Kornimate/medical-research-clean huggingface dataset:
personalized spacing of eculizumab infusions based on therapeutic pharmacological monitoring (espacecu)

Conditions: Hemolytic-Uremic Syndrome, Atypical

Summary: eculizumab is an anti-c5 monoclonal antibody approved for rare diseases including atypical haemolytic-uraemic syndrome. the maintenance phase dosing regimen is identical for all adult patients but several studies have shown a high interindividual kinetics variability. a tailored administration of eculizumab based on therapeutic drug monitoring will be compared with real-life administration in adults suffering from an atypical haemolytic uraemic syndrome. the objective is to improve efficiency of eculizumab administration.

eculizumab is a very expensive drug (450 000 euros per year per patient). according to the usual administration scheme, the eculizumab is administrated by intravenous infusion, every 14 or 21 days in hospital. studies have shown the possibility of extending the administration intervals in patients with a high concentration of eculizumab. a personalized spacing of eculizumab infusions, based on a therapeutic drug monitoring, is expected to improve the patient's quality of life and lead to substantial savings. for these reasons, the objective of this study is to explore the efficiency of a personalized spacing of eculizumab infusions compared to the usual administration scheme (without personalization) from the french health insurance perspective. the efficiency will be assessed by estimating the incremental cost per qaly (quality-adjusted life year) gained at 18 months (duration of follow-up in the clinical trial) and at 5 years thanks to a markov model. the total duration of the study is 24 months (6 months of enrolment and 18 months of follow-up).

Eligibility criteria:
inclusion criteria: 1. adults with an atypical hemolytic and uremic syndrome defined by at least 2 of the following parameters: * thrombopenia (platelet count \< 150 g/l) * mechanical lytic anemia (hb \ upper limit of normal, undetectable haptoglobin, presence of schistocytes on blood smear) * acute renal failure 2. eculizumab treatment * without project of withdrawal in the next 18 months * started since at least 6 months * administrated with an unchanged administration schedule since at least 3 months (initial episode or relapse) 3. atypical hemolytic and uremic syndrome in remission 4. patients who give informed consent. exclusion criteria: 1. patients on dialysis. 2. women treated starting or planning a pregnancy. 3. patients suffering from a typical or secondary microangiopathic hemolytic anemia (drugs, malignancies, autoimmune disease...) 4. patients under protection of a judicial authority

Keywords: hemolytic-uremic syndrome kidney diseases thrombotic microangiopathies therapeutic drug monitoring eculizumab tailoring cost-utility analysis markov model
prevention with the health and lifestyle tool

Conditions: Type2 Diabetes

Summary: in this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. the investigators will prospectively via clinical registries follow the incidence and development of type 2 diabetes over three years in those using the tool regularly and those in the control group.

considerable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes, and self-care behaviors largely determine hba1c. modifiable lifestyle factors have been established as key drivers of disease onset, progression, and prognosis, motivating the use of "lifestyle as medicine". digital health tools are increasingly incorporated into diabetes care, and have the potential to improve both behavioral and clinical outcomes on a broad basis. however, low levels of uptake, reduced user engagement over time, and low acceptance among patients, raise concerns about their effectiveness. the objective or this study is to evaluate a new web-based tool, developed at the university gothenburg, sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes. the investigators will test the hypothesis that individuals who have access to the tool get lower incidence of type 2 diabetes or in case they already have diabetes develop improved glucose control compared with control individuals. the participants will complete the findrisc questionnaire to assess the risk for type 2 diabetes to enable analysis of high-risk individuals. the study is an investigator-initiated single-center study conducted over three years. the tool is web-based and used via a computer or mobile phone. it is used at each individual's preferred pace but participants are recommended to login at least every other week. every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. participants then reflect on the content and how it could be implemented in daily life. when returning for next round participants are asked to reflect on any changes done since last time. there is no interaction between individual participants. there will be two primary endpoints: 1. incidence of type 2 diabetes as measured in non-diabetic participants with increased risk for type 2 diabetes (controls vs. those using the tool regularly) 2. change of hba1c, reflecting long-term blood glucose control, from baseline to end of follow-up in participants who have type 2 diabetes (controls vs. those using the tool regularly).

