Kornimate/medical-research-clean huggingface dataset:
a study of anti-vegfr2 ak109 in subjects with advanced solid tumors

Conditions: Solid Tumor

Summary: this is a first in human(fih) study to characterize the safety, tolerability, pharmacokinetics (pk), immunogenicity and anti-tumor activity of ak109, an anti-vegfr2 monoclonal antibody, as a single agent in adult subjects with advanced solid tumor.


Eligibility criteria:
inclusion criteria: * have signed written informed consent form voluntarily. * histologically or cytologically documented advanced solid tumor that is refractory/relapsed/intolerant to standard therapies, or for which no effective standard therapy is available, or subject refuses standard therapy. * have radiologically measurable disease based on recist 1.1 * ecog of 0 or 1. * estimated life expectancy of ≥3 months. * adequate organ function. * have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration. exclusion criteria: * have been diagnosed other advanced tumors within 2 years before the first use of the study drug, except for the cured localized tumors. * with active central nervous system metastasis, cancerous meningitis, or spinal cord compression. * prior use of any anti-vegf or anti-vegfr antibodies. * receipt of anti-tumor treatment, other study drug, major surgery, or serious infection within 4 weeks prior to c1d1 (cycle 1 day1, the first dose of study drug). * have received central venous catheterization within 7 days prior to c1d1. * severe or uncontrolled cardiovascular and cerebrovascular diseases. * uncontrolled hypertension. * have a high risk of bleeding. * uncontrolled gastrointestinal diseases. * uncontrolled pleural/pericardial or peritoneal effusion. * have occurred any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 monthsprior to c1d1. * with cirrhosis of child-pugh b or c. * active or unstable viral hepatitis; or active tuberculosis. * known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * received live vaccines prior 30 days within the first dose. * take apart in other clinical studies at the same time. * known to be allergic to any component of ak109, other monoclonal antibodies or any therapeutic protein. * mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements. * any treatment risk or condition that interferes with the study by the investigator judged.
functional changes in the stomach and esophagus after one anastomosis gastric bypass- oagb

Conditions: Obesity, Morbid; GERD; Ulcer, Gastric

Summary: evaluation of the functional changes in the stomach and esophagus of patients undergoing one anastomosis gastric bypass (oagb)


Eligibility criteria:
inclusion criteria: * bmi\> 35 kg/m2 * 2 years of controlled conservative obesity treatment without weight reduction * patients should give their consent to participate in the study exclusion criteria: * less than 2 years of conservative obesity treatment * cancer * cirrhosis child-pough score a * crohn's disease * serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years * drug consumption * non-compliance * hiatal hernia \> 4cm * gastric pouch \< 10cm * barett esophagus * erosive esophagitis grade c or d according to the los angeles classification * endoscopically proven gastric stricture * acid exposition time \> 6% (lyon criteria) * reflux episodes\> 80 /24 hours (lyon criteria) * insufficient low esophageal sphincter according to manometry findings * pathological findings in the impedance ph-metry (acid and non-acid reflux)
a comparative study of proton-pump inhibitor tests for chinese reflux patients in relation to the cyp2c19 genotypes

Conditions: GERD

Summary: backgrounds \& aims: proton-pump inhibitor (ppi) test has been proposed as a valuable tool in the diagnosis of gastroesophageal reflux disease (gerd) in western populations. we assumed that a higher prevalence of poor metabolizers in chinese population might affect the diagnostic accuracy of a ppi test. methods: in this open-label, randomized trial, patients with symptoms suggestive of gerd were randomly assigned to receive a 2-week test with daily rabeprazole 40-mg or daily pantoprazole 80-mg after diagnostic endoscopy. therapeutic response was assessed with a five-grade daily record. genotypes of cytochrome p450 (cyp) 2c19 polymorphism were determined.

as described above

Eligibility criteria:
inclusion criteria: * consecutive patients with symptoms suggesting gerd will be enrolled from gastroenterology outpatient clinics in our academic institute. the typical gerd symptom was defined as heartburn and/or regurgitation at least 3 episodes per week in recent 3 months. exclusion criteria: * those who were under maintenance ppi treatment, have a medical contraindication to ppi therapy, report a history of peptic ulcer disease or gastrointestinal surgery, malignancy proven by endoscopy, or unwilling or unable to provide informed consent.

