Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of bms-908662 alone or in combination with cetuximab in subjects with k-ras or b-raf mutation positive advanced or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of the study is to identify a safe and tolerable dose of bms-908662 in combination with cetuximab; and then to evaluate the tumor response to bms-908662 when administered alone or in combination with cetuximab

phase 1: single arm study phase 2: randomized controlled, parallel

Eligibility criteria:
inclusion criteria: * subjects with k-ras (codon 12 or 13) or b -raf (v600e) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies. * histologic or cytologic confirmation of the diagnosis. * eastern cooperative oncology group (ecog) ≤ 1 * adequate organ \& marrow function. exclusion criteria: * uncontrolled or significant cardiovascular disease. * phase 2: prior therapy with a raf inhibitor.
assessing benefits of near infrared autofluorescence (niraf) detection for identifying parathyroid glands during total thyroidectomy

Conditions: Thyroid Neoplasms; Thyroid Diseases; Hypoparathyroidism; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases

Summary: this study will see if the use of near infrared autofluorescence (niraf) detection with a 'parathyroid eye (pteye)' for identifying parathyroid glands (pgs) during total thyroidectomy (ttx) is better than surgeon's detection alone. it compares risk, benefits and outcomes in ttx patients where niraf detection with pteye for parathyroid identification is either used or not used.


Eligibility criteria:
inclusion criteria: * patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland). * patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy. exclusion criteria: * pregnant women * patients with concurrent parathyroid and thyroid disease * patients with incidental enlarged parathyroid discovered during thyroidectomy procedure. * patients undergoing thyroid lobectomy or partial thyroidectomy

Keywords: total thyroidectomy intraoperative parathyroid identification near infrared autofluorescence postoperative hypocalcemia postoperative hypoparathyroidism
encouraging calcium absorption and bone formation during early puberty

Conditions: Osteoporosis; Osteopenia

Summary: increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life. the purpose of this study is to compare calcium absorption and bone growth in boys and girls on diets including either a nondigestible oligosaccharide (ndo) or simple sugar.

rapid increases in bone mass occur during calcium absorption and bone calcium deposition during puberty, and these increases can enhance peak bone mass and ultimately decrease the lifetime risk of osteoporosis. however, dietary, hormonal, and genetic factors likely affect increased bone mass. this study will examine if adding ndo to a pubertal diet allows more absorption of calcium by the body, producing stronger bones. the study will also assess how the hormones produced by the body during puberty affect bone growth and whether genetic factors affect calcium absorption or bone growth. this study will last 2 years. at study entry, baseline pubertal hormone levels and bone mass will be assessed. both a dual-energy x-ray absorptiometry (dexa) scan and a calcium stable kinetic study measuring calcium absorption will be performed. participants will then be randomly assigned to receive calcium fortified food with or without added ndo for 1 year. calcium absorption will be measured again at 2 months. after the first year, calcium kinetic, hormonal, and dexa studies will be performed and compared to baseline results. a final dexa scan will be performed at the end of 2 years.

Eligibility criteria:
* tanner stage 2 or 3 * girls must not have started menstruating * in the 10th to 90th percentile in body mass index (bmi) for their age

Keywords: bone growth calcium children diet puberty
extended delivery of bupivacaine study in herniorrhaphy

Conditions: Analgesia

Summary: this is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.


Eligibility criteria:
inclusion criteria: * is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia * has an american society of anesthesiologists physical status of i, ii, or iii * female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives. exclusion criteria: * had any prior inguinal hernia repair * has a planned concurrent surgical procedure * has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain * has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications * has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * has taken any nsaids within least 10 days prior to the scheduled surgery * has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting) * has been administered bupivacaine within 5 days prior to the scheduled surgery. * has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. * has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug * has a medical condition such that, in the opinion of the investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments * has a known history of hepatitis b, human immunodeficiency virus (hiv), or active hepatitis c * has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the investigator, might interfere with study assessments * had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix * has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. note: subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. subjects taking medical marijuana are not allowed to participate in the study. * received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives * has undergone 3 or more surgeries within 12 months * has a body mass index (bmi) \>39 kg/m2.

