Kornimate/medical-research-clean huggingface dataset:
effects of glp-1 analogues on fluid intake in patients with primary polydipsia (the gold-study)

Conditions: Primary Polydipsia

Summary: glucagon like peptide -1 (glp-1) receptor agonists are well known to stimulate glucose-induced insulin secretion and to reduce energy intake. recent findings from animal and human studies suggest a role of glp-1 in regulating water and salt homeostasis. glp-1 has been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a hypodipsic effect. the aim of this study is to elucidate whether these putative hypodipsic properties of glp-1 might be of advantage in persons with an exaggerated thirst perception as is the case in patients with primary polydipsia.

glp-1 analogues are currently used for the treatment of hyperglycaemia associated with type 2 diabetes mellitus and given his properties as a natural satiety hormone, the glp-1 analogue liraglutide was recently approved by the fda for weight management. in studies related to the influence of glp-1 and -analogues in controlling food intake a concomitant reduction of fluid consumption has been observed. the investigators hypothesize that glp-1 analogues not only modulate appetite and provide satiety but also reduce fluid intake and thirst sensation in humans - especially in those with excessive thirst perception (patients with primary polydipsia). in view of future therapeutic options for these patients we aim to investigate the influence of the long-acting glp-1 analogue dulaglutide on fluid intake, thirst perception and quality of life in patients with primary polydipsia compared to placebo.

Eligibility criteria:
inclusion criteria: * age over 18 years * polyuria of \> 50 ml/kg/day * polydipsia of \> 3 liters/day exclusion criteria: * known or probable central or nephrogenic diabetes insipidus, expected from patient's history * polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia * pregnancy * previous treatment with glp-1 agonists within the last 3 month * history of pancreatitis * severe renal insufficiency (egfr (ckd epi) \<30 ml/min/1,73 m2) * cancer
a dose-ranging study of the effect of glycopyrrolate in subjects with axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: the purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

this is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. there are 5 arms in this study. efficacy will be assessed through the hyperhidrosis disease severity score (hdss), dermatology life quality index (dlqi) and a gravimetric assessment of sweat production. safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ecgs, physical examination and vital signs. pk samples will be taken from 20 to 30 subjects participating in the study.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older. * primary, axillary hyperhidrosis of at least 6 months duration. * a hyperhidrosis disease severity score (hdss) of 3or 4. * a gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature. * male or non-pregnant, non-lactating females. exclusion criteria: * prior surgical procedure for hyperhidrosis. * any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational) * prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year. * treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment. * prior axillary treatment with axillary iontophoresis within 4 weeks. * axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment. * known history of a condition that may cause secondary hyperhidrosis. * known history of sjögren's syndrome or sicca syndrome. * abnormal findings on screening ecg deemed clinically significant by the investigator.
personalised postoperative radiochemotherapy in patients with head and neck cancer

Conditions: Head and Neck Cancer

Summary: the current trial is evaluating the integration of a pretherapeutical fdg-pet/mri in the adjuvant radiochemotherapy in patients with head and neck cancer. as a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γh2ax-analysis and genetic information.


Eligibility criteria:
inclusion criteria: * locally-advanced hnscc (oro- and hypopharynx) stage iii and iv without distant metastases * no contraindications for pet/mri * no contraindications for radiochemotherapy * informed consent * ecog ps 0/2 exclusion criteria: * secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the hnscc * previous pet/ct * induction therapy * pregnancy or breastfeeding

Keywords: personalized medicine radiation oncology functional imaging biomarker decision support system radiomics
articaine 4% efficacy and safety in extraction and pulpotomy of primary molars of children below the age of four years

Conditions: Pain; Behavior

Summary: compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.


Eligibility criteria:
inclusion criteria: * healthy children * 3-6 years * primary molar indicated for pulpotomy * body weight not less than 15 kg exclusion criteria: * intellectual problem * sever emotional problems * previous dental experience * medically or mentally compromised children
evaluation of mri-conditional 12-lead ecg

Conditions: Atrial Fibrillation

Summary: with mri's increasing role in detecting central nervous system and orthopedic diseases, patients with ischemic history are increasingly referred for mri exams. currently, 3-lead ecg gating systems are utilized during cardiac mri scanning as standard of care. however, this monitoring system is often insufficient to evaluate for the development of important arrhythmias or ischemia during mri scanning. morevoer, mri associated magnetic fields and radio frequency pulses can produce interference in the ecg signal that leads to non-diagnostic ecg signals. mirtle medical, a massachusetts-based medical device company, has developed a high-fidelity, mri-conditional 12-lead ecg monitoring system. this 12-lead ecg system is a first of its kind that addresses the mri-induced interference and safety issues. this study is to evaluate the efficacy of this 12-lead ecg system in the clinical setting. the investigators hope that this system will be helpful for image-guided therapeutics especially electrophysiology.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * atrial fibrillation * provision of informed consent * eligible for the ontario health insurance plan exclusion criteria: * failure to provide informed consent * pregnant women * cmr contra-indicated * hemodynamically unstable * permanent pacemaker/icd * aneurysm clip/carotid artery vascular clamp * claustrophobic
timing of closure of patent foramen ovale following birth

