Kornimate/medical-research-clean huggingface dataset:
efficacy of tenofovir-emtricitabine and efavirenz in hiv infected patients with tuberculosis (anrs129)

Conditions: HIV Infections; Tuberculosis

Summary: successful therapy of both tuberculosis and hiv disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. this study will test the efficacy and safety of a once daily antiretroviral regimen in hiv-tuberculosis coinfected patients.

the proposed research consists of conducting a pilot trial "bkvir" designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive hiv-infected patients. as the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy, we propose to set up systematic, continuous registration of hiv-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial. the initial declaration phase in the register, in addition to facilitating inclusions in the pilot trial, should also allow: 1) a better understanding of the reasons for non-inclusion in the trial, allowing the eligibility criteria to be adjusted if necessary during the trial; and 2) to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy. this research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in hiv-infected patients. the data collected will constitute a unique database on this issue not only in france, but also internationally, which will also be useful to optimize management strategies of these two diseases in developing countries.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * infected by hiv-1 * naive to antiretroviral therapy * presenting an indication to start antiretroviral therapy (according to the recommendations of the delfraissy 2004 report) * histologically or microbiologically confirmed tuberculosis * receiving tuberculostatic therapy for less than three months exclusion criteria: * isolated hiv-2 infection * neoplasm treated by chemotherapy and/or radiotherapy * pregnancy or plans for pregnancy * breastfeeding * contraindication to one of the antiretroviral drugs * atypical mycobacterial infection * hemoglobin below 8 g/dl * neutrophils below 750/mm3 * platelets below 50,000/mm3 * creatinine clearance below 60 ml/min * alkaline phosphatase, asat, alat or bilirubin over 3 times the upper limit of normal

Keywords: hiv infections tuberculosis tuberculosis agents anti hiv agents treatment naive
the effect of lower limb kinetic chain exercise in shoulder impingement

Conditions: Shoulder Impingement Syndrome

Summary: the goal of this clinical trial study is to investigate the effect of performing lower limb kinetic chain exercise on muscle activation of scapular muscle strength ratio in patients with shoulder impingement. the main question it aims to answer is: does the addition of lower limb kinetic chain exercise to a shoulder exercise program improve scapular muscles strength ratio in patients with shoulder impingement? participants will be devided into two groups to be compared: the first group will be given a rehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula) the second group will be given the same exercises in addition to lower limb kinetic chain exercise

the term "kinetic chain" (kc) describes the sequential activation of body segments during functional movement patterns (wilk et al., 2016). an effective kc will produce, summate, and enable effective mechanical energy transmission along the entire chain, which will support function. any link in the kc that is inefficient has the potential to adversely affect force transfer to nearby segments (ben kibler et al., 2000 \& martic et al., 2014). consequently, therapists usually recommend incorporating trunk and lower extremity movements into shoulder rehabilitation programs in order to maximize efficient energy transfer throughout the entire kc (sciascia et al., 2012 \& magarey et al., 2003). thus, the investigators hypothesize that adding a lower limb (ll) kinetic chain exercise to a shoulder exercise program will improve scapular muscles strength ratio.

Eligibility criteria:
inclusion criteria: * age ranges between 20 and 45 years old * unilateral shoulder pain lasting more than 6 weeks * at least one positive finding in each of these categories: 1. painful arc of movement during flexion or abduction 2. positive neer or hawkins-kennedy impingement signs 3. pain on resisted lateral rotation, abduction or jobe test exclusion criteria: * history of surgery * history of fracture or dislocation * type iii acromion * rotator cuff tear * long head of biceps tendon tear * cervical radiculopathy
role of acetaldehyde in the development of oral cancer

Conditions: Alcohol-Related Carcinoma; Fanconi Anemia; Oral Cavity Carcinoma

Summary: this is a minimal risk intervention study where healthy volunteers and individuals with fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. biospecimens to be collected include saliva, oral cells collected via mouthwash and cheek brush, and urine. the collection of two blood samples (5 ml each) will be optional and banked for future use.


