Kornimate/medical-research-clean huggingface dataset:
manual therapy in the treatment of hemophilic arthropathy of the ankle

Conditions: Hemophilia

Summary: introduction: hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity. design. randomized pilot trial. aimed: to evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy. patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study. patients will be recruited in seven centers, from different regions of spain. intervention: each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 weeks. the treatment program includes 10 exercises that must be administered bilaterally. measuring instruments and study variables: visual analog scale and pressure algometer (joint pain); leg motion (ankle range of motion); and haemophilia joint health score (joint health). at the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment. expected results: to demonstrate the safety of this physiotherapy technique in patients with hemophilia. likewise, an improvement in ankle pain, joint motion, joint health and pressure pain threshold.


Eligibility criteria:
inclusion criteria: * patients diagnosed with hemophilia a and b * with severe (\<1% fviii/fix) or moderate (1-5% fviii/fix) phenotype of hemophilia * over 18 years * with medical diagnosis of ankle arthropathy and with clinical evaluation by hemophilia joint health score * in prophylactic treatment with fviii / fix concentrates for coagulation exclusion criteria: * patients with inhibitors (antibodies against fviii or fix) * patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests * failure to sign the informed consent document
impact for developmental coordination disorder

Conditions: Developmental Coordination Disorder

Summary: this study investigates the impact of developmental coordination disorder on the child and its environment in belgium within the following domains: diagnosis, activities and participation, school, therapy/support, and socio-emotional impact.


Eligibility criteria:
inclusion criteria: * parents of children living in belgium * parents of children between 4 and 18 years old * parents of children who experience movement problems and/or there is a suspicion or diagnosis of dcd exclusion criteria: • parents of children who have another other medical condition that would explain the movement difficulties (e.g. cerebral palsy, muscle disease,...)

Keywords: child diagnostics early development neurodevelopmental disorders
the effect of partial and complete sleep deprivation on heat tolerance

Conditions: Sleep Deprivation

Summary: the purpose of the present study is to evaluate the effect of partial and complete sleep deprivation on exercise heat tolerance. twelve healthy young male volunteers will participate in the study. they will arrive to our lab four times, in each visit the will undergo vo2 test and heat tolerance test (htt) after sleeping different amount of hours.

the volunteers will arrive to our lab fout times- during their first visit they will go through a vo2 max test in order to evaluate their aerobic fitness, and their physiological efficiency will be measured. during their second visit they will go through an exercise heat tolerance test according to our validated protocol after a full night sleep. during the third and fourth visit they will go through an exercise heat tolerance test and a measurement of their physiological efficiency after a partial and complete sleep deprivation, respectively. the physiological tests will take place in the heat chamber that is located at the heller institute of medical research. the results will be then analyzed, and a comparison between the physiological measurements during the heat tolerance tests and the physiological efficiency tests after the various sleep conditions will be performed.

Eligibility criteria:
inclusion criteria: * age 18-30 * healthy * after medical checkup * after signing concent form exclusion criteria: * heart disease * respiratory disease * baseline bp above 140/90 mmhg * sleep disorders * diabetes * anhydrosis * skin disease * acute illness

Keywords: sleep htt heat illness
efficacy and safety of mp-513 in combination with metformin in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of mp-513 in combination with metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of mp-513 in combination with metformin with an extension treatment for up to 52 weeks.


Eligibility criteria:
inclusion criteria: * patients who are aged ≧ 18 years old. * patients whose hba1c is ≧ 7.0 % and \< 10.0%. * patients whose bmi is ≧ 20.0 and ≦40.0 ㎏/㎡. * patients who took metformin monotherapy for at least 56 consecutive days at the screening visit. exclusion criteria: * patients with type 1 diabetes or secondary form of diabetes. * patients with heart failure symptoms. * patients with serious diabetic complications. * patients with severe hepatic disorder or severe renal disorder. * patients who are the excessive alcohol addicts. * patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.

