Kornimate/medical-research-clean huggingface dataset:
the safety and effectiveness of peridex in preventing or delaying fungal infections of the mouth in hiv-infected patients

Conditions: Candidiasis, Oral; HIV Infections

Summary: to evaluate the safety and effectiveness of peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in hiv-positive patients, who are at risk of the disease based on previous history of candidiasis.


Eligibility criteria:
inclusion criteria prior medication: allowed within 6 months of study entry: * treatment for oral candidiasis. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * either history of esophageal candidiasis or current mucocutaneous candidiasis (angular cheilitis). * allergies to chlorhexidine. * gross periodontal neglect or need for periodontal treatment within the past two weeks. concurrent medication: excluded: * systemic or oral topical mucocutaneous antifungal therapy. * systemic or oral topical corticosteroids. * antibiotics. * mouth rinses other than the study drug. concurrent treatment: excluded: * dental prophylaxis. patients with the following are excluded: * complete dentures, full partial dentures, removable dentures which fit poorly, or any prosthetic appliances which cannot be cleaned with sodium hypochlorite. * allergies to chlorhexidine. * sensitivity/intolerance to alcohol. * anterior composite/acrylic restorations with poor marginal adaption. * gross periodontal neglect or periodontal treatment within the past two weeks. * inability to comply with the study protocol based on the investigator's discretion. prior medication: excluded within 7 days of study entry: * systemic or oral topical mucocutaneous antifungal therapy. * antibiotics. * daily use of mouth rinses. * excluded within 1 month of study entry: * systemic or oral topical corticosteroids. prior treatment: excluded within 2 weeks of starting study drug: * dental prophylaxis or periodontal treatment. patients must be: * hiv positive. * previously experienced at least one episode of clinically diagnosed oral candidiasis but currently free of clinical signs of oral candidiasis. * willing to sign informed consent. * willing to complete a medical history.

Keywords: aids-related opportunistic infections chlorhexidine gluconate acquired immunodeficiency syndrome anti-infective agents, local aids-related complex candidiasis, oral
evaluating the response to neoadjuvant chemotherapy with circulating tumor dna in pancreatic cancer

Conditions: Pancreas Cancer

Summary: for patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. the purpose of this research study is to understand if we are able to detect pancreatic cancer dna in the blood stream before, during, and after treatment.

cancer dna in the blood stream is called circulating tumor dna or ctdna. the presence or absence of pancreatic cancer ctdna in the blood stream may help clinicians to better understand pancreatic cancer behavior in response to specific treatments, like chemotherapy and surgery. understanding how treatment alters the ctdna can help future patients diagnosed with pancreatic cancer. the presence or absence of ctdna or the clearance of ctdna after treatment may help to guide further treatment decisions for cancer patients after surgery.

Eligibility criteria:
inclusion criteria: * biopsy or cytology proven adenocarcinoma of the pancreas * no clinical evidence of metastatic disease on imaging * age 18 or older * receiving chemotherapy for non-metastatic pancreatic cancer exclusion criteria: * biopsy proven metastatic disease
open label, safety, tolerability and efficacy of afq056 in parkinson's patients with l-dopa induced dyskinesias

Conditions: Parkinson Disease; Dyskinesia, Drug-Induced; Levodopa

Summary: the purpose of this study is to generate long-term safety, tolerability and efficacy data for afq056 in patients who have participated in and completed any afq056 phase ii study in pd-lid (parkinson's disease, l-dopa induced dyskinesias).


Eligibility criteria:
inclusion criteria: * outpatients with parkinson's disease (pd), treated with l-dopa, experiencing dyskinesias who have been eligible for, participated in and completed an afq056 phase ii core study. exclusion criteria: * surgical treatment for pd * cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) * advanced, severe or unstable disease (other than pd) that may interfere with the study outcome evaluations other protocol-defined inclusion/exclusion criteria may apply

Keywords: parkinson disease l-dopa levodopa dyskinesia involuntary movement motor complication
efficacy of aurosling in frontalis sling suspension surgery

