Kornimate/medical-research-clean huggingface dataset:
virtual reality therapy for treatment-resistant auditory hallucinations in schizophrenia

Conditions: Auditory Hallucination, Verbal; Treatment-resistant Schizophrenia

Summary: treatment of verbal hallucinations in schizophrenia is clinically challenging for both the patient and the therapist. for the therapist, one of the main difficulties arises from the impossibility of directly communicating with the entity persecuting the patient. for the patient, the therapeutic process is challenging because it aims at getting to better cope with an entity that keeps repeating stereotyped and abusive sentences without having the emotional strength to reply to the persecutor. to help overcome these clinical challenges, virtual reality enable patients to recreate the face and the voice of their persecutor.the hypothesis is that the engagement of patients in a dialogue with an external representation of their persecutor, with the support of the therapist, would help them to gain better control over their voices.


Eligibility criteria:
inclusion criteria: * distressing auditory verbal hallucinations * medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent) * dsm-5 diagnosis of schizophrenia or schizoaffective disorder exclusion criteria: * any change in medication within the past 2 months; * substance use disorder within the last 12 months * neurological disorder or unstable and serious physical illness * ongoing psychotic episode * cognitive behavioural therapy for psychosis within the last 12 months

Keywords: auditory hallucination schizophrenia treatment-resistant psychotherapy virtual reality avatar
microbiome and non-caloric sweeteners in humans

Conditions: Glucose Intolerance; Glucose, Low Blood; Glucose, High Blood

Summary: non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. while they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. the investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. the proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.


Eligibility criteria:
inclusion criteria: 1. bmi\<28 2. age - 18-70 3. capable of working with smartphone application 4. capable to work with a glucometer exclusion criteria: 1. consumption of antibitioics 3 months prior to the first day of the experiment. 2. consumption of non caloric sweetners 6 months prior to the first day of the experiment. 3. diagnosis with type 1 or type 2 diabetes. 4. pregnancy, fertility treatments 5. breastfeeding (including baby to breast and bottle feeding expressed breast milk) 6. chronic disease (e.g. aids, cushing syndrome, ckd, acromegaly, hyperthyroidism etc.) 7. cancer and recent anticancer treatment 8. psychiatric disorders 9. coagulation disorders 10. ibd (inflammatory bowel diseases) 11. bariatric surgery 12. alcohol or substance abuse 13. bmi\>28 14. aspartame group only: phenylketonuria.
evaluation of wearable vest for lung monitoring

Conditions: Chronic Lung Disease

Summary: this was the pilot study of the eu funded research and innovation project welmo (wearable electronics for effective lung monitoring) -grant agreement number: 825572. the clinical trial involved patients suffering from a variety of respiratory pathological conditions and examined the ease-of-use and efficacy of the welmo system, comprising a sensors vest for thorax auscultation and recording of electric impedance tomography (eit) signals and transmitting those on the cloud for review by physicians. the study recruited and briefly monitored 27 patients who underwent brief training and subsequent wearing of the sensors vest for 15-20 minutes, after manual auscultation, spirometry and oximetry. the collected data were transmitted wirelessly to a tablet and then securely to the cloud for review by attending physicians. the usability of the system, the quality of the obtained signals and the validity of the results were evaluated.

the study recruited and briefly monitored 27 patients at the outpatient department and the medical ward of the pulmonology department of "g. papanikolaou" general hospital of thessaloniki, greece, as well as the 1st intensive care unit of the same hospital. patients were recruited during their hospitalization or at the outpatient setting and informed consent was obtained before participation. they were examined with spirometry, manual auscultation of the thorax and where necessary, with chest x-ray or ct scan. they wore the welmo sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. at the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest. patients from various thoracic disease categories were included from both sexes and aged 18-90 years. the study was approved by the bioethics committee of the hospital and personal data protection provisions were in place. the obtained signals (lung sounds and eit signals) were examined for consistency with conventionally obtained medical data and the usability, comfort, patient acceptance and practicality of the welmo vest was assessed.