Keywords: insulin resistance
the possible effect of the antiviral inhibitors for treatment of hepatitis c virus infection in cardiac function

Conditions: Hepatitis

Summary: it has been known for many years that the heart and the liver are intimately related. there is a mutual interaction between the function of the heart and the liver and a broad spectrum of acute and chronic entities that affect both the heart and the liver. chronic hepatitis c virus infection affects more than 3% (170 million) of the world's population.

assessment of systolic function by echocardiography will be done to 100 hepatitis c virus infected patients who receive antiviral treatment (sofosbuvir and daclatasvir) by biplane simpson's method and by speckle tracking. assessment of diastolic function by echocardiography to 30 hepatitis c virus infected patients who will not receive antiviral treatment, by left atrium volume , mitral inflow pattern , tissue doppler annular early and late diastolic velocities .

Eligibility criteria:
inclusion criteria: 1. patients on continuous regimen (sofosbuvir and daclatasvir) for 3 months 2. normal baseline trans thoracic echocardiography 3. normal electrocardiography exclusion criteria: 1 - diabetes mellitus, hypertension and chronic kidney disease. 2- hepatitis c virus patients with any baseline electrocardiography abnormality. 3- patients with underlying any structural heart disease.
dose escalation of icotinib in previously treated patients with routine dose

Conditions: Non-small Cell Lung Cancer

Summary: to determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in china with over 5 times incidence rate increase during the past 30 years. tyrosine kinase inhibitors (tkis) of the epidermal growth factor receptor (egfr) have been widely used for the treatment of patients with non-small cell lung cancer(nsclc). icotinib is a novel egfr-tki developed by a group of chinese scientists and clinician. icotinib appears to be non-inferior to gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase i-iii trials. in this study, an open , single-center, single arm phase iv trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced nsclc patients after failure with routine dose. pfs (progress free survival) is the primary end-point with os (overall survival), orr (objective response), ttp (time to progress), hrqol and safety as the secondary end-point.

Eligibility criteria:
inclusion criteria: 1. confirmed nsclc with histology or cytology; advanced （iiib/iv). 2. must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment. 3. measurable, evaluable disease outside of a radiation port. exclusion criteria: 1. previous usage of egfr-tki or antibody to egfr: gefitinib, erlotinib, herceptin, erbitux. 2. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Keywords: efficacy safety egfr-tki phase iv nsclc dose escalation
reduction of triglycerides in women on hormone replacement therapy

Conditions: Cardiovascular Diseases; Atherosclerosis; Postmenopause; Heart Diseases

Summary: the purpose of this study is to test the effect of lifestyle intervention on subclinical cardiovascular disease measures in women taking hormone replacement therapy (hrt).

background: cardiovascular disease is a common cause of morbidity and mortality in older women. better methods of prevention via health promotion are needed. estrogen hrt may beneficially affect women's cardiovascular health, based on evidence from observational studies, but recent trial evidence suggests hrt may actually lead to increased risk of cardiovascular disease in new users. understanding this untoward effect of hrt and how to prevent it is a significant aim. design narrative: this randomized trial of 500 women on hrt for at least two years, aged 52-60 years, and three or more years postmenopausal will test whether reduction in waist circumference, triglycerides, dense low density lipoprotein cholesterol (ldlc), number of ldl particles, c-reactive protein, and plasminogen activator inhibitor-i (pai-i) by aggressive diet and exercise, versus a health education control, and will decrease progression or result in regression of measures of subclinical vascular disease. the intervention is designed to reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. the primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels, a 5 cm decrease in waist circumference, and a 10 percent decrease in ldlc. this will result in changes in subclinical measurements, including carotid ultrasound, electron beam computer tomography of the coronary artery and aorta, pulse wave velocity, endothelial function, and tonometry of the radial artery. nuclear magnetic resonance spectroscopy of lipoproteins, inflammatory markers, and estrogen metabolites will also be evaluated.

Eligibility criteria:
inclusion criteria: * on hrt for at least two years * women 52 to 60 years of age * three or more years postmenopausal * waist circumference greater than 80 cm * ldlc between 100 and 160 mg/dl * body mass index 25-39.9 kg/m2 * blood pressure less than 160/95 mm hg * beck depression inventory score less than 20 exclusion criteria: * current use of cholesterol-lowering medication * diagnosis of diabetes * on diabetes medication
wavefront analisys and contrast sensitivity of spherical and aspherical intraocular lenses

Conditions: Cataract; Pseudophakia

Summary: purpose:to compare visual performance, total and high order wavefront aberrations (coma, spherical aberration and other terms) and contrast sensitivity in eyes implanted with one monofocal aspheric intraocular lens (iol) and two spherical iols (sofport ao, soflex,acrysof®iq (40 eyes), acrysof®natural and amo®sensar)


