Kornimate/medical-research-clean huggingface dataset:
foot orthoses in patellofemoral pain syndrome: a prospective randomized study of morpho-specific versus placebo orthoses

Conditions: Patellofemoral Pain Syndrome

Summary: patellofemoral pain syndrome is one of the most common musculoskeletal disorders. it is defined as an anterior knee pain. its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload. a few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. however, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study. the purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses. morpho-specific foot orthoses are designed according to the patient's morphotype. they are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.


Eligibility criteria:
inclusion criteria: * male or female aged 12-40 years * patellofemoral pain syndrome * patient affiliated to a social protection regime * patient who signed an informed consent * for teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months * patient informed of the results of the prior medical examination * normality (no sign of osteoarthritis) of the knee radiographs * ability to read and understand french exclusion criteria: * knee osteoarthritis * systemic disease * inflammatory rheumatism disease * unstable knee * prior patellofemoral dislocation * osteochondrosis * referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers) * a history of patellar trauma * a history of knee surgery * meniscus, ligament or osteochondral pathology * knee tendinitis or bursitis * neurologic disease * pregnancy * antidepressant therapy or behavioral disorder * patient unable to comply the required maximum observance * impossibility to give enlightened information to the patient * patient under guardianship

Keywords: patellofemoral pain syndrome feet orthoses koos
evolution of hypodopaminergic syndrome in early parkinson's disease

Conditions: Parkinson Disease; Apathy

Summary: the objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with parkinson's disease.

all patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study ("non motor aspects in de novo parkinson's disease (honeymoon) nct02786667") between june 2012 and june 2016. 3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again. the objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome. secondary objectives are the evolution of other parameters including pain, personality and behavior. all parameters measured have been determined of each patient in the honeymoon study.

Eligibility criteria:
inclusion criteria: * patients who participated in "non motors aspects in de novo parkinson's disease (honeymoon)" nct02786667 * patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months * patients with medical insurance * signed informed consent exclusion criteria: * diagnosis other than parkinson's disease * dementia (mattis \<130) * patients protected by law (i.e. pregnant or parturient women)

Keywords: non motor symptoms
osseoscrew versus fenestrated pedicle screws augmented with polymethylmethacrylate

Conditions: Osteoporosis; Poor Bone Quality

Summary: the purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the osseoscrew system. the osseoscrew system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. the study was designed to compare the safety and efficacy of osseoscrew compared to any other commercially available fenestrated pedicle screw system augmented with pmma for posterior spinal fixation after surgical correction of spinal deformity or pathology.

this was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the osseoscrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (pmma) (control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. the study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. spinal instability or deformity requiring fusion with instrumentation 3. osteopenia defined as (t-score of less than -1.0) 4. no response to nonoperative treatment modalities preceding enrollment. 5. subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations exclusion criteria: 1. active systemic or local infection 2. a life expectancy less than the study duration 3. autoimmune disorders 4. currently an alcohol, solvent, or drug abuser 5. psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements 6. history of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or zirconium oxide (zro2)

Keywords: osteopenia stenosis instability tumor
ai youmian (love better sleep) for people living with hiv

Conditions: Sleep; HIV Infections

Summary: people living with hiv (plwh) frequently report sleep disturbances. the social rhythm theory, which proposes that stressful life events can interfere with sleep by disrupting the stability of daily routines, provides new insights into identifying predictors of sleep disturbances and improving sleep in plwh. this study is a randomized controlled trial. plwh with poor self-reported sleep quality (pittsburgh sleep quality index\>7) was randomly divided into a control group or an intervention group. the control group receives the usual care, that is, daily disease management and routine drug guidance (set as waitlist). the intervention group received a sleep promotion intervention program based on social rhythm theory, along with daily disease management and routine drug guidance. the intervention period was 8 weeks, once a week, and the duration of each intervention was about 40-60 minutes. the sleep-related outcome indicators were measured before the intervention (t0), immediately after the intervention (t1), and 3 months after the intervention (t2), and the participants' social rhythm, daytime sleepiness, sleep belief and attitude, depression, etc. were evaluated to verify the effects of the intervention. at the same time, participants who insisted on completing all intervention modules were selected from the intervention group after the end of the whole study. self-designed satisfaction questionnaires and semi-structured interviews were used to understand the participants' experience and feedback on the intervention program. in addition, the investigator asked the reasons for the withdrawal of participants who withdrew from the study through an interview during the outcome period.


