Kornimate/medical-research-clean huggingface dataset:
vitamin d3 effects on musculoskeletal symptoms with use of aromatase inhibitors

Conditions: Muscle Pain; Joint Pain

Summary: the purpose of this study is to determine whether vitamin d3 supplements will decrease the muscle and bone pain that are reported by women who take aromatase inhibitors.

this project will determine the efficacy of vitamin d3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. the aromatase inhibitors (ai) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. these symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (aimss), decrease quality of life and medication adherence. identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. we hypothesize that vitamin d3 may decrease symptoms associated with the use of aromatase inhibitors.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * women with a history of stage i-iiia invasive breast cancer * history of hormone-receptor positive cancer (either er + or pr + or both) * are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of ai treatment remaining * are experiencing aimss exclusion criteria: * unable to read or understand english * history of psychiatric disability affecting informed consent or compliance with drug intake * malabsorption syndrome or inability to take oral medication * has less than 7 months of ai therapy remaining
expanding rapid ascertainment network of schizophrenia families in taiwan

Conditions: Schizophrenia

Summary: this proposal responds to request for applications rfa-mh-08-131, which seeks applications that propose to enrich pre-existing resources for schizophrenia in the national institute of mental health (nimh) human genetics initiative and to apply genomic methods to further the investigators understanding of the molecular etiology of the disorder. the overarching aims of this proposal are to quickly and cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to discover causal variants for the disorder in the first family-based genome-wide association study (gwas) of the disorder. in taiwan, there is no such kind of policy to support this kind of gwas study as it is a very expensive study, including collecting large family samples and genome-wide single-nucleotide polymorphism (snp) scanning. the investigators, thus, collaborate with professor ming t, tsuang and his entended subcontracted researchers to apply for this project. the investigators, the research team in taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. through additional ascertainment within this framework, the investigators will collect an aggregate sample with adequate power for detecting in a gwas those variants that make even small contributions to the risk for the disorder. the investigators will meet the overarching goals of this project by accomplishing several specific aims, as follows: 1) rapidly ascertain schizophrenia trio families from taiwanese clinical ascertainment sites; 2) supplement nimh genetics initiative collections by sending all clinical data and biomaterials to the appropriate repositories; 3) assess the association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (snps) and their constituent haplotypes; 4) analyze quantitative schizophrenia phenotypes such as age at onset ; 5) perform a genome-wide survey for copy-number variations related to schizophrenia; 6) test for gene-gene interactions (epistasis); and 7) test for gene-environment interactions, such as the well-established effect of season of birth.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia and their parents, and parents are still alive exclusion criteria: * person with mental retardation * persons with epilepsy * alcohol or substance abuse combined * in combination with other organic brain damage syndrome
a study to evaluate the effect of bms-955176 on pharmacokinetics of dolutegravir and the effect of dolutegravir on the pharmacokinetics of bms-955176

Conditions: Infection, Human Immunodeficiency Virus

Summary: the purpose of this study is to evaluate how bms955176 affects pharmacokinetics (pk) of dolutegravir (dtg) and also how dtg administration affects the pk of bms955176


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. target population: healthy males and females. 3. women of child bearing potential (wocbp) with negative serum pregnancy test 4. women must not be breastfeeding 5. men and wocbp must agree to follow instructions for contraception exclusion criteria: 1. history of any chronic or acute illness, gastrointestinal disease, gi surgery, cardiac disease or clinically significant cardiac arrhythmia 2. history of frequent headaches or acute diarrhoea. 3. any major surgery within 4 weeks of study drug administration 4. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population 5. history of allergy to hiv maturation and integrase inhibitors,or related compounds 6. history of smoking
influence of ribavirin on the initial virological response in treatment naïve patients with hepatitis c genotype 1 infection

Conditions: Hepatitis C, Chronic

Summary: this study examined the influence of ribavirin on the initial virological response in treatment-naïve participants with chronic hepatitis c, genotype 1. participants were randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000 milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon (peg-ifn) alfa-2a (pegasys®) 180 micrograms (mcg) subcutaneously (sc) weekly, for 6 weeks. following the initial 6 weeks, all participants received combination therapy with peg-ifn alfa-2a plus ribavirin (copegus®) for 12 weeks. if there was an initial virological response after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks outside of the study.


