Kornimate/medical-research-clean huggingface dataset:
photodynamic therapy in treating patients with premalignant or early stage head and neck tumors

Conditions: Head and Neck Cancer; Precancerous Condition

Summary: rationale: photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. when the drug is active, tumor cells are killed. purpose: this randomized phase i trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.

objectives: primary * to evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions. secondary * to assess the efficacy of this regimen in these patients. outline: this is a dose-escalation study of photodynamic therapy. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later. * arm ii: patients receive aminolevulinic acid as in arm i and then undergo fractionated photodynamic therapy 4-6 hours later. after completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed diagnosis of 1 of the following within the past 3 months: * erythroplakia with dysplasia * severe dysplasia * carcinoma in situ of the head and neck for which standard therapy is not indicated, according to any of the following: * medical condition that precludes surgery * lesions that cannot be completely resected based on size or location * significant functional morbidity would be anticipated with further surgery * refused standard therapy after the treatment has been discussed and offered * no invasive squamous cell carcinoma of the head and neck patient characteristics: * ecog performance status of 0-2 * platelet count ≥ 100,000/mm\^3 * total bilirubin ≤ 2 times upper limit of normal (uln) * ast or alt ≤ 2 times uln * alkaline phosphatase ≤ 2 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior chronic liver disease or cirrhosis of the liver * no porphyria or hypersensitivity to porphyrins * no significant cardiovascular history that, in the opinion of a cardiologist, would deem the patient at risk for hypotension that may occur with oral administration of aminolevulinic acid (levulan®) * no prior adverse reaction to ondansetron or lorazepam prior concurrent therapy: * not specified

Keywords: precancerous condition stage 0 hypopharyngeal cancer stage 0 laryngeal cancer stage 0 lip and oral cavity cancer stage 0 nasopharyngeal cancer stage 0 oropharyngeal cancer stage 0 paranasal sinus and nasal cavity cancer
effect of curodont repair or placebo on the remineralisation in patients with class 5 carious lesions

Conditions: Dental Caries

Summary: the purpose of this study is to evaluate the therapeutic benefit of curodont repair for the treatment of early buccal carious lesions compared to placebo.

all study participants must have two early class v carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). one lesion will be treated with curodont repair and one with placebo as control (single application). 3 months later fluoride (duraphat) will be applied on both lesions. study duration is 9 months. for assessment visual and tactile evaluation, pictures, ecm, diagnodent pen, canary system, vas is used.

Eligibility criteria:
inclusion criteria: * two class v carious lesions which do not require an invasive treatment * size and form of the lesions: the lesions must both be fully visible and assessable and accessible * patients must be able and willing to observe good oral hygiene throughout the study -≥ 20 teeth * permanent dentition and ≤ 65 years * willing and able to attend the on-study visits * willing and able to understand all study-related procedures * written informed consent before participation in the study * negative pregnancy test for women of childbearing potential exclusion criteria: * the two study lesions must not be on adjacent teeth * no adjacent restoration on study tooth surface * fluoride varnish application \< 6 months prior to study treatment * patient suffers from diabetes * evidence of tooth erosion (due to excessive acidic drink consumption or reflux) * history of head and neck illnesses (e.g. head/neck cancer) * any pathology or concomitant medication affecting salivary flow or dry mouth * any metabolic disorders affecting bone turnover * concurrent participation in another clinical trial with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry * pregnant and lactating woman

Keywords: dental caries curodont repair p11-4
michigan men's diabetes project 2

Conditions: Diabetes Mellitus, Type 2

Summary: the michigan men's diabetes project 2 (mend 2) is an 18-month pilot randomized clinical trial. we are looking to recruit 60 black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. interested participants need to be under the care of a physician for their diabetes, have access to reliable transportation for study activities, and be willing to participate in 4 health assessments where they will get their a1c, blood pressure, height, and weight measured and they will complete a survey. all participants will receive 10 hours of diabetes self-management education with a certified diabetes care and education specialist. participants randomized to the intervention arm will also be offered 6 months of monthly diabetes self-management support (dsms) sessions with trained peer leaders who are also black men with type 2 diabetes. after the 6 months of support, this group will transition into 6 months of ongoing support where they can continue dsms and/or other diabetes related initiatives that are important to the group and chosen by the group. due to the covid-19 pandemic, dsme and dsms sessions will likely be held via zoom, ongoing support sessions have potential to be in person. the 4 health assessments will take place at baseline, 3-months, 9-months, and 15-months.


