Kornimate/medical-research-clean huggingface dataset:
greater occipital nerve blockade in veterans with post-concussion headache: sub-study 1

Conditions: Post-Traumatic Headache

Summary: the acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. each veteran participant will be randomized to receive three different concentrations, which will be injected one week apart each.

military servicemembers are at elevated risk for traumatic brain injury (tbi) and its consequences, including post-traumatic headache (pth). the most common phenotype of pth is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. therefore, the consideration of other methods to manage pth in servicemembers and veterans is warranted. anesthetic greater occipital nerve (gon) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. this intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden. the acute burning that occurs during injection and then the numbing over the scalp that occurs shortly after anesthetic gon blockade make controlled investigations against placebo difficult to interpret. in sub-study 1 of this project, different concentrations of bupivacaine (0.0%, 0.01%, 0.05%, 0.1%) will be examined in order to identify a suitable control dose to later compare to the full dose of 0.5%. acute and subacute sensations from bupivacaine gon blockade will be measured and the lowest concentration that resembles the sensations elicited by full dose (0.5%) will be used in a subsequent efficacy trial (sub-study 2).

Eligibility criteria:
inclusion criteria: * united states military veterans within va connecticut healthcare system * chronic post-traumatic headache per ichd-3 criteria (i.e., headaches are continuing to occur three months after the head injury) * at least two headache days per week * mri brain scan completed within the past 3 months if chronic pth for less than one year, within the past year if chronic pth for less than 5 years, and within 5 years if chronic pth for more than 10 years * review of mri and the medical record does not reveal another source for headache exclusion criteria: * skull defect * other contraindication to bupivacaine 1. allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine 2. instruction from clinician to avoid amide anesthetics, such as lidocaine * pregnant or lack of adequate birth control

Keywords: traumatic brain injury veteran va connecticut healthcare system
a study of docetaxel and ramucirumab versus docetaxel and placebo in the treatment of stage iv non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: the purpose of this study is to evaluate the effects of ramucirumab in combination with docetaxel in participants with stage iv non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer disease * clinical stage iv or recurrent disease * one prior first-line platinum-based chemotherapy regimen with or without maintenance therapy * for non-small cell lung cancer (nsclc) tumors other than squamous cell histology, the epidermal growth factor receptor (egfr) mutation status is known prior to randomization * for participants with activating epidermal growth factor receptor (egfr) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (egfr-tki) monotherapy (only one regimen in the setting of single use) should be utilized * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * measurable disease as defined by response evaluation criteria in solid tumors (recist) version recist version 1.1 * adequate organ function * estimated life expectancy of at least 3 months. exclusion criteria: * have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment * receiving concurrent treatment with other anticancer therapy * central nervous system disease other than stable and treated brain metastasis * has major blood vessel invasion or encasement by cancer * has intratumor cavitation * has a history of uncontrolled thrombotic disorder * is receiving therapeutic anticoagulation with drugs * is receiving chronic therapy with nonsteroidal anti-inflammatory drugs * has a history of hemoptysis within 2 months prior to randomization * has clinically relevant congestive heart failure * has experienced any arterial thromboembolic event * has uncontrolled arterial hypertension * has had a serious or nonhealing wound or, ulcer * has significant existing conditions
the effect of methylsulfonylmethane (msm) on cardiometabolic health

Conditions: Obesity

Summary: obesity- related diseases are linked to elevated levels of inflammation, oxidative stress, and metabolic dysfunction. methylsulfonylmethane (msm) is a naturally occurring compound that demonstrates antioxidant and anti-inflammatory effects. improvements in measures of metabolic health have been observed in mouse models of obesity and type 2 diabetes following msm treatment. however, the effect of msm on obesity-related risk factors for disease in humans has not been investigated. therefore, the purpose of this investigation will be to determine whether msm supplementation improves metabolic health, and markers of inflammation and oxidative status.


