Kornimate/medical-research-clean huggingface dataset:
risk assessment of long-haul truck drivers

Conditions: Gonorrhea; Chlamydia Infections; Hepatitis B; Hepatitis C; Diabetes Mellitus; Hypertension; Obesity; HIV Infections; Hyperlipidemia

Summary: international studies have repeatedly documented a substantial prevalence of sexual risk behaviors and high rates of human immunodeficiency virus (hiv) and other sexually transmitted infections (sti) ranging from 5%-56% amongst long-distance truck drivers ("truckers") living in diverse international settings including india, bangladesh, south africa, china, laos and thailand. the prevalence of sexual risk factors and sti/hiv in us drivers is unknown. this proposal will provide both qualitative and quantitative data on hiv risk behaviors by interviewing and testing truckers working for established long-distance trucking firms, the sector which accounts for most of the jobs in the trucking and warehousing industry in the united states. the data obtained from this study will be used to inform the development of an hiv prevention intervention for long-haul truck drivers.

the study proposed in this r34 application will address the following specific aims: specific aim 1. to perform focus groups and in-depth interviews with long-haul truck drivers to guide development of both a behavioral risk assessment instrument and an acceptable hiv/sti screening protocol for long-haul truckers. specific aim 2. to perform in-depth interviews with trucking industry executives to determine barriers to routine hiv/sti assessment and screening of their employees. specific aim 3. to perform a pilot phase with a subsample of long-haul truck drivers characterized by the following steps: ttm-based "cognitive interviews" (n=5); pilot testing of the survey and biomedical screening protocol (n=15); and a follow-up focus group (n=8) specific aim 4. to assess a sample of (n=300) truck drivers for general health and sexual risk behaviors using the adapted theory-based survey and to determine the prevalence of hepatitis b, hepatitis c, hypertension, hyperlipidemia, diabetes and obesity, hiv, n. gonorrhoeae, and c. trachomatis

Eligibility criteria:
inclusion criteria: 1. long-haul truck driver as defined as a driver, part-time or full-time, who drives a truck across state lines (interstate) 2. english speaking 3. age 21 or greater 4. willing to participate 5. able to provide written informed consent exclusion criteria: 1. does not fit definition of truck driver in inclusion criteria #1 2. unwilling to participate 3. unwilling or unable to provide informed consent 4. unable to understand or speak english 5. age \< 21 years

Keywords: sexual risk behavior diabetes mellitus hypertension obesity human immunodeficiency virus hyperlipidemia chlamydia
first in human (fih) study of aln-sod in adult participants with amyotrophic lateral sclerosis associated with mutation in the sod1 gene (sod1-als)

Conditions: Amyotrophic Lateral Sclerosis (ALS); Mutation in the Superoxide Dismutase-1 (SOD1) Gene

Summary: this study is researching an experimental drug called aln-sod (called "study drug"). this study is focused on people with amyotrophic lateral sclerosis (als) caused by a change in a gene called the superoxide dismutase-1 (sod1) gene. this type of als is known as "sod1-als". this is the first time that aln-sod will be given to people. the aim of the study is to see how safe and tolerable the study drug is. the study is looking at several other research questions, including: * the effect the study drug has on specific biomarkers, which are substances in the blood or in the fluid that surrounds the brain and spinal cord, known as cerebrospinal fluid (csf) * how much study drug is in the blood and in the csf, at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) * what effects the study drug has on als symptoms


Eligibility criteria:
key inclusion criteria: 1. weakness attributable to als and a sod1 mutation that has been previously described as associated with als or is considered likely to cause als, as defined in the protocol 2. slow vital capacity (svc) ≥50% predicted value based on age, gender and height, measured in upright position 3. body mass index (bmi) ≤35 kg/m2 at time of screening 4. if participants are taking riluzole or edaravone, they must be on a stable dose for at least 4 weeks prior to initial dosing visit and are expected to remain at that dose until the end of the study 5. platelet count \>50,000/microliter 6. has normal blood pressure readings, as defined in the protocol key exclusion criteria: 1. concurrent participation in another interventional clinical trial 2. has had a tracheostomy 3. has dementia, as assessed by the investigator 4. has uncontrolled psychiatric disease, including psychosis, active or recent suicidal ideation, untreated major depression, in the past 30 days 5. has a medical history of brain or spinal disease/injury that would interfere with the lumbar puncture (lp) process, csf circulation or safety assessment, as defined in the protocol 6. presence of an implanted shunt for the drainage of csf or an implanted central nervous system (cns) catheter 7. presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study 8. was hospitalized (ie, \>24 hours) for any reason other than als within 30 days of screening 9. has received treatment with tofersen within 6 months prior to screening note: other protocol defined inclusion / exclusion criteria apply

