Kornimate/medical-research-clean huggingface dataset:
nab-paclitaxel as salvage treatment in locally advanced or metastatic gastric cancer

Conditions: Stomach and Gastro-Esophageal Junction (GEJ) Cancer

Summary: the investigators propose to study the efficacy and safety of nab-paclitaxel in a phase ii trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction

adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. the promising results of nab-paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and gej adenocarcinomas. we design a phase ii study in order to evaluate the effect of nab-paclitaxel as salvage treatment for patients with advanced cancer of the stomach and gej previously treated with the dcf regimen.

Eligibility criteria:
inclusion criteria: * age \>18 years old * disease progression after treatment with the dcf regimen * assessable target lesion(s) as defined by recist criteria * ecog performance status ≤ 1 * estimated life expectancy more than 3 months * serum bilirubin less than 1.5 times the upper normal limit * aspartate aminotransferase and alanine aminotransferase less than 2.5 times the upper normal limit * creatinine clearance ≥50 ml/min * neutrophil count more than 1.5x 109 /l * platelet count more than 100x 109 /l * hemoglobin more than 8g/dl * before patient enrollment, written informed consent must be given according to good clinical practice guidelines and national/local regulations. exclusion criteria: * gastrointestinal bleeding * clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort * cns metastases * subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment * subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment * known hypersensitivity reaction to the component of the treatment * active infection or malnutrition or bowel obstruction * legal incapacity or limited legal capacity * definite contraindications for the use of corticosteroids * history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan * chronic inflammation of the bowel * clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment * medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent * second primary tumor other than non-melanoma skin cancer or in situ cervical cancer

Keywords: cancer stomach gastro-esophageal junction salvage treatment nab-paclitaxel
perioperative oral nutrition intervention for patients undergoing radical cystectomy

Conditions: Bladder Cancer

Summary: the current study is designed to assess the impact of an enriched oral nutritional shake (ensure plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. this operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition. the investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not. patients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. once enrolled, they will be randomly assigned to one of two groups. one group will be offered ensure plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. the investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.


Eligibility criteria:
inclusion criteria: * all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution exclusion criteria: * inability to tolerate oral supplementation

Keywords: radical cystectomy urinary diversion nutrition oral supplementation enteral nutrition
pandia iris: patients with diabetes and kidney failure, an interdisciplinary medication adherence support program

Conditions: Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Summary: monocentric, randomised, controlled and open study. subjects will be included prospectively and consecutively and randomly assigned into two groups. intervention group a will benefit a medication adherence support program during 12 months while intervention group b during 6 months only. adherence will be monitored using an electronic monitoring system (em, named mems®; aardex ltd.) during 24 months. at each pharmacy visit, the pharmacist will conduct a semi-structured interview in 15 minutes based on fisher's sociocognitive model with the patients. a summary of the interview and the adherence graph will be send to the patient' health professionals.

in addition to usual care, patients are included in a medication adherence support program combining an electronic monitoring system (em, named mems®; aardex ltd) and motivational semi-structured interviews. this programm is held by the unisanté's community pharmacists\*, in coordination with medical and nurse staff , to support medication adherence and to promote the continuity of care. for patients not speaking french, english, or italian, the interviews will be done with a interpreter. the medication adherence data will be analysed in both groups along with clinical data obtained through draw samples regularly prescribed by the physician. \*since the 1st january 2019, the policlinique médicale universitaire became unisanté, university center for primary care and public health (lausanne, switzerland).

Eligibility criteria:
inclusion criteria: * mdrd or ckd-epi egfr ≤60 ml/min/1.73m2 or albumin/creatinin \>30mg/mmol * type 2 diabetes * at least one medication in the following list : oral antidiabetics and/or statins and/or antihypertensive drugs and/or aspirin * patients speaking french, english or italian or interpreter present at each pharmacy visit * patients have to sign the written consent form * patients have to agree to use the electronic monitoring system (em, named mems®; aardex ltd) * complete laboratory exams in the last 6 months: egfr and hba1c and (albumin/creatinin ratio or total cholesterol + ldl + hdl) exclusion criteria: * not being able to understand or sign the consent form * pregnancy * recent cancer diagnosis * cognitive disorder * the subject does not manage the treatment alone

Keywords: medication adherence diabetes mellitus renal insufficiency, chronic interprofessional relations
safety and efficacy of adipose derived stem cells for chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the health of patients with human chronic obstructive pulmonary disease.

this will be an open-label, non-randomized multi-center patient sponsored study of autologous svf (ad-svf) implantation after liposuction using an iv delivery system and inhalation infusion. ad-svf will be derived from the patient's adipose-derived tissue. liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. the cells will be delivered intravenously. the adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. the adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for iv delivery. the number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.

