Kornimate/medical-research-clean huggingface dataset:
effects of low glycemic index diet in children with drug-resistant epilepsy

Conditions: Ketogenic Diet; Drug Resistant Epilepsy; Oxidative Stress; Quality of Life; Psychological Health

Summary: the goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet (lgid) on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy. based upon the aims, the following hypotheses were tested: 1. lgid reduces seizure frequency in children with drug-resistant epilepsy. 2. lgid improves oxidative parameters in children with drug-resistant epilepsy 3. lgid improves quality of life and mental health in children with drug-resistant epilepsy participants were prescribed the lgid for 3 months.at baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (sdq), pediatric inventory of quality of life (pedsql) and depression scales were administered and samples for biochemical measurements were collected. diet compliance was evaluated by food consumption records during monthly follow-up visits (at 1 , 2, and 3 months).

the aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy.this study was a prospective, non-randomized, single centre intervention conducted in children with drug-resistant epilepsy. low glycemic index diet was started on an out-patient basis. children and their parents were educated about the diet and the effect of the diet on seizures. children who were willing to follow the diet were included in the study. the research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the diet.at baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (sdq), pediatric inventory of quality of life (pedsql) and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected. a 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance. parents were asked to record the seizure frequency and severity in a seizure diary.

Eligibility criteria:
inclusion criteria: * being between the ages of 4-18, * being diagnosed with drug-resistant epilepsy, * having more than one seizure per week, * not having followed a ketogenic diet before. * willing to come for regular follow up exclusion criteria: * children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated. * non-compliance with the diet recommended by the patient and/or parents * enteral tube or parenteral feeding
color flow doppler ultrasound in subclinical thyroid dysfunction

Conditions: Subclinical Hypothyroidism; Hyperthyroidism; Thyroid Dysfunction

Summary: overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. the purpose of this study is to investigate the thyroid vascularity and blood flow by color flow doppler sonography in patients with subclinical thyroid dysfunction

color flow doppler sonography (cfds) has become in the last years an increasing procedure to assess the thyroid blood flow. previous studies showed specific changes of thyroid blood flow in hyperthyroidism, hashimoto's thyroiditis and thyroid nodules when investigated by cfds. subclinical hyperthyroidism and hypothyroidism are common laboratory findings, defined by normal thyroid hormones concentrations along with ,respectively,decreased or increase thyroid stimulating hormone (tsh) level. we purpose to investigate thyroid vascularity by cfds in patients with subclinical hyperthyroidism or hypothyroidism and compared them with euthyroid patients.

Eligibility criteria:
inclusion criteria: * patients with subclinical hypothyroidism or hyperthyroidism * patients with thyroid nodules and normal thyroid function exclusion criteria: * patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone * patients who had thyroid surgery or radioiodine therapy * patients with nyha class 3 or 4 heart failure

Keywords: hypothyroidism hyperthyroidism thyroid dysfunction ultrasound doppler
a survey on hypoglycaemia among insulin-treated patients with diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this survey is conducted in south america. the aim of this survey is to investigate hypoglycaemia among insulin-treated patients with diabetes.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities * the following patients will be considered eligible for inclusion in the study: patients with t1dm (type 1 diabetes mellitus) or t2dm (type 2 diabetes mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey exclusion criteria: * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * illiterate patients and patients otherwise unable to complete a written survey * non-ambulatory patients * simultaneous participation in any other clinical study with an investigational product
randomized study of l-baclofen in patients with refractory trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: objectives: i. evaluate the efficacy of l-baclofen in patients with refractory trigeminal neuralgia. ii. evaluate the safety and tolerance of l-baclofen in these patients.

