Kornimate/medical-research-clean huggingface dataset:
risperidone treatment for military service related chronic post traumatic stress disorder

Conditions: Stress Disorders; Post-Traumatic

Summary: the purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of post-traumatic stress disorder (ptsd). it is a placebo-controlled study, meaning that half of the participants will be assigned to receive a pill that contains no drug. the treatment phase of the study will last for 6 months, during which time participants will continue to receive all their usual treatments in addition to the study treatment and will be asked to complete procedures and assessments (questionnaires, interviews, laboratory tests, physical exams, etc.) related to their ptsd symptoms at various points within the 6-month treatment phase. at the end of the 6-month study, participants will discontinue the study treatment.

primary hypothesis: risperidone will reduce symptoms of ptsd, relative to placebo, in veterans with military service related chronic ptsd who have been partial or non-responders to antidepressant medications. secondary hypothesis: risperidone is safe and well-tolerated in veterans with military service related chronic ptsd, and patients will comply with its prescription. as a result, patients will show improvement in the secondary consequences of ptsd for the veteran and for the va. intervention: usual (ptsd) care plus risperidone vs usual (ptsd) care plus placebo study abstract: four hundred veterans with the diagnosis of military-related ptsd will be enrolled at 20 vamc hospitals over a two-year period. an equipoise stratification design will be used to randomize patients in a double-blind manner to risperidone or placebo (\~200 patients in each group) for six months of treatment. usual care will be provided for all patients for treatment of ptsd and other psychiatric and medical disorders. comparisons between the risperidone and placebo groups will be made at the end of six months to answer the primary question. the sample size is calculated to give 90% power at the two-sided alpha level of 0.05 for the overall test for the caps score change. study update/notes: the study kicked-off in late july 2006 with recruitment expected to begin october 1, 2006. oct2006 - participating sites are seeking approval for the protocol amendment which resulted from the kick-off meeting. patient recruitment at each site will begin as soon as they receive approval of the amendment.

Eligibility criteria:
inclusion criteria: * 18 years or older * military service related chronic ptsd * caps score \>50 * participant in va outpatient ptsd clinic * history of non-response to two or more antidepressants exclusion criteria: * comorbid axis i diagnosis requiring antipsychotic medication * substance dependence diagnosis (excluding nicotine) * hepatic or renal problems * incompatible medical diagnosis or medication (i.e., coumadin, insulin) * unstable living arrangements * assault or suicide gesture within 1 year

Keywords: ptsd
efficacy and safety of fecal microbiota transplantation for chronic intestinal pseudo-obstruction

Conditions: Chronic Intestinal Pseudo Obstruction

Summary: chronic intestinal pseudo obstruction(cipo) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. fecal microbiota transplantation (fmt) results in restoration of the normal intestinal microbial community structure. the investigators planned to observe the eﬃcacy of fmt in the treatment of a series cipo patients. patients received fmt on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. rate of clinical improvement and remission, feeding tolerance of enteral nutrition, ct score of intestinal obstruction, and gastrointestinal quality-of-life index(giqli) were evaluated.


Eligibility criteria:
inclusion criteria: patients had to have a ﬁrm diagnosis diagnostic criteria for cipo proposed by ministry of health, labour, and welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction. exclusion criteria: none.

Keywords: fecal microbiota transplantation chronic intestinal pseudo obstruction efficacy and safety
kyrgyz asthma rehabilitation at high altitude

Conditions: Effect of High Altitude

Summary: prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control.

low altitude baseline measurements will be performed in bishkek. participants will then either be assigned to a rehabilitation program in bishkek (760m) or in tuja ashu (3200m). the rehabilitation programs in high or low altitude will be identically performed and will comprise * asthma education and awareness * instruction on inhaled therapies * smoking cessation counseling * respiratory and skeletal muscle training in groups * guided walks / cycle ergometer training * questionnaires on asthma control, quality of life * spirometry and peak flow measurements * echocardiography measurement on study subjects will be performed at baseline (bishkek), during the rehabilitation program, after completion of the rehabilitation program and during a follow-up at week 15.

