Kornimate/medical-research-clean huggingface dataset:
basal androgens and lh needing for ovarian stimulation for in vitro fertilization

Conditions: Infertility

Summary: basing the investigators study on the evidence that basal serum androgens decrease with age, the investigators hypothesize that women with serum androgens below a certain level could be the population obtaining a benefit of luteinizing hormone (lh) supplementation. the objective of the present study is to explore the relationship between basal serum androgen levels and the need of lh for controlled ovarian stimulation (cos) in ivf.

design: single centre, open label, randomized controlled trial. * population: patients with indication of in vitro fertilization (ivf) with the following criteria: * protocol: all patients are tested on day 3-5 of cycle for total testosterone (te), dehydroepiandrosetnodione sulphate (dheas) and androstenodione (δ4). samples are frozen and stored at -20ºc for later analysis. fsh, lh, e2, prl and tsh are also determined. all patients follow controlled ovarian stimulation for ivf with a gnrh agonist long protocol. they are randomized to receive recombinant (r) fsh alone (225 iu/day) or r-fsh + r-lh (225+75 iu/day). * sample size calculation: to detect a difference from 40 to 60% (relative risk: 1.50) on pregnancy rate (pr) between patients with low and high androgen levels with respect to the mean of each cos protocol, with a confidence level of 95% (error α=0.05) and 80% of power (error β=0.2), 97 patients per arm were needed. (n=388 patients). rounding up, 400 patients are to be recruited.

Eligibility criteria:
inclusion criteria: * 1st-2nd ivf cycle * regular cycle (25-35 days) * age 18 - 42 * bmi: 18-29.9 exclusion criteria: * lh:fsh \> 2 * low response background (\< 5 oocytes) * recurrent pregnancy loss * preimplantational genetic diagnosis indication * any systemic, metabolic or endocrinological disorder.
use of local warming in children venipuncture

Conditions: Phobia Phlebotomy

Summary: the aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with emla.


Eligibility criteria:
inclusion criteria: * age between 8 and 13 years * intravenous drug therapy prescribed by a physician * no allergy to lidocaine * no local skin disease * absence of burns scars * child and his/her family are native speaker of italian * bmi not lower than 10° centile for sex and age according to the cdc standards exclusion criteria: * age of child not included in the age range established for the study * intravenous drug therapy not needed * presence of an allergy to lidocaine products * skin disease * presence of burns scars * the child or his/her family are not native speaker italian * bmi lower than 10° centile according to the cdc standards

Keywords: child venipuncture pain
autonomic nervous system and sickle cell disease

Conditions: Heart Rate Variability (ANS Function)

Summary: sickle cell disease (scd) children and adults with asthma have an increased rate of vaso-occlusive crisis, acute chest syndrome episodes, and premature mortality when compared to those without asthma. we hypothesised that either asthma diagnosis and/or bronchodilator treatment may aggravate scd via their modulating effect on autonomic nervous system.

heart rate variability during pulmonary function tests (spirometry, static volumes, dlco/dlno, exhaled no at multiple flow rates) including salbutamol administration will be evaluated in patients with scd (n=60) receiving asthma treatment or not, as compared to asthmatic children without scd (n=30) matched for ethnicity

Eligibility criteria:
inclusion criteria: * age from 8 to 16 years (≥ 8 years and \< 16 years) (spirometry and dlco study feasible) * sub-saharan african or caribbean ethnic origin. * child with sickle cell disease referred for monitoring of respiratory function in the framework of its sickle cell disease and whether or not it presents a possible disease asthmatic (asthma treatment prescribed in the past year) * or asthmatic child (typical functional signs + history of exacerbation severe hospitalized or reversible obstructive pulmonary disorder) not sickle cell * addressed for respiratory function monitoring exclusion criteria: * refusal to participate (lack of consent) * sickle cell child of north african origin

Keywords: sickle cell disease; asthma; beta-agonist; hear rate variability
pilot study to evaluate the self-management of gait, speech, and dexterity symptoms in parkinson's disease using a smartphone application

Conditions: Parkinson Disease

Summary: the purpose of this study is to evaluate the impact of a smartphone application that delivers at-home therapy exercises on patients' self-management of gait, speech, and dexterity symptoms.