Eligibility criteria:
inclusion criteria: 1. confirmed hiv infection, 2. aged 18 years or above, 3. total score of pittsburgh sleep quality index \> 7, 4. possess basic literacy, 5. voluntary participation in the study. exclusion criteria: 1. self reported previous diagnoses of severe sleep disorder disorders such as obstructive sleep apnea, restless legs syndrome, periodic limb movement of sleep, nocturnal urinary frequency or diurnal phase shift disorder, 2. initiation of antiretroviral therapy within the past 30 days or change in antiretroviral therapy regimen within the past 30 days, 3. current treatment with psychotropic medication, or use of any medication with sedative or excitatory effects, 4. working in jobs that require night shifts that may affect the circadian rhythm and no consideration of changing jobs in the recent month, 5. currently participating in other research projects.

Keywords: social rhythm sleep quality people living with hiv
allergen challenge chamber study with single dose oral gsk835726 compared with placebo

Conditions: Rhinitis, Allergic, Seasonal

Summary: a randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose gsk835726 (100mg, 50mg, 10mg), cetirizine (10mg) and placebo to evaluate the efficacy and safety using an environmental challenge chamber in male subjects with seasonal allergic rhinitis


Eligibility criteria:
inclusion criteria: * subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. can have mild asthma. * male * aged 18 - 60 * weight 50kg+, bmi 19-32 kg/m2 * exhibit response to challenge chamber and skin prick test. * non-smoker * capable of giving informed consent exclusion criteria: * no nasal structural abnornmality/polyposis, surgery, infection. * any respiratory disease, other than mild asthma or seasonal allergic rhinitis * participated in another clinical study within 30 days. * subject has donated a unit of blood within 1 month * use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial. * history of sensitivty to drug * history of alcohol/drug abuse within 12 months. * positive hepatitis b antibody test * positive hiv antibody test * risk of non-compliance with study protocol * perenial allergic rhinitis * administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks. * past or present disease that may affect outcome, as judge by investigator * specific immunotherapy within 2 years

Keywords: proof-of-concept allergic rhinitis
comparison of effects of mrp vs ndt for balance and gait in chronic ischemic stroke patients rct

Conditions: Stroke

Summary: to determine the comparison between effects of motor relearning program (mrp) and neuro-development treatment (ndt) on balance and gait in chronic ischemic stroke patients.


Eligibility criteria:
inclusion criteria: 1. chronic ischemic stroke patients more than 6 months. (55) 2. patient with good cognitive status minimum 20 or greater out of 30 in mini mental state examinations.(56) 3. age between 45-65 years.(57) 4. patient with limb spasticity equal to 2 or less than 2 on modified ashworth scale.(56) 5. both male and female patients.(58) exclusion criteria: 1. history of neurologic disease(59, 60) 2. history of lower limb fracture.(61) 3. history of spinal cord fracture.(61) 4. patient with skin discoloration, skin ulcers and skin allergy.(62) 5. patients with a history of the recurrent stroke. (63) 6. patients with any peripheral vascular disease.(60)
effect of a carbohydrate-rich diet in healthy subjects

Conditions: Lipid Metabolism Disorder

Summary: the present research protocol will analyze whether a short-term modification (one week) of dietary habits would have an impact on the postprandial metabolism of dietary fatty acids and on their uptake by non-adipose tissues, in healthy subjects. each subject will participate in two protocols randomly determined and separated by a period of one month: a 7-day isocaloric diet (protocol a) and a 7-day carbohydrate-rich diet containing +50% of the subject's energy needs. (protocol b). at the end of each diet, the subject will go through a postprandial metabolic study of 8 hours where different parameters will be measured thanks to pet imaging and perfusions of stables isotopes.


