Kornimate/medical-research-clean huggingface dataset:
fecal microbiota transplantation for the treatment of recurrent urinary tract infections

Conditions: Recurrent Urinary Tract Infection

Summary: recurrent urinary tract infections are quickly becoming a public health obstacle in our aging population. almost 50% of women have at least one urinary tract infection in their lifetime; following this first infection, there is a 25-35% chance that she will have another infection in the subsequent 3-6 months. with each documented infection, a patient receives anywhere from a three to seven day course of antibiotics for treatment. repeated courses of antibiotics often lead to the development of multi-drug resistant infections that are difficult to treat with our arsenal of oral medications. it is theorized that most, if not all, urinary tract infections are caused by bacteria from the gastrointestinal tract. if there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will likely be difficult to ever adequately treat repeat urinary tract infections. this same theory led to the development and utilization of fecal microbiota transplantation in the treatment of refractory clostridium difficile diarrhea. there are now several studies that have reported on the efficacy of fecal transplantation in the treatment of c.difficile infections as well as the correction of gut dysbiosis. given this positive response in treatment of refractory infectious diarrhea, the investigators propose that the correction of gut dysbiosis can also treat refractory recurrent urinary tract infections. therefore, the investigators propose this pilot study to determine the effectiveness of fecal transplantation in the treatment of refractory, recurrent urinary tract infections.


Eligibility criteria:
inclusion criteria: * english speaking * meet criteria for recurrent urinary tract infections a. each infection with bacterial colony count of greater than 100,000 and b. 2 culture proven urinary tract infections within the preceding 6 months or culture proven urinary tract infections within the preceding 12 months * failed conservative management of recurrent urinary tract infections a. completed 6-month trial of macrobid, trimethoprim or methenamine suppression or b. completed 6-week series of intravesical instillations with dmso or heparin/lidocaine exclusion criteria: * pregnant * managed with a colostomy * managed with a suprapubic catheter * known renal abscess * acute or chronic renal failure * cardiac disease * rectal prolapse or bleeding * colon surgery in preceding 12 months
the impact of paramedic training in simulation on the experience of patients treated for malignant brain tumors in neurosurgery (ipsimanon)

Conditions: Brain Tumor Adult

Summary: the goal of this clinical trial is to demonstrate that simulation training for paramedical staff in neurosurgery departments, in announcing and accompanying patients with a brain tumor, improves patient satisfaction when a (potentially malignant) brain tumor is discovered, compared with usual care. the main question it aims to answer is: - are patients more satisfied (as measured by scores on the eorct in-patsat32 questionnaire) with their neurosurgical hospitalization following the discovery of a brain tumor in centers where paramedics have been trained by simulation? researchers will compare the results of the eortc in-patsat32 questionnaire to determine whether paramedic training improves patient satisfaction between simulation-trained and untrained centers. participants will be asked to complete the eort in-patsat32 questionnaire at the end of their hospital stay.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * patient covered by a social security scheme * patient signed informed consent form * patient found to have a brain tumor (potentially malignant, primary or secondary if this is the mode of entry into the disease) * hospitalization in the neurosurgery department at the time of tumor discovery, before the histological diagnosis is announced. exclusion criteria: * patients with a personal history of cancer * patient without family and unable to receive information

Keywords: brain tumor simulation training paramedical neurosurgery
international prospective registry of disseminated intravascular coagulation

Conditions: Disseminated Intravascular Coagulation

Summary: objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (dic) in a large prospective registry. design: prospective, multicenter, international registry. study population: patients 18 years or older with severe infection to be potentially associated with dic will be eligible for the study. the clinical visits and monitoring of the patients will follow local routine practices. no specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. all the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis. study outcomes: the primary outcome of the study is the development of dic. secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days. study sample, feasibility, and analysis plan: we plan to enroll a minimum of 1000 patients.


Eligibility criteria:
inclusion criteria: * admission to the intensive care unit * 18 years or older and one of the following conditions: * sepsis/severe infection * solid tumor * hematological malignancy * trauma * obstetric complications * acute pancreatitis exclusion criteria: -\<18 years

Keywords: disseminated intravascular coagulation sepsis trauma pancreatitis malignancy obstetric complication
erwinase master treatment protocol

Conditions: Leukemia, Acute Lymphoblastic; Acute Lymphoid Leukemia

Summary: the purpose of this study is to make erwinase available to patients with acute lymphoblastic leukemia (all) who have had previous allergic reactions to certain formulations of l-asparaginase.


