Kornimate/medical-research-clean huggingface dataset:
speech-derived digital biomarkers study

Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease

Summary: the goal is to assess the accuracy of an application that analyzes voice characteristics to diagnose patients with mild cognitive impairment (mci) and alzheimer's disease (ad). the main question is whether the application's diagnosis is the same as the clinician's for mci and ad patients.

the study aims to assess the sensitivity and specificity of an application that uses vocal biomarkers to diagnose patients with mild cognitive impairment (mci) and alzheimer's disease. the application will use clinically validated survey instruments and voice recordings to determine the disease status of patients with mci and alzheimer's disease. the diagnosis developed by the application is the primary outcome variable. to determine the sensitivity and specificity, the application diagnosis will be compared against the physician's clinical diagnosis.

Eligibility criteria:
inclusion criteria: * males and females between the ages of 50 and above * willing and capable of participating in all aspects of the study * willing and capable of giving informed consent * diagnosis of mci or alzheimer's by the physician * subjects are free of any medical condition(s) that, according to exclusion criteria, might audibly affect voice characteristics * subject must be able to speak and read with fluency in the english language. exclusion criteria: * all participants below 50 years * failure to provide informed consent * individuals with the following medical conditions will be excluded: i) parkinson's disease ii) huntington's disease iii) cancer and active cancer treatments * persons with speech characteristics (heavy accents, slurring, stuttering, etc.) that would interfere with voice recording or voice analysis

Keywords: vocal biomarkers mild cognitive impairment alzheimer's disease deep machine learning artificial intelligence application
potassium containing salt-substitute in hemodialysis-dependent end stage kidney disease

Conditions: End Stage Kidney Disease

Summary: 16 individuals with hemodialysis-dependent end stage kidney disease will receive 16 days of a potassium-containing salt-substitute and 16 days of standard table salt in random order. there will be a 19 day wash out period between the salt-substitute and table salt periods. potassium concentration will be measured bi-weekly prior to hd each week during intervention. the primary endpoint will be the change in potassium from baseline. additional measurements will include assessment of dietary intake, ambulatory blood pressure, occurrence of peri-dialytic symptoms, and per-dialytic vital signs.


Eligibility criteria:
inclusion criteria: 1. receiving outpatient maintenance hd therapy. 2. age ≥ 21 years. 3. negative serum pregnancy test for women of child-bearing capacity. childbearing capacity will be defined by report of menstruation within ≤ 6 months. exclusion criteria: 1. currently incarcerated. 2. insufficient capacity for informed consent. 3. non-hemolyzed serum potassium concentration \>6.0 meq/l within ≤30 days. 4. unscheduled hd for hyperkalemia within ≤30 days. 5. attendance at ≤10 of last 13 scheduled op hd sessions. 6. co-habiting family member with known hyperkalemia. 7. co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity. 8. hemoglobin \< 8.0 mg/dl. 9. use of other potassium supplements.

Keywords: potassium-containing salt substitute
scalp block decreases pain and side effects

Conditions: Craniosynostoses; Pain, Postoperative

Summary: postoperative analgesia after corrective surgery of paediatric craniosynostosis is crucial in term of short and long-term outcomes. the objective of this observational case- control study was to evaluate the effectiveness of an analgesic technique based on the scalp block versus traditional pharmacological approach.

several studies on craniosynostosis and the correlated risk factors have been published, the majority of them focusing on the perioperative management of blood losses and avoidance of haemorrhagic shock. other issues related to anaesthetic management of the surgical correction of craniosynostosis are metabolic and electrolyte disturbances. even if craniosynostosis surgery is an invasive procedure, there is a current misconception that it would be associated with minimal pain, despite the extensive exhibition of the skull and periostea dissection. the literature about the assessment and management of postoperative pain in this particular surgical setting is scarce. assessment of pain in infants is challenging, and often relies on clinical observation. to date, there are no evaluative and therapeutic parameters globally accredited in this category of patients. the scalp nerve block (snb) is a regional anaesthetic technique, performed since several years in children undergoing a variety of procedures, from neurosurgery to eye-nose-throat surgery.snb has been proposed as a complement to the routine craniosynostosis anaesthetic protocol, and should be associated to a reduced need for opioids. thirteen patients, aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis were subjected to snb (group sb) with levobupivacaine 0.125% (total dose 2 mg/kg), performed before awakening, in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight \>10kg, 7 mg/kg if body weight \< 10 kg). the snb procedure was performed using the modified pinosky technique, with levobupivacaine 0,125%(10). a targeted infiltration of 0,75-2ml of local anaesthetic (la) solution was done at multiple sites with a 23g needle. this group of patients were compared with another group of 13 patients, derived from our database, and treated with the traditional pharmacological approach given intraoperatively (intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg).