Eligibility criteria:
inclusion criteria: * age \>16 years * suffering from respiratory disease * outpatient at pulmonology department of g papanikolaou hospital * hospitalized at pulmonology department of g papanikolaou hospital * hospitalized at 1st icu of g papanikolaou hospital exclusion criteria: * age \<16 years * skin allergies or broken skin * unwilling to provide informed consent

Keywords: respiratory disease lung auscultation electric impedance tomography sensors biosignals acquisition
multicenter dispensing study of biofinity lenses in extended range

Conditions: Myopia; Hyperopia

Summary: to obtain subjective and objective feedback on the clinical performance of biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.


Eligibility criteria:
inclusion criteria: * has had an oculo-visual examination in the last two years * is at least 18 years of age and has full legal capacity to volunteer * has read and understood the information consent letter * is willing and able to follow instructions and maintain the appointment schedule * is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction * currently wears soft contact lenses * they should require contact lens powers between -12.00 and -20.00d or between +8.00 and +15.00d * has clear corneas and no active ocular disease * demonstrates an acceptable fit with the study lenses. exclusion criteria: * has any systemic disease affecting ocular health * is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. propanolol, timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants * have any active ocular disease and/or infection that would contraindicate contact lens wear. * active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. * has worn gas permeable contact lenses within the last month. * is aphakic * has undergone corneal refractive surgery. * is participating in any other type of clinical research study * female who is currently pregnant or is breast-feeding.
a phase 2b study to evaluate rist4721 in palmoplantar pustulosis (ppp)

Conditions: Palmoplantar Pustulosis

Summary: a 12-week randomized, double-blind, placebo-controlled, dose ranging phase 2 study to evaluate the efficacy and safety of rist4721 in subjects with palmoplantar pustulosis followed by an open-label extension phase.


Eligibility criteria:
inclusion criteria: * at least 6 months history of moderate or severe ppp, as defined by pppasi ≥12 and pppga ≥3 at screening * males and females must be willing to use birth control as indicated exclusion criteria: * moderate to severe psoriasis covering ≥10% of total body surface area (bsa) at screening * breastfeeding or pregnant * known immunodeficiency or subject is immunocompromised * active/latent infection with hbv, hcv, hiv, sars-cov-2 or tb * any topical medications for ppp excluding emollients within two weeks of randomization and systemic therapies (including phototherapy) within 4 weeks of randomization
the effect of montelukast on asthma control in overweight/obese atopic asthmatics

Conditions: Asthma; Obesity; Inflammation

Summary: background: in recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the united states. given the concurrent rise in the two epidemics, there may be an underlying link. obesity contributes to asthma severity and control, and may play a role in its underlying cause. obesity is associated with a state of heightened inflammation that may lead to an increase asthma symptoms and severity. obese adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better asthma control than those treated with other standard asthma medications. the use of montelukast in obese children and adolescents has not been specifically studied. hypotheses and specific aims: the use of montelukast will improve asthma symptoms and objective markers of asthma to a greater degree in obese, as opposed to non-obese children and adolescents. the investigators would like to determine if the use of montelukast will improve objective asthma scores, pulmonary function, markers of inflammation and medication use to a greater degree in obese as opposed to non-obese children/adolescents. potential impact: given the growing epidemic of obesity-associated asthma in the u.s., a tailored approach focused on obese asthmatic children may help reduce the burden of this disease, health care costs and potential long-term complications as these children enter adulthood. furthermore, this study may help clarify the underlying mechanisms that link asthma and obesity. although this proposal is focused on one medication, it provides an example of how certain medications may have differential efficacy in the obese asthmatic.


