Kornimate/medical-research-clean huggingface dataset:
effects of intravenous gc4419 on the incidence and severity of esophagitis due to chemoradiotherapy for lung cancer

Conditions: Esophagitis

Summary: gti-4419-203 will be an open-label, multi-center study to evaluate gc4419 (avasopasem manganese) administered intravenous (iv) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable stage 3a/3b or post-operative stage 2b non-small cell lung cancer (nsclc) or small cell lung cancer (sclc) treatable with chemoradiotherapy.


Eligibility criteria:
inclusion criteria: 1. subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in combination with chemotherapy once daily for stage 3a/3b or post-operative stage 2b nsclc or limited stage sclc 2. treatment plan for subjects show that 5 cm of the esophagus for at least one surface, is included in the 60 gy isodose volume. dose volume histograms show esophagus dose exposure meet v38\>30% and/or v60\>20% 3. age 18 years or older 4. ecog performance status ≤ 2 5. adequate hematologic, renal and liver function 6. use of highly effective contraception exclusion criteria: 1. metastatic disease 2. prior radiation therapy to the region of the study cancer 3. subjects not receiving chemotherapy 4. grade 2 or greater esophagitis at baseline 5. inability to provide information in the electronic symptom-reporting device 6. receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy 7. participation in another clinical trial or use of another investigational agent within 30 days of first does of gc4419 8. malignant tumors other than the current lung cancer within the last 5 years 9. previous diagnosis of pneumonitis 10. untreated, active infectious disease requiring systemic anti-infective therapy 11. untreated hiv or active hepatitis b/c 12. females who are pregnant or breastfeeding 13. known allergies or intolerance to chemotherapy and similar platinum-containing compounds 14. requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure 15. clinically significant heart disease
efficacy, immunogenicity, and safety of v503 in chinese males (v503-052)

Conditions: Papillomavirus Infections

Summary: this study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vhpv; v503) vaccine in chinese men 20 to 45 years of age. it will enroll heterosexual men (hm) and men who have sex with men (msm), will be stratified by age and sexual orientation, and will have two stages. the primary hypothesis of stage i is: 9vhpv vaccine reduces the combined incidence of hpv 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related external genital and intra-anal 12-month persistent infection (pi) compared with placebo in males 20 to 45 years of age who are seronegative at day 1 and polymerase chain reaction (pcr) negative from day 1 through one month post-dose 3 to the relevant hpv type. the primary hypothesis of stages i and ii combined is: 9vhpv vaccine reduces the combined incidence of hpv 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts, penile/perianal/perineal intraepithelial neoplasia (pin), or penile/perianal/perineal cancer compared with placebo in males 20 to 45 years of age who are seronegative at day 1 and pcr negative from day 1 through one month post-dose 3 to the relevant hpv type.


Eligibility criteria:
inclusion criteria: * is a chinese male. * has no more than 5 lifetime sexual partners. exclusion criteria: * has a history of known prior vaccination with an hpv vaccine. * has a history of hpv-related external genital lesions, hpv-related intra-anal lesions, or hpv-related head and neck cancer. * has a history of severe allergic reaction that required medical intervention. * has received immune globulin or blood-derived products in the past 3 months or plans to receive any before month 7 of the study. * has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (hiv), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. * has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids. * has a known thrombocytopenia or coagulation disorder that would contraindicate im injections.
dahanca 20 palliative radiotherapy for head and neck cancer

Conditions: Head and Neck Neoplasms; Recurrence; Neoplasms, Second Primary

Summary: palliative radiotherapy for head and neck cancer is widely used but the effect and side effects are largely unknown. we will study the effect of short hypofractionated palliative radiotherapy (20 gy in 4 fractions) on symptom intensity and -frequency as weel as side effects


Eligibility criteria:
inclusion criteria: * incurable primary or second primary head and neck cancer * speaks and reads danish * capable of filling out questionnaires for at leas two months after radiotherapy * age\>=18 years * expected survival\> 3months

Keywords: palliative radiotherapy recurrent head and neck neoplasm quality of life
duodenal jejunal bypass for type 2 diabetes (djbd)

Conditions: Diabetes Mellitus

Summary: study the effect of duodenal jejunal bypass on human adults with type 2 diabetes.

adults non obese ( bmi less than 34 ) will undergo duodenal jejunal bypass. the outcome measures: blood sugar, insulin,hba1c, cck,gastrin, gip1and 2, ghrelin, cholesterol, triglycerides,ffa, c-peptide.

