Kornimate/medical-research-clean huggingface dataset:
probiotic lgg for prevention of side effects in patients undergoing chemoradiation for gastrointestinal cancer

Conditions: Gastrointestinal Neoplasms

Summary: phase 3 placebo-controlled trial to determine efficacy of the probiotic lgg for reducing acute treatment related gi toxicity in patients with gi malignancy with phase 1 safety lead-in.


Eligibility criteria:
inclusion criteria: * current diagnosis of a gastrointestinal, abdominal, or pelvic cancer for which the use of continuous definitive or adjuvant external-beam rt to the abdomen or pelvis to a minimum dose of 4500 cgy is planned. * scheduled to receive concurrent administration of fluoropyrimidine chemotherapy (5-fu or capecitabine) during radiation therapy. * age ≥ 18 years. * life expectancy ≥ 6 months. * negative pregnancy test done ≤7 days prior to registration (for women of childbearing potential only). * the following laboratory values obtained ≤ 28 days prior to registration: * hemoglobin ≥ 9.0 g/dl * wbc ≥ 3,500 * absolute neutrophil count ≥ 1,500 * platelets ≥ 100,000 * ecog performance status (ps) of 0, 1, or 2. * willingness to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment. * ability to complete questionnaire(s) alone or with assistance. * ability to understand and willingness to sign informed consent. exclusion criteria: * previous bowel resection which, in the opinion of the investigator, would decrease the benefit of the probiotic. patients who have undergone recent bowel surgeries which would not decrease the benefit of the probiotic are eligible provided they are more than 30 days from surgery with no serious complications. * known allergy to a probiotic preparation. * any history of inflammatory bowel disease. * grade 3 or 4 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool ≤7 days prior to registration. * any medical condition that may interfere with ability to receive protocol treatment. * prior abdominal or pelvic rt. * use of probiotics ≤ 2 weeks prior to registration. * use of antibiotics ≤ 3 days prior to registration. * planned continuous antibiotic treatment during rt. * history of gastrointestinal or genitourinary obstruction or porphyria. * history of irritable bowel syndrome (ibs). * history of hypersensitivity to all of the following antibiotics: penicillin, erythromycin, clindamycin, and any fluoroquinolone.
a study of nivolumab in participants with hepatocellular carcinoma who are at high risk of recurrence after curative hepatic resection or ablation

Conditions: Hepatocellular Carcinoma; Liver Cancer

Summary: this study will investigate if nivolumab will improve recurrence-free survival (rfs) compared to placebo in participants with hcc who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence


Eligibility criteria:
inclusion criteria: * participants with a first diagnosis of hcc who have undergone a curative resection or ablation * participants are eligible to enroll if they have non-viral related-hcc, or if they have hbv-hcc, or hcv-hcc * child-pugh score 5 or 6 * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc * any evidence of tumor metastasis or co-existing malignant disease * participants previously receiving any prior therapy for hcc, including loco-regional therapies * participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation * participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[mmr\]). other protocol defined inclusion/exclusion criteria apply
microbiota of the respiratory flora in children with cystic fibrosis during the first year of life

Conditions: Cystic Fibrosis

Summary: the goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (cf). another goal is to determine when cf patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with cf. ten subjects will be recruited into the study. throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. this study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.


Eligibility criteria:
inclusion criteria: * male and female subjects, newborn to age 3 months * have a diagnosis of cystic fibrosis (diagnosis of cf will be based on either a positive sweat chloride of \>60 meq/l or the identification of two detectable mutations associated with cf * parent/guardian plans to have follow-up care for approximately one year at designated cf clinic * parent/guardian provides informed consent to participate in the study exclusion criteria: * contraindications for obtaining oropharyngeal swabs

Keywords: cystic fibrosis microbiota upper respiratory tract 16s rrna sequence analysis staphylococcus aureus pseudomonas aeruginosa burkholderia cepacia haemophilus influenzae streptococcus pneumoniae
topical application of imiquimod gel at different concentrations in actinic cheilitis

