Kornimate/medical-research-clean huggingface dataset:
trial of second generation designer t cells in colorectal carcinoma

Conditions: Colorectal Cancer

Summary: the purpose of this study is to collect data on the safety and effectiveness of 2nd generation designer t cells in patients with colorectal cancer. designer t cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen (cea). these modified cells are then given back into the participant so that they can attack and kill tumor cells.

t cells can penetrate virtually every biologic space and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remissions of cancer. however, t cells are easily tolerized to self or tumor antigens and "immune surveillance" has manifestly failed in every cancer that is clinically apparent. it is the goal of this study to supply the specificities and affinities to patient t cells without regard for their "endogenous" t cell receptor repertoire, directed by antibody-defined recognition to kill malignant cells based on their expression of antigen. we will achieve this by preparing chimeric igcd28tcr genes in mammalian expression vectors to yield "designer t cells" from normal patient cells. prior studies in model systems demonstrated that recombinant igcd28tcr could direct modified t cells to respond to antigen targets with il2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an effective, self-sustaining immune response. it therefore becomes of paramount interest to extend these studies to a human system of widespread clinical relevance to explore the clinical potential of this new technology. the target antigen for these studies is carcinoembryonic antigen (cea), which is prominently expressed on tumors of the stomach, colon and rectum, breast, pancreas and other sites. patients receive a single dose of gene-modified autologous t cells on this dose-escalation trial. doses are 10\^9, 10\^10 and 10\^11 modified t cells. patients are monitored for safety and response. patients are on-study for one month after dosing.

Eligibility criteria:
inclusion criteria: * must have cancer of the colon or rectum * must have metastatic or unresectable locally advanced disease * tumor must express cea by tumor staining or by elevated serum cea (\>10 ng/ml) * must have measurable disease radiologically or by physical exam * must have failed potentially curative standard therapy * must be 18 years of age or older * good performance status (ps 0-1) exclusion criteria: * requiring systemic steroids * serious medical conditions * concurrent malignancies

Keywords: colorectal cancer t cells gene transfer
post marketing surveillance study for adynovate in south korea

Conditions: Hemophilia A

Summary: the main aim of this study is to check for side effects and medical problems in participants with hemophilia a who are receiving adynovate in routine clinical practice. also, it will be checked how effective adynovate is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries. participants with hemophilia a who will be newly prescribed with adynovate treatment or have already been taking adynovate treatment according to the physician's decision will be included in this study. participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.


Eligibility criteria:
inclusion criteria participants with a diagnosis of hemophilia a who will be newly prescribed with adynovate or already have been prescribed adynovate according to the study physician's judgment shall be included in this study if: * the participant or legally authorized representative has given written informed consent to participate in the study. * the participant is indicated for treatment according to the adynovate south korea prescribing information (pi). exclusion criteria participants should be excluded from this study if: * the participant or legally authorized representative does not wish to participate in the study. * any of the contraindications included in the pi for adynovate apply. * participant is enrolled in an interventional trial using an investigational product other than adynovate.
differences in gastric microbiota in patients who were infected between caga positive and negative helicobacter pylori

Conditions: Gastric Microbiota; Helicobacter Pylori; CagA; Gastric Cancer

Summary: the goal of this clinical trial is to study the differences in gastric microbiota (diversity index) between patients who were infected with caga-positive helicobacter pylori and caga-negative helicobacter pylori. the main question it aims to answer are: the effect of helicobacter pylori typing (caga status) on gastric microbiota, what is the different? patients indicated for egd at siriraj endoscopic center will undergo a helicobacter pylori test (rapid urease test) if the result is positive, a stomach biopsy for gastric microbiota testing and caga antibody testing will be conducted. then, the patients will be divided into two groups: caga-positive helicobacter pylori and caga-negative helicobacter pylori. to compare the differences in gastric microbiota in terms of species and biodiversity, as well as endoscopic results, etc.


