Kornimate/medical-research-clean huggingface dataset:
personalized caries management versus standard of care for preventing incidence of caries in young egyptian adults

Conditions: Dental Caries

Summary: basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. for this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. this is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.

aim of the study: is to conduct an rct to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients hypothesis: this project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures primary objective: is to measure the incidence of new caries lesions

Eligibility criteria:
inclusion criteria: 1. high caries risk patients 2. 18-25 years 3. males or females 4. patients approving to participate in the study - exclusion criteria: * patients with systemic conditions * current periodontitis (sites of probing pocket depth ≥ 5 mm) * allergy to any of the ingredients of the study products * evidence of parafunctional habits * dysfunction of temporomandibular joint * use of antibiotics in the previous 30 days * patients with developmental dental anomalies * patients with removable prosthesis * patients with orthodontic appliance * periapical abscess or fistula and exposed pulps.

Keywords: caries, prevention, personalized medicine
aldara for the treatment of large and/or multiple sbcc

Conditions: Carcinoma, Basal Cell

Summary: bcc is the most common form of skin cancer. current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. the purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sbccs.


Eligibility criteria:
inclusion criteria: * one or more sbcc on torso, neck or face * total surface area \<= 40 sq cm exclusion criteria: * pregnancy or women who are breastfeeding * xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors * metatypical, adnexal, or sclerodermiform carcinomas * current or other previous malignant skin tumor (epidermoid carcinoma, melanoma) in the region of the current lesion * known hiv positive serology * skin tumor that is already or highly likely to become metastatic * presence of a clinically significant anomaly or illness (immunological, cardiovascular, pulmonary, hematological, neurological, hepatic, renal, endocrine, gastrointestinal, collagenous) * previous organ transplant history

Keywords: aldara, sbcc
ileal pouch-anal anastomosis registry

Conditions: Ileal Pouch-Anal Anastomosis

Summary: little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (ipaa). our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. retrospective studies concerning ipaa outcomes and will be conducted using these data.

in order to better understand the long-term outcomes following ipaa, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. establishing this registry will allow us to follow patients who have an ipaa and organize retrospective medical information into a meaningful system.

Eligibility criteria:
inclusion criteria: * diagnosed with one of the following: ulcerative colitis, crohn's disease, indeterminate colitis, familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, lynch syndrome i or ii, or gardners' syndrome * treated by a center for digestive disorders physician * scheduled for, or has undergone, ileal pouch-anal anastomosis procedure exclusion criteria: * patients who do not speak a language for which the irb has approved an informed consent form or short form * patients who are currently incarcerated

Keywords: ileal pouch anal anastomosis ipaa pull through ibd ulcerative colitis familial adenomatous polyposis fap hereditary nonpolyposis colorectal cancer hnpcc
allogeneic cart-33 for relapsed/refractory cd33+ aml

Conditions: Relapsed and/or Refractory CD33+ AML

Summary: the purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (cd33)-directed chimeric antigen receptor modified t cells (cart-33) infusions in patients with relapsed / refractory acute myeloid leukemia (aml).

the relapsed and/or refractory aml patients will receive infusions of allogeneic cart-33 within 1 week after chemotherapy. the re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (gvhd) prevention was conducted pre- and post- therapy.

Eligibility criteria:
inclusion criteria: * age ≥ 50 years * patient with relapsed and/or refractory cd33 positive acute myeloid leukemia (aml) * estimated life expectancy ≥ 12 weeks (according to investigator's judgment) * eastern cooperative oncology group (ecog) performance status ≤ 2 exclusion criteria: * previous treatment with investigational gene or cell therapy medicine products * cd33 negative leukemia * any uncontrolled active medical disorder that would preclude participation as outlined * pregnant or lactating women

Keywords: cart aml
survival outcomes and tumor molecular profile following bicalutamide neoadjuvant therapy

