Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the long-term clinical safety and efficacy of subcutaneously administered c1-esterase inhibitor in the prevention of hereditary angioedema

Conditions: Hereditary Angioedema Types I and II

Summary: the aim of this study is to assess the long-term safety of c1-esterase inhibitor (c1-inh) in preventing hereditary angioedema (hae) attacks when it is administered under the skin of subjects with hae. the safety of participating subjects will be assessed for up to 54 weeks. the long-term efficacy of c1-inh will also be assessed. each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume c1-inh. subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. the study aims to enroll eligible subjects who completed study csl830_3001 (nct01912456). subjects who did not participate in study csl830_3001 may also participate, if eligible and if space permits. subjects from the united states (us) who complete treatment period 2 will be allowed to participate in an extension period. during the extension period participating us subjects will continue to receive treatment with open-label csl830 for up to an additional 88 weeks.


Eligibility criteria:
inclusion criteria: * males or females aged 6 years or older. * a confirmed diagnosis of hae type i or ii. * hae attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment. * for subjects who have used oral therapy for prophylaxis against hae attacks within 3 months of first study visit: use of a stable regimen within 3 months of the first study visit. exclusion criteria: * incurable malignancies. * any clinical condition that will interfere with the evaluation of c1-inh therapy. * clinically significant history of poor response to c1-esterase therapy for the management of hae. * suspected or confirmed diagnosis of acquired hae or hae with normal c1-inh. * inability to have hae managed pharmacologically with on-demand treatment.
study for multiple doses of hm15136(efpegerglucagon) in obese or overweight subjects with comorbidities

Conditions: Obese With Comorbidities; Overweight With Comorbidities; Type2 Diabetes

Summary: the planned period of each cohort is 22 weeks including subject screening, treatments for 12 weeks, and follow up period.

the current phase i study was a two-part study. part 1 was designed to assess the safety, pk, and pharmacodynamics (pd) after repeated doses of hm15136 in obese or overweight subjects with comorbidities (i.e., dyslipidemia and/or hypertension). part 2 was designed to assess the safety, pk, and pd after repeated doses of hm15136 in obese or overweight subjects with t2dm and comorbidities (i.e., dyslipidemia and/or

Eligibility criteria:
inclusion criteria: 1. male or female subjects 2. age ≥ 18 to ≤ 65 years at screening visit 3. body mass index ( bmi ≥ 30 kg/m 2 or 27 kg/m 2 with presence of comorbidities (subjects in part 1 and subjects with pre diabete s mellitus (dm) in part 2: dyslipidemia and or hypertension except for type 2 (t2) dm, t2dm subjects in part 2: dyslipidemia and/or hypertension with t2dm) with/without medication treatment and have had stable weight for 3 months (weight changes less than 5%) exclusion criteria: 1. previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal surgery that may induce malabsorption, history of bowel resection \> 20 cm, any malabsorption disorder, severe gastroparesis, any gi procedure for weight loss (including lapband®), as well as clinically significant gastrointestinal disorders (e.g. peptic ulcers, severe gerd ) at screening. 2. use of antacids, anticoagulants, or drugs that directly modify gastrointestinal (gi) motility, including antacid s anticholinergics, anticonvulsants, serotonin type 3 (5ht3) antagonists, dopamine antagonists, opiates; anticoagulation within 2 weeks of screening (but, it is not limited to the above listed drugs.) 3. uncontrolled hypertension, defined as systolic blood pressure \> 160 mmhg and/or diastolic blood pressure ≥ 100 mmhg at screening independent of subjects being on antihypertensive medication or no t). but, if the results are out of the reference range at the screening visit, they can be tested again on another day. subjects with uncontrolled hypertension may be rescreened after 3 months, following initiation or adjustment of antihyp ertensive therapy.)
efficacy study of intra-hepatic administration of therasphere® in association with intravenous chemotherapy to treat cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: the purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of yttrium 90-labelled microsphere (theraspheres®, nordion) in association with intravenous chemotherapy with gemcitabin and cisplatin for the treatment of intra-hepatic cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed intra-hepatic cholangiocarcinoma. 2. measurable target of at least 2 cm diameter. 3. healthy liver or cirrhosis child \< b8. 4. who-ps: 0-1. 5. age ≥ 18 years. 6. non-metastatic disease in extra-hepatic (are permitted: local lymph nodes \< 3 cm, less than 5 lung nodes \< 11 mm). 7. creatinine clearance (calculated with cockcroft and gault formula) ≥ 55 ml/min, polymorphonuclear neutrophils ≥ 1500 g/l, platelets ≥ 80 g/l, prothrombin ≥ 40% (inr ≤ 2.3), serum albumin ≥ 28 g/l, serum bilirubin ≤ 3 x lsn. 8. pregnancy test: negative for women of childbearing potential. 9. reliable contraception for a childbearing couple, men and woman must have an reliable contraception during the treatment and until 6 months following the end of the treatment by chemotherapy 10. signed informed consent form. 11. patient with national health insurance. exclusion criteria: 1. pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder. 2. extra-hepatic metastasis (including local lymph nodes measuring \> 30 mm). 3. primary sclerosing cholangitis. 4. history of chemoembolization or radioembolization. 5. cirrhose child \> b7 6. portal vein trunk tumoral thrombosis 7. history of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy. 8. contra indication of gemcitabine and/or cisplatin. 9. other invasive active cancer, excepting in situ cervical cancer and basocellular or spino cellular skin cancer treated adequately. any history of cancer not considered as completely cured for at least one year. 10. technical failure of the diagnostic arteriography. 11. extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography. 12. dosimetry study predicting lung exposure \> 30 gy. 13. any unstable medical history (diabetes, hypertension ...). 14. history of organ transplant. 15. symptomatic grade 1 angina pectoris or grade ≥ 2 angina pectoris. 16. an evolutive neuropathy. 17. patient who already has been involved in a clinical trial with drug intake, whether this drug was experimental or not, within 30 days before. 18. pregnant patient or patient with breastfeeding. 19. patient under administrative supervision. 20. regular follow-up impossible for various reasons (psychological, familial, economical, and social).