Eligibility criteria:
inclusion criteria: * 21-45 years of age for alcohol drinkers * occasionally consume alcohol * at least 1 drink per month for healthy volunteers * at least 1 drink in the last 3 months for fanconi anemia patients * meets one of the three criteria * healthy volunteer - aldh2\*1/1\* homozygotes-not of eastern asian decent; * healthy volunteer - aldh2\*1/2\* heterozygotes-of eastern asian decent and experience flushing when drinking * individual's with fanconi anemia (fa). * 18-45 years of age for non-drinkers * never consume alcohol/not had alcohol in the last 6 months * healthy volunteers. * non-smoker (smoked \< 100 cigarettes in a lifetime) exclusion criteria: * pregnant or nursing * taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption * healthy volunteers who have taken any antibiotics in the last 3 months * currently consuming more than 21 drinks per week * have any history of alcohol or drug related problems * current or former tobacco/nicotine product(s) user * any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco) * "trying" or limited use of any nicotine products or marijuana in the last 1 month * active infection (influenza, cold, covid, respiratory / sinus infection) - admission in the study will be delayed pending improved health * non-fa volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues) * experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol
adjuvant transcatheter arterial chemoembolization versus adjuvant systemic chemotherapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to determine that adjuvant systemic chemotherapy is superior to adjuvant transcatheter arterial chemoembolization(tace) in prolonging recurrence free survival（rfs） in patients after radical resection of hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. a preoperative diagnosis of hcc with no previous treatment; 2. compensated cirrhosis with child-pugh class a, b or no cirrhosis; 3. multiple tumors more than 5 cm or tumor involving a major branch (the wrstor second branch) of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasonography and gross examination of the liver during operation; 4. on exploration and intraoperative ultrasonography, the tumor with multiple lesions localized in right or left hemiliver,or the main tumor localized in one lobe only with a small solitary lesion in contralateral lobe, or tumor involving a major branch (the wrst or second branch) of the portal or hepatic vein(s), which could be safely resected without grossly remaining tumors, and the patient was judged to have well preserved liver function to survive the operation. 5. adequate organ and marrow function, with neutrophil count≥1.5x10e9/l, platelet count≥75×10e9/l, ast or alt﹤2.5×upper limit of normal (uln), total bilirubin\<1.5×uln, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. patients with ast and alt\<5 ×uln could be recruited if total bilirubin was in the normal range. exclusion criteria: 1. documented allergy to study drugs; any previous tace or systemic chemotherapy treatment before random assignment; 2. concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion); 3. cns metastasis; 4. other serious illness or medical condition.
pharmacokinetics of oral hydroxyurea solution

Conditions: Sickle Cell Disease; Sickle-Cell; Hemoglobin Disease, Thalassemia; Sickle Cell-beta-thalassemia; Sickle Cell Hemoglobin C

Summary: an open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15 month treatment period for each participant. the study treatment duration will be for 6 months at the maximum tolerated dose \[mtd\], which is usually reached by 6 months after initiation of treatment. for patients in whom time to mtd is longer than 6 months or not achieved at all, the maximum duration of study treatment will be 15 months.


Eligibility criteria:
inclusion criteria: 1. male or female aged from 6 months to 17.99 years of age (i.e. to the day before 18th birthday). 2. diagnosis of sickle cell anemia (hbss and hbsβº). 3. parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study. 4. where applicable, the child should assent to undergo blood sampling for pharmacokinetic and biochemistry purposes and to allow physiological measurements to be made. exclusion criteria: 1. any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might have compromised the safety of the patient or which might have interfered with the study. 2. hydroxyurea use within 6 months before enrolment. 3. renal insufficiency (known creatinine more than twice the upper limit of normal (uln) for age and \>1.0 mg/dl \[88.4 μmol/l\]). 4. clinical evidence of hepatic compromise with alanine aminotransferase (alt) \>3 times the uln (a temporary swing in alt did not result in exclusion). 5. other significant organ system dysfunction based on the site investigators discretion. 6. severe active infections: fungal, viral or bacterial (as confirmed by culture), examples included tuberculosis, malaria, active hepatitis, osteomyelitis or any other illness that would have precluded the use of hu in normal clinical practice. 7. active chronic leg ulcers. 8. known allergy to oral hu solution or any of the excipients. 9. positive pregnancy test for females of child-bearing potential (in post-menarcheal females) before initiation of treatment, unless participant was sexually abstinent. note: true abstinence was considered as being in line with the preferred and usual lifestyle of the participant. periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 10. inadequate contraception measures in sexually active females (post-menarcheal females) and males of child-bearing age (see section 9.5.1.10.4). 11. breastfeeding at study initiation. 12. participation in another clinical trial of an imp. 13. known infection with hiv.

