Kornimate/medical-research-clean huggingface dataset:
recombinant human papillomavirus nonavalent vaccine in preventing human papilloma virus in younger healthy participants

Conditions: Human Papillomavirus-Related Carcinoma

Summary: human papillomavirus (hpv) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. this phase iia trial studies how well does the nonavalent hpv vaccine (which can prevent nine different types of hpv) work when given in an alternative dosing schedule to heathy young research participants.

primary objectives: i. to determine the persistence and stability of serologic geometric mean titer (gmt) of hpv 16/18 between 6, 12, 18, and 24 months after the prime dose and prior to the administration of the second dose. secondary objectives: i. to determine the persistence and stability of serologic gmt of hpv types 6/11/31/33/45/52/58 between 6, 12, 18, and 24 months after prime dose and prior to the administration of the second dose. ii. to assess safety and reactogenicity to each vaccine dose. outline: participants receive recombinant human papillomavirus nonavalent vaccine intramuscularly (im) at baseline (priming injection) and at 24 and 30 months (booster injections). after completion of study, participants are followed up for 2 weeks.

Eligibility criteria:
inclusion criteria: * healthy, medically well girls and boys * ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant * ability to understand and the willingness to sign a written assent document by the participant exclusion criteria: * previous vaccination against hpv * the use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product * chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed * receiving active treatment for cancer or an autoimmune condition * confirmed or suspected immunosuppressive or immunodeficient condition * known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia) * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine * history of allergic reactions attributed to compounds of similar chemical or biologic composition of gardasil 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy * are pregnant
follow-up of elderly patients in ambulatory surgery

Conditions: Breast Cancer; Skin Cancer; Surgery; Ambulatory

Summary: the number of surgical procedures performed in ambulatory hospitalization for cancers of the skin or breast is increasing for medical and economic reasons. but the protocols of care and the clinical pathways are poorly adapted for elderly patients with physical or cognitive impairment. the goal of this study is to test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in henri mondor hospital on the increase in the proportion of patients operated on an outpatient basis


Eligibility criteria:
inclusion criteria: * patient ≥ 75 years old with breast cancer or skin cancer and requiring surgical excision: partial mastectomy, lumpectomy, axillary dissection, cutaneous excision, etc. * with an indication of ambulatory care * patient (legal representative or trusted person or member of the family) having been informed and having given his non-oral objection to his participation in the study * possessing a health insurance exclusion criteria: * patients reserved for breast reconstruction to the operative gesture of tumor resection. * patients do not consent to care because of deficient mental state. * formal surgical contraindication due to a pathology medical device does not allow anesthesia. - participation in another interventional research or be in the exclusion period after a previous search, if applicable

Keywords: breast cancer skin cancer surgery ambulatory
treatment of persistent pulmonary hypertension in neonates with nebulized magnesium sulfate

Conditions: Magnesium Sulfate - PPHN

Summary: we conducted this study to compare between effect of nebulized and intravenous magnesium sulfate (mgso₄) for better treatment of persistent pulmonary hypertension of neonates with less side effects.

persistent pulmonary hypertension of the newborn (pphn) is a serious syndrome characterized by sustained fetal elevation of pulmonary vascular resistance (pvr) at birth. the syndrome is seen in two of 1000 live-born infants and is associated with anormal or low systemic vascular resistance. pulmonary hypertension is defined as a mean pulmonary artery pressure greater than 25 mmhg at rest and \> 30 mmhg during exercise. pphn-targeted therapy is used for infants with pphn who fail to respond to general cardiopulmonary supportive care. oxygen and inhaled nitric oxide (ino) are the only well-studied pulmonary vasodilators in neonates with pphn. magnesium is a potent vasodilator and hence has the potential to reduce the high pulmonary arterial pressures as it's able to dilate constricted muscles in the pulmonary arteries. however, its action is not specific and when given via an intravenous infusion, it will act on other muscles in the body including other arteries. excessive magnesium causes hypotonia, hypotension, and cardiorespiratory failure. however, no studies have demonstrated long-term benefit. delivering magnesium sulfate by nebulization may enhance effectiveness and minimizes systemic adverse effects.