Eligibility criteria:
inclusion criteria: * patients aged over 18 with an indication for egd * helicobacter pylori infection (rapid urease test positive) exclusion criteria: * severe comorbidities: poorly controlled dm, esrd, decompensated cirrhosis, malignancy * bmi ≤ 23 kg/m2 * receiving medications that affect the gastric microbiota include antibiotics, probiotics, or bismuth within 4 weeks, ppi within 2 weeks, nsaids or metformin within 2 weeks * history of cholecystectomy or proximal small bowel surgery

Keywords: gastric microbiota helicobacter pylori caga gastric cancer
the drug-drug interaction of sp2086 and simvastatin

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to investigate the potential interaction between sp2086 and simvastatin after the multiple oral doses treatment in healthy adult volunteers.

this is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of sp2086 and simvastatin in healthy adult volunteers. all subject were randomized into two groups, and the drugs will be administered according to the ab and ba sequences. the a sequence was that sp2086 was taken at 40mg qd on day1-day 10; simvastatin will be administered orally (by mouth) as 200mg on day 6-day10.the b sequence was that simvastatin was taken at 40mg qd on day6-day10. there were 5 days washout period between a and b. the total time of this trial was 27 days.

Eligibility criteria:
inclusion criteria: * healthy volunteers with a body mass index(bmi) between 19 and 24 kg/m2 * had signed the informed consent himself or herself voluntarily. exclusion criteria: * have the abnormal lab or other examination results and the change have clinical significance. * history of or current clinically significant medical illness as determined by the investigator. * have a family history of thyroid cancer, submandibular gland cancer or long qt syndrome * known allergy to sp2086 or glyburide or any of the excipients of the formulation of sp2086 or glyburide. * history of using the sulfa or sulfonylureas or dpp-ivor glp-1 drugs or other similar structure drugs. * history of severe unconsciousness hypoglycemia * history of any surgery prior to screening in 6 months. * history of blood donation≥400 ml prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month. * history of participate any drug or medical device prior to screening in 3 months. * within a month before the screening using any prescription drugs, over-the-counter drugs, chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins). * 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion. * the hepatitis b surface antigen, hepatitis c antibody, hiv antibody and syphilis antibody was positive. * pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. * researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Keywords: sp2086 simvastatin drug-drug interaction
adults with moderate to severe asthma

Conditions: Asthma

Summary: a study to compare the safety and effectiveness of 5 different ways of taking pulmicort when given to asthma patients aged 12 years and above.


Eligibility criteria:
inclusion criteria: * male or female aged 12 or over who have asthma * ability to properly use an electronic diary * able and willing to nebulize for up to 20 minutes every morning and evening exclusion criteria: * hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months * planned hospitalisation during the study * pregnant women or women planning to become pregnant

Keywords: asthma pulmicort budesonide respules turbuhaler
a study of fruquintinib plus chemotherapy for postoperative treatment of her2-negative gastric cancer with poor trg

Conditions: Gastric/Gastroesophageal Junction Adenocarcinoma

Summary: given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (trg) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of fruquintinib in combination with standard chemotherapy for postoperative treatment of her2-negative gastric cancer patients with poor trg, in order to bring greater survival benefits to patients.

given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (trg) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of fruquintinib in combination with standard chemotherapy for postoperative treatment of her2-negative gastric cancer patients with poor trg, in order to bring greater survival benefits to patients. the primary endpoint of this study is to evaluate the recurrence-free survival (rfs) in patients with poor trg after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with fruquintinib combined with standard chemotherapy postoperatively. secondary endpoints include overall survival (os) and safety .

Eligibility criteria:
inclusion criteria: 1. fully understand the study and voluntarily sign the informed consent form; 2. age between 18 and 75 years; 3. histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma; 4. tumor regression grade (trg) 2 or 3 after preoperative adjuvant therapy; 5. r0 resection after neoadjuvant chemotherapy; 6. eastern cooperative oncology group (ecog) performance status of 0-1; 7. life expectancy of at least 2 years; 8. no prior anti-cancer treatment received; 9. good compliance and cooperation with follow-up. exclusion criteria: 1. inability to comply with the study protocol or procedures; 2. history of prior gastric cancer surgery; 3. contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery; 4. distant metastasis to organs other than the liver, such as lung, brain, and bone; 5. known her2-positive patients; 6. uncontrolled hypertension despite medication prior to enrollment; 7. poorly controlled diabetes despite medication prior to enrollment; 8. urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification \>1.0g; 9. presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment; 10. patients deemed ineligible for this study by the investigator.
study of neoadjuvant nivolumab in patients with non-metastatic stage ii-iv clear cell renal cell carcinoma

Conditions: Clear Cell Renal Cell Carcinoma

Summary: this study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, programmed cell death-1 (pd-1).


