Kornimate/medical-research-clean huggingface dataset:
ketamine for sedation in severe traumatic brain injury

Conditions: Severe Traumatic Brain Injury; Intracranial Hypertension; Intracranial Hemorrhage, Hypertensive

Summary: this protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.

patients meeting eligibility criteria and consent having been obtained by lar will undergo randomization to either the ketamine with propofol intervention arm or the standard of care control arm. patients enrolled in the intervention arm will receive propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine, for sustained icp elevations over 22mhg for greater than 5 minutes not attributed to other causes (coughing etc.). in the control arm, patients will receive their institutional analgosedation protocol. the sedation protocols will be continued until removal of intracranial pressure monitoring. this study will take place during the participant's hospital care. the clinical team will administer treatment using standard practices, including all safety precautions available. side effects will be monitored closely and may decide to discontinue the subject's participation in the study should the subject's health or safety are at risk. the research team will performed one outpatient follow-up after study intervention ends.

Eligibility criteria:
inclusion criteria: * adults 18-65 years of age * severe traumatic brain injury (tbi), with a glasgow coma scale (gcs) ≤ 8, requiring intracranial monitoring * placement of intracranial pressure monitor * receiving treatment in an intensive care unit (icu) exclusion criteria: * significant cardiovascular disease with recent coronary intervention * pregnancy * prisoners * known allergy to ketamine or propofol

Keywords: tbi severe tbi traumatic brain injury sedation ketamine
observational study providing 12 months of safety follow-up from first exposure to hp802-247

Conditions: Venous Leg Ulcer (VLU)

Summary: this observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product hp802-247 for venous leg ulcers, who received at least one application of hp802-247 or vehicle (placebo). this study is being done for the following purposes: 1. to identify new adverse events, 2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-032 trial, 3. to record wound status, and 4. to determine if there are differences in health related quality of life (hrqol) associated with the treatment assignment from the 802-247-09-032 trial. about 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. the study was conducted in approximately 50 sites in europe.

subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. this ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of hp802-247. this study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of investigational medicinal product in the prior study. specifically, this study examines all new and unresolved ongoing adverse events.

Eligibility criteria:
inclusion criteria: * the informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. * subject was randomized in 802-247-09-032 and received at least one application of test article. * subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion. exclusion criteria: * subjects who refuse to provide written informed consent for this study will be excluded from this study.

Keywords: venous stasis ulcer vlu
open-label pharmacokinetic study of diazoxide choline coated vs. uncoated formulations

Conditions: Hypertriglyceridemia

Summary: this is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. the primary objective is to compare the pharmacokinetic (pk) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. secondary objectives are to assess diazoxide choline pharmacokinetic (pk) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.


Eligibility criteria:
inclusion criteria: * signed informed consent * healthy male and female subjects 18 to 75 years of age * body mass index (bmi) between 22-35 kg/m2 * fasting glucose ≤ 125 mg/dl and hba1c ≤ 6.5. * fasting triglyceride ≥100 mg/dl and ≤ 500 mg/dl * not pregnant exclusion criteria: * significant underlying medical conditions * clinical laboratory test values outside the accepted range * smokers, tobacco users, or subjects currently using nicotine products * substance abuse * history of allergic response(s) to diazoxide or related drugs * recent significant weight loss * use of medication affecting body weight, lipid or glucose metabolism * unable to comply with study procedures
exploratory study of early biomarkers allowing dynamic assessment of response to treatment in cancers of the head and neck

