Kornimate/medical-research-clean huggingface dataset:
(dds) in india: a screening tool to identify prediabetes and undiagnosed type 2 diabetes in dental settings

Conditions: PreDiabetes; Type2diabetes; Periodontitis

Summary: this study is conducted to evaluate validity of diabetes risk assessment in dentistry score (dds) in indian population as a screening tool to identify patients with prediabetes and undiagnosed type 2 diabetes in dental setting. the dds score of the patient will be correlated with the hba1c levels and periodontal status of the patient. such a study has been conducted in germany but none has been validated in indian population. hence this study aims to assess the performance of dds screening tool in indian population.

background- most of the models for t2dm risk assessment exist for use in medical settings and include data which is commonly unavailable to dentists. to overcome the limitation of applicability of existing diabetes-risk assessment tools in dental settings, the diabetes risk assessment in dentistry score (dds) was developed utilizing measures routinely available to dentists. it has been developed and validated in a german population and found to perform broadly at par with those validated for use in medical settings. rationale-models developed in a specific population need to be validated in other populations before they can be adopted. the dds screening tool has not been validated in indian population till date. objectives- to assess performance of dds screening tool in predicting the risk of prediabetes and type 2 diabetes mellitus among individuals seeking dental consultation in indian population. methods-the study participants will include individuals seeking dental consultation at a university teaching hospital in india. all participants will undergo dds risk-assessment followed by measurement of serum hba1c levels to establish diagnosis of health, prediabetes or undiagnosed t2dm. expected outcomes-it is expected that the dds screening model performs well in indian population, with scope for incorporation of the model during regular dental visits.

Eligibility criteria:
inclusion criteria: * inclusion criteria-adults aged ≥ 40 years exclusion criteria: * individuals with existing physician-diagnosed diabetes (of any kind) * pregnant females
long-term safety of protopic in atopic eczema

Conditions: Dermatitis, Atopic; Eczema, Atopic

Summary: patients who have participated in previous studies with tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with tacrolimus ointment 0.1%

a long-term, multi-centre, open label, non-comparative phase iii study in patients with atopic dermatitis. all centres in europe which have participated or are still participating in the fg-506-06-12, fg-506-06-18 or fg-506-06-19, fg-506-06-22 or fg-506-06-23 studies will be offered a participation in the protocol. only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. treatment is restarted after signs and symptoms reoccur. safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. the safety evaluation will include monitoring of routine hematology and serum chemistry parameters at baseline/day 1, week 1, month 6, month 12, month 18, month 24, month 30, month 36, month 42 and/or at the end of the study (end-of-study visit).

Eligibility criteria:
inclusion criteria: * every patient who has participated in the fg-506-06-12, fg-506-06-18, fg-506-06-19, fg-506-06-22 or fg-506-06-23 study, and has received at least one dose of study medication * patient is likely to benefit from further treatment with tacrolimus (fk506) ointment in the opinion of the investigator * patient has atopic dermatitis with body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older exclusion criteria: * patient has an infection requiring treatment * patient is known to be hiv positive * patient has a systemic disease, including cancer or history of cancer or aids, which would contraindicate the use of tacrolimus (fk506) ointment

Keywords: tacrolimus administration, topical drug safety adults children
study to evaluate the pharmacokinetics of filgotinib in participants with impaired hepatic function

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the pharmacokinetics (pk) of filgotinib and its metabolite, gs-829845, in participants with varying degrees of impaired hepatic function relative to matched, healthy controls.


Eligibility criteria:
key inclusion criteria: * eligible individuals will be male and nonpregnant, nonlactating females, aged 18 to 70 years (inclusive), body mass index (bmi) between 18 and 36 kg/m\^2 (inclusive), with either impaired hepatic function or normal hepatic function. * individuals will be current nonsmokers (no use of tobacco, nicotine-containing, or tetrahydrocannabinol \[thc\]-containing products within the last 14 days). * individuals with hepatic impairment will be categorized by the child-pugh-turcotte (cpt) classification system indicating hepatic impairment as follows: * class a (mild): cpt score 5-6 * class b (moderate): cpt score 7-9 * class c (severe): cpt score 10-15 * hepatic impairment must have been stable during the 3 months (90 days) prior to study drug. each individual in the control group will be matched to a individual with impaired hepatic function by age (± 10 years), gender, and body mass index (± 15%). note: other protocol defined inclusion/exclusion criteria may apply.
a novel method of preoxygenation using a bain circuit