Eligibility criteria:
inclusion criteria: * newborns with documented persistent pulmonary hypertension as confirmed by echocardiography. * neonates born at ≥ 35 wk. gestation with a birth weight of 2.5-4 kg * neonates have to be connected to mechanical ventilation with an oxygenation index (oi) \>30 on two occasions at least 15 min apart. * the echocardiogram had to show a predominant right-to-left or bidirectional shunt (through ductus arteriosus and/or foramen oval) and/or tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of the systemic systolic blood pressure. exclusion criteria: * infants of parents who refuse to give informed consent. * infants of mothers who receive magnesium sulfate within 48 h before labor. * congenital heart diseases other than patent ductus arteriosus (pda) and foramen ovale. * major congenital anomalies, including congenital diaphragmatic hernia and lung hypoplasia. * prior need for cardiopulmonary resuscitation * mean arterial blood pressure (mabp) \< 35 mmhg despite therapy with volume infusions and vasoactive inotropes. * impaired kidney function; and prior administration of pulmonary vasodilators or prior administration of surfactant.

Keywords: pphn magnesium sulfate neonates
duloxetine for perioperative pain in hip arthroplasty: a rct

Conditions: THA

Summary: the primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.


Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * patients undergoing primary total hip arthroplasty * ambulatory patient prior to fracture * subjects must be capable of providing informed consent * english or spanish speaking exclusion criteria: * previous hemiarthroplasty or tha on ipsilateral hip * history of complex regional pain syndrome in ipsilateral extremity * history of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation * acute or chronic hip infection in ipsilateral extremity * pregnant or breastfeeding * open fracture * polytrauma * intravenous or drug users within 6 months of surgery * liver failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40 * patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant * severe renal dysfunctions, such as glomerular filtration rate less than 30 * moderate to severe depression as diagnosed by a clinician * taking cytochrome p450 1a2 inhibitors and cytochrome p450 1a6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives * history of uncontrolled narrow angle glaucoma
improving family engagement in coordinated specialty care for first episode psychosis

Conditions: Family Members

Summary: investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (fames) and implementation toolkit for coordinated specialty care (csc) programs for first episode psychosis. first, 5 family member participants will be recruited into a three-month trial of fames and implementation toolkit. the investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 csc programs in community-based mental health clinics.

fames involves three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the diagnostic and statistical manual of mental disorders 5th edition (dsm-5) cultural formulation interview (cfi). the overarching objective of this study is to assess the feasibility and acceptability of a brief provider-led family engagement motivational strategy (fames) and its accompanying implementation toolkit. the investigators will also preliminary examine whether fames improves family engagement and retention in treatment, and motivation. a total of 50 participants with a loved one enrolled in csc program for fep will be recruited from five csc programs in washington state to take part in a non-randomized stepped-wedge pilot trial. each csc program will represent a cluster and serve as its own control. a two-month implementation transition period will occur at each csc program and during which providers will be introduced to the intervention using the implementation toolkits and trained to conduct fames. a 12-month open cohort design will be utilized to recruit approximately 50 family members during the study period.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or older; 2. one family member (e.g., parent, guardian, aunt, uncle, spouse, grandparent, sibling, close friend) of an individual enrolled in a washington state csc program; and 3. received no more than 6 months of services exclusion criteria:

Keywords: coordinated specialty care family engagement first episode psychosis
efficacy of icu-vte scale in icu patients

Conditions: Venous Thromboembolism

Summary: venous thromboembolism (vte) is a common cause of morbidity and mortality among critically ill patients. no uniform standard model of vte risk for critically ill patients was formatted by now. in 2020, viarasilpa et al. developed the icu⁃vte rating table, mainly for icu patients. however, it lacks validation. we examined and compared how well the icu-vte score predict and stratify vte risk in comprehensive icu patients.

