Kornimate/medical-research-clean huggingface dataset:
optimization of the anesthetic regimen using the smartpilot® system and influence on different outcome parameters - a pilot study.

Conditions: Postoperative Cognitive Disturbances

Summary: this study investigates whether general anesthesia using a pharmacokinetic/pharmacodynamic (pk/pd) -model-based index indicating the compound effect of different anesthetics leads to optimized outcome compared to manually controlled clinical anesthesia and computerized electroencephalogram (eeg).


Eligibility criteria:
inclusion criteria: * offered patient information and written informed consent * male/female patients with intended ratio of 1:1 * patients aged greater than or equal to 60 years * scheduled duration of surgery longer than or equal to 60 minutes * elective surgery (general/abdominal surgery, traumatological/orthopedic surgery, gynecology, urology) in general anesthesia exclusion criteria: * persons without the capacity to consent * unability of german language use * lacking willingness to save and hand out data within the study * participation in another study according to the german medicinal products act within 30 days before participation in the smart-outcome study * accommodation in an institution due to an official or judicial order * (unclear) history of alcohol or substances disabuse * member of staff of the charité * neurological or psychiatric disease * american society of anaesthesiologists (asa) classification greater than or equal to class iv * moribund patients due to the underlying pkpd models of the smartpilot® system, patient with the following characteristics cannot be anesthetized using smartpilot®: * height \ 200 cm, respectively * weight \ 140 kg, respectively * body mass index \> 30 * age \ 90 years of age, respectively
compare the effects of fluticasone furoate nasal spray vs placebo in patients with nasal polypoid disease

Conditions: Patients With Nasal Polyps

Summary: fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.


Eligibility criteria:
inclusion criteria: 1. male and female patients 18-70 years of age, in general good health. 2. current evidence of nasal polyps on physical exam. 3) able to understand the protocol and comply with instructions. 4) have a negative urine pregnancy test in women of childbearing potential. 5) women of childbearing potential must be on an acceptable method of birth control or willing to remain abstinent through the duration of the study. exclusion criteria: 1. are pregnant and/or breast-feeding. 2. history of alcohol or drug abuse in the past year. 3. signs and symptoms suggestive of fulminant bacterial sinusitis (fever \>101 f, persistent severe unilateral facial or tooth pain, facial swelling). 4. allergies to nasal corticosteroids 5. .other chronic significant medical illnesses 6) maintenance oral prednisone therapy for other chronic medical conditions. - -

Keywords: nasal polyps nasal steroid fluticasone furoate
evaluation of the effect of pramlintide on satiety and food intake

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

Summary: this is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.


Eligibility criteria:
for healthy volunteers: •bmi \>=20 to \ =30 to \<=40 kg/m2 for subjects with type 1 or type 2 diabetes: * treated with insulin for at least 6 months prior to screening * hba1c value between 6.5-10% inclusive * bmi between 20-40kg/m2
the effect of daily consumption of extra virgin olive oil on blood glucose among diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: saudi arabia has the highest prevalence (24%) of type 2 diabetes mellitus (t2dm) among the modern nation states in the world. in addition, majority of saudi diabetic patient do not have their blood glucose controlled. data suggests that diet, rich in olive oil and nuts, significantly reduces fasting plasma glucose and hba1c (glycated hemoglobin). olive oil has been associated with weight reduction as well as improvements in lipid profile (increase in high density (hdl) and decrease in low-density lipoprotein (ldl)). no randomized controlled trial has specifically examined the effect of olive oil as a supplement on blood glucose among diabetics. the study objective is to test the effect of daily consumption (30 ml) of extra-virgin olive oil (evoo) on hba1c among patients with type 2 diabetes.

problem: saudi arabia has the highest prevalence (24%) of type 2 diabetes mellitus (t2dm) among the modern nation states in the world. in addition, majority of saudi diabetic patient do not have their blood glucose controlled. significance: data suggests that diet, rich in olive oil and nuts, significantly reduces fasting plasma glucose and hba1c (glycated hemoglobin). olive oil has been associated with weight reduction as well as improvements in lipid profile (increase in high density (hdl) and decrease in low-density lipoprotein (ldl)). no randomized controlled trial has specifically examined the effect of olive oil as a supplement on blood glucose among diabetics. objectives: to test the effect of daily consumption (30 ml) of extra-virgin olive oil (evoo) on hba1c among patients with type 2 diabetes. methods: the study design will be an open-label randomized controlled trial with 2 groups (evoo versus no oil). the study will include 420 patients and each patient will be followed for 3 months. group difference in hba1c will be compared at 3 months to determine the effect of evoo. implications: dietary supplementation of evoo could aid saudi diabetic patients in keeping blood glucose levels controlled.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes within 10 years of enrollment * baseline hba1c \> 7%, * willing to supplement the diet with oil * able to read and write exclusion criteria: * type 1 diabetes mellitus * have gall-bladder or liver diseases or malabsorption or crohn's disease * have advanced heart disease * have an aversion or allergy to olive oil * already using olive oil daily as a dietary supplement * morbidly obese (body mass index \>40 kg/m2)

