Kornimate/medical-research-clean huggingface dataset:
the transrectus sheath pre-peritoneal (trepp) technique for strangulated inguinal hernia: a case-series

Conditions: Strangulated Inguinal Hernia

Summary: n the sint jansdal hospital in harderwijk, the netherlands, the trepp technique is the standard operating procedure for patients with inguinal hernia. starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the more common lichtenstein technique. the goal of this retrospective case series is to assess the feasibility of the trepp technique in case of an acute strangulated inguinal hernia. patient records from 2006 until 2016 will be used to search for patients treated for acute inguinal hernia in that period. after applying the in- and exclusion criteria, patients who are eligible for inclusion will be contacted by telephone. they will be asked if they are willing to visit the surgical outpatient department once and fill out two questionnaires. the data of these questionnaires will be analyzed and published.


Eligibility criteria:
inclusion criteria: * emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission) * e-trepp performed exclusion criteria: * no emergency surgery (for instance, surgery day after admission or later). * no e-trepp performed

Keywords: inguinal hernia strangulated trepp transrectus sheath pre-peritoneal
pharmacoscopy-guided clinical standard-of-care in r/r aml

Conditions: AML, Adult

Summary: with an overall survival of below 12 months, the outcome of relapsed/refractory aml (rr aml) is poor, making it a critical challenge to identify effective therapies at this stage. the rapid-01 trial aims to show for the first time in a randomized and controlled clinical trial that pharmacoscopy (pcy), a functional precision medicine platform, helps improve clinical standard-of-care treatment selection for patients suffering from relapsed/refractory aml.


Eligibility criteria:
inclusion criteria * patient with refractory or relapsed aml according to eln2022 criteria. * age 18-70 years. * considered to be eligible for intensive chemotherapy. * written informed consent. exclusion criteria * acute promyelocytic leukemia (apl) with pml-rara or one of the other pathognomonic variant fusion genes/chromosome translocations. * blast crisis after chronic myeloid leukemia (cml). * considered not eligible for intensive chemotherapy. * condition of the patient does not allow to wait for pcy results (patient requires immediate treatment). * pcy not working / patient sample did not pass the qc steps of pcy. * any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the principal investigator may interfere with the project or affect patient compliance. * legal incompetence or subjects lacking capacity to provide informed consent. * participation in a clinical trial with an investigational drug within the 30 days preceding and during the present investigation.

Keywords: relapsed / refractory aml pharmacoscopy functional precision medicine
study of nitazoxanide tablets in the treatment of mild to moderate active crohn's disease

Conditions: Crohn's Disease

Summary: the primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active crohn's disease in adults.

there is a significant need for a safe and effective treatment of crohn's disease. it is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. antimicrobials have often been used in treating crohn's disease although their effectiveness has not been well established. pro-inflammatory cytokines are also believed to play an important role in this disease. nitazoxanide, a thiazolide anti-infective, is active in vitro against a broad spectrum of anaerobic bacteria, and it inhibits secretion of pro-inflammatory cytokines including il-2, -4, -5, -6, -8, -10 and tnf alpha. the drug is also highly concentrated in the gastrointestinal tract. with these characteristics, nitazoxanide offers a unique approach to treatment of crohn's disease.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * diagnosis of crohn's disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data. * cdai score ≥200 and ≤400. exclusion criteria: * subjects known to have stool positive for clostridium difficile toxin a or b, bacterial enteric pathogens, rotavirus, cryptosporidium species (spp.), and/or ova/parasites. * evidence of bowel obstruction. * females that are pregnant, breast-feeding or not using birth control and are sexually active. * serious systemic disorders incompatible with the study. * history of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation. * uncontrolled gastro-intestinal bleeding. * evidence of intestinal abscess, non-perianal fistula or stricture. * patients who have received antibiotics in the past 7 days. * patients receiving \>20 mg of prednisone, or its equivalent. * patients receiving anucort-hc or rectal steroids. * patients receiving immunosuppressive therapy that has not been stabilized. * patients who have received tnf-alpha inhibitor treatments such as infliximab or other biological agents within three months prior to start of treatment. * patients with crohn's disease confined to the esophagus, stomach and small bowel.

