Kornimate/medical-research-clean huggingface dataset:
before decision aid implementation study

Conditions: Decision Support Techniques; Breast Neoplasm Female; Young Adult; Evaluation Studies

Summary: fertility is of great importance to young women with cancer. concerns about the ability to become pregnant after cancer treatment may influence treatment decisions and fertility decision-making is challenging. despite these challenges, there is a lack of fertility decision support tools. our team developed the begin exploring fertility options, risks and expectations (before) decision aid for young breast cancer patients in canada. this study aims to evaluate the implementation of the before decision aid in hospital settings through a stepped wedge cluster randomized trial.

the investigators will conduct a stepped wedge cluster randomized trial to sequentially implement the before decision aid in clinical settings that are currently recruiting young breast cancer patients for the reducing the burden of breast cancer in young women (ruby) study (www.womensresearch.ca/ruby-study/). for this trial 24 participating ruby sites were grouped into 14 clusters (1 to 3 sites per cluster). the decision aid intervention will be sequentially rolled out over the course of 48 weeks to all clusters. none of the clusters will be switched from control to intervention during the first 6 weeks of the study to establish a baseline. then two clusters will move from the control to the intervention every 6 weeks (called a 'step'). there will be 7 steps total during the study period. at the end of the 7th step all clusters (i.e., participating ruby sites) will have received the decision aid intervention. the time-point of when the clusters will be switched from control to intervention will be randomized. the data collection includes obtaining secondary data collected as part of the ruby study from all patient participants who were enrolled in ruby during the study period. the primary outcome is the number of patients reporting that fertility tools were recommended to them, based on ruby participant responses to a 3-month fertility questionnaire. the investigators hypothesizes that following the implementation of the decision aid intervention a 20% difference will be observed, from 10% in the control to 30% in the intervention, in the number of patients who report that someone in their care team recommended a fertility tool.

Eligibility criteria:
inclusion criteria: * young females diagnosed with histologically-confirmed breast cancer will be eligible to participate if they: 1. are age =18 years and prior to their 41st birthday; 2. are able to provide verbal informed consent and complete the interviews in english or french; 3. completed the 3-month fertility questionnaire as part of the ruby study.

Keywords: decision aid breast cancer young females implementation stepped wedge trial
evaluating chronic pain management program

Conditions: Chronic Musculoskeletal Pain

Summary: this interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.


Eligibility criteria:
inclusion criteria: * adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology * self referred or referred willing to give informed consent exclusion criteria: * autoimmune disorder * malignancies * cognitively impairment
truth or dare; artificial blastocoel collapse using laser before blastocyst's vitrification versus non-laser usage

Conditions: Blastocyst Disintegration

Summary: : this prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.

one arm study of 60 patients with sibling blastocysts divided into 2 groups: study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.

Eligibility criteria:
inclusion criteria: * age limit 20-37 at least 6 good quality blastocysts per case. expansion rate 3-4 exclusion criteria: * bad quality blastocysts expansion rate less than 3

Keywords: blastocyst vitrification artificial collapse survival rate
casimas: catumaxomab safety phase iiib study with intraperitoneal infusion in patients with malignant ascites due to epithelial cancers

Conditions: Cancer; Neoplasms; Carcinoma; Malignant Ascites

Summary: this is a randomized phase iiib study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. in order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated. a total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.

safety data of the completed pivotal phase ii/iii trial, ip-rem-ac-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported aes were cytokine release-related symptoms such as fever, nausea, and vomiting (based on the pharmacodynamic mode of action of catumaxomab) and abdominal pain. in order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone. prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time.

Eligibility criteria:
key inclusion criteria: 1. patients with malignant ascites requiring therapeutic ascites puncture 2. histological confirmed diagnosis of epithelial cancer 3. patients where standard therapy is not available or no longer feasible 4. karnofsky index ≥60 % 5. life expectancy \>12 weeks key exclusion criteria: 1. concomitant treatment with other investigational product, chemo-, or radiotherapy 2. recent exposure to an investigational product 3. known or suspected hypersensitivity to catumaxomab or similar antibodies 4. inadequate respiratory, renal or hepatic function 5. inadequate blood count (platelets, neutrophils) 6. required entirely parenteral nutrition 7. patients with ileus or subileus within the last 30 days 8. liver metastases with volume \>70 % of liver tissue 9. known portal vein obstruction 10. known brain metastases 11. acute or chronic infection 12. not sufficiently recovered from previous treatment (toxicity present) based on laboratory values and general status 13. albumin lower than 3 g/dl or total protein \< 6g/dl

Keywords: cancer neoplasms carcinoma malignant ascites drug therapy antineoplastic protocols immunotherapy phase iii trifunctional antibody monoclonal antibody epcam
prospective study on the incidence of adrenal crisis in patients with chronic adrenal insufficiency

Conditions: Adrenal Insufficiency

Summary: prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis in patients with chronic adrenal insufficiency.

this is a prospective study following patients with chronic adrenal insufficiency by contacting them every 6 months via questionnaires and telephone. questionnaires assess incidence and causes of adrenal crisis, frequency of hospitalization.

