Kornimate/medical-research-clean huggingface dataset:
a phase 1/2 study of amg 193 in combination with ide397 in participants with advanced methylthioadenosine phosphorylase (mtap)-null solid tumors

Conditions: MTAP-null Non-Small-Cell Lung Cancer; MTAP-null Solid Tumors

Summary: the main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (mtd) or the recommended combination dose of amg 193 in combination with ide397 in adult participants with metastatic or locally advanced mtap-null solid tumors, and to evaluate the preliminary anti-tumor activity of amg 193 in combination with ide397 in adult participants with metastatic or locally advanced mtap-null non-small-cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria 1. evidence of homozygous loss of mtap (null) and/or mtap deletion. 2. presence of advanced/metastatic solid tumor not amenable to curative treatment 1. part 1: mtap-null or lost mtap expression solid tumor for which no standard therapy exists 2. part 2: mtap-null or lost mtap expression nsclc with progression after 1 to 2 prior lines of systemic therapy. 3. able to swallow and retain po administered study treatment and willing to record adherence to investigational product 4. disease measurable as defined by recist v1.1 5. adequate organ function as defined in the protocol. 6. archived tumor tissue. participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing. exclusion criteria 1. prior treatment with an mat2a inhibitor or a prmt5 inhibitor. 2. radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease. 3. cardiovascular and pulmonary exclusion criteria as defined in the protocol. 4. gastrointestinal tract disease causing the inability to take po medication, malabsorption syndrome, requirement for iv alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, crohn's disease, ulcerative colitis) 5. history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry. 6. prior irradiation to \> 25% of the bone marrow 7. use of prescription medications that are known strong cyp3a4/5 inducers or strong cyp3a4/5 inhibitors within 7 days for cyp3a4/5 inhibitors, 14 days for cyp3a4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.

Keywords: oncology amg 193 ide397
comparison of multiple percutaneous needle aspiration versus incision and drainage in small breast abscesses: pain, cosmesis, and early breastfeeding outcomes

Conditions: Breast Abscess

Summary: this study aims to compare the effectiveness of multiple percutaneous needle aspiration (mpna) versus incision and drainage (id) for the management of small breast abscesses in breastfeeding women. the trial evaluates three key outcomes: post-procedure pain levels, cosmetic satisfaction, and the timing of breastfeeding restoration. the study is conducted at the department of surgery, bahawal victoria hospital bahawalpur, enrolling 110 lactating women aged 18-45 years with abscesses ≤5 cm in diameter. participants were treated with either mpna or id based on clinical decision and patient preference. pain levels were assessed using a standardized scale, cosmetic outcomes were evaluated via patient-reported satisfaction, and breastfeeding restoration was monitored at baseline, one week, and one month post-treatment. findings indicate that mpna is associated with lower pain scores, better cosmetic satisfaction, and faster resumption of breastfeeding compared to id, suggesting mpna as a preferred first-line treatment for small breast abscesses.


Eligibility criteria:
inclusion criteria: * married breastfeeding women age: 18-45 years diagnosed with breast abscess (≤5 cm in diameter) exclusion criteria: * complicated abscesses compromised immune system history of prior surgical interventions for breast abscess unwilling to participate in the study
ablative stereotactic mr-guided adaptive reirradiation

Conditions: Abdominal Cancer; Pelvic Cancer

Summary: this research study will enroll people who have cancer in their abdomen or pelvis that was treated previously with radiation therapy. the purpose of this research study is to test the safety and possible harms of treating tumors in these regions with another round of radiation therapy, called reirradiation or "rert." the researchers want to find out what effects (good and bad) rert has in people with cancer in the abdomen and pelvis.


Eligibility criteria:
inclusion criteria: * a primary or metastatic lesion in the abdomen or pelvis for which reirradiation will be delivered. there is no maximum lesion size. * single course of prior radiation therapy with prescribed equivalent dose in 2 gy fractions (edq210) of at least 40 gy. * 50% isodose line of the prior radiation therapy course is expected to overlap at minimum the 50% isodose line of the radiation therapy delivered in this study. * at least 6 months from completion of prior radiation therapy to initiation of study therapy. * eastern cooperative oncology group (ecog) performance status 0-2. * life expectancy at least 6 months. * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. abstinence is acceptable if it is the participant's preferred method. should a participant become pregnant or suspect pregnancy while participating in this study, the treating physician must be informed immediately. * concurrent hormonal therapy or immunotherapy such as immune checkpoint inhibitor is allowed exclusion criteria: * contraindication to having an mri scan. * lesion that would receive study therapy arises from or invades a gastrointestinal (gi) luminal organ (a lesion abutting but not invading a gi luminal organ is permitted) * lesion that would receive study therapy is not located in the abdomen or pelvis. * \> 1 course of overlapping radiation therapy delivered to the abdomen or pelvis. * \< 70% of the gross tumor volume (gtv) receives at least the 95% of the prescribed dose on the original plan using the simulation day anatomy. * more than 1 lesion in the abdomen or pelvis that requires reirradiation. * history of inflammatory bowel disease. * unable to acquire dicom radiation therapy treatment plan from the prior radiation therapy. * unresolved grade 2+ toxicity (common terminology criteria for adverse events version 5.0) from previous anti-cancer therapy. * any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of participant safety or study results. * individuals who are pregnant. * chemotherapy given within 1 week prior to or following reirradiation. * vascular endothelial growth factor (vegf) inhibitor given within 8 weeks prior to or following reirradiation
chewing and oral processing of solid food

