Kornimate/medical-research-clean huggingface dataset:
elbasvir/grazoprevir (ebr/gzr) and sofosbuvir (sof) with and without ribavirin (rbv) in cirrhotic subjects with chronic hepatitis c virus (hcv) genotype 3 (gt3) infection (mk-5172-083)

Conditions: Hepatitis C

Summary: this is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (fdc) of ebr 50 mg + gzr (100 mg) (ebr/gzr) and sof 400 mg, with and without rbv, in treatment-naïve (tn) and treatment-experienced (te) participants with chronic hcv gt3 infection with compensated cirrhosis.


Eligibility criteria:
inclusion criteria: * has hcv rna (\>= 10,000 iu/ml in peripheral blood) at screening * has documented hcv gt3 (with no evidence of non-typeable or mixed gt infection) * has compensated cirrhosis of the liver * has liver imaging within 6 months of day 1 with no evidence of hepatocellular carcinoma (hcc) * is either hcv tn or te (i.e., has documented prior virologic failure or intolerance to peg-interferon/ribavirin) * is otherwise healthy as determined by medical history, physical examination, electrocardiogram (ecg), and clinical laboratory measurements * has compensated cirrhosis of the liver * is tn or te (i.e., documented prior virologic failure or intolerance to peg-interferon/ribavirin) * is not of reproductive potential, or agrees to not impregnate a partner or become pregnant for at least 2 weeks prior to the first dose of study drug, and for 7 months after the final dose of study drug (or longer if dictated by local regulations) exclusion criteria: * has previously received one or more doses of a direct-acting antiviral (daa) * has evidence of decompensated liver disease * is coinfected with hepatitis b (hepatitis b surface antigen \[hbsag\] positive) * has a recent (within 5 years) history of malignancy or is under evaluation for hcc or other suspected malignancy * is currently or has participated (within past 30 days) in a study with an investigational compound * has clinically-relevant drug or alcohol abuse within the past 12 months of screening * is a female and is pregnant or breast-feeding * is a male whose female partner is/are pregnant * has any of the following: * organ transplants * poor venous access * history of gastric surgery or malabsorption disorder * current or history of clinically significant cardiac abnormalities or dysfunction * chronic pulmonary disease * hemoglobinopathy * history of hospitalization within 3 months prior to enrollment * medical or surgical condition that may result in need for hospitalization during the course of the study * any condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (tnf) antagonists, or other immunosuppresant drugs during the course of the study * any condition, prestudy laboratory or ecg abnormality, or history of any illness, which could confound results of the study or pose additional risks in administering study drugs in the opinion of the investigator * has a life-threatening serious ae (sae) during the screening period * has evidence of history of chronic hepatitis not caused by hcv
does subtotal cholecystectomy rate for acute cholecystitis change with a previous ercp?

Conditions: Cholecystectomy, Laparoscopic; Cholangiopancreatography, Endoscopic Retrograde

Summary: study is designed to investigate whether the history of ercp is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.

the results of patients who underwent surgery for acute cholecystitis in a single center between january 2016 and december 2019 were included and evaluated retrospectively. primary outcome was subtotal cholecystectomy rate. secondary outcomes were conversion to open, complications and serious complications. within examining demographic findings, operative records (rates for subtotal cholecystectomy and conversion to open, operative duration) and follow-up results (postoperative complications, serious complications, length of hospital stay and mortality) for all cases were investigated. complications that clavien-dindo score ≥ 3 accepted as serious complication. intraoperative detection of gallbladder perforation was also noted and included in comparison. any biliary tract complication that needed any percutaneous or endoscopic intervention to handle was named as "biliary leak" in the study.

Eligibility criteria:
inclusion criteria: * patients operated with the diagnosis of acute cholecystitis with an age greater or equal to 18 years old in a single center between january 2016 and december 2019 exclusion criteria: * initial and direct preferance of open method * being diagnosed with malignity after histopathological evaluation * being operated just before one week after ercp or after more than six weeks after ercp

Keywords: acute cholecystitis, laparoscopic subtotal cholecystectomy
efficacy of pain neuroscience education in genito-pelvic pain/penetration disorder. a randomized controlled trial.