Keywords: saudi arabia, extra virgin olive oil, blood glucose
a study to evaluate the safety, tolerability, efficacy, and drug levels of cc-97540 in participants with relapsing forms of multiple sclerosis, progressive forms of multiple sclerosis or refractory myasthenia gravis (mg) (breakfree-2)

Conditions: Multiple Sclerosis; Myasthenia Gravis

Summary: the purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of cc-97540 in participants with relapsing forms of multiple sclerosis (rms), progressive forms of multiple sclerosis (pms) or refractory myasthenia gravis (mg).


Eligibility criteria:
inclusion criteria - relapsing forms of multiple sclerosis (rms) - cohort 1. i) participants must have an expanded disability status scale (edss) of ≥ 3.0 and ≤ 5.5. ii) participants must have a diagnosis of multiple sclerosis (ms) with relapsed/refractory ms or conversion to active secondary progressive multiple sclerosis (aspms), and worsening of disease within 12 months prior to screening and while on treatment with a high-efficacy dmt for at least 6 months. - progressive forms of ms - cohort 2. i) participants must have an edss ≥ 3.0 and ≤ 6.0. ii) participants must have a diagnosis of primary progressive multiple sclerosis (ppms) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (ispms). - myasthenia gravis - cohort 3 i)mgfa classification of ii-iv at screening ii) documentation of autoantibodies against achr or musk (historical or at screening) iii) refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, nsis, or biologics. iv) has had thymectomy, only if indicated according to current guidelines. exclusion criteria * cohorts 1 and 2: participants that cannot complete the 9-hole peg test (9-hpt) in at least 1 hand in \<240 seconds unless extenuating medical conditions unrelated to ms prohibit this. * participants that cannot perform a timed 25-foot walk test (t25fwt) in \< 150 seconds. * presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, lambert-eaton myasthenic syndrome. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: cc-97540 car t cart nex t next bms-986353 rms pms multiple sclerosis rrms aspms ppms ispms mg gmg refractory myasthenia gravis general myasthenia gravis cd19
observation of the immune response after covid-19 additional vaccine doses in chronic patients in hemodialysis therapy

Conditions: Chronic Kidney Diseases; COVID-19; Hemodialysis

Summary: observation of humoral and cellular immune response after additional dose vaccine with different covid-19 vaccines in eskd patients in hemodialysis therapy.

in this open, prospective, observational trial the humoral and cellular immune response in eskd patients undergoing hemodialysis shall be analyzed after administration of a fourth dose of vaccine. the total follow-up time per patient is up to 12 months after the fourth dose of vaccine. in total, 340 patients (170 patients per country) shall be included. only adult patients capable of giving consent will be enrolled. the humoral immune response will be analyzed in all patients, whereas the analysis of the cellular immune response will only be conducted in 15% of the enrolled patients. the hd-covid-ir-eu study shall be conducted in portugal and in spain.

Eligibility criteria:
inclusion criteria: * informed consent signed and dated by study patient and investigator/authorized physician * minimum age of 18 years * ability to understand the nature and requirements of the study * eskd patients on maintenance hemodialysis with a minimum of 4hrs three times a week at the time of recruitment and a dialysis vintage ≥3 months in nc clinics * patients that already received three doses against covid-19 as detailed in the manufacturer's instructions * patients that are scheduled to receive a fourth vaccine dose of either comirnaty (biontech/pfizer) or spikevax (moderna) after approval of respective national authority. exclusion criteria: * any conditions which could interfere with the patient's ability to comply with the study * participation in an interventional clinical study during the preceding 30 days * previous participation in the same study * patients with proven current covid-19 infection as identified by routine clinical practice * patient in therapy with immunosuppressive medications / immunomodulators * patients who already received a fourth covid-19 vaccination dose

Keywords: chronic kidney disease covid-19 immune responses
an efficacy and safety study of galantamine for the treatment of patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with alzheimer's disease.

this is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day \[mg/day\]) in patients with alzheimer's disease. the study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. for patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. the primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the alzheimer's disease assessment scale - japan cognitive subscale (adas-j cog) and the clinician's interview-based impression of change plus - japan (cibic plus-j). safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ecgs), and physical examination findings. the study hypothesis is that galantamine will be effective in the treatment of alzheimer's disease. study drug taken orally twice a day.

