Kornimate/medical-research-clean huggingface dataset:
just breathe, breathing life into innovative therapies for ards- cohort b: paridiprubart

Conditions: Acute Respiratory Distress Syndrome (ARDS); ARDS; ARDS (Acute Respiratory Distress Syndrome); Acute Respiratory Distress Syndrome

Summary: this is a phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with acute respiratory distress syndrome (ards) utilizing a platform trial design. cohort b: participants will be randomized to receive either a placebo or paridiprubart. this record describes the default procedures and analyses for cohort b. please see nct06703073 for information on the bp-ards-p2-001 master protocol.

this is a master protocol for a phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, ip) for the treatment of hospitalized participants diagnosed with ards. the safety and efficacy of each ip will be studied within its own cohort (ip versus placebo). all patients will continue to receive standard treatments for ards as per the investigator. an individual participant will complete the study in approximately 90 days. the study will include a screening period (\<24 hours from providing informed consent to treatment), in-hospital treatment period with ip/placebo starting on day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (day 90 + 2 weeks). outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). functional status using the who ordinal scale and karnofsky scale will be collected. resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival). all participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ecg, chest x-ray or ct scan, and questionnaires through day 90. exploratory biomarkers will be evaluated over time to facilitate clinical learning. this record only includes information relevant to the paridiprubart cohort.

Eligibility criteria:
inclusion criteria: the following inclusion criteria are in addition to the exclusion criteria specified in the master protocol nct06703073: - ards severity of moderate or severe based on pao2/fio2 or spo2/fio2 assessment at the time of randomization. exclusion criteria: the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol nct06703073. -participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80

Keywords: barda just breathe ards acute respiratory distress syndrome acute respiratory failure
bioequivalence study of generic tretinoin 0.1% microsphere gel, 0.1% retin-a micro® and placebo

Conditions: Acne

Summary: the objective will be to assess clinical bioequivalence of 0.1% retin-a micro® gel and spear pharmaceutical's generic 0.1% tretinoin microsphere gel with a placebo arm.

not required

Eligibility criteria:
inclusion criteria: * normal, healthy male and female children and adult * written and verbal informed consent must be obtained. patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent. * women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study. * able to refrain from the use of all other topical acne medications or antibiotics during the treatment period. * considered reliable and capable of understanding their responsibility and role in the study. exclusion criteria: * significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease. * abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders). * use topical acne therapy during the two week period prior to study initiation. * use of systemic retinoid treatment within six months prior to study initiation. * pregnant or breast-feeding. * serious psychological illness. * participation in any clinical research study during the 30 day period preceding study initiation.
pain in neonates during screening for retinopathy of prematurity using two methods

Conditions: Retinopathy of Prematurity; Pain

Summary: retinopathy of prematurity screening is painful. wide field digital retinal imaging (wfdri) and binocular indirect ophthalmoscopy (bio) are being used for screening examinations. the aim of edinburgh, uk based study is to compare the pain experienced by infants using both examination techniques.

infants undergoing routine eye screening at edinburgh royal infirmary neonatal intensive care unit are to be recruited. infants will be excluded if they require mechanical ventilation or analgesic medication or if they have moderate/severe neurological impairment. the first screening examination for each baby was included. infants' eyes will be examined by both wfdri and bio with eyelid speculum by 2 experienced pediatric ophthalmologists in random order. observations will be video-recorded during examinations to generate a pain score (premature infant pain profile) for both wfdri and bio. the pain scores, heart rates, oxygen saturations and time taken for wfdri and bio will be compared using paired t tests.

Eligibility criteria:
inclusion criteria: * infants born at less than 32 weeks gestation and/or birth weight of less than 1500g. exclusion criteria: * infants requiring mechanical ventilation * infants requiring analgesic medication * infants with moderate/sever neurological impairment

Keywords: screening retinopathy prematurity pain
study of vitamin d supplementation tailored to vitamin d deficiency in breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of this study is to compare normalization of vitamin d serum level after 6 months of vitamin d supplementation adjusted to baseline vitamin d serum level vs.conventional vitamin d supplementation.