protocol outline: this is a randomized, double blind, placebo controlled, parallel study. patients are randomized to receive either l-baclofen or placebo orally at increasing daily doses for 1 week. patients then continue to receive the maximum dosage acceptable for a 1 week maintenance period. patients, thereafter, may enroll in a long term open label study with l-baclofen. patients are followed at 1, 3, 6, 9, and 12 months. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- idiopathic trigeminal neuralgia - paroxysmal attacks of facial or frontal pain lasting a few seconds to less than 2 minutes - pain has at least 4 of the following characteristics: distribution along one or more divisions of the trigeminal nerve sudden, intense, sharp, superficial, stabbing, or burning quality pain intensity severe precipitation from trigger areas, or by certain daily activities such as eating, talking, washing the face, or cleaning the teeth between paroxysms entirely asymptomatic - no neurological deficit - attacks are stereotyped in the individual patient - exclusion of other causes of facial pain by history, physical examination and special investigations when necessary must be uncontrolled or refractory as defined by occurrence of at least 2 paroxysms of pain per day despite conventional treatment with maximally tolerated doses of carbamazepine --prior/concurrent therapy-- no concurrent medication for trigeminal neuralgia other than carbamazepine, phenytoin, and neurontin concurrent medication for other conditions allowed concurrent medication must be on stable dose(s) --patient characteristics-- hepatic: no significant hepatic disease renal: no significant renal disease neurological: no evidence of progressing neurological disorder (e.g., intracranial neoplasm, multiple sclerosis) other: no history of drug abuse not pregnant effective contraception required of all fertile patients

Keywords: neurologic and psychiatric disorders rare disease trigeminal neuralgia
comparison of biphasic insulin aspart (30, 50 and 70) and insulin aspart in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.


Eligibility criteria:
inclusion criteria: * body mass index between 18 and 28 kg/m\^2 inclusive * hba1c within the normal laboratory range * non smoker for at least three months * females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (iud) , the oral contraceptive pill or barrier methods exclusion criteria: * subjects who have received any investigational drug in the 3 months prior to the start of dosing * any disease requiring regular use of non topical prescription medicines * any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug * any intercurrent illness or endocrine disorders that may affect blood glucose * subject with a history of drug or alcohol dependence * subject with a first degree relative with diabetes mellitus * subject with a history of clinically relevant allergic reactions to medical products * subjects who have donated any blood or plasma in the past 3 month preceding screening
mhealth-supported telecolposcopy for cervical cancer programs in low-resource settings: evaluation (mivaa)

Conditions: Cervical Cancer

Summary: the central hypothesis is that use of mivaa (mobile inspección visual con ácido acético - spanish for visual inspection with acetic acid (via)) will increase the proportion of via positive women who complete follow-up clinical evaluation compared to via positive women in situations in which mivaa was not used, thus potentially improving cervical cancer treatment and survival rates. the study will collect qualitative and quantitative data to examine the feasibility and preliminary impact of mivaa on reducing attrition for follow-up clinical evaluations.

the study will be conducted in lima, peru in the context of mobile units operated by la liga for promoting cancer screening. mivaa comprises two components: a digital imaging device and a telemedicine platform. 1. the digital imaging device is either a mobile phone camera or the pocket colposcope plugged into a mobile phone. 2. the telemedicine platform is mobile phone-based, with an interface for midwives in the mobile units to enter patient information and acquire and upload cervical images, and an interface for the colposcopists based remotely to review the cervical images and patient information and return feedback. the specific aim is to pilot test mivaa in a community-based setting in peru.

Eligibility criteria:
inclusion criteria: * age 18 or older * patients coming to the mobile unit for cervical cancer screening * willing to allow use of mivaa during screening with via. * agree to be audio recorded exclusion criteria: * currently pregnant * history of hysterectomy * does not understand the study purpose and details * is not willing to sign an informed consent

Keywords: cervical cancer screening colposcopy digital health
safety and efficacy of nnc 0142-0000-0002 in subjects with moderately to severely active crohn's disease

Conditions: Inflammation; Crohn's Disease

Summary: this trial is conducted in europe and north america. the aim of the trial is to assess disease activity and safety in subjects with moderately to severely active crohn's disease (cd) when treated with nnc 0142-0000-0002.


Eligibility criteria:
inclusion criteria: * subjects with cd for at least 3 months * subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound exclusion criteria: * any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess * history of dysplasia or malignancy in the colon * any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation * body mass index (bmi) higher or equal to 38.0 kg/m\^2
oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion

Conditions: Family Planning

Summary: the aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.


