Kornimate/medical-research-clean huggingface dataset:
continuous intraventricular methotrexate in treating patients with leptomeningeal disease

Conditions: Leptomeningeal Metastases

Summary: this pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease

primary objectives: i. determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease. secondary objectives: i. describe the dose limiting toxicities. ii. describe the pharmacodynamics of continuously delivered intraventricular methotrexate. iii. assess for response. outline: patients receive intraventricular methotrexate continuously on days 1-14. treatment continues in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * subjects with leptomeningeal carcinomatosis (from solid tumors) * subjects with lymphomatous or leukemic meningitis * the effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately * karnofsky performance status greater than 70% * all subjects must have the ability to understand and the willingness to sign a written informed consent * we will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months exclusion criteria: * prior therapy with methotrexate for management of leptomeningeal disease * subjects with evidence of hydrocephalous * subjects with intraparenchymal lesions or bulky disease * subjects with ventriculoperitoneal shunt in place * previous history of whole brain radiation therapy * subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial

Keywords: unspecified adult solid tumor, protocol specific
clarithromycin is an adjunct to scaling and root planing

Conditions: Periodontitis

Summary: the present study was done to evaluate the effect of clarithromycin as an adjunct to scaling and root planning at baseline, three months and six months intervals . clinical, microbiological and immunological parameters were taken. clinical parameters include gingival index , probing depth and clinical attachment level. in the present study, improved clinical and microbiological outcomes were attained using adjunctive clarithromycin, including gi, pd reduction, cal gain and reductions in the frequency of detection of c-reactive protein, pg, aa. these results together with the recommended easy dosage and limited side effects make the use of this antibiotic in the treatment of periodontitis patients but only for a shorter period of time.

background \& objectives: along with conventional non-surgical periodontal therapy (nspt) systemic antimicrobials may provide more effective treatment for chronic periodontitis by targeting tissue-invasive bacteria. the aim of this study was to evaluate the adjunctive effects of oral clarithromycin (clm) to nonsurgical periodontal therapy for chronic periodontitis. materials and methods: 30 patients were categorized into two groups: test group - base line scaling and root planing(srp) was done. clarithromycin tablet 500 mg( clarino-500) was given for a period of 7 days orally two times per day. control group -only srp done . clinical parameters were recorded at baseline , 3 months, and six months interval .they included gingival index (gi), probing depth (pd), and clinical attachment level (cal). also microbial analysis of subgingival plaque samples was done at baseline, 3months and six months interval to estimate the levels of pg and aa bacteria using culture methods. immunological parameter like estimation of c-reactive protein was done in both groups at baseline 3 months and 6 months period. tests were used for statistical analysis.

Eligibility criteria:
inclusion criteria: * patients age ranged between 30- 50 years with chronic periodontitis * patients with probing depth (pd)- \>5mm, clinical attachment level( cal)- \>3mm * systemically healthy individuals exclusion criteria: * patients below the age of 30 years * patients who have undergone periodontal therapy 3 months prior to study * active /passive smokers * any antibiotic use 3 months prior to study * pregnant women and lactating mothers * un co- operative/ retarded patients * drug allergy/ other allergies * any systemic diseases

Keywords: colony forming units antimicrobial agents microbial colonization
a global active surveillance for community acquired pneumonia

Conditions: Community Acquired Pneumonia

Summary: this study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of community-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * adult subjects 50 years of age or older * subject must reside in the surveillance area * subjects who present to a study healthcare facility where the treating physician clinically suspects cap exclusion criteria: * any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital). * hospital acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more).

Keywords: cap
gonadal hormone, gonadotropin and cardiovascular events

Conditions: Aging; Menopause

Summary: deficiency in gonadal hormone has been considered to play a role in ageing related increased incidence of cardiovascular events. but the mechanism has not been fully elucidated. on the other hand, the dramatic increase in gonadotropin level didn't drew much attention when talking about the increased risk of cardiovascular disease during menopausal transition. this study aim to investigate the association between gonadal hormone, gonadotropin and long-term cardiovascular events.


