Kornimate/medical-research-clean huggingface dataset:
the use of deep inspiration breath hold and prone irradiation to decrease cardiac radiation exposure

Conditions: Breast Cancer; Ductal Carcinoma in Situ; Invasive Breast Cancer

Summary: this study aims to discover more about radiation techniques for people treated for left-sided breast cancer that minimizes exposure to the heart, as noted by mean heart dose.

this study aims to discover more about radiation techniques for people treated for left-sided breast cancer that minimizes exposure to the heart, as noted by mean heart dose. both prone (lying face down) radiation and deep inspiration breath hold (dibh) are more labor-intensive and usually require longer treatment times for patients than traditional supine (lying face up) free-breathing radiation treatments. thus, identifying people that benefit most from these techniques can better utilize resources. this study compares supine and prone positioning, with or without dibh, to further assess which positioning technique will achieve the lowest cardiac radiation doses.

Eligibility criteria:
inclusion criteria: * patients must have a pathologically proven diagnosis of left-sided invasive breast cancer or ductal carcinoma in situ receiving breast/chestwall irradiation +/- regional nodal irradiation, or a right-sided invasive ductal cancer status post-mastectomy or lumpectomy who will be receiving breast/chest wall and nodal irradiation. * patients must have undergone breast conserving surgery (i.e. lumpectomy, partial mastectomy) or mastectomy prior to enrollment. * patients must be 18 years of age or older. * study entry must be prior to ct simulation. * per medical college of wisconsin department of radiation oncology standard of care, women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable forms of contraception during radiation therapy. patients under age 50 with a uterus and ovaries must have a negative serum pregnancy test within one week of planned ct simulation per radiation oncology departmental guidelines prior to ct simulation. * patients must provide study specific informed consent prior to study entry. * patients must be able to hold their breath long enough to undergo ct simulation in dibh (ten to fifteen seconds). the patient should also affirm they can lie in the prone position. this will be determined by the treating radiation oncologist, as per current standard of care. exclusion criteria: * patients who are unable to hold their breath long enough to undergo ct simulation in dibh. while this may affect patients with chronic obstructive pulmonary disease (copd) and/or other respiratory conditions, the presence of these comorbidities alone will not exclude patients from enrollment so long as they can maintain breath hold long enough to perform dibh.

Keywords: radiation deep inspiration breath hold stage i stage ii stage iia
virtual reality in reducing pain and anxiety in cancer participants undergoing painful procedures

Conditions: Malignant Neoplasm

Summary: this trial studies how well virtual reality (vr) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. virtual reality may impact pain and anxiety during and after the procedure.

primary objectives: i. to determine the feasibility of vr in patients undergoing procedural intervention. secondary objectives: i. to estimate differences between the two arms in terms of pain and anxiety. ii. to document any adverse events that could possibly be attributed to the vr intervention. exploratory objectives: i. explore the use of biomarkers as a tool to reflect the impact of intervention. outline: participants are randomized to 1 of 2 arms. arm i: participants undergo vr intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure. arm ii: participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).

Eligibility criteria:
inclusion criteria: * patient has been diagnosed with any cancer * patient is currently hospitalized and receiving treatment for a primary or secondary cancer at university of southern california (usc) norris comprehensive cancer center and hospital * patient is undergoing a bone marrow biopsy or lumbar puncture exclusion criteria: * inability to sign informed assent and/or consent * patient with an underlying diagnosis of epilepsy, dementia, parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated * patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified * patient with active clostridium difficile infection * patient on any acute (within last \< 24 hour \[hr\]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug \[nsaid\], steroid) * patient on chronic steroids \> 10 mg prednisone equivalent daily or other immunosuppressant \> 1 week * patient who is post bone marrow transplant * patient with a body mass index (bmi) \> 35
an acupuncture study for prostate cancer survivors with urinary issues

Conditions: Survivorship; Prostate Cancer

Summary: the purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. this is the first time acupuncture is being studied for nocturia in prostate cancer survivors. researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. the study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.


Eligibility criteria:
inclusion criteria: * age 18 or older * prior pc diagnosis * no evidence of prostate cancer * clinically meaningful nocturia, defined as ≥2 nocturia episodes every night for the past month exclusion criteria: * \<1 month since completion of pc treatment (surgery, chemotherapy, radiation, adt) * score of ≥5 on the stop-bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea * other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome) * untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia) * initiation of new medications for urinary symptoms in the past 4 weeks * altered dosing of medications for urinary symptoms in the past 4 weeks * plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study * implanted electronically charged medical device * unable to provide consent for himself * unwilling to adhere to all study-related procedures

Keywords: acupuncture urinary issue nocturia 22-270
efficacy, safety and tolerability of rotigotine nasal spray for the acute treatment of parkinson symptoms

Conditions: Parkinson's Disease

Summary: the objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (spm 952) in a single dose application scheme. subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. subjects will then be hospitalized for one night. in the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. efficacy will be assessed by application of motor examination scores. the first subject is planned to be enrolled in february 2006. the last subject is planned to be enrolled in may 2006. last subject out is expected for august 2006.

the objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (spm 952)in a single dose application scheme. subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. subjects will then be hospitalized for one night. in the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. efficacy will be assessed by application of motor examination scores.

