Kornimate/medical-research-clean huggingface dataset:
alcohol's impact on inflammatory markers in hiv disease - russia arch cohort

Conditions: HIV Infection; Alcohol Use

Summary: the purpose of this study is to assess the longitudinal association between alcohol consumption and biomarkers of microbial translocation (scd14) and inflammation/altered coagulation (il-6/d-dimer); to establish a cohort of hiv-infected russian drinkers; and to establish a sample repository.

heavy alcohol consumption in an hiv-infected person may accelerate hiv disease progression and end organ disease with one leading explanatory pathway being via enhanced microbial translocation and inflammation/altered coagulation. heavy alcohol consumption and hiv infection are both causes of microbial translocation, the process by which bacterial products leak across the gastrointestinal membrane with resultant destructive immune activation. among hiv-infected people, high levels of microbial translocation (as measured by soluble cd14) and inflammation/altered coagulation (as measured by il-6 and d-dimer) are each associated with an increased risk of death. of importance, among hiv-infected persons, heavy drinking is also significantly associated with higher levels of d-dimer in cross-sectional studies. of note, initiation of antiretroviral therapy (art) is associated with a reduction in d-dimer levels. yet the following is not known: is there a longitudinal relationship between alcohol consumption and these biomarkers independent of art? thus, as part of the uganda, russia, boston alcohol network for alcohol research collaboration on hiv/aids (urban arch)consortium, the investigators seek to create the russia arch cohort (n=375) from participants of a recently completed niaaa-funded randomized controlled trial (rct) of hiv infected russian heavy drinkers. the investigators will be collecting blood from participants at baseline, and at 12- and 24-months post enrollment. in addition to collecting and storing blood samples the investigators will be administering surveys to participants at all 3 timepoints. the investigators will conduct phone interviews with participants at 6- and 18-months post enrollment. the investigators will conduct laboratory tests on the stored samples, including measures of microbial translocation (scd14) and inflammation/altered coagulation (il-6/d-dimer) and peth. this study will clarify the association between alcohol and key biomarkers over time in hiv-infected heavy drinkers. in addition, the investigators will be collecting and storing blood samples from participants in the study to use for the analyses specified and for future studies looking at hiv-infected heavy drinkers.

Eligibility criteria:
inclusion criteria: * age 18-70 years old * hiv-infected * provision of contact information for two contacts to assist with follow-up * stable address within st. petersburg or districts within 100 kilometers of st. petersburg * possession of a home or mobile phone * art-naive at the time of enrollment exclusion criteria: * not fluent in russian * cognitive impairment resulting in inability to provide informed consent

Keywords: hiv alcohol use microbial translocation inflammation altered coagulation russia
exercise and physical activity in adults with acquired brain injury

Conditions: Acquired Brain Injury

Summary: exercise and physical activity in adults with acquired brain injury

although emerging approaches have emerged in the design of interventions that promote an orientation towards physical activity scientific evidence on their efficacy in this particular population remains limited. this underscores the need for further research to evaluate the efficacy of these intervention approaches in the context of abi.

Eligibility criteria:
inclusion criteria: * aged more than 18 years of age and present a medical diagnosis of acquired brain injury. * have the informed consent completed and signed * present a state that allows following indications for the practice of exercise and physical activity. exclusion criteria: * have medical comorbidities that contraindicate the safe performance of the program (i.e., cardiac or respiratory instability, uncontrolled seizures). * have additional disabling conditions, such as cognitive impairment and/or an inability to communicate with the researcher verbally, in writing, or through an emissary.

Keywords: acquired brain injury physical activity intervention
effect of a program of physical activity and nutritional therapeutic education in breast cancer patients

Conditions: Breast Cancer

Summary: this multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.

the experimental arm "apad": tailored pa program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment the experimental program will include: * 8 pa sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week. * 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment. the control arm: standard of care

Eligibility criteria:
inclusion criteria: * female patient with histologically proven breast cancer * age ≥18 years old * patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 fec100, or 3fec100 + 3 taxanes) followed by radiotherapy * satisfactory healing from surgical act on breast and lymph nodes * ability to understand the nature, goal and study methodology * consent to cooperate for clinical assessments * affiliation to a social security regime or beneficiary of equivalent social protection * written informed consent provided before any study specific procedures exclusion criteria: * metastatic disease * any other primary tumor * contra-indication to moderate physical activity: unchecked high blood pressure; family history of sudden death in a first degree relative; not stabilized heart disease; acute or chronic lung disease resulting in dyspnea for moderate effort; uncontrolled diabetes, carrying a stent; other severe pathologies unstabilized, disabled or not indicated to physical practice. * contra-indication to adjuvant chemotherapy or radiotherapy * pregnancy or breast feeding (according to the recommendations of the usual adjuvant breast cancer) * inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions * legal inability or restricted legal ability

