Kornimate/medical-research-clean huggingface dataset:
open-label, long-term extension study to investigate the safety, tolerability, and efficacy of disc-1459 (bitopertin) in participants with epp

Conditions: Erythropoietic Protoporphyria

Summary: this is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of disc-1459 in participants with epp.


Eligibility criteria:
inclusion criteria: * participants with diagnosis of epp who are participating (or who have participated) in a prior disc medicine bitopertin study and who have completed the randomized treatment phase and end-of-study visit * aged ≥12 years upon study consent * body weight ≥32 kg for participants \<18 years of age and bmi ≥18.5 kg/m2 for adult participants exclusion criteria: * participants who have an ongoing sae from a clinical study that is assessed by the investigator as related to bitopertin * other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgement of the investigator or sponsor, would put the participant at unacceptable risk or otherwise preclude participation in the study * condition or concomitant medication that would confound the ability to interpret clinical, clinical laboratory, or participant diary data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months * planned treatment with afamelanotide or dersimelagon during the study * planned use of any drugs or herbal remedies known to be strong inhibitors or inducers of cytochrome p450 (cyp)3a4 enzymes throughout the study * if female, pregnant, or breastfeeding * participation in any other clinical protocol or investigational trial, other than disc medicine bitopertin trials, that involves administration of experimental therapy and/or therapeutic devices within 30 days of day 1 * score of phq-8 ≥10 at screening or imminent suicidal risk identified by the c-ssrs as defined as suicidal ideation with intent (grade 4 or 5) within the last year or any suicidal behavior within the last 5 years. * consumption of grapefruit/seville orange and products containing these for 14 days prior to first dose of study drug and throughout the study

Keywords: epp disc-1459 porphyria ro4917838
study on the effects of mutations under inherited retinal disease in korean

Conditions: Inherited Retinal Dystrophy Primarily Involving Sensory Retina; Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium

Summary: to develop comprehensive genetic maps of inherited retinal diseases in korean * establishment of comprehensive genetic database in koreans with inherited retinal diseases including frequently mutated genes, genotype-phenotype correlations, and visual prognosis."

group/ cohort label : subject with age between 6 months and 65 years who have not receive molecular genetic testing group / cohort description : consecutive subjects with inherited retinal disease who are willing to do genetic testing using whole exome sequencing (n=265) and whole genome sequencing (n=15) and agree to informed consent of the study

Eligibility criteria:
inclusion criteria: * inherited retinal disease * age between 4 months and 75 years * subject who has clinically confirmed visual impairment including night blindness or photophobia. subject should meet one of the following criteria * pigmentary retinopathy in both eyes * reduced response in photopic or scotopic electroretinogram in both eyes * photoreceptor degeneration in optical coherence tomography in both eyes exclusion criteria: * unilateral retinal disease * subject who had previously confirmed genetic testing * age less than 4 months or more than 75 years * when congenital infection or trauma are suspicious for the cause of retinal disease * when age-related macular degeneration, myopic degeneration, autoimmune origin are suspicious for the cause of retinal disease * no visual impairment or normal electroretinogram (e.g., benign fleck) * illiterate subject who can not understand informed consent * foreigners
aorif complex ankle fractures

Conditions: Ankle Fractures

Summary: the aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.

starting 05/01/13 patients with complex ankle fractures, older than 17 years, who sustained the injury less than 14 days before surgery and giving informed consent are consecutively enrolled. a complex fracture is defined as either an isolated malleolar fracture in combination with ligamentous instability, or a bi- or trimalleolar fracture. an unstable ligamentous injury is defined as either a disruption of the deltoid ligament leading to increased medial talar tilt, or an unstable syndesmotic injury assessed by the external rotation test both after osteosynthesis of all fractures. exclusion criteria are isolated unimalleolar fractures, pilon fractures, open fractures, multiple injuries, mental illness, incompliance or pregnancy. data assessed are: * demographics * medical history * classification (ao, haraguchi, icrs, location and size defect) * surgery details * complications * proms (faam, aofas, omas, faos, tas, sf-12, eq-5d, moxfq)