Eligibility criteria:
inclusion criteria: * a prior diagnosis of moderate or severe copd * gold iii and iv * age between 25 and 80 years * up to date on all age and gender appropriate cancer screening per american cancer society exclusion criteria: * females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * active infectious disease patients known to have tested positive for hiv, htlv, hbv, hcv, cmv (igm \> igg) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status * any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * patients on chronic immunosuppressive transplant therapy * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * severe asthma that would contraindicate surgery * history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * unwilling and/or not able to give written informed consent.

Keywords: copd pulmonary lungs
two different antibiotics versus one antibiotic for pediatric perforated appendicitis

Conditions: Perforated Appendicitis; Postoperative Infection

Summary: after appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. in the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. now there is a recent literature suggesting a single-drug therapy may be safe and adequate. in fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are fda approved and regulated antibiotics for intra-abdominal infection. there is a clear need to compare outcomes between these two options.

the diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. patients will be randomized to 121 in each arm. postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

Eligibility criteria:
inclusion criteria: * postoperative perforated appendicitis (documented by intraoperative photo) * postoperative laparoscopic appendectomy exclusion criteria: * nonperforated gangrenous appendicitis * nonperforated purulent appendicitis * open appendectomy
trastuzumab deruxtecan (t-dxd) alone or in sequence with thp, versus standard treatment (ddac-thp), in her2-positive early breast cancer

Conditions: Breast Neoplasms; Breast Cancer; HER2-positive Early Breast Cancer

Summary: this study will look at the efficacy and safety of trastuzumab deruxtecan (t-dxd) in a neoadjuvant setting, in high-risk, her2-positive early non-metastatic breast cancer.

the target population of interest in this study is participants with high-risk her2-positive early-stage breast cancer. the purpose of this study is to determine the efficacy and safety of t-dxd neoadjuvant therapy. participants will be randomised to one of 3 arms: t-dxd monotherapy (arm a), t-dxd followed by thp (arm b), or ddac-thp (arm c).

Eligibility criteria:
key inclusion criteria: * patients must be at least 18 years of age. * histologically documented her2-positive early breast cancer (ebc) participants, including clinical stage at presentation (based on mammogram or breast mri assessment): t0-4 (inclusive of inflammatory breast cancer), n1-3, m0 or ≥ t3, n0, m0 as determined by the ajcc staging system, 8th edition * ecog performance status of 0 or 1 at randomization * adequate organ and bone marrow function * lvef ≥ 50% within 28 days before randomization * ffpe tissue block (2 cores) or 20 freshly-cut, serial tumor slides for her2 assessment by central lab. if blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the astrazeneca study physician exclusion criteria: * prior history of invasive breast cancer * stage iv breast cancer (determined by ajcc staging system) * any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) note: this includes a second current breast primary malignancy (ie, bilateral breast cancer) * history of dcis (except those treated with mastectomy \>5 years prior to current diagnosis) * history of, or current, ild/pneumonitis * prior systemic therapy for the treatment of breast cancer * previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy

Keywords: trastuzumab trastuzumab deruxtecan (t-dxd; ds-8201a) destiny-breast11 receptor, erbb-2 breast neoplasms antineoplastic agents, phytogenic antineoplastic agents;molecular mechanisms of pharmacological action db11 enhertu her2 (human epidermal growth factor receptor 2) breast cancer
comparison of casting materials for the treatment of clubfoot using the ponseti method

Conditions: Clubfoot; Ponseti Method; Talipes Equinovarus; Casting

Summary: the purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the ponseti method.

congenital idiopathic clubfoot is the most common congenital deformity in children. it can be a major cause of disability for children, as well as an emotional stress for parents. the ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now the gold standard of treatment. it has traditionally been described using plaster of paris (pop) above-knee casts; however, recently semi-rigid fiberglass softcast (srf, 3m scotchcast) has grown in popularity. there are currently no randomized controlled trials to prove its efficacy with respect to pop.

