Kornimate/medical-research-clean huggingface dataset:
phase ii study of the effect of leuprolide acetate and spironolactone on insulin resistance in hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome

Conditions: Acanthosis Nigricans; Polycystic Ovary Syndrome

Summary: objectives: i. evaluate insulin resistance in thin and obese hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome and in thin and obese controls, using an estimation of tissue sensitivity to insulin. ii. evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on insulin secretion and resistance.

protocol outline: participants are treated with subcutaneous leuprolide acetate followed by oral spironolactone. each treatment is administered daily for 6 weeks, with a 6-week washout between drugs. patients and controls are alternately assigned to begin treatment with leuprolide acetate or spironolactone.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- polycystic ovarian disease oligomenorrhea or amenorrhea hirsutism hyperandrogenism hyperandrogenism insulin resistance acanthosis nigricans syndrome hyperandrogenism oligomenorrhea or amenorrhea insulin resistance acanthosis nigricans hematocrit at least 30% women with normal menstrual cycles not using oral contraception entered as controls

Keywords: acanthosis nigricans dermatologic disorders endocrine disorders polycystic ovarian syndrome rare disease
effect of high-intensity interval training compared to hydrochlorothiazide on ambulatory blood pressure

Conditions: Hypertension,Essential; Exercise Activity

Summary: the number of persons with hypertension is increasing and with it the number of related cardiovascular events and related functional or cognitive declines. while studies have suggested that physical activity, in particular, high-intensity interval training (hiit), could be as efficient as the commonly used antihypertensive medications, no studies have actually compared their effects in the same population. this protocol will determine if hiit is at least as efficient as hydrochlorothiazide in order to lower 24h-ambulatory blood pressure (bp) in prehypertensive older adults.


Eligibility criteria:
inclusion criteria: 1. age at consent ≥ 60 years; 2. systolic blood pressure measured through bptru™ between sbp ≥ 120 mmhg and \< 140 and or dbp ≥ 80 mmhg 3. being able to sign the informed consent form exclusion criteria: 1. considered "highly active" according to the international physical activity questionnaire 2. practicing more than 20 min per week of high-intensity interval training 3. use of antihypertensive medication 4. contraindication for the practice of intense physical activity 5. functional limitations related to the exercise test and to intensive training 6. cardiovascular pathology 7. atrial fibrillation 8. psychiatric or neurological disorder 9. renal failure 10. mmse score \< 26 11. persons benefiting of enhanced protection: persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and patients in emergency situations. 12. diabetes
the changes of cd4+t cells frequency and function during antiviral therapy

Conditions: Chronic Hepatitis B Infection

Summary: pegylated interferon α-2a(peg-ifn-α) not only inhibit viral replication, but also play an important role in immune regulation, while nucleoside analog(ue) drugs only inhibit viral replication. in hepatitis b infection, cd4+t cells are the main effector cells in adaptive immune response. this study was aimed at investigating the changes of cd4+t cells frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators want to verify whether peg ifn - alpha suppressed the virus and the reduction of virus led to the recovery of cd4+t cells function, or peg ifn - alpha enhanced cd4+t cells function which gave rise to the decline of the virus.

pegylated interferon α-2a(peg-ifn-α)and nucleoside analog(ue) drugs can inhibit viral replication , but peg-ifn-α also play an important role in immune regulation . in hepatitis b infection, cd4+t cells are the main effector cells in adaptive immune response.peg-ifn-α recommended as the first-line treatment has a higher chance to achieve hbeag seroconversion and even hbsag disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of cd4+t cells in the case of hepatitis and the function enhancement of cd4+t cells during peg-ifn-α therapy. this study was aimed at investigating the changes of cd4+t cells frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators want to explore whether the decline of hbsag and hbeag resulted in recovery of cd4+t cells function, or recovery of cd4+t cells function led to the decrease of hbsag and hbeag. several studies demonstrated that hbsag and hbeag could damage cd4+t cells function, and the loss of hbsag and hbeag led to recovery of cd4+t cells function.

