Kornimate/medical-research-clean huggingface dataset:
diffuse myocardial fibrosis in fontan patients

Conditions: Congenital Heart Disease; Single Ventricle; Myocardial Fibrosis

Summary: the purpose of this protocol is to measure the relaxation of the heart in subjects with single ventricles who have undergone the surgical fontan procedure. we will do this by measuring relaxation with mri, echocardiography, and cardiac catheterization and compare to blood levels that measure heart scarring. we will also measure relaxation before and after boluses of intravenous (iv) fluids to see if the relaxation changes when there is more fluid in the heart. measurements of heart relaxation will be obtained from the mri, echocardiogram, and cardiac catheterization for each patient and compared to blood markers of heart scarring. we aim to compare all of these measurements to see if we can accurately identify heart scarring and, if present, how much it correlates with impaired heart relaxation.


Eligibility criteria:
inclusion criteria: adult patients (age ≥18) with a previous fontan procedure (including all variants) referred for catheterization. this includes individuals with tricuspid atresia, double inlet left ventricle, unbalanced atrioventricular septal defect, and pulmonary atresia with intact septum. control subjects will be selected from individuals referred to the lab for evaluation/closure of a patent foramen ovale (pfo). all subjects must be willing to participate in all portions of the study and provide written informed consent. exclusion criteria: contraindications to mri such as ferromagnetic objects in the chest, claustrophobia, or contraindication to gadolinium contrast (estimated creatinine clearance \< 30 ml/min/1.73m2). fontan patients with a morphologic right ventricle (namely hypoplastic left heart after a norwood palliation) will be excluded, because of the disproportionate risk of systolic dysfunction in the morphologic right ventricle.33 control patients with hypertension, diabetes, coronary disease, or reduced systolic function will be excluded.

Keywords: congenital heart disease myocardial fibrosis diastolic dysfunction
artificial intelligence versus expert endoscopists for diagnosis of gastric cancer

Conditions: Gastric Cancer

Summary: title: a single-center, retrospective randomized controlled trial of artificial intelligence (ai) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy. précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of ai and expert endoscopists. objectives primary objective: to evaluate the diagnostic detection rate for gastric cancer of ai and expert endoscopists. secondary objectives: to determine whether ai is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (iou), and the detection rate of diagnosis of early and advanced gastric cancer. endpoints primary endpoint: diagnosis of gastric cancer. secondary endpoints: image based diagnosis of gastric cancer and iou. population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in japan. describe the intervention: ai-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images. study duration: 3 months.

prior to study: total 500: screen potential subjects by inclusion and exclusion criteria; obtain endoscopy images. randomization was performed. intervention: ai diagnosis was performed for 250 patients using upper gastrointestinal endoscopy images, and expert endoscopists diagnosis was performed for 250 patients by same methods. primary analysis: perform primary analysis of primary and secondary endpoints for 250 patients in each group cross over diagnosis between ai and expert endoscopists was performed. perform secondary analysis of agreement of gastric cancer diagnosis per images and iou between ai and expert endoscopists for 500 patients.

Eligibility criteria:
inclusion criteria: 1. males or females aged ≥ 20 years who underwent upper gastrointestinal endoscopy at tokyo university hospital during 2018. 2. informed optout consent, obtained from each patient before completion of the study. exclusion criteria: 1. patients who underwent gastrectomy. 2. patients who underwent transnasal upper gastrointestinal endoscopy.

Keywords: artificial intelligence gastric cancer
effectiveness of transcranial direct current stimulation (tdcs).

Conditions: Ankle Sprains; Musculoskeletal Injury

Summary: reducing pain and recovery of strength and function are major challenges in physical therapy. transcranial direct current stimulation (tdcs) is a novel intervention that has gained popularity in the rehabilitation of athletic injuries, pain management, and sports performance. acute application of tdcs has been shown to modulate the perception of effort and fatigue, enhance motor learning, improve endurance performance, and improve muscular power and strength. tdcs has also been shown to reduce pain in patients with chronic pain conditions. using a double-blind, randomized clinical trial design, we aim to evaluate the effectiveness of tdcs plus standard rehabilitation compared to rehabilitation alone on pain, balance and proprioception, functional performance, and strength following acute ankle inversion sprain. we hypothesize that the group using tdcs will demonstrate superior outcomes in all variables of interest.