Eligibility criteria:
inclusion criteria: * diagnosed with atopic or non-atopic asthma for at least 3 months * partly controlled on regular or on demand inhaled therapy according to guidelines. * asthma variability in peak expiratory flow \> 10%/day and/or a reversible airflow obstruction in spirometry * history of asthma consisting of variable symptoms (cough, dyspnea, wheezing). exclusion criteria: * unstable and severely uncontrolled asthma needing systemic corticosteroids. * need of continuous oral steroids for their asthma control * heavy smokers (\>20 cigarettes per day) * severe concomitant diseases preventing patients to adhere to the protocol and/or altitude exposure (severe metabolic, kidney- or liver disease, heart failure (ejection fracture \<50%). * chronic lung diseases with a persistent fvc \< 60% an/or arterial oxygen saturation \<92%). * severe mental- or musculoskeletal disorders * pregnant or breast feeding women * patient which are unable to comply with the study procedure.
efficacy and safety on som3355 in huntington's disease chorea

Conditions: Huntington Chorea

Summary: phase iib, randomized, double-blind, placebo-controlled study in parallel groups assessing the efficacy and safety of two doses of som3355 in patients suffering from huntington's disease with choreic movements.


Eligibility criteria:
inclusion criteria: 1. males or females ≥21 years old. 2. patients with a diagnosis of huntington's disease determined by a movement disorders expert and confirmed by a number of htt gene cag repeats ≥36. 3. uhdrs® total maximal chorea (tmc) score ≥10. 4. uhdrs® total functional capacity (tfc) ≥7. 5. able to walk independently or with minimal assistance. 6. females of child-bearing potential must use a medically accepted effective method of birth control and should not be breast-feeding. 7. in the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements. 8. able and willing to provide written informed consent. exclusion criteria: 1. onset of hd symptoms prior to age of 21 years (juvenile forms of hd). 2. hd patients presenting rigid akinesia. 3. use of other vmat2 inhibitors such as tetrabenazine, deutetrabenazine, or valbenazine; and use of other antichoreic treatment such as any neuroleptic, or amantadine, memantine, riluzole. 4. patients who experienced severe depression or suicide attempt in the last 5 years. 5. severe untreated or under-treated psychiatric illness such as active suicidal ideation or behavior or depression. 6. patients with a history of, or current, hypotension, bradycardia, or orthostatic hypotension. 7. patients with hypertension already treated with more than 2 antihypertensive drugs. 8. other active clinically significant illness, which could interfere with the study conduct, counter-indicate the study treatment, place the patient at risk during the trial, or compromise their study participation. 9. any significant serious abnormality in the electrocardiogram (ecg), or a known history of long qtc syndrome. 10. patients with severe hepatic impairment, or with severe renal impairment, or with any other significant abnormality in the physical examination or clinical laboratory results that, in the investigator's opinion, would not be compatible with study participation or represent a risk for the patient while in the study. 11. females who are pregnant or lactating, or who intend to become pregnant during the study period. 12. patients with allergy under desensitization, with known psoriasis, or a known allergy/hypersensitivity to any ingredients of the trial medication or placebo. 13. history of alcohol or substance abuse in the previous 12 months. 14. patients participating in any other study, and the use of any investigational therapy.

Keywords: huntington chorea som3355
study of a randomized intervention designed to increase exercise in pregnancy

Conditions: Gestational Weight Gain

Summary: this project aims to determine whether a mobile-health (m-health) tool, accessible via smartphone or website, intervention for overweight and obese pregnant women improves physical activity, gestational weight gain, quality of life, stress and depression during pregnancy. this study will examine factors associated with using the m-health tool and the most highly utilized features of the tool, with a goal of understanding how it can be used and improved in future behavior change interventions. the hypothesis is that compared with usual care, an m-health intervention will result in increased minutes of moderate-to-vigorous physical activity and increased knowledge of the iom gwg guidelines. the study design is a small pilot randomized trial to assess feasibility. this study will recruit and follow 70 overweight and obese pregnant women during the first trimester of pregnancy from kaiser san francisco and other facilities. the m-health intervention has the advantage of enabling overweight and obese women to monitor and improve their health behaviors without impacting the work flow of clinical care. depending on the results of this initial evaluation, the clinical implications may include its implementation at the health system level and/or being evaluated and improved in the future by a larger investigation in a randomized controlled trial. the study team will assess adherence and acceptability of the intervention to inform future studies.


