Kornimate/medical-research-clean huggingface dataset:
study of best1 vitelliform macular dystrophy

Conditions: Best Vitelliform Macular Dystrophy; Retinitis Pigmentosa

Summary: the purpose of this study is to establish the natural history of of participants with bestrophin 1 vitelliform macular dystrophy. the blinding disorder best vitelliform macular dystrophy (vmd) is caused by any one of more than 250 different mutations in the best1 gene. as new treatments are developed, a clear understanding of the natural history of disease progression of best1 vmd is necessary. the goals of this natural history study are to: 1. report the natural history of retinal degeneration in participants with a clinical diagnosis of vmd with molecular confirmation of a pathogenic best1 mutation(s). 2. identify sensitive structural and functional outcome measures to use for future multicenter clinical trials for the treatment of bestrophin 1 vmd. 3. compare progression of the identified structural and functional measures between the two eyes to judge the suitability of the second untreated eye as a control for a future clinical trial involving unilateral treatment 4. identify well-defined patient populations for future clinical trials of investigative treatments for best1 vmd.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * diagnosis of best1-associated vmd by study physician, who are trained retinal specialists in the university clinic must be able to commit to 4 follow-up study visits (3 years) exclusion criteria: * systemic condition that prevents the participant from undergoing the exams
dose exploring and setting study for tolvaptan to treat hepatic cirrhosis with ascites

Conditions: Ascites; Hepatic Cirrhosis

Summary: to observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.

tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of water reabsorption by renal collecting ducts without corresponding increase in electrolyte excretion. it has been confirmed that tolvaptan is able to increase urine volume without any adverse effects on renal functions.

Eligibility criteria:
inclusion criteria: 1. hepatic cirrhosis patients after 7days treatment of loop diuretics and aldosterone antagonist but still with ascites 2. hospitalized patients or those who can be hospitalized in this trial between observation period and posttherapeutic observation (visits at clinic will be allowed after day 8); 3. during the observation period (-3 day to -1 day ), subjects whose body weight difference fall within ±1.0 kg range 2 days (day-2 and day -1) prior to initiation of trial drug treatment; 4. ages: ≥18 and ≤75 years of age; 5. genders: men or women; 6. signed the informed consent form. exclusion criteria: 1. patients with the following diseases, complications or symptoms: * hepatic encephalopathy (coma scale note 1) grade 2 or higher); * malignant ascites; * uncontrolled spontaneous bacterial peritonitis; * patients are likely to experience alimentary tract hemorrhage during the trial; * heart failure (nyha cardiac function scale note 2) stages 3 and 4); * anuria (daily urine volume below 100ml); * dysuria resulting from urethral stricture, calculus and tumors. 2. patients with the following medical history: * alimentary tract hemorrhage within 10 days prior to screening; * cerebrovascular accident within 1 month prior to screening; * gout attack within 1 month prior to screening; * past allergy or hypersensitive reactions to benzodiazepines (e.g. benazepril hydrochloride) 3. systolic pressure below 90mmhg at screening; 4. patients with the following abnormalities in laboratory examinations at screening: serum creatinine exceeds 2.5x upper limits of normal, serum na+\>145mmol/l (or exceeds upper limits of normal), serum k+\>5.5mmol/l, uric acid\>8.0mg/dl (476μmol/l), child-pugh scale greater than 12. 5. patients cannot take drugs orally; 6. pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures; 7. patients received albumin or other blood preparations within 4 days prior to trial drug administration; 8. patients participated in clinical trials of other drugs within 1 month prior to screening; 9. patients participated in tolvaptan trials and took tolvaptan previously; 10. patients are unsuitable to participate in this trial in investigators' opinion.
clinical trial evaluating rituximab in ocular cicatricial pemphigoid

