Kornimate/medical-research-clean huggingface dataset:
determining the feasibility of spinal cord neuromodulation for the treatment of chronic heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to determine the feasibility of spinal cord stimulation (scs) as a chronic therapy for systolic heart failure.


Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction (lvef) of 35 percent or less * new york heart association (nyha) functional class iii at time of screening * qrs duration less than 120 milliseconds (ms) * left ventricular end diastolic diameter (lvedd) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months * receiving stable optimal medical therapy for heart failure prior to enrollment * serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dl) * 18 years of age or older * willing and able to comply with study procedures * expected lifespan greater than 12 months beyond study enrollment as assessed by physician exclusion criteria: * interruption of thromboprophylaxis (e.g., heparin, lmwh, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician * polyneuropathy * requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy * unable to perform an exercise capacity test * pregnant or planning to become pregnant during this study * currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study * had coronary artery bypass graft/percutaneous coronary intervention/bare metal stent (cabg/pci/bms) procedures within the past 90 days * had a heart transplant * has complete heart block * had acute coronary syndrome within the past 90 days * has congenital heart disease with significant hemodynamic shunting * has chemotherapy-induced heart failure * has reversible cardiomyopathy * has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area) * has diagnosed unstable angina pectoris * has unstable coronary artery disease * has a cardiac resynchronization therapy (crt) device implanted and is receiving crt therapy * has a non-medtronic implantable cardioverter defibrillator (icd), pacemaker, or any non-transvenous defibrillation lead * has a medtronic icd whose sensing threshold cannot be programmed to 0.3mv or greater * has an existing neurostimulator
brain imaging and retreatment study of persistent lyme disease

Conditions: Lyme Disease; Lyme Neuroborreliosis

Summary: the purpose of this study is to determine whether patients with persistent memory problems after lyme disease benefit from an additional longer course of iv antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment.

some people with a history of lyme disease continue to have problems despite having received "textbook duration" antibiotic therapy. when memory, attention, or thinking problems persist, the syndrome is called persistent lyme disease (pld). this study seeks to answer critical scientific questions about the treatment and cause of pld symptoms. this 24-week treatment study will evaluate each patient's response to treatment using neuropsychological testing and state-of-the-art brain imaging. the brain tests include neuropsychological testing of memory and attention, brain imaging (mri and pet scans) to look at blood flow in the brain and nerve cell structure and metabolism, a neurological exam, and studies of the fluid that surrounds the brain (cerebrospinal fluid). the treatment involves 10 weeks of either intravenous antibiotic called ceftriaxone (also known as rocephin) or intravenous placebo (inactive substance). after the first visit to columbia presbyterian medical center, the remaining treatments will be done in the patient's home. patients will be screened over the phone and in person to confirm study eligibility.

Eligibility criteria:
inclusion criteria: eligible participants must: * be 18-65 years old * have persistent problems with memory, verbal fluency, or attention after having contracted lyme disease. * be able to travel to new york for 4-5 evaluations over the course of one year. travel costs for participants in need may be partially or fully reimbursable. * have had a history of well-documented lyme disease using the cdc's clinical criteria and a current positive igg western blot or pcr. * have received, at some point in the past at least 3 weeks of iv antibiotic therapy for lyme disease. exclusion criteria: ineligible from participation are people with the following: * other major medical or neurologic problems * smoke more than 10 cigarettes a day * uncontrolled high blood pressure * allergy to ceftriaxone (rocephin) * history of marked cocaine abuse twenty healthy subjects are also being sought for the study.

Keywords: neurologic lyme disease lyme disease ceftriaxone rocephin pet scans lyme encephalopathy neuroborreliosis borreliosis
a study of mk0217a and dietary supplement in men and postmenopausal women with osteoporosis (0217a-227)

Conditions: Osteoporosis; Vitamin D Deficiency

Summary: the purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin d insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.