Conditions: Head and Neck Cancer

Summary: dart is an exploratory molecular analysis study to assess potential early biomarkers of treatment response in squamous cell carcinoma of the head and neck (hnscc)

if cancer that starts in the head or neck is not suitable for surgery or radiotherapy, then it cannot be cured. unfortunately, people in this situation have a short life expectancy, with half dying within 12 months. there are treatments available that have helped people in this situation live longer, most recently drugs that stimulate the body's own immune system to attack the cancer, known as 'immunotherapy'. some people do very well on these treatments, living many years, while the same treatments offer no benefit to others - it is not known why. this study is looking at collecting samples of a person's cancer, along with other body fluids, particularly blood and saliva, to see if the investigators can track changes in blood and saliva that happen in a person's cancer while they are receiving treatment. additionally, samples of the cancer will be used to see if they can be grown in the laboratory to test growth behaviour and how well different treatments work. the investigators will ask people being treated for incurable cancer that started in the head and neck for permission to collect their blood and saliva, along with samples of their cancer tissue, while they are having treatment. nearly all patients will require a sample of their cancer tissue taken with a needle (a 'biopsy') anyway, and tissue samples can be taken as part of this process. similarly, the safe administration of cancer drugs requires blood tests before every course of treatment, and research bloods can be taken from the same blood draw. a small number of people will be asked whether they give their permission for an extra biopsy of their cancer to allow further comparisons in the laboratory.

Eligibility criteria:
inclusion criteria: * age 18 years or older * patients with histologically confirmed cancer of the head and neck with evidence of recurrent or locally advanced cancer not suitable for treatment with curative intent, or metastatic disease. * receiving immunotherapy * ability to give informed consent for biological sample collection. exclusion criteria: * unable to undergo serial sample collection * pregnancy
role of pentoxifylline and celecoxib in parkinsonism

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a chronic neurodegenerative disease clinically characterized by bradykinesia, hypokinesia, rigidity, resting tremor, and postural instability. these motor manifestations are attributed to the degeneration and selective loss of dopaminergic neurons in the substantia nigra pars compacta (snpc), leading to a dopamine (da) deficiency in the striatum. the environmental factors are the most common risk factor for parkinson's disease, while hereditary determinants have minor role for disease. furthermore, the clinical diagnosis of pd rests on the identification of characteristics related to dopamine deficiency. however, nondopaminergic and nonmotor symptoms, including cognitive dysfunction and depression, which is one of the most common and persistent symptoms, are sometimes present at an earlier disease stage and, almost inevitably, emerge with the disease progression. neuroinflammation is considered one of the most important factors contributing critically to pathophysiology of pd . recently, high mobility group box-1 (hmgb1) protein has been encoded as a potential inflammatory biomarker in pd. hmgb1 mediates immune response mostly through endothelial cells and macrophage activation via targeting two vital cell receptors; toll-like receptor 4 (tlr4) and advanced glycation end products (rage). hmgb1 leads to a sequential cascade of inflammatory response through enhanced release of tumor necrosis factor-alpha (tnf-α) and interleukins (ils), prominently il-1β and il-6. hmgb1 mediated also up-regulation of nuclear factor kappa-β (nf-κb) with subsequent flared pro-inflammatory storm.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * both male and female will be included. * patients diagnosed with pd according to unified parkinson's disease rating scale. exclusion criteria: * breast feeding * patients with significant liver and kidney function abnormalities. * alcohol and / or drug abusers. * patients with known allergy to the study medications
change in pain with virtual reality-augmented remote rehabilitative care

Conditions: Musculoskeletal Pain

Summary: pain is among the most common chronic conditions in the adult population, often associated with decreased quality of life, functional impairments, increased medication use, increased medical expenditures, and significant economic costs. due to the worsening opioid crisis, non-pharmacological approaches, such as rehabilitative care, are needed. however, access to in-person rehabilitative care may be limited due to transportation barriers, time constraints, and patient preference to remain at home. the covid-19 pandemic has further exacerbated barriers to access in-person care, bringing the benefits of tele-rehabilitation into sharper focus. remote models of care and novel treatment strategies, specifically the utilization of virtual reality (vr) augmented care are emerging as potentially viable treatment alternatives. this paper intends to explore the potential effectiveness of this method of care delivery in patients presenting for rehabilitative care with a primary complaint of pain.

