Kornimate/medical-research-clean huggingface dataset:
point-of-care ophthalmic diagnostic imaging of retinopathy of prematurity

Conditions: Retinopathy of Prematurity (ROP); ROP Examination

Summary: the goal of this proposal is to develop novel hh-sectr technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (rop) patients that lead to more informed clinical decision making. providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.

imaging studies using hh-sectr will be performed to assess and quantify structural and vascular disease features associated with rop. weekly hh-sectr imaging will be performed concurrently with standard-of-care weekly rop screening. no additional treatments will be given to study patients to benefit hh-sectr imaging (e.g., sedation, dilation, etc.). study patients will primarily be imaged in the nicu, but may also be performed under sedation or anesthesia in the operating room concurrent with standard-of-care exams. because this study will evaluate diagnostic features prognostic of rop progression and severity, hh-sectr imaging will be performed until 45 weeks, cessation of rop screening, or first therapeutic intervention, whichever comes first. both eyes will undergo hh-sectr imaging. diagnostic imaging data will be analyzed following each imaging session. no experimental data will be used to alter the management of patients from the standard-of-care. research materials obtained from subjects will include digital hh-sectr images, digital fundus photography images, and documented examination timeline as part of the standard-of-care. patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables. the duration of the study will be 5 years. the study records and information will be indefinitely archived per nih rules using the methods noted above.

Eligibility criteria:
inclusion criteria: * preterm male and female infants born at 24-34 weeks gestational age and weighing \&lt;1500g at birth exclusion criteria: * infants surgically treated for rop * infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team

Keywords: retinopathy of prematurity rop prematurity oct imaging
safety study of adjuvant gemcitabine started one week after laparoscopic distal pancreatectomy for adenocarcinoma

Conditions: Pancreatic Neoplasms

Summary: we believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. this will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.

gemcitabine-based chemo¬therapy remains the cornerstone for treatment of locally advanced or metastatic pancreatic cancer. other novel chemotherapeutic combinations have been investigated in clinical trials, but the overall conclusions are that these agents have failed to improve outcomes. our hypothesis is that nodal and hematologic micrometastasis make pancreas cancer a systemic problem at the time of surgery. waiting the traditional six weeks to begin adjuvant therapy allows this very aggressive cancer to metastasize while the patient is waiting to begin therapy. this leads to the increased incidence of locoregional recurrence and poor prognosis. we believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. this will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence. methods: we will perform a prospective, non-randomized phase ii study with patients undergoing laparoscopic distal pancreatectomy for pancreatic adenocarcinoma at johns hopkins hospital. gemcitabine will be given as a single-agent chemotherapy regimen one week following laparoscopic distal pancreatectomy according to the protocol designed by our medical oncologist. six cycles of gemcitabine will be given. the patients will be followed in the medical oncology clinic weekly. our primary outcome variable will be all cause postoperative morbidity. our sample size will be small (6-10 patients) as this is a phase ii study. early termination rules include development of prohibitive toxicity or death. our endpoints are an improvement in overall survival, quality of life, progression free survival, or disease free survival. exclusion criteria will include patients with t4 or m1 disease, r2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Eligibility criteria:
inclusion criteria: * male or female patients older than 18 with clinical diagnosis of distal pancreas adenocarcinoma exclusion criteria: * patients with t4 or m1 disease, r2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Keywords: distal pancreas adenocarcinoma laparoscopic gemcitabine
next-generation sequencing (ngs) of peripheral blood immune repertoire in graves' disease

Conditions: Graves Disease

Summary: graves' disease (mim 27500) is the leading cause of hyperthyroidism worldwide. the prevalence of graves' disease is quite high (2.7% in women), and there is solid evidence of genetic predisposition. despite its clinical and scientific significance, graves' disease is still mysterious in terms of its susceptibility genes or pathophysiological mechanisms. the immune repertoire, being the sum of t and b lymphocytes in a body at any given time, is both a snapshot and a historical record of a person's immune function. thanks to the power of next-generation sequencing (ngs), massively parallel sequencing of the b cell and t cell receptors suddenly becomes plausible, and opens a door for many creative approaches to study immune related diseases. the ultimate goal of this project is to use both the ngs deep sequencing and immune repertoire experiment to perform graves' disease sub-group genetic fine mapping, and to identify graves' disease-specific t cell and b cell receptors. furthermore, using the immune repertoire approach, investigators want to study the critical epitopes of thyroid auto-antigens, and to delineate the pathophysiological steps in various disease stages and in various sub-groups. investigators expect to solve the immune repertoire of graves' disease of different sub-group presentations and at various disease activity stages.