Eligibility criteria:
inclusion criteria: * pregnant * women aged 21 years or older receiving prenatal care at kaiser permanente san francisco and oakland and whose obstetric care clinicians approved their participation in the study; * pregravid bmi 25 to \<40 (as determined from a measured pregravid weight in electronic medical record); * has access to a smartphone and wi-fi; * provides informed consent to participate. exclusion criteria: * multiple births; * planning to move out of the area during the study period; * diagnosis of any of the following conditions: diabetes outside of pregnancy, severe disease of the cardio-pulmonary system, serious gastrointestinal disease (e.g., crohn's disease, ibd), kidney disease, lung disease (e.g., emphysema, copd), major psychiatric disorder, thyroid disease (diagnosed in the last month), cancer (not including non-malignant skin cancer), drug and alcohol abuse, or history of an eating disorder; * history of bariatric surgery; * use of metformin or corticosteroids; * inability to speak, read, or understand english; * placed on bed rest at time of enrollment; * \>15 weeks' gestation at enrollment.

Keywords: lifestyle intervention body weight pregnancy overweight obesity signs and symptoms body weight changes
prostate cancer enhanced diagnosis by calibration technology

Conditions: Prostate Cancers

Summary: the care® phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (adc) in the prostate of patients undergoing a multi-parametric mri (mpmri) scan to detect prostate cancer. the final device system will comprise three elements: a calibration mat containing phantoms and embedded monitoring software, a docking station to transfer data from the phantoms, and software as a medical device (samd) for calibrating the resulting mpmri images. in this clinical trial, patients will undergo mri scanning in different scanners using the gsp phantoms to provide mpmri images and phantom data for subsequent in silico analysis. the captured images and data will be used to further develop and calibrate the gsp prototype samd part of the medical device system, and to establish the degree of optimised reproducibility that can be achieved.


Eligibility criteria:
inclusion criteria: * men with clinically suspected prostate cancer and referred for prostate mri * men willing and able to provide a written informed consent * mri likert/pirads 3 or above * prior decision made to perform targeted biopsy exclusion criteria: * prostate specific antigen (psa) level \&gt; 20ng/ml within 6 months * previous diagnosis of prostate cancer * ongoing hormone treatment within 3 months prior to mri, excluding antiandrogens or 5-alpha reductase inhibitors * contraindication to mri scan

Keywords: mri calibration prostate cancer quantitative imaging biomarker reproducibility data interoperability phantom apparent diffusion coefficient adc pirad diagnosis biopsy
cgh array in bilateral clubfoot

Conditions: Clubfoot; Prenatal Disorder

Summary: in prenatal diagnosis of isolated bilateral clubfoot our team propose genetic analysis: a cgh-array. we want to study the rate of aberrations in these cases.


Eligibility criteria:
inclusion criteria: * pregnant women * fetus with isolated bilateral clubfoot exclusion criteria: * no
a study of the effect of r1507 in combination with tarceva (erlotinib) on progression-free survival in patients with stage iiib/iv non-small cell lung cancer (nsclc) having received tarceva monotherapy.

Conditions: Non-Small Cell Lung Cancer

Summary: this single arm study in patients with advanced stage iiib/iv nsclc who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with r1507 and tarceva. patients will receive r1507 (9mg/kg iv) weekly in combination with tarceva (150mg oral daily) for up to a maximum of 24 months. other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. the anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * male or female patients \>=18 years with histologically documented inoperable, locally advanced or metastatic (stage iiib or iv) nsclc; * currently receiving tarceva monotherapy and having failed at least one standard chemotherapy regimens; * prior response or stable disease 12 weeks from start of tarceva; * documented progressive disease at enrollment; * measurable disease according to the recist criteria; * ecog performance status 0-2; * life expectancy \>12 weeks. exclusion criteria: * patients with active cns lesions; * prior treatment with agents acting via igf-1r inhibition or egfr targeting; * administration with high doses of systemic corticosteroids; * radiotherapy in the 4 weeks prior to study start; * surgery or significant traumatic injury with in the last 2 weeks prior to study start.
a comparison of xelox regimen and eox regimen as neoadjuvant chemotherapy regimen for locally advanced gastric cancer.