Keywords: herniorrhaphy inguinal hernia hernia hernia surgery postoperative pain
effects of intermittent theta burst stimulation in addition to constraint-induced movement therapy in stroke patients

Conditions: Stroke, Ischemic

Summary: in recent studies, it has been reported that intermittent theta-burst stimulation (itbs) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). in our study, it was aimed to evaluate the effectiveness of itbs applied in addition to modified constraint-induced movement therapy (mcimt). by doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.


Eligibility criteria:
inclusion criteria: * first time and unilateral stroke * 1-12 months after the incident * getting 24 points or more in mini mental status examination * being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary. * being a low-functioning patient according to the cimt criteria: a) at least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers exclusion criteria: * those who score more than 2.5 points on the motor activity log-28 scale, * who have severe pain in the upper extremity (5 and above on the visual analogue scale) and spasticity (3 and above on the modified ashworth scale), which may affect the treatment, and * those who do not have adequate communication skills. * patients who have visual problems
impact of nutritional deficit in emergency surgery

Conditions: Emergencies; Surgery; Malnutrition

Summary: patients in emergency settings might become malnourished. there are different ways to identify the group as 'at risk' of malnutrition. there are also several different ways to measure outcomes. this pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

patients in emergency settings might become malnourished. there are different ways to identify the group as 'at risk' of malnutrition. there are also several different ways to measure outcomes. this pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

Eligibility criteria:
inclusion criteria: * willing to consent, -≥ 18 years old * eligible for inclusion in national emergency laparotomy audit * first procedure during admission (\<7 days from admission). exclusion criteria: * recent discharge from hospital (within 60 days), * unable to provide informed consent * life expectancy \<12 months * prisoners * lack mental capacity * language barrier affecting ability to provide consent

Keywords: emergency surgery malnutrition pilot study
the real world study of apatinib for gastric cancer treatment in anhui province

Conditions: Gastric Cancer

Summary: the investigators conduct the real world study to explore the efficacy and safety of apatinib in gastric cancer .


Eligibility criteria:
inclusion criteria: 1. male or female patients . 2. confirmed by pathology or histology of gastric cancer 3. patients should be voluntary to the trial and provide with signed informed consent 4. the researchers believe patients can benefit from the study. exclusion criteria: 1. patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories 2. pregnant or lactating women 3. patients with apatinib contraindications 4. patients of doctors considered unsuitable for the trial

Keywords: apatinib
symptoms associated with chemotherapy-induced peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy; Breast Cancer; Breast Cancer Female

Summary: breast cancer remains the most frequent type of cancer globally. nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. chemotherapy-induced peripheral neuropathy (cipn) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with cipn of patients with breast cancer who underwent systemic chemotherapy. in addition, it was aimed to assess the potential associations between experienced symptoms of cipn and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.).

patients with breast cancer who underwent systemic chemotherapy were assessed with the european organization for research and treatment of cancer-chemotherapy induced peripheral neuropathy (eortc-cipn20) questionnaire within 1-2 months after completion of systemic chemotherapy. a simple data form was implemented in which patients' age, weight, height, marital status, smoking status, etc were investigated. in addition, the dose of the exposure of systemic chemotherapy was calculated according to the body surface area (bsa) and dubois formulation as follows: bsa \[m2\] = weight \[kg\]0.425 × height (cm)0.725 × 0.007184\]. the universal dose calculations were used to calculate the mean exposure according to the following doses for each patient-specific to their chemotherapy regimen: four cycles of anthracycline were applied 14 days apart 60 mg/m2 intravenous (iv), 12 cycles of paclitaxel were applied seven days apart 80 mg/m2 iv, and four cycles of docetaxel were applied 21 days apart 75 mg/m2 iv.

Eligibility criteria:
inclusion criteria: * being a volunteer to participate * aged over 18 years old * being female * being a candidate for systemic chemotherapy exclusion criteria: * having distant metastasis * having comorbidities that might contribute to or cause sensorial and motor deficits such as multiple sclerosis, diabetes, polyneuropathy, etc., * prolonged surgical (if any) complications (i.e. pain, seroma, etc.)

