Kornimate/medical-research-clean huggingface dataset:
direct-acting antiviral therapy to prevent hcv infection for hcv positive donor to hcv negative recipient kidney transplant

Conditions: Renal Failure Chronic; Hepatitis C

Summary: open label single center study for the donation of hcv positive kidneys to hcv negative recipients with interventional treatment to prevent hcv transmission upon transplantation.

the study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of hcv infection from donor kidney with known hcv infection (all genotypes) to an hcv negative recipient as evidenced by a negative hcv viral rna at 12 weeks post treatment.

Eligibility criteria:
inclusion criteria: * donor meets mgh transplant center criteria and already listed for isolated kidney transplant * no available living kidney donor * recipient has ≤ 730 days of accrued transplant waiting time * recipient chronic hemodialysis or peritoneal dialysis * recipient must agree to birth control. °.weigh ≥ 50kg * serum alt within normal limits * subject's insurance company approves payment for daa therapy post-kidney transplant exclusion criteria: * ab blood type * hcv genotype 1 * bmi \> 35 * any liver disease in recipient * pregnant or nursing (lactating) women * known allergy or intolerance to tacrolimus that would require administration of cyclosporine * albumin \< 3g/dl or * platelet count \< 75 x 103/ml * positive crossmatch or positive donor specific antibodies * hcv rna positive * hepatitis b surface antigen positive * patients with primary focal segmental glomerulosclerosis (fsgs) * any contra-indication to kidney transplantation per our center protocol

Keywords: hemodialysis renal failure kidney transplant
a trial of tai chi intervention for youngsters with visual impairments

Conditions: Visual Impairment and Blindness (Excl Colour Blindness)

Summary: investigators conducted a single-blind, randomized trial of taijiquan exercise as compared with a control intervention consisting of wellness education and jogging for youngsters with visual impairments. sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups. the primary end point was a change in the brockport physical fitness test (bpft) at the end of 12 weeks. secondary end points included summary scores of the medical outcomes study 36-item short-form health survey (sf-36) and pittsburgh sleep quality index (psqi)at the end of 12 weeks.

* brockport physical fitness test (bpft) for youngsters with visual impairments, including 20-meter lap scores, body mass index (bmi), dominant grip strength, curl-up, trunk lift, back-saver sit-and-reach and shoulder stretch. * basic information about visually impaired youth, including age, gender, height, weight. * summary scores of the medical outcomes study 36-item short-form health survey (sf-36) * summary scores of of the medical outcomes study pittsburgh sleep quality index (psqi)

Eligibility criteria:
inclusion criteria: * the age ranges from 10 to 17 years old, regardless of sex. * had no previous experience as an athlete. * could follow simple instructions. * could walk without assistance. * could maintain a regular lifestyle during the experiment. * provided informed consent. exclusion criteria: * the exclusion criterion applied to those who suffered any severe illness or ailment which hinders mobility.

Keywords: tai chi physical fitness sleep quality quality of life
feasibility study to develop sentinel lymph node mapping in rectal cancer patients

Conditions: Rectal Cancer

Summary: the purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (tc-sulfur colloid), a dye (spot), and imaging, both pre- and intraoperatively. eligible patients are those with stage i-iii rectal cancer undergoing standard low anterior resection or abdominoperineal resection. investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity. subjects will receive injections of the tracer and dye prior to surgery, have preoperative spect/ct imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. during surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection. if surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (tem) for early stage rectal cancer patients.


Eligibility criteria:
inclusion criteria: * adult patients with stage i,ii, or iii rectal cancer undergoing standard trans- abdominal low anterior resection or abdominoperineal resection surgery at the university of virginia * willing and able to give written informed consent exclusion criteria: * patients less than 18 years of age * women who are pregnant and/or breastfeeding * prisoners * unable to give written informed consent * participants with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator

Keywords: sentinel lymph node lymphatic mapping rectal tumor
a proof-of-concept study of lunsekimig compared with placebo in adults with chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this is a parallel, phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of crswnp. the purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with crswnp who are inadequately controlled on intranasal corticosteroid treatment. participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. the study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.