Keywords: physical activity nutrition therapeutic education breast cancer
safety and efficacy study of vp20621 for prevention of recurrent clostridium difficile infection

Conditions: Clostridium Difficile Infection

Summary: the objectives of this study are: (1) to evaluate the safety and tolerability of vp 20621 dosed orally for up to 14 days in adults previously treated for cdi; (2) to characterize the frequency and duration of stool colonization with the vp 20621 strain of c. difficile; (3) to evaluate the efficacy of vp 20621 for prevention of recurrence of cdi; and (4)to select a dose regimen of vp 20621 to be used in future studies.


Eligibility criteria:
inclusion criteria: 1. adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study. 2. subjects who are experiencing a first event or first recurrence of clostridium difficile (cdi) within the last 28 days and have been successfully treated with an antibiotic for cdi. 3. subjects who are medically stable. 4. subjects who are willing and able to comply with the study procedures and visit schedules outlined. 5. if female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control. exclusion criteria: 1. subjects who have had more than 2 episodes of cdi within the last 6 months. 2. subjects who have been diagnosed with inflammatory bowel disease,active irritable bowel syndrome, celiac disease, active gastroparesis, toxic megacolon. 3. gi surgery within 6 weeks before the day of randomization 4. have known immunodeficiency disorder, such as hiv infection 5. pregnant or breast feeding females. 6. concurrent acute life-threatening diseases. 7. inability to tolerate oral liquids. 8. have an absolute neutrophil count \< 1000/mm3 at screening

Keywords: diarrhea clostridium difficile clostridium infections signs and symptoms digestive bacterial infections pharmacologic actions
chemotherapy and radiotherapy to treat patients with limited stage of small cell lung cancer (sclc)

Conditions: Small Cell Lung Cancer

Summary: this is a multicenter, phase ii, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with limited stage of small cell lung cancer

two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[iv\] infusion) and carboplatin (target area under the curve \[auc\] 5 iv infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 iv infusion) and carboplatin (target auc 5 iv infusion) with concurrent radiotherapy (2 gray \[gy\] per fraction, 5 fractions per week, up to a dose of 50 gy is administered).

Eligibility criteria:
inclusion criteria: * histologic and/or cytologic diagnosis of limited stage of small cell lung cancer * measurable disease * good performance status * adequate bone marrow reserve, hepatic, pulmonary and renal functions exclusion criteria: * serious concomitant systemic disorder * prior chemotherapy for this cancer and/or prior thoracic radiotherapy * pregnancy/breast-feeding * significant weight loss over the previous 6 weeks before study entry * inability or unwillingness to take vitamin supplementation and corticosteroids
vietnam era twin (vet) registry

Conditions: Cardiovascular Diseases; Blood Disease; Heart Diseases; Lung Diseases

Summary: to conduct a baseline survey on cardiovascular, respiratory, and other major systemic disease and risk factors in members of the vietnam era twin registry.

background: the vietnam veteran twin registry, maintained by the nas-nrc, was created with funding from the veterans administration. department of defense records were searched for subjects born between 1939-1957 and having the same last name and date of birth. follow-up of induction records determined if the subjects were twins. the registry supplemented the older world war ii veterans twin registry supported by the national heart, lung, and blood institute. the new registry provided an opportunity to create a resource with black and hispanic twins as well as whites. the new registry also included data on greater educational, socioeconomic, and lifestyle diversity than was available in the world war ii veterans twin registry. design narrative: during the first year a mailed questionnaire was designed which provided baseline data on family history, body size, morbidity, psychosocial characteristics, smoking, alcohol consumption, diet, physical activity, and drug use. the baseline data were used for analysis of cardiovascular, pulmonary, and blood diseases, and for follow-up. from the original survey, the veterans administration provided magnetic tape data on zygosity, smoking, alcohol consumption, heart, lung, and blood diseases, discharge rank, education, occupation, and family income. the questionnaire was completed by almost 8,900 individuals including over 3,000 twin pairs. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
no eligibility criteria
single dose versus multiple doses of dexamethasone in children with acute bronchiolitis

Conditions: Bronchiolitis

Summary: this study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the emergency department


Eligibility criteria:
inclusion criteria: * infants 2 to 24 months of age * acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress * moderate to severe baseline disease severity (respiratory distress index (rdai) score 6 to 15) * only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized exclusion criteria: * previous wheezing and/or bronchodilator therapy * hospitalization at 240 minutes * critically ill patients needing airway stabilization * patients with low or very high baseline disease severity (rdai \ 16) * patients under 8 weeks of age * patients on corticosteroids prior to arrival at emergency department * contact with varicella within 21 days * past history of ventilation for greater than 24 hours * existing cardiopulmonary disease, multisystem disease or immunodeficiency * insufficient command of the english language

