Kornimate/medical-research-clean huggingface dataset:
effect of perioperative selective alpha1-blockers in non-stented ureteroscopic laser lithotripsy for ureteric stones: a randomized controlled trial

Conditions: Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones

Summary: to assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.

objective: to assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones. patients and methods: a randomized control trial was conducted at two high volume urological centers from september 2017 to december 2018. we enrolled 120 patients with lower ureteric stones. they were randomly divided into two groups. group a had 58 patients who underwent non-stented ureteroscopy using ho-yag laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while group b had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.

Eligibility criteria:
inclusion criteria: * patients with single lower ureteric stones of size range between 0.5 and 2 cm exclusion criteria: * patients under the age of 18, pregnant women, or those with urinary tract infections, uncorrected bleeding disorders or coagulopathies, bilateral ureteric stones, single kidney, ureteral stricture, multiple ipsilateral ureteric stones were excluded from our study. also, any patients who required ureteric stenting were excluded from our study.

Keywords: uretroscopic lithotripsy non-stented alpha1-blocker luts postoperative pain
compression is life in cardiac arrest - quality study (cilica-qs)

Conditions: Cardiac Arrest

Summary: context: chest compressions quality is known to be essential in cardiopulmonary resuscitation. despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. feedback impact on chest compressions quality preservation during cardiopulmonary resuscitation remains to be assessed. study design: simulated prospective monocentric randomized crossover trial. participants and methods: sixty five professionals rescuers of the pre-hospital care unit of university hospital of caen (doctors, nurses and ambulance drivers) are enrolled to performed continuous chest compression on manikin (resuscianne®, laerdal), twice, with and without a feedback device (cprmeter®). correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously). hypothesis: feedback device preserve chest compression quality above the 2 minutes recommended switch over during cardiopulmonary resuscitation.


Eligibility criteria:
inclusion criteria: * operational staff of university hospital of caen pre-hospital unit * ability in cardiopulmonary resuscitation exclusion criteria: * medical contraindication * refusal
treatment efficacy for developmental motor speech disorders

Conditions: Randomized Controlled Trial for Speech Disorders in Children

Summary: the purpose of this study is to carry out a high-level treatment efficacy study on children with speech sound disorders with motor speech involvement (ssd-msi) using a well-controlled randomized controlled trial design. the intervention of choice is the prompts for restructuring oral muscular phonetic targets (prompt) approach, which has been effective in treating motor speech disorders in adults and in children with autism and cerebral palsy.

the results of this study will allow us to determine if there is a causal relationship between prompt treatment and outcome measures and predict how much improvement can be expected from this therapy. this study is being conducted as a part of a multicenter clinical trial in the province of ontario, canada with three sites: the john mcgivney children's centre in windsor, the erinoakkids centre for treatment and development in mississauga, and the speech and stuttering institute in toronto. the study integrity will be monitored by an arms-length, external agency, the applied health research centre (ahrc) at st. michael's hospital in toronto. the study is coordinated by the department of speech-language pathology at the university of toronto and funded by the prompt institute in santa fe, new mexico.

Eligibility criteria:
inclusion criteria: * the child is between 3 and 10 years. * english is the primary language spoken by the primary caregiver at home. * hearing/vision (corrected is acceptable- e.g., spectacles) is within normal limits. * readiness for direct speech therapy. * age appropriate social interaction and play skills. * age appropriate or mildly delayed receptive language skills. * normal to any amount of delay in expressive language development. * moderate to severe speech sound disorder. * age appropriate or slight delay non-verbal intelligence. * 4 red flags for motor speech involvement. exclusion criteria: * signs and symptoms suggesting global motor involvement (cerebral palsy). * signs and symptoms suggesting autism spectrum disorders. * oral structural deficits. * feeding impairments. * signs of dysarthric speech or significant drooling. * prosodic and / or resonance disorders. * diagnosis of childhood apraxia of speech features

Keywords: speech sound disorders randomized controlled trial speech intelligibility prompt treatment developmental motor speech disorders children functional outcomes treatment efficacy
safety and tolerability of intravenous spm 927 as replacement for oral spm 927 in subjects with partial seizures