Eligibility criteria:
inclusion criteria: * hbsag and hbeag positive for more than 6 months, hbv dna detectable with alt level abnormal lasted for three months and at least time190 iu/l or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled. exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b hepatitis b virus cd4+t cells pegylated interferon α-2a nucleoside analogues
99th percentile upper reference limit (url) for the meritas troponin i test

Conditions: Acute Coronary Syndrome

Summary: prospective multicenter sample collection and testing study.

prospective multicenter sample collection and testing study. approximately 750 apparently healthy subjects, including healthy subjects with stable co-morbidities, age, gender and ethnicity dispersed will be eligible for enrollment

Eligibility criteria:
inclusion criteria: 1. male or female at least 21 years of age at the time of enrollment in the study. 2. subjects with no medications or no changes in their medications in the last 3 months. 3. subjects with and without chronic stable morbidities (i.e., renal insufficiency, hypertension, diabetes, hypercholesterolemia, pulmonary disorders, coronary disease, musculoskeletal disorders, etc.). 4. subjects able to understand and sign the informed consent and the patient questionnaire. exclusion criteria: 1. subjects with a history of heart failure and/or, having received treatment for heart failure. 2. subject with renal failure. 3. subjects with a history of unstable heart disease or angina complaints. 4. subjects with any change in their medication in the last 3 months (diabetics may have small variations in glucose medications but may not have unstable disease, or have suffered a diabetic crisis in the last 6 months). 5. any known acute infection in the last 30 days. 6. marathon runners or extreme athletes. 7. pregnant (self-reported).
topical simvastatin for treating infantile hemangioma

Conditions: Hemangioma Skin

Summary: this is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial ih. the primary objective: to evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial ih over 24 weeks. the secondary objective: 1.1 to evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. evaluation is performed at each clinic visit via investigator global assessment (iga) based on standardized 3d digital photography and hemangioma activity score (has). 1.2 to evaluate the impact of 5% simvastatin ointment on quality of life using the ih-qol questionnaire.


Eligibility criteria:
inclusion criteria: * healthy children aged between 3 months and 5 years. * newly diagnosed superficial ih or experiencing rebound growth with a superficial component. * participants must possess at least one ih lesion with the longest diameter equal to or greater than 2 cm, located on any part of the body except the lips. * participants must not have received any of the following treatments for their ih: * topical medical therapy within the past 2 weeks. * systemic medical therapy within the past 3 months. * laser treatment within the past 6 weeks. * written informed consent from the parent(s)/guardian(s) of minor participants must be obtained before any study procedure is performed. exclusion criteria: * ih is primarily characterized as subcutaneous, and deep, with minimal cutaneous involvement for evaluation. * ih with active ulceration. * ih to be treated involving the lips mainly. * participants with concurrent skin conditions that may impede accurate clinical assessment of the ih. * participants with hereditary or metabolic disorders requiring systemic statin therapy. * participants who are allergic to statins, or other ingredients present in the topical medication.
ketonemia through menstrual cycle

Conditions: Epilepsy; Drug Resistant Epilepsy; GLUT1DS1; Ketogenic Dieting; Menstrual Epilepsy

Summary: ketogenic dietary therapies (kdts) are well-established, safe, non-pharmacologic treatments used for children and adults with drug-resistant epilepsy and other neurological disorders. ketone bodies levels undergo a significant inter-individual and intra-individual variability and can be affected by several factors. this evidence suggests the need for personalized monitoring for diet optimization, especially at the beginning of the treatment but during whole follow-up. possible variations in glycemia and ketone bodies' blood level according to different phases of menstrual cycle have not been systematically assessed yet, but this time window deserves special attention because of hormonal and metabolic related changes. we present the methodological protocol for a longitudinal, multicentric study aimed at searching for subtle changes in ketone bodies blood level during menstrual cycle in epileptic female patients undergoing a stable ketogenic diet. the study will be divided into two phases. the first one will be purely observational, aiming at the assessment of ketonemia during menstrual cycle. whether this finding will be confirmed, a second phase of ketogenic diet therapy adjustment will be scheduled.


