Kornimate/medical-research-clean huggingface dataset:
simvastatin and metformin therapy in pcos women. prospective randomised trial.

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (pcos).


Eligibility criteria:
inclusion criteria: * pco - eshre/asrm criteria:oligomenorrhea (\ 70 ng/ml) normal prolactin, tsh, 17-oh progesterone no evidence of androgen producing malignancy, cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy exclusion criteria: * elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study

Keywords: pcos statin metformin testosterone menstrual cycle lipids
premorbid personality profile of patients with cognitive and behavioral disorders

Conditions: Behavioral Variant of Frontotemporal Disorder (bvFTD); Phenocopy Frontotemporal Dementia (phFTD); Frontal Variant of Alzheimer Disease; Bipolar Disorder

Summary: damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. symptoms vary both quantitatively and qualitatively from disease to another and from person to person. it cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility. the study will assess the relationship between premorbid profile using neo-pi 3 inventory and cognitive and behavioral/psychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvftd), phenocopy frontotemporal dementia (phftd), frontal variant of alzheimer disease, bipolar disorder characterized with frontal damages.


Eligibility criteria:
inclusion criteria : * patients with behavioral variant of frontotemporal disorder (bvftd) according to rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phftd) who fulfill criteria for possible bvftd and have no imaging abnormalities or patients with frontal variant of alzheimer disease according to ossenkopele criteria (2022), or patient with bipolar disorder according to cim 10 criteria * score for mini-mental state examination ≥ 18 * patient with caregiver who has who has known him/her in the 10 years preceding the disease onset. * patient and caregiver consents (no opposition) exclusion criteria : * patient with no caregiver * pregnant or breast feeding women

Keywords: bvftd fvad phftd bipolar disorder,personality
evaluation of a multi-electrode linear type catheter (d-1368-01-si)

Conditions: Persistent Atrial Fibrillation

Summary: the purpose of this trial is to assess acute safety and performance of the multi-electrode linear type catheter in conjunction with generator software v2.4.0 or above when used for the treatment of persistent atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. signed the patient informed consent form (icf) 3. documented ongoing or previous symptomatic persistent af (by physician's note indicating continuous af ≥ 7 days) 4. failed at least one antiarrhythmic drug (aad) (class i or iii) as evidenced by recurrent symptomatic af, or intolerable to the aad. 5. able and willing to comply with all pre-, post-, and follow-up testing and requirements. exclusion criteria: 1. previous surgical or catheter ablation for atrial fibrillation 2. current condition of continuous af \> 12 months (1 year) (longstanding persistent af) or previously diagnosed as having longstanding persistent af 3. any carotid stenting or endarterectomy 4. known with cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. 5. la size \> 55 mm 6. lvef \<40% 7. af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 8. significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms 9. uncontrolled heart failure or nyha function class iii and iv 10. mi within the past 2 months 11. any cardiac surgery (i.e. cabg) within the past 2 months 12. subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) 13. awaiting cardiac transplantation or other cardiac surgery within the next 12 months 14. documented thromboembolic event (including tia) within the past 12 months 15. significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study 16. active illness or active systemic infection or sepsis 17. unstable angina 18. history of blood clotting or bleeding abnormalities 19. contraindication to anticoagulation (eg, heparin or warfarin) 20. life expectancy less than 12 months 21. presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation 22. presence of a condition that precludes vascular access 23. women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation 24. currently enrolled in another device, biologics, or drug study 25. contraindication for use of the investigational devices , as indicated in the respective instructions for use
impact of bariatric surgery on women fertility

Conditions: Fertility Issues

Summary: obesity is a multifactorial risk factor for subfertility, in relation to chronic hormonal change induced by adipose tissue. this prospective cohort study aims to evaluate the impact of bariatric surgery induced weight loss on women fertility.

females undergoing sleeve gastrectomy will be assessed for improvement of fertility indicators

Eligibility criteria:
inclusion criteria: * age from 20-40 years. * bmi \>35 kg/m2 exclusion criteria: * women with medical endocrinal disorders as dm, thyroid, hyperprolactinaemia, etc. * women using any hormonal treatment or fertility drugs like oral contraceptive pills and/or metformin. * women have any surgical complication intra-operatively or post operatively. * women refused to participate in the study.
a study in male and female adult participants with chronic rhinosinusitis with nasal polyps in the greater gulf region

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: primary objective: - to describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (crswnp) in terms of disease severity, type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting secondary objectives: * describe the progression in treatment outcomes at different visits (baseline, 3 months, 6 months, and 12 months). * to assess the healthcare resource utilization of participants with crswnp in countries of the gulf region (number of visits, emergency room (er), surgery, etc).


