurement acquisition start: when the technician starts to acquire tbe first measurement stop: when the technician has completed all measurements second timed measurement: subject data entry start: when the technician starts to enter the subject data. stop: when the technician has completed subject data entry. third timed measurement: complete ophthalmic exam with each test product start: when tbe subject is seated at the instrument, just prior to the technician entering any subject data into the test product. stop: upon completion of all measurements using one of the test products, just prior to printing results. three trained technicians will operate tbe same study devices (haag-streit lenstar version i4 and iol master 500). approximately equal number of subjects will be assigned to each technician.

Eligibility criteria:
inclusion criteria: subjects wbo meet all of the following criteria are eligible to participate in tbe study: 1. male or female l8 years of age or older on the date of informed consent. 2. at least one eye of each subject must be a phakic eye. 3. subject must be able to fixate on a target. 4. able to understand and willing to sign tbe informed consent. exclusion criteria: subjects will be excluded from the study if the following applies: 1. history of corneal surgery. 2. use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam. 3. any ophthalmic condition preventing use of either of the instruments used in the study. 4. any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study. 5. any medical condition, which, in tbe investigator's judgment, interferes with the subjects ability to comply with tbe protocol, compromises subject safety, or interferes with tbe interpretation of the study results.

Keywords: biometry of the eye intraocular lens implantation iol
the effect of blood pressure on cerebral perfusion during vascular surgery

Conditions: Anesthesia; Peripheral Arterial Diseases

Summary: anesthesia reduces blood pressure and cerebral blood flow is normally considered to be maintained despite marked changes in blood pressure. vascular surgical patients are often elderly, have high blood pressure and atherosclerosis and in these patients cerebral blood flow may decrease if blood pressure is reduced during anesthesia. the purpose of this study is to assess the effect of blood pressure for preservation of cerebral blood flow during anesthesia in vascular surgery. the hypothesis is that in vascular surgical patients, during anesthesia, cerebral blood flow is higher with blood pressure maintained at a higher level than that used in normal clinical practice.

background: induction of anesthesia reduces mean arterial pressure (map) and cerebral blood flow is normally considered to be maintained by cerebral autoregulation despite changes in map between 60 - 150 mmhg and standard of care during anesthesia is to maintain map above 60 mmhg. vascular surgical patients are often elderly with hypertension and atherosclerotic manifestations that may impair cerebral autoregulation of importance for anesthesia-induced reduction in blood pressure. objective: to assess the effect of map for preservation of cerebral blood flow and oxygenation during vascular surgery. hypothesis: the primary hypothesis is that during general anesthesia in vascular surgical patients, cerebral blood flow velocity and oxygenation is higher with map maintained at 80-90 mmhg, compared with a map maintained at a minimum of 60 mmhg. map is controlled in both groups using continuous infusion of phenylephrine. phenylephrine is used as a tool in order to assess the effect of map on the cerebral circulation. in both groups, central blood volume is optimized by infusion of lactated ringer´s solution using a goal directed fluid therapy following induction of anaesthesia and before commencement of phenylephrine infusion. trial size: the investigators will include 40 participants (2 x 20) in order to detect or reject a 20% difference in middle cerebral artery velocity with a type i error risk of 5% and a type ii error risk of 20% (power at 80%). interim analysis will be conducted after inclusion of 20 patients (2 x 10). excluded patients will be replaced.

