Kornimate/medical-research-clean huggingface dataset:
diet and stool metabolites in fecal incontinence

Conditions: Fecal Incontinence

Summary: fecal incontinence (fi) is a debilitating and common condition with a prevalence ranging from 7-15% in community dwelling women. fi has an immense impact on quality of life and is associated with increased care giver burden, increased rates of institutionalization, and significant cost burden in older women. traditionally believed to be primarily caused by child birth injury, recent studies show that the typical age of onset of fi is age 40 which is remote from child birth. treatment options for fi are limited because the mechanism underlying fi in older women are poorly understood. the overriding goal of this project is to investigate the relationship between diet, stool metabolites and fecal incontinence.


Eligibility criteria:
inclusion criteria: * age greater than 18, * parous women with fecal incontinence (defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment), * current negative colon cancer screening exclusion criteria: * current bloody diarrhea, * current or past diagnosis of colorectal or anal malignancy, * diagnosis of inflammatory bowel disease, * recent antibiotic treatment, * history of immune deficiency diseases, * history of recent treatment with immune suppressant medications.

Keywords: fecal incontinence diet nutrition metabolites stool fi
comparison of early versus delay reconstruction in anterior cruciate ligament tearing

Conditions: Anterior Cruciate Ligament Tear

Summary: the purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.

the anterior cruciate ligament (acl) is one of the most commonly injured ligaments of the knee. this study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.

Eligibility criteria:
inclusion criteria: a. patients with confirmed anterior cruciate ligament tearing exclusion criteria: one of the following associated injuries to the index knee as visualized on mri and/or arthroscopy: 1. an unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited rom) interferes with the rehabilitation protocol 2. bi-compartmental extensive meniscus resections 3. a cartilage injury representing a full thickness loss down to bone 4. a total rupture of mcl/lcl as visualized on mri

Keywords: anterior cruciate ligament,early,delay,reconstruction
one-year cardiac follow-up of patients with covid-19 pneumonia

Conditions: Covid19; Cardiac Complication

Summary: the primary objective of the study is to assess the cardiac status of covid-19 pneumonia patients during 1 year after discharge

although covid-19 manifests in most cases with respiratory symptoms, cardiovascular abnormalities is common in hospitalized patients. patients with cardiovascular risk factors or established disease appear to have a worse prognosis. myocardial dysfunction could be a direct manifestation of covid-19. the investigators hypothesize that subjects after covid-19 pneumonia present myocardial and vascular remodeling during 1 year after discharge, even in the absence of prior cardiovascular disease.

Eligibility criteria:
inclusion criteria: -patients with documented covid-19 pneumonia exclusion criteria: * patients with cancer * impossible to follow up

Keywords: covid19 cardiovascular disease echocardiography
an open label, study of the systemic exposure to articaine after topical ocular dosing of ag-920

Conditions: Healthy

Summary: this is a phase 1, open-label, non-comparative study in healthy subjects performed in the us. it is designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of ag-920 in the randomized study eye.

this is a phase 1, open-label, non-comparative study in healthy subjects designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of ag-920 in the randomized study eye. in this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will receive a single dose of study drug in one eye. the study eye will be randomized. the single dose will be administered by the clinic staff as two drops 30 seconds apart in study eye. subjects will have pharmacokinetic (pk) blood samples taken at multiple periods over 24 hours following dosing. safety will be assessed by monitoring any changes in heart rate, blood pressure, intraocular pressure, visual acuity, biomicroscopy, and aes. the study will consist of 3 clinical visits: screening visit, dosing and pk blood level sampling (0-8 hours) visit and a follow up visit (with pk blood level sampling 24 hours after study drug treatment).