Eligibility criteria:
inclusion criteria: - a minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening ongoing symptoms for at least 2 months prior to screening, including: * nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (score 2 or 3 on nc score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (nc score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe). * at least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * patient who has received any therapies such as for example systemic corticosteroids, anti-ige therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit * patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom nps cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery * patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint * signs or a ct scan suggestive of allergic fungal rhinosinusitis * active/chronic helminthic infection * history of human immunodeficiency virus (hiv) infection or positive hiv screen (anti-hiv- and hiv-2 antibodies) at screening visit * patients with positive or indeterminate hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), or hepatitis c antibody at screening visit note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
stratification of the acute respiratory distress syndrome - a second phase study

Conditions: Acute Respiratory Distress Syndrome

Summary: current definitions of the acute respiratory distress syndrome (ards) could be adequate for epidemiological studies but are not adequate for inclusion of patients into therapeutic clinical trials. it is a matter of debate whether the assessment of hypoxemia at ards onset is appropriate for stratifying lung severity and risk of death in ards patients. the investigators will perform an observational, non-interventional, multicenter, prospective audit in a network of intensive care units in spain for evaluating the severity and risk of death based on the assessment of respiratory and ventilatory function at 24 hours after ards diagnosis under standardized ventilatory conditions. this study is the confirmatory phase of the study nct02288949.

in 2012, an update of the ards definition (the berlin criteria) was published and an empirical classification was proposed according to three pao2/fio2 cut-off values at ards onset: severe (≤100 mmhg), moderate (\>100 - ≤200 mmhg), and mild (\>200 - ≤300 mmhg) on positive end-expiratory pressure (peep) ≥5 cmh2o. however, despite that there is sufficient evidence about the interactions between peep and fio2, these cut-off values did not mandate the assessment of hypoxemia under standardized guidelines. the pao2/fio2 can be easily manipulated. alterations in peep and fio2 can dramatically change the pao2/fio2. despite recent reports on the effects of standardized ventilator settings on pao2/fio2, is still a matter of debate whether the assessment of hypoxemia must be performed at 24 hours instead of at ards onset, and whether the assessment of hypoxemia under standardized ventilator settings is the most appropriate tool for stratifying lung severity in patients with ards. the investigators will examine whether the values of relevant variables (including age, plateau pressure, driving pressure, compliance, pao2/fio2) at 24 after ards diagnosis under standardized ventilator settings have an impact on the stratification and prediction of death in ards patients. this study is an extension of the study nct02288949.

Eligibility criteria:
inclusion criteria: * patients meeting the berlin criteria for moderate and severe ards. exclusion criteria: * none
analgesia for positioning patient with femur fracture for spinal anaesthesia

Conditions: Femoral Fracture

Summary: this study is performed to determine the efficacy of ultrasound-guided fascia iliaca compartment block during positioning for spinal anaesthesia in patient undergoing repair of proximal femur fracture surgery comparing with intravenous fentanyl.

this a prospective, single-blind, randomized control study that compare the efficacy of ultrasound-guided fascia iliaca compartment block with intravenous fentanyl in positioning patient with femur fracture for spinal anaesthesia.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists (asa) score i and ii * elective surgery of repair of unilateral, single femoral fracture under spinal anaesthesia performed in general operation theatre, hospital kuala lumpur. the fracture may involve femoral neck or femoral shaft. exclusion criteria: * patient with contraindication for spinal anaesthesia * known hypersensitivity or contraindication to medication used in this study * morbid obesity (body mass index (bmi) \> 35 kg/m2) * infection at the intended site of administration of fascia iliaca compartment block * patient with impaired cognitive function

Keywords: fascia iliaca compartment block fentanyl
chemotherapy and amifostine in treating patients with recurrent or refractory solid tumors

Conditions: Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. chemoprotective drugs, such as amifostine, may protect normal cells from the bad side effects of chemotherapy. purpose: randomized phase i trial to study the effectiveness of amifostine in treating patients who are receiving chemotherapy for recurrent or refractory solid tumors.