Keywords: crohn's disease
mothers living with hiv and their adolescent children

Conditions: Family Relations; Mental Health; Physical Health; Risky Sexual Behavior; Substance Use; HIV Infections

Summary: * context: mothers living with hiv (mlh) and their children face predictable challenges: maintaining physical and mental health, parenting while ill, and addressing hiv-related stressors. * objective: to evaluate the efficacy of a family-based intervention over time; to contrast the life adjustments of hiv-affected families and their non-hiv-affected neighbors in the current treatment era. * design: randomized controlled trial of mlh and a longitudinal comparison of mlh to a neighborhood cohort using random effect regression. * participants and intervention: mlh (n = 339) and their school-age children (n = 259) were randomly assigned to receive 1) an intervention of 16 sessions in a cognitive-behavioral, small-group format; or 2) control. mlh and their children were compared to non-hiv-affected families recruited at shopping markets. participant retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months. * main outcome measures: family functioning and conflict, mental and physical health, sexual behavior, and substance use.


Eligibility criteria:
inclusion criteria for intervention/control, mother living with hiv: * mother or primary female caregiver * enrolled in hiv-related clinical cares * at least one child between the age of 6 and 20 years inclusion criteria for neighborhood control, non-hiv-affected mother: * mother or primary female caregiver * not hiv-positive * at least one child between the age of 6 and 20 years exclusion criteria (intervention/control/neighborhood): * mother less than 18 years old * unable or willing to give informed consent * psychosis or neurological damage as judged by the investigator in consultation with clinical supervisor

Keywords: mothers living with hiv family intervention family functioning conflict mental health and physical health family relationships (functioning and conflict)
aromatherapy for anxiety among children with autism spectrum disorder

Conditions: Anxiety; Autism Spectrum Disorder

Summary: this study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. h

bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a pediatric population with autism spectrum disorder. because autism spectrum disorders often include hypersensitivity to sensory experiences, the use of essential oils in this population should be evaluated.

Eligibility criteria:
inclusion criteria: * between 6-11 years of age * diagnosed with an autism spectrum disorder exclusion criteria: * none

Keywords: aromatherapy essential oils children
sensitivity and predictive value of frozen section of sentinel lymph node biopsy in post neoadjuvant setting

Conditions: Lymph Node Metastasis; Breast Cancer

Summary: axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. it allows to determine the axillary lymph node status, which if negative, saves the patient from axillary dissection (ad) and its potential complications. to assess tumor response to neoadjuvant chemotherapy in the sln, pathological evaluation is the gold standard. response to neoadjuvant systemic therapy is an excellent predictor of outcome, and achievement of pathological complete response (pcr) in the sln is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival. post-treatment isolated tumor cells (itcs) and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting. histologically partial response to therapy, is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis. most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error. the timing of further axillary surgery, immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes, along with the potential for negative intraoperative findings and positive nodes on final pathology.


Eligibility criteria:
inclusion criteria: 1. patients greater than 18 years of age 2. all diagnosed breast carcinoma patients ranging from t1 to t4 and n0 to n1, who have received neoadjuvant chemotherapy will be included. exclusion criteria: 1. poorly preserved biopsy material, insufficient to assess all the histological features.
study evaluating the impact of electronic surveys on patient-physician communication and quality of life in breast cancer patients

Conditions: Breast Neoplasm Malignant Female

Summary: pro-com project: randomized-controlled study evaluating the impact of electronic patient reported outcome (epro) surveys on patient-physician communication and quality of life in patients with advanced breast cancer


