Kornimate/medical-research-clean huggingface dataset:
natural history study of atp1a3-related disease

Conditions: ATP1A3-related Disease; Alternating Hemiplegia of Childhood; Rapid Onset Dystonia Parkinsonism; CAPOS

Summary: an observational study aiming to study the natural history of a uk-wide patient cohort with atp1a3-related disease.

alternating hemiplegia of childhood (ahc) is a rare very disabling neurodevelopmental syndrome caused by mutations in the gene atp1a3. ahc is characterized by paroxysmal events including attacks of hemiplegia (weakness), dystonia (painful stiffening), oculomotor abnormalities and epileptic seizures. as the condition progresses permanent neurological symptoms, including unsteadiness and learning problems, emerge. mutations in atp1a3 also cause other related syndromes: rapid-onset dystonia-parkinsonism (rdp), less severe and usually presenting in adulthood, as well as cerebellar ataxia, areflexia, pes cavus, optic atrophy, and sensorineural hearing loss (capos) syndrome, a severe syndrome of early childhood. currently therapeutic options are very limited aiming at symptomatic relief with limited success. as atp1a3-related syndromes are very rare diseases, with an estimated prevalence of about 1/1000000, randomised clinical trials of available therapies are not possible due to lack of a large enough patient cohort. however, the revolution in genetic diagnostics has made the identification of these patients and the correlation between their phenotypes possible. at the same time further novel technologies in neuromonitoring and neuroimaging, as well as videography and sleep monitoring have become available that could help us further examine and understand the underlying mechanisms especially of the paroxysmal episodes that characterise all atp1a3-related syndromes. the investigators believe that based on these scientific advances they will be able to recruit a uk-wide patient cohort to conduct an in depth study of the progression of this disease. this is particularly relevant at the moment as rapid progress in genetic therapies and other novel therapeutics makes the availability of new treatment options in the near future a realistic prospect and, even though we will most probably still not be able to identify a large enough cohort for randomised clinical trials, our natural history study will act as a much needed benchmark to which the success of novel treatments can be evaluated.

Eligibility criteria:
inclusion criteria: * children and adults of any age carrying a mutation in the atp1a3-gene. * children and adults of any age matching an atp1a3-related disease phenotype without a mutation in the gene. * written informed consent given by patient and/or parent/guardian. exclusion criteria: • patients with a phenotype not fitting atp1a3-related disease and no mutation in the atp1a3 gene.
a study to evaluate the pharmacokinetics, safety and tolerability of abbv-157 in healthy volunteers and in participants with chronic plaque psoriasis

Conditions: Psoriasis

Summary: this is a study to evaluate pharmacokinetics (pk), safety and tolerability of abbv-157 in healthy volunteers and in participants with chronic plaque psoriasis, and to evaluate the efficacy of abbv-157 in the participants with psoriasis. this study consists of two substudies. substudy 1 is a randomized, double-blind, placebo-controlled evaluation of multiple ascending oral doses of abbv-157 in healthy adult volunteers. substudy 2 is a randomized, double-blind, placebo-controlled study in which participants with moderate to severe chronic plaque psoriasis will be administered multiple oral doses of abbv-157.


Eligibility criteria:
inclusion criteria: * volunteer should be between 18 and 55 years of age and in general good health for substudy 1 and participant with moderate to severe chronic plaque psoriasis between 18 and 75 years of age for substudy 2 at the time of enrollment. * participant should meet the laboratory assessments as mentioned in the protocol. exclusion criteria: * participant has a history of epilepsy, any significant cardiac, respiratory, renal, hepatic, gastrointestinal, opthalmologic, hematologic,or psychiatric disease or disorder, or any uncontrolled medical illness.

Keywords: psoriasis chronic plaque psoriasis abbv-157 healthy volunteers
study to assess the safety and efficacy of cd-np in the treatment of patients with acute decompensated heart failure

Conditions: Acute Decompensated Heart Failure

Summary: the primary objective of the study is to assess the safety and tolerability of iv administration of cd-np and the dose relationship of cd-np on improvement of clinical symptoms and renal function in adhf patients.