objectives: i. evaluate the ability of amifostine to facilitate increased dose escalation of gemcitabine and cisplatin. ii. compare the dose limiting toxicities of gemcitabine and cisplatin administered with and without amifostine in these patients. iii. determine the maximum tolerated dose of gemcitabine and cisplatin administered with amifostine in these patients. iv. determine whether synergy is produced by administering gemcitabine and cisplatin on the same day. outline: this is a two stage study. the first stage is a randomized study, and the second stage is a dose escalation study. in the first stage of the study, patients receive either intravenous gemcitabine/amifostine/cisplation (gap) or gemcitabine/cisplatin (gp) in the first cycle. patients are administered the other arm in the second cycle. in the second stage of the study (dose escalation), the initial dose of gp or gap is given on days 1 and 8 every 28 days. dose escalation is carried out in cohorts of 3 patients per dose level. if 1 of 3 patients experiences dose limiting toxicity (dlt), then 3 more patients are accrued at the same dose level. the maximum tolerated dose (mtd) is defined as the lowest dose at which 2 of 6 or 2 of 3 patients experience dlt. patients experiencing grade 3 or 4 toxicity or tumor progression are removed from the study. patients will be reassessed every 12 weeks. projected accrual: a total of 32 patients will be accrued over 12-24 months in the first stage of this study, and 9-12 patients will be accrued for the second stage..

Eligibility criteria:
disease characteristics: histologically proven recurrent or refractory solid tumors platinum sensitive patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 1.5 mg/dl sgot less than 3 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl other: no psychosis no significant medical illness no sensory neuropathy greater than grade 2 prior concurrent therapy: at least 3 weeks since prior therapy

Keywords: unspecified adult solid tumor, protocol specific drug/agent toxicity by tissue/organ
healthy restart intervention to improve health and functioning

Conditions: Mental Disorder

Summary: this study tests an intervention that uses health coaching, motivational interviewing, positive psychology, and online wellness tools to help adults with mental illness return to active lives after major disruptions such as the covid-19 pandemic.

this study is testing the efficacy of a brief intervention delivered to adults with mental illness by trained health coaches, designed to help recipients engage in health and mental health self-management, while setting goals to return to an active life after major disruptions such as a pandemic. adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. they are assessed at baseline and 6 months later. analysis of covariance (ancova) models are used to assess the primary outcome of changes in mental and physical health, functioning, perceived competence for life self-management, and mental health recovery. also examined are study condition differences in self-advocacy skills, access to services, and disruptions from covid-19. hypothesis 1: compared to services as usual (sau), intervention recipients will report better health, well-being, and service use. hypothesis 2: compared to sau, intervention recipients will have more perceived competence and self-advocacy. hypothesis 3: healthy restart recipients will report high levels of satisfaction with the intervention.

Eligibility criteria:
inclusion criteria: * age 18 and older * diagnosis of serious mental illness defined as a dsm 5 psychiatric disorder and moderate to severe functional impairment * membership in a collaborating community mental health agency * access to the internet for online meetings * able to provide informed consent exclusion criteria: * a cognitive impairment preventing informed consent * unable to communicate in english
pulmonary rehabilitation for long covid (post covid-19 condition)

Conditions: COVID-19; Long COVID; Post COVID-19 Condition

Summary: in the pure covid study (a randomized, controlled, multicenter, pragmatic trial) the investigators aim to assess the effect of a pulmonary rehabilitation program in primary care on exercise capacity (6mwt) and daily life physical activity in patients with long covid. 134 patients with long covid, defined by self-reported persistent covid related symptoms ≥6 weeks after covid-19 infection and a positive symptom score (cat score ≥10 or mmrc score ≥2 or cis-fatigue ≥36 or pcfs score of ≥2), will be recruited and divided into an intervention group or a control group. the intervention group will get twelve weeks of primary care pulmonary rehabilitation (pr) including coaching by primary care physiotherapists. the control group consists of usual care, which does not include a pulmonary rehabilitation program. this study will help determine whether the type of symptoms or affected body system can impact recovery form long covid during rehabilitation and after follow-up. the investigators will analyze determinants and risk factors that characterize non-responders and non-adherers to better understand which patients with long covid benefit from rehabilitation.


