Kornimate/medical-research-clean huggingface dataset:
rtms treatment of spasticity in children with cerebral palsy/ hemiplegia due to abi - a rct

Conditions: CP (Cerebral Palsy)

Summary: this rct aims to investigate the effect of repetitive transcranial magnatic stimulation (rtms) in treating children with hemiplegoc cerebral palsy. the study will measure any improvement in spasticity after using contra-lesional inhibitory rtms follow by intensive limb training. participants will attend a 10-day rtms treatment sessions, follow by intensive training of the impaired limb. they will also undergo mri scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using tms as well as mr-dki. researchers will compare the intervention group and the sham group to see if rtms could result in improvement of participants' spasticity.

cerebral palsy is the most common cause of lifelong physical disability in childhood, with an estimated prevalence of 1.5 per 1000 living biths for primary school-aged children. spasticity is the most common symptoms in children with cerebral palsy, leading to muscle weakness affecting gross motor functions and causing complications such as pain, contracture and subluzation which will lead to inability to perform activity-based training and subsequently lead to further muscle weakness. standard therapy with regular physiotherapy and occupational therapy are essential but time-consuming and the effects might not last for longer duration. patients or caregivers decline medications because of side effects drowsiness while other interventions such as intra-thecal baclofen pump, rhizotomy or surgery are invasive. repetitive transcranial magnetic stimulation (rtms) is a non-invasive brain stimulation technique that has the ability to modulate excitation of the motor cortex area of the brain. there were past studies suggesting that using contralesional inhibitory rtms was safe and feasible for patients with paediatric subcortical stroke and seemed to improve hand function in patients with hemiparesis. however, limited studies have been published on the effects of rtms on improving spasticity in children with cerebral palsy. hence, the objective of this study is to use low-frequency rtms to the contra-lesional hemisphere in children with hemiplegic cerebral palsy to investigate if rtms follow by intensive limb training would improve spasiticity of these children and whether the improvement can be sustained for a longer time. the underlying mechanisms that lead to the changes clinically will also be investigated by tms and mri.

Eligibility criteria:
inclusion criteria: * patients aged between 7 years and 18 years * diagnosis of cerebral palsy with hemiplegia * upper limb spasticity ≥ 1 * iq ≥ 50 exclusion criteria: * any contra-indications to rtms * severe spasticity (score of 4 or more in ashworth scale) * uncontrollable epilepsy * history of botulinum toxin a injection in previous 6 months * upper limb casting in previous 6 months

Keywords: tms cerebral palsy spasticity
effectiveness of sms in diabetes control

Conditions: Diabetes

Summary: introduction: the spanish society of family and community medicine, started the program of preventive activities and health promotion, which generates periodic recommendations of preventive methods based on scientific evidence. in the last update it has become evident the need of modifications to adapt the program to modern times and focuses on improving accessibility and offering more flexible responses to users of the program. in this sense, the mobile phone technology could be useful, specifically the messaging service to remind patients their appointments and increase attendance rates. main objective compare the percentage of patients in the intervention group compared with the control group who achieved a figure of hba1c \<7% in 2013.design: single blind randomized clinical trial. study population: patients with diabetes with or without hypertension or lipid metabolism disorder, over 18 years, belonging to the public health system of basque country (primary care) meeting the inclusion / exclusion criteria. sample size: 238 patients (119 per arm) to detect a difference of 16% in the percentage of patients with hba1c lower than 7% between groups: short messages standard (sms) group: mobile messages reminding the next review of papps. control group: routine clinical practice. statistical analysis: the relationship between the intervention received and the main variable (compliance with preventive activities at 12 months) were analyzed using a logistic regression model.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with or without hypertension or lipid metabolism disorder, * aged between 35 and 74 years old with or without hypertension or lipid metabolism disorder, * mobile phone holder, * able to read messages via mobile phone. exclusion criteria: * pregnant women, * patients whose next date for hba1c control is less than 2 months * patients with hba1c \<7%

Keywords: diabetes management glycated hemoglobin preventive activities
correlates of left ventricular global longitudinal strain and surgical intervention on myocardial bridges

Conditions: Myocardial Bridge of Coronary Artery

Summary: to examine the changes in left ventricular (lv) global longitudinal strain (gls), using two-dimensional speckle tracking analysis, after left anterior descending (lad) unroofing, in myocardial bridges (mbs) refractory to optimal medical therapy (omt).

the present study is enrolling all the mbs-patients who underwent angina surgical relief or medical treatment at the "ospedali riuniti" of ancona, italy, and the "university hospital" of chieti, italy. all the participants will be examined utilizing echocardiography before and after the treatment. the two-dimensional speckle-tracking analysis will be performed with an off-line dedicated software from the apical 4-chambers-view. all the unroofing procedures will be performed under cardiopulmonary bypass.

