Kornimate/medical-research-clean huggingface dataset:
a phase 1 safety and immunogenicity study of the epitope based dna vaccine (ep hiv-1090) in hiv-1 infected individuals receiving antiretroviral therapy (art)

Conditions: HIV Infections

Summary: the use of a bioject 2000 needle free injection device (nfid) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the hiv-1 ctl epitope dna vaccine (ep1090) in hiv-1 infected individuals receiving potent combination antiretroviral therapy (art) and who have undetectable levels of viral replication in plasma.


Eligibility criteria:
inclusion criteria: * hiv-1 infection * cd4 tcell count \>350 * hiv-1 rna levels to \<400 copies * negative hbsag and anti-hcv antibody exclusion criteria: * recent receipt of experimental hiv-1 vaccines * recent use of immunomodulatory agents * hypersensitivity or serious reactions to study vaccine components * active opportunistic infections

Keywords: hiv human immunodeficiency virus vaccines hiv vaccines peptide peptide vaccines hiv 1
profiling the endocannabinoid response to hedonic eating

Conditions: Obesity; Food Preferences

Summary: study into the endocannabinoid response to consuming a palatable versus a neutral food.


Eligibility criteria:
inclusion criteria: * healthy (self-report) * dutch * evaluating one of the used foods as palatable * evaluating one of the used foods as neutral * hb value between 8.1 and 11.0 mmol/l at screening exclusion criteria: * restraint eating * lack of appetite * difficulties eating/swallowing * endocrine disorders * energy restricted diet two months prior to study * weight change \> 5 kg in two months prior to study * stomach or bowel disease * taste or smell disorders (self-report) * not consuming foods used in the study * smoking \> 1 cigarette per day * drinking \> 21 units alcohol per week
china diabetes type 1 study (cd1s) by china alliance for type 1 diabetes

Conditions: Type1diabetes; Diabetes

Summary: the aim of the china diabetes type 1 study (cd1s) is to conduct a nationwide type 1 diabetes (t1d) registry study in patients with t1d and in pediatric adolescent patients with diabetes who had an age of onset \<= 20 years. cd1s compromises a retrospective study enrolling inpatients hospitalized from jan 1st, 2016 to dec 31, 2021, and a prospective study beginning from the year 2022.

the aim of the china diabetes type 1 study (cd1s) is to conduct a nationwide type 1 diabetes (t1d) registry study to investigate the demographic characteristics, metabolic control, complications occurrence as well as risk factors of patients with t1d, and to investigate the clinical features, complications' burdens and risk factors in pediatric adolescent patients with diabetes who had an age of onset \<= 20 years.

Eligibility criteria:
inclusion criteria: * 1. patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3) 1. clinical diagnosis of type 1 diabetes by a specialist 2. age at onset \< 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random c-peptide \< 200 pmol/l 3. initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies or 2. children and adolescents with diabetes mellitus at age of onset \<= 20 years, regardless of type and duration of disease. exclusion criteria: * for enrolment of patients with t1d, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age) * no insulin dependence for at least 6 months after diagnosis of diabetes mellitus. * no dka for 1 month off insulin for those with a history of diabetes \> 1 year. ③ c-peptide \> 800 pmol/l at any time point.

Keywords: type 1 diabetes; diabetes in young
use of a subcutaneous catheter for controlled ovarian stimulation

Conditions: Infertility, Female

Summary: subcutaneous medications are an integral part of controlled ovarian stimulation protocols for in-vitro fertilization (ivf), but daily or twice daily injections are both physically and emotionally burdensome for patients and their partners. this is a feasibility study to evaluate the use of the neria guard™ (unomedical, convatec) subcutaneous catheter for ovarian stimulation in ivf.

daily or twice daily injections are a standard part of controlled ovarian stimulation for in-vitro fertilization (ivf). these injections are both physically and emotionally burdensome for patients and contribute additional stressors to those already inherent to infertility. subcutaneous catheters have been demonstrated to be effective for administration of insulin, anticoagulants, and other medications in pediatric patients, and subcutaneous gonadotropin-releasing hormone pumps have also been used in hypothalamic patients. this study aims to assess the feasibility of a subcutaneous catheter in patients undergoing ovarian stimulation for ivf. primary outcomes will include the incidence of safety and catheter-related issues as well as assessment of patient satisfaction in cycles using the subcutaneous catheter. we will also closely monitor estradiol and follicle-stimulating hormone levels during stimulation to ensure adequate medication administration via the catheter as well as ivf outcomes including mature oocyte yield, embryo maturation, and pregnancy rates.