the investigators are proposing a retrospective health and medical records review with a waiver of consent on 52 patients who had remote vr-augmented rehabilitation services from aug 2020 to sept of 2021 at xrhealth, a telehealth rehabilitation company utilizing virtual reality applications to augment traditional rehabilitative care. included patients had an initial and follow-up score on the brief pain interference scale-intensity and severity to explore the association with remote care and changes over time in this validated outcome assessment. in addition, vr headset data will be analyzed to explore the usage and type of vr applications by primary treatment region to help inform the establishment of optimal treatment protocols and explore the association between changes by applications used. de-identified data will be extracted from the proprietary xr health data portal and will include a unique patient identifier, qualitative and quantitative ratings on the patient experience with xrhealth, number of treatment visits, usage in minutes of the vr applications utilized, and scores on the brief pain inventory: interference and severity sub scales. individual patient records will be reviewed to extract information regarding co-morbidities, condition chronicity, and medications used.

Eligibility criteria:
inclusion criteria: * presented for treatment at xrhealth with the primary complaint of musculoskeletal pain exclusion criteria: * none

Keywords: chronic pain virtual reality pain management tele-rehabilitation
effects of relighting on smoke toxicant deliveries and subjective smoking measures

Conditions: Tobacco Use; Cigarette Smoking; Nicotine Dependence

Summary: characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. this will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. we will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. hypothesis: relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.


Eligibility criteria:
inclusion criteria: * smoking at least 10 cigarettes/day for at least 1 year (confirmed by co \> 8 ppm or nicalert test of 6) * engaging in relighting for at least half of their cpd * no smoking quit attempts in the past month nor intentions to quit in the next month * stable medical or psychiatric conditions with systolic blood pressure \< 160, diastolic blood pressure \< 100 and heart rate \< 105 bpm exclusion criteria: * participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month * currently trying or planning to quit smoking in the next month * planning to become pregnant, pregnant or breastfeeding. pregnancy exclusion will be confirmed through a urine test.
circulating tumor dna guiding (olaparib) lynparza® treatment in ovarian cancer

Conditions: Ovarian Epithelial Cancer

Summary: this is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.


Eligibility criteria:
inclusion criteria: * with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum * at least 1 previous line of chemotherapy * measurable disease * patients have a normal organ and bone marrow function measured within 28 days of randomization * who 0-2 exclusion criteria: * primary platinum-refractory disease * known hypersensitivity to olaparib * resting ecg with qtc \> 470 msec * concomitant use of known potent cyp3a4 inhibitors * symptomatic uncontrolled brain metastases * patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
building a renewed image after head & neck cancer treatment (bright) multi-site rct

Conditions: Head and Neck Cancer; Body Image Disturbance; Body Image; Survivorship; Psychosocial Impairment; Mental Health Issue

Summary: in this multi-center randomized clinical trial, head and neck cancer (hnc) survivors with clinically significant body image distress (bid) (n=180) will be randomized to bright (a brief video tele-cognitive behavioral therapy intervention) or attention control (ac, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). hnc survivors will complete image-hn (a validated patient-reported outcome measure \[prom\] of hnc-related body image distress \[bid\]; primary endpoint), measures of psychological and social well-being and quality of life (qol), and measures of theory-derived mechanisms of change underlying bright (mediators).

