Kornimate/medical-research-clean huggingface dataset:
avatrombopag combined with ist as first-line treatment for saa

Conditions: Severe Aplastic Anemia

Summary: this single-center study aims to evaluate the early efficacy and safety of avatrombopag combined with immunosuppressive therapy (ist) in the first-line treatment of severe aplastic anemia (saa).

this is a single center, single arm, phase ii clinical study. fifty-three patients will be enrolled. treatment protocol is as follows: 1) anti-human thymocyte porcine immunoglobulin (p-atg 20mg/kg/d) or rabbit anti human thymocyte globulin (r-atg 3.0mg/kg/d) was administered intravenously for 5 days; 2) cyclosporine (csa) is given at 3-5 mg/kg.d in divided doses for at least 6 months. the trough concentration is maintained at 150-250 ng/ml. 3) avatrombopag is given orally at 60 mg once a day for patients with body weight ≥ 50 kg, and 40 mg orally once a day for patients with body weight\<50 kg, for a total of 12 weeks.

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed severe aplastic anemia. 2. men and women aged between 12 and 60. 3. subjects must complete all screening assessments as outlined in the test protocol. 4. able to swallow or administer orally. 5. before the start of the research procedure, the patient or guardian should fully understand the research procedure and purpose and sign the informed consent form. if the patient's signature is not conducive to the treatment of the disease, the patient's immediate family should sign the informed consent form. exclusion criteria: 1. congenital bone marrow failure (eg. fanconi anemia). 2. accompanied by cytogenetic cloning changes (chromosomal karyotype and fish detection found somatic cloning abnormalities; simple -y abnormality can be included in this study;) . 3. atg or middle/high-dose cyclophosphamide was used in the past. 4. previous treatment with cyclosporine or tacrolimus \> 6 months. 5. the total course of treatment with tpo receptor agonists (including thrombopoietin, eltrombopag,hetrombopag and avatrombopag) was more than 1 month. 6. serious infectious diseases (tuberculosis without effective control, pulmonary aspergillosis, viral infections). 7. aids patients. 8. pregnant or breastfeeding, fertile but unwilling to take effective contraceptive measures. 9. patients with malignant tumors who are not suitable for atg treatment. 10. a newly diagnosed history of cardio/cerebral vascular thrombosis within 12 months. 11. those who are assessed as unsuitable for inclusion by the investigator.

Keywords: avatrombopag
sequent® scb "all comers" post market clinical follow-up (pmcf)

Conditions: Coronary Artery Disease; Myocardial Ischaemia

Summary: the aim of the study is to assess continued safety and efficacy of the sequent® scb. the product under investigation will be used in routine clinical practice according to the latest european society of cardiology (esc) guidelines and according to the instructions for use (ifu). those data that are obtained in routine clinical use will be documented in the case report form (crf).

the objective of the study is to assess the continued safety and efficacy of sequent® scb for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts. study goals are based on non-inferiority for drug-coated balloon (dcb) compared to paclitaxel-coated balloon (pcb) and dru-eluting stents (des) (historical data) with 80% power. primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (dapt). the aim of the study is to assess the safety and efficacy of the sequent® scb in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. there is no limitation of lesion lengths. in case the lesion is longer than 34 mm, more than one stent needs to be used.

Eligibility criteria:
inclusion criteria: * all common significant coronary lesions * target lesion length \>34mm need to be covered with at least 2 devices * patients eligible for this study must be at least 18 years of age * the patient must fulfil the standard recommendations for percutaneous coronary intervention (pci), based on the last esc recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment exclusion criteria: * intolerance to sirolimus * allergy to components of the coating * pregnancy and lactation * complete occlusion of the treatment vessel because of an unsuccessfully re-canalized * cardiogenic shock * risk of an intraluminal thrombus * hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy * surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior * severe allergy to contrast media * lesions which are untreatable with pci or other interventional techniques * patients with an ejection fraction of \< 30 % * vascular reference diameter \< 2.00 mm * treatment of the left stem (first section of the left coronary artery) * indication for a bypass surgery * contraindication for whichever accompanying medication is necessary

Keywords: coronary artery disease myocardial ischemia drug-coated balloon catheter
exploring the role of the gabaergic modulation in pain transmission in human

