Kornimate/medical-research-clean huggingface dataset:
pilot, opened, randomized clinical trial to assess the efficacy of duloxetine in the treatment of fibromialgy in patients with infection by hiv 1+

Conditions: Fibromyalgia; HIV-1 Infection

Summary: the purpose of this study is to compare duloxetine with conventional treatment of pain in hiv-1 infected patients.

among hiv-1-infected patients, diagnosis of fibromialgy has increased over the last years . appropriate identification of firomialgy in these patients is challenging and sometimes can be more complicated than in hiv-negative population. concomitant infectious processes and symptoms due to hiv infection itself need to be ruled out before establishing a formal diagnosis. the treatment of this disease frequently includes muscular relaxants , pain-killers, anti-inflammatories and antidepressives despite no drug is formally indicated for this pathology. duloxetine approved indications include both treatment of major depressive disorders (mdd) and diabetic neuropathic pain. recent studies in hiv negative patients show efficacy to control pain and depressive symptoms in patients with fibromialgy the main purpose of this pilot study is to assess the efficacy of duloxetine in hiv-1-infected patients with fibromialgy. the main purpose of this pilot study is to assess the efficacy of duloxetine in hiv-1-infected patients with fibromialgy or chronic fatigue syndrome presenting with widespread pain.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years old and more. age +18 years old. 2. documented hiv-1-infection. 3. former diagnosis of fibromialgy. 4. history of good compliance with visit schedule and medication intake. 5. patients voluntary signed the informed consent. exclusion criteria: 1. pregnant or breast-feeding females 2. suspicion of intolerance to duloxetine. 3. history of any clinical condition that, in the investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc). 4. concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis) 5. or acute illness within 15 days prior to the inclusion 6. patients with major depressive disorder with psychotic symptoms, major depressive disorder melancholic type or bipolar disorder. patients with other depressive disorders can be included (dysthymic disorder and depressive disorder nos) 7. anorexia or nervous bulimia 8. history or suspected drug or alcohol abuse. 9. glaucoma 10. history of heart disease including cardiac arrhythmias 11. severe obesity (body mass index \> 45). 12. concomitant medication with imaos, cimetidine or quinolonas 13. patients with hepatic or renal serious failure (creatinin clearance \<30 ml/min) 14. patients with hypericum perforatum as a concomitant treatment.

Keywords: hiv fibromialgy chronic fatigue syndrome duloxetine pain treatment experienced fibromialgy in patients with hiv-1 infection
the effect of walking on fatigue after chemotherapy in patients 65 and older

Conditions: Cancer; Geriatric; Fatigue

Summary: this study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. it is hypothesized that the walking program will help lessen fatigue.

the investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- senior physical activity after chemotherapy (s-pact). participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the brief fatigue inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. the design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). the primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.

Eligibility criteria:
inclusion criteria: * men and women age 65 years and older * histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating md * within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment) * any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation) * maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer * moderate to severe fatigue (\>4 on bfi) * less than 120 minutes/week of physical activity * english speaking * signed irb approved written informed consent * approval from their treating physician to engage in moderate-intensity physical activity * patient-assessed ability to walk and engage in moderate physical activity * willing and able to meet all study requirements. exclusion criteria: * receiving hormonal therapy for prostate cancer * unable to walk or engage in moderate-intensity physical activity * have bfi≤3. * report more than 120 minutes/week of physical activity

Keywords: cancer chemotherapy fatigue elderly geriatric any cancer cancer treatment weakness tiredness
randomized crossover study of neurally adjusted ventilatory assist (nava) in preterm infants

Conditions: Infant, Preterm

Summary: the purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (nava) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (fio2) and partial pressure of co2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, simv+psv).

the investigators will apply crossover comparison in preterm infants who received a ventilatory support. in patient whose frequency of mandatory support is under 25, the two ventilatory modes (simv+psv and nava) are delivered by the same ventilator (servo-i; maquet critical care ab, solna, sweden) and will set to maintain similar blood gas analysis results. determination of the type of ventilatory mode used is performed using a cluster randomization. the randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. to rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. recordings will be obtained over a total 8 hours.

