Kornimate/medical-research-clean huggingface dataset:
evaluation of safety/efficacy of diagnostic skin test panel and desensitization hormone kit for treatment of premenstrual syndrome (pms)

Conditions: Premenstrual Syndrome

Summary: the eve-pms technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe premenstrual syndrome (pms) and desensitizes them with the relevant sex hormones in order to reduce pms symptoms. the system includes skin testing panel for identification of hormones to which the patients might be sensitive. tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. results of skin tests and patient's history will determine the eligibility of the patients to enter a desensitization protocol. during the desensitization period hormones to which the patient were found sensitive to, are injected intradermally three times (once a month) within the luteal phase in increasing doses. the end-point of the study is a statistically significant decrease, or elimination of pms symptoms, compared to a solvent group.


Eligibility criteria:
inclusion criteria: 1. person is over the age of 20 but not older than age 45. 2. person is willing to participate as evidenced by signing the written informed consent form. 3. suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of pms symptoms severity) 4. other severe symptoms of premenstrual syndrome (based on who and acog criteria). this may include one or more of pms symptoms with level 7-10 according to standard scale of pms symptoms severity. 5. at work, school, home, or in daily routine, at least one of the pms symptoms caused reduction of productivity or inefficiency 6. at least one of the pms symptoms caused avoidance of or less participation in hobbies or social activities 7. at least one of the pms symptoms interfere with relationships with others * timing of pms symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow. * pattern and length of pms symptomatic period: minimum of 2 days, up to 14 days. * for pms diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms. * timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle. * cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no pms symptoms to pms symptoms. * reliable non hormonal contraception. exclusion criteria: 1. pregnant or lactating woman 2. oral contraceptives during last three months, including hormonal iud (trade name mirena). 3. serious health problems. 4. unexplained menstrual disorders. 5. treated by hormones (estrogen and progesterone).

Keywords: premenstrual syndrome hormones skin tests desensitization allergen immunotherapy
impact of fluticasone and salmeterol on airway dendritic cells (dcs) in smokers

Conditions: Smoke-related Lung Diseases; Chronic Obstructive Pulmonary Disease

Summary: airway dendritic cells (dcs) play a key role in smoke-related lung diseases. in this study, the researchers investigate the effects of fluticasone and salmeterol on human airway dcs in smokers. the researchers hypothesize that fluticasone and salmeterol impact on the number and the characteristics of airway dcs in smokers.


Eligibility criteria:
inclusion criteria: * men aged 30 - 60 years * at least 15 years of smoking * current smoker, at least 10 cigarettes per day exclusion criteria: * any acute or chronic disease (except copd oder hypertension) * any regular medication (except drugs against hypertension) * fev1 \< 80% predicted * oxygen saturation \< 90% * acute infections of the lower respiratory tract in the last 7 days before the first day of the study

Keywords: dendritic cells airway smoker copd
gallium ga 68-labeled psma-11 pet/ct in detecting recurrent prostate cancer in patients after initial therapy

Conditions: Prostate Adenocarcinoma; Recurrent Prostate Carcinoma

Summary: this clinical trial studies how well gallium ga 68-labeled prostate-specific membrane antigen (psma)-11 positron emission tomography (pet)/computed tomography (ct) works in detecting prostate cancer that has come back (recurrent) in patients after initial therapy. diagnostic procedures, such as gallium ga 68-labeled psma-11 pet/ct, may help doctors detect tumors that have come back after initial therapy.

primary objective: i. to assess the sensitivity on a per-patient and per-region-basis of gallium ga 68 gozetotide (68ga-psma-11) pet for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. secondary objectives: i. to assess the positive predictive value (ppv) on a per-patient and per-region-basis of 68ga-psma-11 pet for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up (composite reference standard). ii. to assess the sensitivity and positive predictive value (ppv) on a per-patient and per-region-basis of 68ga-psma-11 pet for detection of tumor location confirmed by histopathology/biopsy only. iii. to assess the detection rates on a per-patient basis of 68ga-psma-11 pet stratified by prostate specific antigen (psa) value (0.2 - \ = 5.0). iv. to assess the impact of 68ga-psma-11 pet on clinical management in biochemical recurrence (bcr) patients. v. to assess the inter-reader reproducibility. vi. to assess the safety of 68ga-psma-11 pet. vii. to assess the detection rates on a per-patient basis of 68ga-psma-11 pet stratified by psa velocity and psa doubling-time. outline: patients receive gallium ga 68-labeled psma-11 intravenously (iv). beginning 50-100 minutes after receiving gallium ga 68-labeled psma-11, patients undergo pet imaging. after completion of study, patients are followed up for 3-12 months.