Eligibility criteria:
inclusion criteria: * caucasians, male or female aged between 18 and 70 years * indication: serological proof of a chronic hepatitis c infection with positive result of anti-hepatitis c virus (hcv) test and detectable hcv- ribo nucleic acid (rna) in serum * proven hcv genotype 1 by means of the reverse hybridization assays * proven histological infection activity within the liver with or without proven compensated cirrhosis within the last 24 months prior to start of the study (child-pugh degree a) * participants without previous anti-hcv therapy exclusion criteria: * known hypersensitivity to interferon or ribavirin or any of the other component parts * pregnant or nursing women, women with child bearing potential and without using a high effective method of contraception. the urine and serum pregnancy test at visit 0 in fertile participants or cohabitants of participants must show a negative result * male partners of pregnant women * infection with hcv genotype 2, 3, 4, 5, or 6 * pretreatment with interferon and/or ribavirin * immunocompromised participants * treatment of systemic anti-neoplastic or immunomodulatoric medication (including supraphysiological doses of steroids or radiation therapy) within the last 6 months prior to the start of treatment and during the complete time interval of study treatment * chronic hepatitis due to hepatitis c virus (e.g. haemochromatosis, autoimmunohepatitis, metabolic or alcohol-related liver disease) * decompensated liver cirrhosis or liver disease child-pugh degree b or c or condition after decompensation * signs of a hepatocellular carcinoma within 2 months prior to randomization in case of a cirrhosis or a transition to cirrhosis * ascites or esophagus varices with bleedings as documented in anamnesis * any medical condition that questions in the opinion of the investigator the participant's enrollment and participation in the trial * hemoglobin \<13 grams/deciliter (g/dl) in females and \<14 g/dl in males in screening phase * patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or patients which would be at a particular medical risk in case of an anemia * diagnosed neutropenia \<1.500/microliter (mcl) or thrombocytopenia \<90.000/mcl in screening phase
a study to evaluate the drug levels, efficacy and safety of deucravacitinib in pediatric participants with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. this study includes two cohorts; cohort 1 (age 12 to \<18 years) and cohort 2 (age 4 to \<12 years), with two parts; for each cohort. part a will evaluate the drug levels of bms-986165 to enable selection of 2 dose levels to be studied in part b. part b will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. the 5-year long-term extension (lte) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed parts a or b of the study.


Eligibility criteria:
inclusion criteria: * males and females aged 12 to \<18 years for cohort 1. males and females aged 4 to \<12 years for cohort 2. * plaque psoriasis for at least 6 months * moderate to severe disease * candidate for phototherapy or systemic therapy * must have completed the week 52 treatment period in part a or b for long-term extension (lte) period exclusion criteria: * participants weighing ≤ 30.0 kg at screening for cohort 1 (age 12 to \< 18 years), part a and part b. participants weighing ≤ 18.0 kg at screening for cohort 2 (age 4 to \< 12 years), part a and part b. * other forms of psoriasis * history of recent infection * prior exposure to deucravacitinib (bms-986165) or active comparator * evidence of active tb for lte period other protocol-defined inclusion/exclusion criteria apply

Keywords: adolescent psoriasis bms-986165 clinical trial deucravacitinib pediatric pediatric psoriasis plaque psoriasis psoriasis
flaxseed lignan supplementation in elderly participants with stage i hypertension

Conditions: Hypertension

Summary: current recommendations today suggest that use of therapeutic lifestyle changes, such as supplementation with specific dietary components and moderate exercise, are appropriate interventions for individuals with borderline high blood pressure. dietary intervention with natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular disease (adolphe 2010). lignans are the active compounds in flaxseed believed to mediate the cardiovascular health benefits following flaxseed consumption (peterson 2010). clinical trials indicate benefit of flax lignan enriched complex (flc) (beneflax® from archer daniels midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing blood cholesterol and glucose (pan 2007; zhang 2008) and blood pressure (cornish 2009). furthermore, a recent study in atherosclerosis patients showed significant clinical benefit of flaxseed meal for reducing blood pressure (rodriguez-leyva 2013). as a therapeutic lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the effectiveness of flc supplementation alone or in combination with moderate exercise merits investigation.


