Kornimate/medical-research-clean huggingface dataset:
mostegra trial:mo-(dified) ste-(nt) gra(-ft): surgeon-modified fenestrated-branched stent-grafts

Conditions: Complex Aortic Aneurysms

Summary: this trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-fbsg) for abdominal aortic aneurysms (aaa) that are custom-made intra-operatively with no waiting period by a qualified vascular surgeon. in addition, it aims to examine the alternative sm-fbsg for patients with restricted access to centers performing clinical trials with commercially available devices and those patients with aortic emergencies.

complex aortic aneurysms are those involving the renal and visceral arteries, and open repair of these aneurysms requires more extensive dissection, aortic clamping above the renal or mesenteric arteries, and possible reconstruction of aortic branches. recovery time tends to be longer, including more hospital days, than for endovascular repair, and there is a greater potential for complications. many high-risk patients with aneurysms of the abdominal aorta (aaa), including thoracoabdominal aortic aneurysms (taaa), and significant co-morbidities will be denied elective open surgery because of heightened risks associated with open repair of complex aneurysms, and therefore, the potential benefit of an endovascular option increases as well. endovascular aneurysm repair has been shown to be an effective alternative in treating uncomplicated infrarenal and thoracic aneurysms in both the elective and urgent setting, yet there is limited experience with this technology in complex conditions. fenestrated grafts have been developed as a minimally invasive treatment for patients with complex aortic aneurysms who are unfit for traditional open surgery. surgeon-modified fenestrated-branch stent grafts (sm-fbsg) with branches for the visceral vessels are custom-made by a qualified vascular surgeon for patients with complex aortic conditions. it is expected that they will minimize surgical risks and promote quicker recovery, and they could represent a therapeutic option for high-risk patients unfit for open surgery.

Eligibility criteria:
inclusion criteria (abbreviated): * patients presenting for elective or urgent repair of a complex aortic aneurysm * no other investigational agents or devices while on protocol * patient must be able and willing to comply with all follow-up exams * life expectancy of more than 1 year * patients with medical conditions that would make them unfit for open repair exclusion criteria (abbreviated): * estimated life expectancy \<1 year * contraindication to angiography * active infection * patients with ruptured or contained ruptured aortic aneurysm who are persistently hemodynamically unstable at the time of presentation * morbid obesity with inability to visualize the aorta with available intraoperative imaging techniques anatomic exclusion criteria: iliac arteries and aorta must be able to accommodate endovascular devices and procedure

Keywords: aortic sm-fbsg aneurysms fenestrated stent-grafts vascular endovascular
a study to evaluate the pharmacokinetics of afq056 in subjects with hepatic impairment compared to healthy subjects

Conditions: Hepatic Impairment

Summary: this study will assess the pharmacokinetics of afq056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.


Eligibility criteria:
inclusion criteria: * groups 1, 2, 3 and 4 (all subjects) * male and female caucasian subjects * group 1, 2 and 3 (subjects with hepatic impairment) * subjects must satisfy the criteria for hepatic impairment as evidenced by a child-pugh score of a, b or c at screening * group 4 (healthy subjects) * each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3. exclusion criteria: * groups 1, 2, 3 and 4 (all subjects) * use of any tobacco products from 1 week prior to cotinine screening assessments until study completion. * group 1, 2 and 3 (subjects with hepatic impairment) * history of drug or alcohol abuse within 3 months prior to screening * history or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition. * any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. * history or presence of encephalopathy within 6 months prior screening (except for subjects in groups 2 and 3). * documented presence of a porto-systemic shunt. * documented presence of esophagus varices (stage iii or iv). * group 4 (healthy subjects) * history or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases. * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. history of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline. * history or presence of hepatitis b or c and/or positive hepatitis b surface antigen (hbsag) or hepatitis c test result at screening. other protocol-defined inclusion/exclusion criteria may apply

Keywords: afq056 hepatic impairment hepatic impaired
prevalence of gastroesophageal reflux disease (gerd) in patients with upper gastrointestinal track (git) symptoms in thailand

Conditions: Upper GIT Symptoms

Summary: this is a prospective , epidemiological, multi-centre, phase iv study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. each patient will be assessed for gerd with gerdq thai version.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * female or male aged at least 18 years * patient must be having symptoms suggestive of upper gastrointestinal tract symptoms such as heart burn/ regurgitation exclusion criteria: * involvement in the planning and /or conduct of the study (applies to both astrazeneca staff and /or staff at study site * participation in a clinical study(excluding non-interventional study or registry) during the last 3 months