Eligibility criteria:
inclusion criteria: * unimalleolar fracture + ligamentous injury * bi- or trimalleolar fracture ± ligamentous injury * \> 17 years * date of injury less than 15 days * written informed consent exclusion criteria: * isolated unimalleolar fracture * pilon fracture * open fracture * mental illness, incompliance, pregnancy * multiple injuries

Keywords: arthroscopy ankle fracture patient rated outcome
prv-based detection of cad in comparison to standard methods

Conditions: Coronary Artery Disease

Summary: this is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.

the study will validate a pulse wave based algorithm for the detection of coronary artery disease (cad) with parameters from standard methods. subjects will be patients admitted to coronary angiography due to suspected cad. pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of cad and/or myocardial ischemia. these results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose \>=50%. for secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.

Eligibility criteria:
inclusion criteria: * coronary angiography indication present * informed written consent exclusion criteria: * previous coronary angiography * known cad (history of coronary angioplasty, stent implantation and/or bypass surgery) * atrial fibrillation (at time of measurement) * severe ventricular extrasystole (e.g. \>=10% ventricular extrasystoles, bigemina) * pregnancy, lactation

Keywords: coronary artery disease diagnosis non-invasive
a multicentre clinical test of the ultracore repose® mattress to prevent pressure ulcers cat. ii-iv in nursing homes

Conditions: Pressure Ulcer

Summary: a mixed method desgin study will be conducted to study pressure ulcer incidence cat. ii-iv (including deep- tissue injury,unstageable), not associated with the use of medical devices, on the ultracore repose® mattress (frontier therapeutics ltd) and to study differences in caretakers' experiences and perceptions when using the ultracore repose® mattress versus the repose overlay mattress®

quantitative part: before the start of the study, nurses on the participating wards will be educated by the researcher about skin observation, pressure ulcer classification, risk assessment, risk assessment, and use of the ultracore repose® mattress (frontier therapeutics ltd). skin assessment and risk assessment are performed on a daily basis by the staff nurses. reliability testing will be done by the researcher on a weekly basis and without pre-announcement. reliability checks and compliance with the protocol will be completed by the researcher as well as the collection of additional data. qualitative part three focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the ultracore repose® mattress (versus the repose overlay mattress® and an alternating air mattress).the researcher will encourage group interactions to capture the data and to provide a more comprehensive understanding of experiences and perceptions of using the ultracore repose® mattress (versus the repose overlay mattress® and an alternating air mattress). non-verbal communication will also be captured in each focus group.

Eligibility criteria:
inclusion criteria: * high risk of pressure ulcers (braden score \< 12) and/or pressure ulcer category 1 * bedbound (\> 8 hours in bed) or chair bound (\> 8 hours in chair) * aged \> 65 years exclusion criteria: * pressure ulcer category ii-iv, deep tissue injury (dti) or unstageable pressure ulcer * expected length of stay \< 2 weeks * end of life care * medical contraindication for use of static air support devices

Keywords: pressure ulcer static air mattress prevention
examining tdcs effect on cannabis use disorder in patients with schizophrenia

Conditions: Schizophrenia; Cannabis-Induced Disorder

Summary: cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. validated care has limited effectiveness in this population and development of new management strategies seems necessary. transcranial direct current stimulation (tdcs) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. it is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (dlpfc) and cathodal stimulation of the medial prefrontal cortex (mpfc) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. it is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.

stimulation will be performed using a neurocan dc-stimulator plus with two 7×5 cm sponge electrodes soaked in a saline solution. electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over f4 (right dlpfc), the cathode over fp1 (mpfc). the stimulation level will be set at 2 ma for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays. the control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tdcs material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. the same device will be used for both the sham and the active procedures.

