Kornimate/medical-research-clean huggingface dataset:
multiple myeloma patient registry

Conditions: Multiple Myeloma

Summary: the purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the united states who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (pi) and/or immunomodulatory drug (imid) used either as monotherapy or combination therapy with other treatments.


Eligibility criteria:
inclusion criteria: * must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (icf) allowing data collection and source data verification in accordance with local requirements * have a diagnosis of relapsed mm \[according to 2014 international myeloma working group (imwg) criteria\] with 1 to 3 prior lines of therapy. (an induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.) * participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (pi) and/or immunomodulatory drug (imid) within 90 days prior to enrollment. a short course of corticosteroids is allowed prior to initiating the new line of induction therapy * must be willing and able to complete the protocol-required patient-reported outcome (pros) exclusion criteria: * participant has plasma cell leukemia \[greater than (\>) 2.0 \* 10\^9 per liter\] circulating plasma cells by standard differential), waldenstrom's macroglobulinemia, poems syndrome (polyneuropathy, organomegaly, endocrinopathy, m-protein, and/or skin changes), or amyloid light-chain amyloidosis * participant has a life expectancy of less than 6 months * at the time of screening, participant is enrolled in an interventional clinical trial for mm using an anti-neoplastic agent that is not currently approved by the united states (us) food and drug administration (fda)
effects of cognitive behavioral therapy (cbt) on weight maintenance after successful weight loss

Conditions: Obesity; Overweight

Summary: the purpose of this study is to assess the effects of cbt after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan. * must be able to have moderate exercise. * must be interested to keep weight loss. exclusion criteria: * pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. * taking medications that could affect metabolism or change body weight. * report heart problems, chest pain, and cancer within the last five years. * smoking * menopause * diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Keywords: weight maintenance cognitive behavior therapy successful weight loss
evaluating clinical outcomes of targeted radiofrequency ablation and kyphoplasty (also known as vertebral augmentation) to treat painful metastatic vertebral body tumors

Conditions: Metastatic Lesions in Vertebral Bodies

Summary: to evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-rfa) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.


Eligibility criteria:
inclusion criteria: * one to 2 painful vertebrae (t1-l5) with evidence of osteolytic metastatic lesion with known primary histology with pathologic fracture(s) at index vertebra by mri * pain score ≥ 4 on the numerical rating pain scale * life expectancy of ≥ 6 months exclusion criteria: * primary tumors of the bone at index vertebra * benign tumors of the bone at index vertebra * osteoblastic tumors at index vertebra * index vertebra with more than one (1) pedicle involved * epidural extension of tumor within 5 mm of the spinal cord or without sufficient room for thermal protective maneuvers * spinal cord compression or canal compromise requiring decompression * radiation therapy is planned to be started on the index vertebra within 4 weeks post procedure * radiation therapy was performed on the index vertebra within 2 months before enrollment * major surgery of the spine was performed within 3 months before enrollment * index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty * additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra

Keywords: metastatic lesions vertebral body ablation targeted radio-frequency ablation radio-frequency targeted vertebral augmentation radiofrequency kyphoplasty spine vertebral augmentation kyphoplasty spinal ablation pain quality of life
a randomized study of the safety and efficacy of fg-2216 in subjects with renal anemia not requiring dialysis and not receiving recombinant human erythropoietin

Conditions: Renal Anemia

Summary: the purpose of this study is to test the safety and efficacy of fg-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.


Eligibility criteria:
inclusion criteria: * stage 3 or 4 chronic kidney disease * appropriate hemoglobin levels exclusion criteria: * neovascular age related macular degeneration requiring treatment * macular edema or proliferative retinopathy in diabetic subjects, requiring treatment * any history of malignancy * therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks * renal transplant

Keywords: renal anemia renal failure kidney disease human epo
study with quadrivalent recombinant influenza vaccine (riv4) in participants 9 through 49 years of age.

Conditions: Influenza Immunization

Summary: the purpose of this study was to demonstrate the non-inferiority (ni) of the hai immune response of riv4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of riv4 in all participants.

the participation duration was approximately 6 months for each participant.