Eligibility criteria:
inclusion criteria: * male and female subjects at least 30 years of age or older, * history of idiopathic parkinson's disease (hoehn and yahr stage of ii-iv), * normal joint range of motion in both legs, * able to walk independently for 10 feet with or without an assistive device, * parkinson's gait and mild to moderate speech impairment, * no history of vestibular disease, * no evidence of dementia (mmse ≥24), * clear benefit from levodopa, * agrees to beats medical application privacy policy and terms of use, * access to an iphone 7 or higher to use the beats medical applications. exclusion criteria: * medical condition for which exercise is contraindicated, * history or evidence of neurological deficit other than parkinson's disease that could interfere, such as previous stroke or muscle disease, * history or evidence of orthopaedic or muscular problems, * subject is currently enrolled in a study to evaluate an investigational drug or device, * subject unable or unwilling to provide informed consent, * vulnerable populations as deemed inappropriate for the study by site principal investigator, * history of falls in the past 6 months, * pregnancy, * current or previous use of the beats medical parkinson's application.

Keywords: nervous system diseases movement disorders neurodegenerative diseases brain diseases central nervous system diseases
prevalence of molar incisor hypominerlization (mih) among a group of egyptian children

Conditions: Molar Incisor Hypomineralization

Summary: to determine the prevalence of mih in a group of egyptian children attending the pediatric dentistry and dental public health department, faculty of dentistry, cairo university.

one single operator, master degree student in the department of pediatric dentistry and dental public health, faculty of dentistry, cairo university will assess incidence of molar incisor hypomineralization for all the patients who will be included in the study sample. the survey will involve a structured questionnaire which will be followed by clinical examination to assess the presence / absence of molar incisor hypomineralization and its severity based on eapd criteria

Eligibility criteria:
inclusion criteria: 1. children age from eight to twelve years. 2. medically free. 3. singed informed consent. 4. both sexes are included 5. parent and children cooperation. exclusion criteria: 1. children with (amelogenesis imperfecta, tetracycline tooth stains, extensive destruction due to caries, or have restoration or crown and fluorosis). 2. children with orthodontic bands on the first permanent molars preventing adequate clinical examination.
p11-4 and nanosilver fluoride varnish in treatment of white spot carious lesions

Conditions: White Spot Lesion

Summary: background: great efforts have been undertaken for dental caries prevention. among the recent remineralizing materials, nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy using self-assembling peptide p11-4 (curodont repair) which enhances remineralization of white spot lesions. purpose of the study: the aim of this study is to compare clinically and microbiologically the therapeutic effect of self assembling peptide p11-4 (curodont repair), nano silver fluoride varnish and 5% fluoride varnish (duraflor) on remineralization of enamel white spot lesions in permanent teeth of adults.

the study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: one application of curodont repair, study group 2: one application of nano-silver fluoride varnish and control group twice application of fluoride varnish (duraflor).

Eligibility criteria:
inclusion criteria: 1- an age range of 10-24 years ( age of young adolescents and youth as described by the who was selected (who, 2019). 2. the presence of at least one visible wsl in the buccal surface of permanent teeth with icdas ii score of 1, or 2. 3. completion of an informed consent to participate in the study exclusion criteria: * 1. patients receiving the following medications: tetracyclines, any other medication known to stain teeth or any medication causing dry mouth and/or limiting salivary flow. 2. patients receiving any antibiotic within 1 month prior to each saliva sample collection 3. selected tooth with microcavities or dentinal involvement due to loss of enamel tissues. 4. selected tooth with a restoration adjacent to the lesions to avoid false- positive readings. 5. selected tooth with fluoride application \&lt; 3 months prior to study treatment. 6. selected tooth with discolouration, enamel hypoplasia or fluorosis. 7. patients with multiple cavitations to avoid variability in microbiological analysis.
rfc1 natural history study

Conditions: Ataxia

Summary: this international, multi-center, multi-modal and prospective observational study aims to determine the phenotypic spectrum and the natural progression of the rfc1 repeat expansion disease, and to seek and validate digital, imaging, and molecular biomarkers that aid in diagnosis and serve as outcome measures in future clinical trials of this novel, but frequent ataxia with late adult-onset.

