Kornimate/medical-research-clean huggingface dataset:
streamlining the efficiency of prep implementation

Conditions: HIV Prevention; HIV Preexposure Prophylaxis; Implementation

Summary: this is a pilot facility-based direct-to-pharmacy prep refill delivery to streamline care pathway in kenyan public health hiv facilities implementing prep. data on up to 500 prep users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.

a prospective, pilot implementation evaluation of patient-centered differentiated care service. the core components of the multifaceted implementation strategy include: 1) 3-monthly refills, 2) direct-to-pharmacy refill visits, 3) hiv self-testing (hivst) while waiting for refills, 4) rapid risk assessment for ongoing risk, adherence, side effect, and acute hiv symptoms. clinics will implement either: 1) current prep patient flow without any change or 2) a pilot differentiated pharmacy-based follow up prep care pathway. clinics will implement only one delivery model thus eliminating risk for confusion in the clinic about delivery models and permitting a full-scale test of the system, since the efficiency in prep delivery is in part at the system level, above and beyond the individual client encounter. for this pilot project designed to primarily test delivery efficiency, feasibility and acceptability of direct-to-pharmacy care pathway at systems level using existing public health infrastructure, pilot and control clinics will be of comparable size selected to reflect the implementation nature of the design. the specific aims are: aim 1: to evaluate whether a differentiated care model improves the efficiency of prep delivery while resulting in equivalent or better: 1) patient waiting time, 2) early prep continuation, and 3) adherence. aim 2: conduct mixed-methods study to understand patient and provider perception, experiences , feasibility and acceptability of a differentiated prep delivery model. aim 3: assess the efficiency, cost and cost-effectiveness of a facility-based differentiated prep care.

Eligibility criteria:
inclusion criteria: for hiv-negative participants: * of legal age (≥18 years) * able and willing to provide written informed consent for research component of the project (blood draw for adherence, brief surveys and in-depth qualitative interviews) * hiv uninfected based on negative hiv tests, per kenya national guidelines * currently or previously accessed prep at participating hiv clinic for key delivery informants: * able willing and able to provide consent in order to participate in the survey and qualitative interviews. * works at any of the clinics implementing prep delivery. key informants may include hiv testing service nurses, counselors, clinicians, social workers, or clinic managers. exclusion criteria: * not meeting any of the inclusion criteria listed above.
optical defocus to stimulate eye elongation in hyperopia

Conditions: Hyperopia; Refractive Error

Summary: axial hyperopia results when the length of the eye is too short for the eye to properly focus distance objects on the retina while the focusing system is relaxed. emmetropization is the process by which the eye actively adjusts various components of the eye to gradually improve the focus of the eye. emmetropization frequently involves either an increase or a decrease in the growth of the eye, particularly during infancy and childhood. numerous animal studies suggest that if an animal is exposed to retinal images located behind the retina either centrally or peripherally, the eye will grow in the direction of the focused image. if an abnormally short eye has resulted in hyperopia, exposing such an eye to retinal images partially located behind the retina might encourage axial elongation, thus reducing the hyperopia.

hyperopia or farsightedness may cause distance vision and near vision to be blurred. depending on the severity of the condition and the age of the patient and the status of the binocular vision system, hyperopia can also cause fatigue, asthenopia, headaches, double vision, and amblyopia. low to moderate amounts of hyperopia rarely cause much difficulty in the young person, but will eventually cause significant near vision problems as the patient ages. hyperopia can be caused by the eye being too short (axial hyperopia) or by the cornea being too flat or the crystalline lens being to weak (refractive hyperopia). it has been established by the pi that axial growth can be dramatically lessened in children and adolescents with myopia through the use of bifocal contact lenses prescribed in a particular way (the control study). studies by earl smith, o.d., ph.d. have suggested that multi-zonal contact lenses that provide proper axial focus while manipulating peripheral defocus can either discourage or encourage axial growth to treat myopia or hyperopia respectively. in the present study, simultaneous vision bifocal soft contact lenses will be used to encourage axial growth in hyperopic children and adolescents with axial hyperopia in an effort to reduce hyperopia. subjects will be randomly assigned to wear either bifocal soft contact lenses or single vision soft lenses. the bifocal contact lenses will be prescribed to provide for clear central vision at both distance and near with the near zone of the contact, thus exposing the retina to hyperopic defocus from the distance zone.