Eligibility criteria:
key inclusion criteria: 1. hospitalized for acute decompensated heart failure. 2. systolic blood pressure ≥ 115 mmhg and ≤ 200 mmhg, and diastolic blood pressure ≥ 60 mmhg and ≤ 110 mmhg at screening 3. renally compromised. 4. female patients must be post-menopausal or surgically sterile. key exclusion criteria: 1. acute or suspected acute myocardial infarction (ami) or troponin levels \> 3x the upper limit of normal at the institution's local laboratory 2. cardiogenic shock 3. evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events 4. clinically significant aortic or mitral valve stenosis 5. temperature \>38°c (oral or equivalent), sepsis or active infection requiring iv anti-microbial treatment 6. adhf due to significant arrhythmias 7. severe renal failure defined as creatinine clearance \< 30 ml/min 8. current or planned ultrafiltration, hemofiltration, or dialysis 9. significant pulmonary disease 10. major neurologic event, including cerebrovascular events in the prior 60 days. 11. acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) 12. known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds

Keywords: adhf ahf hf
comparison of treatment response to intravitreal injection of combined propranolol and bevacizumab versus bevacizumab monotherapy in patients with wet age related macular degeneration :a clinical trial

Conditions: Age Related Macular Degeneration

Summary: this study is designed to compare the effect of combined intravitreal bevacizumab and propranolol injection versus bevacizumab monotherapy in patients with age related macular degeneration. methods: in this study patients with age related macular degeneration who are naïve or had history of previous treatment are included. the eligible patients in randomized in two groups "bevacizumab" and "bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. in "bevacizumab+propranolol" group patients receive two injections at each session bavacizumab and propranolol. in "bevacizumab" group patients receive only bevacizumab. the patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. baseline ancillary exams include fluorescein angiography and oct-angiography which is performed at the final exam as well. patients needing any therapeutic intervention is addressed during the 6 month follow up period.


Eligibility criteria:
inclusion criteria: * patients with wet amd and vision less than 20/40 exclusion criteria: * history of cardiac ,renal, respiratory diseases (due to beta blocker toxicity), * associated with other macular abnormalities such as diabetic retinopathy, macular traction * history of ocular inflammation * subretinal fibrosis * history of cataract surgey less than 6 months * history of glaucoma surgery ,vitreoretinal surgery * media opacity
pain after lung cancer surgery - comparing traditional versus prolonged release nerve blockades

Conditions: Postoperative Pain; Lung Cancer; Video Assisted Thoracoscopic Surgery; Blockades Neuromuscular; Anesthesia, Local

Summary: to investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing video-assisted thoracoscopic surgery.

video-assisted thoracoscopic surgery (vats) is a minimally invasive routine procedure. it's less invasive than thoracotomy but postoperative pain is still a problem. at aalborg university hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing vats. adding adjuvants to the blockades may prolong the effect. the aim of this study is to examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine hydrochloride.

Eligibility criteria:
inclusion criteria: * adults independent of sex with an age of ≥ 18 years * patients undergoing vats as a part of either examination or treatment of lung cancer exclusion criteria: * patients who are unable to understand oral and written information. * patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery. * pregnant and nursing women. * patients with hypersensitivity / allergy / intolerance to dexamethasone or bupivacaine. * patients receiving a planned preoperative epidural blockade during their stay. * patients converted to open surgery.
very long term results after laparoscopic retrocolic antegastric gastric bypass

Conditions: Clinically Severe Obesity

Summary: the main aim of this study is to analyze and report the very long-term outcomes after primary laparoscopic proximal roux-en-y gastric bypass surgery for clinically severe obesity.

there is lack of very-long term outcomes after bariatric surgery; a few series have been reported. however, most of them analyze medium-term outcomes. for rygb, there are just two retrospective cohort studies reporting very long-term outcomes. both studies have an open approach and a proximal roux-en-y configuration with different pouch orientation and size. maclean´s series, with a better follow-up rate (83.4%), had a 67.6%ewl at a mean of 11.4 years; failure rates were 20 and 35% for the morbidly obese and super obese, respectively. we will analyze our own series with a laparoscopic approach, vertically, lesser-curve base \< 10-15ml pouch and proximal roux limb. the main end-points for our study are 1) morbidity including status of specific biochemical markers \& mortality, 2) weight loss expressed as bmi or %ewl, 3) trends in major comorbidities and 4) assessment of quality of life.

Eligibility criteria:
inclusion criteria: * patients who met nih criteria for recommendation of a bariatric procedure with a combination of the following characteristics * status post primary laparoscopic proximal rygb surgery with or without subsequent open or laparoscopic revisions or re-operations * follow up \> 10.0 years (very long term outcome) exclusion criteria: * patients who had a previous gastric or bariatric procedure * patients who underwent primary laparoscopic rygb somewhere else by other surgical group * missing records and/or unreachable patients with scant information for analysis

Keywords: severe obesity morbid obesity gastric bypass efficacy of gastric bypass
caregiver-aided powered wheelchair skills