Eligibility criteria:
inclusion criteria: * schizophrenia diagnostic according to dsm (diagnostic and statistical manual of mental disorder) 5 criteria, without change in psychotropic treatment since at least 4 weeks * moderate to severe cannabis use disorder according to dsm 5 criteria and active consumption during the last 7 days * subjects motivated to reduce or quit their cannabis consumption * patients with ambulatory compulsory care may be included exclusion criteria: * other substance use disorder, excluding nicotine, according to dsm 5 criteria * other current psychiatric disorder according to dsm 5 criteria, excluding personality disorder * inpatient hospitalization * history of head injury, neurological disorder with cerebral consequence or severe unstable somatic disorder * pregnancy or no contraception * contraindications for tdcs and/or mri (implanted material, uncontrolled epilepsy, intracranial hypertension)

Keywords: dorsolateral prefrontal cortex medial prefrontal cortex schizophrenia cannabis-induced disorder
adjunct minocyline in treatment-resistant depression

Conditions: Major Depressive Disorder

Summary: this study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (ad-st), for patients with unipolar major depressive disorder (mdd).

this is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial of adjunctive minocycline for patients with unipolar major depressive disorder (mdd). the study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (ad-st), for patients with unipolar major depressive disorder (mdd). the respective ad, for which non-response has been documented, must be on a stable regimen for at least 14 days prior to inclusion. ad-st will then be continued throughout the trial. trial medication is adjunct oral minocycline 200 mg/day or placebo. response to treatment will be measured via the montgomery-asberg depression rating scale (madrs). the total study duration for each patient will be 6 weeks.

Eligibility criteria:
inclusion criteria: * informed consent * male or female * between age 18 and 75 * bmi between 18 and 40 inclusive * non-lactating, non-pregnant females of child-bearing potential must be willing to use an effective contraceptive method * all participants must fulfil diagnostic criteria of moderate or severe mdd according to the dsm-5. * hamd-17 score of at least 16 points at baseline and a * cgi-s score of at least 4. * ad-st must have been administered at a sufficient dose for at least 6 weeks in the current episode and at a * stable regimen for at least 14 days prior to baseline. * dose and duration of ad-st must be verifiable exclusion criteria: * prevalence of neurodegenerative disorder * prevalence of any neurological disorder that caused the depressive symptoms * prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease * prevalence of any other psychiatric disorder that better explains the presence of depressive symptoms * improvement by more than 50% in hamd-17 score during the last 14 days prior to baseline * pregnant or nursing women will not be allowed. * substance or alcohol abuse within past 6 months or positive urine drug screening * abnormal thyroid function (euthyroid at presentation), liver or kidney dysfunction * history of autoimmune disease (except hashimotos thyroiditis) * clinically significant laboratory abnormalities (outside normal ranges) * current medication with anti-inflammatory substances (nsaids, corticosteroids)

Keywords: treatment resistant depression inflammation microglia minocycline
prospective trial of eus-fna versus eus-fnb using a novel core biopsy needle

Conditions: Pancreatic Cancer; Lymphadenopathy; Gastrointestinal Stromal Tumor

Summary: endoscopic ultrasound (eus) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. eus allows for the acquisition of cellular (fine needle aspirate - fna) or tissue biopsy (fine needle biopsy - fnb) for diagnostic purposes. this has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. more recently, a needle that allows a tissue biopsy for histologic analysis has been fda approved. the echotip procore (cook medical) core biopsy needle (etp), has been demonstrated to provide excellent efficacy for core biopsy samples. final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than eus-fna for lesions requiring histology for diagnosis. however, there is currently only limited data from prospective studies comparing eus-fna to eus-fnb with the etp needle. the investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of eus-fna to eus-fnb.

endoscopic ultrasound (eus) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. eus allows for the acquisition of cellular (fine needle aspirate - fna) or tissue biopsy (fine needle biopsy - fnb) for diagnostic purposes. this has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. more recently, a needle that allows a tissue biopsy for histologic analysis has been fda approved. we will compare tissue samples obtained by standard fna to fnb with a sample size of 140 patients with the primary outcome being diagnostic yield. each patient will be randomized to fna or fna. if after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.

