Kornimate/medical-research-clean huggingface dataset:
single and two-visit pulpectomy in primary molars

Conditions: Dental Pulp Necroses

Summary: a total of 64 primary molars of 5-8 years old children will be randomly selected from pediatric dental clinic at faculty of dentistry, mansoura university. children will have two bilateral carious primary molars indicated for pulpectomy ; one side will be treated in one visit and the other will be treated in two visits. clinical and radiographic evaluation for 3 , 6, 12 months

all the pulpectomy steps will be carried out by a single operator. after confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam. caries will be removed by sterile round diamond burs. proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. the working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. then, root canal system will be dried by sterile paper points. in case of single visit pulpectomy (21): root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown. in case of two visit pulpectomy (13): first, root canals will be filled by calcium hydroxide powder mixed with saline followed by temporary coronal restoration and left for 7 days. in the second visit, calcium hydroxide will be removed from the canals using k -files then irrigated by naocl 2.5%. the canals will be dried by sterile paper points before obturation and final restoration as mentioned in single- visit treatment protocol. a postoperative periapical x-ray film will be taken for future review. clinical and radiographic follow up will be carried out after 3, 6, 12 months respectively.

Eligibility criteria:
inclusion criteria: * cooperative 5-8 years old children with no systemic diseases or chronic conditions. _every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure. exclusion criteria: * children received antibiotics in the past month before the study. primary molars with sinus tract, abscess, or facial cellulitis. primary molas with root resorption exceeding one third of root length

Keywords: pulpectomy, single visit, two visits
study of peginterferon alfa-2a, ribavirin, and daclatasvir (bms-790052) with or without bms-650032 for participants in some hepatitis c virus trials

Conditions: Hepatitis C Virus Infection

Summary: the purpose of this study is to provide anti-hepatitis c virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior bristol-myers squibb (bms) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. approximately 100 genotype 1b patients who received placebo in bms study nct01428063 (ai447-028) will receive active drugs in this study.

* intervention model: * parallel: for all patients entering the trial * cross-over: for genotype 1b patients rolling over from nct01428063 (ai447-028) who require rescue therapy after initial treatment in this study * peginterferon alfa-2a * ribavirin * daclatasvir * asunaprevir

Eligibility criteria:
key inclusion criteria: * prior participation in any bms-790052, bms-650032, or bms-791325 trial and assigned to control arm (pegifnα-2a/ribavirin + placebo) during the trial * hepatitis c virus (hcv) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted) * hcv rna viral load detectable key exclusion criteria: * discontinuation from a prior bms hcv clinical trial due to a pegifnα-2a/ribavirin-related event * any anti-hcv therapy following initial treatment with bms-650032, bms-790052, or bms-791325 * positive for hepatitis b infection (hepatitis b surface antigen) or hiv-1 or hiv-2 antibody at screening * evidence of medical condition associated with chronic liver disease other than hcv infection * evidence of decompensated cirrhosis based on radiologic criteria or biopsy
tpc vs. gp induced chemotherapy combined with nimotuzumab and toripalimab in the treatment of locally advanced nasopharyngeal carcinoma

Conditions: High Risk Locally Advanced Nasopharyngeal Carcinoma

Summary: we expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (tpc vs. gp) with combination therapy of nivolumab and triprolizumab.


