Kornimate/medical-research-clean huggingface dataset:
staccato loxapine pulmonary safety in healthy volunteers

Conditions: Healthy

Summary: the objective of this trial is to assess the pulmonary safety of 2 inhaled doses of staccato loxapine within a day.

the planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Eligibility criteria:
inclusion criteria: * nonsmoker subjects in good general health with normal spirometry at screening and baseline exclusion criteria: * history of asthma, copd, or any other acute or chronic pulmonary disease or bronchodilator use

Keywords: healthy volunteers
immunosuppression during penetrating keratoplasty, using a subconjunctival implant releasing dexamethasone : tolerance and safety pilot study

Conditions: Keratoconus; Fuchs' Endothelial Dystrophy; Congenital Hereditary Stromal Dystrophy of the Cornea

Summary: immune rejection episodes after penetrating keratoplasty occur in 30% of patients and constitute one of the main factors reducing graft survival. they mainly occur during the first 18 months. prevention usually relies on a topical treatment with dexamethasone or prednisolone for standard risk patients. eye drops are instilled three times a day during at least 3 months then tapered. ozurdex is an absorbable small implant that releases a total of 700 micrograms dexamethasone during several months. it is indicated for intravitreal injection to treat macular edema. the investigators hypothesized that this implant could be used after subconjunctival injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop instillations.


Eligibility criteria:
inclusion criteria: * keratoconus * fuch's dystrophy * hereditary stromal dystrophy * age 18 years old and more * signed informed consent * affiliated to the french social security exclusion criteria: * hypersensitivity to dexamethasone or the excipients (polylactic and glycolic acid) * active ocular or periocular infection * advanced glaucoma * history of herpetic or zoster keratitis * retinal disease for which an intravitreal injection of ozurdex is planed for the next 3-4 months

Keywords: absorbable implant subconjunctival immune rejection safety profile dexamethasone
common safety follow-up trial of tecemotide (l-blp25)

Conditions: Non-Small Cell Lung Cancer; Multiple Myeloma

Summary: this is an open-label, common follow-up trial. subjects who were enrolled in a merck kgaa, emd serono or merck serono japan sponsored trial with tecemotide (l-blp25) were enrolled in this follow-up trial to continue their maintenance treatment with tecemotide (l-blp25). subjects were transferred once the feeder trial (emr 63325-005 \[nct00157209\], emr 63325-006 \[nct00157196\] and emr 63325-008 \[nct01094548\]) objectives were met. subjects who received tecemotide (l-blp25) in a feeder trial continued tecemotide (l-blp25) treatment in this follow-up trial and have safety assessments performed as well as were observed for progressive disease (pd) and survival in 6- month intervals. subjects who had not received tecemotide (l-blp25) in feeder trials, or discontinued treatment were only observed for pd and survival in 6-month intervals and were not provided treatment with tecemotide (l-blp25).


Eligibility criteria:
inclusion criteria: * signed written informed consent. * registration and treatment in a clinical trial with tecemotide (l-blp25) under sponsorship of merck kgaa/emd serono/merck serono japan (feeder trial). \[note, subjects who have been allocated to treatments not containing tecemotide (l blp25) in the feeder trial are eligible for this trial and will be followed-up for progressive disease (pd) (if applicable) and survival.\] * end of treatment procedures have been performed in the feeder trial. * other protocol defined inclusion criteria could apply exclusion criteria * pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the investigator. subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard * known hypersensitivity to any of the trial treatment ingredients (if applicable) * legal incapacity or limited legal capacity * any other reason that, in the opinion of the investigator, precludes the subject from participating in the trial * other protocol defined exclusion criteria could apply

Keywords: vaccine stimuvax tecemotide l-blp25 non-small cell lung carcinoma multiple myeloma
ketamine effects as preemptive analgesia

Conditions: Pain, Postoperative

Summary: the goal of this randomized controlled trial is to compare the effect of preemptive ketamine administration to placebo administration in patients underwent hysterectomy surgery. the main questions it aims to answer are: 1. to determine the effect of ketamine at a dose of 0.5 mg/kgbw as preemptive analgesia on the duration of analgesia after hysterectomy surgery 2. to determine the effect of ketamine at a dose of 0.5 mg/kgbw as preemptive analgesia on the need for fentanyl after hysterectomy surgery


Eligibility criteria:
inclusion criteria: 1. patients aged 18-50 years. 2. asa i and ii physical status (american society of anesthesiologists). exclusion criteria: 1. the patient is not willing to be included as a research subject 2. the patient takes anti-pain medication before surgery 3. history of allergies to the drugs to be used 4. history of chronic pain