Conditions: Epilepsies, Partial

Summary: subjects enrolled in the sp615, sp756, or sp774 open-label extension (ole) trials receiving oral spm 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may participate in a research trial at approximately 30 locations. trial objectives include investigating whether iv spm 927 is safe and well tolerated when given twice daily for a short period of time and identifying the appropriate infusion rate(s). subjects will receive spm 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5 days based on notification by the research doctor and subject choice. subjects will remain on the same stable dose as received in the ole trial. trial procedures will include medical history update, physical/ neurological exams, ecgs, blood /urine sample collections and seizure diary completion. subjects completing the trial will return to the ole trial to resume dosing with oral spm 927.


Eligibility criteria:
inclusion criteria: * partial seizures with or without secondary generalization. exclusion criteria: * subject has previously received iv lacosamide. * subject meets the withdrawal criteria for the open-label extension trial.

Keywords: partial seizures with or without secondary generalization
registry on the experience of extracorporeal co2 removal in intensive care units

Conditions: Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Patients With Acute Respiratory Distress Syndrome

Summary: investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by extracorporeal carbon dioxide removal (ecco2r) in 10 critical care units of paris and its surburb (aphp, assistance publique des hôpitaux de paris). secondary objectives will be: 1. to assess efficacy and safety of ecco2r, 2. to compare the data issue from the registry to others studies assessing the same population and to other centers and 3. to compare the different eccor devices in terms of efficacy and adverse events.

the registry will be conducted prospectively during 2 years in 10 icus of l'aphp on behalf on the cedit. the 10 centers are : (1) icu of l'hôpital europeén georges pompidou, (2) icu of l'hôpital louis mourier, (3) icu of l'hôpital de bicêtre, (4) icu of ghps, (5) respiratory icu of ghps, (6) icu of l'hôpital lariboisière (7) icu of l'hôpital cochin (8) icu of l'hôpital saint-antoine (9)icu of l'hôpital henri mondor and (10) icu of l'hôpital tenon. the primary outcome will be the number of patients implanted by ecco2r monthly in each center during the 2 years period study. secondary outcomes will be icu-mortality, invasive ventilation duration, non invasive ventilation duration, icu duration, modalities of ventilation at the icu discharge, hemorragic complications due to the eccor device, thrombotic complications due to ecco2r device, intravascular hemolysis due to ecco2r device, duration of ecco2r, adjunct therapy to ecco2r and reasons of ecco2r discontinuation.

Eligibility criteria:
inclusion criteria: * patients implanted with eccco2r exclusion criteria: * contra-indication to ecco2r

Keywords: extracorporeal co2 removal registry copd and ards cedit on behalf of aphp
trial to promote recovery from covid-19 with endocrine therapy

Conditions: COVID-19; SARS-CoV 2

Summary: patients with covid-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. this will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with covid-19.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * covid-19 infection, confirmed by polymerase chain reaction (pcr) test \<=3 days from enrollment * require inpatient hospitalization due to covid-19 with minimal respiratory symptoms * able to provide informed consent exclusion criteria: * unable to take oral medication * pregnant or breastfeeding * on non-invasive positive pressure ventilation or mechanical ventilation at time of study entry * requiring ≥6l oxygen or respiratory rate ≥30 * taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for covid-19 within one month of study entry * known hypersensitivity to bicalutamide or its components. * a past medical history of cirrhosis or ast/alt/alk phos/bilirubin \> 3x the upper limit of normal * patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction \< 40% * patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.

Keywords: covid-19 coronavirus covid sars-cov-2
the neuguide™ system for vaginal colpopexy in the treatment of uterine prolapse

Conditions: Uterine Prolapse Without Vaginal Wall Prolapse

Summary: the objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the neuguide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.


