Kornimate/medical-research-clean huggingface dataset:
rechallenge of braf +/- mek inhibitors following an adverse event in patients with cancer

Conditions: Cancer

Summary: very little data are published on the safety of a rechallenge with a braf inhibitor or combination of braf and mek inhibitor (brafi and meki) after an adverse event (ae). this study aimed at identifying the recurrence rate of the same ae after a brafi +/- meki rechallenge in patients with cancer and the factors associated to the recurrence.

this is an observational, cross-sectional, pharmacovigilance cohort study. aes were extracted from safety reports from the world health organization database vigibase®, to evaluate the safety of a rechallenge with a braf inhibitor or combination of braf and mek inhibitor (brafi and meki) after an adverse event (ae) in patients with cancer.

Eligibility criteria:
inclusion criteria: * all consecutive ae cases associated with brafi and meki therapy. combination therapy cases, where brafi were concurrently reported with meki will be identified, as well as the combination therapy regimen (v+c, d+t, e+b). we will not study meki monotherapy cases exclusion criteria: * meki monotherapy cases * cases concurrently reporting on immune checkpoint inhibitor therapies
sheathotomy vs. intravitreal triamcinolone for branch retinal vein occlusion

Conditions: Macular Edema; Branch Retinal Vein Occlusion

Summary: branch retinal vein occlusion (brvo) is a common retinal vascular disease occurring in a significant number of individuals older than 50 years.the most common cause of visual disturbance in brvo patients is macular edema, which has been reported in 60% of patients. macular grid laser photocoagulation has been shown to be effective in the treatment of macular edema arising from brvo. some eyes are resistant to conventional grid laser treatment, and the conventional treatment is not useful in patients with intraretinal hemorrhages that may interfere with laser photocoagulation. moreover, several studies have shown that conventional grid laser treatment for macular edema may be associated with complications. intravitreal triamcinolone acetonide (ivta) injection has recently been reported to be effective in the treatment of macular edema of various etiologies.on the other hand, arteriovenous sheathotomy is a surgical method suggested for treatment of macular edema in brvo patients, and has been reported to be efficacious in patients refractory to conventional focal or grid laser macular photocoagulation.both treatment modalities have been reported to be associated with reductions in central macular thicknesses and improved visual acuities. the purpose of the study is to compare the efficacies of arteriovenous (av) sheathotomy and intravitreal triamcinolone (ivta) injection in the treatment of macular edema associated with branch retinal vein occlusion (brvo).


Eligibility criteria:
inclusion criteria: * recent onset (within the 6 months prior to enrollment) of macular edema resulting from brvo * best corrected early treatment diabetic retinopathy study (etdrs) scores ≤ 40 letters (snellen equivalent ≤ 20/40 * intraretinal hemorrhages involving the foveal centers * generalized breakdown of the inner blood-retina barrier, as documented by diffuse fluorescein leakage on angiography, or diffuse thickening of the retina on optical coherence tomography (oct), with involvement of the foveal center and most of the macular area, and with foveal thicknesses ≥ 250 micrometer exclusion criteria: * prior history of intraocular surgery including cataract extraction * prior history of laser treatments including panretinal photocoagulation and focal/grid macular photocoagulation * prior history of elevated intraocular pressure secondary to steroid treatment * prior history of glaucoma or ocular hypertension * presence of comorbid ocular conditions that might affect visual acuity (va).

Keywords: branch retinal vein occlusion; treatment
efficacy study of ultrasound-assisted debridement to influence wound healing

Conditions: WOUNDS

Summary: the ultraheal study is a randomized controlled trial to compare healing response of low frequency contact ultrasonic-assisted debridement in addition to best practice wound care to best practice wound care alone in a vascular surgery clinic patient population with wounds of the lower extremity.

the study will also investigate the bacterial tissue burden and protease activity to provide further insight into the infection and inflammation aspects of healing barriers in a challenging population.

