Kornimate/medical-research-clean huggingface dataset:
evaluation of ocoxin®-viusid® in advanced stomach cancer and gastric esophagogastric junction

Conditions: Stomach Neoplasm; Gastrointestinal Neoplasms; Digestive System Neoplasm; Esophageal Neoplasms; Head and Neck Neoplasms; Gastrointestinal Disease; Digestive System Disease; Esophageal Diseases; Stomach Diseases; Esophagogastric Junction Disorder

Summary: our main objective is to evaluate the effect of ocoxin-viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. the ocoxin-viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with chemotherapy.

* to evaluate the effect of ocoxin-viusid on the quality of life of patients * to evaluate the toxicity of ocoxin-viusid in combination with chemotherapy (qt). * to assess the influence of ocoxin-viusid on tolerance to treatment with chemotherapy. * identify the changes that occur in the nutritional status of patients receiving the supplement.

Eligibility criteria:
inclusion criteria: 1. patients with cyto-histological diagnosis of stomach adenocarcinoma and gastric esophageal junction in stages iii and iv, which are tributaries of the folfox chemotherapy scheme. 2. patients of any sex with age ≥ 18 years. 3. patients with clinical status according to karnofsky index ≥ 70%. 4. patients with life expectancy ≥ 3 months. 5. clinically fit patients to receive the folfox chemotherapy scheme. 6. patients who have signed informed consent for the investigation. 7. patients with laboratory parameters within normal limits that do not contraindicate the administration of chemotherapy: hemoglobin ≥ 90 g / l, total leukocyte count ≥ 3.0 x 109 / l, absolute neutrophil count\> 1.5 x 109 / l, platelet count\> 100 x 109 / l, total bilirubin ≤ 1.5 times the upper limit of the normal range established in the institution, tgo / tgp ≤2.5 times the upper limit of the normal range established in the institution, creatinine within the limits normal of the institution. 8. patients of childbearing age with negative pregnancy test and use appropriate contraceptive methods such as intrauterine devices, barrier or tubal ligation methods, hormonal contraceptives. in the case of male sex (vasectomy, use of condoms) while the treatment lasts. exclusion criteria: 1. patients with stomach cancer and gastric esophageal junction in stages iii and iv, tributaries of surgical treatment and / or radiotherapy. 2. patients who are being treated with another product under investigation. 3. patients with known hypersensitivity to any component of the investigational product. 4. patients with known hypersensitivity to any component of the chemotherapy (folfox). 5. patients with acute allergic states or history of severe allergic reactions. 6. patients with acute, chronic, or inflammatory decompensated infectious diseases. 7. patients with brain metastases. 8. patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up. 9. patients in the period of breast-feeding or puerperium.
sharp versus blunt uterine incision expansion

Conditions: Cesarean Section Complications

Summary: comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss \& postoperative pain

the study includes 200 pregnant women, primigravidas, at term who underwent elective transverse lower segment cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy. the patients are divided randomly into two groups as follows: * group (a): undergoing blunt uterine incision expansion * group (b): undergoing sharp uterine incision expansion

Eligibility criteria:
inclusion criteria: * singleton pregnancy. exclusion criteria: * previous pid * any medical or psychiatric * patients with bmi ≥ 40 * multigravidas * chronic analgesia use, * allergy to analgesics, * multiple pregnancies are also excluded
rucaparib in patients with locally advanced or metastatic urothelial carcinoma

Conditions: Bladder Cancer; Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Renal Pelvis Carcinoma; Ureter Carcinoma; Urinary Bladder Carcinoma; Urethra Carcinoma; Muscle Invasive Bladder Cancer

Summary: the purpose of the atlas study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed locally advanced unresectable or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra) * received 1 or 2 prior treatment regimens for advanced or metastatic disease * confirmed radiologic disease progression during or following recent treatment * mandatory biopsy is required during screening * measurable disease per recist v1.1 * adequate organ function * ecog 0 or 1 exclusion criteria: * prior treatment with a parp inhibitor * symptomatic and/or untreated cns metastases * duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib

Keywords: parp inhibitor parpi hrd atlas homologous recombination dna repair loh dna defect dna anomaly rucaparib mibc
research for papillomavirus as the examination of orientation in the organized screening of the cervical cancer

Conditions: Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test

Summary: auto-takings by apu and vaginal apv during the consultations for fcu in the department of gynecology-obstetrics (group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, apu and apv, is made for other consultations requiring a screening on the chru (group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). auto-takings transmitted in the laboratory of the chru of brest for test hpv by quantitative real-time pcr. results transmitted to the women and to the doctors of consultation. in case of positive test (15 %), the patients are directed to a gynecologist. confrontation with the cytological data when available (group 1) .


Eligibility criteria:
inclusion criteria: * all the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the chru of brest exclusion criteria: * women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.

Keywords: papillomavirus vaginal auto-takings urinary test
diagnostic performance of a novel lipoarabinomannan.

Conditions: HIV Primary Infection

Summary: the fujifilm silvamp tb lam (fujilam; fujifilm, tokyo, japan) is a novel (not commercialized) urine based point-of-care assay to diagnose tb in hiv-positive patients. a first study using urine frozen samples has reported a higher sensitivity of this test over the currently commercialised alere determine tb lam ag assay (alerelam).

the study aims to assess the performance of a new test called the fujifilm silvamp tb lam or simply the fuji-lam test. the fuji-lam test is a test that can be done on urine to look for specific proteins that are produced by the bacteria that causes tuberculosis. this test offers an advantage over the tests that are based on phlegm because most patients can produce urine for testing even when they are very sick. additionally, this test does not require a complex laboratory set up and it can therefore be used by health workers as they interact with the patient. this study will also look at how the new test compares with an existing test alerelam - that is based on similar technology. initial laboratory-based studies conducted on frozen urine samples show that the new test has better performance than the existing test. this study is different from the first studies because it is being conducted in real life settings rather than in a laboratory. the study will be conducted at the homa bay county hospital in kenya. individuals living with hiv with and without signs and symptoms of tb will be invited to take part. individuals who agree to participate will be seen by the health workers in the study and will provide samples for testing using the fujilam test and other standard tests used to investigate individuals for suspected tuberculosis. investigators are also conducting similar studies in other african countries including uganda, mozambique and south africa. this will enable investigators to assess the performance of the test in diverse settings.

Eligibility criteria:
inclusion criteria: * 15 years of age or older * hiv-positive group 1: at least one symptom of tb group 2: * advanced hiv disease (cd4 count less than 200cell/µl or clinical stage iii/iv) * no signs and symptoms of tb * signature of the informed consent exclusion criteria: * intake of anti-tuberculosis drugs for more than 5 days in the month prior to the consultation except preventive tb treatment. * decline to sign informed consent.

Keywords: tuberculosis in hiv
acute & chronic post-mastectomy pain: can pecs block alter the geography?

Conditions: Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration

Summary: post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. pecs block is used for acute and chronic post mastectomy pain management. surgical infiltration is also used in this field. patients in our study are divided in two groups receiving pecs block or surgical infiltrationbefore incision. multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.

patients are randomly assigned to 2 groups, pecs block or surgical infiltration group. patients assigned to pecs group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. local aneshetic is administered in both groups after the induction of general anesthesia and before incision. pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.

Eligibility criteria:
inclusion criteria: * over 18 years of age * asa physical status i-iii * elective partial mastectomy exclusion criteria: * refusal of patient participation or inability to participate to the study * known allergic reaction to drugs included in the study design * contraindiations of performance of peripheral regional anesthesia * diabetes melitus or known neurological disorder * chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain * all male patients * all patients not speaking the greek language

Keywords: pain mastectomy pecs
study of aro-rage in healthy subjects

Conditions: Asthma

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of aro-rage injection in normal healthy volunteers.