venous thromboembolism (vte) is a group of thromboembolic diseases including deep vein thrombosis (dvt) and pulmonary thromboembolism (pe), which is a systemic disease caused by a combination of risk factors. the risk of venous thromboembolism can be greatly reduced by the preventive treatment of it in hospitalized patients according to their risk level. the common risk assessment tools for inpatient vte include the padua score for medical patients and the caprini score for surgical patients, but there is no clinical basis for implementing risk assessment for critically ill patients. the question of how to perform vte risk assessment in icu patients to prevent and treat the occurrence of vte is worth exploring. this study was designed according to a prospective study method. data and information were collected from the time the patients were admitted to the icu to the time the patients were discharged from the icu.there are three purposes for this study. first, to observe the predictive effect and evaluate the value of the icu-vte scoring scale in comprehensive icu patients; second, to compare the advantages and disadvantages of the icu-vte scoring tool with the padua score (internal medicine) and caprini score tool (surgery); to analyze the risk factors for vte in comprehensive icu patients and to optimize the vte risk prediction model; third, to look into the prevention and treatment of vte in critically ill icu patients.

Eligibility criteria:
inclusion criteria: * patients age greater than or equal to 18 years; * patients or their family members agreed to the study and signed informed consent. exclusion criteria: * patients admitted to icu with vte diagnosis or diagnosed with vte within 24 hours of admission to icu; * use the therapeutic dose of anticoagulation before admission to icu or within 24 hours in icu; * expected icu stay of less than 48 hours; * patients cannot obtain imaging data to confirm the presence of vte during icu admission

Keywords: venous thromboembolism deep vein thrombosis icu critically ill
effect of covid-19 pandemic on perceived stress, anxiety, mood, and training quality in elite athletes.

Conditions: COVID-19; Life Satisfaction; Anxiety; Mental Health Wellness 1; Athlete; Stress

Summary: in this study, the investigator aims to measure stress, anxiety, mood, life satisfaction measures among elite athletes during covid-19 and measure the relationship between these measures and the changes in training characteristics in elite athletes during the covid-19 pandemic.

on 11 march 2020, the world health organization declared the covid-19 outbreak as a pandemic. on the same day, the first covid-19 case reported in turkey and nationwide quarantine regulations started after a spike in case numbers. in the world of sports, the effects of the covid-19 pandemic started with staging games without spectators, gradually all sports events and team practices were postponed. soon later, athletes advised to quarantine at home and continue training individually. similar to previous study results, the covid-19 outbreak expected to cause a profound and wide range of psychosocial impacts on people during outbreaks of infection. in fact, preliminary results from a study in china showed a moderate to severe degree psychological impact on more than half of the respondents. however, the effect of covid-19 on mental health symptoms in elite athletes has not been investigated. in this study, the investigator aims to investigate stress, anxiety, mood, life satisfaction measures among elite athletes during covid-19 and explore the potential relationship between these measures and the changes in training characteristics during the covid-19 pandemic.

Eligibility criteria:
inclusion criteria: * elite athletes between age of 18-35 exclusion criteria: * athletes with history of covid-19 disease * athetes with first-degree family members who have/had the covid-19 disease * athletes with non-covid related injuries restraining from physical activity * history of psychiatric disease

Keywords: covid-19 athlete mental health
detecting infections rapidly and easily for candidemia trial - part 2 (direct2 study)

Conditions: Candidemia

Summary: the purpose of this study is to validate clinical performance (i.e. estimated sensitivity and specificity) of the t2 candida test on the t2 dx instrument compared to blood culture results and/or known candida positive status of prospectively collected and contrived (i.e. candida-spiked) clinical specimens.

this study will prospectively collect and analyze whole blood t2 clinical research specimens and concomitant blood culture specimens from patients who have been referred for a blood culture per routine standard of care. additional analysis of blinded, contrived (i.e. candida spiked and un-spiked whole blood) specimens will be completed by study sites to augment the analysis of candida positive blood specimens prospectively obtained from the study population. the clinical performance of the t2 candida test on the t2 dx instrument will be evaluated by calculating the: * estimated clinical specificity of the t2candida test results compared to candida negative blood culture results in prospectively collected specimens, and the * estimated sensitivity of the t2 candida test results compared to the known candida positive status or candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to candida positive blood culture results in prospectively collected clinical specimens.