Conditions: Healthy Volunteers

Summary: the purpose of this study is to determine whether rebreathing for a short time (a bit like breathing into a paper bag) will stimulate faster breathing and thus make the giving of oxygen more effective. the hypothesis is that the investigators method (rebreathing) will be faster than the current method of administering oxygen.

it is standard practice for patients to breathe oxygen before receiving a general anaesthetic. this is called preoxygenation. it is done by using a mask which fits snugly onto the face. but for how long should patients breathe oxygen? is taking deep breaths a good idea? what is the best oxygen flow rate? these questions are important because preoxygenation is one of the things which makes anaesthesia safe, so finding the best way of doing it might help save lives. previous research has attempted to identify the best way to give oxygen before anaesthesia. it seems that breathing pure oxygen for three minutes is enough, or if you are in an urgent situation, then taking deep breaths of pure oxygen for a minute will do. however, there is another possible way of doing it which has not yet been looked at. asking someone to breathe back in the air they have just exhaled seems, on the face of it, to be pointless at best. but doing just that for a very short time will make the person breathe harder. then when you give them pure oxygen, they will breathe it in really deeply and this might make the preoxygenation quicker. that's the theory. to test it we plan to ask 40 healthy people to do the standard preoxygenation, then try our new way. we won't be giving anaesthetic, just the oxygen. the hypothesis is that our new method will be quicker than the existing one.

Eligibility criteria:
inclusion criteria: * bmi 18-27 * non-smoker * no chronic cardiorespiratory or neuromuscular illness * no intercurrent illness exclusion criteria: * unable/unwilling to consent
a randomized trial of induction methods in premature rupture of membranes

Conditions: Preterm Premature Rupture of Fetal Membranes; Induction of Labor Affected Fetus / Newborn

Summary: this study evaluates the addition of transcervical foley catheter balloon and vaginal prostaglandin e2 induction in premature rupture of membranes. half of participants will be used combine transcervical foley catheter balloon and vaginal prostaglandin e2, while the other half will be used alone vaginal prostaglandin e2.


Eligibility criteria:
inclusion criteria: 1. singleton pregnancy, 2. gestational age ≥34 weeks, 3. rupture of membranes, 4. cephalic presentation, 5. bishop score ≤5, 6. had less than three uterine contractions in every 10 minutes. exclusion criteria: 1. patients who had contraindications for vaginal delivery, 2. previous uterine surgery, 3. fetal malpresentation, 4. multifetal pregnancy, 5. more than three contractions in 10 minutes, 6. contraindications to prostaglandins, 7. a category ii or iii fetal heart rate pattern, 8. anomalous fetus, 9. fetal demise 10. women with immediate delivery indications -
evolution of intracardiac electrograms recorded by left bundle branch pacing lead in patients with icd or crt-d

Conditions: Ventricular Tachycardia (VT); Ventricular Fibrillation

Summary: the goal of this observational study is to investigate the changes of lbb egm during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of icd/crt-d patients. the main question it aims to answer is: • does the lbbp lead can provide accurate, stable, and valid egm for icd/crt-d sensing and detection of ventricular tachyarrhythmia events? in each patient intracardiac egms of lbbp lead will be collected by ambulatory holter monitor at the time of peri-implantation and up to 6-month follow-up. egm collection will be collected at resting and walking conditions and overdrive pacing.


Eligibility criteria:
inclusion criteria: * patients aged \>=18 yrs. * patients indicated for icd or crt-d (primary or secondary prevention) * patients who recently (\<=30 days) received icd/crt-d implantation with lbbp * patients' egm can be digitally recorded * patients are willing to participate in the study and provide signed informed consent exclusion criteria: * patients received cied upgrade or replacement with old pacing leads * patients are pregnant * patients participate in another study that will confound this study
gastrocnemius recession vs. conservative treatment for chronic plantar fasciitis

Conditions: Plantar Fasciitis

Summary: the purpose of the study is to compare the clinical results for patients suffering from plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.

all patients will be instructed in stretching exercises. half of the patients will be randomized to proximal medial gastrocnemius recession. all patients will be followed for 1 year. additional long term follow-up will be 6 years after inclusion

Eligibility criteria:
inclusion criteria: * symptoms of plantar fasciitis lasting more than 12 months. * isolated gastrocnemius contracture exclusion criteria: * no previous surgery to foot or ankle * no active arthritis

Keywords: plantar fasciitis gastrocnemius recession
cholesterol and antioxidant treatment in patients with smith-lemli-opitz syndrome (slos)

Conditions: Smith-Lemli-Opitz Syndrome; Cone-Rod Dystrophy; Hearing Loss

Summary: patients with biochemically confirmed slos are being treated with cholesterol supplementation and antioxidant medication. they are carefully monitored with visits to clinic, laboratory testing including cholesterol and 7-dehydrocholesterol levels, vitamin levels, blood counts and liver and kidney function. on a serial basis, no more often than once a year, the patients undergo a series of tests under anesthesia, including electroretinogram (erg), brainstem audiometry (abr), and ophthalmologic exam under anesthesia to follow pigmentary retinopathy.

smith-lemli-opitz syndrome (slos) is an autosomal recessive disorder caused by a metabolic error in the final step of cholesterol biosynthesis, leading to cholesterol deficiency and accumulation of the cholesterol precursor, 7-dehydrocholesterol.patients with slos display complex medical problems including growth failure, intellectual disability, behavioral disorders, progressive retinal dystrophy, hearing loss and photosensitivity. dr elias was one of the original geneticists who discovered the cause of this disorder in 1994, and ever since has been treating slos patients with cholesterol supplementation. in 2008, a second medication called aquadeks, a mixture of vitamins and other compounds with antioxidant properties was added to the treatment regimen. aquadeks has since been replaced with a comparable medication named dekas plus.the purpose of the dekas plus is to allow treatment with antioxidant medications in an effort to prevent retinal degeneration, hearing and skin problems associated with slos. this protocol has been approved by the colorado multiple institutional review board and supported by the clinical translational research center (ctrc) since 2001. the following updated information is available about the protocol: 1. research has revealed that oxysterols are toxic compounds made from the cholesterol precursor, 7-dehydrocholesterol. these oxysterol compounds are severely neurotoxic and toxic to the retina, and treatment with antioxidants may help lower their levels, resulting in slowing of retinal deterioration. testing of oxysterol levels in patients with slos is now ongoing, in collaboration with a laboratory at university of washington in seattle (dr libin xu). it is hoped that testing of oxysterol levels in blood may help provide more updated info to help guide treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of smith-lemli-opitz syndrome * elevated levels of 7-dehydrocholesterol and 8-dehydrocholesterol * must be able to travel to children's hospital colorado annually * must have insurance coverage for erg/abr studies exclusion criteria: * absence of detectable 7-dehydrocholesterol/8-dehydrocholesterol * allergy to antioxidant medication

Keywords: antioxidant treatment oxysterols cholesterol deficiency accumulation of 7-dehydrocholesterol electroretinogram (erg) auditory brainstem response (abr)
cytokine-induced killer cell immunotherapy for surgical resected stage iii colorectal cancer patients after chemotherapy

Conditions: Stage III Colon Cancer

Summary: we hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage iii colon cancer can improve survival in this patient population over control. stage iii colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. we wish cik cell therapy can improve the survival rate of stage iii colon cancer patients.


Eligibility criteria:
inclusion criteria: * male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent * stage iii colon cancer * undergone complete resection of primary tumor * completed standard adjuvant chemotherapy * within 120 days of completion of standard therapy * ecog performancer status 0-2 * satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ascolt trial management group * anc ≥ 1.0 x 109/l * platelets ≥ 100 x 109/l * creatinine clearance ≥ 30 ml/min * total bilirubin ≤ 2.0 x the upper limit normal * ast \& alt ≤ 5 x the upper limit normal * completed the following investigations * completed the following investigations exclusion criteria: * hiv positive or other immunodeficiency disease * recently use of high dose glucocorticoid * uncontrolled hypertension (untreated systolic blood pressure \> 160 mmhg, or diastolic blood pressure \> 95 mmhg) * history of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years * patient having known allergy to capecitabine or oxaliplatin * pregnant, lactating

Keywords: colon cancer cytokine-induced killer cell immunotherapy
abt-378/ritonavir in combination with reverse transcriptase inhibitors in antiretroviral naïve hiv-infected subjects

Conditions: HIV Infections

Summary: to assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-hiv-1 infected subjects.