Eligibility criteria:
inclusion criteria: * male or female participants. * participants diagnosed with chronic rhinosinusitis with nasal polyps (crswnp) for at least one year prior to study start. * participants diagnosed with crswnp according to criteria of american academy of otolaryngology-head and neck surgery (i.e. the diagnosis is confirmed in medical records by clinical symptoms and objective evidence of nasal polyps by using anterior rhinoscopy and nasal endoscopy when available and/or computed tomography (ct) scan). * participants should be at least 18 years old. * participants must have signed an informed consent. exclusion criteria: * participants with chronic rhinosinusitis without nasal polyps (crssnp) * pregnant/breastfeeding participants or participants planning for a pregnancy. * participants participating in other interventional clinical trials involving any investigational drug. * participants with granulomatous diseases such as vasculitis or sarcoidosis. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
psychosocial outcomes in hand therapy

Conditions: Hand Injuries

Summary: rationale: there is a need for psychosocial symptom management in hand therapy which has been understudied. mindfulness-based interventions are used to address psychosocial symptoms in other settings such as chronic injury but have yet to be implemented or explored for patients in acute outpatient rehabilitation. intervention: a supplemental mindfulness-based intervention (mbi) will be provided to the experimental group while the control group will receive standard care. the mbi will begin with an explanation of the purpose of a mindfulness, how mindfulness relates to hand therapy, and lead to a 20-minute guided meditation using an audio recording. objectives: to establish the feasibility of providing a mbi in hand therapy and evaluate preliminary effects of the mbi on patients' stress, anxiety, and depression. population: adult patients at an outpatient hand therapy clinic in the los angeles area who have received a traumatic injury (e.g., tendon laceration, compound fracture, finger amputation). methodology: the study will use a mixed-methods, non-randomized, 2-group, comparative trial design with 40 participants in total. quantitative data on psychosocial outcomes, including salivary cortisol, will be collected once a week for 4 weeks while patients are attending hand therapy and qualitative interviews will be conducted at the end of the study. study arms: the experimental group (n = 20) will receive the mbi just before regularly scheduled standard care visits. the control group (n = 20) will receive only standard care. outcomes: this pilot study will be used to inform a future fully powered trial on mindfulness-based interventions in hand therapy. feasibility and preliminary psychosocial effects of mbis will be evaluated and used to inform future work. analysis: (1) a repeated measures anova for intervention group, time, and time by intervention group effects on the psychosocial outcomes (i.e., cortisol, anxiety, depression, and pain catastrophizing). (2) a descriptive qualitative process will be used to analyze themes in participant interview responses.


Eligibility criteria:
inclusion criteria: * at least 18 years old; newly entering hand therapy, having a diagnosis of distal radius fracture, flexor tendon injury and repair, extensor tendon injury and repair, tramatic finger amputation, or other traumatic injury; established therapy plan of care lasting at least 4 weeks; able to read and with in english; with regular access to a computer. exclusion criteria: * diagnosed with a severe mental illness; currently an expert in mindfulness practices

Keywords: mindfulness complementary medicine integrative health hand therapy
a study to compare the pharmacokinetics, efficacy, safety, and immunogenicity of pembrolizumab (sb27, eu sourced keytruda, and us sourced keytruda) in subjects with stage ii-iiia nsclc following complete resection and adjuvant platinum-based chemotherapy