Conditions: Prostate Cancer

Summary: as clinical primary endpoints we assessed whether existed differences in: 1. psa recurrence rate stratified according to treatment modalities 2. egfr and her2/neu overexpression rate stratified according to treatment modalities 3. psa recurrence rate stratified according to egfr and her2/neu overexpression levels. as secondary clinical endpoints we assessed whether existed differences in: 1. prostate cancer-specific mortality according to treatment modalities 2. prostate cancer-specific mortality stratified according to egfr and her2/neu overexpression levels. for this purpose a post treatment psa-doubling time of less than 3 months found following psa recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality pre-clinical endpoints as pre-clinical endpoint we assessed whether exist differences in efficacy rate of bicalutamide and gefitinib treatment in primary tumor cultures stratified for high and low egfr and her2/neu expression levels. the evaluation of efficacy rate of these treatments was documented by comparing the differences of drugs ic50 values among the groups stratified for egfr and her2/neu levels.


Eligibility criteria:
inclusion criteria: * patients were eligible if they had histologically confirmed adenocarcinoma of the prostate and the following high-risk features: (1) clinical stage t3a disease with (2) gleason sum of 7 with a predominant component of 4 (i.e., gleason 4 + 3 = 7) or (4) gleason sum of 8, 9 or 10. exclusion criteria: * prior hormonal therapy, * prior radiation, * prior investigational agents, * prior malignancy within the last five years or had any other serious medical or psychiatric condition or illness that would not permit the patient to be managed according to the protocol were excluded.
the effects of two different orthosis on pain, hand strength and function in patients with thumb carpometacarpal osteoarthritis

Conditions: Osteoarthritis Thumb

Summary: the investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis

the investigators will randomized 60 patients with stage 1 or 2 thumb osteoarthritis in two groups. the investigators will prescribe a neoprene cmc orthosis for patients in group 1 and a thermoplastic cmc orthosis for patients in group 2. the investigators will recommend these orthosis for six weeks. they will assess pain and disability before and after the treatment.

Eligibility criteria:
inclusion criteria: * being aged between 18 and 70 * grade 1 or 2 thumb osteoarthritis exclusion criteria: * the other hand disorders such as fracture and carpal tunnel syndrome * previous hand surgery

Keywords: osteoarthritis thumb orthosis functioning
clinical trial of gene therapy for the treatment of leber congenital amaurosis (lca)

Conditions: Leber Congenital Amaurosis

Summary: a clinical trial of aav2/5 vector for patients with defects in rpe65

a dose escalation and dose expansion (phase i/ii) trial of adults and children with retinal dystrophy associated with defects in rpe65. atimp will be administered to one eye only in a single sub-retinal procedure

Eligibility criteria:
key inclusion criteria: * aged 3 years or older * early-onset severe retinal dystrophy consistent with rpe65 deficiency key exclusion criteria: * females who are pregnant or breastfeeding * have participated in another research study involving an investigational therapy for ocular disease within the last 6 months.
exercise in advanced parkinson's disease (pd) with deep brain stimulation (dbs)

Conditions: Parkinson Disease

Summary: this project is a 3-month prospective study assessing the immediate and long-term changes associated with aerobic exercise in quality-of-life measures, nonmotor scores, brief neuropsychological batteries, and local field potentials (lfps) in those with parkinson's disease (pd) who have undergone deep brain stimulation (dbs) surgery for management of their symptoms. in this study, the investigators will assess the feasibility of an aerobic exercise regimen in those with advanced pd and dbs, characterize the immediate and long-term changes in neuronal activity with exercise in pd, and assess the nonmotor impact of exercise in individuals with advanced pd and dbs. the investigators will recruit individuals who are not regular exercisers and develop an individualized 3-month exercise plan with the assistance of physical therapists, using heart rate targets for moderate exercise. outcomes will be measured at baseline and following 3-months of regular exercise. field potentials will be noted at baseline, during exercise every 2 weeks, and then a final baseline at the end of 3 months in on-medication and on-stimulation states. this will allow for characterization of field potential changes over time both during exercise as efficiency improves as well as impact on baseline neuronal activity in the resting state. this study is novel in that most aerobic exercise studies target early pd subjects and rarely include those who have undergone dbs surgery. the study will specifically focus on the feasibility of developing an aerobic exercise regimen in those with more advanced disease as well as gathering preliminary data on the impact it will have on motor and nonmotor features in this cohort. in addition to the clinical outcomes, investigators are now able to capture neuronal activity with novel fda-approved dbs technology, allowing us to non-invasively monitor real-time changes in the basal ganglia in those who have undergone dbs surgery. this study will also aim to characterize baseline neuronal activity in this cohort and monitor for changes that occur during exercise as well as determine if there is a change in baseline neuronal activity as exercise tolerance improves and with consistent, regular aerobic exercise.


