Kornimate/medical-research-clean huggingface dataset:
a a single dose efficacy study in inducing laxation in advance illness patients

Conditions: Advanced Illness Patients With Opioid Induced Constipation

Summary: to test the effectiveness of mntx in advanced illness subjects.

to determine the efficacy of mntx compared to placebo to induce laxation in patients receiving opioids.

Eligibility criteria:
inclusion criteria: 1. advanced medical illness with a life expectancy of 1 to 6 months 2. no clinically significant laxation within 48 hours prior to the first dose of study drug 3. on stable opioid and laxative regimen for a least 3 days prior to treatment 4. age greater than 18years 5. females of child-bearing age must have a negative pregnancy test. exclusion criteria: 1. females who are pregnant or nursing. 2. previous treatment with mntx or prior treatment with naltrexone or naloxone for treatment of oic 3. any disease process suggestive of gastrointestinal obstruction 4. fecal ostomy.
msi in circulatory dna of endometrial cancer

Conditions: Microsatellite Instability; Lynch Syndrome; Endometrial Cancer; Circulating Tumor Cell

Summary: this study aims to analyze the microsatellite instability (msi) in the circulatory tumor dna and in the tumor tissue in the patients diagnosed with uterine endometrial cancer. these data will be used for the study of "cohort study of universal screening for lynch syndrome in chinese patients of endometrial cancer" (nct03291106, clinicaltrials.gov).


Eligibility criteria:
inclusion criteria: * confirmed primary endometrial cancer before any surgical or chemotherapy treatment * signed an approved informed consents * feasible for sampling exclusion criteria: * not meeting all of the inclusion criteria
efficacy and safety of bn101 in subjects with chronic graft versus host disease (cgvhd)

Conditions: GVHD, Chronic

Summary: this is a phase 2, open-label, multicenter trial to evaluate the efficacy and safety of bn101 in subjects with chronic graft versus host disease (cgvhd) after at least first line of systemic therapy.

approximately 30 subjects will be enrolled to receive orally administered bn101 200 mg qd (once daily) study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity. subjects may receive study drug in the inpatient or outpatient setting. curative effect analysis the efficacy was analyzed based on mitt the point estimate and 95%ci of orr were calculated based on the exact probability method of binomial distribution.if applicable, a logistic regression model will be used for multivariate analysis. descriptive statistical analyses were provided for all secondary efficacy endpoints. the following subgroups will be analysed: * severe cgvhd (yes/no) * number of organs involved (\<4 vs. ≥4) * number of previous systemic cgvhd treatment (1 vs. ≥2) * duration of cgvhd before inclusion (i.e., from the time of cgvhd diagnosis to the time of inclusion) * lung involvement (yes/no)

Eligibility criteria:
inclusion criteria: * male and female subjects at least 18 years of age who have had allogenic hematopoietic cell transplant (hct). * previously received at least 1 and not more than 5 lines of systemic therapy for cgvhd * receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening; * have persistent cgvhd manifestations and systemic therapy is indicated exclusion criteria: * subject has not been on a stable dose / regimen of systemic cgvhd treatments for at least 2 weeks prior to screening. (note: concomitant corticosteroids, calcineurin inhibitors, sirolimus, mmf, methotrexate, rituximab, and extracorporeal photophoresis (ecp) are acceptable. systemic investigational gvhd treatments are not permitted). * histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening. * current treatment with ibrutinib. prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to treatment.
cetuximab and simvastatin in treating patients with advanced or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. some block the ability of tumor cells to grow and spread. others find tumor cells and help kill them or carry tumor-killing substances to them. simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. simvastatin may help cetuximab work better by making tumor cells more sensitive to cetuximab. giving cetuximab together with simvastatin may kill more tumor cells. purpose: this phase ii trial is studying giving cetuximab together with simvastatin in treating patients with advanced or metastatic colorectal cancer.

objectives: primary * to determine the percentage of patients with k-ras mutant, advanced or metastatic colorectal cancer who are free from progression and alive after 12.5 weeks following the first dose of cetuximab in combination with simvastatin. secondary * to determine the correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy. * to determine the predictive value of pten, pik3ca, b-raf, and erk and mek status. (exploratory) * to determine the predictive value of snps, proteomics, and circulating dna. (exploratory) * to evaluate cholesterol, proteomics, and circulating dna as biomarkers in this setting. (exploratory) outline: this is a multicenter study. patients receive cetuximab iv weekly and oral simvastatin once daily on days 1-7. courses repeat every 7 days in the absence of disease progression or unacceptable toxicity. blood samples are collected for laboratory studies at baseline, during study, and after completion of study. after completion of study therapy, patients are followed up for 30 days.