Eligibility criteria:
inclusion criteria: * patients undergoing cranioplasty for the correction of craniosynostosis exclusion criteria: * allergies to local anesthetics and/or analgesics * specific drug therapies (pain relievers, sedatives and/or epileptic) * denied consent to the study; development of postoperative intracranical bleeding and/or gastrointestinal bleeding * need of nasogastric tube * development of gastrointestinal infections.
detection of immunotoxic gluten peptides in feces

Conditions: Celiac Disease

Summary: the purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.

certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. gluten-free diet (gfd) is the only effective treatment for celiac disease (cd) and its compliance should be monitored to avoid accumulative damage. however, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available. this study assesses the capacity to determine the gluten ingestion, and to monitor the gfd compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.

Eligibility criteria:
inclusion criteria: * celiac patient * 1-12 years old * written informed consent exclusion criteria: * known inflammatory bowel diseases * participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study

Keywords: celiac disease gluten-free diet gluten peptides feces
transpalpebral microcurrent stimulation for the improvement of visual acuity in patients with macular degeneration

Conditions: Age-Related Macular Degeneration; Nonexudative Age-related Macular Degeneration

Summary: the goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration. participants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. a follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.


Eligibility criteria:
inclusion criteria: * adults aged at least 50 years with dry amd in at least one eye exclusion criteria: * eye diseases other than dry amd * implanted electrical devices * seizure disorders
psilocybin-assisted group therapy for demoralization in long-term aids survivors

Conditions: Distress; Depression; Grief

Summary: the purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term aids survivors (ltas).

this study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.

Eligibility criteria:
inclusion criterion: * older individuals who are long-term aids survivors and suffer from moderate-to-severe demoralization. exclusion criteria: * a physical, neurological or cognitive condition that makes participating in the study unsafe or unfeasible. * regular psychotropic medication use. * personal or family history of serious mental illness. * severe depression requiring immediate standard-of-care treatment. * exclusion by the clinical judgment of the study investigators.

Keywords: hiv/aids demoralization psilocybin group therapy
effects of using customized insoles with anterior or posterior plantar support in cross-pelvis syndrome and perception of body alignment in young adults: a randomized clinical trial

Conditions: Crossed Pelvis Syndrome

Summary: introduction: custom insoles with anterior or posterior support are described in the literature mainly for the treatment of foot and knee dysfunctions and this therapeutic effect extends to the promotion of biomechanical alignment between pelvis and trunk, by an ascending propceptive response. in this perspective, it can be hypothesized that the use of these insoles may favor individuals with anterior and posterior cross pelvis syndrome, who have biomechanical imbalance in the pelvis segment. to date, there is no literature data on the effect of continuous, noninvasive and inexpensive therapy on this individual profile. objective: to evaluate the effects of using customized insoles with anterior or posterior plantar support in cross pelvis syndrome and in perception of body alignment in young adults. methods: this is a blinded randomized controlled trial in individuals of both sexes aged 18-25 years and functionally diagnosed with posterior or anterior pelvic syndrome. excluding thoracic deformities, lower limb differences, diabetic neuropathy, previous reports of some specific surgeries and treatment of ongoing physiotherapy. a pilot study will be carried out with 20 individuals divided into two groups for sample calculation (personalized insole group and placebo group). after the pilot study, an initial screening will be carried out to verify the eligibility criteria. for the eligible, the pre-intervention evaluation will be carried out, which will be contemplated by personal data; scale of presence and intensity of pain; foot health status; foot posture index; by ely and thomas hamstring tests associated with an inclinometer and by photogrammetry. individuals will be randomized into blocks of 10 individuals. a day will be marked to make the insole, in which the researcher will make the adaptations based on the biomechanical evaluation of the volunteer. to the invidious with the posterior cross pelvis syndrome an anterior support will be made in the insole and for those with anterior cross pelvis syndrome a posterior support will be made in the insole. for the placebo group, the insole will be made of the same material as that of the custom insoles, although, without support.