Conditions: Caregivers

Summary: there has been only minimal research on wheelchair skills by the caregivers of manual or powered wheelchair. there are no published data on the extent to which caregivers can enhance the mobility of powered wheelchair users. the primary objective of this study is to test the hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance of the powered wheelchair users to whom they provide assistance. our secondary objective is to add to the literature on the measurement properties of the wheelchair skills test (questionnaire and capability version) for powered wheelchair users and their caregivers.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * able to communicate in english and/or french (depending upon the site) * live within 50 km of the research centre * be willing to participate (as evidenced by completion of the assessment) * be able to set a scheduled time for the study visit when both the caregiver and wheelchair user will be present and provide informed consent caregivers: * must be an unpaid caregiver (e.g. a family member or friend) * spend an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility. wheelchair user: * must have his/her own powered wheelchair * use the powered wheelchair for at least 6 hours per week * have a caregiver who spends an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility. exclusion criteria: * have unstable medical conditions (e.g. angina, seizures) that might make the use of a powered wheelchair dangerous * emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
corticosteroid rhythms in hypoparathyroid patients

Conditions: Hypoparathyroidism; Hyperparathyroidism

Summary: the investigators hypothesise that parathyroid hormon (pth) depletion interferes with normal activity of the hypothalamus-pituitary-adrenal (hpa)-axis and the renin-angiotensin-aldosterone-system (raas), which in turn may impact morbidity and quality of life. the main objective of the current study is to test if pth deficiency influences the secretion of corticosteroids and whether any abnormalities in the hpa-axis and the raas-system can be reversed by pth infusion.

visit 1: optimizing conventional treatment regarding s-magnesium, s-calcium, s-phosphorous and 25-hydroxyvitamin d (25(oh)d)-levels. visit 2 (in-hospital 4-7 days): day one: 24h microdialysis sampling, venous blood sampling and 24h urine will be collected. day 2: start of pth pump-treatment. day 3-x: dose adjustment of pth pump therapy according to calcium levels, the first two days after started pth six daily venous blood-samplings will be performed. day x: 24h microdialysis sampling and 24h urine-sampling and a venous blood sampling. restart of conventional treatment. the control patients (healthy volunteers and patients with hyperparathyroidism) will perform 24h microdialysis-sampling only.

Eligibility criteria:
inclusion criteria: * postsurgical hypoparathyroidism of at least one year duration. undetectable pth values (\ 50 nmol/l prior to baseline. * healthy male and female volunteers, aged 18-60 years * patients with primary hyperparathyroidism, defined as simultaneous increased pth and serum calcium levels, normal or increased urine calcium to exclude hypocalciuric hypercalcemia, normal kidney function (estimated glomerular filtration rate (egfr) above 60), aged 18-60 years exclusion criteria: * patients with diabetes mellitus, addison's disease and patients on steroid medication will not be included in this study. * other exclusion criteria are unstable cardiovascular disease, active malignant disease, epilepsy, pregnancy or lactation, significant hepatic or kidney disease (alanine aminotransferase (alat) and or aspartate aminotransferase (asat) \> 2 times upper limit of normal, egfr \< 30 ml/min), pharmacological treatment with pth the last 3 months, treatment with other drugs that could interfere with interpretation of the results. allergy to metacresol, lidocaine or multiple allergies.
efficacy and safety of pimecrolimus for the treatment of vitiligo vulgaris

Conditions: Vitiligo Vulgaris

Summary: patients with vitiligo vulgaris are treated with pimecrolimus twice a day during 6 months. after a baseline visit, patient returns for a control visit after 3 and 6 months of treatment. one reference lesion is clinically evaluated with pictures.


Eligibility criteria:
inclusion criteria: * active or stable vitiligo vulgaris * lesions at head or neck + maximum 10% lesions at the rest of the body exclusion criteria: * topica during last 2 weeks * photo(chemo)therapy during last 4 weeks * segmentary vitiligo
bs-fu01 follow-up study of flubhpve6e7 study subjects

Conditions: Safety Issues; HPV Infection

Summary: this is a follow-up study for patients treated with flubhpve6e7 in previous interventional studies.

bs-fu01 is a follow-up study for patients treated with flubhpve6e7 in previous phase 1 and 2 interventional studies. the aim of the follow-up study is to assess the safety and immunogenicity of flubhpve6e7, changes in the hpv infection status, cervical cytology, and biodistribution after treatment with flubhpve6e7 in previous studies.

Eligibility criteria:
inclusion criteria: * patient who enrolled in previous phase 1 or 2 clinical studies of flubhpve6e7 * negative pregnancy test at baseline * written informed consent exclusion criteria: * pregnancy, breastfeeding
antibiotic, gingival-biopsy, and oral-smear samples.