Eligibility criteria:
inclusion criteria: * patients with bilateral visually significant senile cataract, corneal astigmatism less than 2.0 diopters and potential acuity meter (pam) better than 0.2 logmar exclusion criteria: * any other ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, iol tilt, decentration (estimated by retro illumination and digital photo) greater than 0.4mm13 or loss of follow-up
gallium nitrate in treating children with brain tumor, neuroblastoma, rhabdomyosarcoma, non-hodgkin's lymphoma, or refractory solid tumors

Conditions: Brain and Central Nervous System Tumors; Lymphoma; Neuroblastoma; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: : phase i trial to study the effectiveness of gallium nitrate in young patients who have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-hodgkin's lymphoma, or refractory solid tumor.

objectives: i. determine the safety and side effects of gallium nitrate (gan) when used as an anticancer agent in pediatric patients with refractory solid tumors, including malignant brain tumors, neuroblastoma, rhabdomyosarcoma, and non-hodgkin's lymphoma. ii. evaluate these side effects in these patients. outline: single-agent chemotherapy. gallium nitrate, gan, nsc-15200. projected accrual: at least 3 patients will be accrued at each dose studied.

Eligibility criteria:
disease characteristics: biopsy-proven rhabdomyosarcoma, non-hodgkin's lymphoma, or other solid tumor refractory to conventional therapy or for which no effective curative therapy is known re-biopsy required if disease recurs more than 2 years after initial diagnosis recommended if radiographic abnormalities suggest tumor recurrence within 5 months of completing radiotherapy or chemotherapy patient characteristics: age: 21 and under at diagnosis performance status: karnofsky 50%-100% life expectancy: more than 4 weeks hematopoietic: (unless extensive bone marrow involvement) anc greater than 750 platelets greater than 75,000 hepatic: not specified renal: creatinine normal for age or glomerular filtration rate at least 50 ml/min per 1.73 square meters other: adequate nutritional status no serious uncontrolled infection no pregnant or nursing women prior concurrent therapy: at least 2 weeks since other anticancer therapy and recovered prior radiotherapy or surgery for symptomatic lesions allowed provided site of evaluable disease remains untreated prior bone marrow or stem cell transplantation allowed no concurrent anticancer therapy

Keywords: recurrent childhood rhabdomyosarcoma recurrent childhood brain tumor recurrent neuroblastoma recurrent childhood lymphoblastic lymphoma unspecified childhood solid tumor, protocol specific recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma
open label access study of sildenafil in adult patients with pulmonary arterial hypertension completing a1481244 study

Conditions: Pulmonary Arterial Hypertension

Summary: in an earlier study, sildenafil citrate administered to patients of pah led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. this protocol provides mechanism for patients who have clinical deterioration on other pah approved therapies to have access to sildenafil prior to marketing authorization in india.


Eligibility criteria:
inclusion criteria: * subject who complete the a1481244 study and require sildenafil (revatio tm) 20 mg tid therapy. * all women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study exclusion criteria: * pregnant or lactating women * participation in other studies during study participation * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Keywords: open label access sildenafil pulmonary arterial hypertension
unified protocol for bariatric surgery candidates

Conditions: Emotional Disorder; Anxiety; Depression

Summary: the present pilot study with a multiple baseline experimental desing will verify the feasibility and clinical utility of the unified protocol, applied in an online group format in a mental health setting of the spanish national health system to patients waiting for bariatric surgery with diagnosis or symptoms of emotional disorders

obesity is currently becoming a serious global public health problem due to the high prevalence and the large increase in recent years. this condition is associated with different health problems, including physical and mental diseases. the presence of anxiety or depression disorders among candidates for bariatric surgery it is very high and predicts worse results. the present study aims to explore the feasibility and clinical usefulness of an online group format application of the unified protocol, a transdiagnostic emotion-based intervention for patients waiting for bariatric surgery with at least one emotional disorder diagnosis or emotional symptoms. we will conduct a pilot study with a repeated single case experimental design (multiple baseline design) in a public mental health service. the sample will consist of 45 participants who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days before the intervention. depression and anxiety symptoms and diagnostic criteria will be the primary outcome measures. secondary measures will include evaluation of affectivity, personality traits, general fit, quality of life, and different body image and eating outcomes. an analysis of treatment satisfaction will be also performed. assessment points include baseline, pre-treatment, post-treatment, and follow-ups every three months until two years after post-treatment.