Conditions: Locally Advanced Gastric Cancer

Summary: this study is designed to assess what is the better neoadjuvant chemotherapy regimen for patients with initially unresectable locally advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * more than 2 regional bulky lymph nodes macroscopic tumor type is either the borrmann type 4 or large type 3 tumor invades adjacent structures (t4b) exclusion criteria: * peritoneal metastasis confirmed by ct scan lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis
contrast-enhanced mammography for breast cancer staging in patients referred for a second opinion

Conditions: Breast Carcinoma; Invasive Breast Carcinoma

Summary: this clinical trial investigates contrast-enhanced mammography (cem) in detecting breast cancer. cem is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. diagnostic procedures, such as cem, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.

primary objective: i. to compare the accuracy of cem and low energy (le) images (equivalent of full field digital mammogram \[ffdm\] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast. secondary objectives: i. to evaluate the sensitivity, specificity, positive and negative predictive value of cem compared to le cem images (ffdm equivalent), digital breast tomosynthesis (dbt) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast. ii. to evaluate the difference of the index cancer size estimation among cem, le images, dbt, and ultrasound compared to pathology measurements as the ground truth. iii. to evaluate the incremental cancer detection rate provided by cem, dbt, and ultrasound (us) compared to the outside facility (osf) diagnosis. exploratory objectives: i. to evaluate the rate of referral to breast magnetic resonance imaging (mri) in the study cohort. ii. to evaluate the performance of mri for breast cancer diagnosis and compare it with other imaging modalities of cem, le images, dbt, and us. iii. to evaluate the feasibility of cem-guided biopsy of cem-only detected lesions. outline: patient receive iodinated contrast agent intravenously (iv) and undergo cem. patients who have not undergone dbt as part of their screening or diagnostic imaging within 3 month, undergo dbt. patients medical records are reviewed. after completion of study treatment, patients are followed up for 12 months.

Eligibility criteria:
inclusion criteria: * female patients 18 years of age or older with known invasive or in-situ breast cancer (bc) diagnosed at an outside facility and presenting to md anderson for staging with imaging * female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (breast imaging reporting and data system \[bi-rads\] 5 or 4c) on outside imaging or on rereview by md anderson's radiologists and referred for staging at md anderson cancer center (mdacc) * willingness to participate in the study and ability to provide informed consent exclusion criteria: * breast surgery within 6 months * known allergy to iodine-containing contrast agents * history of anaphylactic reaction to any substance that required hospitalization or iv placement * renal insufficiency; hyperthyroidism * detection of non-breast primary or metastatic cancer in the breast
clinical outcomes in chronic low pain back utilizing activity trackers

Conditions: Back Pain

Summary: this is a randomized controlled study to assess the effects of activity monitors, with telehealth follow ups, on the treatment of chronic low back pain subjects.

this is a randomized controlled study to assess the effects of activity monitors, with telehealth follow ups, on the treatment of chronic low back pain subjects. subjects with low back pain will present for evaluation to the nyit academic health care center. once serious complications have been ruled out and a diagnosis of chronic low back pain has been made, subjects will be informed about this proposed study and asked if they would like to participate. voluntary subjects will then be consented by designated investigators. the subjects will then be randomized into either the activity tracker and telemedicine follow up group or the control group. once enrolled, all subjects will complete the study as outlined in the procedures. it will involve the use of several validated assessment tools. following the initial visit, subjects in both groups will return in 6 weeks for reassessment. subjects in the experimental group will additionally be given an activity tracker and have 2 telemedicine visits at 2 and 4 weeks.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years age and younger than 75 years of age * subjects evaluated and found to have low back lasting longer than 3 months exclusion criteria: the subject suffers from any of the following: * foot drop * recent diagnosis of malignancy * recent infection * saddle anesthesia * urinary or bowel incontinence * progressive neuromotor or sensory loss * the subject is unable to complete the assessment tools * the subject is pregnant