Eligibility criteria:
inclusion criteria: * myocardial bridge of the anterior descending left coronary artery exclusion criteria: * poor echocardiographic imaging quality

Keywords: coronary abnormalities angina global longitudinal strain speckle-traking echocardiography myocardial ischemia
pioglitazone/glimepiride (sonias) combination tablets special drug use surveillance survey in patients with type 2 diabetes mellitus who respond poorly to pioglitazone

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (sonias combination tablets ld) in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) in the routine clinical setting.

this is a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (sonias combination tablets ld) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day). the usual adult dosage is one tablet (15 mg/1 mg of pioglitazone/glimepiride) administered orally once daily before or after breakfast.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus for whom treatment with pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) is considered inefficacious as per physician's assessment and for whom long-term treatment with pioglitazone/glimepiride combination tablets is considered necessary exclusion criteria: * (1) patients with cardiac failure or a history of cardiac failure (2) patients with serious hepatic or renal impairment (3) patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) patients with severe infection, severe trauma, or pre- and post-operative patients (5) patients with gastrointestinal disorders such as diarrhea and vomiting (6) pregnant or potentially pregnant women (7) patients with a history of hypersensitivity to the ingredients in sonias combination tablets or sulfonamides

Keywords: pharmacological therapy
wilate in subjects with von willebrand disease who undergo surgery

Conditions: Prevent Bleeding in Major Surgery

Summary: proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.


Eligibility criteria:
inclusion criteria: * diagnosed with congenital vwd (von willebrand disease) * require therapy with a vwf (von willebrand factor) product to treat any major surgical procedure exclusion criteria: * known coagulation disorder other than vwd * known history of, or suspected vwf or fviii inhibitors * subjects with hepatic liver disease * known or suspected hypersensitivity or previous evidence of severe side effects to wilate or other vwf/fviii concentrates * pregnant women in the first 20 weeks of gestation
va conditioning regimen allo-hsct for elderly higher-risk mds

Conditions: Higher-risk Myelodysplastic Syndromes

Summary: the goal of this phase 1/2 trial is to test the safety and efficacy of venetoclax plus azacytidine conditioning regimen allo-hsct in treating patients with higher-risk mds.

the investigators will evaluate 2 year overall survival(os) after transplantation in patients with higher-risk mds. progression free survival (pfs), incidence of acute gvhd, non-relapse mortality (nrm), graft-versus-host disease (gvhd)-free relapse-free survival(grfs), and incidence of chronic gvhd at 1 and 2 years after transplantation will be counted.

Eligibility criteria:
inclusion criteria: * the patient should, in the investigator's opinion, be able to meet all clinical trial requirements. * the patient is willing and able to adhere to the study visit schedule and other protocol requirements. * the patient should be diagnosed with higher risk mds according to the standard criteria of the world health organization (who). exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
second-line therapy of unresectable cholangiocarcinoma by radioembolization

Conditions: Cholestasis, Progressive Familial Intrahepatic 3

Summary: cholangiocarcinoma (cck) is a rare tumor (2000 new cases/year in france) with very poor prognosis (overall survival \< 3% at 5 years). less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. it is not standard first-line chemotherapy validated for unresectable cck, but the best objective response rate (or) and overall survival (os) are observed with gemcitabine and platinum associations (or 24 to 36% and os between 9.5 to 15.4 months). in case of tumor progression ater this first line therapy, no treatment is currently being validated. radioembolization (re) is a new, transarterial approach to radiation therapy using 90 yttrium microspheres. in the patients with unresectable cck , the first pilot studies showed interesting results with rates of or 45 to 90% and a median os of 14.9 mots and an acceptable safety. study hypothesis : re could help achieve tumor stabilization in patients with intra-hepatic cck in tumor progression after first-line therapy.

extended description of the protocol, including information not already contained in other fields, such as comparison studied. it is a pilot study including 20 patients with unresectable intra-hepatic cck in tumor progression after first-line therapy. description of the protocol : 1. information and signed consentment 2. preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting. 3. therapeutic phase : intra-arterial administration of resin-based microspheres ( sirspheres, sirtex). the re can be performed in 2 sessions, especially if liver disease is bi-lobar. 4. follow up to j15,m1,m2,m4 and m6 : clinical examination and imaging evaluation ( scans and /or mri)

Eligibility criteria:
inclusion criteria: * unresectable intra-hepatic cck histologically proven * tumor progression documented on imaging evaluation ( ct or mri) according to recist criteria version 1.1 after first-line therapy * performance status \< 2 ; 4) bilirubin \< 36 micromol/l * age \> 18 years exclusion criteria: * extra-hepatic metastases * uncontrolled biliary obstruction * contra-indications to re.