Eligibility criteria:
inclusion criteria: * patient must give written informed consent to receive erwinase. * patient must be treated for acute lymphoblastic leukemia. * patient must have either systemic hypersensitivity reactions to native (elspar) or pegylated e.coli asparaginase (oncaspar). this includes patients with generalized rash with or without anaphylactic symptoms, or patients with previously documented local or systemic reactions to e.coli derived l-asparaginase. exclusion criteria: * previous allergic reaction to erwinia l-asparaginase (erwinase) * previous acute pancreatitis * pregnant or lactating woman

Keywords: all
mobile health technology to enhance abstinence in smokers with schizophrenia

Conditions: Schizophrenia; Cigarette Smoking

Summary: this study is designed to evaluate if a treatment the investigators call icommit is effective at helping smokers with schizophrenia stop smoking. icommit is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.

the purpose of this 2-arm randomized controlled trial (rct) is to evaluate the efficacy of multi-component mobile-enhanced treatment for smoking cessation (icommit) in helping individuals with schizophrenia or other psychotic disorders stop smoking. eligible participants will be randomized to receive icommit, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. the control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects. the primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. self-reported prolonged abstinence will be verified by saliva cotinine assay. secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days.

Eligibility criteria:
inclusion criteria: * currently smoke at least ten cigarettes a day * have been smoking for at least one year * meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview * can speak and write fluent conversational english * are between 18 and 70 years of age * are willing to make a smoking cessation attempt * score 26 or higher on the montreal cognitive assessment exclusion criteria: * have a history of myocardial infarction in the past 6 months * have a contraindication to nrt with no medical clearance from the primary care provider or study physician * use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco * are pregnant * meet criteria for a current manic episode based on structured clinical interview * are currently enrolled in another smoking cessation trial * are currently imprisoned or in psychiatric hospitalization
a clinical study to evaluate the efficacy and safety of liv-gamma sn inj. in primary immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia

Summary: the main purpose of this study is to assess the efficacy and safety of liv-gamma sn inj. in adult subjects with itp. the primary objective of this study is to determine the responder rate. a response is defined as a platelet count of ≥30×10\^9/l and at least a 2 fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. the secondary objectives are to evaluate the further efficacy assessments including duration of response, and the safety of liv-gamma sn inj.


Eligibility criteria:
inclusion criteria: * diagnosis of itp * mean screening platelet count of \<30×10\^9/l from 3 qualifying platelet counts performed within 14 days before the start of treatment, with no individual platelet count above 35×10\^9/l. * no other factors inducing itp * stable doses of itp active treatment must not have modified the dose in the preceding 1 month and must maintain their prestudy dose during the study. exclusion criteria: * known for hypersensitivity reactions to blood products, intravenous immunoglobulin (ivig) or immunoglobulin g * immunoglobulin a (iga) deficiency * therapy with live attenuated virus vaccines 3 months before the first administration of liv-gamma sn inj. * administration of other investigational product 1 month before the first administration of liv-gamma sn inj. * administration of rituximab 3 months before the first administration of liv-gamma sn inj. * treatment with anti-coagulants, which may affect the function of platelet * positive hiv, hbv, hcv * 3-fold increase of alt or ast compared to normal upper limit * ecfr \< 30ml/min/1.73m\^2 * history of deep vein thrombosis (dvt) or ivig-induced thrombotic compliances * hemoglobin \> 10g/dl
no antimicrobial prophylaxis for laparoscopic distal gastrectomy

Conditions: Stomach Neoplasms

Summary: the aim of this study is to evaluate the feasibility and safety of no use of antimicrobial prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.

this is a phase ii clinical trial investigating the postoperative surgical site infection (ssi) rates after no antimicrobial prophylaxis use during laparoscopic distal gastrectomy. target ranges of ssi rates after laparoscopic distal gastrectomy were determined based on the previous reports and our data. if ssi rates are within the target range, the investigators will proceed to a randomized controlled trial investigating the efficacy of no antimicrobial use for laparoscopic gastrectomy.

Eligibility criteria:
inclusion criteria: * histologically proven gastric adenocarcinoma clinical stage t1-2n0m0 patients who underwent laparoscopic distal gastrectomy * age between 18 and 65 years * american society of anaesthesiologists (asa) status \>2 * eastern cooperative oncology group (ecog) performance status 0-1 * normal blood, liver, pulmonary, cardiac, and renal function * informed consent exclusion criteria: * administration of antibiotics within 1 month before surgery * active infection at the time of surgery * combined resection during operation (i.e., spleen, liver, colon, etc.) * history of upper abdominal surgery * previous chemotherapy or radiotherapy within 6 months before surgery * uncontrolled underlying comorbidities * malnutrition with bmi less than 18.5 kg/m2

Keywords: stomach neoplasms surgical site infection laparoscopic gastrectomy antimicrobial prophylaxis
difluprednate vs. a prednisolone acetate - phenylephrine on post-operative inflammation following cataract surgery.