Eligibility criteria:
inclusion criteria: * mild to moderate persistent asthma based on 2007 nih asthma guidelines * age 7-17 years old exclusion criteria: * present smoking or smoking history * other significant pulmonary or cardiac condition * recent (within the past three months) use of montelukast * on allergen immunotherapy * on omalizumab * pregnancy

Keywords: asthma obesity pediatric inflammation leukotriene montelukast
gut microbiome and colorectal cancer

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. it can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. in egypt, crc represents the seventh most common cancer. it is the third most reported cancer in males and the fifth most common cancer in females. microbiome dysbiosis may be involved in the pathogensis and thus pose a therapeutic target

many reports suggested the role of westernized dietary lifestyles, including high consumption of red meats, animal fats, and cholesterol-rich foods, as well as smoking, decreased physical activity, obesity, diabetes, alcohol consumption, or smoking, in crc development. these changes in lifestyle are called the external factors, which are now linked to changes in the inner gut microenvironments, mainly the microbiomes. our aim is to investigate the the changes in microbiome profile in relation to clinical, pathological and lifestyle factors

Eligibility criteria:
inclusion criteria: * age of 40 years to 80 years * patients with a newly diagnosed crc exclusion criteria: * patients with previously known crc * pregnancy or lactation * abdominal surgery within/up to 6 months prior to sample collection * antibiotics, corticosteroids, or probiotics up to three months prior to sample collection * history of other types of cancer * subjects on a special diet * diabetes, liver, or kidney diseases * crc patients who used enema or underwent colonoscopy up to one week before sample collection.

Keywords: crc microbiome
treatment of malaria with quinine plus sulfadoxine-pyrimethamine

Conditions: Malaria

Summary: quinine remains the treatment of choice of hospitalised malaria cases. the long treatment duration of 7 days, and adverse reactions often hamper its adequate use. reducing the treatment duration by adding sulfadoxine-pyrimethamine may enhance compliance and reduce side effects. the efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment of hospitalised, uncomplicated malaria cases was assessed.

one main concern of clinicians in malaria endemic areas is to find a simple malaria treatment with short treatment duration. the concept of combination therapy, which may reduce treatment duration and delay the spread of drug resistance in addition to an increase in efficacy, has been therefore introduced. in contrast to the outpatient treatment of malaria where emergence of resistance has lead to new drugs policies, the treatment of hospitalised malaria cases remains, in many endemic countries, intravenous quinine for 7 days. the efficacy of this regimen is well established throughout africa. the effectiveness of the quinine treatment may be considerably lower because of discontinuation of treatment due to early discharge, the occurrence of side effects or because of the fact that patients feel better and stop the treatment. therefore, sulfadoxine-pyrimethamine (sp) is often added at discharge. this regimen has been shown to be effective. but in africa, where the practice seems widespread, it has been assessed in only two trials. since resistance of plasmodium falciparum to sp is increasing rapidly in africa and there is evidence that sp monotherapy induce gametocytaemia, we hypothesize that the combination quinine/sp increases sp efficacy and prevents induction of gametocytaemia. in addition, since the use of the full course of quinine therapy may be hampered by many factors (hospital cost, hospitalisation duration, availability of beds, compliance and side effects), the addition of the long acting sp to complete a short course of quinine treatment may prevent recrudescence or reinfection and may increase effectiveness of malaria treatment and reduce postdischarge morbidity. the efficacy and safety of the short course of intravenous quinine (3-day treatment) plus a single dose of oral sp for the treatment of falciparum malaria was investigated.

Eligibility criteria:
inclusion criteria: * uncomplicated falciparum malaria * asexual parasitaemia between 20,000 and 200,000/µl * no mixed plasmodial infection * fever with temperature above 38 °c or history of fever during the preceding 24 hours * no effective anti-malarial treatment for the present attack * informed consent exclusion criteria: * haemoglobin \< 7 g/dl * packed-cell volume \< 20% * white cell count \> 16,000/µl * platelet count \< 40,000/µl * schizontaemia \> 50/µl * impaired consciousness * convulsions or history of convulsions * concomitant diseases masking assessment of response

Keywords: malaria quinine sulfadoxine-pyrimethamine gabon
effectiveness of a lifestyle intervention on metabolic syndrome.

