Kornimate/medical-research-clean huggingface dataset:
analyzing clinical outcomes and genomic data of american indian patient population

Conditions: Immune Checkpoint Inhibitors; Metastatic Solid Tumor; Nonsmall Cell Lung Cancer; Melanoma; Renal Cell Carcinoma; Gastrointestinal Cancer; Squamous Cell Carcinoma

Summary: the aim of this study is to describe the outcomes in american indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

immune checkpoint inhibitors have been shown to increase survival in metastatic solid tumor patients when compared to the previously standard of care chemotherapy. epidemiologic studies of american indian cancer patients demonstrated having significantly worse survival when compared with caucasians when controlled for age, sex, alcohol abuse, smoking, insurance, and disease stage. there are no current studies specifically examining the american indian population receiving treatment with immune checkpoint inhibitors. the aim is to describe the outcomes in american indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

Eligibility criteria:
inclusion criteria: * above age 18, * histologically and cytologically confirmed nsclc, melanoma, head and neck squamous cell carcinoma, gastrointestinal cancers,, renal cell carcinoma, or any other solid tumors where immune checkpoint therapy has been used * received immunotherapy as part of their treatment * self-identified american indian in ethnicity * patients at the stephenson cancer center between 2015 to 2021 exclusion criteria: * patients who did not receive immune checkpoint inhibitor therapy
treatment of malignant sinonasal tumours with intensity-modulated radiotherapy (imrt) and carbon ion boost (c12)

Conditions: Sinonasal Malignancies; Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses

Summary: the imrt-hit-snt trial is a prospective, mono-centric, phase ii trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (imrt) and carbon ion (c12) boost. primary endpoint is mucositis ≥ ctc°3, secondary endpoints are local control, disease-free survival, overall survival, and toxicity. planned accrual of the trial includes 36 patients with histologically proven (≥r1-resected or inoperable) sinonasal malignancies.

local control in sinonasal malignancies is dose dependent. however, dose escalation at acceptable toxicity is technically demanding even with modern radiotherapy techniques. raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher doses at comparable or reduced side-effects. methods/ design: the imrt-hit-snt trial is a prospective, mono-centric, phase ii trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (imrt) and carbon ion (c12) boost in 36 patients with histologically proven (≥r1-resected or inoperable) adeno-/ or squamous cell carcinoma of the nasal cavity or paransal sinuses. patients receive 24 gye carbon ions (8 fractions) and imrt (2.0 gy/ fraction). study objectives: incidence of mucositis ≥ ctc°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, overall survival, and toxicity (incl. mucositis ctc °i-ii and late toxicity at 2 years post rt)are secondary endpoints.

Eligibility criteria:
inclusion criteria: * histologically confirmed or surgically removed adenocarcinoma or squamous cell carcinoma of the nasal cavity or paranasal sinuses * inoperable tumour or refusal to undergo surgical resection * macroscopic or microscopic residual tumour (r2/ r1) or * ≥t3/t4 or * written informed consent * pts aged 18 - 80 years * effective contraception for pts in childbearing age (\<12 months post beginning of menopause) exclusion criteria: * prior radio- or chemotherapy for tumours of the head and neck * other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators * legal incapacity or limited legal capacity * positive serum/ urine beta-hcg/ pregnancy * drug abuse

Keywords: imrt carbon ion therapy paranasal sinus nasal cavity adenocarcinoma squamous cell carcinoma
food delivery, remote monitoring, and coaching-enhanced education for optimized diabetes management (freedom)

Conditions: Diabetes Mellitus, Type 2

Summary: brief summary: the freedom study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income black adults in the deep south. the intervention targets social determinants of health (sdoh) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.

detailed description: 1. freedom study (type 2 diabetes mellitus): the freedom study is a 12-month clinical trial enrolling 304 black adults with type 2 diabetes mellitus across three healthcare systems in alabama and mississippi. participants are randomly assigned to one of eight combinations of three intervention components: * digital health coaching: participants receive one-on-one phone-based coaching for optimized diabetes management. * food box delivery: food boxes are delivered every two weeks to participants' homes, * remote patient monitoring (rpm): participants receive essential supplies, including glucometers, for remote blood glucose measurement. data is monitored remotely for timely interventions. the study involves three in-person visits at baseline, month 6, and month 12, as well as two telephone study check-ins at month 3 and 9. survey packets are administered at each time point. 2. freedom-hiv study (type 2 diabetes mellitus and hiv cohort): additionally, a cohort within the study, known as the freedom-hiv study, will enroll additional 80 adults who have both type 2 diabetes mellitus and hiv. this cohort will be observed over a 6-month period and will also consist of the same three intervention components.

