Kornimate/medical-research-clean huggingface dataset:
to evaluate the efficacy and safety of minocycline hydrochloride foam in the treatment of moderate-to-severe acne vulgaris

Conditions: Acne Vulgaris

Summary: this is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of fmx101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.

qualified subjects will be randomized to receive 1 of the following 2 treatments: * fmx101 4% minocycline foam * vehicle foam subjects with qualifying lesion counts and investigator's global assessments (iga) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. subjects will apply the assigned study drug topically once daily for 12 weeks as directed. subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. both the investigator and subject will be blinded to the study drug identity. subjects will return for visits at weeks 1, 2, 4, 6, 8, and 12. at the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the weeks 1, 2, 4, 8 and 12 visits. efficacy evaluations (acne lesion counts and igas) will be performed at each visit during the study.

Eligibility criteria:
inclusion criteria: 1. has completed and signed an appropriately administered informed consent form (icf) prior to any study-related procedures. subjects less than 18 years of age (or as required by state law) must sign an assent form for the study and a parent or legal guardian must sign the icf. 2. has facial acne vulgaris with: * 20 to 50 inflammatory lesions (papules, pustules, and nodules) * 25 to 100 non-inflammatory lesions (open and closed comedones) * no more than 2 nodules on the face * iga score of moderate (3) to severe (4) 3. willing to use only the supplied non-medicated cleanser (cetaphil gentle skin cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study. exclusion criteria: 1. acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations. 2. sunburn on the face.
non-immersive virtual reality for pediatric pain management

Conditions: Procedural Pain

Summary: this is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.

background: recent studies have shown that the use of virtual reality (vr) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children. aim: to assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting. method: this clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. the experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. the control group will receive treatment as usual. the llanto pain scale will be used to measure different characteristics of pain. this scale has been validated in colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents. expected results: to show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.

Eligibility criteria:
inclusion criteria: * patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers. exclusion criteria: * fever (axillary temperature greater than 38°c). * systemic inflammatory response syndrome or sepsis. * pulmonary disease. * neurological deficit of any kind. * susspected or confirmed metabolic disease. * undernutrition or obesity as defined by deviations from the mean of local values.

Keywords: child, preschool virtual reality procedural pain phlebotomy vaccination
doravirine concentrations and antiviral activity in genital fluids in hiv-1 infected individuals

Conditions: HIV-1-infection

Summary: this study aims to evaluate the ability of doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of doravirine as part of treatment strategies as prevention.

objectives: * to determine doravirine concentrations in seminal plasma and cervicovaginal fluid in hiv-1 infected male and female individuals receiving antiretroviral therapy (atr) with doravirine plus descovy®. * to evaluate hiv-1 viral load in seminal plasma and cervicovaginal fluid in hiv-1 infected male and female individuals receiving art with doravirine plus descovy®. study phase: phase ii study design: open label, single arm, single center, prospective study. study disease: hiv-1 infection study endpoints: * concentration of doravirine in seminal plasma and cervicovaginal fluid in hiv-1 infected male and female individuals, respectively, 8 weeks after switching to doravirine plus descovy®. * hiv-1 rna in seminal plasma and cervicovaginal fluid in hiv-1 infected male and female individuals, respectively, 8 weeks after switching to doravirine plus descovy®. target population: male and female adult hiv-1 infected patients receiving standard art with tenofovir alafenamide/emtricitabine (taf/ftc), tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine , plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor during at least 3 months, with plasma hiv-1 rna suppression (\<40 copies/ml) during at least 6 months. number of subjects planned: 15 male and 15 female individuals. study duration: 16 weeks

Eligibility criteria:
inclusion criteria: 1. asymptomatic, hiv-1 infected individuals ≥ 18 years of age. 2. be on a stable art consisting of taf/ftc, tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine, plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor, continuously for at least 3 consecutive months preceding the screening visit. 3. plasma hiv-1 rna \<40 copies/ml for at least 6 months at the screening visit. 4. signed and dated written informed consent prior to inclusion. 5. female subjects of childbearing potential must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study. exclusion criteria: 1. severe hepatic impairment (child-pugh class c) 2. ongoing malignancy 3. active opportunistic infection 4. resistance to any of the antiretroviral (arv) included in the study or history of virologic failure with risk of resistance selection to any of the study drugs. 5. any verified grade 4 laboratory abnormality 6. alt or ast ≥ 3xuln and/or bilirubin ≥ 1.5xuln 7. severe renal impairment (estimated creatinine filtration rate \<50ml/min). 8. females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.

