Kornimate/medical-research-clean huggingface dataset:
patient compliance for metabolic evaluation and medical management in calcium stone patients

Conditions: Kidney Calculi; Nephrolithiasis; Patient Compliance; Calcium Oxalate Urolithiasis

Summary: calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance. however, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients

nephrolithiasis is an important health problem that can deteriorate the renal functions in long term and affects the patients' quality of life. one of the major problems about renal stones is the high rate of recurrence. calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance. however, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. in the previous studies, even in case of a dedicated stone clinic, the drop out rate for preventive measures were over 37% per year. the patients' non-compliance may be related to a number of factors associated with the stone clinic, demographic characteristics of the patients, past medical history of the patients, and even the recommended tests and the therapeutic advices. therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients methods: parameters to be recorded age gender level of education * of stone episodes * of surgical intervention type of surgical intervention history of swl concomitant diseases other medications type of metabolic evaluation (24 hour urine, spot morning urine, serum etc.) drug for medical prophylaxis dosage of medication (bid/tid, etc.) side effects dietary recommendations compliance to metabolic evaluation compliance to medical treatment statistics: patients will be grouped based on: compliance to metabolic evaluation compliance to medical treatment the parameters listed above will be compared between the groups with univariate analysis (logistic regression).

Eligibility criteria:
inclusion criteria: * diagnosis of calcium oxalate kidney stones * suggested metabolic evaluation for kidney stone * suggested dietary and/or medical treatment for kidney stone * accepted participation in the study exclusion criteria: * age less than 18 * mental disorders

Keywords: kidney stone calcium oxalate stone patient compliance nephrolithiasis
development of a therapeutic endpoint in pediatric rheumatologic conditions

Conditions: Juvenile Idiopathic Arthritis; Systemic Lupus Erythematosus; Fibromyalgia

Summary: the overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. this would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. this is a single site observational study that aims to collect initial pilot data in three distinct patient groups. as this is observational, there is no randomization or blinding in the study. patients will be followed for a period of one year after enrollment. baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. as this is an observational study, there will be no change to the treatment for any patient due to research activities. the primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. the secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. this is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.


Eligibility criteria:
inclusion criteria: in order to be eligible for inclusion in the study, an individual must meet all of the following criteria: * male or female ≥ 5 years of age at screening. * documentation of a jia, sle or fm diagnosis as evidenced by history exclusion criteria: any individual who meets any of the following criteria will be excluded from participation in this study: • documented history of eye disease precluding pupillometry
long-term extension study in participants with multiple sclerosis who have completed study 205ms301 (nct01064401) to evaluate the safety and efficacy of biib019

Conditions: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Summary: the primary objective of the study is to assess the safety and tolerability of long-term treatment with biib019 (daclizumab high yield process; dac hyp) monotherapy in participants with relapsing remitting multiple sclerosis (rrms) who completed study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318). secondary objectives of this study in this study population are as follows: to describe ms-related outcomes, including ms relapse, disability progression, ms lesion formation, and participant-reported impact of ms, following long-term treatment with dac hyp to assess the long-term immunogenicity of dac hyp administered by prefilled syringe (pfs) to assess the safety, tolerability, and efficacy of switching to dac hyp in participants previously on long-term treatment with interferon β-1a (avonex) in study 205ms301(nct01064401).

enrollment will include up to 1600 participants, this includes approximately 1200 participants who completed study 205ms301 (nct01064401). additionally, approximately 400 participants from the other biib019 extension studies 205ms203 (nct01051349) and 205ms302 (nct01462318) will be eligible to enter study 205ms303 at week 144 of study 205ms303 \[study 205ms301 (nct01064401), study 205ms203 (nct01051349) and study 205ms302 (nct01462318) have been referred to as parent studies in the protocol\]. all participants will receive the same dose of dac hyp as received in the parent studies; i.e., 150 mg by an sc injection every 4 weeks.

Eligibility criteria:
key inclusion criteria: * must be a subject currently participating in study 205ms301 (nct01064401), or subject currently participating in study 205ms203 (nct01051349) or study 205ms302 (nct01462318) who has completed end of study visit (week 96 or later). * women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment. key exclusion criteria: * any subject who permanently discontinued study treatment in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318) prior to the end of the study treatment period, or had an early termination visit in study 205ms301, study 205ms203 (nct01051349) or study 205ms302 (nct01462318). * any significant change in the subject's medical history that would preclude administration of biib019, including laboratory tests or a current clinically significant condition that, in the opinion of the investigator, would have excluded the subject's participation in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318). the investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this study 205ms303. note: other protocol-defined inclusion/exclusion criteria may apply.
combined chromoendoscopy and water method for screening colonoscopy

Conditions: Colon Polyp

Summary: in a rct in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of indigocarmine (ic) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).

background: warm water infusion in lieu of air insufflation (water method) improves overall success of screening colonoscopy and our retrospective data indicate a higher adenoma detection rate. dye spray methods to improve neoplastic polyp detection such as targeted staining or pancolonic chromoendoscopy have been described. aim: in a rct in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of indigocarmine (ic) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method). methods: after informed consent patients undergoing screening colonoscopy will be randomized to be examined by the study or control method. study method will employ a 0.008% ic solution. control method will employ plain water. the water method in both study and control groups will be applied as previously described. the colonoscopy will be performed under sedation. primary outcome measure: adenoma detection rate; secondary outcome: relevant procedure-related variables.