we will perform a multi-site randomized clinical trial (rct) comparing bright with ac to test our hypotheses that bright reduces bid and improves psychological and social well-being and qol at 2, 3, 6, and 9-months post-randomization by enhancing body image coping skills and decreasing unhelpful automatic thoughts. hnc survivors with clinically significant bid (n=180) from multiple sites in the united states will be randomized 1:1 to bright or ac. we will conduct semi-structured interviews with key stakeholders (n=10/site) and in-depth site visits to assess barriers and facilitators of the adoption of bright and develop an implementation toolkit to enhance the future adoption of bright into routine clinical care.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years on the day of informed consent 2. history of pathologically confirmed squamous cell carcinoma (or histologic variant) of the oral cavity, pharynx, larynx, nose/paranasal sinuses, carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck 3. history of curative intent surgery with or without adjuvant therapy, with or without reconstruction 4. completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion) 5. cancer-free at the time of accrual -patients with known indolent malignancies (e.g., non-melanoma skin cancer, low risk thyroid cancer, untreated prostate cancer, etc) would not exclude a patient from the study 6. no planned significant hnc ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the hnc oncologic surgeon at the time of study accrual 7. willingness to be randomized to either bright or ac 8. image-hn score \> 22 exclusion criteria: 1. inability to speak or write english 2. pre-existing, ongoing cbt services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial 3. initiation or adjustment (\< 3 months of baseline) of psychotropic medication 4. severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)
thiamine vs. placebo to increase oxygen consumption after cardiac arrest

Conditions: Cardiac Arrest; Shock; Lactic Acidosis; Thiamin Deficiency

Summary: this study is to evaluate whether thiamine can increase oxygen consumption and lower lactate in patients who initially survive an in-hospital cardiac arrest. patients who are successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical ventilation in the intensive care unit will be enrolled, and will get either thiamine or placebo. their oxygen consumption and lactate will be measured at serial time points and compared between groups. the investigators' hypothesis is that thiamine will help restore the body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in oxygen consumption and a decrease in lactate.

in-hospital cardiac arrest often leads to shock and organ failure, and low oxygen consumption and high lactate are associated with worse outcome. thiamine is a b vitamin necessary to maintain the body's ability to use oxygen effectively, and the investigators have found that many patients are thiamine deficient after cardiac arrest. the investigators have also found that thiamine can decrease lactate in thiamine-deficient patients who are critically ill. patients in this study will be randomized to receive either thiamine or placebo every 12 hours for 2 days after surviving an in-hospital cardiac arrest. the investigators will measure oxygen consumption continuously during that time with a monitor attached to the ventilator tubing, and will also measure lactate and other lab values at several time points.

Eligibility criteria:
inclusion criteria: * adult patient (age \> 18 years) * cardiac arrest occurring while admitted to the hospital, with sustained (\>20 minutes) return of spontaneous circulation (rosc) * mechanically ventilated at the time of enrollment * within 12 hours of cardiac arrest event exclusion criteria: * clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days * comfort measures only or anticipated withdrawal of support within 24 hours * severe agitation * protected populations (pregnant women, prisoners)

Keywords: cardiac arrest thiamine oxygen consumption lactate shock
clinical study to assess the efficacy and safety of olaparib in chinese patients with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have brca1/2 mutations

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of olaparib compared with standard of care (enzalutamide or abiraterone acetate) in chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have brca1/2 mutations.

this is a phase iv, randomized, open-label, 2-arm, multicenter study evaluating the efficacy and safety of olaparib in chinese men with metastatic castration-resistant prostate cancer (mcrpc) who have failed prior treatment with a new hormonal agent (nha) and have brca1/2 mutations. approximately 42 subjects will be randomized in a 2:1 ratio to olaparib or to investigator's choice of nha (enzalutamide or abiraterone acetate).

Eligibility criteria:
inclusion criteria： 1. histologically confirmed diagnosis of prostate cancer. 2. documented evidence of metastatic castration resistant prostate cancer (mcrpc). 3. subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or crpc . 4. ongoing therapy with lhrh analog or bilateral orchiectomy. 5. radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy). 6. deleterious or suspected deleterious brca1/2 mutation in tumor tissue. 7. normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 8. eastern cooperative oncology group (ecog) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. exclusion criteria： 1. any previous treatment with a poly (adenosine diphosphate \[adp\] ribose) polymerase (parp) inhibitor, including olaparib. 2. subjects who had any previous treatment with dna-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization. 3. history of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence. 4. spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.

Keywords: metastatic castration-resistant prostate cancer (mcrpc) brca1/2 mutations