Keywords: hydroxyurea hydroxycarbamide xromi
teicoplanin prophylaxis for total hip or knee arthroplasty

Conditions: Total Hip and Knee Arthroplasties

Summary: this is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other antibiotics. the study is aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

this is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with a single dose of teicoplanin or with multiple doses of other antibiotics according to the habits of the attending physicians aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

Eligibility criteria:
inclusion criteria: * patients admitted for total hip arthroplasty * patients admitted for total knee arthroplasty exclusion criteria: * revision arthroplasty * history of any infection within the preceding two months * history of an operation in the same hip or knee for other causes * known history of allergy to the studied drug * pregnancy or lactation * any antibiotic therapy in the week before operation.

Keywords: teicoplanin prophylaxis arthroplasty surgical site infections
impact of heart rate variability modulation on stress management among physicians

Conditions: Burnout, Professional

Summary: the purpose of this research is to examine a wearable device called apollo that emits gentle vibrations found to benefit mood, energy, and focus. we want to understand how it affects burnout in physicians.

this study will be conducted by using a tuned vibroacoustic stimulation (tvs) device(the commercially available tvs device known as the apollo wearable), that has been shown in clinical studies at university of pittsburgh to improve heart rate variability and recovery under stress. the apollo wearable generates low volume sound waves that feel like a soothing touch to the skin. this study will assess whether slight modulation of heart rate variability (hrv) will result in a reduction in stress, improved recovery, and recovery in and around the hospital. physicians will wear the apollo device for heart rate variability modulation and complete questionnaires before and after use of the apollo device for comparison of outcomes.

Eligibility criteria:
inclusion criteria: * upmc attending physicians and residents. the participants must have either ios or android phones. exclusion criteria: * unwillingness or inability to participate in the study * currently own an apollo device
developing culturally-tailored information-based support groups for chinese immigrants with breast cancer

Conditions: Chinese Immigrants With Breast Cancer

Summary: there are few breast cancer support groups that focus on the specific needs of chinese women. the purpose of this study is to learn about two different ways of providing support groups to help women of chinese descent cope with the difficulties of a diagnosis of breast cancer and its treatment. the investigators want to learn about how best to support chinese women with breast cancer by providing two different types of groups: an in-person support group and a virtual (online/phone) support group.


Eligibility criteria:
inclusion criteria: * female * non-us born * resident in the us \< 20 years * of chinese descent * age 21 years through 80 years * language spoken: mandarin * diagnosis of breast cancer within 3 months prior to recruitment \*not required that breast cancer is the patients' first and/or only cancer diagnosis * currently receiving cancer treatment; * will be living continuously in the us for the next year * has a telephone that he/she is willing to use for the study exclusion criteria: * presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection * another household member is already enrolled. * prior participation in a cancer support group

Keywords: support groups breast cancer mandarin speaking 12-105
dysvascular amputation self-management of health

Conditions: Amputation; Diabetes Mellitus; Peripheral Artery Disease

Summary: the purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. this study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. the proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.

Eligibility criteria:
inclusion criteria: * within the age range of 50-85 years * confirmed diagnosis of type ii diabetes mellitus (dm) and/or peripheral artery disease (pad) * transtibial, knee disarticulation, or transfemoral lower-limb amputation (lla) (or re-amputation) within the past 12 months * participant goal of household walking or better using a prosthesis exclusion criteria: * trauma or cancer-related etiology of the lla * decisionally challenged individuals (mmse score below 24) * prisoners * active cancer treatment * recent stroke (within 2 years) * clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.

