Kornimate/medical-research-clean huggingface dataset:
a study on the preference of risperidone dosage forms

Conditions: Schizophrenia; Bipolar Affective Disorder; Autism Spectrum Disorder; Conduct Disorder; Mental Retardation

Summary: this study aimed to understand patients' needs and preferences for antipsychotic dosage forms.

this study aims to understand patients' needs and preferences for antipsychotic dosage forms and to clarify the clinical value of patch-form antipsychotics.

Eligibility criteria:
inclusion criteria: * patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study. exclusion criteria: * have difficulty reading and understanding chinese or refuse to participate in the study.

Keywords: risperidone patch cross-sectional study preference
the incidence of gingival fissures _ a crossover single-blinded randomized clinical trial

Conditions: Gingival Recession; Wounds and Injuries

Summary: the objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium.

gingival recession constitute a functional and aesthetic problem that affects much of the population. one of the possible causes refers to a traumatic brushing. individuals who have an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures. these lesions have been considered subrogated outcomes of gingival recession noninfectious. the literature only reports and case series showing the gingival fissures, which were once associated with traumatic occlusion. this is the first clinical trial to evaluate the gingival fissures according to the type of brush used.

Eligibility criteria:
inclusion criteria: * good/ excellent health; * idade de 14 a 20 anos; * at least 20 teeth without a history of destructive periodontal disease, absence of gingival bleeding; * absence of loss of attachment/recession ≥2mm in molars and pre-molars in the buccal areas. exclusion criteria: * were unable to provide consent or comply with the sudy protocol; * smokers; * pregnant women; * persons under orthodontic treatment or with dental or implant prosthesis, presence of cervical abrasions, restorations or caries; * need of antibiotic prophylaxis associated with dental procedures.

Keywords: toothbrushing gingival recession
pilot evaluation of a new galyfilcon a contact lens compared to a marketed galyfilcon a contact lens

Conditions: Myopia

Summary: the purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.


Eligibility criteria:
inclusion criteria: * the subject must be at least 18 years of age and no more than 39 years of age. * the subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (dw) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study. * the subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00d. * any cylinder power must be ≤ -0.75d. * the subject must have visual acuity best correctable to 20/25+3 or better for each eye. * the subject must read and sign the statement of informed consent. * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: * ocular or systemic allergies or disease which might interfere with contact lens wear. * systemic disease or use of medication which might interfere with contact lens wear. * clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. * clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * pregnancy or lactation. * diabetes. * infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv). * habitual contact lens type is toric, multifocal, or is worn as extended wear.
flu2text: text message reminders for 2nd dose of influenza vaccine

Conditions: Influenza; Vaccination

Summary: this multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place primarily in practices from the american academy of pediatrics (aap) pediatric research in office settings (pros) network.

the study is to be conducted over the 1st season (september 2017-april 2018) as an effectiveness trial and the 2nd (september 2018-april 2019) as a replication study. this approach tests that the intervention effects can be replicated across seasons, during which the severity and incidence of influenza disease may vary. eligible parents will have a child who received his/her first vaccine dose and is in need of 2 doses that season. current recommendations require 2 doses for certain children 6 months through 8 years old. within each practice site, parents will be randomized to receive either: 1) text message reminders embedded with influenza vaccine health-literacy promoting information, or 2) usual care. randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language (spanish, english).

Eligibility criteria:
inclusion criteria: * parenting adult (or legal guardian) of a child that: * is between 6 months through 8 years at the time of enrollment (or the age for which 2 doses of influenza are recommended should centers for disease control and prevention (cdc) recommendations change) * received 1st dose of influenza vaccine within last 7 days * receives care at study site * needs 2 doses of influenza vaccine that season as determined by their clinician at the study site * plan to continue to receive care through april 30 of that season (to the best of their knowledge) (season 2017-18 only) * ability to speak and read english or spanish * has a cell phone that has text message capability exclusion criteria: * parenting adult of a child that: * already enrolled in the study in this or the previous season * will leave practice before end of season (april 30) (to their best knowledge) (2017-18 season only) * was told by a health care provider that child should not get the flu shot again due to an allergic reaction or anaphylaxis (2017-18 season only) * unable to speak and read english or speak and read spanish * unable to receive or read text messages on their cell phone

