Kornimate/medical-research-clean huggingface dataset:
bevacizumab versus combined bevacizumab and triamcinolone for refractory diabetic macular edema; a randomized clinical trial

Conditions: Diabetic Macular Edema

Summary: the purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.

according to the early treatment diabetic retinopathy study (etdrs), the treatment of choice for diabetic macular edema is laser therapy, which may be neither effective nor curative in some patients. corticosteroids may have a beneficial effect on diabetic macular edema. other newly introduced medications for macular edematous lesions are anti-vegf vascular endothelial growth factor)drugs. in this randomized, sham-controlled, multicenter, three-arm clinical trial,we try to evaluate the safety and efficacy of intravitreal bevacizumab alone and in combination with intravitreal triamcinolone in the treatment of refractory diabetic macular edema.

Eligibility criteria:
inclusion criteria: * cases with clinically significant macular edema (csme) with persistent retinal thickening after initial or supplemental macular photocoagulation exclusion criteria: * monocularity, * history of vitrectomy, * glaucoma or ocular hypertension, * significant media opacity, * existence of traction on the macula

Keywords: cystoid macular edema diabetic macular edema hard exudates intravitreal bevacizumab intravitreal triamcinolone macular thickness
a trial of two on-line interventions for child brain injury

Conditions: Traumatic Brain Injury; Depression; Anxiety Disorders

Summary: the primary aims of this project are to examine the feasibility and relative efficacy of two models of on-line intervention for families of children with traumatic brain injury: one, a model emphasizing cognitive appraisals and problem solving skills; the other, emphasizing linking families to resources and providing professionally-moderated peer support.

the feasibility of the two interventions will be evaluated by examining family utilization of on-line materials and satisfaction with receiving services this way. previous studies suggest the longer-term effects of tbi often create significant stress for both child and family and the need for psychological services.

Eligibility criteria:
inclusion criteria: * child between 5 and 17 years old who experienced a tbi in the past 12 months

Keywords: tbi intervention depression anxiety
financial incentives to increase pediatric hiv testing pilot study (fit-pilot)

Conditions: HIV

Summary: the aim of the pilot study is to evaluate the feasibility, acceptability and costs of a financial incentive intervention to motivate pediatric hiv testing in western kenya. the study will evaluate 3 cash incentive values and determine percent uptake of testing. a post-test questionnaire will explore parental satisfaction, mechanisms of incentive effectiveness and the impact of testing on emotional health and pediatric healthcare utilization.

the study will be a randomized trial with 3 arms (1:1:1 allocation) with small, medium, and large cash incentive. the investigators will randomize 60 parents with children of unknown status at kisumu county hospital in western kenya.

Eligibility criteria:
inclusion criteria: * parent/caregiver receiving hiv care * parent/caregiver is female * parent/caregiver has one or more children \<13 years old * child is hiv exposed (parent/caregiver report or clinic confirmation) * caregiver reports child's hiv status is unknown exclusion criteria: -none \*the investigators reserve the right to exclude any potential enrollee who is deemed to be a high personal risk, or whose children are at high personal risk, of interpersonal violence, by study participation.

Keywords: hiv financial incentive pediatric hiv testing
neural indices associated with relapse in cannabis dependence

Conditions: Cannabis Dependence

Summary: the aim of this fmri study is to investigate neural indices of relapse in cannabis dependence. the development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. therefore, neural markers of brain processes underlying the beforementioned components will be studied. subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.


Eligibility criteria:
inclusion criteria: * cannabis dependence * 24 hours abstinence exclusion criteria: * other dsm-4 diagnosis * neurological disorder

Keywords: cannabis fmri addiction relapse
a dose-ranging study of orvepitant in patients with chronic refractory cough

Conditions: Chronic Refractory Cough

Summary: the purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.

a multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (crc). doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups. each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately 292 subjects in total). all subjects will enter a three-week screening period to determine eligibility. eligible subjects will be randomized at the baseline/day 1 visit and enter a 12-week double-blind dosing period. during this period there will be four visits at weeks 2, 4, 8 and 12. there will be a final safety follow-up visit at week 14.

