Kornimate/medical-research-clean huggingface dataset:
impact of covid-19 on mental health of patients with skin picking

Conditions: Skin Picking

Summary: skin picking disorder (spd) affects up to 10% of the general population, causing significant socioeconomic damage in 75% of affected individuals. it is characterized by the repeated habit of touching the skin itself, causing or aggravating wounds, with difficulty in controlling the habit. it is associated with anxiety disorders in about 20% of cases and with depressive disorder in about 50%. patients with spd have difficulties in regulating emotions, being more vulnerable to having their mental symptoms aggravated in face of stressful situations, such as the current coronavirus-19 pandemia. among the treatments available to spd, cognitive behavioral therapy is the only intervention superior to placebo, and there is still no medication approved by the fda indicated specifically to spd. the effectiveness of cognitive behavioral therapy was assessed in a randomized clinical trial with brazilian patients with spd, but its long-term benefit has not yet been evaluated. additionally, telemedicine interventions can be effective and used during pandemia, but the effectiveness of internet delivered cognitive behavioral therapy for spd is not clear yet.

this study is a randomized clinical trial, in which patients diagnosed with skin picking disorder (spd) will be evaluated and, if symptomatic for the disease, will be randomized to one of the arms: intervention arm with 2 booster sessions of cognitive behavioral therapy in online format; active control arm, in which individuals will watch videos with quality of life orientation. patients included in this study are coming from a brazilian clinical trial conducted between the years of 2014 and 2018, in wich patients with spd were treated with a cognitive behavioral treatment protocol in individual or group formats, resulting in improvement of spd symptoms and comorbid anxiety and depression. before the intervention, individuals will be evaluated by a psychiatrist, to assess spd and comorbid symptoms severity, thru the application of some instruments to assess spd, anxiety, depression and emotional regulation. also, the crisis questionnaire, about the impact of covid-19 in mental health, will be applied. after the interventions, the instruments will be applied again, by the same evaluator, wich is blinded to the type of intervention that the patient received.

Eligibility criteria:
inclusion criteria: * skin picking as a primary diagnosis * treatment with cognitive behavioral therapy in the past, received in previous clinical randomized trial conducted by our research group between 2014 and 2018 exclusion criteria: * acute psychotic disorder, bipolar affective disorder in an acute episode, substance use disorder (except tobacco), severe depressive episode or suicidal ideation, dementia
photodynamic therapy combined with bevacizumab vs bevacizumab alone for neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: this phase ii study was designed to evaluate the safety, tolerability, and efficacy of bevacizumab treatment in conjunction with pdt at the low fluence rate compared with bevacizumab alone or combined with pdt at the standard fluence rate, in patients with all types of choroidal neovascularization secondary to amd. hypothesis: bevacizumab in combination with pdt (low and standard fluence rate) will i) delay time to retreatment, ii) reduce the average number of treatments required compared to bevacizumab alone and iii) at low pdt fluence rate will improve long-term safety profile.


Eligibility criteria:
inclusion criteria: * all lesion subtype of cnv secondary to age-related macular. * sub-foveal cnv. * patients who fail to respond to photodynamic therapy. * patients who are not eligible for pdt (greatest linear dimension of the lesion \>/= 5400 um, cnv with hemorrhage \>/= 50 % of the entire lesion, minimally classic or occult cnv with greatest linear dimension of the lesion \>/= 4600 um.). * patients affected by pigment epithelium detachment with cnv. * patients affected by retinal angiomatous proliferation. * willingness and ability to participate and provide written informed consent. exclusion criteria: * individuals with choroidal neovascularization from causes other than amd (myopia, angioid streaks). * any intraocular surgery within 2 months in the study eye. * prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye. * any significant ocular disease that has compromised or could compromise vision in the study eye. * prior stroke, myocardial infarction, or end-stage malignancy. * active hepatitis or clinically significant liver disease, renal failure. * any patient with recent history of new onset cardiac disease or thromboembolic cns event in the past. * patients who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks. * patients who are a poor medical risk because of other systemic diseases or active uncontrolled infections.