Keywords: symptomatic known pathogenic mutation predicted pathogenic mutation
a study of embeda (kadian nt, alo-01) in subjects with pain due to osteoarthritis of the hip or knee

Conditions: Osteoarthritis; Chronic Pain

Summary: the purpose of this study is to evaluate the efficacy of kadian nt (alo-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.

the primary objective of this study is to evaluate the efficacy of alo-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary brief pain inventory (bpi) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Eligibility criteria:
inclusion criteria: * subject is 21 years of age or older * subject is either not of childbearing potential or subject must use an acceptable method of birth control if of childbearing potential * negative pregnancy test if female of childbearing potential * subject is in general good health * subject required treatment of joint pain within the last 90 days * subject has primary diagnosis of osteoarthritis (oa) of the hip or knee exclusion criteria: * subject has a documented history of allergic reaction or intolerance to morphine or other opioids * subject is pregnant or breast-feeding * subject is receiving systemic chemotherapy * subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence * subject has history of major depressive disorder not controlled with medication * subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of oa * subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (gerd) * subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (nsaid)-dependent inflammatory arthritis

Keywords: hip knee pain osteoarthritis oa kadian alpharma naltrexone opioid morphine embeda alo-01
effects of blood flow restriction (bfr) therapy on acl graft maturation

Conditions: Knee Injuries; Anterior Cruciate Ligament Injuries

Summary: this is a study comparing the effects of blood flow restriction (bfr) therapy on the maturation of the anterior cruciate ligament (acl) graft after reconstruction surgery compared to physical therapy without the use of bfr.

the study will be a randomized controlled trial to compare outcomes between physical therapy with bfr and physical therapy without bfr on the acl graft maturation following reconstruction surgery. bfr therapy will begin as early as 2 weeks after surgery. the initial 2 weeks after surgery, or prior to initiation of bfr, will consist of the physical therapy following the surgeon's postoperative protocol. to be considered for participation in this study, patients must be 18 years and older undergoing primary acl reconstruction. in addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Eligibility criteria:
inclusion criteria: * ages 18 or older, all gender * patients receiving any type of acl graft, either autograft or allograft, and any type of tissue exclusion criteria: * patients who do not meet the the comprehensive bfr screening criteria based on predetermined contraindications and precautions * patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery * revision procedures * patients unable to lay still in an mri scanner * patients receiving treatment outside stanford * patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative acl reconstruction protocol * patients who are unable to lay still in an mri scanner * patients with a torn acl or previous acl reconstruction in the contralateral knee
genetics study of tissue collected from patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at changes in the dna of tissue samples that were collected from patients with acute myeloid leukemia.

objectives: * validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (aml) treated uniformly on calgb-19808, preliminary results from calgb-9621 showing that baalc and erg overexpression and microarray gene-expression signatures can stratify the patients prognostically. * establish whether micrornas are differentially expressed in subsets of patients with aml and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically. * explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal aml using genetic markers such as baalc, erg, and evi1 overexpression, mll partial tandem duplication, flt3 internal tandem duplication, npm1 and cebpa mutations, and microarray gene expression microrna signatures. outline: this is a multicenter, pilot study. peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (pcr) or reverse transcriptase-pcr assays and microarray assays. genes to be studied include baalc, erb, evi1, mll, flt3, npm1, and cebpa. projected accrual: a total of 100 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of acute myeloid leukemia * normal karyotype * bone marrow and/or peripheral blood samples from patients treated on calgb-19808 and registered on calgb-9665 required * no additional samples required

