Kornimate/medical-research-clean huggingface dataset:
dynamic splinting for plantarflexion in spastic hemiplegia

Conditions: Spastic Hemiplegia

Summary: the purpose of this study is to examine the effectiveness of onabotulinum toxin a (btx) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.


Eligibility criteria:
inclusion criteria: * patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following: 1. diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study 2. reduced arom and prom in ankle dorsiflexion 3. ability to ambulate safely 20 feet without an ankle-foot orthosis (afo) 4. inability to ambulate with initial heel-contact 5. no prior btx treatment within 6 months 6. r1 of -10° or greater (using the tardeiu method of assessment) 7. mean ashworth scale test ≥3 for plantarflexors exclusion criteria: 1. bell's palsy 2. viral encephalitis 3. muscular dystrophy 4. multiple sclerosis 5. prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle 6. subjects with a fixed contracture of the ankle 7. female subjects who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or are of childbearing potential and do not practice a reliable method of birth control 8. bleeding disorders 9. diagnosis of a disease that may interfere with neuromuscular function (ie. myasthenia gravis, lambert-eaton myasthenic syndrome, amyotrophic lateral sclerosis) 10. subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function 11. subjects with profound weakness or atrophy of the muscles in the target areas of injection 12. active systemic infection or infection at the injection site 13. allergy or sensitivity to botulinum toxin a
effect of cpap on myocardial dysfunction in type 2 diabetes mellitus and obstructive sleep apnea patients

Conditions: Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2; Continuous Positive Airway Pressure; Myocardial Dysfunction; Echocardiography; Obesity

Summary: this study evaluates the effect of the use of nasal cpap in the cardiac function, measured by strain and tei index, in patients with type 2 diabetes mellitus, obstructive sleep apnea and obesity. in order to do so, 76 patients will be studied, half will use sham cpap and half will use therapeutic cpap for three months, with echocardiogram, laboratory studies, ambulatory monitoring of arterial tension and sleep study before and after cpap use.

the obstructive sleep apnea syndrome (osas) is a disease characterized by repeated episodes of partial of total obstruction of the upper airway during sleep. it affects 3.2% of adults in mexico city. these patients have a higher risk of suffering traffic accidents, cardiovascular diseases, a lower quality of life and premature death. the association between osas and heart failure is complex, but it is known that they have a higher risk of myocardial dysfunction with or 2.4 (ic 95% 1.2 - 4.6), with higher mortality against controls. type 2 diabetes mellitus (dm2) is a chronic metabolic disease that leads to macro and micro vascular damage, and is the first cause of mortality in mexico (13.8% of all deaths in people older than 20 years). its general prevalence in adults is of 7%. there is a strong association between osas, insulin resistance and dm2, with studies with 86% of patients with dm2 having some degree of sleep apnea reported, with 22.6% having severe osas. the presence of dm2 doubles the risk of cardiovascular disease in men and triples it in women, with coronary cardiac disease being the main cause of death. patients with osas have altered myocardial function even in asymptomatic state, also patients with dm2 have been shown to have abnormalities in myocardial function, myocardial performance and myocardial elongation in comparison with a control group. there is no current information about the effect of treatment with cpap on myocardial performance of patients with osas, dm2 and obesity.

Eligibility criteria:
inclusion criteria: * clinical data of obstructive sleep apnea: snoring, witnessed apneas, excessive daytime somnolence. * previous diagnosis of type 2 diabetes mellitus, with medical treatment according to the ada 2012 guidelines, but only with one of the next drugs: biguanides, sulphonylurea, meglitinide, thiazolidinedione, alpha-glucosidase inhibitors. * obesity, defined by a body mass index higher than 29 kilogram per square meter. exclusion criteria: * type 1 diabetes mellitus. * insulin dependent type 2 diabetes mellitus * fasting plasma glucose higher than 212 mg/dl . * antecedent of myocardial infarction, heart failure or arrhythmia. * obstructive sleep apnea in treatment. * urgent need of cpap treatment (public transport drivers, heavy machine operators).

Keywords: sleep apnea, obstructive obesity dm2 tei index cpap
the study to evaluate efficacy and safety of candesartan vs losartan in hypertension with heart failure (honor)

Conditions: Hypertension

Summary: the purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.

this is a randomized, open-label, phase 4 study. wash out periods need at least 14 days if the patients take arb or ace inhibitor to control blood pressure. patients take candemore or cozzar once a day during 16 weeks.