Eligibility criteria:
inclusion criteria: * stage iv breast cancer * start of a systemic anti cancer therapy: chemotherapy -/+ antibody therapy 1st until 3rd line (palliative), endocrine therapy or other therapy without limit * estimated life expectancy of minimum six months * signed informed consent * no cognitive or speech impairments
a study to look at how safe insulin nnc0471-0119 is and how it works in people with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: this study is looking at the safety of the new medicine, insulin nnc0471-0119, its concentrations in the blood and effect on blood sugar for the treatment of type 1 diabetes. insulin nnc0471-0119 will be compared to faster aspart. the purpose of this study is to test how insulin nnc0471-0119 is tolerated by participants body, how it is transported in participants bloodstream, how long it stays there and how the blood sugar is lowered compared to faster aspart. participants will get either the new insulin nnc0471-0119 or faster aspart-which treatment participants get is decided by chance. it is the first time insulin nnc0471-0119 is tested in people. faster aspart is a globally used medication for treatment of diabetes mellitus. participants will get one single injection in a fasting state which will take place at the study site. the medicine will be injected under the skin in the stomach. the study will last for about 13-53 days, depending on individual visit schedule. participants will have four clinic visits with the study doctor, one of which will require an in-house visit period of 3 days. during the in-house visit, two intravenous cannulas will be inserted for sampling of blood and infusion of insulin. participants cannot be in the study if the study doctor thinks that there are risks to their health. women: women cannot take part if they are of childbearing potential.


Eligibility criteria:
inclusion criteria: * male subject or female subject of non-childbearing potential. non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. * aged 18-55 years (both inclusive) at the time of signing informed consent. * diagnosed with type 1 diabetes mellitus (t1dm) greater than or equal to 1 year prior to the day of screening. * current total daily bolus insulin treatment less than 0.7(i)u/kg/day. exclusion criteria: * known or suspected hypersensitivity to investigational medicinal products (imps) or related products. * participation in any clinical trial of an approved or non-approved imp within 90 days before screening.
improve sca bridge study

Conditions: Sudden Cardiac Arrest; Acute Myocardial Infarction

Summary: the purpose of the improve sca bridge study is to characterize the care pathway flow of post-acute myocardial infarction (mi) patients as a result of standard assessments of left ventricular ejection fraction (lvef) in the acute phase (≤14 days post- acute mi) and chronic phase (≥40-90 days post-acute mi).

to determine how many patients are referred for sudden cardiac death (scd) risk stratification and management, indicated for implantable cardioverter defibrillator (icd), or cardiac resynchronization therapy- defibrillator (crt-d) implant, and how many receive such devices within 12 months of experiencing an mi.

Eligibility criteria:
inclusion criteria: * age 18 and above (or meet age requirements per local law) * patients who have an acute myocardial infarction (mi) (stemi or non-stemi) ≤ 30 days of study enrollment and have a lvef \<50% measurement ≤ 14 days post-acute mi * willing and able to give valid informed consent exclusion criteria: * patient has previously received or currently implanted with an icd or crt-d * patient has any contraindication for icd/crt-d * patient has a life expectancy of less than 12 months * patient who has had an ep referral within the last 12 months * any exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.) * patient is unable (e.g. mental disorder) or unwilling to be compliant with the responsibilities as specified in the informed consent form. * patient is enrolled in a concurrent study that has not been approved for concurrent enrollment by the medtronic clinical trial leader
sofosbuvir plus ribavirin administered for either 12 or 24 weeks in treatment-naive and treatment-experienced egyptian adults with chronic genotype 4 hepatitis c virus (hcv) infection

Conditions: Hepatitis C Virus

Summary: this study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (sof) plus ribavirin (rbv) in egyptian adults with genotype 4 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * treatment experienced and naïve subjects * chronic genotype 4 hcv-infection * not co-infected with hiv * screening laboratory values within defined thresholds * use of highly effective contraception methods * subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. exclusion criteria: * history of any other clinically significant chronic liver disease * pregnant or nursing female or male with pregnant female partner * history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * excessive alcohol ingestion or significant drug abuse

Keywords: liver diseases digestive system diseases hepatitis, viral, human virus diseases enterovirus infections picornaviridae infections rna virus infections flaviviridae infections antiviral agents anti-infective agents therapeutic uses pharmacologic actions antimetabolites molecular mechanisms of pharmacological action hcv genotype 4 (gt-4) hcv sustained virologic response direct acting antiviral combination therapy gs-7977 ribavirin open label sofosbuvir additional relevant mesh terms: hepatitis hepatitis, chronic hepatitis c hepatitis c, chronic
antibiotics and tissue expanders in breast reconstruction

