Kornimate/medical-research-clean huggingface dataset:
pecs ii block and single port robot-assisted transaxillary thyroidectomy

Conditions: Thyroid Cancer

Summary: the da vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). although the system has many advantages, skin incision, wide flap dissection, and pneumatic/mechanical retraction remain essential, but cause postoperative pain and slower recovery. previous studies found that pectoralis fascial blocks were easy to establish; local anesthetics are injected between two adjacent myofascial layers under ultrasound guidance, providing the surgeon with a clear image. analgesic efficacy has been validated during robotic thyroidectomy in our institution. the pain outcomes were comparable between the groups, but there were fewer complications in the pecs ii group. the investigators investigated whether this block can reduce postoperative pain during wide flap dissection for single-port robot-assisted transaxillary thyroidectomy.


Eligibility criteria:
inclusion criteria: * patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy) * patients with cancer stages t1 or t2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination * patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination * patients with a bmi greater than or equal to 18.5 and less than 30.0. exclusion criteria: * patients requiring lateral cervical lymph node dissection * pregnant women * uncontrolled diabetes * chronic kidney failure * patients with previous neck surgery * patients with graves' disease * people with chronic alcoholism * patients with vocal cord paralysis before surgery * severe obese patients with a body mass index \>35 kg/m2 * patients participating in another clinical trial within 30 days * patients who expect that it will be difficult for medical staff to fill out the questionnaire on their own * patients whose medical staff determines that participation in the study is difficult due to other underlying diseases
study to assess oct: rnfl and gcl in ms patients

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to collect preliminary data on retinal nerve fiber layer and ganglion cell layer damage in multiple sclerosis (ms) patients, using optical coherence tomography (oct). for this study the zeiss cirrus oct imaging system will be used. the same system will be used consistently for the duration of the study.

hypothesis: multiple sclerosis results in axonal degeneration which can be assessed objectively and non-invasively by serial oct measurements of the rnfl and gcl. this will be a prospective cross-sectional, non-interventional study; total recruitment will be 200 subjects. recruitment will be stratified to enroll at least 50 subjects currently taking lemtrada and 50 subjects with a documented diagnosis of on. the study will enroll subjects primarily from practices in the tampa bay area and adjacent counties. it is a planned non-interventional study; subjects will be followed by their neurologist and the study ophthalmologist and will receive standard of care. all subjects will have the ophthalmological examination and diagnostic measures, by the principal investigator, dr. grace levy-clarke, at tampa bay uveitis center. study duration: the study duration will be 24 months, with an interim analysis at 50% recruitment status. there are two primary aims of this longitudinal observational study: 1. to determine whether atrophy within specific retinal layers over time is associated with clinical neurological progression of ms 2. to determine whether an on history affects the relationship described in aim # 1 eye exam: subject will have an eye exam, including: visual acuity testing color vision testing automated perimetry/peripheral vision testing completing the national eye institute visual functioning questionnaire (nei/vfq) slit lamp examination measurement of intraocular pressure (iop) dilated fundus examination (ophthalmoscopy) fundus photography optical coherence tomography: rnfl and macular oct neurologic assessments: must be performed no more than 60 days prior to screening/assessment day 0 ophthalmic assessments

Eligibility criteria:
inclusion criteria: * age 18 or older * pregnant women will be excluded by self declaration * male or female * a diagnosis of ms, that meets the 2010 revised mcdonald diagnostic criteria * a visual acuity of 20/400 or better in at least one eye exclusion criteria: * any ocular disease than prevents assessment of the optic nerve and macula by oct * advance glaucoma with optic nerve damage * any optic neuropathy not diagnosed as on associated with ms * a diagnosis of macular degeneration * any previous ocular trauma * any medical history of a cerebrovascular accident * any planned ocular or systemic elective surgery during study duration * any contraindication to a comprehensive dilated ophthalmic examination * inability to give informed consent

Keywords: optical coherence tomography
a humanized anti-interferon-γ monoclonal antibody (huzaf) for moderate to severe crohn's disease

Conditions: Crohn's Disease; Colitis; Intestinal Disease; Gastrointestinal Disease; Digestive System Disease

Summary: the purpose of the harmony study is to assess the safety and efficacy of an investigational drug called huzaf, in patients with moderate to severe crohn's disease (cd). huzaf is a humanized anti-interferon-gamma (anti-ifn-γ) monoclonal antibody, which binds and blocks ifn-γ, a protein in the immune system that is involved in inflammation. antibodies are proteins normally produced by our immune system to help fight off foreign substances. scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.

participants will be randomized, assigned by chance, to one of five treatment groups consisting of: four groups differing in the amount of study drug given and one placebo group. the initial dose of study drug will be given intravenously, injected into a vein in the arm. four weeks later, three subsequent doses of study drug will be given subcutaneously, through the skin, every four weeks for three doses. patients will be followed for approximately six months after receiving their final dose.