Eligibility criteria:
inclusion criteria: * black/african american males, age 21 years or older with diagnosis of t2d for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions. exclusion criteria: * we considered restricting eligibility to a higher-risk population of participants with a1c ≥ 8%. preliminary data suggest that over 50% of the proposed study sample will have an a1c ≥ 8%. focusing on all older black men with t2d allows us to cast a wide net for secondary prevention and public health impact.
a double blind randomized controlled of placebo and nebulized lidocaine for migraine headache

Conditions: Migraine Headache

Summary: migraine headaches have previously been shown to be responsive to intranasal lidocaine in a small study. using a nebulizer to administer the drug would improve the feasibility of using the treatment. it would also spare the patient narcotics with their attendant side effects. because of the potential for placebo effect a placebo control is necessary in this study.


Eligibility criteria:
inclusion criteria: * meets ihs criteria for migraine exclusion criteria: * pregnant * breast feeding * allergic to lidocaine * worst or first headache * abnormal neurological exam * substance abuse within 6 months * cardiac, liver or pulmonary disease * participation n another study within 30 days

Keywords: migraine lidocaine headache
effect of intradialytic blood flow restriction training on functional capacity, estimated glomerular filtration rate and health related quality of life in patients on hemodialysis

Conditions: Blood Flow Restriction Training; Glomerular Filtration Rate; Quality of Life; Hemodialysis

Summary: this study was done to investigate the effect of intradialytic blood flow restriction training on functional capacity, estimated glomerular filtration rate and health related quality of life in patients on hemodialysis

chronic kidney disease affects 10% to 15% of the population and is characterized by a progressive decline in glomerular filtration rate. the disease can lead to frailty, muscle mass wasting, and sarcopenia, affecting functional mobility and quality-of-life measures. the increased protein catabolism in chronic kidney disease is partly due to inflammatory status, nutrient loss during dialysis, and musculoskeletal system changes. assessment of muscle functionality can provide additional diagnostic and prognostic information for clinical outcomes, quality of life, and mortality rates. exercise training with blood flow restriction is a potential method for clinical musculoskeletal rehabilitation, potentially improving strength, physical function, blood pressure control, glucose homeostasis, autonomic function, renal deterioration, dialysis adequacy, and antioxidant defenses.

Eligibility criteria:
inclusion criteria: all patients were 1. both sex aged from forty to sixty years 2. stable chronic hemodialysis patient (\< 3 months) 3. participants will be deemed medically eligible by their treating physician before participation in the present study 4. free from any other disease could interfere with exercise exclusion criteria: 1. hemodynamic instability during hemodialysis over the last month 2. neurodegenerative diseases 3. autoimmune diseases (i.e., lupus erythematosus) 4. surgery within the past 3 months 5. severe arrhythmia, angina or cerebrovascular disease 6. unstable on dialysis 7. any musculoskeletal problem interfere with exercise
ncf gene & tnfsf4 in sle patients

Conditions: System; Lupus Erythematosus

Summary: the investigators objective is to identify the association of snp polymorphisms in the tnfs4, and ncf gene and sle egyptian patients.

systemic lupus erythematosus (sle) is a chronic autoimmune disease characterized by clinical heterogeneity with variable severity. among the sle patients, two may share the same clinical manifestations but have different phenotypes. this is why studies are searching for the different genes that might be associated with sle susceptibility. the neutrophil cytosolic factor (ncf) gene provide the instruction for the synthesis of group of proteins that form the nadph oxidase enzyme complex, that is critical for the induction of reactive oxygen species (ros) which in turn is important in the regulation of immune system. while the tumor necrosis factor superfamily 4 (tnfsf4) encodes the ligand for ox40 (ox40l), which delivers a strong costimulatory signal to activated effector t-cells and enhances both th1 and th2 responses when engaged with its receptor. therefore, increased levels of cell surface ox40l may augment b cell differentiation and proliferation. the consequence of which is that the resulting autoantibodies and immune complexes cause disease pathology in sle. so, ncf and tnfsf4 gene polymorphism are supposed to be associated with sle risk and pathophysiology.