Keywords: intra-hepatic cholangiocarcinoma treatment
development and evaluation of a new diagnostic test in female urinary stress incontinence

Conditions: Urinary Incontinence, Stress

Summary: the investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence. the main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral tvt (tension-free vaginal tape) or tot (trans-obturator tape) treatment for stress urinary incontinence in women. the q-tip test (test mentioned in the french and international recommendations) is compared to test a new test (clip strip).

secondary objectives include: * compare the prognostic ability of the clip strip test with the bonney maneuver * compare the prognostic ability of the clip strip test with the tvt maneuver * compare the maximum intraurethral pressure during various tests * compare the quality of life before / after surgery * estimate patient satisfaction one year after surgery * describe the intra and inter-operator reproducibility of various prognostic tests. * estimate the optimal threshold of the q-tip angle based on surgical results and compare with the reference threshold of 30 ° found in the literature.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 60 weeks of follow-up * candidate for stress urinary incontinence surgery by tvt or tot procedures * positive cough or valsalve maneuver test exclusion criteria: * the patient is participating in another study (except the pisq-r study) * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a contra-indication for stress urinary incontinence surgery via tvt or tot procedures. * the patient has an untreated vaginal or urniary infection * the patient has a history of allergy to polyurethane and / or watershed xcx11122

Keywords: predicting surgical success simple diagnostic test device
cell marker predictors in barrett's esophagus

Conditions: Barrett's Esophagus Without Dysplasia

Summary: the purpose of this study is to analyze biopsied tissue samples for changes in cells and genes involved in barrett's esophagus.

patients with a history of barrett's esophagus who are scheduled for a routine endoscopy will have an additional biopsy taken for genetic testing.

Eligibility criteria:
inclusion criteria: * history of barrett's esophagus; scheduled for routine upper endoscopy exclusion criteria: * under 18 years of age * unable to consent on own behalf
development and evaluation of a portable wedge device for calf stretching to alleviate strain and spasms

Conditions: Spasm

Summary: this research aimed to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues.

by combining economical, ergonomic principles and user-friendly features, the proposed device offered individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms. developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. this innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.

