Kornimate/medical-research-clean huggingface dataset:
the psychological experience of pathological pregnancy. study of the case of premature rupture of membranes and evaluation of the impact of hypnosis support

Conditions: Preterm Premature Rupture of Membrane

Summary: this research investigates the impact of a hypnosis-based intervention in alleviating state anxiety in preterm premature rupture of membranes (pprom). our main hypothesis is that a two-session intervention can decrease anxiety for pregnant women with pprom compared to usual care. this research also studies the impact of the experience of a pprom during a pregnancy on several variables such as perinatal depression, pregnancy-related anxiety, bonding and childbirth experience, as well as control and pain perceived during chilbirth. our hypotheses are that the experience of pprom negatively influences these variables, and that this impact is alleviated by the hypnosis-based intervention for the experimental group.


Eligibility criteria:
inclusion criteria: * being an adult french-speaking woman, * primi or multipara, * less than 33 weeks and 6 days of amenorrhea * having being diagnosed with pprom exclusion criteria: * women cognitively impaired or with important hearing issues, * being placed under protective measures, * caring more than one fetus, * having a severe, preexisting or triggered during the pregnancy, * psychiatric pathology, * caring a fetus with an abnormality having required further medical investigations, or participating in another clinical trial comprising an intervention measuring psychological variables

Keywords: pprom hypnosis psychology anxiety complicated pregnancy
study to evaluate efficacy and safety of oral abexinostat in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl)

Conditions: Diffuse Large B-cell Lymphoma (DLBCL)

Summary: an open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of abexinostat, as monotherapy in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl)

an open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (hdac)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl)

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diffuse large b-cell lymphoma (dlbcl); 2. have received only two prior standard therapy lines for diffuse large b-cell lymphoma (dlbcl) including anti- cluster of differentiation antigen (anti-cd20) antibody and cytotoxic therapy; 3. confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy; 4. have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion; 5. eastern cooperative oncology group (ecog) performance status of 0 to 2; 6. meet various hematological, liver and renal function lab parameters. exclusion criteria: 1. have primary central nervous system (cns) lymphoma or secondary central nervous system (cns) infiltration, transformed lymphoma, unclassified b-cell lymphoma with features intermediate between dlbcl and classical hodgkin's lymphoma (hl), primary effusion lymphoma, plasma lymphoma; 2. toxicity not yet recovered from previous anti-tumor therapies; 3. uncontrolled systemic infections or infections requiring intravenous antibiotics; 4. have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol; 5. unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug; 6. have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol; 7. presence of active graft-versus-host reaction; 8. have undergone a major surgery within the last month; 9. evidence of possible human immunodeficiency virus (hiv) infection or hepatitis c virus (hcv) infection; 10. have any cardiac impairment as defined per protocol; 11. have prior history of malignancies other than diffuse large b-cell lymphoma (dlbcl).
a natural history study of participants with potassium sodium-activated channel subfamily t member 1 (kcnt1)-related epilepsy

Conditions: KCNT1-Related Epilepsy

Summary: the primary objective of the study is to characterize seizures in participants with kcnt1-related epilepsy. the secondary objectives are to characterize head growth, symptom severity, neurocognitive and social functions, adaptive behavior, sleep, quality of life, caregiver burden, and mood in participants with kcnt1-related epilepsy.


Eligibility criteria:
key inclusion criteria: * must have clinically and genetically confirmed diagnosis of kcnt1-related epilepsy provided by the investigator. for purposes of this study, mutations that are genetically confirmed to cause kcnt1-related epilepsy are defined to specifically exclude known benign variants (e.g., distal c terminus, splice site, etc.). * willingness of the participant and/or the participant's legally authorized representative (lar) to comply with scheduled visits and study procedures. key exclusion criteria: * any condition that may interfere with the assessment of kcnt1-related epilepsy and that is clearly not related to this disease (in the judgment of the investigator). * history of human immunodeficiency virus infection. * history of central nervous system (cns) tumors or malignancies, including cns metastatic disease. * current enrollment or past enrollment in an interventional clinical study in which an investigational gene therapy is/was administered. * enrollment in an interventional clinical study in which an investigational small molecule, antibody or antisense oligonucleotide (aso) treatment or approved small molecule, antibody or aso therapy for investigational use is administered within 1 month (or 5 half-lives of study agent, whichever is longer) prior to the screening visit. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: epilepsy of infancy with migrating focal seizures (eimfs) early-onset epileptic encephalopathy (eoee) sleep-related hypermotor epilepsy (she) autosomal dominant nocturnal frontal lobe epilepsy (adnfle)
effectiveness of valsartan/amlodipine (exforge®) and nifedipine treatment comparison in treating chinese hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study was to compare the efficacy and safety of valsartan/amlodipine (exforge®) with nifedipine, as well as vascular function index.


