Kornimate/medical-research-clean huggingface dataset:
b-cell depletion using the monoclonal anti-cd20 antibody rituximab in chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Summary: based on pilot patient observations, and experience from the prior study kts-1-2008, the investigators anticipate that chronic fatigue syndrome patients may benefit from b-cell depletion therapy using rituximab induction with maintenance treatment. the hypothesis is that at least a subset of cfs patients have an activated immune system involving b-lymphocytes, and that prolonged b-cell depletion may alleviate symptoms.


Eligibility criteria:
inclusion criteria: * patients with cfs * age 18-66 years * informed consent exclusion criteria: * patients with fatigue, not fulfilling criteria for cfs * pregnancy or lactation * previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ * previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis * previous long-term use of immunosuppressive drugs, except steroids e.g. in obstructive lunge disease * endogenous depression * lack of ability to comply by the protocol * multi-allergy with risk of serious drug reaction * reduced renal function (creatinin \> 1.5 x unl) * reduced liver function (bilirubin or transaminases \> 1.5 x unl) * hiv positivity * evidence of clinically significant infection

Keywords: chronic fatigue syndrome cfs myalgic encephalomyelitis rituximab b-cell depletion
epidemiological analysis for hereditary angioedema disease

Conditions: Abdominal Pain; Functional Abdominal Pain

Summary: an international, multicenter, epidemiological, observational study investigating the prevalence of hereditary angioedema (hae) disease among participants with recurrent episodes of abdominal pain of no obvious etiology.

hereditary angioedema (hae) is a rare autosomal dominant disorder characterized most commonly by deficient (type 1) or nonfunctional (type 2) c1 inhibitor protein (encoded by serping1 gene). the disorder is associated with episodes of angioedema of the face, larynx, lips, abdomen, and extremities. the angioedema is caused by the activation of the kallikrein-kinin system that leads to the release of vasoactive peptides, followed by edema, which in severe cases can be life threatening. gastrointestinal involvement occurs in 93% of patients with hae and may be the only manifestation of the disease. however, individuals with gastrointestinal symptoms are rarely considered for hae and the disease can be misdiagnosed for several years. eha study focuses on the gastrointestinal complications of hae as a potential area of misdiagnosis leading to surgical morbidity. aim of the study is to investigate the prevalence of hae among participants experiencing recurrent abdominal pain attacks with no clear etiology. the hae-positive samples in the study will be further analyzed biochemically to identify disease-specific biomarker that may support the development of new diagnostic tools for hae disease.

Eligibility criteria:
inclusion criteria * informed consent will be obtained from the participant or the parent or legal guardian * participants with previous episodes of abdominal pain of no obvious etiology * participants aged between 2 to 60 years old exclusion criteria * previous diagnosis of hae * inability to provide informed consent * the etiology of abdominal pain attacks is determined * participants that are younger than 2 years old or older than 60 years old * previous enrolled in the study

Keywords: hereditary angioedema dbs-based biochemical and genetic assay for hae type i/ii biomarker
copper and molybdenum balance in participants with wilson disease treated with alxn1840

Conditions: Wilson Disease

Summary: this exploratory study will investigate the effects of alxn1840 on copper balance in participants with wilson disease (wd).

participants who are treatment experienced (which includes standard-of-care therapies or alxn1840) and treatment naïve are eligible for this study.

Eligibility criteria:
inclusion criteria: 1. diagnosis of wd by leipzig criteria ≥ 4. 2. able to reside in the clinical research unit for intensive metabolic monitoring of copper and molybdenum. 3. participants willing to adhere to copper/molybdenum-controlled diet during the study. 4. willing and able to follow protocol-specified contraception requirements. 5. capable of giving signed informed consent. exclusion criteria: 1. decompensated cirrhosis or model for end stage liver disease score \> 13. 2. modified nazer score \> 7. 3. clinically significant gastrointestinal bleed within past 3 months. 4. alanine aminotransferase \> 2 × upper limit of normal. 5. hemoglobin less than lower limit of the reference range for age and sex. 6. significant medical history (current or past). 7. previous treatment with zinc within 30 days prior to the screening visit. 8. participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance \< 30 milliliters/minute.

Keywords: copper balance molybdenum balance wilson disease alxn1840
patient registry assessing effectiveness and safety of heart failure treatment with lcz696 across canada

Conditions: Heart Failure

Summary: the purpose of the study is to describe the heart failure with reduced ejection fraction (hfref) patient population receiving sacubitril/valsartan treatment.

the purpose of the study is to describe the heart failure with reduced ejection fraction (hfref) patient population receiving sacubitril/valsartan treatment.