Eligibility criteria:
inclusion criteria: * male and female patients diagnosed with calf strain and spasm * age above 18 * participants who are volunteer for the study * patients who suffer from leg pain or functional disability exclusion criteria: * unconscious patients * patients with difficulty in seeing and hearing * patients having a history of mental illnesses (stroke, multiple sclerosis, parkinsonism, alzheimer's disease) * patient history of severe mobility disorder * systemic illness (liver failure, active cancer, cardiopulmonary distress) * decline to participate in this study * active fracture and dislocations * arthritic disorders (such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, and fibromyalgia)
candesartan effect in second stage arterial hypertension

Conditions: Stage II Hypertension

Summary: to compare the changes in mean sitting dbp from baseline after 4 weeks of therapy with either candesartan cilexetil/hct combination therapy or candesartan cilexetil monotherapy regimen


Eligibility criteria:
inclusion criteria: * stage ii essential hypertension (sbp≥ 160 or dbp≥100 mmhg), untreated, or treated with a maximum of 2 class of antihypertensive drugs exclusion criteria: * current serum-creatinine \>3 mg/dl, current serum-potassium \>5.5 mmol/l, 16. * pregnant or lactating women or women of childbearing potential who were not protected from pregnancy

Keywords: candesartan cilexetil hydrochlorothiazide severe hypertension
large scale implementation of ministop 3.0

Conditions: Obesity, Child

Summary: ministop is an evidence-based app for parents of preschool aged children with the overall aim to promote healthy lifestyle behaviors and prevent the development of overweight and obesity. ministop has been previously been evaluated in two previous trials (ministop 1.0 and 2.0) with promising results. therefore, the overall aim of this trial is to evaluate the large scale implementation of ministop within swedish primary child healthcare. the specific aims are to: (i) to compare two different implementation strategies for ministop 3.0 (i.e., basic vs. enhanced) on: a) acceptability, appropriateness, feasibility as well as organizational readiness to implement ministop 3.0 within primary child healthcare (primary outcomes) and b) reach, costs, adoption, and sustainability of ministop 3.0 within primary child healthcare (secondary outcomes). (ii) to compare two different implementation strategies of ministop 3.0 within primary child healthcare on children's key dietary indicators, physical activity, and screen time (secondary outcomes). (iii) to compare the cost-effectiveness of two different implementation strategies for ministop 3.0.


Eligibility criteria:
inclusion criteria: * child healthcare nurse at participating child healthcare centers no exclusion criteria.
ai-powered diy screening system for diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: a pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. it will be run for 3 months in each clinic to complete data collection of up to 100 patients in spgc and optometry clinics, 200 at gpgc and 200 in gopc in total. all the subjects will conduct a diy screening, physician consultation, survey with questionnaires and a phone interview three months after their baseline assessment. this study will assess automated screening in terms of success rate of the diy system without active assistant help, accuracy, screening rate and detection rate, adherence to referral and experience of participants, as well as cost-effectiveness in real-world settings.


Eligibility criteria:
inclusion criteria: 1. subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and 2. have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease). 3. provide written informed consent. exclusion criteria: 1. individuals with physical disabilities that prevent the use of a fundus camera, or 2. individuals with speech impairments who are unable to complete telephone follow-ups.

Keywords: diabetic retinopathy ai screening system
psma-pet imaging before and after adt in advanced sdc patients

Conditions: Salivary Gland Cancer; Salivary Duct Carcinoma

Summary: explorative study, which evaluates the effect of androgen deprivation therapy (adt) on the psma ligand uptake on 68ga-psma-pet/ct in salivary duct carcinoma patients.

