Kornimate/medical-research-clean huggingface dataset:
patient-operated valved catheter versus indwelling transurethral catheter

Conditions: Bladder Dysfunction; Urinary Retention

Summary: following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. the goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. this new catheter, the option-vf, is approved by the fda and is available on the market.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the umass memorial medical center with one of the urogynecology/reconstructive pelvic surgery faculty. exclusion criteria: * inability to provide consent * \<18 years old * non-english speaking * patients using intermittent self-catheterization * patients sustaining bladder injury during surgery * prisoners * pregnant women

Keywords: transurethral catheterization urinary retention bladder dysfunction patient comfort pelvic reconstructive surgery postoperative bladder dysfunction postoperative urinary retention
trial comparing hcg triggering versus hcg associated with gnrh agonist

Conditions: Infertility

Summary: the purpose of this study is to see whether patients triggered with only human chorion gonadotropin (hcg) have higher number of metaphase ii oocytes (mii) and implantation rate than patients triggered with hcg combined with gonadotropin releasing hormone (gnrh) agonist.


Eligibility criteria:
inclusion criteria: * intra-cytoplasmic sperm injection (icsi) patients below 38 years * 1,2 or 3 rd ivf-cycle exclusion criteria: * polycystic ovary syndrome (pcos) patients * patients with endocrinological diseases or problems

Keywords: ovarian hyper stimulation syndrome (ohss) metaphase ii oocytes (mii) good quality embryo's implantation pregnancy
implementing pathways to improve pediatric asthma care

Conditions: Asthma

Summary: background: asthma affects nearly 10% of american children, and is a leading cause of pediatric emergency visits and hospitalizations. clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. single-site studies of pediatric asthma pathways have shown significant improvements in quality of care. primary objective: to evaluate the effectiveness of clinical pathways for improving quality of care for children with asthma in a diverse, national sample of emergency department (ed) and hospital settings. primary endpoints: 1. emergency department: the proportion of eligible children who receive systemic steroids within 60 minutes of ed arrival 2. inpatient/hospital: mean length of hospital stay study design: this project will be implemented through an established quality improvement collaborative of hospitals across the united states, the value in inpatient pediatrics network (part of the american academy of pediatrics). a cluster randomized design will be employed. group 1 hospitals will receive a multifaceted implementation strategy that includes: 1) a pathway implementation toolkit, 2) local multidisciplinary champions in the ed and inpatient settings, 3) audit and feedback, 4) educational seminars, and 5) practice facilitation (via teleconference). group 2 will receive the same intervention with the addition of a mobile app pathway tool.


Eligibility criteria:
participant/local champion eligibility criteria: inclusion criteria: * working as a physician at the study site exclusion criteria: * none patient/child eligibility criteria: inclusion criteria: * age 2-17 years * primary diagnosis of asthma exclusion criteria: * transferred in from another inpatient facility * presence of a chronic medical condition that precludes pathway use
to assess the efficacy of granulocyte colony stimulating factor versus standard medical therapy in patients of decompensated cirrhosis

Conditions: Cirrhosis

Summary: background and aims: liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. granulocyte colony stimulating factor (gcsf) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. the investigators evaluated the efficacy of gcsf therapy in decompensated cirrhosis in an open labelled randomized control trial. patients and methods: consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of gcsf (5 μg/kg/d) plus standard medical therapy for 6 months (group-a); or standard medical therapy alone for 6 months (group-b). at the end of 6 months their survival were compared.


Eligibility criteria:
inclusion criteria: * age 18 years to75 years * patients of decompensated cirrhosis with ctp ≥6 and ≤ 13 * liver transplantation not feasible soon (due to financial reasons or unavailability of donors). exclusion criteria: * hepatocellular carcinoma * sepsis (any culture positive: blood, urine, any other obvious source of infection: uti, sbp): patients were included after sepsis is controlled. * any organ failure * grade 3 or 4 hepatic encephalopathy, active variceal bleed, hepatorenal syndrome: patients might be included after clinical improvement * hiv seropositivity * pregnancy * refusal to participate in the study * previous known hypersensitivity to g-csf
precision medicine applied to the study of endometrial cancer: application of ngs for molecular classification

Conditions: Endometrial Cancer, Endometrial Neoplasm

Summary: in recent years, knowledge about cancer biology has expanded significantly. the study of gene expression profiles has revealed the heterogeneous nature and potential reclassification of the various tumor subtypes based on specific genetic alterations. this is of great importance since it allows a therapeutic approach more directed to the intrinsic characteristics of each tumor (precision medicine). integrating clinicopathological information with molecular classification could provide new guidelines when approaching patients with ec, both in preoperative assessment and in adjuvant treatment and surveillance. the application of molecular classification in endometrial carcinomas shows a subgroup of patients with an excellent prognosis, corresponding to the polemut subgroup that could be reclassified with eventual therapeutic de-escalation. the clinical guidelines for the management of patients with endometrial cancer proposed by esgo/estro/esp in 2020 recommend the use of this new classification, and warn that clinical management may be modified by the molecular classification in scenarios where adjuvant chemotherapy is considered (high-grade/high-risk disease).