Eligibility criteria:
inclusion criteria: 1. subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them. 2. subject has had a blood culture ordered, per routine standard of care. 3. subject is between 18-95 years of age exclusion criteria: 1. subject has other co-morbid condition(s) that, in the opinion of the investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study. 2. subject has had previous specimens tested by the t2candida assay with valid results. 3. subject has had an anti-fungal drug administered through the same port or central line as is used to collect the clinical research specimens. 4. treatment of subject with any novel drug compound within 30 days prior to the collection of t2 blood specimens. 5. t2 clinical specimen, tube a contains \<3ml of blood.

Keywords: candida candidemia blood culture diagnostics
effect of an experimental cannabidiol gel on tooth sensitivity

Conditions: Dentin Sensitivity

Summary: the goal of this clinical trial will be to evaluate the effect applying an experimental gel based on cannabidiol oil (cbd) on tooth sensitivity induced by tooth bleaching with 35% hydrogen peroxide (hp). volunteers will be selected and allocated to the following groups: gp - placebo gel, gcbd - experimental cannabidiol gel and gkf - potassium nitrate and sodium fluoride gel. in each group, the corresponding desensitizing gel will be applied to on the teeth for 10 minutes. all groups will then undergo in-office whitening treatment with 35% hydrogen peroxide. patients will be instructed to record tooth sensitivity on a daily basis during the 21 days of follow-up. pain intensity will be measured using a visual analog scale (vas), while the risk of developing sensitivity will be recorded after each session of the whitening procedure, with two response option.


Eligibility criteria:
inclusion criteria: * participants must have at least 28 teeth in the cavity * good oral and general health exclusion criteria: * active caries or periodontal disease * visible cracks in front teeth upper or lower * with evident malocclusion * restorations and prosthetics in teeth anterior teeth * gastroesophageal disorders * severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth) * dentin exposure in anterior teeth and /or later * parafunctional habits * tooth sensitivity * whitening treatment prior to or undergoing orthodontic treatment * furthermore, smokers, pregnant or breastfeeding women do not will be included.

Keywords: tooth bleaching cannabidiol dentin sensitivity
a study to evaluate the potential for interpersonal transfer of testosterone following single dose application

Conditions: Hypogonadism

Summary: the hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% testosterone md-lotion® if the donor has a covered application area with a t-shirt.


Eligibility criteria:
healthy male subjects: inclusion: * healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests. exclusion: * men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder. healthy female subjects: inclusion: * healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests. exclusion: * women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.

Keywords: open label, single dose, pharmacokinetic study
evaluation of local mechanisms for staff motivation to reduce hospital mortality

Conditions: Hospital Mortality; Malaria

Summary: we observed in a randomised intervention trial in bissau that mortality due to malaria could be reduced by half by adding a small monetary incentive to the staff and strict follow-up of a standard protocol for available drugs. the government and donors are not able to sustain such incentives. we intend to evaluate whether strict organisation of a cost recovery system and the use of part of the funds for staff incentives would improve performance of the staff and contribute to reduction of hospital and post-discharge mortality.

a committee will organise collection and use of the money, and decide on incentives to be paid to the staff based on performance indicators. all children \< 5 years of age admitted to the ward will be registered and followed-up until two months after the consultation. data on the level of mortality before and after the study period will be collected. furthermore, interviews on quality perception of the parents will be carried out before and after the study.

Eligibility criteria:
inclusion criteria: * children under five years of age admitted to the ward * parents of these children

Keywords: staff motivation hospital mortality perception of quality of care
a eye movement desensitization reprocessing (emdr) study in bipolar traumatized patients

Conditions: Bipolar Disorder; PTSD

Summary: the purpose of this pilot study is whether eye movement desensitization reprocessing (emdr), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and bdnf levels in subsyndromal bipolar patients with trauma.


Eligibility criteria:
inclusion criteria: * bipolar i or ii disorder following dsm-iv criteria * instable, subsyndromal course defined as at evaluation baseline (hamd \> 8 \ 7 \< 14) * good adherence to pharmacological treatment * major or minor traumatic life-events * emdr therapists \> 3 years experience * able to sign informed consent exclusion criteria: * major affective episode in last 3 months * active drug abuse/dependency * neurological disease * suicidal thoughts/ideation * prior treatment emdr * des \> 25

Keywords: emdr bipolar disorder trauma subsyndromal symptoms ptsd