Keywords: ppi test gastroesophageal reflux disease cyp2c19 rabeprazole pantoprazole
fiber use in pediatric short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: short bowel syndrome (sbs) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. infants with short bowel syndrome suffer from diarrhea and poor growth. the care of these infants is limited by the lack of effective therapies. soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children. the purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with sbs

short bowel syndrome (sbs) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. infants with short bowel syndrome suffer from diarrhea and poor growth. the care of these infants is limited by the lack of effective therapies. as the intestine tries to grow back some of its length, a process that can take many months, these infants become dependent on intravenous (iv) nutrition in order to survive. liver disease and sepsis (a blood stream infection) are common complications of iv nutrition and are the two most common causes of death in this population. therefore, clinicians have tried different ways to improve feeding and shorten the amount of time of iv nutrition, for example continuous feedings through the intestine, use of partly digested formulas and change in diet. soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children. the purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with sbs.

Eligibility criteria:
pediatric infants (less than 1 y of age) who 1. have short bowel syndrome defined by a history of congenital or surgical loss of intestinal absorptive function resulting in parenteral nutrition dependency of longer than 30 days; 2. are receiving at least 20% of their caloric needs from enteral nutrition and have been on enteral nutrition for at least 1 week following intestinal resection; 3. have increased stool output as manifested by watery stools (3-12/day) and increased ostomy output (20-50 cc/kg/day); 4. have not received antibiotics, probiotics or prebiotics for 2 weeks prior to study entry;

Keywords: pediatrics, short bowel syndrome, soluble fiber
post-market optimization study of the empower® rf catheter to ablate soft tissue lesions in the lung

Conditions: Lung Diseases

Summary: a post-market study to assess the performance and safety of a rf ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lung cancer or metastatic lung lesions who are scheduled for surgical resection.

this study is a prospective, single-arm, multi-center, post-market study of bronchoscopic radio frequency (rf) ablation treatment malignant lung lesions prior to surgical resection. up to 15 patients will be treated at the participating sites. patients identified for the study will have been scheduled for surgical resection as part of their treatment for lung lesions. the rf ablation procedure will be performed during a standard-of-care bronchoscopic procedure at minimum of 24 hours prior to resection. the patients exits the study following surgical resection. the resected tissue will undergo pathological evaluation for tissue viability.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at screening 2. proven nsclc or pulmonary metastases from extra-thoracic primary tumor 3. eligible for standard of practice lung resection (pneumonectomy, lobectomy) 4. tumor/lesion \> 2cm along the major diameter with no visible necrosis 5. signed informed consent form exclusion criteria: 1. an implantable pacemaker, defibrillator, or other active implants 2. any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic rf ablation
chemotherapy for potentially resectable locally advanced esophagogastric junction carcinoma

Conditions: Esophagogastric Junction Cancer

Summary: this is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction


Eligibility criteria:
inclusion criteria: * histologically or cytological proved locally advanced esophagogastric junction cancer * ecog performance status ≦2 * stage iia-iiic * no distant metastasis (m0) * sign in informed consent form exclusion criteria: * history of hypersensitivity to fluoropyrimidines, tegafur，gimeracil and oteracil potassium capsules , capecitabine, oxaliplatin or the ingredients of this product * pregnancy or lactation women, * inadequate hematopoietic function： wbc≦3,500/mm3; anc≦1,500/mm3; platelet≦80,000/mm3 * inadequate organ function which is defined as below: total bilirubin \>2 pper limit of normal range (uln); alt / ast \> 2.5 upper limit of normal range (uln); serum creatinine \> 1.5 mg/dl, and ccr \> 60 ml/min (estimated by cockcroft-gault formulation); * symptomatic peripheral neuropathy * receiving a concomitant treatment with other fluoropyrimidines * fluoropyrimidines (dpd) congenital absence
a single-arm, open-label clinical study to evaluate the efficacy and safety of vrt106 in combination with chemotherapy for advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of vrt106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.

this is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of vrt106 in combination with chemotherapy in the treatment of advanced pancreatic cancer. the study is planned to enroll 10 subjects. the entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 months).

Eligibility criteria:
inclusion criteria: * subject voluntarily agrees to participate in this study and signs an institutional review board -approved informed consent prior to performing any of the screening visit procedures. * males and females≥18 years of age, inclusive, at the screening visit. * have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology. * no prior systemic therapy for unresectable locally advanced and metastatic pancreatic cancer. * have at least one measurable lesion according to recist v1.1 criteria. * an eastern cooperative oncology group (ecog) score of 0 or 1. * expected survival time of≥3 months. * no serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions. exclusion criteria: * have suffered from other malignant tumors in the past 5 years, except for cured basal cell skin cancer, non-melanoma skin cancer, and cervical cancer in situ. * previous treatment with other oncolytic viruses. * immunocompromised patients. * known alcohol or drug dependency. * women who are pregnant or breastfeeding.