Eligibility criteria:
* patients 18-70 years old * patients with moderate to severe crohn's disease * patients who have had crohn's disease for at least 6 months * patients who have previously been treated for crohn's disease

Keywords: crohn's disease colitis monoclonal antibody therapy anti-interferon gamma
designing team clinic for youth with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the goal of this clinical trial is to learn about if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. the main question\[s\] it aims to answer are: * design four group activities centered around nutrition therapy, peer interactions, exercise and stress management. * design the clinical workflow for implementation phase. participants will attend quarterly clinic appointments and group activities and take surveys. researchers will compare this intervention to standard of care.


Eligibility criteria:
aya advisory council inclusion criteria * age 12 to 18 at time of study enrollment * receives care for type 2 diabetes * willingness to attend all meetings * english-speaking exclusion criteria • non-verbal or unable to participate in group activities and discussions caregiver advisory council inclusion criteria * age 18 or above * caregiver of aya with type 2 diabetes * willingness to attend all meetings * english- or spanish-speaking exclusion criteria * non-verbal or unable to participate in group activities and discussions stakeholder advisory board inclusion criteria * age 18 or above * on staff at chla or ucsf * clinical or administrative member of the diabetes clinic * willingness to participate in monthly meetings. if unable to attend, willingness to review meeting minutes. exclusion criteria • none curriculum reviewers inclusion criteria * age 18 or above * cdcess, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic * clinical members of the diabetes clinic exclusion criteria • member of the stakeholder advisory board

Keywords: youth onset type 2 diabetes shared medical appointments group appointments pediatric type 2 diabetes
an open-label extension to assess the continued efficacy of omacor plus simvastatin

Conditions: Dyslipidemias

Summary: the primary objective of this trial is to assess the continued efficacy of omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-hcl-c) levels.

the present trial is an open-label, uncontrolled extension to the previous trial (prv-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits. the current trial consists of nine clinic visits over 104 weeks. there will be two treatment periods in this study: * phase i: all subjects will receive simvastatin 80 md/d plus omacor 4 g/d for the first six weeks of the trial. * phase ii: all subjects will receive simvastatin (at a dose to be determined at the discretion of the investigator) plus omacor 4 g/d for the remainder of the treatment period.

Eligibility criteria:
inclusion criteria: * must have met all relevant inclusion/exclusion criteria prior to and throughout the previous double-blind study (prv-06009) * must have completed the previous double-blind study to week 12. * provide written informed consent and authorization for protected health information exclusion criteria: * study drug compliance less than 50% in prv-06009 * any ongoing serious adverse event from prv-06009

Keywords: cholesterol dyslipidemia omega 3
telehealth cbt for adolescents and young adults with childhood-onset systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this study aims to investigate the feasibility and effectiveness of a remotely delivered psychological intervention for youth with csle. this intervention aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.

this project is investigating whether a remotely delivered psychological intervention is acceptable and beneficial to teens and young adults coping with csle. this study uses a cognitive behavioral therapy (cbt) intervention called the treatment and education approach for childhood-onset lupus (teach) to address symptoms of fatigue, depression, and pain that commonly occur in individuals with csle. the teach program includes six-weekly, one hour sessions, conducted over hipaa-compliant video conferencing. participation in this study will take approximately 8-15 weeks, with a follow-up survey occurring 3-months after post-assessment, and a long-term follow-up survey occurring between 12-27 months after post-assessment. after qualifying for the study, participants will be randomly selected, like flipping a coin, to the teach program plus medical treatment as usual (tau) or medical tau alone for six weeks. after this six-week time period, a post-assessment will be completed. participants that only continued medical tau will then be eligible to receive teach after completing the post-assessment. if these participants choose to undergo the teach treatment, they will be asked to complete a short interview about the program and answer questions about how their mood, pain, and fatigue.

