Kornimate/medical-research-clean huggingface dataset:
evaluation of efficacy and safety of agalsidase beta in heterozygous females for fabry disease

Conditions: Fabry Disease

Summary: fabry disease (omim 301500) is an x-linked inborn error of sphingolipid metabolism resulting from the deficiency of the lysosomal enzyme alpha-galactosidase a. heterozygous females for fabry disease may be symptomatic with cardiac, renal or cerebrovascular involvement. clearance of gb3 and stabilization of renal function has been demonstrated in male patients treated with agalsidase beta (fabrazyme). in contrast, no randomized, controlled study of the efficacy of recombinant alpha-galactosidase a has been reported in heterozygotes for fabry disease.

the primary objective is to evaluate cardiac left ventricular mass (measured with echocardiography by unique investigator) in females over 15 years of age affected with fabry disease receiving 70 mg of agalsidase beta every other week, as compared with an untreated controlled group matched for gender and age. the secondary objectives include evaluation of : * left ventricular posterior wall thickness (echocardiography) * interventricular septum thickness (echocardiography) * tissue doppler imaging (myocardial function) * ekg * creatinaemia * serum cystatin c level * urinary protein/creatinine ratio * microalbuminuria * gb3 urinary levels evaluation of tolerance and safety with : * home therapy infusions follow up * vitals * physical examination * adverse events * antibodies levels

Eligibility criteria:
inclusion criteria: * female patients over 15 years with clinical and biological evidence of fabry disease (gla gene mutation detected) exclusion criteria: * pregnancy * allergy to agalsidase beta * congestive heart failure * creatinaemia \> 135 µmol/l * medical history of stroke during the last year * medical history of more than 2 transient ischemic attack * blood pressure \> 160/95 * modification in medications treating for blood pressure during the last 3 months before enrollment * complete absence of clinical or biological symptoms * weight \> 87 kg or \< 35 kg

Keywords: heterozygous females cardiomyopathy
asp8825 - study in patients with restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: to demonstrate the superiority of asp8825 over placebo and the dose response in patients with restless legs syndrome

three doses of asp8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome

Eligibility criteria:
inclusion criteria: * patients with rls, based on the international rsl study group diagnostic criteria * history of rls symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started * documented rls symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period exclusion criteria: * a sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of rls * a history of rls symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment * neurologic disease or movement disorder (e.g., diabetic neuropathy, parkinson's disease, multiple sclerosis, dyskinesias and dystonias

Keywords: asp8825 restless legs syndrome xp13512
construction and biological study of blood and placenta samples associated with gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: gestational diabetes mellitus (gdm) is a type of diabetes mellitus with normal glucose metabolism before pregnancy. pregnant women with prepubertal diabetes have complicated clinical experiences, and the effects of severe disease or poor glycemic control on mothers and infants. the incidence of gestational diabetes mellitus is very high, and the short-term and long-term complications of the mother and the child are higher. through the detection of blood samples, we can not only obtain the basic information related to the disease such as blood cells and blood biochemistry, but also learn the important information such as enzymes, antibodies and cell metabolites in the blood that are conducive to the diagnosis of the disease. more importantly, blood contains genetic material (such as genomic dna) that can be used to screen for genes and break down molecules. placenta tissue examination can provide important cellular, biochemical, immunological and other information. however, due to the complex etiology of gestational diabetes. especially associated with genetic or immunological factors, in the short term often cannot make a definite diagnosis, and patients in hospital time is limited, some check items such as gene detection, placental tissue can't complete them in hospital, need to return the patient's blood, cord blood and placenta tissue, to facilitate later further screening and biology research. this study intended to establish gestational diabetes patient's blood, cord blood and placenta tissue samples library, screening is closely related to the disease biomarkers, such as disease-causing gene mutations, susceptible gene mutation and protein metabolism product, so as to clarify disease relationship between genotype and clinical phenotype, the pathogenesis of diseases, etc., and provide the basis for the diagnosis of disease and treatment optimization.

the registry procedures: we collected data and blood samples from pregnant women diagnosed with gdm and matched healthy pregnant women as controls on the day admitted to hospital for delivery. all of the participants recruited were han chinese. placental tissue was collected immediately after delivery and saved at -20 °c for analysis.

