Kornimate/medical-research-clean huggingface dataset:
hemodynamic changes of upper and lower extremities after spinal anesthesia

Conditions: Hypertension

Summary: the aim of this study is to evaluate the changes of venous flow, volume, and resistance in upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients compared with elderly hypertensive patients who undergoing spinal anesthesia for transurethral prostatectomy.


Eligibility criteria:
inclusion criteria: * \> 65yr men * who undergoes spinal anesthesia for elective turp * normotensive/hypertensive exclusion criteria: * vascular disease * contraindications for spinal anesthesia

Keywords: ultrasonographic exam on upper and lower extremities
a multi-center, randomized, double-blind, placebo-controlled study of the efficacy and safety of adefovir dipivoxil when added to standard antiretroviral therapy for the treatment of hiv-infected patients with cd4 cell counts >= 200/mm3

Conditions: HIV Infections

Summary: to evaluate the anti-hiv activity, safety, and tolerance of adefovir dipivoxil ( bis-pom pmea ) in combination with standard antiretroviral therapy for 48 weeks.

patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection with hiv rna titer \>= 2500 copies/ml (2.5 keq/ml) plasma. * cd4 count \>= 200 cells/mm3. * no new aids-defining event within the past 2 months. * life expectancy at least 1 year. * consent of parent or guardian if less than 18 years old. * tolerated antiretroviral therapy for the past 2 months. note: * kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active, serious infections other than hiv that require parenteral antibiotic or antiviral therapy. * gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication. * malignancy other than kaposi's sarcoma or basal cell carcinoma. concurrent medication: excluded: * immunomodulating agents such as systemic corticosteroids, il-2, or interferons. * isoniazid. * rifampin. * investigational agents (unless approved by sponsor). * systemic chemotherapeutic agents. prior medication: excluded: * parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks. * immunomodulating agents such as systemic corticosteroids, il-2, or interferons within the past month. * systemic therapy for ks within the past month. required: * antiretroviral regimen other than study drug. required: * antiretroviral therapy for at least the past 2 months. current alcohol or substance abuse that would interfere with compliance.

Keywords: drug therapy, combination acquired immunodeficiency syndrome aids-related complex antiviral agents adenine
intranasal insulin and its effect on postprandial metabolism in comparison to subcutaneous insulin

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine if glucose peaks higher and earlier after a meal when a patient is given intranasal insulin instead of conventional insulin treatment.

diabetes mellitus is a common metabolic disorder characterized by hyperglycemia which when untreated is associated with microvascular disease. most people with type 1 diabetes are treated with a combination of long-acting (basal) insulin and short-acting (prandial) insulin administered prior to meals. this necessitates multiple daily injections (\>3) which is a significant barrier to long-term compliance and treatment. intranasal administration of insulin has been developed in an effort to overcome the need for insulin injection prior to meals. the pharmacokinetic properties conferred to insulin by this route of administration suggest that postprandial glucose disposal may be stimulated leading to lower glucose concentrations in comparison to dosing via other routes. we propose to study postprandial glucose turnover in healthy volunteers with type 1 diabetes to determine the effect of intranasal insulin on glucose disposal. we wish to do so in order to develop a greater understanding of how the different bioavailability timing of intranasal insulin might alter postprandial glucose disposal and suppression of endogenous glucose production. in order to address these questions we will address specific aims: * peak postprandial glucose disposal is higher and occurs earlier, in the presence of intranasal insulin administration than it is in more conventional forms of insulin dosing. * peak suppression of endogenous glucose production is greater and occurs earlier, in the presence of intranasal insulin administration than it is in more conventional forms of insulin dosing.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes * age 18-50 * treatment management of mdi(multiple daily injections) or insulin pump * bmi between 19-30 kg/m2 * hba1c less than or equal to 8.0% * 75 g ogtt (oral glucose tolerance test)study with insulin concentrations \>80uu/ml exclusion criteria: * active proliferative retinopathy * active nephropathy * chronic upper respiratory conditions determined by md * pregnant or lactating female