Eligibility criteria:
inclusion criteria: * histopathological proven prostate adenocarcinoma * rising psa after definitive therapy with prostatectomy or radiation therapy. * post radical prostatectomy (rp) * psa equals to or greater than 0.2 ng/ml measured more than 6 weeks after rp * post-radiation therapy - american society for therapeutic radiation and oncology (astro)-phoenix consensus definition * nadir + greater than or equal to 2 ng/ml rise in psa * karnofsky performance status of \>= 50 (or eastern cooperative oncology group \[ecog\]/ world health organization \[who\] equivalent) * ability to understand a written informed consent document, and the willingness to sign it exclusion criteria: * concomitant investigational therapy * known inability to lie flat, remain still or tolerate a pet scan * patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
school-based oral health education program using experiential learning

Conditions: Caries; Gingivitis

Summary: the aim of this project was to compare the effectiveness of experiential learning (el) and traditional lecturing (tl) school-based oral health education on the oral health knowledge, attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old greek children. thee hundred and fifty children were selected from three areas of greece. information on oral health knowledge, attitude and behaviour were obtained using a questionnaire. dental plaque was recorded using a modified hygiene index, gingivitis was assessed using the simplified gingival index and dental caries was measured by recording the number of decayed, missing and filled teeth (dmft) using the british association for the study of community dentistry (bascd) criteria. all children were examined by two calibrated dentists, using a world health organisation (who) periodontal probe and artificial light. questionnaires were delivered and clinical examinations were performed at baseline and at 6 and 18 months post-intervention. the el oral health educational program was implemented by teachers using the program's manual.


Eligibility criteria:
inclusion criteria: * 10 and 13 year-old children * for the el group, students were recruited from schools that had teachers previously trained in el * students recruited for the tl group attended schools of the same geographical location as students in the el group exclusion criteria: * contributory medical history
amoxicillin susceptibility of oral streptococci after a 3-day or a 7-day amoxicillin therapy

Conditions: Odontogenic Infection

Summary: antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. to limit the risk to select resistant bacteria, the rules of prescription are to use high doses and short durations of treatment. the purpose of this study was to evaluate the interest to reduce amoxicillin treatment from 7 days to 3 days, in cases of odontogenic infection requiring the extraction of the tooth associated with amoxicillin monotherapy. the 3-day treatment will be compared to the classical 7-day treatment for clinical efficacy (pain, wound healing) and impact on the susceptibility of oral streptococci to amoxicillin.

amoxicillin treatment starts the day of the inclusion in the study (day 0). dentists and participants were blinded to treatment assignment for the duration of the study. the infected tooth was extracted 2 days after the beginning of the antibiotic treatment, and the post-operative follow-up was done 1 week after tooth extraction (day 9). an additional follow-up was done one month later (day 30). clinical parameters were collected one week after tooth extraction (day 9). pain was evaluated by its intensity during the days following surgery (using an analog visual scale varying from 0 -no pain- to 10 -very intense pain-), and by the total amount (in mg) of paracetamol ingested. the infectious state was evaluated by local wound healing, regional adenopathy and fever. the wound healing score combined local inflammation and sensitivity, and the presence or absence of a blood clot. the streptococci resistance was assessed at the patient-level by the proportion of patient with at least one resistant streptococcus, and at the streptococcus-level by the proportion of resistant streptococcus out of the total streptococci flora. intermediate susceptibility to amoxicillin was defined as a minimum inhibitory concentration (mic) of 0.5-16 mg/l; resistance was defined as an mic greater than or equal to 16 mg/l.

Eligibility criteria:
inclusion criteria: * odontogenic infection requiring tooth extraction asociated with amoxicillin monotherapy * good condition * 18-60 years old * written informed consent provided exclusion criteria: * antibiotic prophylactic treatment * special infectious risk (immunodeficiency, diabetes..) * pregnant or breastfeeding women * amoxicillin contraindication * antibiotic treatment during the lasts 45 days

Keywords: amoxicillin drug resistance, microbial streptococcus surgery, oral
study to assess exactech's guided personalized surgery egps® in total knee arthroplasty

Conditions: Osteoarthritis

Summary: study to collect outcomes data for patients who are undergoing an exactech optetrak® primary total knee replacement using the exactech guided personalized surgery (egps®) manufactured or distributed by (exactech, gainesville, florida, usa).

the purpose of this study is to collect patient outcomes data for patients who are undergoing an exactech optetrak® primary total knee replacement using the exactech guided personalized surgery (egps®) manufactured or distributed by (exactech, gainesville, florida, usa). patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.