Eligibility criteria:
inclusion criteria: * overweight or obese adults without any diagnosed disease or current medications other than birth control. participants must agree to maintain diet and physical activity levels throughout study. exclusion criteria: * normal weight adults, or overweight/obese adults that do not meet the criteria for metabolically unhealthy obesity. individuals currently on medications, or with diagnosed disease. pregnant or nursing women, or women planning to become pregnant within the study timeframe. lack of access to reliable transportation to study site, lack of internet access, or non-english speaking.
genetic and immune studies of rheumatoid arthritis and related conditions

Conditions: Arthritis, Psoriatic; Autoimmune Diseases; Joint Diseases; Osteoarthritis; Rheumatoid Arthritis

Summary: this protocol will examine blood, synovial fluid and synovial tissue from patients with rheumatoid arthritis and other chronic inflammatory joint diseases to study genetic and immunologic factors involved in the cause, development and progression of these conditions. synovial fluid is the lubricating fluid in joints. the synovial membrane is a delicate tissue lining the inner surface of joints, which, in arthritic conditions, thickens and becomes infiltrated with various types of cells. patients with rheumatoid arthritis and certain patients with other forms of arthritis may be eligible for this study. those enrolled will be followed periodically for follow-up and disease evaluation. they may undergo the following procedures: 1. synovial fluid aspiration, when medically indicated (for example, for joint swelling and inflammation). for this procedure, an area of skin around the joint is numbed with an anesthetic, and a needle is inserted into the joint to withdraw a small fluid sample. 2. periodic blood sampling, not to exceed 450 milliliters (15 ounces) during any 6-week period, for genetic studies of rheumatoid arthritis. the samples are usually taken at the same times that synovial fluid is withdrawn. 3. synovial tissues, collected by needle biopsy or during surgical procedures for arthroscopy (examination of the interior of the joint and repair of the joint) or total joint replacement. for the needle biopsy, the skin over the biopsy site is washed and anesthetized. a needle is inserted and fluid is aspirated. the biopsy needle is then inserted through the outer needle and a tissue sample is suctioned. patients who qualify for other research studies may be invited to participate.

blood, synovial fluids and/or synovial tissues will be obtained from patients with rheumatoid arthritis and related chronic inflammatory arthritides. the synovial tissues will be obtained by one of the following methods: a) needle biopsy, or b) at the time of a total joint replacement or a therapeutic arthroscopic procedure. these materials will be utilized for laboratory studies of etiopathogenetic mechanisms of rheumatoid arthritis and related autoimmune joint diseases.

Eligibility criteria:
patients with rheumatoid arthritis, particularly new onset disease, but certain patients with other forms of arthritis will also be included. significantly swollen or tender knee or significantly swollen shoulders, elbows, wrists, ankles, olecranon bursa or even smaller joints. synovial tissue specimens will not be obtained from patients when any of the following conditions are present: abnormal bleeding or clotting tests, platelet count less than 100,000, or sepsis.

Keywords: osteoarthritis psoriatic arthritis rheumatoid arthritis synovial biopsy synovitis synovium
study of rapamycin plus ketoconazole in advanced cancers

Conditions: Advanced Cancer

Summary: to determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities, and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.


Eligibility criteria:
inclusion criteria: * histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * patients with hematologic malignancies (lymphoma, multiple myeloma and cll only) are eligible to participate in the phase ib portion of the trial only * at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last regimen included bcnu or mitomycin c). * age \>18 years. * ecog performance status less than or equal to 2 * life expectancy of more than 3 months. * normal organ and marrow function as defined below: * hemoglobin ≥ 10 g/dl * leukocytes ≥ 3,000/µl o wbc ≥ 1,500/µl for patients with hematologic malignancies * absolute neutrophil count ≥ 1,500/µl (≥ 1,000/µl for patients with hematologic malignancies) * absolute lymphocyte count ≥1000/µl * platelets ≥ 100,000/µl (≥ 50,000/µl for patients with hematologic malignancies) * total bilirubin within normal institutional limits * ast (sgot) and alt (sgpt) ≤ 2.5 times institutional uln * serum triglycerides ≤ 500 mg/dl * creatinine within normal institutional limits or * creatinine clearance ≥ 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal. * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * able to understand and the willing to sign a written informed consent document. exclusion criteria: * chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or not recovered from adverse events due to agents administered more than 4 weeks earlier. * receiving any other investigational agents. * uncontrolled brain metastases or malignancy. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin. * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * severe immunodeficient state (as judged by the treating physician) * pregnancy (breast-feeding must be discontinued) * hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with rapamycin. * concurrent use of cyclosporine, tacrolimus, and rifampin, terfenadine, astemizole, cisapride, rosiglitazone or pioglitazone due to possible interactions with the study drugs. ketoconazole cannot be taken within 2 hours of an antacid.
effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control

