Kornimate/medical-research-clean huggingface dataset:
mucosal versus fecal microbiota in fmt

Conditions: Clostridium Difficile

Summary: clostridium difficile infection is the most common cause of antibiotic-associated diarrhea. treatment of this infection usually occurs using other antibiotics, but many individuals have persistent diarrhea and multiple relapses. fecal transplant (fmt), or intestinal microbiota transplantation, (imt) has been shown to be efficacious when administered after treatment for c. difficile. this study will involve taking biopsies from patients during their fmt/imt via colonoscopy, and determine if there are differences in the mucosal flora as compared to the stool flora. the investigators hope to discover the critical parts of a healthy microbiota.

a total of 20 subjects with at least one relapse of clostridium difficile infection undergoing intestinal microbiota transplantation via colonoscopy will be recruited in this study. the patients will produce a stool specimen at the time of colonoscopy and a biopsy will be obtained during the colonoscopy. at 2 weeks and 10 weeks, stool specimens and anoscopy will be collected to be tested for c. difficile polymerase chain reaction (pcr) and the fecal microbiota. subjects will be referred from all locations of emory healthcare.

Eligibility criteria:
inclusion criteria: * inpatient or outpatient adults, age ≥18 * have had at least 1 relapse of c. difficile * patients who have had previous fmt exclusion criteria: * pregnant or breastfeeding * critically or acutely ill (fever will be defined as a documented temperature \>37.8°c) * ileus or toxic megacolon * unable to give consent

Keywords: clostridium difficile intestinal microbiota transplantation diarrhea fecal microbiota transplant
extended retroperitoneal lymphadenectomy and nerve plexus clearance versus standard lymphadenectomy in pancreaticoduodenectomy

Conditions: Pancreaticoduodenectomy

Summary: this clinical trial is about the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.

the purpose of this clinical trial is for assessing the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma. and we will focus on the r0 resection using leepp(leeds pathology protocol) methods to check whether the tumor is eradicated or not.

Eligibility criteria:
inclusion criteria: * 18-70 years; karnofsky performance\>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form. exclusion criteria: * also have severe cardiopulmonary disease, autoimmune disease, chronic renal failure disease; recurrent pancreatic tumor or unresectable tumor; benign pancreatic tumor; also have other malignant tumors.

Keywords: extended retroperitoneal lymphadenectomy, nerve plexus clearance, survival benefit
to estimate the efficacy of treatment with tnfi as monotherapy or combination therapy with mtx and compare and contrast efficacy with tofacitinib as monotherapy and combination therapy in a real world setting.

Conditions: Rheumatoid Arthritis

Summary: to estimate the efficacy of treatment with tnfi as monotherapy or combination therapy with mtx and compare and contrast efficacy with tofacitinib as monotherapy and combination therapy in a real world setting.


Eligibility criteria:
inclusion criteria: * ra patients in corrona initiating a tnfi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in corrona with no prior use of tofacitinib exclusion criteria: * patients with no history of cdmard but history of 1+ biologics - these cases will be excluded from analyses * patients using combination therapy with a cdmard other than mtx will be excluded * patients using combination therapy of mtx and another cdmard will be excluded
comparison of self-collection using dry compared to wet swabs for hpv detection

Conditions: Human Papillomavirus Infection

Summary: this study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrhpv dna lbc as the reference standard.

self-collected vaginal samples for high-risk human papillomavirus (hrhpv) dna testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. dry transport of samples has the advantage of lower cost and ease of handling. evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (lmics). the effect of using dry swabs on hpv-dna detection in lmics needs to be determined. this study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrhpv dna using lbc and as reference standard.

