Kornimate/medical-research-clean huggingface dataset:
effects of programming parameters on back pain relief in subthreshold spinal cord stimulation

Conditions: Low Back Pain

Summary: the purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.


Eligibility criteria:
inclusion criteria: * chronic intractable pain of the trunk and/or limbs * documented history of trunk and/or limb pain of at least 180 days * average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the screening visit * pass study site's routine psychological/psychiatric evaluation within 180 days of the trial lead insertion visit * if taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the trial lead insertion visit and agree to continue on the same prescription throughout study participation * subject is willing and able to comply with all protocol-required procedures and assessments/evaluations * subject is able to independently read and complete all questionnaires and/or assessments provided in english * 18 years of age or older when written informed consent is obtained * subject signs a valid, ethics committee-approved informed consent form (icf) provided in english exclusion criteria: * unable to operate the precisionplus™ system * primary source of pain is cancer-related, pelvic, visceral, angina, or migraine * is a high surgical risk * is diabetic * is immunocompromised * currently on any anticoagulant medications that cannot be discontinued during perioperative period * untreated major depression or untreated generalized anxiety disorder * diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder * diagnosed with any major psychiatric disorder not specifically listed in previous two exclusion criterion * currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care * current abuse of alcohol or illicit drugs * subject requires magnetic resonance imaging (mri) while implanted with lead(s). * subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study * subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (ipgs, implantable drug pump, etc) or pacemaker or implantable cardiac defibrillator * patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the trial lead insertion visit in women of child-bearing potential and the test result document)
pain after proximal digital amputation prevention

Conditions: Pain; Amputation Neuroma; Amputation

Summary: finger amputations are common and may be complicated by debilitating nerve pain. this study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (tmr) or regenerative peripheral nerve interfaces (rpni)-compared to standard treatment by traction neurectomy (tn).

patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.

Eligibility criteria:
inclusion criteria: * patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint). * patients have the capacity to complete the informed consent process exclusion criteria: * patients less than 18 years of age, prisoner, or other vulnerable population * patients with significant concomitant ipsilateral extremity injuries that would confound study * patients requiring emergent, staged (guillotine-type) amputations of any kind

Keywords: pain amputation neuroma finger amputation
phase 1 study of lqt-1213 in healthy adults

Conditions: Long QT Syndrome

Summary: this is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (sad) incorporating a food effect arm and multiple ascending dose (mad). potential participants for each part will undergo screening procedures within 28 days of enrollment.


Eligibility criteria:
key inclusion criteria: * healthy adult male or female participants * females of childbearing potential must agree and commit to use an adequate form of contraception. * men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception. * aged at least 18 years but not older than 60 years (inclusive) * body mass index (bmi) within 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusively. * non- or ex-smoker * have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ecg, as determined by an investigator. exclusion criteria: * clinically significant diseases or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results. * clinically significant abnormal findings on the physical examination or medical history during screening as deemed by the principal investigator * female who is lactating * female who is pregnant * male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system * male participants who are undergoing treatment or evaluation for infertility. * history of significant hypersensitivity to lqt-1213, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * use of immunosuppressant in the 28 days prior to the first study drug administration * maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic) * intake of an investigational product or participation in a clinical trial in the 90 days prior to the first study drug administration

Keywords: lqt-1213 congenital long qt syndrome lqts serum glucocorticoid regulated kinase-1 sgk-1 inhibitor
tdcs-augmented prolonged exposure therapy

Conditions: Posttraumatic Stress Disorder; PTSD; Anxiety; Depression

Summary: the purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tdcs, on the benefits of prolonged exposure therapy, or pe, which is an effective treatment for posttraumatic stress disorder, or ptsd. tdcs has been demonstrated to be safe and effective for influencing brain activity by passing a weak electrical current through the scalp. in this study, tdcs is provided in addition to pe treatment, through the national crime victim's research and treatment center at musc, or the ptsd clinical team clinic within the ralph h. johnson va medical center.