Eligibility criteria:
inclusion criteria: 1. patient with pop-q c point greater than (-) 1 cm. 2. patients who have previously had a partial hysterectomy in which the cervix is intact may be included in this study. 3. non-pregnant female (female of child bearing potential must have a negative pregnancy test). 4. patient understands the nature and potential hazards of the procedure and provides written informed consent prior to any study specific assessments. 5. patient is able to complete written questionnaires. 6. patient is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone. exclusion criteria: 1. known diagnosis of reproductive tract abnormalities. 2. prior pelvic radiation therapy, any malignancy or active pelvic inflammatory disease. 3. known history of severe pelvic inflammatory disease (pid). 4. prior total hysterectomy. 5. prior pelvic prolapse surgery using synthetic mesh. 6. pathological pap in the past year. 7. moderate or severe bacterial cervicitis. 8. moderate or severe pelvic pain (\> 3 on vas). 9. severe morbid obesity (bmi \>45). 10. temperature \> 38°c (oral or equivalent), sepsis, or active infection requiring iv anti-microbial treatment. 11. significant cognitive impairment. 12. active malignancy other than non-melanoma skin cancer. 13. planned surgery (more than a minor one) in the next 30 days. 14. patient has a known hypersensitivity to device materials (nickel, suture material). 15. moribund patient or patient with severe or deteriorating damage in critical body systems. 16. any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results. 17. concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.

Keywords: prolapse sacrospinous fixation minimally invasive
safety and efficacy study of denosumab in patients with recurrent or unresectable giant cell tumor of bone

Conditions: GCT; Giant Cell Tumor of Bone

Summary: to determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.


Eligibility criteria:
inclusion criteria: * adults, 18 years and older * histologically confirmed and measurable giant cell tumor (gct) * recurrent gct confirmed by radiology or unresectable gct * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 exclusion criteria: * pateints for whom surgery to the affected limb/area is planned within 27 days after receiving 1st dose of denosumab * radiation to affected region within 28 days before enrollment to study * known diagnosis of osteosarcoma or brown tumor of bone * known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ * concurrent treatment with bisphosphonates, calcitonin, or interferon. other criteria also apply.

Keywords: giant cell tumor of bone
swiss prospective, multicenter study sentinel lymph node procedure in colon cancer

Conditions: Colonic Neoplasms

Summary: the study is a feasibility and validation study of the sentinel lymph node (sln) procedure in all stages of colon cancer. if the sln can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). the detection of micrometastases in the sln (occult stage iii, upstaging) is possible. patients with micrometastases should be considered at higher risk. additionally, a search for occult metastatic tumor cells in the bone marrow is performed.


Eligibility criteria:
inclusion criteria: * colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. the diagnosis of cancer must be certain in the definitive histology. * possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded). * patient's informed consent exclusion criteria: * prior intrabdominal tumor surgery * other preexisting malignancies * hypersensitivity/allergy to dye (isosulfan blue) * pregnancy * breast-feeding * no patient's informed consent

Keywords: sentinel lymph node lymph node analysis bone marrow analysis
diacutaneous fibrolysis and subacromial syndrome

Conditions: Subacromial Impingement Syndrome

Summary: subacromial impingement syndrome (sis) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. in occupational population is the most common upper extremity disorder. symptoms include pain, a variable degree of mobility limitation and a more or less pronounced functional impairment. conservative treatment is usually the first therapeutic option and some physiotherapeutic techniques have proved its efficacy but nevertheless treatment remains challenging. according to the investigators clinical experience, diacutaneous fibrolysis has a beneficial effect on patients suffering from sis, but no one published clinical trial has evaluated this manual technique previously. the investigators hypothesis is that adding diacutaneous fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. the investigators objective was to assess the effect of diacutaneous fibrolysis on pain, mobility and functional status in patients suffering from sis. a double-blind (patient and evaluator) randomized clinical trial was carried out in two public centres of primary health care of the spanish national health system. the study protocol was approved by the clinical research ethics committee from the jordi gol institute of research in primary health care and all the patients provided written consent. a hundred and twenty patients with clinical diagnosis of sis were included and randomly allocated to one of three groups. all groups received the same daily protocolized treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks. additionally, intervention group received six sessions (two a week) of actual diacutaneous fibrolysis; placebo group received six sessions (two a week) of placebo diacutaneous fibrolysis, while control group received only the protocolized treatment. pain intensity (vas), active range of motion (flexion, abduction, extension, external and internal rotation) and functional status (constant-murley score) were measured in baseline, after the three weeks of treatment and three months after the end of treatment.


