Kornimate/medical-research-clean huggingface dataset:
determination of vaginal colonization and the effect of an oral probiotic (prosalvag)

Conditions: Microbial Colonization; Dysbiosis; Fertility Issues

Summary: the aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.

after being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing l. rhamnosus, l. plantarum and l. crispatus once daily.

Eligibility criteria:
inclusion criteria: * aged: 35-43 years old * vaginal ph \> 4,5 and low lactobacillus count or nugent score of 4-6 * with interest in getting pregnant and ideally in ivf waiting list * history of recurrent genitourinary infections exclusion criteria: * any pathology that interferes with the study * current intake of food supplements or probiotics * current intake of contraceptives * use of oral or vaginal probiotics in the last 6 months * hypersensitivity to any of the components of the studied product * current vaginal infection * pregnant women * breastfeeding * use of intrauterine device * use of spermicide * use of cervical caps as hormonal therapy
safety and technical performance of plastalgin and plastalgin fast in patients requiring a dental impression

Conditions: Dental Malocclusion; Edentulous Mouth; Dental Misalignment

Summary: the aim of this study is to gather clinical data related to the use of plastalgin and plastalgin fast, in order to comply with the new medical device regulation. the target population for this study is the same as the intended population specified in the study device's instructions for use: children from 5 years old and adults. collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of participating patients during and after the study


Eligibility criteria:
inclusion criteria: * patient fulfilling all the following criteria is eligible for the clinical investigation: * male or female patient ≥ 5 years of age. * indication of dental impressions for the fabrication of prosthesis such as mouth guards and trays, total or partial dentures, and fixed prosthesis (crowns, bridges, dental veneers). * total or partially edentulous patient or patient with disocclusion or patient with misalignment. * patient affiliated or beneficiary of a social security system. * written informed consent must be obtained before any study-related assessment is performed. exclusion criteria: * the presence of any of the following exclusion criteria will lead to the exclusion of the patient: * inability to comply with study procedures. * patient opposing the processing of their data.

Keywords: fabrication of prosthesis alginate dental impression
a study to evaluate the effect of volanesorsen on cardiac repolarization conducted in healthy volunteers

Conditions: Abnormalities, Cardiovascular

Summary: the primary objective of this study is to assess the corrected qt interval (qtc) effect of volanesorsen (isis 304801) administered as a 300 mg subcutaneous (sc) therapeutic and a 300 mg intravenous (iv; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.


Eligibility criteria:
inclusion criteria: * must have given written informed consent and be able to comply with all study requirements * males and females aged 18-55 at the time of informed consent * females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method * males must be surgically sterile, abstinent or using an acceptable contraceptive method * the subject has a bmi of 19 to 32 kg/m\^2 inclusive * consumption of nicotine or nicotine-containing products for at least 6 months before screening exclusion criteria: * history of risk factors for torsades de pointes, unexplained syncope, known long qt syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia * abnormal screening ecg * use of concomitant medications unless authorized by the sponsor medical monitor * known history of or positive test for human immunodeficiency virus (hiv), hepatitis c or chronic hepatitis b * treatment with another study drug, biological agent, or device within one-month of screening * tests positive for drugs of abuse or cotinine * considered unsuitable for inclusion by the principal investigator

Keywords: thorough qtc, therapeutic dose, supra therapeutic dose
cohive: coronavirus (covid-19) outcomes in hiv evaluation in resource limited settings

Conditions: HIV-infection/Aids; Coronavirus Infection

Summary: cohive is an observational cohort nested in four antiretroviral therapy research studies (advance - nct03122262; d²eft - nct03017872; dolphin2 - nct03249181 and namsal-anrs12313 - nct02777229). cohive will include participants who are possible covid-19 cases with symptoms or confirmed covid-19 cases, and participants who agree to have a serology testing for sars-cov-2 regardless of covid-19 history.

cohive is an observational cohort study nested within four parent open label randomised clinical trials of first- and second-line antiretroviral therapies (advance - nct03122262; d²eft - nct03017872; dolphin2 - nct03249181 and namsal-anrs12313 - nct02777229). cohive objective is to study the occurrence and outcomes of covid-19 in people living with hiv across a variety of clinical settings. taken together, these pivotal trials provide an established population and encompass a range of hiv therapies, hiv populations, and geographic regions to capture the full spectrum of these global public health emergency as it pertains to people living with hiv. the sample will include participants who are possible symptomatic or confirmed covid-19 cases, and participants who agree to enrol in the sars-cov-2 seroprevalence cohort (regardless of sars-cov-2 infection). approximately 2,500 participants are enrolled in these 4 studies. enrolment into cohive substudy is voluntary and optional for participants in advance, d²eft, dolphin2 and namsal studies. parameters relevant to cohive substudy including demographics, arm of randomised art, medical and hiv history, immunological and virological results, adverse events at required time points will be collected as part of parent studies. substudy specific assessments performed at baseline include optional sample collection for sars-cov-2 rt-pcr and serology; for the possible symptomatic or confirmed covid-19 cases, the management of the patients, diagnostic test results, and outcomes, will be collected.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old. * either: i) meet local testing criteria for covid-19, or present with symptoms that in the opinion of the investigator are consistent with covid-19 and do not have an alternative explanation, or have tested elsewhere and found positive for covid-19; or ii) agree for serology testing for sars-cov2, regardless of history of covid-19. * have signed the informed consent of one of the parent study. * give informed consent to the cohive substudy. exclusion criteria: * refuse to participate in the cohive substudy. * any condition which would place the participant at risk if they participated.

