Kornimate/medical-research-clean huggingface dataset:
study to evaluate safety, tolerability, and immunogenicity of candidate human cytomegalovirus vaccine in healthy adults

Conditions: Cytomegalovirus Infections

Summary: the purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.

this study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (cmv) vaccine (0.5 μg gb content with aluminum phosphate (alum), 1.0 μg glycoprotein b (gb) content with alum, 2.0 μg gb content with alum, or 1.0 μg gb content (without alum) as compared with placebo in approximately 125 healthy cmv-seronegative volunteer participants between 18 and 40 years of age.

Eligibility criteria:
inclusion criteria: 1. generally healthy adult female and male 18 to 40 years of age, inclusive; 2. serologically confirmed to be cmv seronegative at screening; 3. female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator 4. sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study exclusion criteria: 1. history of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results 2. clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator 3. previous receipt of any cytomegalovirus vaccine 4. history of allergic reactions or anaphylactic reaction to any vaccine component 5. pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine 6. known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or hiv/aids 7. chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). inhaled and topical steroids are allowed 8. participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study 9. any skin abnormality or tattoo that would limit post-vaccination injection site assessment 10. any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease 11. are family members of study center staff

Keywords: vbi-1501a vbi-1501 prophylactic vaccine virus diseases cytomegalovirus (cmv) cytomegalovirus infections cytomegalovirus vaccines herpesviridae infections phase 1 human herpesvirus 5 (hhv5) vaccines, virus-like particle (vlp) enveloped virus-like particle (evlp)
prevalence of nonalcoholic fatty liver disease (nafld) and nonalcoholic steatohepatitis (nash) utilizing ultrasound and percutaneous liver biopsy

Conditions: Fatty Liver

Summary: prospective determination of the prevalence of non-alcoholic fatty liver disease (nafld) and non-alcoholic steatohepatitis (nash)in a primary care setting using ultrasound and percutaneous liver biopsy.

patients between the ages of 18 and 70 years who are eligible for care at brooke army medical center are considered for enrollment. after obtaining informed consent, a baseline questionnaire is given to patients who present to the primary care clinic for routine clinic visits or during colon cancer screening classes within the gastroenterology clinic. the questionnaire includes information about the patient's past medical history to include: known history of chronic liver disease, current medications, current and past alcohol ingestion, dietary habits that included consumption of fructose containing beverages and frequency of fast food visits. patients are excluded if they are found to have a history of chronic liver disease, hiv, on medications that are associated with a fatty liver, or consumption of more than 20 grams of alcohol per day. right upper quadrant ultrasound will then be performed to determine if there is evidence of fatty liver disease. all patients with a positive ultrasound for hepatic steatosis are then offered a liver biopsy after obtaining fasting blood work that included a complete blood count, coagulation studies, liver function tests, fasting lipid panel, glucose and insulin. patients with a negative ultrasound for fatty liver are not referred for liver biopsy and are considered as completed study patients. serum is also stored for adipokine and cytokine analysis. a study investigator using a 14g bard monopty biopsy gun will perform the liver biopsy. a single expert hepatopathologist will review all liver biopsies and utilize the brunt system (9) for grading and staging of steatohepatitis if present.

Eligibility criteria:
inclusion criteria: * patients 18 to 70 years of age were recruited from the primary care clinics or the gastroenterology clinic at brooke army medical center. after completing a baseline questionnaire, all patients had a right upper quadrant ultrasound. if fatty liver was identified, then laboratory data and a liver biopsy were obtained. exclusion criteria: * etoh consumption over 20 grams/day * known fatty liver disease, chronic liver disease, hiv, or medication ingestion associated with fatty liver disease

Keywords: fatty liver disease
clinical outcomes and routine management of adults with chronic lymphocytic leukaemia treated with idelalisib and rituximab in the united kingdom (uk) and ireland

Conditions: Chronic Lymphocytic Leukaemia

Summary: the primary objective of this study is to evaluate the effectiveness of idelalisib and rituximab in adults with chronic lymphocytic leukaemia (cll) in a real world setting