Eligibility criteria:
inclusion criteria: * male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of angiotensin receptor blockers (arb), angiotensin converting enzyme inhibitors (acei), calcium channel blockers (ccb), diuretics or β receptor blocker) exclusion criteria: * systolic bp (sbp) level ≥160 mm hg (≥160 mm hg in diabetics) or a diastolic bp (dbp) level ≥110 mm hg (≥100 mm hg in diabetics) at any time between screening and randomization. * patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin \>8.0%) * patients had evidence of hepatic disease or renal impairment * other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease. * women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception. other protocol-defined inclusion/exclusion criteria applied.

Keywords: hypertension valsartan amlodipine single pill combination bp control abpm hypertensive patients not adequately controlled by mono antihypertensive drugs
interest of combining speech therapy with a non-invasive brain stimulation (tdcs) for the aphasic patient

Conditions: Aphasia

Summary: aphasia is a frequent symptom after a left hemisphere stroke. it has serious impacts on social, family and professional lives. aphasic patients need to be rehabilitated. to date, no pharmacological treatment being available only speech and language therapy (slt) can improve patients, but its efficiency is moderate. several studies have investigated the link between the recovery of language and neural reorganization. tdcs, a noninvasive technology for modulating neural excitability, could potentiate the effects of the slt. about 25 studies in literature have described beneficial effects of tdcs coupled with slt on aphasic patients. however to the investigator knowledge the feasibility of tdcs and speech therapy in clinical pathways has never been investigated. that is why the investigator propose to study in real care conditions how slt proves more efficient on the recovery of language in a discursive assessment when coupled with active stimulation than with placebo stimulation.

this is a multicenter, cross-over, randomized, controlled and double blind study. 24 patients will be included between november 2015 and november 2017. during each session of speech and language treatment, aphasics will receive a weak 2 milli amperes (electric) current delivered by a tdcs device for 20 minutes. the stimulation will be either active or placebo. each stage of the cross over will last three weeks. patients will be administered the usual number of slt sessions, no particular therapy being imposed. to evaluate the long-time effects of the therapy, three follow-up measures will be proposed.

Eligibility criteria:
inclusion criteria: * patient more than 18 years * aphasic following a brain injury identified by mri. * present a aphasia severity score\> 1 on the boston diagnostic aphasia examination (bdae) severity scale. * no post stroke delay is retained but the patient should be stable from a medical point of view. * master of the french language in spoken and written * affiliated to a social security * patient who signed the informed consent exclusion criteria: * other previous neurological pathologies * epileptic crisis during the previous 2 months * patient denies * presence of a cranial flap * intracerebral metal hardware presence * patient under guardianship * patient unable to understand the study * patient subject to an exclusion period for another search.

Keywords: aphasia speaking therapy language therapy transcranial direct current stimulation
predictive urodynamic parameters for the treatment efficacy of onabotulinum a toxin in neurogenic lower urinary tract dysfunction

Conditions: Neurogenic Bladder Disorder

Summary: purpose: to evaluate urodynamic parameters predicting the treatment efficacy of onabotulinumtoxin a (onabont-a) in patients with neurogenic lower urinary tract dysfunction (nlutd). methods: patients with nlutd who received 200 iu onabont-a injections at gaziantep university, faculty of medicine, department of urology between september 2013 and september 2023 were included in the study. urodynamic parameters, including cystometric capacity, detrusor pressure (pdet), and compliance, detrusor leak point pressure (dlpp), phasic or terminal neurogenic overactivity were assessed. additionally, the correlations between these parameters and treatment outcomes were analyzed. changes in the number of pads used per day due to ui were assessed every 3 months during the postoperative period. the time lapsed to return to the pad usage levels before onabont-a injections was recorded as the duration of the benefit. preoperative urodynamic data of the patients were compared between groups. additionally, a subgroup analysis was conducted in patients who benefited from treatment to evaluate the correlation between treatment efficacy, duration of benefit from treatment, and urodynamic parameters.


