Kornimate/medical-research-clean huggingface dataset:
post-traumatic brain injury (post-tbi) fatigue and its treatment

Conditions: Fatigue

Summary: randomized clinical trial of modafinil vs. placebo for treatment of fatigue after tbi.

purpose: the purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post tbi. background: after tbi, fatigue is one of the most common complaints, as documented in our work and that of many other researchers. people with tbi experience fatigue that seems to them out of proportion to whatever work they are doing or effort they are making. fatigue after tbi is associated with decreased participation in normal activities in the community and has been linked to depression. need for research: research on use of drugs to treat post-tbi fatigue is inadequate. while studies of fatigue in people with other chronic conditions suggest that modafinil helps relieve fatigue and has fewer side effects than some other drugs used in treating fatigue, the use of modafinil has not yet been tested in people with tbi. current and future research activity: more than 100 men and women volunteers who complain of post-tbi fatigue will be randomly assigned to a 4-week period of taking modafinil or a placebo. at the beginning and end of the study, the severity of their fatigue and associated symptoms (e.g., cognitive function, mood, pain, daytime sleepiness, sleep quality, health status) will be assessed, as well as their participation in activities and perceived quality of life. it is hypothesized that modafinil will reduce the symptoms of fatigue and will increase level of activity and perceived quality of life to a significantly greater extent than will the placebo.

Eligibility criteria:
inclusion criteria: - individuals who sustained a tbi with a documented loss of consciousness or evidence of a tbi on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the barroso fatigue scale will be eligible to participate in this study. subjects must not meet criteria for alcohol or substance abuse using the structured clinical interview for dsm-iv (scid) for at least six months prior to study enrollment. exclusion criteria: - diagnosis of chronic neurological disease (including lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm hg, or clinically significant major systemic disease. in addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.

Keywords: fatigue tbi brain injury modafinil traumatic brain injury
aquamid reconstruction for osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: osteoarthritis (oa) causes degradation and deformities of joints, including knees, hips, hands, and feet. approximately more than 55% of populations above 45 years and more than 70% of population above 70 years will develop oa in at least one joint. the symptoms are dominated by pain but also stiffness and swelling occur. there is currently no cure for oa, and the ultimate treatment is joint replacement surgery. however, there is an unmet need to identify other treatment options that may delay or avoid surgery. aquamid reconstruction (ar) is a polyacrylamide hydrogel (paag) which is a non-degradable, highly visco-elastic synthetic gel, which is atoxic with durable effect and tissue-compatibility and well tolerated by mammal tissue by allowing in vivo vessel and fibrous in-growth. experimental studies supported by histopathological observations have shown that ar exerts its effect via integration over time within the soft tissues, through a combination of vessel in-growth and molecular water exchange. intra-articular injection of ar is expected to provide permanent pain relief and improve the functional ability through a cushioning or padding effect on the joint and thereby reduce symptoms and improve patients' quality of life. the purpose of this study is to obtain information of the safety and effectiveness of ar in patients with oa of the knee.


Eligibility criteria:
inclusion criteria: * age \> 18 years * womac pain score \>/= 5 * kellgren and lawrence radiographic scoring \>/= 1 * signed informed consent form exclusion criteria: * other diseases affecting the joints such as rheumatoid arthritis * actual or recurrent infections requiring intravenous antibiotic treatment within the last 30 days or oral antibiotic treatment within the last 14 days before inclusion * less than 12 weeks since injection of ha or corticosteroids in study-knee joint before treatment * pregnancy or lactation * not able to comply with the requirements of the study * previous alloplasty
abraxane in patients with visceral metastases dominant metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: abraxane in patients with visceral metastases dominant metastatic breast cancer

a prospective, single-center, open-label, phase ii study of abraxane in patients with visceral metastases dominant metastatic breast cancer