Conditions: Pain; Dysfunction Sexual

Summary: patients suffering pelvic persistent pain deal with significant pain that affects their quality of life. often, conservative treatment interventions are scarce for these patients and are therefore not considered. education has been developed as a relevant tool in the treatment of patients who suffer from chronic pain or any other pain processing alterations, and has the potential to become a powerfull treatment alternative.

in this intervention, the effects of implementing educational programs in patients suffering from pelvic persistent pain will be assessed. patients with pelvic persistent pain have both problems directly related with their pain and other issues that appear derived from suffering pain over a determined period, such as alterations in the sexuality or overall quality of life. facing these patients is a challenge for professionals, and many can't find the treatment that properly fits the patient's clinical presentation. education, and educating patients on their problem, is an exponentially growing alternative used in physical therapy involving patients who suffer from a dysfunctional pain, chronic pain, or any kind of pain presentation that affects the patient's well-being. this study will assess firstly if the implementation of a pain-related education program is relevant in the treatment of pelvic persistent pain, and will further observe which modality (presential workshops or online-accessed material) is the most effective involving adherence and improvement.

Eligibility criteria:
inclusion criteria: * patients over 18 years-old suffering from dyspareunia for more than 3 months exclusion criteria: * patients suffering from a previous medical condition that explains logically the presence of pain
pre-approval access program for talquetamab in relapsed or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells \[white blood cells that produce antibodies\] which has returned or difficult to treat) who have relapsed on or are refractory to all locally available and clinically appropriate treatment and who are not eligible for a clinical trial.

talquetamab (jnj-64407564) is a humanized immunoglobulin g4 proline, alanine, alanine (igg4paa) bispecific antibody designed to target g-protein coupled receptor (5dgprc5d) and cluster of differentiation 3 (cd3). redirecting t-cells to a tumor surface antigen using bispecific antibody approaches may be an effective means to harness the immune system to destroy cancer cells expressing gprc5d and create meaningful and long-lasting clinical responses. talquetamab is supplied as single-dose investigational product (ip) vials for subcutaneous administration. safety assessments will include adverse events, serious adverse events, adverse drug reactions, and special situations which will be reported during the duration of the pre-approval access program.

Eligibility criteria:
inclusion criteria: * participant diagnosed with relapsed or refractory multiple, myeloma * participant exhausted all commercially approved and clinically appropriate treatment options, and is ineligible for a clinical trial
resistance and aerobic exercise for subclinical anthracycline cardiomyopathy

Conditions: Cardiomyopathy

Summary: this application proposes a prospective, single arm feasibility clinical trial of a 12-week period of combined endurance and resistance training in survivors of childhood cancer who were treated with doxorubicin and/or daunorubicin and have impaired cardiac function. baseline and post intervention imaging, laboratory, and neuropsychological evaluations will be used to determine the effects of the intervention on body composition, serum lipid profile, exercise tolerance, and neurocognitive functioning. participants will be called weekly to monitor compliance with the intervention. incentives will be given at intervals during the trial to optimize compliance with the intervention.

this study will evaluate the feasibility of a 12-week exercise intervention on the cardiac function of survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy. as a secondary objective, the study will document the effect of a 12-week exercise intervention on exercise tolerance, as determined by measurement of peak vo2 and peak exercise workload, shortening fraction, ejection fraction, and left ventricular wall thickness, and assess the impact of the intervention on neurocognitive functioning in survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy.

Eligibility criteria:
inclusion criteria: * treated at st. jude children's research hospital (sjcrh) * ages 0 - 17 years at time of treatment * treated for any type of cancer * ≥ 10 years from date of diagnosis * ≥ 2 years after completion of active cancer therapy * ≥ 18 years of age * treated with doxorubicin and/or daunorubicin (any cumulative dose) * ejection fraction of \< 55% without medications * does not currently meet the centers for disease control (cdc) recommendations for exercise for adults exclusion criteria: * ejection fraction ≤ 40% * pregnant females (positive urine pregnancy test). * history of congenital heart disease * history of myocardial infarction * history of acute coronary syndrome * individuals with pacemakers or implanted defibrillators * history of radiation therapy that included any part of the heart * ≥1-mm j-point depression (depression measured 80 msec after j-point) with st segment flat or down-sloping in the majority of complexes in any ecg lead except avr with exercise testing. * all patients will be classified using the recommendations of the american heart association. patients found to be in class a, c or class d will not be eligible for study

Keywords: childhood cancer anthracyclines cardiomyopathy
efficacy and safety of aricept in the treatment of severe alzheimer's disease

Conditions: Alzheimer's Disease; Dementia

Summary: donepezil hydrochloride (aricept) has been approved to treat symptoms associated with mild to moderate alzheimer's disease (ad). aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. the purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe alzheimer's disease. donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. this chemical helps a person's memory to work better.


