Kornimate/medical-research-clean huggingface dataset:
fmt in checkpoint inhibitor-mediated diarrhea and colitis

Conditions: Diarrhea; Colitis; Malignant Melanoma; Kidney Cancer

Summary: the goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (imc) treated with faecal microbiota transplantation (fmt) in a randomised, placebo-controlled trial. the aim of the present study is to assess the feasibility, pilot efficacy, and safety of fmt for patients with imc. participants will be treated two times with capsule fmt or placebo capsules in a 1:1 ratio. the intervention treatment will be an add-on to the patients' standard treatment for imc. researchers will compare the fmt-treated group to the placebo-treated group to see if fmt promotes remission of imc.

as above

Eligibility criteria:
inclusion criteria: 1. age 18 years or above. 2. histologically proven diagnosis of malignant melanoma and/or kidney cancer. 3. treatment with any immune checkpoint inhibitor (nivolumab, pembrolizumab, cemiplimab, atezolizumab, durvalumab, avelumab, ipilimumab), alone or in combination, within the last 8 weeks. 4. grade 2 or higher ctcae diarrhea, of which at least 3 stools are bristol chart score 6-7. 5. negative pcr for enteric pathogens including c. difficile, after the onset of diarrhea. 6. signed written informed consent. exclusion criteria: 1. diagnosed bacterial infection requiring antibiotic treatment at inclusion. 2. pregnancy or breastfeeding. pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hcg) urine test. 3. primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease. 4. unable to ingest capsules. 5. unable to understand written or oral patient information.
pilot evaluation of cvt-e002 in pediatric upper respiratory tract infection.

Conditions: Upper Respiratory Infection

Summary: this is a randomized double-blind three-arm trial to evaluate two dosages of cvt-e002 against placebo in pediatric upper respiratory tract infections (urti). it is hypothesized that cvt-e002 use at standard doses reduces the duration of urti in children aged 3-12 years.

the eligible children, for whom parental consent has been obtained, will be randomized to one of three groups (standard dose, low dose, or placebo). the standard dose group will receive an oral aqueous solution using the standard dose of cvt-e002, adjusted according to the child's weight. the second group will receive an oral aqueous solution with half of the standard dose of cvt-e002, adjusted according to the child's weight, and the third group will receive a placebo as an aqueous solution of starch that does not contain any cvt-e002 or active medication, volume adjusted for the child's weight. parents will be provided with a 3-day supply of study medication according to the randomization schedule. cvt-e002 will be administered by the parent to the child three times daily for three consecutive days following the onset of a urti. severity and duration of urti will be measured using the reliable and valid canadian acute respiratory infection flu score (carifs).

Eligibility criteria:
inclusion criteria: * children aged 3-12 years who present to their pediatrician with in 48 hours of the onset of an acute upper respiratory tract infection. * signed informed consent form exclusion criteria: * children who have had an immunization in 3 months prior to the study * children with known hypoglycemia or diabetes * children who have a bacterial illness diagnosed at the same visit (e.g. otitis media, pneumonia, etc.) which will be treated with antibiotic therapy * children who have a malignancy or who have undergone treatment for a malignancy in the previous three months * children with known active liver disease (e.g. hepatitis) * known hypersensitivity to ginseng products * concurrent treatment with warfarin, digoxin, ginseng products or phenelzine * patients with coagulation disorders

Keywords: cold flu respiratory tract infection
a prospective chart review to validate the wfirs (weiss functional impairment rating scale)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: the purpose of the study is to evaluate the psychometric validation of the weiss functional impairment rating scale and the weiss symptom record. it is hypothesized that the weiss functional impairment rating scale has strong psychometric properties and good convergent validity with other measures of functioning and discriminant validity from symptoms and quality of life.

the measures for this rating scale were developed at the request of the canadian attention deficit disorder resource alliance to provide clinician friendly tools free of charge as a way of improving screening for adhd and comorbidity. patients are consented during clinic visits and agree to allow use of clinic data for the purpose of this research. they complete additional measure(s) for the purpose of the study. the data is then entered. internal consistency will be measured using cronbach's alpha. convergent, concurrent and discriminant validity will be measured using pearson correlations. domain reliability is determined with factor analysis. up to 220 patients will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * compliance to complete the wfirs is key to inclusion.

Keywords: adhd wfirs wsr
effectiveness, safety, and tolerability study of oxymorphone immediate release (ir) oral liquid in opioid tolerant pediatric subjects

Conditions: Chronic Pain

Summary: the purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (ir) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.