Eligibility criteria:
inclusion criteria: * diagnosis of cll documented within medical records * individuals who have received treatment for cll with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation at the time of starting idelalisib treatment * idelalisib and rituximab initiated on or before 31 december 2017 exclusion criteria: * individuals who received idelalisib as part of an interventional clinical trial * individuals who received idelalisib for other indications including follicular lymphoma (fl) * individuals who previously received idelalisib in combination with ofatumumab * use of idelalisib which is not in accordance with its marketing authorisation at the time of starting idelalisib treatment

Keywords: idelalisib zydelig
investigation of the effectiveness of core stabilization training in patients with subacromial impingement syndrome

Conditions: Subacromial Impingement Syndrome

Summary: subacromial impingement syndrome (sss) is one of the most common shoulder problems. the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. the decrease in core stabilization affects both trunk control and the quality of extremity movements depending on the kinetic chain in the body. the improvement in core stabilization balances the load transfer between the trunk and the extremities and reduces the asymmetry between the extremities. core stabilization training should be included in rehabilitation programs as core stabilization is adversely affected in patients with cns. for this reason, this study was planned to examine the effects of core stabilization training applied in addition to conventional treatment in patients with cns on pain, range of motion, upper extremity function and core stability.


Eligibility criteria:
inclusion criteria: * being diagnosed with subacromial impingement syndrome, * being between the ages of 18-65, * not having received medical treatment, * not having received a shoulder-related physiotherapy program in the last 1 year, * not having undergone any shoulder-related surgery, * being able to read and understand turkish exclusion criteria: * neurological deficits of the upper extremity and the presence of another orthopedic disease, rheumatic and congenital disease other than cns * presence of mental problems, * to have received corticosteroid treatment in the last year, * having cardiovascular and systemic diseases that prevent work, * pregnancy, * those with communication problems

Keywords: subacromial impingement syndrome core stabilization training core stability pain range of motion upper extremity function subacromial impingement impingement core stabilization exercises core stability exercises
physical activity and protein supplementation after bariatric surgery (papab)

Conditions: Bariatric Surgery Candidate

Summary: the purpose of this study is to determine wether regular physical activity in combination with protein supplementation after bariatric surgery can reduce the loss of muscle mass and wether a computer-assisted exercise program is more effective than a usual exercise program regarding frequency of physical activity, fitness and muscular strength.

bariatric surgery has become a major treatment option for severe obesity in adults. despite the advantages of bariatric surgery, attention needs to be paid to the possible risks following the surgical treatment. postoperative risks include protein deficiency and pronounced muscle mass loss. indeed, numerous studies indicate a significant reduction in lean body mass resulting from protein deficiency after bariatric surgery. dietary proteins have shown to play an important role in body weight regulation. a protein-rich diet attains satiety and thereby facilitates reduction in overall energy intake. it has also shown to enhance food-induced thermogenesis. furthermore, a protein-rich diet - ideally in combination with exercise - preserves lean body mass and thus resting energy expenditure leading to an improvement of long-term energy balance. therefore, protein-rich diets or protein supplements, respectively, might facilitate weight loss, especially body fat loss and protect against loss in muscle mass in patients who underwent bariatric surgery. the aim of the present randomized, placebo-controlled, double blind pilot study was to test the possible benefit of proteins in combination with exercise in patients undergoing bariatric surgery, and to examine, whether computer-assisted exercise is advantageous when comparing it to a usual exercise program using written exercise instructions. therefore, we study the influence of postoperative protein supplementation in combination with computer-assisted exercise on body composition changes, and body weight reduction, as well as physical fitness, protein status and muscle function in obese patients after bariatric surgery.