Conditions: Lifestyle Intervention

Summary: the investigators compared the effectiveness of a lifestyle intervention program carried out by trained professionals versus standard unstructured information on healthy lifestyle given by the family physicians in ameliorating the metabolic pattern of adults with multiple metabolic and inflammatory abnormalities.

intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. it is unknown if a less intensive program might also be effective in the general population. the investigators' aim was to compare the effectiveness of two different modalities that recommend a healthier lifestyle to reduce multiple metabolic abnormalities-a lifestyle intervention program with general recommendations carried out by trained professionals and standard unstructured information given by the family physician-in a dysmetabolic population-based cohort. all subjects aged 45-64 (n=1,877) from 6 family physicians, representative of the local health districts of asti (northern italy), were contacted. a metabolic screening was carried out on 1,658 subjects (88.3%) who accepted to participate. out of those subjects, 375 patients had either the metabolic syndrome (ms) or two components of the ms plus high-sensitivity c-reactive protein (crp) serum values ≥3 mg/l, the cutoff point that differentiates high-risk groups for future cardiovascular events, and did not have any of the exclusion criteria. then,187 were randomly allocated to the intervention arm and 188 to the control arm; 18 and 22 individuals refused to participate, respectively. finally, 169 patients were assigned to the lifestyle intervention program carried out by trained professionals (intervention arm) and 166 to the standard, unstructured information given by the family physicians (control arm). all participants received verbal, not-written, information, emphasizing the importance of a healthy lifestyle from their family physicians, who had previously participated in 3 meetings on standard practice lifestyle recommendations. no further individualized programs were offered to the control arm. the intervention arm received detailed verbal and written individualized diet and exercise recommendations from trained professionals during five 60-min sessions covering diet, exercise, and behavior modifications (the first was a one-to-one meeting, the following were group sessions). anthropometric measurements and blood samples were collected from all participants at the beginning and at the trial end, after 1-year.

Eligibility criteria:
inclusion criteria: * subjects aged 45-64 from 6 family physicians, representative of the local health districts of asti (northern italy) * presence of the metabolic syndrome (ms) or hs-crp\>3mg/l and 2 components of the ms exclusion criteria: * diabetes, cardiovascular diseases, chronic liver or kidney disease, advanced cancer
epic-peds: a study to learn about the study medicine called pf-07321332 (nirmatrelvir)/ritonavir in patients under 18 years of age with covid-19 that are not hospitalized but are at risk for severe disease

Conditions: COVID-19

Summary: the purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (covid-19). the study medicine will be given to patients under 18 years of age with covid-19 that are not hospitalized but are at risk for severe disease.


Eligibility criteria:
inclusion criteria: * male and female, age 0 to \< 18 years, able to swallow for some participants * confirmed sars-cov-2 infection within 72 hours prior to enrollment * initial onset of covid-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified covid-19 signs/symptoms present at enrollment * has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from covid-19 exclusion criteria: * history of or need for hospitalization for the medical treatment of covid-19 * total bilirubin \>=2x upper limit of normal (uln) (except for gilbert's syndrome) * receiving dialysis or have known moderate to severe renal impairment * suspected or confirmed concurrent active systemic infection other than covid-19 * history of hypersensitivity or other contraindication to any of the components of the study intervention * current or expected use of any medications or substances that are highly dependent on cyp3a4 for clearance or strong inducers of cytochrome p450 (cyp)3a4 * has received or is expected to receive antibody treatment, antiviral treatment or convalescent covid-19 plasma * participating in another interventional clinical study with an investigational compound or device, including those for covid-19 through the study follow up * females who are pregnant or breastfeeding

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) pediatrics