Eligibility criteria:
key inclusion criteria: 1. voluntarily provide written informed consent prior to any study-related procedures being performed. 2. female subjects of childbearing potential must have negative pregnancy test. 3. certified as healthy by clinical assessment. 4. have an early treatment of diabetic retinopathy study best corrected visual acuity of 20/200 or better in each eye. 5. have an intraocular pressure between 7 and 30 mmhg inclusive. 6. are able to tolerate instillation of over-the-counter artificial tear product . 7. blood pressure \< 140/90 mmhg and heart rate \< 100 bpm at screening. key exclusion criteria: 1. have previously received ag-920. 2. have a contraindication to local anesthetics. 3. have had ocular surgery or general surgery within the past 90 days. 4. have had an intravitreal injection in either eye within 14 days of treatment. 5. have a history within the last year of or current ocular surface disease or nasolacrimal duct abnormalities including obstructions or requiring punctal plugs. 6. have evidence of any current ocular inflammation. 7. have a known current condition which could cause vision problems. 8. current ocular allergy symptoms. 9. have donated or lost more than 400 ml of blood within 12 weeks. 10. plasma donation within 7 days prior to the first dosing.

Keywords: articaine ag-920
arixtra local study for registration in china.

Conditions: Thromboembolism; Knee Replacement; Hip Replacement

Summary: this is a local registration study in china to compare the safety and efficacy of arixtra to enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.


Eligibility criteria:
inclusion criteria: * patients undergoing either an elective major hip or knee replacement or revision. * signed written informed consent. men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child. exclusion criteria: * history of serious active bleeding in last 3 month * concurrent or history of thrombocytopenia ( platelet\< 100x109/l) * history of hypersensitivity reaction to heparin, low molecular weight heparin or pork product * acute bacterial endocarditis * congenital or acquired bleeding disease in last 3 months * concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia * concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye * conditions need to leave a tubule in intradural or extradural * contraindication to anticoagulant or condition required to take long term oral anticoagulant * abnormality in hepatic (\>1.5x unl), renal (clcr \< 30ml/min) or cardiac function, uncontrolled hypertension or tumor concurrent disorder of blood vessel in lower limb * positive result in human chorionic gonadotropin test participated in any other investigational study on deep vein thrombosis prevention in last 90 days. * concurrently to have hip and knee or double hip/knee replacement at the same time

Keywords: arixtra prevention of dvt
osteopathic otitis media research study

Conditions: Otitis Media With Effusion

Summary: the purpose of this study is to determine if the application of osteopathic manipulative medicine speeds the rate of resolution of middle ear effusion (fluid) in children following an episode of acute otitis media.

acute otitis media is a significant world wide problem commonly affecting children between 6 and 18 months, and is the most frequent reason for childhood illness visits to a physician in the us. by three years of age, 50-70% of children will have had one episode, while one-third will have had more than three. persistence of middle ear effusion following an episode of acute otitis media is thought to predispose the child to recurrent infection. the standard care for recurrent acute otitis media includes long term antibiotic prophylaxis and surgery. the risks of standard care are recognized, and alternative means of treating acute disease and preventing recurrent otitis media are needed. for over a century, osteopathic physicians have reported favorable clinical outcomes in children treated with osteopathic manipulative medicine (omm) in addition to standard medical care. to determine if a standardized omm protocol will reduce the duration of middle ear effusion (mee) after onset of acute otitis media, we outline a prospective, randomized, blinded, multi-center efficacy study of children ages six months to two years with a single episode of acute otitis media. subjects will be randomized into one of two treatment groups: standard care plus omm and standard care only. subjects will be followed for one month to determine rate of resolution of middle ear effusion following onset of the acute otitis media. statistical analysis will determine any differences between subjects in the two treatment groups.

Eligibility criteria:
inclusion criteria: * age 6 months up to second birthday * documented presence of acute otitis media following the 2004 aap/aafp guidelines within 3 days of entry into the study exclusion criteria: * chromosomal abnormalities * major congenital malformations of the head and neck, including torticollis * immunologic abnormalities or deficiencies * any prior ear-nose-throat surgery performed as a treatment for otitis media * any tube placement surgery scheduled during the four weeks of the study. * normal tympanograms at entry into study

Keywords: otitis media effusion omm omt resolution
neoadjuvant toripalimab in combination with gemcitabine therapy in cisplatin ineligible local advanved bladder cancer

Conditions: Urothelial Carcinoma; Bladder Cancer

Summary: this is a pre-surgical study involving subjects with muscle invasive bladder urothelial cancer, who are candidates for cisplatin ineligible neoadjuvant therapy. it is a one-arm phase ii study in single center.


Eligibility criteria:
inclusion criteria: * be willing and able to provide written informed consent for the trial. * 18-75 years of age on day of signing informed consent. * have histologically confirmed muscle invasive disease of the urinary bladder. * histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features. * clinical stage ii-iiib and have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy. * ecog 0-1 and good organ function. * cisplatin ineligible. exclusion criteria: * a non-surgical approach recommended by the treating urologist due to any reason. * is currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration. * has a diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. * has a known additional malignancy that is progressing or required treatment ≤ 48 months of study registration. exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer. * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * has an active autoimmune disease requiring systemic treatment. * has known evidence of interstitial lung disease or active, non-infectious pneumonitis. * has an active infection requiring systemic therapy. * has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * has received prior therapy with an anti-pd-1, anti-pd-l1, antibody. * has a known history of human immunodeficiency virus. * has known active hepatitis b or hepatitis c.

Keywords: toripalimab neoadjuvant therapy
ucp (ultrasound cyclo plasty) in the treatment of chinese patients with primary open-angle glaucoma

Conditions: Glaucoma; Glaucoma, Primary Open Angle

Summary: traditional ciliary body photocoagulation treatment uses the photocoagulation of long-wavelength laser to destroy the ciliary body tissue that can produce aqueous humor. therefore, it is a kind of palliative treatment which has proved efficacy but causes great pain to patients. the "ultrasonic glaucoma treatment instrument" produced by french eye tech care company is referred to as eyeop1. it uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. eyeop1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast.

1. efficacy: 1. main objective: (1)assess the decrease in postoperative intraocular pressure from baseline and evaluate the final results (the percentage of patients whose conditions have significant improved and the variation of the percentage of median intraocular pressure. (2)assess the amount of medication after surgery. 2. secondary goals:(1) compare median intraocular pressure with baseline at each postoperative follow-up and access the variation of median intraocular pressure from baseline at each postoperative follow-up. (2) count the number of intraocular pressure lowering drugs at each postoperative follow-up. b.safety: investigate the incidence of all device-related(or procedure-related) adverse events during the study (intraoperative and postoperative follow-up).

Eligibility criteria:
inclusion criteria: * the target eye was diagnosed as primary open-angle glaucoma; diagnostic criteria: iop(intraocular pressure)≥ 21, open angle, typical glaucoma visual field and optic disc damage; * patients treated with glaucoma medications cannot control intraocular pressure effectively; * patients with 21mmhg ≤ iop ≤ 30mmhg; * va(visual acuity)≥hm(hand motions); * patients that have failed conventional glaucoma surgery (trabeculectomy) or are not suitable for surgery; * patients who have not received intraocular surgery or laser treatment 90 days before receiving hifu; * aged from 18 to 90 years old; * sign informed consent and be willing to provide visit data; exclusion criteria: * either eye have any infections two weeks before the surgery; * the target eye has history of ciliary surgery, intraocular or retrobulbar tumor; * the target eye is neovascular glaucoma; * the target eye is aphakic eye; * anterior anatomical abnormalities cause scleral expansion or ciliary body ectopic; * non-glaucoma intraocular diseases that affect intraocular pressure; * within 30 days, the patient participated in or was simultaneously included in other clinical trials; * patients during pregnancy or lactation; * any systemic disease that may affect patient follow-up.

Keywords: primary open-angle glaucoma ucp(ultrasound cyclo plasty) efficacy and safety
easytrak 3 downsize lead

Conditions: Heart Failure

Summary: the primary objective of this clinical investigation is to evaluate the safety and effectiveness of the easytrak 3 downsize lead.

this is a prospective, non-randomized, multi-center us clinical investigation, designed to demonstrate the safety and effectiveness of the guidant easytrak 3 downsize lead in humans.