Conditions: Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage IIIA

Summary: the goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that sb27 works in the same way as eu and us sourced keytruda in early or locally advanced non-small cell lung cancer (nsclc) patients who underwent surgery and adjuvant chemotherapy. the main question it aims to answer is: • what the body does to the study drug, which is called "pharmacokinetic" participants will receive investigational product (ip) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected. researchers will compare 3 medicines (sb27, eu sourced keytruda, and us sourced keytruda) to see if sb27 works in the same way as eu and us sourced keytruda.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older * diagnosed as nsclc stage ii-iiia (staging should be confirmed after surgery) * have completely removed all of the cancer from the body surgically * have been received 3 or 4 cycles of platinum-based chemotherapy after surgery exclusion criteria: * have received anti-cancer therapy before surgery * have or had autoimmune disease in past 5 years
epidemiologic features of kawasaki disease in shanghai from 2008 through 2012

Conditions: Kawasaki Disease

Summary: to investigate the epidemiological pictures of kawasaki disease (kd) in shanghai from 2008 through 2012, and illustrate the risk factors of coronary arterial lesions .

a questionnaire form and diagnostic guidelines for kd will be sent to 50 hospitals providing pediatric medical care in shanghai, china. all patients with kd diagnosed during january 2008 through december 2012 will be recruited and analyzed. distribution of age at onset and seasonal features of disease incidence wil be described. univariate and multivariate association analyses will be performed to identify risk factors to coronary arterial lesions (cal) defined as ectasia or aneurysm by using multivariate logistic regression model.

Eligibility criteria:
inclusion criteria: * the 5th revised edition of diagnostic criteria for kd, issued by the japan kawasaki disease research committee at the 7th international kawasaki disease symposium in 2002, was adopted. cases were included in the study if the patients had at least five of the following six clinical manifestations or at least four signs together with coronary abnormalities documented by echocardiography or coronary angiography: 1. fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy) 2. bilateral conjunctival congestion 3. changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa 4. polymorphous exanthema 5. changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage 6. acute nonpurulent cervical lymphadenopathy. in addition, the cases of incomplete kd, diagnosed with referring to the guidelines for incomplete kd made by american academy of pediatrics (aap) and american heart association (aha) in 2004, were also included in this investigation exclusion criteria: * the cases were not in accordance with the recruited criteria

Keywords: kawasaki disease epidemiology incidence coronary arterial lesions shanghai
role of aloe vera versus fluoride toothpaste in changing high to low salivary bacterial count

Conditions: Caries, Dental

Summary: patient's salivary bacterial count will be evaluated , then the patient will bbe instructed to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be evaluated another time.

variables of study: each patient will be instructed to follow oral hygiene measures including aloe vera or fluoride toothpaste outcomes: salivary bacterial count will be evaluated using mitis salivarius agar plates before the use of the aloe vera toothpaste then after 15 days then after 30 days . participant timeline: enrolment baseline assessment 15 days 30 days (1st visit ) (2nd visit) (3rd visit ) ii.6.sample size calculation : based on previous study , the mean percent change reduction in bacterial count was 3+4 . using power 80 % and 5 % significance level , we will need to study 29 in each group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. the type i probability associated with this test of this null hypothesis is 0.05. recruitment \& recruitment strategy: screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. the patients will be subjected to full examination and diagnosis using dental charts. once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. randomization and assignment of interventions: randomization will be done according to a check list including the number of participants divided into 2 groups according to interventions/control assessment method allocation sequence generation: the allocation sequence will be generated using (www.randomization.com). allocation concealment mechanism: a checklist will be designed to identify each assessment method. implementation a participant will generate the random allocation sequence. the researcher will enroll the patients but an unbiased participant will assign the intervention/control identification procedures to respective teeth. blinding: the participants will be blinded to intervention/control assessment methods. also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period. data collection methods: high caries index will be assessed 3 times , at base line , then 15 days and 30 days. funding: the research will be self-funded by the researcher.