Conditions: Complications; Breast Prosthesis, Infection or Inflammation

Summary: this study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction. the investigators hypothesize that use of prophylactic antibiotics after breast reconstruction does not reduce surgical site infections.

surgical site infections occur in up to one-third of patients who undergo implant-based breast reconstruction following mastectomy for cancer; most of such cases require subsequent prosthetic removal. this elevated risk relative to other surgical procedures and patient populations has been attributed to cancer-related immunocompromise, foreign body placement, postoperative drainage tube maintenance, and chemoradiotherapy administration. the use of extended postoperative prophylactic antibiotics is prevalent amongst plastic surgeons despite lack of evidence supporting efficacy of such practice. further, the national surgical care initiative project (scip) as sponsored by the centers for medicare \& medicaid services (cms) mandates discontinuation of antibiotics by 24 hours after surgery, as further extension not only fails to reduce infection risk in the general surgical population, but also may contribute to bacterial resistance. the primary objective of this study is to compare the risk of surgical site infection in implant-reconstruction patients who receive extended prophylactic antibiotics with those who do not. in this randomized-controlled trial, women at a single institution who undergo implant-based breast reconstruction will be assigned to receive either less than 24 hours or 7 days of prophylactic postoperative antibiotics. primary outcome measures will include development of superficial incisional, deep incisional, and organ/space surgical site infections at one year as defined by the centers for disease control (cdc). following adjustment for patient age, body mass index, comorbid disease, reconstructive timing, disease stage, adjuvant therapy, implant volume, drain use, and other procedural variables, relative risk of postoperative infection with use of extended prophylactic antibiotics will be estimated. secondary outcome measures will include prosthetic explantation and, in cases of infection, bacteriology and antibiotic susceptibilities.

Eligibility criteria:
inclusion criteria: * patients in whom implant-based breast reconstruction is selected based on clinician recommendation, patient agreement, and mutual consensus. * ability to understand the purposes and risks of the study and willingly give standard written informed consent for treatment established by emory university hospital and affiliates. exclusion criteria: * pregnancy * incarceration * non-implant based reconstructive plan * any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.

Keywords: breast reconstruction cancer expander antibiotics infection surgical site infection surgery oncology plastic surgery
treatment of suicidal ideation with intravenous ketamine infusion

Conditions: Depression; Suicidal Ideation

Summary: this study is dedicated to achieving better treatments for suicidal thoughts. specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.

this study is dedicated to achieving better treatments for suicidal thoughts. specifically, we are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression. patients will be asked to participate in a research study to study how the use of a medication, ketamine, decreases your suicidal thoughts and improves their symptoms of depression. ketamine is approved by fda for use at higher doses in anesthesia, and recent clinical research suggests that it might benefit patients with major depressive disorder and suicidal thoughts. during clinical trials with over 10,000 patients, ketamine was proved to be safe as an anesthetic and studies with hundreds of patients with depression have demonstrated safety and lack of lasting side effects. this is a pilot study to test a new use of ketamine: treatment of suicidal thoughts. the study medication will be given in addition to usual psychiatric care.

Eligibility criteria:
inclusion criteria: 1. age : 19-64 2. significant suicidality score on the columbia suicide severity rating scale (c-ssrs) 3. willing and able to provide informed consent. 4. individuals with current substance abuse are allowed exclusion criteria: 1. pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method) 2. post-partum state : defined as being within 2 months of delivery or miscarriage 3. homicide risk as determined by clinical interview 4. treatment with any medication known to specifically target the glutamate-nmda receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium) 5. any known hypersensitivity or serious adverse effect associated with ketamine treatment. 6. any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina 7. medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment. 8. any of the following dsm-iv diagnoses or categories: * any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia) * currently in a manic or mixed episode * current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine * any dissociative disorder * any pervasive developmental disorder (e.g., autism) * a cognitive disorder (e.g., alzheimer's disease) * cluster a personality disorder (e.g., schizoid or schizotypal); note that cluster b and c personality disorders may be included * any eating disorder