Keywords: adult acute minimally differentiated myeloid leukemia (m0) adult acute myeloblastic leukemia without maturation (m1) adult acute myeloblastic leukemia with maturation (m2) adult acute myelomonocytic leukemia (m4) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) adult acute megakaryoblastic leukemia (m7) adult acute eosinophilic leukemia adult acute basophilic leukemia untreated adult acute myeloid leukemia
totem: switch from other nucleoside reverse transcriptase inhibitors (nrtis) to once daily truvada

Conditions: HIV Infections

Summary: this study looked at lipid changes in human immunodeficiency virus type 1 (hiv-1) infected patients when the nucleoside reverse transcriptase inhibitors (nrtis) in their existing highly active antiretroviral therapy (haart) regimen were switched to truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg \[ftc/tdf\]). subjects continued their nonnucleoside reverse transcriptase inhibitor (nnrti) or protease inhibitor (pi) at the same dose.

this was a phase iv, multicenter (in france), open label study. the study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase. study phase 1, day -14 to week 12: patients were randomized on a 1:1 basis to one of two groups: * a. truvada (substitution of their current nrtis by truvada \[ftc/tdf\] with continuation of their current nnrti or pi at the same dose) * b. maintain baseline regimen (continuation of previous haart regimen, i.e., maintained baseline regimen). this phase of the study served the primary objective of the study. study phase 2, roll-over follow-up, week 12 to week 48: patients in the truvada group continued with truvada + an nnrti or pi. patients in the control group could switch their nrtis to truvada in this phase of the study (delayed truvada group). patients were assessed for efficacy and safety during both phases of the study.

Eligibility criteria:
inclusion criteria: * patients displaying abnormal fasted triglycerides (\> 2 g/l \[2.26 mmol/l\] and less than or equal to 10 g/l \[11.29 mmol/l\]) and/or fasted low density lipoprotein cholesterol (ldl-cho; \> 1.6 g/l \[4.15 mmol/l\]) * patients on stable haart with 2 nrtis + 1 nnrti or 1 pi for at least 3 months prior to screening, and with plasma viral load \< 400 copies/ml for at least 6 months prior to screening

Keywords: hiv 1 infection
comparison of analgesic efficacy of fentanyl, sufentanil and butorphanol after remifentanil anesthesia

Conditions: Postoperative Pain

Summary: fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. in addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. how to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. this study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.


Eligibility criteria:
inclusion criteria: 1. asa physical status i-ii 2. chinese 3. 19-45yr 4. selective laparoscopic surgeries exclusion criteria: 1. allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records 2. participants younger than 18 years, older than 45 years or pregnancy was eliminated 3. due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of spo2 under 20-40% nasal tube oxygen at any time should be excluded from the study 4. those who were not willing to or could not finish the whole study at any time

Keywords: postoperative analgesia opioids laparoscopic surgery
a study of a moisturizing cream and baby wash in the management of mild to moderate atopic dermatitis in infants, toddlers and children

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to evaluate the effectiveness (assessed by clinical evaluation of eczema/atopic dermatitis severity and parent-perceived benefits) and tolerability (assessed by clinical grading and parent-perception) of the investigational cream when used in conjunction with a baby wash in babies, toddlers, and children with mild to moderate atopic dermatitis.


Eligibility criteria:
inclusion criteria: for child * fitzpatrick skin type i to vi * child must have at least 1 target lesion based on the atopic dermatitis severity index (adsi) with a score of 2-12 and an erythema sub score of at least 2 (moderate) * has mild to moderate atopic dermatitis (as per rajka-langeland severity index; graded as 3.0 to 7.5 inclusive) * child must have parent-assessed history of itch * has parent-perceived sensitive skin for parents * willing to undergo a 3-day washout period prior to the baseline assessments. during this run-in period, parents will be asked to refrain from using prescription and over-the-counter (otc) eczema treatments on their child; acute rescue treatment will be permitted (type of rescue treatment will be determined by principal investigator \[pi\]) * has signed the informed consent document (icd), including health insurance portability and accountability act (hipaa) disclosure exclusion criteria: * has known allergies or adverse reactions to common topical skincare products or ingredients of the investigational products (ips) * has a history of a confirmed or suspected coronavirus disease 2019 (covid-19) infection within 30 days prior to visit 1 for child * presents with a skin condition that may influence the outcome of the study (specifically psoriasis or active skin cancer) * severe atopic dermatitis (ad) as determined by the rajka-langeland severity index for parent * is self-reported to be pregnant or planning to become pregnant during the study
treatment of chronic antibody-mediated rejection in kidney transplant with acthar