Eligibility criteria:
inclusion criteria: * patients with drug resistant epilepsy or glut1ds undergoing kd from at least 3 months before inclusion to the study * patients who had menarche at least 3 months before inclusion to the study * absence of recognized endocrinologic problems/ disease exclusion criteria: * patients who experienced secondary amenorrhea * patients who have irregular menstrual cycle * pregnant patients

Keywords: ketogenic diet ketonemia menstrual cycle
study of amantadine for risperidone consta or paliperidone treated patients to decrease prolactin elevation

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to show that amantadine might help to reduce the side effect of the medications which are prescribed to treat schizophrenia or schizoaffective disorder. high level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be developed in patients treated with the paliperidone er or risperidone consta. high level of prolactin might stimulate breast development, might decrease sexual desire (libido). the goals of this study are to demonstrate that amantadine lowers prolactin levels, decreases side effects, and improves psychiatric symptoms.

trial description: a double-blind, placebo-controlled, prospective, randomized trial to evaluate the effects of two doses of amantadine or placebo in the management of antipsychotic-induced hyperprolactinemia and psychiatric status in patients with schizophrenia or schizoaffective disorder who are clinically stable on paliperidone er or risperidone consta. placebo or amantadine 100 mg or 200 mg bid will be administered to participants for 4 consecutive weeks as an adjunctive therapy in 72 schizophrenia subjects treated with paliperidone or risperidone consta to examine amantadine effects on fasting am serum prolactin levels. participants will be followed after suspension of amantadine or placebo for an additional 4 weeks for safety purposes. the goals of this study are to prospectively demonstrate that amantadine lowers prolactin levels, and evaluate the impact of amantadine on psychiatric symptoms, and on prolactin-related side effects in patients treated with paliperidone er or risperidone consta.

Eligibility criteria:
inclusion criteria: * male or female * age 18-65 years * diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder * well established compliance with out-patient medications including paliperidone er or risperidone consta for 3 months exclusion criteria: * current substance or alcohol abuse * significant medical illness * women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study * subjects treated with more than one antipsychotic drug

Keywords: schizophrenia schizoaffective disorder paliperidone er risperidone consta prolactin hyperprolactinemia
clinical evaluation of cad/cam vs. conventional veneer restorations

Conditions: Malformed Tooth

Summary: the aim of the study is to clinically evaluate tooth-supported veneer restorations fabricated using the cad/cam process in comparison to conventionally manufactured pressed veneers on anterior teeth and to assess their long-term performance. survival and success rates of anterior veneer restorations, as well as patient satisfaction, will be evaluated.

functional and aesthetic complaints caused by congenital malformations and acquired tooth damage are widely spread. discomfort involves reduced chewing ability, phonetic problems, hypersensitivity and aesthetic impairments. conventionally fabricated all-ceramic veneer restorations reveal a long history of clinical success in minimally invasive rehabilitation of the anterior dentition. nevertheless, conventional manufacturing techniques are prone to fabrication mistakes and must be handled by experienced dental technicians and dentists which results in very high fabrication costs. therefore, access to minimally invasive restorations is currently restricted for most of the patients. innovative cad/cam techniques have revolutionised restorative treatment options over the last decades and have made all-ceramic restorations more affordable for patients. with further improvements of the cad/cam milling devices the machinability of high-strength glass ceramic is now possible. the aim of both treatment procedures will be to avoid any extensive additional tooth structure removal, to provide long-term survival and success of the integrated restorations and to improve patient´s satisfaction. up to now scientific evidence on the clinical performance of cad/cam fabricated veneers is very limited. aim of this trial is to evaluate if the clinical performance of anterior restorations after minimally invasive therapeutic intervention with cad/cam veneers compared to conventionally fabricated veneers. functional and aesthetic treatment results will be assessed for five years and evaluated with regard to failure and succes veneer restorations as well as patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * patients that reveal indication for a minimum of 2 and a maximum of 6 anterior veneer restorations exclusion criteria: - patients that reveal multiple missing teeth, poor oral hygiene, pronounced parafunctions or with allergies to any of the applied materials
a prospective study to examine the effectiveness and safety of neuraminidase inhibitors in volunteers who receive long-term prophylaxis against pandemic influenza: pipet b

Conditions: Pandemic Influenza

Summary: this aim of this project is to evaluate the efficacy of neuraminidase inhibitors as prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in the context of a place of employment or profession. the study is observational only. the primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. this project will commence upon pandemic influenza being declared in australia, hong kong or singapore. data will be analysed as quickly as possible to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency response to pandemic influenza.

the aim of this study is to 1. describe the incidence of symptomatic pandemic influenza infection in participants receiving neuraminidase inhibitor prophylaxis in the context of a place of employment or a profession 2. describe the incidence of seroconversion to pandemic influenza 3. describe the incidence of adverse events in volunteers taking long term antiviral prophylaxis 4. compare the effectiveness of oseltamivir and zanamivir prophylaxis the study is an open label prospective cohort study. participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