Keywords: ketamine preemptive analgesia
the road 2.0 to sustainable medication use: redispensing unused oral anticancer drugs

Conditions: Cancer; Oncology; Pharmacy; Drug Prescriptions

Summary: the goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs. the main questions it aims to answer are: * what are the cost-savings of redispensing unused oral anticancer drugs? * what is the environmental impact of redispensing unused oral anticancer drugs? researchers will compare redispensing unused oral anticancer drugs to the standard practice of disposal. participants will receive their oral anticancer drugs in a sealed bag with a temperature indicator if needed. they will be asked to return any unused oral anticancer drugs to the pharmacy during their next visit to the hospital.


Eligibility criteria:
inclusion criteria: * patients of all ages * a clinical diagnosis of cancer using an oral anticancer drug that requires storage at room temperature according to the summary of product characteristics (smpc). exclusion criteria: * patients that do not understand the dutch or english language, in written or spoken. * patients receiving prescriptions that contain an amount of tablets that deviates from the regular package size, resulting in the pharmacy dispensing an opened package
gene therapy for ada-scid using an improved lentiviral vector (ivlv-ada)

Conditions: Adenosine DeAminase Severe Combined ImmunoDeficiency (ADA-SCID)

Summary: this is a phase i/ii trial of in vivo lentiviral gene therapy for treating adenosine deaminase severe combined immunodeficiency (ada-scid) using a self-inactivating lentiviral vector (lv) ivlv-ada to functionally correct the genetic defect. the primary objectives are to evaluate the safety and efficacy of the direct intravenous (iv) lv gene therapy protocol.

this clinical trial will evaluate safety and efficiency of an improved lv system for delivering a therapeutic gene to patients with severe combined immunodeficiency (scid) due to a defective adenosine deaminase (ada) gene. this gene encodes for the adenosine deaminase enzyme, which is essential for the proper growth and function of infection-fighting white blood cells called t and b lymphocytes. patients who lack this enzyme are vulnerable to frequent and severe infections. ada-scid patients are normally rescued by a bone marrow transplant (bmt) from a matched healthy donor. however, matched donors are difficult to find and donor bmt is associated with high risk. this trial aims to treat ada-scid via direct intravenous (iv) injection of a safety and efficiency improved self-inactivating lv carrying a functional ada gene (ivlv-ada) to correct the genetic defect. by direct iv injection of ivlv-ada, the defective immune cells and blood stem cells in the body can be modified to exhibit ada activity and correct the immunodeficiency. the primary objectives are to evaluate the safety of the improved ivlv-ada, the iv lv gene transfer clinical protocol and the efficacy of immune recovery in patients to overcome frequent infections present at the time of treatment. we will assess the in vivo lentiviral gene transfer efficiency and the long-term effect of this gene transfer procedure.

Eligibility criteria:
inclusion criteria: * diagnosis of classical ada-scid based on: * a proven defective adenosine deaminase (ada) gene as defined by direct sequencing of patient dna. * t-cell immune deficiency defined as one or more of the following: cd3+ autologous t cells \< 300/ul, or less than 50% of normal value for in vitro mitogen stimulation, or absent proliferation in vitro to antigens. * with severe infections, including but not limited to: pneumonitis; protracted diarrhea requiring total parenteral nutrition; infection with herpes viruses or adenovirus or fungus; disseminated bcg infection. * no cytogenetic abnormalities (medullary karyotype) and no detection of main rearrangements associated with acute leukemia of children. * no prior allogeneic stem cell transplantation. * life expectancy ≥ 2 months. * negative for hiv infection. * written, informed consent obtained prior to any study-specific procedures. exclusion criteria: * none

Keywords: adenosine deaminase severe combined immunodeficiency lentiviral vector in vivo gene therapy
comparing the effects of smoked and oral marijuana in individuals with hiv/aids

Conditions: HIV Infections

Summary: smoked marijuana (mj) and dronabinol (also known as thc or by the trade name marinol) are used to increase appetite, food intake, and weight in patients with hiv who experience unintended weight loss. this study will compare the effects of mj and marinol use in marijuana smokers who are hiv infected.

little is known about the efficacy and tolerability of oral thc versus smoked mj in a clinically relevant population. additionally, it is not clear how thc's effects vary as a function of the duration of treatment or the patient's current patterns of smoked mj use. this study directly compares 3 doses of smoked marijuana and 3 doses of marinol across a range of behavioral measures in hiv infected marijuana smokers. outcome measures will include analysis of food intake, body composition, mood, physical symptoms (e.g., nausea, stomach pain), psychomotor task performance, and sleep.