Eligibility criteria:
inclusion criteria: * aged 5-12 * hyperopia \> +1.25 each eye (cycloplegic refraction) * ability to wear soft contact lenses exclusion criteria: * amblyopia * strabismus * astigmatism \> 1.00 diopters * axial length \> 24.00 mm

Keywords: hyperopia refractive error ocular biometrics axial length contact lenses bifocal contact lenses
abdominal pain and symptoms post gastric sleeve

Conditions: Abdominal Pain; Quality of Life

Summary: exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

the primary aim is to evaluate abdominal pain in morbid obese patients before and after sleeve gastrectomy. the investigators will especially focus on chronic abdominal pain, and its relation to quality of life and weight loss. in a sub-analysis the investigators will compare the findings of the present cohort with patients operated with roux-en-y gastric bypass. primary endpoints/outcomes: - define the prevalence of chronic abdominal pain 2 years after sleeve gastrectomy secondary endpoints/outcomes: - evaluate and characterise chronic abdominal pain in regard to: * weight development * obesity-related comorbidities * health-related quality of life * postoperative complications * metabolic effects after surgery * nutritional status * socioeconomic status

Eligibility criteria:
* inclusion criteria * patients undergoing sleeve gastrectomy at the center for morbid obesity and bariatric surgery, oslo university hospital and a collaborating center. * signed written and informed consent for study enrollment * exclusion criteria * patients who dont understand norwegian language * previous bariatric surgery * indication for sleeve gastrectomy for other reasons than for morbid obesity
aschistosoma haematobiumspecific micrornaas a tumor marker for early diagnosis and prognosis of bilharzial bladder cancer in eygpt

Conditions: Bladder Cancer

Summary: mirnas have been detected in different bodily fluids, which suggests significant potential, such as their use as biomarkers in diagnostics and prognostics. sha-mir-71a was abundantly found in the urine of patients with bladder cancer as compared to benign bladder cystitis associated with schistosomiasis . additionally, this mirna was more highly detected in urine samples from patients with bilharzial bladder cancer than bladder cancer not associated with bilharziasis (schistosomiasis), suggesting its specificity in the identification of bladder cancer associated with infection.


Eligibility criteria:
inclusion criteria: * urinary symptoms (hematuria, urinary retention, dysuria... etc.), who were planned to undergo cystoscopy for suspicion of bladder cancer (bc) or benign bilharzial cystitis (bil), will be selected. exclusion criteria: * : in bladder cancer group patients who have received chemotherapy, or with previously diagnosed other malignancy within the past 5 years.
efficacy and safety of lorundrostat in addition to sodium-glucose cotransporter-2 inhibitors (sglt2i) in subjects with hypertension and chronic kidney disease (ckd) with albuminuria

Conditions: Chronic Kidney Disease

Summary: this is a randomized, double-blind (db), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg qd lorundrostat (an aldosterone synthase inhibitor \[asi\]) in addition to a sglt2i for the treatment of hypertension in subjects with ckd and albuminuria while receiving stable treatment with an angiotensin-converting enzyme inhibitor (acei) or an angiotensin receptor blocker (arb). subjects will be at least 18 years old with hypertension, and mild to severe ckd with albuminuria at the screening visit.

the study consists of up to a 2-week screening period, a 2-week run-in period where subjects will either begin study provided dapagliflozin 10 mg or continue on their regularly prescribed sglt2i, and two db 4-week treatment periods separated by a 4-week washout period. subjects will be randomized (1:1) to two treatment sequences: lorundrostat-placebo (lp) and placebo-lorundrostat (pl).

Eligibility criteria:
major inclusion criteria: 1. at screening, uacr of 200-5000 mg/g, inclusive, in first morning urine void 2. at screening, egfrs of ≥30 ml/min/1.73 m2 3. at screening, aobp sbp of 135-180 mmhg, inclusive 4. on a stable treatment with an acei or arb for at least 2 months prior to screening 5. at screening, body mass index (bmi) of \>18 kg/m2 major exclusion criteria: 1. subjects with known hypersensitivity to lorundrostat or any of its respective excipients 2. subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (subjects beginning dapagliflozin only) 3. at screening, serum potassium \>5.0 mmol/l 4. history of clinically significant hyponatremia within 1 year prior to screening 5. use of epithelial sodium channel (enac) inhibitors or mineralocorticoid receptor antagonist (mras), including, but not limited to amiloride, triamterene, spironolactone, eplerenone, finerenone, from 4 weeks prior to the screening visit and during study participation. with the exception of mras in primary aldosteronism 6. medical history of kidney disease related to autoimmune diseases (lupus, anti-neutrophil cytoplasmic antibody \[anca\] vasculitis), multiple myeloma or other known paraproteins, infiltrative diseases of the kidney, obstructive nephropathy, cystic kidney diseases, and renal transplantation 7. medical history of advanced liver disease, including cirrhosis 8. medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy 9. diabetes mellitus with a glycosylated hemoglobin (hba1c) \>10% (\>86 mmol/mol) at screening

