Kornimate/medical-research-clean huggingface dataset:
a post-approval lap-band® lower body mass index (lbmi) study

Conditions: Obesity; Overweight

Summary: this is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the lap-band® ap system in a lower obese population (bmi ≥ 30 kg/m2 and \< 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation. the reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the osb lead-hero-002 study and published literature.

fda post-approval study designed to collect prospective data in a real-world setting to evaluate long-term safety and effectiveness of the lap band® system in patients with a bmi of ≥ 30 kg/m2 and \< 40 kg/m2 and one or more comorbid conditions. the apollo-001 study is a prospective, 10 year, multicenter study of patients who have decide to undergo implantation of the lap-band ap® system. outcomes include device explants, changes in weight, comorbid condition status, device- and procedure-related aes, and reoperations. the lbmi study was part of the condition of approval (coa) for the lap-band device. it was terminated because it was no longer required to fulfill the condition of approval for the device. apollo was able to fulfill the condition of approval (coa) for the lap-band device by using data from published literature and another recently completed study (osb lead-hero-002 study) which had long-term safety and effectiveness data addressing the conditions of approval.

Eligibility criteria:
inclusion criteria: 1. lap-band® system placed in a facility in the united states 2. bmi ≥ 30 kg/m2 and \< 40 kg/m2 prior to lap-band® placement 3. presence of 1 or more obesity-related comorbidities prior to lap-band® placement 4. aged 18 or older exclusion criteria: 1. prior bariatric surgery. 2. participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study. 3. vulnerable patients or those unable to exercise free informed consent. 4. inability to complete the questionnaires. 5. patients who are addicted to alcohol and/or drugs.

Keywords: lap band
evaluation of a mobile therapy for elevated depressive symptoms

Conditions: Depressive Symptoms; Depression

Summary: the purpose of this research study is to evaluate a mobile application (app) for depression treatment. participants will be randomly assigned to either receive the mobile app, "moodivate", or not. if provided with moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. participants will be asked to complete electronic questionnaire measures throughout the study period. participation in this study will take about 12 weeks.


Eligibility criteria:
inclusion criteria: * elevated depressive symptoms, defined as a score of \> 10 on the patient health questionnaire-9 (phq-9)57 * age 18+ * currently own an ios- or android-compatible smartphone * report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item) * have a current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments) * enrolled in epic's mychart program * english fluency exclusion criteria: - current suicidal ideation at study screening, defined as a response \>1 (several days) on item nine of the phq-9 ("over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")
prognostic role of positron emission tomography and computed tomography parameters in stage i lung adenocarcinoma

Conditions: Stage I Pulmonary Adenocarcinoma

Summary: the clinical and derived data from the preoperative computed axial tomography (ct) and positron emission tomography (pet) of patients with pathological stage i pulmonary adenocarcinoma will be analyzed retrospectively, classified according to the current pathological classification iaslc / ats / ers of pulmonary adenocarcinoma, subjected to surgical treatment in our operating unit between august 2006 and july 2011. a follow-up will be performed on the patients enrolled in the study up to the date of death, and in any case no later than october 31, 2019


Eligibility criteria:
inclusion criteria: * patients suffering from pulmonary adenocarcinoma in stage i underwent ct, pet and surgical treatment with radical intent, at san raffale hospital (thoracic surgery) between august 2006 and july 2011 exclusion criteria: * primary pulmonary neoplasms other than adenocarcinoma; locally advanced or metastatic disease stage; non-radical resection.
outcome of pancreatic stump closure following resection of tumors of the head of the pancreas.

Conditions: Pancreatic Neoplasms

Summary: chart review evaluating outcome of patients in whom following resection of a tumor involving the head of the pancreas no anastomosis of the pancreatic stump was done to the gastrointestinal tract.


Eligibility criteria:
inclusion criteria: * pathologically proven carcinoma of the head of pancreas or other periampullary carcinoma treated by pancreaticoduodenectomy. exclusion criteria: * patients undergoing pancreaticoduodenectomy for other indications (i.e. trauma) * charts not available for review.
study of samarium sm-153 lexidronam combined with docetaxel for patients with prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.

the principal objective of this trial is to evaluate the safety, feasibility, and anti-tumor effects of a novel bone-targeted regimen consisting of samarium sm-153 lexidronam combined with docetaxel and prednisone. this present study design permits evaluation of the clinical activity of combining two distinct agents that have shown benefit for the treatment of patients with advanced androgen-independent prostate cancer and bone metastases. it enables assessment of potential synergistic interactions between a cytotoxic chemotherapy agent and a bone-targeting radioisotope agent in the setting of a bone-targeted therapy.