Eligibility criteria:
inclusion criteria: inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site: * sexually active adult females ≥30 years of age (≥25 years of age if hiv+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy) * able to understand scope of study * able to provide written informed consent * willing to provide all necessary samples exclusion criteria: * vaccinated for hpv * pregnancy * patient not willing or unable to provide the all three swab samples (self-collected dry and wet and hcw collected cervical swabs)
use of prone position ventilation in danish patients with covid-19 induced severe ards treated with vv-ecmo

Conditions: ARDS, Human; Extracorporeal Membrane Oxygenation; COVID-19 Acute Respiratory Distress Syndrome; Prone Position; Adverse Event

Summary: prone position ventilation was used 220 times in 44 out of 68 patients with severe covid-19 induced ards treated with vv-ecmo. ppv treated patients did not benefit from ppv and the incidence of ppv related adverse events was high

purpose: to describe the use and effects of prone position ventilation (ppv) in patients with covid-19 induced adult respiratory distress syndrome (ards), treated with veno-venous extracorporeal membrane oxygenation (vv-ecmo). methods: nationwide retrospective analysis of all covid-19 patients in denmark from march 2020 - december 2021with severe ards and need of vv-ecmo treatment. data on the number of patients treated with ppv, number of ppv-events, timing, the time spent in prone position, physiological response types, adverse events and outcomes are reported.

Eligibility criteria:
inclusion criteria: patients with covid-19 induced severe ards accepted for and treated with vv-ecmo in denmark - exclusion criteria: * none

Keywords: ards vv-ecmo prone position ventilation adverse events
immunomodulatory effects of ivig on pregnancy rate of patient with recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss

Summary: miscarriage occurs in about 1-2% of human pregnancies and is one of the common pregnancy problems before 12 weeks of pregnancy. anatomical and chromosomal abnormalities, microbial factors and auto and alloimmune reactions have been speculated to attribute in recurrent miscarriage. unexplained recurrent miscarriage (urm) is defined as three or more repeated abortions, probably caused by maternal immunological rejection . given that maternal immune system encounters semi-allogeneic fetus, pregnancy outcome is associated with the interaction between maternal immune system and immuno-regulatory capability of the fetus. effectiveness of treatment approaches in rm patients has been controversial and remained to be discovered. immunomodulatory agents such as corticosteroids and allogeneic lymphocyte immunization showed variable success rates in rm patients. therapeutic effects of ivig in unexplained rm is controversial and most positive results were obtained from the trials in rm women with cellular immune abnormalities, such as increased nk cell level and/or cytotoxicity, and t cell abnormalities. previous studies have shown that the incidence of genetic abnormalities in children who have received immunosuppressive drugs such as ivig like normal people and normal society. in this study we used ivig at the time of positive pregnancy,400 mg/kg ivig was administered intravenously. following the first administration, ivig well given every 4 weeks through 32 weeks of gestation to suppress the immune system in patients with immunological causes of rpl and the results will be compared with a control group that did not receive any type of drug.


Eligibility criteria:
inclusion criteria: * enrolled patients will experience at least 3 times recurrent pregnancy loss. * patients dont have history of any type of immunotherapy. * patients must have abnormal nk cell or nk cell cytotoxicity or th1/th2 ratio exclusion criteria: - our criteria for exclusion of patients from the study include the following: * patients or their spouse has abnormal karyotype or chromosomal and genetically disorders. * patients who have bleeding problems. * patients who have chronic disorders those are forced to use the specific drug. * patients who have positive test for hiv, hcv or hbv infection. * patients who have a history of asthma and allergies. * patients who have uterus abnormalities.

Keywords: recurrent pregnancy loss ivig pregnancy rate
nutrition status of adults treated with pegvaliase

Conditions: Phenylketonurias

Summary: conduct a cross-sectional analysis of the nutritional status of individuals with pku treated with pegvaliase for one or more years or who have followed an unrestricted diet for 6 or more months while on pegvaliase treatment. we will evaluate laboratory markers of nutritional status, including markers of protein and micronutrient nutriture. in addition, a three-day food record and food frequency questionnaire will be obtained to assess protein intake and overall diet quality.


