Kornimate/medical-research-clean huggingface dataset:
efficacy study of topical twice weekly fluticasone treatment to reduce relapse in atopic dermatitis in children

Conditions: Dermatitis, Atopic

Summary: the relapsing nature of atopic dermatitis (ad) presents a challenge for its long-term treatment. efficacy and safety of corticosteroids have been proven in the acute treatment of ad, but not its efficacy and security to reduce or prevent relapses. objectives to investigate long-term management (16 weeks) of ad with fluticasone propionate (fp) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of ad with fp cream.

patients 2-10 years of age with a history of mild to moderate ad will be eligible for this multicentre, randomized, double-blind, controlled study if they present an acute flare of ad (\<30% affected body surface area; no head). after successful treatment of the flare in an acute phase, patients will receive either, fp twice weekly plus vehicle or vehicle alone over a 16-week maintenance phase. the primary study end point will be probability of a relapse of ad occurring. we will conduct survivor analysis of results.

Eligibility criteria:
inclusion criteria: * children, aged 2 to 10 years, with mild or moderate acute flare of ad (scorad up to 50) and no treatment for this episode of ad. * written informed consent to patients' parents. exclusion criteria: * \>30% of affected body surface area ad. * head affected. * fluticasone o vehicle allergy. * patients with any medical condition for which topical corticosteroids were contraindicated * patients with other dermatological conditions that may have prevented accurate assessment of ad * patients with receiving any concomitant medications that might have affected the study's outcome. * other medical history that could interfere with the evaluation of study treatment.

Keywords: dermatitis, atopic randomized controlled trial child fluticasone preventive therapy
comparison of central venous oxygen saturation measurements by non-invasive mespere venous oximeter and central venous catheter

Conditions: Sepsis; Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy; Cardiogenic Shock Post Myocardial Infarction; Hypoxemic Respiratory Failure.

Summary: the intent of this study is to validate the venous blood oxygenation measurements of the mespere va oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is currently the standard of care for measuring svo2

the conventional bedside pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring and measures arterial blood oxygenation. to date, a non-invasive bedside monitor for measuring mixed venous oxygen saturation (svo2) has not been developed. the clinical applications of venous oximetry are numerous and include management of severe sepsis and septic shock, trauma and hemorrhagic shock, heart failure and cardiac arrest. the existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling through a central venous catheter oximetry. however, svo2 measurements using fiber optic catheters are very expensive, and all central line insertions include inherent risks. also, insertion of a central line is in some circumstances not feasible (e.g. discomfort/limited experience in central line insertion, unavailability of specific monitoring systems etc.) resulting in inappropriate therapy usually guided by svo2. therefore, a non-invasive monitor to measure svo2 at the bedside negating the requirement for a central line insertion would be of clinical benefit and allow appropriate therapy of many patients listed above at a time when therapy has the most benefit. the mespere va oximeter is a non-invasive medical device for monitoring of venous blood oxygenation. continuous measurement of venous oxygenation will be beneficial because it will help the physician better understand local ischemia as well as provide better guidance for the physician to be able to best treat the patient and decrease their burden of illness.

Eligibility criteria:
inclusion criteria: * age 18 and older * patients admitted to the icu * patients who have or are scheduled to have an indwelling central venous catheter inserted via the internal jugular vein or subclavian vein as part of their usual care exclusion criteria: * abnormal neck anatomy * unable to identify jugular vein under ultrasound guidance * allergic to adhesive tape * presence of known anatomical shunt or av dialysis fistula * known central vein stenosis

Keywords: venous oximeter co-oximeter icu patients sepsis non-invasive device
real-world experience study of elagolix for the treatment of endometriosis in canada

Conditions: Endometriosis

Summary: the objective of this study is to evaluate real-world effectiveness of elagolix in canadian women with endometriosis.


Eligibility criteria:
inclusion criteria: * prescribed elagolix as part of standard treatment * naive to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to the start of this study * symptomatic endometriosis (clinically or surgically diagnosed) including currently experiencing dysmenorrhea * has provided written informed consent allowing the use of their data for the study exclusion criteria: * did not consent * cannot fill out questionnaires * prescribed elagolix for a period of 1 or 2 months only * post-menopausal (naturally or surgically) * symptomatic uterine fibroid(s) * had medical treatment for uterine fibroids (any length of treatment)

Keywords: endometriosis elagolix real-world effectiveness
artificial intelligence for real-time detection and monitoring of colorectal polyps

