Kornimate/medical-research-clean huggingface dataset:
a phase 2/3 study to evaluate the efficacy and safety of tinlarebant in subjects with stargardt disease

Conditions: STGD1; Stargardt Disease 1

Summary: the goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with stargardt disease

this study will be comprised of a phase 1b part conducted in japan and a phase 2/3 part. the phase 1b part of the study will be open-label and will evaluate the pharmacokinetics (pk), pharmacodynamics (pd), safety, and tolerability of daily doses of 5 mg tinlarebant, administered for 7 days, in japanese subjects with stargardt disease (stgd1). the phase 2/3 part of the study will be randomized, double masked, and placebo controlled to evaluate the safety, tolerability, and efficacy of daily doses of 5 mg tinlarebant, administered for 24 months, in subjects with stgd1.

Eligibility criteria:
inclusion criteria: * subjects must have clinically diagnosed stgd1 with at least one mutation identified in the abca4 gene. * subjects must have a defined aggregate atrophic lesion in 1 or both eyes. * minimum bcva is required in the study eye exclusion criteria: * any ocular disease other than stgd1 that, in the opinion of the investigator, would complicate assessment of a treatment effect. * history of ocular surgery in the study eye in the last 3 months. * any prior gene therapy.
magnetic localization of sentinel nodes in squamous cell oral carcinoma.

Conditions: Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe

Summary: sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. the aim of this study was to describe the magnetic localization of sentinel nodes (sn) after peritumoral injection of superparamagnetic iron oxide (spio) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. the technique located sns (with minimal complication) in 95.6 % (22/23) of the patients. three relapses occurred, one in a patient who had shown negative in magnetic sn location and elective neck dissection. the diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. magnetic localization of sns has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.


Eligibility criteria:
inclusion criteria: * oral squamous cell carcinoma t1-t2, cn0. * absence of alterations to iron metabolism. exclusion criteria: * previous neck surgery. * treatment with iron chelators. * pregnant
study the safety and effectiveness of tadalafil in men with diabetes who have problems getting and keeping an erection

Conditions: Impotence

Summary: study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.


Eligibility criteria:
inclusion criteria: * history of erectile dysfunction for at least 3 months. * currently have diabetes mellitus of at least 3 months duration. * agree to not use any other ed treatment during the study. * anticipate the same female sexual partner for the study. * must be willing to make the required number of sexual attempts. exclusion criteria: * history of other primary sexual disorder * treatment with nitrates or potent cyp3a4 inhibitors * have a penile implant or clinically significant penile deformity * history of certain heart problems * have kidney or liver problems
software monitoring of treatment related toxicities in advanced renal cell carcinoma

Conditions: Advanced Renal Cell Carcinoma

Summary: to determine if carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (rcc). additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.


Eligibility criteria:
inclusion criteria: * diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease * greater than 18 years of age * a participating wilmot cancer center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced rcc; this can be for first-line or any subsequent line therapy * able to provide written informed consent * proficient in the english language and self-reports as literate * must have an active email address or access to a smart device on which text messages can be received exclusion criteria: * women cannot be breast-feeding * does not have regular access to the internet * unable to come to the wilmot cancer center for appointments every 3-4 months for routine visits with their primary oncologist * subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change
plasma amino acid levels after protein ingestion or amino acid injection during dialysis

Conditions: End Stage Renal Disease on Dialysis (Diagnosis)

Summary: the aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with hemodialysis maintenance.


Eligibility criteria:
inclusion criteria: * men and women over 18 (limit included), * patients treated with hemodialysis for at least 3 months (limit included), * patient with normal albuminemia ≥ 35 g/l * patient capable and willing to comply with the protocol and willing to give written informed consent, * patient affiliated to a social security scheme. exclusion criteria: * patient with a known food allergy or intolerance, * patient with alcohol consumption ≥ 20 g/day (equivalent to 2 glasses per day), * patient following a specific diet (vegetarian, hypocaloric, restrictive gluten-free diet....) outside the high-protein diet of the patient with terminal renal insufficiency or deviant behavior, * pregnant or breastfeeding woman or intending to become pregnant within the next 3 months * patient taking vitamin or mineral supplementation for less than one month, * patient participating in another clinical study or in a period of exclusion from a previous clinical study; * patient refusing to give written consent, * patient not able to read and understand information, consent or other study related documents (self-administered questionnaires), * patient unable to give informed consent, * patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship.
outcomes in spontaneous and art twin pregnancies