Eligibility criteria:
patients with graves disease

Keywords: immune repertoire graves' disease
sedvasc (radico cohort) (radico-sedvasc)

Conditions: Ehlers-Danlos Syndrome, Vascular Type

Summary: the goal of this observational study is to describe the natural course of vascular ehlers-danlos syndrome, in particular the order of appearance of different types of complications (arterial, digestive, pulmonary and uterine).


Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to fulfil all of the following criteria: * patients (adults and children) with genetically-proven veds (presence of a pathogenic mutation at the col3a1 gene); * patients (or his/her legal guardian) who does not oppose to his/her personal data collection. there are no exclusion criteria for this study.
behavioral and affective skills in coping (basic) open trial

Conditions: Anxiety Disorders; Depressive Disorders; Disruptive Behavior Disorders

Summary: the overall objective of the project is to develop and assess the feasibility of a brief, practice-friendly approach to psychotherapy for children, entitled behavioral and affective skills in coping (basic) and designed for use as a first step toward evidence-based practice by practitioners in clinical service settings.

the investigators seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. the protocol will be designed for implementation in everyday community practice settings by practitioners. because many empirically supported treatments for youth disorders address only one area of impairment, they may not be an ideal fit to community clinics, where (a) most practitioners treat an array of disorders rather than specializing in just one, (b) most referred youths present with multiple disorders, and (c) priority problems and treatment needs may shift for many youths during an episode of care. moreover, because many evidence-based treatments have been developed in research settings, they may not be designed in ways that are ideal for front-line therapists in community settings. the investigators hope to reduce the difficulty of transporting treatments into community practice by incorporating the perspectives of community practitioners in the development and design of the protocol. by incorporating the feedback of expert treatment developers, the investigators hope to ensure that basic is not only appealing to users but also consistent with what has been learned through treatment research over the years. finally, the trial will provide preliminary evidence on whether this brief "first course" in evidence-based treatment is beneficial for youths with depression, anxiety, and disruptive behavior problems-three clusters that account for a large percentage of youth referrals.

Eligibility criteria:
inclusion criteria: * 8-15 year-old youth * the youth will meet diagnostic criteria for one or more target disorders in the broad areas of anxiety (including generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, specific phobia, panic disorder, anxiety disorder not otherwise specified, adjustment disorder with anxiety), depression (including major depressive disorder, dysthymic disorder, minor depression, depressive disorder not otherwise specified, adjustment disorder with depressed mood), and conduct (oppositional defiant disorder, conduct disorder, disruptive behavior disorder not otherwise specified, adjustment disorder with disturbance of conduct). exclusion criteria: * youth with primary adhd * youth with developmental disorders * youth with symptoms of a thought disorder including delusions and hallucinations
evaluation of the triamcinolone -acetonide therapy for the treatment of the medial plica syndrome

Conditions: Medial Plica Syndrome

Summary: the aim of this pilot study is to evaluate the clinical and radiological outcomes (ultrasound and mri) for a treatment utilized in the medial plica syndrome resistant to conservative therapy. will be evaluated an intra-plica ultrasound-guided injections of triamcinolone-acetonide and lidocaine percutaneously, and associated rehabilitation therapy. the aim of the study will be to evaluate the efficacy and safety of the injection procedure by revealing clinical improvement and monitoring the incidence of adverse events following treatment.

30 patients affected by the medial plica syndrome will be included in a pilot study in which one will be evaluated the effect of treatment with triamcinolone-acetonide and lidocaine, injected intraplical with an ultrasound-guided procedure. for evaluating the treatment, will be considered functional and pain outcomes. patients will be evaluated before treatment by a clinical, an mri and an ultrasound examination. after the injection, they will be followed up at 1, 3, 6 and 12 months. at the 1 and 3 month fu visits patients will be evaluated by an ultrasound examination and at the 6 month fu they will be evaluated by an mri examination.