Eligibility criteria:
inclusion criteria: 1. histologically confirmed metastatic breast cancer; 2. radiologically or histologically confirmed visceral dominant metastases; 3. patients who are expected to acquire benefit from chemotherapy: er and/or pr positive patients who developed resistance after prior endocrine therapy; her2+ patients who experienced disease progression on prior target therapy and are not suitable for subsequent target therapy; mtnbc patients who relapsed after platinum therapy; 4. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1); 5. patients who received paclitaxol in metastatic setting should be proven effective to prior paclitaxol based regimen and disease progressed after at least 3 months from the last administration of paclitaxol; those who received paclitaxel as neoadjuvant/adjuvant therapy can be enrolled if disease relapsed after at least 6 months from the completion of neoadjuvant/adjuvant chemotherapy. patients who received docetaxol have no limitation for enrollment; 6. eastern cooperative oncology group performance (ecog) status of 0-1; 7. all patients enrolled are required to have adequate hematologic, hepatic, and renal function; 8. life expectancy longer than 12 weeks; 9. no medical history of serious cardiovascular, hepatic, respiratory or renal diseases; 10. informed consent; 11. patients with good compliance. exclusion criteria: 1. pregnant, lactating women or women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study; 2. patients who are expected to acquire benefit from endocrine or target therapy; 3. radiotherapy of axial bones within 4 weeks before enrollment or lack of recovery from prior radiotherapy; 4. treatment with other experimental drug within 4 weeks before enrollment; 5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to enrollment; 6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia; 7. patients with a history of symptomatic cardiovascular, hepatic, respiratory, renal , hematological, endocrinal, neurological or psychiatric diseases; 8. uncontrolled serious infection.
does echocardiographically guided ventriculo-ventricular optimization yield a sustained improvement in echocardiographic parameters in cardiac resynchronization therapy patients? (devise crt)

Conditions: Cardiomyopathy; Heart Failure

Summary: the purpose of this study is to determine whether using an echocardiogram (a painless test where ultrasound is used to see your heart) while using mild electrical stimulation from your own crt-d device to stimulate the ventricles (the lower chambers of the heart) to squeeze one slightly earlier than the other will show a sustained increase your heart's productivity (cardiac output (co)), following implantation of a cardiac resynchronization device (crt-d). we believe that squeezing some parts of the heart earlier than others may make the heart a stronger pump.


Eligibility criteria:
inclusion criteria: 1. lvef \</= 35% as assessed by echocardiography. 2. new york heart association functional class iii or iv chf despite contemporary medical therapy for chf. 3. qrs duration of \>/= 120 ms. 4. ability to provide written, informed consent. 5. age \> 18 years. 6. successful implant of a biventricular/icd pacemaker device. exclusion criteria: 1. documented chronic atrial fibrillation 2. life expectancy less that 6 months due to non-cardiac causes 3. inability to place a coronary sinus left ventricular pacing lead 4. pregnancy 5. scheduled cardiac surgery within the next 6 months 6. prosthetic tricuspid valve
correlation of physical exam versus non-invasive assessment versus invasive assessment of central venous pressure

Conditions: Central Venous Pressure

Summary: the purpose of this study is to establish the accuracy of a non-invasive device that uses near infrared spectroscopy (nirs) to estimate central venous pressure (cvp) comparing it to physical exam and invasive hemodynamic measurement via right heart catheterization (rhc).

estimation of volume status is crucial when making treatment decisions for heart failure patients. volume status is often assessed clinically by estimating the cvp, which is an estimate of right atrial filling pressure, by assessing the level of jugular venous distention. this method is quick and non-invasive but can be prone erroneous measurement due to human error and limitations secondary to body habitus and anatomical variation. rhc is a procedure used for invasive hemodynamic measurement commonly used in heart failure patients. cvp can be measured directly via rhc using a pulmonary artery catheter. it is considered the gold standard for measuring intra-cardiac filling pressures and calculation of cardiac output and pulmonary and systemic vascular resistance. the obvious downside of rhc is that is invasive, time consuming, and has many potential serious risks including vascular complication, pneumothorax, infection, arrhythmia, valvular damage, etc. a non-invasive, quick, and accurate way to estimate central venous pressure and oximetry could benefit patient care. nirs is an optical imaging technology that has been proposed to estimate central venous pressure non-invasively. our intent is to determine the accuracy of nirs in assessment of cvp using the mespere venus device.