Eligibility criteria:
inclusion criteria: * high normal blood pressure (130/85 - 139/89) or stage i hypertension (140/90 - 150/90) * ability to follow simple instructions exclusion criteria: * age below 60 years. * individuals living in long term care homes. * individuals unable to walk for 30 minutes. * unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study ). * current cancer or diagnosed with cancer in the past 2 years. * significant liver or other gastrointestinal disorder including inflammatory bowel disease. (while constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication) * significant kidney disorder. * have taken oral antibiotics in the past three months * unstable or severe cardiac disease, recent myocardial infarction, or stroke (either in past 6 months or significantly affecting physical mobility). * unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder. * migraine with aura within the last year (as this is a risk factor for stroke). * current diagnosis of a bleeding condition, or at risk of bleeding. * significant immune-compromise. * current use of hormone replacement therapy (except thyroid). * current use of blood pressure medications and/or diuretics * current use of flax seed supplement * participation in any other clinical trial with an investigational agent within one month prior to randomization.

Keywords: high normal blood pressure stage i
ms detection of somatic mutations in hematological malignancies

Conditions: Hematological Malignancy

Summary: detection of somatic mutations in hematological malignancies is now routinely assessed by ngs sequencing. this powerful approach is nevertheless time consuming and its costs represent limitation for its availability. an original approach is now available, using mass spectrometry (ms). in this study the analytical performance of both methods will be compared, using samples that were previously analyzed by ngs. the goal of the study is to assess whether ms can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies


Eligibility criteria:
inclusion criteria: * adults \>18 years old * anonymized samples already studied with ngs in strasbourg university hematology center for somatic mutations * non-opposition of the patient for testing the archive sample with the new method exclusion criteria: * opposition for testing the archive sample with the new method * insufficient archival material * patient under protection

Keywords: hematological malignancy mutations ngs sequencing mass spectrometry
canola oil multi-center intervention trial ii

Conditions: Cardiovascular Disease; Metabolic Syndrome

Summary: building on the findings from the investigators previous study, comit i, the purpose of the comit ii study is to supplement the dexa measurement of body composition with a supplementary dexa measurement of visceral adipose tissue and to specifically target the impact of oleic acid consumption on body composition as the primary objective. comit ii also will include analysis of fatty acid ethanolamines (faes) and their precursors to elucidate the mechanisms by which canola oil may be modifying body composition, measurement of endothelial function, inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.


Eligibility criteria:
inclusion criteria: * waist circumference ≥94 cm for men and ≥80 cm for women * elevated triglycerides - ≥150 mg/dl and ≤ 400 mg/dl * reduced hdl - \< 40 mg/dl for men and \< 50 mg/dl for women * fasting glucose - ≥ 100 mg/dl and ≤ 126 mg/dl * elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm hg \[unmedicated participants - upper limit of stage 1 hypertension: systolic \< 160 and/or diastolic \<100 mm hg and participants must be free of end stage/target organ disease symptoms\] \[bp medicated participants: acceptable as long as individuals meet the specified blood pressure range of \<140/90 mmhg, and have been stable for at least 6 months\] exclusion criteria: * individuals with thyroid\*\*, kidney, or liver disease \[individuals with thyroid disease whose blood values are within normal limits and that have been stable (on medication) for the past 6 months are considered eligible\] * individuals with diabetes mellitus * smokers * individuals consuming \>14 alcoholic beverages per week * individuals taking lipid lowering medication (ex: cholestyramine, colestipol, niacin, cloribrate, gemfibrozil, probucol, hmg coa reductase inhibitors) for at least the last 3 months * pregnancy or lactation
effect of wb-ems on parkinson's disease

Conditions: Parkinson Disease

Summary: the aim is to establish adequate and suitable protocols for pd patients and to determine the wb-ems effects on muscle strength, balance, walking, cognitive functions,neurotrophic factors and alpha-synuclein. thirty-six pd patients, aged from 50 to 80 years, will be recruited and randomly assigned to two experimental groups (egs and egc) and one control group (cg), in order to perform dynamic movements with wb-ems. egs will undergo to 12-20 minutes of progressive supervised wb-ems (4 sec. 85 hz and 4 sec. rests) combined to light dynamic movements, two-time per week for 12/24 weeks. ege will undergo to 12-20 minutes of progressive supervised wb-ems 7 hz) combined with cardiovascular training with rowing machine. cg will not perform any type of physical activity. pre and post intervention assessment will be carried out on the following areas: physical assessment, neurocognitive, neurotrophic factors and alpha-synuclein assesments. a 3 months follow-up will be performed.