Keywords: doravirine
fibrinogen in haemorrhage of delivery

Conditions: Post-Partum Hemorrhage

Summary: the purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of pph on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.

randomised, double-blind,multicenter, placebo-controlled study

Eligibility criteria:
inclusion criteria: * signed and dated informed consent form * vaginal delivery * pph requiring iv administration of prostaglandins * at least one available result of hb level during the third trimester of pregnancy * 18-year-old female patients and older * covered by healthcare insurance in accordance with local requirements exclusion criteria: * caesarean section * haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion * known placenta praevia or accreta * hb level \< 10g/dl during the third trimester of pregnancy * history of venous or arterial thromboembolic event * known inherited bleeding or thrombotic disorders * treatment with low-molecular-weight heparin (lmwh) within 24 hours prior to the inclusion * treatment with acetylsalicylic acid within 5 days prior to the inclusion * treatment with vitamin k antagonists within 7 days prior to the inclusion * administration of fibrinogen concentrate within 48 hours prior to the inclusion * administration of ffp, platelets units or prohaemostatic drugs, tranexamic acid and rfviia or prothrombin complex concentrates (pcc) within 48 hours prior to the inclusion * administration of rbcs within 3 months prior to the inclusion * participation in another interventional clinical study within 30 days prior to the inclusion * previous inclusion/enrolment in the present clinical study * known history of hypersensitivity or other severe reaction to any component of clottafact® or placebo * minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom * known drug or alcohol abuse * patients whose use of concomitant medication may interfere with the interpretation of data * any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement * patients who are unlikely to survive through the treatment period and evaluation * patients transferred from another service

Keywords: pph fibrinogen vaginal delivery
nicotine delivery rate and its abuse potential: impact of menthol

Conditions: Nicotine Dependence

Summary: a placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an iv infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).

a placebo-controlled study that will enroll male and female tobacco smokers' menthol to participate in five experimental sessions. during the experimental session, subjects will be given an iv infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). the infusion conditions for each experimental session will be determined in random order. aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products. presented is the time frame at which the peak change was strongest by treatment arm. the possible peak numbers could be 1, 3, 5, 7 and 10 minutes."

Eligibility criteria:
inclusion criteria: * female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year * smoke ≥ 5 and less than 20 cigarettes per day; * urine cotinine levels \> 100 ng/ml consistent with nicotine intake of an active smoker (23) * not seeking treatment at the time of the study for nicotine dependence; * in good health as verified by medical history, screening examination, and screening laboratory tests * for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods. exclusion criteria: * history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study * regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) * current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine * use of e-cigarettes more than 10 days in the past 30 days * urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
testing a prediction algorithm into a running telehealth system for patients with copd

Conditions: Chronic Obstructive Pulmonary Disease; COPD Exacerbation; COPD Exacerbation Acute; COPD

Summary: this trial will test a copd prediction algorithm into a telehealth system from the previous danish large-scale trial, telecare north (nct01984840). the copd prediction algorithm aims to support clinical decisions by predicting exacerbations in patients with copd based on selected physiological parameters (blood pressure, oxygen saturation, and pulse). a prospective, parallel two-armed randomized controlled trial with approximately 200 copd participants will be conducted.

several studies call for research investigating telehealth' ability to predict exacerbations. use of clinical prediction tools might be promising to improve telehealth services related to prediction of exacerbations and to support decision-making. however, more research is needed to further develop, test, and validate prediction algorithms to ensure that these algorithms improve clinical outcomes before they are widely implemented in practice. this trial seeks to demonstrate that through telehealth, the implementation of a copd prediction algorithm might have potential to support early detection of exacerbations. the copd prediction algorithm might initiate timely treatment, which can potentially led to improvement in copd patients' health and fewer hospitalizations. the primary outcome is the number of exacerbations defined as an all-cause acute hospitalization from baseline to follow-up in both groups. the trial hypothesizes that integrating a copd prediction algorithm into the telehealth system will lead to a significantly lower number of exacerbations through early identification and timely preventive treatment. the primary outcome will be statistically analyzed, and the hypothesis will be tested between groups. all participants are familiar with the telehealth system in advance. in addition to the participants' usual monitored measurements, they are asked to measure their oxygen saturation twice a week during the trial period. the participants will receive the questionnaires; euroqol-5d-5l, short-form 12 item, version 2 health survey, the european health literacy survey questionnaire, the danish test of functional health literacy in adults, danish telehealth usability questionnaire, and a questionnaire containing selected demographic characteristics at baseline and at 6-month follow-up.

Eligibility criteria:
the trial population consists of patients with copd who already use the telehealth system. inclusion criteria: * men and women \>18 years * diagnosis of copd * fixed residence in aalborg municipality. exclusion criteria: * unable to monitor vital signs * unable to complete study questionnaires

Keywords: chronic obstructive pulmonary disease denmark acute episodes machine learning telehealth telemonitoring rct decision support systems predictive analytics
clinical trial of sb-509 in subjects with diabetic neuropathy

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy

Summary: the purpose of the study is to evaluate the clinical effects of the investigational drug, sb-509, in subjects with diabetic neuropathy.

sb-509 contains the gene (dna-a kind of biological "blueprint") for a protein. when a researcher injects sb-509 into your legs, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. this protein causes your cells to increase production of another protein called vascular endothelial growth factor (vegf), which may improve the structure and function of nerves. in addition, there are changes in the levels of additional proteins in your cells. these proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. this increase in your own vegf proteins may protect and repair the damaged nerves caused by diabetic neuropathy.

