Kornimate/medical-research-clean huggingface dataset:
behavioral research of environment and air pollution through education

Conditions: Attitude to Health; Pollution Related Respiratory Disorder; Health Behavior

Summary: the breathe (behavioral research of environment and air pollution through education) study is a pilot randomized control trial comparing the efficacy of a classroom-based intervention to no intervention in helping middle-school students understand and make behavioral decisions about air pollution. this study is designed to evaluate the effectiveness of the classroom-based intervention on knowledge of air pollution, understanding of air pollution sources, and behavioral choices made to reduce both contributions to air pollution and personal exposure to air pollution. it has been well established that pollution is a racial and economic issue. low-income areas with populations of predominantly people of color tend to be those with the highest rates of pollution and the largest particulate exposure. creation of and exposure to this pollution is a key issue for the health of inhabitants of these areas, and of those in the broader surrounding areas. by developing, and assessing the effectiveness of, the investigators hope that the breathe study will give the investigators insights into how to better combat this higher exposure and reduce the health risks for those in high pollution areas. the study will take place in 4 visits over a period of 12 months. the hypothesis is that the classroom-based intervention will be effective in leading to behaviors that will reduce exposure to air pollution.


Eligibility criteria:
inclusion criteria: * ability to read, write, and understand english at a middle school level * willing to participate in follow up visits exclusion criteria: * learning disabilities such as autism * moving out of the area in the next 6 months * inability to complete the questionnaires
irradiation of large lung tumors or two or more lung metastases simultaneously

Conditions: Lung Cancer; Metastatic Lung Cancer

Summary: treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using stereotactic body radiation therapy (sbrt) in a mean-lung dose escalation study.

a phase i/ii multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (nsclc) \> 5 cm without lymph node involvement (group a) or medically with ≥ 2 or more lung metastases (group b). radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (mld). the mld escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (tite-crm). all patients will receive 3-5 fractions sbrt to the lung tumor(s), with a minimum mean ptv dose ≥ 42 gy. fraction size may be downscaled based on the mld constraint.

Eligibility criteria:
inclusion criteria for group a and b: * weight loss \< 10% in the last three months. * who-performance status ≤ 2 * medical inoperable patients or patients refusing surgery. * chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-sbrt and 6 weeks post-sbrt. * before patient registration, written informed consent must be given according to ich/gcp, national and local regulations. risk group a specification: * nsclc (cytological or histological proven) patients with peripheral tumors \>5 cm with tumor staging ct2bn0m0 or ct3n0m0 (chest wall infiltration is no exclusion criteria, as long as the tumor diameter is \> 5 cm). * single peripheral lung metastasis in inoperable patients with a diameter of \> 5 cm. in case of first presentation of metastatic disease, cytological or histological proof is obligated. * in patients without cytological or histological confirmation of nsclc, a growing fdg-pet positive lesion (suv \>5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present. risk group b specification: * patients with ≥ 2 simultaneous peripheral lung metastases ≤ 5 cm of any origin at any location in the lung. * in case of first presentation of metastatic disease, cytological or histological proof is obligated. this is not necessary in case of a history of an already proven disseminated disease. * patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap. exclusion criteria: * patients with central tumors * pancoast tumors * prior radiotherapy treatment to the thorax * patients receiving any systemic treatment during sbrt * pregnant patients * patients previously treated with adriamycin agents in case of heart involvement within the treatment field.

Keywords: lung sbrt mld toxicity
live-c-free: early and late treatment of hepatitis c with sofosbuvir/ledipasvir in liver transplant recipients

Conditions: Hepatitis C

Summary: the predominant remaining questions for post-transplant treatment of hepatitis c virus (hcv) in the daa (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase iv study

this is a multicenter, prospective, randomized, open-label phase iv study. compare ledipasvir/sofosbuvir + ribavirin for 12 weeks vs ledipasvir/sofosbuvir alone for 12 weeks in patients over 90 days post-liver transplant

Eligibility criteria:
inclusion criteria 1. at least 18 years of age and able to give informed consent 2. history of hcv genotype 1 or 4 3. normal ekg 4. at least 91 days post orthotopic liver transplant 5. screening laboratory values within defined thresholds 6. detectable hcv rna at screening 7. creatinine clearance of at least 40ml/min using the cockcroft gault equation 8. negative pregnancy test for female subjects within 48 hours prior to receiving study medication 9. use of two effective contraception methods if female of childbearing potential or sexually active male unless status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy exclusion criteria 1. serious or active medical or psychiatric illness 2. history of significant or unstable cardiac disease 3. stomach disorder that could interfere with the absorption of the study drug 4. pregnant or nursing females or males with a pregnant female partner 5. co-infected with hepatits b (hbv) or hiv 6. recipients of an allograft from a donor that was infected with hcv with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 hcv replication post-transplant 7. allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin 8. history of exposure to an nonstructural protein (ns5a) inhibitor 9. within 1 year of transplant and history of hepatocellular carcinoma (hcc) with tumor burden outside of the milan criteria (see appendix ii) prior to transplant 10. participated in a clinical study with an investigational drug or biologic within the last 30 days 11. combined liver/kidney transplant 12. history of organ transplant other than liver 13. childs turcotte pugh (ctp) b or c 14. patients with fibrosing cholestatic hepatitis 15. platelet count of ≤ 30 k/mm3 16. hemoglobin \< 10g/dl 17. total bilirubin \> 10mg/dl 18. alanine aminotransferase (alt),aspartate aminotransferase (ast), or alkaline phosphatase ≥ 10x upper limit normal 19. serum sodium \< 125mmol/l 20. current use of any of the prohibited interventions (section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening
positron nuclide labeled dota-fapi pet study in colocrectal cancer

Conditions: Tumor, Solid; Positron-Emission Tomography; Colorectal Cancer

Summary: to evaluate the normal physiological distribution of positron nuclide labeled dota-fapi pet/ct in human body and its diagnostic efficiency for colorectal cancers

participants first undergo an 18f-fdg pet/ct, followed by 68ga-fapi04 pet/ct in groups. the purpose of the study is to explore the possibility of superiority of fapi in diagnosis of colorectal cancer (tnm staging) by the comparison of the two tracers uptake (the maximum of standardized uptake value, suvmax). histopathology and conventional imaging follow-up are served as the reference standard.

Eligibility criteria:
inclusion criteria: * ecog score 0-2 * patients with newly diagnosed or previously treated colorectal cancers * patients who underwent paired 18f-fdg and 68ga-fapi pet/ct for tumor staging to decide the most proper treatment strategy * patients who underwent paired 18f-fdg and 68ga-fapi pet/ct to detect tumor recurrence and metastases (repeat staging) * expected survival ≥12 weeks * blood routine, liver and kidney function meet the following criteria : blood routine: wbc≥4.0×109l or neutrophils ≥1.5×109l, plt≥100×109/l, hb≥90g/l;pt and aptt uln 1.5 or less; liver and kidney function: t-bil ≤1.5×ult(upper limit of normal value), alt/ast≤2.5uln or ≤5×ult(subjects with liver metastasis), alp≤2.5uln(alp≤ 4.5uln if there is bone metastasis or liver metastasis);bun 1.5 x or less ult, scr 1.5 x or less ult * at least one measurable target lesion according to recist1.1 * women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period * able to understand and sign the informed consent voluntarily, with good compliance. exclusion criteria: * severe abnormalities of liver and kidney function; * women preparing for pregnancy, pregnancy and lactation; * cannot lie supine for half an hour; * refuse to join the clinical researcher; * suffering from claustrophobia or other mental illness;

Keywords: colorectal cancer positron-emission tomography fapi
clinical trial of lurbinectedin (pm01183) in selected advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: multicenter, open-label, exploratory, phase ii clinical trial to evaluate the efficacy and safety of pm01183 in previously treated patients with advanced solid tumors

patients with relapsed small cell lung cancer (sclc), head and neck carcinoma (h\&n), neuroendocrine tumors (nets), biliary tract carcinoma, endometrial carcinoma, brca 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (gcts), and ewing's family of tumors (efts) will be enrolled in nine different cohorts. up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the sclc cohort).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * voluntary signed informed consent (ic) * pathologically proven diagnosis of any of the following malignancies: * small cell lung cancer (sclc). * head and neck carcinoma (h\&n). salivary glands tumors are excluded. * neuroendocrine tumors (nets), grade 2 and grade 3 according to world health organization classification. * biliary tract carcinoma. * endometrial carcinoma. * brca 1/2- associated metastatic breast carcinoma * carcinoma of unknown primary site. * germ cell tumor (gcts), excluding immature teratoma, or teratoma with malignant transformation. * ewing's family of tumors (efts) * prior treatment. patients must have received: * sclc, endometrial carcinoma: one prior chemotherapy-containing line. * h\&n, nets, biliary tract, cup: one or two prior chemotherapy-containing lines * gcts: no limit of prior therapy * efts: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting. * brca 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines. * performance status ≤ 2 \[eastern cooperative oncology group (ecog)\] * adequate major organ function * at least three weeks since the last chemotherapy * women of childbearing potential must have pregnancy excluded by appropriate testing before study entry exclusion criteria: * prior treatment with pm01183 or trabectedin * prior or concurrent malignant disease unless in complete remission for more than five years * known central nervous system (cns) involvement * relevant diseases or clinical situations which may increase the patient's risk * pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception
development of self-administrable psychological intervention programs supported by new technologies as a treatment for patients with functional digestive disorders.

Conditions: Irritable Bowel Syndrome

Summary: disorders of gut-brain interaction (dgbi) are produced by disturbances in the interplay between the gut and the central nervous system. several psychological factors like anxiety, depression and altered coping are over-represented in these disorders. recent surveys have shown that dgbi affect up to 40 % of the general population. psychological interventions like cognitive behavioral therapy and hypnosis have been shown to be beneficial for managing these disorders. however, access to psychological interventions is very limited due to lack of resources to treat these very frequent conditions. objective: to determine the effects of psychological interventions using specifically developed therapeutic programs based on virtual reality, for telematic use at home, on symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients with dgbi. methodology: after development of a program of psycho-education on dgbi using interactive immersion by means of virtual reality (vr) a randomized clinical trial will be developed. consecutive patients will be randomized 1:1 to active treatment or placebo. in each patient in the active treatment group a session of psychoeducation using specifically developed vr-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions of psycho-education leaded by a psychologist. during the 6 weeks of the treatment period patients will be instructed to perform self-administrable sessions of psychotherapy at home (by means vr). patients in the placebo group willl take a placebo capsule daily. outcome measures. in all patients, severity of symptoms (primary outcome), qol, somatic and psychological comorbidities (using specific questionnaires), visceral sensitivity (by means of a barostat) and microbiota analysis, will be performed before and at the end of the treatment period. symptom severity will be assess also in follow-up phone calls at 3 and 6 months.


Eligibility criteria:
inclusion criteria: * bmi (body mass index) between 18.5-24.99, with variations of up to 15%. * ability to understand instructions and follow protocol. * access to internet network from usual residence. exclusion criteria: * previous history of abdominal surgery with the exception of appendectomy and herniorrhaphy. * abuse of alcohol, tobacco or narcotics. * medical evidence of organic gastrointestinal pathology, hepatopathy, endocrinopathy, heart disease or contagious disease, as well as major psychiatric disorder.
systemic dickkopf-related protein 1 (dkk1)during estrogen level changes in post-menopausal breast cancer patients treated with aromatase inhibitors

Conditions: Breast Cancer

Summary: the investigators are hypothesizing that decreasing estrogen levels will cause serum dkk1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. the investigators also believe that the peak in dkk1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway. the investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated ais. the study will observe anthromorphic and serum marker changes during the first year of their treatment.


Eligibility criteria:
inclusion criteria: * post menopausal breast cancer patients with planned treatment of aromatase inhibitors. * 18 years or older exclusion criteria: * bmi \>30 or \<18 * osteoporosis as defined by protocol. * subjects currently on bisphosphonate therapy. * history of primary or secondary hyperparathyroidism * history of hypo-or hyperthyroidism * history of vitamin d levels below lln * history of creatinine clearance below the egfr * history ofliver function tests above 1.5 times uln including ldh, sgot, sgpt, alkaline phosphatase, and bilirubin * history of documented cirrhosis of the liver * history of chronic heparin use * history of chronic glucocorticoid therapy

Keywords: aromatase inhibitors
whole genome sequencing in the detection of rare undiagnosed genetic diseases in children in china

Conditions: Intellectual Disability; Multiple Congenital Anomaly; Rare Diseases

Summary: to assess the indications and diagnostic efficiency of whole genome sequencing (wgs) in pediatric patients with unexplained intellectual disability/developmental delay, multiple congenital abnormalities and other rare and undiagnosed diseases

this project will recruit 100 rare, undiagnosed pediatric genetic disease families (core families: patients, patients' parents, immediate family members such as brothers and sisters, all of them can be enrolled whether they have disease or not, so generally 3, for a few cases 4 or 5) all over the country. the expert team will review the clinical materials, the molecular team will review the experimental process, and the bioinformatics team will review the chip, the analysis of whole exome sequencing data and screen the samples all over the country; whole-genome sequencing of 100 rare, undiagnosed pediatric genetic disease families (illumina novaseq high-throughput sequencer); the study will provide preliminarily performance data on the comparison of whole exome data and whole genome data. in addition, it will generate the chinese consensus on clinical applications of whole-genome sequencing in the diagnosis of birth defects and undiagnosed rare genetic diseases in children based on the statistical analysis of clinical phenotype and genotype association, which could guide the clinical application of pediatrics, laboratory testing and reporting. construction of the chinese detection genome database of genetic disease

Eligibility criteria:
inclusion criteria: 1. intelligence tests results of less than 40 (patients \ 6 years old using old wechsler intelligence scale for screening). 2. neurodevelopmental defects can be expressed as mental retardation, motor development retardation, language delay, epilepsy, etc. may have or not have multiple congenital abnormalities, families with more than one affected patient will be enrolled priority 3. families went through at least one of the high throughput technology(wes or cma) and receive the negative result exclusion criteria: 1. intellectual disability caused by pregnancy, perinatal infection, ischemia, and hypoxia and other non-hereditary causes, 2. obvious genetic metabolic diseases (such as different types of genetic metabolic diseases, bone disease, fragile x syndrome, etc.);
the pharmacokinetic(pk)/pharmacodynamics(pd) study of shr7280 tablets in premenopausal subjects with endometriosis.

Conditions: Endometriosis

Summary: the primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of shr7280 tablets in premenopausal subjects with endometriosis. in addition, this study will provide information on efficacy of shr7280 tablets in premenopausal subjects with endometriosis.

endometriosis is a common disease, aﬀecting 5-10% of women of reproductive age . it is an estrogen-dependent and estrogen-driven disease and so hormonal manipulation and suppression of estrogen production form the basis of the majority of medical treatment. the primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of shr7280 tablets in premenopausal subjects with endometriosis. in addition, this study will provide information on efficacy of shr7280 tablets in premenopausal subjects with endometriosis.

Eligibility criteria:
inclusion criteria: phase i/ii 1. premenopausal females, aged 18-45 2. history of regular menstrual cycles 3. endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography. 4. participant must agree to use only protocol specified rescue analgesics during the screening and treatment periods for endometriosis-associated pain. 5. participant in general good health. no clinically significant findings in laboratory parameters or clinically significant abnormality on x-ray phase i (only) participant has mild or moderate pelvic pain associated with endometriosis at screening. phase ii(only) participant has moderate or severe pelvic pain associated with endometriosis at screening. exclusion criteria: phase i/ii 1. subjects with severe trauma or surgery within 6 months prior to the screening； 2. known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose; 3. pregnant or serum β-human chorionic gonadotropin (hcg)\> 5 million international units(miu)/ml at screening or baseline 4. pregnant or breast feeding ; 5. have pelvic pain that is not caused by endometriosis 6. abnormal uterine bleeding 7. are currently receiving gonadotropin-releasing hormone (gnrh) agonist, a gnrh antagonist or danazol or have received any of these agents within 6 months of the start of screening. 8. are currently receiving subcutaneous medroxyprogesterone acetate (dmpa-sc) or intramuscular medroxyprogesterone acetate (dmpa-im) or have received any of these agents within 3 months of the start of screening. 9. are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 2 months of the start of screening. phase i (only) one month prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening; phase ii (only) screening dual-energy x-ray absorptiometry (dxa) scan results of the lumbar spine, femoral neck, or total hip bone mineral density corresponding to 1.5 or more standard deviations below normal (t-score at or below -1.5)
subthreshold stimulation on chronic low neck pain myofascial trigger points

Conditions: Chronic Neck Pain

Summary: this study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.

the study will include 2 groups. one group will receive subthreshold stimulation and other will not receive any treatment. the measurements will include pain and myscle activity.

Eligibility criteria:
inclusion criteria: * chronic neck pain * one or more trigger point exclusion criteria: * any musculoskeletal or neuromuscular diseases
inulin supplementation in patients with type 1 diabetes

Conditions: Diabetes

Summary: the aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo. therefore, the primary objective of the study is represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (hba1c, lipid profile, c-rp).


Eligibility criteria:
inclusion criteria: * patients with t1d, diagnosed before 35 years of age will be enrolled exclusion criteria: * advanced complications of t1d (established renal failure, severe retinopathy and diabetic neuropathy) * bmi\> 30 kg / m2.