Kornimate/medical-research-clean huggingface dataset:
the impact of the spikes protocol with ivf patients

Conditions: Infertility

Summary: the purpose of this study is to determine if the utilization of the spikes protocol for delivering bad news is perceived to be more compassionate and effective than the current standard of care for ivf patients receiving negative pregnancy test results.

presently, nurses at boston ivf (bivf) and weill cornell medical center division of reproductive medicine (cornell) do not have a scripted method to deliver negative pregnancy tests to in vitro fertilization (ivf) patients. this study will invite clinic nurses to assist in the research protocol; half of the nurses will be randomized to be trained on a compassionate way to deliver bad news following the spikes protocol, while the other half will continue with the current standard of care of news delivery. the patients who receive the negative test phone calls from participating nurses will be surveyed to see if the method of which the news was delivered was scored as more compassionate, as well as if it was associated with reduced participants reported level of distress and depression.

Eligibility criteria:
inclusion criteria: * female * age \>18 * underwent an embryo or blastocyst transfer using their own eggs at participating clinic * able to read and understand english * access to email * received a negative pregnancy test result phone call from a nurse involved in the research study exclusion criteria: * partners of patients undergoing treatment

Keywords: infertility ivf spikes protocol
exercise during pregnancy and urinary incontinence

Conditions: Pregnancy; Healthy

Summary: the aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on urinary incontinence.


Eligibility criteria:
inclusion criteria: * healthy pregnant women exclusion criteria: -

Keywords: pregnancy physical exercise urinary incontinence
a non-interventional study of roactemra/actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this multi-center observational study will evaluate the use and efficacy of roactemra/actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. eligible patients initiated on roactemra/actemra treatment according to the licensed 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 * patient in whom the treating physician has made the decision to commence roactemra/actemra treatment in accordance with the local label (dmard-ir, tnf-ir or need of roactemra/actemra monotherapy); 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 an 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
propofol for sedation of postoperative electively ventilated liver transplant recipients.

Conditions: Liver Cirrhoses

Summary: all consenting, adult patients aged 18 years and above who will require elective ventilation after liver transplant recipient surgery will be enrolled for the study. patients in acute liver failure, hepatic encephalopathy or patients with history of allergic reactions to propofol will be excluded from the study. this is an observational study. as per institute treatment protocol, propofol will be given post-operatively at a dose of 1 mg/kg/hr and than titrated to maintain a bi-spectral index (bis) score of 60-80 till the patient is on ventilator. there will be no deviation from our routine institutional protocol and no other sedative drugs like opioids or benzodiazepines will be used and no interventions will be done. hemodynamics will be maintained targeting a mean arterial pressure (map) of at least 65 mm hg. during the study period using appropriate measures.


Eligibility criteria:
inclusion criteria: • living donor liver transplant (ldlt) recipient adult patients ≥ 18 years of age requiring postoperative elective ventilation. exclusion criteria: * propofol allergy * acute liver failure (alf). * hepatic encephalopathy (he)
study of oxaliplatin, calcium folinate, and 5-fluorouracil as neoadjuvant chemotherapy for resectable advanced gastric cancer

Conditions: Stomach Neoplasms; Gastric Cancer

Summary: this is a randomized phase ii multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mfolfox7) as neoadjuvant chemotherapy for resectable advanced gastric cancer. hypothesis: neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.

the study hypothesis is that the 5 year survival rate will reach 35% from 25% when neoadjuvant chemotherapy is carried out. with the alpha value to be 0.05 and beta value to be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.

Eligibility criteria:
inclusion criteria: * ecog score 0-2 * ambulatory males or females, aged 30-70 years. * histologically confirmed gastric adenocarcinoma, staged preoperatively ajcc/uicc stage iii(t3n1,t2n2,t4n0,t3n2)and ivm0 and operable * life expectancy more than 3 months * give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. * normal hepatic, renal, and bone marrow function (gpt\ 4000/dl, tbil\<1.5mg/dl, cr\<1.5 fold of upper limit value) exclusion criteria: * patients can not bear surgical procedure. * pregnant or lactating women or women do not agree conceptive procedures. * previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer. * history of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. * history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake. * clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, new york heart association (nyha) grade ii or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months. * organ allografts requiring immunosuppressive therapy. * serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. * moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (uln). * prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dpd deficiency) or patients with known dihydropyrimidine dehydrogenase (dpd) deficiency. * hypersensitivity to platinum compounds or any of the components of the study medications. * received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization. * unwilling or unable to comply with the protocol for the duration of the study.