Conditions: Actinic Cheilitis

Summary: actinic cheilitis is a potentially malignant lesion on the lower lip, which can progress to more serious illnesses such as cancer if not treated. usually treatment of this condition is only based on clinical appearance, but there is no established cure treatment. topical imiquimod is a medicine indicated for the treatment of skin diseases, but it has not yet been proven to treat actinic cheilitis. in this research, the investigator's aim is to evaluate the response to actinic cheilitis treatment with the current standard treatment compared to high and low concentration imiquimod topical formulations.

three formulations are used in this research: imiquimod 5%, imiquimod 0.05% e imiquimod nanoencapsulated 0.05%. nanoencapsulation is a process that concentrates the drug into a capsule not visible to the naked eye, allowing it to penetrate skin more easily and will only release the drug at the lesion site. the drug is presented in a free form inside the gel in the others formulations.

Eligibility criteria:
inclusion criteria: * individuals with clinical and histopathological diagnosis of actinic cheilitis; * no previous lip treatment with imiquimod. exclusion criteria: * present lesions suspected of squamous cell carcinoma of the lip. * previous history of lip cancer treatment. * prior treatment other than standard treatment. * history of allergic reactions to imiquimod or any other component of the formulas.

Keywords: imiquimod nanoencapsulation
allergy testing of soldiers prepared for international mission

Conditions: Adult Military Personnel

Summary: the goal of this prospective mono centric study is to identify relevant commercially available allergen extracts for allergy testing in soldiers prepared for international mission. participants will receive a skin prick test with the skin prick automated test device including 22 allergens and 2 controls on both forearms.


Eligibility criteria:
inclusion criteria: * adult military personnel (18-65y) will be included. soldiers with and without previous exposure to allergens in the regions of interest will be included. soldiers who are performing desk tasks and not selected for international missions will serve as controls. exclusion criteria: * skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment * use of antihistaminic medication \< 7 days before the start of the study * use of tricyclic antidepressants (antihistamine activity) \< 7 days before the start of the study * use of topical corticoids on the forearm \< 7 days before the start of the study * use of omalizumab \< 6 months before the start of the study * pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery).
application of the health action process approach model program to patients with heart attacks

Conditions: Heart Attack Patients

Summary: this research is conducted to determine whether the nurse-led health action process approach model-based cardiac rehabilitation program is effective in patients with myocardial infarction. the population of the study will consist of coronary angiography patients with myocardial infarction in the cardiology service of a state hospital. in this study, which is planned as a randomized controlled experimental model, 35 intervention and 35 control groups will be studied. as data collection tools; patient identification form, laboratory investigations monitoring form, perceived stress scale, health action process approach based participant assessment form, health action process approach based myocardial infarction risk factors participant assessment form functional capacity assessment form, myocardial infarction dimensional assessment scale and turkish modified morisky scale will be used. health action process approach modeled cardiac rehabilitation program will be applied to the intervention group and no intervention will be applied to the control group. data will be collected with data collection tools at 6, 12, 24 weeks. spss 25.0 (stastical package for social science) package program will be used for statistical analysis of the data. descriptive statistics will be given as number, percentage, mean, standard deviation and median values. the normal distribution of the data of numerical variables will be evaluated by shapiro wilk test. two group comparisons will be made with independent two sample t-test for normally distributed variables and with mann-whitney u test for variables that do not show normal distribution. comparisons of the groups' pre-test, week 6, week 18 and week 24 scale scores will be made with two-way analysis of variance in repeated measures from general linear models.