Conditions: Neonatal SEPSIS; Perinatal Mortality; Maternal Morbidity

Summary: during the last decades, assisted reproductive technique has been transformed from a miracle to real and has become widely used for treatment human infertility. this was associated with increased the rate of twin pregnancies

twin pregnancies are associated with an increased risk of maternal mortality \& morbidity and an increase in the incidence of neonatal morbidity and mortality compared to singleton pregnancy. the heterogeneous results reported so far can also depend on differences in the studied populations and/or in the management approach to twin pregnancy, variability in data regarding neonatal and maternal outcomes. evidence on pregnancy outcomes of twins conceived by artificial reproductive technology (art) compared with those naturally conceived (nc) is conflicting, a 2004 systematic review and a large 2008 study both were praised that in cases of twin pregnancy after assisted conception the perinatal mortality is significantly lower, when compared with those spontaneously conceived .

Eligibility criteria:
inclusion criteria: * twin delivered \>24-week gestational age * weight ≥ 500g * diachronic diamniotic twins. exclusion criteria: * intrauterine fetal deaths * higher-order multiple pregnancies * deliveries complicated by early vanishing fetuses * twin pregnancies reduced to singleton * triple pregnancy reduced to twin.

Keywords: twins art induction of ovulation perinatal mortality
effects of myofascial releasing on neck pain in patients with trigger points

Conditions: Trigger Point Pain, Myofascial; Neck Pain

Summary: aim of this study is to investigate effectiveness of myofascial releasing on neck pain related to trigger points located on upper cervical region.

neck pain is the second most common musculoskeletal pain after lumbar pain. prevalence is 27.2% female and 17.4% in male population. approximately 1/3 of acute onset neck aches become chronic. it causes increasing the cost of treatment and also the loss of labor. myofascial pain is usually considered caused by myofascial trigger points. the trigger points in the neck muscles have been associated with a possible source of referred facial and cranial pain. mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected to the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome. myofascial releasing is a specific type of passive soft tissue mobilization. triggers points often considered as a pathology that occurs after excessive load or trauma on soft tissue which disturbs blood circulation. fascial restriction can be found with triggers points and taut band. in this study effects of myofascial release on triggers points will be investigated.

Eligibility criteria:
inclusion criteria: * non specific cervical pain * symptoms should last longer than 4 weeks * palpable trigger points on upper thoracic region exclusion criteria: * cervical radiculopathy * previous manual therapy treatment history * sensory or motor function loss * rheumatologic diseases * structural damage on cervical spina * trauma history

Keywords: myofascial release manual therapies
comparison of the effects of open and endovascular aortic aneurysm repair on long-term renal function

Conditions: Long-term Renal Dysfunction

Summary: compare the renal complication of endovascular and open repair of acute aortic dissection by including patient treated at ntuh in 2010\~2013.


Eligibility criteria:
patient underwent endovascular and open repair of aortic aneurysm at ntuh in 2010\~2013 age \> 20 years old

Keywords: acute kidney injury,aortic dissection
the effect of whole body vibration on muscle elasticity

Conditions: Lordosis; Postural; Lordosis; Hyperlordosis

Summary: this study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis. flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels vas; muscle elasticity myoton pro device; physical functions will be evaluated with the modified oswestry low back pain scale.

this study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis. flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels vas; muscle elasticity myoton pro device; physical functions will be evaluated with the modified oswestry low back pain scale. the viscoelasticity properties ( tone, stiffness, elasticity) of the musculus trapezius and musculus pectoralis were assessed with myotonpro® (myoton as, estonia) during prone position on both sides. individuals will be divided into two groups: hyperlordosis and normal lordosis. whole body vibration will be applied twice a week for six weeks, with a frequency of 30 hz and an intensity of 2 mm. a total of 28 females and males (14 individuals for each group) with hyperlordosis (\>40°) and normal lordosis participated in the study.