Eligibility criteria:
inclusion criteria: * persons with lower extremity wound referred to vascular surgery service. * full thickness wound below the knee with surface area of at least 1cm2. * age \>18 years * english speaking * ulcer of known etiology including diabetic foot wounds, and arterial or venous leg ulcers * willing and able to adhere to 12 week study protocol that includes attending weekly clinic appointments, and wearing prescribed footwear or compression therapy exclusion criteria: * leg wounds due to inflammatory conditions (e.g. pyoderma gangrenosum, vasculitis), malignancy, or other unknown etiologies. * severe arterial insufficiency: absence of pedal pulses combined with ankle brachial index ≤ 0.3, toe pressure ≤20, or trans cutaneous oxygen measure ≤20 * presence of acute limb threatening infection * vascular surgery planned within next 3 months * exposed vascular graft or blood vessel, bone or tendon in the base of the wound. * currently receiving advanced wound therapy treatments: hyperbaric therapy, biological dressings \[collagen or extracellular matrix dressings\]. * increased likelihood of an adverse reaction to ultrasonic debridement due to: * excessive wound pain (\>5 vas scale) or patient described intolerable * allergy to topical anesthetic (lidocaine) * individuals who have factors/circumstances that are known to limit their ability to demonstrate healing in 4 weeks. for example: * medically unstable or palliative medical status * poor nutritional status (low serum albumin \< 15), * anemia (hb \< 75 mg/dl), * taking immunosuppressant medication (prednisone, chemotherapy; transplant anti-rejection medication), * individuals with medical conditions that contraindicate the use of ultrasound energy * cardiac pacemaker or defibrillator * excessive bleeding tendency (\> 5 mins post debridement) or identified coagulopathic disorders * exposed bone in the wound base * untreated osteomyelitis

Keywords: wounds lower extremity diabetes arterial insufficiency debridement low frequency ultrasound contact ultrasound wound clinic wound bed preparation wound infection chronic wound inflammation
multicenter retrospective study on streptobacillus moniliformis infections in france

Conditions: Streptobacillus Moniliformis Infections

Summary: french data on streptobacillus moniliformis infections (zoonosis transmitted by rat bites) are rare and there are no case series in the literature to date. this is a pathology presenting atypical clinical manifestations for a bacterial infection and which therefore remains underdiagnosed. streptobacillus moniliformis infections can be fatal without appropriate antibiotic treatment. this study could improve diagnosis, develop early treatment strategies and contribute to the overall understanding of zoonotic diseases


Eligibility criteria:
inclusion criteria: * minor patient aged 1 to 17 years * adult patient ≥18 years * proven streptobacillus moniliformis infection between 01/01/2007 and 31/12/2023 * subject not objecting, after being informed, to the reuse of their data for the purposes of this research * holders of parental authority not objecting, after being informed, to the reuse of their data for the purposes of this research their child for the purposes of this research exclusion criteria: * subject and/or holder of parental authority having expressed opposition to participating in the study

Keywords: streptobacillus moniliformis zoonosis rat bites zoonotic diseases
happy mother - healthy baby: supplement study on biological processes underlying anxiety during pregnancy

Conditions: Anxiety

Summary: as a supplement to the ongoing randomized evaluation of the cognitive behavioral therapy (cbt) anxiety prevention intervention in pakistan (r01-mh111859), the investigators propose to explore potential biological mechanisms (related to inflammation and endocrine functioning) of antenatal anxiety through additional data collection with 300 pregnant women.

this study will leverage the ongoing randomized evaluation of the cbt anxiety prevention intervention in pakistan (r01-mh111859) to explore potential biological mechanisms. this cbt intervention targets both sub-threshold anxiety symptoms and generalized anxiety disorder (gad) in early- to mid- pregnancy, aiming to both prevent and treat common mental disorders (cmds) (gad and major depressive episodes (mde)) as well as improve birth outcomes. the study team proposes to additionally study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), the study will also include 100 healthy women without anxiety or depression. the aims are to 1) characterize the "immune phenotype" of anxious women across the peripartum, specifically by measuring the relation among anxiety symptoms and peripheral markers of inflammation within and across women (both anxious and healthy) and between those receiving the intervention and control; 2) determine the relation between levels of allopregnanolone (allo) in pregnancy and concurrent anxiety symptoms and future symptoms of postpartum depression (ppd), 3) examine the relation between changes in immune functioning and allo levels in anxious pregnancy across time, 4) examine whether immune function and/or allo are mediators or moderators of the association between antenatal anxiety and preterm birth and/or small-for-gestational age, and 5) examine the effects of both anxiety and the intervention (including biomarkers) on infant development at six weeks postpartum.

Eligibility criteria:
inclusion criteria: * ability to understand spoken urdu * pregnant, ≤22 weeks' gestation * age ≥18 years * residence ≤20 km of holy family hospital * intent to reside in the study areas until the completion of the study exclusion criteria: * current anemia * current major depressive episode (mde on scid) or life-threatening health conditions including e.g. active severe depression or suicidal ideation * self-report of past or current significant learning disability * self-report of past or current psychiatric disorder (e.g. bipolar disorder or schizophrenia) or psychiatric care (e.g. current use of anxiolytic drug and/or other psychotropic drug) * medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101) * icu admission indicated by diagnosis (not only for assessment)

Keywords: randomized controlled trial inflammation hormones
acute effects of an herbal tea on immune surveillance and activation.