Keywords: albuminuria arterial hypertension hypertension proteinuria diabetic nephropathy chronic kidney disease aldosterone synthase inhibitor
cardiovascular risk evaluation in psoriasis treated with photochemotherapy

Conditions: Psoriasis Vulgaris

Summary: ultraviolet (uv) phototherapy is a standard treatment for many inflammatory dermatological diseases, including psoriasis. the systemic effects of uv phototherapy are still not well studied. there are several factors that may affect patient's cardiovascular (cv) risk during uv phototherapy. atherosclerosis is now known to have an inflammatory origin and to be frequently associated with psoriasis. in this study the investigators aim at studying the effect of psoralen-uva phototherapy on several biomarkers of cv risk in patients with psoriasis with or without atherosclerosis.


Eligibility criteria:
inclusion criteria: * disease affecting \> 10% body surface area * patient willing to commit to 3 sessions weekly for 3-6 months without interruption exclusion criteria: * disease severity less than 10% body surface area * patients unable to commit for therapeutic schedule due to work or residence issues. * pregnant and lactating females * photosensitive dermatoses

Keywords: psoriasis photochemotherapy atherosclerosis metabolic syndrome cardiovascular risk
study on basal joint arthritis prospective

Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Summary: the data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. there are no interventions or changes in patient care associated with this study.

basal joint arthritis of the thumb is a common condition associated with considerable morbidity. many non-operative and operative treatments have been described but few multi-center prospective evidence based trials comparing standard treatments have been done. this continuing search for consensus of best clinical practices has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. through the systematic collection of data regarding patient-specific characteristics, treatment interventions, and longitudinal functional outcome measurements the investigators believe patient outcomes and satisfaction can improve through the elucidation of risk factors for disease progression, and the timing and selection of treatment modalities, either conservative or surgical, for any particular patient. the establishment of a multi-center clinical registry will greatly facilitate these goals. the study hypothesizes that there exist effective non-operative and operative treatments for certain patient populations with basal joint arthritis of the thumb. there also exists a functionally superior, cost effective, and low risk non-operative or minimally invasive operative treatment regime to alleviate pain and slow the progression of disease in those with less advanced disease. likewise, there is significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis with one of the popularized procedures currently in practice.

Eligibility criteria:
inclusion criteria: * patients who have symptomatic basal joint arthritis. * patients who are capable of providing informed consent. exclusion criteria: * patients younger than 18 years old at the time of enrollment. * patients with neuromuscular disease affecting the operated hand, not caused by the cmc operation. * patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic arthritis. * patients with a history of or current infection of the basal joint of the affected hand. * patients who are demented or are unable to provide informed consent. * patients unable to comply with study guidelines. * patients who have metacarpophalangeal joint hyperextension are not excluded. these patients will be followed and if they receive a capsulodesis or other procedure at the mcpj at the same time as their basal joint arthroplasty this will be noted in their data records.

Keywords: carpometacarpal arthritis basal joint arthritis cmc arthritis osteoarthritis
genetic predictors of responsiveness to radiofrequency denervation in chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the investigators have designed this exploratory study in patients suffering from zygapophysial joint mediated pain to investigate if a correlation exists between inter-individual genetic variability (genotype) with treatment response (phenotype). more specifically, the investigators aim to identify any form of correlation between a specific snp of the bdnf gene (val66met) and the effectiveness and/or duration of radiofrequency facet joint neurotomy. the study population is patients suffering from chronic low back pain who have been scheduled for radiofrequency neurotomy following the diagnosis of facet joint mediated pain (using medial branch block test). the investigators will evaluate if a common variant of bdnf gene (val66met) can be directly correlated to a significant degree of pain relief following rf treatment, and whether the result of such a procedure can be predicted from a specific genetic profile.

study hypothesis it is possible to predict individual responsiveness to radiofrequency denervation for zygapophysial (facet) joint mediated pain on the basis of a specific genetic pattern (single nucleotide polymorphism, \[snp\])?