Keywords: type 1 diabetes nasal insulin insulin deficiency insulin-dependent
smad4 methylation and expression levels in non-melanocytic skin cancers; smad4 protein positivity

Conditions: Basal Cell Carcinoma

Summary: non-melanocytic skin cancers are the most common type of cancer worldwide. in the development of this cancer type, environmental factors such as uv and smoking are emphasized. epigenetics are genetic conditions that develop due to environmental factors and can be inherited. epigenetic modifications such as dna methylation play an integral role in carcinogenesis, cancer progression and metastasis. the tgf-/ smad4 pathway plays a tumor suppressive role in cancer pathogenesis. epigenetic changes in this pathway also lead to a decrease in expression level, leading to different types of cancer. however, there is no study showing the epigenetic relationship between non-melanocytic skin cancer and smad4 methylation. in this study we planned, it was aimed to show the change in smad4 methylation and smad4 rna expression level in cancerous tissue. in addition, it is planned to measure the smad4 protein positivity rate in non-melanocytic cancers as an immunohistochemical marker. in this context, 60 patients who applied to trakya university dermatology and venereal diseases outpatient clinic and diagnosed with non-melanocytic skin cancer clinically and dermoscopically will be included in the study. tissue materials obtained from both cancerous and intact skin of the patients will be examined in trakya university medical biophysics and medicine pathology laboratories through various steps. our project is the first study to be conducted on this subject in terms of handling all non-melanocytic skin cancers, using human tissue and having a large sample. in addition, with the data to be obtained; we think that better clarification of the role of smad4 in non-melanocytic cancers and the use of smad4 as both a prognostic factor and an immunohistochemical marker in future studies will prevent this study. again, we anticipate that different treatment modalities will be developed and different functional studies can be designed through this pathway.


Eligibility criteria:
inclusion criteria: 1. people diagnosed clinically and dermoscopically with non-melanocytic skin cancer 2. no other cancer history 3. over 18 years old 4. newly diagnosed 5. no systemic or topical therapy exclusion criteria: 1. under 18 and pregnant 2. people with non-melanocytic skin cancer who are in the process of follow-up and treatment 3. has another cancer history

Keywords: basal cell carcinoma squamose cell carcinoma actinic keratoses smad4 methylation smad4 expression
comparative evaluation of melatonin versus mta on vital pulp therapy in young permanent first molars: an in vivo study

Conditions: Dental Caries in Children; Vital Pulp Therapy

Summary: the process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. untreated dental caries causes pulpal injury, inflammation, and necrosis. melatonin plays an essential role in the regulation of bone growth. the actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts.

the aim of this study is to evaluate and compare the pulp response of young permanent first molars after apexogenesis procedure, using melatonin versus mta clinically and radiographically. this study will be performed on 45 young permanent first molars that will be divided equally into three groups according to the material used following apexogenesis; groupi: mta, groupii: melatonin and groupiii: mta and melatonin. apexogenesis procedures will be carried out in children aged 6 to 8 years old. this will be followed by placement of mta or/and melatonin material as a sub base in the pulp chamber according to the group. then, placement of a conventional glass ionomer cement (fugi ix) as a permanent restoration will be conducted. then, an immediate postoperative periapical digital x-ray film will be taken for the patients. the patient follow-up will be assigned 1,3,6,9 and 12 months after treatment.

Eligibility criteria:
inclusion criteria: * 1- apparently healthy and medically free children. 2- their age ranges from 6-8 years. 3- both boys and girls will be included. 4- children should have mandibular permanent first molars with the following clinical and radiographic criteria. 4.1restorable young permanent first molars. 4.2absence of clinical evidence of pulp degeneration: * no history of spontaneous pain, history of night pain or pain that not relieved by analgesics. * no pain on percussion. * no mobility. * absence of abscess, purulent sinus or soft tissue edema. * bleeding should stop within 5 minutes after the amputated pulp stumps. exclusion criteria: * internal root resorption. * external root resorption. * inter radicular or periapical bone destruction (radiolucency) * a deep carious lesion radiologically that approaches the pulp
studying the effects of 7 days of gonadotropin releasing hormone (gnrh) treatment in men with hypogonadism