Eligibility criteria:
inclusion criteria: * have histological evidence of adenocarcinoma of the prostate. * have progressive castrate metastatic disease. * castrate levels of testosterone (\<50 ng/ml). treatment to maintain castrate levels of testosterone must be continued. * must have evidence of at least 3 bone metastases on bone scan. * patients for whom initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, must show progression of disease following withdrawal of the anti-androgen prior to enrollment. * patients undergoing prior bisphosphonate treatments are eligible. * patients who have received one prior treatment with 153sm lexidronam or 89sr are eligible provided it is at least 12 weeks from treatment with 153sm lexidronam or 24 weeks from treatment with 89sr. * life expectancy of at least 12 weeks (based on co-morbidity). * kps\>60. * lab requirements: * white blood count (wbc) ≥ 3,000/mm3; * absolute neutrophil count (anc) ≥ 1,500/ mm3; * platelet (plt) ≥ 100,000/mm3; * hemoglobin (hgb) ≥ 10 mg/dl; * bilirubin ≤ 2.0 mg/dl; * alt/ast≤ 3 times the upper limit of normal; * serum creatinine ≤ 2.0 mg/dl. * patients must sign an informed consent. exclusion criteria: * patients with small cell carcinoma. * patients with predominant visceral metastases (\>3 lung or liver lesions) or symptomatic lymphadenopathy (scrotal or pedal edema). * patients who have received more than one course of external beam radiation therapy directed at bone lesions. * clinically significant cardiac disease (new york heart association class iii/iv). * history of other malignancies (other than non-melanoma skin cancer), unless in complete remission or off therapy for that disease for at least five years. * have or are participating in a research study protocol or clinical trial protocol within 30 days of the date of the baseline visit.

Keywords: prostate cancer
to discuss the best mode for taking lapatinib under the influence of the diet

Conditions: Breast Cancer

Summary: food can make a big difference on the bioavailability of lapatinib in breast cancer patients,and fatty food can increase the lapatinib bioavailability.by examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with fatty food.

metastatic breast cancer is the leading cause of cancer-related death among women worldwide ,those overexpress the her2 are associated with a higher risk. lapatinib is approved for use to treat advanced metastatic breast cancer. the pharmacokinetic parameters of lapatinib have been characterized previously.it can reach steady state concentration after 6 or 7 days oral dosing, but the bioavailability is very different between different patients. the effect of food on lapatinib pharmacokinetics in humans was first examined in 19 healthy participants who were given single 100-mg doses with a high-fat breakfast. food caused a 60% increase in the relative bioavailability of lapatinib.another test showed that the bioavailability of lapatinib was 3 times more in low-fat diet than in emptiness. some investigators think that it can change the mode for taking lapatinib with food or without food to enhance the absorption.it may decrease the oral dose but the lapatinib can reach the same steady state concentration,so it can achieve maximum economic benefits. by continuous change for lapatinib and fat diet, the change of lapatinib pharmacokinetic is lack of discussion. if the adverse reactions increase since the absorption of lapatinib increase, the existing research data are still lacking. the trial by examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib, emptiness or taken with fatty food, discuss the best mode of taking lapatinib with fatty food.

Eligibility criteria:
inclusion criteria: 1. advance breast cancer with her2 positive 2. the patients are ready to use or using lapatinib for tumor treatment, and plans to keep the treatment for at least a month 3. the ecog score is 0 to 2 4. hemoglobin≥ 9 gm/dl 5. serum albumin concentration is normal 6. alt / ast / bilirubin\<1.5ul 7. creatinine clearance rate≥ 40 ml/min 8. signed icf exclusion criteria: 1. pregnancy or pregnancy 2. stomach absorption dysfunction 3. difficulty in taking fatty food 4. severe heart disease or medical condition

Keywords: lapatinib steady state plasma concentration high-fat breakfast
impact of intranasal insulin on sympathetic activity and cerebral vasodilation

Conditions: Healthy; Vasodilation; Insulin Resistance; Autonomic Dysfunction; Obesity

Summary: the purpose of this project is to examine the impact of increases in brain insulin on sympathetic nervous system activity, as well as peripheral and cerebral blood flow in humans.