Keywords: text message short message service (sms) mhealth
comparison of ipx054, ir carbidopa-levodopa, and cr carbidopa-levodopa in subjects with parkinson's disease

Conditions: Idiopathic Parkinson's Disease

Summary: the objective of this study is to compare the pharmacokinetics and pharmacodynamics of ipx054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic parkinson's disease.

ipx054 contains two different drugs called levodopa and carbidopa in one tablet. * levodopa turns into a material called 'dopamine' in your brain. the dopamine helps to improve the symptoms of your parkinson's disease. * carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. it helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease. * currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose. * must experience "wearing off" between doses of medication. exclusion criteria: * diagnosed with atypical parkinsonism. * allergic or non-responsive to previous carbidopa-levodopa therapy. * active or history of narrow-angle or wide-angle glaucoma. * history of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures. * treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months. * treatment with any dopaminergic blocking agent within the previous 3 months.
topical ruxolitinib evaluation in vitiligo study 1 (true-v1)

Conditions: Non-segmental Vitiligo

Summary: the purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (bsa).


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% bsa on the face, ≥ 0.5 f-vasi, ≥ 3% bsa on nonfacial areas, ≥ 3 t-vasi, and total body vitiligo area (facial and nonfacial) not exceeding 10% bsa. * agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted. * must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation. key exclusion criteria: * no pigmented hair within any of the vitiligo areas on the face. * other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor). * have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas. * use of protocol-defined treatments within the indicated washout period before baseline.

Keywords: vitiligo non-segmental jak inhibitor
antioxidant capacity and vitamin a profile in young adults who consume a snack bar made from tropical fruits treated with uv-c

Conditions: Nutritional and Metabolic Disease

Summary: the objective of the present study was to evaluate the impact of a snack bar on some health indicators associated with diet (plasma antioxidant capacity, lipid profile, vitamin a profile (retinol and carotenoids)) and on the nutritional status (impact on energy and nutrients consumed) in a group of upper level students.

a blind randomized controlled clinical study of healthy adults, which was carried out with the approval of the ethics committee of the centro de investigación en alimentación y desarrollo, a.c. (ciad, a.c.) with registration ce/001/2017. the intervention was carried out in a public university in mexico from january to april 2017. each subject signed an informed consent form. this study lasted 30 days (4 weeks), where each participant consumed daily a snack bar irradiated with uv-c. the participants were personally interviewed by the research team with a structured selection questionnaire. thirty subjects who met the inclusion criteria were recruited, 15 of them men and 15 women. through a simple randomization process, the participants were assigned in 3 groups of 10 people each with 5 women and 5 men, subsequently treatments (without treatment, pineapple snack bar, or mango snack bar) were randomly assigned. the outcomes between groups were analyzed with one way anova, with a p-value of 0.05 or less when there was statistical significance, using statistical software. the participants, and the laboratory technicians were blinded to the treatment assignments until the conclusion of the trial.

Eligibility criteria:
inclusion criteria: * young adults of 18 years of age or older, * healthy in appearance exclusion criteria: * people in current medical treatment * used antibiotics in past 15 days * have presented infectious symptoms on previous days * smokers * narcotic consumers * women in use of hormonal treatment * contraceptives or pregnancy

Keywords: antioxidant capacity
probiotics as a prophylactic aid in women with recurrent urinary tract infections (uti's)

Conditions: Urinary Tract Infections

Summary: to investigate if administration of probiotics, either orally or vaginally, * can reduce the number of episodes of acute bacterial cystitis and/or * has tolerable adverse effect profile * improves general qol in these women * improves the immune function and other physiological stress markers * reduces inflammation in urinary bladder epithelium