the investigators will perform an international, multi-center, multi-modal, and registry-based standardized prospective natural history study (nhs) in rfc1 repeat expansion disease. participants will be assessed annually. study visits with a standardized clinical examination will apply several clinical rating scales, and data will be entered into a clinical database (arca registry; www.arca-registry.org) customized to the requirements of this specific study. at all study visits, patients will be asked to donate biosamples; biomaterial collection is optional, and participants can elect to participate in sampling of blood, urine, csf, and/or a skin biopsy. optionally, and depending on local availability at each participating site, additional examinations may be performed including imaging, quantitative movement and speech analysis, vestibular testing, a neuropsychological examination, or examination of swallowing function, all to fully capture the multisystemic presentation of the rfc1 repeat expansion disease. this study will delineate variable phenotypes of this relatively novel disease, and systematically characterize the longitudinal progression of multi-model biomarkers to determine the most sensitive, comprehensive, and reliable outcomes measures for future therapeutic trials. here, longitudinal validation of targeted fluid biomarker candidates will be an important part. the multi-modal longitudinal design of the study and its comprehensive assessment will also provide mechanistic insights into the multisystemic evolution of the disease, which will especially allow to track and understand selective as well as overlapping dysfunction of the cerebellum, sensory peripheral nerves, the vestibular system, and additional systems known to be involved in rfc1 disease or 'canvas' as its related syndrome.

Eligibility criteria:
inclusion criteria: * rfc1: genetic diagnosis of bi-allelic pathogenic repeat expansions in rfc1 * unrelated healthy controls: no signs or history of neurological or psychiatric disease and * written informed consent and * participants are willing and able to comply with study procedures exclusion criteria: * rfc1: missing informed consent * controls: evidence of neuropathy, neurodegenerative disease, or movement disorder; inability to give informed consent

Keywords: rfc1 canvas natural history study biomarker
exhaled breath analysis in human subjects

Conditions: Exhaled Breath Pattern After Medication Intake, in OSA Patients, or Other Pulmonary Diseases

Summary: identification of exhaled breath pattern of human subjects

breath analysis with mass spectormetry as a non-invasive method to identfy exhaled breath patterns.

Eligibility criteria:
inclusion criteria: * \>= 18 years * informed consent exclusion criteria: * specific exclusion criteria for different subgroups
mid-term radiological outcomes of femoral neck fractures treated with osteosynthesis: a comparative analysis

Conditions: Femoral Neck Fractures; Femoral Neck Shortening

Summary: objectives: this study assesses the efficacy of dynamic hip screw (dhs) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (avn) incidence, and functional outcomes. methods: design: retrospective cohort study. setting: academic level i trauma center. patient selection criteria: included were patients with femoral neck fractures treated with dhs or cannulated screws, with follow-up data available. outcome measures and comparisons: main outcomes were femoral neck shortening, incidence of avn, and harris hip score (hhs) for functional assessment.


Eligibility criteria:
inclusion criteria: * patients aged 80 years and younger * minimum of 2 years' follow-up * diagnosed with a femoral neck fracture * treated with either cannulated screws or a dynamic hip screw (dhs). exclusion criteria: * patients with multiple fractures in the same extremity * presence of malignancy * diagnosis of osteoporosis * systemic inflammatory or metabolic diseases * infection or malignancy in the hip joint * insufficient medical records * patients unwilling to participate in the study.
training study to evaluate the benefit of exercise for patients with chronic heart failure

Conditions: Dilated Cardiomyopathy; Chronic Heart Failure

Summary: the study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure


Eligibility criteria:
inclusion criteria: * chronic heart failure nyha stage 2 and 3 exclusion criteria: * valvular disease * recent decompensation * other complaints that might interfere with ergometer exercise

Keywords: exercise heart failure dilated cardiomyopathy endurance training
fludarabine and total-body irradiation in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery

Conditions: Kidney Cancer

Summary: rationale: giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. it also stops the patient's immune system from rejecting the donor's stem cells. the donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening. purpose: this phase ii trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.

objectives: * determine the efficacy of nonmyeloablative conditioning comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic stem cell transplantation, in terms of 6-month and 12-month response rate, in patients with unresectable metastatic renal cell carcinoma. outline: * nonmyeloablative conditioning regimen: patients receive fludarabine iv on days -4 to -2 and total-body irradiation (tbi) on day 0. * allogeneic hematopoietic stem cell transplantation (ahsct): after tbi, patients undergo ahsct on day 0. * immunosuppression: patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper until day 81. patients also receive oral mycophenolate mofetil twice daily on days 0-27 (if patient has a related donor) or three times daily on days 0-29 and then twice daily on days 30-149 followed by additional tapering until day 180 (if patient has an unrelated donor). projected accrual: a total of 15 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed renal cell carcinoma, including 1 of the following subtypes: * clear cell * papillary * medullary * metastatic disease * not amenable to curative surgery * no cns metastases patient characteristics: performance status * karnofsky 70-100% life expectancy * more than 6 months hematopoietic * not specified hepatic * bilirubin \< 2 times upper limit of normal (uln) * ast or alt \< 4 times uln renal * creatinine clearance \> 50 ml/min cardiovascular * lvef \> 35% * no symptomatic congestive heart failure pulmonary * dlco \> 40% of predicted or * total lung capacity or fev_1 \> 30% of predicted prior concurrent therapy: biologic therapy * more than 30 days since prior biologic therapy chemotherapy * more than 30 days since prior chemotherapy radiotherapy * more than 30 days since prior radiotherapy