Keywords: amputation dysvascular amputation diabetes peripheral artery disease physical activity
surface decontamination in treatment of peri-implantitis

Conditions: Peri-implantitis

Summary: peri-implantitis represents a major biological complication of implant dentistry with reported prevalence of up to 47% of implants. the disease is characterized by inflammatory response to the biofilm inhabiting the implant surface. to treat this inflammatory disease, surgical and non-surgical therapies have been proposed, all of which entail biofilm removal through implant surface decontamination. systematic review of various surface decontamination protocols has failed to demonstrate superiority of any of the protocols. one possible explanation is that most studies have examined decontamination of implant surfaces following experimentally-induced peri-implantitis, where implant surfaces lack the tenacious mineralized biofilm often found in clinical peri-implantitis and are therefore easily decontaminated. the investigators have hypothesized that control of inflammation and repair of pathologically damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface decontamination therapy. the aims of this study are to 1) determine the most effective surface decontamination protocol that can lead to control of peri-implant inflammation and 2) delineate the microbial and immunological mediators that are associated with the changes in peri-implant inflammation. the investigators propose to compare conventional implant surface contamination techniques to a comprehensive mechanical plus chemical protocol. this randomized controlled clinical trial seeks to enroll 68 participants with at least one implant diagnosed with moderate to severe peri-implantitis. pre-op parameters to be assessed include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial sampling, and digital intra-oral peri-apical radiograph. subjects will be randomly assigned to one of the four surgical debridement intervention groups: (a) gauzes soaked in sterile saline and chlorhexidine; (b) titanium brush; (c) air power abrasion; (d) comprehensive surface decontamination, including titanium brush, air powder abrasion and surface etching with 9.6% hydrofluoric acid gel. at 3-months post-operative, the initial clinical assessment will be repeated. the clinical examination will be used to analyze the efficacy of each treatment in controlling peri-implant mucosal inflammation. the ultimate objective of this research is not only to identify an effective method for control of peri-implant inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that can potentially be helpful in future studies as risk factors of this disease.


Eligibility criteria:
inclusion criteria: * ppd \>6 mm * positive bop * peri-implant marginal bone loss (mbl) \>3 mm * age: 18 to 75 years exclusion criteria * implant mobility * smoking * current cancer * steroids use (last 2 years) * bisphosphonates use (last 4 years) * uncontrolled diabetes (hba1c \>7) * other systemic conditions that affect wound healing
a study to evaluate cortisol reserve in response to adrenocorticotropic hormone (acth) stimulation test following baxdrostat treatment compared to placebo in participants with uncontrolled hypertension

Conditions: Uncontrolled Hypertension

Summary: the main purpose of this study is to assess the serum free cortisol response after acth stimulation test at baseline and at week 8 in participants with uncontrolled hypertension.

this is a placebo-controlled study to evaluate cortisol reserve after acth stimulation test following treatment with 2 milligrams (mg) baxdrostat versus placebo. the study consists of 3 period: * 4-week screening period. * an 8-week double-blind treatment period. * a safety follow-up 2 weeks after last dose. participants will be randomized in a 2:1 ratio to one of 2 treatment arms: 1. baxdrostat 2. placebo participants will receive either baxdrostat or placebo. the overall study duration will be up to 16 weeks.

Eligibility criteria:
inclusion criteria: * participants with mean seated systolic blood pressure (sbp) on automated office blood pressure measurement (aobpm) greater than equal to (\>=) 130 millimeter of mercury (mmhg) and less than (\<) 170 mmhg at screening. * participants with mean seated sbp on aobpm of \>=130 mmhg and \< 170 mmhg at randomization. * participants must have a stable regimen of \>=1 antihypertensive medication (at least one should be a diuretic), for at least 4 weeks prior to screening. * participants must have an estimated glomerular filtration rate (egfr) \>=45 milliliter per minute (ml/min)/1.73-meter square (m\^²) at screening. * participants must have a serum potassium+ (k+) level \>=3.5 and \< 5.0 millimole per liter (mmol/l) at screening. exclusion criteria: * mean seated diastolic blood pressure (dbp) on aobpm \>=110 mmhg at randomization. * prior treatment (within the 4 weeks before screening) with angiotensin receptor blocker (arbs) and angiotensin converting enzyme inhibitor (aceis) (both taken simultaneously). * serum sodium (na+) level \< 135 millimole per liter (mmol/l) at screening, determined as per central laboratory. * new york heart association functional heart failure (hf) class iv at screening. * planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening. * uncontrolled diabetes with glycated haemoglobin (hba1c) \> 10.0% (86 mmol/mol) at screening. * fridericia's corrected qt (qtcf) value \> 470 milliseconds (ms) at screening, unless having a pacemaker. * heart rate \ 110 beats/min in a resting position, as per vital signs assessment.

Keywords: adrenocorticotropic hormone stimulation