Kornimate/medical-research-clean huggingface dataset:
intravitreal ert to prevent retinal disease progression in children with cln2

Conditions: Neuronal Ceroid Lipofuscinosis Type 2

Summary: this is a phase i/ii randomized, masked, clinical trial to determine the safety and efficacy of intravitreal administration of cerliponase alfa.

this is a phase i/ii study for 5 subjects receiving an intravitreal injection of cerliponase alfa under sedation into the proclaimed study eye(s) in a 4-week interval over 24 months. this study will be monitored by a data safety monitoring committee (dsmb). each subject will participate in the ongoing study for an active period of 2 years. subjects will then transfer to a bi-annual monitoring program where data will be collected from bi-annual standard of care visits for an additional 3 years.

Eligibility criteria:
inclusion criteria: * genotypic confirmation of classical cln2 batten's disease from a clia certified lab. * enzyme level deficiency of tripeptidyl-peptidase * minimum age requirement: 24 months of age at enrollment * maximum age requirement: 72 months of age at enrollment * currently receiving intraventricular cerliponase alfa * willing to participate in the proposed study visits over the 2-year period * minimum central retinal thickness (crt) of 140μm based upon oct assessment * clear ocular media * no ocular pathology present to account for vision loss other than optic atrophy and pigmentary retinopathy that is felt to be due to the cln2 disease process exclusion criteria: * any opacities in the clear ocular media including vitreous debris. * history of ocular trauma or prior ocular surgery. * episode of generalized motor status epilepticus within four weeks before the first dose visit * severe infection (e.g., upper respiratory tract infection, pneumonia, pyelonephritis, or meningitis) within four weeks before the first dose visit (enrollment may be postponed) * those with a history of bleeding disorders. * history of or current chemotherapy, radiotherapy or other immunosuppression therapy within the past 30 days (corticosteroid treatment may be permitted at the discretion of the pi) * has a medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with the protocol required testing or procedures or compromise the subject's wellbeing, safety, or clinical interpretability
pulmonary arteriovenous malformations (pavms) in hereditary haemorrhagic telangiectasia (hht)

Conditions: Hereditary Haemorrhagic Telangiectasia; Pulmonary Arteriovenous Malformation; Cerebral Disorder

Summary: computed tomography (ct) is the modality of choice to characterize pulmonary arteriovenous malformations (pavms) in patients with hereditary haemorrhagic telangiectasia (hht). the objective of this study was to determine if ct findings were associated with frequency of brain abscess and ischaemic stroke. this retrospective study included patients with hht-related pavms. ct results, pavm presentation (unique, multiple, disseminated or diffuse), the number of pavms and the largest feeding artery size, were correlated to prevalence of ischaemic stroke and brain abscess.


Eligibility criteria:
inclusion criteria: * hereditary haemorrhagic telangiectasia (hht) diagnosis * pulmonary arteriovenous malformations (pavms) related with hht exclusion criteria: * clinical follow-up not available in the database
effect of ketamine (ketalar) on intracranial pressure

Conditions: Traumatic Brain Injury; Intracranial Hypertension

Summary: objectives: ketamine is an effective, short-acting anesthetic drug, which does not decrease blood pressure. it is widely stated that ketamine increases intracranial pressure (icp), which prevents its use in many emergency situations, specifically in patients with traumatic brain injury (tbi) and with increased icp. based on previous clinical experience, we hypothesized that ketamine decreases - rather than increases - icp. methods: prospective, controlled, clinical trial. children with icp monitoring will receive a single ketamine dose (1-1.5 mg/kg) either for increased icp and/or before a potentially distressing activity. hemodynamic variables, icp and cerebral perfusion pressure (cpp) will be recorded 1 minute before and every minute for 10 minutes following ketamine administration (before/after design).

objectives: ketamine is an effective, safe, rapid, short-acting anesthetic drug, and - contrary to all other anesthetic drugs - it does not decrease blood pressure. it is widely believed that ketamine increases intracranial pressure (icp), which prevents its use in many emergency situations, including trauma and specifically in patients with traumatic brain injury (tbi) and with increased icp. based on our previous clinical experience in patients with icp monitoring, ketamine did not increase icp. we therefore hypothesize that ketamine decreases - rather than increases - icp. methods: prospective, controlled, clinical trial performed in a pediatric icu of a regional trauma center. children with icp monitoring receive a single ketamine dose (1-1.5 mg/kg) either for increased icp and/or before a potentially distressing activity. hemodynamic variables, icp and cerebral perfusion pressure (cpp) will be recorded 1 minute before and every minute for 10 minutes following ketamine administration (before/after study design). parents/guardian of patients will be informed and asked to sign an informed consent.