Eligibility criteria:
inclusion criteria: * age of 18 - 65 years * body weight of ≤ 150 kg * bmi \> 35 kg/m2 * indication for laparoscopic sleeve gastrectomy and laparoscopic roux-en-y gastric bypass. the decision about the type of surgery is performed independent of the study by the surgeons in charge according to the german s3 guideline. exclusion criteria: * kidney diseases of any kind * serious gastrointestinal diseases (e.g. morbus crohn, colitis ulcerosa, etc.) * serious musculoskeletal diseases * serious heart diseases (myocardial infarction, stent implantation, stroke, etc.) * intake of blood thinning medicine (e.g. ass, marcumar, etc.)

Keywords: bariatric surgery protein supplementation physical activity muscle mass weight loss physical fitness muscle strength
post-approval study of the duraloc® option ceramic-on-ceramic hip prosthesis system

Conditions: Non-inflammatory Joint Disease; Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Post-traumatic Arthritis

Summary: this study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available duraloc® option ceramic-on-ceramic hip prosthesis system.

this two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase. the duraloc® option ceramic-on-ceramic hip prosthesis system consists of: 1. a modular ceramic bearing insert that secures to a titanium metal alloy duraloc® option acetabular shell via a taper locking mechanism; and 2. a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.

Eligibility criteria:
inclusion criteria: * skeletally mature * provide informed consent * sufficient acetabular and femoral bone stock to seat the prosthesis * willing and able to return for follow-up as specified by the study protocol * willing and able to complete the hip outcomes questionnaire and quality of life survey (sf12) * undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis. exclusion criteria: * diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc. * active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc. * loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation. * poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant. * morbid obesity * involvement in high levels of activity or participation in active sports * involvement in heavy manual labor employment * increased likelihood of falls due to concomitant illnesses or impairment * pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser * diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant * known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. paget's disease, charcot's disease) * known presence of active metastatic or neoplastic disease * known allergic reactions to implant materials (e.g. ceramic, metal) * known history of tissue reactions to implant corrosion or implant wear debris * disabilities of other joints that impedes evaluation (e.g. knees, ankles) * known presence of highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis etc.) * previous prosthetic hip replacement device (any type including tha, surface replacement arthroplasty, endoprosthesis etc.)

Keywords: total hip replacement, total hip arthroplasty
intralipid therapy for women 35-40 years with positive natural killer cells undergoing intracytoplasmic sperm injection (icsi)

Conditions: Infertility

Summary: intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. it provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. the effects of intralipid in suppressing natural killer cell activity (nka) were found to be comparable to intravenous immunoglobulin (ivig) by laboratory experiments.we will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells


Eligibility criteria:
inclusion criteria: subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing intracytoplasmic sperm injection (icsi ) cycle. exclusion criteria: * women above 40years or less than 35 years * disturbances of normal fat metabolism such as pathologic hyperlipidemia,lipoid nephrosis or acute pancreatitis with hyperlipidemia. * allergic to eggs, soybean oil, or safflower oil. * severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder. * uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx. * antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (immunoglobulin g or m)\[igg or igm\]); other recognised thrombophilic conditions (testing according to usual clinic practice). * intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). * fibroids distorting uterine cavity. * abnormal parental karyotype.

Keywords: infertility intralipid invitro fertilization repeated implantation failure repeated miscarriage
effects of xanthophylls on optical density

Conditions: Age-Related Macular Degeneration

Summary: the objective of the study was to investigate the influence of a intervention with lutein und zeaxanthin from crucifers on the optical density of the macular pigment of patients with non exudative age-related maculopathy. it is hypothesized that the applied study beverage elevates plasma concentrations of the administered xanthophylls and the optical density after 4 weeks of intervention.