Keywords: bronchiolitis pediatrics corticosteroids
the role of butirprost® in combination with antibiotics in chronic bacterial prostatitis (cbp) treatment

Conditions: Prostate Inflammation; Prostate Disease; Chronic Bacterial Prostatitis

Summary: bacterial prostatitis (bp) is a common prostatic infection characterized by pain and urinary symptoms, often with negative bacterial cultures from prostatic secretions. it affects young and older men bimodally and significantly impacts quality of life (qol). treatment typically involves antibiotics, but a multimodal approach with additional nutraceuticals may enhance outcomes. this work aims to assess the efficacy of butirprost® in association with fluoroquinolones in patients with chronic bacterial prostatitis (cbp).


Eligibility criteria:
inclusion criteria: * patient aged between 18 and 50 years * symptoms consistent with cbp * positive mears-stamey test exclusion criteria: * patients younger than 18 years * history of neurological disease, urinary stones or cancer * allergy to fluoroquinolones or any components of butirprost® * post-void residual \> 50 ml * use of alpha-blockers or 5-alpha-reductase inhibitors (5-ari) * previous prostatic surgery, antibiotic treatment within four weeks prior to the study * refusal to provide informed consent and incomplete follow-up data * patients testing positive for certain pathogens like chlamydia trachomatis (ct), ureaplasma urealyticum, neisseria gon-orrhoeae, herpes simplex virus types 1 and 2 (hsv-1/2), and human papillomavirus (hpv)

Keywords: bacterial prostatitis antibiotics luts qol ipss hyaluronic acid
trilogy ab acetabular hip system post approval study

Conditions: Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Traumatic Arthritis

Summary: this is a post-approval study with prospective enrollment in the united states and a retrospective enrollment outside the united states to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the zimmer trilogy ab acetabular hip system.

to obtain functional, quality of life and radiographic data to evaluate the clinical performance of the zimmer trilogy ab acetabular hip system in primary total hip replacement surgery.

Eligibility criteria:
inclusion criteria: * non-obese patients * the patient is a good candidate for a primary hip arthroplasty using the zimmer trilogy ab acetabular hip system. * patient is willing and able to give informed consent to participate in the follow-up program. * patient is suitable for surgery and able to participate in the follow-up program. exclusion criteria: * skeletally immature * rheumatoid arthritis * osteoradionecrosis * infection * nerve or muscle disease that may have a negative affect on gait or weight bearing * loss of abductor musculature in the affected limb * poor bone stock * poor skin coverage around the hip joint * rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray * previous total or cemented hemi-arthroplasty of the affected hip * previous pinning or plating of the affected hip * patients with heavy labor jobs or extreme activity levels * patients who participate in sports activities or require deep flexion * patients who are obese * patients who have other disabilities * patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.

Keywords: arthritis total hip ceramic hip replacement total hip arthroplasty (tha) joint disease
an open-label, non-randomized trial to evaluate the tolerability and safety of viramune (nevirapine) in adult and pediatric patients with progressive hiv disease

Conditions: HIV Infections

Summary: to provide access to viramune and to evaluate the tolerance and safety of viramune in patients with progressive, symptomatic hiv disease who failed or are intolerant to currently approved treatment for hiv-1 infection and who are unable to participate in another viramune controlled clinical trial and have a compelling need for anti-hiv treatment.

eligible adult patients (\>= 13 years of age) will receive treatment with viramune once daily for 2 weeks and then twice daily. eligible pediatric patients (\< 13 years of age) will receive a lower dose of viramune once daily for 2 weeks and then twice daily. all patients will receive viramune with or without concomitant antiretroviral therapy. patients will be evaluated at weeks 2, 4, 8, 16, 24, 32 and every 8 weeks thereafter. per amendment 01/31/97: enrollment closed to adult patients. as of 1/31/97 only enrolling pediatric patients.

Eligibility criteria:
inclusion criteria patients must have: * patients \> 18 months of age with history of positive serology for hiv-1 infection or patients \<= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture. * patients \>= 13 years of age with a cd4+ cell count \ =20%. * patient has failed or is intolerant to currently approved treatments for hiv-1 infection and is unable to participate in a controlled viramune clinical trial. * written and informed consent from a parent or guardian for patients \< 18 years of age. * patient or guardian is willing and able to follow protocol requirements. (per amendment 1/29/97: * enrollment is closed to adults, as of jan. 29th only pediatric patients will be enrolled.) exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: patient qualifies for participation in an actively accruing viramune controlled clinical trial. concurrent medication: excluded: * dicumarol, warfarin, and other anticoagulant medications. * tolbutamide. * investigational drugs, all protease inhibitors, and all other non-nucleoside transcriptase inhibitors. * neurotoxic drugs. * cimetidine. * erythromycin. required: patient has failed or is intolerant to currently approved treatments for hiv-1 infection.

