Kornimate/medical-research-clean huggingface dataset:
a phase ii clinical trial of yh23537 in patients with chronic periodontal disease.

Conditions: Chronic Periodontitis

Summary: this study is designed to evaluate the efficacy and the safety of yh23537 in korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

at screening visit, at least existing 18 teeth,mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the cdc / aap (center for disease control / american academy for periodontology) periodontitis classification (2012).

Eligibility criteria:
inclusion criteria: * subjects must be 19 years of age or older * have at least 18 natural teeth * have been diagnosed with chronic periodontitis * have been diagnosed mild/moderate/severe periodontitis with according to cdc / aap periodontal classification (2012)) * provide informed consent and willingness to cooperate with the study protocol exclusion criteria: * women of childbearing potential (wocbp) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product. * pregnant or lactating females * systemic diseases such as diabetes and hypertension * patients who take anticoagulants or antiplatelet agents * continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month * patients who received periodontal treatment within the last 6 months * patients who have malignant tumor * history of positive serologic evidence of current infectious liver disease including hbsag, or anti-hcv. * patients with mental retardation and dementia
cruz tunisia-multivessel registry

Conditions: Patient Population With Multivessel Disease

Summary: the primary objective of this registry is to evaluate the safety and clinical performance of the biodegradable polymer-coated supraflex cruz sirolimus-eluting stent (ses) in an unselected, all-comer patient population with multivessel disease. this population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (des).

this is a prospective, observational, single-arm, multi-center, registry designed to evaluate the safety and clinical performance of the supraflex cruz ses in an unselected, all-comer patient population with multivessel disease. the multivessel disease, defined as the presence of two or more vessels that will be exclusively treated with the supraflex cruz ses. the registry aims to reflect daily clinical practice including, but not limited to patients with chronic coronary artery disease (cad) as well as acute coronary syndrome (stemi and nstemi). all patients will be followed as per routine clinical practice together with either telephonic or clinical follow-up at 30 days, 6 months, and 12 months after the index procedure. subgroups are pre-specified for post-hoc exploratory analyses with respect to the primary endpoint of target lesion failure (tlf) at 12 months. the following subgroups are pre-defined according to their presentation at enrolment: 1. treatment in relation to clinical presentation \[acute coronary syndrome (acs)\] 2. treatment in relation to specific lesion subsets \[left main, chronic total occlusion\] 3. patients undergoing atherectomy

Eligibility criteria:
inclusion criteria: 1. patient must be at least 18 years of age 2. patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two supraflex cruz stents into the coronary vasculature during the index procedure 3. the patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a patient informed consent form 4. the patient is willing and able to co-operate with study procedures and required follow up visits exclusion criteria: 1. women with known pregnancy or who are lactating 2. high probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons) 3. currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements 4. patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for pci, cobalt chromium, sirolimus or contrast media

Keywords: multivessel disease, supraflex cruz, ses
share: simple haart with abacavir, reyataz, and epivir

Conditions: HIV Infections; Lipodystrophy

Summary: share: simple haart with abacavir, reyataz, and epivir

open-label, multicenter study of abc/3tc + atv in subjects who have completed at least 24 weeks of treatment on abc/3tc+atv/rtv as their first line regimen and have plasma hiv-1 rna \<50 copies/ml at entry

Eligibility criteria:
inclusion criteria: * currently taking abacavir/lamivudine (epzicom) in combination with atazanavir (reyataz) boosted with ritonavir (norvir) as first antiretroviral regimen * viral load \<50 copies/ml exclusion criteria: * viral load \>50 copies/ml * having taken more than one antiretroviral regimen

Keywords: hiv reyataz atazanavir norvir ritonavir boosted lipodystrophy treatment experienced
providing speech therapy awareness in private schools

Conditions: Speech and Language Disorder; Speech Therapy; Speech Delay; Swallowing Disorder; Acquired Language Disorders; Developmental Delay Disorder; Stuttering; Hearing Impairment; Head and Neck Cancer

Summary: there has been limited research in the area of speech and language therapy awareness in pakistan. the study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. this quasi experimental study will be a means of reaching out to schools and directly create awareness regarding the field and its scope. pre-assessment will be carried out and after which a 45 minutes presentation will be conducted face to face or through a webinar as per school directives. the results will be analysed quantitatively and pre-post assessment of the participants will be measured.