Eligibility criteria:
inclusion criteria: * male or female with intact uterus and at least one ovary * aged of 18 to 75 years old; exclusion criteria: * pregnancy or lactation women; * presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome or other endocrinal and metabolic disorders that known to compromise hypothalamic-pituitary-gonadal function; * receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies; * taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health; * obviously poor compliance.

Keywords: gonadal hormones gonadotropins cardiovascular diseases lipids obesity atherosclerosis glucose metabolism disorders metabolic syndrome non-alcoholic fatty liver disease
evaluation of pain in the course of in vitro fertilization: the endalgofiv-2 study

Conditions: Infertility

Summary: the endalgofiv study of pain assessment during the ivf pathway at lille university hospital, conducted from november 2018 to july 2020, showed that endometriosis patients have intense pain, particularly of a neuropathic nature, even before starting their ivf pathway compared to patients without endometriosis, but without an increase in pain scores during the ivf pathway. as a result of this study, a new pain management protocol for all patients undergoing ivf have been implemented in our mpa center. the study will be evaluated the impact of this new management. main objective to evaluate the effect of the change in pain management protocol in all patients (endometriotic or not) undergoing ivf treatment during the study period by comparing them to the data of the endalgofiv 1 study.


Eligibility criteria:
inclusion criteria: * all patients who start an ivf cycle in the medically assisted procreation department of the jeanne de flandres hospital (chru lille) exclusion criteria: * previously enrolled patient (endalgofiv or endalgofiv 2) * refusal to participate in the study * minor patient * patient over 43 years old * bmi patient \> 35 * pregnant woman * unable to provide clear information to the patient * patient under guardianship or lack of health cover * patient in ivf with donation of oocyte * ivf patients for oocyte preservation * patient who had already participated in the study

Keywords: infertility in vitro fertilization endometriosis pain evaluation
high-dose cyclophosphamide for steroid refractory gvhd

Conditions: Graft Versus Host Disease

Summary: rationale: high-dose cyclophosphamide may be an effective treatment for acute graft-versus-host disease that did not respond to steroid therapy. purpose: this phase ii trial is studying the side effects, best dose, and how well high-dose cyclophosphamide works in treating patients with acute graft-versus-host disease that did not respond to steroid therapy.

objectives: * determine the maximum tolerated dose of high-dose cyclophosphamide in patients with steroid refractory acute graft-versus-host disease (gvhd). * determine the efficacy of this regimen at 28 days post-treatment in these patients. outline: this is a dose-escalation study. patients receive high-dose cyclophosphamide once daily for 1-4 days beginning on day 1 and filgrastim (g-csf) subcutaneously once daily beginning on day 10 and continuing until blood counts recover. cohorts of 3-6 patients receive escalating doses of high-dose cyclophosphamide until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. after completion of study treatment, patients are followed weekly for 4 weeks.

Eligibility criteria:
disease characteristics: * histologically confirmed acute graft-versus-host disease (gvhd) ≥ clinical grade ii, that is steroid refractory * steroid refractory gvhd is defined as gvhd that has progressed (increasing in grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg or gvhd that has failed to improve (no change in grading stage) despite 4 days of treatment with methylprednisolone of ≥ 2.0 mg/kg * prior allogeneic hematopoietic stem cell transplantation using either bone marrow, peripheral blood stem cells, or cord blood or prior donor lymphocyte infusion required * evidence of myeloid engraftment * no chronic gvhd patient characteristics: * ecog (eastern cooperative oncology group) performance status (ps) 0-2 or karnofsky ps 60-100% * anc (absolute neutrophil count) \> 500/mm³ * not pregnant or nursing * fertile patients must use effective contraception * must be geographically accessible * no allergy or intolerance to cyclophosphamide or mesna * no hiv positivity * no mechanical ventilation * no active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic cystitis * no other uncontrolled illness including, but not limited to, the following: * ongoing or active infection * medical condition precluding patient from stopping azoles (e.g., fluconazole, itraconazole, or voriconazole) or other adequate antifungal therapy during cyclophosphamide administration * symptomatic congestive heart failure * unstable angina pectoris * psychiatric illness/social situations that would preclude compliance prior concurrent therapy: * see disease characteristics

Keywords: graft versus host disease
efficacy and safety of glimepiride as oral anti-diabetic (oad) initiation mono-therapy in chinese type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: to investigate the glycosylated hemoglobin (hba1c) control of glimepiride (amaryl) as oad initiation mono-therapy in type 2 diabetic patients in china.