chronic recurrent bacterial cystitis is a condition that is disabling to a great extent and which influences quality of life and freedom of movement. the episodes can be painful, and lead to extensive use of antibiotics, which in itself promotes development of bacterial strains increasingly resistant to antibiotics, but do not prevent relapses. almost all cystitis' in women are ascending infections from bacteria in the vagina, following colonization from the rectum. there have, however, been reported indications that there may be bacteria colonies within the urothelium that might give rise to relapses of the infections, rather than pure reinfection from ascending pathogens. probiotics are cultures of viable microorganisms, which show a positive effect on the general condition of the host when administered. among the lactic acid bacteria (lab), lactobacilli are the most commonly used for probiotics, and they have an excellent safety record. in terms of uti, weekly or twice weekly intravaginal instillation of lactobacillus strains gr-1 and b-54 have led to reduced recurrences. this concept has been supported by a 2006 pilot study showing that intravaginal administration of lactobacillus crispatus gai 98322 every two days for one year, had the potential to reduce the uti recurrences. another approach has been taken whereby lactobacilli are administered orally with a view of simulating how the pathogens reach the vagina. the studies have shown that l. rhamnosus gr-1 and l. reuteri (formerly fermentum) rc-14 can reach the vagina after daily oral ingestion, and they can lower the bacterial and yeast pathogen numbers. the aim of the study is to try to normalize the vaginal bacteriological milieu so that the more pathogenic subpopulation of bacteria strains are displaced and are less likely to cause uti.

Eligibility criteria:
inclusion criteria: * women 18-70 years old * spontaneous urination * \> 3 uti's previous year * no ongoing prophylactic antibiotic treatment exclusion criteria: * \> 50 ml residual urine * neurological bladder disease * known neoplasia, kidney stone or urinary tract abnormalities * use og indwelling catheter * pregnancy * diabetes * infrequent voiding pattern * symptoms that indicate interstitial cystitis * creatinin \> 250 micmol/l * participating in other clinical trial

Keywords: probiotics qol inflammation nutritional factors prophylactic aid lactobacillus rhamnosus gr-1 lactobacillus reuteri rc-14 recurrent lower uti in women
the gut microbiome and immune checkpoint inhibitor therapy in solid tumors

Conditions: Non-Small-Cell Lung Carcinoma; Malignant Melanoma; Renal Cell Carcinoma; Triple-Negative Breast Cancer

Summary: the microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. however, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. the proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ici treatment efficacy across multiple cancer types.


Eligibility criteria:
inclusion criteria: 1. men or women ≥18 years of age 2. screened negative for covid-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the covid-19 pandemic 3. diagnosed with stages i-iv primary nsclc, mm, tnbc or rcc 4. plan to be treated at a partner cancer site with a checkpoint inhibitor (anti-pd-1, anti-pd-l1, or anti-ctla-4) as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with fda-labeled use of the agent 5. able to provide informed consent and answer study questionnaires in either english or spanish 6. able to provide stool specimens for research purposes exclusion criteria: 1. mental incapacity 2. incarcerated individuals 3. pregnancy (by self-report of pregnancy status) 4. experiencing active brain metastasis/metastases 5. treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial 6. active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study
diagnostic biomarkers and symptoms in patients with alzheimer's disease and lewy body dementia

Conditions: Dementia With Lewy Bodies; Alzheimer Disease; Mild Cognitive Impairment

Summary: this a study to improve diagnosis of dementia with lewy bodies with rt-quic in different biospecimens.

background. the number of persons living with dementia is increasing in denmark and worldwide because the population is generally growing older. dementia with lewy bodies (dlb) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia. dlb is characterized by many prodromal symptoms years before dementia is evident. currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of dlb can be clinically challenging, especially in the early stages. a novel technique for the measurement of misfolded alpha-synuclein (asyn) is real-time quaking-induced conversion (rt-quic), which may be able to support the diagnostic process. objective: determining which biospecimen alone or in conjunction with other biospecimens can most accurately discriminate patients with dlb from alzheimer's disease (ad) assessed by rt-quic for asyn. design: cross-sectional case-control study of the diagnostic accuracy of pathological alpha-synuclein assessed by rt-quic in different biospecimens (csf, skin, olfactory mucosa, saliva, feces, and urine) from patients with dlb versus ad. patients will also be scored with tests for cognitive function, dysautonomia, and movement disorders.

