Kornimate/medical-research-clean huggingface dataset:
biomarkers in dna samples from patients with high-risk acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is studying biomarkers in dna samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.

objectives: * to perform pooled dna sequencing in 56 genes from the genomic dna of unaffected children and matched non-tumor and blast dna from patients with high-risk (hr) acute lymphoblastic leukemia (all) enrolled on cog hr all protocols. * to identify loci enriched for genetic variation between dna of unaffected children and dna of these patients. * to individually validate novel, putatively functional single nucleotide polymorphisms (snps) identified via pooled sequencing with another genotyping platform. * to correlate hr all with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation. outline: dna specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-b acute lymphoblastic leukemia by microarray and pcr assays. sequencing is performed on each of the 3 pcr pools of dna.

Eligibility criteria:
disease characteristics: * newly diagnosed with high-risk b-precursor acute lymphoblastic leukemia * matched patients non-tumor and blast dna samples * enrolled on cog-p9906 or cog-aall0232 protocols * cohort of random pediatric dna samples extracted from newborn infants' blood spots from the state of missouri patient characteristics: * newborn infants from the state of missouri prior concurrent therapy: * not specified

Keywords: b-cell adult acute lymphoblastic leukemia b-cell childhood acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia
role of dietary habits in efficacy of bariatric surgery - study c

Conditions: Bariatric Surgery; Sleeve Gastrectomy; Obesity

Summary: the purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.

the obesity epidemic is a major public health concern with a significant economic burden in the usa. bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. among different types of bariatric procedures, sleeve gastrectomy (sg) has become the most commonly performed in usa. while sg is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. the mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. therefore, the purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery. since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

Eligibility criteria:
inclusion criteria: * bariatric surgery (sleeve gastrectomy) patients exclusion criteria: * insulin-dependent diabetes * anemia * smoking * shift work within the past 1 year * drug or alcohol dependency * bipolar disorder * post traumatic stress disorder (ptsd)

Keywords: diet dietary habits weight changes
motivational interviewing to address freshman weight gain

Conditions: Motivational Interviewing

Summary: the purpose of the study is to determine the effect of motivational interviewing and e-health education on body composition and psychological outcomes. after baseline testing, participants will be randomly assigned to a motivational interviewing or e-health education group for a 10-week intervention. variables of interest include: body composition, physical activity, food consumption and self-determination theory constructs.


Eligibility criteria:
inclusion criteria: 1. classified as a college freshman and 18 years of age. 2. low risk for medical complications from exercise (as determined by physical activity readiness questionnaire (parq+). 3. neither currently engaging in exercise nor consistently exercising over the last three months (2 days per week or less). 4. be considered overweight based on bmi (bmi at or above 25) 5. not pregnant. exclusion criteria: * those that do not meet inclusion criteria.
the incidence of thyroid cancer in 4474 patients treated for hyperthyroidism or goiter

Conditions: Hyperthyreosis and Goiter; Thyroid Cancer

Summary: patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan before they are treated with radioiodine for their thyroid disease. because the investigators do not get a histologically/final diagnosis the investigators want to make sure, that the patients treated do not have a thyroid cancer when treated. the investigators have found that thyroid cancer is not overlooked.


Eligibility criteria:
inclusion criteria: * all patients treated with radioiodine
ropivacaine after sternotomy

Conditions: Postoperative Pain

Summary: continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (cabg) or heart valve surgery to diminish postoperative pain.

a multiporous catheter will be introduced into sternotomy wound to cabg or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. ropivacaine infusion will be administered during 48 postoperative hours. all patients receive patient controlled analgesia (pca) oxycodone after extubation in the pacu. all patients receive a standardized anesthesia during surgery.