Eligibility criteria:
inclusion criteria: 1. age 18-40 2. within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain exclusion criteria: 1. self-reported pregnancy 2. being treated for and on medication for a mental health diagnosis 3. concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months 4. open wound or dermatologic lesion on the head or region of application 5. active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.). 6. epilepsy or history of seizures 7. participants who are not fluent in english
activated recombinant human factor vii following cardiac bypass surgery for paediatric congenital heart disease

Conditions: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass

Summary: this trial is conducted in oceania. the aim of this trial is to investigate the efficacy of activated recombinant human factor vii and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (cpb) surgery for paediatric congenital heart disease.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained from parent or legal guardian before any trial-related activities. trial-related activities are any procedure that would not have been performed during normal management of the subject * children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (cpb) exclusion criteria: * congenital heart disease that does not require cpb surgery
non-gene edited anti-cd7 car t cells for relapsed/refractory t cell malignances

Conditions: T-cell Acute Lymphoblastic Leukemia; T-cell Acute Lymphoblastic Lymphoma; T-cell Non-Hodgkin Lymphoma

Summary: this is a phase i, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-cd7 car (also called anti-cd7 car) t cells in patients with relapsed and/or refractory t cell lymphoma or leukemia

anti-cd7 car is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing cd7 antigen. t-cell acute lymphoblastic leukemia, t-acute lymphoblastic lymphoma and t-cell non-hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein cd7. the purpose of this study is to evaluate the efficacy and safety of anti-cd7 car t cells.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent; patients volunteer to participate in the research 2. diagnosis is mainly based on the world health organization (who) 2008 3. patients have exhausted standard therapeutic options 4. systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks 5. female must be not pregnant during the study exclusion criteria: 1. patients declining to consent for treatment 2. prior solid organ transplantation 3. potentially curative therapy including chemotherapy or hematopoietic cell transplant 4. any drug used for gvhd must be stopped \>1 week

Keywords: anti-cd7 car cd7car t cell leukoma/lymphoma t-all t-cell acute lymphoblastic leukemia t-cell acute lymphoblastic lymphoma
ai chi versus stretching in fibromyalgia management

Conditions: Fibromyalgia

Summary: the purpose of the study is to compare the efficacy and tolerability of ai chi, an adaptation of tai chi exercise to water, with stretching on fibromyalgia symtomatology.

physical therapies have shown to be effective in the treatment of fibromyalgia and it is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. as these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. at this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. in a previous study comparing short term physiotherapy with stretching and ai chi we found that ai chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. the objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia according to the acr criteria * 18 years or older * written informed consent to participate exclusion criteria: * unable to tolerate warm chlorinated water * associated medical condition contraindicating exercise in warm water

Keywords: fibromyalgia physical therapies stretching ai chi
efficacy of ultrasound-guided transverse carpal ligament release for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is one of the most common peripheral nerve entrapment neuropathies, and it is characterized by pain, numbness, tingling, and weakness in the regions innervated by the median nerve (mn). cts is believed to result from compression of the mn as it passes through the narrowed carpal tunnel with regard to gradual ischemia and fibrosis.ultrasound-guided needle release of transverse carpal ligament(tcl) is an effective method to decompress the carpal.there are two main approaches to perform the release, short-axis or long-axis. however, there is no consensus about the optimal strategy.thus, this study aimed to compare the efficacy of these two approaches for patients with mild-to-moderate cts.


Eligibility criteria:
inclusion criteria: * 18-80 years old * typical clinical signs of cts present for at least three months, including pain, numbness, and tingling of the hands * positive phalen or tinel sign * electrophysiological parameters supportive of mild to moderate cts * high-resolution ultrasonography demonstrated mn compression at the carpal. exclusion criteria: * bifid mn or bilateral cts * pregnancy * disorders such as rheumatic immune diseases, chronic renal failure, diabetes mellitus, hypothyroidism and other systemic diseases * any accompanying disorder that could mimic cts, such as thoracic outlet syndrome, cervical radiculopathy, polyneuropathy, proximal median nerve entrapment * history of carpal tunnel surgery or injection into the affected carpal tunnel * cts caused by trauma, surgery, intracarpal lesions, or mn lesions malignant tumors or severe cardiorespiratory diseases

Keywords: transverse carpal ligament ultrasound carpal tunnel syndrome
homoharringtonine and interferon alfa in treating patients with chronic myelogenous leukemia

Conditions: Leukemia

Summary: phase ii trial to study the effectiveness of homoharringtonine and interferon alfa in treating patients with chronic myelogenous leukemia. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. interferon alfa may interfere with the growth of cancer cells. combining chemotherapy with interferon alfa may kill more cancer cells.

objectives: i. determine the efficacy of homoharringtonine administered simultaneously with interferon alpha in achieving complete cytogenetic response in patients with chronic myelogenous leukemia in chronic phase. outline: single-agent chemotherapy plus biological response modifier therapy. homoharringtonine, hh, nsc-141633; plus interferon alfa (schering), ifn-a, nsc-377523.