Eligibility criteria:
inclusion criteria: * age from 50 to 80 years old * clinical diagnosis of parkinson's disease from 1 to 3 of hoehn and yahr scale * no partecipation to other physical activity program exclusion criteria: * mmse values \< 24 * inability to walk 6 minutes without assistance * use of medications and other things that may affect cognitive and motor functions * presence of contraindications in the use of wb-ems
comparison of effects of mobilization with movement and kinesiotaping in patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: patellofemoral pain syndrome (pfps), also known as the anterior knee pain, is one of the most common musculoskeletal disorders. most of the patients suffer from knee pain for long time. the aim of this study was to investigate the short-term effects of mobilization with movement and kinesiotaping on pain, function and balance in patient with pfps.

patellofemoral pain syndrome is one of the most common musculoskeletal problem in the world. it's incidence is also becoming higher and most people who have knee pain suffer from it for long time. in the treatment of pfps, conservative treatment methods are preferred prior to surgical ones. when the literature was reviewed, no study in which mobilization with movement (mwm) method was used and in which the effects of it was shown and compared with (kinesiotaping) kt has been found so far with respect to the treatment of pfps. thirty-five female patients diagnosed with unilateral pfps were randomly assigned into 2 groups. the patients in the first group (n=18) received two techniques of mobilization with movement intervention while kinesiotaping was applied to the other group (n=17). both groups were treated with exercise. all patients received 4 sessions of treatment twice a week for a period of 2 weeks and followed up in accordance with a 6-week-home exercise program. primary outcomes: pain severity, knee range of motion, hamstring flexibility, and physical performance (10-step stair climbing test, timed up and go test), kujala patellofemoral pain scoring and y-balance test were assessed.

Eligibility criteria:
inclusion criteria: * having knee pain at least 3 months and more than 3 points according to visual analog scale exclusion criteria: * no complying to the rehabilitation * if patient wants to finished and want to complete study, they were excluded * having meniscus, bursa, ligament, patellar tendon lesions, patellofemoral dislocation and/or recurrent subluxation, undergone lower extremity surgery

Keywords: knee mobilization taping function balance
influence of the dominance of the shoulder stabilized by the open latarjet procedure on the functional recovery of the shoulder at 4.5 months postoperatively.

Conditions: Latarjet; Shoulder Injuries

Summary: the aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of latarjet at 4.5 months postoperatively compared to healthy controls.


Eligibility criteria:
* patients from two studies : "reproducibility of functional tests of the shoulder for the return to sport of patients operated on anterior instability of the shoulder "cpp n ° 2018-a03013-52 and "validation of the s-starts composite score to assess the functions of the shoulder and the patient's ability to return to sport after stabilization of the shoulder by the latarjet procedure (val-s-starts)" mr3016020520 * healthy volunteers from two studies : "reproducibility of functional tests of the shoulder for the return to sport of patients operated on anterior instability of the shoulder "cpp n ° 2018-a03013-52" and "risk factors for shoulder dislocation in rugby players. predictive validity of the s-starts composite score "mr4612110620 inclusion criteria: patients: o patient between 15 and 45 years old * occurrence of the injury requiring surgery during a sports activity * reduced shoulder instability by the open latarjet procedure * surgery performed by surgeons from the santy orthopedic center (lyon) * inclusion by decision of the surgeon during the visit 4 months postoperatively healthy volunteers : * volunteer between 15 and 45 years old * practice a regular sporting activity both groups: * patient having signed an informed consent * subject affiliated or beneficiary of a social security scheme exclusion criteria: patient group: * contraindication of the surgeon * have another pathology in the upper limbs * present a constitutional hyperlaxity * have stiffness or recurrence of dislocation of the shoulder post-surgery healthy volunteers : * medical history of upper limb pain / injury within the past 12 months * medical history of orthopedic surgery on the upper limbs both groups: * protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
study of cm518d1 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of cm518d1 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * 1. male or female ≥ 18 and ≤75 years of age. * 2. subjects with histologically or cytologically confirmed advanced solid tumors. * 3. at least one measurable lesion according to recist v1.1. * 4. expected survival time ≥ 3 months as judged by the investigator. exclusion criteria: * 1. subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or antibody-drug conjugates(adcs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter). * 2. subjects who have received major surgery within 28 days prior to the first dose. * 3. subjects who have received radiotherapy within 21 days prior to the first dose. * 4. subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose. * 5. subjects who have received any cdh17-targeted therapy. * 6. history of other malignancies within 5 years prior to the first dose, excluding cured basal or squamous cell carcinoma of skin, carcinoma cervix in situ, or breast ductal carcinoma in situ. * 7. hypersensitivity to the investigational drug or its excipients. * 8. pregnant or lactating female patients.