Conditions: Ocular Cicatricial Pemphigoid

Summary: cicatricial pemphigoid is an autoimmune blistering disease which affects the skin, mucous membranes, and, in a small subset of patients, the eye. progressive ocular disease can lead to irreversible damage and blindness. conventional treatments include systemic steroids, dapsone, and immunosuppressive agents. these treatments, however, are not successful with all patients. rituximab has been very effective in the treatment of other autoimmune disorders, and has recently been shown to be effective for autoimmune blistering pemphigus. we propose that it will also be effective in the treatment of cicatricial pemphigoid.

cicatricial pemphigoid is an autoimmune blistering disease which can affect the skin, mucous membranes, and, in a small subset of patients, the eyes. progressive ocular disease can lead to irreversible damage and blindness. conventional treatments have included high dose systemic steroids, dapsone, and immunosuppressive agents such as azathioprine, methotrexate, cyclophosphamide, and mycophenolate mofetil. however, there are a subgroup of patients who fail to respond to these treatments, develop intolerable side effects, or have contraindications to their use. patients may also develop resistance to these conventional treatment modalities. for these reasons, alternative treatment modalities are needed. rituximab has been very effective in the treatment of other autoimmune disorders. it has recently been shown to be effective in the treatment of another autoimmune blistering disorder known as pemphigus. we thus propose that rituximab will be effective in the treatment of cicatricial pemphigoid.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of ocular cicatricial pemphigoid (symptoms of conjunctivitis, irritation, burning, increased lacrimation, photophobia, dryness of the eyes along with conjunctival inflammation, trichiasis, and scarring 2. one of the following: * failed response to the use of one or more conventional treatments for a minimum of 10 weeks; or * minimal conventional medication doses, with a significant adverse effects, contradiction to use, or progressive disease despite treatment 3. adults age 19 and older 4. adequate renal function as indicated by serum creatinine levels less than 1.5 exclusion criteria: 1. known hypersensitivity to rituximab or its components 2. age less than 19 years 3. any other condition deemed by the investigator to be a significant hazard to the subject if the investigational therapy were initiated.

Keywords: pemphigoid blistering diseases blindness autoimmune rituximab
the impact of delayed diagnosis of alpha-1 antitrypsin deficiency

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the objective of this study is to prospectively assess whether there is any interval between first symptom and initial diagnosis that is experienced by patients with newly diagnosed alpha-1 antitrypsin deficiency (aatd) and then to assess whether this diagnostic interval is associated with worsened clinical status at the time of initial diagnosis.

the study protocol proposes to assess participants' clinical status based on the results of spirometry tests that are performed by the patient's managing physician as a routine part of clinical care of individuals with aatd within +/- 6 months of the initial diagnosis, subjects' st. george's respiratory questionnaire (sgrq) at the time of initial diagnosis, and their copd assessment test (cat) result at the time of initial diagnosis of aatd (hereafter called "time zero" or t0 defined as the day on which the patient's test shows aatd from the blood work submitted for testing to biocerna llc by the patients' managing physicians as part of their routine clinical management). after offering verbal consent, subjects will complete a survey that assesses various clinical domains, including demographic features, how was aatd ascertained, initial symptom ascribable to aatd, the number of healthcare providers (and specific types of providers) seen before initial diagnosis, and clinical status at t0 or within a defined, relatively narrow temporal window (+/- 6 months) of t0. as in prior studies, the diagnostic interval will be defined as the duration between self-reported initial symptom of aatd (usually dyspnea in \> 80% of cases3) and initial confirmed diagnosis of aatd (t0).

Eligibility criteria:
inclusion criteria: * 18 years of age or older * positive aatd test result exclusion criteria: * previous positive aatd test result * negative test result for aatd
periorbital massage for nausea and vomiting after laparoscopic surgery

Conditions: Nausea; Vomiting; Laparoscopic Cholecystectomy

Summary: laparoscopic cholecystectomy is one of the commonly used surgical treatment methods for gallbladder diseases. however, many patients experience significant nausea and vomiting after laparoscopic cholecystectomy. it is observed that approximately 20% to 30% of patients experience postoperative nausea and vomiting as the most common complaint after laparoscopic cholecystectomy. this study aims to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

this study aimed to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. one group received periorbital massage, while the other group did not receive massage.

