Kornimate/medical-research-clean huggingface dataset:
high order spectral analysis of local field potential data on a subgroup of parkinson's disease patients who are carriers of mutations in the glucocerebrosidase (gba) gene undergoing dbs electrode placement

Conditions: Parkinson Disease

Summary: the aim is to study a specific group of pd patients, carriers of mutations in the glucocerebrosidase (gba) gene, which is the most common genetic risk factor for pd and is a harbinger of aggressive cognitive and motor decline. approximately 12-17% of pd patients undergoing dbs are gba mutation carriers. gba mutation carriers with pd have a specific phenotype characterized by more significant motor dysfunction and reduced short-term visual memory function compared with their non-gba counterparts. thus as gba mutation carriers have a "signature" phenotype, the investigators hypothesize that these gba mutation carriers have a unique "signature" of oscillatory activity that can be distinguished from non-mutation carriers during motor activation and during cognitive tasks. identification of this "signature" will provide critical information that is required to: 1) understand the underlying neurophysiological mechanisms responsible for the aggressive disease course of gba associated pd, and 2) further develop customized adaptive dbs systems.


Eligibility criteria:
inclusion criteria: * undergoing bilateral stn-dbs * diagnosis of parkinson's disease exclusion criteria: * no parkinson's disease
evaluation of the safety and effectiveness of sepraspray™ in reducing post-surgical adhesions

Conditions: Abdominal Adhesions

Summary: this study will examine the safety and efficacy of sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. adhesion formation will be evaluated laparoscopically at ileostomy take down. note: a decision was made to terminate this study in june 2008 due to low enrollment.


Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy. exclusion criteria: * patients who are pregnant. * patients with ongoing abdominal abscess. * patients with ongoing bacterial peritonitis.
real world data collection on the synergy cervical disc

Conditions: Cervical Disc Degeneration

Summary: this trial is a real world data (rwd) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility criteria:
inclusion criteria: 1. over the age of 21 at the time of the surgery. 2. have had (retrospective cohort) or the decision has been made to have (prospective cohort) the synergy disc implanted 3. skeletally mature patients for reconstruction of the disc from c3-c7 following a single or multiple level discectomy for intractable radiculopathy 4. intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: herniated disc and/or osteophyte formation 5. symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (ct, mri, x-rays, etc.) 6. failed a minimum of 6 weeks conservative treatment 7. written informed consent given by subject, as applicable. exclusion criteria: 1. moderate to advanced spondylosis 2. diagnosis of osteoporosis 3. active systemic infection or infection at the operative site 4. pregnancy 5. marked cervical instability on lateral, coronal, or flexion/extension radiographs 6. cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level 7. severe pathology of the facet joints of the involved vertebral bodies 8. previous diagnosis of osteopenia or osteomalacia 9. more than one immobile vertebral level between c1 and t1 from any cause 10. morbid obesity 11. currently a prisoner

Keywords: degenerative disc cervical radiculopathy myelopathy motion preservation
a first in man study to determine the safety at various dose levels of ags-16m8f in advanced kidney cancer

Conditions: Renal Cell Carcinoma; Pharmacokinetics of AGS-16M8F

Summary: the purpose of this dose escalation study is to examine the safety and pharmacokinetics (pk) of ags-16m8f administered in subjects with advanced renal cell carcinoma.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amenable to cure by surgery or other means. * non-measurable or measurable disease according to response criteria for solid tumors (recist version 1.1) * eastern cooperative group (ecog) performance status of 0-1 * negative pregnancy test (women of childbearing potential) * hematologic function, as follows: * absolute neutrophil count (anc) ≥ 1.5 x 109/l * platelet count ≥ 100 x 109/l * hemoglobin ≥ 9 g/dl (transfusions are allowed) * renal function, as follows: * creatinine ≤ 1.5 x upper limit of normal (uln), or calculated glomerular filtration rate (gfr) \> 50 ml/min if creatinine \> 1.5x uln * hepatic function, as follows: * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln or ≤ 5x uln if known liver metastases * total bilirubin ≤ 1.5 x uln * international normalized ratio (inr) \< 1.3 (or ≤ 3.0 if on therapeutic anticoagulation) * women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for four weeks after the last ags-16m8f infusion administration exclusion criteria: * past or present documented central nervous system (cns) tumor or cns metastasis * use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening * history of thromboembolic events and bleeding disorders ≤ 3 months (e.g., dvt or pe) * active angina or class iii or iv congestive heart failure (new york heart association chf functional classification system) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication * major surgery (that requires general anesthesia) within 4 weeks of study enrollment * women who are pregnant (confirmed by positive pregnancy test) or lactating * known positive test for human immunodeficiency virus (hiv), hepatitis c, or hepatitis b surface antigen * active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening

Keywords: advanced renal cell carcinoma advanced kidney cancer ags-16m8f
evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image ai technology

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image ai technology in patients with chronic obstructive pulmonary disease who will undergo lung volume reduction surgery with endobronchial valve implantation. the main question it aims to answer is: evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image ai technology. participants will be evaluated by lung ct (quantitative analysis based on chest image ai technology and artificial analysis) and imported chartis detection system.


Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease who meet the gold diagnostic criteria * fev1 ≤ 45% pred and fev1/fvc\<70% * tlc\>100% pred and rv\>175% pred * cat≥18 * \>50% of emphysema destruction * smoking prohibition\>6 months * sign the informed consent form exclusion criteria: * paco2\>8.0 kpa, or pao2\<6.0 kpa * 6-minute walking test\<160m * obvious chronic bronchitis, bronchiectasis or other infectious lung diseases * three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment * previous lobectomy, lvrs or lung transplantation * lvef\ 50mmhg * anticoagulant therapy that cannot be stopped before surgery * the patient has obvious immune deficiency * participated in other lung drug studies within 30 days before this study * pulmonary nodules requiring intervention * any disease or condition that interferes with the completion of the initial or subsequent assessment
a study evaluating the safety, tolerability, and initial efficacy of recombinant human anti-t-cell immunoreceptor with ig and itim domains (tigit) monoclonal antibody injection (ibi939) in subjects with advanced malignant tumors

Conditions: Advanced Malignancies

Summary: this is an open-label, dose escalation, phase i study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ibi939 in subjects with advanced malignancies


Eligibility criteria:
inclusion criteria: 1. able to understand and willing to sign the icf. 2. adults 18 years of age or older. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. life expectancy at least 12 weeks. 5. adequate organ and bone marrow function. eligibility criteria： 1. previous exposure to any anti-tigit antibody. 2. participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study. 3. any investigational drugs received within 4 weeks prior to the first study treatment. 4. receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy. 5. immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug. 6. medication requiring long-term systemic hormones or any other immunosuppression therapy. 7. major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy. 8. primary central nervous system (cns) malignancy, or untreated/active cns metastases, or leptomeningeal disease. 9. history of autoimmune disease , present active autoimmune disease or inflammatory diseases 10. positive human immunodeficiency virus (hiv) test. 11. active hepatitis b or c, or tuberculosis. 12. history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 13. known history of hypersensitivity to any components of the ibi939 or sintilimab. 14. pregnant or nursing females.
progressive strength in hand osteoarthritis

Conditions: Hand Osteoarthritis

Summary: background: hand osteoarthritis (oa) is highly prevalent, affecting 55-70% of the population over 55 years with an age-related progressive increase. the oa of interphalangeal (if) and carpometacarpal joints may have varying degrees of deformity associated with pain, decreased of grip and pinch strength, decreased range of motion and functional impairment. systematic reviews and meta-analyzes have shown the beneficial effect of exercise for lower limb oa, however for hand oa exercise is still used based on recommendations based on clinical experience and low quality studies, not allowing a conclusion about the effects of exercise in pain, function and strength in hand oa patients. objective: assess the effectiveness of progressive resistance strength training program on pain, function and strength in hand oa patients. methods: diagnostic of hand oa according to american college of rheumatology of at least 1year, age over 50 years, both genders, pain in if joints between 3-8 cm on a 10-cm numerical pain scale (nps). sixty patients who meet the eligibility criteria were randomized into exercise group (eg) and control group (cg). both groups performed a session regarding joint protection and energy conservation before randomization. the eg performed a progressive resistance strength training program for intrinsic muscles of the hand for 12 weeks. the outcome measures were nps; australian/canadian (auscan) hand osteoarthritis index and cochin hand functional scale for hand function; grip and pinch strengthening using the hydraulic hand dynamometer and a pinch gauge dynamometer and satisfaction with the treatment using a likert scale. a blinded evaluator performed the evaluations at baseline, 6 and 12 weeks after treatment baseline.