Eligibility criteria:
inclusion criteria: 1. the patient was older than 18 years old and had not been diagnosed with diabetes before pregnancy. a 75-gram glucose load examination was performed during 24-28 weeks of gestation：gdm should be diagnosed at any time in pregnancy if one or more of the listed criteria are met following a 75-gram glucose load: fasting pg ≥5.1 mmol/l; 1-hour pg ≥10.0mmol/l; 2-hour pg 8.5-11.0 mmol/l. 2. if the patient is younger than 18 years old, consent from parents or guardians is required; 3. inclusion objects in line with the above sample sources; 4. signed the informed consent; exclusion criteria: 1. refuse to sign the informed consent 2. severe mental symptoms, unable to cooperate with blood collection
ultrasound guided block for postoperative analgesia in arthroscopic shoulder surgery

Conditions: Analgesia

Summary: this study aimed to compare the efficacy of high thoracic-espb with shoulder block as analgesic options for arthroscopic shoulder surgery. primary outcome: • 24-hour analgesic consumption. secondary outcomes: * postoperative pain evaluated by: visual analogue pain scale (vas). * time to first rescue analgesia and total postoperative consumption of analgesia. * effect of the block on hemodynamics. * adverse effects in the form of postoperative nausea and vomiting (ponv). * patient satisfaction.


Eligibility criteria:
inclusion criteria: * all patients within the age range ≥ 21 to ≤ 70 years old. * body mass index (bmi) ≤ 35kg m2. * asa i, ii of both sex exclusion criteria: * refusal of the patient to the study. * infection at the site of injection. * previous known allergy to any drug used in the study by history. * renal disease \[creatinine. \>3mg/dl.\]. * hepatic disease. \[alt\>50u/l, ast \>50u/l\]. * un cooperative or psychological unstable patients. * coagulopathy or anticoagulant therapy. * pregnancy.
comparison of immunization quality improvement dissemination study

Conditions: Immunization; DTaP Vaccine; Hepatitis B Vaccine; MMR Vaccine; HIB-vaccine; Poliovirus Vaccine, Inactivated; Chickenpox Vaccine; Pneumococcal Polysaccharide Vaccine

Summary: dissemination research examines the processes and factors that lead to widespread use of evidence-based interventions. there are several theories on how to best minimize the perceived and actual burdens on practitioners associated with implementing evidence-based medicine. for instance, the pay for performance model attempts to improve physician compliance with quality guidelines by providing financial incentives. recent studies suggest pay for performance is effective in improving practitioner performance, but it is unclear whether the gains are sustainable once incentives are stopped. another approach to promoting best practices is the model for improvement whose main method is to employ plan-do-study-act (pdsa) cycles of small changes although this approach has been successful within individual institutions, there is minimal evidence of its effect when employed simultaneously in multiple autonomous institutions. there is also little evidence of the sustainability of outcomes after intervention activities end. the specific aims of the proposed study are to examine the effect of quality improvement dissemination models on the immunization coverage of children ages 3 to 18 months old. the investigators propose to: 1. determine the effect on immunization compliance of two different models of dissemination which will provide physicians 12 months of quality improvement (qi) activity support for implementing cdc immunization best practices. hypothesis 1a: study participants receiving the qi technical support intervention (qits) will have more improvement in immunization rates from baseline to immediately after support ends than participants receiving the pay for performance intervention (p4p). hypothesis 1b: study participants receiving qits will increase immunization coverage for their practices over baseline. hypothesis 1c: study participants receiving p4p will increase immunization coverage for their practices over baseline.


Eligibility criteria:
inclusion criteria: * regular patient of a participating practice exclusion criteria: * fewer than 2 encounters at a participating practice * moved or gone elsewhere prior to assessment date * medical contraindication to vaccination

Keywords: n05.300.150.410 practice guideline d20.215.894.899.290.130 health knowledge, attitudes, practice
effect of pelvic floor-based training on dysmenorrhea

Conditions: Dysmenorrhea

Summary: the aim of this study is to examine the effect of patient education, knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. the main question it aims to answer is the questions are as follows: 1. is patient education effective in improving symptoms in young women with primary dysmenorrhea? 2. is there a relationship between knowledge level and symptoms in young women with primary dysmenorrhea? participants will: after the training group was given the training in 2 sessions, the participants were asked to apply the exercises in which the training was given. the control group applied conventional self-methods when dysmenorrhea symptoms occurred. the evaluations were made before the training and at the end of the first menstrual cycle.