Eligibility criteria:
inclusion criteria: those who have laparoscopic cholecystectomy surgery under general anesthesia, * those between the ages of 18-70, * those who do not have a psychiatric disease, * those who understand what they read and volunteer patients, * those who do not have a hearing or speech problem, exclusion criteria: * patients undergoing emergency surgery, * patients with psychiatric disorders * patients who have taken another antiemetic drug within 24 hours before surgery

Keywords: nausea voming periorbital massage
measuring the volumes of hypertrophic scars and keloids, two specific kind of scars, over different points in time in patients who have undergone surgery and evaluate 3d-cameras as a possible measuring and documenting tool including volumetry

Conditions: Keloid Scar Following Surgery; Scars, Hypertrophic; Scar Keloid

Summary: measuring the volumes of hypertrophic scars and keloids, two specific kind of scars, over different points in time in patients who have undergone surgery and evaluate 3d-cameras as a possible measuring and documenting tool including volumetry.

the objective of this study is to utilize a 3d camera to measure the volumes of hypertrophic scars and keloids in patients at specified time points. the time points for measurement include day 0, as well as 3, 6, and 12 months. the 3d camera will be evaluated for their efficacy in measuring and documenting the volumes of the scars. this evaluation will include volumetry, which is the measurement of the three-dimensional space occupied by an object.

Eligibility criteria:
inclusion criteria: * all patients with hypertrophic scars or keloids, written consent to participate in the study, minimum age of 18 years. exclusion criteria: * absence of written consent, unwillingness to contribute data, inability to understand the study protocol. * lack of hypertrophic scars or keloid
physical activity behavioral change intervention in lung cancer

Conditions: Lung Cancer; Sedentary Behavior; Fatigue

Summary: patients with lung cancer have poor physical activity and increased sedentary behavior, with the presence of high levels of fatigue. a randomized controlled trial will be carried out to compare usual care versus a personalized exercise program in the community, in order to explore the changes on physical activity and sedentary behavior and its impact on cancer-related fatigue.

patients with lung cancer are characterized by having low levels of physical activity (pa) and high sedentary behavior (sb), with direct impact on their quality of life, complications and survival. previous studies have observed that pa programs have high dropout rates and are not very sustainable over time, making it necessary to incorporate models that consider the preferences and possibilities of patients. objectives: to compare the effects on pa levels and sb of a 6-month personalized program vs. conventional care, in community-dwelling lung cancer survivors. methods: controlled and randomized pilot study, with intervention and control group, pilot study. 40 non-small cell lung cancer survivors (18 to 70 years old) will be included. the control group will receive the usual recommendations regarding an active and healthy lifestyle. the intervention group will follow a personalized pa and behavior change program in the community, supervised by a physiotherapist expert in therapeutic exercise. pa and sb measurements will be carried out using accelerometry and self-reported questionnaires. as secondary variables, functional capacity, lung function, dyspnea and fatigue, as well as quality of life will be measured. a motivational interview will be conducted to personalize the intervention considering clinical characteristics, treatment, motivation and preferences. the intervention will be re-evaluated and adapted monthly, considering the results reported weekly. through covariance analysis, the levels of pa and sb, among other factors, measured at the beginning and at the end of the intervention will be evaluated.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of non-small cell lung cancer who are candidates for radical and/or metastatic treatment * ages between 18 and 70 * ability to answer questionnaires in spanish * who have accepted participation and signed the informed consent exclusion criteria: * participants with a life expectancy of less than 6 months * patients with levels of physical activity greater than 240 metabolic equivalents (met) mets/day * patients who have a contraindication to exercise * patients with dementia or spatial disorientation or behavioral disorders

Keywords: physical activity community physiotherapy
evaluation of the performance of the idbioriv method in pathogen identification and antibiotic susceptibility testing in patients with sepsis

