Kornimate/medical-research-clean huggingface dataset:
simulation of risk of adverse drug events associated with the initiation of drugs repurposed for the treatment of covid-19 in frail elderly adults with polypharmacy

Conditions: COVID; Drug Effect; Drug Interaction; Adverse Drug Event

Summary: this retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the medication risk score (mrs) in elderly people enrolled in pace organizations. our clinical tool would enable to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ade) developing in elderly patients infected with covid-19.

certain investigational agents have been described in observational series or are being used anecdotally based on in vitro or extrapolated evidence. it is important to acknowledge that there are no controlled data supporting the use of any of these agents, and their efficacy for covid-19 is unknown. fda-approved drugs such as chloroquine/hydroxychloroquine, lopinavir/ritonavir, monoclonal il-6 antibodies, jak inhibitors, thalidomide and the new investigational drug, remdesivir have been proposed for repurposing to fight covid-19 and its complications. a medication risk stratification strategy will be used to simulate the impacts of different potential repurposed drugs for covid-19 on the medication risk score (mrs) which is used as a predictive tool for ades. a retrospective study will be conducted using de-identified drug claims data of elderly patients with polypharmacy. patients meeting all the following criteria will be included: 1. patient enrolled in a pace organization during the implementation period; 2. pace organization contractually receiving pharmacy services from carekinesis; exclusion criteria a) no drug claims data available for the period of 2019-2020 this retrospective cohort will utilize 178,867 drug claims from approximately 12,123 patients enrolled in pace. mrs will be calculated using the last available 3-month period of drug claims in 2019. the data elements required for the calculation of the full set of risk scores are: prescribed drugs, dose, age, gender. medication risk stratification using 5 factors will be performed to obtain the mrs. various repurposed drugs (drugs associated with the highest probability or efficacy or shown interest as per their inclusion in current clinical trials will be prioritized) will be added to the patient drug regimen except for the patients that are currently taking the repurposed drug. a new mrs will be generated for all stratified patients.

Eligibility criteria:
inclusion criteria: * patient enrolled in a pace organization during the implementation period; * pace organization contractually receiving pharmacy services from carekinesis; exclusion criteria: * no drug claims data available for the period of 2019-2020

Keywords: covid-19 elderly adverse drug event repurposed drug drug interaction lqts
pals-catch intervention for obesity prevention among at-risk toddlers

Conditions: Childhood Obesity

Summary: the purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. investigators hypothesize that the children participating in the intervention will have significantly lower bmi z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity.


Eligibility criteria:
inclusion criteria: * child is 2 - 3 years at the time of enrollment * child is \>85th percentile for bmi * ability of the parents to speak and read in english at the 4th grade level * provide primarily in-home care for the children at the time of enrollment * child is medicaid eligible exclusion criteria: * acute secondary complications of obesity for child (e.g., severe respiratory insufficiency) * child with endocrine abnormalities * child with severe obesity (\>99.5th bmi percentile) * children who have participated in an obesity treatment program within the past year * parent with significant sensory impairments (e.g. deaf, blind) * parent with bmi \>40.0
the effect of punctal plugs on tear volume and osmolality

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.

50% of contact lens wearers have dryness/discomfort during contact lens wear. significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality. similar tear film changes occur with dry eye disease. a commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health. this study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.

Eligibility criteria:
inclusion criteria: * over 18 years of age exclusion criteria: * corneal refractive surgery * contraindications to contact lens wear * latex allergy * corneal hypoesthesia * active corneal infection * acute or sub-acute inflammation or infection of the anterior chamber of the eye

Keywords: contact lenses intolerance punctal plugs tear volume intolerance to contact lens wear due to dryness symptoms
a study to evaluate the effect of testosterone replacement therapy (trt) on the incidence of major adverse cardiovascular events (mace) and efficacy measures in hypogonadal men

Conditions: Hypogonadism; Cardiovascular Diseases

Summary: this is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (trt) in symptomatic hypogonadal men with pre-existing cardiovascular disease (cvd) or increased risk for cvd.