Eligibility criteria:
inclusion criteria: * aged 9 to 49 years on the day of inclusion * a female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. to be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile or 2) was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration * assent form or informed consent form had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative exclusion criteria: * known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * thrombocytopenia * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the investigator's judgment * personal or family history of guillain-barre syndrome (gbs) * personal history of clinically significant development delay (at the discretion of the investigator), neurologic disorder, or seizure disorder note: the above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
raptor: rad001 as monotherapy in the treatment of advanced papillary renal cell tumors program in europe

Conditions: Carcinoma; Renal Cell; Non Clear Cell Renal Carcinoma; Papillary Cell Renal Carcinoma; Adenocarcinoma

Summary: to evaluate the preliminary efficacy and safety of rad001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old. 2. patients with metastatic papillary renal cell carcinoma, type i or ii. 3. patients with at least one measurable lesion. 4. patients with an ecog performance status ≤1. 5. adequate bone marrow function. 6. adequate liver function. 7. adequate renal function. 8. adequate lipid profile. exclusion criteria: 1. patients who had radiation therapy within 28 days prior to start of study. 2. patients who have received prior systemic treatment for their metastatic rcc. 3. patients who received prior therapy with vegf pathway inhibitor. 4. patients who have previously received systemic mtor inhibitors. 5. patients with a known hypersensitivity everolimus or other rapamycins or to its excipients. 6. patients with uncontrolled central nervous system (cns) metastases. 7. patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. 8. patients with a known history of hiv seropositivity. 9. patients with autoimmune hepatitis. 10. patients with an active, bleeding diathesis. 11. patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. 12. patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix. 13. female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. 14. patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start. 15. patients unwilling to or unable to comply with the protocol.

Keywords: renal cell carcinoma non clear cell carcinoma papillary cell renal carcinoma adults everolimus
a trial of idn-6556 in post orthotopic liver transplant for chronic hcv

Conditions: Liver Fibrosis; Hepatic Fibrosis; Liver Cirrhosis; Hepatic Cirrhosis

Summary: this is a double-blind, multicenter study involving patients with chronic hcv infection who had a liver transplantation; developed hcv-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response (svr) following anti-hcv therapy; but still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with idn-6556 is better than placebo in reversing or stopping the progression of the damage to the new liver caused by hcv.

there are data to suggest that with eradication of the hcv virus, improvements in liver fibrosis can be seen in the post-transplant population. however, amelioration of inflammatory activity, and deceleration of fibrosis progression is a gradual process over the course of many years. this placebo-controlled study is designed to evaluate the effects of idn-6556, compared to placebo, on markers of apoptosis and inflammation, and liver histology.

Eligibility criteria:
inclusion criteria: * male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study * history of orthotopic liver transplantation for hcv-induced liver disease * diagnosis of hcv infection (hcv-rna detectable in serum) and liver fibrosis and/or incomplete cirrhosis status post liver transplantation, and achieved a sustained virologic response (svr) with anti-viral hcv treatment within 18 months of day 1 * liver fibrosis on liver histology as read by central histopathologist of ishak f2 to f6 within three months of day 1 (up to 15 subjects with an ishak score of f6 can be enrolled) * willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug exclusion criteria: * known infection with hepatitis b virus (hbv) and/or human immunodeficiency virus (hiv) * history of renal transplant and/or severe renal impairment defined as egfr (estimated glomerular filtration rate) of less than 30 ml/min/1.73 m2 * evidence of tumor burden \>milan criteria, or evidence of micro- or macrovascular invasion in explanted liver * hepatocellular carcinoma (hcc) at entry into the study * concurrent sirolimus (rapamycin) use * history or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) qt or qtc interval of \> 480 milliseconds (msec) * subjects with diagnosed or suspected systemic lupus erythematosus (sle) and/or rheumatoid arthritis (ra) * if female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding

Keywords: liver transplant hepatitis c liver fibrosis hepatic fibrosis liver cirrhosis hepatic cirrhosis
individualized diet improvement program for weight loss and maintenance, cohort 1

Conditions: Obesity; Overweight; Weight Loss; Diet Habit

Summary: this research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>28 kg/m2; * not currently pregnant or lactating; * have wi-fi at home, a working email, and an iphone or android smartphone; * no self-reported severe metabolic, cardiovascular or musculoskeletal disease; * not using insulin injection; * able to attend the 22 (1 hour) diet improvement sessions; * willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year; * keep weighing their weight for one and a half years; * fluent in reading and writing english. exclusion criteria: * age \ 64 years; * body mass index of \<28 kg/m2; * currently pregnant; * currently lactating; * self-reported with severe metabolic, cardiovascular, or musculoskeletal disease; * use insulin injection; * not able to attend the 22 (1 hour) diet improvement sessions for 1 year; * failed to set up a wi-fi scale; * failed to submit a ffq.
a study to evaluate the efficacy and safety of kh001 in patients with dentin hypersensitivity

Conditions: Dentin Hypersensitivity

Summary: the purpose of this study is to evaluate the efficacy and safety of kh001 in patients with dentin hypersensitivity.

this study is multicenter, double-blind, placebo-controlled, randomized, parallel-designed, phase 2 study to evaluate the efficacy and safety of kh001. the total duration of the study will be approximately 7 to 11 weeks. clinical safety evaluations will include physical examinations, vital signs, clinical laboratory results, and adverse event monitoring.