Eligibility criteria:
key inclusion criteria: * male and female subjects ≥18 years of age. * diagnosis of crc or unexplained cough for at least 1 year (see accp/bts guidelines attached). * an awake average cough frequency of ≥10 coughs/ hour, as assessed using an acm during the screening period. key exclusion criteria: * subjects with respiratory tract infection (\<4 weeks prior to study start) * current smokers or ex-smokers with \ 10 pack years * treatment with angiotensin converting enzyme (ace) inhibitors within 3 months of screening * fev1 \<80% predicted, measured at screening using spirometry * history of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (copd) * any clinically significant abnormal laboratory test result(s) * inability to comply with the use of prohibited and allowed medications as described in the protocol.
chemoradiotherapy after surgery versus preoperative chemoradiotherapy for stage ii/iii mid-low rectal cancer with or without high-risk factors

Conditions: Radiotherapy

Summary: the purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage ii/iii low- and medium-level rectal cancer with or without high-risk factors


Eligibility criteria:
inclusion criteria: 1. the patient is between 18 and 80 years old; 2. adenocarcinoma confirmed by pathology; 3. colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin is ≤10cm; 4. ecog score ≤2 (4) imaging diagnostic analysis was ct1-3nxm0; (for phase ii/iii) (5) ct examination of the chest and abdomen and pelvis showed no evidence of metastasis (6) patients undergoing chemoradiotherapy and surgery exclusion criteria: 1. history of malignant tumors in the past; 2. diagnosis of simultaneous multiple primary colorectal cancer or other cancers; 3. history of chemotherapy or radiotherapy prior to this trial 4. those with contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency; 5. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery; 6. pregnant or lactating women; 7. evidence of distant metastases prior to surgery 8. t4b tumors were found to invade the uterus, vagina, bladder, seminal vesicles, prostate, bone, and pelvic plexus
examining heart attacks in young women

Conditions: Acute Myocardial Infarction

Summary: heart disease and heart attacks pose a serious health risk to young women, and women tend to experience less successful recoveries after a heart attack than men do. this study will examine various factors that may predispose women to heart attacks and to poor recovery after a heart attack. the differences between men and women in the medical care that they receive following a heart attack will also be studied.

heart disease is one of the leading causes of death in women 55 years and younger, accounting for more than 8,000 deaths each year in the united states. approximately 40,000 young women are hospitalized each year in the united states as a result of a heart attack. research has shown that young women who have heart attacks are twice as likely to die in the hospital as young men who have heart attacks. while there has been an increase in awareness, little research has been conducted on understanding heart disease and heart attacks in young women. specific biologic markers involved with inflammation, metabolic abnormalities, sex hormones, and genetics may indicate a predisposition to a heart attack and poor recovery. this study will analyze the biologic, demographic, psychosocial, environmental, and behavioral factors that may contribute to premature heart disease and to poor recovery after a heart attack in women. researchers will examine if delays in receiving medical care following a heart attack can affect recovery and health outcomes for women. gender differences in outcomes and the quality of medical care that is received following a heart attack will also be examined. this study will enroll women and men who are hospitalized following a possible heart attack. at study entry, participants will be interviewed to collect information about symptoms, functioning, quality of life, and medical care. a medical record review will also occur. at 1 month after admission from the hospital, an interview will occur via phone and a blood sample will be collected when the participant returns to the hospital or alternatively be collected at a medical clinic convenient to the participant. another telephone interview will occur at 12 months. participants' blood samples will be stored for future biologic and genetic studies.

Eligibility criteria:
inclusion criteria: * elevated cardiac markers within 24 hours of arrival at initial or enrolling institution * supporting evidence suggestive of a heart attack exclusion criteria: * previously enrolled in the virgo study * does not speak english or spanish * too ill to interview * current prisoner

Keywords: acute myocardial infarction heart attack gender differences risk factors quality of care
targeting insomnia to improve outcomes in adults with problematic cannabis use

Conditions: Insomnia

Summary: this study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (cbti-cb-tm) to telemedicine-delivered sleep hygiene education (she-tm) on sleep, cannabis use, and daytime functioning. we will also evaluate the effects of cbti-cb-tm on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.


Eligibility criteria:
inclusion criteria: * self-reported chronic insomnia * insomnia severity index (isi) score indicative of at least mild insomnia * cannabis use disorder identification test-revised (cudit-r) indicative of at least problematic cannabis use * a positive urine drug screen (uds) for cannabis * self-reported use of cannabis to manage insomnia at least three times weekly for the past month * stable residence (e.g., stable sleep arrangements), consistent access to wi-fi, and ability to travel to ann arbor for sleep laboratory assessments exclusion criteria: * individuals who do not understand english * individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence) * diagnosis or high suspicion of a sleep disorder other than insomnia * diagnosis of psychotic disorder, bipolar disorder, or post-traumatic stress disorder * terminal or progressive physical illness (e.g., cancer) or neurological degenerative disease (e.g., dementia) * use of medications known to have initiated their insomnia (e.g., steroids) * previous receipt of cbti * self-reported pregnancy * self-reported regular work schedule of rotating or night (3rd) shift work.