Eligibility criteria:
inclusion criteria: * patients over 18 years of age with a diagnosis of ec diagnosed by histological biopsy and surgically treated sequentially in the participating centers in the last 5 years with clinical follow-up. * patients over 18 years of age, diagnosed with ce iii-iv by histological biopsy, not susceptible to surgical treatment in each institution during the last 5 years in clinical follow-up. cases with a diagnosis of carcinosarcoma (a rare subtype of endometrial carcinoma with sarcomatous transdifferentiation) are included. * material blocks fixed in formalin and embedded in paraffin with a tumor volume in the paraffin block of at least 1 cm3 exclusion criteria: * the following uterine neoplasms will be excluded: * biphasic tumors (epithelial-mesenchymal) such as adenosarcoma. * mesenchymal neoplasms such as endometrial stromal sarcoma and leiomyosarcomas. * others: primary lymphoproliferative processes of the uterine body; neuroendocrine tumors; gestational trophoblastic disease, secondary lesions either of the genital tract (example: cervical carcinomas with extension to the endometrium) or of distant sites (breast cancer metastasis). * patients with synchronous endometrial and ovarian carcinoma * for technical reasons, they will be excluded * tumors smaller than 0.2 cm in which sufficient material cannot be obtained for immunohistochemical and molecular biology determinations. * tumors with severe artifacts due to poor processing, such as autolysis. * samples with low-quality dna * patients operated on outside participating centers. * patients under 18 years of age. * patients with primary non-surgical treatments (neoadjuvant chemotherapy).

Keywords: endometrial cancer molecular classification polemut subgroup
precision diagnosis for intraoperative frozen section of early stage lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is: 1. to establish a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma, including clinicopathologic and molecular characteristics. 2. to assess its clinical usefulness in guiding surgical procedure for early stage lung adenocarcinoma.

the detection rate of small pulmonary nodules is increasing due to the widespread use of high-resolution computed tomography (ct) screening in clinical practice. these minute pulmonary nodules are suggestive of atypical adenomatous hyperplasia (ahh), adenocarcinoma in situ (ais), minimally invasive adenocarcinoma (mia), and invasive adenocarcinoma. hence, the precision diagnosis of intraoperative frozen section is particularly imperative for its fundamental role in assess indeterminate lung lesions and guide the extent of subsequent surgical procedure. however, it is still difficult for the surgical pathologist to apply the various features according to the newly revised who classification of lung adenocarcinoma (2015) to guide surgical management due to their unascertained accuracy or heterogeneity of lung cancer or technique problem. therefore, the establishment and assessment for a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma are our primary aim in this study.

Eligibility criteria:
inclusion criteria: 1. patients with suspected pulmonary nodules (5\~20 mm) by chest ct scan; 2. patients received surgical operation. exclusion criteria: 1. patients compliance is poor and cannot accept follow-up; 2. patients nursing or pregnant; 3. patients with a history of any cancer; 4. patients with confirmed pathological diagnosis or received radiotherapy or chemotherapy or target therapy preoperatively.

Keywords: early stage lung adenocarcinoma intraoperative frozen section diagnostic criteria
testing scalable, single-session interventions for adolescent depression in the context of covid-19

Conditions: Depression

Summary: most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. in a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (ssis): a behavioral activation ssi, targeting behavioral md symptoms; an ssi teaching growth mindset, targeting cognitive md symptoms; or a control ssi. the investigators will test each ssi's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. results will reveal whether ssis that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.


Eligibility criteria:
inclusion criteria: * are fluent in english * have consistent internet and computer/laptop/smartphone access * report elevated depressive symptoms (a score of \>2 on the patient health questionnaire-2 item version \[phq-2\]) exclusion criteria: * fail to meet the above-listed inclusion criteria * exit the study prior to condition randomization * respond with either copy/pasted responses from text earlier in the intervention to any of free response questions * obvious lack of english fluency in open response questions * responding with random text in open response questions * duplicate responses from the same individual in baseline or follow-up surveys we will also exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of fewer than 3 words to writing prompts that ask for at least 2 sentences or more.

Keywords: single-session interventions
homeopathic cold remedy for children study

Conditions: Upper Respiratory Tract Infections

Summary: a randomized controlled trial of a commercially available homeopathic cold remedy will be conducted. a total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract infection will be randomized to receive either the homeopathic remedy or placebo. parents of study children will administer 5 ml of the study medication up to 6 times per day as needed to treat cold symptoms. one hour after giving a dose the parent will rate change in symptoms (for up to the first 10 doses). in addition, parents will rate their child's overall symptom severity and functional status over the first 3 days of the cold. it is postulated that children receiving the active homeopathic remedy will have better symptom relief and that their symptom severity and functional status will improve more rapidly than those receiving placebo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of upper respiratory tract infection * duration of symptoms \< 7 days * parent who speaks english exclusion criteria: * history of asthma * on any prescribed medication * prescribed any medication other than acetaminophen or ibuprofen at index visit * use of homeopathic remedy within 48 hours of index visit

Keywords: children upper respiratory tract infections homeopathy
interactive exoskeleton robot for walking - knee joint

Conditions: Stroke

Summary: an exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. this robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank and reduce the hyperextension in the knee joint. the robotic knee system is able to sense the gait pattern from the stroke patients and assist the walking and control the knee angle. the clinical trial will use repeated measurements to evaluate the effectiveness of the robotic knee system in gait rehabilitation post stroke.


