Kornimate/medical-research-clean huggingface dataset:
less-tlh versus less-lavh

Conditions: Benign Uterine Disease

Summary: during the last 2 decades, several studies have tried to define the best surgical approach to hysterectomy for benign uterine diseases1. accumulating evidence demonstrates that abdominal hysterectomy has a higher incidence of complications, a longer hospital stay and a slower convalescence in comparison with laparoscopic hysterectomy (lh). the main advantage of lhs is the absence of a wide abdominal scar, which results in fewer wound-related complications and in a significant decrease of postoperative pain. technologic advances in endoscopic instrumentation and optics have allowed the development of an even less invasive procedure than conventional lh using multiple ports: laparoendoscopic single-site (less) surgery, also known as single-port access (spa) laparoscopy3. in the less approaches, total laparoscopic hysterectomy (tlh) and laparoscopically-assisted vaginal hysterectomy (lavh) are all feasible, with comparable conventional lh. however, it is yet to be determined which of two alternative and less invasive approaches (less-tlh and less-lavh) should be preferred. in particular, none has focused on postoperative pain as the primary outcome of the study. the investigators have therefore designed the randomized trial to investigate specifically differences in postoperative pain after less-tlh and less-lavh.


Eligibility criteria:
inclusion criteria: * women with indication for hysterectomy for a supposed benign uterine disease * women with an age of 18 years or older * women who were not pregnant at the time of presentation * women who were appropriated medical status for laparoscopic surgery (american society of anesthesiologists physical status classification 1 or 2) exclusion criteria: * uterine volume \> 18 weeks of gestation by pelvic examination * suspicion of malignancy * pelvic organ prolapse \> stage 1 according to pop-q classification * inability to understand and provide written informed consent.
an analysis of clinical efficacy based on the robotic, laparoscopic, and open approach in radical resection of rectal cancer

Conditions: Rectal Cancer

Summary: a retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from september 2017 to july 2018 at the first afﬁliated hospital of xi'an jiaotong university.in the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. comparing the perioperative conditions and hospitalization related costs of the three groups.


Eligibility criteria:
inclusion criteria: * endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative ct, mri examination did not see the tumor directly invaded the surrounding organs; * blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications; * without distant metastasis such as liver, lung, bone, and abdominal cavity. exclusion criteria: * there is distant organ transfer or extensive abdominal metastasis; * emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.; * combined with other primary malignant tumors; * other colonectomy and combined with other organ resection; * patients with severe basic diseases unable to tolerate surgery; * pregnant and lactating women; * patients who underwent neoadjuvant radiotherapy and chemotherapy before surgery; * those who underwent palliative surgery.
a study to determine the safety and tolerability of herceptin as an adjuvant therapy of early breast cancer

Conditions: Breast Cancer, Early Breast Cancer

Summary: this was an open-labeled, multi-center, prospective, non-comparative study of the safety of herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.


Eligibility criteria:
inclusion criteria: * female patients \> or = 18 years of age * human epidermal growth factor receptor 2 (her2)-neu overexpression * previously treated with adjuvant antracycline containing chemotherapy * left ventricular ejection fraction (lvef) \> 50% * eastern cooperative oncology group (ecog) score \< or = 2 * life expectancy \> or = 12 weeks exclusion criteria: * left ventricular ejection fraction (lvef) \< 50% * advanced pulmonary disease * severe dyspnea * abnormal laboratory results within 14 days prior to registration * peripheral neuropathy * presence of central nervous system (cns) metastasis
phase 1 study in patients with advanced and/or refractory solid malignancies to evaluate the safety of ator-1015

Conditions: Solid Tumor; Neoplasms

Summary: the aim of the study is to investigate the safety and tolerability of ator-1015 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.


Eligibility criteria:
major inclusion criteria: * diagnosis of advanced and/or refractory solid malignancy * eastern cooperation oncology group (ecog) performance status of 0 or 1 * life expectancy of at least 3 months major exclusion criteria: * organ transplant recipient * active autoimmune disorder * other malignancy
study on the occurrence of head and neck cancers during pregnancy

Conditions: Head and Neck Cancer; Pregnancy Related

Summary: head and neck cancers that occurred during pregnancy


Eligibility criteria:
inclusion criteria: * 18 year old woman or over at the time of participation * ps 0 -2 * cancer diagnosed (biopsy date) from 01/01/2010 between the second week of pregnancy and the 12 months postpartum. * primitive may concern the following sites: oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, prevalent lymphadenopathy, nasal cavity, salivary glands, dental tumors, ear tumors, paragangliomas optic pathways, facial sinus / facial mass, nose, ear and other head and neck * all histologies (epithelial tumors, sarcomas, mucosal melanomas, embryonic tumors, undifferentiated tumors) * patient receiving or having received a specific oncological treatment among surgery, radiotherapy, chemotherapy, hormone therapy. * all stages allowed: localized stages and metastatic stages immediately. * no opposition of the patient to participate in this study exclusion criteria: * any other neoplastic antecedent * exclusion of metastases at the level of the vads of another primitive than a cancer of the vads * exclusion of hematological tumors (lymphoma) and glial tumors * person subject to a legal protection measure or unable to express their consent
vienna vascular access studied on exchange of dialysis catheters for shunts where feasible