Conditions: Closure of the Foramen Ovale and Ductus Arteriosus

Summary: it is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. the purpose of this study is to observe the natural profile of closure of the foramen ovale and ductus arteriosus for the first 36 hours after birth. this understanding may help to avoid unnecessary treatment and exams for newborns with findings that are natural for their stage of development.

we will observe the patency and size of foramen ovale five times within the first 36 hours of life. we will also describe the anatomy of the foramen ovale and the septum primum during this time. the direction of flow across the foramen ovale will also be observed. other cardiac lesions will be checked for as well. we will measure the change in size of the pulmonary arteries and the closure of the ductus arteriosus.

Eligibility criteria:
inclusion criteria: * any baby born in term and with normal delivery exclusion criteria: * sick newborns in need of neonatal intensive care for any medical reason. * newborns with congenital heart disease except for small, muscular ventricular septal defects

Keywords: patent foramen ovale patent ductus arteriosus pfo pda
empowerment and support for the diabetic patient

Conditions: Type 2 Diabetes

Summary: change-d objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients. evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.

research group 300 type 2 diabetics: 150 from jewish sector and 150 from arab sector will be recruited from 7-10 clinics in each district: north district and haifa district a personal coaching intervention will be tailored from the offered tools: face to face, group, telephone participants will be monitored for clinical and self treatments outcomes comparison group 300 patients with similar characteristics to the research group will receive clalit's standard of care participants will be monitored for clinical and self treatments outcomes like the research group

Eligibility criteria:
inclusion criteria: * type 2 diabetes * at least one oral anti diabetic drug * hba1c above 7.5% ot above 0.5% of personal target * preparedness for change * fluent hebrew or arabic exclusion criteria: * type 1 diabetes * pregnancy or lactation * incompetency to sign consent * participation in another clinical trial * unstable psychotic disease * complex health condition

Keywords: type 2 diabetes type ii diabetes
matrix: measuring neutralizing antibodies in the patients treated with interferon beta 1a im, in mexico and colombia

Conditions: Multiple Sclerosis

Summary: this is a cross sectional phase 4, multicenter, study of avonex® and jumtab® to determine the frequency of ifn induced neutralizing antibodies (nabs). a secondary component is the long term retrospective observational evaluation conducted to measure efficacy, adherence to therapy, tolerability, and safety in subjects with relapsing ms related to antibody status and treatment.

the primary objective of this study is to evaluate the frequency of neutralizing antibodies in patients treated with ifn beta 1a im (avonex) and ifn beta 1a im biosimilar formulation (jumtab). secondary objectives: * evaluate the effect of nabs on the severity of the relapses on each treatment group, measured by: * the need and duration of steroid courses * the need and duration for hospitalization. * to evaluate the safety and tolerability of the ifn beta 1a im treatments \[avonex and jumtab\]. * to identify the genetic profile of the patients with relation to the predisposition to nab development (hla dr4 (in particular hladrb1\* 0401 and 0408) and dr16 (in particular hladrb1\* 1601) * at selected sites: to evaluate the influence of the interferon and the nabs on the activation of neopterin

Eligibility criteria:
inclusion criteria: * to be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection: * no limitation of age, edss or other disease parameters will be applied. * subject with ms * subjects treated with ifn beta 1a im (avonex) or the biosimilar formulation of ifn beta 1a im (jumtab) in line with the local prescription information * the ifn beta 1a im (avonex or jumtab) treatment should be the first disease modifying treatment * the subject should be treated with the same drug for at least 18 months and up to a maximum of 3 years exclusion criteria: * candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection: * no informed consent * patients with combination therapy (ifn + immunosuppressive therapy) * patients pretreated with immunosuppressive therapy * treatment with any investigational product, including investigational symptomatic therapies for ms (e.g., 4aminopyridine) and investigational therapies for nonms indications, during the review period. note: subjects may receive investigational symptomatic therapies for ms at any time prior to evaluation period.
acute anterior uveitis: psychic burden and pain

Conditions: Anterior Uveitis

Summary: acute anterior uveitis (au) is a common reason for attendance at ophthalmic outpatient clinics. the painfulness and the fear of a transient or even persistent loss of vision may markedly reduce the individual's subjective well-being and pose a psychological burden. this study will test the hypothesis that during an attack of au the patient experiences a marked reduction in psychological and physical well-being. prospective, hospital-based epidemiologic study using a patient questionnaire with standardized psychological tests and a pain scale.