Keywords: age-related macular degeneration choroidal neovascularization bevacizumab photodynamic therapy
studying normal breast tissue and cancer risk

Conditions: Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases

Summary: breast cancer is the most common cancer among women in the united states. breast cancer research has been hampered by the difficulty in collecting normal breast tissue. in this study, researchers will obtain samples of normal breast tissue from organ donors and will collect risk-factor data from next-of-kin. the purpose of this study is to learn how normal breast develops and responds to stresses that are known to increase a woman s chance of developing breast cancer. following the breast-tissue donation from 20 volunteers, surgical technicians will make small incisions in the skin and tissue of the breast and remove several samples measuring about one-inch. technicians also will take samples of the uterine lining to estimate the date of the last menstrual period. the tissue will then be sent to the national cancer institute for laboratory research studies. steps will be taken to ensure that the identity of the participants remains confidential.

this pilot project, funded by a breast cancer faculty infrastructure award, would determine the feasibility of obtaining samples of normal breast tissue from organ donors and collecting risk factor data from next-of-kin. the underlying goal of this initiative is to determine the associations between stages of breast development, risk factors for breast cancer, and gene expression. the study investigators are members of dceg, ccr and the transplant resource center of maryland (trc), a non-profit organization certified by hcfa and the state that processes most organ and tissue donations in maryland. trained staff or social workers employed by trc who routinely obtain consent for donation from next-of-kin will also obtain consent for this study. the existing consent form for organ or tissue donation also includes informed consent for donation of tissue for research. following organ procurement from 20 volunteers, trained surgical technicians employed by trc who routinely assist intra-operatively, will sterilely remove tissue from each breast quadrant and split the samples; one portion will be embedded in oct and snap frozen in liquid nitrogen and the other fixed in 10% buffered formalin. samples of adipose tissue, blood, urine and endometrium (for menstrual dating) will also be obtained. mes in conjunction with smh and bkv will assess the samples histopathologically and determine the quantity and quality of macromolecules (rna, dna, protein) contained within the tissues. pending demonstration of the feasibility of this general approach, we will pursue additional funding for a larger study with optimized procedures. we have stopped recruiting patients.

Eligibility criteria:
* inclusion criteria the study will enroll girls or women aged 11 years or older. exclusion criteria men are excluded.

Keywords: mammary development cancer risk genes
enoxaparin 20mg versus 30mg subcutaneously once daily in elderly patients with impaired renal function

Conditions: Venous Thromboembolism; Renal Impairment

Summary: this is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. patients are randomized to receive either 20 mg or 30mg of enoxaparin. both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.


Eligibility criteria:
inclusion criteria: * non-surgical patients * 70 years of age or older * with renal impairment (creatinine clearance ≤35ml/min) * requiring pharmacological thromboprophylaxis exclusion criteria: * indication for a treatment dose of anticoagulant treatment * knee surgery or hip surgery within 10 to 35 days, respectively * surgery, trauma, hemodialysis, peritoneal dialysis, or bleeding * history of heparin-induced thrombocytopenia * known or suspected hypersensitivity to any component of study drug * patients with an excessive risk of bleeding and not eligible for pharmacological thromboprophylaxis based on physician assessment or due to any of the 3 major risk factors including active gastroduodenal ulcer, bleeding within the past three months prior to hospital admission, or a platelet count of \<50,000 platelets/ mm3

Keywords: anticoagulation thromboprophylaxis anti-xa levels elderly prevention enoxaparin low molecular weight heparin
development and validation of a clinical prediction rule for lower limb critical limb ischaemia (prediccmi)

Conditions: Lower Limb Ischaemia

Summary: critical limb ischaemia (cli) is the most serious stage of peripheral occlusive arterial disease (poad). despite progress in the revascularization procedures, half these patients experience amputation or death after one year. one issue is to identify these subjects because aggressive treatment is necessary in those cases, while in others (ie leg ulcer in a patient with poad but no rest lower limb ischaemia), revascularization will not be necessary. then it would be useful to develop a simple score to help the physician to improve diagnosis of cli.

today many patients with suspected critical limb ischaemia do not have objective assessment of limb ischaemia despite recommendations, mainly because of lack of vascular medicine units able to measure ischaemia with adequate methods such as toe pressure or tcpo2. it would be very useful to better identify the patients who need to be explored, or at least to have an evidence-based clinical assessment in those who cannot be explored . the objective is to develop a simple clinical prediction rule of critical lower limb ischaemia. two definitions are currently used for critical limb ischaemia. in both definitions, objective confirmation is needed for critical limb ischaemia by measurement of ankle pressure, toe pressure or transcutaneous oxygen pressure. these two latter measurements are mandatory in the numerous patients whose ankle pressure measurement is not possible (diabetes, chronic renal failure). unfortunately few vascular medicine units exist to carry out these measurements, so that it would be useful to better identify those patients who need to be explored. in those who cannot be explored, better clinical assessment would also be very useful. the investigators aim to develop a simple clinical prediction rule by completing a specific clinical chart in the patients hospitalized for peripheral occlusive arterial disease in bordeaux, toulouse and limoges university hospital vascular medicine units and included in the copart ii cohort. internal validation will be performed using cross-validation and bootstrap methods. to achieve the secondary objective, the patients will be followed-up for the duration of the study (ie from 1 to 3 years) to evaluate the prediction of clinical outcomes (death or amputation) by both definitions of critical limb ischaemia.