Eligibility criteria:
inclusion criteria: * men or postmenopausal women who are osteoporotic exclusion criteria: * vitamin d deficiency * other disease of bone or mineral metabolism * digestive disease causing malabsorption * other medical conditions that are not adequately treated
vegf signaling promotes cell growth and metastasis in extrahepatic cholangiocarcinoma in a vegf receptor mediated pathway (ecc)

Conditions: Extrahepatic Cholangiocarcinoma

Summary: the investigators study the vegf signaling in ecc cell lines,patients and its mechanism in ecc growth, proliferation and apoptosis.

several studies have documented the elevated expression of vegf, vegfr1 and vegfr2 in cancer cell lines. another study observed a sequential elevation of vegf in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. clinical analyses have discovered the high expression of vegf is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. however, few studies have been conducted to investigate the vegf signaling in ecc cells and its possible mechanism in regulating ecc growth.therefore,we try to clarify the mechanism of vegf signal in ecc growth,proliferation and apoptosis.

Eligibility criteria:
inclusion criteria: 1. extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of extrahepatic cholangiocarcinoma 2. child-pugh a or b 3. well preserved renal and hematopoietic function 4. receive surgical therapy 5. achieve complete section accessed by contrast-enhanced ct exclusion criteria: 1. incomplete section 2. remote metastasis 3. child-pugh c 4. combination with other hepatobiliary disease 5. suffer from other tumors concurrently or in last five years

Keywords: extrahepatic cholangiocarcinoma ecc vegf signaling
silodosin vs placebo in the treatment of female luts

Conditions: Lower Urinary Tract Symptoms

Summary: this trial will be conducted to study the efficacy and safety of silodosin in the treatment of female lower urinary tract symptoms.

the double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.

Eligibility criteria:
inclusion criteria: * females complaining of lower urinary tract symptoms * ipss ≥ 8 or oab - v8 score ≥ 8 exclusion criteria: 1. patients with documented hypersensitivity to silodosin. 2. patients receiving alpha blockers or anticholinergic medications for any other reason. 3. patients with history of orthostatic hypotension. 4. pregnant or breastfeeding females. 5. patients with stress urinary incontinence. 6. patients with active urinary tract infection. 7. history of previous pelvic surgery or radiation. 8. patient with diabetes mellitus. 9. patients diagnosed with bladder cancer. 10. patients with hepatic impairment (child-pugh score \>9). 11. patients with severe renal impairment with creatinine clearance of less than 10 ml/min. 12. patients planned to undergo any ophthalmic procedure. 13. patients with history of urinary retention or gastric retention.

Keywords: silodosin luts female
the goals of care initiative

Conditions: Decision-Making Oncology; Chemotherapy Effect

Summary: a single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper gi \& sarcoma) are randomised sequentially to initiate the goals of care initiative into clinical practice.


Eligibility criteria:
inclusion criteria: * undergoing, or being considered for, systemic treatment from one of the cluster teams. * 18+ years. * able to give written consent. * able to understand verbal and written english. exclusion criteria: • patient is not being considered for systemic anti-cancer treatment.
study evaluating orally administered erb-041 in subjects with active interstitial cystitis

Conditions: Cystitis, Interstitial

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered erb-041 in subjects with active ic. the primary objectives of this study will be to investigate erb-041's activity on levels of urinary apf, explore the gene expression response in peripheral blood mononuclear cells (pbmc), and to evaluate the safety of erb-041 in women with active ic.