Eligibility criteria:
inclusion criteria: * informed consent * age above 35 years exclusion criteria: * type 1 diabetes, mody or secondary diabetes * conditions or treatments that in the judgement of the investigator could affect the study evaluation * connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
adding motion to contact: a new model for low-cost family centered very-early onset intervention in very preterm-born infants

Conditions: Premature Birth; Brain Injuries

Summary: this project is a randomised clinical trial that includes a tactile-kinesthetic somatosensory stimulation or family centred education intervention with families of preterm infants at risk for sensori-motor disorders. this is a study will be based on the adaptation of the intervention previously described and published by guzzetta and colleagues (2009), and will include an improved and increased kinesthetic component, to be performed in infants born very prematurely and preterm infants with a documented brain injury. the intervention will start in neonatology during the infant hospitalization and continue at the child's home until two months of correct age.

preterm babies, specifically with gestational age \< 33+6 weeks, will be recruited and assigned (randomized) into an a multisensory stimulation + family education group (msg) or a family education only group (feg). when the clinical condition of the child is stable and after a short training, parents of the msg will be asked to carry out up to two treatment sessions per day with their child, until they reach the 8th post-term week. sessions will initially be carried out together with a therapist who will have the task of transmitting the necessary skills to parents/caregivers. the therapist will assist parents through practical demonstrations, theoretical explanations and by answering the parents' questions. the treatment will consist of sessions of approximately 25-30 minutes. the main purposes of the intervention will be clearly explained to the parents, and in particular the goal of maintaining a calm and natural interaction during the session. in addition, all families will receive the evidence-based program of family education which is based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. it takes its conceptual basis from the mother infant transaction program (mitp). it is a specific and re-adapted version for the preterm infant hospitalized in nicu the family education group sessions involve about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalization in the nic directly at the child's bed between the operator and one or both parents. each meeting involves the discussion of one of the following topics.

Eligibility criteria:
inclusion criteria: * premature infants born \<29 weeks of gestation age or premature infants (born \< 33+6 weeks gestation age) with a documented brain injury . exclusion criteria: * clinical instability, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation) * genetic-malformative conditions

Keywords: early intervention family-centered care neonatology high-risk infant sensory motor stimulation maternal voice tactile stimulation kinesthetic stimulation
letrozole combined with gonadotropins (gn) for ovarian stimulation undergoing in vitro fertilization/intracytoplasmic sperm injection (ivf/icsi) in patients with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovarian Syndrome

Summary: the purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for ivf/icsi in patients with pcos.

polycystic ovarian syndrome (pcos) occurs in 4% to 7% of all women of reproductive age and 20% of women presenting with anovulatory infertility. a significant proportion of these women will ultimately need assisted reproductive techniques. various protocols of ovarian stimulation such as step up protocol, coasting, gnrh antagonists et al have been proposed for optimizing ivf results in patients with pcos. the results of these studies have shown it not to be satisfied. the preliminary studies have proven that letrozole, a potent and highly specific nonsteroidal aromatase inhibitor, could successfully induce ovulation in women with polycystic ovary syndrome. in spite of only a little study research of letrozole in ivf/icsi cycle, for poor ovarian responders, addition of letrozole improved ovarian response to fsh and reduced gonadotrophin dose required for coh without having a negative impact on pregnancy rates. these reports prompted us to hypothesize that adjunctive use of letrozole in coh protocol for patients with pcos would minimize the gonadotrophin dose, and consequently the cost, and lower the risk of ohss in a ivf/icsi treatment cycle.

Eligibility criteria:
inclusion criteria: * patients with pcos

Keywords: letrozole ovarian stimulation pcos ivf-et
tricaprilin phase 3 alter-ad (alternative-alzheimer disease) study

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, activities of daily living, resource utilisation, safety and tolerability, in subjects with mild to moderately severe probable ad. this is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.