Eligibility criteria:
inclusion criteria: * diagnostic of hand oa according to american college of rheumatology of at least 1year; * age over 50 years; * both genders; * pain in interphalangeal joints between 3-8 cm on a 10-cm numerical pain scale exclusion criteria: * other joint disease in hands; * other rheumatic systemic disease; * surgery in hands or writs; * exercise or joint injection in hands in the previous 3 months; * disability to perform the exercises.
genetics, metabolism and weight loss in older, obese veterans

Conditions: Obesity

Summary: this study is designed to determine whether sequence variation in the lipoprotein lipase (lpq) gene affects the amount of weight loss and metabolic responses during a hypocaloric diet treatment for overweight and obese (bmi=25-35 kg/m2), older (50-65 yrs), sedentary veterans.

veterans who are 50-65 yrs, non-smoking, sedentary and weight stable with a bmi between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam. exclusion criteria are: diabetes, hypertriglyceridemia (\>400 mg/dl), history of cancer or myocardial infarction, clinical depression, renal, liver or hematologic disease, and medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers). changes in total and visceral body fat are measured by dual x-ray absorptiometry and computerized tomography, resting energy expenditure and fat oxidation rate by indirect calorimetry, and lipoprotein lipids by enzymatic assay. glucose tolerance is assessed during a three-hour oral glucose tolerance test with measurement of glucose- and insulin levels every 30 minutes. lpl activity is measured in 3050mg pieces of subcutaneous abdominal and gluteal adipose tissue.

Eligibility criteria:
* 50-65 yrs, non-smoking, sedentary and weight stable with a bmi between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam. exclusion criteria: * diabetes, * hypertriglyceridemia (\>400 mg/dl), * history of cancer or myocardial infarction, * clinical depression, * renal, liver or hematologic disease, and * medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers).

Keywords: behavioral weight loss genetics lipoprotein lipase visceral fat lipoprotein
daily monitoring of respiratory symptoms and spirometry during eti treatment in persons with cystic fibrosis.

Conditions: Cystic Fibrosis

Summary: the goal of this observational study is to provide optimal monitoring and support when initiating eti treatment in eligible persons with cystic fibrosis (aged 12 y +) and to document on a daily basis, from 72 hours before the start of treatment and then for 14 days i) i) fev1 changes (home spirometry), ii) ii) respiratory symptoms changes, iii) any possible side effects. through a dedicated electronic platform, these data will be monitored every day by the medical team, which will be fully available for any questions or concerns patients may have.


Eligibility criteria:
inclusion criteria: * cystic fibrosis diagnosis * at least 12 years old * carrier of at least one copy of f508del mutation * ability to perform reliable and reproducible spirometry * medical and psychological stability * written consent * owning a smartphone exclusion criteria: * lung transplant * fev1 \> 120 % pr (%gli) at the inclusion test * pulmonary exacerbation

Keywords: elexacaftor time course fev1 respiratory symptoms
sonodynamic therapy in the treatment of perivascular adipose tissue on patients with pad and claudication

Conditions: Peripheral Arterial Disease

Summary: the purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (sdt) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (pwt) among peripheral artery disease (pad) patients with symptom of intermittent claudication.

atherosclerotic lower extremity pad affects the living quality of more than 20 million people in the world. pad is associated with a major decline in functional status and claudication is the most evident symptom. current claudication therapies reveal significant limitations. pharmacotherapy and exercise are recommended in 2016 aha/acc guideline on the management of lower extremity pad patients with claudication. however, they may not achieve an ideal clinical therapeutic effect. furthermore, endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries. the aim of this trial is to verify the hypothesis that sdt can reduce the inflammation of pvat and improve pwt among pad patients with symptom of intermittent claudication.