Eligibility criteria:
inclusion criteria: * receiving sacubitril/valsartan as per the canadian product label and treatment initiation within the last 3 months * able to communicate with investigator exclusion criteria: * participation in a clinical trial of an investigational drug, concurrently, or within the last 30 days * presence of any condition that in the opinion of the investigator, prohibits patient from participating in the trial

Keywords: heart failure heart failure with reduced ejection fraction hfref
eus-rfa pancardinal-1 trial

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)

Summary: the objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (eus) radiofrequency ablation (rfa) plus standard-of-care neoadjuvant chemotherapy (nac) in the treatment of pancreatic ductal adenocarcinoma (pdac). endoscopic ultrasound (eus) radiofrequency ablation (rfa) and neoadjuvant chemotherapy (nac) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.


Eligibility criteria:
inclusion criteria: * diagnosed and histologically-confirmed pdac by biopsy * permanent street address * consent to study participation * axial ct scan consistent with pdac * no prior chemotherapy or less than 2 months of pre-operative chemotherapy for pdac * eastern cooperative oncology group (ecog) performance status of 0-2 exclusion criteria: * male or female patients \< 18 years of age * no permanent street address or telephone number * pregnant patients * inmates or prisoners * unable to provide informed consent

Keywords: endoscopic ultrasound radiofrequency ablation (eus-rfa)
detection of viable ctcs using the epidrop technology in metastatic prostate cancer (epidrop)

Conditions: Prostate Cancer

Summary: the use of liquid biopsy could be the key for precision medicine. circulating tumor cells (ctcs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. however, their detection and capture are still a challenge as they are very rare in the bloodstream. in this clinical trial named "epidrop", the investigators will use an innovative device called epidrop (for epispot in a drop) in metastatic prostate cancer. epidrop is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic ctcs at the single cell level. the investigators will stain cells in the sample for epcam, psma, cd45 before to encapsulate them one by one in microdroplets and measure the psa secretion by only the viable ctcs. this study aims to demonstrate the non-inferiority of the epidrop compared to the cellsearch system.

methods : one hundred patients with a metastatic prostate cancer will be recruited plus 50 healthy donors. twenty ml of blood will be drawn : 10 ml of blood will be drawn on cellsave tubes (fixed cells) for ctc detection using the fda-cleared cellsearch system (gold standard) and 10 ml of blood will be drawn on edta tubes (viable cells) for the detection of functional ctcs using the epidrop. patients will be followed for 18 months. samples from fifty control subjects will be provided by the etablissement français du sang.

Eligibility criteria:
inclusion criteria : * to be male, over 18 years old * metastatic prostate cancer naive to any treatment or metastatic prostate cancer in biological recurrence (psa increase) and/or clinical recurrence after hormone suppression (mcrpc) exclusion criteria: * non-metastatic prostate cancer in biological and/or clinical recurrence after hormone-suppression (nmcrpc) * other active or treated cancer less than 5 years old * be protected by law (guardianship or curatorship) * be deprived of liberty by administrative decision * not being affiliated to a social security scheme, or not being a beneficiary of such a plan * being in a period of exclusion from another protocol * inability to understand and/or respond to questionnaires * inability to understand the nature, purpose and methodology of the study * refusal to sign informed consent

Keywords: circulating tumor cells (ctcs) biomarker cellsearch epidrop
this study will compare force production in double-leg squats of college students before and after a standardized foam rolling session

Conditions: Force Production; Pain Intensity Assessment

Summary: this study is a within-subject controlled trial . the investigators will compare unilateral force production in a bodyweight double-leg squat before and after a standardized foam rolling session with the use of vald forcedecks. theforcedecks use sensors embedded within separate plates to record the forces exerted. participants will have their weight, height, and dorsiflexion range of motion measured prior to performing 3 double-leg squats. participants will then be instructed on the foam rolling technique. they will perform the technique on each quadriceps group and will state their pain level at 30 seconds and at 2 minutes using the vas pain scale.

the invetigators will compare independent bilateral double-leg squat force productions before and after a structured foam rolling routine. participants will first be measured for height, weight, and dorsiflexion rom (sads; standing ankle dorsiflexion screen). quadriceps muscle belly length will be determined by measuring from the asis to the superior pole of the patella and marking the middle 2/3 of the region. participants will then stand on vald forcedecks for normalization. (the forcedecks use sensors embedded within separate plates to record the forces exerted by each leg.) with hands on hips, participants will perform three body weight double leg squats (squatting above 90 degrees of knee flexion). participants will then watch a demonstration of single leg quadriceps foam rolling which will consist of 3-point contact in a plank position with the targeted leg not having contact with the ground. participants will be cued for continuous motion on a count of 3 seconds in each direction without pausing. participants will be asked to respond to a visual analog scale for pain at 30 seconds and at 2 minutes (end of session). participants will be given a 30-second rest between sides. upon completion, participants will return to the forcedecks and perform 3 additional body weight double-leg squats with hands on hips (approximate same depth of squat as the initial set).