Eligibility criteria:
inclusion criteria: healthy subjects: subjects with normal glucose tolerance determined according to an oral glucose tolerance test and with a bmi above 25 kg/m2 without first degree of familial history of type 2 diabetes (parents, siblings). exclusion criteria: * overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ecg * treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted) * presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness * smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day * prior history or current fasting plasma cholesterol level \> 7 mmol/l or fasting tg \> 5 mmol/l * any other contraindication to temporarily interrupt current meds for lipids or hypertension * being pregnant * not be barren
continuous azithromycin in cystic fibrosis patients beyond two years

Conditions: Cystic Fibrosis

Summary: azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients. it was shown that this treatment taken every day or every week for 12 months, can improve the respiratory state of patients. from the second year of treatment, it would appear there is more profit to continue such treatment. the main objective is to study the association between continuous use of azithromycin and lung function measured by forced expiratory volume in one second (fev1), after two years of treatment.


Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis (whatever the genetic form) * age ≥ 8 years * fev ≥ 30% the year of azithromycin (n0) * continuous treatment with azithromycin for at least 2 years. exclusion criteria: -

Keywords: azithromycin cystic fibrosis pulmonary function
a research study to see how much semaglutide and snac is in the milk of healthy, breastfeeding women taking semaglutide tablets

Conditions: Diabetes Mellitus, Type 2

Summary: participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. on day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide.


Eligibility criteria:
inclusion criteria: * healthy, female subjects who have given birth at least 3 months prior to screening and who breastfeed (breastfeeding is defined by feeding the baby milk produced by the mother. using a breast pump to collect milk and subsequently feeding it to the baby by bottle, is also defined as breastfeeding ) their infant to an extent, where the majority of the infant's total energy intake is from breastfeeding and sufficient milk is produced to fulfil the trial requirements, as judged by the investigator. * agree to abstain from breastfeeding their infant from first dose of oral semaglutide to the "end of trial" visit (total of 47 days) to avoid potentially exposing their child to semaglutide and snac. * the breastfed infant is able to feed from a bottle (expenses related to alternative infant nutrition during trial participation will be covered by novo nordisk) prior to screening. * age above or equal to 18 years at the time of agreement to take part. * body mass index (bmi) between 20.0 and 32.4 kg/m\^2 (both inclusive). exclusion criteria: * female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method. * glycated haemoglobin (hba1c) greater than or equal to 6.5 % (48 mmol/mol) at screening. * presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. * history (as declared by the subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). * personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject or reported in the medical records). * presence or history (as declared by the subject or reported in the medical records) of malignant neoplasm within 5 years prior to the day of screening (basal or squamous cell skin cancer, or any carcinoma in-situ is allowed). * presence or history (as declared by the subject or reported in the medical records) of pancreatitis (acute or chronic).
sentinel lymph node biopsy using peritumoral injection with blue dye confirmation

Conditions: Breast Cancer

Summary: we continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.

using a technique combining technetium-99 sulfur colloid and lymphazurin blue dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. this minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. if the sentinel node is negative, no further surgery is necessary. if positive, a complete axillary node dissection is performed. in addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.