Eligibility criteria:
inclusion criteria: * children who have an icp monitoring device, who either have increased icp and/or who should undergo a potentially distressing activity (suction, position change etc.).

Keywords: ketamine traumatic brain injury intracranial hypertension
a study based on medical records in spain that looks at diarrhoea control in people with pulmonary fibrosis who are taking nintedanib

Conditions: Idiopathic Pulmonary Fibrosis; Diarrhoea

Summary: this is an observational, non-interventional, and prospective post authorization safety study (pass) that will describe the real-world proportion of patients that achieve nintedanib-associated diarrhoea control after 12 weeks of follow-up, in hospital settings in spain. it will include outpatients (i.e., those attending ambulatory visits) with interstitial lung diseases (ipf) and other progressive pulmonary fibrosis (ppf) treated with nintedanib (150 mg bid) and having a first episode of diarrhoea after nintedanib initiation.


Eligibility criteria:
inclusion criteria/definition * adults (≥18 years old) at diarrhoea initiation. * ability to consent and to conduct all procedures of the study, as judged by the study investigator, and agreeing to participate providing informed consent at baseline. * diagnosis of idiopathic pulmonary fibrosis (ipf) or progressive pulmonary fibrosis (ppf) (other than ipf), as registered in electronic medical records (emr) using free text or international statistical classification of diseases and related health problems (icd) codes (icd-9 and/or icd-10), at least 1 day before diarrhoea initiation. * being treated with 150 milligram (mg) bid of nintedanib when initiating diarrhoea symptoms, defined as having a nintedanib anatomical therapeutic chemical (atc) code (l01ex09) or the molecule/commercial name registered in the emr, for at least 1 day before diarrhoea initiation. * first pulmonologist consultation (face-to-face) at the time of recruitment due to a first diarrhoea episode as defined by the pulmonologist since nintedanib initiation. diarrhoea defined as the passage of three or more loose or liquid stools in a 24-hour period (loose or liquid stools defined as stools with a bristol stool form scale (bsfs) of 6 or 7 points). exclusion criteria 1. patients diagnosed with systemic sclerosis associated interstitial lung disease (ssc-ild) as registered in emr using free text or icd codes (icd-9 and icd-10). referent to any time before or at diarrhoea initiation. 2. participation in any clinical trial including a drug or device at any time before or at diarrhoea initiation. 3. participation in any patient support programme (psp) at diarrhoea initiation. 4. having history of chronic gastrointestinal disorder (e.g., inflammatory bowel disease or the short gut syndrome), pancreatic dysfunction/insufficiency, or colon cancer; due to the likelihood of faecal incontinence. referent to any time before or at diarrhoea initiation. 5. having a performance status (ps) ≥3 points on the eastern cooperative oncology group scale (ecog) scale at diarrhoea initiation, due to the likelihood of faecal incontinence.
non-interventional study describing healthcare resource utilisation and clinical outcomes associated with vns therapy in uk.

Conditions: Epilepsy

Summary: this is a uk, multi-center, non-interventional study based on the use of health service administrative and medical records (paper-based and/or electronic, as applicable) along with the use of prospectively collected subject-reported outcomes on experience with use of vns therapy using validated and bespoke self-completion questionnaires. data for hospital resource utilisation will be extracted from the hospital episode statistics (hes) database.

failure to control seizures in subjects with treatment resistant epilepsy can have a significant burden on the healthcare system. vagus nerve stimulation (vns) is an adjunctive treatment for patients with drug resistant epilepsy and is reported to reduce the frequency of seizures in adults and children. however, real-world data on healthcare resource utilization by patients with treatment-resistant epilepsy and their clinical outcomes prior to and post vns device implantation in the uk are limited. the current study aims to describe the resource utilization and clinical outcomes prior to and following the implantation of different vns devices (demipulse®/aspire hc®, aspire sr® and sentiva®) in subjects with drug resistant epilepsy

Eligibility criteria:
inclusion criteria: living subjects who meet all of the following criteria will be considered for enrolment: * clinical diagnosis of drug resistant epilepsy * subjects who have had their first vns device (demipulse®/aspire hc®, aspire sr® and sentiva®) implanted at least 18 months prior to their enrolment in the study data (with no change in generator, battery or lead). * for sentiva® and aspire sr®, autostim was first activated within 1 month of implantation. * for sentiva®, scheduled dosing mode was activated within 1 month of implantation. * subjects must be able and willing to provide informed consent; subjects aged 7-12 years old and 13-15 years old will be provided with appropriate information and consent forms to explain the study in age appropriate language. these subjects will be asked to provide their assent to take part in the study, with consent provided by their parent/carer. subjects under 7 years will be included in the study with consent from their parent/carer. for adult subjects (≥16 years) lacking the mental capacity to consent, advice about participation will be sought from an appropriate consultee, according to the mental capacity act 2005. * adult and paediatric subjects (aged over 2.5 years at study enrolment) with available medical records for at least 12 months prior to vns device implantation. exclusion criteria: * subjects whose medical records are not available for review. * deceased subjects.