Conditions: Active Immune Response

Summary: a small cross-over trial on 24 people involving an herbal tea blend to test whether consuming 1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation as evidence of immune cell trafficking within 2 hours.

a randomized, cross-over, controlled study design will be used to evaluate the effects of consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water. the study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water at week 1 and week 2 with a one week washout between visits. on each visit, a baseline blood draw is performed, followed by consuming of the herbal tea blend or warm water. blood draws are performed at 1 and 2 hours after consumption.

Eligibility criteria:
inclusion criteria: * healthy adults; * age 18-75 years (inclusive); * veins easy to see in both arms (to allow for the multiple blood draws); * willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements; exclusion criteria: * previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder); * taking anti-inflammatory medications on a daily basis; * currently experiencing intense stressful events/ life changes; * currently in intensive athletic training (such as marathon runners); * currently taking antipsychotic medications such as clozapine, risperdal, abilify, zyprexa or seroquel; * actively depressed; * an unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying); * unwilling to maintain a constant intake of supplements over the duration of the study; * anxiety about having blood drawn; * women of childbearing potential: pregnant, nursing, or trying to become pregnant; * known food allergies related to ingredients in active test product.
once-daily therapy for streptococcal pharyngitis

Conditions: Streptococcal Sore Throat

Summary: in some studies once daily amoxicillin therapy might be treatment of choice for group a β-hemolytic streptococcus pharyngitis in comparison with three to four times daily treatment with oral penicillin v.


Eligibility criteria:
inclusion criteria: inclusion criteria: 1. age of 6 to 15 years old. 2. the criteria in clinical examination including objective signs (fever, erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). neck tenderness, abdominal pain and pharynx petechia were also considered. 3. no antibiotic was used during the week before. 4. -performing throat culture before the initiation of drug administration 5. positive throat culture indication gabhs 6. no previous history of allergy to penicillin . exclusion criteria: 1. age of below 6 years old or above 15 years old. 2. no signs of pharyngitis in the clinical examination 3. antibiotic use during the week before. 4. throat culture was not performed before the initiation of drug administration. 5. negative throat culture or the culture indicates a microorganism other than gabhs. 6. history of allergy to penicillin 7. not using drugs or not following the treatment in the field of having the second culture performed.

Keywords: pharyngitis group a β-hemolytic streptococci exudate erythema penicillin amoxicillin
treatment of hypertension with two exercise intensities

Conditions: Hypertension

Summary: to determine whether exercise training could significantly replace medication as a treatment for mild essential hypertension.

background: arterial hypertension affects over 50 million americans. while drug treatment is effective, exercise would be safer, might be cheaper, and would bring added health benefits if it could replace drugs in controlling hypertension. design narrative: randomized, controlled trial. known hypertensives (n=162) whose diastolic blood pressures rose to between 90 and 104 within four months of discontinuing medication under careful observation had their pressures controlled with enalapril. oxygen consumption (v02) peak was measured during cycle ergometry. eligible subjects were randomly assigned to 18 months participation in one of three groups: 1) high intensity endurance training (35 minutes three times/week at heart rate at 70-85 percent of v02 peak), 2) moderate intensity endurance training (35 minutes three times/week at heart rate of 50-70 of v02 peak), and 3) contact control. enalapril was forward or back titrated or discontinued to maintain a normal blood pressure. after 12 months participation, medication was withdrawn under careful supervision from all subjects still taking it. the trial tested the hypotheses that: 1) a greater number of subjects undergoing either or both of the two 18 month exercise training programs would be able to stop anti-hypertensive medication than non-exercising controls, 2) moderate and high intensity endurance training were equally effective in replacing drugs in the treatment of mild essential hypertension, and 3) subjects that were successful at withdrawing anti-hypertensive medication would have: greater improvements in v02 peak, better initial psychological status or greater improvements in psychological status, and greater compliance with the exercise training program. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
gene editing as a therapeutic approach for rett syndrome

Conditions: Rett Syndrome

Summary: we designed the project to validate crispr/cas9-based gene editing combined with aav-based delivery for correction of the most common mecp2 mutations both in vitro and in vivo.

the project aims to validate crispr/cas9-based gene editing combined with aav-based delivery for correction of the most common mecp2 mutations both in vitro and in vivo. the laboratory of the principal investigator is an active member of the european reference network for rare malformation syndromes and rare intellectual and neurodevelopmental disorders (ern-ithaca).

Eligibility criteria:
inclusion criteria: * patients -exclusively female- since the pathology is linked to the x chromosome, with a clinical diagnosis of rett syndrome confirmed at the genetic level by the identification, through ngs analysis, for one of the recurrent mutations (mutational hotspots) in the mecp2 gene object of the study: c. 473c\>t - (p.(t158m)), c.502c\>t (p(r168x)), c.763c\>t (p.(r255x)), c.916c\>t (p.(r306c)); * age above 6 months; * availability of parents or legal guardians to provide free and informed consent to participate in the study exclusion criteria: * ngs diagnosis with the normal outcome; * positive ngs diagnosis for mutation in mecp2 but with the presence of a mutation different from those under study. * unwillingness of parents or legal guardians to provide free and informed consent to participate in the study;
low-dose cortisol in chronic posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder

Summary: the aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.


Eligibility criteria:
inclusion criteria: * female and male patients with chronic ptsd due to adult trauma; ptsd is diagnosed according to the dsm-iv, as measured with the caps * age between 18 and 60 exclusion criteria: * history of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis) * severe or chronic somatic diseases * topic glucocorticoid therapy (for large skin parts) * inhaled glucocorticoids * current psychotic, bipolar, substance-related, or severe personality disorder * current severe depressive disorder * severe cognitive impairment or a history of organic mental disorder * evidence of ptsd or depression immediately prior to the index trauma * prominent current suicidal or homicidal ideation * asylum seeking status * body weight \>20% above or below normal range * changes in psychopharmacologic or psychotherapeutic management less than 8 weeks before start of the study

Keywords: ptsd cortisol memory treatment
comparison of asct and conventional chemotherapy in high risk waldenström macroglobulinemia

Conditions: Waldenström Macroglobulinemia

Summary: the purpose of this study is to evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk waldenström macroglobulinemia, compared with conventional chemotherapy.

wm patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). after transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Eligibility criteria:
inclusion criteria: 1. 70 years\>=aged \>=18 years 2. diagnosed with high-risk lpl/wm according to the isswm criteria 3. untreated or mild treated without standard regimens 4. suitable for asct 5. with life-expectancy more than 3 months. exclusion criteria: 1. diagnosed with other malignancies outside b-nhl within one year(including active center neural system lymphoma) 2. transformed lymphoma 3. liver or renal function lesion unrelated to lymphoma 4. serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician 5. hiv positive or active hbv infection or other uncontrolled systematic infection 6. clinical central nervous dysfunction 7. serious surgery within 30 days 8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.

Keywords: high-risk asct
hypoactive sexual desire disorder in males

Conditions: Low Libido

Summary: the purpose of this study is to determine if the study drug will increase sexual desire in men with hsdd. half of the participants will take addyi while the other half will receive a placebo (a look-alike pill with no medicine).

this pilot randomized placebo controlled study will include 60 men (30 treatment and 30 placebo). arm 1 will take flibanserin 100mg orally every night and arm 2 will take a placebo orally every night. there will be four study visits and the study duration is approximately 4 months. participants will have physicals at each visit. blood draws for tests will be done at 3 visits and up to 4 questionnaires will completed at each visit. study drug will randomized.

Eligibility criteria:
inclusion criteria: * men age 18 through 69 years old * men who are distressed by their low libido as defined by sdi-2, and sci-m questionnaires. (appendices a,c) * men who are not depressed as defined by phq-9 (patient health questionnaire) score of 9 or less. (appendix d) * men with good erectile function as defined by iief greater than 22 * men with normal testosterone and liver function values (may be on testosterone therapy) * men who are satisfied in their relationship or with their partners * men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit. * willing to give informed consent exclusion criteria: * hypogonadal patients (less than 350 ng/dl) * iief-ef less than 22 * cyp3a4 and cyp2c19 inhibitors use of moderate or strong cyp3a4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the cyp3a4 inhibitor * hepatic impairment not greater than 1.5 upper limit of normal of ast/alt * men with normal to high libido * depressed patients as assessed by the phq-9 questionnaire as defined as 10 or greater. * men who are stressed or fatigued as determined by the pi * men with partners who have low libido as determined by the pi * men with pre-existing conditions that might predispose to hypertension * men who are not willing to meet the requirements for drinking alcohol during their participation in the study * men who are taking digoxin

Keywords: low libido erectile dysfunction sexual desire