Eligibility criteria:
inclusion criteria: * adults age 20-65 * clinical diagnosis of type 2 diabetes * non obese with bmi less than 34. * oral agents or insulin to control t2dm. * inadequate control of diabetes as defined as hba1c\>/7.5 * understanding of the mechanisms of action of the treatment exclusion criteria: * children with type 1 diabetes * obese with bmi over 34 * coagulopathy * liver cirrhosis * unable to comply with study requirements, follow-up or give valid consent * currently pregnant * previous upper abdominal surgery * inabilty to tolerate general anesthesia

Keywords: bypass duodenal jejunal type 2 diabetes non-obese adults
oral vinorelbine and capecitabine in advanced her2-negative breast cancer

Conditions: Breast Cancer

Summary: this study was a prospective, single-arm, open-label phase ii clinical trial conducted at national cancer center in china.

metronomic chemotherapy is a relatively low-dose, high-frequency, continuous application of cytotoxic agents. phase i/ii victor-1 studies have shown that the dual oral beat combination of vincristine and capecitabine is highly active and well tolerated in patients with locally advanced or metastatic breast cancer. the long-term efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in chinese advanced her-2 negative breast cancer patients stays unclear. the current study was designed to explore the efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in advanced her-2 negative patient china.

Eligibility criteria:
inclusion criteria: * female; * aged ≥ 18 years and ≤75 years; * histologically proved metastatic her-2 negative breast cancer. her2-negative status determined by situ hybridization (fish) or immunohistochemistry (ihc) (ihc 0, 1+, 2+ and/or fish her2 negative); * at least one measurable or evaluable lesion based on recist 1.1 criteria; * estimated life expectancy ≥ 3 months; * normal heart, liver, and kidney function; * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; * informed consent signed by the participants exclusion criteria: * received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation; * participated in other new drug clinical trials within 4 weeks before enrollment; * inflammatory breast cancer; * symptomatic visceral disease; * second primary malignancy; * mental disorder.

Keywords: breast cancer metronomic treatment
observational study on effectiveness and safety of liraglutide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: the study is conducted in europe. the aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in belgium.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * insufficiently controlled after 3 months of treatment with oads (oral anti-diabetic drugs) exclusion criteria: * previously treated with liraglutide * hypersensitivity to liraglutide or to any of the excipients (disodium phosphate dihydrate, propylene glycol, phenol, water for injections) * pregnant, breast feeding or have the intention of becoming pregnant
leukemia inhibitory factor level in intrauterine growth restriction neonates

Conditions: to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA

Summary: to see if there is a relationship between the level of lif in iugr fetuses and compared to the level of lif in aga fetuses

during embryonic development, there are several cytokines such as: lif (leukemia inhibitory factor), ciliary neurotrophic factor (cntf), epidermal growth factor family (egf), neuregulin 1 (nrg1) and transforming growth factor β (tgfβ) that were found are associated with neurogenesis and differentiation of brain cells . lif is a cytokine that is essential for the development of the central nervous system, and has recently been shown in rats that maternal lif stimulates placental acth that in turn promotes secretion of fetal lif from nrbc , which in turn promotes brain development of the fetus other studies on iugr (intra uterine growth restriction) have shown that iugr fetuses have more cp (cerebral palsy) than those who were aga (average for gestational age) the hypothesis is that lif is related to the proper development of the nervous system in the fetus and by testing cord blood of embryos iugr and the placenta we will find changes in lif and acth compared with aga fetuses level. studies have also shown a relationship between cp and iugr, but the mechanism for this relationship is unclear. the purpose of our research is to see if there is a relationship between the level of lif in iugr fetuses and compared to the level of lif in aga fetuses, in one of two ways: * changes in the secretion of acth in placenta * changes in levels of lif in the umbilical cord blood

Eligibility criteria:
inclusion criteria: * women that the fetal weight estimate puts the fetus bellow the 10th percentile and those that the fetal weight estimate are between 20th and 80th percentiles exclusion criteria: * women who do not agree * known genetic diseases of abnormalities in the fetus

Keywords: lif iugr
randomised, double-blind, placebo-controlled, parallel-group, multi-centre, dose ranging study to evaluate the efficacy and safety of losmapimod tablets administered twice daily compared with placebo for 24 weeks in adult subjects with chronic obstructive pulmonary disease (copd).

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (bid) versus placebo on exercise tolerance. eligible subjects will be randomised to treatment after a one-week run-in period. the duration of the treatment period is 24 weeks. an estimated 1000 subjects will be screened to reach the target enrolment of approximately 600 randomised subjects.