Eligibility criteria:
inclusion criteria: * male and female subjects with idiopathic parkinson's disease for at least 3 years in duration * at least 30 years of age exclusion criteria: * patients with atypical parkinson's or clinically relevant concomitant diseases or medical conditions

Keywords: rotigotine rotigotine nasal spray efficacy, safety and tolerability parkinson's disease
home-based exercise training for copd patients (homex-2)

Conditions: Chronic Disease; Lung Diseases, Obstructive; Respiratory Disease

Summary: the aim of this study is to assess the effectiveness of a home-based exercise training program in copd patients who did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.

exercise training is an important component of pulmonary rehabilitation (pr) the management of chronic obstructive pulmonary disease (copd) and numerous trials have shown large improvements in health-related quality of life (hrqol) and exercise capacity in persons with copd. however, the great majority of patients who would benefit from pr never follow such a program. moreover, many copd patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing pr. this study evaluates a newly developed exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.

Eligibility criteria:
inclusion criteria: * signed informed consent after being informed * diagnosis of copd, defined as forced expiratory volume in 1s/forced vital capacity (fev1/fvc)\<70% predicted, fev1\<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a gold stage ii-iv * no participation in an inpatient or outpatient pulmonary rehabilitation within the last 12 months * male and female patients ≥40 years of age * knowledge of german language to understand study material and assessments exclusion criteria: * patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations. * planned participation in a pulmonary rehabilitation program

Keywords: exercise minimal equipment home-based copd exercise training intervention randomized controlled trial
steroid injection vs. biodrestore for patients with knee oa

Conditions: Knee Osteoarthritis

Summary: this study will include patients who are diagnosed with knee oa and are recommended for a knee injection. study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (biodrestore). study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. at 6 months post-injection, knee aspirations will be taken and sent for analysis. study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. x-rays will also be taken at the 1-year post-injection appointment.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 80 years. * willing and able to give voluntary informed consent to participate in this investigation. * patient presents with knee osteoarthritis and kellgren lawrence grade 2-4 (oa diagnosed and confirmed by treating physician using standing x-ray). * candidate for intra-articular knee injection. * bmi \< 40 exclusion criteria: * patients who have received intra-articular injection(s) in the last 3 months. * patients who have undergone arthroscopic surgery on the study knee in the past year. * patients who have undergone arthroplasty on the study knee. * ligament instability * diabetes (type 1 or ii) * inflammatory arthropathies. * fibromyalgia or chronic fatigue syndrome. * female patient who is pregnant or nursing. * chronic use of narcotics. * any other reason (in the judgment of the investigator).
noninvasive spinal neuromodulation enables locomotor recovery in individuals with cerebral palsy

Conditions: Cerebral Palsy

Summary: assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy


Eligibility criteria:
inclusion criteria: * 1) individuals above the age of 2 years of age and 2) diagnosed with cerebral palsy (cp). the exclusion criteria included 1) children with selective dorsal root rhizotomy, 2) intramuscular botox injection in the preceding 12 months, 3) current antispastic medications 4) unhealed fractures or contractures that would prevent them from performing functional tasks and 5) tendon lengthening surgeries. exclusion criteria: * intramuscular botox injection in the past 12 months
debio 1143 in combination with carboplatin and paclitaxel in patient with advanced solid malignancies

Conditions: Solid Tumors

Summary: this is a two-part trial in patients with squamous non-small cell lung cancer (nsclc), platinum (pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (tnbc). the primary objective of part a is to determine the maximum tolerated dose (mtd) of debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin. the primary objective of part b is to consolidate the safety profile of the recommended dose of debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification and contraception * is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications * voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures exclusion criteria: * has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff; 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); or 3. the analysis of results
ema-defined tinnitus subgroups

Conditions: Tinnitus

Summary: the purpose of this research study is to test a new way of measuring the severity of tinnitus using a tool called ecological momentary assessment (ema) of tinnitus. we will compare the relationship with this tool with another widely used questionnaire. previous studies we have done suggest there are different patterns of tinnitus bother; we plan to explore how often these patterns occur, and how many patterns of tinnitus bother there are. and lastly we want to test how reliable this type of testing is for measuring the amount of bother people experience from their tinnitus. hypothesis 1: we will be able to identify 6 or more distinctive patterns of tinnitus. hypothesis 2: ema will provide a reliable method for more accurately capturing the amount of bother individuals have from tinnitus.