Eligibility criteria:
inclusion criteria: 1. males or females 2 to ≤6 years of age, inclusive 2. chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose \>1 mg/kg qd oral morphine equivalent) 3. expected to continue to require a strong opioid for pain relief for at least 4 months 4. able to swallow the oxymorphone hcl immediate-release oral liquid 5. have been informed of the nature of the study and informed consent and assent by minor (if irb required) has been obtained from the legally responsible parent/legal guardian in accordance with irb requirements exclusion criteria: 1. known allergy to, or a significant reaction to, oxymorphone or another opioid 2. life expectancy \<4 months 3. any clinical condition in the investigator's opinion that would preclude participation 4. plan to undergo a surgical procedure within 1 month of study entry or anytime during study 5. currently prescribed a long-acting opioid (eg., kadian® morphine sulfate extended release) as part of their analgesic regimen 6. received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study 7. an ileostomy 8. received a monoamine oxidase inhibitor (maoi) within 14 days prior to the start of study medication 9. investigator anticipates that the subject would be unable to comply with the protocol 10. parent/legal guardian is unable to complete the subject's daily study medication diary 11. parent/legal guardian is unable to effectively communicate the subject's status to the investigator

Keywords: sickle cell anemia juvenile rheumatoid arthritis burn victim cancer chronic pain of malignant or non-malignant etiology
evaluation of tolerance and efficacy retrospective data of xofigo

Conditions: Prostate Cancer; Bone Metastases; Hormone-resistant Prostate Cancer

Summary: since 13 november 2013, xofigo has been authorised on the european zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy. bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment. xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

since 13 november 2013, xofigo has been authorised on the european zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. prostate cancer is the most common non-cutaneous cancer in men internationally, and more than 90% of patients with hormone-resistant prostate cancer will have bone metastases. they frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy. bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment. there is therefore a need for bone-targeting therapeutic agents that provide a benefit in terms of survival. xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases. this treatment appears to have fewer side effects than chemotherapy (and does not call into question subsequent chemotherapy) or that the currently available metabolic bone radiotherapy as well as better pain control and survival gain than the latter do not

Eligibility criteria:
inclusion criteria: all patients who received treatment with xofigo in the framework of the amm, in france since november 2013 are potentially eligible. exclusion criteria: patients expressing a refusal to use this research data

Keywords: xofigo clinical database
the prevent anal cancer self-swab study

Conditions: Anal Cancer

Summary: the purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (msm) and transgender persons. this study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.

this is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based dna screening of anal canal exfoliated cells among milwaukee hiv+ and hiv- men who have sex with men (msm) and transgender persons aged ≥25 years. at study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. then, persons will receive high-resolution anoscopy (hra)-directed biopsy to assess precancerous lesions by study arm. we hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. the proposed research could indicate that annual hpv dna screening and subsequent hra are acceptable to msm and transgender persons; thus, we will determine how high-risk persons are identified for hra in light of limited hra resources. the duration of each participant's activities is expected to be 12 months. the study is expected have participant activity from 2019 to 2023.

Eligibility criteria:
inclusion criteria: * be \> 25 years of age * sex at birth is male or gender identity is a transgender person * acknowledge sex with men in the last 5 years, or identify as gay or bisexual * understand and be willing to give informed consent * be willing to be randomized and able to comply with the protocol * spanish and/or english speakers/readers, and * hiv+ or hiv- exclusion criteria: * not acknowledge sex with men in the past five years and not identify as gay or bisexual * use of anticoagulants other than aspirin or nsaids * prior diagnosis of anal cancer * plans to move within 12 months * not milwaukee metro residents * not willing to attend one of the designated study clinics at baseline, or * inability to give informed consent

Keywords: anal cancer human papillomavirus
parastomal reinforcement with strattice

Conditions: Parastomal Hernia

Summary: the purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.


Eligibility criteria:
inclusion criteria: * adults * need for permanent ileostomy or colostomy exclusion criteria: * history of hernia at new ostomy site * has previously implanted surgical mesh at site of planned ostomy * requires a temporary ostomy * has need for multiple ostomies * is receiving chronic immunosuppression therapy, has meld score of \> 17, has severe copd, systemic infection, or known collagen disorder * is bedridden or otherwise non-ambulatory

Keywords: ostomy creation parastomal hernia
catheter evaluation for endocardial ablation in patients with ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: the primary objective is to provide additional corroborative safety and efficacy data for the navistar thermocool catheter for the treatment of subjects with ischemic ventricular tachycardia.

this study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. the device is currently fda approved for commercial distribution. subjects with ischemic ventricular tachycardia will be considered for the condition of approval study. this study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects.