Eligibility criteria:
inclusion criteria: * clinically diagnosed alzheimer's disease with mmse score 1\~12 * have not been treated by any medication for alzheimer's disease in past 3 months * live in community or assisted living facility * healthy or with chronic diseases that are medically controlled or stabilized * able to swallow tablets exclusion criteria: * any primary neurological or psychiatric diagnosis (including depressive disorder) other than alzheimer's disease * dementia caused by organic diseases other than alzheimer's disease

Keywords: alzheimer's disease dementia acetylcholinesterase donepezil aricept memory loss severe dementia of the alzheimer's type
increased calorie intake to reverse energy deficiency in exercising women: impact on bone and menstrual cyclicity

Conditions: Menstrual Irregularity

Summary: the purpose of this study is to examine the effects of increased food intake on the menstrual cycle and bone health in physically active women who have irregular or absent menstrual cycles. this study will examine whether a 12 month period of increased food intake will cause menstrual cycles to resume and help bones get stronger.

low levels of estrogen found in physically active, premenopausal women with irregular or absent menstrual periods is likely caused by insufficient energy (calorie) intake compared to energy expenditure. premenopausal women with menstrual disturbances and amenorrhea suffer from reductions in bone mineral density, particularly in the lumbar spine. bone loss observed in amenorrheic women may be serious enough to result in osteoporotic fractures, but is also associated with a high prevalence of stress fractures. increased calorie intake should help improve energy status, menstrual status, and bone health. comparison: premenopausal women with irregular or absent menstrual periods will be assigned to either receive additional calories or serve as controls. a group of premenopausal women with normal menstrual periods will also be used for comparison.

Eligibility criteria:
inclusion criteria for ovulatory control volunteers: * 18-35 years * bmi 16-25 kg/m2 * at least 2 hr/wk of aerobic exercise * gynecological age \>/= 5 years * weight stable (+/- 2 kg) last 6 months * history of regular menses for 6 months inclusion criteria for women with irregular or absent menses: * 18-35 years * bmi 16-25 kg/m2 * at least 3 hr/wk of aerobic exercise * gynecological age \>/= 5 years * weight stable (+/- 2 kg) last 6 months * no menses within past 3 months or 6 or less menses in last 12 months * low to normal bone mass (l1-l4 z score \</=0) exclusion criteria for all participants: * hormonal contraceptives in last 6 months * smoking currently * current clinical diagnosis of an eating disorder * use of medications incompatible with measurement of reproductive or metabolic hormones, including thyroid medications that may interfere with any of the study outcomes. * dietary habits incompatible with prescribed diet for study * any metabolic, reproductive or bone disease * sedentary individuals with less than 120 minutes (2 hrs) of activity per week

Keywords: amenorrhea energy deficiency resting energy expenditure bone metabolism bone mineral density exercise
study of st266 versus saline in treating skin irritation from radiation

Conditions: Radiation-induced Dermatitis

Summary: the objective of this study is to evaluate the safety and efficacy of st266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare st266 treated burns with those treated with saline placebo controls.


Eligibility criteria:
inclusion criteria: * a signed irb - approved informed consent; * women 18 - 80 years of age; * biopsy-proven diagnosis of breast cancer with the tumor surgically removed. * whole breast radiation with or without ipsilateral axilla radiation therapy recommended by her radiation oncologist. * if a woman is of child-bearing potential, she and her partner must use an effective form of birth control. * willing to participate in the clinical study and comply with the requirements of the trial. exclusion criteria: * abnormal liver or kidney function studies being greater than 2x the upper limit of normal. * patients on hemodialysis * psychiatric condition or substance abuse which in the investigator's opinion may pose a threat to patient compliance; * history of non-compliance with treatment or clinical visit attendance. * participation in an investigational trial within 30 days of study entry. * women who are pregnant or lactating
hiv prevention within high-risk bulgarian and hungarian social networks

Conditions: HIV Infections

Summary: this study will evaluate the effectiveness of peer-led hiv/sexually transmitted disease (std)risk reduction educational counseling in reducing hiv risk behavior among the social networks of young men who have sex with men and roma men and women in bulgaria and hungary.

hiv is spreading more rapidly in eastern europe than anywhere else in the world. bulgaria and hungary are still in the early stages of the crisis. however, without efforts to prevent the spread of hiv and aids, both countries are likely to fall victim to the hiv/aids growth curve that has already affected the rest of eastern europe. bulgarian and hungarian young men who have sex with men (ymsm) and roma men and women are at the greatest risk for hiv infection. in both countries, hiv is spread primarily through sexual transmission. prevention efforts that are undertaken now could help these countries avoid an explosive hiv/aids epidemic. ymsm and roma men in bulgaria and hungary are more likely to trust hiv/aids information received from someone they know than from an official statement. therefore, entire social networks will be recruited for this study and the leader of each network will be responsible for delivering the prevention information to his or her peers. this study will evaluate the effectiveness of peer-led hiv/std risk reduction educational counseling in reducing hiv risk behavior among the social networks of ymsm and roma men and women in bulgaria and hungary. this study will recruit 40 ymsm and 40 roma high-risk social networks. each network will be randomly assigned to receive either standard hiv/aids risk reduction or the intervention. networks assigned to receive the intervention will be assessed sociometrically to determine the 'social influence' leaders of each group. the leaders will then attend a 9-session program over the course of 3 months that will train them to deliver theory-based risk-reduction messages and peer-counseling to their respective social networks. the messages will focus on promoting safer sex knowledge, attitudes, intentions, perceived norms, and self-efficacy. all participants will be offered std testing and their hiv-risk behavior will be assessed at months 3 and 12. participants assigned to receive the standard hiv/aids risk reduction will then receive the network intervention for an additional 12 months.

