Kornimate/medical-research-clean huggingface dataset:
alzheimer's disease multiple intervention trial

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.

the proposed study builds on our findings from a previous clinical trial that demonstrated the effectiveness of collaborative care for older adults with alzheimer's disease cared for in primary care practices. in the prior trial, we demonstrated that guideline-level medical care resulted in improved quality of care and improved behavioral and psychological symptoms over one year among patients and their caregivers. however, despite finding significant differences among study groups on neuropsychiatric inventory scores, we did not find a significant difference between groups in functional decline. both study groups experienced a significant decline in function over 18 months. the current study proposes to test a home-based intervention specifically designed to slow the rate of functional decline among older adults with alzheimer's disease. in addition to building on our past research, the study also builds from recently reported research which demonstrated the short-term efficacy of home-based occupational therapy interventions among older adults with dementia. these trials show that older adults with dementia, including alzheimer's disease, can both participate in and benefit from occupational therapy-based interventions delivered in the home. the specific aim of this study is to conduct a two-year, randomized, controlled clinical trial to improve functioning among older adults with alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention. we will test the primary hypothesis that subjects with alzheimer's disease in the intervention group will have improved function at two years compared with the best practice primary care control group.

Eligibility criteria:
patient inclusion criteria: * currently a patient within wishard health services in central indiana * diagnosed with possible or probable alzheimer's disease * age 45 or older * english speaking * hear well enough to answer questions in person or by telephone * community-dwelling (includes senior communities, but not skilled nursing facilities) * caregiver willing to participate in the study * willing to receive home visits * lives in indianapolis metro area and planning to continue care at primary care clinic caregiver inclusion criteria * age 18 or older * english speaking * hear well enough to answer questions in person or by telephone * community-dwelling * willing to receive home visits exclusion criteria: * not a current patient within wishard health services * does not speak english * currently enrolled in another study * non-community dwelling, or residing in a skilled nursing facility
can the femoral nerve block be improved by ultrasound guidance?

Conditions: Pain

Summary: studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients. this study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint. local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement. the patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded. a standard anaesthetic and a hip replacement operation will then be performed. standard pain relief protocols will be used the operation and after the operation. after the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation. the first day the patient is able to walk on their new hip replacement will also be recorded.


Eligibility criteria:
inclusion criteria: * elective primary total hip arthroplasty under general anaesthesia * asa\<=4 * able to give informed consent * able to cooperate with sensory and motor testing of lower limb function exclusion criteria: * abnormal clotting screen (coagulopathy) or thrombocytopenia (\<100,000) * acute mental test score of \<=7 at any time pre or post operatively * allergy to local anaesthetic * signs, symptoms or laboratory evidence of local infection or systemic sepsis * no pre-existing neurological deficit (sensory or motor) affecting lower limb * patients with lower limb amputations

Keywords: ultrasound hip pain
a phase iii study to evaluate the safety, tolerance, and efficacy of early treatment with zidovudine (azt) in asymptomatic infants with hiv infection

Conditions: HIV Infections

Summary: primary: to determine the efficacy of early treatment with zidovudine (azt) in hiv-infected asymptomatic infants. to determine the safety and tolerance of azt in this patient population. secondary: to compare the virologic and immunologic parameters between the treatment groups. to determine the efficacy of azt as an early treatment to prevent development of cd4+ cell depletion in hiv-infected asymptomatic infants. azt is currently indicated for primary treatment in children with hiv-associated signs and symptoms and for those with significant immunodeficiency. this study will attempt to determine whether early treatment with azt prevents the development of symptoms in hiv-infected infants who are asymptomatic.