you to need to complete this brief survey to determine if you meet the criteria for participation in the study. you are free to skip any questions that you prefer not to answer. we will only use the information you provide in this survey to determine if you qualify for the ema-defined tinnitus subgroups study. to be in this study, you will be required to have a smart phone that can receive text messages, is connected to the internet, and will allow you to connect via the internet to a washington university secure server. it is necessary to connect to the washington university server in order to complete a short survey four times a day for two separate two-week periods. the study involves us sending you text messages at 4 random times during the day, between the hours of 8: 00 am - 9: 00 pm. the texts prompt you to click on a link and respond to a short ema survey regarding what you are doing, what your environment is, and how your tinnitus is at that moment. these text messages will be sent daily for two weeks. then you will have two weeks off. finally you will again receive the text messages asking for you to respond to the survey for two more weeks. you will receive a total of 112 text messages over four weeks. in addition we will send you four emails or texts asking you to complete a survey at the following times: before you complete your first set of ema surveys, at the end of the first set ema surveys, prior to starting the second set of ema surveys, and a final time after you have completed the final ema survey. this study requires no visits to washington university. in order to participate you must complete this short prescreening survey to see if you qualify.

Eligibility criteria:
inclusion criteria: * age between the ages of 21 and 80. * have subjective, unilateral or bilateral, tinnitus of 6 months' duration or longer. * must be score of 1, 2, 3, or 4 on global bother score. (range is 0-4, with 0 being not bothered and 4 being extremely bothered) * must have access to a smart phone device compatible with the notification system. * must be able to read, write, and understand english. exclusion criteria: * tinnitus related to workman's compensation claim or other litigation-related situations.

Keywords: tinnitus ema bothersome
renal transplantation and raltegravir in hiv-infected patients

Conditions: HIV-1 Infection; Chronic Renal Insufficiency

Summary: the aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in hiv-infected patients under three antiretroviral drugs regimen including raltegravir.

antiretroviral treatment of hiv-1 infection might interact with immunosuppressive treatments which increase rejection of renal graft incidence. in addition hiv infection may be modified together with cardiovascular risk. patients participating to this study will receive after transplantation antiretroviral regimen including raltegravir. raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the treatment of choice to be associated with immunosuppressive drugs.

Eligibility criteria:
inclusion criteria: * registration on the french national renal transplantation waiting list (biomedicines agency) for a living or cadaveric donor organ * hiv-1-infected patients treated by a three-drug arv regimen * immuno-virologic criteria at renal transplantation: undetectable viral load (\ 200/mm3 for at least three months on stable arv * age \>18 years and \<70 years * effective contraception for women * written informed consent * patient with social security coverage exclusion criteria: * permanent: * hepatic cirrhosis * serious psychiatric illness history * ebv or hhv8 lymphoproliferation (lymphoma, systemic kaposi's sarcoma or multifocal castleman's disease) * history of pml * htlv-1 seropositivity * severe pulmonary or cardiovascular disease with poor short-term vital prognosis * patient with aghbs+ * history of cryptosporidiosis * history of fungal infection with multi resistant fungi not likely to respond to oral antifungal therapy * impossibility or refusal of raltegravir switch, decision made by doctor or patient * temporary: * recent malignancy (between 2 and 5 years according to type) * hpv-related cervical or anal disease: carcinoma in situ, ain iii, cin iii in remission for less than three years * active infection * hcv infection (pcr-positive)

Keywords: raltegravir renal transplantation hiv-1 acute renal graft rejection
an expanded access program to provide nintedanib to patients with non-ipf ild who have no alternative treatment possibilities

Conditions: Lung Diseases, Interstitial

Summary: this expanded access program is intended to facilitate the availability of ofev to patients suffering from non idiopathic pulmonary fibrosis-interstitial lung disease (non ipf-ild) with a progressive clinical course despite standard of care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.


Eligibility criteria:
inclusion criteria: none exclusion criteria: - patients who are eligible for and can participate in an ongoing non idiopathic pulmonary fibrosis-interstitial lung disease (non ipf-ild) study will be excluded from participation in this expanded access program (eap).
to evaluate 2 doses of gsk biologicals' oral live attenuated human hrv vaccine co-administered with either opv or ipv

Conditions: Rotavirus Infections

Summary: "the primary objective of this study was to demonstrate that co-administering hrv vaccine with opv does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines. the primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% ci for the difference in seroprotection rate between the group b and c pooled and (minus) the group a was below 10% for each polio serotype."

the study had three groups: group a: hrv + opv + dtpa/hib; group b: hrv + placebo opv + dtpa-ipv/hib; group c: hrv placebo + opv + dtpa/hib. two cohorts: subjects enrolled before the 2002 rv season were to receive two doses of hrv or placebo at approximately 6 and 10 weeks of age (first cohort) and subjects enrolled after the 2002 rv season received vaccinations at approximately 10 and 14 weeks of age (second cohort). routine epi vaccinations were to be administered concomitantly with the study vaccines.

Eligibility criteria:
inclusion criteria: healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 rv season) confirmed negative hiv status of the subject's mother during pregnancy or thereafter. exclusion criteria: history of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.

Keywords: prophylaxis rotavirus