Eligibility criteria:
inclusion criteria: * outpatients with a diagnosis of alzheimer's disease according to the national institute of neurological and communicative disorders and the alzheimer's disease and related disorders association (nincds-adrda) criteria * having a mini-mental status examination (mmse) score of 10 - 22 inclusive * having an alzheimer's disease assessment scale - japan cognitive subscale (adas-j cog) score of at least 18 * exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period exclusion criteria: * patients with neurodegenerative diseases other than alzheimer's disease, such as lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), parkinsonism, etc * patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc * patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease * patients with clinically significant cardiovascular disease * patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism

Keywords: alzheimer's disease cognitive dysfunction dementia galantamine r113675
a study of recombinant aav2/6 human factor 8 gene therapy sb-525 (pf-07055480) in subjects with severe hemophilia a

Conditions: Hemophilia A

Summary: the purpose of the study is to evaluate the safety, tolerability and time-course profile of fviii activity after dosing with sb-525 (pf-07055480)

the proposed clinical study uses a recombinant adeno-associated virus 2/6 (aav2/6) vector encoding the cdna for the b-domain deleted human f8 (hf8). the secreted fviii has the same amino acid sequence as approved recombinant anti hemophilic factors (refacto® and xyntha®). the sb-525 (pf-07055480) vector encodes a liver-specific promotor module and aav2/6 exhibits liver tropism, thus providing the potential for long-term hepatic production of fviii in hemophilia a subjects. the constant production of fviii after a single sb-525 (pf-07055480) administration may provide potential benefit in durable protection against bleeding and the complications thereof without lifelong repetitive iv factor replacement administration.

Eligibility criteria:
inclusion criteria: * male ≥18 years of age * severe hemophilia a (past evidence of circulating fviii activity of \< 1% normal) * treated or exposed to fviii concentrates or cryoprecipitate for at least 150 exposure days * ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months * agree to use double barrier contraceptive until at least 3 consecutive semen samples are negative for aav 2/6 after sb-525 infusion exclusion criteria: * presence of neutralizing antibodies * current inhibitor, or history of fviii inhibitor (except for transient low titer inhibitor detected in childhood) * history of hypersensitivity response to fviii * history of hepatitis b or hiv-1/2 infection * history of hepatitis c, unless viral assays in two samples, collected at least 6 months apart, are negative * evidence of any bleeding disorder in addition to hemophilia a * markers of hepatic inflammation or overt or occult cirrhosis * history of chronic renal disease or creatinine ≥ 1.5 mg/dl * presence of liver mass on magnetic resonance imaging (mri), or, positive alpha fetoprotein * presence of \> grade 2 liver fibrosis on elastography for subjects with history of treated hepatitis c or suspicion of chronic liver disease
4-week serial fit analysis in patients with crc

Conditions: Colorectal Cancer

Summary: assimilation of fit into primary and secondary care diagnostic pathways will lead to an increased prominence of the investigation in the diagnosis of colorectal cancer (crc). questions remain about whether serial fit analysis improves accuracy, and what factors affect it. our study will analyse fit results in recently diagnosed crc patients to determine the risk of a false-negative fit result and evaluate whether repeated analysis improves diagnostic accuracy. the study aims to advise on whether there is an optimal interval between sample collection to improve diagnostic accuracy and whether any patients are at risk of a false negative based on demographics, medications or other pathological factors.