Eligibility criteria:
inclusion criteria: * women not taken analgesics or anxiolytics in the 24 hours prior insertion * women not taken misoprostol prior to intrauterine device insertion * women who will accept to participate in the study exclusion criteria: * any contraindication to intrauterine device placement
efficacy and safety of aut00063 versus placebo in age-related hearing loss

Conditions: Age-Related Hearing Loss

Summary: this study aims to demonstrate that the investigational drug aut00063 is effective and safe in the treatment of age-related hearing loss.

reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears). aut00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems. the main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). subjects will undergo a safety follow-up after the treatment period. safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.). the amount of drug in the blood will also be measured. it is expected that around 70 people (at least 35 in each arm) with age-related hearing loss may take part in the study. the study participants will be recruited at around 13 sites in the usa.

Eligibility criteria:
* be between ages 50-89 years old * american-english speaking * have difficulty hearing speech in a noisy environment * no recent history of middle ear disease * no severe insomnia, major depressive disorders, severe anxiety or post-traumatic stress disorder * not a current or previous user of hearing aids. you are eligible if you were noncompliant and stopped wearing a hearing aid device \>6 months earlier for intermittent use or \>3 years if you were a full-time consistent user of hearing aid devices * not be dependent on alcohol or drugs * have not participated in another research study within 30-days * if female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile) * if male, you must confirm to use a barrier method (condom) * not be a professional musician * no history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor while you are in the study, you must: * follow the instructions you are given * come to the study centre for all visits with the study doctor or study staff * answer the telephone at the scheduled date and time for the 2 telephone calls * tell the study doctor or study staff about any changes in your health or the way you feel * tell the study doctor or study staff if you want to stop being in the study at any time * bring your diary to each visit * not eat or drink anything containing grapefruit beginning 7-days before baseline visit (visit 3, day 1) until the end of the study * use sun screen if you plan to sunbathe * not use headphones or headsets at high volume * not use hearing aids or devices at any time during the study

Keywords: hearing loss speech-in-noise
study to assess the efficacy and safety of umbralisib in participants with non-follicular indolent non-hodgkin's lymphoma

Conditions: Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia; Non Follicular Indolent Non-Hodgkin Lymphoma

Summary: this research study will evaluate the safety and efficacy of a study drug called umbralisib (also known as tgr-1202) alone as a possible treatment for waldenstrom's macroglobulinemia that has come back or that has not responded to standard treatment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of waldenstroms macroglobulinemia * relapsed or refractory after at least one prior treatment regimen * eastern cooperative oncology group (ecog) score of 0 to 2 exclusion criteria: * any major surgery, chemotherapy or immunotherapy within the last 21 days * evidence of hepatitis b virus, hepatitis c virus or known hiv infection * prior autologous stem cell transplant within 6 months of study entry
high-dose antioxidants for central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: central serous chorioretinopathy (csc) is the serous neurosensory detachment that usually involves the macular area. it is common in patients between 30-50 years old and effects male more often than female with the ratio of 5-10. the common risk factors are psychologic stress, type a personality, systemic steroid use, hypertension and pregnancy. the treatment is usually observation especially in the first three-months. the laser or photodynamic therapy should be considered when the condition does not improve after that time. nevertheless, the pathogenesis of csc is still not well understood but the study from indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal leakage. the causes of this abnormality are supposed to be from nitric oxide, prostaglandins or even free oxidative radicals. from this hypothesis, the oxidative process might be involved in the pathogenesis of the disease especially in the early stage. this study is to determine the effect of antioxidants drugs in the acute stage of csc and to determine whether they can improve the outcomes of the disease.


Eligibility criteria:
inclusion criteria: 1. patients with acute central serous chorioretinopathy within 6 weeks of onset 2. age between 30-50 years 3. new or recurrent attack (the symptom-free period should longer than 6 months) 4. fluorescein angiography (fa) confirmed the diagnosis with the inkblot or smoke-stack leakage and the optical coherence tomography (oct) showed definite subretinal fluid 5. patients' ability for proper follow up. exclusion criteria: 1. chronic central serous chorioretinopathy(longer than 6 weeks) 2. complicated central serous chorioretinopathy such as secondary choroidal neovascularization (cnv) that detected from fa 3. pregnancy, steroid user and patients that contraindicated for high dose antioxidants therapy such as heavy smokers, lung cancer, thyrotoxicosis, renal stone and anemia (hematocrit less than 30%).

