Kornimate/medical-research-clean huggingface dataset:
mid-urethral sling tensioning trial

Conditions: Urinary Stress Incontinence

Summary: prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. primary outcome is rate of abnormal bladder function. secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.


Eligibility criteria:
inclusion criteria: * age 18 or older * women who have elected for surgical management of symptomatic urinary incontinence * ability to read \& write in english * other prolapse surgery at time of sling placement is allowed * must consent to participation in trial exclusion criteria: * women with a prior incontinence procedure * clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence) * declines participation in trial * women with existing urinary retention or significant overactive bladder (requiring medication)

Keywords: tension-free vaginal tape suburethral slings midurethral slings mid-urethral sling urinary retention
renal stone treatment global registry

Conditions: Urolithiasis

Summary: this is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.

renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc. different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. the main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. this is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. the decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference. new advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (fans), direct in scope suction (diss), intrarenal pressure (irp) and intrarenal temperature (irt) monitoring devices, new lasers and pulse modulation, etc. therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. this information will be important for audit, treatment comparison and also patient education.

Eligibility criteria:
inclusion criteria: * patient at the age of 18 or above exclusion criteria: * patient is unable to give consent

Keywords: urolithiasis eswl rirs flexible ureteroscopy pcnl fans flexible and navigable suction ureteral access sheath intrarenal pressure irp intrarenal temperature irt
a study evaluating the impact of venetoclax on the quality of life for subjects with relapsed (your cancer has come back) or refractory (no response to previous cancer treatments) chronic lymphocytic leukemia (cll) while receiving venetoclax monotherapy (a single agent).

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: the purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (r/r) chronic lymphocytic leukemia (cll; a type of cancer affecting the blood and the bone marrow) with or without the 17p deletion or tp53 mutation, including participants with an unknown status, as well as r/r cll participants who had been previously treated with b-cell receptor inhibitor (bcri) therapy. the starting dose of venetoclax was 20 mg once daily. the dose must have been gradually increased over a period of 5 weeks up to the daily dose of 400 mg. participants may have continued receiving venetoclax for up to 2 years. after the treatment period, participants may have continued on into a 2-year follow-up period.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance score of ≤ 2 * participant has relapsed/refractory disease (received at least one prior therapy) * diagnosis of cll that meets published 2008 modified international workshop on cll national cancer institute - working group (iwcll nci-wg) guidelines and: * has an indication for treatment according to the 2008 modified iwcll nci-wg guidelines * has clinically measurable disease (lymphocytosis \> 5 × 10\^9/l and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam) * with or without 17p deletion or tp53 mutation * may have been previously treated with a prior b-cell receptor inhibitor therapy * adequate bone marrow function exclusion criteria: * participant has developed richter's transformation or prolymphocytic leukemia (pll) * participant has previously received venetoclax * history of active malignancies other than cll within the past 2 years prior to first dose of venetoclax, with the exception of: * adequately treated in situ carcinoma of the cervix uteri * adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin * previous malignancy confined and surgically resected (or treated with other modalities) with curative intent * active and uncontrolled autoimmune cytopenias (within 2 weeks prior to screening), including autoimmune hemolytic anemia (aiha) or idiopathic thrombocytopenic purpura (itp), despite low dose corticosteroids * prior allogeneic stem cell transplant

Keywords: relapsed cll refractory cll 17p deletion tp53 gene b-cell receptor inhibitor (bcri) european organization of research and treatment of cancer quality of life core questionnaire (eortc qlq-c30) overall response rate (orr) duration of overall response (dor) complete remission rate (cr + cri) progression-free survival (pfs) overall survival (os)
vitamin d regulation of gut specific b cells and antibodies targeting gut bacteria in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Summary: specific aim 1: characterize the effects of vitamin d treatment on expression of α4β7 on b cells in patients with inflammatory bowel disease (ibd). specific aim 2: determine the effects of vitamin d treatment on fecal immunoglobulins, percentage of ig-coated gut bacteria, gut microbiome composition (global and bound by immunoglobulins) in patients with ibd and the association of these parameters with change in α4β7+ b cells . specific aim 3: compare bcr repertoire (bcr clonotypes, immunoglobulin heavy chain gene (ighv), and isotype usage) between α4β7+ and α4β7- b cells in patients with ibd and identify α4β7+ bcr clonotypes associated with ig-bound gut bacteria .