Conditions: Adenomatous Polyps

Summary: the investigators hypothesize that the clinical implementation of a deep learning ai system is an optimal tool to monitor, audit and improve the detection and classification of polyps and other anatomical landmarks during colonoscopy. the objectives of this study are to generate preliminary data to evaluate the effectiveness of ai-assisted colonoscopy on: a) the rate of detection of adenomas; b) the automatic detection of the anatomical landmarks (i.e., ileocecal valve and appendiceal orifice).

in this trial, the investigators aim to evaluate the followings: 1. the accuracy of automatic detection of important anatomical landmarks (i.e., ileocecal valve, appendiceal orifice); 2. the accuracy of automatic detection of polyps/adenomas (pdr/adr);

Eligibility criteria:
inclusion criteria : * signed informed consent * age 45-80 years * indication to undergo a lower gi endoscopy. exclusion criteria : * coagulopathy * poor general health, defined as an american society of anesthesiologists (asa) physical status class \>3 * emergency colonoscopies * hospitalized patients * known inflammatory bowel disease (ibd) * patients currently in the emergency room

Keywords: polyps detection artificial intelligence adenoma detection polyps classification quality indicators
the preventive effects of sub hypnotic dose of propofol for nausea and vomiting induced by hemabate

Conditions: Nausea and Vomiting

Summary: this is a randomized, placebo-controlled trail, the objective of this study is observation the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by hemabate during spinal anesthesia for elective cesarean section. the primary outcome is the presence of post-delivery intra-operative nausea and vomiting in parturients. the patients demographic characteristics, blood pressure, sensory block level, and the medications will be collected.


Eligibility criteria:
inclusion criteria: * patients aged 20-40 years; * american standards association status i-ii. exclusion criteria: * patients with allergy or hypersensitivity to propofol, lipid emulsion, or granisetron; * history of nausea or vomiting within 24h before cesarean delivery; * history of gastrointestinal or psychiatric disease, motion sickness, smoking, postoperative nausea and vomiting; * morbid obesity; * consumption of drugs such as opioids, antiemetics , h2 antagonists, phenothiazines and/or corticosteroids within 24h before the study period; * any chronic medical or surgical disorders complicating the pregnancy; * conditions contraindicating regional anesthesia.

Keywords: nausea and vomiting hemabate propofol
needs assessment among carers of someone with suicidal thoughts

Conditions: Suicide Prevention; Informal Caregivers

Summary: with this study the investigators would like to gain insight into the experienced needs carers of individuals with suicidal thoughts, who attempted suicide or who died by suicide. by carers the investigators mean everyone who knows/knew someone close to them who is thinking about suicide, attempted suicide or died by suicide. by mapping out these needs, the investigators hope to better support carers and develop/improve initiatives and tools. the investigators examine this by means of an online one-time questionnaire. in this questionnaire the investigators ask the participants questions about what it is like to be a carer and what are some of the experienced needs, as well as experiences with existing initiatives/tools.


Eligibility criteria:
inclusion criteria: * 16 years or older * someone close to them has experienced suicidal thoughts, attempted suicide or died by suicide in the past three years * access to internet * understand sufficient dutch (to complete the questionnaire) exclusion criteria: * /

Keywords: needs assessment informal caregivers suicide
impact of covid-19 on mental health of ocd patients and live-in family members

Conditions: Obsessive-Compulsive Disorder

Summary: the impact of the current covid-19 pandemic on mental health of people with preexisting psychiatric problems is enormous. this longitudinal study investigates the prevalence of mental health problems (obsessive compulsive, or depressive symptoms, anxiety, stress...) of obsessive-compulsive disorder (ocd) patients and their live-in family members. we also aim to investigate the impact of the pandemic, isolation measures, exposure to media and changing therapeutic setting in ocd patients and their live-in family members through qualitative research.

the impact of the current covid-19 pandemic on mental health of people with preexisting psychiatric problems is enormous. previous studies during the sars outbreak demonstrated a significant burden and increase of mental health problems in people with preexisting psychiatric problems, but little is known about the impact on preexisting obsessive-compulsive disorder (ocd). this longitudinal study aims to investigate the prevalence of mental health problems of ocd patients during and after the covid-19 pandemic. we also want to investigate the impact on family accommodation (fa). there is growing evidence that fa maintains and/or facilitates ocd symptoms. ocd patients and their live-in family members, followed at the centre for ocd of the ghent university hospital, will be included. sociodemographic data, data regarding employment and previous mental health problems will be collected at the first survey. the y-bocs (ocd symtoms) and fas (family accommodation) will be taken from patients and family members respectively at the start, after 1, 3 and 6 months. the depression, anxiety and stress scale (dass-21), the dutch translation of the covid-19 peritraumatic distress index (cpdi) will be administered at the same time points through an online survey. secondly, patients and live-in family members will be interviewed about their experiences concerning the covid pandemic, the isolation measures, media exposure and change of mental health practice and the impact on the ocd (qualitative research).