Eligibility criteria:
inclusion criteria: * chronic primary or secondary adrenal insufficiency requiring glucocorticoid substitution therapy exclusion criteria: * adrenocortical carcinoma * long term glucocorticoid treatment above 7.5 mg prednisone equivalent dose for other reasons than adrenal insufficiency * age \< 18 years
round spermatid injection protocol

Conditions: Male Infertility Due to Azoospermia

Summary: to evaluate embryology outcomes after application of a technique known as round spermatid injection (rosi) into donor oocytes in a high-volume clinical infertility practice.

the objective of this study is to assess embryology outcomes after implementation of a laboratory protocol known as rosi at a high-volume clinical infertility practice. all samples from enrolled male patients with azoospermia who proceed with surgical sperm extraction (tese or microtese) will be evaluated for the presence of round spermatids. these round spermatids will be used as research samples as opposed to being discarded. the investigators aim to identify whether the injection of round spermatids into donor oocytes can lead to successful fertilization, progression to the blastocyst stage, and euploid status. performance of rosi using donor oocytes not intended for implantation will allow the investigators to gain valuable insight regarding fertilization and development without any direct risk to patients or future offspring. these embryos are being generated for research purposes only and will ultimately be destroyed after the study has concluded. the investigators will measure rates of isolation of round spermatids from surgical samples, fertilization rates using donor oocytes, rates of progression to the blastocyst stage, and rates of aneuploidy using the previously described technique of rosi.

Eligibility criteria:
major inclusion criteria: the following are major inclusion criteria: 1. a diagnosis of azoospermia after semen analysis. 2. indication to proceed with testicular sperm extraction (tese or microtese) based on a urologic evaluation. 3. presence of round spermatids from testicular sperm extraction (tese or microtese), irrespective of the presence or absence of mature spermatozoa. major exclusion criteria (must not meet any): the following are exclusion criteria: 1. under 18 years old 2. all patients who do not voluntarily give their written consent for participation. 3. men who do not wish to use their gametes (round spermatids) for fertilization of donor oocytes for research purposes.
predictors of muscle injury risk in non-professional football players

Conditions: Sport Injury

Summary: background. football accounts for 30% of all sports injuries. muscle injuries in football are the most common non-traumatic and non-contact injuries. a comprehensive approach to injury prevention must consider the design of the footwear and the environmental conditions in which the match is played. objective. to assess the risk of injury as a function of footwear and field of play in non-professional football players and to identify the best predictive model of muscle injury in these athletes. method. ambispective cohort study. ninety-seven players will be recruited. the primary variable will be the number of lower limb muscle injuries in the last 3 seasons. secondary and modifying variables will be: age, body mass index, boot type, pitch turf, training load and field position. potential confounding variables will be motivation for choice of footwear, date of muscle injuries, time playing in the category and presence in the starting team. the analysis will calculate the risk of adverse effects in these patients and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders. expected outcomes. to calculate the risk of muscle injury as a function of anthropometric variables, and footwear and turf type. to identify the predictive model of muscle injuries in football players.


Eligibility criteria:
inclusion criteria: * federated, non-professional football players. * competing in category 3 rfef (group 2). * who compete in the territorial delimitation of the principality of asturias. * subjects who have not undergone previous musculoskeletal surgery in the seasons under study. * who were federated at least one year before the study period. exclusion criteria: * players who have not participated in competition, during the seasons under study, for a period of more than 6 months due to a musculoskeletal injury.

Keywords: muscular diseases football risk secondary prevention physiotherapy
efficacy and safety of nitazoxanide for the treatment of hospitalized patients with moderate covid-19

Conditions: COVID-19

Summary: this is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg bid) to treat hospitalized patients with moderate covid-19.

this is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg bid) to treat hospitalized patients with moderate covid-19. the aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate covid-19 by treating them with nitazoxanide for 7 days on top of standard care compared to patients who receive standard care and placebo. patients hospitalized with confirmed diagnosis of covid-19 will be randomized to receive either nitazoxanide or placebo.

Eligibility criteria:
inclusion criteria: 1. informed consent from patient or legal representative. 2. male or female, aged ≥ 18 years; 3. laboratory confirmation of 2019-ncov infection by reverse-transcription polymerase chain reaction (rt-pcr) from any diagnostic sampling source; 4. signs of respiratory failure requiring oxygen therapy 5. hospitalized for up to 36h with non-invasive ventilation 6. negative result for pregnancy test (if applicable). exclusion criteria: 1. participating in another rct in the past 12 months; 2. known allergy to nitazoxanide 3. severely reduced lv function; 4. severely reduced renal function; 5. pregnancy or breast feeding; 6. use of hydroxychloroquine and/or azithromycin in the past 15 days; 7. any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
a non-interventional study of roactemra/actemra (tocilizumab) treatment in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this multicenter, observational study will evaluate the use and efficacy of roactemra/actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. eligible patients initiated on roactemra/actemra treatment in accordance with the local label will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis according to the revised (1987) acr criteria * patients in whom the treating physician has made the decision to commence roactemra/actemra treatment (in accordance with the local label); this can include patients who have received roactemra/actemra treatment within 8 weeks prior to the enrolment visit exclusion criteria: * patients who have received roactemra/actemra more than 8 weeks prior to the enrolment visit * patients who have previously received roactemra/actemra in a clinical trial or for compassionate use * patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra * patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
study evaluating the tolerability of multiple doses of hki-272

Conditions: Healthy Subjects

Summary: study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.