Eligibility criteria:
inclusion criteria for healthy controls (hc): * age 18 - 40 years of age * able to cooperate as evaluated by the primary investigator (pi) * able to give informed consent exclusion criteria * signs of neurological/psychiatric conditions * known genetic neurodegenerative disease in close family inclusion criteria for patients with dementia with lewy bodies (dlb): * probable dlb (mckeith et al., 2017) or mci-lb (mckeith et al., 2020) * age \> 50 years of age * able to give informed consent * able to cooperate as evaluated by the pi * mci, mild or moderate dementia, and mmse \> 18 exclusion criteria for patients with dlb: * patients not able to give informed consent. * current alcohol or drug abuse * terminal illness * diagnosed with major neurological/psychiatric conditions other than dlb. inclusion criteria for controls (patients with alzheimer's disease (ad)): * probable ad (mckhann et al., 2011) or mci-ad (albert et al., 2011) * age \> 50 years of age * able to give informed consent * able to cooperate as evaluated by the pi * mci, mild or moderate dementia, and mmse \> 18 exclusion criteria for controls (patients with ad): * patients not able to give consent. * current alcohol or drug abuse * terminal illness * diagnosed with major neurological/psychiatric conditions other than ad.

Keywords: rt-quic dementia with lewy bodies csf saliva olfactory mucosa urine feces blood skin
an investigation of safety and tolerability of nnc0114-0006 in subjects with systemic lupus erythematosus (sle)

Conditions: Inflammation; Systemic Lupus Erythematosus

Summary: this trial is conducted in europe and the united states of america (usa). the aim of the trial is to investigate the safety and tolerability of nnc0114-0006 in subjects with systemic lupus erythematosus (sle) concomitantly treated with stable background therapies.


Eligibility criteria:
inclusion criteria: * men and women (not pregnant and not nursing) * subjects with sle meeting the american college of rheumatology (acr) criteria, with a disease duration of at least 6 months * subjects with clinically active sle defined as a safety of estrogens in lupus erythematosus national assessment (selena)-systemic lupus erythematosus disease activity index (sledai) score of at least 6 and positive for antinuclear antibody (ana) and/or anti-double-stranded dna antibody (anti-dsdna) * if taken, background medication must be stable exclusion criteria: * presence or history of active lupus nephritis (ln) within the last 4 months or active central nervous system (cns) disease within the last 12 months * body mass index (bmi) below 18 kg/m\^2 or above 38 kg/m\^2
safety, tolerability and efficacy of mk0773 in healthy postmenopausal women (0773-003)

Conditions: Osteoporosis

Summary: this study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of mk0773 in healthy postmenopausal women.


Eligibility criteria:
inclusion criteria: * subject is a nonsurgical postmenopausal female * subject is neither grossly overweight nor underweight for her height * subject is in good health * subject is willing to avoid excess alcohol and strenuous physical activity during the study * subject agrees to refrain from consuming st. john's wort, grapefruit or grapefruit juice during the study exclusion criteria: * subject has significant drug allergies * subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks * subject is a regular user or past abuser of any illicit drug (including alcohol) * subject drinks excessive amounts of caffeinated beverages * subject has a history of cancer
delayed antibiotic therapy in non-severe ventilator acquired pneumonia (vap)

Conditions: Ventilator Associated Pneumonia; Critical Care; Antibiotic Therapy

Summary: this retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for ventilator acquired pneumonia suspicion without severity symptoms.

ventilator acquired pneumonia (vap) is the leading cause of nosocomial infection in intensive care patients, and has been associated with increased antibiotic consumption, increased morbidity and mortality. vap diagnosis is difficult due to subjective or non-specific criteria. delaying antibiotic treatment for vap suspicion without severity symptoms raises question since the probability of vap diagnosis, as well as the risk of delaying treatment, is very uncertain. it may nonetheless limit the environmental impact of antibiotic use which is a public health concern. we compared antibiotic sparing and patient outcome, before and after the implementation of a restrictive (delayed) antibiotic strategy versus an aggressive (immediate) antibiotic strategy in vap suspicion without severity symptoms.

Eligibility criteria:
inclusion criteria: * under mechanical ventilation from more than 48 hours * suspected for a ventilator acquired pneumonia, requiring a distal pulmonary bacterial sample exclusion criteria: * new or worsening shock requiring vasopressor * new or worsening severe hypoxemia (pao2/fio2\<150 in fio2≥60% and peep 10) * patient under veno-veinous extracorporeal membrane oxygenation * neutropenia \ 6 months or \>0.5mg/kg/j) * disease (endocarditis, spondylodyscitis, deep abcedation...) requiring prolonged antibiotic therapy