Eligibility criteria:
inclusion criteria: * patients with non exudative age-related maculopathy exclusion criteria: * intake of dietary supplements containing lutein and zeaxanthin

Keywords: human study amd lutein zeaxanthin optical density
sequence of midurethral sling placement during robotic sacrocolpopexy

Conditions: Stress Incontinence Female; Pelvic Organ Prolapse

Summary: this study looks at the best time to place a midurethral sling (mus), which is a small piece of mesh used to treat stress urinary incontinence (sui) (leaking urine when you cough, laugh, or exercise). the sling is placed during a type of surgery called robotic sacrocolpopexy (rsc). this surgery helps fix pelvic organ prolapse, when organs like the bladder or uterus drop from their normal place. doctors can place the sling either before or after they lift and support the top of the vagina during surgery, but they aren't sure which timing works better. in this study, investigators are comparing what is the best time to place the sling, how the patient feels after surgery and if a patient's symptoms got better or worse.

investigators will conduct a prospective, randomized, noninferiority trial on patients undergoing retropubic midurethral sling (rp mus) placement at the time of robotic-assisted sacrocolpopexy (rsc). patients scheduled to undergo retropubic midurethral sling placement at the time of robotic- assisted sacrocolpopexy will be invited to participate during regularly scheduled preoperative visits with their urogynecologic provider. participants will be randomized to receive rp mus before rsc or after rsc. randomization will be conducted in redcap. randomization will be performed using a variable permutated block randomization scheme. the randomization window will be +/- 4 days before their scheduled surgery, and patients will be blinded to sequence of mus placement intraoperatively.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * able to speak and read english and spanish * diagnosis of pelvic organ prolapse stage 2-4 * planning to undergo a robotic-assisted sacrocolpopexy * demonstrable sui (either by cst, with or without prolapse reduction, or uds) within the year prior to enrollment * planning to undergo concomitant sui correction with mus at the time of rsc exclusion criteria: * less than 18 years of age * unable to speak and read english or spanish * no diagnosis of sui (prophylactic slings) * history of prior surgery for sui * bladder capacity \ 150 ml * current genitourinary fistula or urethral diverticulum

Keywords: stress incontinence pelvic organ prolapse midurethral sling sucess rates complication rates patient satisfaction
genetic identification of monogenic disorders in early-onset stroke using targeted next generation sequencing panel

Conditions: Stroke, Acute; Transient Ischemic Attack; Single-gene Disorders

Summary: the study was designed as a multicenter multiracial prospective observational study of acute ischemic stroke and tia patients across china. the purpose of this study is to determine the monogenic disorders incidence of chinese early-onset stroke patients. we plan to consecutively enroll more than 500 patients with early-onset stroke(in the 18- to 45-year age range) admitted in stroke units within 7 days after symptoms onset in participating centers. these early-onset stroke patients are referred for targeted sequencing using 'cerebrovascular disease panel'. by analyzing the sequencing results, we intend to identify monogenic causes causing early-onset stroke and develop clinical algorithms that might assist the clinician in deciding in which early-onset stroke patients testing for monogenic causes of stroke.

the study was designed as a multicenter multiracial prospective observational study of acute ischemic stroke and tia patients across china. the purpose of this study is to determine the monogenic disorders incidence of chinese early-onset stroke patients. we plan to consecutively enroll more than 500 patients with early-onset stroke(in the 18- to 45-year age range) admitted in stroke units within 7 days after symptoms onset in participating centers. patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be referred for targeted sequencing using 'cerebrovascular disease panel'. when one or multiple pathogenic or possible pathogenic exonic mutations are found, a sanger sequencing (ss) on somatic dna from peripheral blood leukocyte of the index case and affected relatives will be performed for the screening of the same mutations. and the sporadic patient's mutations will be checked by ss in the unaffected family members. by analyzing the sequencing results, we intend to identify monogenic causes causing early-onset stroke and develop clinical algorithms that might assist the clinician in deciding in which early-onset stroke patients testing for monogenic causes of stroke.

Eligibility criteria:
inclusion criteria: * provision of informed consent. * female or male aged ≥ 18 years and ≤ 45 years. * acute ischemic stroke or transient ischemic attack((neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset) patients that can be enrolled within 7 days of symptoms onset defined by the"last see normal"principle. exclusion criteria: * asymptomatic brain infarction * neurological deficit due to causes other than ischemic stroke or tia

Keywords: stroke transient ischemic attack targeted sequencing panel early-onset