Eligibility criteria:
inclusion criteria: * patient coming for consultation or hospitalized for lower limb arterial disease and suspected to have critical ischaemia (ie rest pain or ulcer) non inclusion criteria: * patient coming for consultation or hospitalized for lower limb arterial disease without rest pain

Keywords: critical limb ischaemia peripheral occlusive arterial disease clinical prediction ankle pressure transcutaneous oxygen pressure toe pressure microcirculation
injections in the diagnosis and treatment of lumbar facet syndrome

Conditions: Facet Joint Pain; Facet Syndrome of Lumbar Spine; Facet Joints; Degeneration

Summary: in suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. the main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.

facet joint pain is considered as a nonspecific cause of spinal pain with an estimated prevalence of 12-61% of the population. at present, there are no unanimous clinical criteria to achieve and accurate diagnosis and the imaging findings do not show a direct correlation with the clinical symptoms. facet syndrome treatment is also controversial and, although most clinical guidelines recommend nerve block as a diagnostic test, followed by neurolysis as therapeutic technique, there are many detractors of this therapeutic sequence. the confusion is even greater when considering the variability of specialists who perform these techniques, the variability of methods used ranging from blind injections to injections guided by ultrasound, fluoroscopy or ct, or the amount of medication injected. the investigators have long experience in the percutaneous treatment of pain and in the use of different imaging techniques. although the investigators objectives are multiple, the main one is to know if there are any difference in the outcome of the facet syndrome treated by intra-articular injections and the block of the medial branch of the dorsal branch of the spinal nerve. along with the collaboration of other specialists the investigators want to address secondary objectives such as the usefulness of ultrasound and fluoroscopy in the treatment of facet syndrome and its comparison with those performed under ct guidance that is considered as the standard technique for its greater precision.

Eligibility criteria:
inclusion criteria: 1- lumbar facet syndrome diagnosed by the referring specialist: rehabilitation, traumatology or neurosurgery 2 -mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation. 3- failure of conservative treatment (pharmacological and physical therapy). 4-symptoms present more than 3 months exclusion criteria: 1. previous back surgery and other ablative treatments. 2. contraindication for the use of corticosteroid or local anesthetic. 3. uncontrolled acute or chronic medical illness. 4. pregnancy or lactation. 5. presence of inflammatory arthropathy or neuropathy. 6. wounds or skin lesions in the area. 7. diabetes mellitus. 8. psychiatric disorders 9. refusal to participate in the study. 10. demonstration by imaging techniques of other causes that could justify the symptomatology.

Keywords: facet joints facet injections nerve block
treatments of migraine with triptans in individuals with elevated cardiovascular risk and in pregnant women

Conditions: Migraine; Cardiovascular Diseases; Pregnancy

Summary: researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.

migraine is a very common condition that can be associated with significant morbidity. for the acute treatment of migraine attacks, the use of triptans, nsaids, acetaminophen, dihydroergotamine, calcitonin gene-related peptide antagonists, lasmiditan, and some nonpharmacologic treatments are associated with improved pain and function. the effectiveness of these therapies has been documented in various studies and summarized in systematic reviews. however, systematic reviews have demonstrated evidence gaps in two groups of patients that were excluded from treatment trials. these are patients with cardiovascular disease or at high risk of cardiovascular events, and pregnant women. triptans, the mainstay treatment for migraine attacks and the one supported by the highest quality evidence, are considered vasoactive and are contraindicated per formulary in individuals who have a history of myocardial infarction, stroke, or uncontrolled vascular risk factors such as hypertension. these individuals are usually excluded from randomized trials. similarly, pregnant women have been excluded from triptans trials and the observational studies offered low certainty evidence about their safety. yet, 44% of surveyed members of the american headache society reported being somewhat or very comfortable using triptans in pregnancy. therefore, the investigators intend to evaluate the safety of triptan treatment of migraine in individuals with cardiovascular disease or multiple cardiovascular risk factors, and in pregnant women in two target trial emulations.