Conditions: Neuropathic Pain

Summary: neuropathic pain affects about 7% of the general population in european countries. meta-analyses indicate that only a minority of neuropathic pain patients has adequate response to drug therapy and management of neuropathic pain is still an unmet medical need. new insights into the contribution of defined subtypes of gabaa receptors (gabaars) to the different clinical effects of benzodiazepines, including analgesia, have suggested that α1-sparing selective benzodiazepines, such as n-desmethylclobazam (ndmc), may be a new realistic alternative for the treatment of neuropathic pain. results from our previous study in healthy volunteers assessing the antihyperalgesic and sedative effects of benzodiazepines on a uvb-induced pain model of central sensitization showed that, at the time of maximum effect, clobazam and clonazepam antihyperalgesic effect was greater than placebo by respectively 15.7% (95% ci 0.8 - 30.5) and 28.6% (95% ci 4.5 - 52.6), p\<0.05. moreover difference in sedation (vas), as compared to placebo, was only significant for clonazepam 26.3mm (95%ci 15.0-37.7), p\<0.001. our preclinical data also demonstrate that, in recombinant receptors, ndmc has a better α2- over α1gabaars activity ratio than clobazam and diazepam. and, unlike diazepam, ndmc caused no or modest sedation at antihyperalgesic doses in two strains of wild-type mice. in addition ndmc α2/α1 in vitro activity profile and long term clinical experience from its marketed parent compound (clobazam) make it an advisable clinical candidate for further proof-of-concept assessments in human. therefore the geneva university hospitals have manufactured a new chemical entity and initiated a drug development program for ndmc starting with this proof-of-concept phase 1b randomized double-blind crossover (4 arms) study that will assess the analgesic and sedative effects of ndmc 20mg and 60mg compared to clonazepam 1.5 mg or placebo on a uvb-induced erythema pain model in healthy volunteers.


Eligibility criteria:
inclusion criteria: * male subject, age between 18 and 50 years old * caucasian * type 3 skin phototype (white skin that can tan gradually and burns moderately) * non smoker or moderate smoker (\< 10 cigarettes/day) * no clinically abnormal findings on history and/or on physical examination * positive minimal erythema dose (med) determination exclusion criteria: * any active significant illness * current or past history of drug and alcohol abuse or current intake of more than 3 glasses of alcohol a day or more than 21 glasses of alcohol per week * psychotropic drug intake during the last month * sun allergy or any skin disease * any regular drug intake * cyp2c19 poor metabolizer (phenotype)

Keywords: chronic pain benzodiazepine central sensitization selective compound gabaa receptors antihyperalgesia rct
the protective potential of exercise training on the cardiopulmonary morbidity after covid-19

Conditions: COVID-19, SARS-CoV2

Summary: 40 covid-19 survivors that have been discharged from the hospital will be included in this investigator-blinded randomised study with a 12-week exercise intervention. patients will be 1:1 block-randomised by sex to either a supervised high intensity interval-based exercise group or standard care (control group).

40 patients will be recruited and undergo baseline testing, including examination, biochemistry, ecg, dxa, ogtt, pulmonary function, vo2max, rm, plasma volume, ax3, cgm, echocardiography, cardiac mri. after baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. the randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. following the 12-week intervention period, both groups will complete a series of follow-up tests (as baseline testing). a 1-year follow-up experimental day is also planned in order to evaluate fitness, cardiac and pulmonary structure and function.

Eligibility criteria:
inclusion criteria: * age ≥ 40 years * a laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) ≤ 6 months after hospital discharge * ≤10 l oxygen requirement during hospitalization exclusion criteria: * present atrial fibrillation * diagnosed with acute myocarditis * health conditions that prevent participating in the exercise intervention * patients who cannot undergo mr scans (e.g. kidney disease or metallic implants) * treatment with il-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
efficacy and safety of tegoprazan dual therapy and furazolidone-based bismuth quadruple therapy for helicobacter pylori eradication: a prospective, multicenter, open-label, randomized controlled clinical study

Conditions: Helicobacter Pylori Infection; Tegoprazan; Furazolidone

Summary: to compare the efficacy and safety of tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of h. pylori infection were compared in a multi-center clinical joint study in jiangsu province.