Keywords: gerdq
safety and performance investigation of a new 1-piece ostomy product compared to standard of care 1-piece in subjects with ileostomy

Conditions: Ileostomy - Stoma

Summary: the objective of the investigation is to document new mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to standard of care.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. be at least 18 years of age and have full legal capacity 3. be able to handle the appliance themselves or with help from caregiver (e.g. spouse) 4. have an ileostomy with a diameter between 15 and 45 mm 5. have had their ostomy for at least three months 6. currently use a 1-piece flat product with open bag 7. use minimum 1 product every second day. 8. be suitable for participation in the investigation and for using a standard adhesive, flat base plate 9. must use custom cut product 10. accept to test two 1-piece products within the study exclusion criteria: 1. use irrigation during the study (flush the stoma with water) 2. currently receiving or have within the past 2 months received radio- and/or chemotherapy 3. currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area 4. are pregnant or breastfeeding 5. participating in other interventional clinical investigations or have previously participated in this investigation 6. has more than three days wear time
preventing chemotherapy-induced peripheral neuropathy with acupuncture (pact trial)

Conditions: Acupuncture; Early-stage Breast Cancer; Chemotherapy-induced Peripheral Neuropathy; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III

Summary: this research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (cipn), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet. this research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer. the names of the study activities involved in this study are/is: * acupuncture treatments for participants in the acupuncture group * nature videos with a relaxation exercise for participants in the relaxation/ exercise group the comprehensive and integrative medicine institute (cimi) of south korea is supporting this research study by providing funding.

this study randomly assigns patients with breast cancer who are starting a chemotherapy program that includes a taxane to one of two groups: * the acupuncture group will receive acupuncture treatments for 12 weeks during chemotherapy treatment. * the relaxation exercise group will receive a program of weekly videos accompanied by a relaxation exercise. both programs will last 12 weeks. participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program, so participants be on this research study for up to 24 weeks (6 months). it is expected that about 80 people will take part in this research study.

Eligibility criteria:
inclusion criteria: * history of histologically proven stage i-iii breast cancer, without evidence of distant metastasis * scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (with or without her-2 directed therapy or with or without immunotherapy). patient must enroll before the second infusion of a taxane. * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status of 0 or 1 * signed informed consent exclusion criteria: * previous receipt of cipn-inducing chemotherapy agents (1 prior dose of a taxane is allowed). * unstable cardiac disease or myocardial infarction within 6 months prior to study entry * wearing a pacemaker or implantable cardioverter-defibrillator * uncontrolled seizure disorder * history of pre-existing peripheral neuropathy * use of acupuncture within the 3 months prior to study enrollment * self-report of any cipn symptoms via staff-administered pro-ctcae cipn, defined as either: * report of "mild", "moderate", "severe", "very severe" on the severity item on pro-ctcae cipn assessment * report of "a little bit", "somewhat", "quite a bit", "very much" on the interfere item on pro-ctcae cipn assessment

Keywords: acupuncture early-stage breast cancer chemotherapy-induced peripheral neuropathy breast cancer stage i breast cancer stage ii breast cancer stage iii
clomiphene citrate (cc) co-treatment with hp urinary fsh vs hp urinary fsh in cc-resistant pcos

Conditions: Polycystic Ovary Syndrome

Summary: to test whether adding small doses of hp urinary fsh to standard regimen of clomiphene citrate in clomiphene resistant pcos well yield better results in terms of better ovulation rate,lower follicle number, less consumption of hp urinary fsh,lower treatment cost , better pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of hp urinary fsh in these cases.

to test whether cc co- treatment with chronic low dose hp ufsh vs chronic low dose hp ufsh in cc resistant pcos will yield better results in terms of ,ovulation rate, lower follicle number,lower hp ufsh dose ,better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates,lower cycle cancellation.

Eligibility criteria:
inclusion criteria: * cc resistant pcos * infertile * females * age 18-38 exclusion criteria: * hyperprolactinaemia * cushing syndrome * adult onset adrenal hyperplasia * age \>38 * other infertility factors in the couple than pcos: male factor,tubal factor,edometriosis

Keywords: pcos clomiphene resistance ovulation induction low dose ufsh ufsh step-up protocol
shared decision making with anal cancer patients on radiation dose

Conditions: Anal Cancer

Summary: the purpose of this study is to maximize patient involvement in the treatment of anal cancer. specifically, the investigators will investigate whether patients wish to take part in the decision making on radiation dose and whether they want a high or low radiation dose.

the study will also provide new knowledge on the effect and side effects of irradiation of anal cancer, and detailed data from the dose planning will be instrumental in optimizing future decision aids.