Eligibility criteria:
inclusion criteria: * female between 18 and 45 years of age undergoing controlled ovarian stimulation exclusion criteria: * none
validity of the electronic self-administered gerocognitive examination (esage)

Conditions: Mild Cognitive Impairment; Dementia

Summary: the self-administered gerocognitive examination (sage) is a valid and reliable cognitive assessment tool used to identify both mild cognitive impairment (mci) and early dementia. sage's self-administered feature, pen and paper format, and four equivalent interchangeable forms allows it to be given in almost any setting, does not require any staff time to administer and makes it practical to rapidly screen large numbers of individuals in the community or in their home.this trial is being conducted to study the validity of sage in a digital format (esage) for cognitive screening. the investigators will analyze the data to learn the correlations between esage and gold standard neuropsychological testing designed to differentiate normal cognition from mci and early dementia. the investigators will also find out whether the paper (sage) and electronic (esage) versions of sage could be used interchangeably or not. addendum: the esage was previously validated in an earlier stage of this trial. it was initially designed for tablet use and the exact same test has recently been formatted for smartphone use. this addendum is being conducted to study the validity of the smartphone esage compared to the tablet esage for cognitive screening.

participants will be recruited based on their esage scores and evaluated with neuropsychological testing and medical history to determine their status as normal, mild cognitive impairment, or dementia. the investigators will analyze the data to learn the correlations between esage and gold standard neuropsychological testing designed to differentiate normal cognition from mci and early dementia. the investigators will also find out whether the paper (sage) and electronic (esage) versions of sage could be used interchangeably or not. addendum: subjects will be scheduled for a one time visit where they will be administered both the tablet esage and the smartphone esage. esage tablet scores will be compared to esage smartphone scores to determine if the two formats are equivalent to each other.

Eligibility criteria:
inclusion criteria: * adults over 49 years old of either gender * vision and hearing sufficient for compliance with tests exclusion criteria: * diagnosis by a physician of moderate or severe dementia * intellectual disability
an observational study of patients with her2-positive metastatic or locally advanced breast cancer treated with herceptin (trastuzumab) in 1st line and without progression for 3 years

Conditions: Breast Cancer

Summary: this observational study will characterize retrospectively patients with her2-positive metastatic or locally advanced breast cancer who had received treatment with herceptin (trastuzumab) in 1st line and who were without progression for at least three years. patients will be followed prospectively for one year.


Eligibility criteria:
inclusion criteria: * female patients, \>/= 18 years of age * her2-positive metastatic breast cancer or locally advanced breast cancer * systemic treatment included herceptin as 1st line therapy * without progression for at least 3 years after the beginning of herceptin treatment * alive or not alive and treated or not treated with herceptin at the time of inclusion exclusion criteria: * disease progression \<3 years after beginning 1st-line therapy with herceptin
therapeutic effects and effects on body fat of glp-1 receptor agonists in patients with type 2 diabetes for 1-4 years

Conditions: Diabetes

Summary: the efficacy of long-term treatment with different glp-1ra (duragtide, semaglutide, losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and the effects of long-term treatment on blood glucose and body fat of patients.

at present, there has been no evaluation on the efficacy of long-term treatment of different glp-1ra (duragtide, semaglutide, losenatide, tirzepatide, ebenatide, etc.), and the effects of long-term treatment on patients' blood glucose and body fat. this study intends to follow up for 1-4 years. to observe the effects of different glp-1ra on body fat, insulin resistance, body weight, blood glucose, blood lipids, stomach volume, etc., in patients with type 2 diabetes, and explore the factors affecting the efficacy, so as to provide more evidence-based medical evidence for drug treatment and benefit patients.