this project implements a multiple baseline within-subject clinical trial design aiming to test whether tdcs targeting excitation of the medial prefrontal cortex (mpfc) can enhance a standard course of pe in a sample of adult civilians and veterans (ages 18-65) who meet full dsm-5 criteria for chronic ptsd (i.e., \> 3 months post-trauma; n = 20). all participants will receive a total of ten 60-min. sessions of manualized pe, preceded by 20 min. of either active or sham hd-tdcs. the stepped-wedge multiple baseline design features tdcs as a 2-level within-subject factor (sham tdcs+pe vs. active tdcs+pe), and between-subject comparisons based on stratified random assignment to cross-over from sham to active tdcs just prior to sessions 4 through 8. strata will be defined by dichotomous classifications of possible confounds, including baseline severity (moderate vs. severe), psychotropic medication status (no vs. yes), and sex (female vs. male). the sample will consist of treatment-seeking civilian and veteran participants referred by either of two of our consortium sites, including the national crime victim's research and treatment center (ncvc) at musc, or the ptsd clinical team (pct) at the ralph h. johnson vamc, as well as community participants who respond to study advertisements.

Eligibility criteria:
inclusion criteria: * age 18-65. * fluent in english. * diagnosis of chronic ptsd based on mini for dsm-5 (\> 3 mo. post-trauma) * for veterans recruited at the ralph h. johnson va only: eligible to receive pe in the pct clinic. exclusion criteria: * currently receiving psychotherapy for another anxiety- or stress-related condition. * unstable dose of psychotropic medications within 6 weeks prior to baseline assessment * medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems). * pregnancy * current severe major depressive disorder * current, or history of bipolar disorder * current, or history of psychotic symptoms * serious suicidal risk * active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion * contraindications for tdcs: * metal in the head. * implanted brain medical devices.

Keywords: non-invasive brain stimulation transcranial direct current stimulation exposure therapy prolonged exposure civilians veterans trauma posttraumatic stress disorder ptsd
prone positioning and r/i ratio in covid-19 patients with ards (sydrac-dv)

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: the purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in covid-19 patients with acute respiratory distress syndrome.

high positive end-expiratory pressure (peep) level and prone positioning (pp) are recommended in patients with moderate to severe acute respiratory distress syndrome (ards) in order to recruit lung and thus to improve oxygenation. thus, high peep level and prone positioning will be more effective in patients with high potential for lung recruitment. recently, the recruitment-to-inflation ratio (r/i ratio) has been described and validated in patients with ards to estimate the potential for lung recruitment. in this regard, the r/i ration may be of interest to titrate peep level in patients with ards. this would be of particular interest in covid-19 patients with ards, since different ards phenotypes with heterogeneous potential of lung recruitment have been described in these patients. however, the effects of prone positioning on r/i ratio have been scarcely described so far. thus, the main goal of this study is to investigate the effects of prone positioning on the r/i ratio in covid-19 patients with ards. the second goal of this study is to determine the effects of prone positioning on oxygenation and respiratory mechanics according to the r/i ratio.

Eligibility criteria:
inclusion criteria: 1. invasive mechanical ventilation 2. patients with acute respiratory distress syndrome according to the berlin definition 3. positive covid-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs or pulmonary samples. 4. indication to a prone positioning session by the attending physician exclusion criteria: 1. age \<18 years and pregnant women 2. patients under legal protection 3. acute core pulmonale 4. pneumothorax and/or chest drainage 5. hemodynamic failure 1. increase in norepinephrine dosage \>30% within the last 6 hours 2. norepinephrine dosage \> 0.5 mg/kg/min

Keywords: ards covid-19 prone positioning lung recruitement
dream study: dna/rna-ngs co-testing in driver-negative, treatment-resistant nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: the study is divided into two parts, part a and part b. the purpose of part a is to reveal the proportion of nsclc patients who are primarily resistant to first-line non-targeted therapy due to the omission of driver genes (especially fusion variations) by dna-ngs, the median pfs of patients in the first line, and clinical characteristics through synchronous co-testing of dna and rna ngs. the purpose of part b is to compare the difference in orr between patients with driver gene positivity identified through synchronous co-testing of dna and rna ngs who receive and do not receive targeted therapy.