Eligibility criteria:
inclusion criteria: 1. ultrasonographic and/or mri signs of medial plica pathology; 2. vas pain 4-8 at time of inclusion; 3. failure, defined as the persistence of symptomatology, after at least one course of conservative treatment of at least 6 weeks (rest and drug treatment, physiotherapy); 4. ability and consent of patients to actively participate in clinical follow-up; exclusion criteria: 1. bmi \> 35; 2. patients with: rheumatic diseases, diabetes, infectious processes, epilepsy, severe stage osteoporosis 3. patients undergoing intra-tendon infiltration of other substance within the previous 6 months; 4. patients undergoing surgery on the affected knee within the previous 12 months; 5. patients undergoing femoro- patellar joint stabilization surgery to the affected knee; 6. trauma to the affected knee within the past 6 months; 7. episodes of patellar dislocation and subluxation to the affected knee; 8. state of immunodepression; 9. ongoing systemic inflammatory diseases (stabilized outcomes of these diseases are not considered absolute contraindications). 10. contraindications to use or hypersensitivity to the active ingredient (triamcinolone acetonide) or to the excipients (sodium chloride, benzyl alcohol, sodium carboxymethylcellulose, polysorbate 80 and water for injectable preparations)found within kenacort as per the product package insert; 12. contraindications or hypersensitivity to the active ingredient of the local anesthetic (lidocaine) or their excipients; 13. pregnancy or lactation status or intention to become pregnant during the period of study participation. in particular, in the case of a suspected pregnancy , this will be excluded by serological testing (hcg).

Keywords: medial plica syndrome medial plica knee pilot study triamcinolone acetonide injection treatment
high intensity focused ultrasound ablation virus myomectomy to treat uterine fibroids

Conditions: Uterine Fibroid

Summary: the purpose of this study is to determine whether hifu has superiority over traditional surgery on satisfaction and adverse impact.

uterine fibroids (leiomyomas) are common in reproductive aged women. patients are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. high intensity focused ultrasound therapy (hifu) is a novel non-invasive method for uterine fibroid. preliminary clinical studies proved hifu ablation is a safe and effective technology. however, it is not clear whether hifu has superiority over traditional surgery on satisfaction and adverse impact.the study is to confirm these questions.

Eligibility criteria:
inclusion criteria: * age 18 to 45; the size of fibroid situated at anterior wall not lower than 2 cm in mri feature; the size of fibroid situated at posterior wall not lower than 4 cm in mri feature. exclusion criteria: * cervical fibroids; subserosal fibroids with pedicle, the width of pedicle≤ 2cm; type 0 submucosal fibroids according to european gynecologic endoscopy classification; combined with acute reproductive inflammation, or other benign and malignant gynecological diseases such as endometriosis, ovarian cancer; pregnant (pregnancy test is positive), and lactating women; allergy to mri contrast agent; the history of collagen connective tissue, radiotherapy, especially abdominal radiotherapy; surgical and anesthetic contraindications such as serious cardiac, vascular and other systemic diseases; poor compliance; patients who are not subject to experimental design.

Keywords: uterine fibroids myoectomy high intensity focused ultrasound ablation
effect of a meal replacement on weight loss obesity patients with metabolic syndrome

Conditions: Abdominal Obesity-Metabolic Syndrome

Summary: the purpose of this study is to determine whether meal replacement, slimwell ®, is effective in the treatment of obesity patients with metabolic syndrome.

the participants are divided into two groups: intervention group and control group. in the intervention group, the participants receive a meal replacement plus life style modification. in the control group, the participants receive only life style modification. sample size calculation is 69 participants per group. primary outcome is to compare the weight loss between the intervention group and control group.

Eligibility criteria:
inclusion criteria: * body mass index more than or equal to 25 kg/m2 * patients with metabolic syndrome * patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs. exclusion criteria: * uncontrolled diabetes patients * patients with gastrointestinal abnormalities * patients with cardiovascular diseases * patients with hematologic disorders * patients with glomerular filtration rate less than 60 ml/min/1.73m2 * patients with drug or alcohol abuse * pregnancy and lactation
an open label, double-blind discontinuation study of quetiapine extended release(xr)

Conditions: Social Anxiety Disorder

Summary: purpose of study: to examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) xr for the treatment of social anxiety disorder (sad); and 2) continuation effects of quetiapine xr in preventing sad relapse.