Keywords: cannabis
post-discharge pharmacist-led rapid medication optimization for heart failure (post-discharge pharm-hf)

Conditions: Heart Failure with Reduced Ejection Fraction HFrEF

Summary: this study will recruit 100 patients from a post-discharge medicine clinic to test if the addition of a pharmacist to manage heart failure medications can increase appropriate use of these medications. participants will be randomly assigned to usual care alone or with the addition of a pharmacist to help manage medications. they will be followed for 3 months by telephone/electronically-administered questionnaires, and 12 months using administrative health records. outcome data will include information from patients on quality of life, treatment burden, medication adherence, as well as information from their medical record on heart failure events.


Eligibility criteria:
inclusion criteria: 1. age ≥19 years; 2. attending their initial visit to the pdmc; 3. diagnosis of hf. exclusion criteria: * none.
ex-vivo performance evaluation of the histolog™ scanner for human breast carcinoma detection on fresh breast core biopsies

Conditions: Breast Cancer

Summary: fresh breast core biopsies suspicious for breast cancer that are usually taken during clinical breast assessments will be imaged via confocal microscopy. the device so called histologtm scanner is based on confocal fluorescence and displays microscopic histology images superficial layers of fresh tissue. after the imaging procedure the fresh breast tissue specimen will be followed according to the gold standard workflow (h\&e-stained images). subsequently, two pathologists will analyze the histologtm scanner obtained-images and h\&e-stained images for potential breast cancer structures. a comparison of both analyses for cancer visualization will be performed to evaluate the feasibility of using confocal microscopy for breast cancer detection.

during clinical breast assessments physicians may detect diagnostic findings suspicious for breast cancer. in such situations a biopsy has to be taken to confirm the diagnosis histologically. once informed consent will be obtained, the physician will collect a biopsy sample using the standard procedure with us- or mg-guided biospy. immediately prior to gold standard pathology workflow (formalin fixation), histologtm scanner will be used to image the fresh biopsy specimens. the histologtm scanner (v1.0, samantree medical sa, lausanne, switzerland, ce marking) is based on confocal fluorescence and displays microscopic histology images of superficial layers of fresh tissue after nuclear staining with acridine orange (30 seconds) and rinsing in saline solution. finally, the specimen will be processed following the gold standard workflow (h\&e-stained images). two independent pathologists will assess the histologtm scanner- and h\&e-stained images subsequently according to the b-classification (categories b1-b5; "0" was defined as "no diagnosis possible") and determine the correspondence of the results.

Eligibility criteria:
inclusion criteria: * adult female patient ≥18 years old. * patient presenting with suspected breast carcinoma. * patient eligible for biopsy sampling. * patient must sign a written informed consent prior to research project entry. exclusion criteria: * patient previously treated for breast carcinoma. * patient has undergone previous neo-adjuvant treatment. * patient is not willing to participate in the research project. * patient is not capable of consenting. * patient is younger than 18 years old * patient is male
effects of mat and reformer pilates in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: our study aims to investigate the effects of core stability-based mat pilates and equipment-based pilates training on anticipatory postural adjustments (apa), balance, and gait in individuals with multiple sclerosis (ms). participants diagnosed with ms will be randomly assigned to mat pilates, equipment-based pilates, or a control group. both pilates programs will be conducted twice a week for eight weeks. assessments will be conducted before and after the training period. anticipatory postural adjustments (apa) will be evaluated using electromyography (emg) electrodes placed on the erector spinae and tibialis anterior muscles while participants take a step. biomechanical responses related to apas, specifically center of pressure displacement, will be measured using a force platform (biodex® biosway). core endurance will be assessed using the lateral bridge test, modified biering-sorensen test, trunk flexion test, and prone bridge test, while core strength will be evaluated through sit-ups and push-ups. balance will be measured using posturography. the activities-specific balance confidence (abc) scale will assess confidence in performing daily activities requiring balance. functional mobility will be evaluated using the timed up and go (tug) test. spatiotemporal gait parameters and variability will be analyzed with the bts® g-walk system. the multiple sclerosis quality of life questionnaire (msqol-54) will assess quality of life. this study is unique in that, unlike previous pilates studies, it will be the first to examine the effects of different pilates methods on apas, which are crucial for both locomotor activities and postural stability in individuals with ms. additionally, it will be the first study to evaluate two commonly used pilates techniques in terms of their impact on balance and gait.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis by a specialist physician * having a disability level between 0-4.5 according to the expanded disability status scale (edss) * being between the ages of 18-65 * not having had an attack in the last 3 months * mini-mental test score \> 25 exclusion criteria: * having another neurological disorder * having orthopedic, cardiovascular, and pulmonary problems that may affect the research results * having vision, hearing, and perception problems * having a disease that may affect the immune system, such as infection, cancer