Keywords: vns dre drug resistant epilepsy vagus nervus stimulation healthcare resource utilization
a crossover designed study to evaluate effects of microcurrent therapy on knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: this crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. ín a previous study patients were randomized into four different groups. group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group. in the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).

the objective of the previous randomized, controlled pilot study was to evaluate the effect of microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. the secondary objective was to compare the effects of different currents. (group 1 - 4) after receiving 10 sessions of microcurrent therapy the statistical calculation showed a slightly significant difference in the verum-group a (parameters channel a: channel b, frequency ...) after a wash-out-phase we are now trying to evaluate and possibly confirm the positive effect of the previous trial. therefore the control - and sham group from the previous study will now receive microcurrent therapy of apparatus a. the whole procedure (number of session, duration of the treatments, main outcome measurements, secondary outcome measurements) of the following study is identical with the previous pilot study. assessments four the group will be at the first day of treatment (t1) and at the end of treatment (t2).

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee * pain intensity \> 3 on the numerical rating scale (0-10) exclusion criteria: * knee arthroplasty * gravity * dermal irritation at the skin of the knee * carcinoma * known osteoarthritis grade 4 (kellgren and lawrence score)

Keywords: osteoarthritis microcurrent knee electrotherapy
safety and efficacy of folatescan (technetium tc 99m ec20) in patients with suspected ovarian carcinoma or recurrent endometrial carcinoma

Conditions: Ovarian Carcinoma; Recurrent Endometrial Carcinoma

Summary: the folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. technetium tc 99m ec20 (99mtc-ec20; folatescan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. thus, folatescan may provide an effective method to determine folate receptor-positive (fr+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.

this phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to: * expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of folatescan in tumors (primary objective). * calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of folatescan compared with immunohistochemical (ihc) staining (secondary objective).

Eligibility criteria:
inclusion criteria: * subjects must meet the following eligibility requirements to be enrolled in the study. 1. subject must be 18 years of age or older. 2. subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion \> 1.5 cm as diagnosed by ultrasonography, mri, or ct. 3. subject must have good kidney function. 4. subject must provide written informed consent prior to enrollment. exclusion criteria: * subjects must be excluded if any of the following conditions are present: 1. subject is pregnant or breastfeeding. 2. subject is simultaneously participating in another investigational drug study. 3. subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study. 4. subject is unable to tolerate conditions for radionuclide imaging. 5. subject has been administered another radiopharmaceutical that would interfere with the assessment of technetium tc 99m ec20.

Keywords: ovarian carcinoma recurrent endometrial carcinoma
evaluating the efficacy, safety and long term functional outcomes of percutaneous mechanical aspiration thrombectomy for treatment of acute pulmonary embolism using the alphavac multipurpose mechanical aspiration (mma) f1885 system

Conditions: Acute Pulmonary Embolism (PE); Pulmonary Embolism

Summary: to evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the alphavac multipurpose mechanical aspiration (mma) f1885 system for the treatment of acute pulmonary embolism.