Conditions: Sepsis

Summary: sepsis is a disruption of homeostasis in the human body in response to bloodstream infection and is associated with a high risk of mortality. worldwide, sepsis is affecting approximately 30 million people and resulting in six million deaths. blood culture is a specific blood sample used to identifying microbial agent (bacterium or yeast) and determine the sensitivity of these microorganisms to antibiotics and antifungals. any delay in identifying the microorganism and/or determining the ast (antibiotic susceptibility testing) has a direct impact on the administration of appropriate antibiotic treatment and, consequently, on mortality of the patient. the faster the diagnosis, the faster the antibiotic treatment will be adapted, the higher the survival rate/probability of patients, and the lower the ecological impact. in routine, clinical microbiology laboratories currently use 2 automatized techniques: maldi-tof ms® for microorganisms identification and vitek2® method for ast determination. based on a proteomic approach, the idbioriv method is a rapid method (90 minutes) in comparison of current methods (24/48 hours) able to identifying a large panel of 113 pathogens and determine the antibiotic resistance profile of 49 species for 4 classes of antibiotics (beta-lactams, aminosides, glycopeptides, colistin). the main objective of this study is to evaluate the performance of the idbioriv method in pathogen identification and antibiotic susceptibility testing in comparison with current methods of analysis of positive blood cultures used at the microbiology laboratory of the hospices civils de lyon, in a real clinical situation, over a 2-year period.


Eligibility criteria:
inclusion criteria: * adult or child patient * hospitalized in one of the departments registered with hospices civils de lyon * showing signs of infection * confirmed by a 1st positive blood culture * patient or close relative (trustworthy person or family member) or holder of parental authority who has given his or her non-objection after receiving the information note exclusion criteria: * patients under court protection * patients under guardianship or curatorship

Keywords: sepsis bacteria microbiology diagnosis method identification resistance antibiotic susceptibility testing virulence
renal artery contrast-free trial

Conditions: Renal Artery Stenosis; Kidney Diseases; Hypertension

Summary: this study will compare the results of a clinically ordered abdominal ct angiography to a research non-contrast mr angiogram (mra). cta is a "gold-standard" for identifying blockages in the kidney arteries or other blood vessel problems. cta requires radiation and contrast to obtain useful images. conversely, the mr abdomen technique being used for the study uses no radiation or contrast and is felt to be a safer option for individuals who have kidney problems. there is benefit to establishing non-contrast mra as a clinically accurate test.

react is a prospective, minimal-risk, and multi-center international trial. the purpose of the study is to evaluate the safety and efficacy of non-contrast magnetic resonance angiography (mra) for the diagnosis of renal artery stenosis (ras). the current "gold standards" for diagnosing ras are non-invasive 3d angiography with contrast-enhanced cta/mra or invasive x-ray angiography. all of these techniques require the use of an intravenous injection of either iodinated contrast material or gadolinium based agents. iodinated contrast agents are contraindicated in patients with renal dysfunction and have increased risk of allergic reaction. contrast-enhanced magnetic resonance angiography (mra) with gadolinium has fewer risks associated with it, however, is currently contraindicated in patients with severe renal insufficiency because of concerns about developing a rare but often fatal condition termed nephrogenic systemic fibrosis (nsf). non-contrast mra techniques are felt to provide an avenue for safer, effective vascular imaging in patients both with and without kidney dysfunction. in this trial we propose to validate the contrast-free mra technique, t-slip (time-spatial labeling inversion pulse), for diagnosing ras. this study will compare t-slip to the reference standard of contrast-enhanced cta and is designed to test its efficacy, reproducibility, reliability, and safety.