Eligibility criteria:
inclusion criteria: * is at least 19 years old by the time of the screening visit * be in good general health as determined by the investigator * have at least 2 non-adjacent teeth and is diagnosed with hypersensitive exclusion criteria: * is allergic to the active drug substance or other excipients used in the investigational product * has any history of alcohol or drug abuse * has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit * has active dental caries or history of dental caries

Keywords: dentin sensitivity denin hypersensitivity
safety and efficacy of bi 1744 cl in patients with chronic obstructive pulmonary disease ii

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of bi 1744 cl inhalation solution (5 and 10 mcg) delivered via the respimat® inhaler, in patients with copd.


Eligibility criteria:
inclusion criteria: 1. all patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator fev1\<80% of predicted normal (ecsc) and a post-bronchodilator fev1/fvc \<70% at visit 1 2. male or female patients, 40 years of age or older 3. patients must be current or ex-smokers with a smoking history of more than 10 pack years: exclusion criteria: 1. patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an sgot \>x2 uln, sgpt \>x2 uln, bilirubin \>x2 uln or creatinine \>x2 uln 2. patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3 3. patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute) 4. patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse 5. patients who have undergone thoracotomy with pulmonary resection 6. patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 7. patients who regularly use daytime oxygen therapy for more than one hour per day. 8. patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (visit 1) or patients who are currently in a pulmonary rehabilitation program 9. pregnant or nursing women 10. women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
association between metabolic syndrome and serum nerve growth factor levels in women with overactive bladder

Conditions: Overactive Bladder

Summary: nerve growth factor (ngf-r) receptors are between the detrusor muscle fibers and can cause afferent signals. metabolic syndrome and obesity have been advocated to be risk factors for the development of overactive bladder.

overactive bladder is a clinical syndrome characterized urgency, frequency and nocturia. infection or other obvious causes must be excluded. the overactive bladder is loss of inhibition of the detrusor muscle during the filling or emptying of the bladder. specific receptors and neurotransmitters have role in development of overactive bladder. these includes adrenergic, cholinergic, non-adrenergic, non-cholinergic receptors and interstitial cells. nerve growth factor (ngf-r) receptors are between the detrusor muscle fibers and can cause afferent signals. metabolic syndrome and obesity have been advocated to be risk factors for the development of overactive bladder. the investigators believe that our findings will shed light on treatment.

Eligibility criteria:
inclusion criteria: * women with urgency, nocturia and frequency * abdominal obesity, defined as a waist circumference in men ≥88 cm * serum triglycerides ≥150 mg/dl (1.7 mmol/l) or drug treatment for elevated triglycerides * serum hdl cholesterol \<40 mg/dl (1 mmol/l) in men and \<50 mg/dl (1.3 mmol/l) in women or drug treatment for low hdl-c * blood pressure ≥130/85 mmhg or drug treatment for elevated blood pressure * fasting plasma glucose (fpg) ≥100 mg/dl (5.6 mmol/l) or drug treatment for elevated blood glucose exclusion criteria: * chronic obstructive pulmonary disease allergy * psychiatric disorders * urinary tract infection * neurological diseases * metabolic diseases * pure stress or mixed urinary incontinence * history of pelvic surgery * diabetes mellitus

Keywords: urinary bladder nerve growth factor overactive bladder
a phase iii, open-label, single-dose study to evaluate the safety and immunogenicity of fluviral® vaccine

Conditions: Influenza

Summary: vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. once a year, a meeting of who experts takes place, leading to a recommendation on the influenza a and b strains that should be used for the production of vaccine for the coming influenza season. this study is designed to test the safety/reactogenicity and the immunogenicity of the fluviral trivalent split virion influenza vaccine containing the influenza strains recommended for the 2007-2008 season.


Eligibility criteria:
inclusion criteria: * healthy male and female adults, 18 years of age and older. * female subject of non-childbearing potential. written informed consent obtained from subject. exclusion criteria: * acute disease at the time of enrollment. * blood pressure abnormalities. * any immunosuppressive condition, such as hiv or cancer. * renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus. * unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment. * any demyelinating disease, including guillain-barré syndrome. * alcohol consumption and/or drug abuse. * receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment. * any known or suspected allergy to the fluviral vaccine.

Keywords: influenza