Kornimate/medical-research-clean huggingface dataset:
a study of ly2090314 in patients with advanced or metastatic cancer

Conditions: Advanced Cancer

Summary: the purpose of this study is to determine a recommended phase 2 dose and dosing regimen of ly2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. part a of this study will consist of dose escalation of the study regimen, and part b will consist of an expanded cohort to confirm the dose provided from part a.


Eligibility criteria:
inclusion criteria: * have a performance status of less than or equal to 2 on the eastern cooperative oncology group (ecog) scale * have a life expectancy of greater than or equal to 12 weeks * males and females with reproductive potential agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug * have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease for which no proven effective therapy exists * have the presence of measurable or nonmeasurable disease as defined by the response evaluation criteria in solid tumors (recist) * have adequate hematologic, hepatic, and renal function * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-c or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy. exclusion criteria: * have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication * have serious preexisting medical conditions (left to discretion of investigator) * have one of the following conduction abnormalities: corrected time between start of q wave and end of t wave (qtc) prolongation \>450 millisecond (msec) on screening electrocardiogram (ecg), previous history of qtc prolongation with another medication that required discontinuation, congenital long-qt-syndrome, or left bundle branch block (lbbb) * are taking any concomitant medication that may cause qtc prolongation, or induce torsades de pointes * have systolic blood pressure greater than or equal to 140 millimeters of mercury (mm hg), and diastolic blood pressure greater than or equal to 90 mm hg that is not controlled by medical therapy * have serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the new york heart association class ii or higher; have history of arrhythmia that is symptomatic or requires treatment * have chronic atrial fibrillation and/or bradycardia * have uncorrected electrolyte disorders including potassium \<3.4 molar equivalent per liter (meq/l) (\<3.4 millimole per liter \[mmol/l\]), calcium \<8.4 milligram per deciliter (mg/dl) (2.1 mmol/l), or magnesium \<1.2 mg/dl (\<0.62 mmol/l) * have symptomatic central nervous system (cns) malignancy or metastasis (screening not required) * have a hematologic malignancy * females who are pregnant or lactating
the crosstalk between calcium-sensing receptor signaling and endocannabinoid system in primary hyperparathyroidism

Conditions: Primary Hyperparathyroidism

Summary: despite the strong association of hyperparathyroidism with arachidonic acid related lipid signals, little research has been performed over the years. a better understanding of the link between arachidonic acid remodeling, prostaglandin and endocannabinoid production with primary hyperparathyroidism in primary tissue/cells might open up new avenues for biomarker and thus to a potential therapeutic target. arachidonic acid remodeling might also have an impact on depression and elevated cytokines in patients with primary hyperparathyroidism. the investigators therefore will assess the correlation between postoperative improvement of phq-9 and cytokine levels with arachidonic acid remodeling.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * primary hyperparathyroidism with planned surgery * written informed consent exclusion criteria: * age \<18 years * secondary/tertiary hyperparathyroidism * renal insufficiency * participant is pregnant * participant is incapable of giving an informed consent
impact of physical activity on cognitive outcomes in youth with pediatric-onset multiple sclerosis (poms)

Conditions: Pediatric Onset Multiple Sclerosis (POMS)

Summary: the purpose of this study is to to determine how implementing a home-based virtual reality video (vr) game exercise program in young people with multiple sclerosis(ms) can improve disability outcomes by measuring its impact on cognitive assessments (bicams), subjective measures of cognitive, physical and psychosocial disability, and motor assessments (6mwt).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pediatric-onset ms (\<18 years) according to the 2017 revised mcdonald criteria (relapsing-remitting) * expanded disability status scale (edss) ≤ 5.0 * relapse free for the past 30 days (including no corticosteroids) * no contraindications to physical activity, including pregnancy * participant and parent (if between 15 and 18 years of age) written informed consent. exclusion criteria: * history of visual provoked seizures * edss \> 5.0

Keywords: multiple sclerosis cognitive impairment physical activity
baduanjin exercises on shoulder dysfunction post thyroidectomy

Conditions: Thyroiditis, Chronic

Summary: this study will be carried out at the outpatient clinic of the faculty of physical therapy, cairo university, el galaa general hosbital after referral from endocrine surgeon. participants will perform these exercises in a room supervisor physiotherapist. all participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

this study will investigate the effects of baduanjin exercises on shoulder dysfunction post thyroidectomy. to assign patients to different treatment groups, a table of random numbers generated by a computer was used. patients were allocated randomly into two groups using this method. this study will be carried out at the outpatient clinic of the faculty of physical therapy, cairo university, el galaa general hospital and national cancer institute in cairo to be treated in the outpatient clinic after referral from endocrine surgeon. participants will perform these exercises in a room supervisor physiotherapist. all participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

