Kornimate/medical-research-clean huggingface dataset:
an exploratory sub-study for the red-hf™ (reduction of events with darbepoetin alfa in heart failure) trial

Conditions: Anemia; Cardiovascular Disease; Congestive Heart Failure; Heart Failure; Ventricular Dysfunction

Summary: the purpose of study 20060172 was to measure echocardiographic parameters and biomarkers in a subgroup of study subjects enrolled in study 20050222 (the red-hf trial). this substudy 20060172 was terminated early due to feasibility constraints. all subjects enrolled in 20060172 were also enrolled in study 20050222, which is ongoing. study data will be analyzed when study 20050222 ends, since unblinding before then would adversely affect study 20050222.


Eligibility criteria:
inclusion criteria: * signed informed consent for study 20060172 * randomized into study 20050222 exclusion criteria: * any condition or situation that, in the investigator's opinion, may put the subject at significant risk, render the subject unsuitable for accurate echocardiography, may confound the study results, or may interfere significantly with the subject's participation in study 20060172 or in study 20050222.

Keywords: exploratory study anemia pharmacogenetics testing biomarkers echocardiography
bone healing at non-submerged implants installed with different insertion torques.

Conditions: Edentulous; Alveolar Process, Atrophy

Summary: the objective of the study is to evaluate histomorphometrically the healing at implants installed with standard or very low insertion torque values.

very high insertion torque values have been recommended when immediate loading is applied to implants.1 however, it has been shown that similar clinical outcomes may be achieved even with insertion torque values ≤15 ncm when implants are splinted together. due to the contradictory outcomes on the influence of the torque on osseointegration and a lack of histological data in humans, there is a need of more evidences that may support the clinicians in the decision making when an unintentional low insertion torque occur at implants during the daily practice. so the aim of the study i evaluate histomorphometrically the healing at implants installed in twelve volunteer patients that will be recruited. two screw-shaped titanium devices will be installed in the distal segments of the mandible using insertion torque values of either \<10 ncm or \~30 ncm. the implants were left to heal in a non-submerged fashion. after 8 weeks, biopsies will be retrieved and ground sections will be prepared for histological evaluation.

Eligibility criteria:
inclusion criteria: * presence of at least two edentulous zone in the posterior segment of the mandible * ≥ 25 years of age * smoking ≤ 10 cigarettes per day * good general health * no contraindication for oral surgical procedures. * not being pregnant. exclusion criteria: * presence of systemic disorders * chemotherapy or radiotherapy; * smokers \>10 cigarettes per day * previous bone augmentation procedures in the region
associations between diabetes care and haptoglobin genotype on outcomes

Conditions: Diabetes; Cardiovascular Disease; Myocardial Infarction; Stroke

Summary: the adhoc cohort comprised 3044 dm individuals, treated in 47 chs primary care clinics, that underwent haptoglobin genotyping between 2 march, 2005 and 26 september 2006. individuals were eligible for inclusion if they had dm and were 55 years of age or older. all treatment decisions, regarding all aspects of care and follow-up of the study participants, remained at the discretion of the individual's primary care physician, who was blinded to the individual's hp type. hp distribution was: hp 1-1 285 (9.4%); hp 2-1 1248 (41.0%); hp 2-2 1511 (49.6%). hypothesis: strict glucose control (hba1c\<7%) reduces the rate of cardiovascular events only to diabetic patients with the hp 2-2 phenotype. we also postulated that, since hp 2-2 dm individuals are at an increased genetic susceptibility for cardiovascular disease (cvd), this unique cohort merits an investigation on the associations between various cvd risk variables and cvd events and establish whether any evident association was dependent of the individual's hp type.


Eligibility criteria:
inclusion criteria: * diabetic patients * 55 years old or older at the time of icare initiation. * known haptoglobin genotype * signed informed consent for icare study and registry

Keywords: diabetes mellitus cardiovascular disease haptoglobin
a bavarian evaluation of dorsal root ganglion (drg) stimulation for the treatment for chronic post surgical pain of the groin

Conditions: Post Surgical Groin Pain

Summary: 15-smi-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available axium neurostimulator in the management of chronic post surgical groin pain