Eligibility criteria:
inclusion criteria: * elective cabg or heart valve surgery patients exclusion criteria: * psychic disorders * sleep apnea syndrome * diabetes mellitus (insulin dependent) * obesity, body mass index (bmi) ≥ 35 * cardiac insufficiency, ejection fraction (ef) ≤ 30

Keywords: requirement of postoperative pain medication
phase i trial: 68ga-nodaga-e(c[rgdyk])2 positron emission tomography for imaging angiogenesis in primary and metastatic tumor lesions in humans

Conditions: Neuroendocrine Carcinoma; Breast Cancer; Ovarian Cancer

Summary: the primary objective of the trial is to test the new radio tracer 68ga-nodaga-e\[c(rgdyk)\]2 for pet imaging of angiogenesis. the tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment. this is a first-in-man study to test the radio tracer in cancer patients. safety, biodistribution and dosimetry will be evaluated by repeated pet imaging (10 minutes, 1 hour and 2 hours post injection).

the primary objective of the trial is to test the new radio tracer 68ga-nodaga-e\[c(rgdyk)\]2 for pet imaging of angiogenesis. the tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment. this is a first-in-man study to test the radio tracer in cancer patients. safety, biodistribution and dosimetry will be evaluated by repeated pet imaging (10 minutes, 1 hour and 2 hours post injection). the primary end points are safety, biodistribution and dosimetry of 68ga-nodaga-e\[c(rgdyk)\]2. in addition, the quantitative uptake of 68ga-nodaga-e\[c(rgdyk)\]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. the study will be monitored and evaluated in accordance with the principles of good clinical practice (gcp).

Eligibility criteria:
inclusion criteria: * diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer * capable of understanding and giving full informed consent exclusion criteria: * pregnancy * lactation * obesity (weight above 140 kg) * claustrophobia
arasertaconazole nitrate pessaries - dose finding study for the vulvovaginal candidiasis (vvc) treatment

Conditions: Vulvovaginal Candidiasis

Summary: in order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).


Eligibility criteria:
inclusion criteria: * women aged between 18 to 65 years of age who have signed the informed consent. * not pregnant, not nursing. * no indication of other vulvovaginitis or genital infections * positive 10% potassium hydroxide (koh) preparation for budding yeast and/or pseudohyphae. * negative wet mount results for t. vaginalis and clue cells. * exclusion criteria: * subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response. * hypersensitivity to imidazole products administered topically. * any other medical condition which in the opinion of the investigator could interfere with study conduct.

Keywords: vvc candidiasis vaginal candidiasis
effects of ginseng on stress, emotional and cognitive processing

Conditions: Stress

Summary: this study aims to confirm the positive effect of the red panax ginseng on the cognitive performance and regulation of stress and fatigue in adults with moderate stress level.

this study has been designed as a randomized double-blind placebo-controlled interventional study. one hundred and fifty participants (aged between 18 and 60), presenting a moderate level of perceived stress, were randomly allocated to the control (placebo) or test (ginseng supplement) group. participants will be supplemented during 3 weeks with those products. cognitive performance and emotional processing will be measured with tests and questionnaires before (baseline) and at the end (3 weeks) of the intervention. fasted blood glucose level will be measured in blood before (baseline) and at the end (3 weeks) of the intervention.

Eligibility criteria:
inclusion criteria: i.1. healthy woman or man, aged of 18 to 60 years (inclusive); i.2. with a moderate level of perceived stress (pss scores ranging from 14 to 26); i.3. provision of signed and dated informed consent form; i.4. stated willingness to comply with all study procedures and availability for the duration of the study; i.5. speaking french. exclusion criteria: e.1. subject with severe medical or cognitive problems which, in the opinion of the principal investigator, could interfere with the evaluation of the study criteria or with participant safety; e.2. subject with a coffee consumption of more than 5 cups per day; e.3. subject consuming drugs and/or with historical drug addiction (\<5 years); e.4. subject with alcohol consumption exceeding 3 glasses of wine per day, or two halves of a beer per day, or one glass of strong alcohol per day; e.5. subject undergoing medical treatment which, in the opinion of the principal investigator, could interfere with cognitive and emotional processing; e.6. subject with type 1 or type 2 diabetes; e.7. subject participating in another intervention trial; e.8. women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, iud, abstinence, ...).

Keywords: panax ginseng stress fatigue emotion processing
clinical study to assess safety and efficacy of a new armsleeve in the management of arm lymphoedema

Conditions: Lymphedema

Summary: the objective of the study is to assess the effect of a new armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with day-time usual lymphology hosiery.