Eligibility criteria:
inclusion criteria * hiv infected * smoke marijuana * taking hiv medications exclusion criteria * naive marijuana smokers * people with history of respiratory/pulmonary disease

Keywords: hiv marijuana marinol oral thc appetite complementary therapies
circadian rhythm of erythropoietin and melatonin in renal disease

Conditions: Chronic Kidney Disease

Summary: rationale: investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency objectives: primary objective: is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency? primary objective: is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency compared to patients with a normal renal function? secondary objective: is there a circadian rhythm of cortisol and igf in patients with various degrees of renal insufficiency? secondary objective: is there a circadian rhythm of cortisol and igf in patients with various degrees of renal insufficiency compared to patients with a normal renal function? study design: comparative study in 4 groups with various degrees of renal insufficiency, duration for each patient 24 hrs. total duration of study 12 months, patients admitted to the hospital (on nursing ward) study population: patients with various degrees of renal insufficiency main study parameters/endpoints: analysis of the existence of a circadian rhythm in patients with a normal renal function and in patients with variable degrees of renal insufficiency nature and extent of the burden and risks associated with participation, benefit and group relatedness: better knowledge of the circadian rhythm in renal insufficiency. this could lead to a more efficient administration of erythropoietin and melatonin in the future. extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11 times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour continuous ambulant blood pressure monitoring.


Eligibility criteria:
inclusion criteria: * patient with various degrees of renal insufficiency, stable creatinin clearance: minimum 10 ml/min (measured with mdrd), admitted to our hospital * informed consent * man/women between 18 and 85 years * understanding and knowledge of the dutch language exclusion criteria: * instable angina pectoris, heart failure nyha class iv * therapy with erythropoetin, melatonin and hypnotics * acute renal failure or rapidly progressive glomerulonephritis * bleeding or hemolysis as a cause of anemia * deficiency of iron, folate and/or vitamin b12 * presence of chronic inflammatory disease or clinically significant infection * hemoglobinopathies * alcohol and/or drug abuse * enrolment in another study * any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Keywords: chronic kidney disease melatonin erythropoietin circadian rhythm
practice of acceptance, awareness, and compassion in caregiving (paacc)

Conditions: Dementia

Summary: the primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, practice of acceptance, awareness, and compassion in caregiving (paacc) compared to an established cognitive behavior therapy based dementia caregiver intervention, resources for enhancing alzheimer's caregiver health (reach) in improving caregiver burden and quality of life of care recipient.

the study is a randomized controlled trial comparing a mindfulness-enhanced evidence-based caregiver skill-building intervention (paacc) to reach-va to reduce caregiver burden and increase quality of life of the care recipient. for this, caregivers of persons with adrd or tbi-ad who have moderate to severe burden will be randomly assigned to either receive paacc or receive reach-va. both the interventions will include 4 biweekly sessions delivered by trained interventionists, followed by an outcome testing session after the intervention. outcomes of caregiver stress, health and well being will be assessed at baseline and at the end of the intervention.

Eligibility criteria:
inclusion criteria: * caregivers will include family members living with the individual diagnosed with alzheimer's disease( ad) or alzheimer's disease related dementia(adrd) or traumatic brain injury -ad(tbi-ad) with moderate to severe caregiver burden . * care recipients with diagnosis of diagnosis of ad or adrd or tbi-related ad . exclusion criteria: * care givers: determined to be an imminent risk to self or others,the care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr. * care recipient: determined to be an imminent risk to self or others, caregiver is not interested in the study, unable to obtain informed consent from the care recipient
azithromycin+amoxicillin/clavulanate vs amoxicillin/clavulanate in covid19 patients with pneumonia in non-intensive unit

Conditions: COVID-19 Pneumonia

Summary: the global pandemic of novel coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) began in wuhan, china, in december 2019, and has since spread worldwide.1 as of april 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. a recent open-label nonrandomized french study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at day 6 in covid-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.


