Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of switching from stavudine or zidovudine to tenofovir df in hiv-1 infected children

Conditions: HIV Infections

Summary: the primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (tdf) compared to continuing stavudine or zidovudine in maintaining virologic suppression in hiv-1 infected children.


Eligibility criteria:
major inclusion criteria: * documented laboratory diagnosis of hiv-1 infection * plasma hiv-1 rna \< 400 copies/ml * currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks * naive to tenofovir df key inclusion criteria for the first 96-week extension * completed 48 weeks of treatment in arm 1 or arm 2 of the study * \<18 years of age (at the start of the extension) * participants initially randomized to arm 2 will be given the option to replace stavudine or zidovudine with tenofovir df in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir df is safe and beneficial for the participant. key inclusion criteria for the second and third 96-week extension and fourth open-ended extension * completed of treatment with study drug in the first extension phase * \<18 years of age at the start of the extension. this inclusion criterion is not applicable in those regions where tenofovir df is not commercially available for treatment of hiv-1 infection in adults. key exclusion criteria: * participants receiving ongoing therapy with any of the following * nephrotoxic agents * systemic chemotherapeutic agents * systemic corticosteroids * interleukin 2 (il 2) and other immunomodulating agents * investigational agents * pregnant or lactating participants * evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication * current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance * malignancy other than cutaneous kaposi's sarcoma (ks) or basal cell carcinoma. * active, serious infections (other than hiv-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening * prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis) * prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures) note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: phase 3 randomized, open-label treatment-experienced highly active antiretroviral therapy hiv tenofovir df pediatrics
slider versus tensioner neural mobilization in diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: neurodynamics, i.e., the mobilization of the peripheral nervous system, is a physical approach to the treatment of pain; the method relies on influencing pain physiology via mechanical treatment of neural tissues and the non-neural structures surrounding the nervous system. neural mobilization (nm) is used to treat various disorders of the nervous system concerning the length and mobility of peripheral nerves, as the nerve mobilizing refers to techniques that help to reestablish motion between a nerve and its surrounding soft tissues, thus to treat the nerves that have become entangled within the soft tissue, as it leads to tension release on a nerve by stretching and pulling one end of the nerve during keeping the other end in a relaxed state.

the neurodynamic technique both sliders and tensioners results in changes of the mechanical or physiological function of nerve tissues along with the interface; restoring pressure gradients, relieving hypoxia and pain resulting in reducing associated symptoms. through clinical reasoning the nervous system seems to be the logical place for treatment and explanations and previous descriptions of this method have clarified the overall impact on quality of life in diabetic peripheral neuropathy but it doesn't discuss which technique of neural mobilization is more effective and its effects on diabetic peripheral neuropathic population. within this reasoning it is important to determine which neurodynamic technique is more effective in improving quality of life and reduce pain in patients with diabetic peripheral neuropathy.

Eligibility criteria:
inclusion criteria: * patient having≥12score on self report leads assessment of neuropathic symptoms and sign * patients with lower limb pain ≥4 to ≤7 on nprs exclusion criteria: * diabetic foot ulcer * complex regional pain syndrome * infection in lower limb * lower extremity amputation * discogenic pain * restricted joint deformity * dependency on chemical or drugs * pregnancy
prescription opioids, brain structure, and cognition in older adults with chronic pain

Conditions: Pain, Chronic

Summary: the purpose of this study is to determine whether exposure to prescription opioids is associated with brain structural changes on magnetic resonance imaging (mri), with the primary outcome of white matter integrity as measured by fractional anisotropy of the corpus callosum.

the investigators will recruit 200 adults aged 65 years and older with chronic pain of the knee or shoulder. each will receive an individualized multimodal pain treatment pathway for 6-weeks - for half of participants this will include a prescription opioid; the other half will receive an identical placebo. after 6 weeks, participants will undergo opioid/placebo taper. the investigators will obtain neuroimaging (mri), psychometric/cognitive testing, pain scores, and several exploratory patient-reported outcomes at several time-points: before the intervention (all tests), at 6 weeks (all tests except mri), 6-month phone call (only phone based patient reported outcomes- no mri), and at 1 year (all tests).