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of the anal duct or perianal (non-hairy skin, max 5 cm from the anal verge) * t2-t4 n0-3 * age ≥ 18 years * performance status 0-2 * sufficient organ and bone marrow function defined as: * neutrophils ≥ 1.5 x 10\^9/l * thrombocytes ≥ 100 x 10\^9/l * curative intent radiation treatment deemed possible * patients chooses 1 of 3 options: * i do not wish to decide on details of my treatment, but i would like to receive the standard treatment * i want to receive the high radiation dose * i want to receive the low radiation dose * written and orally informed consent exclusion criteria: * non-resectable metastases * tumor \> 10 cm or the total tumor volume (incl. lymph node metastases) is too large to be included in an appropriate radiation field (after possible neoadjuvant chemotherapy) * pregnant or breastfeeding women * fertile women not willing to use effective contraception * serious co-morbidity that would hinder interfere with radiation treatment or hinder patient compliance (e.g. incapacity to understand or complete questionnaires)

Keywords: anal cancer shared decision making
natural history and risk factors of tao

Conditions: Thyroid Associated Ophthalmopathy

Summary: the aim of this study is to complete the identification of genetic factors predisposing to thyroid associated ophthalmopathy (tao) by constituting a cohort of 400 grave's patients with or without ocular signs.

graves' disease (gd) is a common autoimmune condition, and its ocular condition is known as thyroid-associated ophthalmopathy (tao). there is considerable evidence that both genetic and environmental factors are involved in the development of tao. we conduct a study of 400 grave's patients, with or without tao, and obtain the following data: genetic tests, ocular imaging and life style information. genetic tests are obtained by collection of blood samples for dna extraction, whole-genome sequencing, and identification of cellular biomarkers, using transcriptomics and mass cytometry. ocular imaging data are collected from orbit mri examination. life style data are collected using a standardized questionnaire.

Eligibility criteria:
inclusion criteria: 1. patients of grave's disease with the history of more than 1 years 2. informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study exclusion criteria: 1. pregnancy (positive test) or lactation 2. participating in another simultaneous medical investigation or clinical trial within 3 months 3. having received cellular therapy 4. with a history of psychotropic drugs abuse 5. with a history of mental disorder 6. with a history of malignant tumor 7. any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
performance under sglt-2-inhibitors in humans

Conditions: Diabetes Mellitus, Type 2

Summary: the push study is conceived to investigate the early effects of sglt-2-inhibitors on the physical performance of patients with type-ii-diabetes mellitus compared to patients under other therapy regimes. patients shall be divided into 3 groups: i - patients with type ii diabetes mellitus under new treatment with an sglt2-inhibitor. ii - patients with type ii diabetes mellitus without sglt-2- inhibitor medication. iii - patients without type ii diabetes mellitus but with similar comorbidities to the previous groups.

sglt-2-inhibitors have been shown to improve cardiovascular outcomes in patients with type ii diabetes mellitus. present evidence shows this effect to be not directly related to better serum glucose levels because the effect was measurable within several days of initiation of the treatment. in a prospective single-centre double-blinded comparative observational study, other aspects of the effect of sglt-2-inhibitors shall be analyzed from patient registry, particularly the physical performance of patients under new treatment with sglt-2-inhibitors. patient consent will be sort for the analysis of clinical data during the duration of stay. patients included in the registry suitable for analysis shall be divided into 3 groups: i - patients with type ii diabetes mellitus under new treatment with an sglt2-inhibitor. ii - patients with type ii diabetes mellitus without sglt-2- inhibitor medication. iii - patients without type ii diabetes mellitus but with similar comorbidities to the previous groups.