this study is a prospective, multicenter, open-label, randomized, parallel-controlled study. a total of 600 hp-positive patients who had not received hp eradication therapy before or who had previously eradicated hp but had not undergone eradication therapy in the past six months were recruited, and the basic clinical data of the patients (age, gender, drug allergy history, diagnosis and treatment, etc.) were recorded, and they were randomly divided into two groups according to the ratio of 1:1. group a subjects received oral tegoprazan 50mg, bid + amoxicillin 1000mg, tid; group b subjects received oral tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. the duration of treatment is 14 days. during the 14-day eradication treatment period, all participants were asked to record their adverse reactions and adherence to the medication. on the 7th and 14th days of medication, the researchers will conduct follow-up visits through wechat or telephone to determine the adverse reactions and compliance of the patients, and observe and record whether the subjects have nausea, diarrhea, dizziness, bitter mouth, rash, constipation and other adverse reactions. in addition, subjects returned to the hospital 4-6 weeks after the end of treatment to check for h. pylori eradication by 13c-ubt or 14c-ubt.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years old; 2. patients who have had a positive 13c or 14c breath test and have not received helicobacter pylori eradication therapy before, or who have failed to eradicate in the early stage but have not received eradication therapy within half a year; 3. voluntarily join this trial and sign the informed consent form. exclusion criteria: 1. allergy to the study drug (penicillin, amoxicillin, furazolidone, tegoprazan, etc.); 2. patients with active peptic ulcer disease; 3. patients who have received helicobacter pylori eradication therapy within half a year; 4. use of antibiotics, bismuth, histamine h2 receptor antagonists or ppis for 4 weeks before starting study treatment; 5. use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants; 6. history of esophageal or gastric surgery; 7. pregnant or lactating women; 8. suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease; 9. alcoholism. 10. gastric mucosa-associated lymphoid tissue lymphoma (malt), malignant tumor diseases.
prolonged hospital stay and readmission after elective ventral hernia repair

Conditions: Ventral Hernia

Summary: the aim of the present study was to analyse factors associated with prolonged length of hospital stay, readmission and death in a nationwide group of patients undergoing elective ventral hernia repair in search for areas of interest to improve outcome after ventral hernia surgery

detailed analysis of reasons for prolonged hospital stay and readmission in patients undergoing a ventral hernia repair

Eligibility criteria:
inclusion criteria: * patients with elective ventral hernia repair in denmark 2008 exclusion criteria: * emergency repairs

Keywords: length of hospital stay readmission ventral hernia
quality of life and addiction among hospital night workers

Conditions: Health Services Research; Quality of Life; Addiction; Substance-Related Disorders; Health Personnel

Summary: the current context of the covid-19 health crisis leads to an over-solicitation of health systems, with hospital staff in the front line. these personnel are undergoing high levels of stress, an alteration of their life rhythm, but also of their health status and quality of life at work. in addition, night work, through the disruption of circadian rhythms, has consequences on physical and mental health. the more frequent worsening of the condition of certain patients at night increases the burden and responsibilities of night staff. increasing the use of psychoactive substances (spas) can become a solution for managing stress, work rhythms, sleep disorders and their consequences. this self-medication behaviour is not without risks, neither for staff nor for patients. the aladdin study is a project made up of 2 waves of questionnaires - one during and the other after the covid "hospital" crisis - filled in by the hospital night staff of ap-hp. this project will assess the impact of the covid-19 epidemic on the quality of work life, mental health disorders, post-traumatic stress and substance use of hospital night staff. the main objectives of this study is to evaluate the prevalence of psychoactive substance consumption among the night shift healthcare workers of the ap-hp and to describe the participants' quality of working life. methods the study is prospective study using an online self-completed questionnaire. the questionnaire was elaborated on the basis of the validated scales assist (alcohol, smoking, and substance involvement screening test), audit-c (alcohol use disorder test, shortened version) and had (for anxiety and depression) and on qualitative interviews conducted among care staff working the night shift. the questionnaire will be completed at t0 (baseline) and 18 months after. this study will provide data on the consumption psychoactive substances by night hospital workers adn their quality of working life. it will also allow us to compare their consumption with the general population, and to describe the risk factors influencing the consumption.


Eligibility criteria:
inclusion criteria: - hospital workers at aphp, working at night or night and day alternance (working at least 3 hours between 9 p.m and 6 a.m, 2 times a week) exclusion criteria: * hospital workers working during the day * workers working less than 3 hours a night two time a week * doctors
combined therapy in radiation proctopathy

Conditions: Chronic Radiation Proctitis

Summary: the aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (apc) alone and apc in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.

chronic radiation proctopathy (crp) or proctosigmoiditis is a late complication of pelvic radiotherapy. symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (apc) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. to address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of apc alone and apc in combination with sucralfate administered orally.