Eligibility criteria:
inclusion criteria: * must be indicated for a guidant crt-p or crt-d device * creatinine \< 2.5 mg/dl obtained no more than two weeks prior to enrollment * age 18 or above, or of legal age to give informed consent specific to state and national law * willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol * geographically stable residents who are available for follow-up exclusion criteria: * have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate * have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement * have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads) * currently requiring dialysis * have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment * have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis) * documented life expectancy of less than six months or expected to undergo heart transplant within the next six months * enrolled or participating in any concurrent study, including drug investigations, without guidant written approval, that may confound the results of this study * have a pre-existing unipolar pacemaker that will not be explanted/abandoned * have a mechanical tricuspid heart valve * women who are pregnant or plan to become pregnant. note: women of childbearing potential must have a negative pregnancy test within seven days of enrollment.

Keywords: left ventricular lead pacing heart failure
effects of huperzine a on presbycusis(δ,khz, db,mmse, ad)

Conditions: Presbycusis; Tinnitus; Cognitive Impairment

Summary: to investigate the effects of huperzine a on tinnitus suppression, hearing and cognitive function protection in patients with presbycusis-related subjective tinnitus and cognitive impairment.

this study is a randomized, controlled trial. 60 eligible participants in total will be recruited. participants in each group will be evenly and randomly assigned to the huperzine a subgroup and control subgroup using simple randomization method. participants in the treatment subgroup will receive huperzine a (a dose of 0.2 mg/time, 2 times/day) with basic treatment and health education(bthe), and those in the control subgroup will receive bthe only. the primary outcome (auditory function) and secondary outcomes (tinnitus, cognitive symptom and quality of life) will be evaluated at baseline, 3-, 6-, 12-month follow-up.

Eligibility criteria:
inclusion criteria: (1) 60 to 85 years old; (2) mild-to-moderate sensorineural hearing loss (the pure tone averaged across octave frequencies between 0.25 to 4khz of 26-70 db hl), with subjective tinnitus, subjective cognitive decline or mild cognitive impairment; (3) able to tolerate huperzine a treatment; (4) more than 3 months' experience of constant tinnitus; (5) tinnitus handicap inventory score values \>10; (6) no participation in any other clinical trial in the past 3 months; (7) able to accomplish relevant tests and follow-up. exclusion criteria: (1) conductive hearing loss; (2) current (3+ months) hearing aid(s) user; (3) dependence due to poor physical activity; (4) allergic to huperzine a; (5) history of malignancy within 5 years or other serious medical conditions before screening, including severe bradycardia, hypotension, angina, asthma, ileus, renal insufficiency, neurological diseases (e.g. epilepsy), psychiatric disorder (e.g. schizophrenia, severe depression and anxiety); (6) acute brain trauma and stroke within 2 weeks; (7) history of general pain disorder and the use of pain relief drugs on a regular basis; (8) patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before investigation starts. (9) individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices. (10) ongoing serious life event; (11) vision impairment.

Keywords: presbycusis tinnitus cognitive impairment huperzine a age-related hearing impairment
long-term study of safety and efficacy of roflumilast in japanese patients with bronchial asthma (20 to 71 y) (apta-2217-07)

Conditions: Bronchial Asthma

Summary: the aim of this long-term study is to investigate the effect of roflumilast (apta-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study apta-2217-05. roflumilast will be administered orally once daily. the present study consists of a 28 weeks treatment period, and is the extension of the 24-week study apta-2217-05 (registered study). the study will provide further long-term safety and efficacy data of roflumilast.


Eligibility criteria:
main inclusion criteria: * patients with asthma disease * written informed consent * patients who completed the 24-week evaluation of study apta-2217-05 main exclusion criteria: * % fev1.0 \< 60% at both 18 weeks and 24 weeks measurements during apta-2217-05 * patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, pef value worsened for 2 or more consecutive days * serious diseases

Keywords: asthma roflumilast phosphodiesterase 4 inhibitor