Eligibility criteria:
inclusion criteria: * chronic pain of moderate to severe intensity (greater than or equal to 5 /10 average pain on peg scale) nearly every day for at least 3 months due to osteoarthritis of the knee or shoulder * 65 years of age or older exclusion criteria: * severe mental health disorder (schizophrenia, bipolar disorder, psychosis, history of suicidality, uncontrolled severe depression or anxiety, severe ptsd) * severe liver (cirrhosis) or kidney disease (esrd on dialysis or gfr\< 30) * cognitive impairment (kokmen short test of mental status score \< 29) * life expectancy \< 12 months * contraindications to mri * non-english speaking * opioid use within the past 6 months * contraindications or previous intolerance to prescription opioids * substance use disorder or high-risk for opioid-related adverse effects (opioid risk too l\> 8) * residence outside of minnesota or wisconsin during opioid intervention period * another pain generator that is greater than their knee or shoulder pain * anticipated surgery for joint replacement (knee or shoulder) sooner than 23 months.
osteoarthritis, balance, and fear of falling

Conditions: Osteoarthritis

Summary: osteoarthritis (oa) is a progressive and irreversible degenerative joint disease characterized by marginal bone hypertrophy, erosion, and subchondral sclerosis in the articular cartilage.it has been determined that being of advanced age and joint involvement due to osteoarthritis are a risk factor for addiction in activities and this increases the individual's self-care ability and dependency in daily living activities.older individuals with knee osteoarthritis may be at risk of falling.this study was planned to examine the relationship between activity-specific balance confidence and fear of falling, autonomy and social participation in individuals with knee osteoarthritis over 65 years of age.

osteoarthritis (oa) is a progressive and irreversible degenerative joint disease characterized by marginal bone hypertrophy, erosion, and subchondral sclerosis in the articular cartilage.it has been determined that being of advanced age and joint involvement due to osteoarthritis are a risk factor for addiction in activities and this increases the individual's self-care ability and dependency in daily living activities.older individuals with knee osteoarthritis may be at risk of falling.considering the relationship between the concepts of osteoarthritis and old age with the common concepts of daily life activity problems, falling, loss of autonomy and affecting social participation; this study was planned to examine the relationship between activity-specific balance confidence and fear of falling, autonomy and social participation in individuals with knee osteoarthritis over 65 years of age.

Eligibility criteria:
inclusion criteria: * 65 years old * diagnosed with knee osteoarthritis according to acr diagnostic criteria exclusion criteria: not having enough cooperation
validation of point partial user needs with partial finger amputees

Conditions: Amputation; Traumatic, Hand

Summary: the objective of the device feasibility study will be to validate the user needs of the point partial system. this study will be a single group intervention model where one group of 5 partial finger amputees will be asked to perform several tasks. successful completion of a task results in a fulfilled user need. failure to complete a task results in an unfulfilled user need.


Eligibility criteria:
inclusion criteria: * partial finger amputees with partial absence of index and/or middle fingers and presence of thumb. additional finger loss is acceptable if all other criterion are met. * fluent in english * individuals aged 18 or greater * patients may present with either fused or mobile mcp joints. exclusion criteria: * significant cognitive deficits as determined upon clinical evaluation * significant neurological deficits as determined upon clinical evaluation * significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation * uncontrolled pain or phantom pain impacting full participation in the study as determined upon ot evaluation * serious uncontrolled medical problems as judged by the project therapist.
clinical study to compare the pharmacokinetics and safety of trastuzumab for injection with herceptin® in healthy male volunteers

Conditions: Metastatic Breast Cancer; Metastatic Gastric Cancer

Summary: trastuzumab for injection is a biosimilar of herceptin ® produced by chia tai tianqing biotechnology co., ltd, which is a humanized igg1 monoclonal antibody produced by chinese hamster ovary (cho) cells. a randomized, double-blind, single-dose, parallel phase i study comparing trastuzumab for injection with herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of trastuzumab for injection and herceptin®.