Eligibility criteria:
inclusion criteria: * participants must be diagnosed with csle, meeting the revised american college of rheumatology classification criteria for sle by age 18 years * participants must have at least one elevation (based off of screening measures) in fatigue, or depressive symptoms, or pain * patient participants must have english language proficiency * for participants under age 18, must have a primary caregiver willing to participate. exclusion criteria: * patients with other chronic medical conditions (e.g., juvenile arthritis), * patients with a documented developmental delay, severe cognitive impairment, or thought disorder * patients with an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression, or active suicidal ideation) * patients currently receiving psychological treatment for depression, fatigue or pain will be excluded to prevent overlapping treatments that may confound outcomes.

Keywords: lupus depression depressive symptoms fatigue pain sle rheumatic disease rheumatology telehealth cbt
the effect of vitamin d3 therapy in post menopausal women and assessment of changes in bone mineral density after orally vitamin d3 administration

Conditions: Vitamin D Deficiency

Summary: a study design based on vitamin d deficiency in postmenopausal women with low bone density. pre-test for bmd will be done then vitamin d oral supplements will be provided for the period of 3 months. post-test of bmd will explore the results.

sample description study design randomized control trial. settings opd patients duration 8 months sample size 200 masking single blind (only participants) study subjects routine visit opd patients with orthopedic problems sampling techniques rct will be done by giving vitamin d (pre-test and post-test of bmd will be done . inclusion criteria female patients above 50 years (post-menopausal) exclusion criteria all other women study variables : independent: vitamin d data collection will be done through randomized control trial. patient with age above 50 years female, with menopausal changes. the bmd test will be done in all participants either placebo or actual treated patients to check the effect of vitamin d3 therapy. treatment plan includes vitamin d3 at 50,000 international units daily for 15 days then two times a month for four months along with dietary changes which will consider high dose d3 therapy, and low dose vitamin d3 therapy includes dietary changes along with 1000 international units of vitamin d3 tablet form. daily white placebo pills to other group of participants. bone mineral density will be observed through pre-test and post-test.

Eligibility criteria:
inclusion criteria: * postmenopausal women exclusion criteria: * all other women

Keywords: postmenopausal women, low bone density
intervention, prognosis and mechanism of covid-19 infection in patients with underlying diseases

Conditions: Chronic Liver Disease; Malignant Tumor; Autoimmune Diseases; Healthy

Summary: the goal of this observational study is to explore the influence of covid-19 infection and risk factors of severe outcomes in vulnerable population including patients with chronic liver disease, malignant tumor, autoimmune disease, medical staff. the main questions it aims to answer are: 1. the clinical characteristics of vulnerable population after covid-19 infection. 2. risk factors for severe illness in vulnerable groups after infection with the covid-19. 3. the impact of covid-19 infection on the progression of underlying diseases. information of participants will be collected such as gender, age, underlying diseases, medication status, vaccination status, clinical and biochemical indicators. researchers will compare the mild and severe outcomes after covid-19 infection to identify the "truly vulnerable" population and explore the potential mechanism and intervention for these population.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form before enrollment, and be able to complete the research according to the requirements of the research protocol. 2. enrolled patients need to have basic diseases, including chronic liver disease, chronic kidney disease, chronic lung disease, solid tumors, aids, rheumatic immune diseases, diabetes, etc. 3. when entering the group, patients with new crowns need to be confirmed by evidence of a positive test for new coronavirus nucleic acid (ct value \<35) or a positive test for new coronavirus antigen. exclusion criteria: 1. participate in clinical trials of other investigational drugs or medical devices within 3 months before screening, and take experimental drugs or use medical devices. 2. positive pregnancy test during lactation or screening period. 3. subjects who, in the investigator's opinion, have other factors that are not suitable for participating in this study.
multi center study to obtain bladder tissue specimens from patients undergoing transurethral resection biopsy procedure

Conditions: Bladder Disease

Summary: the objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at tengion, inc.