Eligibility criteria:
inclusion criteria (abbreviated): 1. confirmed non-metastatic high-risk clear cell renal cell carcinoma (t2a-t4nanym0 or tanyn1m0) 2. schedule to undergo either partial or radical nephrectomy as part of treatment plan 3. patient agrees to have a tumor biopsy 4. ecog performance status of 0 or 1 5. adequate organ and marrow function defined by study-specified laboratory tests 6. must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion 7. willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures exclusion criteria (abbreviated): 1. other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer) 2. need for urgent or emergent nephrectomy to relieve symptoms 3. prior treatment for rcc including surgery, radiation, thermoablation or systemic therapy 4. surgery within 28 days of starting study treatment (some exceptions for minor procedures) 5. received live vaccine for infectious diseases within 28 days of starting study treatment 6. prior treatment with any antibody or drug targeting t-cell costimulation or immune checkpoint pathways (anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla-4, etc) 7. use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug. 8. current use of immunosuppressive agents 9. history of severe hypersensitivity reaction to other monoclonal antibodies 10. current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to rcc 11. uncontrolled psychiatric illness/social situations that would limit compliance with study requirements. 12. active infection requiring therapy. 13. known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids)-related illness. 14. positive tests for hepatitis b surface antigen or hepatitis c ribonucleic acid (rna). 15. history of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply). 16. pulse oximetry of \<92% on room air 17. pregnant or breastfeeding women

Keywords: immunotherapy pd-1 anti-pd-1 antibody kidney cancer rcc non-metastatic
a controlled study of stem cell transplantation medical home care compared to standard hospital care

Conditions: Hematologic Malignancies

Summary: the primary goal with this study is to document whether patients can maintain their normal bowel microbiota by staying at home compared to those who live at home but are treated in clinic, and those who are treated in the hospital. in addition, the investigators would predict that the quality of life will be higher for those patients treated at the medical home compared to those that stay at the hospital. the investigators also predict that the costs associated with this approach will be significantly lower compared to hospitalized patients. finally, the investigators propose that the treatment related morbidities and mortality will not be different between the two groups.

subjects enrolled in the medical home arm and those serving as concurrent controls will have the following studies: 1. stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly for the first four weeks, at day 60 and 100. 2. the pg-sga, fact-bmt and other patient-reported symptom instruments will be collected weekly for the first 4 weeks, at day 60, 100 and patients will be required to complete a daily food diary. 3. other assessments for toxicities or gvhd will proceed as per current standard of care, for a total blood draw amount of 100 mls from home care subjects and concurrent controls.

Eligibility criteria:
inclusion criteria: 1. scheduled to undergo a hematopoietic stem cell transplant for any cancer or non-cancer illness from any autologous, related or unrelated donor source including bone marrow, peripheral blood progenitor cell, or umbilical cord blood 2. age 18-80 years of age 3. karnofsky performance scale (kps) \> 80 4. a home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of duke (home care group only) exclusion criteria: 1. lack of a caregiver 2. pregnant women (it is standard of care to assess for pregnancy for all females of child-bearing potential with a serum beta human chorionic gonadotropin (hcg) test within 7 days of starting the preparative regimen prior to transplant. no additional research pregnancy testing will occur.) 3. patients with a documented active infection prior to starting their preparative regimen. this includes grade 3 or higher viral, bacterial, or fungal infection.

Keywords: stem cell transplant bowel microbiota home care
bezlotoxumab - in "real life" - during the first episode of clostridium difficile infection in patients with high risk of recurrence.

Conditions: Clostridium Difficile Infection

Summary: the main hypothesis of the study is that bezlotoxumab is well tolerated and effective in reducing the recurrence of icd (clostridium difficile infection) in patients with a high risk of recurrence in the first episode of icd. as a consequence, the number of readmissions and hospital stays, will be reduced in patients treated with bezlotoxumab.

this is a comparative study of patients with a high risk of recurrence of icd in the first episode, treated with bezlotoxumab (together with standard icd therapy), with patients with first episode of icd from a paired retrospective cohort (1: 2) using a propensity score.

Eligibility criteria:
inclusion criteria: * patients who have granted the ic and who are going to comply with the study visits and procedures according to their life expectations. * patient ≥ 18 years of age * having a first episode of dci and presenting an estimated recurrence risk greater than 35%. exclusion criteria: * patients \<18 years old * pregnant or lactating women * women of childbearing age who are not willing to use an appropriate contraceptive method (such as oral contraceptives, intrauterine device or contraceptive barrier method along with spermicide or surgical sterilization) during the study. * life expectancy less than 6 months * impossibility or serious difficulties of clinical follow-up * any digestive disease that, at the discretion of the researcher, makes it difficult to assess the response due to impaired bowel habits. * immunoglobulin treatment in the last 3 months * previous treatment with bezlotoxumab * treatment with an experimental drug in the previous 30 days or participating or planning to participate in any other clinical trial with an experimental drug during the 12-week trial period. * anti- icd treatment forecast for more than 14 days (eg vancomycin in descending pattern) for the current episode. * health center staff * direct family members of the research team
plasma adiponectin level and vascular endothelial and smooth muscle cell function in children with prader-willi syndrome

Conditions: Prader-Willi Syndrome; Obesity

Summary: context: prader-willi syndrome (pws) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life. objectives: to assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (imt) was measured and correlated with known atherosclerotic risk factors in 27 children with pws and 24 age-, sex-, and body mass index (bmi)-adjusted controls.

main outcome measures: correlation of imt with age, standard deviation score of bmi (bmi-sds), high-density lipoprotein cholesterol (hdl), low-density lipoprotein cholesterol (ldl), c-reactive protein, homa-ir and ghrelin.

Eligibility criteria:
inclusion criteria: * obesity with pws exclusion criteria: * chronic disease

Keywords: intima-media thickness ghrelin prader-willi syndrome
clinical trial of npb-01 in patients with bullous pemphigoid unresponsive to corticosteroids.

Conditions: Bullous Pemphigoid

Summary: patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. patients who meet all inclusion criteria and conflict the exclusion criteria will receive npb-01(intravenous immunoglobulin) 400mg/kg/day for five consecutive days or placebo(physiological saline). subsequently, efficacy of npb-01 for therapy of bullous pemphigoid will evaluate using pemphigoid activity score involving skin lesion area and number of new blisters. as a safety endpoint, the safety of npb-01 will be investigated the occurrence of adverse events by 57 days after the start of the study treatment.


Eligibility criteria:
inclusion criteria: 1. patients with corticosteroids over 20mg/day(prednisolone) at informed consent. 2. patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent. 3. patients who pemphigoid activity score is score1 and more before study medication received. 4. patients who symptom is not improve before study medication received. 5. patients with twenty years old at informed consent. 6. patients with hospitalization during five consecutive days of study medication. exclusion criteria: 1. patients treated with plasmapheresis at 28 days before informed consent. 2. patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent. 3. patients treated with intravenous immunoglobulin at 56 days before informed consent. 4. patients who receive or adjust in increments immunosuppressants at 14 days before informed consent. 5. patients with malignancy or a history of this disease. 6. patients with history of shock for npb-01. 7. patients with history of hypersensitivity for npb-01. 8. patients with iga deficiency. 9. patients with impaired liver function. 10. patients with impaired renal function. 11. patients with cerebro- or cardiovascular disorders. 12. patients with high risk of thromboembolism. 13. patients with hemolytic/hemorrhagic anemia. 14. patients with decreased cardiac function. 15. patients with decreased platelet.

Keywords: ivig in pemphigoid patients with bullous pemphigoid unresponsive to corticosteroids