Eligibility criteria:
inclusion criteria: * ocd patients * live-in family members of ocd patients exclusion criteria: * not speaking fluently dutch

Keywords: family accommodation covid-19
a randomized-withdrawal phase 3 study evaluating the safety and efficacy of oral nalfurafine hcl (ac-820)in subjects on hemodialysis with uremic pruritus (renal itch)

Conditions: Uremic Pruritus

Summary: primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered ac-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population pk analysis.


Eligibility criteria:
inclusion criteria: * 18 yrs old or older * moderate to severe pruritus * end stage renal disease * 3x weekly hemodialysis exclusion criteria: * pruritus not due to renal disease * abnormal liver function * ca-p \> 80 mg/dl or hgb \ pg/ml * within four months spkt/v \< 1.05

Keywords: uremic pruritus
lufwanyama neonatal survival project

Conditions: Mortality

Summary: we seek to determine whether we can reduce day 28 mortality in zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (nrp) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.

this is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in zambia. 120 tbas are randomized into intervention/control. intervention tbas receive nrp training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. control tbas continue according to prior standard of care. primary outcome is mortality at 28 days life as a proportion of births attended by tbas in each study arm.

Eligibility criteria:
inclusion criteria: * tba trained in safe delivery; * willing to sign informed consent; willing to be randomized; willing to adhere to study procedures exclusion criteria: * tba living outside of lufwanyama district

Keywords: birth asphyxia neonatal sepsis maternal to child transmission of hiv
total body pet-ct imaging of prostate cancer using illuccix

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: illuccix will be used per the prescribing instructions for pet-ct imaging on the united imaging scanner uexplorer to establish a standard scanning protocol.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. male ≥ 18 years of age 3. patients meeting clinical need for illuccix pet scan: 1. patients with suspected metastasis who are candidates for initial definitive therapy 2. patients with suspected recurrence based on elevated serum prostate-specific antigen (psa) level 4. patient is physically able to lay flat for the pet-ct procedure exclusion criteria: 1. assessment by the investigator as unable or unwilling to comply with the requirements of the protocol.
an adaptive randomized controlled trial

Conditions: Multi Drug Resistant Tuberculosis; HIV Infections

Summary: this is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed mdr-tb hiv initiating bedaquiline-containing mdr-tb treatment regimens and on art (integrase strand transfer inhibitor (insti)-based fixed dose combination therapy) in kwazulu-natal, south africa. interventions arms include: enhanced standard of care; psychosocial support; mhealth using cellular-enabled electronic dose monitoring; combined mhealth psychosocial support. level of support will be adjusted using a differentiated service delivery (dsd)- informed assessment of treatment support needs.

this study will follow a 4-arm bayesian, adaptive trial design. as patients are enrolled, they will be randomized into one of the four arms. the study will be carried out within a common structure to allow for efficient enrollment and analysis. the overall structure is a 4-arm adaptive platform of mhealth and psychosocial adherence support interventions informed by a differentiated service delivery (dsd) approach. aim 1 is an adaptive study of mhealth and psychosocial adherence support interventions using a bayesian adaptive design to allow comparison of elements of the intervention separately and in combination. aim 1 participants will be randomized into one of 4 arms and followed monthly through the 6 months of intervention, then through the end of treatment telephonically, with an additional in-person visit to establish the primary outcome. primary outcome is a combined clinical/biological outcome at 12 months described below. hypothesis 1a utilizes all participants while 1b utilizes only those in the mhealth intervention arms (3+4) since granular edm-measured adherence is required.

Eligibility criteria:
inclusion criteria: 1. culture or molecular test positive for mtb 2. molecular test positive for hiv or a documented hiv positive history 3. drug-susceptibility testing by molecular (i.e. genexpert mtb/rif) or conventional testing consistent with at least rifampicin-resistant tb, 4. initiating treatment with a bedaquiline -containing tb regimen within 4 weeks of enrollment and first-time being treated with bdq 5. on treatment with antiretroviral therapy (art) regimen, including dolutegravir-containing combination antiretroviral therapy regimen (i.e. tenofovir-lamivudine-dolutergravir), or starting within 4 weeks of enrollment, 6. capacity for informed consent in either isizulu or english exclusion criteria: 1. pregnancy 2. prisoners 3. discretion of ior or clinician
montelukast asthmatic smoker study (0476-332)(completed)

Conditions: Asthma

Summary: this is a multicenter study to evaluate the efficacy and safety of mk0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.