Eligibility criteria:
inclusion criteria: * subjects seeking medical treatment for symptoms consistent with ic that have been ongoing for \> 9 months or seeking medical treatment for a previous documented diagnosis of ic * subjects who are not surgically sterile or postmenopausal (amenorrheic \> 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or iud), non-hormonal form of birth control during the study and for 30 days after the last dose of test exclusion criteria: * use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components) * history of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state * vaginitis or vaginal infection within 1 month before randomization

Keywords: cystitis
high dose pet/ct-guided intensity modulated radiotherapy and concurrent chemotherapy in esophageal cancer

Conditions: Esophageal Cancer

Summary: to assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer

standard dose chemoradiotherapy (scrt) results in poor local control for localregionally advanced esopgageal cancer patients. most local failures occur in the gross tumor volume.\[f-18\]-fluorodeoxyglucose (fdg) pet/ct can identify residual metabolic disease (rmd). hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. our previous phase i radiation dose escalation trial demonstrated that 86 gy could be safely delivered to the rmd with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.the aim of this phase ii study is to examine the efficacy of this regimen.

Eligibility criteria:
inclusion criteria: * patients must have fdg-avid and histologically or cytologically proven esophageal cancer. * patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. * eastern cooperative oncology group （ecog） performance status 0 to 2 no prior radiation to the thorax that would overlap with the current treatment field. * patients with nodal involvement are eligible * adequate bone marrow, renal and hepatic functions as assessed by the following: hemoglobin \>/= 10.0 g/dl, platelet count \>/= 1 00,000/ mm\^3,absolute granulocyte count (agc) ≥2 × 10\^9 cells/l,bilirubin and aspartate transaminase ≤1.5 ×upper limit of normal (uln), creatinine \</ =1 .5 times uln. * a signed informed consent must be obtained prior to therapy. * no prior radiation to the thorax that would overlap with the current treatment field. induction chemotherapy is allowed. exclusion criteria: * the presence of a fistula. * prior radiotherapy that would overlap the radiation fields. * gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall. * uncontrolled concurrent illness including, but not limited to: chronic obstructive pulmonary disease(copd) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (chf),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. * known hypersensitivity to paclitaxel. * any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study. * acquired immune deficiency syndrome. * conditions precluding medical follow-up and protocol compliance
new method for distal interlocking of cannulated intramedullary nails

Conditions: Fracture

Summary: we intend to include10 patients in this study and trial. prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study. five patients will undergo regular operation with universal tibial reamed nail (ao-synthes) using the fluoroscopy device: oec 9800 (general electric). five patients will undergo the same operation using the new navigation system:"the guiding star" method. the allocation will be random.


Eligibility criteria:
inclusion criteria: 1. signing informed consent. 2. conscious patients. exclusion criteria: 1. hemodynamic instability. 2. multiple system injuries. 3. pregnancy. 4. soldiers.

Keywords: fracture fixation
ganaxolone expanded access program compassionate use

Conditions: CDKL5 Disorder

Summary: the primary objective is to provide gnx to patients ≥ 2 years with cdd-related seizures who are refractory to, or intolerant of, standard therapy.

this is a multi-center, long-term, open-label, expanded access protocol of adjunctive gnx treatment in children, adolescents, and adults with cdd. patients with inadequate seizure control on their current anti seizure medications at therapeutic doses will be eligible for enrollment.

Eligibility criteria:
inclusion criteria: * molecular confirmation of a pathogenic cdkl5 variant, early onset, difficult to control seizures, and neurodevelopmental impairment are required. male or female patients aged ≥ 2 years. in the opinion of the investigator, the patient has inadequate seizure control on current anti-seizure medications at therapeutic doses. exclusion criteria: -
effect of liraglutide for weight management in pubertal adolescent subjects with obesity

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted globally. the aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation * bmi corresponding to equal to or above 30 kg/m\^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity) * stable body weight during the previous 90 days before screening v2 (below 5 kg self-reported weight change) * history of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record exclusion criteria: * pre-pubertal subjects (tanner stage 1) at screening v2 * type 1 diabetes mellitus (t1dm) * family or personal history of multiple endocrine neoplasia type 2 (men2) * medullary thyroid carcinoma (mtc) * history of pancreatitis (acute or chronic) * subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes) * treatment with medications within 90 days before screening v2 that, based on the investigator's judgement, may cause significant weight change. this should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (glp-1) receptor agonists, or metformin (used as treatment for obesity) * anti-diabetic treatment other than metformin * history of major depressive disorder within 2 years before screening v2
a prospective study looking at the use of rebif® in subjects with clinically isolated syndrome