Eligibility criteria:
inclusion criteria: * breast cancer requiring lymph node evaluation * clinically negative lymph nodes in the axilla * willing participation following an informed consent process exclusion criteria: * patients with clinically positive lymph nodes * pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis) * previous axillary lymphadenectomy

Keywords: sentinel lymph node biopsy axillary node dissection intraoperative injection lumpectomy mastectomy
long-term pharmacokinetics of tacrolimus in renal recipients

Conditions: Renal Transplantation

Summary: an evaluation of the effects of genetically determined variant metabolizing and transporting proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal transplant recipients. in a five year follow-up study tacrolimus dose-corrected exposure changes significantly and the effect(s) of single nucleotide polymorphisms of the cyp3a4/cyp3a5 and mdr1 genes on the latter is assessed in this study.

a 5-year pharmacokinetic follow-up study in 95 renal allograft recipients assessing tacrolimus exposure using repeated abbreviated area-under-the-concentration-time (auc) curve measurements at regular time points after grafting. the effects of the cyp3a5\*1, cyp3a4\*1b, mdr1 g2677t/a and c3435t single nucleotide polymorphisms on the evolution of tacrolimus disposition are studied over 5 years in order to clarify the interrelationship between cyp3a5, cyp3a4 and mdr1 genotypes, time-dependent exposure and tacrolimus-related toxicity.

Eligibility criteria:
inclusion criteria: * primary or secondary single kidney transplantation * age older than 18 yrs exclusion criteria: * combined organ transplantation

Keywords: tacrolimus pharmacokinetics cyp3a4 - cyp3a5 p-glycoprotein single nucleotide polymorphisms renal transplantation calcineurin-inhibitor-associated nephrotoxicity
molecular imaging of her2 expression in her2-positive breast cancer using 99mtc-adapt6 vs 99mtc-darping3

Conditions: Breast Cancer Female

Summary: an open-label, single center study with 99mtc-adapt6 and 99mtc-darping3 spect and biopsies of primary tumour in her2-positive breast cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mtc-adapt6 and 99mtc-darpin g3 spect in her2-positive breast cancer patients.

the primary objectives are: compare spect/ct imaging properties of 99mtc-adapt6 and 99mtc-darpin g3 in her2-positive primary tumour of breast cancer patients before system (chemo/targeted) therapy. the secondary objectives are: to compare the spect/ct tumor imaging data with the data concerning her2 expression obtained by immunohistochemistry (ihc) and/or fluorescent in situ hybridization (fish) analysis of biopsy samples.

Eligibility criteria:
inclusion criteria: 1. subject is \> 18 years of age; 2. diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy); 3. availability of results from her2 status previously determined on material from the primary tumor: her2-positive, defined as a dako herceptest™ score of 3+ or fish positive; 4. sequential injection of 99mtc-adapt6 and 99mtc-darping3 in the interval of 3-4 days in each her2-positive breast cancer patient; 5. hematological, liver and renal function test results within the following limits: * white blood cell count: \> 2.0 x 109/l * hemoglobin: \> 80 g/l * platelets: \> 50.0 x 109/l * alt, alp, ast: =\< 5.0 times upper limit of normal * bilirubin =\< 2.0 times upper limit of normal * serum creatinine: within normal limits 6. a negative pregnancy test for all patients of childbearing potential. sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination; 7. subject is capable to undergo the diagnostic investigations to be performed in the study; 8. informed consent exclusion criteria: 1. second, non-breast malignancy 2. active current autoimmune disease or history of autoimmune disease 3. active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. known hiv positive or chronically active hepatitis b or c 5. administration of other investigational medicinal product within 30 days of screening 6. ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to us national cancer institute's -

Keywords: 99mtc-adapt6 99mtc-darping3 breast cancer her2 expression
outcomes in patients taking fluticasone propionate/salmeterol combination or other inhaled corticosteroids

Conditions: Asthma

Summary: the objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("fsc 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.


Eligibility criteria:
inclusion criteria: * subjects with asthma as determined by icd-9 codes and asthma drug use * at least 12 years of age * treated with inhaled corticosteroids exclusion criteria: * subjects with copd or treatment for copd

Keywords: fluticasone propionate/salmeterol combination asthma inhaled corticosteroids outcomes