Keywords: multiple sclerosis balance pilates gait
brain derived neurotropic factor response to aerobic exercise intensity in depressive patients.

Conditions: Depressive Disorder; Depressive Disorder, Major

Summary: acute aerobic exercise improves affective stats in patients with mental illnesses. brain derived neurotropic factor (bdnf) may be a biological mechanism that contributes to the affective benefits. the magnitude of the increase of serum bdnf might be exercise intensity dependent, but no study has compared low high-aerobic-intensity training at 90-95 % of the maximal heart rate (hrmax) with long-slow-distance training at 70 % of the hrmax in patients with depression. the aim of this study is to compare changes in serum bdnf levels after high-aerobic-intensity training and long-slow-distance training in a intra-individual design in patients suffering from depression. the results will give indications of a possible difference in bdnf response between aerobic intensities and may be uses as pilot data for calculating sample size.


Eligibility criteria:
inclusion criteria: * moderate or severe depression (icd10: f32-f33) exclusion criteria: * bipolar disorder.

Keywords: exercise therapy
two patterns of micropulse laser in the treatment of chronic central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: central serous chorioretinopathy (csc) is a common eye disease mainly involving the macular area, causing central visual acuity loss. recently, subthreshold micropulse laser used in treating chronic csc is proved to be safe and effective. however, some studies indicate that it's less effective than half dose photodynamic therapy (pdt). certain physicians, including us, think that this may be related to micropulse laser parameters. thus we need to explore better laser patterns to replace pdt in treating chronic csc. the aim of this study is to compare the treatment effect of two different patterns of laser parameters (small and regular spot diameter) in treating chronic csc. in this randomized, double blinded, controlled trial, by comparing the subretinal fluid regression ratio, central retinal thickness, macular microvisual field, macular vascular density, chroidal volume changes and visual acuity of two groups 6 months after micropulse laser treatment, we aim to evaluate the safety and efficacy of refined micropulse laser in treating chronic csc.


Eligibility criteria:
inclusion criteria: * patients age range 18-50 years * patients diagnosed with chronic central serous chorioretinopathy * patients have signed informed consent exclusion criteria: * a history of other fundus diseases or refractive media opacity * patients have underwent other treatment methods for chronic central serous chorioretinopathy * diopter\>-6d * a history of system diseases such as hypertension or diabetes * a history of using local or systemic corticosteroids
covid-19 : study of inflammasome and platelets functions

Conditions: COVID-19

Summary: covid-19 pandemic is a severe viral sepsis characterized by the occurrence of acute respiratory distress syndrome (ards) whose pathophysiology is little described

the new severe acute respiratory syndrome coronavirus 2 (sars-cov-2) epidemic started on december 2019 in china and spreaded in worldwide. the coronavirus disease 2019 (covid-19) is responsible of case of severe pneumonia whose the major risk is the development to ards. concerning the pathophysiology, there appear to be hemostasis abnormalities including thrombocytopenia and coagulopathy. in recent studies, this thrombocytopenia is described as a risk factor to develop severe covid-19 infection. sepsis is associated with a major systemic inflammatory response with an increased production of pro-inflammatory cytokines. since their discovery, inflammasomes have an important role during inflammatory response following an aggression. there are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including il-1β. most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets. thus, the present work aims to study the activation of the platelet nlrp3 inflammasome and the platelet functions and coagulation during a sars-cov-2 viral pneumonia according to different levels of severity

Eligibility criteria:
inclusion criteria: * patients suffering from covid-19, hospitalized in intensive care unit and in standard care unit. exclusion criteria: * patients suffering from malignant blood disease, cryopyrinopathy, sickle cell disease, rheumatoid arthritis and crohn's disease

Keywords: covid-19 nlrp3 inflammasome platelets functions coagulopathy acute respiratory distress syndrome