Eligibility criteria:
inclusion criteria: * radiotherapy due to pelvic tumors completed at least three months prior to enrollment * presence of rectal bleeding * radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy * informed written consent to participate in the study exclusion criteria: * history of clinically significant rectal bleeding prior to radiotherapy * conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream * sucralfate treatment during the two weeks prior to enrollment * renal insufficiency (creatinine level ≥2 mg/dl) * concurrent chemotherapy * concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction) * concurrent therapy with oral anticoagulants

Keywords: chronic radiation proctopathy argon plasma coagulation sucralfate
macrolide antibiotic therapy for patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate whether biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (cf). biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have cf, and is sometimes used in cf patients as well. studies done in a disease called diffuse panbronchiolitis (which is similar to cf) and some preliminary studies that have been done in cf patients suggest that biaxin might have a beneficial effect on cf sputum in ways unrelated to its antibiotic activity.


Eligibility criteria:
inclusion criteria: * diagnosis of cf * ability to reliably perform spirometry * fev1 of 30% predicted at the time of screening exclusion criteria: * mycobacterium in a sputum culture ever recorded * a respiratory exacerbation requiring iv antibiotics in the 60 days prior * used a investigational drug or device in the 60 days prior * significant (\>30ml) of hemoptysis in the past year * require oxygen or have significant liver or renal disease

Keywords: cystic fibrosis (cf) macrolide antiobiotics airway inflammation
the effect of sodium-glucose cotransporter (sglt) 2 inhibitors on cystine stone formation: a preliminary study

Conditions: Cystinuria

Summary: cystinuria is an inherited autosomal recessive disorder of the kidney that is the result of an inability to reabsorb cystine from the urine. supersaturation of cystine in the urine produces crystals that precipitate and form stones in the kidney, which can be a cause of obstruction, infection, and chronic kidney disease. cystine stones constitute a major health challenge for affected individuals with cystinuria because of the frequent recurrence of painful symptoms and the current absence of effective, patient-accepting treatment. a mainstay of therapy is breaking or preventing the cystine bond on the molecular level such that cystine (which is formed from the joining of two cysteine amino acids and their corresponding sulfur atoms) cannot precipitate in the urine. it is hypothesized that a glucose molecule may be able to do this if introduced into the urine. sglt-2 inhibitors are a class of drug that are fda approved to treat diabetes mellitus (dm) and heart failure by inhibiting an enzyme in the kidney that allows for reabsorption of glucose from the urine. this effectively increases the concentration of glucose in the urine. our hypothesis suggests that administration of this drug to patients with cystine will introduce sufficient glucose into the urine to prevent the formation of cystine stones. to date, there has been no published data on the effectiveness of this therapy for this indication, although the dosage and administration would be identical to that already approved by the fda for the treatment of dm and heart failure.

this is a single center, proof of concept prospective cohort trial designed to assess the effect of daily oral administration of dapagliflozin on cystine formation in freshly voided urine. five subjects are planned, each with previously diagnosed cystinuria and without current treatment except with potassium citrate medication. total duration of subject participation with be up to four weeks. total duration of the study is expected to be 6 months.

Eligibility criteria:
inclusion criteria: * males and females age 18 or older * documented cystinuria on prior 24-hour urine collection and/or stone analysis * history of previous cystine kidney stones * able and willing to provide consent exclusion criteria: * prior diagnosis of diabetes mellitus (type i or type ii) * current sglt-2 inhibitor administration at the time of screening * sglt-2 inhibitor administration within the last year prior to screening * vulnerable populations including incarceration status * anticipation of pregnancy during the study duration * unable to give informed consent * non-english primary language * pregnancy, lactation, or child- bearing age without birth control devices * serious illness likely to cause death within the next 5 years.
sodium imbalance in traumatic brain injury patients: prevalence, predictors and prognostic significance in a tertiary care centre

Conditions: Sodium Imbalance in Traumatic Brain Injury

Summary: observational study about prevalence, predictors of sodium imbalance and prognostic significance.


Eligibility criteria:
inclusion criteria: * adult and paediatric patients with isolated head injury exclusion criteria: * age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma