Kornimate/medical-research-clean huggingface dataset:
adaptive behaviors among women with bowel incontinence: the abbi trial

Conditions: Fecal Incontinence

Summary: this study focuses on the validation of the adaptation index instrument as a measurement of adaptive behaviors used to reduce symptoms of fi and to describe the use of adaptive behaviors among women with fi.

it is common knowledge that women with pelvic floor dysfunction will develop, initiate and adopt behaviors which mitigate their symptoms or impairment. for some women, this involves wearing a pad and for others, knowledge of restroom locations. little is known about the role of such behaviors in helping women adapt to urinary incontinence (ui), pelvic organ prolapse (pop), or fecal incontinence (fi). additionally, there are no studies that address the persistence of these behaviors following treatment as measured by traditional outcomes. results of a pilot study that assessed quality of life (qol) in women with pelvic floor disorders (pfd) indicated that women relied heavily on behavioral adaptation in order to cope with pfd symptoms. subsequently, a draft adaptation index was developed with input from investigators of the pelvic floor disorders network (pfdn). this measure was further refined by focus groups as part of the 1j06 protocol. the 1j06 study is investigating the properties of this tool in subjects with ui and pop. this study focuses on the validation of this instrument as a measurement of adaptive behaviors used to reduce symptoms of fi and to describe the use of adaptive behaviors among women with fi.

Eligibility criteria:
inclusion criteria: * primary complaint of fi with liquid, solid stool, or mucous incontinence, occurring at least monthly for 3 consecutive months. these women are planning to have treatment for fi. * women with prior treatment, including surgery for their fi, ui, and/or pop may be included if they now have a primary complaint of fi as defined above and are planning to have additional or new treatment for fi. exclusion criteria: * diagnosis of interstitial cystitis, , bladder or colo-rectal malignancy or inflammatory bowel disease * refusal or inability to provide written consent * inability to complete telephone interviews conducted in english or spanish * prior pelvic irradiation * incontinence only to flatus * prior removal of any portion of the colon or rectum * current or history of rectovaginal fistula(e) * rectal prolapse * neurologic disorders known to affect continence, including multiple sclerosis, spinal cord injury, debilitating stroke, and parkinson's disease

Keywords: fecal incontinence bowel incontinence pelvic floor disorder
neorad breast cancer study

Conditions: Breast Cancer

Summary: the neorad trial tests whether preoperative radiotherapy results in an improved dfs and less radiation induced late effect compared to postoperative radiotherapy in higher risk breast cancer after nact.

the standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). in case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. the optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (nact) has never been addressed in a randomised controlled trial. the study chairman of the neorad trial is prof. dr. med. christiane matuschek. the deputies of the study chairman are prof. dr. med. wilfried budach and prof. dr. med. tanja fehm.

Eligibility criteria:
inclusion criteria: * histologically proven invasive, unilateral breast cancer * indication for radiotherapy * indication for neoadjuvant chemotherapy (+/- antibody treatment or other targeted therapies) in accordance with national and international guidelines * female * informed consent for the trial signed by the patient * hormone receptor and her2 status: no restrictions * all grades g1-g3 * age ≥ 18 years at the time of informed consent * performance status ≤ 2 * no pre-existing conditions that prohibit therapy exclusion criteria: * neoadjuvant treatment solely with endocrine therapy * bilateral breast cancer * pregnancy or lactation * prior radiotherapy of the thorax * connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans * pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onset allergies, such as farmer's lung, severe lung emphysema, copd °iii) * cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure nyha ≥ii or aha ≥c, pacemaker, and/or implanted defibrillator * malignoma except basalioma or in-situ-carcinomas in complete response * distant metastasis * plexopathies of the arm of the treated side * stiffness of the shoulder of the arm of the side of the breast cancer of any origin (e.g. following a road accident) * lymph edema ≥°ii of the arm at the side of the breast cancer * other medical conditions that prohibit the neoadjuvant radiotherapy (i.e. expected non-compliance, etc.) * male patients * patients who have previously been assessed for chemotherapy response

Keywords: neoadjuvant chemotherapy preoperative radiotherapy capsular contraction immediate reconstruction
post partum thyroiditis 2: long term observations

Conditions: Hypothyroidism

Summary: the study tries to determine if post partum thyroiditis has marked long term (20 years after partum) risk for developing hypothyroidism.

this is study where we follow up women who in 1985 were checked for the occurrence of post partum thyroiditis 6 week after labour. the former patients have been invited to participate by answering a questionnaire and by providing results from blood tests.

Eligibility criteria:
inclusion criteria: * defined group of women who tested positive for post partum thyroiditis in 1985. * control group randomly picked from those who tested negative. exclusion criteria: -

Keywords: hypothyroidism
functional performance assessments in overhead athletes with shoulder injury

Conditions: Sports Physical Therapy; Rehabilitation

Summary: background \& purpose: shoulder injuries are commonly seen in overhead athletes due to the mechanism of the repetitive and high velocity movement. while the injury usually cost the lost of time in playing, making the decision of the time to return to play (rtp) is a critical issue that should be standardized and objective. however, current studies showed that the decision making of rtp is so complicated that there's lack of objective measurements especially for upper extremity injuries. so, investigating the usage of convenient and valid tools, functional performance assessments for assessing the ability to rtp is the main objective of this study. objective: there are 2 objectives for this study: (1) to investigate the difference between rtp group and non-rtp in overhead athletes with shoulder injury; (2) to investigate the responsiveness of the functional performance assessment in return to play for overhead athletes with shoulder injury. methods: overhead athletes with shoulder injury or surgery which leads to temporary leaving to the sport within will be recruited in this study. the shoulder joint range of motion (flexion, extension, external/internal rotation, and abduction), shoulder muscle strength (flexors, abductors and external/internal rotators), patient-reported outcome (kjoc and dash questionnaire) and functional performance assessments (fms, ybt-uq, ckcuest, ussp and tput) will be assessed at 6 months after the athlete was injured or received surgery, and at the time point if the athletes successfully complete at least one formal game or practice game (rtp group). if the athlete doesn't return within 12 months after injury or surgery, the assess will be done at the 12th month after injury or surgery. significance and contribution: this study is going to provide an objective measurement value of functional performance assessment in injured overhead athletes, determining whether the strength, endurance or power of the upper extremity is good enough to return to the sport that the athlete played before this injury. the result is also expected to have significant contribution in the area of sports medicine in return to play especially in overhead athletes, which has limited evidence providing specific criteria and objective measurement value previously.


Eligibility criteria:
inclusion criteria: * overhead athletes diagnosed with shoulder injury within 6 months and can't play the current sports * accepting the routine rehabilitation * have the intention to go back to current sports exclusion criteria: * other severe orthopedic injuries in upper extremity, lower extremity and spine within 1 year * has no intention to return to play

Keywords: sports physical therapy return to play overhead athletes
perioperative chemotherapy for potentially resectable gastric cancer

Conditions: Gastric Cancer

Summary: stage i：neoadjuvant therapy * tegafur，gimeracil and oteracil potassium capsules plus oxaliplatin is superior to surgery alone;capecitabine plus oxaliplatin is non-inferiority to tegafur，gimeracil and oteracil potassium capsules plus oxaliplatin stage ii: perioperative therapy * perioperative tegafur，gimeracil and oteracil potassium capsules plus oxaliplatin is superior to adjuvant tegafur，gimeracil and oteracil potassium capsules plus oxaliplatin alone;capecitabine plus oxaliplatin regimen is noninferiority to tegafur,gimeracil and oteracil potassium capsules plus oxaliplatin * a regimen of tegafur，gimeracil and oteracil potassium capsules plus oxaliplatin(sox) and capecitabine plus oxaliplatin(xelox) improves survival among patients with incurable locally advanced or metastatic gastric cancer. the investigators assessed whether the addition of a perioperative regimen of sox or xelox regimen to adjuvant alone improves r0 resection rate and survival among patients with curable locally advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * age 18 -75 * histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) * ecog performance status ≦2 * tumor stage t3/4nxm0 * no distant metastasis (m0) exclusion criteria: * history of hypersensitivity to fluoropyrimidines, tegafur，gimeracil and oteracil potassium capsules , capecitabine, oxaliplatin or the ingredients of this product * inadequate hematopoietic function： wbc≦4,000/mm3; anc≦2,000/mm3; platelet≦100,000/mm3 * inadequate organ function which is defined as below: total bilirubin \>2 pper limit of normal range (uln); alt / ast \> 2.5 upper limit of normal range (uln) (\>5.0 x uln if hepatic metastasis); serum creatinine \> 1.2 mg/dl, and ccr \> 60 ml/min (estimated by cockcroft-gault formulation); * symptomatic peripheral neuropathy * receiving a concomitant treatment with other fluoropyrimidines * pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method. * mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication: * active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study. * history of ventricular arrhythmia or congestive heart failure. * significant co-morbid medical conditions, including, but not limited to, chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.

Keywords: tegafur，gimeracil and oteracil potassium capsules capecitabine oxaliplatin perioperative chemotherapy gastric cancer
autologous adipose derived mesenchymal stromal cells transplantation in women with premature ovarian failure (pof)

Conditions: Premature Ovarian Failure

Summary: the goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy adscs intra ovarian injection on ovarian function improvement.

in this study 9 patients with the diagnosis of premature ovarian failure will participate. the patients will be divided randomly in 3 groups, each group contains 3 patients. first group will receive 5 millions of adscs, second group receive 10 millions cells and the third group receive 15millions of adscs. stem cell transplantation method is intraovarian injection of adscs which will be performed under guidance of transvaginal sonography. all the patients will be followed for 12 months after cell injection to evaluate any adverse events .

Eligibility criteria:
inclusion criteria: * female * age : 20-39 * fsh\>20 exclusion criteria: * liposuction contraindication * thyroid dysfunction * immune system disease * past history of cancer , chemotherapy , radiotherapy * hiv+, hepatitis b, c * severe endometriosis

Keywords: premature ovarian failure adipose derived stromal cells intraovarian injection
evaluation of periomonitor for detection of oral inflammatory (oi) in human subjects in medical practice

Conditions: Oral Inflammation

Summary: the purpose of the study is to evaluate the usability of periomonitor™ in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation. periomonitor™ is an in vitro diagnostic (ivd) device intended as an aid in the detection of oral inflammation in individuals of 18 years and older. this test is intended for use at point-of-care (poc) sites by health care professionals (e.g., physicians, nurses, medical assistants, dentists, dental hygienists, and dental assistants).


Eligibility criteria:
inclusion criteria: * subject fluent in english * subject has signed the icf exclusion criteria: * subject with altered mental status/inability to provide informed consent or follow the procedure of the study * previous enrolment into the current study * patients with known severe oral diseases such as oral cancer
safety and efficacy of t8 on treating chronic abnormal immune activation in hiv/aids patients

Conditions: Chronic Abnormal Immune Activation in HIV/AIDS

Summary: this is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic hiv infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (haart). a total of 150 eligible subjects will be selected and randomized at a ratio of 1:1:1 into t8 0.5 mg qd, 1 mg qd, and placebo group, with background haart unchanged, for 48 consecutive weeks.


Eligibility criteria:
inclusion criteria: 1. chinese subjects aged 18-65, male or female； 2. subjects with body mass index (bmi) ≥18 (kg/m2); male weight ≥50kg, female weight ≥45kg； 3. subjects must meet the criteria; 4. no birth planning； 5. understand and sign informed consent form voluntarily. exclusion criteria: 1. allergic constitution； 2. pregnant or lactating women； 3. subjects who have been diagnosed with malignant tumors； 4. subjects whose laboratory tests meet the conditions； 5. subjects who have been diagnosed with severe gastrointestinal diseases； 6. subjects who have been diagnosed with severe cardiovascular disease； 7. subjects who have been diagnosed with severe cerebrovascular disease； 8. subjects with history of alcohol and drug abuse； 9. subjects who have participated in any other clinical trial； 10. subjects who have any conditions that the investigator considers not suitable for this trial.

Keywords: chronic abnormal immune activation aids t8 efficacy safety
effects of diaphragmatic breathing on pain, function, balance and quality of life in pregnant women with low back pain

Conditions: Pregnancy Related; Low Back Pain

Summary: the aim of the study was to investigate the effects of diaphragmatic breathing on pain, function, balance and quality of life in pregnant women with low back pain.

individuals with pregnancy-related low back pain who present to the obstetrics and gynecology clinic of i̇zmir menemen state hospital are identified as the study population. patients meeting the eligibility criteria will be included in the study.

Eligibility criteria:
inclusion criteria: * over 18 years of age * pregnancy between 19-29 weeks * low back pain that started with pregnancy (at least 1 week; no previous history of low back pain) * no treatment for the lumbar region or spine in the last 3 months exclusion criteria: * history of cardiovascular disease * multiple pregnancy * medical complications (e.g., bleeding, pre-eclampsia, placenta previa, etc.) * diagnosed cognitive disorders * high-risk pregnancy * history of abdominal and/or thoracic surgery
detection of minimal residual disease in resectable stage ii-iiib non-small cell lung cancer

Conditions: Lung Cancer

Summary: predicting relapse and overall survival in potentially resectable stage iiia-iiib non-small cell lung cancer (nsclc) patients remains challenging. it is now widely recognized that patients with detectable mrd have a worse prognosis than those with undetectable mrd. therefore, investigators performed this prospective clinical trial to evaluate the predictive value of mrd with increased risk of relapse and improves prediction of outcome in potentially resectable stage iiia-iiib nsclc with neoadjuvant chemoimmunotherapy. in this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of mrd. the predictive value of mrd with disease-free survival (dfs) rate was observed as the primary endpoint. besides that, the correlation of mrd with major pathologic response (mpr) rate, pathologic complete response (pcr) rate，event-free survival(efs) rate and overall survival (os) were observed as the second endpoints. investigators hope it will provide a new insight for these potentially resectable stage iia-iiib nsclc with neoadjuvant chemoimmunotherapy.


Eligibility criteria:
key inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 2. * have previously untreated and histological examination confirms resectable stage ii-iiia/iiib non-small cell lung cancer (according to the 8th edition of the ajcc tnm staging criteria), and the pathological type of squamous cell carcinoma and non-squamous cell carcinoma needs to be distinguished, and egfr, alk, and ros1 should be negative for non-squamous non-small cell lung cancer * adequate organ function and expected survival time ≥ 12 weeks; * evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. key exclusion criteria: * presence of mixed carcinoma component on histology. * patients with other active malignancies within 5 years prior to enrollment. * known active autoimmune diseases. * currently participate in an interventional clinical study treatment or have been treated with another drug or investigational device within 4 weeks prior to the first dose. * use of immunosuppressive agents within 14 days prior to the first dose of study treatment. * presence of other uncontrolled serious medical conditions.

Keywords: neoadjuvant non small cell lung carcinoma
effect of training intensity on health outcomes in diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.


Eligibility criteria:
inclusion criteria: type 2 diabetes age: 30-70 non smokers (minimum the last 15 years) inactive lifestyle (\<2 hours pr. week) bmi \<35 kg/m2 exclusion criteria: smoking prior cardiavascular diseases alcohol intake 14\> units pr. week.

Keywords: exercise
safety and efficacy of boceprevir in asia pacific participants with chronic hepatitis c genotype 1 (p07063)

Conditions: Hepatitis C, Chronic

Summary: this study will assess the efficacy of boceprevir (boc) in combination with pegintron (pegylated interferon alfa-2b) (peg) and ribavirin (rbv) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis c (chc) genotype 1 who failed prior treatment with pegylated interferon and rbv in the asia pacific population. the primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (boc/peg+rbv) is superior to that in the control arm (placebo/peg+rbv), in the full analysis set (fas) population.


Eligibility criteria:
inclusion criteria: * previously documented chc genotype 1 infection. other or mixed genotypes are not eligible. * liver biopsy with histology consistent with chc and no other etiology. * participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma * failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus rbv * weight between 40 kg and 125 kg, inclusive * of 'local' ancestral descent * sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception exclusion criteria: * co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus. * required discontinuation of previous interferon or rbv regimen for an adverse event considered to be possibly or probably related to rbv and/or interferon. * treatment with rbv within 90 days and any interferon-alpha within 1 month prior to screening. * treatment for hepatitis c with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity. * treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit. * evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. * diabetes and/or hypertension with clinically significant ocular examination findings. * any condition the could interfere with participation in and completion of the trial. * evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin). * pregnant or breast-feeding.