Eligibility criteria:
inclusion criteria: university student; 18-22 years of age - exclusion criteria: unable to get up from the ground without assistance; current lower extremity injury; prior lower extremity surgery in the past 10 years -
impact of the systematic closure of the epigastric trocar on postoperative incisional hernia after sleeve gastrectomy rate of first intention. monocentric study, before / after prospective.

Conditions: Bariatric Surgery

Summary: the sleeve gastrectomy (sg) is a bariatric surgery procedure performed by laparoscopic booming in recent years. this is an effective intervention on weight loss over the long term with few early postoperative complications and low morbidity in the long term. obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a relative risk of 29% in connection with cholecystectomy. several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical evaluation. recently, it was shown eventrations rate between 26 and 38% under the roux-en-y gastric bypass with a rupture rate increased on epigastric trocar. the assessment in the context of this series was ultrasound. recent data suggest that the absence of closure of the epigastric trocar of 12mm through an sg of first intention was associated with a hernia rate of 17% with a scannographic evaluation. also, recently, tabone suggests that the systematic closure of the epigastric trocar site would not be as effective as lateralize inserting the trocar from the white line of the abdomen. change the positioning of this trocar induce an additional difficulty in handling instruments for the realization of the sg with an désaxassion instruments, a conflict between the instruments for the realization of the sg and the optical laparoscopy.


Eligibility criteria:
inclusion criteria: * major patients (≥ 18 years) who underwent sg 1st intention by laparoscopy as part of the surgical management of obesity. exclusion criteria: * antecedent of previous gastric band. * history of sg (repeat-sg). * median laparotomy history or subcostal right. * sg performed as an ambulatory surgery. * patients with early postoperative complications (≤ j90) specific to the sg (postoperative gastric fistula, postoperative bleeding, hematoma or postoperative intra-abdominal abscess)

Keywords: the sleeve gastrectomy (sg) bariatric surgery laparoscopy systematic closure of the epigastric
a study to evaluate efficacy and safety of gc3110b in healthy adults

Conditions: Influenza, Human

Summary: the purpose of this study is to evaluate immunological efficacy and safety of gc3110b versus gcflu quadrivalent inj. among healthy adults in 18 to 60 years of age.

adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either gc3110b or gcflu quadrivalent inj.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18 to 60 years * informed consent form has been signed and dated * able to comply with the requirements of the study exclusion criteria: * known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components * personal history of guillain-barré syndrome * subjects with severe chronic disease who are considered by investigator to be ineligible for the study * subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study * immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Keywords: influenza vaccines
left atrial appendage occlusion versus novel oral anticoagulation for stroke prevention in atrial fibrillation

Conditions: Atrial Fibrillation; Stroke

Summary: atrial fibrillation (af) is progressively common, and increases the risk of stroke five-fold. oral anticoagulation is the mainstay therapy; however, it increases the risk of bleeding. moreover, 30% with af and at risk of stroke are not in relevant anticoagulation. the randomized protect-af trial has demonstrated the superiority of left atrial appendage occlusion (laao) as compared to warfarin for prevention of the combined endpoint of stroke, major bleeding and cardiovascular mortality. however, studies comparing laao to therapy with novel oral anticoagulants (noac) have not been carried out. this study aims to assess the effect of left atrial appendage occlusion (laao) to reduce the incidence of stroke, systemic embolism, major bleeding and all-cause mortality in patients with atrial fibrillation (af) and a prior ischemic stroke or transient ischemic attack (tia).

an investigator-initiated multicenter, randomized open-label non-inferiority trial with blinded outcome evaluation (probe design). the active comparison laao is tested against noac therapy in a 1:1 stratified randomization. patients should have af, and an ischemic stroke or tia within 6 months prior to enrollment. in total 750 patients will be included. follow-up will be based on in-office and telephone follow-up during the first 3 years after randomization, along with up to 10 years long-term follow-up through the national patient registries. the main study outcomes: the primary outcome is a composite of stroke (hemorrhagic or ischemic), systemic embolism, major bleeding or all-cause mortality assessed after at least two years follow-up for the last enrolled patient. secondary outcomes will examine early and late safety outcome measures. the long-term outcome will be assessed up to 10-years after randomization through the national patient registries.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * documented non-valvular atrial fibrillation (paroxysmal, persistent or permanent) * eligible for long-term novel oral anticoagulation (noac) therapy * ischemic stroke within the recent 6 months verified by neuroimaging, or * transient ischemic attack within 6 months with proven cerebral ischemia based on cerebral magnetic resonance imaging (mri) exclusion criteria: * modified rankin scale \> 3 at time of enrollment * glomerular filtration rate (gfr) below 15 ml/min/1.73 m2 * contraindication towards long-term aspirin therapy * planned combined cardiovascular interventional procedures at the time of enrollment * terminal illness or cancer with life expectancy less than 2 years.