Eligibility criteria:
inclusion criteria: 1. diagnosis of phenylketonuria 2. aged 18-65 years 3. currently treated with pegvaliase 4. have either 1) received treatment with pegvaliase for one or more years or 2) followed an unrestricted diet for 6 or more months while on pegvaliase 5. currently following an unrestricted diet that meets or exceeds the rda for protein (0.8 g/kg/day) exclusion criteria: 1. unable to consent to study 2. under age 18 years or over age 65 3. routine food intake provides less than the rda for protein (0.8 g/kg/d) 4. consuming any pku medical foods
blood pressure lowering effects of amosartan regarding proviso in patients with high blood pressure

Conditions: Hypertension

Summary: blood pressure lowering effects of amosartan regarding proviso in patients with hypertension

after taking amozatan (ams, amlodipine / rozanthin combination) in patients with essential hypertension, the percentage of patients who reached the mean systolic target blood pressure was evaluated

Eligibility criteria:
inclusion criteria: * patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy * in patients with stage 2 hypertension (sbp 160-179 mmhg), patients requiring a combination therapy to reach the target blood pressure * patients who were changed to amosartan while using other hypertensive agents exclusion criteria: * patients with hypersensitivity to dihydropyridine derivatives of amosartan * women who are pregnant or who may be pregnant and breastfeeding * patients with severe hepatic dysfunction * patients with severe aortic stenosis * patients at risk of shock * patients participating in other clinical studies
effect of smoking, abstention and nicotine replacement therapy on wound healing

Conditions: Wound Healing

Summary: the aim was to determine the wound healing capacity in healthy never smokers and smokers who continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.

two wound healing models were applied: the excisional skin biopsy model to study wound histology and the suction blister model to study epidermal regeneration and skin transudate. in addition blood sampling was made to validate compliance to the study arms and to study systemic markers of collagen metabolism and oxidative stress. in addition, wound infections and wound ruptures were recorded post hoc as complications to the excisional skin biopsy model were not expected to occur.

Eligibility criteria:
inclusion criteria: * daily smokers smoking between 15-25 cigarettes per day and never smokers exclusion criteria: * chronic medical disease * atopic dermatitis or other skin disease * pregnancy * menopause * allergy to dressings or patches * current or recent medication with corticosteroids or nsaid
observational study to investigate the melatonin and cortisol circadian rhythms of individuals with smith-magenis syndrome (sms)

Conditions: Smith Magenis Syndrome

Summary: the purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes


Eligibility criteria:
inclusion criteria: * a confirmed clinical diagnosis of sms with a prior positive genetic test result as indicated by a parent/guardian * informed consent from the patient or the legal guardian/assent provided by the individual with sms, when possible * male or female between the ages of 6-50 years of age * history of sleep disturbances * willing and able to comply with study requirements and restrictions exclusion criteria: * failure to confirm diagnosis of sms by molecular cytogenetic methods and/or dna-based mutation analysis of the rai1 gene * totally blind with no light perception * institutionalized or living in an assisted living facility * unwilling or unable to follow medication restrictions (medications that affect sleep or melatonin secretion) or unwilling or unable to sufficiently wash-out from use of a restricted medication * any medical condition, as determined by the clinical investigator that would make it unsafe for blood draws (e.g., anemia, blood clotting disorders, anxiety, etc.) * any other sound medical reason as determined by the clinical investigator
phase i study of wx-037 alone and in combination with wx-554 in solid tumours

Conditions: Advanced Solid Tumours

Summary: the purpose of this study is to test the safety of escalating doses of the novel pi3k inhibitor wx-037 and to explore its effectiveness in combination with wx-554 which targets mitogen activated protein kinase (mek1 and mek2). preclinical evidence indicates that these two novel compounds could provide targeted inhibition of both pathways to block tumour growth.


Eligibility criteria:
inclusion criteria: * patients with advanced, metastatic and/or progressive solid tumors for whom there is no effective standard therapy available (for part 2 in addition patients for whom their pi3k pathway is deregulated) * evaluable or measurable disease * has normal organ function; is no greater than 2 on the ecog performance scale * negative hcg test in women of childbearing potential exclusion criteria: * history of diabetes requiring daily medication or history of grade 3 or more fasting hyperglycemia * patients with major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study * clinical significant, unresolved toxicity from previous anti-cancer therapy * patients who previously received a mek inhibitor (for combination part only) * presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs * known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm hg or patient considered at risk of retinal vein thrombosis (combination part only) * known hiv positivity or active hepatitis b or c infection * history of clinically significant cardiac condition
improving diagnosis in idiopathic cytopenia using gene sequencing