Eligibility criteria:
inclusion criteria: * preterm infants mechanically ventilated * ventilatory set frequency is under 25 * with informed consent of their parents exclusion criteria: * major congenital anomalies * patients without self respiratory effort * use of sedative or anesthetic drugs * grade iii or iv intraventricular hemorrhage * phrenic nerve palsy or insufficiency

Keywords: mechanical ventilation diaphragm electrical activity pressure support
transforming pci informed consent into an evidence-based decision-making tool

Conditions: Non-emergent Percutaneous Coronary Intervention (PCI)

Summary: using individualized patient estimates of procedural risks and benefits, this project will transform the process of informed consent for coronary angioplasty into a dynamic educational tool for patients and physicians and is a direct response to the institute of medicine's call for a more evidence-based, efficient, patient-centered healthcare system. it is hypothesized that patients will develop a greater understanding of their individual risks and benefits from pci, will be empowered to more actively engage in shared decision-making, as well as have improved awareness of their responsibility to adhere to dual anti-platelet therapy if treated with a drug eluting stent (risks for target vessel revascularization with bare metal and drug eluting stents are also provided in the new consent form). it is also anticipated that physicians, in turn, will use these individualized estimates to better discriminate between risks and benefits among different bleeding avoidance therapies so as to improve the safety and cost-effectiveness of pci.

this study will test the impact of a new mechanism for eliciting informed consent from patients undergoing percutaneous coronary intervention (pci) on 1) patients' comprehension of procedural risks/benefits and participation in shared decision-making; and 2) upon clinicians' use of effective strategies to minimize the risk of bleeding at the time of pci. to facilitate these goals, we will prospectively provide each patients' risks for bleeding at the time that the informed consent document is generated. this will be accomplished by transforming the infrastructure of the informed consent process at participating study centers using a novel, web-based system - the personalized risk information services manager (prism) - to generate individualized consent forms with estimates of risks and outcomes using validated multivariable models from the american college of cardiology's ncdr. the goals of this study are to 1) identify barriers in implementing individualized consent forms in clinical care and to test whether this novel consent process 2) improves the quality of the informed consent process, 3) supports the more rational use of bleeding avoidance therapies (bats), 4) reduces bleeding events after pci, and 5) supports a more cost-effective pci procedure. this will be done using a pre-post design at 6 enrolling hospitals and comparing changes in practice with contemporaneous controls matched from the broader ncdr cath/pci registry.

Eligibility criteria:
inclusion criteria: * all patients receiving a pci in a participating institution exclusion criteria: * previously enrolled in the prism * does not speak english or spanish * dementia * too ill to interview * current prisoner

Keywords: heart diseases cardiovascular diseases acute myocardial infarction decision making percutaneous coronary intervention informed consent quality of care
analyzing the association of gene variants with increased risk of coronary heart disease in women with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: systemic lupus erythematosus (sle) is an autoimmune disease that predominantly affects younger premenopausal women. the risk of coronary heat disease (chd) in women with sle is up to 50 times higher than in the general population. the conventional risk factors are insufficient to explain this increased risk of chd in sle-affected women. this study will perform genetic analysis to determine if genetic variation in the f2 gene is associated with both sle risk and chd risk in women with sle.

sle is a condition of chronic inflammation of the internal organs, caused by an autoimmune disease. an autoimmune disease is a disorder in which the body's immune system attacks its own tissues through production of abnormal antibodies in the blood. current treatments for sle focus on reducing inflammation and production of unusual antibodies. while the exact cause of sle is unknown, genetics, drugs, viruses, and ultraviolent light are all possible contributors. previous genetic studies have determined that antiphospholipid antibodies (apa) are present in 50% of people with sle compared with only 1 to 5% in the general u.s. white population. these antibodies interfere with standard blood vessel function, resulting in blood clots and narrowing of vessels. the f2 gene codes for prothrombin, a precursor of thrombin, which is a key enzyme in blood clotting. prothrombin can be detected by apa as an antigen, resulting in anti-f2 antibodies. recent studies have reported the association of f2 genetic variants with non-fatal heart attack, further suggesting that the f2 gene and apa play a role in chd. in addition to being a biological candidate gene for chd, f2 is also a positional candidate gene for sle, as it is close to a region of linkage for sle on chromosome 11. this study will perform genetic analysis to determine if genetic variation in the f2 gene is associated with both sle risk and chd risk in women with sle. using genetic analysis techniques, this study will examine previously collected case-control samples of serum dna. study researchers will resequence the entire f2 gene and then examine the role of sequence variations in relation to sle and the risk of chd in sle patients. researchers will identify rare and common variants of the f2 gene and further screen variants to determine gene-trait relations.