Eligibility criteria:
inclusion criteria: * congenital idiopathic clubfoot exclusion criteria: * positional equinovarus * teratologic etiologies of clubfoot * treatment started at another center * refuse randomization * do not understand english
comparing the baerveldt and paul glaucoma drainage devices and their effects on the corneal endothelium

Conditions: Glaucoma

Summary: rationale: the baerveldt glaucoma drainage device (gdd) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. supposedly, the tip of a gdd tube with a thinner diameter, such as the paul implant, will remain at a larger distance from the cornea and, thereby, cause less damage. objective: to determine whether the paul tube induces less damage to the corneal endothelium than the baerveldt gdd. study design: randomized clinical trial. study population: phakic patients scheduled for surgical gdd implantation. intervention: either a baerveldt or a paul gdd implant. main study parameters/endpoints: endothelial cell density and tube position at 24 months. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the paul gdd may have a less harmful effect on corneal endothelium. otherwise, both gdds will probably have a similar risk/benefit profile. the risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * informed consent. * caucasian ethnicity (to facilitate comparison of results with those of earlier work). ethnicity will be based on self-reported origin of subject and/or parents. * primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma. exclusion criteria: * history of intraocular surgery (e.g. vitrectomy, cataract surgery, cyclodestructive procedures etc). * history of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy). * pseudophakia. * functionally monocular patients. * need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery. * narrow anterior chamber angle. * best corrected visual acuity less than 0.1. * severe blepharitis.
surface ecg signal recording for the implantable subcutaneous string defibrillator (issd) detection algorithm performance assessment

Conditions: Tachyarrhythmia; Arrhythmias, Cardiac

Summary: recorded cutaneous ecg containing arrhythmia events are separately analysed by an expert electrophysiologist and the issd detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.

cutaneous ecg electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the issd sense electrodes, are used to record patients undergoing defibrillation threshold (dft) studies or electrophysiology (ep) studies of different types. two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the issd detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.

Eligibility criteria:
inclusion criteria: * candidate for icd implantation * candidate for an icd dft study * candidate for an ep study exclusion criteria: * age \<18
efficacy of the chronic application of tear formulations

Conditions: Dry Eye

Summary: the purpose of this study is to determine the therapeutic effect of the chronic application of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition of environmental stress. the effect will be studied in terms of changes in tear physiology and the inflammatory biomarkers on the ocular surface.

environmentally induced dry eye is a condition which occurs in otherwise asymptomatic individuals in certain situations, for example with the use of computers, in overheated or air conditioned workplaces and in conditions of low humidity. the most common ocular complaints associated with these environments are burning, dryness, stinging, and grittiness. although the exact cause of these symptoms is unknown, it is thought that increased tear evaporation rate due to low humidity plays a vital role. the changes in tear film physiology, which occurs in these environments, have traditionally been dealt with by the use of eye drops (particularly the highly viscous variety), which have been shown to be an effective therapeutic option in the treatment of environmental dry eye disease. previous studies of the use of eye-drops of various formulations has shown improvements in tear physiology in mild to moderate dry eye patients with their use in both acute and chronic application protocols. in this study, an attempt was made to relate the effects on tear physiology induced by variations in environmental conditions to the beneficial effect produced by the use of eye-drops.

Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 79 years of age. * must understand and be able, willing and likely to fully comply with study procedures and restrictions. exclusion criteria: * active ocular allergy * current contact lens wear * any topical ophthalmic drops within 1 week of initial screening visit. * started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial screening visit. * systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days initial of screening visit. * known hypersensitivity to any of the agents used in testing.
prospective analysis of spinal epidural abscess

Conditions: Spinal Epidural Abscess

Summary: this is a prospective study involving all patients treated at the university of kentucky for spinal epidural abscess over a 2-year period. based on ongoing referrals of patients with sea, we expect that 200 patients will be enrolled during this time window. we propose to study all available clinical, pathological, radiological, and socioeconomic data of patients diagnosed with a spinal infection with or without a history of drug abuse over this study period. all patients' charts will be prospectively reviewed starting at the time of presentation for a period of 1 year.


Eligibility criteria:
inclusion criteria: * all patient with icd codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion. exclusion criteria: * patients unwilling or unable to attend follow up appointments.
testing a gender-inclusive hiv prevention program

Conditions: HIV Prevention

Summary: if, over time, data suggest the intervention impacts hiv preventive behavior at the population level, it will be unique in that it can be quickly and cost effectively scaled up to impact thousands of trans girls and nonbinary youth assigned male at birth.


Eligibility criteria:
inclusion criteria: 1. assigned male sex at birth and currently have a non-cisgender identity (e.g., transgender girl, non-binary, gender fluid, unsure); 2. aged 14-18 years and have not yet graduated high school; 3. english-speaking; 4. the sole user of a cell phone with an unlimited text messaging plan; 5. have access to the internet to complete online surveys; 6. intend to have the same cell number for the next 6 months; 7. provide informed assent; 8. not have taken part in a previous #transcendenthealth study activity or know someone who is in the study to increase the diversity of input from transgirls, and 9. agree to enroll over the phone with study staff. exclusion criteria: * none beyond not meeting inclusion criteria

Keywords: hiv adolescence mhealth