rationale: prostate specific membrane antigen (psma) is a transmembrane protein, which is expressed on prostate cancers cells and other malignancies. recently, several ligands have been developed that target psma. linked to gallium-68, this enables diagnostic 68ga-psma-pet/ct scans. linked to lutetium-177 enables therapeutic 177lu-psma radioligand therapy. most research on the diagnostic and therapeutic possibilities of psma has been conducted in patients with advanced prostate cancer. this research group investigates whether these findings also apply to salivary gland cancer (sgc), a rare cancer. previously the investigators conducted a phase ii 68ga-psma imaging study (nct03319641), to evaluate psma ligand uptake in locally advanced, recurrent and metastatic acc and sdc (two subtypes of sgc). a relevant psma-ligand uptake was observed in 93% of acc patients and 40% of sdc patients. however, since 60% of sdc patients showed low ligand uptake, these patients are not suitable for psma radioligand therapy. for advanced sdc, androgen deprivation therapy is often given as first-line treatment, because the majority of sdcs are androgen receptor positive. in prostate cancer, androgen deprivation therapy (adt) can increase psma-ligand uptake. therefore the aim is to investigate if adt can increase the uptake of 68ga-psma in patients with r/m sdc, as has previously been demonstrated in prostate cancer. objective: the primary objective is to investigate if adt can increase the uptake of 68ga-psma in patients with r/m sdc. study design: interventional clinical trial, an explorative study. study population: patients with locally advanced, recurrent or metastatic (r/m) sdc ar+ and who will start adt as standard of care.

Eligibility criteria:
inclusion criteria: * patients must have the ability to provide written informed consent. * patients must be ≥ 18 years of age. * patients must have histological, pathological, and/or cytological confirmation of salivary duct carcinoma, androgen receptor positive. * only patients with locally advanced, recurrent or metastatic salivary duct carcinoma can participate. * patients must have at least one lesion with a diameter of ≥ 1.5 cm. * patients whom intend to start androgen deprivation therapy, after this has been recommended by the treating physician as standard treatment. exclusion criteria: * contra-indication for pet imaging (pregnancy, breast feeding severe claustrophobia) * impaired renal function: mdrd \<30 ml/min/1,73 m2 * impaired liver function: ast and alt alt ≥ 2.5 x uln (≥5 x uln for patients with liver metastases)

Keywords: positron-emission tomography 68ga-psma-pet/ct 18fdg-pet/ct androgen deprivation therapy
the incidence of venous thromboembolism in atopic dermatitis

Conditions: Venous Thromboembolism; Atopic Dermatitis; Pulmonary Embolism; Deep Vein Thrombosis; Allergic Rhinitis; Allergy to House Dust Mite; Allergy to Animal Dander; Food Allergy; Cows Milk Allergy

Summary: this study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.

the aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with ad such as those with higher body mass index or using oestrogen containing contraceptives. such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.

Eligibility criteria:
inclusion criteria: * all eligible adult people (aged ≥ 18) registered with gp practices contributing data to opcrd between january 1, 2010 and january 1, 2020, were eligible for inclusion in the study. exclusion criteria: * people with less than 5 years potential follow up. people with atopic dermatitis that was not active atopic dermatitis during the study period. people without atopic dermatitis but diagnosed with other skin conditions.
real-world analysis of workup at disease progression and implementation of osimertinib for egfr+ nsclc

Conditions: EGFR Positive Non-small Cell Lung Cancer

Summary: tyrosine kinase inhibitors (tki) have greatly improved prognosis of epidermal growth factor receptor (egfr)-positive non-small cell lung cancer (nsclc), with tumor responses in the majority of cases and a median overall survival currently exceeding 2.5 years. however, clinical courses vary widely and eventual treatment failure is inevitable. the most common resistance mechanism against first- and second-generation egfr inhibitors is the egfr t790m mutation, which emerges in about 50% of cases and is amenable to next-line treatment with the third-generation compound osimertinib. however, experience in everyday clinical practice shows that implementation of egfr tki sequencing is often problematic, for example because a considerable number of egfr+ nsclc patients failing first- and second-generation egfr inhibitors do not undergo t790m mutation testing at the time of disease progression. this study will use patient records to analyze the clinical course of egfr+ nsclc patients treated with first- and second-generation egfr inhibitors at the thoraxklinik heidelberg (germany) during the past years. the main aim is to analyze the diagnostic and therapeutic measures, including implementation of osimertinib, taken at the time of disease progression as well as their effect on patient outcome in a real-world, routine clinical setting.


Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced (stage iii) and not suitable for definitive local treatment, or metastatic (stage iv) nsclc * activating egfr mutation confirmed * treatment with egfr tki exclusion criteria: none

Keywords: non-small cell lung carcinoma egfr mutation tyrosine kinase inhibitor osimertinib egfr t790m