Eligibility criteria:
inclusion criteria: 1. age range: 18-65 years old; 2. diagnosed with nasopharyngeal carcinoma through histopathology or cytology; 3. advanced nasopharyngeal carcinoma, ajcc 8th standard stage iii-iva, excluding t3-4n0/t3n1; 4. ecog score is 0-1; 5. sufficient organ or bone marrow function: 6. sign a written informed consent form exclusion criteria: 1. diagnosed with other malignant tumors within 5 years prior to the first administration, excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ. 2. symptomatic congestive heart failure, with echocardiogram indicating a left ventricular ejection fraction (lvef)\<50%. 3. individuals infected with acute or chronic active hepatitis b or c, with hepatitis b virus (hbv) dna\>2000iu/ml or 10\^4 copies/ml; hepatitis c virus (hcv) rna\>10\^3 copies/ml; hepatitis b surface antigen (hbsag) and anti hcv antibody were positive at the same time. after nucleotide antiviral treatment, if the score is lower than the above standard, it can be included in the group. 4. past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases. 5. individuals with active pulmonary tuberculosis (tb) who are currently receiving anti tuberculosis treatment or have received anti tuberculosis treatment within one year prior to their first dose. 6. human immunodeficiency virus (hiv) infected individuals (hiv 1/2 antibody positive), known syphilis infections requiring treatment. 7. severe infections that are active or poorly controlled clinically. within 4 weeks prior to the first administration, there was a severe infection, including but not limited to hospitalization due to infection, bacteremia, or complications of severe pneumonia. 8. an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to the first administration. allow the use of alternative therapies such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency. known history of primary immunodeficiency. only patients with positive autoimmune antibodies need to confirm the presence of autoimmune diseases based on the researcher's judgment. 9. pregnant or lactating female patients. 10. has received radiotherapy, chemotherapy, or surgical treatment for nasopharyngeal and neck lesions (excluding biopsy). 11. history of allergies to the drugs and their components used in this study
trial comparing iron supplementation versus routine iron intake in very low birth weight infants

Conditions: Iron Deficiency Anemia

Summary: in preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?

fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.

Eligibility criteria:
inclusion criteria: * birth weight \<1500 grams * tolerating iron fortified preterm formula or fortified human milk at 120cc/kg/day by 8 weeks of age * \</= 32 weeks adjusted post-menstrual age at the time of enrollment exclusion criteria: * cyanotic heart disease * bowel resection prior to enrollment

Keywords: very low birth weight infants anemia iron supplementation
metabolic and cognitive parameters following partial sleep deprivation

Conditions: Sleep Deprivation; Sleep

Summary: the purpose of this study is to determine whether partial sleep deprivation, as compared with normal sleep, influences certain metabolic and cognitive parameters, related to food intake, hunger and memory functions, when participants are shielded from external time cues.

it is predicted that partial sleep deprivation negatively affects the hormonal status, e.g. upregulating ghrelin and other hunger-promoting hunger hormones, while showing impaired memory functions. it is also predicted that participants will tend to increase their desired portion sizes after partial sleep deprivation, compared with after a normal night's sleep.

Eligibility criteria:
inclusion criteria: * male * age 20-28y * healthy (self-reported) and not on medication * non-smoking * normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported and verified by sleep diaries) * normal dietary habits (regular meal pattern with daily breakfast) exclusion criteria: * major illness * taking any serious medications * any sleep conditions (e.g. irregular bedtimes, sleep complaints) * any dietary issues with the food items provided * a history of endocrine, neurological or psychiatric disorders * shift work in the previous 3 months * travel over several time zones within the previous two months
mitomycin as a hyperthermic peritoneal perfusion in treating patients with malignant ascites

Conditions: Metastatic Cancer

Summary: rationale: hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells. purpose: this phase ii trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.

objectives: primary * determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin c in preventing relapse at 4 weeks post-treatment in patients with malignant ascites. secondary * determine any improvement in the quality of life of patients treated with this procedure. outline: this is a nonrandomized study. patients undergo laparoscopic surgery to remove ascitic fluid and any intraabdominal adhesions and to place 2 inflow and 2 outflow catheters. mitomycin c is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes. quality of life is assessed at study entry and at 4 weeks. after completion of study treatment, patients are followed periodically for 2 years.

Eligibility criteria:
inclusion criteria: * diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or ct scan * not eligible for cytoreductive surgery based on any of the following criteria: * metastases outside peritoneal cavity * poor performance status * unresectable peritoneal disease * must have undergone at least 1 prior paracentesis procedure * no ascites caused by any of the following conditions: * cardiac failure * nephrotic syndrome * pancreatic ascites * chylous ascites * eastern cooperative oncology group (ecog) performance status 0-3 * wbc ≥ 3,000/mm\^3 * platelet count ≥ 70,000/mm\^3 * bilirubin ≤ 2.0 mg/dl * creatinine ≤ 1.5 mg/dl * not pregnant or nursing * negative pregnancy test exclusion criteria: * prior peritoneal chemotherapy * dense intraabdominal adhesions limiting laparoscopy

