Kornimate/medical-research-clean huggingface dataset:
lateral shelf acetabuloplasty in perthes disease

Conditions: Orthopedic Disorder

Summary: the incidence of legg-calvé-perthes disease (lcpd) ranges from 0.4/100,000 to 29.0/100,000 children \<15 years of age. there is significant variability in incidence within racial groups and is frequently higher in lower socioeconomic classes. the typical age at presentation ranges from 4 to 8 years (average 6.5 years).the optimal treatment goal in legg-calvé-perthes disease (lcpd) is to obtain a spherical femoral head with good congruency to prevent or delay the onset of osteoarthritis after skeletal maturity. there is agreement that patients younger than 5years with a good remodeling capacity have a particularly excellent prognosis, irrespective of treatment.

older children more than 8 years usually have a poor prognosis, especially without treatment. apart from the age at diagnosis and surgery, the severity of femoral head flattening and the signs of "head at risk" are also associated with the final clinical outcome. the current surgical treatment options, including proximal femoral varus osteotomy, innominate osteotomy, lateral shelf acetabuloplasty,triple pelvic osteotomy, and chiari pelvic osteotomy have proved to be effective in covering the femoral head within the acetabulum. to promote the coverage of the femoral head, shelf acetabuloplasty directly increases the size of the acetabulum by implanting graft bone to the lateral rim. when used as salvage surgery, it may provide relief from pain and benefit the involved hip via femoral head flattening, especially in older children. it also improves the spherical remodeling of the femoral head and acetabulum by stimulating lateral acetabular growth. lateral shelf acetabuloplasty is able to increase the coverage of the femoral head, which is an important tissue for remodeling and preventing further femoral head deformation.

Eligibility criteria:
inclusion criteria: * age between 8 up to 14 years * patients with perthes disease and hinged abduction . * written consent, free and informed exclusion criteria: * age below 8 or above 14 years * patients without hinged abduction based on clinical exam and arthrogram under general anaesthesia * epiphyseal dysplasia * coagulopathy * unfit for surgery
efficacy & safety of zomig nasal spray for acute migraine treatment in subjects 6 to 11 years, with ole

Conditions: Migraine

Summary: to evaluate the efficacy and safety of zolmitriptan nasal spray (zns) in the acute treatment of migraine headache in subjects ages 6 to 11 years. part 1: approximately 20 weeks (includes screening and double-blind treatment). * screening will be performed based on the inclusion exclusion criteria specified in the study protocol. * randomize approximately 288 subjects into the double-blind crossover phase. part 2: approximately 100 subjects who complete the double-blind crossover phase will enter part 2, a 6 month open-label safety extension (ole). efficacy will be evaluated in the double-blind part of the trial. safety will be evaluated in both the double-blind and the ole.


Eligibility criteria:
inclusion criteria 1. parent or legal guardian is able to provide written informed consent and subject is able to provide assent. 2. subjects ages 6 to 11 years throughout the double-blind portion of the studyan established diagnosis of migraine 3. by history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3 hours per attack 4. by history, experiences at least 16 headache-free days per month on average exclusion criteria: 1. history of ischemic or vasospastic heart disease, arrhythmias associated with accessory conduction pathways (eg, wolff-parkinson-white syndrome), cerebrovascular disease, hemiplegic or basilar artery migraine, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, recent (within 24 hours) or use of another 5ht1 agonist, ergots or ergotamine-containing medications. 2. any medical condition, including severe hepatic impairment, which, in the opinion of the investigator, may put the subject at increased risk with exposure to zolmitriptan, or may interfere with the safety or efficacy assessments. 3. had an unacceptable adverse experience following previous use of any 5ht1b/1d agonist drug (in the opinion of the investigator). 4. had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans. 5. prior use of any nasal spray (triptan or dihydroergotamine \[dhe\]) for the acute treatment of migraine 6. disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of zns.