Conditions: Ptosis, Eyelid

Summary: to study the efficacy of aurosling as a suspension material in frontalis suspension surgery in ptosis

silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.the elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. in the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery

Eligibility criteria:
inclusion criteria: * congenital ptosis * severe ptosis (mrd\<0) * poor levator function (\<4mm by berke's method) * myogenic ptosis (myasthenia gravis) * chronic progressive external ophthalmoplegia * neurogenic ptosis (third cranial palsy) * blepharospasm * ptosis caused by trauma exclusion criteria: * acquired ptosis * horners syndrome * blepharochalasis/dermatochalasis * mechanical ptosis * mild or moderate ptosis (mrd 1\>1) * good or fair levator function (\>4 mm by berke's method) * previous ptosis surgery * ptosis associated syndromes/other anomalies including * marcus gunn jaw winking syndrome * blepharophimosis syndrome * dry eye syndromes * corneal anesthesia * medical/pediatric/anesthesia condition contraindicating to surgery or anesthesia * nystagmus where adequate measurements could not be done * uncorrected vertical squint of any sort

Keywords: blepharoptosis ophthalmoplegia blepharospasm
the effect of weight loss and dietary protein intake on bone

Conditions: Weight Loss; Bone Density

Summary: the purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health. we will also examine how two levels of protein intake affects diet quality.

it is unclear whether protein intake during dieting influences bone density. this information is important for determining optimal nutrient requirements during weight loss. this study will compare the effects of weight loss with a lower-carbohydrate, high-protein (hp) diet to a high-carbohydrate, moderate protein (hc) diet on bone mass and quality in postmenopausal women (ages 50-70 years) with the hypothesis that bone turnover and loss of bone will be reduced on the hp compared to the hc weight loss diet. in a secondary aim, we will examine bone markers, hormones and the impact of protein intake on diet quality. participants will be randomly assigned to one of 2 groups: a) weight loss with recommended level of protein intake, and b) weight loss with higher protein intake. all participants will attend regular counseling sessions (about 50 minutes per session) with a dietitian for approximately 1 year, and will be asked to take a daily vitamin/mineral supplement. also, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. these measurements will provide information about body composition (fat, muscle mass, and bone mineral density). participants will be asked to attend 8 diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions during the year.

Eligibility criteria:
inclusion criteria: * postmenopausal women who are more than 2 years since last menses * obese or overweight * must live in the geographic vicinity of rutgers university exclusion criteria: * currently on any medication known to influence calcium or bone metabolism, including hrt, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal ekg\], active malignancy or cancer therapy within the past year) * history of kidney stones * weight gain or weight loss (5% of body wt) within 3 months prior to recruitment * participation in other investigational studies during the 12-month study period * usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)

Keywords: bone mass calcium absorption bone quality fracture risk
retrospective analysis of survival in adult mrd positive acute lymphoblastic leukemia patients

Conditions: Acute Lymphoblastic Leukemia

Summary: a retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative b-pre-cursor acute lymphoblastic leukemia patients.

a retrospective observational study reviewing historical survival data (relapse free survival and overall survival) for adult patients who have philadelphia negative b-precursor acute lymphoblastic leukemia, and are in complete hematological remission with minimal residual disease.

Eligibility criteria:
inclusion criteria: * patients with philadelphia-negative b-precursor acute lyphmoblastic leukemia in complete hematological remission defined as less than 5% blasts in bone marrow after at least 3 intensive chemotherapy blocks (i.e. any standard or investigational regimen according to adult protocols as long as 3 age appropriate chemotherapy blocks were given, this also includes relapse treatment * detection of minimal residual disease (molecular failure or molecular relapse) at a level of greater than or equal to 10\*(-4) by pcr or greater than or equal to 10\*(-3) by flow cytometry at a reference lab * age 15 or greater at time of initial diagnosis with acute lymphoblastic leukemia. for patients aged 15-17 treatment according to adult protocols is required * initial diagnosis in the year 2000 or later * history of acute lymphoblastic leukemia treatment (including response to first therapy, number of prior relapses) is available * relapse status and disease follow up after timepoint of minimal residual disease detection is available exclusion criteria: * patients with extramedullary disease at timepoint of minimal residual disease detection * use of blinatumomab within 18 months of minimal residual disease detection * allogeneic hematopoietic stem cell transplantation prior to minimal residual disease detection at the required level
drug use investigation of comirnaty intramuscular injection