Keywords: malignant ascites
copmere between bleaching and laminate veneers

Conditions: Discoloration, Tooth

Summary: the present study is aimed to evaluation of shade for clinical color change of discolored teeth treated by bleaching vs laminate veneers.

dental aesthetics, including tooth color, is of great importance for majority of the people and any discoloration or staining can affect their quality of life negatively1,2. in the uk it has been reported that 28% of grownups are dissatisfied with the appearance of their teeth and in the usa that 34% of grownups population are dissatisfied with their current tooth color. moreover, in a survey of 3215 subjects from the uk 50% have admitted that they had some kind of tooth discoloration3,4. tooth bleaching has become one of the most popular aesthetic dental treatments. because tooth bleaching is an effective, non-invasive procedure for the change of tooth discoloration, it is the best of treatment options for improving teeth color 5. ceramic restorations with excellent biocompatibility are widely used to achieve highly aesthetic characteristics in ﬁxed prosthodontics6. porcelain laminate veneers have become a popular method of treated tooth discoloration. but are expensive, brittle and difficult to repair7.

Eligibility criteria:
inclusion criteria: * patients included in this clinical trial : * men and women between 15and 40 years of age. * had good general and oral health. * the participants needed to have six vital maxillary or mandibular anterior teeth without caries lesions or restorations. * the maxillary canine was shade a3 or darker as judged by comparison with a shade guide (vita classical shade guide or spectrophotometer measurement ). exclusion criteria: * participants were excluded from the study * if they presented with anterior restorations; had bruxism habits. * were pregnant/lactating; presented with non vital tooth discoloration. * were taking any drug with anti-inflammatory, analgesic, or antioxidant effect; or presented with recession and dentin exposure

Keywords: bleaching agent
99mtc-hfapi spect/ct in pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: this prospective study will investigate the potential usefulness of 99mtc labeled fapi spect/ct in the diagnosis, treatment response assessment, and follow-up of pulmonary fibrosis.

idiopathic pulmonary fibrosis refers to a specific form of chronic fibrous interstitial pneumonia that occurs spontaneously, limited to the lung, and shows features of usual interstitial pneumonia on high resolution computed tomography and histological examination. radionuclide labeled fapi has been developed as a new tracer for tumor and inflammatory lesions imaging. recent studies have shown that fapi pet/ct imaging is a promising new imaging method for pulmonary fibrosis. hfapi is obtained by conjugating 99mtc-chelator moiety (6-hydrazinonicotinamide, hynic) with fap targeting moiety. the aim of this study is to investigate the location and extent of 99mtc labeled fapi tracer (99mtc-hfapi) in normal and fibrotic lung tissue of patients with pulmonary fibrosis, and to explore the clinical significance of 99mtc-hfapi spect/ct in the diagnosis, treatment response evaluation and follow-up of pulmonary fibrosis.

Eligibility criteria:
inclusion criteria: * suspected or confirmed pulmonary fibrosis patients; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against fapi * any medical conditions that are considered by the investigator to be likely to seriously interfere with study compliance
a study to observe how adolescent patients with severe atopic dermatitis despite less extensive skin lesions (eczema area and severity index score < 16) respond to dupilumab treatment

Conditions: Dermatitis Atopic

Summary: in adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (ad) signs and symptoms, with a good safety profile. in these clinical trials, only patients with eczema area and severity index (easi) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. further data about the effectiveness of dupilumab in adolescent participants with moderate to mild easi score and severe itching and/or localized ad are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations. this is an italian multicenter, 52-week observational (non-interventional) study which will collect data on the characteristics of adolescent (aged 12 to 17 years) participants who suffer from severe ad with easi score less than (\<) 16, eligible for systemic dupilumab treatment according to italian reimbursement criteria. it will study the real-world effectiveness and safety of dupilumab in this population, the effect of dupilumab on itching (pruritus), sleep, quality of life and related outcomes, localized ad in sensitive/visible areas, and on coexisting atopic conditions in adolescent participants who receive dupilumab for ad. it will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants.

the individual observational period is planned to be up to 52 weeks.