Eligibility criteria:
inclusion criteria: 1. self-identified as black/african american 2. icd diagnosis of t2dm 3. ≥18 years of age 4. ongoing insulin treatment 5. hba1c ≥8% within 6 weeks of study screening 6. has the ability to converse in and read english 7. must provide written informed consent prior to enrollment exclusion criteria: 1. current enrollment in any diabetes-related interventional study 2. cognitive impairment 3. end-stage kidney disease (ckd-5) 4. pregnant or plans to become pregnant within 12 months 5. currently enrolled in a structured lifestyle change program 6. enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention hiv cohort criteria inclusion criteria 1. ≥ 18 years of age 2. icd diagnosis of t2dm 3. hba1c ≥ 7% 4. confirmed hiv+ diagnosis 5. prescribed hiv art therapy as part of care exclusion criteria 1. current enrollment in any diabetes-related interventional study or structured lifestyle change program 2. enrolled in rpm or health coaching (except for coaching on smoking cessation) within 60 days of the intervention 3. cognitive impairment 4. end-stage kidney disease (ckd-5) 5. pregnant or plans to become pregnant within 12 months

Keywords: diabetes mellitus, type 2 hiv
study assessing the effects of chemotherapy in advanced esophagogastric adenocarcinoma

Conditions: Esophageal Neoplasms; Stomach Neoplasms

Summary: the main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.


Eligibility criteria:
key inclusion criteria: * patients with histologically verified, unresectable or metastatic, her2-negative, adenocarcinoma of the esophagus or stomach * men or women less than 80 years of age * performance status 0 or 1 * life expectancy \>12 weeks * adequate organ-function * written informed consent key exclusion criteria: * prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months * progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach * chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry * prior cumulative dose of \>300 mg/m2 of epirubicin * grade ≥ 2 side-effects from previous chemotherapy

Keywords: esophageal cancer gastric cancer
a study of rc48-adc combined with js001 for perioperative treatment of muscle-invasive bladder cancer

Conditions: Muscle Invasive Bladder Carcinoma

Summary: this study will evaluate the efficacy and safety of intravenous rc48-adc combined with js001 in perioperative treatment of muscle-invasive bladder cancer.


Eligibility criteria:
inclusion criteria: * voluntary agreement to provide written informed consent. * male or female, age ≥ 18 years. * predicted survival ≥ 12 weeks. * histologically confirmed diagnosis of muscle invasive bladder cancer (mibc) .naive of antitumor systematic treatment or radiotherapy. * have clinically non-metastatic bladder cancer (ct2-t4a, n0-1, m0) determined by imaging. * be deemed eligible for radical cystectomy (rc) + pelvic lymph node dissection (plnd). * her2 expressing (i.e. ihc 1+ 2+ or 3+) as confirmed by the local lab. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment. * male and female participants are eligible to participate if they agree to the contraception use as per study protocol. * willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. exclusion criteria: * has received other antitumor therapy before planned start of trial treatment. * history of major surgery within 4 weeks of planned start of trial treatment. * diagnosed with hbsag, hbcab positive and hbv dna copy positive, or hcvab positive, or hivab positive. * has received a live virus vaccine within 4 weeks of planned start of trial treatment. * nyha class iii heart failure. * suffering from active infection requiring systemic treatment. * uncontrolled hypertension, diabetes, interstitial lung disease, or copd; * treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment. * history of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above. * has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * pregnancy or lactation. * assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
lack of acute tolerance development to effects of nitrous oxide - 4

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. to examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.


Eligibility criteria:
please contact site for information.

