Kornimate/medical-research-clean huggingface dataset:
effect of preoperative amoxicillin/clavulanic acid combination on postoperative endodontic pain

Conditions: Symptomatic Periapical Periodontitis

Summary: the aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

medical and dental history will be obtained from all patients participating in this trial. clinical and radiographic evaluation for each tooth included in this study will be recorded. clinical diagnosis of symptomatic apical periodontitis is to be confirmed. prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment). root canal treatment will then be carried out in a single visit. each patient will receive a 7-day diary to record postoperative pain and swelling. in case of pain, the participant will be instructed to take an analgesic. post-operative pain will be measured as a primary outcome on 11-point scale (nrs) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. the occurrence of swelling will be reported by participant as a secondary outcome.

Eligibility criteria:
inclusion criteria: * patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement. * mandibular posterior teeth. * patients with non-contributory systemic condition. * patients who can understand pain scales and able to sign informed consent. exclusion criteria: * patients allergic to penicillin. * patients who have a draining sinus tract. * retreatment cases.
comparison of corneal aberrations and visual outcomes in acrysof iq toric patients versus limbal relaxing incision (lri) patients

Conditions: Cataracts

Summary: a prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an acrysof iq toric intraocular lens (iol) group or a group implanted with a sn60wf iol and having concomitant limbal relaxing incision.


Eligibility criteria:
inclusion criteria: 1. operable cataracts 2. good ocular health 3. 0.5 d to 2.0 d of corneal astigmatism exclusion criteria: 1. \> 2.0 d astigmatism 2. irregular astigmatism 3. prior or ongoing corneal disease or scarring 4. history of ocular disease

Keywords: cataract toric iol acrysof, lri
eating disorders programs: an indicated trial

Conditions: Body Image; Eating Disorders

Summary: the purpose of this study is to assess the effectiveness of two body acceptance programs for women. participants may experience reduction of eating pathology and prevention of future obesity and eating disorders; may derive a sense of altruism and contribution to furthering understanding of a public health problem.


Eligibility criteria:
inclusion criteria: * participant indicates sub-threshold or threshold eating disorder. * participant is available to participate in the intervention sessions. * participants must be mri eligible. exclusion criteria: * participant does not indicate sub-threshold or threshold eating disorder. * participant is unable to attend intervention sessions. * participant cannot participate if mri ineligible.
a study on predictive value of ercc1 in esophageal cancer patients treated with paclitaxel and cisplatin

Conditions: Esophageal Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer

open label single arm phase ii study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer. 92 patients will be enrolled in this local trial. the primary objective of this study is to determine the response rate of the treatment.schedule for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous infusion over 3 hour on days 1, followed by cisplatin 50 mg/m2 on days 2. this study will also include the investigation of ercc1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population.

Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus * locally advanced, recurrent or metastatic disease * performance status of 0-2 on the eastern cooperative oncology group (ecog) performance status scale * previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment * adequate organ function including the following: bone marrow: absolute neutrophil count (anc) \>or equal to 1.5 \* 109/l, platelets \>or equal to 100 \*109/l, hemoglobin \> or equal to 10 g/dl. hepatic: bilirubin \ or equal to3g/dl. renal: calculated creatinine clearance major or equal to 60 ml/min (using the standard cockcroft-gault formula). exclusion criteria: * no prior palliative chemotherapy for advanced disease * previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). prior radiotherapy must be completed at least 30 days before study enrollment * known or suspected brain metastasis * second primary malignancy

Keywords: esophageal cancer paclitaxel cisplatin
phase 1/2 lyme vaccine study

Conditions: Prophylaxis of Lyme Borreliosis

Summary: section 1: the purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant ospa lyme borreliosis (mv rospa lb) vaccine with and without adjuvant in seronegative healthy adults aged 18 to 70 years. the outcome shall provide the basis for dose/formulation selection for section 2 of the study. section 2: an additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rospa lb vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.