Eligibility criteria:
inclusion criteria: 1. diagnosed type 2 diabetes according to the 1999 who standards; 2. received at least 8 weeks of simple diet control and physical exercise before screening; patients with type 2 diabetes who were treated with stable hypoglycemic drugs and had inadequate glycemic control within 8 weeks prior to screening; 3. hba1c≥7.5%； 4. bmi\>24kg/m2; 5. subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (smbg); 6. be willing to sign written informed consent and comply with the study protocol exclusion criteria: 1. use of any of the following drugs or treatments in the 3 months prior to screening: treatment with glp-1ra, glp-1 analogue, dpp-4 inhibitor, or any other incretin analogue; 2. long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening; 3. use of weight control drugs or surgery that can lead to weight instability within 2 months before screening, or are currently in a weight loss program and not in the maintenance stage: 4. history of acute and chronic pancreatitis; a history of medullary c-cell carcinoma, men (multiple endocrine tumors) 2a or 2b syndrome, or related family history; 5. clinically significant gastric emptying abnormalities; 6. tumors of any organ system that have been treated or not treated in the 5 years prior to screening; 7. had received coronary angioplasty, coronary stenting, or coronary artery bypass within 6 months before screening. negligent compensatory heart failure (nyha rating iii and iv), stroke or transient ischemic attack, unstable angina, myocardial infarction, persistent and clinically significant arrhythmia; 8. acute metabolic complications occurred within 6 months before screening; 9. before screening, any of the laboratory test indicators meet the following criteria: glutamic-pyrugenic transaminase \>2.5 times or aspartate transaminase \>2.5 times; egfr \ 5.64mmol/l.
apidra children & adolescents study

Conditions: Diabetes Mellitus, Type 1

Summary: primary objective: evaluate the percentage of patients achieving glycosylated hemoglobin (hba1c) level \< 8% (in patients of 6-12 years old) and hba1c level \< 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment secondary objectives: change in hba1c level at 6 and 12 months of treatment monthly rate of hypoglycaemia/per patient from the baseline to the end of the study change in daily dose of glargine and glulisine at 6 and 12 months of treatment.


Eligibility criteria:
inclusion criteria: * childrenadolescents with type 1 diabetes mellitus l(t1dm) onger than 1 year duration * age 6 -17 y.o. * with 8%\<hba1c \<10% * treated with insulin glargine and any rapid insulin * ability to perform a self blood-glucose monitoring (sbgm) * signed informed consent. exclusion criteria: * diabetes mellitus type 2 * childrenadolescents with type 1 diabetes mellitus previously treated with apidra * hypersensitivity to insulin glulisine * pregnant or lactation women * gestational diabetes mellitus * treatment with systemic corticosteroids in the 1 month prior to study entry * t1dm complications: such as already existing active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
us nab with rose versus us fnab with no rose

Conditions: Lung Cancer

Summary: this is an investigator-initiated, single center, controlled, randomized clinical trial with two parallel arms in a 1:1 ratio. the objective of the study is to systematically assess the influence of rapid on-site evaluation (rose) on the diagnostic yield for diagnosis and molecular profiling, as well as on the safety, of pulmonologist-performed ultrasound-assisted needle aspiration biopsy (us-nab) of superficial lesions across different metastatic sites in a series of consecutive patients with suspect locally advanced or advanced lung cancer.


Eligibility criteria:
inclusion criteria: * known/suspected lung cancer * presence of a suspected "superficial" metastasis at imaging studies (ct and/or pet) * indication to tissue sampling for diagnosis, staging and/or molecular profiling * 18 years or older * provision of a written informed consent exclusion criteria: * inability or unwillingness to consent * known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (ffp) * use of antiplatelet (excluded aspirin) or anticoagulant drugs that cannot be discontinued

Keywords: lung cancer rapid on-site cytological examination ultrasound-guided needle aspiration biopsy lung adenocarcinoma molecular profiling
photopheresis in gvhd after hematopoietic transplantation: characteristics of the procedure and of the cell product

Conditions: Graft Vs Host Disease; Extracorporeal Photopheresis

Summary: this is an observational study on extracorporeal photopheresis,an established therapy for the treatment of graft versus host disease (gvhd) post allogeneic haemopoietic stem cell transplantation. there are different techniques and devices to perform cell collection procedure, photoactivation and infusion of mononuclear cells. the investigators will enrol patients undergoing allogeneic transplants and extracorporeal photopheresis in order to understand whether the different ways in which photopheresis is performed affect cell products and clinical response.