Keywords: migraine headache pain efficacy pediatric
non-invasive characterization in cardiac sarcoidosis

Conditions: Cardiac Sarcoidosis

Summary: in a study of cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to examine inflammation.

cardiac sarcoidosis is a serious medical condition which affects the heart. the purpose of this study is to characterize the relationship between the fdg pet findings and other markers of inflammation including using a new targeted pet radiotracer, 11c-pbr28, and analysis of blood specimens.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. must have undergone a cardiac positron emission tomography (pet) scan using 18f-fluorodeoxyglucose (fdg) for clinical reasons (i.e. referred by your doctor) within the preceding 30 days which showed evidence of active inflammation in your heart. exclusion criteria: 1. if you have two copies of a genetic variation called rs6971 which will prevent this tracer from generating high-quality images you may not participate. if you consent, a blood sample will be drawn to check whether you have this genetic variation. 2. pregnancy or breastfeeding. if you are female and still experience menstrual periods, you must be willing to use contraception until your participation in the study is complete. 3. allergy or intolerance to contrast dye containing gadolinium 4. claustrophobia which would prevent you from completing an approximately one hour mri scan 5. inability to lie flat with your arms by your head 6. abnormal kidney function (estimated gfr(glomerular filtration rate) \<60 ml/min/1.73 m2) 7. implanted pacemaker, defibrillator or other medical devices which are not safe for 3 tesla mri 8. metal in the eyes or shrapnel in the body 9. if you are clinically unstable you may not participate in this study. for example, if you have potentially life threatening abnormal heart rhythms which are not controlled by medication or other treatments, you cannot participate. also, if you need medications to increase your blood pressure or cardiac function due to weak heart muscle, you cannot participate. -

Keywords: pet cardiac sarcoidosis fdg cardiac mri
earliest stage treatment of aktinic keratosis with imiquimod 3.75% cream

Conditions: Actinic Keratoses

Summary: earliest stage treatment of actinic keratosis with imiquimod 3.75% cream: the study is to demonstrate that aktinic keratosis are present before they are clinically visible, i.e. in a subclinical stage. since on the basis of the research situation, also subclinical ak can proliferate into the dermis, it is possible that with the application of imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.


Eligibility criteria:
inclusion * male and female supposed-healthy volunteer outpatients, age: \> 50 years. * diagnosis: patients with chronically uv-exposed photodamaged facial skin. * consent by signing the icf (informed consent form) exclusion * current participation in another clinical trial * patients who are using topical glucocorticoids on the face. * known intolerance/hypersensitivity to imiquimod * pregnant/breastfeeding women * systemic disease, immunodeficiency
inhaled tacrolimus, add-on to inhaled corticosteroids & long acting b2 agonists in moderate to severe persistent asthma

Conditions: Asthma, Bronchial; Bronchial Asthma

Summary: this study will evaluate the efficacy and safety of tacrolimus in patients with asthma.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma * patients treated with inhaled corticosteroid and long acting beta 2 agonist * fev1(forced expiratory volume in 1 second)\>50% to 80% exclusion criteria: * respiratory infection within 2weeks * asthma exacerbation within 6 weeks

Keywords: tacrolimus immunosuppressant anti-asthmatic drug administration, inhalation
safety and efficacy on deoxyspergualin (nkt-01) in patients with lupus nephritis

Conditions: Lupus Nephritis

Summary: the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of nkt-01 in induction of response in treatment of lupus nephritis.

the purpose of this phase i/ii study ia to establish that dose of nkt-01 which leads to complete response during a minimum of 6 cycles of treatment without causing who grade 3 leukopenia (wbc \< 2x10\^9/l). the patients suffered from uncontrolled lupus nephritis (ln) and took ocs (\<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to nkt-01. therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of nkt-01 in induction of response in treatment of lupus nephritis.