Conditions: Clinically Isolated Syndrome

Summary: the primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (ifn) beta - 1a, (rebif®), versus no treatment in delaying the conversion to clinically definite multiple sclerosis (cdms) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with clinically isolated syndrome (cis) accompanied by an abnormal magnetic resonance imaging (mri). the secondary objectives are to: * assess the effectiveness of sc ifn beta - 1a (rebif®) therapy in reducing the proportion of patients with cis converting to cdms * assess the safety of sc ifn beta - 1a (rebif®) in the patients with cis


Eligibility criteria:
inclusion criteria: * subject must have experienced a first clinical episode suggestive of demyelinating disease * subject must present with an abnormal mri displaying at least 3 t2 weighted hyperintense lesions typical of multiple sclerosis (ms) * subject must be greater than or equal to 18 years old * subject must have had onset of the clinical attack within the last 120 days * subject must give written informed consent * female subjects must be neither pregnant nor breast feeding, and must not be of child-bearing potential as defined by either: * being post-menopausal or surgically sterile * using hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study subjects electing treatment: * subject must be eligible for interferon-beta 1-a therapy exclusion criteria: * subject has evidence of other neurological diseases that could explain his/her symptomatology * subject is pregnant or in lactation * subject suffers from an intercurrent autoimmune disease * subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the procedures required by this study * subject has received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, campath), within 12 months of study day 1 subjects electing treatment: * subject has inadequate liver function, defined by total bilirubin, aspartate transaminase (ast), alanine aminotransferase (alt), or alkaline phosphatase \> 2.5 times the upper limit of normal values * subject has inadequate bone marrow reserve, defined as white blood cell count less than 0.5 times the lower limit of normal * subject has a known allergy to ifn or any of the excipients of the drug product
intravenous or intra-abdominal local anesthetics for postoperative pain management.

Conditions: Uterine Myoma; Persistent Post-menpausal Bleeding; Uterine Cancer

Summary: local anesthetics (la) are increasingly used for postoperative pain management. speicifically, several studies have found benefit of la injected intra-abdominally following abdominal hysterectomy. however, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. the aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. all patients would have rescue analgesia using the patient controlled analgesia (pca) pump with morphine in order to achieve adequate pain management during 24 h.

abdominal hysterectomy with or without salipingo-oophorectomy is associated with moderate-severe postoperative pain. poor pain control in the postoperative period can lead to increased postoperative morbidities and poor quality of life. furthermore, an emerging clinical literature suggests that acute pain may rapidly evolve into chronic pain if poorly treated. a meta-analysis of the literature found that \> 30% patients had chronic pain one year after abdominal hysterectomy (5). therefore, efficient postoperative pain management is imperative for the patient and is one of the new pain management standards recommended recently. local anesthetics (la) have been infiltrated subcutaneously, infused intra-abdominally, as well as injected into the peritoneal cavity as a single dose at the end of the operation following abdominal hysterectomy with variable effects. when injected as a single dose, analgesia is limited to approximately 2-4 hours due to the short duration of action of local anesthetics. in one recent study, the authors used a catheter inserted intra-abdominally and local anesthetic or placebo infusion into the abdominal cavity for 24 h postoperatively and found a reduction in postoperative analgesic requirements by 40% during 4-24 h. in another study, the investigators found that la injected intermittently intra-abdominally resulted in better pain relief compared to intra-abdominal infusions.

Eligibility criteria:
inclusion criteria: * asa 1-2 * 30 - 75 yrs * informed consent * 50 - 100 kg exclusion criteria: * allergy to la * chronic pain * major liver/kidney insufficiency * av block 1-2 participation in another clinical trial

Keywords: surgery: abdominal hysterectomy anesthetics: local postoperative: pain drugs: morphine