Eligibility criteria:
inclusion criteria: * normal pulmonary function tests at screening prior to sputum induction * normal 12-lead electrocardiogram (ecg) at screening * non-smoking * able to produce an induced sputum sample at screening * participants of child-bearing potential (male and female) must use highly effective contraception and cannot donate sperm or eggs during the study or for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. women must have a negative pregnancy test and cannot be breastfeeding * willing to provide written informed consent and to comply with study requirements exclusion criteria: * acute lower respiratory infection within 30 days prior to first dose and/or acute upper respiratory infection within 7 days prior to first dose * positive covid-19 test during screening window * chronic or acute infection that is clinically significant or requires treatment with systemic antibiotics, antivirals, antifungals, or antiparasitics within 30 days prior to first dose * any history of chronic pulmonary disease * use of immunosuppressive medication within 90 days prior to first dose * receipt of any intranasal vaccine within 30 days prior to first dose * human immunodeficiency virus (hiv) infection, seropositive fo hepatitis b virus (hbv), seropositive for hepatitis c virus (hcv) * uncontrolled hypertension * use of illicit drugs * unwilling to limit alcohol consumption to within moderate limits for the duration of the study * use of an investigational agent or device within 30 days prior to first dose * prior use of any formulation of aro-rage note: additional inclusion/exclusion criteria may apply per protocol
remotely supervised exercise for adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a genetic disease characterized by abnormal chloride transport in epithelial tissues. inflammation is a key component contributing to the main alterations induced by the disease. the increase in life expectancy comes with a higher prevalence of cf-related comorbidities, but also with new emerging complications directly related to aging. physical fitness and exercise practice have been previously associated to survival and better quality of life in patients with cystic fibrosis. thus, the aim of this study is to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

this study aims to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.

Eligibility criteria:
inclusion criteria: * confirmed clinical and genetic diagnosis for cystic fibrosis; * age from 16 years. exclusion criteria: * musculoskeletal disorders that do not allow the performance of physical exercise; * pregnancy; * absence of registration of clinical required.

Keywords: cystic fibrosis exercise program lung funcion inflammation
flx475 in combination with ipilimumab in advanced melanoma

Conditions: Advanced Melanoma

Summary: this clinical trial is a phase 2, open-label study to determine the anti-tumor activity of flx475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-pd-1) or anti-programmed cell death ligand 1 (anti-pd-l1) agent. the study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of flx475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.


Eligibility criteria:
inclusion criteria: * stage iv or unresectable stage iii advanced melanoma * prior treatment with at least 2 months of anti-pd-(l)1 agent * measurable disease at baseline * tumor available for biopsy exclusion criteria: * history of allergy or severe hypersensitivity to biologic agents * history of grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy * prior treatment with ipilimumab or other (cytotoxic t-lymphocyte-associated antigen 4) ctla-4 antagonists

Keywords: neoplasms ipilimumab antineoplastic agents immunological
genetic factors of idiopathic polypoidal vasculopathies in the atm gene (ataxia telangiectasia mutated)

Conditions: Choroidal Neovascularization

Summary: polypoidal choriodal vasculopathy (pcv) is an ophthalmologic disease, characterized by vascular abnormalities of the walls of small choroidal vessels, reproducing the specific aspect of polyps (cluster aspect). pcv is one of the "boundary-forms" of age related macular degeneration. these vasculopathies can be idiopathic. following the radiotherapy treatments of active and occult-typed neovessels in age-related macular degeneration (armd), 10% of the patients would present typical polypoidal vasculopathic lesions. these polypoidal secondary lesions have been induced by radiotherapy treatment and may show an increased sensibility to radiation in these patients. such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in relation to the atm gene mutations. the secondary or idiopathic polypoidal vasculopathic lesions are to be brought closer to telangiectasias in ataxia telangiectasia. considering the iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it seems legitimate to search for predisposing variants to polypoidal vasculopathies in the atm gene. considering the frequency of pcv worldwide, it seems important to identify the predisposing genetic factors of the atm gene. these biomarkers to the pathology might enable us to offer prevention (reinforced protection against radiations, including light) and to develop therapeutics (recruitment of other kinases, atm's partners, in the stability and cellular control of dna).