Conditions: COVID-19

Summary: post-marketing study, chotor study of comirnaty vaccenees followed for 11months. serious adverse events and covid-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.

the healthcare professionals who are vaccinated with this product early after the marketing approval of this product (participants in the investigation of health status of recipients vaccinated first conducted by the science research group of the ministry of health, labour and welfare) will be followed for 11 months from the day following 28 days after the final vaccination of the initial immunization with this product (end date of observation period in investigation of health status of recipients vaccinated first) to 12 months after the final vaccination of the initial immunization with this product, information on serious adverse events and covid-19 observed during the follow-up period will be collected. if booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed. if booster vaccination is conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination will be confirmed, and information on serious adverse events and covid-19 will be continuously obtained after booster vaccination.

Eligibility criteria:
inclusion criteria: * subjects who have participated in the investigation of health status of recipients vaccinated first and have provided written consent to continue participation in this study. exclusion criteria: * no exclusion criteria.

Keywords: covid-19 post-marketing study, comirnaty,vaccine
diabetes coaching study

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to compare the effect of telemedical coaching versus telemedical control on hba1c, weight, bmi, blood pressure, blood lipids, medication, nutrition, physical activity and quality of life in type 2 diabetes patients with poor glycaemic control.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * hemoglobin a1c (hba1c) \>7.5% * at leat two different antidiabetic drugs * body mass index \>27kg/m2 exclusion criteria: * acute infections * diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (copd), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (egfr) \< 30ml / min / 1.73 m2 * acute chemotherapy or chronic cortisol treatment * smoking cessation for less than 3 months and or planned smoking cessation during study * known intolerance of any ingredient of almased (especially soy protein) * pregnancy or breast feeding, lack of contraception (women) * other study participation in the last 6 months prior to study start
cesarean wound closure in women with bmi 40 or greater

Conditions: C.Delivery; Penetration, Pregnant Uterus, by Instrument; Obesity

Summary: the purpose of this randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a bmi of 40 or greater. the study will compare two closure methods: subcuticular sutures and surgical staples.

the study will screen and attempt to enroll pregnant women admitted to labor and delivery who have a bmi of 40 or greater. the participants will be randomized to receiving skin closure with subcuticular sutures or surgical staples if they undergo cesarean section. either technique is currently standard of care. participants who end up undergoing cesarean section will be included in the final data analysis. the participants will be followed for wound complication in the first 6 weeks post operatively. wound complication will be defined as wound disruption or infection within 6 weeks post operatively. design and project type this study is a randomized controlled trial. at the study facility, in 2012 and 2013, over 300 cesarean sections were performed each year in women with bmi of 40 or greater. based on this, the investigators expect the duration of the study to be 2 years. randomization and data collection will be completed on 420 women. description of intervention two interventions will be used in this project: subcuticular suture and surgical staples. the subcuticular suture will be the size and type of suture chosen by the surgeon at the time of cesarean. the surgical staples will be the standard staples used on the labor and delivery unit.

Eligibility criteria:
inclusion criteria: * pregnant woman * time to approach and consent the patient prior to undergoing cesarean delivery * able to give informed consent, include age 18 or greater and ability to read and understand english * bmi of 40 or greater on most recent hospital documentation * willingness to participate in the study and ability to read, understand and sign the informed consent document exclusion criteria: * inability to give informed consent, including inability to read and understand english and age under 18 years * evidence of current skin infection or breakdown at or near the site of surgical incision * any immune compromised status, including aids * negative pressure wound therapy applied at time of surgery
treating children with obstructive sleep apnea after surgery failure

Conditions: Pediatric Obstructive Sleep Apnea; Pediatric Obesity

Summary: the aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (cpap), versus no treatment.

consenting patients and their parents will choose one of three options (within the context of medical/craniofacial appropriateness): cpap, orthodontic intervention, or to remain untreated (control). it would be ideal if each patient was randomly assigned to one of three groups. however, in our study, random allocation is not an option as the established clinical pathways for treatment, financial resources, and physiological presentation of the patient determines the appropriate intervention. in each group, the effectiveness of the intervention will be analyzed through the evaluation of sleep parameters, medical history, questionnaire responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and at 12 months.