Eligibility criteria:
key inclusion criteria: * mini mental state exam (mmse) score between 14 to 24 * meets diagnostic clinical criteria of probable alzheimer's dementia according to the nia-aa criteria * magnetic resonance imaging (mri) compatible with a diagnosis of probable ad according to central mri reader. * participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and/or memantine key exclusion criteria: * current use or use within 3 months of visit 3 (baseline), of medium chain triglyceride -containing products. * completed less than 6 years of formal education. * has any medical or neurological condition, other than ad, that could explain the subject's dementia (e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, parkinson's disease, alcohol-related dementia) * has a modified hachinski ischaemia score \> 4
mechanical insufflation-exsufflation (cough assist) in critically ill adults

Conditions: Critically Ill

Summary: the goal of this randomized feasibility trial is to evaluate the feasibility of mechanical insufflation-exsufflation (mi-e) in invasively ventilated critically ill patients. the main question\[s\] it aims to answer are: * is mi-e feasible? * is mi-e safe? participants in the intervention group will receive: * mi-e * airway secretions will be removed by endotracheal suctioning, as part of routine airway care. * manual hyperinflation will only be used when necessary in an emergency situation. patients in the control group will receive endotracheal suctioning and manual hyperinflation when clinically indicated. the primary outcome is the proportion of delivered mi-e sessions (2 times per calendar day a mi-e session of 3 x 3 cycles of an in- and exsufflation) per patient according to study protocol (feasibility). secondary outcomes are the total number of serious adverse events in relation to mi-e (safety) and preliminary exploratory data on the need for airway care interventions and clinical outcomes including duration of invasive ventilation, length of stay in icu and mortality (efficacy).

bedside nurses, trained in using the mi-e device, will apply mi-e sessions at two moments per calendar day (morning and afternoon) for a maximum of 7 days while a patient is invasively ventilated. mi-e settings are a 2-second insufflation and an immediate 2-second exsufflation. the cycles of the mi-e session will be performed with a positive and negative pressure of 40 cmh2o. the program is set up with the possibility of auto-triggering by the patient.

Eligibility criteria:
inclusion criteria: * admission to one of the participating icus; * receiving invasive mechanical ventilation via an endotracheal tube; and * expected to need invasive ventilation for more than 48 hours from consideration for inclusion. exclusion criteria: * use of mi-e before hospital admission, i.e., at home; * known presence of bullous emphysema; * known bronchopleural fistula; * known pneumothorax or pneumomediastinum; * known rib fractures; * known barotrauma; * known unstable spinal fractures; * unsecured subarachnoidal haemorrhage; * uncontrollable intracranial pressures; and * any infection, or colonization with pathogens that requires strict aerogenic isolation. with an exception for patients in cohort isolation due to covid-19.

Keywords: mechanical insufflation-exsufflation cough assist
efficacy of continuous fascia iliaca block in hip surgery in elderly

Conditions: Hip Fractures

Summary: the goal of this clinical trial is to investigate the analgesic effect of ultrasound-guided continuous fascia iliaca block in very elderly patients with hip fracture after hip surgery compared to systemic analgesia . the main question\[s\] it aims to answer are: * does continuous fascia iliaca block provide adequate post operative analgesia after hip surgery ? * does it lower the incidence of post operative complications in old age ? participants will receive continuous fascia iliaca block through ultrasound , introducing epidural catheter 18 g , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours. researchers will compare the study group receiving continuous fascia iliaca block to the control group receiving traditional systemic analgesia in the post operative period . to see if the analgesic effect is more effective

patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. all patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, all patients of both groups ,once arrived to the or, monitor will be attached, baseline sbp, dbp,map,spo2,pulse will be recorded, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of l3-l4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle. at the end of surgery, goup 1 will receive continuous fascia iliaca block through ultrasound patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. an ultrasound apparatus (sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head.once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 g , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours the control group will receive traditional analgesia including 50 mg pethidine with a maximum 6 hour interval and 1gm paracetamol as per need .

Eligibility criteria:
inclusion criteria: * age \> 65 years * american society of anesthesiologists (asa) physical status classification class ii,iii exclusion criteria: * age \< 65 years * asa iiii * refusal of peripheral nerve block * infection at the site of injection * coagulopathy inr \> 1.8 * platelets count \< 50,000 * known allergy to used medications.
randomized directly observed therapy study to interpret clinical trials of doxy-pep

Conditions: Sexually Transmitted Diseases, Bacterial

Summary: rates of bacterial sexually transmitted infections (stis) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent stis. the united states doxycycline post-exposure prophylaxis (doxypep) study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (pep) among men who have sex with men and transgender women; but puzzlingly, doxycycline pep was found ineffective in cisgender women in the kenyan doxycycline post-exposure prophylaxis (dpep) study, with preliminary data suggesting the low medication adherence may explain the null result. by study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the kenyan dpep study, and to examine the relative performance of these methods within the united states doxypep trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis


Eligibility criteria:
inclusion criteria: * not currently at risk of a sexually transmitted infection and willing to use other methods, such as condoms, for sti prevention; * if diagnosed with an sti in the past two years and/or a partner was diagnosed with an sti in the past year, is willing to use condoms for sti prevention; * willing to provide hair, blood, and urine samples; * not currently enrolled in other sti prevention studies; * able to speak english * transgender women participants should be currently using estrogen gender affirming hormone therapy with blood estrogen levels demonstrating consistent use * transgender men participants should be currently using testosterone gender affirming hormone therapy with blood testosterone levels demonstrating consistent use * able to provide a hair sample of \~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length * willing to not shave hair or have a very short haircut or apply bleach for the duration of the study * has suitable venous access for consecutive blood draws exclusion criteria: * any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions; * pregnancy or plans to become pregnant; * liver cirrhosis or fulminant liver disease; * known hypersensitivity reaction to doxycycline. * detectable doxycycline in hair at enrollment. * unable to provide a hair sample of \~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length * does not have suitable venous access for consecutive blood draws
a study of albuferon and ribavirin in interferon naive subjects with chronic hepatitis c genotype 1

Conditions: Hepatitis C, Chronic

Summary: the purpose of the study is to evaluate the efficacy and safety of albuferon in combination with ribavirin in interferon (ifn) alfa treatment-naïve subjects with chronic hepatitis c genotype 1. the study will randomize subjects to 1 of 4 treatment groups including 3 different albuferon groups or to the active control group, peginterferon alfa-2a (pegasys, peg-ifnalfa-2a). all subjects will also receive oral daily ribavirin.


Eligibility criteria:
key inclusion criteria: * interferon treatment naive subjects with chronic hepatitis c, hcv genotype 1. * compensated liver disease key exclusion criteria: * pregnant or lactating female or males with a pregnant partner. * a positive test for serum antibodies to the human immunodeficiency virus (hiv-1) or serum hepatitis b virus surface antigen (hbsag). * a history of moderate, severe or uncontrolled psychiatric disease. * a history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.

Keywords: hepatitis c
study evaluating inotuzumab ozogamicin (cmc-544) in indolent non-hodgkins lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (cmc-544) in subjects with indolent non-hodgkins lymphoma (nhl) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. the investigational drug will be given to subjects with indolent nhl by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.


Eligibility criteria:
inclusion criteria: * subjects who have been previously diagnosed with cd22-positive, indolent nhl (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies. * previous anticancer treatment given must have contained rituximab and chemotherapy, or anti cd20 radio immuno therapy. subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of radio immuno therapy. * measurable disease with adequate bone marrow function, renal and hepatic function exclusion criteria: * history of, or suggestive of, veno-occlusive disease (vod) or sinusoidal obstruction syndrome (sos) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse. * prior allogeneic hematopoietic stem cell transplant (hsct). * clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

Keywords: refractory indolent nhl lymphoma