Kornimate/medical-research-clean huggingface dataset:
microdose study of melphalan, bortezomib and dexamethasone

Conditions: Multiple Myeloma

Summary: the purpose of the study is to identify specific genes that are up- or downregulated in multiple myeloma patients who receive a microdose of either melphalan (alkeran®), bortezomib (velcade®) or dexamethasone (dexaven®). the study treatment constitutes 1% of the planned standard myeloma treatment and will be given two hours prior to standard treatment. blood samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.


Eligibility criteria:
inclusion criteria: * planned treatment for multiple myeloma (newly diagnosed as well as relapse and refractory disease) with one of the following chemotherapy regimens: 1) highdose melphalan, 2) bortezomib or 3) dexamethasone * 18 years or older. * understand and have the will to sign the informed consent. exclusion criteria: * prior treatment with the study drug * received treatment with biphosphonates in the week prior to study treatment

Keywords: multiple myeloma phase 0 study microdose study micro array gene expression profiling
efficacy and safety of 2 dose regimens of tev-48125 versus placebo for the preventive treatment of episodic migraine

Conditions: Migraine

Summary: the study is being conducted to evaluate two doses of tev-48125 in adult patients with episodic migraine


Eligibility criteria:
inclusion criteria: * males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age * patient signs and dates the informed consent document * patient has history of migraine according to international classification of headache disorders, or clinical judgment suggests a migraine diagnosis * 85% e-diary compliance * total body weight between 99 and 265 lbs, inclusive * additional criteria apply, please contact the investigator for more information exclusion criteria: * clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator * evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years * history of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[eg, cerebral ischemia\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism * known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis b or c infection * past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma * pregnant or nursing females * history of hypersensitivity reactions to injected proteins, including monoclonal antibodies * participation in a clinical study of a new chemical entity or a prescription medicine within 2 months or 5 half-lives, whichever is longer * additional criteria apply, please contact the investigator for more information
prospective study on the use of transdermal analgesic buprenorphine patches for chronic pain in the uk

Conditions: Chronic Pain

Summary: the primary objective of the study is the descriptive analysis of incidence \& severity of side effects \& reasons for discontinuation of the treatment of chronic pain with transdermal analgesic buprenorphine patches.

750 patients that are treated with transdermal buprenorphine patches for chronic pain will be included in the study. about 20% of patients are aimed to be patch-naive, ie have received their first prescription of transdermal analgesic patches within 1 month before inclusion in this observational study. furthermore the study should not include more than 25% of cancer patients that are treated for chronic pain in order to ensure an appropriate mix of patient population.

Eligibility criteria:
inclusion criteria * patient age \> 18 * patient is treated with transdermal buprenorphine * the patient is able to answer the patient's survey \& has an estimated overall survival of minimum 6 months * the patient gives his/her informed, written consent to participate in the study exclusion criteria * patient age \< 18 * patient has less than 6 months survival expectancy * patient is unable to answer the patient survey for whatever reason in any feasible form
electrochemotherapy for the inoperable vulva carcinoma

Conditions: Advanced Inoperable Vulva Carcinoma

Summary: electrochemotherapy (ect) with bleomycin in non-operable advanced vulva carcinoma

prospective evaluation of tumor response towards ect by photo documentation. in addition prospective documentation of life quality after ect treatment as well as evaluation of pain. .

Eligibility criteria:
inclusion criteria: * informed consent * age ≥ 55 years (postmenopausal) * histologically proved cutan accessible vulva carcinoma * a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm * applied electrochemotherapy with electroporation exclusion criteria: * non compliant patients * patients with symptomatic or rapidly progredient metastasis outside of the vulva
study of ngx-4010 for treatment of painful hiv-associated neuropathy

Conditions: HIV Infections; Peripheral Nervous System Diseases; Pain

Summary: the purpose of the study is to determine if an investigational drug, ngx-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful hiv-associated neuropathy.


Eligibility criteria:
key eligibility criteria: * must have had hiv-associated neuropathy for at least 2 months, with moderate to severe pain in both feet. * must not have significant pain in feet due to other causes (for example, arthritis). * must have intact skin at the treatment area. * must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks). * must not use topical pain medications for hiv-associated neuropathy. * must be able to comply with study requirements such as completing daily pain diary and attending study visits. * must be at least 18 years old, not pregnant, and be able to take care of self independently, with only occasional assistance if needed. * no significant medical problems of the heart, kidneys, liver or lungs, or cancer. * no history or current problem with substance abuse.

Keywords: dermal assessment pain measurement diary neuropathy analgesics/*therapeutic use capsaicin/*administration & dosage/adverse effects hiv infections/*complications/*drug therapy pain complementary therapies
epix, a study to gather more information about characteristics of patients and other factors which may contribute to survival over a long period of time in patients with metastatic castration-resistant prostate cancer (mcrpc) treated with radium-223 (xofigo)

Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)

Summary: in this observational study researchers want to gather more information about the characteristics of patients treated with radium-223 (xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels (metastatic castration-resistant prostate cancer, mcrpc). in addition researchers want to identify the factors which may contribute to survival over a long period of time in those patients. radium-223 (ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mcrpc).