Keywords: recurrent renal cell cancer stage iv renal cell cancer clear cell renal cell carcinoma
prudente; diabetes prevention via exercise, nutrition and treatment

Conditions: Diabetes Mellitus, Type 2; Prediabetic State

Summary: the prudente study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (dmt2) in adult subjects with obesity and pre-diabetes in mexico city. half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.

diabetes in mexico is considered a national emergency given its high prevalence, incidence, mortality and costs. mexico has one of the highest prevalence of diabetes; in only 6 years (2000 to 2006) this prevalence increased from 7.5% to 14.4%. in 2015, 151 deaths per 100,000 inhabitants occurred in mexico due to diabetes complications. metformin is a hypoglycemia drug and it´s the first line medication for the treatment of type 2 diabetes.there is currently a significant amount of evidence that metformin administration reduces the progression from pre-diabetes to diabetes and, despite its monotherapy being less effective than lifestyle changes, the good biosafety profile and low cost have made it the drug of choice in a joint treatment. the prudente study proposes to perform this intervention in a real environment in the clinics of the first level of care of the ministry of health of the government of mexico city, in order to provide evidence about the cost-effectiveness of metformin as a public health intervention for the prevention of diabetes.

Eligibility criteria:
inclusion criteria: * having received primary care in the chosen health center (ideally two or more visits to that clinic in the prior year). * subscribers to "seguro popular" ( mexican national health insurance) * body mass index \>=30 kg / m2 * results of fasting serum glucose with values for pre-diabetes diagnosis (glucose between 100 and 125 mg / dl) optional: * family history of dmt2 (1st grade relative). * previous diagnosis of hypertension or dyslipidaemia. * have received antihypertensive medication and / or for cholesterol / lipids. * history of gestational diabetes mellitus. exclusion criteria: * renal insufficiency (glomerular filtration rate (gfr) \<30 ml/min). * known hepatic impairment or altered liver enzymes (aspartate aminotransferase (ast) ast or alanine aminotransferase (alt) three times above normal values) * active alcoholism or drug addiction * allergies or previous known intolerance to exercise or metformin. * current pregnancy. * plans to leave the area in the next three years. * previous diagnosis of type 2 diabetes mellitus

Keywords: diabetes prevention metformin mexico city
a study of equfina® on the incidences of adverse drug reactions in participants with parkinson's disease (including participants with hepatic impairment)

Conditions: Parkinson Disease

Summary: the purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with equfina in participants with parkinson's disease (including participants with hepatic impairment).


Eligibility criteria:
inclusion criteria: 1. participants with parkinson's disease, who are naïve to equfina exclusion criteria: 1. participants previously treated with equfina 2. participants who have contraindications on package insert of equfina

Keywords: parkinson disease parkinsonian disorders prospective non-interventional hepatic impairment equfina
sleep quality in patients with advanced cancer

Conditions: Sleep Disorders; Neoplasms

Summary: the primary focus of this clinical study is the objective and subjective measurements of sleep quality in patients with advanced cancer using opioids. it also examines sleep disturbances and associations between sleep quality and symptoms in order to improve symptom management in patients with advanced cancer. the overall aim of this study is to improve the clinical understanding of sleep quality in patients with advanced cancer using opioids and to improve the understanding of how sleep quality may best be measured in order to improve symptom management.


Eligibility criteria:
inclusion criteria: * a verified diagnosis of a malignant disease * presence of metastatic/disseminated disease * regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment corresponding to step iii at the who pain ladder with a duration of treatment not less than 3 days * able to comply with all study procedures * signed informed consent according to ich good clinical practice and national/local regulations exclusion criteria: * not consenting to participation * not mastering the language used at the study centre * severe cognitive impairment as judged by the principal investigator * any reason why, in the opinion of the investigator, the patient should not participate * impaired use of the dominant arm * local anatomical illness or abnormalities precluding the use of polysomnography (e.g. facial tumour) * having received chemotherapy for more than 4 weeks, having received the previous dose less than 5 days ago and receiving the next dose within the study period.

Keywords: sleep