Eligibility criteria:
inclusion criteria: * to be between 18-70 years old, * becoming literate, * living in the city center * having had a heart attack within the last month, * not having had a heart attack before, * dyspnea less than 4-5 degrees according to the modified borg scale * no deformity or diagnosis related to the musculoskeletal system that may prevent physical activity, no orthopedic limitation * stable new york heart association (nhya) functional class i or ii coronary artery disease with myocardial infarction exclusion criteria: those with communication disabilities such as speech, vision, hearing * dyspnea score of more than 4-5 degrees according to the modified borg scale * those who stayed in intensive care for a long time after mi * complications related to treatment and interventions after mi * those who underwent surgical treatment after mi, * those with chronic diseases (chronic obstructive pulmonary disease, chronic renal failure, hypertension, diabetes, pulmonary emphysema, rheumatic valve disease, cancer diagnosis, etc.) * those who indicated that they would not participate in intervention programs due to time constraints. * failure of the six-minute walk test
evaluation of the efficacy of intralesional injection of combined digoxin and furosemide versus 5 - fluorouracil in treatment of plantar warts

Conditions: Plantar Wart

Summary: warts are common skin infections caused by human papillomavirus (hpv), which can cause a variety of skin presentations according to its type, site and the immune status .nongenital warts may be presented as common, plane, plantar, filiform, or mucosal warts .most people are affected by cutaneous warts, either plantar warts or common warts .prevalence of skin warts is between 3% and 13% and plantar warts are about 30% of skin warts in western world .majority of cases occur in adolescent and young adults


Eligibility criteria:
inclusion criteria: * age:\>18 years . * sex: both males and females will be included. * confirmed diagnosis by clinical and dermoscopic examination of plantar warts will be made exclusion criteria: * patients with history or evidenced hypersensitivity to any component used in this study. * pregnancy \& lactating. * patients who receive immune suppressive therapy. * patients who receive any wart treatment during the last 2 months before enrollment in the study. * patients with systemic illness especially cardiac patients. * patients who refused participation in the study
efficacy on helicobacter pylori eradication with two antibiotic regimens

Conditions: Helicobacter Infections

Summary: clinical trial to compare efficacy on eradicating helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.

in patients with documented infection with helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.

Eligibility criteria:
inclusion criteria: * helicobacter pylori infection in biopsy * eradication required exclusion criteria: * antibiotic received two weeks prior * previous treatment for h pylori infection * allergy to any of the treatment drugs * smoking \> 5 cigarettes daily.

Keywords: sequential therapy triple therapy eradication
study of cr011-vcmmae to treat locally advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the safety and tolerability of cr011-vcmmae in patients with locally advanced and metastatic breast cancer. cr011-vcmmae will be administered intravenously (iv) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (mtd) in breast cancer patients. once the mtd is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the phase ii portion of the trial to further evaluate the safety and efficacy of cr011-vcmmae.


Eligibility criteria:
main inclusion criteria: * females with confirmed breast cancer * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status 0 to 2 * locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows: * at least one regimen must have been for locally advanced or metastatic disease * subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents * hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens * subjects with her2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab * documented progressive disease within 6 months of the last regimen * adequate bone marrow, renal and liver function * signed informed consent main exclusion criteria: * chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start * neuropathy \> nci-ctcae grade 1 * active brain metastases. * new york heart association class iii or iv heart disease * unstable angina * uncontrolled arrhythmia * a marked baseline prolongation of qt/qtc interval * pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception

Keywords: cr011-vcmmae locally advanced breast cancer metastatic breast cancer breast cancer curagen
new multiplex real-time pcr for genital ulcer disease

Conditions: Genital Ulcer Disease (GUD)

Summary: (i) to compare a new diagnostic pcr with established diagnostic procedures for t. pallidum (serology, dark field microscopy), h. ducreyi (cultivation), hsv types 1 and 2 (cultivation, pcr). (ii) to assess the frequency of infections with t. pallidum, h. ducreyi and hsv types 1 and 2 in patients with genital, anal and oropharyngeal ulcers by a new pcr.