Conditions: Kallmann Syndrome; Idiopathic Hypogonadotropic Hypogonadism; GnRH Deficiency

Summary: men with idiopathic hypogonadotropic hypogonadism (ihh) lack a hormone called gonadotropin releasing hormone (gnrh). this hormone is important for starting puberty, maintaining testosterone levels, and fertility. the purpose of this study is to research the effects of treating ihh men with gnrh for 7 days.

despite variability in the triggers, timing, and pace of sexual maturity between species, all species utilize the final pathway of hypothalamic secretion of gonadotropin releasing hormone (gnrh) to initiate and maintain the reproductive axis. thus, gnrh is required for reproductive competence in the human. the classic studies from the 1970s clearly demonstrate that pulsatile release of gnrh from the hypothalamus is a prerequisite for physiologic gonadotrope function. absence, decreased frequency or decreased amplitude of pulsatile gnrh release results in the clinical syndrome of hypogonadotropic hypogonadism (hh). the phenotypic expression of gnrh deficiency in the human demonstrates considerable heterogeneity. defining the physiology of gnrh is critical to understanding the clinical heterogeneity of isolated gnrh deficiency and its comparison to other conditions resulting in hypogonadotropic hypogonadism (hh). the overall goal of this protocol is to investigate the neuroendocrine control of reproduction and specifically the physiology and pathophysiology of gnrh secretion and action in the human male. subjects will be selected from a group of adult men (18-65 years)based on the demonstration of a low testosterone level (\<100 ng/dl) in association with low or inappropriately normal gonadotropin levels. all patients will undergo an initial assessment that includes an overnight 12-hour frequent blood sampling study to determine their degree of endogenous gnrh secretion. following the overnight evaluation, subjects will have daily outpatient visits for 7 consecutive days when they will receive a gnrh bolus followed by 2hrs of blood sampling.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic hypogonadotropic hypogonadism (ihh) or kallmann syndrome (ks)adult male 18-65 years of age * serum testosterone \<100 ng/dl exclusion criteria: * no specific exclusion criteria

Keywords: kallmann syndrome idiopathic hypogonadotropic hypogonadism gnrh deficiency
a study to learn more about the long-term safety and effectiveness of molidustat as a treatment for japanese men and women with renal anemia

Conditions: Renal Anemia

Summary: in this study, the researchers want to learn more about the safety and effectiveness of molidustat in japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells. in previous clinical trials with a small number of participants, several important adverse events were observed. the researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of molidustat. the researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. the data from this study will be submitted to the health authority in japan in accordance with the local regulation.


Eligibility criteria:
inclusion criteria: * female or male participants with a diagnosis of renal anemia * decision to initiate treatment with molidustat was made as per investigator's routine treatment practice * molidustat naïve participants (with including the participants treated within three months before the contracted date at each site) * signed informed consent exclusion criteria: - contra-indications according to the local marketing authorization
study of ranibizumab administered in conjunction with photodynamic therapy with verteporfin in patients with subfoveal choroidal neovascularization and age-related macular degeneration

Conditions: Age-Related Macular Degeneration (ARMD)

Summary: ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (vegf) antibody and can penetrate through the many retinal cell layers following intravitreal injection. the present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal cnv secondary to armd


Eligibility criteria:
inclusion criteria: * patients 50 years of age or greater who have provided written informed consent * patients with subfoveal choroidal neovascularization lesions secondary to amd, either predominantly classic or occult with no classic component * patients who have a bcva score between 73 and 24 letters, inclusively, in the study eye using etdrs (approximately 20/40 to 20/320) * willing to return for all scheduled visits exclusion criteria: * - patients who have a bcva of \< 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters) * prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy * previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase c inhibitors, etc.) other protocol-defined inclusion/exclusion criteria may apply