Eligibility criteria:
inclusion criteria: * adult patients with status post covid-19 (positive covid-19 pcr or an official pharmacy performed antigen test or a self-performed test confirmed by a physician during the acute covid-19 ≥ 6 weeks ago or positive antibodies before vaccination or positive antibodies before vaccination). * persistent covid related symptoms that were not present pre-covid-19 or were less severe pre-covid. * symptomatic: quantified by dyspnea on exertion, loss of energy, fatigue or sleep impairment based upon the score of four questionnaires: * copd assessment test (cat) ≥10, and/or * modified medical research council dyspnea scale (mmrc) ≥2, and/or * cis-fatigue ≥36, and/or * post-covid-19 functional status (pcfs) ≥2. exclusion criteria: * patients with known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that make it impossible to participate in pulmonary rehabilitation. * prior physiotherapy for long covid if: * patients who have completed ≥9 sessions of physiotherapy in total for long covid. * patients who completed any physiotherapy session in the previous 12 weeks for long covid (primary care or hospital based; pulmonary or non-pulmonary). * patients with predominantly neurological disorders impacting respiratory function will not be eligible for the study. * patients that are not able to give informed consent or not able to complete questionnaires. * patients who have had any organ transplatation in the past, have to undergo any transplantation or are on an active transplantation list. * patients with active malignancy and/or (maintenance) treatment for active malignancy or curatively treated carcinoma within the past year.

Keywords: pulmonary rehabilitation physiotherapy respiratory physiotherapy
a study of r-mini-mcop in the treatment of elderly, previously untreated dlbcl

Conditions: Diffuse Large B-Cell Lymphoma

Summary: research purpose： to evaluate the efficacy and safety of r-mini-mcop in first-line treatment of primary treatment of diffuse large b-cell lymphoma (dlbcl) in elderly patients experimental design： single-arm, multicenter, prospective study


Eligibility criteria:
inclusion criteria: 1. age ≥ 80 years 2. the histopathological diagnosis was diffuse large b-cell lymphoma, and immunohistochemistry was positive for cd20 3. previously untreated disease 4. ann arbor stage i-iv disease 5. according to lugano2014 criteria, there must be at least one matching evaluable or measurable lesion: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; for non-lymph node lesions, the measured extra-nodal lesions should be \> 1.0cm in length; 6. ecog score 0-4(ecog score 0-2 after pre-treatment and before r-mini-mcop regimen) 7. bone marrow function: neutrophil count ≥1.5×109/l, platelet count ≥75×109/l, hemoglobin ≥80g/l (neutrophil count ≥1.0×109/l, platelet count ≥50×109/l, hemoglobin ≥75 g/l in patients with bone marrow involvement); 8. liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; ast and alt ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion; 9. have the swallowing power 10. life expectancy \> 3 months 11. patients fully understand the study, voluntarily participate and sign an informed consent form (icf) - exclusion criteria: 1. previous systemic antitumor therapy (except pre-therapy used before the first cycle of r-cmop); 2. metastatic diffuse large b-cell lymphoma； 3. known central nervous system lymphoma 4. hypersensitivity to any investigational drug or its ingredients; 5. uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.); 6. hepatitis b and hepatitis c active infection (hepatitis b virus surface antigen positive and hepatitis b virus dna more than 1x103 copies /ml; more than 1x103 copies /ml of hcv rna); 7. human immunodeficiency virus (hiv) infection (hiv antibody positive); 8. other serious comorbidities, intolerance to this protocol or inappropriate participation in this study (judged by the investigator) 9. previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years); 10. inability to swallow the drug or any significant removal of the small intestine that may prevent full absorption of the drug; 11. situations in which other investigators have determined that participation in this study is not appropriate.

Keywords: diffuse large b-cell lymphoma， mitoxantrone hydrochloride liposomal