Kornimate/medical-research-clean huggingface dataset:
evaluating and comparing the safety and efficiency of asc09/ritonavir and lopinavir/ritonavir for novel coronavirus infection

Conditions: 2019-nCoV

Summary: base on arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of asc09 /ritonavir and lopinavir/ritonavir in patients with 2019-ncov pneumonia.


Eligibility criteria:
inclusion criteria: * 1. aged between 18 and 75 years, extremes included, male or female * 2. laboratory (rt-pcr) and clinical symptoms confirmed case of 2019-ncov pneumonia, according to the official guideline "pneumonia diagnosis and treatment scheme for novel coronavirus infection (trial version 5)" * 3. hospitalised with a new onset respiratory illness (≤7 days since illness onset) * 4. no family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose * 5. must agree not to enroll in another study of an investigational agent prior to completion of day 30 of study * 6. informed consent form (icf) signed voluntarily exclusion criteria: * 1. severe 2019-ncov pneumonia met one of the following criteria: respiratory distress, rr ≥ 30 times / min, or sao2 / spo2 ≤ 93% in resting state, or arterial partial pressure of oxygen (pao2) /concentration of oxygen (fio2) ≤ 300mmhg (1mmhg = 0.133kpa) * 2. critical severe 2019-ncov pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required icu monitoring treatment * 3. severe liver disease (e.g. child pugh score ≥ c, ast \> 5 times upper limit) * 4. known allergic reaction to any of components of asc09 / ritonavir compound tablets * 5. patients with definite contraindications in the label of ritonavir * 6. positive serum pregnancy test result for women with childbearing potential at screening * 7. using hiv protease inhibitor drugs * 8. not suitable for the study, in the opinion of the investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)
" sweeper " and epiretinal membrane surgery

Conditions: Epiretinal Membrane

Summary: epiretinal membrane (erm) is a pathological phenomenon requiring surgery when vision is altered. erm surgery requires erm peeling, then active internal limiting membrane (ilm) peeling if it is not spontaneously peeled with erm. initiation of peeling is very delicate and can lead to micro scotoma when realized with microscopic forceps. the sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. it may reduce retinal trauma and visual sequelae. purpose of our study is to evaluate use of sweeper during 20 erm surgeries. the investigator will compare microperimetry before surgery versus those after 1 month (m1) and 3 months (m3), and measure difference of number and depths of micro scotoma. the investigator will note: number of forceps uses if sweeper is inefficient and all areas of sweeper use to correlate them with micro scotoma. the investigator will evaluate visual and optical coherence tomography improvement after surgery.

epiretinal membrane (erm) is a pathological phenomenon that leads to visual loss, visual distortions, central scotoma, and diplopia. no medical treatment is yet available. erm surgery requires separation of normal retina and epiretinal membrane. after epiretinal peeling, if internal limiting membrane (ilm) is not spontaneously peeled with erm, surgeon peels ilm from retina (also named active peeling). initiation of peeling is very accurate and delicate. either microscopic forceps or sweeper are used to initiate peeling. sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. it may reduce retinal trauma and visual sequelae. ilm active peeling reduces recurrence of erm and rate of repeat surgery. no visual acuity loss has been found. but 2 studies show increase of micro scotoma at micro-perimetry after active ilm peeling with forceps. purpose of our study is to evaluate use of sweeper during 20 erm surgeries. the investigator will compare microperimetry before surgery versus those after 1 month (m1) and 3 months (m3), and measure difference of number and depths of micro scotoma. the investigator will note: number of forceps uses if sweeper is inefficient, all areas of sweeper use to correlate them with micro scotoma. the investigator will evaluate visual and optical coherence tomography improvement after surgery. our study doesn't include any intervention while surgeries would be realized with or without study participation. examinations are non-invasive, usual, and done during usual medical visit without additional visit.

Eligibility criteria:
inclusion criteria: * consent, * adult patient, * epiretinal membrane exclusion criteria: * perimetry impossible

Keywords: epiretinal membrane, sweeper, forceps, microperimetry
treatment of crohn's fistula using a porcine intestine submucosa graft

Conditions: Anal Fistula; Crohn's Disease

Summary: healing anal fistulas in crohn's patients with an anal fistula plug.

the purpose of this study is to determine whether the surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with crohn's disease.