Eligibility criteria:
main inclusion criteria: * subject is 18 to 70 years old at the time of screening * subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry * subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination * if female of childbearing potential, presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study additional inclusion criterion for seropositive subjects in section 2 only: - subject is seropositive for borrelia burgdorferi sensu lato (s.l.) antibodies at study entry main exclusion criteria: * subject has a physician-diagnosed chronic illness related to lyme borreliosis (lb) or active lb * subject has been treated for lb with antibiotics within 3 months of study entry * subject had a tick bite within 3 weeks prior to screening or first vaccination * subject has a history or active infection with babesia microti (babesiosis) or anaplasma phagocytophilum (ehrlichiosis) * subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder * subject has clinically significant abnormal laboratory values at screening * subject currently has or has a history of immunodeficiency * subject tests positive for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) * subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. * subject has a history of anaphylaxis or severe allergic reactions * subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study * subject is pregnant or lactating at the time of study enrollment additional exclusion criterion for subjects in section 1 and seronegative subjects in section 2: - subject is seropositive for borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
first-line chemotherapy for recurrent cervical cancer

Conditions: Recurrent Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Chemotherapy; Vascular Endothelial Growth Factor 2 Inhibitor; Apatinib; Targeted Therapy

Summary: the response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. this single arm, open, phase ii trial would recruit 37 eligible patients. a combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. if at least 13 patients achieved complete or partial remission, the same regimen would be given for rest patients. the primary end is overall response rate (orr). the second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. a molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.


Eligibility criteria:
inclusion criteria: * female of 18-75 years old * eastern cooperative oncology group score 0-1 * pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage ia1 (with lymph-vascular space invasion) to ivb, which had accepted radical treatment for the purpose of cure * an interval of 3 months or more since the fulfilling of last treatment * at least one measurable lesion defined by response evaluation criteria in solid tumors (recist) guideline 1.1 * anticipative survival period of 3 months or more * lab testing within reference ranges * with appropriate contraception * provided consents of participating the trial exclusion criteria: * with a history of exposure to other antiangiogenic agents * with other malignancies within past 3 years * with vital complications * with uncontrolled hypertension despite of medical treatment * with severe cardiac disease, coagulation disorders, bleeding disorders, vascular diseases, deep venous thrombosis * with brain metastasis * with addiction to psychiatric medications or with mental disorders * with severe open trauma, fracture or major surgery with past 4 weeks * with disorders which would hamper the absorption of oral drugs, or with intestinal perforation or ileus with past 6 months * urine protein ≥++, or 24 hr urine protein ≥1.0 g * with potential allergy or intolerance to study regimens * not eligible for the study judged by researchers
vitamin d status impacts inflammation and risk of infections during pregnancy

Conditions: Inflammation; Infection

Summary: the goal of this study is to characterize the function and efficacy of the bioactive nutrient, vitamin d, in relation to infection and inflammatory status across pregnancy. the three specific aims of this study are 1) to address the impact of maternal vitamin d status on inflammation and infections across pregnancy using retrospective data, 2) to address the impact of vitamin d supplementation on maternal vitamin d status, inflammation and infections across pregnancy using prospective data and 3) to assess the impact of maternal vitamin d status during pregnancy on inflammatory mediators at the level of the placenta.

archived serum collected from 158 adolescents at mid-gestation (approximately 26 weeks) and delivery will be analyzed for inflammatory cytokines. the impact of these inflammatory markers will be assessed by comparing the data to measures of vitamin d (25(oh)d, calcitriol and parathyroid hormone) and infections and inflammatory complications abstracted from medical charts. placental samples were collected from a subset (n=132) of these pregnant teens and these tissues will be analyzed using genome wide microarray of messenger ribonucleic acid (mrna) and microrna (mirna) related to inflammatory processes. a separate group of pregnant adolescents (n=140) will be recruited at entry into prenatal care for a vitamin d supplementation trial. teens will be randomly assigned to one of two supplements (200 iu d3/d vs. 2000 iu d3/d). similar to the retrospective analysis, maternal calciotropic hormones and inflammatory cytokines will be assessed at entry into the study, mid-gestation (23-28 weeks) and at delivery. inflammatory processes and infections reported across pregnancy will be evaluated in relation to vitamin d status and inflammatory markers.

Eligibility criteria:
inclusion criteria: * female adolescents between 13 and 18 years of age * between 12 and \< 30 weeks pregnant exclusion criteria: * hiv-infection * eating disorders * malabsorption diseases * diabetes mellitus * gestational diabetes * pregnancy induced hypertension or elevated diastolic blood pressure (\>110) * steroid use * substance abuse history * taking medications known to influence ca or vitamin d status * diagnosis of elevated blood lead concentrations during childhood * smokes tobacco

Keywords: vitamin d pregnancy inflammation infection placenta cytokine microbiome
nutritional management in respiratory critically ill patients -an observational study in mainland china

Conditions: Nutritional Deficiency

Summary: the important role of nutritional management in the treatment of icu patients has been paid more and more attention. reasonable nutritional management can improve the nutritional status of patients, reduce the risk of malnutrition, shorten the length of icu stay, improve the quality of life of patients, and reduce the mortality of patients, thereby improving the prognosis. many studies have investigated the nutritional status and implementation of icu patients. it is generally believed that the nutritional status of icu patients is not good, and the implementation of standardization needs to be improved.the data on the nutritional status and implementation of ricu patients in mainland china is rare. therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for ricu patients in mainland china.

respiratory critically ill patients have their own disease metabolism and treatment methods. however, ricu medical staff generally do not pay enough attention to nutrition support treatment. the data on the nutritional status and implementation of ricu patients in china is rare. but the data plays an important role in carrying out nutrition-related research, formulating the goals of continuing education programs for nutrition support treatment, guiding the introduction of medical insurance policies and the revision of consensus. therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for ricu patients in tertiary hospitals in mainland china, so as to lay the foundation for further relevant work.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years * the length of ricu stays \>48 hours exclusion criteria: * patients aged ≤18 years * the length of ricu stays ≤48 hours * patients who were admitted to ricu due to or combined with severe trauma or surgery

Keywords: nutritional management respiratory critically ill patients enteral nutrition
sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment

Conditions: Esophagitis; Malignant Neoplasm; Mucositis

Summary: this pilot clinical trial studies sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment. sensory evaluation may help to obtain input about new oral nutritional supplements that may increase nutrient intake and maintain or improve nutritional status, functional capacity, and quality of life in cancer patients.

primary objectives: i. to identify two products (one from the creamy shake category and one from the tea category) with the highest total average score that will be selected to move onto further testing. outline: patients receive 10 different nutrition supplements orally (po) and complete questionnaires based on each sample in a single session over 60-90 minutes.

Eligibility criteria:
inclusion criteria: * undergoing cancer treatment (chemotherapy, radiotherapy, and/or immunotherapy) * at risk for mucositis or with stage i mucositis or esophagitis (i.e. radiotherapy to the head, neck, esophagus or lung or treatment with fluorouracil (5-fu) or other chemotherapeutic agents that are known to cause mucositis or esophagitis) or at risk for xerostomia * within the first 3 weeks of initiation of a new type of therapy * able to read and write in english * able to provide written informed consent exclusion criteria: * food allergy to any component of the supplement * inability to taste or smell due to medication or health condition
a phase iib study of 610 in participants with severe eosinophilic asthma

Conditions: Asthma

Summary: this study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

this is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. subjects divided into 3 groups: a group,b group and placebo group. the study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 20 weeks and follow-up period of 8 weeks.

Eligibility criteria:
inclusion criteria: * 1. able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study. * 2. female and male aged 18 to 75 years. * 3. diagnosed with asthma for ≥12 months that meet gina. * 4. history of physician-diagnosed asthma requiring treatment with ics and at least one other control medication for at least 6 months prior to screening. * 5. documented history of ≥ 1 moderate exacerbations within 12 months prior to screening. * 6. asthma control questionnaire question version (acq) score ≥1.5 at the screening visit and the randomization visit. exclusion criteria: * 1. presence of a known pre-existing, clinically important lung condition other than asthma. * 2. severe asthma exacerbation within 4 weeks prior to randomization. * 3. subjects with any eosinophilic diseases other than asthma. * 4. known, pre-existing severe or clinically significant cardiovascular disease. * 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment. * 6. subjects who have active hepatitis b, hepatitis c or hiv infections as determined by positive results at screening. * 7. subjects with allergy/intolerance to a monoclonal antibody.
effects of orange oil aromatherapy on the pain and anxiety

Conditions: Hematopoietic Transplantation; Bone Marrow Transplantation

Summary: this randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between may 2021 and january 2022. orange oil inhalation used in aromatherapy was applied to patients in the intervention group. visual analogue scale and the state-trait anxiety inventory used for data collection.

introduction: invasive interventions such as peripheral intravenous cannula and port needle placement, and blood collection are often required for both inpatient and outpatient follow-up patients with hematological malignancies and hematopoietic stem cell transplantation patients. this long and difficult treatment process causes anxiety and emotional disorders in most patients. although invasive initiatives in the treatment and monitoring process are widely implemented, they lead to pain, anxiety and discomfort, which is often ignored. this study conducted to assess the effect of orange oil inhalation used in aromatherapy on pain and anxiety levels in invasive interventions to treat patients with hematological malignancies and hematopoietic stem cells transplantation. methods: this randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between may 2021 and january 2022. orange oil inhalation used in aromatherapy was applied to patients in the intervention group. visual analogue scale and the state-trait anxiety inventory used for data collection.

Eligibility criteria:
inclusion criteria: * patients older than 18 years old, * without communication problems, * without allergy and respiratory system problems, * who agreed to participate in the study exclusion criteria: * severe hypotension * other allergic complications that made it difficult for patients to continue the study

Keywords: hematopoietic stem cell transplantation aromatherapy pain anxiety
biseko versus albumin in systemic inflammatory response syndrome (sirs) patients

Conditions: Systemic Inflammatory Response Syndrome

Summary: morbidity and mortality in patients suffering from systemic inflammatory response syndrome (sirs) remain high. the primary aim of the present study is to assess the efficacy of a standardized 5% serum-protein solution containing immunoglobulins on serum cytokine levels. the secondary aim is to evaluate survival of the patients.

out of 40 patients randomised, 18 patients received albumin, 20 patients received biseko and 2 patients died before receiving the complete study medication. during days 1-6 of the study period, serum-levels of il-1ß were significantly lower in patients with biseko-therapy compared to patients receiving albumin (il-1ß-area under the curve 65.04 ± 71.09 days.pg/ml and 111.05 ± 156.97 days.pg/ml respectively, p=0.03). no difference could be found in serum-levels of il-6, tnf-α and tnf-r between both groups. while a statistically not significant trend towards better survival was observed in the biseko-group on day 28, the survival rate on day 180 was significantly higher in the biseko-group \[9/18 (50%)\] vs. albumin- group \[2/20 (10%), (p=0.008)\]. conclusion: data suggest that biseko treatment was associated with significantly lower il-1ß plasma concentrations (d1 to 6) and improved long-term survival rates. the data provided in our study are the first to be collected in a randomized, controlled trial. certainly, the small number of patients and the variety of diseases limit our study, however, the variety of diseases reflects the realistic large scale of morbidity in the medical intensive care unit.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 85 years fulfilling at least two of the four sirs criteria: * body temperature \> 38°c or \< 36°c * tachycardia \> 90/min * tachypnea \> 20/min with spontaneous respiration * leucocytosis \> 12,000/mcl * leucopenia \< 4,000/mcl or more than 10 % immature granulocytes were included \[8,21,22\] exclusion criteria: * patients with proven intolerance against homologous protein solutions * patients with known liver failure * pregnant patients * patients with absolute iga deficiency were excluded

Keywords: immunoglobulins inhibitor proteins human albumin systemic inflammatory response syndrome interleukins standardized serum-protein solution