Eligibility criteria:
inclusion criteria: * diagnosed with chronic low back pain which is unresponsive to conservative treatment (including suitable analgesics and physical therapy); * willing to provide consent * subject is capable of comprehending the patient information sheet and has the capacity to give their informed consent to all study procedures in english * be 18 years or older at the time of enrolment; * have specific low back pain that is aggravated by hyperextension and rotation of the spine, with or without hip, buttock or leg pain that does not follow a known dermatomal distribution * paraspinal tenderness * a "positive" response to a uni/bi-lateral mbb\* (a response is considered positive when a subject experiences at least 50% reduction in pain scores after the block, regardless of the duration of pain relief) exclusion criteria: * patients who had had any previous back surgery * patients who had previous rf treatments for facet joints mediated pain * patients with another significant cause of low back pain (like spinal stenosis, disc herniation, spondylolisthesis, malignancy, infection or trauma); * radicular pain (pain with neuropathic characteristics following one or more nerve root distribution) * patients with bleeding complications or coagulopathy issues; * concurrent participation in other experimental trials; * known history of adverse reactions to local anesthetics; * pregnant or lactating women; * refusal to provide informed consent for blood banking * any other complication which in the view of the investigator may interfere with the study procedures or the measurement of the accurate study outcomes
bay12-8039: 5 days for sinusitis vs placebo

Conditions: Sinusitis

Summary: the purpose of the study is to evaluate the effectiveness and safety of avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study avelox is considered an investigational drug. in this study avelox will be compared to placebo.


Eligibility criteria:
inclusion criteria: subjects must meet all the following criteria at the time of enrollment: * age \>/= 18 years * clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but \< 28 days as defined by a), radiographic, and b) clinical criteria, as follows: * radiographic criteria: the presence of one or more of the following on a radiographic paranasal sinus film (waters' view): - evidence of air-fluid levels - opacification * clinical criteria: the presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below: * major symptoms: - purulent anterior or posterior nasal discharge - unilateral facial pain or malar tenderness * minor symptoms: - frontal headache - fever (oral = 38.0°c/100.4°f, tympanic = 38.5°c/101.2°f, axillary = 37.5°c/99.5°f) - culture material obtained by sinus puncture; the aspirated specimen sent for gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy exclusion criteria: subjects with one or more of the following criteria will not be eligible for this study: * history of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included) * history of sinus surgery (antral sinus puncture is not considered as a surgery) * any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis * known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses

Keywords: respiratory tract infection bacterial sinusitis
olanzapine augmentation therapy in treatment-resistant depression: a double-blind placebo-controlled trial

Conditions: Therapy-resistant Depression

Summary: 60 patients with major depression will be treated with 10 mg olanzapine or placebo for 2 weeks. in case of response (reduction of depressive symptoms)the study will be continued for further 60 days.

the study is using a randomized double-blind, parallel-group, placebo-controlled design. 30 patients per treatment group will be included into the study and randomized to the treatment groups using a computer program. psychotic features of depression will be excluded by a score of 2 or less in the panss subscales p1, p3 and p6. treatment resistance as defined by history of non-response to two antidepressants from different classes at an acceptable dose and period is confirmed retrospectively. if possible, treatment compliance should be confirmed by plasma level examination. after informed consent, visit 1 is performed on day 0 (inclusion criteria, history, demographics, physical examination, vital signs, hamd, madrs, cgi, lab). study medication is started on day 1, the antidepressive therapy is continued at stable dose until the end of the study. patients will receive a double-blind therapy of either 10 mg/d olanzapine or placebo. study visits will be performed on days 4, 7, and 14 (visits 2-4: vital signs, hamd, madrs, cgi, lab). after 14 days, the patients will be classified as responders or non-responders. a responder is defined by a reduction of the initial ham-d score of more than 50%. study treatment will be stopped in non-responders and continued in a double-blind manner in responders for further 60 days. thereafter, the the study medication is stopped and the patients are observed for further 14 days. study visits will be performed every 14 days. this extension phase was added to examine if a prolonged treatment with olanzapine could ensure a sustained treatment effect. it should be excluded that olanzapine has a short-term tranquillizer-like effect or leads to unfavourable medium- to-long-term depressiogenic effects as observed with other neuroleptics used in depression ( e.g. fluspirilene). moreover, withdrawal effects should be excluded.

Eligibility criteria:
inclusion criteria: * major depression without psychotic features * therapy resistance (2 courses of antidepressants from different classes for more than 3 weeks in adequate dose * ham-d score greater/equal than 17 * age 18-65 exclusion criteria: * bipolar disorder * active alcohol or illicit drug use * female with ineffective contraception * severe medical conditions, epilepsy * psychotic features

Keywords: therapy-resistant depression add-on therapy depression