Eligibility criteria:
inclusion criteria: * aged 40-80 years * patients with atherosclerotic peripheral artery disease with symptoms of moderate to severe intermittent claudication (defined as ability to walk at least 2, but not more than 11 minutes on a graded treadmill test using the gardner protocol) * femoral popliteal artery with 50% stenosis by ultrasound * stable use of low to moderate dose statin and the permitted statin drugs/ doses: atorvastatin 20 mg, simvastatin 40 mg, rosuvastatin 10 mg, pravastatin, 40 mg, fluvastatin 80 mg or lovastatin 40 mg for at least 6 weeks prior to screening * written informed consent exclusion criteria: * severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments * critical limb ischemia or other comorbid conditions that limit walking ability * non-atherosclerotic peripheral artery stenosis * active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment * systemic disorders such as hepatic, renal, hematologic, and malignant disease * allergic to contrast media with iodine * contraindication to cta * allergic to dvdms * diagnosis of porphyria * pregnant women and nursing mothers * patient who is attending other clinical trial
convalescent plasma therapy for hospitalized patients with covid-19

Conditions: COVID-19; Convalescent Plasma; SARS-CoV-2; Pneumonia; Coronavirus Infections; Respiratory Tract Diseases

Summary: plasma from donors who have recovered from coronavirus disease 2019 (covid-19) contain antibodies to sars-cov-2 and may be a potential therapy for hospitalized patients with covid-19. the efficacy of high-titer convalescent plasma for covid-19, however, still unclear. the present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with covid-19.

this is an open-label, randomized controlled trial aimed to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with covid-19. participants must be adult hospitalized patients with a confirmed diagnosis of covid-19 and time between symptom onset and inclusion ≤ 7 days. two hundred participants will be randomized in a 1:1 ratio to receive either 200-400 ml of high-titer covid-19 convalescent plasma or standard care. the primary endpoint is the proportion of patients with clinical improvement at day 14 following randomization, defined by an increase of two points in the 7-point ordinal scale based on that recommended by the world health organization. safety will be daily assessed by monitoring the occurrence of adverse effects and reactions to convalescent plasma transfusion. study visits will occur on day 1, day 3, day 7, and day 14 or until hospital discharge, whichever comes first.

Eligibility criteria:
inclusion criteria: * hospitalized patients aged ≥18 years. * confirmed diagnosis of covid-19 by rt-pcr or antigen test in respiratory samples. * time between symptom onset and inclusion ≤ 7 days. * enrolled within 5 days of hospitalization. * sign the consent form. exclusion criteria: * contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure. * history of previous severe allergic reactions to transfused blood products. * limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator. * not currently enrolled another interventional clinical trial of covid-19 treatment. * critically ill patient with covid-19 being treated in intensive care.
value of chest ultrasonography in ild screening

Conditions: Interstitial Lung Disease

Summary: the main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ilds in correlation to chest x- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution ct (hrct) as a golden diagnostic investigation.

interstitial lung disease (ild) refers to a group of disorders that are characterized by varying combinations of inflammation and fibrosis involving the space between the epithelial and endothelial basement membranes.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) diagnosed with ild * all patients must fulfil the 2018 criteria for hrct chest finding for the diagnosis of usual interstitial pneumonia (uip) form exclusion criteria: * patients with cardiac diseases (left-sided heart failure, pulmonary edema) \[they may have findings of multiple b lines on transthoracic ultrasound examination which mimic ild findings\]. * patients with chronic kidney diseases (as patients presented with nephrogenic pulmonary edema may have findings of multiple b lines on transthoracic ultrasound examination which mimic ild findings).
acute hemorrhoidal disease evaluation international study

Conditions: Hemorrhoids

Summary: the primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * patient consulting for symptomatic acute phase of hemorrhoidal disease * confirmed diagnosis of hemorrhoidal disease exclusion criteria: * patient consulting for emergency not related to hemorrhoidal disease; * patient currently taking any treatment for hemorrhoidal disease; * any anorectal procedure or surgery planned during the study ; * anorectal procedure or surgery performed or incomplete convalescence following anorectal procedure/surgery; * known present perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury, diseases of the anal canal; * pregnant or breastfeeding woman.

Keywords: observationnal qol