Keywords: nevirapine reverse transcriptase inhibitors anti-hiv agents
transcutaneous spinal cord stimulation and robotic therapy

Conditions: Spinal Cord Injuries

Summary: lumbosacral spinal stimulation activates the neural network involved in the control of locomotion at the spinal level. however, its effects are limited to the production of robust rhythmic patterns of alternating movement, being currently in the absence of therapeutic value. on the other hand, the use of robotic technology for gait rehabilitation has experienced significant growth during the last years and its clinical efficacy is similar to others traditional interventions.

spinal cord injury (sci) often results in complete or partial paralysis below the level of lesion, having a profound physical, psychological and socioeconomic impact on the affected person's life. between the different approaches for the rehabilitation of sci, we can find robot therapy. robot-assisted gait training has emerged as a promising therapy for improving walking ability, balance and motor function in neurological patients. the underlying principle of this therapy is based on the execution of repetitive and task-specific training able to generate appropriate afferent inputs, activating the central pattern generators in the lumbosacral spinal cord. another novel therapy is the use of transcutaneous spinal cord stimulation (tscs), applied through self-adhesive electrodes in the skin. tscs activates similar mechanisms than epidural stimulation and is able to stimulate the spinal locomotor circuits in sci patients. it allows the activation of rhythmic, flexo-extension movements in the paralyzed lower limbs. the aim of this study is to analyze the feasibility, safety and efectiveness of a program of 20 sessions of 30 hz-tscs applied over t11-12 intervertebral space combined with lokomat training in patients with incomplete sci.

Eligibility criteria:
inclusion criteria: * ais c or d. * 2-6 months after injury. * neurological level of injury between c4-t11. * ashworth less or equal 2. * penn less or equal 2. * to understand and to sign the informed consent. exclusion criteria: * metal implants over t11-t12 * electronic device implants. * epilepsy * allergy to the electrode material * pregnancy * concomitant pathologies * pathology or fracture of the lower limbs * musculoskeletal injury in the lower limbs * lower limbs dysmetria

Keywords: neuromodulation spinal cord injury robotics transcutaneous spinal cord stimulation lokomat
intratumoral cd3+ and nkp46+ cells in colorectal liver metastases

Conditions: Colorectal Liver Metastases

Summary: the long-term outcome of patients resected for colorectal liver metastases (clm) after neoadjuvant chemotherapy (cht) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the cht. the aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for clm after cht in regards to the long-term outcome.

the immunoreactivity to cd3+ and nkp46+ cells inside the tumor, at the border between the tumor and the normal liver, and inside the normal liver will be tested by computer-assisted image analyses in patients undergoing liver resection for clm between 2005 and 2013 preoperatively treated with oxaliplatin or irinotecan with or without bevacizumab or cetuximab. the survival will be assessed in relation to several prognostic factors and to that immunoreactivity.

Eligibility criteria:
inclusion criteria: * histological proven colorectal liver metastases * complete clinical, surgical, pathological and follow-up data exclusion criteria: * non-radical surgery * incomplete clinical, surgical, pathological and follow-up data

Keywords: nk-cells t-cells
pilot-tart cherry, mitral transcriptome, and poaf incidence

Conditions: Post-operative Atrial Fibrillation (POAF)

Summary: assess impact of tart cherry concentrate in cardiac surgical patients on poaf and related clinical and economic outcomes. measure inflammation gene transcripts in cardiac tissue.


Eligibility criteria:
inclusion criteria: 1. males and female patients (age 50-79) at the mitral valve clinic/cvc undergoing elective cardiac surgery for mitral valve repair without the cox maze procedure (mvr patients also undergoing cabg and/or tricuspid valve repair are also eligible) 2. in sinus rhythm (no pre-operative atrial fibrillation, no hx of af) exclusion criteria: 1. age ≥ 80 years 2. diagnosed pre-operative chronic or paroxysmal af 3. prior ablation procedure for af 4. previous cardiac surgery 5. implanted pacemaker 6. active smoker 7. comorbidities such as congenital or cardiac re-operation 8. use of antiarrhythmic agents 9. active inflammatory or infectious disease or malignancy 10. diagnosed autoimmune disease 11. corticosteroid or other immunomodulatory or immunosuppressive medication 12. known sensitivity to sorbitol 13. known gastric sensitivity to acidic juices like orange juice