Eligibility criteria:
disease characteristics: * chronic myelogenous leukemia (cml) in chronic phase * clonal evolution (i.e., the presence of clones other than the ph chromosome) allowed ph chromosome variants or complex ph chromosome translocations are not considered disease acceleration * ineligible for known therapy of higher efficacy or priority * allogeneic bone marrow transplantation should be considered priority therapy for cml patients with a matched related donor * no blastic phase cml (30% or more blasts in peripheral blood or bone marrow) * no accelerated phase cml, defined as any of the following: 15% or more peripheral or marrow blasts or 30% or more blasts and promyelocytes 20% or more peripheral or marrow basophils * thrombocytopenia (platelets less than 100,000) unrelated to therapy * documented extramedullary disease outside of liver or spleen patient characteristics: * age: 15 and over * performance status: zubrod 0-2 * life expectancy: sufficient to fully evaluate the effects of 2 courses of therapy * bilirubin no greater than 2.0 mg/dl * sgot less than 300 * creatinine less than 2.0 mg/dl or creatinine clearance at least 60 ml/min * no severe heart disease (class iii/iv) * no pregnant or nursing women * effective contraception required of fertile women prior concurrent therapy: * no prior interferon alpha * at least 2 weeks since antileukemic therapy, with recovery required * patients who received hydroxyurea within the past 2 weeks and have wbc greater than 50,000 may enter protocol after discussion with the primary investigator

Keywords: relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia
the effect of motivational messages on optimism, hopelessness and life satisfaction

Conditions: Motivation; Optimism; Hopelessness; Life Satisfaction

Summary: the covid-19 pandemic has affected global health systems and required healthcare professionals to show high performance. in this process, the mental health of intensive care nurses, who undertake the biggest burden in health systems, is negatively affected by the high working hours and patient care burden during the pandemic. when the literature is reviewed, pessimistic thinking, feeling hopeless and not enjoying life at more exacerbated levels can be observed in intensive care nurses. it is concluded that studies are needed to increase the motivation of intensive care nurses during the covid-19 pandemic.in this study, it was aimed to evaluate the effect of motivational messages on optimism, hopelessness and life satisfaction of intensive care nurses during the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * agreeing to participate in the study * being a nurse * working in intensive care during the covid-19 pandemic exclusion criteria: * underfilling or not fill out forms and scales
testing the engaged approach to lung cancer screening

Conditions: Lung Cancer

Summary: the goal of this study is to assess feasibility and acceptability of the engaged approach to lung cancer screening (ea-lcs) in diverse lung cancer screening (lcs) programs operating in a variety of geographic regions across colorado and the us.


Eligibility criteria:
inclusion criteria: the trial incorporates a multilevel assessment and enrollment involves inclusion criteria at two levels: (1) lcs program and (2) lcs program staff member. program inclusion criteria (n = up to 8 sites): * must conduct at least 50 low-dose computed tomography (ldct) scans per year (baseline + follow-up) * must be able to identify a primary contact person for lcs program operations (e.g., program coordinator, program navigator, program manager, etc.) staff member inclusion criteria (n \~ 5 at each site/\~40 participants total): * identified staff member of the lcs program site * \>18 years of age * must be able to complete study surveys and interviews in english * willing to provide informed consent exclusion criteria: * none
a pivotal study of su011248 in the treatment of patients with cytokine-refractory metastatic renal cell carcinoma.