Eligibility criteria:
inclusion criteria: * being of a legal age * being a bariatric surgery candidate * presenting anxious or depressive symptomatology (subclinical symptoms with bdi-ii and bai) or meeting the criteria for at least one emotional disorder (anxiety, mood and related disorders) from the international neuropsychiatric interview (mini) * speaking spanish or catalan fluently * committing to attend the sessions * understanding and accepting the contents of the informed consent, expressed by signing it * having internet to fulfill the protocol assessments online, and (8) being agree to maintain the prescribed medication regimen (including dosage) during the evaluation period, if any, and during treatment exclusion criteria: * having a severe condition that would require to be prioritized for treatment, so that an interaction between both interventions cannot be ruled out. these include a severe mental disorder (bipolar disorder, personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months (excluding cannabis, coffee, and/or nicotine).

Keywords: emotional disorders transdiagnostic unified protocol bariatric surgery obesity emotional regulation
tace combined with anlotinib treatment of middle-advanced hepatocellular carcinoma (hcc) patients

Conditions: Carcinoma, Hepatocellular

Summary: this study was designed to evaluate the effectiveness of anlotinib in middle-advanced hepatocellular carcinoma (hcc) patients.

the aim of this study is to include 40 patients with middle-advanced hepatocellular carcinoma .these patients were randomly allocated to tace treatment group or tace+anlotinib treatment group.the treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Eligibility criteria:
inclusion criteria: 1. subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney; 2. subject has middle-advanced liver cancer of barcelona clinic liver cancer stages b/c ; 3. liver function child-pugh class a or b; karnofsky (kps) score \> 60 points; 4. subject could not accept surgical resection or refuse surgical operation;and who did not receive other treatment before operation. 5.18\~75 years old; ecog ps score: 0-1 points; expected survival period is more than 3 months. exclusion criteria: 1. subject has contraindications to chemotherapy; 2. subject has obstacle in the function of major organs such as heart, lung, liver and kidney; 3. severe coagulation dysfunction (prothrombin time \> 18 s or hemorrhagic tendency); 4. uncontrollable hypertension and portal hypertension; 5. hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus; 6. a large amount of ascites or refractory ascites; 7. with distant metastasis.
a study to learn more about how safe dienogest is and how well it works under real world conditions in indian women with endometriosis

Conditions: Endometriosis Associated Pelvic Pain

Summary: endometriosis is a condition that affects women, usually during their reproductive years. in women with endometriosis, the tissue that normally covers the inside of the womb grows outside the womb. this can cause pain during their periods or during sex, and constant pain in the pelvis. endometriosis can decrease a woman's quality of life. it also requires long-term treatment to control the symptoms. the study drug, dienogest, has already been approved as a treatment for endometriosis associated pelvic pain. sometimes, researchers continue studying a treatment after it has been approved to learn more about its safety. in this study, the researchers want to learn more about any medical problems the patients have while taking dienogest. to answer this question, the researchers will collect the medical problems the patients have after taking dienogest and that may or may not be related to dienogest. these medical problems are also known as adverse events. they will also collect information about the endometriosis associated pelvic pain. the pain measured with a standard rating scale called eapp (endometriosis-associated pelvic pain) before treatment start and after 6 months of treatment will be compared. the trial will include women with endometriosis associated pelvic pain whose doctors have decided to start treating them with dienogest. it will include about 160 women in india who are at least 18 years old. all of the patients will take dienogest based on their doctor's instructions. they will then visit their study site 3 times over 6 months. at these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. the doctors will do tests to measure the pain caused by the patients' endometriosis and any other symptoms. the doctors will also do physical examinations and check the patients' overall health.


Eligibility criteria:
inclusion criteria: * female patients in india at least 18 years of age * clinical or surgical diagnosis of endometriosis: clinical diagnosis by suggestive symptoms and positive finding in imaging study (chocolate cyst) * patients diagnosed with endometriosis associated pelvic pain who have not been previously treated with dienogest * decision to initiate treatment with dienogest was made as per investigator's routine treatment practice * signed informed consent exclusion criteria: * participation in an investigational program with interventions outside of routine clinical practice * contra-indications according to the local summary of product characteristics (spc)