azt is currently indicated for primary treatment in children with hiv-associated signs and symptoms and for those with significant immunodeficiency. this study will attempt to determine whether early treatment with azt prevents the development of symptoms in hiv-infected infants who are asymptomatic. patients are randomized to receive oral azt (at age-adjusted doses) or placebo. patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive. patients who meet the criteria for changes to open-label azt will be given the appropriate age-adjusted dose without unblinding the original randomization assignment. patients who complete or discontinue treatment are followed every 6 months for up to 2 years.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4 count \>= 2000 cells/mm3 and \>= 30 percent of total lymphocytes. * no signs or symptoms of hiv infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted). * consent of parent or guardian. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * serious acute infection requiring parenteral therapy at time of entry. * one or more serious, proven bacterial infections including any of the following: * septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by haemophilus, streptococcus (including pneumococcus), or other pyogenic bacteria. * clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile. concurrent medication: excluded: * any agent with known antiretroviral activity. * acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously. prior medication: excluded: * more than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally. recommended: * pcp prophylaxis. * immunizations according to current recommendations.

Keywords: acquired immunodeficiency syndrome aids-related complex zidovudine
point-of-care ultrasound for pediatric thoracic trauma: a multi-institutional trial

Conditions: Trauma Chest; Pediatric ALL

Summary: the objective of the proposed study is to investigate the diagnostic accuracy of ed pocus in pediatric traumatic thoracic injuries including traumatic pneumothorax, hemothorax, lung contusion, rib fractures, and pulmonary edema (from submersion injury). this will be a prospective, multicenter, observational study of children 0-21 years of age presenting to the participating pediatric emergency departments for suspected traumatic thoracic injury. results of pocus will be compared to that of chest x-ray, final clinical diagnosis, computed tomography (ct) or magnetic resonance imaging (mri). study hypotheses are that pocus is highly accurate (90-95%) when compared to chest x-ray, and moderately accurate (\~80%) when compared to ct or mri in diagnosing these conditions.


Eligibility criteria:
inclusion criteria: * eligible subjects will be children 0 to 21 years of age presenting to the participating peds meeting trauma activation criteria and with suspected thoracic injury. exclusion criteria: * congenital or acquired cardiopulmonary or osteogenic conditions rendering pocus ineffective, foreign body/ barrier to lung ultrasound of which removal is contraindicated, subjects under law-enforcement custody, and subjects deemed unsuitable by treating clinicians.

Keywords: ultrasonography
induction of suction blisters in patients with urticaria, blistering diseases, inflammatory dermatoses and neoplastic disorders, and in normal volunteers

Conditions: Dermatitis; Healthy; Neoplasm; Urticaria; Vesiculobullous Skin Disease

Summary: the use of a suction blister apparatus has facilitated study of the immunologic capacity of human epidermal cells. we have been able to prepare purified populations of these cells after blister formation. specifically, using the blister tops, we are able to enrich for epidermal langerhans cells which are very potent stimulators in antigen presenting assays. thus, this normal volunteer study provides an important source of fresh epidermal tissue from which we can study normal epidermal langerhans cell function. in addition, we have recently used blister roofs in important experimental models of hiv-1 transmission. there is no other method available for assessing the biologic function of freshly isolated langerhans cells without altering their milieu. it is a very safe and effective way to obtain human epidermal samples.

the use of a suction blister apparatus has facilitated study of the immunologic capacity of human epidermal cells. we have been able to prepare purified populations of these cells after blister formation. specifically, using the blister tops, we are able to enrich for epidermal langerhans cells which are very potent stimulators in antigen presenting assays. thus, this normal volunteer study provides an important source of fresh epidermal tissue from which we can study normal epidermal langerhans cell function. in addition, we have recently used blister roofs in important experimental models of hiv-1 transmission. there is no other method available for assessing the biologic function of freshly isolated langerhans cells without altering their milieu. it is a very safe and effective way to obtain human epidermal samples.

Eligibility criteria:
inclusion criteria patients with urticaria of all types, blistering diseases, inflammatory dermatoses and neoplastic skin diseases. patients 18 years of age or older. no pregnant women.