Conditions: Carcinoma, Renal Cell

Summary: to assess the safety and efficacy of su011248 in patients with metastatic, refractory renal cell carcinoma


Eligibility criteria:
inclusion criteria: * cytokine refractory metastatic renal cell carcinoma with clear cell component * radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy * prior nephrectomy exclusion criteria: * prior treatment with any systemic therapy other than 1 cytokine therapy * history of or known brain metastases * uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
a placebo-controlled adaptive treatment assignment study of intravenous col-144 in the acute treatment of migraine

Conditions: Migraine

Summary: this study evaluates the efficacy of a range of intravenous doses of col-144 in the treatment of migraine headache in order to select a dose range for further studies.

this study is set up: * to evaluate the efficacy (headache response at two hours) of a range of intravenous doses of col-144 in order to select a dose range for further evaluation, * to explore the time course and effect of a range of dose levels of col-144 on features of the migraine including: headache response, proportion of participants pain-free, headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue medication, patient global impression and vomiting * to explore the safety and tolerability of a range of doses of col-144 in terms of adverse events, physical exam, vital signs, laboratory evaluations, and ecgs * to determine key pk parameters for col-144 and to explore the relationship between the pk of col-144 and the time course and extent of clinical response

Eligibility criteria:
inclusion criteria: * patients with migraine with or without aura fulfilling the ihs diagnostic criteria 1.1 and 1.2.1 (2004) * history of migraine of at least 1 year * migraine onset before the age of 50 years * history of 1 - 8 migraine attacks per month * male or female subjects aged 18 to 65 years * female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, iud, abstinence, vasectomized partner) * able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache * able and willing to give written informed consent exclusion criteria: * history of life threatening or intolerable adverse reaction to any triptan * use of prescription migraine prophylactic drugs * pregnant or breast-feeding women * women of child-bearing potential not using highly effective contraception * history or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures * history of hypertension (controlled or uncontrolled) * sitting bp \>160mmhg systolic or \>90mmhg diastolic on 2 repeated measurements at screening * current use of hemodynamically active cardiovascular drugs * history within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol * significant renal impairment * previous participation in this clinical trial * participation in any clinical trial of an experimental drug or device in the previous 30 days * any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study * relatives of, or staff directly reporting to, the investigator * patients with known hypersensitivity to col-144, other 5ht1f receptor agonists or to any excipient of col-144

Keywords: migraine
regulation of vitamin d metabolism by washed microbiota transplantation in patients with ibd

Conditions: IBD

Summary: wmt could effectively induce clinical response and maintain remission in patients with inflammatory bowel disease (ibd). vd maintains gut microbiota and gut microbiota alter intestinal vitamin d metabolism (vdm),the aim of this study was to evaluate the effect of wmt on vd metabolism by measuring the level of serum 25(oh)d in ibd patients before and after treatment

inflammatory bowel disease (ibd) is a chronic, relapsing disorder that is represented by crohn's disease (cd) and ulcerative colitis (uc), the pathogenesis of ibd is not completely understood, but it is now acknowledged that it is related to intestinal microbiota. the gut microbiota is a central regulator of host metabolism, more and more evidences show that the gut microbiota plays an important physiological role in the pathogenesis of a variety of human metabolic, immune and neurological diseases, including ibd. fecal microbiota transplantation (fmt) transplants the gut microbiota of healthy donors into the patients' intestines, this is an effective strategy to restore the intestinal microbiota and it is also a hot research topic in recent years. our previous studies and other studies have proved that fmt could effectively induce clinical response and maintain remission in patients with ibd. washed microbiota transplantation (wmt) is a fecal bacteria transplantation based on intelligent fecal bacteria separation system and strict quality control of washing process, it is a new stage of fmt development, our group have proved that wmt is safer, more precise and more quality-controllable than the crude fmt by manual. vitamin d(vd) has been shown to have multifaced effects on the skeletal environment,immune system and infection. a number of diseases, including tumors, type i diabetes, ibd and autoimmune diseases are associated with vd deficiency, vd could have an important role in the prevention and possible treatment of these conditions. several studies have shown that intestinal microbiota is closely related to vd，vd maintains gut microbiota and gut microbiota alter intestinal vitamin d metabolism (vdm). a clinical trial shows that probiotics supplementation can change the level of 25 hydroxyvitamind(25(oh)d). serum 25(oh)d correlates with overall storage of vd, which is the preferred clinical measure to assess vd sufficiency. the aim of this study was to evaluate the effect of wmt on vd metabolism by measuring the level of serum 25(oh)d in ibd patients before and after treatment

Eligibility criteria:
inclusion criteria: * ibd patients aged 16-65years exclusion criteria: * previous history of partial small bowel resection; * abnormal thyroid and parathyroid function; * complicated with complicated intestinal fistula and severe infection and treated with antibiotics * women during pregnancy, lactation and oral contraceptives.

Keywords: ibd vitamind wmt microbiota