Eligibility criteria:
inclusion criteria: * they have the development of the shoulder dysfunction (range of motion limitation and shoulder pain) (limitation of 20 ≥ rom in shoulder flexion, abduction, external or internal rotation) after thyroidectomy. * patients who were 6 months to 1 year post unilateral neck dissection * aged 30- 50 years (at the time of surgery) exclusion criteria: * they had severe cardiac disease, uncontrolled hypertension and upper extremity problems started before treatment of thyroid cancer surgery. * patients with neurological disease, rheumatologically disease, communication problems, recurrent infections, and history of head or neck malignancy, history of \> 1 neck dissection, history of bilateral neck dissection, * open wounds or incision presence in the region and patients proceeding with chemotherapy (ct) or radiotherapy (rt) were barred
effect of ultrasound and laser in chronic low back pain: randomized double-blinded controled trial

Conditions: Low Back Pain

Summary: the low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.

the laser will be applied with the dosimetry 3 j/cm², 2 minutes in 6 points around the back spine, during 4 weeks. before the women will be evaluate again.

Eligibility criteria:
inclusion criteria: * chronic low back pain * 3,0 - 7,0 in the visual analogic scale exclusion criteria: * no use of medications * no other treatment * without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations * with diagnostic of low back pain
dose proportionality study with bay94-8862 ir (immediate release) tablets

Conditions: Heart Failure

Summary: this study should estimate the dose proportionality of bay94-8862 ir tablets.


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 46 years (inclusive) at the first screening examination * ethnicity: white * body mass index (bmi): \>= 18 and \<= 29.9 kg / m² exclusion criteria: * clinically relevant findings in the ecg (electrocardiogram) such as a second- or third-degree av block, prolongation of the qrs complex over 120 msec * systolic blood pressure below 100 or above 140 mmhg * diastolic blood pressure below 50 or above 90 mmhg * heart rate below 50 or above 95 beats/ min * positive results for hepatitis b virus surface antigen (hbsag), hepatitis c virus antibodies (anti-hcv), human immune deficiency virus antibodies (anti-hiv 1+2) * participation in another clinical study during the preceding 3 months (last treatment from previous study to first treatment of new study)

Keywords: cardiac disorders
bringing weight management into the primary care pediatric practice

Conditions: Obesity, Childhood

Summary: this project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.

the goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. the primary objectives include tracking changes in bmi (both absolute and percentile) and levels of hemoglobin a1c, liver enzymes (ast, alt levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. secondary objectives include tracking patient adherence, follow-up, and retention.

Eligibility criteria:
inclusion criteria: children with obesity (bmi \> 30 kg/m2 or \> 95th percentile) or in need of weight management of unwanted weight gain. exclusion criteria: none.
outcome study of highly-cross linked polyethylene vs. standard polyethylene for primary posterior stabilized (ps) total knee

Conditions: Arthroplasty, Replacement, Knee

Summary: polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. a variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. the investigators asked the following questions: (1) are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) what is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.

this prospective, randomized study will seek to enroll patients undergoing primary total knee arthroplasty. preoperative evaluation will include a detailed history and physical exam with clinical data collection (sf-36, womac, and knee society scores), a complete description of the procedure, a demonstration of the actual types of implants and tibial inserts, and an outline of the study protocol and informed consent. intraoperatively, the patient will undergo a total knee arthroplasty utilizing standard operative procedures. each patient will receive a zimmer nexgen posterior-stabilized total knee arthroplasty. during the procedure or preoperative visit, the patient will be randomized by sealed envelope to receive either a standard zimmer uhmwpe tibial insert or a zimmer highly cross-linked uhmwpe tibial insert. both surgeon and patient will be blinded to the type of implant used. there will be no variations in surgical technique and hospital management of the patients throughout the course of the study. postoperatively, the patient will be seen for routine follow-up at six weeks, 6 months, 1 year and yearly thereafter. radiographs will be obtained at each visit. clinical data forms will be completed at each visit. at the conclusion of the study radiographs will be assessed for signs of polyethylene wear, osteolysis and component loosening. the preoperative and postoperative knee scores will be calculated for each patient and compared between the patient groups with standard statistical analysis.

Eligibility criteria:
inclusion criteria: * all patients indicated for primary total posterior stabilized knee arthroplasty exclusion criteria: * patients who refused participation * patients who did not comprehend the english language to give informed consent * patients with severe knee deformity thought to require a primary constrained condylar prosthesis

Keywords: knee arthroplasty osteolysis radiolucent lines
study of gammalinolenic acid for juvenile rheumatoid arthritis

Conditions: Juvenile Rheumatoid Arthritis

Summary: objectives: i. determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.

protocol outline: this is a randomized, double blind, placebo controlled, cross over study of 12 months duration. patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease). patients are randomized to receive either gammalinolenic acid (gla) or placebo (safflower seed oil) orally. parents are asked to maintain the child's usual diet over the course of study. patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease) * active synovitis --prior/concurrent therapy-- * no more than 2 concurrent nonsteroidal antiinflammatory drugs * no more than 2 concurrent second line agents (e.g., d-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine) * must have started second line agent at least 3 months prior to study * must be on stable doses of all medications for at least 1 month prior to study * prior prednisone allowed if started at least 3 months prior to study

Keywords: arthritis & connective tissue diseases juvenile rheumatoid arthritis rare disease
ovarian cancer treatment platinum-sensitive relapse - cohort study (prospectyon)

Conditions: Ovarian Cancer

Summary: the french cooperative group gineco proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (yondelis®)-pegylated liposomal doxorubicin(caelyx)®, in ovarian platinum sensitive cancer relapse.

population : patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (yondelis®)-pegylated liposomal doxorubicin(caelyx)®.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and over, * patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive yondelis®-caelyx® in relapse platinum-sensitive * patients should be informed of the study orally and should not have any objection their data to be processed exclusion criteria: * patient participation in a clinical trial * patient non-affiliated to a social security scheme.