Eligibility criteria:
inclusion criteria: 1. ischemic or hemorrphagic stroke with drop foot problem. 2. sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (mini-mental state examination \> 20) 3. capable of standing and walking independently for an extended period of time. (functional ambulation category \> 3, berg balance scale \> 40) exclusion criteria: 1. any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy. 2. any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity. 3. participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the followup.
mk0686 in postsurgery dental pain (0686-002)

Conditions: Pain, Postoperative

Summary: to compare the pain relieving effect of mk0686 to placebo or ibuprofen after dental surgery.


Eligibility criteria:
inclusion criteria: * men and women ages 18-45 years who are scheduled to have 2 or more third molars (wisdom teeth) removed * patients must agree to remain in the clinic for 24 hours after surgery exclusion criteria: * patient has history of heart disease, asthma, pulmonary disease * patient must discontinue use of certain pain medicines 24-72 hours prior to the surgery
designing optimal prevention and management of postoperative nausea and emesis for patients undergoing laparoscopic sleeve gastrectomy

Conditions: Post-operative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy

Summary: bariatric surgery remains the most effective therapy for obesity. postoperative nausea and vomiting (ponv) are commonly reported following bariatric surgery. the proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (lsg), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. the investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.

to test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs nausea specific-intervention group. all subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of post-operative nausea and vomiting. importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life. the total sample size is 83. this study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following sleeve gastrectomy, which is currently poorly characterized. by allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.

Eligibility criteria:
inclusion criteria: * adult patients (18 years and older) undergoing lsg exclusion criteria: * allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents) * inability to provide informed consent * history of chronic nausea and emesis requiring medication * poorly controlled diabetes (hga1c\>9 mg/dl), * history of previous bariatric or gastro-esophageal surgery

Keywords: bariatric procedure
treatment of tumors in the urinary collecting system of the kidney or ureter using a light activated drug (wst11)

Conditions: Upper Tract Urothelial Carcinoma

Summary: the purpose of this study is to test the safety of a combination of the study drug called wst11 and pdt. photodynamic therapy (pdt) is a type of ablation therapy (treatment which destroys tumor cells) which has been previously approved for the treatment of patients with other cancers. it works by using a drug that is given through the vein and then is activated in the tumor by light administered during endoscopy, which results in destruction of the cancer cells.


Eligibility criteria:
inclusion criteria: * age 18 or older * confirmed tissue diagnosis of urothelial carcinoma involving the ureter and/or renal pelvis with pathology reviewed at mskcc * residual or recurrent cancer following prior endoscopic treatment * ineligible, unwilling or refusing to undergo surgical management by resection of involved kidney or ureter. * karnofsky performance status ≥ 50% * patients with existing ureteral obstruction and/or existing ureteral stent will be permitted. demonstration of the site and degree of obstruction must be documented by retrograde pyelography at the time of initial and follow up endoscopic procedures within 60 days. * patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) ≤4 weeks prior to treatment * patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see section 9.2) * adequate organ function defined at baseline as: * anc ≥1,000/ µl * platelets ≥75,000/ µl * hb ≥9 g/dl * inr ≤1.5 (except for patients who are on full-dose warfarin) * calculated creatinine clearance ≥40 ml/min (using cockcroft-gault method) * total serum bilirubin ≤1.5 mg/dl * ast/alt ≤5× upper limit of normal * able to provide written informed consent exclusion criteria: * pregnant or breast-feeding women. women of childbearing potential (wocbp) must undergo a negative pregnancy test (either serum or urine) prior to study entry. both sexes must use contraception while on study. wocbp include: * any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic ≥12 consecutive months) * women on hormone replacement therapy with documented serum follicle stimulating hormone level \> 35 miu/ml * women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence or where the partner is sterile * t4 tumors with involvement of the bowel or major blood vessels • any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease that, in the opinion of the study investigator, would make the patient a poor candidate for the study

Keywords: wst-11 phototherapy 18-140
safety study of subcutaneously administered pl-3994 in subjects with controlled hypertension

Conditions: Hypertension

Summary: the objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (sc) pl-3994, relative to placebo in subjects with controlled hypertension. including in this evaluation is the effect pl3994 has on blood pressure.

uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. this study examines the effect of pl-3994 on patients with controlled hypertension who are receiving antihypertensive medications.

Eligibility criteria:
inclusion criteria: * subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history * subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history. * subject must have a systolic blood pressure at screening between 100 and 150 mmhg, and diastolic blood pressure must not exceed 105 mmhg. exclusion criteria: * subject weight greater than 100 kg or less than 50 kg. * any significant medical condition or abnormal safety laboratory results which, in the judgement of the investigator would place the subject at significant risk.

Keywords: hypertension controlled hypertension hypertensives