Eligibility criteria:
inclusion criteria: * patient is diagnosed with crohn's disease * patient has a chronically draining anal fistula of crohn's origin * patient is 18 years old or older * patient has signed an informed consent exclusion criteria: * patient is pregnant or lactating * patient has peri-anal drainage with originates from outside the anorectal tract

Keywords: anal fistula fistula in ano anorectal fistula crohn's disease
long-term follow-up study of hiv-1 infected adults who received ebt-101

Conditions: HIV-1-infection

Summary: participants who receive ebt-101 in a parent protocol will be eligible to participate in this long-term follow-up (ltfu) study (ebt-101-002).

participants who receive ebt-101 in a parent protocol will be eligible to participate in this ltfu study (ebt-101-002). all participants will have follow-up visits every six months until year 5 post ebt-101. thereafter, all participants will have follow-up visits annually on the anniversary of ebt-101 administration until study completion at year 15.

Eligibility criteria:
inclusion criteria: * willing and able to provide written, signed informed consent * participants who received the investigational study intervention ebt-101 in a parent study exclusion criteria: • participants who did not receive ebt-101 in a parent study

Keywords: crispr gene therapy adeno-associated virus serotype 9 (aav9)
medical yoga for patients with stress-related symptoms and diagnoses

Conditions: Stress; Anxiety; Depression

Summary: background an increasing number of patients are suffering from stress-related symptoms and diseases. no scientific studies have examined the effects of medical yoga on stress-related symptoms in patients in primary care. the purpose of this study was to evaluate medical yoga treatment in patients with stress-related symptoms and diagnosis in primary health care. methods a randomized, controlled study was performed at a primary health care centre in sweden from march to june 2011. patients were randomly allocated to a control group receiving standard care, or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. a total of 37 men and women, mean age 53±12 years, seeking care for stress-related symptoms at the primary health care centre were included and followed up after the 12-week study period. general stress level (measured using perceived stress scale (pss)), burnout (shirom-melamed burnout questionnaire (smbq)), anxiety and depression (hospital anxiety and depression scale (hads)), insomnia severity (insomnia severity index (isi)), pain (visual analogue scale (vas)) and overall health status (euro quality of life-vas (eq-vas)) were measured before and after 12 weeks.

main outcome: the perceived stress scale is a 10-item self report questionnaire that measures persons' evaluation of the stressfulness of the situations in the past month of their lives. the citation for the 10-item scale is cohen, s., \& williamson, g. (1988). perceived stress in a probability sample of the united states. in s. spacapan \& s. oskamp (eds.). the perceived stress scale is the only empirically established index of general stress appraisal. "the pss measures the degree to which situations in one's life are appraised as stressful" (cohen, et al., 1983; p. 385). pss-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. items 4,5, 7, and 8 are the positively stated items. scores can range from 0 to 40, with higher scores indicating greater stress. the pss is not a diagnostic instrument, so there are no cut-offs. there are only comparisons between people in a given sample. there are some normative data on the pss based on a 1983 harris poll of a representative u.s. sample. these data may be helpful in providing comparisons, but they are over 20 years old. see: cohen, s., \& williamson, g. (1988).

Eligibility criteria:
inclusion criteria: * the patients had sought treatment at the primary health centre during the previous 6 months. * the stress-related symptoms included fatigue, insomnia, anxiety, depression, hypertension, and musculoskeletal discomfort in the neck and shoulders. exclusion criteria: * inability to understand instructions, interpretation needs or physical or mental inability to carry out the medical yoga exercises, such as mental retardation or dementia, and severe physical or mental illness.

Keywords: stress anxiety depression quality of life
measurement of gastric band stoma diameter

Conditions: Obesity

Summary: the purpose of this study is to correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment. administration of a barium tablet to gastric band patients with dilute liquid barium allows the accurate measurement of the band stoma diameter. the technique is quick, easy to perform, and eliminates magnification error intrinsic to fluoroscopy. the study data suggests the optimal calibrated gastric band stoma diameter is 3.0 mm. the accurate fluoroscopic measurement of gastric band stoma diameter can optimize band stoma adjustment and improve patient outcomes.

ten patients presenting for an upper gi series with laparoscopically placed gastric bands were enrolled after informed consent. after a standard upper gi evaluation, oral administration of a standard 13 mm barium sulfate tablet was performed and swallowed with dilute liquid barium during fluoroscopic monitoring. a spot radiograph was obtained once the barium tablet was in the gastric pouch and the dilute liquid barium was passing through the gastric band stoma. post-processing software used the longest radiographic dimension of the 13 mm barium tablet as the size reference to calibrate measurement of the gastric band stoma diameter.