Conditions: End Stage Renal Failure on Dialysis

Summary: we will conduct a cross-section analysis regarding patients with catheter-based vascular access (va) in vienna. collected data will include demographic and clinical information such as age, gender, co-morbidities and imaging data from sonography and computer tomography. patients of interest will be assessed through a standardized clinician-executed questionnaire aimed at investigating their medical history regarding their va. patients will be evaluated for the feasibility of an arteriovenous va. patients will receive standard of care ultrasound-based arterial and venous mapping.

we will conduct a cross-section analysis regarding patients with catheter-based vascular access (va) in vienna. collected data will include demographic and clinical information such as age, gender, co-morbidities and imaging data from sonography and computer tomography. patients of interest will be assessed through a standardized clinician-executed questionnaire aimed at investigating their medical history regarding their va. patients will be evaluated for the feasibility of an arteriovenous va. patients will receive standard of care ultrasound-based arterial and venous mapping. study rationale the rate of dialysis via catheter systems is around 40% in vienna whereas in neighboring germany this rate is historically below 15% according to the latest update of the dialysis outcomes and practice patterns study. therefore, possibly up to 20% of the patients receiving chronic dialysis in vienna could be eligible for an arteriovenous va. in absolute numbers we expect up to 400 patients. by means of vienna acts now the current situation will be meticulously assessed with the aim to improve the provision of medical care for dialysis patients in vienna by exchanging catheters for arteriovenous vas (where feasible and desired). the collected data will serve as the basis of a future prospective interventional study.

Eligibility criteria:
inclusion criteria: * age of 18 and above * catheter-based dialysis as of 01.11.2022 exclusion criteria: • age lower than 18

Keywords: haemodialysis dialysis
evaluation of penetration of ceftobiprole into soft tissue determined by microdialysis in healthy volunteers

Conditions: Staphylococcal Skin Infections; Streptococcal Infections

Summary: the primary objective of this study is to measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration over time of ceftobiprole in these tissues and in plasma after administration of a single intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over 2 hours. the secondary objective was to further assess the safety and tolerability of ceftobiprole after a single i.v. infusion.

this is a single-center, open-label (all patients involved know the identity of the drug), single-arm, nonrandomized study of ceftobiprole in healthy men and women. the study is conducted in 2 parts: a pilot study and a main study. each study (i.e. the pilot study and the main study) consists of 3 phases: a pretreatment phase that includes up to a 21-day screening period, an open-label treatment phase (1 day in the pilot study and 2 days in the main study), and a posttreatment phase that included the end of study evaluations and follow-up study visit or telephone contact planned for 1 to 2 weeks after discharge from the study unit. serial blood and dialysis samples will be collected at specified time points from predose through 24 hours after the start of the infusion for estimation of ceftobiprole and ceftobiprole medocaril concentrations. additional samples will be collected for measurement of protein binding. the study will include the following evaluations of safety and tolerability: adverse events, clinical laboratory tests (including hematology, serum chemistry, and urinalysis), electrocardiogram (ecg), vital signs, physical examination, serology, pregnancy tests, urine drug screen, and alcohol breath test. in the pilot study, ceftobiprole will be locally administered via a microdialysis probe at a concentration of approximately 30 µg/ml for 60 minutes. in the main study, each volunteer will receive ceftobiprole locally via the microdialysis probe. after the washout period determined by the pilot study, each volunteer will receive a single 2-hour i.v. infusion of ceftobiprole.

Eligibility criteria:
inclusion criteria: * body mass index (bmi between 18 to 29 kg/m2 * nonsmoker * normal renal function exclusion criteria: * history of gastric or duodenal ulcer * history of allergies or hypersensitivity (including penicillin, cephalosporins, or other ß-lactams or quinolones) * hypersensitivity or intolerance to heparin * history of drug or alcohol abuse

Keywords: staphylococcal skin infections streptococcal infections
evaluation of the bioavailability of two abt-072 tablet formulations as compared to abt-072 capsule formulation

Conditions: Hepatitis C

Summary: the purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.

a single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of abt-072 when compared to that of the original capsule formulation suspended in liquid as a reference.

Eligibility criteria:
inclusion criteria: * overall healthy subjects, non-childbearing females included. exclusion criteria: * use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer. * pregnant or breast-feeding female. * positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab), or hiv antibodies (hiv ab). * positive screen for drugs of abuse, alcohol, or cotinine. * clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder. * use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.

Keywords: phase 1 bioavailability
digital data in mental health therapy

Conditions: Depressive Symptoms; Anxiety Generalized

Summary: the use of patient electronic communication in psychiatric evaluation and treatment intends to better understand how digital data, social media, and electronic communication can be used in mental health therapy.