Eligibility criteria:
inclusion criteria: * over 18 years * diagnosed of subacromial impingement syndrome * signed a written consent form. exclusion criteria: * damaged skin and/or cutaneous lesions in the shoulder area, * a concomitant treatment with platelet antiaggregant agents * acute inflammatory conditions in the shoulder * previous shoulder surgery * a pending litigation or court claim
vitamin b6 and magnesium- a clinical trial on asd patients

Conditions: Autism Spectrum Disorder

Summary: to determine whether vitamin b6 and magnesium improve neurobehavioral status in terms of general observation, cognitive working, socialization, communication and sensory dysfunction in patient with autism spectrum disorder.


Eligibility criteria:
inclusion criteria: 1. children between 2 to 12 years of age suspected asd assessed by dsm-5 and adcl tool 2. each patient will be free of psychoactive medication for atleast 3 months prior to the entry into the trial 3. newly diagnosed patient 4. co-morbid neurological disorder like hyperactivity exclusion criteria: 1. patients with chronic diseases or any known metabolic or hormonal diseases 2. patients with any known chromosomal or genetic syndromes 3. patients unable to give informed consent 4. patients unable to travel to clinical visits or non co-operative
safety, tolerability, pharmacodynamic, efficacy, and pharmacokinetic study of dyne-101 in participants with myotonic dystrophy type 1

Conditions: Myotonic Dystrophy Type 1 (DM1)

Summary: the primary purpose of the study is to evaluate the safety and tolerability of multiple intravenous (iv) doses of dyne-101 administered to participants with myotonic dystrophy type 1 (dm1). the study consists of 4 periods: a screening period (up to 8 weeks), a placebo-controlled period (24 weeks), a treatment period (24 weeks) and a long-term extension (lte) period (144 weeks) in both multiple-ascending dose (mad) and dose expansion cohorts.


Eligibility criteria:
inclusion criteria: * diagnosis of dm1 with trinucleotide repeat size \>100. * age of onset of dm1 muscle symptoms ≥12 years. * clinically apparent myotonia equivalent to hand opening time of at least 2 seconds in the opinion of the investigator. * hand grip strength and ankle dorsiflexion strength. * able to complete 10-mwrt, stair ascend/descend, and 5×sts at screening without the use of assistive devices such as canes, walkers, or orthoses. exclusion criteria: * history of major surgical procedure within 12 weeks prior to the start of investigative product administration or an expectation of a major surgical procedure (eg, implantation of cardiac defibrillator) during the study. * history of anaphylaxis. * medical condition other than dm1 that would significantly impact ambulation or participation in functional assessments. * treatment with medications that can improve myotonia within a period of 5 half-lives of the medication prior to performing screening assessments. * electrocardiogram (ecg) with the corrected qt interval by fridericia's formula (qtcf) ≥450 milliseconds (ms) in men and qtcf ≥460 ms in women, pr ≥240 ms, left bundle-branch block, or a conduction defect, which is clinically significant in the opinion of the investigator. * percent predicted forced vital capacity (fvc) \<50%. * history of tibialis anterior biopsy within 3 months of day 1 or planning to undergo tibialis anterior biopsies during study period for reasons unrelated to the study. * participant has a history of suicide attempt, suicidal behavior, or has any suicidal ideation within 6 months prior to screening that meets criteria at a level of 4 or 5 of the columbia suicide severity rating scale (c-ssrs) or who, in the opinion of the investigator, is at significant risk to commit suicide. * use of glucagon-like peptide 1 (glp-1) agonist medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within a period of 5 half-lives of the medication prior to performing screening assessments. * significant weight loss during study participation may impact weight-based dosing, performance on muscle function assessments, and pharmacodynamic (pd) biomarkers. note: other inclusion and exclusion criteria may apply.