Eligibility criteria:
disease characteristics: * diagnosis of advanced or metastatic colorectal cancer * progressive disease in the past 3 months * failed prior oxaliplatin-, fluorouracil (5-fu)-, and irinotecan-containing regimens and have the presence of a k-ras mutation within codon 12, 13, or 61 patient characteristics: * who performance status 0-2 * adequate organ function * no history of toxicity during statin use * no other malignancy within the past 5 years * no history of severe pulmonary disease * no clinically relevant coronary artery disease prior concurrent therapy: * see disease characteristics * no prior epidermal growth factor receptor (egfr)-targeting agents * no concurrent verapamil or amiodarone

Keywords: recurrent colon cancer stage iii colon cancer stage iv colon cancer recurrent rectal cancer stage iii rectal cancer stage iv rectal cancer
biomarkers of thrombosis as predictors of venous thromboembolism risk in cancer patients

Conditions: Cancer; Thromboembolism; Thrombosis; Biomarkers

Summary: the main venous thromboembolism (vte) risk prediction model for ambulatory cancer patients is khorana. cancer thrombosis is associated with elevated thrombin generation. its quantification is a promising method for evaluating patient's thrombotic profile. this study aims to develop a predictive model of vte risk in ambulatory cancer patients, combining thrombosis biomarkers (d-dimers and thrombin generation potential) with the khorana score. this is a prospective observational study that includes newly diagnosed cancer patients proposed for anti-tumor treatment (chemotherapy, immunotherapy or targeted therapies). patients with disease progression are allowed if chemotherapy-free for 3 months. a 6-month mean incidence of vte 6-10% is expected, requiring a sample size of 600 patients. blood sample is collected at inclusion to analyze thrombosis biomarkers and blood count. the primary endpoint is the occurrence of symptomatic or incidental vte within 6 months of inclusion. models will follow a logistic approach with k-fold cross-validation (k=10). model quality will be assessed with akaike information criterion (aic) and bayesian information criterion (bic). decision for entering predictors in multivariate models will be based on p \<.10 in the univariate analysis.

the main aims will be the following: * evaluate the utility of the combination of thrombosis biomarkers (d-dimers and thrombin generation potential) with the khorana score in order to stratify vte risk in ambulatory cancer patients; * determine the potential of this new score in the stratification of cancer patients into high- and low-risk vte groups, in order to identify patients who would benefit from primary thromboprophylaxis; * determine the applicability of the thrombin generation test as an independent factor in the stratification of vte risk in the cancer population under study; * determine the predictive value of d-dimers in the cancer population under study (high versus low risk discrimination).

Eligibility criteria:
inclusion criteria: * patients older than 18 years. * newly diagnosed cancer patients, proposed for anti-tumor medical treatment (chemotherapy, immunotherapy and targeted therapies). * patients with a cancer diagnosis, previously under medical anti-tumor treatments, with disease progression proposed for a new line of anti-tumor treatment, who have not recently received chemotherapy (within the last three months). * follow-up in medical oncology, clinical hematology, and pulmonology consultations at centro hospitalar vila nova de gaia/espinho. exclusion criteria: * major bleeding in the last 3 months. * major surgery in the last 28 days. * patients on anticoagulation/antithrombotic therapy * pregnant or breastfeeding women. * patients previously submitted to bone marrow transplantation. * inaccessibility to the results of the biomarkers or other elements provided for in the khorana score.

Keywords: khorana thrombin generation venous thromboembolism
arimoclomol in amyotropic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: a multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (als)

screening up to 4 weeks treatment up to 76 weeks

Eligibility criteria:
inclusion criteria: * subject meets revised el escorial criteria for clinically possible, clinically probable / clinically probable als laboratory-supported, clinically definite als or clinically definite familial als laboratory-supported * 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath) * als functional rating scale-revised (alsfrs-r) equal to or above 35 and erect (seated) slow vital capacity (svc) % predicted equal to or above 70% at screening exclusion criteria: * tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of screening and baseline * pregnant or breast-feeding * current or anticipated use of diaphragmatic pacing * any other relevant medically significant condition which could present risk to the subject or interfere with the assessment of safety or has an increased risk of causing death during the trial

Keywords: arimoclomol als
beetroot juice - effects on performance in chronic obstructive pulmonary disease patients

Conditions: Chronic Obstructive Pulmonary Disease Moderate

Summary: the purpose is to evaluate exercise performance in patients with chronic obstructive pulmonary disease (copd) after supplementing with higher doses of dietary no3-, compared to previous studies, as beetroot juice for seven days. the secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.

the purpose is to evaluate exercise performance in patients with chronic obstructive pulmonary disease (copd) using the 6-minute walk test (6mwt) after supplementing with higher doses of dietary no3- compared to previous studies, as beetroot juice for seven days. the secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.