Eligibility criteria:
inclusion criteria: * provision of written informed consent * intention to commence, or already commenced prophylaxis with a neuraminidase inhibitor in the context of a place of employment or profession it is anticipated that participants in this study who are subsequently clinically diagnosed with pandemic influenza will be enrolled in the index case protocol (pipet-a) with follow-up as specified. exclusion criteria: * none

Keywords: prophylaxis pandemic influenza influenza a h5n1 virus
incidence of hypophosphatemia after treatment with iron isomaltoside/ferric derisomaltose vs ferric carboxymaltose in subjects with iron deficiency anaemia

Conditions: Iron Deficiency Anaemia; Iron Deficiency Anemia

Summary: the trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (ida).

this trial was designed to evaluate the effect of iv iron isomaltoside/ferric derisomaltose compared with iv ferric carboxymaltose on s-phosphate in subjects with ida caused by different etiologies. the subjects received either a single intravenous (iv) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two iv doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). the study subjects were monitored for up to 35 days from baseline.

Eligibility criteria:
inclusion criteria include: * subjects diagnosed with ida, caused by different aetiologies * haemoglobin (hb) ≤ 11 g/dl * body weight \> 50 kg * serum ferritin (s-ferritin) \< 100 ng/ml * estimated glomerular filtration rate (egfr) ≥ 65 ml/min/1.73 m2 * serum phosphate (s-phosphate) \> 2.5 mg/dl * intolerance or unresponsiveness to oral iron * willingness to participate and signing the informed consent form (icf) exclusion criteria include: * acute bleeding \> 500 ml within 72 hours * anaemia predominantly caused by factors other than ida * hemochromatosis or other iron storage disorders * previous serious hypersensitivity reactions to any iv iron compounds * treatment with iv iron within the last 30 days prior to screening * treatment with erythropoietin or erythropoietin-stimulation agents * red blood cell transfusion, radiotherapy, and/or chemotherapy * received an investigational drug within the last 30 days prior to screening * planned surgical procedure within the trial period * hepatic enzymes \> 3 times upper limit of normal * surgery under anaesthetic within the last 30 days prior to screening * any non-viral infection within the last 30 days prior to screening * alcohol or drug abuse within the past 6 months * vitamin d deficiency * untreated hyperparathyroidism * kidney transplantation * active malignant disease, disease-free for less than 5 years * history of a psychological illness or seizures * pregnant or nursing women.

Keywords: iron deficiency anaemia iron deficiency anemia ida intravenous iron replacement therapy iron deficiency iron isomaltoside ferric derisomaltose monofer monoferric monover monofar monoferro hypophosphatemia ferric carboxymaltose
task oriented mirror therapy for upper limb motor function in stroke patient

Conditions: Stroke Patients

Summary: stroke remains a major public health disease worldwide ,it usually associating with damage to the motor function and other functional disabilities. persistent upper extremity dysfunction affects many post strokepatients and is strongly associated with decreased activities of daily living . mirror therapy one of the rehabilitation that is beneficial for neuroplasticity .this therapy is used to improve motor function after stroke .

objectives: the objectives of this study are : 1. to imorove upper limb motor function and 2. to improve activities of daily lving . 3. to enhance motor skills. hypothesis: alternate hypothesis: there will be statisticallly significant difference in high intensity task oriented mirror therapy and low intensity task oriented mirror therapy on upper limb motor function ,activities of daily living and enhancing motor skills in stroke patients (p\<0.05) null hypothesis: there will be no statisticallly significant difference in high intensity task oriented mirror therapy and low intensity task oriented mirror therapy on upper limb motor function ,activities of daily living and enhancing motor skills in stroke patients (p\>0.05) research design : experimental study .randomized control trail.

Eligibility criteria:
inclusion criteria: * both genders. * age of patient 45 years and above * both ischemic and hemorrhagic stroke ( subacute and chronic stroke). cognitive function relatively intact score \> 24 moca * the patient can sit with / without support for more than 30 min exclusion criteria: * subjects with visual impairments or unilateral neglect. * having global aphasia. * unstable medical conditions or comorbidities. * score 3 and above on modified ashworth scale. * patient with orthopedic condition or any fractures.

Keywords: mirror therapy stroke neurorehabilitation