Eligibility criteria:
inclusion criteria: * breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment * who performance status 0-1 * age ≥18 years old * affiliation to a social security regime or beneficiary of equivalent social protection * written informed consent provided before any study specific procedures complementary inclusion criterion for randomization - proved vitamin d deficiency as defined by serum vitamin d level lower than 30 ng/ml (75 nmol/l). exclusion criteria: * metastatic disease * history or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) ............. traités dans les 5 ans précédents. * contraindication to calcium or cholecalciferol * known severe hypersensitivity to vitamin d or to calcium supplementation or to one of the excipients. * disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria * calcium lithiasis and tissue calcification * hypervitaminosis d * presence of significant comorbidities: i) uncontrolled endocrine disease ii) known disorders of calcium phophorus laboratory testing iii) proved osteopenia or osteoporosis requiring vitamin d and calcium supplements * concomitant treatment with other experimental products or another vitamin d calcium treatment * pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method * legal inability or restricted legal ability. medical or psychological conditions not allowing proper study completion or informed consent signature

Keywords: breast cancer vitamin d supplementation in neoadjuvant adjuvant setting
the easyflype/easyhiflype post market clinical follow-up study.

Conditions: Peripheral Artery Disease; Peripheral Arterial Occlusive Disease

Summary: the easy flype carbostent™ is a ce-marked nitinol self-expanding stent for superficial femoral artery (sfa) and easy hiflype carbostent™is a ce-marked nitinol self-expanding stent for iliac vessels. the aim of this post-market retrospective study protocl p42201 is to collect clinical data of patients treated with easy flype or easy hi flype for the stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery in routine clinical practice. in order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.

the objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical devices easyflype/easyhiflype in the daily clinical practice in an unselected population treated within the intended use. data will be collected via medical chart review in anonymous form to assess the safety and efficacy of easyflype/easyhiflype. the easy flype carbostent™ is a ce-marked nitinol self-expanding stent for superficial femoral artery (sfa) and easy hiflype carbostent™is a ce-marked nitinol self-expanding stent for iliac vessels.

Eligibility criteria:
inclusion criteria: * patient has been implanted with at least one study stent according to the indications described in the ifu * study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection exclusion criteria: * patients treated less than 12 months prior to study start
partnership programs to reduce cardiovascular disparities- morehouse- emory partnership

Conditions: Metabolic Syndrome

Summary: the theme of this morehouse-emory partnership program focuses on elucidating the etiologic basis of ethnic differences in obesity-related cvd and discovering new intervention strategies to ameliorate cv health in all communities. the proposed program uses a multi-disciplinary strategy to systematically characterize ethnic differences in obesity-related cvd by drawing upon the fields of physiology, psychology, biochemistry, vascular biology, public health, nursing and clinical medicine.

emerging evidence indicates that there are ethnicity-specific differences in the profile of biochemical, metabolic and physiological perturbations associated with obesity. the implications of these ethnic differences remain to be further defined. several epidemiologic studies have shown that vascular disease and its cardiovascular complications, carry significantly higher morbidity and mortality in african americans compared with caucasians.1-3 these observations may be partly explained by a higher prevalence of cardiovascular disease risk factors, such as essential hypertension, diabetes mellitus, and tobacco use among african americans.4-6 however, the pathophysiological processes underlying this racial predisposition have not been fully elucidated.7 it is likely that the etiologic basis of ethnic disparities in cardiovascular disease is multi-factorial and involves dynamic gene-environment interactions in which variances in behavior and the social context are critical determinants. the proposed program recognizes the importance of incorporating both biological factors and social determinants in the analysis of cardiovascular disparities

Eligibility criteria:
inclusion criteria: our methodological approach will involve a random digit-dialing cross-sectional survey of 4000 metro atlanta area aa and white residents (ages 30-65 years). this aim will focus on using well-validated survey instruments to examine self-reported perceptions of psychosocial stress, neighborhood segregation factors and health beliefs related to weight/weight control. these parameters will be assessed in relation to the differential prevalence of three major outcomes: (1) self-reported maladaptive cardiovascular behaviors that predispose to obesity-related cvd (ie high fat/sodium and low fruit/vegetables dietary intake and physical inactivity); (2) obesity; and (3) hypertension. this study will address the following research questions: are the observed racial differences in maladaptive health behaviors (diet/inactivity) and mets components (obesity, hypertension) associated with: a) perceived psychosocial stress, and if so, does depression, neighborhood factors or health beliefs around weight and weight control modify this relationship? - exclusion criteria: -
management of acute tinnitus with migraine medications

Conditions: Tinnitus

Summary: tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. it is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence the prevalence and risk of tinnitus. although the economic and emotional impact of tinnitus is large, there is currently no fda-approved medication to treat this condition. however, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. in this project, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. there are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. the frequency and loudness of tinnitus will be measured before and after the course. functional mri of the brain will be obtained to view any changes that may occur before and after the treatment.

this study is 8-weeks in duration. there are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (240 mg) plus paroxetine (32 mg). this is a double-blinded trial. participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. both groups may receive dosage increases weekly if symptoms do not improve. symptomatic survey scores from each arm will be obtained before and after treatment and weekly. an unblinded clinical researcher will also become involved with patients\&#39; treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.