Keywords: nitrous oxide acute tolerance subjective effects psychomotor analgesia healthy volunteer
pretreatment with norethindrone acetate prior to levonorgestrel ius insertion for heavy menstrual bleeding

Conditions: Heavy Menstrual Bleeding; Menorrhagia; Hypermenorrhea

Summary: problematic uterine bleeding after the insertion of the lng ius is a well documented side effect. the levonorgestrel intrauterine system (lng ius) was approved for treatment of heavy menstrual bleeding (hmb) by the fda in october 2009. to reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the lng ius.

this study will examine whether or not pretreatment with oral norethindrone acetate prior to the insertion of a hormonal intrauterine device will affect post-insertional uterine bleeding. the subjects enrolling in the study will have documented heavy menstrual bleeding (hmb) and desire the levonorgestrel intrauterine system (lng ius) (mirena®, bayer, inc. pittsburgh, pa) for symptomatic relief. hmb for this study is defined as heavy bleeding at regular intervals at least 20-40 days apart. subjects will be randomized to one of two groups. one group will receive norethindrone acetate for two consecutive months prior to lng ius insertion while the other group will proceed with direct insertion of the lng ius with no hormonal pre-treatment. subjects will be followed for a period of 180 days post lng ius insertion. bleeding patterns will be recorded daily.

Eligibility criteria:
inclusion criteria: * you must be between 18-45 years old * you have heavy periods exclusion criteria: * you are pregnant * you are currently using hormonal contraception or hormonal therapy * you have a history of pelvic inflammatory disease (and have not had a normal pregnancy since) * you had an infected abortion within the last three months * you have abnormal or cancerous cells of the cervix or uterus * you have an actine infection in your genital organs * known or suspected breast cancer * active liver disease or tumors * allergy to levonorgestrel or norethindrone * you currently have deep vein thrombosis, pulmonary embolism, or history of these conditions * you currently have active or recent (within the past year) arterial thromboembolic disease (such as a stroke or myocardial infarction) these conditions

Keywords: intrauterine system reproductive age menstrual bleeding
a herbal compound for eczema

Conditions: Eczema; Atopic Dermatitis; Inflammation

Summary: the goal of this interventional clinical trial study is to compare zax.1400.ec.02 and placebo in eczema patients. the main question it aims to answer is: • can treatment with zax.1400.ec.02 for 3 weeks improve clinical signs of skin in eczema patients? participants will be divided into two groups. one group will use zax.1400.ec.02 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks. researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by eczema after treatment with zax.1400.ec.02 for 3 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of the disease by a doctor * age range between 18 and 60 years * both sexes (male and female) * having written informed consent to participate in the study * lack of allergy to food and health products * absence of underlying diseases and immune deficiency * absence of pregnancy and breastfeeding * absence of blisters and infection caused by the disease exclusion criteria: * non-consent of the doctor directly responsible for the patient * incidence of drug product allergy * occurrence of symptoms of skin, digestive, liver or kidney diseases * patients lack of consent to continue for any reason

Keywords: eczema atopic dermatitis inflammation anti-inflammatory herbal medicines natural products
comparison and analysis of blood loss formulas

Conditions: Blood Loss

Summary: although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared.


Eligibility criteria:
inclusion criteria: - adults 18 - 90 yrs. exclusion criteria: * suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents). * surgical blood loss volume \< 200 ml. * requirement for surgical gauzes during surgery, including conversion to open surgical techniques. * transfusion of red blood cells (rbcs) during the perioperative period. * significant postoperative bleeding (\> 50 ml in surgical drains) or any other type of significant blood loss. * fluid infusions or vasoactive drugs after the first 24 postoperative hours.
pre-meal planning and expected satiety

Conditions: Adiposity

Summary: obesity is considered to be caused by an imbalance between energy expenditure and energy intake. a major determinant of our daily energy intake is the size of the meals that we consume. it has been suggested that decisions about portion sizes are often made in advance, before a meal begins. this pre-meal planning is considered to especially depend on the estimated 'expected satiety' and 'expected satiation' of different foods. further, also factors like weight concern and palatability of the food might have their influence on meal size selection. in general, it is not clear how these factors are integrated during pre-meal planning and which brain networks are involved in these decisions/this process. thus, the investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese individuals with functional magnetic resonance imaging under different cognitive instructions including pleasure, expected satiety and self-control in terms of health consequences. the investigators will explore the neural networks involved in pre-meal planning and expect them to be modulated by the before mentioned factors. further, the investigators plan to explore gender differences and expect that female subjects will select smaller portion sizes especially in the self-control condition as they are often more concerned about their weight/health. finally, the investigators will explore differences between lean and overweight subjects to elucidate factors that might lead to increased meal sizes in overweight subjects.