Keywords: blister formation inflammatory mediator assay ultraviolet radiation
charcoal in lung cancer patients undergoing temla

Conditions: Lung Cancer

Summary: this proof-of-concept study serves as the preliminary step to prove safety of oral activated charcoal (oac) in patients with solid tumors before moving to a hematologic malignancy patient population.

temla (transcervical extended mediastinal lymphadenectomy) is a procedure for mediastinal lymph node sampling to stage patients with lung cancer. all patients receive a dose of iv antibiotic pre-procedure to prevent infection. the concept of the proposed study is to protect the gut microbiome against detrimental effects of the antibiotic using oral activated charcoal as a potent adsorbent with no absorption. oral activated charcoal (oac) binds to the fraction of iv antibiotic that reaches the lumen of the gut without interfering with its desired systemic effects. the conceptual goal is to prevent dysbiosis by protecting the gut microbiome. dysbiosis is the leading cause of c. difficile infection and a number of other adverse clinical outcomes such as antibiotic resistance.

Eligibility criteria:
inclusion criteria: * suspected or confirmed diagnosis of lung cancer (non-small cell lung cancer, small-cell lung cancer or neuroendocrine tumor) for which a standard of care transcervical extended mediastinal lymphadenectomy (temla) is planned * planned pre-procedural iv antibiotic. the choice of antibiotic type is up to the treatment physician(s) * able to safely hold all oral medications on the day of surgery and the day after to ensure the absorption of such drugs is not affected due to charcoal ingestion the night before surgery * 18 years of age or older * able to provide written consent prior to any research related activities exclusion criteria: * current pregnancy or breastfeeding (soc pre-temla testing/assessment) * any current diagnosed disease with known involvement of the gastrointestinal tract * known allergy to oral activated charcoal * ctcae v 5 dysphagia grade 2 (symptomatic and altered eating/swallowing) or greater * known risk of aspiration based on history or current complaints * gastrointestinal procedures within 2 weeks before or (planned) after temla * systemic antibiotic use within 8 weeks before planned temla

Keywords: lung cancer activated charcoal gut microbiome temla
oxygen reserve index in airway surgery in children

Conditions: Hypoxemia During Surgery

Summary: this study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (\<90%) in pediatric patients undergoing airway surgery.


Eligibility criteria:
inclusion criteria: * pediatric patients receiving airway surgery exclusion criteria: * baseline oxygen saturation less than 95% * patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements
a trial of shr-1802 in patients with failure of standard treatment for advanced malignant tumours

Conditions: Malignant Tumours

Summary: this is the first study to test shr-1802 in humans. the primary purpose of this study is to see if shr-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent; 2. aged 18-75 years (inclusive), males and females; 3. patient must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment; 4. at least one measurable lesion according to recist v1.1; 5. ecog score of 0-1; 6. expected survival ≥ 12 weeks; 7. adequate bone marrow reserve and organ function were confirmed by baseline examination 8. for female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; for female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum hcg test result within 72 h prior to study enrollment; and they must not be in the lactation period; exclusion criteria: 1. the presence of any active, known, or suspected autoimmune disease. type 1 diabetes, which was admitted to receive stable dose of insulin, hypothyroidism, which required only hormone replacement therapy, skin disease with no need to systemic treatment and no acute exacerbation within 1 year before the screening period; 2. subjects who had received systemic treatment with corticosteroids or other immunosuppressive agents within 28 days prior to initial administration. 3. known and untreated central nervous system (cns) or leptomeningeal metastases; 4. uncontrolled pleural effusion,or ascites requiring recurrent drainage procedures; 5. uncontrolled cardiac diseases or symptoms; 6. known hereditary or acquired bleeding and thrombotic tendencies; 7. patients who have previously received chemotherapy, radiotherapy or surgery which ended within 4 weeks prior to the start of this study; oral molecular targeted therapy with \< 5 drug half-lives from the first study dose; or patients with aes caused by previous treatment (except for alopecia) that have not returned to ctcae grade ≤ 1; 8. known active infection,; 9. congenital and acquired immune deficiency; 10. hbsag-positive and hbv dna \> 2000 iu/ml(or 104 copies/ml); hcv rna copies \> uln; 11. patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
evaluate the safety and efficacy of dura sealant patch in reducing csf leakage following elective cranial surgery

Conditions: Cerebrospinal Fluid Leak

Summary: the objective of the study is to clinically assess the safety and effectiveness of liqoseal® as a means of reducing intra- as well as post-operative csf leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.