Eligibility criteria:
inclusion criteria * hiv-1 positive * antiretroviral-adult males * non-pregnant * non-lactating females at least 18-years old with plasma hiv-1 rna \> 5000 copies/ml, who were not acutely ill exclusion criteria * history of: * prior antiretroviral therapy * significant drug hypersensitivity * psychiatric illness that precludes compliance * an active substance abuser * positive test results for drug abuse * abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, sgpt/ast or sgpt/alt, creatinine, fasting triglycerides, significant abnormal ecg results * pregnancy or lactating female * received another investigational drug within 28 days of study initiation * unlikely to comply or unsuitable candidate in the opinion of the investigator

Keywords: stavudine hiv protease inhibitors ritonavir lamivudine reverse transcriptase inhibitors
vitaflow™ ii transcatheter aortic valve system pre-market trial

Conditions: Aortic Stenosis

Summary: this is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of microport™ cardioflow vitaflow™ ii transcatheter aortic valve system for the treatment of severe aortic stenosis.

this a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of microport™ cardioflow vitaflow™ ii transcatheter aortic valve system for the treatment of severe aortic stenosis. a total of 145 subjects will be enrolled in 18 clinical centers within china. clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.

Eligibility criteria:
inclusion criteria: 1. age≥70 years; 2. symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmhg(1 mmhg=0.133kpa), or effective orifice area\<0.8cm² (or eoa index\<0.5cm²/m²); 3. nyha≥ii class; 4. estimated life-expectancy\>12 months after implantation of the prosthetic valve; 5. anatomically suitable for the transcatheter aortic valve implantation procedure; 6. the patients considered to high-risk or not suitable for surgical aortic valve replacement (savr), as assessed by two or above heart surgeons; the patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement. exclusion criteria: 1. acute myocardial infarction (mi) in last 30 days before the treatment; 2. aortic root anatomy not suitable for the implantation of the transcatheter aortic valve； 3. complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation; 4. previous implantation of heart valve at any position； 5. hemodynamic instability requiring mechanical hemodynamic support devices; 6. need for emergency surgery for any reason; 7. hypertrophic cardiomyopathy with obstruction; 8. severe left ventricular dysfunction with left ventricular ejection fraction (lvef) \< 20%;severe right ventricular dysfunction; 9. active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months; 10. known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements. 11. congenital aortic valve stenosis or unicuspid aortic valve; 12. vascular diseases or anatomical condition preventing the device access; 13. active endocarditis or other active infections at the time of treatment; 14. participating in another trial and the primary endpoint is not achieved. 15. inability to comply with the clinical investigation follow-up or other requirements.
assessing efficacy and safety of dextenza 0.4 mg insert, following cataract surgery

Conditions: Corneal Edema; Corneal Defect; Anterior Chamber Inflammation; Ocular Pain; Corneal Staining; Visual Outcome; CME - Cystoid Macular Edema

Summary: assessing efficacy and safety of dextenza 0.4 mg insert, following cataract surgery

assessing efficacy and safety of dextenza 0.4 mg insert treating pain, and inflammation following cataract surgery compared to topical prednisolone acetate 1%.

Eligibility criteria:
inclusion criteria: * diagnosed with clinically significant cataract and are planning to undergo non-complicated clear cornea incision cataract extraction with posterior capsule intraocular lens in one or both eyes * are willing and able to comply with clinic visits and study related procedures * are willing and able to sign the informed consent form exclusion criteria: * under the age of 18 at the time of signing the informed consent form * pregnant or planning to become pregnant during the trial period * have visual acuity potential of less than 20/30 as recorded by a retinal acuity meter or potential acuity meter glare testing * have active infectious systemic disease * have active infectious ocular or extraocular disease * have punctal plug in the study eye * have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus) * have known hypersensitivity to dexamethasone or are a known steroid responder * have a history of ocular inflammation or macular edema * has history of laser vision correction (lasik, photorefractive keratectomy) in the operated eye * are currently being treated with immunomodulating agents in the study eye * are currently being treated with immunosuppressants and/or oral steroids * are currently being treated with corticosteroid implant (i.e ozurdex) * have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye * have a history of complete punctal occlusion in one or both punctum * currently using topical ophthalmic steroid medications * are unwilling or unable to comply with the study protocol * are determined by the investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
efficacy and safety of biphasic insulin aspart 30 flexpen™ in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any trial-related activities * completed the trial biasp-1236 exclusion criteria: * planned changes in use of any prescription medication that may interfere with glucose regulation * known or suspected allergy to trial products or related products * women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures * any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the investigator