Eligibility criteria:
inclusion criteria: * adult patients (18 years or older) with inflammatory bowel disease (ulcerative colitis or crohn's disease) * low serum vitamin d (25(oh)d ≤ 25 ng/ml * not currently on high dose vitamin d supplementation * no prior bowel resections * no antibiotic use in past 3 months. exclusion criteria: * patients less than 18 years old * no diagnosis of ibd * serum 25(oh)d \> 25 ng/ml * patients already on vitamin d supplementation * prior history of bowel surgery (colectomy or small bowel resections) * recent antibiotic use in past 3 months * renal dysfunction * history of hypercalcemia * history of hiv * history of iga deficiency * history of common variable immunodeficiency (cvid) * active c. diff infection

Keywords: gut microbiome, vitamin d, dysbiosis, inflammation
phenotypic and genotypic characterization of malassezia species isolated from malassezia associated skin diseases

Conditions: Malassezia Infection

Summary: genus malassezia includes 14 species, namely m. furfur, m. sympodialis, m. globosa, m. restricta, m. slooffiae, m. obtusa, m. dermatis, m. japonica and m. yamatoensis associated with normal human flora but can also cause skin lesions, and m. pachydermatis, m. nana, m. equina, m. caprae and m. cuniculiare associated with animals. few studies found that m. pachydermatis may be transmitted to humans from pets. m. pachydermmatis is the only lipid independent species while others are lipid dependent . as malassezia species have similar morphological and biochemical features, the currently used phenotypic techniques for diagnosis of pityriasis versicolor usually do not allow rapid and exact characterization. in addition; they are time-consuming, multi-step processes requiring several experimental methods. therefore, several molecular typing methods have been used successfully, resulting in identification and classification of new malassezia species aim of the work: 1. phenotypic and genotypic characterization of malassezia species. 2. identify antifungal resistance pattern among isolated fungus.


Eligibility criteria:
inclusion criteria: characteristic lesions of hypopigmented or hyperpigmented scaly macules and patches which may be associated with itching in patients with pityriasis versicolor and scales of seborrheic dermatitis and scales from patients with atopic dermatitis. exclusion criteria: patients with skin lesions of extensive desquamation or inflammation that do not match pityriasis versicolor , seborrheic dermatitis or atopic dermatitis. patients who had received topical antifungal therapy within last three months or oral antifungal therapy within the last six months
gastroesophageal tumor, immune microenvionnment (gotim)

Conditions: GastroEsophageal Cancer

Summary: this trial is a prospective, monocentric, non-therapeutic, interventional cohort study aiming to decipher the immune tme through standard neoadjuvant ct in resectable g/gej adenocarcinomas. this study will also longitudinally monitor mrd during neoadjuvant and adjuvant therapy.


Eligibility criteria:
inclusion criteria: * male or female patient \> 18 years of age on day of signing informed consent. * histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, stage ib to iii to be treated with standard neoadjuvant treatment. * surgery of primary tumor to be done at centre léon bérard. * availability of archival ffpe tumor block from initial diagnosis with at least 20% of tumor cells. * eastern cooperative oncology group (ecog) performance status (ps) 0, 1 or 2. * patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. patient should be able and willing to comply with study visits and procedures as per protocol. * patients must be covered by a medical insurance. exclusion criteria: * any condition contraindicated with blood sampling procedures required by the protocol. * known additional malignancy that is progressing or requires active treatment. exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer * any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. * pregnant or breast-feeding woman.

Keywords: junctional adenocarcinomas immune microenvironment
compare the efficacy and safety of donepezil hydrochloride 23 mg treatment with continuation of donepezil hydrochloride 10 mg treatment in japanese subjects with severe alzheimer's disease

Conditions: Alzheimer's Type Dementia

Summary: the purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe alzheimer's disease.