Eligibility criteria:
inclusion criteria: * body mass index: 18-25 kg/m²; 25-35 kg/m², * right-handed, * age: 18-35 years. exclusion criteria: * functional magnetic resonance imaging contraindications, * claustrophobia, * self-reported eating disorders, * vegan or vegetarian diet, food allergies, * intake of antidepressants, * metabolic disorders.
perioperative geriatrics intervention for older cancer patients undergoing surgical resection

Conditions: Pancreatic Cancer; Esophageal Cancer; Gastric Cancer; Rectal Cancer; Hepatobiliary Cancer; Colon Cancer

Summary: the purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.

in the proposed study, the investigators will conduct a randomized controlled trial of a perioperative geriatrics intervention versus usual care in older patients with gastrointestinal (gi) cancers undergoing surgical resection. the perioperative geriatrics intervention will entail pre- and post-operative geriatric care for patients age ≥65 undergoing surgery for gastrointestinal cancers. specifically, geriatric clinicians will evaluate and manage patients preoperatively in the outpatient setting and postoperatively in the inpatient setting as a consultant. the investigators will evaluate the effect of the perioperative geriatrics intervention on postoperative length of stay (primary outcome) and readmissions in a sample of 160 patients. the investigators will also assess the impact of the perioperative geriatrics intervention on patient-reported outcomes, including quality of life (qol) and symptom burden. the study will take place at massachusetts general hospital.

Eligibility criteria:
inclusion criteria: * age 65 or older * diagnosed with pancreatic, esophageal, rectal, colon, hepatobiliary, or gastric cancer (including patients with prior diagnosis of another cancer) * planning to receive surgical resection at mgh (including both curative and palliative resections) * verbal fluency in english exclusion criteria: * unwilling or unable to participate in the study * significant uncontrolled psychiatric disorder (e.g. psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g. dementia, cognitive impairment) which the treating clinician believes prohibits informed consent or participation in the study

Keywords: cancer surgery care
magnesium deficiency in patients hospitalized in internal medicine wards

Conditions: Hypomagnesemia

Summary: hypomagnesemia is a common entity in the inpatient and outpatient setting. in previous retrospective study hypomagnesemic patients have higher mortality and longer hospitalization. whether hypomagnesemia is merely a marker of poor prognosis, or whether replacing it can improve outcomes is unclear. the current standard of care is to discharge these patients without workup or further treatment, even if patients had received intravenous therapy while hospitalized. the investigator wish to examine prospectively whether giving replacement therapy affects mortality, length of hospital stay and overall well-being. in order to replete intracellular levels and replete magnesium stores, magnesium should be given for several months.


Eligibility criteria:
inclusion criteria: * any patient admitted over the age of 18, has hypomagnesemia (magnesium level ≤1.9 mg/dl) and is able to give consent. exclusion criteria: * a patient unable to give consent. * a patient admitted for an elective procedure. * a patient in critical condition or dying. * patients with advanced kidney disease with egfr\<15ml/min or on dialysis. * patients with severe diarrhea, precluding use of magnesium citrate. * patients already receiving magnesium supplements. * patients with severe malnutrition or life-threatening hypomagnesemia (serum level \<1mg/dl), requiring intravenous and oral replacement of magnesium.
proton therapy medical registry

Conditions: Cancer, Therapy-Related

Summary: clínica universidad de navarra proton therapy unit is establishing a registry to capture the full radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. the objectives are parameters prescribed and to have all patients treated at the proton therapy unit to be included in the registry to enable future analysis of treatment outcomes to assist in understanding, which patients can benefit from the use of protons.

proton based radiation therapy has considerable dosimetric advantages over the standard photon based external beam radiation therapy, with an increased cost. now, the clinical advantages, however, may not be identified in general, even with the improved dose distributions. in a large-scale evaluation, in time of personalized/ precision medicine, the impact of dosimetric benefit int clinical benefit meds registration studies.

Eligibility criteria:
inclusion criteria: * all patients treated at the proton center exclusion criteria: * any other than what is supplied in the inclusion criteria

Keywords: proton therapy additional relevant mesh terms: neoplasms, secondary primary neoplasms, cancer