Conditions: Anti-bacterial Agents; Chromosome-defective Micronuclei; Cytology; Histopathology

Summary: antimicrobial or antibiotic agents, which are essential to prevent and treat bacterial infectious diseases, have become one of the most widely used drugs in the world. in the european region, the highest rates of antibiotic consumption are reported in turkey. there is a nearly fivefold difference between turkey and the lowest consuming countries. studies in dentistry evaluate participants according to the basis of predefined criteria. history of antibiotic consumption is one of the most common exclusion criteria for periodontal trials. however, there is still disagreement on how long the effect of systemic antibiotic agents on the oral mucosa and periodontal tissue lasts. it is unclear whether the timing of antibiotic consumption should be an exclusion criterion for genetic damage and histological studies during the selection of healthy participants. periodontal status of participants in study groups is described as with or without periodontitis in many studies, because of the lack of clear definitions of periodontal health and gingivitis. it should be recognized that even the lack of visual signs of inflammation, some mild histopathological changes can be seen in the periodontium. consequently, for the real diagnosis of the clinically healthy periodontium, clinical findings should be supported and confirmed with histological results. micronuclei (mn) are observed as abnormal nuclear structures and indicators of chromosomal level dna damage. the oral mucosa epithelium is an immunologic barrier and affected by chemical factors such as antibiotic consumption. the mn test to exfoliated epithelial cells from the oral cavity is utilized as a non-invasive diagnostic technique for monitoring the status of oral health. to our knowledge, no studies have been conducted on the comparison of the impacts of the timing of antibiotic consumption on human periodontal tissues and oral smear samples. the present study is undertaken to determine whether the different timing of antibiotic (amoxicillin) therapy has effects on the histopathology of gingiva and genetic damage of exfoliated cells from oral mucosa in healthy participants.


Eligibility criteria:
inclusion criteria: * systemically and periodontally healthy participants * presence of probing depth (pd) of ≤ 3 mm14 and bleeding on probing (bop) ˂ 10%15 * no clinical evidence of gingival recession (gr), clinic attachment loss or radiographic evidence of alveolar bone loss * no periodontal treatment within the last 12 months exclusion criteria: * smoking, alcohol or drug abuse * any systemic condition would affect the periodontal health (i.e., pregnancy, lactation, ovulation, and diabetes mellitus) * a history of contagious disease * periodontal treatment within the last 12 months
rehabilitation and outcome for patients on lvad support

Conditions: Exercise Capacity; Quality of Life

Summary: a prospective, multi-module intervention based on nutrition management, psychosocial support, and a controlled home-based physical exercise training program for patients on lvad- support will be provided to improve outcomes in terms of survival and patients health-related quality of life (hrqol) for the long-term. physical capacity, neurocognitive, psychological factors, and adverse events will be assessed as potential independent indicators for hrqol.

the multi-module intervention program for patients on lvad support includes nutrition management, home-based ergometer training program, psychosocial support and neurocognitive screening. the nutrition management and physical reconditioning program will be supplemented by psychosocial support targeting the risk of increased stress, anxiety, and depression level. moreover, standardized neurocognitive screening procedures will be administered to detect neurocognitive dysfunction (except stroke) and will be assessed for their potential to predict limitations in qol. adverse events like re-hospitalizations, thromboembolic and bleeding events will be monitored and assessed for their potential to negatively impact qol.

Eligibility criteria:
inclusion criteria: * all eligible patients after lvad implantation for long-term support with follow-up at our outpatient clinic * written informed consent * sufficient german language skills to read and answer a battery of questionnaires * 18 years and older exclusion criteria: * severe ventricular arrhythmia * severe orthopaedic comorbidities * illiteracy

Keywords: heart-assist-devices rehabilitation outcome assessment (health care) exercise capacity ergometry social support quality of life nutrition assessment nutrition therapy neuropsychological tests
effectiveness of two water-based potassium oxalate desensitizers

Conditions: Dentin Sensitivity

Summary: this study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.


Eligibility criteria:
inclusion criteria: * provide written informed consent to participate in the study * be at least 18 years of age * be in good general health, as determined by the investigator/designee based on review of the health history/update for participation in the study * agree to refrain from participating in any other oral/dental product studies for the duration of the study * agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study * agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study * agree to comply with study/product usage instructions; and * have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the cold air sensitivity schiff scale during screening exclusion criteria: * gross oral neglect or urgent dental treatment needs * severe periodontal disease and/or generalized mobility * active treatment for periodontitis * any disease or condition that could be expected to interfere with examination procedures or safe completion of the study * self-reported pregnancy or nursing

Keywords: sensitivity