Eligibility criteria:
inclusion criteria: * sle patients * patients older than 18 years old exclusion criteria: * patients with other connective tissue diseases * patients older than 70 years old

Keywords: tnfs4, ncf gene
npwt for abdominal incisions in diep reconstructions: a rct

Conditions: Breast Cancer; Surgical Site Infection; Wound Dehiscence

Summary: the current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (cinpt) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (diep) flap based reconstruction. patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.

the current study will examine the effect of closed incision negative pressure wound therapy on diep flap donor site. a total of 520 patients who are candidates for diep flap-based breast reconstruction will be included in this study, and randomly divided into the two groups. those with contraindications to cinpt will be excluded. the surgical consultation and procedure will be conducted same for both groups. patients will be followed by 30 days post-operatively. outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.

Eligibility criteria:
inclusion criteria: * patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy * patients going either unilateral or bilateral reconstruction exclusion criteria: * patients who are not candidates for diep flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. - * patients who have contraindications to the cinpt * patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study. * patients who do not want to carry an additional canister from the cinpt during the initial recovery phase will be excluded from the study.

Keywords: diep negative pressure wound therapy breast reconstruction
a prospective cohort of obinutuzumab and chlorambucil (gc) chemotherapy for the treatment of elderly patients with chronic lymphocytic leukemia including next- generation sequencing (ngs)-based assessment

Conditions: Chronic Lymphocytic Leukemia

Summary: this study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (gc) chemotherapy in treatment naïve cll, and prognostic impact of genetic alterations for cll using ngs.


Eligibility criteria:
inclusion criteria: * eligible subjects will be considered for inclusion in this study if they meet all of the following criteria: 1. newly diagnosed chronic lymphocytic leukemia 2. age≥ 70 years 3. satisfy the one of indications for starting treatment guideline 1. evidence of progressive marrow failure (anemia, thrombocytopenia) 2. aiha, thrombocytopenia refractory to steroids 3. massive (\>6cm, lcm) or symptomatic splenomegaly 4. massive nodes (\>10 cm) or symptomatic 5. progressive lymphocytosis 6. 50% increase over 2 months or ldt \< 6 months 7. constitutional symptoms : weight loss \> 10% in 6 months, significant fatigue, fever \>38 over 2 weeks, night sweat \> 1month 4. ecog performance status 0-2 5. total bilirubin ≤ 1.5 x uln (upper limit of normal) 6. aspartate aminotransferase (ast) ≤ 5 x uln, (alt) ≤ 5 x uln 7. creatinine ≤ 3.0 x uln 8. provide informed consent ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information exclusion criteria: 1. unmet ngs samples by bone marrow biopsy or peripheral bloods at diagnosis 2. hairy cell leukemia or prolymphocytic leukemia 3. uncontrolled infection 4. therapy history with combined chemotherapy or biologic therapy prior to registration 5. history of thromboembolic episodes ≤ 3 months prior to registration 6. active hepatitis b or c with uncontrolled disease 7. active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment 8. any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study 9. concurrent participation in another therapeutic clinical trial.
nhf in acute hypercapnic acute exacerbation of copd

Conditions: Safety of NHF in Acute Hypercapnic AECOPD

Summary: patients with aecopd and niv failure and in absence will be treated with nhf device. inclusion criteria are ph \ 45 mm hg. patients were treated if ph \>7,38 or refusal of therapy.