Eligibility criteria:
inclusion criteria: * patients undergoing one of the following vascular surgical interventions in general anesthesia: infra-inguinal bypass, femoro-femoral cross-over bypass or iliofemoral bypass surgery. * age \> 18 years. informed consent exclusion criteria: * use of monoamine oxidase inhibitors * allergy to phenylephrine * patients that cannot cooperate during examination * dementia defined as mini-mental state examination \< 24 * anesthesia within the last 30 days * alcohol consumption at or above 420 grams per week * lack of fluency in written and spoken danish * severe hearing and vision impairment * neurological disease

Keywords: cerebrovascular circulation anesthesia blood pressure peripheral arterial diseases
influence of protein supplements on serum insulin-like growth factor-i levels in women with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: this multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to investigate whether oral milk protein supplements led to increase in serum insulin-like growth factor-i levels (igf-i) as compared with a control group fed with an iso-caloric supplement, in women with anorexia nervosa. subjects receive either 150g/day of tested product or control product for 4-week, followed by a 4-week follow-up.

study centres: 4 active centres in france and 2 active centres in switzerland

Eligibility criteria:
inclusion criteria: * women aged between 18 to 40 years (bounds included). * women with a serum igf-i level below the 25th percentile of the reference value according to the age (bounds included). * women who had given written inform consent. * women with dsm-iv-confirmed anorexia nervosa lasting for at least 6 months. women with concomitant binge eating and purging type are also included. * women admitted in-hospital for weight and nutritional rehabilitation. it is anticipated that the patient will stay in-hospital during the full duration of the 4-week supplementation phase, and at least 5 weeks within the study. * women being already regular consumers of dairy products. * for women with childbearing potential, use of a contraceptive method. * discontinuation of any mineral and vitamin supplements containing calcium and vitamin d, 1 week before starting the product consumption and during the study. exclusion criteria: * women with primary amenorrhea; * women with lactose intolerance; * women with any other metabolic disease that could affect bone metabolism: osteogenesis imperfecta, paget's disease of bone, hyperthyroidism, primary hyperparathyroidism; * women with current or past neoplasm; * women with any other severe comorbidity; * pregnant or breast feeding women; * women with epilepsy; * women with any current or past use of the following treatments: bisphosphonates, calcitonin, steroids; * patients enrolled in another clinical study within the last 4 weeks; * patients having already received oral nutritional supplements or who need to receive other oral or intravenous (iv) supplements during the follow-up; * patients having received oral or iv nutritional supplements within two weeks before the inclusion; * patients having willed to participate in another clinical study during the present study phase and 4 weeks after the end of their participation in the present study.

Keywords: anorexia nervosa protein supplements igf-i
patient-reported outcome questionnaire for systemic mastocytosis

Conditions: Aggressive Systemic Mastocytosis (ASM); SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD); Mast Cell Leukemia (MCL); Smoldering Systemic Mastocytosis (SSM); Indolent Systemic Mastocytosis (ISM) ISM Subgroup Fully Recruited

Summary: the purpose of this study is to explore the key symptoms of individuals with systemic mastocytosis. interviews of enrolled individuals will be conducted to learn about the disease symptoms and condition. the interview will last approximately 60 minutes and will be conducted by a trained interviewer, be audio-recorded (with patient consent), and all information provided by the patient will be treated confidentially and made anonymous so that it is non-identifiable. the interview may be conducted face-to-face, over the phone, or virtually via skype, a free video conferencing program, depending upon the patient's geographic location. patients will be compensated for their participating time. this is not a medication-related study, and no medication will be distributed or tested during this study. participation in this study will not affect any treatment or assistance that a patient currently receives or may receive in the future.


Eligibility criteria:
inclusion criteria: * documented diagnosis of one of the following conditions based upon world health organization (who) diagnostic criteria: aggressive systemic mastocytosis (asm), systemic mastocytosis with associated clonal hematologic non-mast cell lineage disease (sm-ahnmd), mast cell leukemia (mcl), smoldering systemic mastocytosis (ssm), indolent systemic mastocytosis (ism) * diagnosis confirmed by bone marrow biopsy * fluency in english * willingness and ability to participate in a one-hour interview exclusion criteria: * a condition or situation that would interfere with participation in an interview (e.g., cognitive impairment or disorder, alcohol or drug abuse) * known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness * any other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage i or ii cancer from which the subject is currently in complete remission, or other cancer from which the subject has been disease-free for 2 years

Keywords: systemic mastocytosis patient-reported outcome (pro)