Eligibility criteria:
inclusion criteria: - 3.1.1 all patients referred for eus tissue sampling who provide informed consent exclusion criteria: * 3.2.1 coagulopathy which is not corrected 3.2.2 diagnostic eus determines lesion is not amenable to fna or fnb

Keywords: eus fna fnb
study evaluating effexor xr in chinese subjects with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this primary purpose of this study is to assess the efficacy and safety of effexor xr in preventing recurrence in chinese patients with recurrent major depressive disorder (mdd) following a 1-year maintenance treatment after an 8-week acute treatment and a 6-month continuation treatment phases. the study will also collect data on the prevalence and pattern of co-morbid anxiety and somatic symptoms and their impact on the recurrence of depression.


Eligibility criteria:
inclusion criteria: 1. males or females, 18 years of age or more; 2. outpatients; 3. major depressive disorder based on dsm-iv criteria, with/without current co-morbid anxiety disorder; 4. has two or more episodes of depression (including the current episode) in the past 5 years, with an interval of at lease 2 months between the end of the previous episode and the beginning of the current episode. 5. the baseline score of 17-item hamilton rating scale for depression (ham-d)\>=17; 6 if female of childbearing potential, have a negative urine pregnancy test at baseline, if appropriate, and use a medically acceptable method of contraception throughout the study. exclusion criteria:1.hypersensitivity to venlafaxine;2.received venlafaxine treatment before;3.clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure disorder (with the exception of a single childhood febrile seizure); 4.alcohol or drug abuse within the last year;5.a recent history of myocardial infarction or unstable heart disease (within 6 months of baseline);6.bipolar disorder;7.for female, known or suspected pregnancy or breast feeding;8.use of a monoamine oxidize inhibitor (maoi) within 14 days of baseline; use of any investigational drug within 30 days of baseline.
effects of covid 19 vaccine on egyptian population

Conditions: COVID 19 Vaccine

Summary: the aim of this study is to identify adverse events following vaccination by the covid-19 vaccine by evaluating adverse side effects, hematological values; immunogenicity in the egyptian candidates in response to covid-19 vaccine, summarizing the which may occur following administration of covid-19 vaccine.

coronavirus disease 2019 (covid-19) is an emerging respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) that had infected more than 100 million individuals and caused more than 2 million deaths worldwide by february 13, 2021. a safe and effective vaccination trials against covid-19 is urgently needed. there are currently more than 160 covid-19 candidate vaccines in development worldwide, and 25 are in different phases of clinical trials using different platforms. the efficacy and immunogenicity of vaccines varies depending on the study cohort. race and ethnicity were shown to affect the antibody responses to the rubella vaccine, which elicited significantly higher titers in children of african ethnicity compared to those of european descent or hispanic ethnicity, likely, disparities in serologic responses to vaccines were also observed between different ethnic groups for the haemophilus influenzae type b-tetanus toxoid conjugate vaccine , or the haemophilus influenzae type b polysaccharide-neisseria meningitidis outer membrane protein conjugate vaccine . thus keeping the race an important factor in studding its effect on immunogenicity of vaccine. thus keeping the race an important factor in studding its effect on immunogenicity of vaccine, which pushed us to estimate immunogenicity in egyptian population after vaccination with the inactivated covid-19 vaccine. heamatological changes after vaccination had been detected in many researches; lecuocytosis was found shortly after vaccination of infants, which was primarily a neutrophilia but no participant received antibiotics and all remained well at follow-up . in a case series study, also leukocytosis with fever was detected following pneumococcal vaccine administration . on the other hand, neutropenia was detected following a new vaccine against shigella sonnei . platelets abnormalities also had been detected following vaccination, a previous example is idiopathic thrombocytopenic purpura, linked to the administration of measles-containing vaccines .

Eligibility criteria:
inclusion criteria: 1. people aged 18-80 years. 2. negative for serum-specific igm/igg antibodies against sars-cov-2, as measured by a commercial kit (innovita, china) at the time of screening. exclusion criteria: 1. a history of infection with sars-cov 3 months before the vaccine. 2. fever, cough, runny nose, sore throat, diarrhoea, dyspnoea, or tachypnoea in the 14 days before vaccination. 3. pregnancy. 4. a history of seizures or mental illness. 5. being on immunosuppressive agents. 6. being on anticoagulation therapy. 7. being unable to comply with the study schedule.