Eligibility criteria:
inclusion criteria * adult patients with documented diagnosis of mcrpc (≥18 years at diagnosis), and * received ra-223 as one of the therapies between jan 1, 2013 and jun 31, 2019 after diagnosis of mcrpc exclusion criteria - patients involved in clinical trials
positive node traced before neoadjuvant chemotherapy (nac)

Conditions: Breast Cancer

Summary: to investigate this regression model by injecting and tracing carbon nanoparticles (cns) into the fusion node prior to nac in patients with breast cancer.

guided by ultrasound, 0.3 ml of cns suspension was injected in a fusion node prior to nac in 110 patients with local advanced breast cancer. patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of nac. the distribution by intercostobrachial nerves (icbn) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to nac.

Eligibility criteria:
inclusion criteria: * invasive ductal carcinoma diagnosed by biopsy; * clinically positive node diagnosed by contrast enhance computer tomography (cect), the number of strengthened nodes at level i ≥ 1 with the longest diameter of the strengthened node ≥ 2cm; * nac regimen followed the nccn guideline; * no prior history of breast cancer or other malignancies. exclusion criteria: * the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
the efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and erectile dysfunction

Conditions: Benign Prostatic Hyperplasia; Erectile Dysfunction

Summary: the efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and erectile dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial


Eligibility criteria:
inclusion criteria: visit1 * male aged 45 years old or older * subjects who have psa ≤ 4.0 ng/ml visit2 * subjects who have total ipss score ≥ 13 * subjects who have iief-ef domain ≤ 24 and each point below 3 in question 3 and 4 exclusion criteria: * subjects who have hypersensitivity to investigational product or sulfa medications
safety and efficacy study of the treatment of kidney infections with short course levofloxacin

Conditions: Acute Uncomplicated Pyelonephritis

Summary: the purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy to treat patients with infections of their kidney.

the goal is to complete a pilot study of short course (5 days), high dose, levofloxacin treatment for women with acute uncomplicated pyelonephritis. specific study objectives include: 1. to assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women. 2. to describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis. 3. to identify urine proteins associated with the inflammatory response of acute pyelonephritis, and characterize the time course of resolution of these proteins following initiation of treatment.

Eligibility criteria:
inclusion criteria: * recent onset (less than 7 days) of costovertebral angle pain or tenderness with or without fever, and with or without lower urinary tract symptoms (dysuria, frequency, urgency). diabetic women without long term complications of diabetes (retinopathy, nephropathy, or neuropathy) may be enrolled. * stable hemodynamic status and able to tolerate oral medication. * pretherapy urine culture \>107 cfu/l (\>104 cfu/ml) of a uropathogen (e. coli, other enterobacteriaceae, s. saprophyticus). patients will be enrolled into the study prior to urine culture results being known. if pretherapy cultures are subsequently not positive (usually at 48 hours), subjects will be discontinued. * pyuria (\> 10 wbc/mm3 or \> 10 x106 wbc/l by hemocytometer; \> 6-10 wbc/hpf, or \> 1+ le (leukocyte esterase) dipstick). exclusion criteria: ·pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.

Keywords: pyelonephritis
cryoanalgesia study

Conditions: Pain, Postoperative

Summary: this study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores, and shorter hospital stays. the results of this study may lead to a useful alternative for pain control in cardiac surgery patients.


Eligibility criteria:
inclusion criteria: * scheduled for elective cabg (coronary artery bypass graft) or single valve surgery via median sternotomy * reasonable expectation to be extubated within 24 hours postop exclusion criteria: * prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy) * hemisternotomy approach * history of cold urticaria, cryoglobulinemia, raynaud's disease, or diabetic neuropathy * preoperative use of opioids * history of chronic pain or associated syndromes * concurrent cox maze procedure * need for post-bypass mechanical circulatory support (ecmo, iabp) or open chest * women who are pregnant or breastfeeding * patients who are unable to consent for themselves
effects of protein blends on muscle protein synthesis in healthy older adults

Conditions: Muscle Synthesis

Summary: during aging there is a tendency for muscle protein synthesis (growth) to become less efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can affect strength and mobility. protein consumption may be one opportunity to alleviate this problem especially when consumed in appropriate amounts following resistance training. this study is designed to determine if a soy dairy protein blend, shown to be effective in younger adults, will produce beneficial muscle protein synthesis in older healthy adults following resistance exercise.