Eligibility criteria:
inclusion criteria: * at least 50% of social network members complete baseline assessments * at least 50% of assessed members of a social network report unprotected vaginal or anal intercourse outside of a mutually monogamous relationship in the 6 months prior to study entry exclusion criteria: * does not meet inclusion criteria

Keywords: hiv prevention risk behavior reduction roma bulgaria hiv seronegativity
effect of egdt on hepatic perfusion in patients with septic shock

Conditions: Septic Shock

Summary: to observe the effect of early goal directed therapy (egdt) on hepatic perfusion in patients with septic shock. hypothesis: hepatic perfusion did not improved after egdt in patients with septic shock.

objective to observe the effect of early goal directed therapy (egdt) on hepatic perfusion in patients with septic shock. methods a prospective observational study was carried out. the eligible patients were treated with the standard procedure of egdt. the hemodynamic data were recorded. oxygen metabolism and hepatic function were monitored. indocyanine clearance test was applied to detect the hepatic perfusion. hemodynamics, hepatic perfusion, oxygen metabolism and hepatic function were compared before treatment, after egdt and 24 hours after egdt.

Eligibility criteria:
inclusion criteria: 1. patients with septic shock 2. at least one of the egdt criteria not achieved 3. informed consent accepted exclusion criteria: 1. ages below 18 or above 90 2. pregnancy 3. the time elapsed over 24 hours after onset of septic shock 4. chronic liver disease 5. terminal stage of disease 6. brain death 7. other types of shock 8. brain injury 9. allergic to iodine or indocyanine

Keywords: septic shock early goal directed therapy fluid resuscitation hepatic perfusion indocyanine green
protest trial: txa vs saline

Conditions: Lung Transplant; Complications Surgical

Summary: to determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.

tranexamic acid (txa) is an antifibrinolytic agent. it forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. it also inhibits proteolytic activity of plasmin. txa is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. it has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. it has also been evaluated for prophylactic use with mixed results in reducing bleeding. in our current general pulmonary practice, topical txa is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage. the purpose of this research study is to determine if prophylactic topical txa can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies. a finding of reduced bleeding would be significant as it could improve clinical outcomes, allow for improved diagnostic yield of biopsy samples, and improve patient experience. it therefore has the potential to change clinical practice and standardize bronchoscopy procedures.

Eligibility criteria:
inclusion criteria: 1. single or double lung transplant recipients 2. patients \>18 years old 3. willingness and ability to sign an informed consent for study participation exclusion criteria: 1. platelet count (\<50k/ul) 2. inr (\>1.6) 3. active bleeding 4. decompensated liver disease 5. history of uremic bleeding or bun \>50 6. severe pulmonary hypertension (mean pa pressure \>40 mmhg on rhc or estimated pa systolic pressure \>62 mmhg on tte within one year of procedure) 7. known bleeding disorder 8. allergy to txa 9. prior history of severe tbbx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention) 10. contraindications to topical txa 11. pregnancy 12. vulnerable populations 13. adults of limited english proficiency/non-english speakers
prospective study of minimally invasive spine surgery

Conditions: Degenerative Disk Disease; Spondylolisthesis; Spinal Stenosis; Degenerative Scoliosis

Summary: the population of the us is aging. they remain more active and place greater demands on their musculoskeletal system. a key problem is that pain and disability of age related spinal disorders will increase. problems such as degenerative lumbar spondylolisthesis, degenerative disk disease, spinal stenosis and degenerative scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. traditional open surgery poses significant risk for patients in this age group. the use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.


Eligibility criteria:
inclusion criteria: inclusion criteria: * patient age 21 - 90 years. * diagnosis of spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude). * a spinal fusion is being undertaken via the minimally invasive approach. * the patient agrees to follow-up for routine care for at least 2 years post-operatively. exclusion criteria: * inability for post-operative follow-up

Keywords: mis minimally invasive spine surgery fusion spine smiss