Conditions: Cataract

Summary: this controlled, randomized, double blind, multicenter study will be carried out to demonstrate that the topical ophthalmic nanoemulsion of difluprednate 0.05% (tolf®, poen laboratories), has a high anti-inflammatory efficacy, which would allow it to be administered after cataract surgery 1 drop, twice a day , starting the day before surgery and continuing for 14 days and 1 drop, once a day for the following 2 weeks, achieving an adequate anti-inflammatory activity, with the benefit of reducing the toxicity on the ocular surface, improving the dosage and adherence to treatment. the follow-up time will be 28 days and the outcome measures will be evaluated in a baseline (time 0), on day 1, on day 4 and on day 28 after surgery. the active control will be prednisolone acetate 1% + phenylephrine hydrochloride 0.12% topical ophthalmic suspension (prednefrin® forte, allergan argentina) given 1 drop, 4 times a days and 1 drop, twice a day for the next 2 weeks. corneal thickness, central macula thickness, endothelial cell count, intraocular pressure, visual acuity, anterior chamber clearance and lacrimal film recovery will be evaluated.


Eligibility criteria:
inclusion criteria: * patients of both sexes between 45 and 65 years old (women who are not fertile) who undergo cataract surgery n2 and n3, defined according to bcn10, decimal classification of cataracts. * that the surgical technique is ultrasonic phacoemulsification. * patients who have an initial corneal thickness between 500 and 570 µm inclusive. * patients with initial intraocular pressure between 12 and 18 mm hg inclusive. * patients with an endothelial cell count greater than 1000 cells / mm2 exclusion criteria: * patients who use eye medication, except eye lubricant. * patients who before surgery have not been able to dilate their pupil more than 5 mm * patients who have been treated with corticosteroids or systemic anti-inflammatory drugs for 2 weeks prior to enrollment * patients who have received periocular corticosteroid injections in the study eye within the previous 4 weeks or used depot corticosteroids within 2 months prior to enrollment * patients who have received a topical ocular corticosteroid or non-steroidal anti-inflammatory drug (nsaid) within 24 hours prior to enrollment * history of glaucoma or ocular hypertension in the study eye, history or presence of endogenous uveitis, or corneal abrasion or ulceration * patients with a diagnosis or suspicion of keratoconjunctival disease caused by viruses, bacteria, or fungi * patients which presents an allergy to the drug to be tested or to any similar drug such as other corticosteroids * history of increased intraocular pressure due to the use of corticosteroids * patients with pathological macular features * diabetics * breastfeeding women * patients with rheumatoid arthritis. * patients treated with amiodarone
a phase i/iia study of jab-23e73 in patients with advanced solid tumors harboring kras gene alteration

Conditions: Advanced Solid Tumor

Summary: this is a multicenter, open-label, phase i/iia to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics, and preliminary antitumor activity of jab-23e73 in patients with advanced solid tumors harboring kras mutations or amplification. the study consists of 2 phases: phase 1 dose escalation and phase iia dose expansion.


Eligibility criteria:
inclusion criteria: 1. histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of kras gene alteration (including gene mutation and wild type amplification). 2. able to provide an archived tumor tissue sample or fresh biopsy sample. 3. life expectancy ≥3 months at the start of treatment. 4. eastern cooperative oncology group (ecog) performance status of 0 or 1. 5. ≥1 measurable lesion per recist v1.1. 6. adequate organ function. exclusion criteria: 1. unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication. 2. previous treatment with rat sarcoma (ras) targeting agents. 3. symptomatic, untreated, or actively progressing known central nervous system (cns) metastases. 4. impaired cardiovascular function or clinically significant cardiac disease. 5. mean qt interval corrected using fridericia's formula (qtcf) \>470 msec. 6. females who are pregnant or breastfeeding.
bronchial colonization with fungi and late respiratory acquired pneumonia

Conditions: Ventilator Acquired Pneumonia

Summary: ventilator acquired pneumonia (vap) are severe nosocomial infections. on the other side, bronchial fungi colonization is commonly observed in icu; therefore, the investigators propose to study the role of bronchial fungi colonization on the occurrence of vap taking into account the immune status of the patient and the antibiotic and antifungal treatments he has received.


Eligibility criteria:
inclusion criteria: * patient ventilated for at least 5 days exclusion criteria: * invasive infection candida sp defined by : candidemia, isolation of candida from a normally sterile site, candida pneumoniae.

Keywords: patient ventilated for at least five days
multi-dose, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ddo-3055 tablets in healthy subjects.