Conditions: Exercise

Summary: this study planned to investigate the effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control in symptomatic and asymptomatic participants. we will follow a cross-over study design to compare the effect of hip focused neuromuscular activation exercise or a sham exercise on foot posture and lower extremity biomechanics. foot posture will be assessed by navicular drop test (ndt), and lower extremity neuromuscular control will be assessed with star excursion y-balance test (sebt-y) and frontal plane projection angle (fppa) during single leg squat before and after the experiments. the results of this study may provide scientific knowledge for a kinetic chain approach during functional foot rehabilitation.


Eligibility criteria:
inclusion criteria: * to be included, participants should be between the ages of 18 and 45 years. exclusion criteria: * participants will be excluded from this study if they have a history of lower body trauma or surgery, or positive trendelenburg sign and slump test.
risedronate in postmenopausal women with low bone density

Conditions: OSTEOPOROSIS, POSTMENOPAUSAL

Summary: the primary objective of this pilot study is to estimate the percent change from baseline at week 4, month 6 in ntx bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months the secondary objectives are : * to estimate the percent change from baseline at specified visits other than week 4, month 6 in ntx for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate. * to estimate the percent change from baseline at all specified visits in serum ctx and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate. * to estimate the percent change from baseline at month 6 in lumbar spine bmd for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate. * to evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.


Eligibility criteria:
inclusion criteria: * ambulatory women,postmenopausal \>= 5 years * have lumbar spine baseline bmd within the following criterion : * hologic: \<= 0.827 g/cm2 or * lunar: \<= 0.942 g/cm2 or * norland: \<= 0.768 g/cm2 * be in general good health as determined by medical history, physical examination and laboratory tests exclusion criteria: * serum 25-oh vitamin d level \<= 12 ng/ml * history of osteomalacia * history of active hyperparathyroidism or hyperthyroidism * hypocalcemia or hypercalcemia from any cause * depot injection \>10,000 iu vitamin d in the past 9 months prior to starting the investigational product * use of vitamin d supplementation within 3 months prior to starting the investigational product * use of any of the following medications within a specified number of months prior to starting the investigational product : * any bisphosphonate. * use of any fluoride with the exception of fluoride use for oral hygiene * strontium * other bone active agents * subcutaneous estrogen implant * oral or parenteral glucocorticoids * anabolic steroids * estrogen or estrogen-related drugs, except for low dose vaginal creams * progestogen * calcitonin, calcitriol, or calcifediol * any allergic or abnormal reaction to bisphosphonates * creatinine clearance \< 30 ml/min
genetic analysis of familial cases of premature ovarian failure

Conditions: Familial Premature Ovarian Failure

Summary: the premature ovarian failure (pof) is a rare syndrome observed in women under 40 who induced estrogen deficiency and often leads to infertility final. the etiologies of pof remain unknown in more than 85% of cases. there are 5-10 % of familial cases.the main objective of this study is to recruit, phenotype and genotype 20 families with at least two subjects with nonsyndromic pof in order to identify new loci using a single technical standard nucleotide polymorphisms (snps). this study will also include related population and population control.

it was decided to move towards a study of familial cases of iop. this study will identify areas of susceptibility in new families, identify candidate genes, sequence these genes in cases familial pof and sporadic cases in order to detect potential mutations, and in the control population.