Eligibility criteria:
inclusion criteria: * being over 18 years of age, * having pain \>5 according to vas measurement, * having normal lumbar lordosis angle between 30°-40°, * having hyperlordosis angle \>40° exclusion criteria: * having scheurmann kyphosis, , * having scoliosis (cobb angle \>10°), * having other congenital spine abnormalities

Keywords: whole-body vibration lordosis hyperlordosis
the effect of alternative keyboards on discomfort and typing kinematics

Conditions: Pain

Summary: awkward postures during computer keyboard use have been hypothesized to be one cause of musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity (msd-ue). alternative computer keyboards purport to reduce musculoskeletal pain/discomfort and have been shown to change aspects of keyboard users' kinematics under laboratory conditions. however, research that has examined the effectiveness of alternative keyboards in reducing musculoskeletal pain/discomfort in the workplace is equivocal, and no study has examined the association between postures and musculoskeletal pain. the aims of this 3-year prospective double cross-over trial are: 1) to examine the effectiveness of an alternative keyboard in reducing reports of pain over 6-months; 2) to examine the neutrality and stability of postures during keyboard use; and 3) to identify which postures are associated with lower levels of musculoskeletal pain. seventy-five computer users will be randomly assigned to one of two keyboard use orders: group 1 - ab (standard keyboard, alternative keyboard); group 2 - ba (alternative keyboard, standard keyboard). all subjects will use their assigned keyboards for 6-months before switching to the next keyboard. every week, subjects will report their musculoskeletal pain levels. just prior to and just after each 6-month intervention subjects' kinematics performances on the keyboards will be recorded at the worksite using the keyboard - personal computing style (k-pecs) instrument and in a laboratory setting using 3-dimensional motion capture technology. aim 1: to examine the effectiveness of an alternative keyboard in reducing pain over 6-months. hypothesis 1 (h-1) - at six months subjects using an alternative keyboard will have significantly lower musculoskeletal pain levels than when using a standard keyboard. aim 2: to examine the neutrality and stability of postures during keyboard use. hypothesis 3 (h-2) - subjects using an alternative keyboard will have significantly more neutral postures than when using a standard keyboard at baseline and at 6 months hypothesis 3 (h-3) - subjects 6-months keyboarding postures will remain equivalent to the keyboarding postures documented at baseline.


Eligibility criteria:
inclusion criteria: * use a computer at least 20 hrs per week * aged 18-65 * experiencing some pain during computer use exclusion criteria: * currently use an alternative keyboard * serious trauma injury to the upper extremity * rheumatic disorder
renal sympathetic denervation by iberis system in patients with uncontrolled hypertension - iberis-htn registry

Conditions: Resistant Hypertension

Summary: the purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using iberis renal denervation system.

this study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using iberis system. this registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of iberis renal denervation system and treatment will be applied according to the routine hospital practice. no additional tests are required specific to this registry. the registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the iberis system in patients with resistant hypertension. a minimum of 30 patients will be enrolled in europe

Eligibility criteria:
inclusion criteria: * age ≥18 years or minimum age as required by local regulations. * patient has been thoroughly informed about this registry and signed informed consent form. * patient with true resistant hypertension defined as: * office systolic bp higher than 160 or 150mmhg in case of type 2 diabetes * ambulatory bp with average bp\>130mmhg or mean daytime\>135mmhg in more than 70% of the measurements. * patients should be on stable hypertension therapy for at least 8 weeks before procedure, including spironolactone if they are supposed to be respondent as indicated by the specialized center/excellence unit on hypertension. exclusion criteria: * previous renal artery intervention (balloon angioplasty or stenting). * evidence of renal artery atherosclerosis (defined as a renal artery stenosis \>50%). * main renal arteries of less than 4mm diameter or less than 20mm in length. * presence of multiple main renal arteries in either kidney. * estimated glomerular filtration rate \<45ml/min per 1,73m2 * recent myocardial infarction, unstable angina pectoris or cerebrovascular accident within the past 3-6 months. * false resistant hypertension (pseudo resistance) by using 24h ambulatory bp monitoring (abpm). * secondary arterial hypertension. * pregnancy. * there is another pathological process with well-known life expectancy of less than 5 years. * patient unable to do correct fu. * unable to take correct ambulatory bp. * primary hyperaldosteronism. * known lack of adherence to medical treatment.
the clinical, epidemiological and treatment characteristics of head and neck cancer patients