Eligibility criteria:
inclusion criteria: * adults 18-65 years of age * a primary diagnosis of sad,using diagnostic standard manual iv(dsm-iv) criteria * minimum cgi severity score of 4 and minimum brief social phobia scale (bsps) score of 20 at baseline * written informed consent * a negative serum pregnancy test for women of childbearing potential. exclusion criteria: * current dsm-iv diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition * any current primary anxiety disorder other than sad or current primary depression * history of substance abuse or dependence within the last 6 months * suicide risk or serious suicide attempt within the last year * clinically significant medical condition or laboratory abnormality * women of childbearing potential who are unwilling to practice an acceptable method of contraception * subjects needing concurrent use of psychotropic medications * history of hypersensitivity to quetiapine * history of cataracts.

Keywords: social anxiety disorder quetiapine xr prevention tolerability
vaginal misoprostol for cervical ripening prior to endometrial biopsy

Conditions: Menorrhagia; Endometrial Biopsy; Cervical Ripening

Summary: the purpose of this study is to determine whether using misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure. the investigators' hypothesis is that vaginal misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.

endometrial biopsy is a common gynecological office procedure performed to assist in the pathological diagnosis of abnormal vaginal bleeding. the procedure can be painful and it may be difficult to obtain an endometrial sample with a hard and closed cervix. giving misoprostol before the procedure may soften the cervix sufficiently to allow an easier and more successful test. this medication has been tested before hysteroscopy and in some patients it has been shown to be beneficial. 104 patients need to be recruited for this study. participants will be divided according to pre-menopausal and post-menopausal status. each of these groups will then be divided into a treatment arm (with misoprostol) and a placebo arm. participants will place a vaginal suppository containing either misoprostol 400 ug or a placebo 12h or more before their appointment for the endometrial biopsy.

Eligibility criteria:
inclusion criteria: * patients with abnormal uterine bleeding * age over 35 years exclusion criteria: * pregnancy * allergy to or contraindication to prostaglandin use * active genital tract infections * bleeding disorders

Keywords: vaginal misoprostol cervical ripening endometrial biopsy
a study to investigate the immunogenicity of mrna covid-19 variant-containing vaccine formulations in adults to prevent covid-19

Conditions: SARS-CoV-2

Summary: the purpose of this study is to investigate the immunogenicity of mrna covid-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in previously vaccinated adults.


Eligibility criteria:
inclusion criteria: * participants had previous mrna covid-19 vaccination. * able to comply with study procedures based on the assessment of the investigator. * female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: * has a negative pregnancy test at the screening visit and on the day of vaccination prior to vaccine dose being administered on day 1. * has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose. * has agreed to continue adequate contraception through 28 days following vaccine administration. exclusion criteria: * history of sars-cov-2 infection within 3 months prior to enrollment. * is acutely ill or febrile (temperature 38.0°celsius/100.4°fahrenheit) less than 72 hours prior to or at the screening visit or day 1. participants meeting this criterion may be rescheduled within the screening window. * history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable, or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * history of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mrna vaccine or therapeutic or any components of an mrna vaccine or therapeutic. * receipt of covid-19 vaccine within 3 months prior to enrollment. * receipt of any licensed non-covid-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention. * receipt of systemic immunosuppressants or immune-modifying drugs for \>14 days total, within 6 months prior to screening or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * receipt of systemic immunoglobulins or blood products within 3 months prior to the screening visit or plans for receipt during the study. * has donated ≥450 milliliters of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.

Keywords: mrna-1273 mrna-1273 vaccine sars-cov-2 sars-cov-2 vaccine coronavirus virus diseases messenger rna covid-19 covid-19 vaccine variant moderna
autologous rectus sheath fascia versus midurethral transobturator tension free vaginal

Conditions: Stress Urinary Incontinence

Summary: a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(tvt-o)

a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (tvt-o) conventional mid urethral sling

Eligibility criteria:
inclusion criteria: * stress urinary incontinence exclusion criteria: * previous surgery for stress incontinence

Keywords: female stress incontinence transobturator tension free vaginal tape tvto