Keywords: cholangiocarcinoma radioembolization tumor response progression-free survival safety second-line therapy
assessment of early-detection based on liquid biopsy in lung cancer (ascend-lung)

Conditions: Lung Cancer

Summary: the purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy.

after being informed about the study and potential risks, all patients giving written informed consent will undergo a screening process to determine eligibility of study entry. peripheral blood, tissue sample and imaging examinations of eligible patients will be collected for further analysis. data collected will be used to develop a multi-omics lung cancer diagnosis model.

Eligibility criteria:
inclusion criteria: * signed informed consent * male or female, age equal to or greater than 40 years old and less than 75 years old * blood sample was collected before surgery for the detection of cfdna methylation and other biomarkers * lung cancer patients diagnosed for the first time within 42 days before blood sampling without any anti-tumor treatment; or patients who are highly suspected of lung cancer through imaging evaluation or other routine clinical diagnosis and confirmed by tissue biopsy or surgical specimens within 42 days after blood sampling * the subject has not received any local or systemic anti-tumor therapy before blood collection, including (not limited to) any surgery, local or systemic radiotherapy and chemotherapy, targeted therapy (including anti-angiogenesis), immunotherapy, cancer vaccines and hormone therapy, etc. exclusion criteria: * unable to obtain sufficient and qualified blood samples * female subjects who are pregnant or breastfeeding * patients who have received organ transplantation or non-autologous bone marrow or stem cell transplantation * patients who have received blood transfusion within 7 days before blood sampling * patients who have received anti-infection treatment within 14 days before blood collection * patients who have receiving anti-tumor drugs for other diseases within 30 days before blood collection, such as methotrexate, cyclophosphamide, mercaptopurine, chlorambucil, tamoxifen, etc. * patients who suffered from other malignant tumors or multiple primary tumors at the same time * pathological confirmed benign lesions by tissue biopsy or surgery * insufficient sample for a confirmed pathological diagnosis * lung cancer patients with ground glass nodules on ct imaging.

Keywords: liquid biopsy
procarbazine and lomustine in recurrent glioblastoma

Conditions: Recurrent Glioblastoma Multiforme

Summary: the combination therapy of temozolomide and radiation has been established as the standard therapy for the initial treatment of glioblastoma. however, the prognosis for patients with recurrent/ refractory glioblastoma is dismal, with a median survival of 3\~6 months. there is no efficient and standard care at the time of recurrence or progression following temozolomide administration. recently, many clinicians have reassessed the efficacy of second-line chemotherapeutic agents such as nitrosoureas for the treatment of recurrent/refractory glioblastoma. it is very important that the effect of the agent is sustained and the adverse effect is reduced to preserve the quality of life in recurrent settings. we have realized that the clinical features of korean patients are very different from those of foreign patients. therefore, it is mandatory to develop the new strategy for the treatment of korean patients. we modify the pcv chemotherapy in the dose and administration schedule of ccnu and procarbazine to reduce the side effect, especially hematologic problems. the dose of ccnu is reduced to 75mg/m2 and the interval between ccnu and procarbazine is increased. moreover, vincristine is excluded because bbb permeability of vincristine is very poor and the risk of neurotoxicity is high. we introduce the modified pc chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the first multicenter trial for glioblastoma patients in korea.


Eligibility criteria:
inclusion criteria: * histologically or radiologically confirmed progressive or recurrent glioblastoma with methylated mgmt promoter * within 6 months after or during stupp regimen (tmz-rt ccrt + adjuvant tmz), or after re-treatment of cyclic tmz, 6 months later after stupp regimen * kps ≥ 60% * age ≥ 20 years * at least two weeks apart from prior surgery and prior chemotherapy * adequate hematologic, liver, and renal functions * unstained slides for central pathology review * signed informed consent exclusion criteria: * prior malignancy within 5 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix * maternity or breastfeeding * evidence of active infection within 2 weeks prior to study * previous treatment with procarbazine and/or ccnu * evidence of leptomeningeal metastasis * unable to comply with the study protocol