Eligibility criteria:
inclusion criteria: * the abdominal cta evaluation form has been completed and confirmed to fit criteria for study enrollment * the research mra will be completed within 3 months of abdominal cta * subject signed and dated the informed consent form * subject agrees to a "research" abdominal mra * subject is able to follow breathing and scanning instructions * subject is at least 18 years of age exclusion criteria: * subject has had a significant change in clinical condition between the time of abdominal cta and abdominal mra (e.g. worsening renal function, renal vascular intervention) * subject has renal stents, or other known material that may affect mr image quality * subject has a contraindication to an mri * subject had intravenous gadolinium media within the previous 24 hours * subject has a baseline heart rate \>90 beats per minute or respiratory rate \>25 breaths/minute

Keywords: non-contrast
women in dual with dolutegravir

Conditions: HIV Infections

Summary: strategies for optimizing antiretroviral treatment in virologically suppressed patients are still a major challenge in the field of hiv. these strategies include improving the toxicity and tolerability of drugs in the short and long term, such as replacing toxic agents with safer ones or reducing the number of drugs in the combination. tenofovir alafenamide (taf) is a novel prodrug of tenofovir (tfv) that is converted intracellularly to the active form, resulting in higher concentrations of tfv diphosphate in circulating lymphocytes than those obtained with tenofovir disoproxil fumarate (tdf). because of these pharmacokinetic properties, taf results in 91% lower plasma exposure to tfv. phase 3 studies have established the virological noninferiority of taf to tdf, with a lower frequency of renal and bone adverse events. replacing tdf with taf may be a safe and effective option to reduce toxicities when switching from one arv strategy to another and, to date, could represent the optimization of a three-drug regimen. dolutegravir (dtg) is a potent insti that exhibits rapid and potent viral load reduction and a high barrier to resistance.


Eligibility criteria:
inclusion criteria: * female individuals * hiv-1 documented infection * age \> 18 years * being on an effective (pvl \< 50 copies/ml) three-drug cart regimen containing tenofovir (taf or tdf) (e.g. taf/f/e/c; taf/f/rpv; tdf/f/rpv; taf/f+pi/c; tdf/f/pi/c; taf/f+pi/r; tdf/f/pi/r; taf/f+dtg; tdf/f/dtg; taf/f+rtg; tdf/f/rtg; taf/f/bic) for at least 3 months before the screening. two consecutive hiv-1 rna determinations below the determination threshold before enrollment are required * no known allergy or intolerance to nrtis, nnrtis or instis * women of childbearing potential will be required to adopt an effective birth control system throughout the study period * subjects able to comply with the protocol requirements * informed consent signed exclusion criteria: * having failed virologically any previous art regimen · evidence of any 3tc (presence of m184v/i or k65r/e/n) or insti resistance · having ever been treated with mono or dual arv therapies subsequently intensified to three-drug cart regimen * pregnancy or breast-feeding or not willing to use effective contraception if they are of child bearing potential * an active malignancy or oi requiring active treatment (prophylactic regimens are allowed) · hbv infection · a life expectancy \< 2 years
menstrual phase and postoperative pain

Conditions: Acute Postoperative Pain; Chronic Postoperative Pain

Summary: fluctuations of female sex hormones during the menstrual cycle influence pain perception. endogenous pain is pronounced in the follicular phase of the menstrual cycle. the investigators tested the primary hypothesis that the women having surgery during their follicular phase have more acute pain and require more opioids than those in the luteal phase, and secondarily the investigators tested that women who have surgery during their follicular phase have more incisional pain at 3 month postoperatively.

127 adult females having laparoscopic cholecystectomy were randomized to have surgery during the luteal or follicular phase of their menstrual cycle. standardized anesthesia and pain management regimen was given to all patients. pain and analgesic consumption were evaluated in pacu and every four hours in first 24 hours. adverse effects were also questioned every four hours. time to oral intake and ambulation were recorded. post-surgical pain, hospital anxiety and depression scale, and sf-12 questionnaire were also evaluated at 1- and 3-month visits.

Eligibility criteria:
inclusion criteria: * women with a negative urine pregnancy test exclusion criteria: * patients with pre-existing pain syndromes * patients using routinely using opioids * patients using hormone preparations in the last 6 months * patients with hysterectomy * patients breastfeeding in the previous 6 months * patients with body mass index \>35 kg/m2

Keywords: chronic postoperative pain menstrual cycle