dysmenorrhea is pain that occurs during menstruation due to cramps in the uterus. it is one of the most common causes of pelvic pain, especially experienced by young women. primary dysmenorrhea is distinguished from secondary dysmenorrhea by the occurrence of pain in women with normal pelvic anatomy without any pathology or physiological etiology. in the management of primary dysmenorrhea, non-pharmacological treatment methods such as lifestyle changes, sleep and nutrition changes, exercise, and physiotherapy applications are used in addition to pharmacological treatments. the aim of this study is to examine the effect of patient education on the pelvic floor knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. in this study, participants were divided into two groups: the education group and the control group. the evaluations were made before the education and after the first menstrual cycle. the "statistical package for social sciences (spss) statistics 23.0 (spss inc, chicago, usa) program will be used in the analysis of the study data. the change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". the "chi-square test" will be used to examine the relationship between categorical variables. the relationship between numerical variables will be examined with the "spearman rho correlation coefficient". the probability of error will be accepted as (p\<0.05).

Eligibility criteria:
inclusion criteria: * being diagnosed with primary dysmenorrhea * being between the ages of 18-35 * having a regular menstrual cycle * volunteering to participate in the study exclusion criteria: * not having a history of endometriosis or gynecological pathology • * having a history of gynecological disease or surgery * having a neurological or musculoskeletal problem

Keywords: dysmenorrhea pelvic floor physiotherapy exercise education
retrospective chart review of candida fungemia

Conditions: Candida Fungemia

Summary: background: candida can cause infections. the most common kind of candida at clinics is c albicans. but other kinds have increased at clinics too. researchers want to review the records of people who were in previous nih studies who had candida. they want to find out what risk factors are associaated with this infection. objective: to study the factors that are associated with candida fungemia to develop. the factors are clinical features, diagnoses, and previous antifungal therapy. eligibility: people who were in prior nih studies and had candida design: researchers will review the records of 62 nih participants. the records are from 2004 to 2017. they will look at data such as blood test results, diagnosis, and treatments. researchers will only reach out to participants if they get approval from a review board. this research will probably not reveal data that would be important to participants health. but if it does, researchers will try to contact those participants. data will be stored in secure computers. they will be stored with a code that only the study team can link to a participant.

this protocol is a chart review of patients who had candida species grown from blood cultures drawn at the national institutes of health. the study will involve only review of patient records and will not require new specimens or participant contact. the patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s). principal investigators of each protocol have been contacted to request permission to conduct this study, and to verify that none of the original protocols or informed consent documents precludes such a review of clinical data.

Eligibility criteria:
* the study will involve only review of patient records and will not require new specimens or participant contact. the patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s).

Keywords: candida parapsilosis candida auris candida lusitaniae candida glabrata candida albicans
effects of repeated attachment security priming on depressed mood: a clinical study

Conditions: Unipolar Depression

Summary: the purpose of this study is to explore whether asking participants to visualise a secure attachment figure or a neutral event leads to differences in self-reported felt security or depressed mood. furthermore, the investigators aim to explore whether it is possible to keep a secure prime activated over 3 days via text message visualisation tasks.


Eligibility criteria:
inclusion criteria: -anxiety and depressive symptoms exclusion criteria: -bipolar disorder

Keywords: attachment security priming depressed mood
truerelief efficacy for post-cesarean pain (electron)

Conditions: Post-cesarean Pain

Summary: this is a randomized trial of 134 individualized post-cesarean delivery who will be randomized to twice daily use of non-invasive bioelectronic treatment with truerelief device or identical appearing sham device for post-cesarean pain management.


Eligibility criteria:
inclusion criteria: • post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) singleton, or twin gestation exclusion criteria: * known history of opioid use disorder, by medical record review * contraindication to opioids * contraindications to both acetaminophen and ibuprofen * significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different * fetal or neonatal death prior to randomization * inability to randomize on postoperative day 0 * inability to participate in twice daily use of non-invasive bioelectronic treatment during inpatient stay as assessed by research staff * language barrier (non-english or spanish speaking) * participation in another intervention study that influences the primary outcome in this trial

Keywords: post-cesarean pain non-opioid non-invasive device
imipenem versus cefepime in spontaneous bacterial peritonitis and to evaluate the risk factors for treatment failure