Eligibility criteria:
inclusion criteria: * adult caucasian patient * polypoidal choriodal vasculopathy * informed written consent exclusion criteria: * history of cephalic radiotherapy * absence of affiliation to social security or universal health coverage (cmu)

Keywords: polypoidal choroidal vasculopathy
spyglass direct visualization system clinical registry in china

Conditions: Biliary Tract Diseases

Summary: to document indications for cholangioscopy and clinical utility of the spyglass direct visualization system in china when used per standard of practice. prospective, post market, multi-center, non-randomized study

patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ercp procedure immediately preceding the spyglass procedure will join this study, totally 500 patients across 16 sites throughout china will participate in study. after spyglass operation, all patients will be followed for 72 hours to observe adverse events, and patients with indeterminate stricture or undefined filling defect indication with tissue sampling not yielding histopathology positive for malignancy and unresolved device and/or procedure related sae at 72 hours will continue to be followed up until 6 months. finally, procedure success rate will be analyzed as primary endpoint, and saes and impact of patients management will be analyzed as secondary endpoint.

Eligibility criteria:
inclusion criteria: 1. age above 18 and not above 85. 2. willing and able to provide written informed consent to participate in the study. 3. willing and able to comply with the study procedures. 4. indicated for ercp and cholangioscopy or indicated for ercp with suspected need for cholangioscopy. exclusion criteria: 1. endoscopic techniques are contraindicated. 2. ercp is contraindicated 3. a medical condition that warrants the use of the device outside of the indication for use. 4. requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
optimized resistant starch in inflammatory bowel disease: the mend trial

Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: the purpose of the study is to determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf. * enrolled in the main parent study. * existing crohn's disease or ulcerative colitis diagnosis. * in clinical remission or with mild disease (wpcdai of 0-39.5 for cd; pucai of 0-30 for uc) with no changes in standard of care treatment for the previous month and without anticipated changes for the next month. * ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study. * willing to provide consent/assent for the collection of stool samples. exclusion criteria: * allergy to resistant starch or excipients. * co-existing diagnosis with diabetes mellitus. * treatment with another investigational drug or intervention throughout the study. * current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * inability or unwillingness of an individual or legal guardian to give written informed consent. * concomitant chronic disease requiring medications. * requirement for antibiotic therapy \>2 weeks duration. * participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the rapidaim evaluation following the initial stool sample collection. * patients with previous intestinal surgery.

Keywords: resistant starch microbiome
anastrozole and letrozole

Conditions: Breast Cancer

Summary: aromatase inhibitors (ai) are effective for secondary prevention of breast cancer and may soon replace tamoxifen as first-line therapy in the treatment of hormone-sensitive breast cancer. however, because these medications produce a marked reduction in serum estrogen levels, this is likely to result in an increased rate of bone loss and risk of developing osteoporosis and fractures in postmenopausal women treated with these agents. indeed, substantial bone loss has been reported in several large clinical trials of ais. osteoporosis drugs are available that could prevent this loss, but they have frequent side effects and are expensive. thus, treating all women receiving ais might not be the most appropriate and cost-effective approach. a better approach might be to select women at highest risk of bone loss and only treat them with antiresorptive agents. the proposed pilot study will evaluate women who receive anastrozole or letrozole therapy, are receiving adequate amounts of calcium and vitamin d and have baseline normal or moderately low bone mass in order to determine if early changes in bone turnover markers correlate with bone loss at one year. if data from this pilot protocol support our hypothesis, then we would propose a larger trial to confirm it. the ultimate aim is to predict which women are at higher risk of bone loss and therefore treat them earlier with bone-sparing agents, while those with lower risk could be monitored on conservative therapy.


Eligibility criteria:
inclusion criteria: * postmenopausal women with diagnosis of breast cancer - have not started arimidex or femara yet, but will be starting . exclusion criteria: * history of metastasis * history of chronic kidney * liver gi disease * disorders affecting calcium metabolism

Keywords: breast cancer arimidex femara bone health