Eligibility criteria:
inclusion criteria * diagnosis: diagnostic evidence of probable alzheimer's disease (ad) consistent with diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv-tr) 290.00 or 290.10 * mini mental state examination (mmse) less than or equal to 12 and greater than or equal to1 inclusive, at screening * sib less than or equal to 90 and greater than or equal to10 at both screening and baseline * no evidence of focal disease to account for dementia on any cranial image (magnetic resonance imaging \[mri\] or computed tomography \[ct\]). * subject age range: male and female subjects greater than or equal to 50 years of age inclusive * outpatients (patients in nursing homes are eligible) * the subject must have a caregiver who will provide informed consent separately for his/her own participation in the study, who will have regular contact with the subject. * stable donepezil dose of 10 mg, taken as a single, daily dose for greater than or equal to 3 months prior to the screening visit * subjects who can swallow hole tablets, as tablets should not be broken or crushed * comorbid medical conditions must be clinically stable prior to screening unless otherwise specified. * written informed consent will be obtained from the subject (if possible) or from the subject's legal guardian or other representative (according to japanese regulations as appropriate) prior to beginning screening activities. exclusion criteria * subjects with a known history of disorders that affect cognition or the ability to assess cognition but are distinguishable from ad * subjects with dementia complicated by other organic disease or ad with delirium * known hypersensitivity to donepezil or piperidine derivatives, or to any of the excipients in the study drug formulation * patients who are expected to live in a nursing home within 24 weeks after randomization (eligible if temporary) * use of any prohibited prior or concomitant medications. memantine will be allowed if taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to screening.

Keywords: alzheimer disease dementia delirium amnestic cognitive disorders donepezil brain diseases central nervous system diseases nervous system diseases tauopathies neurodegenerative diseases mental disorders cholinesterase inhibitors enzy
clinical study on adjuvant treatment of coronary heart disease angina pectoris with chinese patent medicine

Conditions: Atherosclerotic Heart Disease With Angina Nos

Summary: a prospective cohort study was performed in patients with angina pectoris who were treated with oral chinese patent medicine and western medicine.collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.to explore the clinical efficacy of chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate, understand and sign the informed consent form; 2. age 35-75 years old, gender is not limited; 3. patients with coronary heart disease and angina pectoris in the department of cardiology or outpatient department, the diagnosis of angina pectoris meets the diagnostic criteria of western medicine and the standard of tcm syndrome differentiation; 4. patients who met the criteria for drug treatment, the exposed group was treated with traditional chinese medicine combined with western medicine, and the non-exposed group was treated with western medicine alone. exclusion criteria: 1. combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain; 2. patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases; 3. pregnant women, lactating women or women of childbearing age who have birth requirements; 4. mental patients, or cognitive dysfunction; 5. participated in other clinical trials in the last 3 months; 6. allergic persons, or those known to be allergic to therapeutic drugs; 7. it is expected that the compliance is poor and it is not possible to visit regularly; 8. patients who do not have a current address or whose current address is incomplete and have no contact number; 9. the investigator believes that there are other situations that are not suitable for the trial.
a study to evaluate rucaparib in combination with other anticancer agents in participants with a solid tumor (seastar)

Conditions: Ovarian Cancer; Triple-negative Breast Cancer; Urothelial Carcinoma; Solid Tumor

Summary: this is an open label, phase 1b/2 study with multiple treatment arms evaluating the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of rucaparib in combination with a second anticancer therapy in participants with an advanced/metastatic solid malignancy (phase 1b), followed by evaluation of the combination in one or more specific participant populations in an expansion phase (phase 2 cohorts).