Eligibility criteria:
inclusion criteria: * eating * s/p lap band placement exclusion criteria: * immediately post operative * s/p lap band placement * significant abnormality found on preceding standard upper gi series

Keywords: laparoscopic gastric band lap band system
new diagnostic tools in the evaluation of the posterior compartment of the women pelvic floor

Conditions: Anal Incontinence; Obstructive Defecation

Summary: the goal of this observational study is to evaluate the pressure and distensibility index of the anal sphincter complex using high-definition anorectal manometry and the impedance planimetry system in women with fecal incontinence or constipation, as well as in a group of healthy volunteer women. the main questions it aims to answer are: assess the diagnostic accuracy of the impedance planimetry system compared to high-definition anorectal manometry (hd-arm) in patients with anal incontinence and obstructive defecation. evaluate the diagnostic accuracy of three-dimensional reconstruction of the anal sphincter complex using hd-arm to identify anal sphincter complex lesions compared to pelvic floor ultrasonography. determine the impact on the quality of life in women with anal incontinence and obstructive defecation based on the severity of symptoms assessed by validated scales participants will undergo the following tasks: undergo high-definition anorectal manometry and impedance planimetry testing. undergo pelvic floor ultrasonography to assess structural and functional aspects complete validated scales to assess symptoms and quality of life related to anal incontinence and obstructive defecation.


Eligibility criteria:
inclusion criteria: * anal incontinence group: women over 18 years old with predominantly fecal incontinence symptoms (st mark \> 6 points) and without constipation (kess score \< 10 points) * obstructive defecation group: women over 18 years old with constipation symptoms and obstructive defecation (kess score ≥ 10 points) and without fecal incontinence symptoms (st mark \< 1 point). * control group (healthy volunteers): women over 18 years old without fecal incontinence (st mark \< 1 point) or constipation (kess score \< 10 points). exclusion criteria: * anal incontinence and obstructive defecation groups: presence of anorectal tumors, ileo-anal/rectal anastomosis, previous anorectal surgeries (except primary repair of obstetric anal sphincter injury), anal stenosis, anal fistula, anal fissure, previous pelvic radiotherapy, use of opioids except loperamide, and history of inflammatory bowel disease (ibd). * control group (healthy volunteers): exclusion criteria are the same as for the patients groups and also include any volunteer with a history of systemic sclerosis, diabetes affecting target organs or insulin dependence, neurological conditions (stroke, multiple sclerosis, spinal cord injury, cauda equina syndrome, polyneuropathies), and history of pelvic floor disorder.

Keywords: impedance planimetry high definition anorectal manometry
the routt-b (reduce over-utilized tests and treatments in bronchiolitis) study

Conditions: Bronchiolitis

Summary: over-testing and over-treatment costs the us healthcare system hundreds of billions of dollars a year, and has measurable negative impacts on patients' physical, emotional, and financial health making it a significant public health concern. the proposed research will advance "de-implementation" science by identifying processes and strategies to stop or reduce over-testing and over-treatment that can be broadly adapted to varied contexts and disease processes to improve the delivery of guideline concordant, evidence-based care and improve patient outcomes.

the overarching goal of this proposal is to use bronchiolitis as a case study to advance the science of de-implementation by identifying strategies and processes for reducing over-testing and over-treatment in bronchiolitis that can later be broadly adapted to varied contexts and disease processes. the challenge in bronchiolitis is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements. therefore, bronchiolitis which is the most common cause of hospitalization among infants, is an ideal condition to study de-implementation. in her set of projects, dr. tyler proposes the innovative application of dissemination and implementation (d\&i) science to the unique problem of de-implementation. within a learning health system called pedsnet, dr. tyler will use the prism d\&i model as a guide to: 1) use qualitative methods to define contextual factors influencing over-utilization in bronchiolitis from the perspective of healthcare providers, parents, and healthcare organizations, 2) develop a set of pragmatic, feasible, and effective de-implementation strategies for bronchiolitis that includes guidance on how to adapt the strategies to local contexts, and 3) conduct a pilot study to determine the feasibility, acceptability, and de-implementation effectiveness of the de-implementation strategies. as one of the first explorations of contextual factors fostering overuse or enabling successful de-implementation, this study is expected to generate valuable knowledge relevant to de- implementation across diseases and healthcare settings. the results will provide pilot data for a large-scale, pragmatic, randomized-controlled trial of the de-implementation strategies so that ineffective and potentially harmful medical practices are reduced.