Eligibility criteria:
inclusion criteria: 1. between 18-65 years of age 2. primarily english speaking (for language analysis) 3. willing to share at least one digital data source this includes facebook, google searches, youtube searches, or screen time by downloading a free application (app) on their smartphone. 4. regular activity viewing and posting on social media sites, defined as once a month posting 5. has a mental or behavioral health provider and/or has a provider from the philadelphia society of clinical psychologists and currently enrolled in mental or behavioral therapy 6. attends therapy at least once a month and intends to remain in therapy for the next three months 7. willing to share dashboard with their behavioral health provider 8. able to provide informed consent 9. owns a smartphone 10. if the patient downloads an app, they are willing to download and keep an app on their phone for 3 months exclusion criteria: 1. under 18 years of age 2. non-english speaker 3. patient is in severe distress, e.g. respiratory, physical, or emotional distress 4. patient is intoxicated, unconscious, or unable to appropriately respond to questions 5. not currently enrolled in mental therapy 6. not expected to remain in mental therapy for the next three months 7. not a regular social media poster, or does not use facebook and/or instagram and/or not willing to share 8. unwilling to share social media summary dashboard with behavioral health provider 9. patient with diagnosed psychosis 10. does not own a smartphone 11. unwilling to download and keep an app on their phone for 3 months
first in human study of torl-2-307-mab in participants with advanced cancer

Conditions: Advanced Solid Tumor; Gastric Cancer; Pancreas Cancer; Gastroesophageal Junction Adenocarcinoma

Summary: this first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of torl-2-307-mab in patients with advanced cancer


Eligibility criteria:
inclusion criteria: * advanced solid tumor * measurable disease, per recist v1.1 * eastern cooperative oncology group (ecog) performance status 0-1 * adequate organ function exclusion criteria: * has not recovered \[recovery is defined as nci ctcae, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of torl-2-307-mab * progressive or symptomatic brain metastases * serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection * history of significant cardiac disease * history of myelodysplastic syndrome (mds) or aml * history of another cancer within 3 years before day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. a history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (dcis) of the breast and prostate cancer with a gleason score less than or equal to 6, are also not excluded * if female, is pregnant or breastfeeding

Keywords: claudin18.2
comparison of two basal insulin therapies for patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ilps) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. a gatekeeper strategy will be employed for sequentially testing the secondary objectives.

phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ilps, also referred to as npl \[neutral protamine hagedorn\]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin a1c (hba1c) from baseline (visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 diabetes for one year or more * age 18 years or older * body mass index (bmi) less than or equal to 35 kilograms per square meter (kg/m2) * have a hemoglobin a1c (hba1c) 1.2 to 2.0 times the upper limit of the normal (uln) reference range within 30 days prior to visit 1 or collected and analyzed at a local laboratory at visit 1 * as determined by the investigator, are capable and willing to do the following: * perform self monitoring of blood glucose (smbg), * complete patient diaries as required for this protocol, * use the insulin injection device(s) according to the instructions provided, * are receptive to diabetes education, * comply with the required study visits. exclusion criteria: * have taken any oral antihyperglycemic medications (oams) within 3 months prior to visit 1. * have had more than one episode of severe hypoglycemia, as defined in the abbreviations and definitions section of the protocol, within 6 months prior to entry into the study * are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding * are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding visit 1. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Keywords: diabetes type 1
long-term iop fluctuation and vf progression after triple procedure

Conditions: Glaucoma; Filtering Surgery; Intraocular Pressure

Summary: long-term intraocular pressure (iop) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low iop after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts.

previous studies reported that lowering intraocular pressure (iop) slowed the advancement of visual field damage in glaucoma patients. however, even if the iop can been substantially lowered, reduction of mean and peak iop does not always prevent visual field progression.we believe that the long-term iop fluctuation may play a significant role in visual field deterioration in those patients.

Eligibility criteria:
inclusion criteria: 1. underwent triple procedure 2. at leas 3 years of follow-up after surgery 3. iop \<18mmhg at each postoperative visit 4. a minimum of 5 visual field examinations 5. a reference visual field defect score of 16 or less 6. good reliability indices of visual field exclusion criteria: 1. any other significant ocular diseases or intraocular surgical histories, 2. diseases that may affect visual field or diabetes
prevention of perioperative acute renal failure

Conditions: Abdominal Surgery

Summary: the purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.


Eligibility criteria:
inclusion criteria: * all patients who are undergoing elective abdominal surgery after appropriate information of the study, and its possible risks that may arise therefrom and that at any time to refuse their cooperation, give a written consent to participate in the study. * patients who at the time of the interview have an asa between 2 and 4. * patients with chronic kidney failure mild moderate (serum creatinine between 1.5 and 3.0 mg / dl) can be included. exclusion criteria: * chronic kidney diseases with serum creatinine higher than 3.0 mg /dl * laparoscopic abdominal surgery * asa 1 and asa 5 patients. * patients with cardiac insufficiency, ascites and respiratory insufficiency * diastolic hypertension \> 100 mmhg