Eligibility criteria:
inclusion criteria: * diagnosis of sle exclusion criteria: * pregnant

Keywords: sle genetics
autologous muscle stem cell therapy for treatment of congenital urinary incontinence in epispadias patients

Conditions: Urinary Incontinence; Epispadias, Male

Summary: the aim of this trial is to evaluate the safety and efficacy of an autologous muscle stem cell therapy in the treatment of congenital urinary incontinence in isolated epispadias.

epispadias is the mildest form of exstrophy-epispadias complex (eec); a congenital malformation disorder involving the midline abdominal and genitourinary structures. patients with epispadias have a defect in the urethral sphincter resulting in urinary incontinence. this trial investigates the injection of autologous primary human muscle stem cells into the urethral sphincter with the aim of repairing the defect and restore the anatomic ability for continence. eligible participants will undergo muscle biopsy during a routine cystoscopy. acquired muscle tissue is used for the isolation and expansion of muscle stem cells ex-vivo. muscle stem cells are injected into the urethral sphincter under visual control using cystoscopy. participants are assessed for safety and efficacy for a minimum of 12 months post-intervention.

Eligibility criteria:
inclusion criteria: * male * isolated epispadias * aged ≥ 3 years * urinary incontinence as defined according to the international children´s continence society * informed consent exclusion criteria: * acute or chronic inflammatory local or systemic disease * coagulation disorder * previous adverse reaction to anesthesia * congenital heart defect, cardiac arrhythmia

Keywords: isolated epispadias urinary incontinence muscle stem cell therapy autologous cell therapy
post operative sensitivity of mta obturation

Conditions: Dental Pulp Disease; Endodontically Treated Teeth; Endodontic Disease

Summary: the aim of this study was to investigate the difference in postoperative pain caused by different root canal sealers in patients with irreversible pulpitis symptoms and no apical lesions.


Eligibility criteria:
inclusion criteria: * asymptomatic tooth with delayed positive response to thermal tests and electric pulp tests * large pulp perforation during caries removal, * inflamed pulp in which bleeding could not be controlled within 5 min, * periodontally healthy mature mandibular first or second molar tooth. exclusion criteria: * patients if they were diabetic, immunocompromised, pregnant, * had a positive history of antibiotic use during the past 1 month, * required antibiotic prophylaxis * used analgesic within 7 days prior to the beginning of treatment, * were allergic to the materials used during root canal treatment, * if the bleeding could be controlled within 5 min and vital pulp treatment could be performed, * the tooth had negative response to vitality tests and/or was symptomatic, * had an associated periapical lesion visible on a radiograph, * needed a post-core or was planned to serve as prosthetic support, * had a calcified root canal and internal or external root resorption, * had tooth with open apex * mandibular third molars

Keywords: mta post-op pain epoxy resin sealer putty mta
effectiveness of methylene blue guidance in total excision of pilonidal sinus.

Conditions: Pilonidal Sinus

Summary: methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.

to study the potential benefits of intraoperative methylene blue use in pilonidal sinus surgery in detecting the borders of the disease, the histopathologic correlation between the specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene blue was investigated. the branches that distinctly exceeded the planned dyed excision borders will tried to be detected histopathologically, if any.

Eligibility criteria:
inclusion criteria: * pilonidal sinus disease of the intergluteal region * primary disease without history of drainage * ages between 18 and 65, both gender exclusion criteria: * recurrent pilonidal sinus disease * acute infection with abscess formation and/or purulent copious drainage * denial to sign informed consent

Keywords: pilonidal sinus methylene blue histopathology surgery
efficacy and safety of baclofen for maintenance of abstinence in alcohol dependent patients

Conditions: Alcohol Dependence

Summary: the purpose of the study is to assess the efficacy of xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving brenda therapy sessions.