Eligibility criteria:
inclusion criteria phase 1b (all arms): * solid tumor, advanced or metastatic, progressed on standard treatment participants in arm b must have either triple negative breast cancer or urothelial carcinoma or ovarian cancer or have a solid tumor with a deleterious mutation in brca1, brca2, palb2, rad51c or rad51d * measurable disease per recist v1.1 * adequate organ function * eastern cooperative oncology group (ecog) 0 or 1 * tumor tissue for genomic analysis exclusion criteria phase 1b (all arms): * known history of myelodysplastic syndrome (mds) * symptomatic and/or untreated central nervous system (cns) metastases inclusion criteria phase 2 (all arms): * histologically or cytologically confirmed solid tumor, previously treated and measurable per recist v1.1, as follows: * arm a: ovarian cancer with gbrcawt disease, either platinum-sensitive or platinum-resistant * arm b: metastatic triple negative breast cancer or advanced/ metastatic urothelial carcinoma or relapsed ovarian cancer * at least 1 prior line of standard therapy for advanced disease * adequate organ function * ecog 0 or 1 * tumor tissue for genomic analysis exclusion criteria phase 2 (all arms): * prior poly (adenosine diphosphate \[adp\]-ribose) polymerase (parp) inhibitor treatment allowed for participants with ovarian cancer * known history of mds * symptomatic and/or untreated cns metastases
the role of perioperative ventilation (gas exchange) during intrabdominal surgery on cognitive function

Conditions: Response to Hyperoxia; Hypocapnia

Summary: abdominal surgery commonly requires perioperative relaxation and therefore controlled mechanical ventilation. however, respiratory support can be associated with minor, yet clinically significant changes in blood gas content. the inadvertent hyperoxia (excessively high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient changes in cerebral blood flow and cognitive impair.

the moderate hyperventilation resulting in hypocapnia as well as hyperoxia are common features of mechanical ventilation during general anesthesia. while mild hyperventilation is routinely advocated in laparoscopic surgical interventions, increased fio2 is set to reinforce safety of respiratory support. hypocapnia may cause disturbances of cerebral blood flow due to narrowing of cerebral vessels and a decrease cerebral blood flow. hypocapnia is particularly injurious to the brain in premature infants. factors that may predispose the immature brain to such injury include poorly developed vascular supply to vulnerable areas, antioxidant depletion by excitatory amino acids, and the lipopolysaccharide and cytokine effects that potentiate destruction of white matter. data from neonates clearly suggest that severe hypocapnia after hyperventilation contribute to adverse neurologic outcomes. the use of high concentrations of oxygen can lead to a number of events such as the formation of harmful free radicals and activation of lipid peroxidation, resulting in secondary brain injury due to hyperoxia, particularly after suffering anoxia of the brain in resuscitated victims of sudden cardiac arrest. it is recommended to use the fraction of oxygen to maintain saturation at the level of 94-98% when performing cardiopulmonary resuscitation (cpr), due to the risk of reperfusion injury. these disturbances of gas exchange, yet transient can interfere in cerebral blood flow and therefore mental functions. the primary aim of this study was the assessment of the impact of intraoperative gas exchange (hypocapnia, hyperoxia and their combinations) on the state of higher nervous activity

Eligibility criteria:
inclusion criteria: * informed consent * age \> 18 years and below 80 yrs * elective abdominal endoscopic intervention exclusion criteria: * known cerebral disorder, incl. traumatic injury and severe vascular impairment * known psychiatric illness * severe drug or alcohol abuse * resent stroke (during last 6 months) * pregnancy * within the 30 days prior to this study, either entry into any other randomized therapeutic study of an agent not licensed for the intended use or administration of any other investigational agent for the treatment of ali. patients must not participate in such studies for at least 30 days after enrolment into this study.

Keywords: cognitive dysfunction mechanical ventilation hyperoxia hypocapnia
potential role of cmv in restenosis following angioplasty, in atherosclerosis, and in endothelial dysfunction

Conditions: Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Cytomegalovirus Infections

Summary: the purpose of this study is to investigate whether the susceptibility of subjects to atherosclerosis is influenced by prior cmv exposure, whether the susceptability to endothelial dysfunction in patients with and in patients without atherosclerosis is influenced by prior cmv exposure.

the purpose of this study is to investigate whether the susceptibility of subjects to atherosclerosis is influenced by prior cmv exposure, whether the susceptability to endothelial dysfunction in patients with and in patients without atherosclerosis is influenced by prior cmv exposure.

Eligibility criteria:
patients who are being evaluated to determine if they have cad or those who have already been studied and the presence or absence of cad has been ascertained. no patients who have not been evaluated for cad.

Keywords: atherogenesis cell mediated immunity coronary artery disease