Eligibility criteria:
inclusion criteria: * fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; voluntary written informed consent in accordance with the helsinki declaration; * healthy male subjects aged ≥ 18 years and ≤ 65 years; * body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2; * the system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance; * subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion. exclusion criteria: * history of hypertension or abnormal blood pressure at screening/baseline measurement; * a history of albuminuria or albuminuria as assessed by the investigator as clinically significant; * received any antibody or protein targeting vascular endothelial cell growth factor (vegf) or vegf receptors in the previous 1 year; * study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months; * have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding; * history of digestive tract perforation or digestive tract fistula; * unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion; * use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use; * positive virology test; * known allergy to trastuzumab; * known history of allergic diseases or allergic constitution; * study the history of blood donation 3 months before drug infusion; * received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening * a history of alcohol or drug abuse in the 12 months prior to screening; * a history of mental illness; * subjects whose spouses plan to become pregnant; * the study cannot be completed according to protocol requirements during the study period; * conditions considered unsuitable for inclusion by other researchers.
cognitive remediation for cocaine dependence

Conditions: Cocaine Dependence

Summary: the purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.


Eligibility criteria:
inclusion criteria: * meet criteria for cocaine dependence * seeking treatment for cocaine dependence * be in acceptable health based on medical history and physical exam exclusion criteria: * dependent on drugs other than cocaine, nicotine, marijuana * have a medical condition contraindicating treatment with study medications * having conditions of probation or parole requiring reports of drug use to officers of the court

Keywords: cocaine cognition medication treatment
efficacy and safety of favipiravir in the treatment of covid-19 patients over 15 years of age

Conditions: COVID-19

Summary: this study is an observational study (non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with covid-19 and initiated treatment with favipiravir before enrollment to the study. patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.

the clinical picture of 2019-ncov disease is in a broad spectrum, which includes asymptomatic infection, a mild upper respiratory tract infection, respiratory failure, and even severe viral pneumonia with death. although the mortality rate is not yet clear, the reported case-fatality risk was 11-14% during the initial studies which included patients with severe disease. the overall case fatality rate was reported as approximately 2%. in addition, most cases have resulted in a pneumonia requiring supplemental oxygen therapy and ventilator support. the alarming levels of spread and severity of covid-19 caused a global emergency and this outbreak has been characterized as a pandemic by the world health organization (who). studies have suggested that investigational product favipiravir can improve the recovery of patients with mild disease and reduce the treatment duration from less than 11 days. the main purpose of this study is to obtain efficacy and safety data for favipiravir use in the turkish patient cohort diagnosed with covid-19 and decided to be treated with "favipiravir" before enrollment to this observational study. this study is designed as an observational drug study which will evaluate the safety and efficacy of favipiravir in patients and diagnosed with covid-19 and older than 15 years of age. this study is designed as an observational drug study to evaluate the safety and efficacy of favipiravir in patients diagnosed with covid-19 and older than 15 years of age with a favipiravir treatment decision. patients who have already had a routine favipiravir treatment decision or favipiravir treatment started will be included in this study. a total of 1000 female and male patients aged 15 years or older will be included in the study. the planned observation duration for each patient is 7 days. this study will be conducted in 14 sites.

Eligibility criteria:
inclusion criteria: * male and female patients, diagnosed with covid-19 disease who are 15 years of age or older at the time of enrollment * patients who have understood all study procedures that will be applied under the study protocol * patients with confirmed diagnosis of covid-19 by pcr and/or other accepted methods and have a treatment decision with favipiravir * patients who will accept oropharyngeal sample and venous blood sample collection periodically within the scope of the study protocol exclusion criteria: * patients who are pregnant or females who are breast feeding * patients under the age of 15
multidomain interventions via face-to-face and video communication platforms in mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.

the physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. cognitive training will be conducted using a tablet-based application. participants will be advised to eat something according to the recommendation of the mind diet. they will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. the purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.