Eligibility criteria:
inclusion criteria: * moderate-severe chronics obstructive pulmonary disease (copd) (fev1 \<80% of predicted). exclusion criteria: * smoking, * failure to complete physical testing, * on-going participation in rehabilitation programs, * pacemaker or use of nicotine products, * oxygen mask, * beta blockers, * antibacterial mouthwash, * chewing gum or stomach-neutralizing medicine during the intervention.

Keywords: dietary nitrate physical performance blood pressure nitrite exercise
study of darunavir/r + tenofovir/emtricitabine vs. darunavir/r + raltegravir in hiv-infected antiretroviral naïve subjects

Conditions: HIV Infections

Summary: the triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. the dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). the expected efficacy profile of this combination is promising. moreover, this combination might have a better tolerance profile and has the advantage of sparing the nrti class. in the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.


Eligibility criteria:
inclusion criteria: * patient with confirmed hiv infection * age ≥ 18 years * written informed consent * male patient or non-pregnant, non-lactating female * no previous treatment with any antiretroviral drugs * hiv-1 rna \> 1000 copies/ml * indication to start an antiretroviral treatment as long as subject has also a cd4 cell count ≤ 500/mm3 either at screening or on a sample taken within 3 months before screening * no major ias-usa mutations on genotypic testing at the screening visit or on any historical genotype, if available non-inclusion criteria: * woman without effective contraception method (recommended contraception during the trial is mechanical + a second method other than an oral contraceptive) * pregnant or breastfeeding woman * woman expecting to conceive during the study * hiv-2 co-infection * creatinine clearance \< 60 ml/mn (cockcroft \& gault equation), alkaline phosphatase, asat, or alat ≥ 5 uln * patient with significant impairment of hepatic function, defined as serum albumin \ 1.7 or presence of ascites, in the absence of another explanation for the abnormal finding * cd4 \> 500/mm3 at screening, except in case of symptomatic hiv disease (defined by conditions qualifying for cdc category b or c) or cd4 ≤ 500/mm3 on a sample taken within 3 months before screening. * any major ias-usa mutation conferring resistance to one or more of reverse transcriptase or protease inhibitors on genotypic testing at screening * mycobacteriosis under treatment * malignancy requiring chemotherapy or radiotherapy * positive hbs ag * hcv infection for which specific treatment is ongoing or planned during the first year on trial treatment * known hypersensitivity to one of the trial drugs or its excipients * contraindicated concomitant treatment * anticipated non-compliance with the protocol * participation in another clinical trial with an on-going exclusion period at screening * subject under legal guardianship or incapacitation * subject, who in the opinion of the investigator, is unable to complete the study period

Keywords: hiv-infected antiretroviral naïve subjects
study of n-acetylcysteine in the treatment of patients with the m.3243a>g mutation and low brain glutathione levels

Conditions: Mitochondrial Disease

Summary: n-acetylcysteine (nac), an anti-oxidant, will be studied to investigate the effects on brain glutathione levels, cognitive skills, motor skills, and quality of life. a group of 18 participants will take either 1800, 3600 or 5400 mg per day of n-acetylcysteine (nac) for 3 months in this dose escalation study. the investigators want to determine first if the 3600 mg dose per day is safe and might provide some efficacy. if the 3600 mg dose is safe, then additional participants will be treated with 5400 mg per day of nac, for up to a total of 18 participants. if the 3600 mg per day dose is unsafe, then participants will be treated with the 1800 mg per day dose. data from this pilot study will be used to determine the most safe and effective dose of nac for a future clinical trial.

patients with the m.3243a\>g mitochondrial mutation often have low brain glutathione levels. these low levels can reduce the repair processes in the brain to fix toxic chemicals that result from a mitochondrial disorder. the investigators are aware of a potent anti-oxidant, called n-acetylcysteine (nac), that may improve the brain glutathione level when taken in sufficient quantity. in turn, cognitive and motor skill impairment may improve as these toxic levels are reduced. will be studied to investigate the effects on brain glutathione levels, cognitive skills, motor skills, and quality of life.