Conditions: Transplant Glomerulopathy

Summary: this is an open label safety and feasibility trial using acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose ivig (intravenous immunoglobulin) (2 g/kg), and/or rituximab, in patients with chronic antibody-mediated rejection (camr).

subjects will receive acthar® 40 units twice a week subcutaneously for 2 weeks. if the drug is well tolerated the dose will be increased to 80 units twice a week for another 22 weeks. the patients will be maintained on their center-specific standard maintenance regimen, typically consisting of tacrolimus, mycephenolate mofetil/sodium, and prednisone. after screening for the inclusion/exclusion criteria, the patients will be consented and enrolled in the study. the initial visit and subsequent study-related visits at 4, 8, 12, 24, 36 and 52 weeks will include routine evaluation and physical examination and laboratory studies including cbc (complete blood count), electrolyte panel, egfr, albumin, liver enzymes, and calcineurin inhibitor (cni)/sirolimus drug level, according to the center's standard of care. donor-specific antibody (dsa) will be tested at week 24, and 52 and patients will undergo a biopsy at week 52, as a part of the investigators standard of care. the biopsies will be evaluated by light and electron microscopy using standard histological banff criteria, and staining for cd68.

Eligibility criteria:
inclusion criteria: * age \>18 years * morphologic diagnosis of camr, by light \&/or electron microscopy any time after transplantation * current or previously documented donor-specific antibody (dsa) and/or focal or diffuse peritubular capillary c4d staining by immunohistochemistry * egfr\>25 ml/min exclusion criteria: * diagnosis of malignancy within a year prior to enrollment (except cured cutaneous basal cell or squamous cell carcinoma). * lack of evidence of antibody involvement * pregnancy, lactation, or refusal to use birth control in women of child bearing potential * active infection, or history of hiv * history of liver or thoracic transplant
rasburicase for hyperuricemia

Conditions: Nutritional and Metabolic Diseases

Summary: primary: to estimate efficacy of sr29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for tumor lysis syndrome, by evaluation of plasma uric acid concentration. secondary: to investigate the safety in this population and anti-sr29142 antibodies, anti-scp antibodies, and pharmacokinetic parameters.


Eligibility criteria:
inclusion criteria: * \<18 years of age * patient with newly diagnosed hematological malignancies presenting with hyperuricemia: * uric acid \> 7.5 mg/dl in patients ≥ 13 years old- uric acid \> 6.5mg/dl in patients \<13 years old or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined: * non-hodgkin's lymphoma, stage iv regardless of uric acid level, * non-hodgkin's lymphomas stage iii regardless of uric acid level with one of the following: * at least one lymph node or mass \>5 cm in diameter * ldh ≥ 3 x uln (iu/l): judging according to modified murphy's classification * acute leukemia with white blood cell count (wbc) ≥ 50,000/mm3 or ldh ≥ 3 x uln (iu/l) regardless of uric acid level. etc. exclusion criteria: * patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of sr29142 administration or during the trial period. * low birth weight infant (\<2500g) or gestational age \<37 weeks * patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of sr29142 or during the trial period. * known history of severe allergic reaction and/or severe asthma. * known history or family history of glucose-6-phosphate dehydrogenase deficiency. * known history of hemolysis and methemoglobinemia. * severe disorders of liver or kidney. alt (gpt) \> 5.0 x uln, total bilirubin \> 3.0 x uln, creatinine \> 3.0 x uln * uncontrollable infections (including viral infections). * known positive tests for hbs antigen, hcv antibodies, or hiv-1, 2 antibodies. etc.

Keywords: urate oxidase, hyperuricemia, lymphoma, leukemia