Eligibility criteria:
key inclusion criteria: * clinical diagnosis of diabetes mellitus type i or ii for at least 12 months * clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes * measurable sural and peroneal response bilaterally * hgba1c level ≤ 10% * ldl cholesterol ≤ 160 mg/dl * blood pressure ≤ 140/90 mm hg * body mass index (bmi) ≤ 38 key exclusion criteria: * moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months * evidence of cardiac enlargement and/or congestive heart failure * current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity * history of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years * immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product * history of or current proliferative retinopathy, macular edema or retinal neovascularization * pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to vegf stimulation * family history of inherited neuropathy (e.g. charcot marie tooth, hereditary predisposition to pressure palsy)

Keywords: diabetic neuropathy diabetes type 1 or 2 moderately severe sensorimotor diabetic polyneuropathy
optimizing cardiovascular preventive care for women following hypertensive disorders of pregnancy

Conditions: Hypertension, Pregnancy Induced; Hypertension Complicating Pregnancy; Preeclampsia; Cardiovascular Diseases; Patient Engagement

Summary: cardiovascular disease is the leading cause of death among women in the united states, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. this research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.

current evidence demonstrates that women with hypertensive disorders of pregnancy have 2-fold higher risk for the later development of cardiovascular disease (cvd) compared to women with healthy pregnancies. cvd prevention is a high priority for women's health, as it is the leading cause of death among women in the united states. in order to improve women's cardiovascular health, interventions for cardiovascular prevention could be initiated shortly after a pregnancy complicated by a hypertensive disorder. however, patient-centered interventions to promote preventive care engagement among postpartum women are lacking. our objective is to address current gaps in knowledge regarding needs, values, and barriers regarding cardiovascular prevention among postpartum women with hypertensive disorders of pregnancy, and to remedy the lack of available evidence-based interventions for this at-risk population. to this end, we will conduct a pilot study to demonstrate feasibility and preliminary efficacy of a patient decision aid to improve patient knowledge and self-efficacy regarding cvd prevention during the postpartum period

Eligibility criteria:
inclusion criteria: * delivered a pregnancy complicated by a hypertensive disorder of pregnancy at the university of utah during the current hospital admission * ability to speak and read english or spanish * written informed consent obtained exclusion criteria: * cardiovascular disease diagnosis (history of peripheral artery disease, stroke, or myocardial infarction) * impairment of cognitive function or vision that prohibits communication and/or reading the decision aid.
neoadjuvant goserelin for triple negative breast cancer

Conditions: Breast Cancer Triple Negative

Summary: this is a phase ii randomized trial that will evaluate the effect of adding lhrh analogue, goserelin, to the standard neoadjuvant chemotherapy to patients with triple negative breast cancer. targeting lhrh might decrease resistance to chemotherapeutic agents in the neoadjuvant setting and increases clinical and pathological response rates. additionally, exploring potential surrogate markers (as ar and lhrh receptors) for molecular distinct subtypes of tnbc.

neoadjuvant chemotherapy (nact) is the mainstay of treatment of locally advanced tnbc and some selected early cases followed by surgery with or without adjuvant radiotherapy. nact is aimed to induce pathologic complete response (pcr) in tumor and lymph nodes, pcr is proofed to be a surrogate and reliable predictive factor of survival rates in tnbc. this study will evaluate the effect of adding lhrh analogue, goserelin, to the standard neoadjuvant chemotherapy. following completion of neoadjuvant therapy, patients will undergo breast conservative surgery or mastectomy. post-neoadjuvant chemotherapy axillary staging will be required, but the choice of the procedure will be at the physician's discretion. postoperative radiation therapy will be given at the physician's discretion. the use of partial breast irradiation techniques will not be allowed. the primary endpoint will be the rate of pathologic complete response. the secondary endpoints will be 3-year-disease free survival, clinical response and toxicity. exploratory endpoints will be correlation of the lhrh receptor expression level with the pcr. the sample size for the trial will be 180 patients accrued over a period of 2 years. definitive analysis of the primary endpoints is expected at year 3.

Eligibility criteria:
inclusion criteria: 1. premenopausal women between 18 and 60 years. 2. histologically proven, newly diagnosed invasive carcinoma of breast. 3. tumors must be er, pgr negative and her2-neu negative. 4. stage ii or iii breast cancer that is indicated for neoadjuvant systemic chemotherapy. exclusion criteria: 1. pregnant females at time of diagnosis of breast cancer. 2. bilateral breast cancer. 3. already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy 4. history or concomitant diagnosis of another primary malignancy. 5. concurrent treatment with oral contraceptives or hormone replacement therapy (ocps or hrt must be stopped at least 4 weeks prior to randomization).