Eligibility criteria:
inclusion criteria: * clinical history of copd in accordance with the definition by the american thoracic society/european respiratory society * fev1/fvc ratio of ≤0.70 * fev1 ≤ 80% of predicted normal * 6mwd \< 350m * male or female outpatients aged ≥40 years of age * current or prior history of ≥10 pack-years of cigarette smoking * aspartate transaminase (ast) or alanine transaminase (alt) \<2x upper limit normal (uln) * alkaline phosphatase (alk phos), and bilirubin \ 1.5xuln is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * qtc \<450 msec\* on baseline ecg. for subjects with baseline complete bundle branch block, the qtc must be \<480msec\* on baseline ecg. exclusion criteria: * current diagnosis of asthma * pregnant or lactating * α1-antitrypsin deficiency * lung resection * chest x-ray (or ct scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of copd * exacerbation of copd within previous 12 weeks * treatment with roflumilast within previous 2 weeks and throughout the treatment period * lower respiratory tract infection that required the use of antibiotics within previous 12 weeks * long-term oxygen therapy (ltot) or nocturnal oxygen therapy required for greater than 12 hours a day * participation in the acute phase of a pulmonary rehabilitation program within 12 weeks or planned during the study * carcinoma that has not been in complete remission for at least 5 years * current or chronic history of liver disease * positive hepatitis b surface antigen or positive hepatitis c antibody * body mass index (bmi) \> 35 * known or suspected history of alcohol or drug abuse within the last 2 years
safety/pharmacokinetic study comparing intracisternal eg-1962 to standard of care enteral nimodipine in adults with asah

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: safety and pharmacokinetic study comparing intracisternal eg-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.


Eligibility criteria:
inclusion criteria: 1. ruptured saccular aneurysm repaired by neurosurgical clipping 2. subarachnoid hemorrhage on computed tomography (ct) scan of grade 2-4 on the modified fischer scale 3. wfns grade 1 or 2 assessed during the pre-randomization phase. if wfns grade 2, must not require an evd prior to aneurysm repair exclusion criteria: 1. major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm 2. angiographic vasospasm prior to randomization 3. evidence of cerebral infarction with neurological deficit

Keywords: aneurysm ruptured nimodipine subarachnoid hemorrhage
fascia iliaca block versus intravenous dexmedetomidine and ketamine for positioning fracture femur

Conditions: Pain; Analgesia

Summary: proximal femur fractures are one of the commonest fractures especially in the elderly population. early surgical fixation is the best analgesic for associated pain. spinal anesthesia has been favored by many anesthesiologists due to the simplicity of the technique, the better analgesic profile, and the lower incidence of complications like delirium and thromboembolic events. however, severe pain, encountered during positioning for spinal anesthesia, can complicate the technique and worsen the patient experience. the study aim to compare the analgesic effect of intravenous dexmedetomidine and fascia iliaca block preoperatively to assist positioning patients for performance of spinal anesthesia.


Eligibility criteria:
inclusion criteria: 1. aged 18-60 years. 2. hip fractures 3. both sexes. exclusion criteria: 1. patient refusal 2. allergy to local anesthetics 3. bleeding diathesis or history of anticoagulant use. 4. impaired cognition or dementia 5. . infection of the skin at the site of needle punctures area 6. multiple fractures 7. any previous analgesic administration during the last 12 hours
peer delivery of hiv self test to improve linkage to hiv prevention

Conditions: HIV

Summary: hypothesis: hiv-self-test (hiv-st) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into hiv prevention and care services. design: a cluster randomized control trial comparing two models of peer delivery of hiv-st, through incentivized respondent driven peer networks and direct distribution by peer navigators compared to standard of care (referral to hiv testing, prevention and care services by peer navigators) in improving the uptake of hiv prevention and care amongst young women (18-24) living in the rural umkhanyakude district of kwazulu-natal, south africa. objectives: 1. to increase the knowledge of hiv status among young women aged 18-24 years old through distribution of hiv-st through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into hiv testing services. 2. to determine an increase in the rate of linkage among young women aged 18-24 to hiv prevention and treatment services facilitated by distribution of hiv-st through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services. 3. to conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to hiv prevention and treatment services of hiv-st distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services. 4. to measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized hiv-st delivery system or direct distribution of hiv-ss by peer navigators, compared to peer navigator referring into services. primary outcomes: the difference between the rate of linkage within three months of 18-24 years old women to hiv confirmatory testing and pre-exposure prophylaxis (prep) eligibility screening if hiv-negative and antiretroviral treatment (art) starting if hiv-positive. it will be between the two peer-delivery approaches to hiv-st distribution (incentivized hiv-st delivery through peer network and direct distribution of hiv-st by peer navigators) compared to standard of care (peer navigator referral to hiv testing, treatment and prevention services). rate is defined as the number of linkages per month of peer navigator outreach activity.