Eligibility criteria:
inclusion criteria: * informed consent * ambulatory patients exclusion criteria: * relevant limitations in movement

Keywords: sglt-2-inhibitor, empagliflozin, canagliflozin, dapagliflozin
recurrence in patients with differentiated thyroid cancer

Conditions: Differentiated Thyroid Cancer

Summary: the aim of this study is to assess the recurrence-free survival (rfs) rate and recurrence-related factors, especially the relationship between rfs and rai dose, in patients who received rai after thyroidectomy.

thyroid cancer is the most frequent cancer of the endocrine system, and its incidence is constantly rising worldwide. this is mainly because of advances in examination modalities that have made it possible to detect smaller cancers at an early stage. owing to advancements in screening techniques and treatment methods, the number of patients who die from thyroid cancer is small compared to the incidence.\[1\] the most common type of thyroid cancer is differentiated thyroid cancer (dtc), which includes papillary and follicular carcinomas. women are three times more likely to develop thyroid cancer than men. \[2\] adjuvant rai131 (at) is recommended post thyroidectomy, because of its therapeutic impact on micro-invasions or micro-metastases, to reduce the likelihood of recurrence in patients who do not have metastases but have risk of recurrence according to the japanese guidelines and american thyroid association guidelines \[3\],\[4\]. at could prolong the survival of patients with intermediate-risk dtc \[5\]. additionally, a meta-analysis has shown that at is effective in reducing recurrence in some studies but not in others, and the effect of at on recurrence prevention, especially in high-risk dtc, remains unclear.\[6\]. although there are reliable reports discussing the relationship between the success or failure of remnant ablation \[7\],\[8\], recurrence after at is rarely reported and the number of cases is small. in addition, no study has so far discussed the relationship between the success or failure of at or remnant ablation and recurrence or death \[9\],\[10\].

Eligibility criteria:
inclusion criteria: * patients with dtc (differentiated thyroid cancer) who underwent total or subtotal thyroidectomy without distant metastasis and gross residual tumors. * followed by ablation with rai and underwent post rai whole body scan. * having baseline tg (thyroglobulin), anti-tg antibodies (anti thyroglobulin) and neck us. * patients with lymph node metastasis will be included if their lymph nodes had been dissected and no unresectable disease remained. exclusion criteria: * patients who received rai and missed follow-up. * patients with no surgical or pathological data.
prophylactic quetiapine on delirium prevention in critically ill patients

Conditions: Delirium

Summary: the purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.


Eligibility criteria:
inclusion criteria: * greater than or equal to 19 years of age, admitting to medical icu, anticipated to stay more than 72hours exclusion criteria: * female patients who are pregnant or breastfeeding * active delirium * received other anti-psychotic drug before attend the study * severe bradycardia * alcohol intoxication * no written consent from the legal representatives * being ill with renal or hepatic failure
physician initiated expanded access request for migalastat in individual patients with fabry disease

Conditions: Fabry Disease

Summary: this program allows physicians to request permission from amicus therapeutics (amicus) for treatment access to migalastat hydrochloride (hcl) for specific patients with fabry disease. treatment is open label.

this physician initiated request program allows physicians to request permission from amicus to receive migalastat hcl for specific patients with fabry disease who have a mutation amenable to this treatment, who do not have access to commercial galafold or available treatment alternatives, or do not meet requirements for participation in an existing migalastat clinical study. up to 20 patients worldwide may be treated. patients must meet specific criteria to receive amicus permission for participation. key criteria for participation include: at least 2 years old; confirmed gla gene mutation shown to be responsive to migalastat; have no treatment option because either unsuitable for enzyme replacement therapy (ert) or unable to access ert.

Eligibility criteria:
inclusion criteria: * confirmed gla mutation predicted to be responsive migalastat in the human embryonic kidney (hek-293) cell-based assay * at least 2 years of age * strong clinical indication for treatment of fabry disease * no other treatment option including either unsuitable for ert or unable to access ert * appropriate female and male contraception * willing to receive treatment with migalastat hcl via this program including having signed an authorization for sharing clinical data exclusion criteria: * scheduled for renal or other organ transplant or replacement therapy * receiving glyset® (miglitol), zavesca® (miglustat) or enzyme replacement therapy fabrazyme® (agalsidase beta), replagal™ (agalsidase alpha), or elfabrio® (pegunigalsidase alfa) * contraindication to migalastat, i.e., sensitivity to other iminosugar such as miglustat, miglitol * treated with another investigational drug within 30 days of start of migalastat hcl treatment * unable to comply with study requirements or deemed otherwise unsuitable for study entry in the opinion of the investigator.

Keywords: at1001 migalastat fabry disease fabry amicus lysosomal disease lysosomal disorder