there has been limited research in the area of speech and language therapy awareness in pakistan. the study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. the study design is quasi experimental study sample size: 385. raosoft sampling technique: purposive sampling inclusion criteria: private english medium schools of islamabad and rawalpindi. schools with no speech and language therapists exclusion criteria: public schools and schools who may have visiting or permanent speech therapists on their panel. delphi technique will be used for development of a tool for the intervention and to assess the impact of the awareness program. the teachers will be tested pre and post program and three months after the completion of the program. three months post they will be a) tested on the same questionnaire b) will determine number of students identified with difficulties c) students referred to a therapist. data will be analyzed quantitative means and quantitative data will be analyzed using spss

Eligibility criteria:
inclusion criteria: * private english medium schools of islamabad and rawalpindi. schools with no speech and language therapists exclusion criteria: * public schools and schools who may have visiting or permanent speech therapists on their panel

Keywords: speech-language pathology awareness intervention teacher training
hyaluronic acid with scaling & root planing in chronic periodontitis patients with diabetes mellitus type 2

Conditions: Chronic Periodontitis

Summary: the present study aimed to assess the adjunctive use of hyaluronic acid with scaling \& root planing (srp) in patients with chronic periodontitis \& diabetes mellitus type 2.

thirty subjects with chronic periodontitis \& diabetes mellitus type 2 were included in this randomized clinical trial. these subjects were randomly allocated into test \& control equal groups. the test group comprised fifteen patients who received srp with subgingival application of hyaluronic acid as an adjunct. the control group included fifteen patients who received srp alone. plaque index (pi), gingival index (gi), probing depth (pd) \& clinical attachment level (cal) were measured \& documented at baseline, 6 weeks \& 12 weeks intervals.

Eligibility criteria:
inclusion criteria: * patients with chronic periodontitis and type 2 diabetes mellitus * minimum of 20 teeth * clinical attachment level (cal) ≥ 3 mm * probing depth (pd) ≥ 4 mm. exclusion criteria: * pregnant females * smokers
taekwondo for children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this study uses a mixed methods design to understand the effectiveness of using taekwondo as an intervention for children with asd and its effect on social interaction skills and everyday life. qualitative research emphasizes that meaning can be explained and interpreted only by those who experience it. a pretest-posttest design will be used to describe what occurs after the introduction of the taekwondo intervention and understand the changes that occur after exposure. collecting information through the lived experiences and observations from the parents will be collated with the pre and post results of the children participants' social interaction skills. qualitative data will be collected through pre and post semi-structured interviews with the parents to understand their observations of their child before and after completing the taekwondo program. interviews will also be conducted with the child to understand their perspectives on physical activity participation. interview questions will also explore how the effectiveness of the program has impacted the children's engagement in daily activities. quantitative research will be collected through pre and post results from the autism social skills profile-2 (\[assp\] assessment that will be completed by the parents. the assp-2 provides a comprehensive measure of social functioning for children and adolescents with asd.


Eligibility criteria:
inclusion criteria: * formal diagnosis of autism spectrum disorder (asd) * able to follow and understand english verbal instructions during the screening process. * no experience or prior experience with martial arts. * able to walk and move without using adaptive equipment exclusion criteria: * physical disabilities that would prevent participation in taekwondo (e.g. wheelchair bound)

Keywords: taekwondo autism spectrum disorder occupational therapy social interaction skills child participants
stad-1 small cell lung cancer toxicity adjusted dosing study

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to compare the activity of fixed doses of cisplatin and etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of small cell lung cancer.

the standard treatment for advanced small cell lung cancer (sclc) is combination chemotherapy of cisplatin or carboplatin with etoposide. standard fixed doses of this combination have been based on calculating a patient's body surface area. this method of dose calculation has been shown to be poorly correlated with the activity of many chemotherapy drugs, and some patients do not obtain adequate levels of the drug in their circulation. recent reports suggest that patients who have a very high tolerability to chemotherapy (without significant toxicity), are at risk for having less effectiveness of the therapy. this study will compare fixed doses of standard chemotherapy with a new strategy of the same chemotherapy with doses that will be adjusted according to the toxicity observed.

Eligibility criteria:
inclusion criteria: * cytologic or histologic diagnosis of small cell lung cancer * extensive disease according to valg classification * one or more target lesions. * performance status (ecog) 0 or 1 * age \<70 years. * patients with asymptomatic cerebral metastases are eligible * patients who have completed treatment with radiation therapy at least 4 weeks prior to enrollment are eligible * written informed consent exclusion criteria: * previous chemotherapy * previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix) * neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl * creatinine \> 1.5 x the upper normal limits * got and/or gpt \> 2.5 and/or bilirubin \> 1.5 times the upper normal limits in absence of hepatic metastases * got and/or gpt \> 5 and/or bilirubin \> 3 times the upper normal limits in presence of hepatic metastases * any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study * hypersensitivity to darbepoetin alpha, to r-huepo or their components * uncontrolled hypertension. * inability to provide informed consent. * inability to comply with follow-up