Conditions: Waiting Times, Patient Pathways, Effect of Lifestyle-related, Clinical and Demographic Parameters on Outcomes

Summary: the aim of our study is to prospectively collect information regarding (1) the demographic, lifestyle-related and clinical characteristics of patients with head and neck cancer and (2) the waiting times to diagnosis and therapy, and the 1-, 3- and 5-year survival of patients. we plan to gain insight into the characteristics and pathways of head and neck cancer patients in baranya county, which can in turn help to identify factors that lead to improved or worse disease outcomes. (thus, these factors can subsequently eliminated or lessened to improve the outcome of head and neck cancer patients. )

the aim of our study is to prospectively collect information regarding (1) the demographic, lifestyle-related and clinical characteristics of patients (including initial symptoms) with head and neck cancer and (2) the patient pathways and waiting times to diagnosis and therapy, the 1-, 3- and 5-year survival, and time to metastasis of patients. study design: prospective data collection and analysis, based on data collected from the clinic's electronic emedsol database and questionnaire (regarding demographic, lifestyle and patient pathway-related data) filled in by interviewing patient. we plan to monitor lifestyle parameters of patients (such as oral hygiene, alcohol consumption and smoking, the knowledge of patients about risk factors of head and neck cancers,etc) and clinical parameters such as time and type of first symptom, ecog state, comorbidities, clinical stage, diagnostic workups, etc. at predetermined time intervals (upon first ent presentation, and at 3-, 6-, 12-, and 24 month intervals. disease progression (time to metastasis) and overall survival will be assessed at the given time points. by gathering data and gaining insight into the characteristics, pathways and survival of head and neck cancer patients we aim to identify factors that may lead to improved or worse disease outcomes.

Eligibility criteria:
inclusion criteria: * patients 18 years or over presenting with head and neck cancer (with morphology of squamocellular carcinoma), who are subsequently given one of the following icd-10 codes: malignant neoplasms of lip, oral cavity and pharynx (c00-c14), malignant neoplasm of larynx (c32) and for whom this is their first cancer. exclusion criteria: * patients who do not meet the inclusion criteria and patients who meet the inclusion criteria but for whom this is a second or recurrent cancer (they already have an "icd-c" code) are excluded from the study

Keywords: head and neck cancer, survival, waiting times, patient pathways
oshes - observational study on hemostasis in surgery (tc-022-it)

Conditions: Blood Loss, Surgical; Hemostasis

Summary: oshes (= observational study on hemostasis in surgery) is a non interventional register settled in italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques in addition to the standard surgical procedures in 40 surgical wards. the availability of these data will allow for a better understanding of the therapeutic needs in the area of hemostatic supporting agents/techniques.


Eligibility criteria:
inclusion criteria: * patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. a special procedure will be implemented for use in emergency situations.

Keywords: intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
stenting of haemodialysis acces trial

Conditions: Outflow Stenosis

Summary: the purpose of this study is to demonstrate the efficacy of a ptfe covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.


Eligibility criteria:
inclusion criteria: * patients of 18 years of age * patients have a life expectancy of at least 2 years * signed informed consent * recurrent stenosis at the venous anastomosis or in the draining vein of a loop arterio venous fistula, within 2 cm from the anastomosis. exclusion criteria: * patient unsuitable for administration of contrast agent * pregnancy * dementia or altered mental status that would prohibit giving conscious informed consent * need for adjunctive major surgical or vascular procedures within one month

Keywords: outflow stenosis stentgraft