Eligibility criteria:
inclusion criteria: 1. documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one) 1. for patients with icds: documented episodes must be four (4) or greater for entry into the study. 2. for patients without icds: documented episodes must be two (2) or greater within two (2) months and the assessment will be performed by a review of ecgs and hospitalization records. 3. incessant vt due to prior myocardial infarction (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion). 2. spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or icd intervention. 3. left ventricular ejection fraction \> 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days. 4. age eighteen (18) years or older. 5. signed patient informed consent form. 6. able and willing to comply with all pre-, post-, and follow-up testing requirements. exclusion criteria: 1. definite protruding left ventricular thrombus on pre-ablation echocardiogram. 2. myocardial infarction within the preceding two (2) months. patients with incessant vt (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion) may be enrolled if their mi is at least three (3) weeks old. 3. patients with idiopathic vt. 4. other disease process likely to limit survival to less than twelve (12) months. 5. class iv heart failure. 6. serum creatinine of \> 2.5 mg/dl. 7. thrombocytopenia (defined as platelet count \<80,000) or coagulopathy. 8. contraindication to heparin. 9. women who are pregnant. 10. cardiac surgery (i.e. ventriculotomy, atriotomy) within the past two (2) months. patients with incessant vt (present 50% of the time with intervention for a period \>12 h) may be enrolled if their surgery is at least three (3) weeks old. 11. acute illness or active systemic infection. 12. unstable angina. 13. severe aortic stenosis or flail mitral valve. 14. uncontrolled heart failure. 15. significant congenital anomaly or medical problem that, in the opinion of the principal investigator, would preclude enrollment in the study. 16. enrolled in an investigational study evaluating another device or drug.

Keywords: ventricular tachycardia heart diseases arrhythmia
evaluation of the effects of eccentric muscle training versus conventional concentric training in chronic heart failure

Conditions: Chronic Heart Failure; Reconditioning to Effort

Summary: this is a single-centre open randomized parallel-group study. patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation. in addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. this group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.


Eligibility criteria:
inclusion criteria: patients : * patients who have provided written informed consent * patients with national health insurance cover * men or women aged between 45 and 85 years with stabilized chronic heart failure (ischemic or dilated cardiopathy) for at least one month, new york heart association stage\> 2. * echocardiographic left ventricular ejection fraction (simpson method) \ 3 x upper limit of normal\* (\*= 125pg/ml for the chu laboratory). * first period of rehabilitation for chronic heart failure. healthy volunteers: * subjects who have provided written informed consent * subjects with national health insurance cover * men or women aged between 18 and 85 years. exclusion criteria: patients: * persons without national health insurance cover * severe obstructive cardiopathy, * severe aortic valve stenosis, * severe progressive heart rhythm or conduction disorders not corrected with a pacemaker, discovered at the initial effort test * intra-cavitary thrombus, * severe pulmonary artery hypertension (systolic pulmonary arterial hypertension \>70mmhg), * recent history of venous trombo-embolism (last 3 months), * impaired executive function making it impossible to understand and follow reconditioning programme (mini mental test \< 24), * heart transplant, * associated medical disorders that could predominately impair functional capacity compared with the chronic heart failure (examples: respiratory insufficiency, non-stabilized metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilized disorder such as neoplasia, systemic disease...). associated chronic motor deficit of a neurological origin (example: sequelae of a cerebrovascular accident), an osteo-articular origin (example: impairment due to rheumatoid arthritis), of a peripheral vascular disease (example: peripheral artery disease, venous disease, lymphedema) will not be included in the exclusion criteria provided thay are compatible with the level of physical ability defined in the inclusion criteria. the presence of an implantable pacemaker and/or defibrillator will not be an exclusion criterion healthy volunteers: * persons without national health insurance cover * any organic disorder whatever its nature (cardiac, respiratory, neurological, orthopedic, ...) that could affect adaptation to effort or is a contra-indication for physical activity.
c11-erlotinib pet/ct as a tool for identification and characterization of tumor with high expression of epidermal growth factor receptor(egfr).

Conditions: Lung Cancer; Pancreatic Cancer

Summary: the egfr is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments. new treatment strategies targeting egfr have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(a review of erlotinib and its clinical use. tang pa, tsao ms, moore mj. expert opin pharmacotherapy. 2006 feb;7(2):177-93.) noninvasive pet/ct imaging of egfr expression activity and mutation status in nsclc could aid in the selection of patients for individualized therapy with egfr kinase inhibitors. whole-body noninvasive pet/ct imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with egfr inhibitors. the purposes of the study are: 1. to adjust an optimal treatment for patients with tumors that have high expression of egfr by identification of this type of cancer using c11-erlotinib pet/ct during pretreatment work-up; as well as to follow up after treatment response. 2. to recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.


Eligibility criteria:
inclusion criteria: * patients with nsc type of lung cancer with high expression of egfr who are candidates for erlotinib as second / third line of treatment; * patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment. exclusion criteria: * lack of histological diagnosis; * not a candidate for erlotinib; * pregnancy.

Keywords: epithelial growth factor receptors lung cancer advanced tumor of pancrease erlotinib c11-erlotinib pet/ct
point of care echocardiography versus chest radiography for the assessment of central venous catheter placement

Conditions: Central Venous Catheterization; Ultrasound; Emergency Medicine; Critical Care

Summary: a prospective study to compare the use of point of care echocardiography versus routine chest radiography for the assessment of central venous catheter placement.


Eligibility criteria:
inclusion criteria: * patients who require central venous catheterization in critical care environments (icu, imc) * patients (or legal guardian) who provide written informed consents * patients aged 18 years or older exclusion criteria: * patients who are unable/unwilling to give informed consent