Eligibility criteria:
inclusion criteria: * ages 18-80 years * low brain glutathione (gsh) levels as determined by magnetic resonance spectroscopic imaging (mrsi) * individuals who carry, or are suspected of carrying the m.3243a\>g mitochondrial mutation (genetic confirmation of mutation required prior to initiation of nac) exclusion criteria: * individuals with normal brain glutathione levels * pregnant or lactating individuals * medically unstable as determined by the principal investigator * allergy to nac or other sulfur-containing drug * inability to adhere to study protocol

Keywords: m.3243a>g melas diabetes deafness
quadrant high dose rate intraoperative radiation therapy (iort) for early-stage breast cancer: a pilot study

Conditions: Breast Cancer

Summary: this study was started to validate the possibility of administering radiation therapy during surgery to the tissue surrounding the tumor once the tumor has been removed. this surrounding breast tissue is at greater risk for developing breast recurrences. this treatment may be as effective as the conventional 5-6week radiation treatment in reducing the risk of further local recurrences after breast-conserving surgery. through this study, we would like to confirm that this procedure is a safe alternative to conventional breast radiation, with no additional side effects when compared with the conventional surgery and radiation therapy.

this pilot trial will evaluate the feasibility of intra operative radiation therapy (iort) given in one fraction at the time of wide local excision as the only adjuvant radiation treatment in a group of patients with early-stage invasive breast cancer. this study will enroll 60 women, older than 60 years of age, with breast cancer not more than 2 cm in size and without evident additional tumoral foci around the tumor or in other areas of the breast. an msk radiologist will review your mammography to be sure you qualify for this study. you may be asked to undergo additional mammography or other examinations, such as breast ultrasound in order to verify that the tumor is located in a single quadrant of the breast. some of these procedures are routinely performed in all candidates for conservative breast surgery.

Eligibility criteria:
inclusion criteria: * core biopsy or prior open biopsy to establish the diagnosis. * over age 60. * no physical or imaging evidence of multicentricity or multifocality. * size equal or less than 2.0 cm radiographically, clinically node negative. * patients scheduled for breast conserving surgery exclusion criteria: * patients younger than 61 years * patients with evidence of multicentric or multifocal disease seen on imaging (mammography ) * patients with a lesion exceeding 2 cm radiographically * paget's disease or pure dcis without invasive ductal carcinoma * histotype not inclusive of ductal carcinoma * condition precluding radiation therapy * condition precluding regular follow-up * evident dimpling of the skin above the tumor * usual contraindications for bcs

Keywords: breast cancer
effect of sugared chewing gum on gastrointestinal recovery after major colorectal surgery

Conditions: Postoperative Ileus

Summary: the purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. the investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.


Eligibility criteria:
inclusion criteria: * able to freely give written informed consent to participate in the study and have signed the informed consent form * american society of anesthesiologists (asa) class i-iii (appendix iii); * due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy exclusion criteria: * mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures * american society of anesthesiologists (asa) class iv or v; * history of abdominal carcinomatosis * history of radiation enteritis * children \ 85 years of age

Keywords: chewing gum ileus gastrointestinal function colorectal surgery abdominal surgery
pilot randomized control trial of telehealth group for improving peer relationships (peers) in nf1

Conditions: Neurofibromatosis 1; Social Skills

Summary: this is a pilot randomized control trial of the ucla peers protocol delivered via telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.


Eligibility criteria:
inclusion criteria: * physician diagnosis of neurofibromatosis type 1 * age 12-17 * main language spoken in the home is english * reliable internet access * current functional impairment in peer relationships * teen is interested and motivated to participate exclusion criteria: * main language spoken in the home is not english * cognitive or developmental difficulties that affect reading comprehension or understanding of treatment material * significant behavioral concerns * other comorbid medical conditions * major surgery in past 6 months * prior social skills group treatment within past 6 months * prior participation in peers
comparing concussion education types

Conditions: Brain Concussion; Knowledge, Attitudes, Practice

Summary: the purpose of this study is to determine if there are differences in knowledge, self-efficacy, and empathy surrounding concussions, as well as intent to report a concussion, after viewing concussion education (crashcourse and brain fly-through) in 2d versus in 3d. in this randomized study, all participants will receive two types of concussion education (crashcourse and brain fly-through). participants will be randomized to the 2d or 3d (virtual reality) group, and will experience both concussion educations in that modality (either 2d or 3d).

in this randomized study, all participants will receive two types of concussion education (crashcourse and brain fly-through). participants will be randomized to the 2d or 3d (virtual reality) group, and will experience both concussion educations in that modality (either 2d or 3d). during their in person study visit, participants will complete a brief ( \~5 minute) pre-survey before viewing the crashcourse and brain fly-through concussion educations. participants will then be asked to complete a brief ( \~2 minute) survey to assess their knowledge, self-efficacy, and empathy surrounding concussions. two months later, participants will receive a brief ( \~5 minute) follow-up survey via email, assessing the same constructs.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * health professions student (ex: nursing, pt, ot, pharmacy, athletic training) and/or a student-athlete at concordia university (ann arbor or mequon campus) exclusion criteria: - have previously viewed the teachaids crashcourse concussion education