Eligibility criteria:
inclusion criteria: * healthy male and female (non-child bearing potential) subjects * ages 18-50.
searching a dysfunction of corticotropic & thyrotropin axis during the acute phase of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm

Conditions: Subarachnoid Hemorrhage

Summary: searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. impact on the incidence of complications and recovery are evaluated at 1 month. blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma acth at 8 am and thyroid hormones (t3, free t4 , and tsh). dynamic test acth stimulation (test synacthene) with renewal of serum cortisol to h + 1 (60min). evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. gos to 1 month.

searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. impact on the incidence of complications and recovery are evaluated at 1 month. blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma acth at 8 am and thyroid hormones (t3, free t4 , and tsh). dynamic test acth stimulation (test synacthene) with renewal of serum cortisol to h + 1 (60min). evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. gos to 1 month.

Eligibility criteria:
inclusion criteria: * acute phase ( ≤48h) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm (glasgow coma scale \>=9) exclusion criteria: * pituitary failure * patient with corticosteroids drugs or antithyroid drugs
vardenafil in tinnitus

Conditions: Tinnitus

Summary: there is incidental evidence (casuistic findings) that the treatment with vardenafil of male patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement of their tinnitus. randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of treatment + 4 weeks follow-up) with 10 mg vardenafil bid p.o. in men and women with chronic tinnitus.


Eligibility criteria:
inclusion criteria: * chronic subjective cochlear tinnitus * no treatment of tinnitus within 4 weeks prior to study entry * duration of tinnitus \> 3 months exclusion criteria: * acute tinnitus * intermittent tinnitus * history of m. menieré * history of conductive deafness * history of psychogenic deafness * history of tumors of the middle ear, inner ear or cerebella-pontine angle (malignant and non malignant) * patients diagnosed of multiple sclerosis * history of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months * nitrates or nitric oxide donors * any other concurrent treatment of tinnitus during study * pregnant and breast-feeding women * women with child-bearing potential not using adequate birth control method (note: as adequate method of birth control oral contraception, spiral or sexual abstinence is recommended) * other exclusion criteria apply according to the summary of product characteristics

Keywords: vardenafil, tinnitus
the impact of a web-based naloxone intervention under standing orders to patients prescribed chronic opioid therapy

Conditions: Overdose; Risk Behavior

Summary: in the setting of naloxone standing orders, this study will assess the impact of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. outcomes are changes in opioid risk behaviors, naloxone uptake, and knowledge about overdose and naloxone.

this is a patient level randomized study of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. this study will be conducted in a health system which has implemented naloxone standing orders. adults prescribed chronic opioid therapy will be identified in the electronic health record, outreached, and recruited for participation. once enrolled, participants will be randomized to usual care or the intervention. the web-based intervention is an animated video which provides education on what is an opioid overdose, how to prevent and recognize an opioid overdose, and how to respond with naloxone. this video also encourages patients to pick up naloxone from a pharmacy under standing orders. participants will be given knowledge and risk surveys over the follow-up. the primary outcome is opioid risk behavior. secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. patients will also be followed in the electronic health record for naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Eligibility criteria:
inclusion criteria: * 18 years of age or greater * prescribed chronic opioid therapy * have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from. exclusion criteria: * non-english speaking, hospice enrollment, do-not-resuscitate order, no internet access

Keywords: opioid antagonist naloxone opioids web-based intervention
opioid based anaesthesia vs opioid free anesthesia in cleft lip, palate ,alveolus surgery.

Conditions: Intravenous Anesthesia

Summary: peri-operative opioid administration has long been one of the three pillars of 'balanced anaesthesia',over the span of just a few years,opioids were widely used in perioperative analgesia because of pain as the fifth vital sign.however, opioid administration is not without concern and is associated with many side-effects such as constipation, urinary retention, respiratory depression and postoperative nausea and vomiting .cleft lip,palate,alveolus are common craniofacial abnormalities and usually require surgical repair.these patients have risks for various perioperative complications due to their young age and craniofacial abnormalities. this study was designed to compare the effects of opioid based anesthesia（oba） and opioid free anesthesia(ofa )on perioperative complications in patients with in cleft lip,palate,alveolus surgery, including respiratory depression, postoperative nausea and vomiting, hemodynamic effects, etc.


Eligibility criteria:
inclusion criteria: * american society anesthesia i, ii； * age between 3 months and 12 years; exclusion criteria: * allergy to anesthetic and analgesic drugs; * history of neuromuscular; * renal, neurological, hepatic disease; * cardiopulmonary diseases; * bradycardia

Keywords: opioid ketamine dexmedetomidine sevoflurane perioperative complications