Conditions: Spontaneous Bacterial Peritonitis

Summary: 1. all consecutive patients with cirrhosis and ascites admitted to ilbs (institute of liver \& biliary sciences) will be evaluated for the presence of sbp (spontaneous bacterial peritonitis) by ascitic fluid examination at admission. 2. sbp (spontaneous bacterial peritonitis) will be diagnosed in the presence of absolute neutrophil count (anc \>250/mm3) with/without positive ascitic fluid culture and patients with sbp (spontaneous bacterial peritonitis) included in the study will be randomized to receive cefepime or imipenem. 3. however, other sbp (spontaneous bacterial peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).

baseline evaluation: baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient. 1. etiology of cirrhosis. 2. severity of liver disease. ctp (child-turcotte-pugh) score meld (model for end-stage liver disease) score meld (model for end-stage liver disease)-na score imsaa score 3. decompensations/complications of cld (chronic liver disease) ugi bleed, hepatic encephalopathy, aki (acute kidney injury) etc. 4. laboratory investigations: serum electrolytes liver function tests kidney function tests pro calcitonin usg/ct abdomen complete blood counts coagulation parameters ascitic fluid analysis- tlc, dlc, protein, sugar, culture, saag. chest x ray pa view hbsag and anti-hcv and other etiological workup as available.

Eligibility criteria:
inclusion criteria: - cirrhotic patients with sbp (spontaneous bacterial peritonitis) having any of the following risk factors would be considered as 'difficult to treat sbp' and would be included - 1. nosocomial sbp: occurence of sbp (spontaneous bacterial peritonitis) after 48 hours of hospital admission, or 2. prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or 3. no response to treatment with 3rd generation cephalosporins after 48 hours. exclusion criteria: 1. age less than 18 years. 2. cirrhotics with sbp (spontaneous bacterial peritonitis) managed as outpatients. 3. post liver transplant, hiv patients. 4. patients on systemic chemotherapy, immunosuppressant drugs. 5. growth of bacteria resistant to intervention drugs in ascitic fluid culture.
the effect of core stabilization exercises in female wrestlers

Conditions: Exercise Addiction; Trunk Muscle Strength; Upper Extremity; Wrestling

Summary: this study was planned to investigate the effect of core stabilization exercise program on trunk muscle strength, spinal stability and upper extremity performance in elite wrestling athletes.


Eligibility criteria:
inclusion criteria: * being between 14 and 21 years old and interested in wrestling * actively pursuing a life of wrestling * participate in training at least 4 days a week * wrestling in freestyle style. * to confirm that there is no injury problem * being a licensed athlete exclusion criteria: * experiencing any serious injury problems
an open label study to evaluate the long-term safety and effectiveness of aerosol pentamidine in the prophylaxis of pneumocystis carinii pneumonia in aids patients

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of aerosol pentamidine when used as a prophylactic agent in patients who have had at least two or more episodes of aids-associated pneumocystis carinii pneumonia (pcp).


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * zidovudine (azt). * standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study. concurrent treatment: allowed: * any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study. patients must have aids with at least one cytologically or histologically proven episode of pneumocystis carinii pneumonia (pcp). * patients must be free of acute medical problems. prior medication: allowed: * zidovudine (azt). exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * requiring ongoing active therapy for an opportunistic infection at the time of study entry. * toxoplasmosis. * cryptococcus. * pulmonary kaposi's sarcoma (ks). * asthma poorly controlled by medication. concurrent medication: excluded: * pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of pcp while on the study (e.g.: * septra, fansidar, dapsone, or eflornithine). concurrent treatment: excluded: * transfusion dependency defined as \> 1 blood transfusion per month. patients with the following are excluded: * requiring ongoing active therapy for an opportunistic infection (o.i.) at the time of entry or having either toxoplasmosis or cryptococcosis at entry. * pulmonary kaposi's sarcoma (ks). * active substance abuse by patients who cannot comply with study procedures. * unwilling to sign informed consent. * in the opinion of the investigator cannot cooperate with study procedure. * asthma poorly controlled by medication. * patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of pcp while on the study (e.g.: * septra, fansidar, dapsone, or eflornithine). prior medication: excluded within 30 days of study entry: * antiretroviral agents, excluding zidovudine (azt). * immunomodulating agents. * corticosteroids. prior treatment: excluded within 7 days of study entry: * blood transfusion. * excluded: * requiring ongoing active treatments for an opportunistic infection at time of study entry. active substance abuse by patients who cannot comply with study procedures.

Keywords: aids-related opportunistic infections pneumonia, pneumocystis carinii pentamidine aerosols acquired immunodeficiency syndrome