Eligibility criteria:
inclusion criteria: * adult ≥ 18 ans, * patient with positive sars-cov-2 rt-pcr on nasopharyngeal sample at randomization or within the previous 48 hours, * patient with pneumonia diagnosed by thorax ct-scan or echography, * patient able to take per os medication, * written and signed consent of the patient, * patients affiliated with or benefitting from a social security scheme. exclusion criteria: * patient hospitalized in intensive care unit, * patient who received more than 24 hours of antibiotic treatment for the ongoing episode, * chronic renal failure with a glomerular filtration rate \< 20ml/min, * severe hepatic failure, * severe chronic cardiac insufficiency, * allergy to macrolides, * electrocardiogram showing corrected qt prolongation greater than 470 ms in men and 480 ms in women. * life-threatening presentation expected to lead to possible imminent death (based on provider assessment)
a study of vadastuximab talirine given prior to or after allogeneic hematopoietic stem cell transplant in aml patients

Conditions: Acute Myeloid Leukemia

Summary: this study will examine the safety and anti-leukemic profile of sgn-cd33a (vadastuximab talirine) in patients with relapsed chemo-resistant aml, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell transplant. the main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (allosct) for adults with relapsed or refractory aml. this will be determined by assessing the safety and tolerability of vadastuximab talirine. in addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.


Eligibility criteria:
inclusion criteria: * relapsed/refractory acute myeloid leukemia (aml) except for acute promyelocytic leukemia * eastern cooperative oncology group status of 0 or 1 * adequate baseline renal and hepatic function * for pre-allo part a (before stem cell transplant): relapsed or refractory aml (greater than 5% blasts) * for pre-allo part a (before stem cell transplant): availability of an hla matched related or unrelated donor * for pre-allo part a (before stem cell transplant): eligible for an allogeneic hematopoietic stem cell transplant * for post-allo part b: transplant must have been performed with active aml (greater than 5% blasts) using a conventional conditioning regimen and have achieved cr or cri post-allosct (with anc greater than or equal to 1,000 and platelet greater than or equal to 50,000) * for post-allo part b: treatment must begin at least 42 days, but no more than 100 days post-transplant. exclusion criteria: * inadequate heart function * inadequate lung function * previous central nervous system leukemia * any history of another metastatic malignancy * anti-leukemia treatment within14 days of study drug (other than hydroxyurea or 6-mercaptopurine), immunosuppressive therapy (except for gvhd treatment/prophylaxis in part b), or investigational agents * for pre-allo part a (before stem cell transplant): partially matched donors (related or unrelated) and umbilical cord blood cells are excluded as the source of hematopoietic stem cells * for pre-allo part a (before stem cell transplant): prior allosct * for post-allo part b: active gvhd grade 2 or higher * for post-allo part b:history of veno-occlusive disease requiring defibrotide * for post-allo part b: history of grade 2 or higher hepatic gvhd * for post-allo part b: concurrent use of corticosteroids equivalent of prednisone at a dose of greater than 0.5 mg/kg

Keywords: acute myeloid leukemia aml antibody-drug conjugate
functional exercise training in cerebral palsy: follow up

Conditions: Cerebral Palsy

Summary: the goal of this cross-sectional study is to compare able-bodied peers to adolescents and young adults with cerebral palsy (cp) who have been regularly performing high-intensity functional training for almost two years. the main research question is: is structured, long-term exercise training able to compensate strength and cardiovascular deficits in adolescents with cp compared to able-bodied peers?

the pilot study investigating the effects of a functional exercise training in adolescents and young adults with cerebral palsy (cp) showed increases in strength, power, daily function as well as cardiovascular health. in order to establish the origin of the improvements and its broader effects, we wish to conduct follow-up measurements to the pilot study. these follow-up measurements would establish whether the positive changes in physical performance are due to neural or muscular changes (or both), and shed more light on how therapy should be performed and prescribed in adolescents with cp. additionally, we wish to measure their aerobic capacity as well as examine their microvascular health. for this cross-sectional analysis, the participants of the cp-fit pilot study who continued to train on a regular basis will be compared to age-matched peers in order to establish whether their strength and fitness deficits compared to peers can be compensated through structured and progressive functional exercise training.

Eligibility criteria:
inclusion criteria: cp individuals: * diagnosis of cp. * between 14 and 26 years of age. * gross motor functional classification system (gmfcs): i-ii. * cognitive abilities must include: ability to verbally or non-verbally communicate pain or discomfort; ability to attend testing and; ability to understand and follow instructions. all included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations. healthy peers: - between 14 and 26 years of age. exclusion criteria: cp individuals: * any surgery or botulinum toxin treatment within 6 months prior to the measurements or scheduled during study period. other medications can be continued as prescribed by the participants' physician. * known cardiovascular or pulmonary diseases that have not received medical clearance to participate in physical exercise. * uncontrolled seizures or epilepsy. * inability to conform to the above mentioned cognitive and physical abilities. healthy peers: * diagnosis of congenital heart defects, pulmonary diseases or any neuromuscular disorders or diseases. * diagnosis of any acute diseases.

Keywords: functional training strength cardiovascular health cerebral palsy