Eligibility criteria:
inclusion criteria: 55-70 yr olds stable body weight exclusion criteria: 1. exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise) 2. significant heart, liver, kidney, blood, respiratory disease or thyroid issues 3. peripheral vascular disease 4. orthopedic injury that prohibits participation in the exercise training 5. diabetes mellitus or other untreated endocrine disease 6. active cancer (all groups) and history of cancer 7. acute infectious disease or history of chronic infections (e.g. tb, hepatitis, hiv, herpes) 8. neurologic injury or disease 9. recent (within 6 months) treatment with anabolic steroids, or corticosteroids. 10. alcohol or drug abuse 11. tobacco use (smoking or chewing) 12. malnutrition (bmi \< 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia) 13. obesity (bmi \> 30 kg/m2) 14. low hemoglobin levels (below normal values) 15. food allergies 16. taking dietary supplements such as green tea, omega 3 fatty acids, etc. 17. females

Keywords: soy whey muscle older mtor sarcopenia
effects of chronic intake of cannabis on contrast sensitivity

Conditions: Cannabis Dependence

Summary: rates of driving under the influence of cannabis have risen in recent years. cannabis is involved in 1/3 of motor vehicle collisions. the chronic use of cannabis is known to affect dopaminergic regulation and may thus impair contrast sensitivity. in turn, contrast sensitivity disorders could originate difficulties to anticipate and avoid collision with objects, especially when objects are in movement. the investigators goal is to examine the effects of a chronic intake of cannabis on contrast sensitivity. the observed values will be compared to standard references. in addition, since smoking cannabis is always associated with tobacco, the investigators will control the effects of tobacco on contrast sensitivity. in this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36 no smokers. the investigators will present gratings with different spatial frequencies and the investigators will determine contrast thresholds for static and dynamic (moving) gratings. the investigators predict that cannabis addicts will present abnormal contrast sensitivity especially in case of dynamic presentation of gradings.


Eligibility criteria:
inclusion criteria: "cannabis" arm * patient addicted to cannabis * positive cast test result * urine tested positive for cannabis metabolites "tobacco" arm * positive fagerström test result * no cannabis intake in the last year before inclusion * no previous history of cannabis use "healthy volunteers" * no tobacco or cannabis intake in the last year before inclusion * no history of addictive disorders exclusion criteria: * addiction to other substances than cannabis or tobacco * benzodiazepine treatment * patient with history of benzodiazepine treatment * patient with history of general anesthesia in the last 3 months before inclusion * patient with history of head trauma * pregnant woman * breast feeding woman * adults under supervision or guardianship
effect of low tidal volume ventilation in improving oxygenation and thus reducing acute lung injury in the cardiac surgical patient

Conditions: Acute Respiratory Distress Syndrome

Summary: we propose that as low tidal volume ventilation has proven to be beneficial in patients with established ards it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. in this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. measurement of pao2 to fio2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. chest x-ray findings, time to extubation and length of icu stay will also determine if there is a role for low tidal volume ventilation in the operating room. we will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ards.

methods- a single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg tv to ventilation with 10 ml/kg tv in patients undergoing elective cardiac surgery. study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent intensive care unit stay. the primary endpoint of the study was time to extubation. secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.

Eligibility criteria:
inclusion criteria: * patients coming in for cardiac surgical procedures will be recruited into the study. * both men and women will be recruited into the study. * all patients over the age of 18 will be recruited into the study. * discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent. exclusion criteria: * patients with preexisting respiratory failure and active infection will be excluded from the study. * patients undergoing one lung ventilation during surgery will be excluded from the study. * patients undergoing emergency cardiac surgery will be excluded from the study.

Keywords: acute lung injury cardiac surgery the incidence of ards after elective cardiac surgery is 1-3% the impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery. the purpose of this study is to assess the efficacy of low tidal volume ventilation. reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.
amifostine to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer

Conditions: Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Radiation Toxicity

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy. purpose: phase ii trial to study the effectiveness of amifostine to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer.

objectives: i. evaluate the reduction in toxicities by combining amifostine with cisplatin, etoposide, and radiotherapy in patients with limited stage small cell lung cancer. ii. evaluate the response rate to this combination by these patients. iii. evaluate the overall survival of patients treated with this regimen. outline: this is a multicenter study. patients receive cisplatin iv on day 1 and etoposide iv daily on days 1-3. this course is repeated every 3 weeks for a total for 4 courses. patients also receive concurrent radiotherapy 5 days per week for 5.5 weeks starting with the first course of chemotherapy. patients receive amifostine iv over 15 minutes 15-30 minutes prior to each dose of chemotherapy on days 1-3. patients are followed at 6 and 12 weeks, then every 3 months for 9 months, every 6 months for 1 year, and then until death. projected accrual: there will be 20 patients accrued into this study.

Eligibility criteria:
disease characteristics: histologically confirmed limited stage small cell lung cancer primary tumor must be evaluable radiographically patient characteristics: age: over 18 performance status: ecog 0-1 life expectancy: at least 3 months hematopoietic: wbc greater than 4,000/mm3 platelet count greater than 100,000/mm3 hepatic: bilirubin less than 1.5 mg/dl sgot and sgpt less than 2 times normal renal: creatinine less than 1.5 mg/dl other: no concurrent active infection no prior malignancy except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix not pregnant or nursing effective contraception required of all fertile patients prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: not specified

Keywords: limited stage small cell lung cancer drug/agent toxicity by tissue/organ radiation toxicity
comparative bioavailability study of morphine sulfate immediate release and controlled release

Conditions: Pain

Summary: characterize the steady-state pharmacokinetics of morphine after oral administration of roxane laboratories' morphine sulfate immediate release tablets and oral solution and to compare their pharmacokinetics to that of avinza.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to morphine sulfate or any comparable or similar product.