Eligibility criteria:
inclusion criteria: * 60 to 85 years of age * having at least one modifiable dementia risk factor * complaints of cognitive decline by a participant or informant * a performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests * mmse z score ≥ - 1.5 * independent activities of daily living * being able to use the tablet pc through education, or having a person who can help a participant use the tablet pc. * having a reliable informant who could provide investigators with the requested information * provide written informed consent exclusion criteria: * major psychiatric illness such as major depressive disorders * dementia * other neurodegenerative disease (e.g., parkinson's disease) * malignancy within 5 years * cardiac stent or revascularization within 1 year * serious or unstable symptomatic cardiovascular disease * other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease * severe loss of vision, hearing, or communicative disability * any conditions preventing cooperation as judged by the study physician * significant laboratory abnormality that may result in cognitive impairment * illiteracy * unable to participate in exercise program safely * coincident participation in any other intervention trial
improving hypertension control

Conditions: Hypertension

Summary: * the overall hypothesis for the project is that racial health disparities will be reduced by improving hypertension control in african americans. * this will be accomplished through the development, implementation, and evaluation of a cost-effective hypertension control strategy based on the involvement of a community health worker.


Eligibility criteria:
inclusion criteria: * african americans with uncontrolled hypertension, followed at progressive community health centers
immunocompetent versus immunocompromised tuberculosis (tb) patients

Conditions: Tuberculosis

Summary: tuberculosis (tb) is caused by mycobacterium tuberculosis and is one of the top 10 causes of mortality worldwide. it is estimated that in 2017, 10 million people were infected with tb, and 1.6 million died from the disease, including 0.3 million people with human immunodeficiency virus (hiv) infection . tb remains the primary killer of hiv-positive individuals. tb incidence is falling at about 2% per year . airborne transmission of m. tuberculosis typically causes tb infection in both immunocompetent and immunocompromised hosts and the disease is symptomatic and contagious .

tb and hiv infections are strictly linked together. tb is the most common opportunistic infection and causes high morbidity rate among people living with hiv. because of the decrease in cell-mediated immunity, hiv alters the pathogenesis of tb, thereby expressively increasing the risk of tb in hiv-positive patients and eventually leading to more severe complications and forms of tb.

Eligibility criteria:
inclusion criteria: * patients with chronic chest disease exclusion criteria: * patients with other respiratory or infectious diseases.

Keywords: hiv immunocompromised cytokines
a retrospective analysis of patients with full thickness wounds in limbs with critical ischemia

Conditions: Critical Limb Ischemia

Summary: once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated. the data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.

clinicians have even learned to group patients into different etiologic categories based on underlying disease such as diabetes mellitus, decubitus ulcer, surgical site infection, venous insufficiency, arterial insufficiency and others. it seems that wounds have been grouped into these categories because of their common barriers, which should allow us more precise algorithms and may provide better outcomes. that is diabetics tend to have the barriers of poor perfusion, endothelial cell dysfunction, white blood cell dysfunction, hyperglycemia, neuropathy and repetitive trauma. venous insufficiency patients tend to have perivascular cuffing and peri wound edema. however patients with venous leg ulcers commonly have peripheral arterial disease and diabetes (3). the point is regardless of the etiology of the wound every patient must be evaluated for all barriers on every visit. arbitrarily dividing chronic wounds in the etiologic categories has not significantly improved wound healing outcomes.

Eligibility criteria:
inclusion criteria: * the inclusion criteria for the study are patients that demonstrate the following: * a limb with a tcpo2 less than 20 with a full thickness wound. * initial visit from august 1, 2002 to december 31, 2005. exclusion criteria: * the exclusion criteria for the study are patients that demonstrate the following: * partial thickness wound or no wound in limb with critical ischemia. * a medical record that does not clearly demonstrate critical limb ischemia or does not clearly demonstrates a full thickness wound.

Keywords: critical ischemia