Eligibility criteria:
inclusion criteria: * male or female, aged between 12 and 17 years at the baseline visit * patients with ad who have been prescribed dupilumab according to agenzia italiana del farmaco (aifa) reimbursement criteria and fulfilling the following criteria: patients with easi\<16 and 1. children's dermatology life quality index (cdlqi) ≥ 10 or 2. peak pruritus numerical rating scale (pp-nrs) ≥ 7 or 3. localization in visible or sensitive areas (head/neck/hands or genitals) * patients able to understand and complete study-related questionnaires * provided signed informed consent or parental/legally acceptable representative consent and patient assent where applicable exclusion criteria: * prior use of dupilumab within 6 months prior the study entry * patients currently participating in any interventional clinical trial which modifies patient care * any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study (e.g., substance abuse) the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
breads: breast adjuvant diet study

Conditions: Breast Cancer

Summary: this is a randomized controlled trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via phone counseling with dietitian plus aromatase inhibitor therapy vs. 6-month control with aromatase inhibitor therapy alone. visits will occur at screening, 3 months, and 6 months. anthropomorphic measurements (such as heart rate, weight, and body measurement) and questionnaires will be taken at all three visits. after screening, patients will be randomized to receive the carbohydrate restricted diet coaching immediately (arm a) or to a control group (arm b). patients randomized to arm a will receive weekly calls for the first 3 months of the intervention, then biweekly calls for the last 3 months of the intervention from the study dietitian. total duration of the study is expected to be 3 years, though each patient's participation will be approximately 6 months.


Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer * planning to start adjuvant hormonal therapy using an aromatase inhibitor or has started adjuvant hormonal therapy using an aromatase inhibitor * able to read, write, and understand english * bmi ≥ 24 kg/m2 * age ≥ 18 years * er and/or pr positive (defined as having ≥ 1% staining for er and/or pr on ihc) * post-menopausal * the absence of menstrual cycles in women who have not undergone hysterectomy for at least 12 months preceding cancer diagnosis or * history of a bilateral oophorectomy or * history of a hysterectomy and age \>55 or * no menses for \<1 year with fsh and estradiol levels in postmenopausal range according to institutional standards * ecog performance status 0 or 1 * female * written informed consent obtained from subject and ability for subject to comply with requirements of the study exclusion criteria: * use of hormonal therapy other than aromatase inhibitors * history of other malignancy within the past 5 years, except for malignancies with a \> 95% likelihood of cure (e.g. thyroid cancer, non-melanoma skin cancer) * already consuming a severe carbohydrate restricted (\<20 g carbohydrates per day) diet or vegetarian diet * currently on or plans to start chemotherapy (her2/neu targeted therapy okay) * medical comorbidities that in the opinion of the investigator limits the patient's ability to complete the study * symptomatic metastases (metastases allowed if asymptomatic) * current use of appetite suppressant medications * current use of any weight loss medications including herbal weight loss supplements or if patients are enrolled in a diet/weight loss program

Keywords: aromatase inhibitor carbohydrate restricted diet
cardiovascular clinical project to evaluate the regenerative capacity of cardiocell in patients with acute myocardial infarction (ami)

Conditions: Myocardial Infarction

Summary: the main objective of the circulate project is to compare the clinical outcomes of cardiocell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.

it is planned to enroll 105 patients into ami trial with randomization into active (cardiocell) therapy and sham procedure/placebo administration with 2:1 ratio. additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled cardiocell to determine the early uptake and retention of imp in the target ischemic tissues. the primary research question of this project is to check if the administration of cardiocell could improve the clinical outcomes in patients with ami. there are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe and way of cardiocell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.

Eligibility criteria:
inclusion criteria: * acute myocardial infarction successfully treated by infarct related artery (ira) successful revascularization * male and female patients, aged 18-80 years * large myocardial injury as demonstrated by lvef ≤45% and/or infarct size (is) ≥10% of the lv muscle on cmri 2-5 days after ppci * signed informed consent exclusion criteria: * pacemaker or other contraindications to cardiac mri * malignancy * moderate or severe immunodeficiency * acute or chronic bacterial or viral infectious disease * soft tissue disease or local infection in a place of required artery puncture * pregnancy or breastfeeding * any objective or subjective reason for inability to attend follow-up visits * females of childbearing potential, who does not want to use a highly effective method of contraception * females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test * participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this project * life expectancy \< 1 year * any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project