Eligibility criteria:
inclusion criteria: * men between 45 and 80 years age * participants with low serum testosterone concentrations (\< 300 ng/dl) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (cv) disease or are at an increased risk for cv disease. exclusion criteria: * participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate * participants with prostate specific antigen (psa) \> 3.0 ng/ml (or 1.5 if on 5-alpha reductase inhibitors) * participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated * confirmed testosterone \< 100 ng/dl * body mass index (bmi) \> 50 * hemoglobin a1c (hba1c) \> 11% * hematocrit (hct) \> 50% * estimated glomerular filtration rate (egfr) \< 30 ml/min * history of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (class iii and iv).

Keywords: hypogonadism cardiovascular (cv) disease androgel testosterone replacement therapy (trt)
explore the effect of bitter melon peptides on glycemic control and metabolic indicators in diabetic patients

Conditions: Diabetes

Summary: the goal of this clinical trial is to learn the potential of bitter melon peptides in stabilizing blood glucose in diabetic adults. it will also learn about the effects of bitter melon peptides on metabolic parameters. the main questions it aims to answer are: * the regulatory effects of bitter melon peptides on glycemic variability * impact on glycemic and metabolic indicators researchers will compare bitter melon peptides to a placebo (a look-alike capsule that contains microcrystalline cellulose) to see if bitter melon peptides works to stabilizing blood glucose. participants will: * take bitter melon peptides or a placebo every day for 12 weeks * visit the clinic on day 0, day 7, day 28 and day 84 for checkups and tests * glucose levels were monitored continuously by cgms in the first 7 days and fasting blood samples were drawn at first visit (day0), third visit (day 28) and fourth visits (day 84)


Eligibility criteria:
inclusion criteria:participants were diagnosed with type 2 dm based on criteria recommended by the american diabetes association and required to have fasting plasma glucose of ≥126 mg/dl or an hba1c of ≥ 6.5%, as measured on two separate occasions exclusion criteria:cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.

Keywords: bitter melon peptides
a randomised controlled trial comparing single shot adductor canal block with local infiltration analgesia for postoperative analgesia after total knee arthroplasty

Conditions: Analgesia in Total Knee Arthroplasty

Summary: total knee arthroplasty or replacement (tka), a commonly performed surgery for osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic approach. a method for analgesia is local infiltration analgesia (lia), where a mixture of drugs is injected around the knee joint. adductor canal block (acb) is an alternative regional anaesthesia technique which has been shown to result in minimal thigh weakness. the investigators aim to study if the analgesia provided by acb is superior to lia while preserving quadriceps strength.


Eligibility criteria:
inclusion criteria: * patients scheduled for primary tka under single shot spinal anaesthesia, between ages 45-85 years old, american society of anesthesiologists (asa) physical status 1 to 3 and bmi 18-35 kg/m2 exclusion criteria: * patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, allergy to local anaesthetics or any drugs included in the study, patients with lower limb surgery in the preceding year, patients with pre-existing neurological deficits and patients who have contraindications for spinal anaesthesia.
the value of the neutrophil to lymphocyte ratio in the diagnosis of bacterial infections

Conditions: Bacterial Infections

Summary: the "gold standard" for diagnosing a bacterial infection is isolation of the pathogenic germ, which is not easy in routine clinical practice. conventional markers do not have sufficient diagnostic value for making a rapid diagnosis on admission. a 2004 literature calculated the diagnostic values of c-reactive protein (crp) and procalcitonin (pct) levels for the diagnosis of bacterial infections, relative to other causes of inflammation. for crp, the sensitivity was 75% (95% ci: 62%-84%) and the specificity was 67% (95% ci: 56%-77%). for pct, the sensitivity was 88% (95% ci: 62%-84%) and the specificity was 81% (95% ci: 67%-90%). the first cellular immune response to infection consists of the mobilization of polynuclear neutrophils from the bone marrow to the infection site under the effect of pre-inflammatory cytokines, as well as the apoptosis of lymphocytes and their sequestration at the infection site. this results in lymphopenia and the elevated polynuclear neutrophil count (pnn) observed in bacterial infections. hence, it is legitimate to hypothesize that the neutrophil to lymphocyte ratio (nlr) can be used in the diagnosis of bacterial infection. this ratio's value in the diagnosis of sepsis in the emergency department was studied and the researchers found higher diagnostic values than for crp and pct. the nlr's potential value in the diagnosis of a bacterial infection in a context of fever or hyperthermia (regardless of the presence or absence of bacteraemia) has not been studied before. this ratio could also be compared with standard biomarkers (crp and pct levels, the white blood cell count and the pnn).