Keywords: gastric adenocarcinoma neoadjuvant chemotherapy efficacy safety chemotherapy
comparison of the effect between levofloxacin and moxifloxacin among mdr-tb patients

Conditions: TB

Summary: fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant tb (mdr-tb). among them, levofloxacin and moxifloxacin has been used most widely. however, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among mdr-tb patients. the investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase iii trial.


Eligibility criteria:
inclusion criteria: * patients with multidrug-resistant tb, but sensitive to levofloxacin and moxifloxacin exclusion criteria: * achieved negative conversion of m. tb culture before the enrollment * positive anti-hiv antibody * pregnant women or sexually active women without using proper birth control method * serum creatine grater than 2mg/dl, or urine protein greater than 2+ * serum total bilirubin greater than 2 mg/dl or ast and alt greater than 1.5 times of normal upper limit * history or current arrhythmia * hypersensitivity to levofloxacin, moxifloxacin,or rifabutin * should use drug containing metal-ion, warfarin, phenytoin, theophylline, probenecid regularly

Keywords: multidrug-resistant tb, sensitive to levofloxacin and moxifloxacin
trial of preemptive treatment with oral valganciclovir compared with intravenous (iv) ganciclovir for cytomegalovirus infection after bone marrow or peripheral blood stem cell transplant

Conditions: Cytomegalovirus Infections

Summary: the purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (cmv) viremia as determined by quantitative cmv polymerase chain reaction (pcr) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.

* to study the effect of preemptive therapy with iv ganciclovir and po valganciclovir as determined by quantitative cmv pcr. * to determine the incidence of cmv disease and cmv related mortality following preemptive treatment with oral valganciclovir and iv ganciclovir. * to compare the incidence of recurrent cmv viremia after treatment with po valganciclovir to that seen after treatment with iv ganciclovir. * to determine the toxicity profile of valganciclovir. * to screen for mutations in the ul97 gene in patients who have increasing cmv viral loads after 14 days of treatment. * to determine if patients treated with po valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with po valganciclovir.

Eligibility criteria:
inclusion criteria: * patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at washington university medical center. * an initial episode of cmv viremia. * at the time of randomization: * anc greater than or equal to 1000 * age greater than or equal to 18 * adequate renal function with creatinine clearance greater than 10 ml/min * total bilirubin less than or equal to 3.0 exclusion criteria: * current gi graft versus host disease grade iii-iv * development of cmv disease prior to or at the time of the first detection of cmv viremia by pcr * uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days * pregnant or nursing female patient * known hypersensitivity to ganciclovir

Keywords: post transplant any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at washington university medical center
comparing one intraarticular injection of a novel hyajoint plus with synvisc-one for the treatment of knee oa

Conditions: Knee Osteoarthritis

Summary: viscosupplementation has been widely used for the treatment of knee osteoarthritis (oa). there is no well controlled trial comparing one injection regimen of ha for the treatment of knee oa. the purpose of this study was to compare the efficacy and safety of one intraarticular injection of a novel crosslinked ha (hyajoint plus) with synvisc-one for the treatment of knee oa.

in a prospective, randomized controlled, double-blind trial with 6-month follow up, patients with knee oa (kellgren-lawrence grade 2 or 3) were randomized to receive one intraarticular injection of 3 ml hyajoint plus (microbial fermented ha, 20 mg/ml) (n=66) or 6 ml synvisc-one (avian derived ha, 8 mg/ml) (n=66). the primary outcome was change in the visual analog scale (vas) pain (0-100mm) over 6 months. secondary outcomes included the western ontario and mcmaster universities osteoarthritis index (womac), lequesne index, timed up-and-go test (tug), single leg stance test (sls), use of rescue analgesics and patient satisfaction.