Eligibility criteria:
inclusion criteria: * subjects 18-90 years and undergoing turbt * willing and able to give signed informed consent exclusion criteria: * known active infection * known colonization with mrsa or vre * receipt of blood or blood products for transfusion during the previous 3 months

Keywords: transurethral resection of bladder tumor turbt
study to find the highest safe dose of soluble guanylate cyclase (sgc) activator, bay 1211163 administered as multiple doses by inhalation to patients who cannot breathe by their own and suffer from a type of lung failure that causes fluid to build up in the lungs making breathing difficult (ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: with this study researchers want to find the highest safe dose of the soluble guanylate cyclase (sgc) activator, bay 1211163 and how safe and well the study drug works. furthermore researchers want to gather information on the way the body absorbs, distributes and gets rid of the study drug given as increasing multiple doses by inhalation to patients who cannot breathe by their own and suffer from a type of lung failure that causes fluid to build up in the lungs making breathing difficult (ards)


Eligibility criteria:
inclusion criteria: * intubated, mechanically ventilated moderate or severe ards patients \[diagnosed according to berlin definition of ards, including peep ≥ 5 cmh2o, x-ray, with pao2/fio2 between 80 and 200 mmhg (inclusive). * initial diagnosis of ards prior to study inclusion, confirmation of ongoing moderate or severe ards with pao2/fio2 between 80 and 200 mmhg (inclusive) during this time under maintained invasive mechanical ventilation. * hypoxemia with pao2/fio2 between 80 and 200 mmhg (inclusive) maintained for at least 8 hours (recommend to be 12 hours) after screening, despite consent to follow recommendation on ventilator strategy and peep management. * time from intubation must be ≤ 96h. * male and non-pregnant female. * informed consent of capable patient or, in case of patient being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations. exclusion criteria: * pao2/fio2 \> 200 mmhg or \< 80 mmhg at time of evaluation for inclusion. * moribund participants not expected to survive 24 hours (clinical decision). * expected duration of invasive mechanical ventilation less than 96 hours (clinical decision). * history of pneumectomy or lung transplant. * current lung malignancy (including lung metastasis), or other malignancy requiring chemotherapy or radiation within the last month. * history of chronic kidney disease and requiring renal replacement therapy dialysis at screening and/or baseline. * chronic liver disease child-pugh class b and c. * hypoalbuminemia - serum albumin \< 2.0 g/dl. * acute left ventricular failure and/or left ventricular ejection fraction \< 30 %. * severe bronchopulmonal fistula. * clinical suspicion of pulmonary veno-occlusive disease. * heart right-sided endocarditis, tumors or mass. * rescue procedures already initiated at screening and/or day 1. * use of co-medications involving moderate and strong inhibitors for cyp2c8 liver enzymes one week before assignment to intervention or during intervention. * off-label use of medication to treat coronavirus sars-cov-2 virus unless recommended by scientific guidelines and accepted by dmc, investigator and sponsor. * plan to participate or past participation (within 30 days prior to study day 1) in other interventional studies.
effect of progesterone on latent phase prolongation in patients with preterm premature rupture of membranes

Conditions: Preterm Premature Rupture of Membrane

Summary: the aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17p) therapy on the latency period in pregnant women with preterm premature rupture of membranes.

after taking informed written consent, the recruited patients will be subjected to the following: 1. detailed history * personal history: name, age ,residence ,special habits of medical importance * obstetric history: first day of last menstrual period for accurate estimation of gestational age and antenatal care * past history: history of any medical disorder or surgical history with particular emphasis on prior pprom or preterm labor * history of the present pregnancy: medical or surgical condition to define high risk pregnancy. 2. examination of the patients general examination: blood pressure, pulse, temperature abdominal examination: * inspection: fundal level, scars, umbilicus. * palpation: presence of contractions, fetal lie and presentation. * pelvic examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement * non stress test to ensure reassuring fetal well being * ultrasound examination to:- * assess fetal viability. * amniotic fluid index. * determine gestational age. * exclude major anomalies. * placental location. 3. baseline laboratory investigations: * complete blood count (cbc). * prothrombin time (pt). * activated partial thromboplastin time (aptt). * liver and kidney function. the included patients were randomized using sealed opaque envelope method into one of two groups: group i (study group): in which 17-hydroxyprogesterone caproate (17p) (250 mg in castor oil, 1 ml total volume, intramuscular injection weekly) will be administered. group ii (control group): in which an identical-appearing placebo (1 ml castor oil only) will be administered.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age between 24 and 34 weeks exclusion criteria: * medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage and infection, such as * emergency cesarean section. * chorioamnionitis. * placenta previa. * multiple gestation. * preeclampsia. * macrosomia. * non reassuring fetal status or fetal distress * presence of fetal anomalies incompatable with life * woman with antepartum haemorrhage * diagnosis of established preterm labor