Keywords: breast cancer neuropathy chemotherapeutic toxicity chemotherapy-induced peripheral neuropathy
to assess the effect of hdf versus high flux dialysis on free light chains and cumulative albumin loss, in end stage renal disease patients.

Conditions: End Stage Renal Disease; Hemodiafiltration; Hemodialysis

Summary: removal of uremic toxins is the main goal of hd, it was improved by using high volume convective technique with high flux (hf) dialyzer. this technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life. this study will assess the effect of hemodiafiltration (hdf) versus high flux dialysis on free light chains (flc) reduction as a marker of hd adequacy and its relation to albumin loss using dialyzer effective surface area 2.6m2.


Eligibility criteria:
inclusion criteria: * prevalent hd patients on regular hemodialysis sessions for \>6 months 3 sessions/week of 4 hours duration. * patients with arterio-venous fistula as dialysis access. exclusion criteria: * patients with hemodialysis catheters. * patients with active inflammation or infection. * decompensated heart failure. * liver cell failure ( child b,c) * patients with known malignancies.

Keywords: end stage renal disease (esrd) hemodiafiltration (hdf) hemodialysis (hd) free light chains albumin loss kappa and lambda
characterisation of intestinal microbiota of patients with spondyloarthritis or rheumatoid arthritis

Conditions: Spondyloarthritis; Rheumatoid Arthritis

Summary: the primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (spa) or rheumatoid arthritis (ra) patients and healthy volunteers, by microbiota dna sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. a comparative analysis will allow to identify the biomarkers of the specific bacteria.

as secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in spa and/or ra. analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota. this study will be performed in the rheumatology department in ambroise paré hospital of aphp group in france.

Eligibility criteria:
inclusion criteria: patients: * patient ⩾ 18 years; * diagnosed as spondyloarthritis (spa) according asas classification, or rheumatoid polyarthritis according acr/eular; * affiliated to a social security scheme; * have signed the written informed consent form. healthy control subjects: * adult women and men; * subjet free of chronic pathology; * affiliated to a social security scheme; * have signed the written informed consent form. exclusion criteria: patients: * patients unable to understand the proposed study and/or sign a informed consent form; * pregnant women or breast feeding women; * patient ⩾ 18 years; * patients under guardianship or curatorship; * have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion; * presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome; * foreign patients under french ame scheme; * patients had have participated in the prior study microbiart. healthy control subjects: * subjects unable to understand the proposed study and/or sign a informed consent form; * pregnant women or breast feeding women; * subjects \< 18 years; * subjects under guardianship or curatorship; * presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome; * refusal of subjects to participate to the study; * foreign patients under french ame scheme; * subjects had have participated in the prior study microbiart.

Keywords: spondyloarthritis rheumatoid arthritis microbiota
group lifestyle balance™ for individuals with stroke (glb-cva)

Conditions: Stroke

Summary: the purpose of this rct is to examine the efficacy of the group lifestyle balance (glb) program adapted for people with stroke (cva) on primary (weight) and secondary outcomes at 3, 6, 12 months from enrollment into the program.

weight gain greatly increases the risk of chronic diseases after stroke such as diabetes, metabolic syndrome, pulmonary and heart disease. approaches to weight-loss are lacking, yet necessary, due to the unique physiological and cognitive needs of persons with cva. there is evidence that interventions that improve physical activity and healthy eating behaviors concurrently offer greatest potential for weight-loss. the group lifestyle balance (glb) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population, but not with people after cva. investigators modified the program to meet the needs of people post stroke (glb-cva). study aims: the study consists of five specific aims. specific aim 1: to create an appropriate adaptation of the dpp-glb program that meets the unique needs of people post cva (glb-cva) using a community-based participatory research approach and advisory board of key stakeholders (patients, caregivers, clinicians, researchers). specific aim 2: to establish the feasibility of delivering the glb-cva intervention. specific aim 3: conduct a randomized controlled trial (rct) to examine the effectiveness of the glb-cva on primary and secondary outcomes in the intervention group compared to the wait-list control group at 3, 6, and 12 months from baseline. specific aim 4: describe the effect of the glb-cva on metabolic biomarkers in the experimental group compared to the wait-list control group at baseline, 3, and 6 months. specific aim 5: describe the association between biomarkers of neurodegeneration and physiologic, functional, and patient reported outcomes at baseline, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * 18 to 85 years of age * bmi ≥25 * all types of stroke * at least 12 months post first stroke * physician approval exclusion criteria: * low cognition * not fluent in the english language * conditions for which physical activity is contraindicated * taking medication for type 2 diabetes * residing in a hospital, acute rehabilitation setting, or skilled nursing facility * pregnancy * pre-existing diagnosis of an eating disorder