Eligibility criteria:
inclusion criteria: * patients with mild to moderate tinnitus. * male or female between the ages of 25 to 85 years. * subjects must be compliant with the medication and attend study visits. * must be able to read and write in the english language to provide consent. exclusion criteria: * pregnancy will result in automatic exclusion from the study. rule out of pregnancy will be done by urine pregnancy test to confirm the situation for all women who are of childbearing potential. * subjects with a history of an adverse reaction to medication being prescribed. * subjects suffering from a medical condition or have a history that may be concerning to the investigator's clinical opinion. * all contraindications for the medications that prevent subjects from randomization will be considered as exclusion criteria.

Keywords: tinnitus acute tinnitus atypical migraine ringing in ears
evaluate efficacy and safety of oral shr0302 in subjects aged 12 years and older with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, placebo-controlled, multicenter phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.

this study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.

Eligibility criteria:
inclusion criteria: 1. male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg 2. subject has a diagnosis of atopic dermatitis for at least 1 year. 3. meets all of the following disease activity criteria: bsa ≥10% of ad involvement. easi ≥16. iga ≥3. wi-nrs ≥4 4. subject has a recent history (within 6 months before the screening visit) of inadequate response or inability to tolerate topical ad treatments (tcs or tci) or who have required systemic treatments for control of their disease. 5. are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). exclusion criteria: 1. medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. 2. have received certain treatments that are contraindicated. 3. subject currently has been diagnosed and has active forms of other inflammatory skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with the evaluation of atopic dermatitis or response to treatment. 4. other active non-ad inflammatory skin diseases or conditions affecting skin 5. subject with active/severe concomitant disease (s)/symptom(s) that requires administering of systemic corticosteroids or otherwise interferes with study participation or requires active frequent monitoring (e.g., unstable chronic asthma). 6. acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation. 7. medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. 8. unwilling to discontinue current ad medications prior to the study or require treatment with prohibited medications during the study 9. subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ. 10. pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception. 11. subject has a previously received systemic jak inhibitors 12. unwilling to discontinue current ad medications prior to the study or require treatment with prohibited medications during the study
efficacy of pregabalin in migraine prevention

Conditions: Migraine Disorders

Summary: the purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.

the anticonvulsants are effective in the treatment of migraine prevention. the sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. the pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. the purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.

Eligibility criteria:
inclusion criteria: * migraine with or without aura according to international headache society (ihs) criteria for at least 6 months before study entry. * frequency of 3 or more headache attacks per month and less than 15 headache attacks per month. * available for follow-up at least 9 months. exclusion criteria: * patients with headache others than migraine. * patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications. * prophylactic drugs for migraine 12 weeks before randomization. * onset of migraine occurred after 50 years. * hypersensitivity to pregabalin or sodium valproate.

Keywords: pregabalin valproic acid migraine prophylaxis prevention treatment
amplifeye colonoscopy vs standard colonoscopy

Conditions: Colon Polyp; Adenoma Colon; Serrated Polyp; Colonic Neoplasms

Summary: colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. amplifeye is a fda-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in amplifeye-assisted colonoscopy versus standard colonoscopy.

this is a prospective, randomized controlled study. patients admitted to queen elizabeth hospital and our lady of maryknoll hospital for colonoscopy are randomly allocated 1:1 to receive either colonoscopy equipped with amplifeye (ac) or standard colonoscopy (sc). all study team members will have a prior run-in phase of performing at least 5 amplifeye colonoscopies before starting the study. the colonic polyp detection rate (pdr), adenoma detection rate (adr), serrated polyp detection rate (sdr), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.

Eligibility criteria:
inclusion criteria: * aged between 50 to 79 years old * scheduled for screening, surveillance or diagnostic colonoscopy exclusion criteria: * colonic strictures * history of bowel surgery * per-rectal bleeding within six weeks * inflammatory bowel disease * pregnancy

Keywords: colonoscopy adenoma detection rate colorectal cancer screening new technology
aripiprazole oral acceptability trial

Conditions: Schizophrenia

Summary: the purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.


Eligibility criteria:
inclusion criteria: * stable patients currently receiving aripiprazole or other antipsychotic medications.