Eligibility criteria:
inclusion criteria: * adult patients meeting dsm iv(diagnosis and statistical manual of mental disorders, 4th edition) criteria for alcohol dependence * willing to participate in the study and express a desire to achieve the objective of continuous and long term abstinence after withdrawal * abstinent (last drinking) for a minimum of 3 days and maximum of 14 days * at least one previous abstinence attempt exclusion criteria: * need for a stay at the end of the withdrawal period in a health care and rehabilitation institution specialized in addiction * need for a heavy psychosocial out of hospital care * history of baclofen intake, by prescription or self medication * porphyria * concomitant treatment with one or several drugs for the maintenance of abstinence * severe renal, cardiac or pulmonary disorder * epilepsy or history of epilepsy * concomitant treatment with psychotropic drugs, except antidepressants at stable dose for 2 months, diazepam and oxazepam * severe psychiatric disease (schizophrenia and bipolar disorder) * suicidal risk or history of suicide * clinically significant cognitive disorders * hepatic encephalopathy * ongoing dependence or within the last 12 months on other addictive substances (opioid, cocaine, cannabis, other substances or drugs...), excepted tobacco

Keywords: baclofene alcohol dependence maintenance of abstinence
psychological pain treatment in endometriosis

Conditions: Endometriosis; Pelvic Pain; Chronic Pain

Summary: this study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. one group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).


Eligibility criteria:
inclusion criteria: * endometriosis diagnosed by laparoscopy or mri. * moderate to severe endometriosis-related chronic pelvic pain. * relevant clinical and surgical treatment according to the european society of human reproduction and embryology (eshre) guidelines for endometriosis have been tried. exclusion criteria: * fibromyalgia, colitis chron or colitis ulcerosa * severe psychiatric diagnosis * pregnancy or planned pregnancy during the study period
evaluate safety and efficacy of abt-335 in combination with rosuvastatin calcium in subjects with multiple abnormal lipid levels in the blood

Conditions: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia

Summary: the purpose of this study is to compare the safety and efficacy of fenofibric acid (abt-335) + rosuvastatin calcium combination therapy with abt-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.


Eligibility criteria:
inclusion criteria: * patients with mixed dyslipidemia exclusion criteria: * subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial. * patients who are taking certain medications or unstable dose of specific medications. * women who are pregnant or plan on becoming pregnant or women who are lactating.

Keywords: dyslipidemia coronary heart disease mixed dyslipidemia
the long term effects of covid on pulmonary function

Conditions: Covid19; COVID-19 Pneumonia; Critical Illness; Quality of Life

Summary: an observational cohort study of patients discharged from the icu following admission with covid19 infection, looking at their medical wellbeing 6 months after discharge from the icu.

the covid-19 epidemic has placed an unprecedented strain on medical services worldwide. throughout 2020 and early 2021, hospitals and their critical care services have been inundated with patients suffering from critical illness due to covid-19, some of whom developed multi-organ failure and required a prolonged icu stay. while the medical literature is now replete with publications and research on the acute phase of illness due to covid-19, including critical illness, there is a paucity of studies detailing the long-term outcomes following covid-19 critical illness. while the negative long-term physical health, mental health and quality-of-life related effects of ards have been well documented, there has been very little long-term covid-19 ards specific outcome studies published. this is an observational cohort study that aims to assess the long-term health outcomes of adult patients admitted to mater dei hospital intensive care unit with covid-19 infection. patients will initially be assessed at 6 months after discharge from itu. they will be interviewed by trained researchers using validated questionnaires. these questionnaires will assess their physical health, mental health and functional status. participants will be examined and asked to do a 6minute walk test also using validated non-invasive physical assessment tools. they will be offered pulmonary function tests to be carried out at the pulmonary function laboratory.

Eligibility criteria:
inclusion criteria: * all patients admitted to the intensive care unit with organ failure secondary to acute covid-19 infection and successfully discharged from mater dei hospital and surviving beyond 6 months after discharge, will be offered inclusion in the study. a positive covid pcr result before or during the patient's admission will be necessary for inclusion in the study. participants will be over 18 years of age, with no restriction as regards race, ethnicity or gender. exclusion criteria: * there are no exclusion criteria

Keywords: covid19 critical illness
the effect of low-level laser therapy on functional treatment of skeletal class ii patients

Conditions: Class II Malocclusion

Summary: this is a controlled clinical trial with 2 groups of patients of class ii skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment


Eligibility criteria:
inclusion criteria: * age (early permanent dentition) * cervical maturation stage cs 3-4 * skeletal class ii due to mandibular retrusion. * overjet more than 4mm. exclusion criteria: * cleft lip or palate. * systemic diseases. * previous orthodontic treatment or abnormal habits. * congenital craniofacial deformity. * poor oral hygiene

Keywords: twin block , functional appliance , low level laser , photobiomodulation