Eligibility criteria:
inclusion criteria: * healthy adult men and women; * 18-45 years of age; * bmi \>18 kg/m2; * non-pregnant/non-breastfeeding; * non-nicotine users; exclusion criteria: * taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic self-reported history of: * hepatic, renal, pulmonary, cardiovascular, or neurological disease; * stroke or neurovascular disease; * bleeding/clotting disorders; * sleep apnea or other sleep disorders; * diabetes; * smoking; * history of alcoholism or substance abuse; * hypertension; * respiratory disease; * active cancer; * autoimmune disease.
diagnosis and treatment of periodontal disease in patients with aml

Conditions: AML; Acute Myelogenous Leukemia

Summary: this is a phase 2 randomized controlled trial of pre-chemotherapy periodontal deep cleaning in acute myelogenous leukemia (aml) patients with asymptomatic periodontitis. once eligibility is confirmed, participants with periodontitis will be randomized in a 1:1 ratio to undergo treatment by scaling and root planing (srp, "deep cleaning") (arm a) or receive no periodontal treatment (arm b). we will compare the incidence of blood stream infection (bsi) during chemotherapy between the two arms. study participation will continue until day 28 of chemotherapy or discharge from hospital, whichever occurs first.

bloodstream infection (bsi) is common in patients with acute myeloid leukemia (aml) and causes significant morbidity and mortality. chemotherapy disrupts oral and intestinal mucosal barriers, facilitating bacterial translocation to the bloodstream. baseline periodontitis is associated with higher risk of bsi during chemotherapy. in aml patients, since baseline screening and treatment of asymptomatic periodontitis is currently not a standard practice, the researchers are hoping to (i) personalize supportive care according to patient-specific risk factors; (ii) promote an interdisciplinary approach to supportive care by bringing periodontists into the treatment team; (iii) improve quality of life by reducing hospitalization length; (iv) decrease the incidence of re-hospitalization during future phases of treatment; (v) decrease early treatment related mortality (trm); and (vi) decrease healthcare costs.

Eligibility criteria:
inclusion criteria: * age \>18 years * newly diagnosed or relapsed aml * planned intensive chemotherapy (any regimen expected to require 3-4 weeks of inpatient stay) * antibacterial prophylaxis using levofloxacin 500 mg daily * sufficient time to perform periodontal examination and treatment by day 1 of chemotherapy exclusion criteria: * prior treatment for aml, except hydroxyurea or leukapheresis * anc \<0.5 x 10\^9/l at the time of enrollment * post-transfusion platelet count \<50x10\^9/l at the time of enrollment * unstable for transfer to the school of dentistry * fever at the time of enrollment * documented infection at the time of enrollment * srp in the last 3 months * symptomatic periodontal disease

Keywords: aml periodontitis blood stream infections
the use of micro vibratory stimulation technique to control the pain of digit block anesthesia

Conditions: Pain, Analgesia

Summary: the investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (mvs) compared with patients who receive injections without the mvs.

research question/hypothesis the investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (mvs) compared with patients who receive injections without the mvs. objectives the primary objective of this study is to compare the pain rating scale from an exposure group (digit block injection with the aid mvs) and the control group (traditional injection).

Eligibility criteria:
inclusion criteria: * healthy individuals between the ages of 18 and 65 who are willing and able to consent and who require the use of local anesthetic digit block to both sides of a finger for the treatment of wounds, injuries, infections, or laceration of the fingers. exclusion criteria: * allergy to any type of local anesthetic. * inability to consent. * inability to complete a numeric pain scale. * clinical appearance or clinical evidence of intoxication. * significant compromising conditions such as major trauma and severe respiratory distress.
a trial to learn if single ascending intravenous (iv) doses of regn7508 are safe and well tolerated, and how it works in the body of healthy adult participants