Eligibility criteria:
inclusion criteria: * age 18 and older * heart failure patients already receiving rhc as part of their usual care * signed written and informed consent exclusion criteria: * lack of patient consent * presence of known anatomical shunt or av dialysis fistula * sepsis, fever * anemia (hgb \< 10) * allergy to adhesive tape * known central vein stenosis * previous cardiac transplant * unable to identify external jugular vein * ongoing photodynamic therapy * pregnancy

Keywords: central venous pressure right heart catheter (rhc) non-invasive monitor physical exam of jugular venous pressure heart failure (hf)
remote bp monitoring in the pp period

Conditions: Hypertensive Disorder of Pregnancy

Summary: the purpose of this study is to trial remote patient monitoring (rpm) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. the investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an rpm trial to those who are being treated with the usual care.

many women develop high blood pressure as a complication of pregnancy. this high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. if untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. using a bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.

Eligibility criteria:
inclusion criteria: * postpartum women * previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart) * at least 18 years of age * english or spanish speakers exclusion criteria: * non-english or spanish speakers * women who are not planning on obtaining their postpartum follow up at cuimc * women who are physically unable to hold or use the tablet * women who do not have a working phone * provider unwilling or unable to set up escalation pathway * women who reside outside of new york state * hypertension diagnosed postpartum

Keywords: hypertensive disorders of pregnancy preeclampsia gestational hypertension hellp
efficacy and safety of relacorilant in patients with cortisol-secreting adrenal adenomas

Conditions: Hypercortisolism

Summary: this is a phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance and/or uncontrolled systolic hypertension.

this phase 3 study patients will be randomized in a 1:1 ratio to treatment with relacorilant (active drug) or placebo. patients will receive relacorilant or placebo for 22 weeks. patients who complete the study may also be eligible to roll over into an extension study.

Eligibility criteria:
inclusion criteria: * shows lack of cortisol suppression * suppressed or low early-morning acth levels * a radiologically confirmed adrenal lesion * has igt or dm * has uncontrolled hypertension exclusion criteria: * has severe, uncontrolled hypertension * has poorly controlled dm * has dm type 1 * has significantly abnormal liver test results or severe renal insufficiency * has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Keywords: cushing syndrome cushing hypercortisolemia type 2 diabetes impaired glucose intolerance hypertension adrenocorticotropic hormone primary pigmented nodular adrenal disease macronodular adrenal hyperplasia adrenal adenoma adrenal autonomy cortisol autonomous cortisol secretion
efficacy and safety of combinations of al-335, odalasvir (odv) and simeprevir (smv) in the treatment of chronic hepatitis c infection

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the efficacy (proportion of subjects with svr12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of al-335, odalasvir (odv) and simeprevir (smv) in chronic hcv genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.

this is a phase 2b multicenter study. the study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. the total study duration for each subject will be 36 to 38 weeks. this study investigates a 3 direct-acting antiviral agent (daa) combination of al-335 (hcv ns5b inhibitor), odalasvir (odv) (a second generation hcv ns5a inhibitor) and simeprevir (smv) (hcv ns3a4 protease inhibitor). the results of this study will enable the selection of treatment and duration to be further developed.

Eligibility criteria:
inclusion criteria: * individuals with chronic hepatitis c virus (hcv) genotype 1, 2, 4, 5 or 6 infection * documented as treatment naive or experienced with a prior regimen consisting of interferon (ifn) +/-ribavirin (rbv) regimen without achieving sustained viral response * absence of cirrhosis * screening laboratory values within defined thresholds * must use specific contraceptive methods if female of childbearing potential or sexually active male exclusion criteria: * co-infection with human immunodeficiency virus (hiv) or hepatitis b virus (hbv) * prior exposure to an hcv direct-acting antiviral agent (daa), either in combination with pegylated interferon (pegifn) or ifn-free * current or prior history of clinical hepatic decompensation * history of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol * pregnant or a nursing female

Keywords: hepatitis c, chronic al-335 odalasvir simeprevir odv smv ach-3102 ach-0143102 tmc435
analgesic value of adductor canal vs femoral block after total knee arthroplasty

Conditions: Osteo Arthritis Knee

Summary: an observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.

subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the nrs-11 pain scale in the recovery room. once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective total knee arthroplasty * asa physical status i-iii * bmi 18-40 kg/m2 exclusion criteria: * inability to cooperate with protocol * inability to understand or speak english * allergy to any local anesthetic * chronic opioid consumption/abuse (30 or more morphine mg equivalents/day) * contraindication to adductor canal or femoral nerve block

Keywords: femoral nerve block adductor canal block analgesia
efficacy of antimicrobial prophylaxis for shock wave lithotripsy (swl) on reducing urinary tract infection (uti)

Conditions: Urolithiasis

Summary: the purpose of this research study is to test whether administering one dose of an antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary infections compared to not taking an antibiotic. this is an important topic to study because urinary tract infections are one of the most common complications after this procedure and there is no clear standard of care regarding the use of pre-procedure antibiotics. our study results will benefit future patients either by decreasing the rate of infections or decreasing the use of unnecessary antibiotics.


Eligibility criteria:
inclusion criteria: * scheduled for swl at st. joseph's hospital; * 18 years of age or older; * willing and able to complete questionnaires; * willing to submit urine sample for analysis at day 7; * able to read and speak english. exclusion criteria: * pre-swl urine analysis positive for nitrites or urine culture reveals \>105 cfu/ml of bacteria (positive urine culture); * taking antibiotics for uti or other cause; * requires an antibiotic post swl; * suspected struvite stone (based on previous stone analysis, or partial staghorn); * presence of nephrostomy tube; * requiring cystoscopy on the day of swl; * requiring ureteral stent on the day of swl; * presence of indwelling urinary catheter or on regular clean intermittent catheterization (cic); * presence of urinary diversion (ie: ileal conduit); * any history of urosepsis; * known allergic reaction to ciprofloxacin/quinolones; * patient known to be pregnant; * previous randomization in this trial; * in the opinion of the urologist, it is not in the patient's best interest to participate.

Keywords: antibiotics shock wave lithotripsy urinary tract infection
single-incision laparoscopic cholecystectomy with inflexible laparoscopic instruments and laparoscopy: a single-center experience

Conditions: Benign Gallbladder Disease

Summary: since being introduced by mühe in 1985, laparoscopic cholecystectomy (lc) has garnered global acceptance and defined as gold standard treatment for benign gallbladder diseases (bgds). minimally invasive surgery technique was applied in a spectrum of surgeries including lc, namely single-incision laparoscopic cholecystectomy (silc), initially reported by navarra in 1997. by then this technique developed dramatically in aspects of both operation and instruments. previous experiences with silc across various centers have consistently demonstrated its robust safety and feasibility. numerous clinical trials have highlighted the benefits of silc over conventional laparoscopic cholecystectomy (clc), particularly in terms of promoted aesthetic outcomes, reduced postoperative pain, and shorter hospital stays.however, discrepancies in postoperative complications including incisional hernias have sparked debate regarding the merits and drawbacks of silc. consequently, further research is urgent with larger cohorts and extended postoperative follow-up periods for a definitive assessment of silc. in the present study lc was performed in cases from january 2023 to march 2024, aiming to compare the overall outcomes and complications between clc and silc. all surgical instruments and laparoscopy were introduced through a single intraumbilical incision in silc group, allowing the resultant scar to be discreetly concealed within the reconstructed navel. furthermore, historical implementations of silc have predominantly utilized specialized and novel instruments. this reliance on special equipment limited the technique's applicability and benefits in settings with more rudimentary clinical facilities. the authors successfully applied conventional laparoscopic instruments and a 10mm laparoscopy with straight and inflexible properties and simplified the surgical process. moreover, the single-incision port used were made on site from basic stuffs and materials easily obtained from operation room.


Eligibility criteria:
inclusion criteria: * gallbladder stone； * acute cholecystitis； * chronic cholecystitis； * gallbladder adenomyomatosis； * gallbladder polyp. exclusion criteria: * combined with liver cirrhosis (child grade b and above)； * gallbladder gangrene perforation; * changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.); * patients and their families do not agree with the treatment lost follow-up.

Keywords: single-incision laparoscopic laparoscopic cholecystectomy cholecystolithiasis