Keywords: covid-19 sars-cov-2 hiv
evaluation of the analgesic and anti-inflammatory impact of photobiomodulation in patients with dental implants

Conditions: Dental Pain and Sensation Disorder

Summary: the aim of this study is to evaluate the analgesic and anti-inflammatory effects of photobiomodulation in participants undergoing dental implant placement. a randomized clinical trial was conducted with 62 participants requiring dental implant placement, divided into two groups of 31 each. immediately after implant placement, one group received diode laser photobiomodulation, while the sham group received sham treatment. pain and inflammation were assessed at 24 h, 48 h, and 7 days. in addition, modified dental anxiety (mda) levels were measured and the oral health impact profile-14 (ohip-14) questionnaire was used to assess oral health-related quality of life.

low-level laser therapy (lllt) has revolutionized medicine, promoting the healing and regeneration of tissues in an innovative way. this study focuses on evaluating the powerful analgesic and anti-inflammatory effects of lllt in patients undergoing dental implant placement. methodology a randomized clinical trial was conducted with 62 patients, divided into two groups of 31 each. one group received photobiomodulation with a combined 630 and 808 nm diode laser, while the sham group received a simulated treatment. inclusion criteria: participants who needed dental implant rehabilitation and signed the informed consent. participants with a poor general health status, decompensated chronic diseases (diabetes) , pregnant women, and those with bleeding disorders were excluded. procedure: informed consent, data collection, complete clinical and oral evaluation, and radiological study with cbct. surgical intervention: placement of dental implants. in the experimental group, low-level laser therapy (lllt) was applied immediately after the placement of the implants in a single session with an epic x biolase diode laser (biolase, inc., usa), voltage 100-240 v, 1.5 a, power 0.5 w, 10-20 j, for 10-30 seconds. it was applied to three points in the area: buccal side, palatal/lingual side, and occlusal side to stimulate the tissue. pain and inflammation were evaluated using visual analog scales (vas) from day 0 to 7 days postoperatively. additionally, mda levels were measured and the ohip-14 questionnaire was used to assess oral health-related quality of life

Eligibility criteria:
inclusion criteria: * participants who needed dental implant rehabilitation and signed the informed consent exclusion criteria: * participants with a poor general health status, decompensated chronic diseases, pregnant women, and those with bleeding disorders were excluded.

Keywords: laser; pain, dental implant , quality of life , mda
incidence of hepatic hemangiomatosis in patients with cutaneous hemangiomas

Conditions: Hemangioma

Summary: this study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.

hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. while most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. in addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. certain "high risk" hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. the true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis. one of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma \>30 cm2 versus imaging results in patients without cutaneous hemangiomas. the study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.

Eligibility criteria:
inclusion criteria: * infants less than 6 months of age * clinical diagnosis of 1-4 cutaneous hemangiomas * clinical diagnosis of 5 or more cutaneous hemangiomas * clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2 exclusion criteria: * infants greater than 6 months of age

Keywords: prospective cohort study
traditional chinese medicine(tcm) syndrome classification of idiopathic pulmonary fibrosis(ipf) and metabolomics

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no specific biomarkers, the treatment effect is not such useful. currently, it is discovered that chinese medicine treatment may be effective. the investigators select patients with idiopathic pulmonary interstitial fibrosis and healthy controls, use metabolomics to study the biological characteristics of idiopathic pulmonary interstitial fibrosis, screen biomarkers of ipf, and label different tcm syndromes of ipf, explore the biological nature of ipf tcm syndromes, find the biological changes that occur during the development and progression of ipf and explore the metabolite marker clusters of ipf. furthermore, the results of this study may find its diagnostic significance for ipf and looking for potential targets for future treatment of ipf.


Eligibility criteria:
inclusion criteria: * case group inclusion criteria 1. according to the diagnostic criteria published in 2015, the new guidelines for the diagnosis and treatment of idiopathic pulmonary fibrosis, jointly developed by the american thoracic society, the european respiratory society, the japanese respiratory society, and the latin american thoracic society; 2. aged 50 to 85 years old; control group inclusion criteria: health people match on the age (±3 years old) and gender with case group with 1:1 rate at the same time. exclusion criteria: * case group exclusion criteria: 1. those with severe heart, liver, kidney and other organ dysfunction or suffering from blood diseases; 2. with malignant tumors; 3. severely infected people; 4. pregnant and lactating women; 5. mental illness, serious obstacles and those who are unwilling to cooperate; control group exclusion criteria: 1. those with severe heart, liver, kidney and other organ dysfunction or blood disease; 2. with malignant tumors; 3. chest x-ray or chest low-dose ct suggesting intra-pulmonary interstitial fibrosis; 4. with chronic pulmonary diseases such as pulmonary interstitial disease, chronic obstructive pulmonary disease, and bronchial asthma; 5. with connective tissue disease and those with a history of exposure to occupational diseases; 6. mental illness, serious obstacles and unwilling to cooperate.