Eligibility criteria:
inclusion criteria: * crossed pelvis syndrome (anterior or posterior) * difference in length leg ≤ 1cm * don't show: scoliotic or kyphotic deformity; chirurgie or fracture in spine in last 12 months; thoracic chirurgie; diabetic neuropathy; cesarean surgery; mixed crossed pelvis syndrome * not participating in any physical activity or physiotherapy exclusion criteria: * join in other physical activity during the study * refuse to wear the insoles

Keywords: posture orthosis foot biomechanical phenomena
study to investigate safety and response to 1 or 2 g rectal suppositories containing 5 or 10 mg nrl001.

Conditions: Fecal Incontinence

Summary: this is a healthy volunteer three-way crossover study. a total of 12 subjects will receive three single administrations of 1 g rectal suppositories (containing either 5 mg nrl001, 10 mg nrl001 or matching placebo), with a washout period of at least 7 days between dosings. a further 12 subjects will receive three single administrations of 2 g rectal suppositories (containing either 5 mg nrl001, 10 mg nrl001 or matching placebo), again with a 7 day washout period between dosings. the pharmacodynamic response, pharmacokinetics and safety profile will be determined.


Eligibility criteria:
inclusion criteria: 1. no previous history of ano-rectal conditions or diseases 2. no history of cardiovascular disease 3. 18 to 60 years of age 4. males and females (pre-menopausal females of child-bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study) exclusion criteria: 1. use of medication in the last 30 days with a vasodilatory activity, or use of any medication currently or within the last 30 days which the investigator believes may affect the study participation or results 2. use of monoamine oxidase inhibitors presently or within the last 2 weeks before study participation 3. use of any medication in the last 30 days applied to the anus and/or via the rectum 4. application of any unlicensed medication within the previous 3 months or participation in any other research study in the last three months which involved being paid a disturbance allowance; having an invasive procedure (e.g. venepuncture \>50ml, endoscopy) or exposure to ionising radiation. 5. regular intake of more than 21 units of alcohol per week 6. history or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160 mmhg or diastolic blood pressure greater than 90 mmhg; based on at least two separate readings), peripheral vascular disease or raynaud's syndrome 7. presence of diabetes mellitus 8. history or symptoms of thyroid diseases, including hypo- or hyperthyroidism 9. pregnant or lactating females 10. history of any clinically relevant allergy 11. presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac) dysfunction 12. volunteers whom the investigator feels would not comply with the requirements of the trial 13. volunteers who have been exposed to more than 5 msv of ionising radiation in the last 12 months.
self-collected vaginal and urine samples in hiv-positive women

Conditions: HIV Infections; HPV-Related Cervical Carcinoma; Cervical Cancer; Coinfection, HIV

Summary: this study assesses topics as human immunodeficiency virus (hiv), human papilloma virus (hpv), and cancer screening methods. the focus will be on evaluating feasibility of implementing novel cancer screening modalities in a low-resource setting in guinea-bissau and further to estimate the prevalence of the precancerous virus hpv amongst women living with hiv. in the study the investigators will collect urinary and vaginal self-samples for hpv testing, and further evaluate the feasibility of implementing the devices as screening modalities through questionnaires given to the women.

this pilot study will partly take place at the outpatient hiv clinic, based in the hospital national simão mendes (hnsm) in the capital city bissau, guinea-bissau. hnsm is the main hospital in bissau, and the hiv clinic is the biggest hiv treatment center in guinea-bissau in terms of patients on follow-up. the bissau nationwide hiv cohort is a clinical hiv cohort started in 2007. as of today, the investigators collect data from 9 outpatient hiv clinics in the country, and samples will be collected from all 9 clinics. study participants who present at the hiv clinic will be thoroughly instructed in correct usage of the vaginal and urine devices by trained healthcare workers. at the hiv clinics, facilities will be available for the women to conduct self-sampling in privacy, before handing in the samples. at the local laboratory, the dry brush head will be suspended in thinprep medium and stored until shipment to denmark. the urine samples will be stored at room temperature for up to 7 days before transferred to a -20º freezer until shipment to denmark. analyses: vaginal and urine samples will be analyzed at randers regional hospital using the cobas 4800 hpv dna test. the department is specialized in self-collected samples from previous studies. this procedure is considered feasible based on data showing that the dry brush is analytically stable for hpv dna detection for up to 32 weeks at temperatures ranging from 4 ºc to 30 ºc. after hpv analyses, residual material from the self-collected samples will be stored in a biobank in denmark at aarhus university hospital and saved for future research.