Keywords: left atrial appendage occlusion novel oral anticoagulation
optimizing the preparation regime prior to colonoscopy procedure with pure-vu system

Conditions: Gastrointestinal Diseases; Colorectal Cancer

Summary: the primary objective of this multicenter, prospective, randomized study is to evaluate the performance of pure-vu system in cleansing patients' colon who are indicated for a colonoscopy procedure using one of two different reduce bowel preparation regimes.in addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event will be evaluated.

this multicenter, prospective, randomized study will include up to 100 patients (30 patients per site and 15 patients per study arm), aimed at evaluating the performance of pure-vu system in cleansing patients' colon who are indicated for colonoscopy procedure using one of two different preparation regimes as detailed below. subjects will be enrolled at up to 10 clinical sites in the united states. subjects who meet the eligibility criteria will be randomly allocated to a given study arm and will be required to follow a specific bowel preparation instruction along with a specific prep agent (bowel preparation instructions for morning and afternoon procedures are provided in appendix b1 and b2, respectively), as per study arm allocation, starting 5 days prior to the colonoscopy with pure-vu. patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (diary log is provided in appendix d). in addition patient will be ask to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime. following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post pure-vu procedure to assess patient well-being and capture any adverse events.

Eligibility criteria:
inclusion criteria: 1. subjects scheduled for colonoscopy procedure 2. subjects in the age range of 22-75 years inclusive 3. subject is willing and able to participate in the study procedures and to understand and sign the informed consent. exclusion criteria: 1. patients with active inflammatory bowel disease 2. patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease 3. patients with known bowel obstruction 4. patient with chronic constipation 5. history of prior surgery to colon and/or rectum 6. asa (physical status classification system) ≥ iii 7. renal insufficiency (creatinine ≥ 1.5mg /dl) (based on medical history) 8. abnormal liver enzymes (alt/ast ≥ 2 times upper limits of normal) (based on medical history) 9. patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy 10. patients with known coagulation disorder (inr \>1.5). 11. pregnancy (as stated by patient) or breast feeding 12. patients with altered mental status/inability to provide informed consent
flexed: a digital, gamified early intervention for eating disorders

Conditions: Eating Disorders; Body Image

Summary: the goal of this multiple baseline experiment is to test the effect of a digital, gamified early intervention for eating disorders on body image flexibility and determine treatment dose. twenty-four young women and girls (between the ages of 15-25) with eating disorder (ed) symptoms will be randomized to different baseline durations (varying between 2-6 weeks). participants will complete eight 20-30 minute sessions of a multimedia application over 10 weeks using their home computer or mobile device. body image flexibility (bif) will be measured repeatedly using a multimodal assessment strategy (behavior, physiological and self-report) during baseline and treatment phases. the investigators will estimate the effect of the intervention on bif and examine when change occurs and plateaus (with no discernable benefit for additional sessions) to determine treatment dose.


Eligibility criteria:
inclusion criteria: * female identified 15-25 years old * weight concerns scale score of \>47 * maladaptive weight control behaviors with onset \<3 years exclusion criteria: * currently meets full diagnostic criteria anorexia or bulimia nervosa or has in the past. * psychosis, substance use disorder or current suicidal ideation or self-harm. * start or change in psychiatric medications within the past month. * nonenglish speaking. * presents with other specified feeding or eating disorder (osfed) that does not have weight/shape concerns as a primary feature (e.g., avoidant restrictive food intake disorder).

Keywords: eating disorders body image flexibility acceptance and commitment therapy psychological flexibility online early intervention
antihypertensive efficacy and safety of approved drugs in japanese patients with essential hypertension (banyu study)(0954a-302)

Conditions: Hypertension

Summary: the purpose of this study is to evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone.

the duration of treatment is 3.5 months.

Eligibility criteria:
inclusion criteria: * japanese ancestry * stable high blood pressure defined by the study criteria exclusion criteria: * pregnant or nursing * significant concurrent kidney, liver, blood, or other disease * recent heart attack or heart surgery * history of stroke, severe hypertension (high blood pressure), significant heart failure or cardiac arrhythmias * significant lab abnormalities * uncontrolled blood sugar * history of certain drug allergies