Keywords: chemotherapy toxicity adjusted dose
pharmacogenetics of vitamin d supplementation in tuberculosis

Conditions: Tuberculosis

Summary: previous studies of vitamin d supplementation have suggested there may be differences in response between individuals. this study is an open label study of vitamin d supplementation in patients with active or latent tuberculosis in which active disease patients take 100000units of vitamin d every 8 weeks during their tuberculosis treatment. genotyping for relevant vitamin d pathway polymorphisms will be carried out and related to clinical and ex vivo markers of vitamin d response. latent patients will only be studied for vitamin d response ex vivo. our hypothesis is that response to vitamin d in both monocytes and t cells will be related to polymorphisms in the dbp gene, and that this may relate to clinical response in terms of post supplementation vitamin d level.


Eligibility criteria:
inclusion criteria: * age 16 or above * microbiologically or histologically confirmed active tuberculosis * clinically confirmed latent tuberculosis exclusion criteria: 1. patients being managed with regimes outside standard nice guidance 2. drug resistant mtb 3. hiv positive 4. known intolerance of vitamin d 5. sarcoidosis 6. hyperparathyroidism or nephrolithiasis 7. taking vitamin d supplementation in the two months preceding enrolment 8. baseline serum corrected calcium \>2.65 mmol/l 9. current haemodialysis 10. children, pregnant or breastfeeding individuals 11. concomitant benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
evaluation of the protection activity of microfine titanium dioxide (ti02), pigmentary ti02 and bisoctrizole and their combinations in voluntary patients with idiopathic solar urticaria (su)

Conditions: Idiopathic Solar Urticaria

Summary: commercially available external photoprotectors (ep) do not provide adequate protection against ultraviolet a (uva) and visible wavelengths. the proposed medicinal product v0096 cr (formula rv3131a-mv1166) is a broad spectrum ep (bsep). the rationale for the use of v0096 cr (formula rv3131a-mv1166) in the proposed condition is based on its ability to broadly block the uva radiations and visible light that are known to trigger solar urticaria (su).


Eligibility criteria:
inclusion criteria: * male or female voluntary patients at least 18 years old * for female patients with child-bearing potential, negative pregnancy test at baseline * patients with a clinical and photobiological diagnosis of idiopathic su * patients with no underlying condition, or with underlying conditions provided that these conditions are stable and under control * patients able to follow instructions * written informed consent from the patients exclusion criteria: * children (less than 18 years old) * pregnant or lactating women * women with a positive pregnancy test at baseline * patients with spontaneous occurrence of su lesions on the back within 3 days prior to study entry * patients with a known allergy to one of the ingredients contained in the test products * patients who have applied ep to back skin over the previous 2 weeks before study entry * patients who have applied topical corticosteroids to back skin within 7 days prior to study entry * patients who have applied an emollient including white soft paraffin on back skin within 2 days prior to study entry * patients with systemic exposure to corticosteroids, anti-inflammatories or other immunosuppressive agents within the last 4 weeks prior to study entry * patients with oral antihistamines within the last 2 days prior to study entry * patients who have been administered systemic or topical photoactive medications for phototherapy or phototherapy alone within 1 week prior to study entry * patients with an unstable or non-controlled underlying condition * patients who are not able to follow instructions * patients who have participated in a study within the 3 months prior to study entry * patients who refuse to give written informed consent
switching from one type of anti-rejection drug (tacrolimus or cyclosporine) to another (sirolimus) approximately 90-180 days after liver transplantation

Conditions: Side Effects of Calcineurin Inhibitors; Renal Toxicity; Hepatic Fibrosis on Biopsy; Neurotoxicity; Post Transplant Diabetes

Summary: sirolimus can be safely switched as early as 90 days after liver transplantation with excellent tolerability and amelioration of the calcineurin inhibitor toxicity that initiated the switch.