Keywords: advanced pancreatic cancer
a study to evaluate the safety, tolerability, and efficacy of biib017 (peginterferon beta-1a) in pediatric participants for the treatment of relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this study will evaluate the safety, tolerability, and descriptive efficacy of biib017 in pediatric participants with relapsing-remitting multiple sclerosis (rrms) and to assess the pharmacokinetics (pk) of biib017 in pediatric participants with rrms in part 1. in part 2, the study will evaluate the long-term safety of biib017 and further describe safety and the long-term multiple sclerosis (ms) outcomes after biib017 treatment in participants who completed the study treatment at week 96 in part 1 of the study.


Eligibility criteria:
key inclusion criteria: part 1: * must have a diagnosis of rrms as defined by the revised consensus definition for pediatric ms. * must have an edss score between 0.0 and 5.5. * must have experienced \>= 1 relapse in the 12 months prior to randomization (day 1) or \>= 2 relapses in the 24 months prior to randomization (day 1) or have evidence of asymptomatic disease activity (gd-enhancing lesions) on brain mri in the 6 months prior to randomization (day 1). part 2: • participants who completed the study treatment in part 1 (week 96 visit), as per protocol. key exclusion criteria: part 1: * primary progressive, secondary progressive, or progressive relapsing. these conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. participants with these conditions may also have superimposed relapses but are distinguished from relapsing participants by the lack of clinically stable periods or clinical improvement. * history of severe allergic or anaphylactic reactions or known drug hypersensitivity. * known allergy to any component of avonex or biib017 formulation. * occurrence of an ms relapse that has occurred within 30 days prior to randomization (day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (day 1). * any previous treatment with pegylated human ifn β-1a. part 2: * any significant changes in medical history occurring after enrollment in part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the investigator, would have excluded the participant's participation in part 1. the investigator must re-assess the participant's medical fitness for participation and consider any factors that would preclude treatment. * the participant could not tolerate biib017 in part 1. note: other protocol defined inclusion/exclusion criteria may apply"
cardiovascular response to two manual techniques for neck pain

Conditions: Neck Pain

Summary: the aim of the investigators study is to investigate whether posteriorly directed (ap) pressures and laterally directed (lat) glides, cause blood pressure and heart rate elevation or lowering in patients with neck pain. the answer will advance the investigators understanding of why manual therapy works.

to be included in the study, these subjects with unilateral non-traumatic, non-chronic neck pain (operationally defined as neck pain with mobility deficits lasting less than 3 months) shall have numeric pain rating scale (nprs) of between 0 and 5 out of 10 as the most painful neck movement even with passive scapular elevation, neck disability index (ndi) of between 16 and 50 out of 100%, resting systolic and diastolic blood pressure between 90/60 and 138/88, and resting heart rate between 60 and 90. subjects are excluded if they are current smoker, over 50 years of age, has a history of fainting spells or loss of consciousness, is on blood thinners, is taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease, has a history of spinal surgeries, and has neck pain classified or associated with headache, radiating pain, and movement coordination impairments. a convenience sample of subjects will be randomly allocated to 1 of 2 groups. both group 1: ap and group 2: lat will receive posterior pressures and lateral glides respectively to one hypomobile segment. baseline nprs, and ndi will be collected at the initial visit. systolic blood pressure (sbp) and heart rate (hr) will be measured with a omron automatic monitor recording time points: (1) 5 minutes, and (2) 7 minutes after lying supine; (3) during the 1st set, (4) 5th set of one of the glides, (5) 2 minutes after time point #4, and (6) 4 minutes after time point #4. after time point #6, a global rating of change (groc) will immediately be collected based on the most painful neck movement. a finger pulse oximeter will be placed on the subjects' index finger to constantly monitor their pulse rate for slowing heart rate or asystole. the primary author will perform one of the techniques on all subjects. after one visit, a follow-up nprs, and ndi will be collected again.

Eligibility criteria:
inclusion criteria: * unilateral, non-traumatic, non-chronic mechanical neck pain * numeric pain rating scale between 0-5/10 as the most painful neck movement (with passive scapular elevation) * neck disability index between 16-50/100 percent * resting blood pressure between 90/60 and 138/88 mmhg * resting heart rate between 60 and 90 beats per minute exclusion criteria: * current smoker * under 18 years and over 50 years of age * history of fainting spells or loss of consciousness * currently on blood thinners * taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease * history of spinal surgery * has neck pain classified or associated headache, arm pain, trauma/whiplash
feasibility study of a 60 minute rapid infusion rituximab protocol in patients with b-cell malignancies

Conditions: Indolent or Intermediate Grade B-cell Malignancy

Summary: the purpose of this study is to assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center.