Keywords: idiopathic pulmonary fibrosis metabolomics chinese medicine
a comparison of non-invasive ventilation methods used to prevent endotracheal intubation due to apnea in very low birth weight infants

Conditions: Apnea of Prematurity

Summary: the purpose of this study is to determine whether nasal intermittent positive pressure ventilation (nippv) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (ncpap).


Eligibility criteria:
inclusion criteria: * infants born at \ 6cm h2o or whose team is considering intubation due to apnea. consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour. * infants on maximum caffeine therapy (10mg/kg/day) exclusion criteria: - major congenital anomalies including congenital heart disease
botox injection for lower extremity lengthening and deformity correction surgery

Conditions: Unequal Length of Limbs; Congenital; Lower Extremity Deformities, Congenital

Summary: the purpose of this six site multi-center study is to determine if btx-a can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.

the specific aims are to determine if btx-a will: * 1a. reduce pain post operatively and during the distraction and consolidation process, * 1b. reduce the amount, frequency and duration of narcotics taken in the postoperative period. * 2. improve the quality of life during the distraction and consolidation process. * 3 decrease muscular spasm and subsequent muscle contracture during the distraction and consolidation process and accelerate earlier return to pre-operative mobility function including earlier weight bearing. * 4. to develop clinical practice guidelines for the interdisciplinary care of children undergoing limb lengthening or deformity correction. methodology: a randomization process for this one time injection will be used to determine who will receive the btx-a or the placebo. 150 subjects will be recruited; 75 to the btx-a group and 75 to the placebo group. there will be an equal number of subjects in each group at each site. the medication will be injected intraoperatively into specific major muscles in the lower limb adjacent to the bone or soft tissue being lengthened or corrected at a dose of 10 u/kg with a maximum of 50 u per site, not to exceed a total maximum dose of 400 units. pain scores, medication dosages, range of motion and an ambulation scale will be measured post-operatively and during the distraction and consolidation phases. in addition families will be asked to complete six different questionnaires related to pain, quality of life and psycho-social issues at various times during the process. the children will receive standard nursing care and physical therapy and will be followed for three months after the external fixator is removed, for a total time of approximately one year.

Eligibility criteria:
inclusion criteria: * age: 5 to 21 years. * aetiology of the deformity: congenital or acquired. * amount of lengthening or deformity correction: any amount. * site of lengthening or deformity correction: lower extremity. * type of fixator: circular or uniplanar. exclusion criteria: * children younger than 5 years of age. * associated neuromuscular conditions that may hinder weight bearing. * individuals on aminoglycosides, as aminoglycosides can potentiate the effect of botulinum toxin a.
multi-centre clinical evaluation of two reusable soft contact lenses

Conditions: Myopia

Summary: the aim of this study is to compare the subjective performance of the comfilcon a contact lens against lotrafilcon b contact lens after 4 weeks of reusable lens wear.

this will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon a versus lotrafilcon b lenses over 4 weeks of daily wear for each lens pair.

Eligibility criteria:
inclusion criteria: * spherical distance cl (contact lens) prescription between -1.00 and -6.00d (diopter) or in both eyes (inclusive) * adapted soft cl wearers (i.e. \>1 month) who are reusable lens wearers\* * spectacle cylinder 0.75d in both eyes * correctable to 6/9 in both eyes * be between 18 and 34 years of age (inclusive) * able to read, comprehend and sign an informed consent * own a mobile phone and be able to respond to sms survey during the period 8am - 8pm * willing to comply with the wear and study visit schedule exclusion criteria: any of the following will render a subject ineligible for inclusion: * existing wearer of daily disposable contact lenses * known allergy to opti-free puremoist multipurpose solution * any active corneal infection, injury or inflammation * systemic or ocular allergies, which might interfere with cl wear * systemic disease, which might interfere with cl wear * ocular disease, which might interfere with cl wear * strabismus or amblyopia * subjects who have undergone corneal refractive surgery * subjects with keratoconus or other severe corneal irregularity contraindicating lens wear * pregnant, planning a pregnancy or lactating * use of systemic/topical medication contraindicating cl wear * diabetic * site employees or family members of investigators * participation in any concurrent trial or in the last 30 days
adjunctive treatment for decreasing symptoms of schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.

a double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen. multicenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the nmda receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. after an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * stable, enduring negative symptoms above a certain level (sans \>19) * clinically stable, with psychotic symptoms measured on bprs below 19, anxiety/depression on bprs below 15 * extrapyramidal symptoms measured on sas below 9 * on stable antipsychotic regimen (not including clozapine) exclusion criteria: * alcohol or substance dependence within last six months * alcohol or substance abuse within last month * organic brain disorder * medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus * female participants could not be pregnant and were required to be using a documented method of contraception.

Keywords: schizophrenia schizoaffective disorder negative symptoms cognitive impairments