Eligibility criteria:
inclusion criteria: * symptomatic knee oa with pain for at least 6 months, despite conservative treatment such as analgesics, nsaids and/or physical therapy * average pain on knee movement of 30 mm or greater on a 100-mm vas * grade 2 or 3 knee oa according to the kellgren-lawrence grading system based on radiographs taken within the previous 6 months * radiological evidence of bilateral knee oa was accepted if global pain vas in the contralateral knee was less than 30 mm. exclusion criteria: * previous orthopedic surgery on the spine or lower limbs * disabling oa of either hip or foot * knee instability, clinical apparent joint effusion or marked valgus/varus deformity * known allergy to avian proteins or ha products * women ascertained or suspected pregnancy or lactating * intraarticular injections within the past 6 months * infections or skin diseases around the target knee * any specific medical conditions (rheumatoid arthritis, hemiparesis, neoplasm, etc.) that would interfere with the assessments

Keywords: knee osteoarthritis hyaluronic acid viscosupplementation
study of the inappropriate secretion of fgf23 in patients followed in hospital in a context of hypophosphatemia

Conditions: Hypophosphatemia Without Immediate Anteriority; Unexplained Hypophosphatemia

Summary: the discovery of fgf23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. by inhibiting the renal reabsorption of phosphate and the production of calcitriol, fgf23 behaves like a hypophosphatemia hormone. hypersecretion of fgf23 can occur in the case of genetic abnormalities (x-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, mccune-albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). oncogenic osteomalacia can be induced by hyperproduction of fgf23 by benign tumours of mesenchymal origin. but more recently, several cases of malignant tumours secreting fgf23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

to date, even if the incidence of fgf23-secreting tumours seems rare, no precise bibliographical data is available in the scientific literature. future studies will have to address this issue in order not to underestimate the frequency of this complication. in this context, investigators would like to study the incidence of inappropriate fgf23 increase from a collection of biological samples carried out on 500 patients treated at the clermont-ferrand university hospital for hypophosphatemia.

Eligibility criteria:
inclusion criteria: * major patient, male or female * taken care of at the clermont-ferrand university hospital or the jean perrin centre * in a context of hypophosphatemia (\< 0.80 mmol/l), without immediate anteriority and not occurring during hospitalisation * in capacity to express informed consent to participate in research * affiliated to a social security system exclusion criteria: * previously diagnosed hypophosphatemia * hypophosphatemia during hospitalisation * haemodialysis patient * refusal to participate

Keywords: fgf-23 unexplained hypophosphatemia phosphate metabolism physiopathology of hypophosphatemia
pharmacological effects of pascoflair® on brain activity in patients suffering from test anxiety

Conditions: Stress; Brain Activity; Passiflora Incarnata; Test Anxiety

Summary: proof of effectiveness of pascoflair using qantitative measurement of electric brain activity during examination stress in 40 subjects suffering from test anxiety. a double-blind, randomized, placebo-controlled, 2-armed, phase iv study in parallel design.

anxiolytic effects of pascoflair® shall be tested in subjects suffering from test anxiety after single intake by aid of a newly developed, validated method consisting of a combination of eye tracking (following glances) with neurocode tracking (quantitative eeg with a time resolution of 364 ms).

Eligibility criteria:
inclusion criteria: * healthy male and female subjects. * age between 18 and 40 years (both included). * anxiety questionnaire paf (pre-selection of subjects) - values above t\> 60 are regarded as conclusive. * inconclusive case history and diagnosis. * subject must be capable of giving informed consent. * acceptance of written consent to participate in the study after education in written and oral form (informed consent). exclusion criteria: * acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. * clinically relevant pathological findings from clinical and laboratory findings. * presence of clinically relevant pathological eeg features or artifact-free portion of the screening eeg \<30%. * clinically relevant allergic symptoms. * detection of alcohol at the time of initial examination (day sc) or on study day a (positive alcohol test) or by case history. * detection of drugs (positive drug test) at the time of initial examination (day sc). * consumption of clinically relevant medication during last fourteen days before and during the active study period based on the notification of the subject or his case history. * consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensives). * known intolerance / hypersensitivity (allergy) to plant derived extracts (passion flower dry extract) or any of the ingredients of the investigational product (anamnestic). * presence of a rare, genetic disease such as fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency (anamnestic). * bmi (body mass index) \ 32. * consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day) or tobacco (more than 20 cigarettes per day). * smoking on day of a.
advanced endoscopy during covid-19