Eligibility criteria:
inclusion criteria: 1. adult (18 years or older) patients undergoing liver transplantation at thomas jefferson university hospital. 2. diagnosed with at least one of the following cni side effects 90-180 days post transplantation: 1. cni renal toxicity. any liver transplant recipient who has elevated creatinine level (greater than 1.4 mg/dl) and impaired creatinine clearance (mdrd) of 40-60 ml/minute or decreased by 15% compared to baseline in the setting of having a therapeutic cni level, without suspicion of acute or chronic allograft rejection. 2. hepatic fibrosis on biopsy. any patient who has fibrosis seen on liver biopsy with lft's 2 times the upper normal limit. 3. cni neurologic toxicity. any patient who has significant neurological side effects from cnis. this will include the following: seizures not secondary to an epileptogenic focus or any metabolic derangement; alteration of speech ranging from aphasia to slurred speech; inability to be awake and alert. 4. post transplant diabetes. any patient who has developed diabetes after transplant and in whom cnis are thought to be contributing to poor glycemic control. 3. signed informed consent at approximately 90 -180 days post transplantation. exclusion criteria: 1. invasive/surgical therapy within 2 weeks of the 90-180 day post transplantation conversion. (e.g. patients with t-tubes would not be eligible for the study because the t-tube removal will coincide with the conversion date). 2. open surgical wound at 90-180 days post transplantation. 3. acute cellular rejection during the first 90-180 days post transplantation. 4. re-transplants or multiple-organ transplants. 5. active infection. 6. pregnancy. 7. malignancy within 3 years prior to liver transplantation (except adequately treated basal cell carcinoma). patients with hcc prior to transplant will not be excluded. 8. total cholesterol \>300 mg/dl on medical treatment or triglycerides \>150 mg/dl at 90-180 days post transplantation. 9. white blood cell count \<3,000/mm3 or platelet count \<100,000/mm3 at 90-180 days post transplantation. 10. ascites. 11. patients on chemotherapy. 12. urine protein/creatinine ration \> 0.5
bn80927 in patients with advanced malignant solid tumors

Conditions: Malignant Solid Tumour

Summary: the purpose of this study was to determine the maximum tolerated dose and the recommended dose of bn80927 in patients with advanced malignant solid tumors.


Eligibility criteria:
inclusion criteria: all included patients: * gave their written (personally signed and dated) informed consent * had histologically or cytologically documented malignant solid tumour * had received no more than three prior chemotherapy regimens * had failed the standard therapy or had no option of an active standard therapy * had an estimated survival time of greater than 3 months (according to the investigator's assessment) * had a world health organisation (who) performance status score ≤1 * were free from other serious concurrent disease * had adequate bone marrow function * had adequate liver function * had adequate renal function * who were female and of child-bearing potential must have had a negative result in a pre-study pregnancy test β-human-chorionic-gonadotrophin (β-hcg). exclusion criteria: no patient included: * was pregnant or lactating * was unable and/or unwilling to comply fully with the protocol and the study instructions; * presented with any concomitant condition, which could compromise the objectives of the study * had received an investigational drug within 30 days prior to study entry or was scheduled to require concurrent treatment with an experimental drug or treatment during the study * had received chemotherapy or hormonotherapy within 4 weeks of study entry, or had received chemotherapy with nitrosoureas or mitomycin-c within 6 weeks of study entry * had received any extensive palliative or curative radiotherapy (no more than 35% of their active bone marrow) within 2 weeks of study entry, or had not fully recovered from such treatment * had previously received a bone marrow transplant (bmt) or peripheral blood progenitor cells (pbpc) * had clinical evidence of major organ failure or brain metastases.
translational investigation of growth and everyday routines in kids (tiger kids) fitness ancillary

Conditions: Childhood Obesity

Summary: the purpose of this ancillary study is to examine cardiorespiratory fitness, cognitive factors related to appetite, and objectively-measured food intake in a subsample of children and adolescents with overweight to severe obesity enrolled in the tiger kids prospective cohort. the primary study also collects data on habitual physical and sedentary activity, body weight and body composition, and cardiometabolic health markers.

the investigators will enroll 30 boys and girls (50% female) between the ages of 10-16 years and above the 85th bmi percentile (i.e., overweight to severe obesity) in this pilot ancillary study. the objective is to examine interactions between the following energy-balance related factors: 1. ad libitum post-exercise food intake 2. cognitive factors, including inhibitory control, food wanting, and motivation for food 3. exercise-related factors, including cardiorespiratory fitness, substrate utilization (carbohydrate versus fat), and perceived exertion 4. habitual physical and sedentary activity 5. body composition and cardiometabolic health the prospective, longitudinal nature of the study will allow the investigators to examine these variables cross-sectionally and quantify change over two years. of particular interest is whether cognitive factors related to energy balance, including perceived exertion, inhibitory control, food wanting, and food motivation, vary across time or are relatively stable. finally, the investigators will assess the ability of these factors to predict changes in body composition and cardiometabolic health over two years.

Eligibility criteria:
inclusion criteria: * eligible for the tiger kids primary study * bmi \>/= 85th percentile * height \>/= 4 feet 6 inches * weight \< 350 pounds exclusion criteria: * anemia * american college of sports medicine (acsm) contraindications to exercise testing (i.e., medical history of cardiovascular or pulmonary conditions, physical conditions that affect the ability to exercise)

Keywords: cardiorespiratory fitness inhibitory control motivation food intake body composition