Eligibility criteria:
inclusion criteria: * patients diagnosed with obstructive sleep apnea by polysomnography who presented with a failure in treatment with surgical removal of the tonsils and adenoid tissue --adenotonsillectomy (t\&a). * patients diagnosed with obstructive sleep apnea but for whom t\&a was not an option following assessment by otolaryngology. exclusion criteria: * autism spectrum * down syndrome * pulmonary hypertension * cystic fibrosis

Keywords: obstructive sleep apnea children orthodontic intervention nutrition metabolomic markers
exposure to nsaids (non steroidal anti-inflammatory drugs) and severity of community-acquired bacterial infections

Conditions: Bacterial Infection

Summary: * nsaids are widely consumed, and some are currently available for self-medication with indications 'pain and fever' (cavalié, national agency for drug safety (ansm), 2014) * there is no recommendation to limit their use in bacterial infections except for chicken pox in children. * to date, no study has highlighted the aggravating role of exposure to nsaids on bacterial infections in adults, based on the usual septic severity levy's score (sss), and mortality, but it delays adequate antibiotics (legras, critical care, 2009) * community-acquired bacterial infections in adults exposed to nsaids are serious by their spread (multiple locations), and suppurative character requiring frequent use of invasive procedures such as surgery or drainage. the sss does not reflect the seriousness of these infections. they are frequently associated with use of ibuprofen (63.4%), and self-medication practices (65.5%). the main hypothesis is that nsaids exposure is associated with a specific severity of community-acquired bacterial infection, marked by dissemination, suppurative complications or even invasive procedures requirement. our objectives are also to: * describe what nsaid use terms are associated to the risk of serious bacterial infections: molecule, dosage, duration of exposure, access (prescription or self-medication), associated drugs. * to determine what type (s) (s) of bacterial infection is worsened by exposure to nsaids. * to determine if other risk factors contribute to severity of bacterial community acquired infection * to describe hospital costs associated to such severity of bacterial infection


Eligibility criteria:
inclusion criteria: * patient : adult patient hospitalized in managed care organization (mco) in one of the study centers for severe community bacterial infection, infected with more than one site, and / or abscess collection, and / or a per-cutaneous drainage of the infection, and / or septic surgery * control: patient hospitalized in the same center (different service or not), during the week or months of the inclusion of cases for infection without abscess or invasive procedure, only one infected site exclusion criteria: * hematologic or solid neoplasia undergoing chemotherapy, long-term corticosteroid, chronic exposure to nsaids, ongoing treatment with methotrexate or monoclonal antibody (anti-tumor necrosis factor (ant-tnf) particular), chronic buffy neutropenia, surgical site infections, catheter infections, disorders of consciousness or cognitive neuro-against-indicating the administration of the drug exposure questionnaire adults under guardianship, minor, no insurance disease, patients already included in a biomedical research with taking medication blind.

Keywords: nsaids bacterial infections severity self medication
posterior ivs versus sacrospinous suspension in vaginal vault prolapse repair

Conditions: Vaginal Prolapse

Summary: hypothesis / aims of study the aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension. study design, materials and methods this study involves 5 centres in french public hospital. patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior ivstm (tyco healthcare, france). prolapse severity will be evaluated using the pop-q system. in order to evaluate the patient's quality of life, the validated pfdi and the pfiq questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. the difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior ivs). then the estimated number of patient is 40 in each arm.


Eligibility criteria:
inclusion criteria: * age more than 18 * vaginal vault prolapse of grade 2 or more (pop-q system) * symptomatic prolapse exclusion criteria: * patient unable to read french language * cystocele without vaginal vault prolapse * vaginal vault prolapse of grade 1 * associated rectal prolapse * rectal inflammatory disease (crohn, rch).