Eligibility criteria:
inclusion criteria: * female and male patients who aged above 19 and below 75 * patients with 90\~109mmhg average sitting dbp on baseline * nyha class 2\~4 * patients who agreement with written informed consent exclusion criteria: * above 110mmhg sitting dbp and/or 180mmhg sitting sbp * patients who have difference values that above 20mmhg sitting sbp or 10mmhg sitting dbp in both arms on screening * patients who have medical history that secondary hypertension or rule out secondary hypertension * malignant hypertension * symptomatic postural hypotension * right heart failure due to pulmonary disease * etc.

Keywords: hypertension, heart failure, candesartan, losartan
uterus transplantation ld - feasibility study - sahlgrenska - bmc

Conditions: Mrk Anomaly; Infertility, Female

Summary: medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery. theory and common animal workshops have been ongoing for 3 years. the team from bellevue medical centre is affiliated to st joseph, university, beirut

Eligibility criteria:
inclusion criteria recipient * age \< 38 years * psychologicaly stable * bmi \< 35 * no systemic disease * no standing medication * in a stable relationship or married * normal ovarian reserve * absolute uterine factor infertility * normal kidney function inclusion criteria donor * close relative to recipient * age \< 60 years * normal pregnancies * maximum two cesarean sections * bmi \< 35 * no major systemic disease * no previous major surgery

Keywords: uterus infertility transplantation
effect of laf237 on glucagon secretion in patients with type 2 diabetes and in healthy subjects

Conditions: Type-2 Diabetes; Healthy

Summary: the purpose of this study is to assess the glp-1 and non-glp-1 effects of laf237 on glucagon secretion, using treatment observations of the overall glycemic response.


Eligibility criteria:
inclusion criteria: inclusion criteria - type-2 diabetes patients * male or female patients aged 30 to 75 years with type-2 diabetes mellitus (t2dm) and who are in otherwise good health * must have been diagnosed with t2dm at least 6 months prior to screening, and whose diabetes is controlled by diet and exercise alone or by stable dosage ( \> 3 months) of metformin * hba1c in the range of 6.5% to 9% at screening inclusion criteria - healthy volunteers * male or female subjects aged 30 to 75 years, determined to be in good health * normal oral glucose tolerance test (ogtt) at screening * age, gender and weight matched to subjects with t2dm exclusion criteria: exclusion criteria - type-2 diabetes patients * a history of: * type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., cushing's syndrome and acromegaly * acute metabolic diabetic complications (such as ketoacidosis or hyperosmolar state (coma)) within the past 6 months * torsades de pointes, ventricular tachycardia or ventricular fibrillation * any severe hypoglycemic episode within 3 months of screening * use of any of the following medications: * antihypertensive or lipid-lowering agents unless on a stable dose for at least 3 months prior to screening * chronic insulin treatment (\> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months * chronic oral/intramuscular/intravenous corticosteroid treatment ( \> 7 consecutive days of treatment) within 8 weeks prior to screening exclusion criteria - healthy volunteers * first degree relative of an individual with t2dm * history of gestational diabetes * use of any prescription medication within 1 month prior to dosing. use of over-the-counter medications or vitamins within 14 days prior to dosing. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetes hyperglycemia healthy vildagliptin adults
from psa to stockholm3: study part 1

Conditions: Prostate Cancer

Summary: this part of the project aims to analyze the effectiveness of the stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer.

background: prostate cancer constitutes about 15 % of new cases of cancer among men globally, but about 27 % of all new cases of cancer in men in norway. it is also the leading cause of cancer death among men, and nearly 1100 norwegian men died from prostate cancer in 2014. however, only about 30 percent of new cases have an aggressive form of the disease. therefore, the challenge is to detect and distinguish patients with aggressive disease from patients who have a low risk cancer. the prostate-specific antigen (psa) is currently the main test used in primary care to detect and prioritize patients for further diagnostics. psa is used for screening in many countries, but the norwegian authorities consider the harms of using psa for screening purposes (over-diagnosis and overtreatment) to outweigh the benefits (potentially reduced mortality). nevertheless, it has been documented that a substantial amount of opportunistic psa screening takes place in norway. at present, a novel test called the stockholm3 test has been developed. a large prospective study has shown that the efficacy of the stockholm3 test is superior to psa, and both the sensitivity and the specificity are substantially higher for stockholm3 than for psa. aim the aim of this study is to analyze the effectiveness of the stockholm3 test in regular clinical practice, including both primary care and specialized health care. study design from september 2017, the urological department at stavanger university hospital requires a stockholm3 answer in referrals of patients for further diagnostics of possible prostate cancer. comparable clinical data will be collected for a period before - and from a corresponding period after the stockholm3 test was taken into use. an analysis will then be carried out where the results from the period where referrals were based primarily on psa will be compared with the results for the period in which the stockholm 3 test was used. power calculation based on results from the original stockholm3 study and aggregated figures regarding psa testing, prostate biopsies and mri of the prostate in stockholm and stavanger, a statistical power has been calculated. based on a two-sided alpha at 0.05 (i.e., 5%) and a 90% power the study need about 8000 participants to reliably answer the main study questions. an interim analysis will be conducted in the inclusion phase. a new power calculation will be performed based on the registered data, and the need of participants will be adjusted if necessary.

Eligibility criteria:
inclusion criteria: * all men where a physicians in regular clinical work finds that there is an indication to take the test exclusion criteria: * known prostate cancer

Keywords: diagnostics, over-diagnosis
orthodontic treatment with clear aligner

Conditions: Orthodontic Pathological Resorption of External Root

Summary: three-dimensional assessment of root resorption following treatment with clear aligners using cone beam computed tomography design: a randomized, controlled, crossover, double-blind clinical study including twenty six adult , aged 18-25 years old.

orthodontically induced root resorption is one of the common undesirable sequalae of orthodontic treatment. one third of the patients treated with fixed appliances showed more than 3 mm of root resorption whereas at least 2% of orthodontic patients showed more than 5 mm of root resorption. there is a controversy in the literature regarding the effect of clear aligners on apical root resorption. one previous study reported that some kinds of removable aligners may have the potential of minimizing orthodontic ally induced root resorption due to the studied piezoelectric property by these materials till now, the degree of apical root resorption following treatment with (in house) aligners has not been reported in the literature.

Eligibility criteria:
inclusion criteria: the clinical diagnosis the age of patients ranges between 18-25 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to little irregularity index 20,class1 according angel classification healthy patient no previous orthodontic treatment vital teeth with periodontal tissue without root absorption, exclusion criteria: previous history of orthodontic or orthopedic treatment. presence of craniofacial anomalies. presence of any signs and symptoms of gingival and periodontal diseases. presence of significant medical history (including drug allergy). pregnant and lactating women

Keywords: orthodontic, clear aligners, fixed appliances, cbct
a study to assess esreboxetine's effect on concentration, memory, decision making and problem solving in patients with fibromyalgia.

Conditions: Fibromyalgia

Summary: the study is designed to assess if esreboxetine can improve the cognitive function of patients with fibromyalgia. cognitive function is defined as the ability to concentrate, remember things and make decisions or problem solve. the study is also designed to assess if there is a difference in cognitive function between fibromyalgia patients and matched control subjects.


Eligibility criteria:
inclusion criteria: * subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender exclusion criteria: * other confounding pain, cognitive disease or impairment, disease that could put the subject at risk or subjects who are on prohibited medications that cannot be washed out. * any subjects with a diagnosis of certain psychiatric disorders in particular major depression or suicidal risk. matched control subjects have similar exclusions.

Keywords: fibromyalgia
detection of early gastric cancers using confocal laser endomicroscopy

Conditions: Stomach Neoplasms; Precancerous Conditions

Summary: the purpose of this study is to determine whether endomicroscopy can improve the detection of early gastric cancers (egc).

endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (gc). confocal laser endomicroscopy (cle), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether cle is helpful to find out early gastric cancer (egc).the aim of the study is to investigate the value of cle in improving the detection of egcs.

Eligibility criteria:
inclusion criteria: * 45 years old ≤ age \< 80 years old * patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy exclusion criteria: * known cancers or gastrectomy * scheduled for endoscopic treatment * alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss * under conditions such as: * ascites * jaundice * liver cirrhosis * impaired renal function * coagulopathy * fever * pregnancy * breastfeeding * inability to provide informed consent * known allergy to fluorescein sodium

Keywords: stomach endoscopy neoplasms
future mental projections in schizophrenia

Conditions: Schizophrenia

Summary: the aim of the study is to investigate temporal organization of future thinking in patients with schizophrenia. patients and control participants will be asked to envision and briefly describe ten personal future events using a cue-words list. then they will be asked to describe everything that came to their minds (i.e. to think aloud) while they attempted to determine when an event will likely occur. the investigators will compare the proportion of several predefined strategies mentioned by the two groups of participants to locate future events in time. the investigators predict that patients will envision less personal future events and will rely to a lesser extent on strategies to locate events in time, than control participants.


Eligibility criteria:
inclusion criteria: * for patients only * male or female * age limits : 18-55 years old * under the protection of health insurance * who have signed up the consent form * schizophrenia or schizo-affective disorder according to the dsm-5 criteria (apa, 2013). * clinically stable for at least 2 months * patients under guardianship or curatorship need agreement of their legal representative * informed of the results of prior medical examination for controls only * male or female * age limits : 18-55 years old * under the protection of health insurance * who have sign up the consent form * recruited from the general population and matched on gender, age years of schooling * no psychiatric history (dsm-5) exclusion criteria: * for both patients and controls * current severe or unstable somatic illness * neurological history (brain injury \> 15 minutes loss of consciousness , epilepsia, brain surgery...) * current substance use disorder (dsm-5) * current major depressive disorder (cdss,bdi, hdrs) * mental retardation (iq \< 70, wais-4, f-nart) * history of general anesthesia 3 months prior to the experiment * pregnancy declared by the subject * breast feeding * current legal control * in emergency situation * included during exclusion period in another experiment * for controls only * taking of antipsychotic drugs for the 3 weeks prior to inclusion * under guardianship or curatorship
efficacy and safety of gsp 301 nasal spray in the treatment of seasonal allergic rhinitis (sar)

Conditions: Seasonal Allergic Rhinitis (SAR)

Summary: study to evaluate the efficacy, safety and tolerability of gsp 301 ns compared with placebo ns and individual monotherapy formulations for the treatment of seasonal allergic rhinitis (subjects 12 years of age and older)


Eligibility criteria:
inclusion criteria: * males and non-pregnant females who are 12 years of age and older. * documented clinical history of sar (for at least 2 years preceding the screening visit \[visit 1\]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen) * a 12-hour rtnss ≥8 out of a possible 12 and a congestion score ≥2 for the am assessment at the screening visit (visit 1). exclusion criteria: * pregnant or lactating women. * history of anaphylaxis and/or other severe local reaction(s) to skin testing. * history of positive test for hiv, hepatitis b or hepatitis c infection. * documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. * subjects with an active pulmonary disorder or infection. * subjects with posterior subcapsular cataracts or glaucoma * plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
concurrent chemotherapy and radiotherapy with nitroglycerin in patients with locally advanced non-small cell lung cancer

Conditions: Locally Advanced Non Small-Cell Lung Canger

Summary: nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. the combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced nsclc

nitroglycerin decreases hypoxia-induced resistance to antitumor drugs due to inhibition of hypoxia inducible factor alfa (hif-1α), it increases oxygen pressure in tumoral tissue by augmenting tumor blood flow, increases apoptosis, activation of p53, and induces cellular growth inhibition. randomized studies showed that the addition of transdermal nitroglycerin to non small cell lung cancer (nsclc) patients with metastasis treated with vinorelbine and cisplatin achieved a significantly better global response to treatment than conventional treatment

Eligibility criteria:
inclusion criteria: * histopathologic diagnosis of non small-cell lung cancer * clinical stage iiia and/or iiib without pleural effusion * ecog functional status 0 or 1 * no renal function alteration (gfr \>50%) * no hepatic function alteration (alt and ast less than 2 times its normal value) * leucocytes more than 2,000/mcl * hemoglobin more than 10mg/dl * platelets more than 100,000/mcl exclusion criteria: * ischemic heart disease * abnormal electrocardiogram

Keywords: nitroglycerin locally advanced non small-cell lung cancer vascular endothelial growth factor hypoxia inducible factor clinical stage iiia and/or iiib (without pleural effusion)
combination of external beam radiotherapy with 153sm-edtmp to treat high risk osteosarcoma

Conditions: Metastatic Osteosarcoma

Summary: the primary goal of this study will be to examine tumor response after radiation treatment via a combination of samarium-153 edtmp and external beam radiotherapy.

samarium tracer infusion of 1 mci/kg administered. spect images wil be used to determine the distribution of dose delivered to the tumor. this information will be used to determine target doses of external beam radiotherapy. the treatment infusion of samarium, 30 mci/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. approximately 14 days after treatment infusion, autologous stem cells infusion is administered. radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

Eligibility criteria:
inclusion criteria: * patients must be between 13 and 65 years of age, inclusive * must have unresectable primary tumor or metastases * must have measurable disease that is demonstrated by positive tc-99m bone scan. not all lesions must be positive on bone scan. * creatinine clearance \>70ml/min/1.73m2 * anc \>500/mm3 * platelets \>50,000/mm3 * life expectancy \> 8 weeks * karnofsky performance status \>50% * stem cell product collected prior to the infusion of samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry. exclusion criteria: * patient may not be pregnant or breastfeeding. * patients who have received prior radiotherapy to all areas of current active disease are not eligible.

Keywords: osteosarcoma osteogenic sarcoma sarcoma bone cancer