Eligibility criteria:
inclusion criteria: * all consecutive patients admitted for fever/inflammatory syndrome to the internal medicine department at amiens university hospital between january 1 st 2011 and december 31 st 2014 (hyperthermia \&gt; 38°5 and/or inflammatory syndrome, defined as an increase in crp \&gt;10 mg/l). exclusion criteria: * known conditions or treatments that may influence the blood count (haematological and neoplastic diseases, seropositivity for hiv, chemotherapy, and corticotherapy). * pregnancy. * a course of antibiotics administered in the 48 hours before the * blood count (risk of sample negativity).

Keywords: fever hyperthermia inflammatory syndrome
zinc with chloroquine/hydroxychloroquine in treatment of covid-19

Conditions: COVID

Summary: we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of covid-19.

we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of covid-19. as, zinc may be of value in these cases and may be of value in enhancing chloroquine effect.

Eligibility criteria:
inclusion criteria: * patients with positive covid-19. exclusion criteria: * contraindications or hypersensitivity to chloroquine.
evaluate the efficacy and safety to tenofovir disoproxil in chronic hepatitis b patients

Conditions: Hepatitis B, Chronic

Summary: this study evaluates the efficacy and safety of switching to tenofovir disoproxil from tenofovir disoproxil fumarate in chronic hepatitis b patients who pretreated with tenofovir disoproxil fumarate. in open-label, phase 3 studies, we randomly assigned patients with hepatitis b e antigen (hbeag)-negative or hbeag-positive chronic hbv infection to receive tenofovir disoproxil or tenofovir disoproxil fumarate (ratio, 2:1) once daily for 48 weeks

tenofovir disoproxil and tenofovir disoproxil fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis b virus (hbv) polymerase. the primary efficacy end point at week 48 of this study was defined as the combination of an hbv dna level of less than 400 copies per milliliter and histologic improvement .

Eligibility criteria:
inclusion criteria: * chronic hepatitis b virus (hbv) infection, defined as positive serum hepatitis b s-antigen (hbsag) for at least 6 months. * hbeag negative and hbeab positive at screening exclusion criteria: * pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study * males and females of reproductive potential who are unwilling to use an effective method of contraception during the study. * decompensated liver disease defined as conjugated bilirubin \> 1.5 x uln, prothrombin time (pt) \> 1.5 x uln, platelets \< 75,000/ml, serum albumin \< 3.0 g/dl, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) * significant renal, cardiovascular, pulmonary, or neurological disease * currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
evaluation of anterior cruciate ligament tears using diffusion tractography

Conditions: ACL Injury; MRI; Tractography

Summary: knees injuries commonly affect the acl. french current methodology is based on mri focused on the knee with morphological sequences (t1, dp fat sat) allowing the study of acl as follows: no lesion / partial tear / complete tear. the treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). however, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the acl in case of partial tear. as a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. any patient who undergo a posttraumatic knee mri at the chu amiens picardie will have an appointment at the 3t "signa" mri that has the knee-centric diffusion tractography sequence.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, * patient referred for non-enhanced knee mri for traumatism. * affiliation to a social security program, exclusion criteria: * person under guardianship or curators, * any contraindications to mri

Keywords: acl injury mri tractography
clinical efficacy of in-office bleaching with different concentrations of hydrogen peroxide

Conditions: Tooth Discoloration

Summary: objective: the study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide. material and methods: randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (hp), 20%hp, and 40%hp in-office bleaching agent. tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (t5) after finishing the bleaching using spectrophotometer. tooth sensitivity was measured with the visual analog scale at baseline, immediately after bleaching, after 1 day, and after 7 days. the impact on quality of life was evaluated using the oral health impact profile (ohip) questionnaire at baseline, and 6 months after bleaching.