Eligibility criteria:
inclusion criteria: * patient requires a primary optetrak logic total knee arthroplasty * patient is skeletally mature with no obvious mechanical defect * patient is mentally capable of completing follow-up visits * patient is 18 years of age or greater at time of surgery * patient will be available for follow-up out to 2 years * patient has consented to participate in the clinical study exclusion criteria: * patient has a mental or physical condition that may invalidate evaluation of the data * patient is a prisoner * surgery is contraindicated according to the applicable product package insert * patient has a local or systemic infection * patient has a known sensitivity to one or more of the materials in the knee replacement system to be used * patient is pregnant
effect of metformin as add-on therapy on glycemic control and other outcomes in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus; Metformin

Summary: aim evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. however, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. this study investigated the effect of metformin as add-on therapy on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

design an open-label, add-on, self-control clinical trial. setting diabetes clinic of a teaching hospital in shenzhen china participants a total of 20 participants with type 1 diabetes, aged 18-60 years, will be recruited and treated with metformin as add-on therapy with insulin for 12 weeks. outcomes primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity c-reactive protein. the gut microbiota profile will be analyzed before and after intervention .

Eligibility criteria:
inclusion criteria: type 1 diabetes patients age 18-60years old 18 kg/m2≤bmi≤30kg/m2 ketonuria (-)； exclusion criteria: pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs
vitamin d and sexual health

Conditions: Bacterial Vaginosis

Summary: bacterial vaginosis (bv) develops when the concentration of healthy lactobacillus species in the vagina declines and is replaced by other bacterial species. bv is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. bv is associated with a 60% increased risk of hiv acquisition as well as numerous other detrimental reproductive outcomes. a profound racial disparity exists in bv prevalence in women in the united states (us): 23% of white women versus. 52% of black women have bv. the investigators hypothesize that inadequate vitamin d contributes to bv development and/or recurrence. vitamin d is essential to immune function, serving both to stimulate mechanisms associated with pathogen elimination and to regulate immune response. according to nationally-representative data, 90% of us blacks have insufficient vitamin d levels. in two recent analyses, low vitamin d was associated with higher bv prevalence in pregnant african-americans; a third replicated this finding in pregnant african-american and white women. the investigators wish to conduct a small, pilot randomized controlled trial (rct) to assess the effect of vitamin d supplementation among non-pregnant, bv-positive women at a public sexually transmitted disease (std) clinic. this small (n=150), two-arm, placebo-controlled, masked, 24-week rct of high-dose vitamin d supplementation will inform the development of future large-scale rct design and implementation.


Eligibility criteria:
inclusion criteria: * speak english; * be between 18 and 50 years old, inclusive; * be pre-menopausal; * have at least one ovary; * be positive for bacterial vaginosis exclusion criteria: * pregnant at enrollment or in the previous 3 months; * planning to become pregnant in the next six months; * currently breastfeeding; * currently be menstruating heavily; * have a contraindication to oral metronidazole treatment
verify the safety and effectiveness of the cerclage pessary in prevention and treatment of high-risk preterm pregnancy

Conditions: High Risk Pregnancy

Summary: verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.

prospective open-label multicentre randomized controlled trial. high-risk preterm pregnancy is that there are at least one history of spontaneous preterm birth and/or late abortion before 34+0 weeks, for high-risk pregnant women that meet the inclusion criteria, the early treatment with cerclage pessary at 12-18weeks compare with routine treatment. the patients will be informed of the intended therapeutic effect and possible side effects. if they agree and after obtaining their informed consent, they will be randomized to test group (cerclage pessary group) and control group (utrogestan group).