Eligibility criteria:
inclusion criteria: * patients with neurogenic lower urinary tract disorder * aged \>18 years * patients who did not respond adequatel to antimuscarinics or could not tolerate their side effects * antimuscarinic treatment failure with at least two different antimuscarinic agents for a minimum of 3 months. exclusion criteria: * patients with lower urinary tract disorder due to functional or non-neurogenic etiologies * patients who received onabont-a doses either other than 200 iu or its multiple doses * in the 12-month period designated for patient follow-up, patients who did not attend their check-ups

Keywords: onabotulinumtoxin a; neurogenic lower urinary tract dysfunction; urodynamics
cohort of prosthetic joint infections

Conditions: Prosthetic Joint Infection

Summary: management of prosthetic joint infections (pji) is a challenging task. these infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing. treatment of pji combines surgery and prolonged antibiotic therapy. in some patients with a high operative risk prolonged suppressive antibiotic therapy can be used. lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to pji management procedures.

large prospective cohort study in a french referral center for bone and joint infections. population * all patients who consented to participate in the study with pji treated with: * debridement-synovectomy for acute infection * with one-stage, two-stage exchange arthroplasty for chronic infection * other procedures (complete removal of the prosthesis) and antibiotic therapy * patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy outcome: * follow-up at least 2 years * events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, pji related or non-related death study duration: 10 years. recruitment period: 4 years. maximal duration of data collection: 6 years. investigator center: monocenter study. mean patient inclusion per year: 100 patients per year.

Eligibility criteria:
inclusion criteria: * patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with: * according to musculoskeletal infection society definition: pji is present when one of the major criteria exists or four out of six minor criteria. major criteria: * two positive periprosthetic cultures with phenotypically identical organisms, or * a sinus tract communicating with the joint, or minor criteria: * elevated serum c-reactive protein (crp) and erythrocyte sedimentation rate (esr) * elevated synovial fluid white blood cell (wbc) * elevated synovial fluid polymorphonuclear neutrophil percentage (pmn%) * the presence of pus in the joint without known cause * positive histological analysis of periprosthetic tissue * a single positive culture or a pji which meets the following three criteria: * medical story suggesting prosthetic joint infection. * the presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause. * germ identification in a single sample of fluid aspiration or tissue culture. * or microbial growth in prosthesis sonication fluid culture greater than 50cfu/ml. exclusion criteria: * patient who does not meet eligibility criteria. * patient lawfully deprived of his liberty. * patient not insured under social security scheme.
focus on us: adapting the focus program for sexual and gender minority (sgm) cancer patients and caregivers

Conditions: Cancer Support; Oncology Patients; Caregivers

Summary: our aim for this study is to assess the feasibility and acceptability and explore potential outcomes of the adapted focus on us intervention in a two-arm pilot trial. the investigators will randomize 80 sexual and/or gender minority (sgm; e.g., lesbian, gay, bisexual, transgender, queer, etc.) cancer patients and their ≥80 informal caregivers (total n≥160) to either focus on us (adapted from the evidence-based focus program) or a waitlist control.


Eligibility criteria:
inclusion criteria: patients must: 1. have been diagnosed or had a biochemical recurrence or progression of any invasive (e.g., stage ≥1) cancer within the past 24 months; 2. have at least one informal (unpaid) caregiver willing to participate in the program; 3. identify as a sexual and/or gender minority (sgm) or have a caregiver who identifies as sgm (e.g., either the patient or caregiver(s) must be sgm); 4. be age 18 or older; 5. be able to complete all written and oral components of the study in english; 6. provide informed consent; 7. live in the united states. caregivers must: 1. self-report having provided support for a cancer patient as an informal (unpaid) caregiver; 2. have a cancer patient for whom they provided support willing to participate in the program; 3. identify as a sexual and/or gender minority (sgm) or have provided support to a patient who identifies as sgm (e.g., either the patient or caregiver(s) must be sgm); 4. be age 18 or older; 5. be able to complete all written and oral components of the study in english; 6. provide informed consent; 7. live in the united states