Eligibility criteria:
inclusion criteria: * newly diagnosed t2dm and inadequately controlled with diet and exercise or t2dm diagnosed \ 3months. * hba1c more than 7.5 and less than 11. exclusion criteria: * fasting plasma glucose of \>13.5mmol/l * type 1 diabetes mellitus (t1dm) * patient with acute illness hospitalized in last 2 months * patient with active liver disease, impaired renal or hepatic functions * known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of amaryl * pregnant and lactating women the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
radiographic assessment of bone dimension around immediate implants with fdba and i-prf vs fdba alone

Conditions: Bone Density Increased

Summary: the present study is a human, prospective, parallel, randomised controlled clinical trial conducted for radiographic assessment of bone dimension around immediate implants with fdba and i-prf vs fdba alone the trial is in accordance with the consolidated standards of reporting trials (consort) criteria, 2010.

twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. a detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. all patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. all the patients were treated with immediate implants in endodontically and periodontically compromised sites. fdba graft along with i-prf is combined to form a sticky bone, this stable element is placed around the implants where bone is compromised. the clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively

Eligibility criteria:
inclusion criteria: 1. patients between 18-55 years of age. 2. presence of non-restorable single rooted teeth (maxillary or mandibular) due to trauma, caries, root resorption, root fracture, endodontic or periodontal failure. 3. grade i or grade ii extraction socket according to el chaar et al 2016. 4. good oral hygiene. 5. good patient compliance. exclusion criteria: 1. systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases). 2. intravenous and oral bisphosphonate therapy. 3. patients who are psychologically unable to participate. 4. pregnant patients, patients with bone diseases and patients on chemotherapy or radiotherapy, alcohol or drug abuse. 5. patients with hemorrhagic disorders.

Keywords: injectable platelet rich fibrin bone dimensions freeze dried bone allograft
potential benefit of the combination of metamizole and ibuprofen after third lower molar extraction

Conditions: Pain, Postoperative

Summary: postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. this randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.


Eligibility criteria:
inclusion criteria: * planned sequential both-sided lower third molar extraction (split-mouth) with osteotomy (with or without upper molar extraction in local anesthesia) * able to understand the study and the nrs scale exclusion criteria: * simultaneous both sided extraction or only upper third molar extraction * general anesthesia * known or presumed abnormal coagulation status * known or presumed liver or renal dysfunction * contraindication against metamizole known or suspected (known or suspected allergy against novalgin or other pyrazolones, anaphylactic reaction against nsaids, decreased bone marrow function or hematopoesis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, and pregnancy/breastfeeding) * contraindication against ibuprofen (known or suspected allergy against ibuprofen, anaphylactic reaction against nonsteroidal anti-inflammatory drugs (nsaid), active or recurrent stomach or duodenal ulcera or bleeding, severe liver or renal insufficiency, inflammatory bowel syndrome, and pregnancy/breastfeeding) * pregnancy and breast feeding mothers
3d printed models for mandibular fracture repair

Conditions: Mandible Fracture; Maxillofacial Trauma

Summary: the investigators will test the hypothesis that patients randomized to the intervention (3d printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3d printing, current standards of care). personalized medicine and care for fracture treatment.

the goal of treatment is to re-establish the patient's preinjury dental occlusion and facial harmony. fractures that are nondisplaced and exhibit no occlusal changes may be amenable to nonsurgical management, but most mandible fractures will require stabilization for satisfactory healing and to restore pretraumatic maxillomandibular orientation. various treatment strategies have been described and vary widely depending on the fracture location and surgeon's preference. the patient's demographics, comorbidities, dentition, and fracture characterization will all influence the choice of fixation by the treating surgeon. there are very few randomized control trials that show outcomes when 3d printing is used for intervention planning and performing a procedure. these data are essential to establish value of 3d printing as a clinical service. there is also anecdotal evidence that a 3d printed model of a mandible fracture can be useful for pre-operative planning because the oral and maxillofacial surgeon can better assess the geometry of the bone lesions and can pre-bend fixation plates before the procedure. this hypothetically decreases the amount of time in the operating room. the investigators propose a parallel design randomized control trial to study the value of 3d printing for preoperative planning in patients with a fracture of the mandible who require open reduction, internal fixation. the study will be split into two arms: 1) patients that will have a 3d model generated for the surgical procedure 2) the control group who will follow normal standards of care as outlined above and won't have the additional 3d model created pre-operatively.