Eligibility criteria:
inclusion criteria: * males and females aged 18-70 years. * a diagnosis of sle according to the acr criteria (at least 4/11 criteria). * sufficient signs to diagnose active sle nephritis. * serum creatinine concentration of \<= 5.0 mg/dl. * leucocyte counts \>= 4000/ul. * receiving ocs (\<= 1.0 mg/kg/day; a maximum dose of 80 mg/day). * prior treatment with cyclophosphamide, azathioprine, cyclosporin a, or any other immunosuppressive drugs. exclusion criteria: * chronic infection of hiv, hepatitis b, hepatitis c. * acute infection including fungal, viral, bacterial or protozoal diseases. * liver toxicity (who ctc class 2 and higher). no adequate liver function (total bilirubin \> 25 umol/l = 1.4 mg/dl unless explained otherwise (e.g. inherited, hemolysis), sgot \> 2.5 x n, sgpt \> 2.5 x n). * pregnant or lactating women * female patients of child bearing age without safe method of contraception. * anemia (hemoglobin \< 8.0 g/dl), leucopenia (leucocytes \< 4000/ul unless attributable to sle: leucocytes \< 2000/ul), thrombocytopenia (platelets \< 50000/ul). * neutrophils below 1000/ul. * hypogammaglobulinemia below 400 mg/dl of serum igg. * any other condition that in the eyes of the investigator might have rendered the patient unsuitable for participation in the study. this especially includes major and active sle organ involvement other than the kidney. patients with sle involvement of the central nervous system are not allowed to be included into the study. * history of malignancy. * current participation in another trial or lass than 6 months since participation in a similar trial.

Keywords: lupus nephritis deoxyspergualin immunosuppression
the study of azd8529 for smoking cessation in female smokers

Conditions: Tobacco Use Disorder

Summary: to evaluate the efficacy and safety of azd8529 for smoking cessation in female smokers.

this is a 19-week, multi-center, randomized, phase 2 clinical study comparing the efficacy of two different doses of azd8529 (1.5 and 40 mg) in smoking cessation. up to 2 weeks will be allowed for the screening period, followed by a 1-week, single-blind run-in period. at the end of study week 1 (on study day 8), medication compliance will be one of the factors used in a predictive enrichment strategy.

Eligibility criteria:
inclusion criteria: * be a female smoker between the ages of 18 to 75 years. * want to quit smoking. * be currently (last 30 days) smoking 10 or more cigarettes per day and report less than 3 months of consecutive smoking abstinence during the past year. * be able, in the opinion of the site investigator (si), to understand and follow all protocol-specified instructions and understand and provide written informed consent. * be willing to provide personal information for entry into a clinical trial registry. * agree to use and continue using at least one acceptable contraceptive method (oral contraceptives, iuds, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, condoms with spermicide, or abstinence) or, if not of childbearing potential, must fulfill one of the following criteria at screening: post-menopausal defined as amenorrhea for at least 12 months and with follicle stimulating hormone (fsh) levels in the laboratory defined post-menopausal range and/or documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation verified by the site investigator. * agree not to use any other smoking behavioral intervention (self-help or formal treatment), acupuncture, or other smoking cessation pharmacotherapy during the study. * agree to refrain from using dietary/herbal supplements other than vitamins and minerals for 7 days prior to receiving study drug and throughout the 13-week treatment period. * agree to attend all required clinic appointments (including 3 eye exams) during the course of the 19-week study. exclusion criteria: * please contact the site for more information

Keywords: smoking smoking cessation cigarette
prophylactic donor lymphocyte infusion after allo-pbsct for patients with very high-risk hematologic malignancies

Conditions: Donor Lymphocyte Infusion; Peripheral Blood Stem Cell Transplantation; Relapse; Graft-versus-host Disease; Decitabine