Eligibility criteria:
inclusion criteria: patients of familial cases of pof : * female subjects between 16 and 40 years or women older than 40 years with a cessation of ovarian function before the age of 40 years with increased levels of fsh * primary or secondary amenorrhea for more than three months with lh and fsh\> 30mui/ml * no cases of fragile x syndrome in the family or blepharophimosis syndrome * at least two cases in the family * origin caucasian * patient signing the consent form for at least the blood sample * patient with social security population index related topics : * the presence of cycles until the age of 40 years with proven fertility, at least one child * amenorrhea and fsh\> 30mui/ml according to the criteria of the index subject * men of the family of index case population control : * women of caucasian origin * women who had regular cycles until at least age 40 and at least one child * lack of land autoimmune (no history of thyroid disease or diabetes type 1) * woman signing the consent form for at least the blood sample exclusion criteria: * blood donation of more than 450ml in the previous three months. * subject with an abnormal karyotype in favor of turner syndrome or having a premutation of the fmr1 gene or a syndromic form * subject exclusion period in another study without direct individual benefit * subject refusing to sign the consent form
reducing hepatitis c virus (hcv)/human immunodeficient virus (hiv) risk behaviors among injection drug users in china

Conditions: Hepatitis C

Summary: the proposed study will investigate the knowledge level, attitudes, and perceptions among staff of methadone maintenance treatment (mmt) clinics and intravenous drug users (idus) who attending mmt clinics, which is the most reachable population for hcv/hiv intervention in china. this study will also explore the barriers that prevent idus from getting hcv/hiv intervention/prevention and medical care services. this study will help to understand and address this important problem in china and other asian countries.

the investigators propose to conduct 3 inter-related studies over 4 years using both qualitative and quantitative research methods to address a series of research questions. firstly, the investigators will begin by assessing hcv/hiv knowledge, attitudes, perceptions, risk behaviors, and infection among idus in mmt clinics (study 1) and hcv/hiv knowledge, attitudes, and hcv/hiv-related services among mmt staff (study 2). secondly, based on knowledge accumulated from studies 1 \& 2; the investigators will adapt and develop hcv/hiv education materials appropriate for chinese idus and drug treatment service providers, and then use the transtheoretical model of behavior change as a conceptual model to measure if our educational program will increase patients' readiness to consider changing hcv/hiv risk behaviors and getting medical care for hcv/hiv (study 3). finally, by integrating findings of these three studies and by consulting with leading experts in hcv/hiv. the investigators plan to develop hcv/hiv intervention program applicable in china, which can be tested in future formal experimental trials.

Eligibility criteria:
inclusion criteria: * several failed attempts to quit the use of heroin * at least two terms in a detoxification center * age at least 20 years * being a registered local resident of the area in which the clinic is located * being of good civil character exclusion criteria: * there is no exclusion criteria

Keywords: hcv， drug users， intervention
self-sampling in cervical cancer screening; sesam study

Conditions: Cervical Cancer

Summary: study aims to support development of evidence based health care in norway through evaluating recently proposed technological improvements in cervical cancer control before their routine use. sesam ii study evaluates the accuracy of vaginal self-sampling for high risk human papillomavirus (hrhpv) testing compared with a physician-taken sample.

concept of collecting cervical cancer screening smear in home through self-sampling is new both for target population and medical professionals. self-sampling increases screening attendance and could be an alternative to recruit more women to cervical cancer screening in norway. as there are is an implementation ongoing to switch from cytology based screening to hpv based screening in norway, a reliable self-sampling method for hpv testing should be available. furthermore, detection of hpv from self-sampled specimen requires laboratory capacity and expertise to comply with quality assurance demands such as internal quality control, external quality assessment and quality improvement. national studies are crucial to obtain knowledge and build expertize among health care providers. this study aims to show non-inferior sensitivity of hrhpv testing on self-sampled vs. clinician-sampled specimens to detect high-grade cervical lesions and cancer (cin2+). additionally we will; * evaluate overall and hrhpv type specific concordance between self-taken and physician-taken samples. * evaluate participants views on feasibility and acceptability of self-sampling (questionnaire) * compare participants screening history with the questionnaire to evaluate the reason for not participating in the national screening program (if that is the case). * biobank biological material collected from self-sample, physician taken samples, blood and urine, for future analysis on hpv-related diseases and cancer. study participants will be recruited from the colposcopy referrals and cancer care units from three different hospitals. patients with cin 2 or cin 3 lesions (n=200) will be recruited from oslo university hospital, ullevål and østfold hospital trust, while cancer patients (n=50) will be recruited from radiumhospital.

Eligibility criteria:
inclusion criteria: * women with histological verified cin 2 or cin 3 * women with histological verified cervical cancer exclusion criteria: * women with mild cervical lesions

Keywords: mass screening coverage self-sampling clinical validity