Keywords: central serous chorioretinopathy,antioxidants
pathology of hepatitis c nephropathy

Conditions: Cryoglobulinaemia Due to Chronic Hepatitis C

Summary: hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have hcv infection.

hepatitis c virus infection is a major public health problem with an estimated global prevalence of 3% and an estimated 5-20% of infected patients will develop liver cirrhosis .the prevalence of hepatitis c infection in end stage renal disease is greater than in the general population especially in those on hemodialysis which reflects nosocomial transmission of the disease in the hemodialysis environment. hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have hcv infection. it most commonly presents as membranoproliferative and mixed cryoglobulinemia it characterized by an indolent course in one third of patients , remission in another third and relapsing course in the remaining patients with potential progression to advanced chronic kidney disease. mechanism of injury : chronic hepatitis c is primarily associated with type ii cryoglobulinemia , in which the primary mechanism of injury is vasculitis that occurs via immune complex deposition. hepatitis c virus related glomerular disease : type i membranoproliferative was the most common finding associated with mixed cryoglobulinemia but other forms of glomerulonephritis were associated with hepatitis c like mesangial glomerulonephritis,focal and segmental glomerulonephritis,minimal change nephropathy,membranous nephropathy , fibrillary glomerulonephritis,immunotactoid glomerulopathy,iga nephropathy, vasculitic renal involvement ,poly arteritis nodosa and interstitial nephritis .

Eligibility criteria:
inclusion criteria: * it will be conducted on chronic hepatitis c patients with chronic kidney disease . * the participants will be classified according to their estimated gfr by modified mdrd equation and * they will be recruited from the renal unit of internal medicine, assiut university hospitals and assiut hepatitis viruses unit-ministry of health, egypt. exclusion criteria: patients will be excluded if the underlying causes of crf are as follows: chronic pyelonephritis,obstructive uropathy,polycystic kidney disease,patients with esrd on regular hemodialysis,patients with advanced liver cirrhosis,hepatocellular carcinoma,patients on steroids or immunosuppressive drugs and solitary kidney.
cetra: neoadjuvant caelyx and trastuzumab in her-2 positive breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the rate of pathologic complete response when giving docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and trastuzumab before surgery in treating women with operable or locally advanced her-2 positive breast cancer.

chemotherapy in association with trastuzumab, a monoclonal antibody, given before surgery, has been shown to reduce tumor size and permit better resection of her-2 positive breast cancers. this study will evaluate the activity of a neoadjuvant treatment with docetaxel and trastuzumab given every 3 weeks for 4 cycles, followed by the combination of caelyx, cyclophosphamide and trastuzumab every 3 weeks for 4 cycles. patients will undergo breast cancer surgery 2-5 weeks after the completion of neoadjuvant therapy. adjuvant therapy after surgery will be given according to existing guidelines, and will include an additional 10 cycles of trastuzumab.

Eligibility criteria:
inclusion criteria: * histological diagnosis of breast cancer * stage ii-iiib (t0-1-2-3-4-n+-m0 or t2-3-4-n0-m0; according to tnm ajcc classification, 2002) * hyperexpression of her-2/neu (herceptest 3+ or positive fish test) * age\> 18 e \< 65 years * left ventricular ejection fraction (lvef) \> or = 55% * ecog performance status 0-2 * neutrophils \> or = 2000/mm³, platelets \> or = 100.000/mm³ , hemoglobin \> or = 10 g/dl), got, gpt and bilirubin \< 1.25 x the upper normal limit, creatinine \< 1.25 x the upper normal limit. * life expectancy \> 3 months * signed informed consent. exclusion criteria: * any prior treatment for breast cancer * metastatic disease (m1) * performance status (ecog) \> or = 3 * current malignancy or history of prior malignancy within past 10 years (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ of the uterine cervix) * neutrophils \< 2.000/mm³ , platelets \< 100.000/mm³ , hemoglobin \< 10 g/dl. * creatinine \> 1.25 x the upper normal limit * got and/or gpt and/or bilirubin \>1.25 x the upper normal limit. * concomitant conditions that, in the investigator's opinion, contraindicate the use of the drugs in the protocol. * congestive heart failure or history of congestive heart failure, unstable angina pectoris, myocardial infarction, clinically significant valvulopathy or uncontrolled arrhythmias * active infection * incapacity or refusal to provide informed consent. * inability to comply with follow up * pregnant or nursing females.

Keywords: locally advanced stage ii stage iiia stage iiib her-2 positive primary