Eligibility criteria:
inclusion criteria: * symptomatic, ctpa-proven acute pe with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery * rv/lv diameter ratio ≥ 1.0 assessed by ctpa * serum troponin levels above upper limit of normal as per hospital policy * ≥ 18 years of age * at least one of the following: 1. electrocardiogram (ecg)-documented tachycardia with heart rate ≥ 100 bpm, not due to hypovolemia, arrhythmia or sepsis 2. systolic blood pressure ≤ 110mmhg for at least 15 minutes 3. respiratory rate \> 20 breaths per minuted. oxygen saturation on pulse oximetry (spo2) \< 90% (or partial arterial oxygen pressure \< 60 mmhg) at rest while breathing room air 4. known history of heart failure * willing and able to provide written informed consent prior to receiving study specific procedures. exclusion criteria: * a contraindication to therapeutic anticoagulation * any comorbid diagnosis consistent with a life expectancy of less than 1 year (e.g., stage 4 cancer) * known serious, uncontrolled sensitivity to radiographic agents * cardiac arrest within last 14 days without documented evidence of recovery of conscious level to glasgow coma scale \>12 * indication for ecmo * pregnant or breastfeeding * participation in another investigational drug or device study that study may confound the results of this study. studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies. * other medical, social, or psychological conditions that, in the opinion of the investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study. * history of congenital or acquired bleeding disorder predisposing to hemorrhagic state * platelet count \< 100,000/μl * any advanced reperfusion therapy for pulmonary embolism within 30 days of the index procedure (e.g lysis, surgery, catheter intervention) * a known clot in transit * ivc filter * a do not resuscitate limitation at inclusion in the study * deprived of liberty or under court protection
mckenzie and rhythmical stabilization technique on chronic neck pain

Conditions: Neck Pain

Summary: the study will be randomized clinical trial. total 40 subjects will be assigned randomly by using non probability convenient into two groups. group a will be given mckenzie protocol, with conventional physiotherapy treatment while group b is rhythmic stabilization group who will receive rhythmic stabilization, with conventional physiotherapy. after confirmation of diagnosis with medical history and physical examination numeric pain rating scale (nprs) and neck disability index (ndi) would be used as an outcome measure tools for pain and disability respectively. measure will be taken by goniometer. after data collection from defined study setting,data will be entered and analyzed at riphah international university, lahore.

neck pain is a very common ailment that results in a great deal of suffering, impairment, and financial expense. the international association for the study of pain is defined as pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck. according to the study's findings, 69% of balochistan university undergraduate students in quetta, pakistan, experienced neck pain. pain in many cervical spine structures has the potential to become chronic neck pain. in epidemiologic research, pain is considered chronic if it lasts more than three months to six months, or five years. mckenzie's treatment regimens were first used in sweden in 1985 to address mechanical spine patient issues. for these kinds of patients, protocols were often employed in the 1990s. repeated neck retraction exercises considerably lessen the pain and restore the cervical spine's lordosis curve in individuals with spinal pain. rhythmic stabilization is characterized by isometric contractions against the resistance provided by the therapist, with the subject trying to maintain their position as the therapist changes the direction of resistance. both techniques are effective in pain and range of motion in chronic neck pain. mckenzie protocol and rhythmic stabilization are both studied individually before but their effects are not compared previously.

Eligibility criteria:
inclusion criteria: * age 30-50 * localized chronic neck pain for more than 3 months. exclusion criteria: * participants suffering their neck pain was caused by any other complications.

Keywords: mckenzie protocol rhythmic stabilization technique
preparation and characterization intranasal film loaded with steroid as a local treatment of anosmia in compare to insulin intranasal film

Conditions: Smell Loss

Summary: this study is a growing step of phase i study published on march 2021. the study was implicated on minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post covid-19 infections. this record will modify the first formulation by addition certain concentration of steroid.


Eligibility criteria:
inclusion criteria: * all patients' adults aged from 18 years to 50 will included in the study. * a confirmed case (positive pcr), recovered/discharged (2 negative pcr), * suffering from sudden recent anosmia or hyposmia with or without loss of taste. exclusion criteria: 1. patients with chronic sinusitis. 2. patients with acute allergic rhinitis. 3. patients' nasal polyposis 4. patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell. 5. patient poly morbidities or poly pharmacy. 6. elder, pregnant, or nursing woman. 7. patients with chronic diseases. 8. autoimmune diseases. 9. patient suffering end organ problems.
the mechanism of melanocyte self-assembly on biomaterials and the functional analysis

Conditions: Melanocyte; Vitiligo

Summary: the aim of this study is to survey melanocytes in the ability of self-assembly on biomaterials and functional analysis in vitro. also, this study may provide a better way for treatment of vitiligo after understanding the functional aspects of melanocytes.

vitiligo is a chronic disease that causes loss of melanocyte and pigment of the skin. traditional treatments for vitiligo including topical corticosteroids and phototherapy lead to limited clinical effects. autologous melanocyte transplantation is another way to treat vitiligo. however, the effect is largely affected by whether cultivated melanocytes are successfully uptaken by vitiliginous skin. the aim of this study is to survey the self-assembly on biomaterials and functional analysis. in the long run, this study may provide a better way for treatment of vitiligo.

Eligibility criteria:
inclusion criteria: * patients receiving cosmetic removal of moles exclusion criteria: * no special exclusion criteria