Eligibility criteria:
inclusion criteria: 1. the patient is at least 18 years old 2. the patient is willing and able to comply with the examination schedule and the trial schedule. 3. the patient has suffered from chronic post-surgical neuropathic groin pain for at least 6 months 4. conservative treatments of the chronic pain including medication, physiotherapy and interventions have been exhausted 5. the pain level at the time of the baseline examination is at least 60mm on the visual analogue scale (vas) in the primary pain area (groin pain) 6. the patient is able to give consent in writing exclusion criteria: 1. pregnant or breastfeeding patients or those who plan to become pregnant during the study 2. it has been established in an examination by the tester that the pain has significantly worsened or changed its characteristics in the course of the previous month. 3. in the last 30 days, the patient has been treated with corticosteroids on an area scheduled for the stimulation. 4. in the last 3 months, the patient has been treated with radio frequency therapy on an area scheduled for the stimulation. 5. the patient has already been treated with an active implantable device, including an implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or an intrathecal medication pump. 6. the patient is not able to operate the stimulation device 7. the patient is currently suffering from an infection 8. the patient has participated in another clinical study in the last 30 days 9. the patient has a coagulation disorder or is taking anti-coagulants, which would make participation impossible, as per the study doctor 10. the patient has been diagnosed with a malignancy in the past 2 years
general clinical study of ajg555 in pediatric patients with chronic constipation

Conditions: Chronic Constipation

Summary: this baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of ajg555 orally administered for 2 weeks in pediatric participants with chronic constipation. the safety and efficacy of 12 weeks of administration will also be evaluated.


Eligibility criteria:
inclusion criteria: main inclusion criteria: * participants with chronic constipation * age: 2 years old or older and 14 years old or younger (at the time of the informed consent) * gender: n/a exclusion criteria: main exclusion criteria: * participants with organic constipation or participants suspected of having organic constipation * participants with symptomatic constipation or participants suspected of having symptomatic constipation * participants with drug-induced constipation or participants suspected of having drug-induced constipation

Keywords: ajg555 constipation phase 3 pediatric participants
gemcitabine, doxorubicin and paclitaxel (gat) as neoadjuvant treatment of breast cancer patients

Conditions: Breast Cancer

Summary: this is a multicenter, open-label, phase ii trial to assess the efficacy of the gat neoadjuvant regimen in patients with stage iii breast cancer.

2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery. the required number of patients has been calculated following simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. patients recruitment will continue until 43 patients have been enrolled. assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.

Eligibility criteria:
inclusion criteria: * stage iii breast cancer disease, with histological confirmation by true-cut or open-biopsy. * ages between 18 and 75 years old. patients older than 70 must have an adequate quality of life to be eligible. * patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy. * performance status of 0,1, 2 eastern cooperative oncology group (ecog). * at least a 6 month life expectancy. * neutrophils \> 1500; platelets \> 100000; haemoglobin \> 10 mg/dl. * adequate renal and hepatic functions, with serum creatinine \< 1.2 mg/dl and total bilirubin \< 2 mg/dl. * adequate contraceptive methods during the study and up to 3 months after. * adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction \> 55%. exclusion criteria: * inflammatory carcinoma or stage i, ii or iv breast cancer disease. * males. * active infection. * other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration. * concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory). * pre-existing motor or sensorial neuropathy \> grade 1. * inability for treatment compliance. * history of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin k. * history of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade. * history of myocardial infarction in the previous 6 months. * hypertension not controlled. * pregnant or lactating women.

Keywords: neoadjuvant chemotherapy. stage iii disease.
comparative analysis of postprandial effects in healthy and obese individuals

Conditions: Obesity; Normal Weigth

Summary: after eating, blood composition changes, including increased triglycerides and glucose, which can trigger postprandial inflammation. particularly with high-fat foods, pro-inflammatory lipopolysaccharide (lps) increases. this activates leukocytes to release pro-inflammatory cytokines. in industrialized countries where "snacking" is common, many people spend the day in a postprandial state. obese individuals tend to have chronic inflammation and show increased susceptibility to infections such as sars-cov-2. the main objective of the study is to investigate the response of leukocytes and the serum metabolome after food intake in individuals with obesity compared to healthy individuals, focusing on lps as a key stimulus of innate immunity.