Eligibility criteria:
inclusion criteria: * unilateral secondary upper limb lymphoedema of stage ii or iii, following breast cancer * patients hospitalized for an intensive phase of decongestive lymphoedema therapy (dlt) for whom a decrease of lymphoedema volume has been achieved during hospitalization * lymphoedema with evident pitting sign (assessed as ++ or +++) * requiring compression therapy for, at least, the next 3 months. * affected arm that fits with one of the 6 standard sizes of the auto-adjustable mobiderm® armsleeve provided. * signed informed consent prior to any study-mandated procedure. * not under any administrative or legal supervision. * covered by a health insurance system exclusion criteria: * stage i lymphoedema * active cellulitis * lymphoedema associated with active cancer needing acute chemotherapy * motor and sensitive neurological deficiency * post-operative oedema (i.e acute oedema following breast cancer-related surgery) * patient participating in any other clinical study * unlikely to be followed up to 3 months with clinical assessment
onabotulinumtoxina for trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: a randomized controlled trial comparing onabotulinumtoxin a to saline (placebo) for trigeminal neuralgia.

this study will offer onabotulinumtoxin a (botox) delivered intradermally into the region of pain for the patient with trigeminal neuralgia. should they derive benefit from the procedure (as determined by decrease in the frequency of attacks), then they will be randomized to receive either onabotulinumtoxin a or saline and followed for 3 months. this study hopes to provide strong data that this is a treatment option for patients with tn who have failed medications, but are not ready for or do not want to undergo surgery.

Eligibility criteria:
inclusion criteria: men and women age 18 or older * judged to be of legal competence * sufficient knowledge of written and spoken english * capable of attending regular in-person visits * have failed/not a candidate/do not want surgery * inadequate response to medication - at least 2 trials * meeting ichd criteria for classical trigeminal neuralgia 13.1.1.1 * patients with frequency \> 10 attacks per week * stable dose of medications in the last 2 weeks exclusion criteria: * secondary or idiopathic tn, or painful trigeminal neuropathy as defined by the ichd (13.1.1.2, 13.1.1.3, 13.1.2) * pregnant or breast feeding (while it is rare that a patient will be pregnant with tn, there is not sufficient data to say definitively that onabota is ok to use during pregnancy and nursing, it is still rated class c) * neuromuscular disease * on aminoglyocosides * not currently enrolled in any other studies

Keywords: botox injection trigeminal neuralgia
identifying optimal smoking cessation intervention components (cessation)

Conditions: Smoking; Smoking Cessation; Nicotine Dependence

Summary: the goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. this research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. the investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.


Eligibility criteria:
inclusion criteria: * 18 years of age or older; * report smoking at least 5 cigarettes per day for the previous 6 months; * able to read and write english; * agree to attend visits, to respond to coaching calls, and to respond to interactive voice response (ivr) phone prompts; * plans to remain in the intervention catchment area for at least 12 months; * currently interested in quitting smoking (defined as would like to try to quit in the next 30 days). * all women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study. exclusion criteria: * currently taking bupropion, wellbutrin, chantix or varenicline (current use of nrt is not exclusionary if the participant agrees to use only study medication for the duration of the study); * study candidate is pregnant, trying to get pregnant, or nursing. * a history of psychosis or bipolar disorder * a history of skin or allergic reactions while using a nicotine patch. * had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.

Keywords: smoking smoking cessation nicotine
probiotc lactobacillus crispatus-m247 (crispact®) supplementation in the sterilization of high-risk human papilloma (hpv-hr) viruses

Conditions: Human Papillomavirus Infection

Summary: there is growing scientific interest in probiotic supplementation as a possible therapy for clearing the human papillomavirus (hpv) infection and reducing the risk of developement of cervical cancer.

this is a multicenter, randomized, longitudinal, prospective, parallel-group, single-blind study aimed to investigate the efficacy of probiotic crispact® (which contains: 20 bld cfu/stick of lactobacillus crispatus m247) in clearance of human papillomavirus (hpv) infection in healthy female who tested positive for human papillomavirus (hpv) infection.