Eligibility criteria:
inclusion criteria: 1. aged 18 and above, male or female 2. pathologically diagnosed with advanced or metastatic inoperable non-small cell lung cancer 3. prior genetic testing \[dna-ngs\] results show no mutations in egfr, braf, met, her2, kras, fgfr2/3，no amplifications in met and her2 and no fusions in alk, ros1, ret, ntrk, nrg1, egfr, met, braf, fgfr2/3 4. based on negative driver gene results, received first-line non-targeted therapy with rapid progression or intolerance, with a progression-free survival (pfs) of ≤6 months (regardless of drug exposure time, calculated from the first day of medication) 5. have retained tumor tissue samples prior to first-line treatment 6. patients are from medical centers that can ethically affiliate and have accessible clinical follow-up data. exclusion criteria: 1. patients who do not meet any of the necessary inclusion criteria 2. presence of other pulmonary diseases that require treatment or are severe, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc. 3. presence of active infections that require systemic treatment 4. history of drug abuse or alcohol abuse, or mental illness, or suspected allergy or intolerance to the study drug or any of its components 5. any other conditions deemed unsuitable for entry into this study by the investigator.

Keywords: nsclc primary resistance dna+rna-ngs driver gene testing targeted therapy
genomics in infection and sepsis to predict organ dysfunction and outcomes in sepsis

Conditions: Sepsis; Infection; Pneumonia

Summary: this is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.

this is a prospective cohort study using single cell transcriptomic profiling and plasma dna tissue mapping on patients with pneumonia with or without sepsis. the major application of the investigator's study would be the discovery of gene expressions in different leucocytes and plasma dna associated with each type of organ dysfunction in sepsis. these include cardiovascular, respiratory, hepatic, renal, neurological and haematological dysfunction. this would help prediction, diagnosis and development of therapies to treat sepsis. leucocyte single cell transcriptome and plasma dna tissue mapping may addresses the limitations of current evidence in 3 ways: (1) differentiate patients with uncomplicated pneumonia versus pneumonia with associated sepsis, (2) correlation with types and severity of organ dysfunction and (3) identifying molecular phenotypes of sepsis.

Eligibility criteria:
inclusion criteria: all of the following: * newly admitted adult patients (≥ 18 years old) * suspected community acquired pneumonia (cap) * compatible history of either sputum or cough or fever or rigors within 1 week * chest x-ray infiltrates exclusion criteria: any of the following: * chest symptoms not solely accounted by pneumonia (cardiac failure, non cardiogenic pulmonary oedema, suspected pulmonary embolism, suspected secondary acute respiratory distress syndrome) * immunosuppression * current malignancy * blood samples for gene expression could not be taken within 24 hours of admission * prisoner/cogni tive impairment * blood transfusion within 1 month * hospitalization within 1 month

Keywords: sepsis infection pneumonia organ dysfunction critical illness
effect of person-centred-care on antipsychotic drug use in nursing homes: a cluster-randomised trial

Conditions: Dementia

Summary: background: up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. according to analyses of prescription prevalence in germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. a huge number is prescribed for inappropriate reasons and too long without regular review. the use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. this study aims to investigate whether a person-centered care approach developed in the united kingdom can be adapted and implemented in german nursing homes. the aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription. methods/design: cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. overall, 36 nursing homes from east, north and west germany will be included and randomised. the primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. cost parameters will be collected and process evaluation will be performed alongside the trial.