Eligibility criteria:
inclusion criteria: pre-operative 1. subjects who are able to provide written informed consent prior to participating in the clinical investigation. 2. subjects who are ≥ 18 years old. 3. subjects who are able to comply with the follow-up or other study requirements. 4. subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of c2) in whom a dural incision will be closed. 5. female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery. intra-operative 1. subjects with surgical wound classification class i/clean. 2. subjects with minimally 5 mm of dural space surrounding dural opening. exclusion criteria: pre-operative 1. female subjects who are pregnant or breastfeeding. 2. subjects with an assumed impaired coagulation due to medication or otherwise. 3. subjects suspected of an infection requiring antibiotics. 4. subjects with any type of dural diseases in planned dural closure area. 5. subjects requiring re-opening of planned surgical area within 90 days after surgery. 6. subjects with a known allergy to any of the components (lactide-caprolactone co-polyester; butanediol-bdi co-polyurethane; polyethylene glycol succinimidyl gluterate; disodium hydrogen phosphate or d\&c green no 6) of liqoseal®. 7. subjects who previously received a liqoseal®. 8. subjects who previously participated in this study or any investigational drug or device study within 30 days of screening. 9. subjects with a presence of hydrocephalus. 10. subjects with contra-indication to mri \[cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants \[e.g. knee replacement\]. intra-operative 1. subjects in whom elevation of peep has a potential detrimental effect. 2. subjects who will require a csf drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery. 3. subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea. 4. subjects in whom no intra-operative csf leakage is present after primary closure of the dura mater with elevation of peep. 5. subjects who after primary closure (including galea, if applicable) of the dura mater have a gap \> 3 mm. 6. subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).
optimisation of radiotherapy in rectal cancer (orrec)

Conditions: Rectal Adenocarcinoma

Summary: this is a retrospective study using images acquired routinely for diagnosis of rectal cancer to see if these could be used to predict responses to radiotherapy treatment and if it can, whether the treatment can be optimised to produce better outcome for patients. using a clinical database, patients who have had neo-adjuvant chemo-radiotherapy will be recruited, their diagnostic images and radiotherapy planning scan will be obtained. by use of imaging registration and clinical information, the question of why some patients respond well to radiotherapy and some don't could be answered.

the treatment of locally advanced rectal cancer is primarily radiotherapy (+/- chemotherapy) followed by surgery. the reason for radiotherapy is to reduce the risk of recurrence after surgery or to shrink the tumour first so that when surgery is done all the cancer will be successfully removed otherwise some will be left behind to grow. more than 80% of patients require a stoma after their surgery, some get reversed by two years after surgery but a third has it lifelong. about 15% of patients after radiotherapy have no disease left (clinical complete response) and can be monitored closely after radiotherapy and will not need to have surgery or stoma. surgery carries a risk of death and complications, having a stoma have a lot of complications and have an effect on patient's quality of life, most end up not going out much and withdraws from friends and family due to the risk of accidents in public places. this study is aimed at looking at ways to increase the number of patients that do not require surgery after radiotherapy by looking at the differences between those that responded well to radiotherapy and the ones that did not by comparing their diagnostic and treatment scans. the main question to answer is why some patients have complete response to radiotherapy and others don't. is there a way to increase the number of these patients through changes in radiotherapy? the study will be looking at the diagnostic images and radiotherapy planning scans to compare these two groups. is there a way of predicting who will respond to radiotherapy treatment? if there is, modifications could be made to the type of treatment given. this study will be looking to radiomics techniques to develop this. this retrospective study will only make use of scans that patients have already had for their diagnosis and treatment so no patient intervention is required. patients will be recruited using the clinical and research database of the christie hospital which is the largest cancer centre in the uk. the study is funded by the charitable fund of the christie hospital nhs foundation trust.

Eligibility criteria:
inclusion criteria: * histologically confirmed rectal adenocarcinoma. * received pelvic radiotherapy (+/- chemotherapy) as neo-adjuvant treatment * age 18 and above exclusion criteria: * other rectal pathologies. * patients less than 18yrs at diagnosis.