Conditions: Renal Anemia

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose ddo-3055 tablets in healthy subjects for 7 days.


Eligibility criteria:
inclusion criteria: 1. healthy volunteers aged 18-45 years; 2. male weight≥50kg, female weight≥45kg, and 19kg/m2≤bmi≤26kg/m2; 3. signed informed consent. exclusion criteria: 1. allergic constitution, suspected to be allergic to the study drug or any component in the study drug; 2. a value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: ast, alt, total bilirubin, direct bilirubin, indirect bilirubin ； 3. subjects with a value at screening is greater than the upper limit of reference range for serum creatinine; 4. subjects with a positive value of hbsag、hcv-ab、hiv-ab、tppa at screening； 5. subjects with blood loss ≥400ml within 3 months before screening; 6. subjects has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study. 7. participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing; 8. patients who had a positive blood pregnancy test and were breastfeeding at the time of screening. 9. smokers (average daily smoking 5 or more); subjects who consumed more than 15 grams of alcohol per day within one week prior to the screening; 10. drug abusers or drug urine screening positive; 11. the researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.
development of a personalised care plan designed to reduce chronic post-operative pain following breast surgery

Conditions: Persistent Post-surgical Pain; Neuropathic Pain; Cancer Pain

Summary: numerous surveys have shown that following breast surgery, longterm pain affects around half of patients. given that 1 in 9 women will get breast cancer and that surgery is the cornerstone of treatment, persistent pain represents a major challenge. in addition to the suffering chronic pain causes to individual patients, the investigators know that it places a substantial burden on families and carers, and that patients with pain represent an excessive demand on healthcare resources. this research will evaluate the impact of introducing a proactive, integrated care plan for patients having breast surgery. it will assess the effect of the care plan on reducing the number of patients with pain at 3 and 12 months after their procedure. the personalised plan involves numerous evidence based steps linked by a single unifying description aimed at controlling pain, before, during and after the procedure, in hospital and at home. patients at risk of developing pain will be identified prior to the procedure and randomly allocated to follow either the personalised care plan or to receive 'usual' care. in the personalised care plan group, participants will get information about chronic pain, be screened for pain and offered immediate treatment. during their procedure both the surgeon and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the likelihood of experiencing pain. after their procedure, patients will be again screened for pain and further treatment instigated. physiotherapists and other allied health professionals such as psychologists will also be involved as appropriate. a package of care for pain will then be passed on to the patients' gp, in the form of a written pain management plan, for ongoing care which will be linked to the hospital. patients from both groups will be followed up for a year at regular intervals.


Eligibility criteria:
inclusion criteria: * women aged 18 and over with breast cancer undergoing breast surgery at the royal marsden hospital. this includes mastectomy, wide local excision with axillary clearance, breast reconstruction surgery i.e diep flap, ld flap exclusion criteria: * previous thoracic surgery. * symptomatic angina pectoris. * renal impairment. * inability to read or to understand consent documentation. * patients undergoing the following surgery; lumpectomy, wide local excision, cosmetic procedures, any day-case breast surgery.

Keywords: persistent post-surgical pain breast surgery complex intervention pain treatment
ophthalmic manifestations of patients with mucopolysaccharidosis

Conditions: Ophthalmic Manifestations

Summary: mucopolysaccharidosis (mpss) are a group of disorders caused by inherited defects in lysosomal enzymes resulting in widespread intra- and extra-cellular accumulation of glycosaminoglycan(1,2). they have been subdivided according to enzyme defect and systemic manifestations and include mps ih (hurler)(3) , mps is (scheie), mps ih/s (hurler/sheie), mps ii(4,5) (hunter), mps iii (sanfilippo)(6) , mps iv (morquio)(7,8), mps vi (maroteaux-lamy)(9), mps vii (sly)(10,11) and mps ix (natowicz)(12). mucopolysaccharidosis have a spectrum of systemic manifestations, including airway and respiratory compromise, skeletal deformities, intellectual and neurological impairment, cardiac abnormalities, gastrointestinal problems and ocular manifestations(13). ocular manifestation are common in the mucopolysaccharidosis and may result in significant visual impairment(14). corneal opacification of varying severity is frequently seen, as well as retinopathy, optic nerve swelling and atrophy, ocular hypertension, and glaucoma(14). new treatment modalities for the systemic manifestations of the mucopolysaccharidosis include bone marrow transplant and enzyme replacement therapy have resulted in an improved prognosis in many cases(15).


Eligibility criteria:
inclusion criteria: * all patients at any age up to 18 years with any type of mps confirmed by the enzymatic assay exclusion criteria: * any patient other than mps