Eligibility criteria:
inclusion criteria: * adult (≥50 years old * male and female patients * scheduled for screening colonoscopy * consented and accept randomization to study or control method exclusion criteria: * patients who decline to participate * unable to give informed consent * unable to complete questionnaires due to language or other difficulties

Keywords: screening colonoscopy adenoma water method
biomarkers in pulmonary arterial hypertension treated with nilotinib

Conditions: PAH

Summary: the investigators hypothesize that bone marrow progenitor cells are mobilized into the circulation in pah, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. as a corollary to this, the investigators hypothesize that anti ckit tyrosine kinase inhibitor (tki), nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. to test this, the investigators will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical response. this will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: this study is a substudy and subjects must be enrolled in the main trial: see study efficacy, safety, tolerability and pharmacokinetics (pk) of nilotinib (amn107) in pulmonary arterial hypertension (pah) in clinical trials. (clinical trial id nct01179737) http://clinicaltrials.gov/ct2/show/nct01179737? exclusion criteria: subjects are not enrolled in the main study: see study efficacy, safety, tolerability and pharmacokinetics (pk) of nilotinib (amn107) in pulmonary arterial hypertension (pah) in clinical trials. (clinical trial id nct01179737) http://clinicaltrials.gov/ct2/show/nct01179737?term=tasigna+and+pulmonary+hypertension\&rank=1
the efficacy of hydrolyzed guar gum ( phgg) in the treatment of patients with irritable bowel syndrome (ibs)

Conditions: IBS

Summary: this study objective is to assess the short and long term effects of partially hydrolyzed guar gum (phgg) administration on clinical symptoms of ibs and quality of life of these patients.


Eligibility criteria:
inclusion criteria: * fulfillment of the rome iii criteria for ibs. * aged 20-68 years at the time of screening. * provision of written informed consent. * commitment of availability throughout the 6 months study period. exclusion criteria: * major abdominal surgery in the past. * the presence of any active (organic)gi disease. * past or present major medical or psychiatric illness. * any concomitant disease. * alarming symptoms (rectal bleeding, weight loss, etc.) * pregnancy. * family history of colorectal carcinoma or inflammatory bowel disease (ibd). * abnormal laboratory studies (blood biochemistry , liver enzymes,complete blood count), abnormal thyroid function. * non-adjusted diet in the case of lactose or gluten intolerance. * recent travel to regions with endemic parasitic diseases.

Keywords: ibs diarrhea constipation fibers
cytomegalovirus (cmv) perilymphatic fluid

Conditions: Hearing Loss, Cochlear; Cytomegalovirus Congenital

Summary: in france, children cochlear implantation (ci) is performed 400 times per year. causes of profound sensorineural hearing loss (snhl) are represented by congenital malformation of the inner ear for 50 to 60%. most of the remaining cases of ci in children are caused by congenital cmv infection. the proportion of cmv inducing snhl with a ci in children is not clearly defined. during ci, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a cmv polymerised-chain-reaction to evaluate the involvement of cmv in snhl.

data on etiology of hearing loss and cmv status are collected. perilymphatic liquid is collected after cochleostomy using a 1ml seringue. the drop of liquid is deposited on a guthrie card; on another card, a drop of blood is deposited on another card. cmv pcr (polymerised chain reaction) is then performed in order to assess for the presence of cmv. the sensibility, specificity, positive and negative positive values are then calculated.

Eligibility criteria:
inclusion criteria: * children (under 18-year-old) presenting with a sensorineural hearing loss with an indication of cochlear implantation exclusion criteria: -
qing'e formula therapy on menopausal symptoms

Conditions: Menopause

Summary: the objective of this study is to evaluate whether a chinese medicine formula (qing'e) is effective in alleviating menopausal symptoms and safety.

this is a double-blind placebo-controlled randomized clinical trial to evaluate whether a chinese medicine formula (qing'e, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 chinese women with menopausal symptoms will be recruited and randomized into two groups. one is treatment group with 12 weeks of qing'e pills (well-controlled), the other is controlled group with 12 weeks of placebo. the treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes), the kupperman index. 2) nei network indices. 3) urine metabolomics. all measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, kupperman index and urine metabolomics. tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.

Eligibility criteria:
inclusion criteria: 1. women age between 40 to 60 years, suffering from irregular menstrual cycle or amenorrhea of 3-11 months. 2. moderate to severe hot flashes (associated with sweating)≥5 times /24 hours. 3. patients unused estrogen tablets or progesterone injection in 6 months. 4. patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months. 5. get subjects informed consent process should comply with gcp requirements. exclusion criteria: 1. patients with hypertension, primary hypotension and chronic anemia (hb ≤ 90 g / l). 2. bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer. 3. allergic constitution and known allergy to the drug. 4. patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill. 5. patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases. 6. alcoholics or smokers (past or smoking). 7. patients are participating in other clinical trials.