Keywords: armd, ranibizumab, verteporfin
effect of a decision aid about statin use in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus; Dyslipidemia; Hypercholesterolemia; Cardiovascular Disease

Summary: background- statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. lack of knowledge or misinformation about statins may be responsible for inadequate statin use. objective- to test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes. methods - the investigators will develop a decision aid called statin choice and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients. outcomes- primary outcomes: adherence to the decision to use or not to use statins three months after using statin choice. secondary outcomes: acceptability of statin choice, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life. expected results- the investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. statin choice, along with a detailed users manual, will be directly applicable in clinical practice. data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of statin choice in diverse practice settings. significance- patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.


Eligibility criteria:
adult patients with type 2 diabetes attending a referral diabetes clinic, who are taking or not taking statins, and give consent to participate. excluded were patients who had sensory or mental impairments or language barriers that preclude them from using the intervention and therefore participate in this trial.
safety, tolerability, and immunogenicity of a clostridium difficile toxoid vaccine in healthy elderly volunteers

Conditions: Clostridium Infections

Summary: the purpose of this study is to determine the safety and tolerability of a modified c. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged \> or = 65 years. this is the companion study to h-030-008, in which healthy younger adults have already been dosed.

clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. hospital outbreaks of clostridium difficile-associated diarrhea (cdad) are associated with substantial patient morbidity and mortality. conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. new strategies are needed to limit the impact of this opportunistic pathogen. considerable evidence exists that immunity against c. difficile toxins may be effective in controlling cdad. 48 subjects will be enrolled to receive one of three dose levels of modified c difficile vaccine or placebo administered on a 3-dose schedule. the study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination.

Eligibility criteria:
inclusion criteria: * adult males or females, \> or = 65 years * in good general health * clinical lab tests within normal range * females must be post-menopausal * able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine exclusion criteria: * evidence of c. difficile infection * evidence of any previous antibiotic-associated diarrhea * active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea * history of malignancy within 5 years * history of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction * known or suspected history of immunodeficiency * active or inactive immune-mediated or inflammatory disease * history of drug or alcohol abuse disorders; * serology positive for hiv, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) * receipt of antibiotic therapy or an investigational drug within prior 30 days * blood or organ donation within prior 30 days.

Keywords: clostridium difficile
a prospective radiostereometric analysis (rsa) and clinical evaluation of the triathlon tritanium total knee replacement

Conditions: Osteoarthritis of the Knee

Summary: this study seeks to find out if the tibial and patellar components of the stryker triathlon tritanium primary total knee replacement achieve adequate fixation to the underlying bone.

primary hypothesis: the investigators expect the tibial and patellar components of the stryker triathlon tritanium knee to achieve adequate fixation to the underlying bone. secondary hypotheses: the investigators expect that there will be no continuous migration between one and two years post-operative in the triathlon tritanium components. the investigators expect to see a correlation between radiolucent lines and migration characteristics using rsa. the investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by rsa measurements as having inadequate fixation. the investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the triathlon tritanium knee.

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the knee indicating surgical intervention * scheduled to undergo a total knee arthroplasty * patients between the ages of 18 and 80, inclusive * patient is a candidate for triathlon tritanium cementless knee components implanted in accordance with product labeling exclusion criteria: * significant co-morbidity affecting ability to ambulate * prior arthroplasty, patellectomy or osteotomy with the affected knee * active or prior infection of the affected knee * morbid obesity (bmi \> 40) * medical condition precluding major surgery * severe osteoporosis * neuromuscular impairment * pregnancy * inability to give informed consent * inability to return for follow-up visits for a minimum of two years after surgery * currently participating in any other surgical intervention study * known allergy to metals * flexion contracture greater than 15° * extension lag greater than 10° * tibial subluxation greater than 10 mm on standing ap radiograph * lateral or medial collateral ligament instability (\> 10° varus/valgus) * leg length discrepancy greater than 10 mm