Eligibility criteria:
inclusion criteria: * ph \< 7,38 * hypercapnic aecopd exclusion criteria: * need of intubation
endoscopic sclerotherapy and/or ligation versus portacaval shunt for bleeding gastric varices

Conditions: Gastric Bleeding; Cirrhosis

Summary: in unselected cirrhotic patients with bleeding gastric varices to compare the influence on mortality rate, duration of life, control of bleeding, quality of life, and economic costs of treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.

background: in patients with cirrhosis, bleeding gastric varices (bgv) are associated with a high mortality rate, but have received much less investigation than bleeding esophageal varices. various therapeutic measures have been used to treat bgv, including endoscopic, radiographic, and surgical procedures, but there have been few prospective evaluations of therapy involving sizable groups of patients that have received acceptable follow-up. management of this serious disorder has been uncertain and often unsuccessful. herein is a prospective randomized controlled trial in unselected cirrhotic patients with bgv that compared the effectiveness of endoscopic therapy (et) and portacaval shunt (pcs) during follow-up for more than 5 years or until death. study design: 518 unselected patients with cirrhosis and bgv were randomized to et or pcs performed as an emergency in 220 and electively in 298. all patients received the same diagnostic workup, initial therapy, post-treatment therapy, and rigorous follow-up. one-, 5-, 10-, and 15-year follow-up rates were 100%, 97%, 97%, and 92%, respectively. et consisted of repetitive sessions of intravariceal injection sclerotherapy and/or variceal band ligation aimed at variceal obliteration. pcs consisted of a direct anastomosis, side to side in 95%. et and pcs were compared specifically with regard to control of bleeding, survival rate, and quality of life.

Eligibility criteria:
inclusion criteria: * all patients with upper gastrointestinal bleeding (blood in the upper gastrointestinal tract) of a magnitude that required 2 or more units of blood transfusion and entered the emergency room directly, or were referred from an area hospital, or developed bleeding while in the hospital, and were shown to have cirrhosis of the liver, and were shown by endoscopy to have bleeding gastric varices, absence of bleeding from esophageal varices, and absence of any other lesion that could reasonably account for the bleeding were included ("all comers"). exclusion criteria: * none

Keywords: bleeding gastric varices cirrhosis of the liver portacaval shunt endoscopic variceal sclerotherapy endoscopic variceal ligation bleeding gastric varices due to cirrhosis of the liver
a phase ii study of irinotecan, oxaliplatin, plus ts-1 in untreated metastatic gastric cancer

Conditions: Stomach Neoplasms

Summary: patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and s-1(80mg/m2/day) from day 1 to 14 every 3 weeks. patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. response assessement will be performed every 2 cycles of chemotherapy.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease 2. age ≥18 years 3. eastern cooperative oncology group (ecog) performance status 0-2 4. disease status must be that of measurable disease as defined by recist criteria:measurable lesions: lesions that can be accurately measured in at least one dimension by any of the following: - ct of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral ct- chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm 5. no prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant therapy is allowed if at least 12 months have elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study. however, prior oxaliplatin and/or irinotecan as adjuvant therapy are not allowed. 6. adequate major organ function including the following: hematopoietic function: anc ³ 1,500/mm3, platelet ³ 100,000/mm3hepatic function: serum bilirubin 1.5 mg/dl, ast/alt levels 2.5 x unl ( 5 x unl if liver metastases are present)renal function: serum creatinine unl 7. patients should sign a written informed consent before study entry exclusion criteria: 1. prior history of peripheral neuropathy 2. inadequate cardiovascular function:new york heart association class iii or iv heart diseaseunstable angina or myocardial infarction within the past 6 monthshistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality 3. serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy 4. other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix 5. psychiatric disorder that would preclude compliance 6. pregnant, nursing women or patients with reproductive potential without contraception 7. patients receiving a concomitant treatment with drugs interacting with s-1 such as flucytosine

Keywords: stomach neoplasms secondary combination chemotherapy s-1 irinotecan oxaliplatin