Keywords: menopausal syndrome climacteric syndrome hot flashes sweat
relevance of the self-assessment of skills for self-administration of adrenaline by auto-injectors in patients at risk of severe anaphylactic reaction (pacadré)

Conditions: Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment

Summary: to investigate the correlation between self-assessment by patients and an assessment by a health professional of the skills needed for self administration of adrenaline by auto-injectors. these skills include the identification of situations requiring the administration of adrenaline and the technical abilities to achieve it. hypothesis: a self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on the patient's self-assessment alone.

intramuscular adrenaline is the standard treatment for severe to moderate anaphylaxis. self-administration of adrenaline by the patient using an auto-injector pen in case of anaphylaxis is a major axis of management of patients with severe food allergy, hymenoptera venom allergy or systemic mastocytosis. this self-administration skill requires prior therapeutic education of the patient. this education must be repeated over time and must include two components: the identification of anaphylactic situations requiring the self-administration of adrenalin and the technical skills and abilities to carry out this self-injection. numerous studies have investigated the technical skills for using adrenaline auto-injector pens according to the device prescribed, the importance of therapeutic education, the optimal frequency of therapeutic education sessions for self-administration and the main barriers to the use of adrenaline. to our knowledge, no study has investigated the correlation between patients' self-assessment of the skills required for self-administration of adrenaline by self-injecting pen and an external assessment of these same skills by a health professional. a self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on patient self-assessment alone.

Eligibility criteria:
inclusion criteria: * adult patient * follow-up at the chu grenoble alpes or at the ch métropole savoie with at least one consultation every 2 years * with a pathology at risk of severe anaphylaxis: * severe food allergy and/or, * allergy to wasp venom and/or * systemic mastocytosis * with a current adrenaline prescription that is more than a year old exclusion criteria: * patient with a pathology at risk of severe anaphylaxis not identified in the inclusion criteria (isolated drug allergy, idiopathic anaphylaxis, etc.) * patient with cognitive or memory disorders * patient not speaking french or with a limited understanding of the language * patient not affiliated to a social security scheme * refusal of the patient to participate in the research or inability of the patient to give his consent * patient under guardianship or subject deprived of liberty

Keywords: adrenaline self-administration self-assessment severe anaphylactic reaction
sleep quality and presence of sleep disordered breathing

Conditions: HIV Infections; Sleep

Summary: the purpose of our study is to survey the quality of sleep and sleep disordered breathing in a hiv infected inner city ambulatory african-american population aged 50 years and older. hypothesis: african-american hiv infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.

the purpose of our study is to survey the quality of sleep and sleep disordered breathing in a hiv infected inner city ambulatory african-american population aged 50 years and older. a secondary objective is to investigate possible relationships between sleep quality and aspects of a patient's medical history including bmi, cd4 count, hiv viral load, history of substance abuse, psychiatric disorders, concurrent medical conditions, current hiv medications and hiv medication compliance. hypothesis: african-american hiv infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.

Eligibility criteria:
inclusion criteria: * african american * aged 50 years and older * hiv infected * receiving hiv care at the boulevard comprehensive care clinic, duval county health department exclusion criteria: * patients refusing to fill out the questionnaires * patients less than 50 years old * non-african americans * persons not receiving care at the boulevard comprehensive care clinic

Keywords: hiv sleep quality sleep apnea berlin questionnaire pittsburgh sleep quality index
hair repigmentation during cerebrolysin therapy

Conditions: Hair Problems

Summary: open-label histological study of scalp biopsies from patients undergoing treatment with cerebrolysin as therapy for cerebrovascular disease. the aim is to assess by histological techniques the causes of follicular repigmentation that occurs during the cerebrolysin treatment.

patients who fulfill the study requirements will receive the standard cerebrolysin protocol as follows: intravenous (iv) infusions of 5 vials per week, 2 vials on mondays and 3 vials on thursdays for 4 weeks, followed by an 8-week resting period prior to the next cycle of treatment. each patient will receive 3 cycles giving a total of 9 months of follow-up. for intravenous infusions, each 10 ml vial containing 215.2mg / ml of cerebrolysin (ever pharma) is diluted with physiological saline solution (naci 0.9%) to a final volume of 100 ml. a pre- and post-treatment biopsies will be collected from the achromotrichia area of each patient. antisepsis of the area will be performed prior to each biopsy with chlorhexidine, followed by local anesthesia with lidocaine 2% and epinephrine. the biopsy will be collected using a 4mm punch and the wound will be sutured with non-absorbable stitches with prolene 4-0.

Eligibility criteria:
inclusion criteria: * known neurologist prescription for cerebrolysin treatment due ischemic or hemorrhagic stroke, traumatic brain injury or dementia. * age-related white or gray hair. * above 40 years old * voluntarily consents in written informed consent by the principal or legal representative exclusion criteria: * patients with a diagnosis of chronic kidney disease (ckd). * known history of seizures, epilepsy, or hypersensitivity to one or any drug components. * pregnant patients. * patients with a history of recent treatment of hair coloring products.

Keywords: hair graying