Eligibility criteria:
inclusion criteria: * signed declaration of consent * from 25 years of age * bmi 20 kg/m2 - 25 kg/m2 or bmi 30 kg/m2 - 40 kg/m2 * good venous conditions for blood collection * sufficient understanding of the german language and sufficient mental state to understand information and instructions related to the study exclusion criteria: * nicotine consumption * high-risk alcohol consumption (more than one standard glass per day for women, more than two standard glasses per day for men) * antibiotic intake * taking probiotics, prebiotics and synbiotics, unless taken for more than 90 days * taking statins or other lipid-lowering medications (e.g., ezetimibe, fibrates) * taking oral antidiabetics * taking antacids * manifest diabetes mellitus * acute/unstable cardiovascular diseases * acute inflammatory diseases * autoimmune diseases * kidney diseases * food allergy or food intolerance to food components of the test meal (e.g. eggs) * celiac disease * pregnancy and lactation * inability to consume the test meal orally * placement in a clinic or similar facility due to official or court order (medical history) * participation in another clinical study (current or within the last 30 days prior to study entry) * a medical condition or regular medication use that, at the investigator's discretion, does not permit study participation or evaluation of study parameters or consumption of the investigational product (individual decision)

Keywords: high-fat diet high-calorie diet leukocytes lps
dynasplint for distal radius fracture

Conditions: Distal Radius Fracture

Summary: the purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures.


Eligibility criteria:
inclusion criteria: * distal radius fracture treated with surgical management and wrist flexion contracture upon follow up exclusion criteria: * carpal fractures (scaphoid, lunate, hamate, and trapezium) * radial nerve entrapment * arthrodesis * traumatic dislocation of the distal ulna

Keywords: distal radius fracture
evaluating sunitinib therapy in renal cell carcinoma using f-18 fdg pet/ct and dce mri

Conditions: Kidney Neoplasms; Carcinoma, Renal Cell; Kidney (Renal Cell) Cancer

Summary: to learn whether flourine-18 fluoro-deoxi-glucose positron emission tomography / computed tomography (f-18 fdg pet/ct) and dynamic contrast enhanced magnetic resonance imaging (dce mri) are better predictors of response to therapy than the current standard of care (ct or mri).

this is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (rcc) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim fdg pet/ct to evaluate the predictive utility of each of these measurements. the objectives were to evaluate the fdg pet/ct measurement parameters for prediction of prognosis after sunitinib therapy in patients with rcc using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.

Eligibility criteria:
inclusion criteria:- measurable disease by recist criteria * pathologic diagnosis of renal cell cancer * advanced (stage iv) renal cell cancer * karnofsky performance status of (kps\>70) * consent to participate in the clinical trial exclusion criteria:- patients who cannot complete a pet/ct scan. * pregnant women. * healthy volunteers. * patients participating in other research protocols will be excluded from this study. * metallic implants (prosthesis, icd, pacemakers), since these are contraindications for mri.
stability of biometry in meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. however, some recent studies indicate that preoperative biometry is influenced by dry eye disease (ded). hence, the investigator's study aims to investigate the effect of the therapy of mgd using the lipiflow® device on the stability of biometry and selection of iol.

accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. 31 patients suffering from ded caused by mgd will be selected and allocated randomly to therapy. patients with pre-existing ded therapy other than lubricants will be excluded. after completing prestudy-screening and baseline visit, lipiflow® therapy is applied to the study eye. follow-up visits will be scheduled two weeks and three months after baseline visit. each visit includes dry eye investigations and iol calculation by iolmaster 700 and cso ms-39. after each study visit an iol will be theoretically selected.

Eligibility criteria:
inclusion criteria: * age older than 18 years * evidence of meibomian gland dysfunction * meibomian gland secretion score equal or less than 15 (for 15 glands of the lower eye lid) using the meibomian gland evaluator (see below) exclusion criteria: * usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-a) * usage of systemic antibiotic therapy * any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia) * ocular surgery within prior 3 months * ocular injury within prior 3 months * ocular herpes of eye or eyelid within prior 3 months * active ocular infection * active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months * eyelid abnormalities that affect lid function * ocular surface abnormality that may compromise corneal integrity * pregnancy

Keywords: lipiflow meibomian gland dysfunction biometry
the increase of lung capacity using the lung master (pulmonary exerciser)

Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease; Asthma

Summary: investigators are studying how a device called the lung master device can help people breathe better. the investigational device increases the amount of air our lungs can hold, which is important for overall lung health. the lung master is not approved by the fda. the study has two visits approximately one month apart. in the first visit participants will take a spirometry test, particularly forced vital capacity (fvc), to measure volume change in the lungs. participants will take the investigational device home to use daily, either in the morning or evening. use will be recorded in a diary. after one month, participants will return for another spirometry test. each study visit will take about one to two hours to complete.

shortness of breath,or dyspnea, occurs when the lungs do not receive enough oxygen leading to discomfort when breathing. this occurs in a quarter of individuals seen in an outpatient setting. several factors can relate to breathlessness, including lung disorders, heart conditions, or stress. patients with breathlessness often experience physical limitations in their daily activities. various treatments for dyspnea are available, however, chronic breathlessness syndrome, such as asthma or chronic obstructive pulmonary disease (copd), still can persist even when treatment is available. the lung master (pulmonary exerciser) is a breathing device used for the respiratory treatment and rehabilitation of chronic breathlessness syndrome. the lung master increases resistance during inhalation and exhalation, which works to strengthen the respiratory muscle and improve overall lung function. therefore, this study will focus on determining how the lung master increases lung capacity in healthy individuals. the device is considered investigational and has not been approved by the fda. two groups of healthy participants will be sought for the study: ages 19 to 35 and ages 65 and above. each participant will have two in-office study visits approximately one month apart. each visit will take around one to two hours to complete. at the visits, a breathing test called a spirometry test will be done. during the one month interim, the study device will be used at home and the use recorded in a diary. the device must be used least once every day, either in the morning or in the evening for 5 to 20 minutes. you will be contacted after two weeks, and then return the device at the second study visit.

Eligibility criteria:
inclusion criteria: * able to complete the at home portion of the study daily * fall within the age ranges: 19-35 and above 65 years old exclusion criteria: * any respiratory or chronic conditions
study to evaluate blood cell lines from patients with gaucher disease

Conditions: Gaucher Disease

Summary: the purpose of this study is to learn more about gaucher disease. the information we collect from medical histories and a blood sample from people with gaucher disease may help us pinpoint certain things that are different between people who have gaucher disease and people who do not have gaucher disease. this information may be useful in the future to help find new treatments for gaucher disease.

this study is designed to evaluate the ex vivo response to pharmacological chaperone therapy by testing blood samples from previously treated and untreated patients with gaucher disease. the study will include patients with non-neuropathic gaucher disease (type i) and neuropathic gaucher disease (types ii and/or iii). all subjects will participate in one study visit. clinical information will be collected retrospectively from medical records. information collected will include gaucher disease diagnosis and history, medical history, family history, assessments of clinical severity, and genotype. a blood sample will be collected and various cells will be isolated for laboratory testing and research.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent by subject or legal guardian 2. male or female of any age 3. confirmed diagnosis of gaucher disease with known genotype 4. clinically stable and either treatment naïve or on a stable dose of enzyme replacement therapy and/or substrate reduction therapy for at least 6 months prior to study entry 5. available medical records for collection of retrospective clinical information exclusion criteria: 1. received any investigational product within 30 days prior to study entry 2. other significant disease or be otherwise unsuitable for the study, as determined by the investigator

Keywords: gaucher disease gaucher disease, type 1 gaucher disease, type 2 gaucher disease, type 3 neuronopathic gaucher disease non-neuronopathic gaucher disease lysosomal storage disease metabolism, inborn errors metabolic diseases sphingolipidoses genetic diseases, inborn
combined endophthalmitis and orbital cellulitis in patients with novel coronavirus disease (covid-19)

Conditions: Endophthalmitis and Orbital Cellulitis

Summary: to report on cases presented with combined endophthalmitis and orbital cellulitis as a first presentation of covid-19 infection.

this observation case series study included 5 patients referred to the ophthalmology department, minia university with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. on doing the work-up of covid-19 infection according to the recommendations of egyptian ministry of health, patients proved to be infected by the novel corona virus. in addition to the corona work-up, all patients were subjected to full ophthalmological evaluation, ocular ultrasound and orbital ct examination.

Eligibility criteria:
inclusion criteria: * patients with endophthalmitis and orbital cellulitis with covid-19 exclusion criteria: * patients without endophthalmitis and orbital cellulitis. * patients with endophthalmitis and orbital cellulitis not having covid-19 infection.

Keywords: endophthalmitis orbital cellulitis covid-19