Eligibility criteria:
inclusion criteria: * women and men (at least 18 years old) * people with good oral and general health * people without periodontal disease * teeth without caries * teeth a3 or darker according to the vita easy shade guide (vita zanhnfabrik, badsckingrn, germany) exclusion criteria: * having undergone teeth bleaching procedure in the last 2 years, * people with tooth sensitivity, * use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth, * people with gingival recession, * discoloration due to parafunction, tetracycline or fluorosis, * smokers, * tooth fracture.

Keywords: hydrogen peroxide in-office bleaching randomized clinical trial tooth sensitivity whitening effectiveness quality of life
a study to assess the safety and efficacy of zpl389 with tcs/tci in atopic dermatitis patients

Conditions: Atopic Dermatitis

Summary: this extension study (czpl389a2203e1) was designed as a 2-year (100 weeks) extension to the core study (czpl389a2203/ nct03517566) which is disclosed separately. it aimed to assess the short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d zpl389 with concomitant or intermittent use of topical corticosteroids (tcs) and/or topical calcineurin inhibitors (tci).

subjects who had received zpl389 30 mg or 50 mg doses in the core study (czpl389a2203), continued to receive the same doses in double-blinded fashion. subjects who had received zpl389 3 mg, 10 mg or placebo in the core study were randomized to 30 mg or 50 mg zpl389 in a 1:1 ratio. all subjects received concomitant or intermittent tcs and/or tci along with zpl389. short-term safety was assessed up to week 16 of this extension study (week 16 to week 32 referring to the start of core study treatment) and long-term safety was assessed after week 16 of this extension study (after week 32 referring to the start of core study treatment). the entire planned time frame (100 weeks) was not assessed as originally planned due to early termination of the core and extension studies.

Eligibility criteria:
inclusion criteria: * subjects must give a written, signed and dated informed consent * subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in czpl389a2203 study. * willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures. exclusion criteria: * inability to use tcs and/or tci due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions). * treatment discontinued subject from czpl389a2203 study. * any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.

Keywords: atopic dermatitis ad eczema itch pruritus h4r zpl389
a study of sintilimab combined with chemotherapy for neoadjuvant treatment of esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, dcf) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.

this study was designed as a single arm, phase ii trial. subjects will receive 3 cycles of sintilimab combined with dcf as neoadjuvant therapy. the primary endpoint is pathologic complete response(pcr).

Eligibility criteria:
inclusion criteria: * ≥18 years old and ≤75 years old * esophageal squamous cell carcinoma diagnosed biopsy histopathology * the primary tumor is located in the middle of the esophagus and t1b-3n1-3m0 /m1 or t3n0m0 diagnosed by ct/mri/eus (ajcc 8th) * at least one measurable lesion * eastern cooperative oncology group (ecog) performance status of 0 to 1 * with adequate organs function exclusion criteria: * patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer * patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula * patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional chinese medicine therapy
domperidone expanded access treatment program

Conditions: Gastroparesis

Summary: to allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.

to provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (gi) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including qt prolongation, torsades de pointes, and death.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 12 and older 3. symptoms or manifestations secondary to gerd (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy. 4. patients must have a comprehensive evaluation to eliminate other causes of their symptoms. 5. patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events exclusion criteria: history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes. patients with minor forms of ectopy (pacs) are not necessarily excluded. 1. clinically significant bradycardia, sinus node dysfunction, or heart block. prolonged qtc (qtc \> 450 milliseconds for males, qtc\>470 milliseconds for females). 2. hepatic dysfunction 3. renal insufficiency 4. clinically significant electrolyte disorders. 5. gastrointestinal hemorrhage or obstruction 6. presence of a prolactinoma (prolactin-releasing pituitary tumor). 7. pregnant or breast feeding female 8. known allergy to domperidone