Eligibility criteria:
inclusion criteria: * hiv-positive (women with hiv-1, hiv-2 and hiv1/2 are all eligible) * age between 18 and 65 years exclusion criteria: * current pregnancy * pregnancy within the last 3 months * prior hysterectomy * women using other vaginal products than contraceptives and water based lubricants * women who don't understand the extent of the study * bleeding due to ongoing period

Keywords: cervical cancer screening self-sampling urine sample vaginal sample
transversus abdominis plane block versus rectus sheath block after cesarean delivery

Conditions: Postoperative Pain

Summary: importance of effective postoperative pain management is well known. the undesired effects of pain can be prevented with multimodal analgesia for the patient. overall, for cesarean delivery, interaction between the mother and her newborn baby can be provided earlier. many regional anesthesia techniques can be prefferred after cesarean delivery. aim of the study is to compare the postoperative analgesia effects of transversus abdominis plane block and rectus sheath block after elective cesarean delivery.


Eligibility criteria:
inclusion criteria: asa i-ii patients patients undergo elective cesarean delivery gestation period between 37-40 weeks exclusion criteria: obesity (body mass index \>35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy

Keywords: postoperative pain transversus abdominis plane block rectus sheath block cesarean delivery
high-resolution, relational, resonance-based, electroencephalic mirroring (hirrem) to relieve insomnia

Conditions: Insomnia

Summary: the purpose of this study is to determine whether the addition of high-resolution, relational, resonance-based, electroencephalic mirroring (hirrem) to usual care will improve insomnia symptoms based on changes in the insomnia severity index at two months following completion of the intervention, compared to placebo plus usual care.

insomnia is the most prevalent sleep disorder and is associated with significant psychosocial and somatic pathology. effective noninvasive interventions for insomnia are lacking. high-resolution, relational, resonance-based, electroencephalic mirroring (hirrem), is a noninvasive, brain feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time. an open label, randomized, crossover pilot trial showed that hirrem was safe and effective, with significant benefits for individuals with moderate to severe insomnia, based on differential change with symptoms of insomnia (insomnia severity index, isi). this study will extend those results in a larger cohort using a single blind, placebo controlled study design.

Eligibility criteria:
inclusion criteria: * moderate to severe clinical insomnia (insomnia severity index score of 15 or higher) exclusion criteria: * unable, unwilling, or incompetent to provide informed consent * physically unable to come to the study visits * known obstructive sleep apnea * diagnosed periodic limb movement disorder or known restless legs syndrome * known seizure disorder * known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance * severe hearing impairment * known, or suspected diagnosis of post-traumatic stress disorder (ptsd) * known, relevant traumatic brain injury (tbi) * ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as ssri, snri, or tricyclics, and sleep medications such as zolpidem or eszopiclone * anticipated and ongoing use of recreational drugs or alcohol * lack of internet or smart phone access

Keywords: insomnia electroencephalic biofeedback neural oscillations auto calibration relaxation
study of soc plus ivig compared to soc alone in the treatment of covid-19

Conditions: Sars-CoV2

Summary: the purpose of this research is to see if intravenous immunoglobulin (ivig) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (covid-19). the principal investigator has successfully utilized ivig for patients infected with the influenza virus. the investigator wants to find out if ivig is equally effective in covid-19 infection patients, and if ivig will give the immune system some help to clear the infection naturally.

this is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding ivig to the standard of care (soc) to the soc without ivig. randomization will be 1:1. the goal of this study is to identify whether or not ivig can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed covid-19. the addition of ivig to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with sarscov-2 induced hypoxia that results in organ injury.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 positive test result (including presumptive positive). * hospitalization * requiring ≥4 liters/min o2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated * age ≥18 years old. * access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail. * able to read/write/speak english or spanish fluently. * subjects must have the capacity to provide consent or an appropriate legally authorized representative (lar) to provide informed consent. provide informed consent, and provide authorization of use and disclosure of personal health information. * negative pregnancy test for women of childbearing potential. exclusion criteria: * severe allergy to any ivig product formulation * history of dvt, pe, thromboembolic stroke or other thrombotic events * hypersensitivity to corn. octagam® contains maltose which is a sugar derived from corn. * uncontrolled hypertension (sbp\>180 mm hg or dbp\>120mmhg) * active participant in another research treatment study * mechanically ventilated patient * code status is do not resuscitate or do not intubate

Keywords: coronavirus ivig covid-19