Eligibility criteria:
inclusion criteria: * females * aged 18-24 years * not currently on art * provide written informed consent exclusion criteria: * under 18 years or older than 24 years * participants not willing to consent or unable to provide informed consent * males * currently on art
pulmonary rehab, dyspnea, walk and step testing in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a multi-site collaborative study that will be done in the context of three quebec hospitals' outpatient pulmonary rehabilitation programs: montreal chest institute; university of laval, and hopital sacre-coeur montreal. the objectives are two-fold. first, to determine the minimal clinical important difference in intensity ratings of perceived breathlessness for each of the 3-min constant rate shuttle walking (3-mwt) and stair stepping (3-mst) protocols in patients with chronic obstructive pulmonary disease (copd). second, to test the hypothesis that both the 3-mwt and 3-mst protocols are able to detect statistically significant and clinically-meaningful improvements in exertional breathlessness following an 7-12 week outpatient rehabilitative exercise training program in copd.


Eligibility criteria:
inclusion criteria: * male or female * ambulatory * moderate-to-very severe copd (gold stage 2-4) exclusion criteria: * respiratory exacerbation in the previous 6 weeks * change in medication dosage/frequency in the previous 6 weeks * clinical evidence of asthma * cardiovascular and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation * any other contraindications to exercise training/testing

Keywords: pulmonary rehabilitation 3-minute constant rate shuttle walk test 3-minute constant rate step test dyspnea
telehealth cognitive behavioral stress management for adults with cystic fibrosis

Conditions: Anxiety; Depression; Stress; Coping Skills; Cystic Fibrosis

Summary: the purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (cbsm) intervention among adults with cystic fibrosis (cf) who exhibit elevated anxiety and/or depression symptoms.


Eligibility criteria:
inclusion criteria: * at least 18 years old * fluent in english * diagnosed with cystic fibrosis * colorado resident * access to personal device (smart phone, computer, tablet) with 1) reliable internet connection, and 2) a built-in web camera and microphone or the capability to install a study-provided web camera and microphone * regular access to a private location with sufficient lighting that is free from distractions or intrusions to use during telehealth sessions * access to private email to complete surveys * mild anxiety and/or depression symptoms (i.e., a score of 5 or higher on the generalized anxiety disorder 7 item scale (gad-7) and/or the patient health questionnaire 9 item scale (phq-9)) exclusion criteria: * currently receiving therapy or counseling with an outside provider for a mental health condition * currently in treatment for alcohol or substance abuse * unstable medical condition (not including cystic fibrosis) * neurological disease * pregnant women * active suicidal intent or plan (a score of 1 or higher on the suicide severity scale)
frequency of reduced leaflet motion after surgical aortic valve replacement and transcatheter aortic valve replacement.

Conditions: Aortic Valve Disorder

Summary: this is a prospective, randomized pilot study in patients undergoing sugical aortic valve replacement (savr) and transcatheter aortic valve replacement (tavr) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.

this will be a pilot prospective randomized controlled trial.the study will enroll 50 adult patients scheduled to undergo savr and 50 adult patients scheduled to undergo tavr. subjects who satisfy inclusion/exclusion criteria will be approached for informed consent. those who give informed consent will be enrolled. after induction of anesthesia, a computer program will be used to randomize patients to one of the 2 treatment groups. 1. savr patients will get either warfarin or aspirin 2. tavr patients will get either warfarin or aspirin. patients will be seen at 4-6 weeks postoperatively for transthoracic echo (tte), 4 dimensional (4d), multidetector computed tomography (mdct) scan and review of medical history. phone follow up at 6,9 and 12 months post-operatively. data from this pilot study will enable us to determine the feasibility of a larger randomized controlled clinical trial to investigate the phenomenon of reduced leaflet motion/subclinical valve thrombosis and, possibly, its clinical importance

Eligibility criteria:
inclusion criteria: scheduled for savr or tavr * age \> 18 years * able and willing to give informed consent * able and willing to return for follow up exclusion criteria: * contraindications to warfarin, plavix or aspirin * pre-existing medical indication for warfarin, plavix or aspirin * history of previous cardiac surgery * history of previous coronary artery stenting * requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm * contraindications to contrast-enhanced mdct including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (gfr \< 60 ml/min).