colorectal cancer (crc) remains a leading cause of cancer death in the uk and worldwide. improving outcomes depends in part on achieving earlier diagnosis of the disease. the faecal immunochemical test (fit) is replacing the less accurate faecal occult blood test (fobt) in the uk and has the potential to help achieve earlier stage diagnosis of crc. whilst fit has been validated as a screening test for the bowel cancer screening programme (bcsp), its role in diagnosing crc in symptomatic populations is yet to be defined. nottingham is a pioneering centre using fit to stratify risk and determine first-investigation in its two-week-wait (2ww) pathway. to optimise use of fit and minimise the chance of missed cancers, this project aims to better understand variation of fit results over time and how certain factors affect fit result. much of the literature has focused on the evaluation of fit in an asymptomatic population, which is inherently low risk (4,6,7). expanding use of fit to stratify risk and guide investigations for cancer in (higher risk) symptomatic populations necessitates a thoroughly evaluated testing strategy. at present there is insufficient information to advise on "negative" fit results in symptomatic patients. this study will comprehensively measure fit variation over time in patients with the target condition (crc) and help answer whether additional samples are likely to improve accuracy of fit. risk factors for false positives and false negatives have been previously identified but are not widely established (4). our study will record the presence of these risk factors, and evaluate their effects on fit-positivity with subsequent statistical analysis.

Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal cancer exclusion criteria: * less than 18 years old * not attending nottingham university hospitals for diagnosis/treatment (attending another trust) * no histological diagnosis of colorectal cancer * unable to provide informed consent - for example due to language barriers or lacking capacity to join study

Keywords: fit symptomatic fit
a phase ii dose response study in japan in chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: to demonstrate the dose response of entecavir in japanese patients as measured by hbv dna levels by pcr (log10 copies/ml) at week 22


Eligibility criteria:
inclusion criteria: * positive for hbsag or, negative for igm core antibody and confirmation of chronic hepatitis b on liver biopsy, * positive for hbeag or negative for hbeag with positive hbeab, * documented hbv viremia on 2 or more occasions: viremia on sample drawn and hbv dna of ≥ 40 meq/ml by quantiplex assay at the screening visit
a multi-center observational trial of symptomatic, high-risk bone metastases treated with percutaneous ablation and palliative radiation therapy

Conditions: Bone Cancer Metastatic

Summary: the objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (rt).


Eligibility criteria:
inclusion criteria: * 1. skeletal metastasis with localized pain not controlled medically \[recall within last 24 hours of worst pain ≥ 5 using the bpi\] * 2. pain must be from one painful metastatic lesion involving the bone (additional less painful metastatic sites may be present). extra-osseous extension of disease is allowed (must have some contact with the bone and be causing bone/tumor interface pain) * 3. lesions that are at high-risk of skeletal related events defined as follows: * a. minimum spinal instability neoplastic score (sins) score ≥ 7 for lesions involving the spine * b. pelvic and appendicular lytic lesions with or without cortical breakthrough causing functional/mechanical pain * 4. target lesion amenable to percutaneous ablation with image guidance and rt by specialists' review * 5. no prior targeted radiation therapy or ablation to the index lesion * 6. ecog performance status 0-2 * 7. age ≥ 21 years * 8. have signed the current approved informed consent form * 9. willing and able to answer follow-up patient reported outcomes (pro) surveys (e.g., promis®, bpi, cost-facit, and omed) for up to 12 months * 10. life expectancy \> 3 months exclusion criteria: * 1. any medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial. * 2. target tumor involves a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone \[mirel score ≥ 7\] * 3. skeletal lesions with unstable pathologic fractures requiring immediate surgical stabilization * 4. concurrent participation in other studies that could affect the primary endpoint * 5. target tumor causing clinical or imaging evidence of spinal cord compression
the effect of magnesium supplementation during general anesthesia on the quality of postoperative recovery in children

Conditions: Emergence Delirium

Summary: evaluation of prevention of emergence delirium and analgesic effect of magnesium on children

children \< 8 years old who scheduled for elective opthalmic surgery are randomly assigned to magnesium (mg) group and control group. before anesthetic induction, modified yale preoperative anxiety scale (m-ypas) is assessed. routine anesthetic induction is performed, and neuromuscular blocker is not used. laryngeal mask airway is inserted and controlled ventilation is started. in mg group, mg of 30 mg/kg is administered for 10 minutes and then continuously infused (10mg/kg/hr) until 5 minutes before surgery end. in control group, the similar volume of saline is infused. pediatric anesthesia emergence delirium (paed) scale and pain score (modified children's hospital of eastern ontario pain scale, cheops) will be measured immediately after and 30 minutes after surgery.

Eligibility criteria:
inclusion criteria: * children aged between 2 and 7 years * american society of anesthesiologist physical status 1 and 2 * children scheduled for opthalmic surgery exclusion criteria: * allergy history to any drugs * risk of malignant hyperthermia * neuromuscular disease * with arrhythmia * any pulmonary, cardiac, hepatic and renal disease * obesity