Conditions: Dysphagia

Summary: food texture modification is commonly used as an intervention for people with dysphagia (swallowing impairment). however, the field currently lacks a proper understanding of how this intervention works. the overall goal of this project was to collect measurements of food bolus transit through the oropharynx (i.e., mouth and throat) during chewing, oral processing and swallowing.

aim: to explore chewing and oral processing behaviors across solid foods of different consistencies (minced and moist, soft \& bite-sized, regular). healthy adult participants will be asked to swallow foods representative of the "minced and moist", "soft and bite-sized" and "regular" consistency levels of the international dysphagia diet standardisation initiative. we will measure the number of chews taken per bolus and the overall duration of chewing to understand differences across consistencies.

Eligibility criteria:
inclusion criteria: * healthy adults under age 60 exclusion criteria: * prior history of swallowing, motor speech, gastro-esophageal or neurological difficulties, chronic sinusitis or taste disturbance. * history of surgery to the speech or swallowing apparatus (other than routine tonsillectomy or adenoidectomy) * type 1 diabetes * current use of dentures * cognitive communication difficulties that may hinder comprehension of the study documents or instructions * known allergies to medical adhesive * known allergies to ingredients of the food products used in the experiment .
the addition of self-compassion skills training to a behavioral weight loss program delivered using video conferencing software

Conditions: Weight Loss

Summary: the current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (sc) skills training to a standard behavioral weight loss program (bwlp), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.

object: the current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (sc) skills training to a standard behavioral weight loss program (bwlp), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes. method: the bwlp program utilized webex video conferencing software to deliver a 12-week, interactive, small group, weekly weight loss intervention. participants were randomized to a standard bwlp or a standard behavioral weight loss program augmented with self-compassion skills training (bwlp+sc).

Eligibility criteria:
inclusion criteria: * 18 or older, at a bmi of 27 kg/m2 or greater, and available to attend weekly online groups exclusion criteria: -
umbilical pilonidal sinus: a case report

Conditions: Umbilical Cyst; Pilonidal Sinus

Summary: umbilical pilonidal sinus (ups) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene; however, it can be seen in females. ups could easily be misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. diagnosis is easy to establish with physical examination and a detailed history. treatment is generally depending on the severity of the disease, ranging from good personal hygiene to surgical excision of umbilical complex. the treatment of choice for chronic, intermittent cases is surgical removal of the affected portion; paying special attention to cosmetic appearance especially in female patients. in this report, we present two cases of ups, one in a man and one in a woman with the explanation of its etiopathogenesis and surgical treatment.

introduction: umbilical pilonidal sinus (ups) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene. it is being diagnosed and reported more frequently; however, there is still no consensus regarding its best treatment options. presentation of cases: in this report, we present two cases of ups, one in a man and one in a woman who had typical symptoms with pain, swelling and intermittent malodorous discharge from the umbilicus. they had small sinus openings with hair protruding deep in the navel. because patients had previous history of failed conservative treatments an umbilicus preserving surgery was performed for both cases.

Eligibility criteria:
inclusion criteria: * no limitation exclusion criteria: * patients followed-up less than 2 years

Keywords: umbilical pilonidal sinus
multihance versus magnevist in breast mri

Conditions: Breast Cancer

Summary: to show if one mri contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology


Eligibility criteria:
inclusion criteria: * provides written informed consent * female * age 18 years or older * suspicious or known breast lesion based on results from mammography or ultrasound * planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the mri exam exclusion criteria: * body weight \> 100 kg * pregnant or lactating * server or end-stage organ failure * moderate to severe renal impairment * undergoing radiotherapy or completed radiotherapy in the last 18 months * chemotherapy within 6 months of the 1st mri exam
study of weight loss effect of the sequential balloons

Conditions: Weight Loss; Balloon

Summary: the effect of the balloon on weight loss is investigated by multiple studies. however, the effect of the sequential balloons is not studied yet.

we are aiming to study the effect of the sequential balloons in the patients who had weight loss with the first balloon and they need subsequent balloons to have more weight loss after their first balloons are removed after 6 months.