Keywords: ovarian cancer fallopian tube or primary peritoneal relapse platinum-sensitive yondelis®-caelyx®
nicotinic acid - pharmacokinetics, pharmacodynamics, receptor expression

Conditions: Healthy

Summary: the study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment, 3--way crossover. subjects will be randomly allocated to a treatment sequence - aab, aba or baa. the two treatments will be: * treatment a: 500 mg nicotinic acid (niacor(r)) * treatment b: niacor(r) placebo each trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. five to seven days after study day 1 of trial period 3 there will be a final safety examination.


Eligibility criteria:
inclusion criteria: * good state of health physically and mentally exclusion criteria: * treatment with any other investigational product in the last 60 days before the day of randomization into the study * regular use of medication in the last 60 days before the day of randomization into the study except of oral contraceptives in female participants * treatment in the 60 days before the day of randomization into the study with any drug known to have a well-defined potential for toxicity to a major organ, or any substance which is known to induce or inhibit hepatic drug metabolism (including general anesthetics) * any drug intake (including over-the-counter remedies) in the 2 weeks before the day of randomization into the study, unless the investigator considers a drug intake to be clinically irrelevant for the purpose of this study * any acute or chronic illness or clinically relevant findings in the pre-study examination * presence, history or sequelae of gastrointestinal (e.g. peptic ulcer), liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs * history of hypersensitivity to the investigational product * history or presence of abnormalities of the vascular bed * history or presence of a dermatologic disease or skin lesions, particular in the area chosen for flush measurement * history of allergy or hypersensitivity to other drugs or to food constituents * history of other allergic diseases or hypersensitivity, unless the investigator considers it to be clinically irrelevant for the purpose of this study * blood donation of \> 400 ml in the 60 days before the day of randomization into the study * smoking * positive result in urine screen for drugs of abuse or in alcohol breath test * known or suspected to be drug-dependent, including consumption of \> 30 g alcohol per day * pregnancy or lactation * subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Keywords: nicotinic acid flush symptom pharmacodynamic pharmacokinetic
mindfulness-based stress reduction (mbsr) for people high on the personality trait sensory processing sensitivity: a mixed methods study

Conditions: Sensory Processing Sensitivity

Summary: this study investigates the efficacy of mbsr training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. participants will be randomly allocated to either the mbsr group or the control group. the primary hypothesis is that participants in the mbsr group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. the secondary hypothesis is that in the mbsr group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores.


Eligibility criteria:
inclusion criteria: * participant has high sensory processing sensitivity (screened for by the highly sensitive person scale (hsps) with a mean score of ≥4.4) * participant is 18 years or older * participant is proficient in dutch * participant lives near the location where the mbsr training takes place (up to about 30km from nijmegen) * participant is able to travel to location of the mbsr training for all sessions * participant is available on the scheduled times of the mbsr sessions (or not available for one session with exception of the silent day) exclusion criteria: * participant has a severe psychological condition (e.g. psychotic or suicidal) * participant has followed mindfulness or meditation training (\~eight-week program) within the previous five years

Keywords: sensory processing sensitivity highly sensitive person mindfulness-based stress reduction mindfulness depression anxiety stress self-regulation
study evaluating sirolimus in end stage renal disease in high risk kidney transplant recipients

Conditions: Chronic Kidney Failure; Graft vs Host Disease; Kidney Transplantation

Summary: the incidence of efficacy failure at 12 months between two regimens.


Eligibility criteria:
inclusion criteria * age: 13 years or older, 40 kgs or more * end-stage renal disease * african-american/black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft exclusion criteria * evidence of active infection * evidence abnormal chest x-ray * patients with hiv.

Keywords: kidney transplant
methylnaltrexone vs naloxegol in the treatment of opioid-induced constipation

Conditions: Constipation Drug Induced

Summary: the purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.

opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. not only are the medical complications potentially severe, patient quality of life can also be impacted. two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. the literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.

Eligibility criteria:
inclusion criteria: * complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners) * age≥18y/o * not pregnant or lactating (negative urinary pregnancy test) * no contraindication to methylnaltrexone or naloxegol exclusion criteria: * age\<18y/o * pregnancy or lactation * contraindication to methylnaltrexone or naloxegol * assigned npo * small bowel obstruction

Keywords: constipation opioid