Eligibility criteria:
inclusion criteria: * participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day exclusion criteria: * participant cannot have a diagnosis of chronic obstructive pulmonary disease (copd) or emphysema.
could the stroke volume variation predict a fluid responsiveness in thoracotomy?

Conditions: Pulmonary Neoplasm; Pulmonary Tuberculosis

Summary: there are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one lung ventilation. the overloading of fluid administration could be related to the development of pulmonary edema in patents after thoracic surgery. but fluid restriction may cause major organ hypoperfusion during the surgery. the purpose of this study is to evaluate the ability of stroke volume variation as an indicator for a fluid responsiveness in patient who receives pulmonary lobectomy via thoracotomy.

perioperative fluid management during thoracic surgery is a significantly important, because it is quite difficult to prevent pulmonary edema due to the fluid overload and compromise perfusion of vital organ. so, it is essential to maintain optimal organ perfusion by appropriate fluid management during thoracic surgery. stroke volume variation (svv) is derived from pulse contour analysis and it is known that svv ≥12\~15% correlate with fluid responsiveness, defined as a significant increase in cardiac output with fluid loading, dung two-lung ventilation. it is a parameter derived from changes in stroke volume (sv) that is according to the heart-lung interaction during mechanical ventilation. positive pressure ventilation induces cyclic changes in left ventricular sv that are related mainly to the expiratory decrease in right ventricular filling and ejection. this is a reflected by variations in the sv. however both ventilator issues, such as tidal volume, peep, chest and lung condition, and the cardiovascular condition, such as heart rate, rhythm, ventricular function, cardiac afterload, arterial compliance may affect svv. recently some studies reported that svv could predict fluid responsiveness in mechanically ventilated patients under various conditions. but it is still unclear whether svv could predict fluid responsiveness during one lung ventilation with the chest open via a thoracotomy. during one-lung ventilation, the shunted blood flow through the non-ventilated-lung dose not contribute to the generation of svv. and with the chest opening by thoracotomy, the pressure generated by ventilator would not be transmitted to the pulmonary vessels but rather to the atmosphere. so, the purpose of this study is to evaluate the ability of svv as an indicator a fluid responsiveness particularly in patients undergoing one-lung ventilation with thoracotomy and to found the optimal threshold value of svv for fluid management during thoracic surgery.

Eligibility criteria:
inclusion criteria: * the patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital exclusion criteria: * the patients with known cardiac disease include arrythmia * american society of anesthesia physical status iii, iv, v

Keywords: stroke volume variation fluid responsiveness one-lung ventilation thoracotomy
safety and efficacy study of egp-437 (dexamethasone phosphate formulated for ocular iontophoresis) to treat dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to assess the safety and efficacy of egp-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the eyegate® ii iontophoresis system in patients with dry eye.

dry eye is the most prevalent form of ocular discomfort and irritation. estimates range from 20 million people in the united states being affected with mild to moderate dry eye, to as many as one out of every five americans. eyegate completed a single-center, randomized, double-masked, placebo-controlled phase 2 efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the controlled adverse environment (cae), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents. in this phase 2 study, the improvements documented in dry eye signs and symptoms relative to the placebo group indicated that the ocular iontophoresis treatments with egp-437 (dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of action and a long-term effectiveness. the phase 3 study is intended to confirm and extend the results from the phase 2 study, utilizing the cae model. the study is designed to assess the safety and efficacy of egp-437 at two different dose levels: ocular iontophoresis with egp-437 4.0 ma-min at 1.5 ma and ocular iontophoresis with egp-437 6.5 ma-min at 2.5 ma compared to ocular iontophoresis with placebo (sodium citrate buffer solution) for the treatment of the signs and symptoms of dry eye.

Eligibility criteria:
inclusion criteria: * have a reported history of dry eye in each eye * be at least 12 years of age * demonstrate a response when exposed to the controlled adverse environment model at visits 1 and 2 exclusion criteria: * have contraindications to the use of the test articles * have known allergy or sensitivity to the study medications or their components * have any ocular infections, active ocular inflammation, or preauricular lymphadenopathy * be current contact lens wearers or wear contacts during the study

Keywords: dry eye keratoconjunctivitis sicca iontophoresis ophthalmic drug delivery egp-437 dexamethasone phosphate