Keywords: glioblastoma, recurrent, refractory, ccnu, procarbazine
efficacy and safety of candesartan associated with chlorthalidone versus losartan associated with hydrochlorothiazide (hyzaar®) in essential hypertension control

Conditions: Essential Arterial Hypertension

Summary: the purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility criteria:
inclusion criteria: * signed consent of the patient; * participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the brazilian society of cardiology (2010), who are being treated with monotherapy. exclusion criteria: * patients with any clinically significant disease that in the investigator opinion can not participate in the study; * secondary hypertension diagnosis or blood pressure above 190x100 mmhg in the screening/randomization visit; * morbid obesity or immunocompromised patients; * participants with greater than 10 mmhg difference in the measurements of systolic or diastolic blood pressure between the two arms; * participants who do not have the two upper limbs; * participants with important electrocardiographic changes; * creatinine clearance - less than 60 ml / min; * history of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months; * microalbuminuria urine sample greater than 30 mg/g; * patients with history of hypersensitivity to any of the formula compounds; * pregnancy or risk of pregnancy and lactation patients; * participation in clinical trial in the year prior to this study;
effectiveness of a breathing and relaxation technique in antenatal education

Conditions: Pregnancy

Summary: the aim of this randomised controlled trial is to compare the effects of an antenatal education class including a breathing and relaxation technique on self-efficacy compared to a standard antenatal education class without a focus on breathing and relaxation techniques.

antenatal education classes were developed to inform expectant mothers about pregnancy, labour and birth and the postpartum period with the aim of improving pregnancy and childbirth experience. they were based, for example, on concepts of lamaze and grantly dick-read. studies indicate positive emotional effects on labour and birth outcomes in women who attended antenatal education classes. this includes lower levels of fear of childbirth, lower rates of caesarean birth at the women's request, a higher rate of spontaneous births, and a stronger involvement of the partner, better chances of initiating breastfeeding, a lower likelihood of developing depression symptoms during the postpartum period. there is limited evidence on the link between birth preparation and neonatal outcomes. considering recent evidence suggesting that antenatal education classes may positively influence maternal and neonatal birth outcomes, we intend to analyse an antenatal education class focusing on a breathing and relaxation technique and assess the impact of such a class on self-efficacy, as well as other maternal and neonatal birth outcomes.

Eligibility criteria:
inclusion criteria: * pregnant women with a singleton low-risk pregnancy * receiving antenatal care * being willing to attend an antenatal education class * planning a vaginal birth * sufficient oral and written german language knowledge exclusion criteria: * women, who plan an elective caesarean section * pregnant with multiples * do not have sufficient oral and written german language knowledge

Keywords: breathing technique birth preparation prenatal education
delphi study on myofascial pain syndrome challenges in turkey: patient journey, burden, diagnosis & treatment needs.

Conditions: Myofascial Pain Syndrome

Summary: myofascial pain syndrome is a chronic pain disorder that affects many people in turkey. this research study aims to explore the challenges faced by patients with myofascial pain syndrome in turkey, including the disease burden, patient journey, and unmet diagnosis and treatment needs. the study will utilize the delphi methodology, which involves gathering input from a panel of experts over multiple rounds to achieve consensus on the topic. the results of this study will shed light on the current state of myofascial pain syndrome management in turkey and provide insights into the areas where improvements can be made.

the study will use a delphi methodology to investigate the challenges faced by patients with myofascial pain syndrome in turkey. a panel of 20 experts with diverse backgrounds in healthcare and pain management will be selected. the study will be conducted in three rounds, with the first round consisting of open-ended questions to identify key themes related to the disease burden, patient journey, and unmet needs. in the second round, experts will rate the importance of each theme, and in the third round, they will review the results of the previous round and provide additional feedback. data will be analyzed using content analysis and descriptive statistics to identify the areas of consensus and divergence among the experts.

Eligibility criteria:
inclusion criteria: * being an expert on healthcare. * giving consent. exclusion criteria: * not giving consent. * any disorder or condition that may negatively affect reading, comprehension, and form filling.

Keywords: disease burden delphi methodology patient journey myofascial pain syndrome quality of life
effect of vitamin b12 on the development of sepsis, in culture positive patients

Conditions: Bacteremia

Summary: this is an prospective observational study assessing the effect of vitamin b12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result. the hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin b12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.


Eligibility criteria:
inclusion criteria: * adults (≥18 years old) * infection, confirmed by a positive culture result * signed informed consent. exclusion criteria: * pregnancy and/or breast feeding * inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia