Kornimate/medical-research-clean huggingface dataset:
neuropsyquiatric evolution after introduction of raltegravir qd in substitution of dolutegravir: near qd study

Conditions: HIV Infections

Summary: open, multicenter, non randomized, single arm, pilot trial.

open, multicenter, non randomized, single arm, pilot trial. the study is aimed at patients infected with hiv in triple antiretroviral therapy based on dolutegravir (dtg) who experience neuropsychological adverse effects related to the treatment. after signing the informed consent, dtg will be replaced by raltegravir (ral) 1200 qd, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * infection with chronic hiv-1. * on triple therapy antiretroviral therapy based on abacavir/lamivudine (abc/3tc) or tenofovir disoproxil fumarate/emtricitabine (tdf/ftc) or tenofovir alafenamide/emtricitabine (taf/ftc), whose third component is dtg in a dose of 50 mg / day. * presence of neuropsychiatric symptoms (insomnia, sleep disturbances, reduced concentration, dizziness, headaches, depression, restlessness or nervousness) with an intensity ≥ 2 on the daids scale. * written informed consent to participate in the study. exclusion criteria: * pregnant women, nursing or of childbearing age who want to get pregnant. * concomitant use of any medication with potential risk of interaction with the therapy under study. * intolerance, hypersensitivity or previous resistance to the therapy under study or presence of any contraindication of it. * subjects in therapy with immunosuppressants or chemotherapy with cytotoxics, including interferon and interleukin-2 at the time of their inclusion in the study. * abuse of alcohol or any other substance that may interfere with adherence to treatment. * subjects who are participating in any other clinical study with the exception of those in which the treatment under study has been suspended for more than 12 weeks. * aids event at the time of diagnosis of hiv infection or in the 3 months prior to its inclusion * any other clinical condition or previous treatment that makes the subject unsuitable for the study or that compromises their ability to comply with the treatment dosing requirements. * history of mental illness or diagnosis of neuropsychological symptoms prior to the use of dtg. * presence of genotypic mutations that confer resistance to abc, tdf / taf, 3tc or ftc. * chronic liver disease in the cirrhosis phase (either by ultrasound criteria or fibroscan ≥ 14.5 kpa) * consumption of tobacco ≥ 20 cigarettes / day. additional exclusion criteria (for patients recruited at the costa del sol hospital in marbella only): * history or diagnosis of claustrophobia, or inability to lie flat on the back inside the positron emission tomograph or mri chamber for a period of 20 minutes. * contraindication to perform an mri, including the presence of a cardiac pacemaker or other electronic device or ferromagnetic metallic foreign bodies in vulnerable positions evaluated by a standard questionnaire prior to mri.

Keywords: hiv infection neuropsychological adverse effects raltegravir
a study to determine if carbon dioxide lavage during total knee surgery reduces intraoperative embolic events

Conditions: Postoperative Complications; Memory Disorders

Summary: the purpose of this study is to determine if the use of a carbon dioxide lavage device (carbojet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques.

elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (pocd) or memory impairment following surgery. transcranial doppler (tcd) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (tka). these cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems. the standard surgical technique for tka involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. the carbojet assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in tka will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.

Eligibility criteria:
inclusion criteria: * adult patients aged 50 years or older who are scheduled for elective tka with a cemented smith and nephew prosthesis design exclusion criteria: * dementia or severe cognitive impairment * severe visual or hearing impairments * inability to follow directions or comprehend the english language * females who are pregnant * abnormal distal femur geometry * pre-existing hardware or abnormal bony architecture in the proximal tibia

Keywords: postoperative cognitive dysfunction total knee arthroplasty cerebral emboli carbon dioxide lavage pulsatile saline lavage
the treatment of hepatocirrhosis and portal hypertension

Conditions: Hepatic Cirrhosis; Portal Hypertension

Summary: this study compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.

endoscopic therapy is the mature treatment of gastroesophageal variceal haemorrhage and pse is an effective method for treatment of the hypersplenism and portal hypertension. existing researches show that endoscopic therapy + pse is more effective than endoscopic therapy alone in prevention of esophageal varices bleeding recurrence in the patients with liver cirrhosis. however, there is few articles which proved long-term effectiveness of endoscopic therapy + pse, it needs further research on this issue. this study compares the efficiency of partial splenic embolization +endoscopic therapy with endoscopic therapy alone in the treatment of gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism in the patients with hepatocirrhosis and portal hypertension.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75 years * patients who had recovered from an episode of vh or patients who had survived from acute vh and there was no bleeding for consecutive 5 days * patients with a diagnosis of liver cirrhosis and portal hypertension on clinical examination, laboratory test, and imaging or histological examination * patients with hypersplenism and thrombocytopenia (platelets \< 100,000/µl). exclusion criteria : * previous therapy (splenectomy, pse, evl, tissue adhesive injection, or usage of (nsbb) to prevent rebleeding * bleeding from isolated gastric or ectopic varices * hepatocellular carcinoma or other malignant tumors * contraindications for the use of nsbbs, hepatic failure, and child-pugh class c with large amount ascites, or grade 3-5 hepatic encephalopathy, or prothrombin activity ≤ 40% * hepatic failure * contraindications for pse * pregnancy and lactation * inability to sign the informed consent.

Keywords: partial splenic embolization hypersplenism thrombocytopenia portal hypertension gastroesophageal varices secondary prophylaxis endoscopic variceal ligation non-selective beta-blocker hepatic recompensation
azilsartan tablets special drug use surveillance: long-term use

Conditions: Hypertension

Summary: the purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (azilva tablets) in patients with hypertension in a routine clinical setting.

this surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (azilva tablets) in hypertensive patients in daily medical practice. the usual dosage for adult is 20 mg of azilsartan administered orally once daily. the dose can be adjusted according to the patient's age and condition. the maximum daily dose is 40 mg.

Eligibility criteria:
inclusion criteria: * hypertensive patients exclusion criteria: 1. patients with a history of hypersensitivity to any of the ingredients of azilsartan 2. patients who are pregnant or having possibilities of being pregnant

Keywords: pharmacological therapy
characterization of epicardial and pericardial adipose tissue in coronary artery disease

Conditions: Coronary Artery Disease

Summary: human epicardial fat is the true visceral fat depot of the heart, and its regional distribution and physiology is of growing scientific and clinical interest. this study aims to characterize the expression profile and function of the epicardial and pericardial adipose tissue compartments of the heart (eat and pat). eat and pat adipose biopsies will be obtained from patients undergoing coronary artery bypass graft surgery (cabg) or valve replacement surgery.

the epicardial adipose tissue (eat) stretches from the myocardium to the visceral layer of the pericardium. adipose located on the outside of the visceral pericardium to the external site of the pericardium is called the pericardial adipose tissue (pat), and is of a separate origin than eat. therefore, this study aims to investigate the global expression profile of the eat and pat compartments, in addition to characterizing the function, structure, metabolic and inflammatory profile. furthermore, this study will determine whether cabg and valve replacement patients display different eat and pat characteristics

Eligibility criteria:
inclusion criteria: * age \<80 years * patients undergoing elective heart surgery either for coronary bypass grafting or for other purposes exclusion criteria: * inability of the patient to provide informed consent * severe kidney failure, gfr\<30 * previous cardio-thoracic surgery * there are no other specific exclusion criteria, as long as the patient is considered eligible for surgery by the clinicians
sensory testing of multiple forms of spinal cord stimulation for pain

Conditions: Chronic Pain; Failed Back Surgery Syndrome; Complex Regional Pain Syndromes; Neuropathic Pain

Summary: doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. this type of treatment is referred to as neurostimulation. a common form of neurostimulation therapy is spinal cord stimulation (scs). in this study, researchers want to learn more about how scs affects pain processing and relieves pain. the researchers will examine multiple forms of scs in chronic pain patients who are receiving scs from their own doctors as part of their standard of care. during the study, participants will be asked to complete a variety of evaluations at certain time points.


Eligibility criteria:
inclusion criteria: * chronic intractable pain of the trunk and/or limbs * undergoing scs as part of standard clinical care for chronic pain management * candidates will have been implanted with a commercial scs device * candidates who are 18 years or older and can speak, read, and understand english * able to understand study procedures and to comply with them for the entire length of the study * must be willing to participate in covid-19 symptom screening and answer questions about covid-19 diagnosis 1-3 days before a scheduled visit * must be willing to wear a face-covering during all study visits exclusion criteria: * subjects who are pregnant or nursing * subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail * subjects who are unable or unwilling to cooperate with clinical testing * subjects having any impairment, activity or situation that in the judgment of study personnel would prevent satisfactory completion of the study protocol * inability or unwillingness of individual or legal guardian/representative to give written informed consent * subjects who currently have or tested positive in the last 14 days for covid-19, or are symptomatic for covid-19

Keywords: spinal cord stimulation
efficacy of albumin for acute encephalopathy in patients with cirrhosis

Conditions: Hepatic Encephalopathy

Summary: the purpose of this study is to determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis.

hepatic encephalopathy is a frequent complication of cirrhosis that is usually associated with poor prognosis. the most common presentation is an acute episode of hepatic encephalopathy precipitated by factors that increase the exposure of the brain to ammonia. current therapies are based on measures that decrease plasma ammonia and counteract the effect of factors such as infection or electrolyte's disturbances. brain edema and abnormalities of cerebral blood flow appear to be important. part of the impairment of astrocyte function could be related to an increase of oxidative stress injury. in patients with cirrhosis and hepatic encephalopathy, the concentration of albumin in plasma is usually low. administration of human albumin in patients with hepatorenal syndrome and spontaneous bacterial peritonitis has a major impact on the prognosis of these complications. albumin prevents circulatory dysfunction and renal failure. the mechanisms of action may include the maintenance of oncotic pressure and a scavenger effect of toxic substances present in blood. albumin has also shown beneficial effects in neurological injury secondary to stroke, probably in relation to this scavenger effect. the administration of intravenous albumin to patients with hepatic encephalopathy may have beneficial effects on the course of encephalopathy.

Eligibility criteria:
inclusion criteria: * cirrhosis of the liver * hepatic encephalopathy stage\>1 * completion of a standardized protocol to investigate precipitating factors * informed consent by next of keen exclusion criteria: * pregnancy * terminal liver disease (advanced liver disease and performance status 3-4 prior to the episode of acute encephalopathy) * need of advanced life support (mechanical ventilation, ionotropic support, dialysis) * need of albumin administration (e.g. bacterial spontaneous peritonitis) * contraindication for albumin administration (e.g. cardiac failure)

Keywords: hepatic encephalopathy cirrhosis albumin
spanish natural history study for lama2 muscular dystrophy

Conditions: LAMA2-MD (Merosin Deficient Congenital Muscular Dystrophy, MDC1A); Merosin Deficient CMD (Full or Partial); Merosin Deficient Congenital Muscular Dystrophy; Muscular Dystrophies; Cohort Studies

Summary: the objective of this natural history study is to comprehensively characterize the disease progression and clinical features of lama2-related dystrophies (lama2-rd) in the pediatric population. the study aims to establish a well-defined cohort of patients in spain, enabling long-term follow-up and facilitating recruitment for future clinical trials.


Eligibility criteria:
inclusion criteria: * all patients with compatible clinical presentation and identification of 2 pathogenic variants in lama2, or muscle biopsy with decreased laminin alpha2 protein and at least one pathogenic variant * signed informed consent by the legal authority responsible and/or assent by the subject (starting from 6 years old)

Keywords: merosin lama2 laminin dystrophy natural history
comparison of twice weekly versus daily iron therapy in treating anemia in children with cerebral palsy

Conditions: Cerebral Palsy; Iron Deficiency Anemia

Summary: a randomized clinical trial to compare the effect of twice weekly versus daily iron therapy in treating anemia in children with cerebral palsy, to be conducted at department of pediatric medicine children's hospital pims islamabad.

a total of 160 children of either gender with age between 6 and 60 months diagnosed with cerebral palsy and concomitant iron deficiency anemia will be enrolled, they will be allocated two groups by lottery method. one group will be given ferrous sulphate 3mg/kg daily in the form of syrup and other group will be given ferrous sulphate 3mg/kg twice weekly in the form of syrup for a period of 4 weeks. the primary outcome will be measured as rise in hemoglobin levels more than or equal to 1g/dl at 4 weeks.

Eligibility criteria:
inclusion criteria: 1. all the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia 2. age 06 months to 5 years 3. both genders exclusion criteria: 1. \>5 years of age 2. children with severe anaemia requiring transfusion (hb\<5 g/l) 3. children with history of taking oral/iv iron supplements or repeated blood transfusions during last one month 4. children with concomitant diarrheal disease 5. where parents are not willing to participate in the study

Keywords: cerebral palsy, anemia
atac - arimidex, tamoxifen alone or in combination

Conditions: Breast Cancer

Summary: the aim of this study is to test whether arimidex alone or in combination with tamoxifen is beneficial in the treatment of breast cancer.


Eligibility criteria:
inclusion criteria: * patients with histologically proven operable invasive breast cancer * patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy * women defined as post-menopausal exclusion criteria: * patients in whom there is any clinical evidence of metastatic disease * patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements * patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
laxative effectiveness of a phytotherapeutic tea

Conditions: Chronic Constipation

Summary: the aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative tea, composed by pimpinella anisum, foeniculum vulgare, sambucus nigra and cassia angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with chronic constipation.

the klein laxative tea is a pharmaceutical phytotherapeutic product that's been used for several years in brazil for the treatment of constipation. this product contains fruit of pimpinella anisum (green anises), fruit of foeniculum vulgare (fennel), flowers of sambucus nigra (elder tree) and flowers of cassia angustifolia (senna). in spite of the beneficial effects of its components, separately demonstrated in vitro, it never had its effectiveness appraised in a randomized clinical trial.the purpose of this study was to evaluate the efficacy and safety of this product in a randomized crossover placebo-controlled clinical trial. twenty patients presenting with the criteria of the american association of gastroenterology for chronic constipation were included, and concluded a two-phase crossover study. the primary endpoint was the evaluation of the intestinal transit time measured through radiological technique. the secondary endpoints were the number of evacuations, subjective impression of the quality in the intestinal habit, quality of life appraised through whoqol-brief and adverse effects.

Eligibility criteria:
inclusion criteria: * patients with 18 to 55 years old with chronic constipation according to the criteria of the american association of gastroenterology (aag); * patients should present good understanding and collaboration capacity, an not be in use of other medications with effects on the intestinal habit; * patients with no abnormalities in the exams; * willing to sign a written informed consent; * women in fertile age should make use of appropriate anti-conception. exclusion criteria: * pregnant or breast feeding women; * patients with history of abuse of alcohol or use of drugs; * significant or not-controlled disease, except constipation.

Keywords: constipation rct phytotherapy
effect of delorme resistance exercises versus treadmill training in cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy is one of the most important source of disability among children and its incidence is almost 3.6 in thousand live births.children with cerebral palsy presents with ambulatory difficulties.the current study highlights the effect of treadmill training as compared to delorme resistance exercises on locomotor activities in cerebral palsy child.the present study would add to the clinical knowledge of physical therapists by promoting the implementation of treadmill training and delorme resistance exercises for this prevalent pediatric neurodevelopmental disorder. the study would decrease the burden of disease among community and enhance the social participation of cerebral palsy children. this in turn would improve the quality of living of these disabling diseased children.


Eligibility criteria:
inclusion criteria: * children with gross motor functional scale level ii and iii * ability to understand commands and directions * diplegic type of cerebral palsy * children who had undergone bilateral tendon of achilles lengthening procedure 3 to 6 months post-operatively exclusion criteria: * children presenting with other types of cerebral palsy * children with audiovisual impairment that can hinder the treatment * leg length discrepancy greater than 2 cm, * fixed contractures, joint instability and associated cardiovascular condition.

Keywords: delorme resistance exercises treadmill training locomotor abilities tendon of achilles lengthening