Eligibility criteria:
treatments of migraine with triptans in individuals with elevated cardiovascular risk: inclusion: * aged \>=18 years * at least 1 year history of migraine with or without aura * confirmed cardiovascular or cerebrovascular disease, including myocardial infarction (mi), coronary artery disease (cad), cerebrovascular disease, stroke; or at least 2 cardiovascular risk factors, including diabetes, hyperlipidemia, hypertension, obstructive sleep apnea, peripheral vascular disease; * at least 1 year of prior triptan treatment or no previous triptan treatment. exclusion: • prescription of ergot alkaloids or dihydroergotamine within 60 days before or after starting treatment treatments of migraine with triptans in pregnant women inclusion: * aged \>=18 years * pregnant woman * diagnosis of episodic or chronic migraine with or without aura before pregnancy exclusion: • prescription of ergot alkaloids or dihydroergotamine \<= 60 days before pregnancy or during pregnancy
group motivational intervention in overweight/obese patients.

Conditions: Overweight; Obesity

Summary: the overall goal of imoap study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in overweight and obese patients. furthermore, the study will evaluate whether this result has a positive impact on quality of life, changes in eating habits, and a reduction in the associated cardiovascular risk factors and overall cardiovascular risk.

the global mortality caused by cardiovascular disease increases with weight. the framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. we have designed a study in two geographically separated groups, one of which would receive the group motivational intervention, and the other one would receive the usual follow up.

Eligibility criteria:
inclusion criteria: 1. overweight (bmi\>25) and obese (bmi\>30) patients of both sexes, registered in the medical history (mh) or newly diagnosed. 2. aged between 30 and 70 years 3. agreement to participate in the study exclusion criteria: 1. patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.) 2. patients with secondary obesity (hypothyroidism, cushing's disease, etc) 3. patients with severe sensorial disorders capable of interfering with the motivational intervention (severe, uncorrected deafness, severe visual deficit, etc). 4. patients with serious psychiatric disorders

Keywords: overweight obesity motivational intervention
human milk for congenital gastrointestinal disorders

Conditions: Congenital Gastrointestinal Disorders

Summary: this study aims to identify whether an exclusive human milk diet (ehmd) would improve outcomes in neonates with congenital gastrointestinal disorders (cgd) and by facilitating an earlier transition off of parenteral nutrition (pn).

infants born with congenital gastrointestinal disorders (cgd) can be very challenging to treat. the cgd require surgery shortly after birth to correct the problems and recovery can take a long time. during the period of time the infant's intestines are sick or don't work properly, they rely on parenteral nutrition (iv fluids containing carbohydrates, proteins and fats) to meet their nutritional needs. being on pn for a long time requires special intravenous lines, and increases the risk of blood stream infections and can make the liver sick. feeding babies who have these cgd is often very difficult, as the intestine needs to adapt. it needs to make appropriately formed stool to eliminate wastes, but not lose too much water or too many electrolytes. there is often a lot of starting and stopping of feeds. human milk (hm) is considered the ideal source of nutrition for all infants. this study aims to identify whether an exclusive human milk diet (ehmd) would improve outcomes in neonates with congenital gastrointestinal disorders (cgd) and by facilitating an earlier transition off of parenteral nutrition (pn).

Eligibility criteria:
inclusion criteria: 1. admission to participating nicu at less than 7 days of age 2. birthweight \>1250g and/or gestational age at birth \>32 weeks 3. less than 7 days of enteral feedings 4. diagnosis of eligible primary "congenital gastointestinal disorders" defined as: gastroschisis, omphalocele and intestinal atresias 5. consent to the use of donor human milk products 6. consent to participate in this study exclusion criteria: 1. admission to participating nicu at \>7 days of age 2. birthweight \<1250g and/or gestational age \<32 weeks 3. diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, hirschsprung's disease, esophageal atresia, imperforate anus 4. evidence of significant liver dysfunction at time of enrollment (direct bilirubin \>4 and transaminases elevated more than 2 sd above upper limit of normal for age) 5. liver malformations such as biliary atresia and choledochal cyst 6. refusal of consent

Keywords: digestive disease and disorders neonatal pediatric disorders