Eligibility criteria:
inclusion criteria: * bmi \> 45 and weight \>120 kg * patients refused to have bariatric surgery. exclusion criteria: * esophageal or gastric or duodenal lesions. * bleeding disorders. * uncooperative patients.
a study of liposomal doxorubicin in women with breast cancer exploiting tissue doppler imaging

Conditions: Breast Cancer

Summary: the randomized lite study will compare liposomal doxorubin versus standard epirubicin in the treatment of female breast cancer. in order to detect as early as possible post-chemotherapy cardiotoxicity, tissue doppler imaging parameters elicited at transthoracic echocardiography will be used and will constitute the primary and co-primary end-points.

the randomized lite study will compare liposomal doxorubin versus standard epirubicin within a comprehensive adjuvant or neo-adjuvant chemotherapy regimen in women undergoing treatment for breast cancer. the study will enrol a total of 80 patients, randomized 1:1 to liposomal doxorubin vs epirubicin. standard and tissue doppler imaging parameters will be appraised at transthoracic echocardiography will be used and will constitute the primary and co-primary end-points. in addition, other efficacy and safety end-points will be appraised, including disease free progression.

Eligibility criteria:
inclusion criteria: * women with age ≥18 and ≤65 years * histological and/or cytological diagnosis of clinically non-metastatic breast cancer (c/ptall, c/pnall, cm0) * indication for integrated treatment with surgical intervention associated with adjuvant or neo-adjuvant chemotherapy, endocrinological and radiation therapy, including adjuvant or neo-adjuvant chemotherapy with anthracycline * ecog (eastern cooperative oncology group) performance status ≤2 * normal kidney, hepatic and hematological function * normal lv ejection fraction at baseline (≥50%) * negative pregnancy test in fecund women exclusion criteria: * metastatic breast cancer * past radiation therapy and chemotherapy * hypertension and other cardiovascular risk factors * prior valvular heart disease * cardiomyopathy * chronic or acute congestive heart failure * lv systolic dysfunction (ejection fraction\<50%) * abnormal complete blood count * pregnancy * breast-feeding

Keywords: breast cancer echocardiography neoplasia
association between nonalcoholic fatty liver disease and acute pancreatitis

Conditions: Acute Pancreatitis; Nonalcoholic Fatty Liver Disease

Summary: the early evaluation of ap severity are vital. previous studies have shown non-alcoholic fatty liver disease (nafld) is associated with severity of acute pancreatitis (ap). this study is aimed to investigate the relationship between nafld and ap severity.

acute pancreatitis (ap) is a potentially lethal disease capable of wide clinical variation. severe acute pancreatitis (sap) is devastating, with a mortality rate ranging from 10% to as high as 85%. so it's important to identify severe patients which require aggressive early treatment and prolonged specialist care. there are a lot of multifactorial scorings and specific laboratory tests in predicting ap severity, such as ranson's, acute physiology and chronic health examination (apache)-ii, serum interleukin-6 (il-6), and c-reactive protein (crp) level. however, they have limitations in predicting outcomes of ap patients. the biochemical markers are not accurate enough. ranson's scores were calculated after 48 hours of admission. their practical utilization as predictors of severity is tough. novel prognostic biomarker is needed to further develop for prognosis in ap patients. nonalcoholic fatty liver disease (nafld) refers to fat deposition and oxidative stress of free radicals in hepatocytes. nafld is the most common chronic liver disease worldwide. the prevalence averages 30% in developed countries, and estimated to be 10% in developing countries. its presentation ranges from asymptomatic steatosis to fibrosis, and cirrhosis with 3-5%. it is evident clinically with increased risk of developing obesity, cardiovascular diseases (cvd), hyperlipidaemia, and type 2 diabetes mellitus (t2dm). acting as an endocrine organ, the liver is the source of adipokines and inflammatory cytokines. alterations in the production and secretion are increased in patients with nafld. it is strongly related to insulin resistance (ir) and metabolic disorders. previous studies noted that nafld is closely related to severity of ap. ct scans are usually performed at admission to diagnose ap severity, which are also helpful to assess nafld. it could act as a valuable prognostic factor in ap patients and help to recognize potential severe patients. however, no clear pathways could explain the association between nafld and ap at present. besides, the data is scarce. more research will pay more attention to this topic. in this study, the investigators investigated the association between nafld and ap.