Conditions: Cholangitis, Secondary Biliary; Cholangiocarcinoma; Obstructive Jaundice; Pancreas Cancer; COVID-19; SARS-CoV-2

Summary: in this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world.

in this study, investigators aim to explore the status of advanced endoscopy (endoscopic retrograde cholangiopancreatography and endoscopic ultrasound on a global level) in different endoscopy units all over the world, to report the characteristics of patients presented to these units and their procedure details. evaluate the validity of different gi societies recommendations applied in different gi endoscopy units on the prevention of sars-cov-2 nosocomial transmission and the overall impact of this recommendations on the service provided by each gi unit. target audience: - physicians performing advanced gastrointestinal endoscopies in different countries. objectives: * primary objective: 1- to explore the status of advanced endoscopy (endoscopic retrograde cholangiopancreatography and endoscopic ultrasound on a global level) in different endoscopy units all over the world, to report the characteristics of patients presented to these units and their procedure details. * secondary objectives: 1. effect of covid-19 precautions on procedure time, procedure success, complications and patient outcomes 2. effect of covid-19 on working time and staff number process: a questionnaire containing advanced endoscopy procedure details in different countries will be distributed via emails. responses will be collected in an online platform and data will be analyzed to reveal the effect of sars-cov-2 pandemic on different aspects of advanced endoscopy practice in the studied countries.

Eligibility criteria:
inclusion criteria: * patients referred for ercp or eus during the study period exclusion criteria: * patients refusing to participate in the study

Keywords: obstructive jaundice cholangitis pancreas cancer covid-19 sars-cov-2 esophagogastroduodenoscopy endoscopy endoscopic retrograde cholangiopancreatography endoscopic ultrasound
evaluation of the french translation of swallowing (soal-vf) patient reported outcomes (pro) after total pharyngolaryngectomy

Conditions: Pharyngeal Cancer; Swallowing Disorder; Larynx Cancer

Summary: a monocentric study to evaluate the french translation of swallowing (soal-vf) patient reported outcomes (pro) after total pharyngolaryngectomy

the soal questionnaire is a validated patient reported outcomes (pro) questionnaire in english language. the aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after total pharyngolaryngectomy.

Eligibility criteria:
inclusion criteria: * total pharyngolaryngectomy * age ≥ 18 years old * read, write and understand the french language exclusion criteria: * patient under guardianship, deprived of liberty, safeguard of justice * refusal to participate in research

Keywords: soal patient reported outcomes
start-to-sport - home-based exercise for adolescents and adults with congenital heart disease

Conditions: Congenital Heart Defect

Summary: almost 1% of all baby's is born with a heart defect (chd) and most of them survive. even though outcomes are good, they need lifelong follow-up because of a higher risk for cardiovascular diseases. studies have shown that patients with chd are not active enough and that a substantial amount of patients is overweight. hence preventive strategies and education should not only focus on the heart problem, but also on a healthy lifestyle including physical activity. recently a new guideline introduced exercise prescription based on the absence/presence of certain key elements. however, a number of important questions remain that preclude implementation in clinical practice. therefore a 'start-to-sport' program for adults with chd, based on this new guideline, will be investigated. this study is a randomized controlled trial that investigates the effects of the program on daily physical activity, exercise capacity, quality of life and exercise self-efficacy both in short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by using a new exercise-testing protocol that looks simultaneously to all body parts that are involved during exercise. ultimately, our findings will result in the implementation of the guideline in clinical practice.


Eligibility criteria:
inclusion criteria: * adolescents and adults with congenital heart disease * 16 to 65 years exclusion criteria: * congenital rhythm or conduction disorders * isolated congenital coronary artery anomalies * pregnancy * being listed for heart transplantation * inability to perform standard physical activities due to mental/physical disability.

Keywords: adult congenital heart disease exercise capacity exercise training physical activity