Summary: unmanipulated allogenic peripheral blood stem cell transplantation (allo-pbsct) has been an established treatment to cure high-risk leukemia/lymphoma. relapse is the main cause of treatment failure for patients with relapsed/refractory disease or with very high-risk gene mutations such as tp53, tet2 and dnmt3a. donor lymphocyte infusion (dli) is an option to reduce relapse after allo-pbsct for very high-risk disease without effective targeted therapy. in this study, the investigators aimed to compare the safety and efficacy of prophylactic dli with g-csf-primed peripheral blood progenitors for prevention of relapse after allo-pbsct in patients with very high-risk leukemia/lymphoma.

conventional dli has invariably been associated with high rates of severe graft-versus-host disease (gvhd) and gvhd-related non-relapse mortality (nrm). thus, in our previous studies, the dli procedure has been modified to use g-csf-mobilized peripheral blood stem cells (pbscs) instead of steady-state lymphocytes. g-csf mobilization results in the modulation of the polarization potential of t cells from th1 to th2. in addition, t-cell hyporesponsiveness is induced via the proliferation of dendritic cell 2 and monocytes and the down-regulation of cd28/b7. furthermore, g-csf augments nk-t-cell-dependent cd8+ cytotoxicity. these data constructed the rationale for the use of g-csf-primed peripheral blood dli to reduce dli-associated gvhd and enhance the gvt effect of dli. to date, there is no effective target therapy for acute leukemia with gene mutations such as dnmt3a, tet2 and tp53 and their response to chemotherapy and survival even after allogenic stem cell transplantation remains poor. hypomethylating agents were reported to reverse the repression of hla molecules and cancer testis antigens on leukemia cells, rendering them more sensitive to anti-leukemic activity mediated by dli. the use of low-dose decitabine after allogenic stem cell transplantation was safe for early hematopoietic reconstitution. therefore, decitabine was planned to be given prior to prophylactic dli in the current study.

Eligibility criteria:
inclusion criteria: * disease in the non-remission (nr) state prior to transplantation, including primary induction failure, relapse untreated or refractory to reinduction chemotherapy. * achieving cr1 with ≥3 cycles of induction of chemotherapy. * carrying tp53, dnmt3a, tet2 or flt3-itd gene mutation. exclusion criteria: * early relapse, either molecular relapse or hematological relapse. * primary or secondary graft failure. * concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure...).
medical data collection for the evaluation of radiofrequency ablation and cement augmentation for the treatment of secondary metastases to the spine

Conditions: Metastatic Malignant Neoplasm in the Spine

Summary: this study collects data on the use of radiofrequency ablation and cement augmentation for the treatment of cancer that has spread to the spine (metastases to the spine). radiofrequency ablation with cement augmentation is a useful approach for the treatment of secondary metastasis to the spine. information collected in this study may help doctors to learn the effectiveness of this therapy, and may help to evaluate optimal technique, appropriate patient selection, and management of complications.

primary objective: i. to evaluate the use of radiofrequency ablation and cement augmentation for the treatment of secondary metastases to the spine. outline: patients' medical data is collected retrospectively.

Eligibility criteria:
inclusion criteria: * patients who underwent radiofrequency ablation with cement augmentation at the department of interventional radiology at md anderson cancer center (mdacc) between 1/1/2017 and 9/26/2020 exclusion criteria: * none
accuracy of cardiac wearables devices to detect atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia. this study is to assess the heart rhythm device accuracy of five cardiac wearable devices (apple watch, kardia mobile/kardia mobile 6l, fitbit sense, samsung galaxy watch 3 and withings scanwatch, withings sa, model number: hwa09) and its detection algorithms in identifying af compared to a nearly simultaneously acquired physician-interpreted 12-lead ecg in a real world cohort of patients.


Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing electrophysiological study, pacemaker or implantable defibrillator (icd) implantation or electric cardioversion at the university hospital basel are eligible for study participation and will be asked to participate exclusion criteria: * use of a radial artery graft for coronary artery bypass grafting * tattoos located on the skin of the wrist or forearm where wearable device will be placed * patients receiving hemodialysis through arteriovenous fistula in the upper extremities * patients with inability to communicate and comply with all study requirements * patients who refused to participate in the trial

Keywords: cardiac wearables devices sinus rhythm (sr) lead-intelligent electrocardiogram (iecg) heart rhythm device accuracy
efficacy and safety of vildagliptin as add-on therapy to metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in japanese patients with t2dm. this study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of type 2 diabetes mellitus (t2dm) in japan.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy. * hba1c in the range of 7.0-10.0% * body mass index in the range 20-35 kg/m2 exclusion criteria: * type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes * significant heart diseases other protocol-defined inclusion/exclusion criteria may apply

Keywords: vildagliptin type 2 diabetes hba1c fasting plasma glucose
periodontal disease, microbiota and miscarriage

Conditions: Miscarriage; Parodontitis

Summary: cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages (= at least 3 miscarriages).the information will be collected during a routine maintenance, complete oral clinical and radiological examination (assessment carious, periodontal, mucosal and functional), which is part of the routine assessment in the service of odontology from toulouse university hospital. saliva and subgingival plaque samples, classically carried out in routine dental surgery as part of the health check-up oral, will be used to carry out bacterial assays.

cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages (= at least 3 miscarriages).the information will be collected during a routine maintenance, complete oral clinical and radiological examination (assessment carious, periodontal, mucosal and functional), which is part of the routine assessment in the service of odontology from toulouse university hospital. as part of the health check-up oral, will be taken: * salivary samples by sputum (1 per patient). the patient will retain her saliva for 1 minute in the mouth and it will be collected in a sterile bottle (approximately 5 ml). * samples of subgingival plaque in the periodontal sulcus (assessed during periodontal probing) using sterile paper points (minimum 3 and maximum 10 per patient) inserted for 30 seconds into the periodontal sulcus then put in a tube sterile. the plate collection is done by capillary action on the paper tip, a very small quantity is thus taken. a collection of the history and disease risk factors will then be carried out. periodontal problems (stress level assessed using the visual analogue scale, history personal and family periodontal diseases, oral hygiene habits, etc.) by a routine care interview, the clinical examination (visual examination and recording of oral and periodontal) and radiological examination.

Eligibility criteria:
inclusion criteria: * women whom had repeated miscarriages * at least 6 natural teeth exclusion criteria: * under antibiotic prebiotic or probiotics treatment one month prior to the study * with high infection risk (hiv,...)

Keywords: repeated miscarriages porphyromonas gingivalis saliva biological samples subgingival plaque
d-oct for detection and subtyping of bcc: a diagnostic cohort study

Conditions: Basal Cell Carcinoma; Optical Coherence Tomography

Summary: the current gold standard for diagnosing basal cell carcinoma (bcc) is the histopathological examination of biopsy specimen. however, non-invasive imaging modalities such as optical coherence tomography (oct) may replace biopsy if bcc presence and its subtype can be established with high confidence. subtype differentiation is crucial; while superficial bccs (sbcc) can be treated topically, nodular (nbcc) and infiltrative bccs (ibcc) require excision. dynamic oct (d-oct) is a functionality integrated within the oct device, enabling the visualization of vascular structures through speckle variance. descriptive studies have unveiled vascular shapes and patterns associated with bcc and its respective subtypes. these findings suggest that d-oct could contribute to the accuracy of bcc detection and subtyping. yet comparative clinical studies between oct and d-oct are lacking. in the proposed diagnostic cohort study, we aim to assess whether d-oct assessment is superior to oct in terms of accuracy for bcc detection and subtyping.


Eligibility criteria:
inclusion criteria: * 18+ years * lesions suspect for non-melanoma skin cancer or premalignancy * patient underwent d-oct scan and biopsy conform regular care exclusion criteria: * patient unable to sign informed consent.

Keywords: basal cell carcinoma optical coherence tomography imaging non-melanoma skin cancer