Eligibility criteria:
inclusion criteria: * acute attack of anterior uveitis exclusion criteria: * other forms of uveitis * chronic anterior uveitis * therapy started
hybrid fractional laser for treatment of off face body skin quality

Conditions: Skin Laxity

Summary: to demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs


Eligibility criteria:
inclusion criteria: 1. healthy male/female subjects between 40 to 65 years of age inclusive 2. fitzpatrick skin type i-iii 3. non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit 4. has poor skin texture 5. has mild thin skin 6. has some level of dyschromia on the treatment area as assessed by the investigator 7. can read, understand and sign informed consent form (english only) 8. has indicated willingness to participate in the study by signing an informed consent form 9. agrees to adhere to the treatment and follow-up schedule and post treatment care instructions exclusion criteria: 1. fitzpatrick skin type iv-vi 2. has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream 3. has tattoos, dysplastic nevi on the treatment area 4. is pregnant and/or lactating 5. history or current photosensitivity 6. history or current use of medication with photosensitizing properties within past 6 months 7. history or current of chronic reoccurring skin disease or disorder affecting treatment area 8. history or current cancer of any type 9. has signs of actinic bronzing 10. has open lacerations, and abrasions on the treatment area 11. history of keloid formation, or hypertrophic scar formation, or poor wound healing 12. history of bleeding disorder, or is currently taking anticoagulation medications 13. has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment 14. has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days 15. the investigator feels that for any reason the subject is not eligible to participate in the study
effects of sex steroid hormones on human brain function, structure and connectivity

Conditions: Gender Identity Disorder

Summary: this ultrahigh-field mri study gives us the unique opportunity to measure changes in brain function and structure induced by long-term opposite-sex steroid hormone administration in transsexual subjects. our aim is 1. to prove the influence of high-dose, long-term opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to investigate the influence of hormone treatment on resting state functional connectivity and brain morphology. 3. to investigate differences between transsexuals and healthy control subjects in brain function and functional connectivity, brain morphology and structural connectivity. in this longitudinal study, transsexuals and healthy control subjects will undergo three 7 tesla ultrahigh-field mri scan sessions: 1. baseline (before hormone treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.


Eligibility criteria:
inclusion criteria for transsexuals are: * dsm-iv diagnosis of gender identity disorder (dsm-iv: 302.85, 302.6; icd-10: f64.9, f64.8) by a structured clinical interview (scid) * general health based on history, physical examination, ecg, laboratory screening, scid * willingness and competence to sign the informed consent form exclusion criteria for transsexuals are: * severe neurological or internal diseases * steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones) * treatment with psychotropic agents such as ssris * any implant or stainless steel graft * abnormal values in routine laboratory screening or general physical examination * current substance abuse (determined using drug screening at the screening visit) * pregnancy (determined at screening visit and first mri scan) * failure to comply with the study protocol or to follow the instructions of the investigating team. inclusion criteria for healthy controls are: * general health based on history, physical examination, ecg, laboratory screening, scid * willingness and competence to sign the informed consent form exclusion criteria for healthy controls are: * severe diseases * any implant or stainless steel graft * steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones) * abnormal values in routine laboratory screening or general physical examination * current substance abuse (determined using drug screening at the screening visit) * pregnancy (determined at screening visit and first mri scan) * failure to comply with the study protocol or to follow the instructions of the investigating team
long-term follow-up of subjects with sickle cell disease treated with ex vivo gene therapy

Conditions: Sickle Cell Disease

Summary: this is a multi-center, long-term safety and efficacy follow-up study for subjects with sickle cell disease who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. after completing the parent clinical study (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. no investigational drug product will be administered in the study.


Eligibility criteria:
inclusion criteria: * provision of written informed consent for this study by subject, or as applicable, subject's parent(s)/legal guardian(s) * treated with drug product for therapy of sickle cell disease in a bluebird bio-sponsored clinical study exclusion criteria: * there are no exclusion criteria for this study

Keywords: hematopoietic stem cells
a new anatomical classification of portal vein location of pancreas tumors

Conditions: Pancreatic Neoplasm Malignant Head Primary

Summary: in this retrospective study, we recorded the location of pancreatic tumors and relation/proximity to the portal vein. the surgical difficulty and requirement of additional interventions were also evaluated.

between may 2014 and october 2018, all patients who underwent pd procedure were retrospectively reviewed. this retrospective cohort study identified all consecutive patients with t3 (stage iia to iii) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (pv/smv) resection. those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded. the local ethical committee was approved this study. data collection included demographical features, tumor characteristics including the pv level of the tumor considering computed tomography results, neoadjuvant therapy, surgical data, hospital stay, morbidity and mortality. anatomical classification was established based on the relationship between portal confluence (pc) and tumor location (figure i). those tumors located superior to the pc were classified as level i, whereas tumors on the confluence inferiorly located to pc were classified as level ii and level iii.

Eligibility criteria:
inclusion criteria: * this retrospective cohort study identified all consecutive patients with t3 (stage iia to iii) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (pv/smv) resection. exclusion criteria: * those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded.

Keywords: pancreas tumors