Keywords: cancer patients and caregivers lgbtq+
early versus expectant treatment of ureaplasma infection in very low birth weight neonates

Conditions: Bacteria Infection; Respiratory Tract Infections

Summary: our hypothesis is that treatment of known ureaplasma spp. infection of the airways in very low birth weight (vlbw) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for bronchopulmonary dysplasia (bpd). we propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for vlbw infants with ureaplasma spp. respiratory tract infection with the following specific aims: (1) determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of ureaplasma spp. in preterm infants, (2) determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract ureaplasma spp. infection


Eligibility criteria:
inclusion criteria: * infants weighing \<1250 grams at birth with respiratory distress syndrome who have respiratory infection with ureaplasma sp organisms. exclusion criteria: * severe respiratory distress syndrome with survival unlikely \>7 days, congenital malformations

Keywords: ureaplasma bronchopulmonary dysplasia very low birthweight
can myotonometry quantify dry needling effectiveness on myofascial trigger points?

Conditions: Muscle Tone Abnormalities

Summary: the main objective of this study is to assess effects of dry needling into myofascial trigger point compared dry needling into taut band point based on the outcomes of myotnometric measurement in healthy subjects. hypothesis: deep dry needling of the latent medial myofascial trigger point (mtrp) of the soleus muscle will achieve changes in myotonometric measures compared to deep dry needling of the taut band of the soleus muscle.

methods: it is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of toledo older than 18 years. there will be a mtrp group (dry needling into the medial mtrp of soleus muscle) and a tb group (dry needling distal to the mtrp but into the taut muscle band of soleus muscle). the intervention will be a unique session. intervention: dry needling technique will be performed by locating the taut band and the myofascial trigger point. depending on the group, a thin needle (0,32x40mm) is introduced 10 times (fast in and fast out) directly within the myofascial trigger point or within the taut band. assessment: myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone. myoton has been adopted to characterize the viscoelastic properties of skeletal muscle as tissue displacement when a mechanical perturbation is applied to the muscle. the device incorporates a probe and an acceleration sensor. the probe was kept perpendicular with its end touching the muscle belly. 10 mechanical impacts (with a duration of 15 ms, a force of 0.4 n and a local deformation in the order of a few millimetres) are delivered to mtrp and tb points. outcome measures: outcome measures will include myotonometric measurements (frecuency, stiffness and decrement) and they will be evaluated before, at 10 min and 1 week after the intervention.

Eligibility criteria:
inclusion criteria: * age range 18-40 years. * healthy volunteers. * presence of a latent medial mtrp of the soleus muscle. * being able to provide written informed consent. * being able to follow instructions and realize clinical tests. exclusion criteria: * any history of ipsilateral lower limb severe injury or intervention (e.g. fracture, surgical intervention). * pain or musculoskeletal injury, ligament injury, tendonitis or plantar fasciitis in the ipsilateral leg for six months previous to the intervention. * peripheral or central nervous system neurological disease. * altered sensitivity in the treatment area. * treatment of a myofascial trigger point in the sural triceps in the six months previous to the intervention. * changes in physical activity which would have affected muscle tone during the study. * fear of needles. * no tolerance to pain caused by dry needling. * no continuance commitment.

Keywords: myofascial trigger points dry needling myotonometry
eye drop dispensers: safety, efficacy and comfort.

Conditions: Glaucoma; Cataract; Healthy Subjects

Summary: one aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel a drop from the bottle. instillation aids are devices that aim to ameliorate one or more of these barriers. several eye drop dispensers had been developed in order to improved outcomes of eye drop instillation, including improved rates of successful administration and increased patient satisfaction compared to standard eye drop bottles. in this study we aim to compare the eye drops various installation aids

subject will evaluate 2 dispensers by questioners. efficacy and safety of each one will be evaluated.

Eligibility criteria:
inclusion criteria: * glaucoma patients exclusion criteria: * none

Keywords: normal patients eye drops dispensers aids glacuoma cataract