the fpg stem cell transplantation programme has indicated extracorporeal photopheresis as the therapy of choice for the second-line treatment of steroid-resistant gvhd. if efficacy is supported by clear evidence in the literature, less clear are the mechanism of action, the qualitative and quantitative characteristics of the cells responsible for the clinical response, and the impact of procedural and instrumental variables on clinical efficacy. indeed, there are different techniques and devices to perform cell collection procedure, photoactivation and infusion of mononuclear cells. the investigators designed a prospective study that aims to collect data on patients, photopheresis procedures and related cellular products. the analysis of the data will allow the investigators to define the qualitative and quantitative characteristics of the cell products, associating them with the different techniques and instruments, and looking for possible associations with clinical response. the data collected will be able to contribute to the characterisation of the techniques, procedures and the definition of a minimum cell dose to be treated in order to obtain the response. the aim is to define the volume to be processed or the number of procedures to be carried out by analogy with what is now established practice for the collection procedures of other autologous or allogeneic therapeutic cells (stem cells, lymphocytes, granulocytes), laying the foundations for optimising the treatments and resources employed.

Eligibility criteria:
inclusion criteria: * diagnosis of gvhd post allogeneic hsc transplantation being treated with photopheresis; * signing of informed consent (ic) and consent to personal data processing exclusion criteria: -

Keywords: extracorporeal photopheresis
evaluation of 3d michigan appliance

Conditions: Myofacial Pain Syndromes

Summary: * 20 patients will be divided into 2 groups * group 1 : in which conventional appliance will be constructed after alginate impression * group 2 : in which 3d printed appliance will be constructed after intra-oral scanning


Eligibility criteria:
inclusion criteria: * patient with bruxism * trigger points * medically stable exclusion criteria: * • absence of other tmj problem
amifostine for head and neck irradiation in lymphoma

Conditions: Lymphoma; Hodgkin's Disease; Non-Hodgkin's Lymphoma

Summary: the purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment.

patients will be randomized into one of two study groups. one study group will receive amifostine prior to daily radiation therapy and the other group will receive radiation therapy alone. amifostine will be administered 30-60 minutes prior to radiation treatment. vital signs will be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately following radiation treatment. patients will also complete a quality-of-life questionnaire on the first and last day of radiation treatment. follow-up questionnaires will be done at follow-up visits 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after completion of radiation therapy. patients will be removed from the study if they develop an allergic reaction to amifostine.

Eligibility criteria:
inclusion criteria: * patients must be 35 years or older * histologically confirmed hodgkin's disease or non-hodgkin's lymphoma receiving radiation therapy to the head and neck area. * involvement of one or more of the following sites: cervical node, supraclavicular node, pre-auricular node, submental node, any salivary glands, any parts of the oral cavity, or any parts of the oropharynx. exclusion criteria: * prior history of head and neck malignancies * prior radiation therapy to the head and neck region * patients with stage i hodgkin's disease receiving radiation therapy alone * pregnant or lactating women * myocardial infarction within the 6 months of enrollment * clinically evident pulmonary insufficiency, except for patients with exertional dyspnea related to chest tumor itself.

Keywords: lymphoma radiation therapy amifostine
clinical evaluation for post bleaching hypersensitivity using desensitizing agent during in-office bleaching

Conditions: Tooth Bleaching

Summary: evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.

a randomized clinical trail will be done to evaluate the effect of a desensitizing agent acp oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.

Eligibility criteria:
inclusion criteria: * patients must show no signs of spontaneous dental pain. * male or female patients between the ages of 18 to 40. * patients with good general and oral health. * patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces. * patients should have central incisors determined to be shade c2 or darker exclusion criteria: * patient with spontaneous dental pain. * patient with anterior restorations or non carious cervical lesion. * patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits. * tempro-mandibular joint problems involving symptomatic pain. * patients taking analgesics that could alter their normal pain perception level. * pregnant or breast feeding women.
hepatomir cacld study

Conditions: Chronic Liver Disease and Cirrhosis; Chronic Liver Disease; Portal Hypertension

Summary: this study looks to gather data on hepatomir, a ce-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (cld). based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * chronic liver disease (more than 6 months) * lsm ≥ 10 kpa * outpatient at the clinical department of internal medicine ii, university hospital st. pölten * signed patient consent form exclusion criteria: * age older than 18 years * pregnancy * primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread

Keywords: hepatomir micro-rna hepatic decompensation acld