Conditions: Cytopenia

Summary: 10% of the cases referred to the specialist diagnostic haemato-pathology service at rmh are for cytopenias. the hypothesis to be tested is that a proportion of patients with idiopathic cytopenias have mutations in myelodysplasic syndrome (mds)-associated genes. the investigators will sequence a panel of known mds-associated genes in patient material (bone marrow and blood) that is sent routinely to the diagnostic service where conventional techniques have failed to establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to determine their survival, blood counts and development of acute leukaemia and other haematological malignancies. the clinical outcomes will be correlated with any mutations detected.

patients with cytopenias will be identified by their local district general consultant haematologist and consent obtained. a bone marrow sample will be sent to rmh as per usual diagnostic pathway. once received at the rmh, an aliquot will be frozen down for sequencing by the molecular pathology lab. only those cases of cytopenia without a specific diagnosis will be the focus of this study. results will be fed back to referring consultants with caveats regarding significance. patients will undergo telephone follow up and data will also be provided by local consultants. the investigators will look at overall survival, development of haematological malignancies and full blood count. this will occur annually.

Eligibility criteria:
inclusion criteria: * signed informed consent * patients \>= 18 years old * life expectancy more than 12 months * cytopenia defined as hb \< 110g/l and/or neutrophils \<1.5 x109/l and/or platelets \<100 x109/l exclusion criteria: * known haematological malignancy or aplastic anaemia/paroxysmal nocturnal haemoglobinuria * cytopenia of known aetiology (after examination of blood film and other investigations have occurred). these include haematinic deficiency (patients unresponsive to appropriate haematinic deficiency may enter the study), autoimmune cytopenias, chronic renal anaemia (for those with isolated anaemia), known haemoglobinopathy (for those with isolated anaemia), chronic viral diseases (hep b/c/hiv), cytopenias associated with liver disease, cytopenias associated with systemic autoimmune conditions (eg sle, rheumatoid arthritis), anaemia of chronic disease (for those with isolated anaemia). * cytotoxic chemotherapy or other myelosuppressive drugs or radiotherapy within 12 months * inadequate bone marrow sample for gene testing
masitinib in locally advanced/metastatic gastro-intestinal stromal tumour (gist)

Conditions: Gastro-intestinal Stromal Tumours

Summary: the objective is to evaluate the efficacy and safety of ab1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic gist.


Eligibility criteria:
inclusion criteria: * male or female patients, age \>18 * life expectancy \> 6 months * histological proven, metastatic, or locally advanced and non-operable, non- pre-treated gist. * patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy * c-kit (cd117) positive tumors detected immuno-histochemically * measurable tumor lesions with longest diameter \>20 mm using conventional techniques or \>10 mm with spiral ct scan exclusion criteria: * documented allergy to the similar drug of ab1010 * inadequate organ function * patients with a history of any other malignancy

Keywords: ckit inhibitor gist
melatonin vs pregabalin for anxiolysis and sedation

Conditions: Anxiety

Summary: preoperative melatonin, pregabalin or both will be given to all patients preoperative

on arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. sedation score (ramsay sedation score)(10) will be recorded on arrival to or an 18-gauge cannula will be inserted in a peripheral vein and a warmed (37°c) lactated ringer solution infusion was started. ondansetron 4 mg will be administered intravenously as a prophylaxis against nausea and vomiting. thereafter the patient will be supported in the sitting position. intrathecal anaesthetic (room temperature hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 ml) will be given under complete aseptic technique . the patient was returned to the supine position for 15 min then to lateral position with operative side up. hr and blood pressure will be measured every 2.5 minutes intraoperatively, however, the values will be recorded in the anesthesia chart only every five minutes for 2 hours then every 15 minutes for 3 hours. durations will be calculated considering the time of spinal injection as time zero. hypotension (sap\<100 mmhg or \<80% of the baseline measured before spinal anaesthesia) will be treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. if bradycardia (hr≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate hr (≥60 bpm).

Eligibility criteria:
inclusion criteria: * asa i or ii * patients undergoing hip arthroplasty * patient consent for spinal anaesthesia * patient alert, concious and good mental condition exclusion criteria: * patients with any neurolgical or psychiatric history before the procedure * patients with a history of chronic pain * patients with known allergy to any of this study drugs * patients have any contraindication to neuraxial block.

Keywords: melatonin pregabalin