Eligibility criteria:
inclusion criteria: * individuals with parkinson's disease * age \>18 * h\&y stage 1-3 in the medication on and stimulation on state * history of stn dbs * able to tolerate exercise from a cardiovascular, cognitive, and orthopedic perspective * not on beta-blockers, as we will be using heart rate-based targets * stable medication and stimulation for 60 days prior to baseline visit * access to exercise equipment exclusion criteria: * medical comorbidities that preclude safe exercise per the discretion of the principal investigator * regular exercisers
identification of breath biomarkers in head and neck squamous cell carcinoma

Conditions: Oral Cavity Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Summary: in this study the investigators aim to determine specific volatile compounds present in breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before and after tumour resection or before and after chemotherapy +/- radiotherapy using gas chromotography-mass spectrometry. the investigators hypothesize that study participants with a tumour will display a distinct set of volatile organic compounds than can serve as potential cancer biomarkers.

head and neck cancer diagnosis is devastating as it frequently disrupts one's ability to communicate, swallow and breathe. each year, physicians diagnose approximately 650,000 cases of head and neck cancer worldwide. many people with head and neck cancer have their cancer detected late, and this can result in a poor clinical outcome. one strategy to improve the clinical outcomes for people with a head and neck cancer is to develop a non-invasive screening assay using breath biomarkers. such a diagnostic tool will identify at-risk individuals early, and potentially offer improved and cost-effective treatment. the idea of using human breath samples to detect cancer began with the observation that dogs can be trained to "sniff out" certain types of cancers from urine and blood. since then the presence of various volatile organic compounds from many types of cancers, including: lung, skin, breast, prostate, and bladder have been characterized. these studies are ongoing, but promise to revolutionize the way physicians screen cancer in the future. in this pilot study, the investigators aim to determine specific volatile organic compounds present in breath samples of patients with oral cavity or oropharyngeal cancer before and after tumor resection, or before and after definitive chemotherapy/radiotherapy. as head and neck cancer can result in significant functional deficit, early detection is the key to improving clinical outcome. much anecdotal evidence exists for the presence of distinct odor emissions from the tumor bed of head and neck cancer patients. therefore, the identification of specific volatile organic compound to head and neck cancer will undoubtedly lead to a novel, cost-effective screening strategy for early detection of head and neck cancer.

Eligibility criteria:
inclusion criteria: * age 18-90 years * clinical diagnosis of oral cavity or oropharyngeal squamous cell carcinoma exclusion criteria: * evidence of metastatic disease * previous treatment of this cancer with surgery, chemotherapy or radiotherapy

Keywords: exhaled breath volatile organic compounds surgery chemotherapy radiotherapy
prevalence of delayed chemotherapy associated nausea

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: this study evaluates the prevalence of delayed chemotherapy induced nausea in adult oncology patients in real clinical practice of day clinics.

chemotherapies are rated to have a high to minimal emetogenic potential in oncology patients. their potential to induce delayed nausea is supposed to often be higher than their emetogenic potential. however, data on delayed chemotherapy-related nausea are scarce, which is problematic because nausea (a) has a large impact on patients quality of life and treatment decisions, (b) is often underestimated by health care professionals, (c) is less responsive to commonly used antiemetic medication, and (d) may even be different from rates that have been established in controlled clinical trials. therefore, the aim of this study is to assess the prevalence of delayed chemotherappy-induced nausea in adult oncology patients in dayclinics.

Eligibility criteria:
inclusion criteria: * first day of chemotherapy of a new cycle (any cycle) * speak and write german * sign the consent forms exclusion criteria: * cognitive or linguistic impairments that would significantly impede consent or participation (as assessed by the nurses in charge) * accompanying radiotherapy; * pre-existing nausea within three days before the start of the first chemotherapy in this cycle; and * prior participation in cinrate (each person participates only once)

Keywords: prevalence chemotherapy-induced nausea and vomiting oncology suportive care
pruritus in patients with chronic kidney disease

Conditions: Kidney Failure, Chronic; Pruritus

Summary: we believe that knowing characteristics of uremic pruritus is the foundation to investigate its pathophysiology and offer better skin care for patients with chronic kidney disease. we therefore conducted this cross-sectional study to evaluate the characteristics of uraemic pruritus.


Eligibility criteria:
inclusion criteria: * adults older than 20 years old, with ckd stage 3 to 5d, with symptoms of pruritus. exclusion criteria: * patients who refused to answer the questionnaire or unable to understand the contents of the questionnaire.
multiomics after cold pressor test of people who are unable to have headache

Conditions: Headache; Headache Disorders; Healthy

Summary: headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in europe. despite this high prevalence, there are persons who have never, in their whole life, encountered a headache. the aim of the study is to identify factors that protect against headache by studying multiomics in people who never have had a headache (headache resistant) versus non-resistant controls. the investigators will measure multiomic changes (transcriptomics and metabolomics) after pain induction by cold pressor test. 3 blood samples, two for rna and one for metabolites are taken 5 minutes before a cold pressor test and again 1 hour after the cold pressor test. the investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.


Eligibility criteria:
inclusion criteria: * headache resistant and non-resistant male participants from the danish blood donor study. * weight: 45 kg to 95 kg exclusion criteria: * daily consumption of any medication. * consumption of any medication less than 12 hours prior to the study day. * headache on the study day or 48 hours prior to the study day. * amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>100 mmhg) or hypotension (systolic blood pressure \<90 mmhg and/or diastolic blood pressure \<50 mmhg). * any severe cardiovascular disease, including cerebrovascular illness. * amnestic or clinical signs of current mental illness. * amnestic or clinical signs of current substance or drug abuse. * amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.
clinical evaluation of a daily wear frequent replacement silicone hydrogel lens

Conditions: Refractive Errors

Summary: the purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. subjects will be expected to attend 6 scheduled study visits. individual participation in the study will be approximately 3 months.

Eligibility criteria:
key inclusion criteria: * successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * manifest cylinder ≤ 0.75 diopter (d) in each eye. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * monovision contact lens wearers. * habitually wearing biofinity® lenses. * other protocol-specified exclusion criteria may apply.

Keywords: contact lens daily wear vision correction
lomustine in treating patients with stage iii or stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well lomustine works in treating patients with stage iii or stage iv non-small cell lung cancer.

objectives: primary * evaluate the response rate to lomustine in patients with stage iiib or iv non-small cell lung cancer with aberrant methylation of the mgmt gene. * determine whether the response rate in these patients is significantly greater than that of the historical control. secondary * collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival. tertiary * evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of mgmt gene. outline: this is a multicenter study. patients receive oral lomustine once on day 1. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed every 3 months. projected accrual: a total of 42 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell bronchogenic carcinoma, including the following histologic subtypes: * squamous cell * adenocarcinoma * adenosquamous * large cell anaplastic * bronchoalveolar * non-small cell carcinoma not otherwise specified (nos) * stage iiib disease (with a pleural effusion) or stage iv disease * stage iv patients with brain metastases are eligible provided the brain metastases are clinically stable after treatment with surgery and/or radiation therapy * tumors must test positive for aberrant methylation of the mgmt gene by methylation-specific polymerase chain reaction * bidimensionally measurable or evaluable disease patient characteristics: * ecog performance status 0-2 * no other active malignancies * wbc ≥ 4,000/mm\^3 or absolute neutrophil count ≥ 2,000/mm\^3 * platelet count ≥ 100,000/mm\^3 * total bilirubin normal * ast \< 5 times upper limit of normal * serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min * no uncontrolled serious active infection * not pregnant or nursing prior concurrent therapy: * see disease characteristics * more than 3 weeks since prior chemotherapy * no more than 2 prior chemotherapy regimens * no prior therapy with nitrosoureas * recovered from prior radiation therapy

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer large cell lung cancer recurrent non-small cell lung cancer squamous cell lung cancer