Eligibility criteria:
inclusion criteria: * age 18-89 * diagnosis of indolent or intermediate grade b-cell malignancy * patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight * first dose given within 3 months of the second dose * infusion scheduled for outpatient administration at the arthur g. james cancer hospital and richard j. solove research institute exclusion criteria: * diagnosis of aggressive lymphoma * absolute lymphocyte count \> 10 x 103 cells/µl * new york heart association (nyha) classification grade ii or greater congestive heart failure * enrolled on another clinical trial * allergy to murine-containing medications * grade iii or iv hypersensitivity reaction during the initial infusion of rituximab * prisoners * pregnant women * mentally or physically unable to give consent

Keywords: hypersensitivity reactions b-cell malignancies
familial prostate cancer

Conditions: Neoplastic Syndromes, Hereditary; Prostatic Neoplasms

Summary: the purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

the purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

Eligibility criteria:
families will be identified with two or more first degree relatives affected with prostate cancer or with one male with prostate cancer that developed before age 55. must have clinical evidence of prostate cancer in the family.

Keywords: familial inherited prostate cancer linkage prostate cancer
68ga-ny104 pet/ct imaging in renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this is a prospective, single-center study in patients with renal cell carcinoma. the goal is to determine the sensitivity and specificity of 68ga-ny104 pet/ct in the detection of clear cell renal cell carcinoma.

two types of patients will be recruited in this study. type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccrcc. each patient will receive one dose of 68ga-ny104 by intravenous route. dedicated whole-body pet/ct imaging will be performed. imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68g-ny104 pet/ct. 46 patients will be recruited in peking union medical college hospital. this study will be conducted according to local regulations and laws, the ethical principles that have their origin in the declaration of helsinki, and the principles of good clinical practice.

Eligibility criteria:
inclusion criteria: 1. written informed consent provided for participation in the trial 2. age ≥ 18 y 3. at least one of the following indications should be applied 1. scheduled for surgical resection of renal mass 2. confirmed recurrent/metastatic clear cell renal cell carcinoma 3. suspicion for recurrent/metastatic clear cell renal cell carcinoma exclusion criteria: 1. on vegf tki treatment less than 1 week before 68ga-ny104 pet/ct. 2. pregnancy or lactation 3. severe claustrophobia.

Keywords: 68ga-ny104 carbonic anhydrase ix
the effect of 16 weeks of hip adduction and abduction resistance exercise

Conditions: Osteoporosis; Osteopenia; Sarcopenia

Summary: performing adduction and abduction resistance exercise will increase hip bone density and strength to a greater extent than doing squat and deadlift exercise. aim #1: to determine if doing hip adduction and abduction resistance exercise training for 16 weeks improves spine bone mineral density and hip bone mineral density and strength as determined by finite element modeling. aim #2: to compare the effects of hip adduction and abduction exercise to squat and deadlift exercise with respect to potential changes in hip bone mineral density and strength. aim #3: to determine if the addition of adduction and abduction exercise to squat and deadlift exercise promotes an "additive" effect with respect to changes in spine bone mineral density and hip bone mineral density and bone strength.

the investigators will carry out a 16-week exercise training study (n=24) consisting of 3 groups (n=8 per group) of healthy, non-resistance trained adult men and women (age 25-55 years). our aim is to determine if hip adduction and abduction resistance exercise is more effective than squat and deadlift exercise with respect to changes in the whole bone strength and density of the proximal femur and spine. group a will do only hip adduction and abduction exercises. group b will do only squat and deadlift exercise group c will do a combination of hip adduction and abduction and squat and deadlift exercise subjects will be imaged with quantitative computed tomography (qct) of the proximal femur and spine, pre-training and post-training, to determine changes in spinal bone density and proximal femoral bone density and strength. serum assays of bone formation (osteocalcin) and bone resorption (serum ctx type i) will be performed four times during the study at 4 week intervals.

Eligibility criteria:
inclusion criteria: * healthy men and women * age of 25 to 55 years old exclusion criteria: * hypertension (high blood pressure) * diabetes or metabolic syndrome * hyperlipidemia (high cholesterol) * cardiovascular disease * asthma or other pulmonary disease (i.e. copd) * not pregnant * have no joint or mobility limitations * do not exercise on a regular basis