Conditions: Healthy Volunteer

Summary: this study is researching an experimental drug called regn7508 (called "study drug"). the aim of this study is to see how safe and tolerable the study drug is in healthy participants. this study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit 2. judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and echocardiograms (ecgs) performed at screening and/or prior to administration of initial dose of study drug 3. participant is in good health based on laboratory safety testing obtained at the screening visit and/or prior to administration of initial dose of study drug 4. normal activated partial thromboplastin time (aptt), normal prothrombin time (pt), and normal platelet counts at screening period and at the day -1 visit as defined by the local laboratory 5. hemoglobin value ≥11.0 g/dl for females and ≥12.9 g/dl for males at the screening and day 1 visits key exclusion criteria: 1. history of any major surgical procedure or clinically significant physical trauma, in the opinion of the investigator, that may pose a risk to the participant by study participation 2. whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit 3. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation, as defined in the protocol 4. estimated glomerular filtration rate (egfr) of \<60 ml/min/1.73m2 at screening 5. current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit 6. confirmed positive drug test result at the screening visit and/or prior to randomization or a history of drug abuse within a year prior to the screening visit 7. history of alcohol abuse within the last 2 years prior to the day 1 visit 8. any malignancy, except for nonmelanoma skin cancer or cervical/anus in situ, that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit 9. history of significant multiple and/or severe allergies (eg, latex gloves) or has had an anaphylactic reaction to prescription or nonprescription drugs or food note: other protocol defined inclusion / exclusion criteria apply

Keywords: thrombotic disorders
clinical study assessment of sr-t100 topical gel against actinic keratosis

Conditions: Actinic Keratosis; Bowen's Disease

Summary: to evaluate the efficacy of sr-t100 gel by observing the lesion size (length x width x height) of human cutaneous squamous cell carcinoma in situ (actinic keratosis and bowen's disease) reduced at least 75%.

an open phase ii study to assess the efficacy and safety of topical sr-t100 gel in the treatment of human cutaneous cell carcinoma in situ (actinic keratosis and bowen's disease). the primary efficacy endpoint defines as the proportion of patients whose lesion size reduced at least 75%. the secondary efficacy endpoints include complete clearance rate as the proportion of patients with no clinical visible ak/bd lesions in the treatment area, partial clearance rate as the proportion of patients at least a 75% reduction of ak/bd lesion size in teh treatment area, and histological response rate as the proportion of patients with biopsy proven clearance of ak and bd in situ. safety was evaluated by clinically significant changes occurring from baseline to the end of the study by observing physical examination, vital signs, laboratory assessments and aes.

Eligibility criteria:
inclusion criteria: * patients met all of the inclusion criteria for the entry of this study: 1. male or female; aged ≧ 20 years old. 2. patients had histologically confirmed squamous cell carcinoma in situ (ak or bd) for the targeted lesion. 3. patients had a measurable lesion 5mm or larger for ak or 10mm or larger for bd. 4. patient had a performance status of \< 2 (ecog). 5. patients who had signed an approved written informed consent. exclusion criteria: * patients were excluded from this study for any of the following reasons: 1. patients with histologic subtypes other than squamous cell carcinoma in situ (ak or bd). 2. patients with tumor extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum. 3. patients who had grossly suspicious or inflamed nodes on physical examination. 4. patients with grossly infected tumors. 5. patients with recurrent invasive squamous cell carcinoma. 6. patients with a history of other invasive malignancies, if there was any evidence of the other malignancy being present within the past 5 years. patients were also excluded if their previous cancer treatment contraindicated this protocol therapy. 7. use of any investigational drug in the 30 days before screening. 8. pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods.

Keywords: actinic keratosis, ak, bowen's disease, bowen
the effect of oseltamivir treatment on the yield of polymerase chain reaction test for confirmed influenza infection

Conditions: Influenza

Summary: the purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir.

a prospective cohort study will be undertaken during the influenza season of 2015 in rambam medical center, haifa, israel. the study group will include inpatients older than 18 years, who have clinical presentation suggestive of influenza virus infection defined by the world health organization and the center for disease control and prevention, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose, who were found positive to influenza virus by polymerase chain reaction test, and in whom anti viral treatment was indicated. exclusion criteria: 1. immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs. 2. pregnant women. 3. patients who were treated with oseltamivir in the previous 6 months. patients who approve their participation will to fill a questionnaire, and a polymerase chain reaction assay for influenza will be performed as follows: the first sample will be taken right before the first dose of oseltamavir, and then on days 2, 3 and 5. samples will be stored at a temperature of +4 celsius degrees for a maximum of 48 hours. outcomes: we will consider a positive polymerase chain reaction test 3 days after the initiation of treatment as prolonged shedding.

Eligibility criteria:
inclusion criteria: 1. clinical presentation that suggest influenza virus infection, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose, 2. positive to influenza virus by pcr test 3. anti viral treatment was indicated exclusion criteria: 1. immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs. 2. pregnant women. 3. patients who were treated with oseltamivir in the previous 6 months

Keywords: influenza viral shedding oseltamivir polymerase chain reaction