Eligibility criteria:
inclusion criteria: patient ≥ 18 years of age * patients who have received either a cone beam or conventional ct * admitted through university of cincinnati hospital and medical center emergency department * all isolated mandible fractures referred to university of cincinnati hospital oral \& maxillofacial surgery clinic * surgical team members from the division of plastic and otolaryngology exclusion criteria: * patient \< 18 years of age * patients who have neither cone beam nor conventional ct * patients requiring a repeat procedure * unexpected exposure of hardware

Keywords: 3d printing personalized medicine maxillofacial trauma
study comparing premarin® vaginal cream versus premarin® oral tablets in atrophic vaginitis

Conditions: Atrophic Vaginitis

Summary: the purpose of this study is to characterize the systemic exposure and bioavailability at steady state of premarin® vaginal cream compared with premarin® oral tablets in postmenopausal women with atrophic vaginitis.


Eligibility criteria:
inclusion criteria: * generally healthy postmenopausal women. * intact uterus. * clinical diagnosis of moderate to severe atrophic vaginitis.
effects of different general anesthesia methods on immune responses in patients undergoing surgery for tongue cancer

Conditions: Tongue Cancer

Summary: surgical excision is the mainstay of treatment for tongue cancer. however, surgery-induced immunosuppression has been implicated in the development of post-operative septic complications and neoplasm metastasis. general anesthesia is considered to not only suppress surgical stress, but also affect the immune function directly，such as altering the number and activity of immune cells. it is reported that some anesthetics increase susceptibility to tumor metastasis, apparently by suppressing natural killer cell activity. different anesthetic techniques and anesthetics used in anesthesia have shown different effects on immunity. many of the studies were animal trials or performed in vitro; in addition, most are focused on a single drug. to date, there is little published prospective clinical research designed specifically to investigate the effects of different general anesthetic technique on immune function in patients with oral malignant tumors. the aim of this study is going to characterize the immune response of patients undergoing surgery for tongue cancer under 3 types of general anesthesia.


Eligibility criteria:
inclusion criteria: * all the patients were scheduled for elective surgery for tongue cancer under general anesthesia. none of the patients had a history of endocrine, immune and circulatory system diseases; * exclusion criteria were also contraindications for receiving chemotherapy exclusion criteria: * contraindications for receiving chemotherapy, * receiving perioperative blood transfusion, or * preoperative and perioperative treatment with hormones and immunomodulatory agent. patients who suffered from any surgical complications such as infection were also excluded from our study. -

Keywords: anesthesia general immunity tongue neoplasms immune general anesthesia
neuropathy walks (cross-sectional)

Conditions: HIV Infections

Summary: cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with hiv (plhiv).

the overall goal of this study is to explore the impact of hiv-associated distal sensory polyneuropathy on physical performance, physical activity, and pain pressure threshold. the aim is to determine if the presence of painful distal sensory polyneuropathy in the feet adversely affects physical performance, physical activity, and pain pressure threshold in plhiv.

Eligibility criteria:
inclusion criteria: * diagnosis of hiv infection currently treated with antiretroviral therapy (art) * cluster of differentiation 4 cell (cd4 cell) count of at least 200 cells/mm3 * 18-64 years of age * able to read and write in english * means to travel to a study site * additional inclusion for cohort with painful neuropathy in the feet: * presence of peripheral neuropathy symptoms in feet * average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale * pain in the feet present for at least the past 3 months * no changes in medications used to manage pain in the past 4 weeks exclusion criteria: * current opportunistic infection(s) * cluster of differentiation 4 cell (cd4 cell) count \<200 cells/mm3 * dementia * uncontrolled psychiatric disorder * wounds or sores on the feet * musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait * pregnancy

Keywords: peripheral neuropathy pain function