Eligibility criteria:
inclusion criteria: 1. diagnosed with ap 2. age \>18 years exclusion criteria: 1. an age of \<18 years 2. without complete data and ct scans 3. previous splenectomy or hepatectomy 4. a past history of ap 5. an ambiguous pancreatic margin
the effect of the microbiome on immune checkpoint inhibitor response in melanoma patients

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8

Summary: this pilot trial studies the effect of the microbiome on immune checkpoint inhibitors response in patients with melanoma by collecting stool and blood samples. gut microbiome plays a critical role in response to immune checkpoint inhibitors. studying the change in an individual's microbiome due to corticosteroid use may help researchers to determine whether an individual's microbiome can predict their response and toxicity to immune checkpoint inhibitors.

primary objective: i. to determine if the microbiome alpha-diversity is predictive of response (response evaluation criteria in solid tumors \[recist\] version \[v\] 1.1) at a 12-week computed tomography (ct) scan or toxicity. secondary objective: i. to determine the recruitment and compliance rates for longitudinal biospecimen collection, including stool, in melanoma patients. exploratory objective: i. to determine if individual microbes or their changes in relative abundance are predictive of response or toxicity. outline: patients complete a food frequency questionnaire (ffq) at baseline, undergo collection of stool samples at baseline, within 2 days of starting corticosteroid treatment (if applicable), when asked for a control sample, and at 12 weeks, and undergo collection of blood samples and computed tomography (ct) at baseline and 12 weeks.

Eligibility criteria:
inclusion criteria: * eligible patients include adults with stage iii, iv melanoma, to be treated with pembrolizumab or nivolumab, regardless of other concurrent therapy or line of treatment exclusion criteria: * patients will be excluded if they are undergoing active systemic or oral corticosteroid use at start of immune checkpoint inhibitors (ici) cycle 1, with the exception of adrenal replacement dosing.
predicting dropout and outcome from neuropsychological functions in sud patients

Conditions: Substance Use Disorder (SUD)

Summary: the aim of this project is to gain a more specific understanding of how different cognitive profiles predict residential treatment drop-out, treatment retention and post-treatment outcome in a population with substance use disorder.

this project collects the neuropsychological profile of residential sud patients, in addition to treatment length, exit reason, hospital journal data and post-treatment clinical outcome data. the project aims to identify clinically relevant neurocognitive domains that predict treatment dropout and post-treatment clinical outcome. this will make it possible for future clinicians to focus their effort on neurocognitive functions most relevant for this particular patient group. research questions: 1. what neurocognitive domain (and sub-domain) are the strongest predictor of treatment drop-out and retention? 2. what neurocognitive domain (and sub-domain) are the strongest predictor of post-treatment clinical outcome variables such as drug use, health and social integration. 3. will data on treatment length, age, gender, substance abuse history or psychiatric co-morbidity predict outcome independently, or in interaction with, the neuropsychological profile? this longitudinal prospective cohort study aims for a continuous collection of neuropsychological data baseline and post-treatment follow-up data until 2030.

Eligibility criteria:
inclusion criteria: * substance use disorder (sud) patients. * 18 years or older. * qualified to consent to research participation. * able to speak and write in norwegian. exclusion criteria: * not qualified to consent to research participation. * insufficient understanding of norwegian.

Keywords: neuropsychology cognition drop-out follow-up
rebound hernia repair device mesh trial

Conditions: Inguinal Hernia

Summary: this is a post-market study of the rebound hernia repair device to further establish the safety, efficacy, and utility of the rebound hernia repair device in a controlled population. the rebound hernia repair device will be used for its approved indication in comparison to "standard" hernia mesh. two-way students t-tests, chi squared analysis and anova will be used to detect differences in variables. the study is sufficiently powered to detect a 25% difference. the study data will include quality of life assessments, visual analogue scale , sf-36, carolinas comfort scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.


Eligibility criteria:
inclusion criteria: * 18 to 80 years of age * unilateral or bilateral inguinal hernia (moderate in size), primary in nature exclusion criteria: * unable to provide informed consent * assessed as asa 3 or 4 * renal failure;creatinine greater than 2.0mg percent * ascites as determined by clinical suspicion/ultrasound confirmation * known pregnancy * femoral hernias * diabetes requiring injectable insulin * prior lower abdominal surgery through lower midline or pfannenstiel incision * tapp approach * requiring anticoagulants during surgery * participation in another study involving another device or drug * emergent procedures for hernia incarceration and strangulation * recurrent inguinal hernias

Keywords: inguinal hernia mesh hernia repair device