Eligibility criteria:
inclusion criteria: * patients age 1-23 months seen at a participating site for bronchiolitis * providers at participating sites that see eligible patients (defined above) * parents who have an eligible child at participating study sites (parent interviews) exclusion criteria: * patients outside the age limits and do not have bronchiolitis * providers not at participating site * parents who do not have an eligible child at participating study site.
mage of anagliptin compared with sitagliptin with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: an exploratory study to evaluate the effect of improving glycemic variability of anagliptin compared with sitagliptin in patients with type 2 diabetes mellitus

this clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(bid) and sitagliptin 100 mg once a day(qd).

Eligibility criteria:
inclusion criteria: * type 2 dm * metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks. * 6.5% ≤hba1c\< 8.5% * agreed therapeutic lifestyle change during the study period * obtained informed consent form exclusion criteria: * type 1 diabetes mellitus, * history of intestinal obstruction * nyha class iii to iv congestive heart failure, * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 3 x upper limit of normal (uln) or total bilirubin \> 3 x uln * creatinine clearance (crcl)\* \< 50 ml/min * thyroid-stimulating hormone (tsh) ≥ 1.5 x uln * allergic history for anagliptin 또는 sitagliptin * being pregnant or nursing or suspected of being pregnant, or * history of participation in other clinical studies in the preceding 3 months.
personalized immune cell therapy targeting neoantigen of malignant solid tumors

Conditions: Carcinoma; Melanoma; Bladder Cancer; Colorectal Cancer

Summary: this single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized dc vaccine and their sensitized t cells in these solid cancers.


Eligibility criteria:
inclusion criteria: * age:18-75 years * pathologically diagnosed advanced (stage iv) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions; * failed in the previous standard therapy; * ecog ps (eastern cooperative oncology group performance status) score 0-2 points; * the estimated survival period is ≥3 months; * rehabilitate from previous therapy; * adequate organ functions; * patient's written informed consent; exclusion criteria: * tumor emergencies; * abnormal coagulation function; * contagious diseases, such as hiv, hbv, hcv infection; * mental disorders; * concomitant tumors; * immunological co-morbidities

Keywords: melanoma bladder cancer colorectal cancer tumor neo-antigen dc vaccine safety clinical efficacy
performance of inherited risk assessment for predicting prostate cancer from prostate biopsy

Conditions: Prostate Cancer

Summary: condition: prostate cancer intervention: biopsy and inherited risk assessment

inherited genetic changes, including rare pathogenic mutations (rpms) in several major genes and single nucleotide polymorphisms (snps)-based genetic risk scores (grs) have been consistently associated with prostate cancer (pca) risk. furthermore, results from retrospective analyses of two clinical trials (pcpt and reduce) and biopsy cohorts revealed caucasian men with higher grs are 1) more likely to have positive biopsy and 2) have higher number of positive biopsy cores. these findings suggest inherited risk assessment may have clinical utility in identifying men who have a higher likelihood of positive results from diagnostic prostate biopsy. the objective of this observational trial is to confirm the clinical utility of both rpms and grs in a prospective study of multi-racial patients. results from this trial will provide a critical piece of evidence for guideline committees to consider the adoption of inherited risk assessment in decision making for prostate biopsy.

Eligibility criteria:
inclusion criteria: * consecutive patients undergoing prostate biopsy for detection of prostate cancer * aged 40 to 69 years * four ethnicity groups (caucasian, african americans, east asians, latinos) * psa between 2.5-10 ng/ml exclusion criteria: * previous diagnosis of prostate cancer. * ethnicity outside the inclusion criterion (including mixed ethnicity). * any prior psa test result outside the range of inclusion criterion.

Keywords: prostate biopsy prostate cancer inherited risk assessment psa