Eligibility criteria:
inclusion criteria: * women with a pregnancy and a history of at least one spontaneous preterm birth before 34+0 weeks and/or a history of late abortion * 12+0 -18+0 weeks of gestation * minimal age of 18 years * informed consent signature exclusion criteria: * the previous preterm delivery is iatrogenic proterm labor * major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * the pregnant woman with severe cervical erosion, cervical polyp, hemorrhage and the doctors think she could not use cerclage pessary * the pregnant woman with uterine cervicitis * the pregnant woman that has been confirmed premature birth * cerclage prior to randomisation * cerclage prior to randomisation * placenta previa totalis * active vaginal bleeding at the moment of randomization * spontaneous rupture of membranes at the time of randomization * silicone allergy * painful regular uterine contractions * the pregnant woman have the indication of operation cervical cerclage * current participation in other rct
transient electrocardiogram assessment in stroke evaluation

Conditions: Atrial Fibrillation; Stroke

Summary: in stroke survivors, atrial fibrillation is typically detected with short-term electrocardiogram (ecg) monitoring in the stroke unit. prolonged continuous ecg monitoring is impractical and requires substantial resources while insertable cardiac monitors are invasive and costly. chest and thumb-ecg could provide an alternative for atrial fibrillation detection post-stroke. the primary objective of our study is to assess the incidence of newly diagnosed atrial fibrillation during 28 days of chest and thumb-ecg monitoring in patients with cryptogenic stroke. secondary objectives are to assess health-related quality of life using short form-36 and the feasibility of the coala heart monitor in patients with stroke.

stroke survivors in region gävleborg, sweden, will be eligible for the study from october 2017. patients with a history of ischemic stroke without documented atrial fibrillation before or during ecg evaluation in the stroke unit will be evaluated by the chest and thumb-ecg system coala heart monitor. the monitoring system is connected to a smart phone application which allows for remote monitoring and prompt advice on clinical management. over a period of 28 days, patients will be monitored twice daily and may activate the ecg recording at symptoms. upon completion, the system is returned by mail. this system offers a possibility to evaluate the presence of atrial fibrillation post-stroke, but the feasibility of this system in patients who recently suffered from a stroke is unknown. in addition health-related quality of life using short form-36 in comparison to swedish population norms will be assessed. the feasibility of the coala heart monitor will be assessed by a self-developed questionnaire.

Eligibility criteria:
inclusion criteria: * patients, aged ≥18 years, with a validated diagnosis of ischemic cryptogenic stroke are eligible for the study. exclusion criteria: * for screening with chest and thumb-ecg, exclusion criteria are as follows: previously known atrial arrhythmia with an indication for anticoagulation, implantable defibrillator, pacemaker or insertable cardiac monitor, pregnancy, permanent indication for anticoagulation (including low-molecular weight heparin) due to atrial arrhythmia, mechanical heart valve, deep vein thrombosis, or pulmonary embolism. patients with a life expectancy ≤6 months (e.g. severe heart failure new york heart association functional class iv or malignancy) are likewise excluded.

Keywords: atrial fibrillation cryptogenic stroke ecg screening health-related quality of life short form-36 stroke thumb-ecg
lifestyle changes by the covid-19 (coronavirus disease 2019) pandemic in children with developmental delays

Conditions: Lifestyle-related Condition; COVID-19 Pandemic; Children With Developmental Delays

Summary: to evaluate the lifestyle changes caused by the covid-19 pandemic in children with developmental delays in taiwan.

two hundred and sixty children with developmental delays in shin kong wu ho-su memorial hospital will be included. the lifestyle questionnaire will evaluate the lifestyle changes of children with developmental delays during home isolation and release from home isolation during the covid-19 pandemic in taiwan. the parents of children with developmental delays will fill out the questionnaire.

Eligibility criteria:
inclusion criteria: * children diagnosed with developmental delays exclusion criteria: * children without developmental delays

Keywords: covid-19 pandemic lifestyle sleep children with developmental delays
a non-interventional clinical study to evaluate long-term safety and effectiveness of humira (adalimumab) in pediatric patients with moderately to severely active crohn's disease (cd)

Conditions: Crohn's Disease

Summary: this is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active cd who are treated as recommended in the local product label.


Eligibility criteria:
inclusion criteria: * for a patient enrolling into the humira treatment group; a pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active cd who has been prescribed humira therapy according to the routine clinical practice. * for a patient enrolling into the immunosuppressant therapy treatment group; a pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active cd who has been prescribed azathioprine, 6-mercaptopurine or methotrexate. * parent or guardian; or patient (if 18 years of age or older at enrollment and rolling over from an abbvie-sponsored investigational pediatric cd investigation trial) has voluntarily signed and dated an authorization for use/disclosure of data (audd)/informed consent form (icf) after the nature of the registry has been explained and the patient, patient's parent or legal guardian has had the opportunity to ask questions. exclusion criteria: * patients should not be enrolled into the registry if they are currently being treated with any investigational agents or are receiving any investigational procedures. * patients should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including humira.

Keywords: crohn's disease registry adalimumab crohn's inflammatory bowel diseases gastrointestinal diseases