Eligibility criteria:
inclusion criteria: * patient with genital, anal or oropharyngeal ulcers * age minimum of 18 years. * informed consent must be obtained from each patient/control patient in written form prior to any study procedure. exclusion criteria: * antibiotic therapy within 2 weeks before the visit
the effects of written emotional disclosure on eating disorder pathology in a clinical eating disordered population

Conditions: Anorexia Nervosa; Bulimia Nervosa; Eating Disorder

Summary: a technique that has been found to be effective at relieving the physical and psychological symptoms associated with inhibiting emotions and emotional thoughts is written emotional disclosure. the goal of this study is to evaluate the effectiveness of written emotional disclosure on the remediation of eating disorder behaviour, cognitions, and management of emotions.

new partial program participants complete a packet of questionnaires during their initial appointment, which will be used as baseline levels of eating disorder symptoms and psychological health. participants will complete the writing as part of their eating disorder therapy. the writing will be completed individually. the writing will consist of continuous writing for fifteen minutes on three consecutive days. the experimental group will write about traumatic or stressful experiences, while the control group will objectively describe events. a post-writing packet of questionnaires will be completed one week after completing the writing. a follow-up evaluation will occur four-weeks after completion of the post-writing packet and will include completing a packet of questionnaires and debriefing.

Eligibility criteria:
inclusion criteria: * willing to sign consent form exclusion criteria: * unwilling to sign consent form

Keywords: anorexia bulimia eating disorder not otherwise specified
clinical features and outcome in patients with osseomuscular type of wilson's disease

Conditions: Clinical Features and Outcome

Summary: the investigators aimed to observe the clinical features and outcome in patients with osseomuscular type of wilson's disease from a large cohort during long-term follow-up


Eligibility criteria:
inclusion criteria: * genetically diagnosed wd patients exclusion criteria: * deny follow-up
incidence of diabetes and metabolic disorders after tips in cirrhotic patients

Conditions: Cirrhosis Portal

Summary: decompensated cirrhosis is associated with sarcopenia. tips is an efficient treatment of portal hypertension. based on our retrospective data, tips induces in 30% of cirrhotic patients metabolic disorders associated with diabetes or pre-diabetes. the main objective is to measure the cumulative incidence of diabetes and pre-diabetes 6 months after tips insertion.

based on our retrospective data, we expect that one-third of cirrhotic patients develop glucose dysregulation after tips. a better knowledge of the metabolic disorders related to the tips could allow to prevent the deleterious effects of the tips on the disease (decrease of the insulin-sensitivity, fat gain ...), by simple interventions on diet or physical activity. we will assess the incidence of diabetes and pre-diabetes, and the influence of tips on nutritional status and sarcopenia. patients will be follow-up 6 months after tips. we will explore the hormonal mechanisms that explain these changes.

Eligibility criteria:
inclusion criteria: * patient cirrhosis and portal hypertension justifying a treatment with tips * written consent. exclusion criteria: * contraindication for tips * indications of tips in emergency or as part of the preparation for a surgical procedure, * hepatocellular carcinoma outside milan criteria or cancer at a palliative stage, * a contra-indication to the realization of an ogtt, * a hyperglycemic treatment (corticosteroids, somatostatin, etc.), * hemoglobin \<7 g / dl, * patients who have had a liver transplant, * those for whom the follow-up is considered impossible or the vital prognosis is engaged in the short term, * pregnant or lactating women, * those unable to receive enlightened information, * those participating in interventional research * and finally the persons placed under safeguard of justice, tutelage or curatorship.
evaluation of onyx in endovascular treatment of cerebral avms

Conditions: Cerebral Arteriovenous Malformations

Summary: to assess safety and efficacy of onyx treatment for cavm:

the main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at: * 12 months post last embolization in case of treatment with embolization only * 12 months after additional treatment with neurosurgery * 36 months after additional treatment with radiosurgery

Eligibility criteria:
inclusion criteria: * the patient presents a cerebral avm (not already treated) that can be treated by embolization with onyx whether or not associated with a cyanoacrylate based adhesive, * the patient is at least 6 years old. exclusion criteria: * during the treatment period for his/her cerebral avm, the patient participates in a study assessing another medical device, another procedure or a drug. * the patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. for patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented. * any condition that could prevent follow-up of the patient.

Keywords: cerebral arteriovenous malformations cavm onyx