Eligibility criteria:
inclusion criteria: * women able to understand and agree to participation in the study and be able to provide written informed consent to the trial. * women aged 25-29 years who perform screening pap smears with the result: low- grade squamous intraepithelial lesion (lsil) or atypical squamous cells of undetermined significanc (ascus) (for which, as per the recommendation of the italian society of colposcopy and cervico-vaginal pathology (sicpcv)/italian group of cervical cancer. screening (gisci), no treatment is indicated but only follow-up with human papillomavirus (hpv) test at 12 months. * women aged 18-64 who independently perform a positive high risk sub-types of hpv (hr-hpv) test outside of screening even in the presence of a negative cytology (for whom, as per the recommendation of the sicpcv, no treatment is indicated but only follow-up with hpv test at 12 months). * women aged 30-64 years hpv hr positive with negative cytology or with positive cytology for ascus or lsil but negative colposcopy (absence of colposcopic lesion or positive colposcopy but subsequent negative biopsy) who do not require treatment (therefore as per the recommendation of the sicpcv go to follow-up with hpv testing at 12 months). exclusion criteria: * women who have been vaccinated for hpv. * patients who have undergone cervical treatments for preneoplastic pathology. * patients with high-grade squamous intraepithelial lesion (hsil) cytological result who on histological examination after biopsy need treatment according to the sicpcv 2019 recommendations. * hypersensitivity to one or more components of the product. * patients being treated with antibiotic, immunomodulatory and immunosuppressive therapies. * patients with immune system or neoplastic pathologies being treated with chemotherapy * patients who are pregnant, breastfeeding, or planning to become pregnant in the next 6 months.
impact of the covid-19 pandemic on surgery for thyroid cancer

Conditions: Thyroid Carcinoma

Summary: the impact of the covid-19 pandemic has heavily influenced routine medical care. in the first months of the pandemic, healthcare authorities restricted medical care to emergency procedures, postponing elective surgical activity. conversely, screening programmes and planned examinations have been temporarily suspended or delayed. gradually, elective surgery and clinical activities have resumed, thanks to the weakening of the pandemic, to a better organization of the healthcare systems and to the diffusion of covid-19 vaccines. in the present study, we aim to evaluate the impact of the covid-19 pandemic on surgery for thyroid carcinoma. particularly, we aim to investigate whether the delay in operations, screening programmes, and planned examinations for patients under follow-up after thyroid surgery have led to an increased number of aggressive tumours. to evaluate this aspect, we aim to compare the patients who had undergone thyroidectomy for thyroid cancer before the covid-19 pandemic (from february 2019 to february 2020), during the first phase of the pandemic (from march 2020 to september 2020), and after the first phase of the covid-19 pandemic (from october 2020 to october 2021).


Eligibility criteria:
inclusion criteria: * patients who have undergone thyroidectomy with preoperative diagnosis of thyroid cancer (cytological diagnosis, including bethesda iii, iv, iv or vi class, or high suspicion of thyroid carcinoma based on clinical and/or ultrasonographic features) during the study period (from february 2019 to october 2021) * patients who underwent reoperative neck surgery for local recurrence of thyroid carcinoma during the study period (from february 2019 to october 2021) exclusion criteria: * age \< 18 yo * incidental diagnosis of thyroid carcinoma
a phase 2b evaluation of daclatasvir/sofosbuvir in non-cirrhotic treatment naive subjects with genotype 1, 2, 3 and 4 chronic hepatitis c virus coinfected with human immunodeficiency virus (hiv-1)

Conditions: Hepatitis C

Summary: the purpose of the study is to determine if combination therapy with daclatasvir (dcv) and sofosbuvir (sof) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis c virus (hcv)/hiv-1 coinfection genotype (gt) 1, 2, 3, 4 patients.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * hcv rna \< 2000000 iu/ml * never taken medication for hcv * no liver cirrhosis * no advanced fibrosis * body mass index(bmi) 18-40 kg/m\^2 * genotype 1-4 exclusion criteria: * infection with hcv other than gt-1, 2, 3 or gt-4 or subjects with mixed infections of any genotype * evidence of decompensated liver * subjects infected with hiv 2 * hepatitis b virus (hbv) coinfection * liver cirrhosis * advanced fibrosis (f3-f4)