Keywords: group lifestyle balance physical activity stroke weight-loss dietary behaviors
clinical trial in 22q13 deletion syndrome(phelan-mcdermid syndrome)

Conditions: 22q13 Deletion Syndrome; Phelan-McDermid Syndrome

Summary: the purpose of this study is to pilot the use of insulin-like growth factor-1 (igf-1) treatment in 22q13 deletion syndrome (phelan-mcdermid syndrome) caused by shank3 gene deficiency in order to evaluate safety, tolerability, and efficacy. igf-1 is an injection under the skin that contains human igf-1. igf-1 is approved by the fda under the brand name increlex for the treatment of children with short stature due to primary igf-1 deficiency. it is being used off-label in the current study and is not fda approved, nor has it yet been studied in humans for the treatment of shank3 deficiency.

overall, there will be 1-3 screening visits, a baseline visit where study drug will first be administered, and then 10 follow-up visits. follow-up visits will occur at week 2, week 4, week 8, and week 12 in each treatment phase (igf-1 or placebo), and then again 4 weeks after study completion, parents/guardians will be asked to administer the igf-1/ placebo by injection at home and will also be responsible for monitoring glucose levels in the child. parents/guardians will be trained in these methods, and will have scheduled phone calls and appointments where the dose and tolerability will be discussed. assessments include the following: * physical and neurological examination * medical and psychiatric history * x-ray of long bone (e.g., hand) to ensure your child's growth plates are not closed * electrocardiography * echocardiography * pregnancy test if applicable * lab safety measures (through blood draw) * autism diagnostic interview (adi) * autism diagnostic observation schedule (ados) * the mullen scales of early learning or the leiter international performance scale-revised * vineland adaptive behavior scale (vabs) * clinical global impressions (cgi) rating scales * the repetitive behaviors scale (rbs) * aberrant behavior checklist (abc) * the caregiver strain questionnaire (csi) * language environment analysis (lena) * the macarthur-bates communication inventory (mcdi) * unified parkinson's disease rating scale (updrs) * quick neurological screening test 2nd edition (qnst-2) * gait analysis with motion capture video systems and interactive 3-dimensional modeling systems

Eligibility criteria:
inclusion criteria: * 5 to 12 years old * pathogenic deletions or mutations of the shank3 gene * stable medication regimens for at least three months prior to enrollment exclusion criteria: * closed epiphyses * active or suspected neoplasia * intracranial hypertension * hepatic insufficiency * renal insufficiency * cardiomegaly / valvulopathy * history of allergy to igf-1 or any component of the formulation (mecasermin) * history of extreme prematurity (\<1000 grams) with associated early neo-natal complications, e.g. intra-cerebral hemorrhage, prolonged hypoxia, prolonged hypoglycemia * patients with comorbid conditions deemed too medically compromised to tolerate the risk of experimental treatment with igf-1

Keywords: shank3 igf-1 autism
clinical trial of quantitative detection kit for hsp90α in breast cancer

Conditions: Breast Cancer

Summary: detect plasma hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients

detect plasma hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients, validate accuracy, specificity and sensitivity of hsp90α kit.

Eligibility criteria:
inclusion criteria: * breast cancer patients, healthy volunteers, benign breast diseases patients exclusion criteria: * patients who previously received radiotherapy