Eligibility criteria:
inclusion criteria: * patients should have poor oral hygiene. * patients should have high bacterial count exclusion criteria: * patients with a compromised medical history. * severe or active periodontal disease .
effects of ankle support on muscle activation and function

Conditions: Ankle Sprain

Summary: the purpose of this study is to examine the effects of ankle taping on improving muscle function and ankle motion in individuals who frequently twist (sprain) their ankle. it is thought that ankle taping may increase muscle function and ankle motion which would benefit individuals who frequently sprain their ankle.

previous research has demonstrated improved dynamic balance following the application of fibular taping. the effects of fibular taping on ankle dorsiflexion rom and muscle activation in individuals with cai are unknown. the purpose of this study is to determine the acute effects of fibular taping on muscle activation of the fibularis longus (peroneus) and soleus muscles, ankle dorsiflexion range of motion (rom) and dynamic balance. the investigators hypothesize that fibular taping will have similar effectiveness as mobilization interventions which have been shown to improve muscle activation, ankle dorsiflexion rom,and dynamic balance. outcomes will be measured immediately before and after intervention. a crossover design will be used and participants will complete two visits at least 48 hours apart, but not more than 1 week apart. after participants complete both arms of the study their participation will be complete (average time to completion for each subject is 1 week).

Eligibility criteria:
inclusion criteria: * age 16-45 years * history of one or more ankle sprains * scoring at least an 85% on the foot and ankle ability measure (faam) sport or at least 3 on the modified ankle instability instrument (aii). * at least 5° ankle dorsiflexion asymmetry compared to the contralateral limb or ankle dorsiflexion rom less than 21° exclusion criteria: * lower extremity injury or surgery within the past 6 months (including lateral ankle sprain) * diagnosed ankle osteoarthritis * history of ankle surgery that involves intra-articular fixation * potential for current pregnancy

Keywords: ankle tape hoffmann reflex balance
phase ia/ib study of rs-0139 in patients with a recurrent, locally advanced or metastatic solid tumors

Conditions: Solid Tumors

Summary: this study designed as a multicenter, open label, two-step study to determine the optimum dose, pharmacokinetics, and the safety of rs-0139 in patients with a recurrent, locally advanced or metastatic solid tumors. the research is planned as a two-step study (phase ia and phase ib) and accelerated titration design (atd) is used.


Eligibility criteria:
inclusion criteria: * patients who have consented to participation in the trial. * patients of both sexes aged between 18 and 75 years. * patients with relapsed or refractory solid tumors who have failed available standard therapy or are not candidates for standard therapy. * patients who are willing to provide fresh or archival biopsy material before their participation to identify the integrin expression levels (for phase ib only). * patients who completed the previous treatments 21 days before the first dose of the study drug. * patients who have at least three months of life expectancy. * patients with ecog performance score 0 to 1. * patients with adequate organ function defined as: * hemoglobin ≥10 mg/dl * neutrophil ≥1,500/µl * platelet ≥100,000/µl * creatinine ≤1.5xuln or creatinine clearance ≥60ml/sec/1.73m2 * total bilirubin ≤ 1.5xuln * ast/alt ≤2.5xuln; for patients who have confirmed liver metastasis: ast/alt ≤5xuln. * prothrombin time ≤1.5xuln (in case of no anticoagulant treatment). * normal levels of serum magnesium and potassium concentrations exclusion criteria: * patients with active and/or uncontrolled central nervous system (cns) metastasis. * patients who have interstitial lung disease or interstitial pneumonia. * patients who have serious cardiac dysfunction. * patients who have insufficient target organ function. * patients with positive tests for hav, hbv, hcv or hiv. * patients who experienced grade 3 or higher toxicity related to the previous docetaxel treatment. * female patients who are pregnant or breastfeeding. * male patients with pregnant female partners. * patients enrolled in another clinical trial at the same time or recently completed an investigational drug study and received the last dose of an investigational drug within 30 days or five half-lives (whichever is longer). * patients who have serious medical conditions such as uncontrolled infection or untreated wounds. * patients who have bone marrow transplantation history. * patients who have hypersensitivity to docetaxel, components of rs-0139 and/or other taxanes. * patients taking inhibitors or inducers of cyp3a4, including grapefruit juice and otc medications such as st. john's wort. * patients who, in the judgment of the pi, are likely to be non-compliant or unable to cooperate. * patients who cannot be contacted in case of emergency. * patients who are the pi or sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conducting the study.

Keywords: solid tumors chemotherapy targeted