Eligibility criteria:
on cluster level inclusion criteria: * nursing homes with at least 50 residents exclusion criteria: * other ongoing trial in the institution on individual level inclusion criteria: * all residents within a cluster are eligible to participate in the study exclusion criteria: * diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis * respite care

Keywords: nursing homes person-centered care inappropriate prescriptions cluster-randomised controlled trial antipsychotic drugs
determine the effects of prone positioning and no in covid-19 ards by eit

Conditions: Respiratory Distress Syndrome, Adult; COVID-19

Summary: we aims to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with covid-19 associated acute respiratory distress syndrome by electrical impedance tomography.

the investigators aim to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with covid-19 associated acute respiratory distress syndrome by electrical impedance tomography (eit). the eit assessment is performed in patients ventilated in supine position, supine position with no inhalation for 1 hour, prone position for 1 hour, prone position for 2 hours with no inhalation for 1 hour, prone position for 3 hours, prone position for 16 hours, re-supine position for 3 hours. arterial blood gas (abg) analysis results, ventilator parameters and hemodynamic parameters are also recorded at each time point.

Eligibility criteria:
inclusion criteria: * adult patients who have covid-19-associated acute respiratory distress syndrome exclusion criteria: * patients who refuse to participate in the study; unable to use eit, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.

Keywords: respiratory distress syndrome covid-19
comparison between functional outcomes of flexor tendon repair under walant and brachial plexus block

Conditions: Flexor Tendon Rupture

Summary: although outcomes after flexor tendon repair have reportedly improved with modern treatment, complications are common. early passive and active motion protocols have improved outcomes of flexor tendon repairs. one potential complication of early motion occurs when the forces produced by this motion exceed the strength of the repair, which leads to gap formation and inhibits healing. wide awake local anesthesia no tournique (walant) is a new anesthesia technique that has gained popularity among plastic surgeons. it was developed by dr. lalonde in canada, and it involves the use of lidocaine and adrenaline in the surgical site to control bleeding without the need for a tourniquet. peripheral nerve blocks are overall safe when performed correctly, there are rare but serious risks associated with them. risks include block failure, bleeding, infection, damage to surrounding structures, permanent nerve injury, and intravascular uptake of local anesthetic resulting in systemic toxicity.

walant can be applied in both elective and emergency surgeries and is commonly used for procedures involving the hand, wrist, and fingers, such as root tunnels syndromes, trigger finger, and fractures. however, it has some limitations and contraindications, including patients with coagulopathy or on anticoagulant therapy, those with allergies to any of the anesthesia components, or patients with a history of psychiatric disorders or aggressive behavior. infraclavicular brachial plexus block (icbpb) is widely used for anesthesia or analgesia during surgery on the hand and forearm. today, it is most frequently performed using a sagittal ultrasound scan at the lateral infraclavicular fossa (licf), where the local anesthetic is injected deep to the pectoral muscles. peripheral nerve blocks are overall safe when performed correctly, there are rare but serious risks associated with them. risks include block failure, bleeding, infection, damage to surrounding structures, permanent nerve injury, and intravascular uptake of local anesthetic resulting in systemic toxicity.

Eligibility criteria:
inclusion criteria: * cooperative patients . * age between 16-60 years. * acute flexor tendon injuries of the hand in both genders in medial four fingers. * sharp mechanism of injury. * single level injury zone 2. exclusion criteria: * associated fractures close to the tendon injury. * vascular injury requiring revascularization * multiple level injury * combined flexor and extensor laceration * insufficient skin and soft tissue coverage * tendon substance loss * patients with coagulopathy or on anticoagulant therapy * patients with allergies to any of the anesthesia components
safety and efficacy of brimonidine tartrate/timolol fixed combination in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (combigan®) compared with brimonidine tartrate (alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.


Eligibility criteria:
inclusion criteria: * open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers * no anticipated wearing of contact lenses during study exclusion criteria: * active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye) * any intraocular surgery or laser (eg, cataract surgery or lasik) within 3 months * required regular use of other ocular medications except for occasional use of artificial tears