Kornimate/medical-research-clean huggingface dataset:
ultrasound in undifferentiated hypotension

Conditions: Hypotension

Summary: background * symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality. * misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions. aim - the aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency. methods * hypotensive (\<100 mm/hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins. * on the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed). * the diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician). * the statistical agreement is calculated by the k of cohen with p-value, confidence intervals and raw agreement (ra).


Eligibility criteria:
inclusion criteria: * arterial pressure \<100 mm/hg at presentation * at least one of the following symptoms: * unresponsive * syncope * impaired mental status * respiratory distress * severe malaise and fatigue exclusion criteria: * patients undergoing cardiopulmonary resuscitation * trauma patients * electrocardiographic and clinical diagnosis of stemi or nstemi * clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose) * late evolution of shock state in a patient already treated with known diagnostic tests

Keywords: emergency ultrasound focused ultrasound point-of-care ultrasound undifferentiated hypotension
clinical phase ii trial to evaluate cd34+ cells mobilization and collection in patients with fanconi anemia for subsequent transduction with a lentiviral vector carring fanca gene. fancostem-1

Conditions: Fanconi Anemia

Summary: fanconi anemia (fa) is a congenital disease characterized by bone marrow failure and increased incidence of malignant tumors. the project pursue the optimization of the collection of hematopoietic progenitor cells for later use in another clinical trial entitled "clinical trial phase i/ii to evaluate the safety and efficacy of the infusion of autologous cd34+ cells mobilized with mozobil and filgrastim, and transduced with a lentiviral vector carrying the fanca gene (orphan drug) for patients with fanconi anemia subtype a ". the objectives of this study are, therefore, to assess the safety and efficacy of cd34+ cells mobilization with mozobil and filgrastim, which is postulated the most efficient for the collection of cd34+ cells from fa patients.


Eligibility criteria:
inclusion criteria: * male or female \> 1 year * diagnosed of fanconi's anemia confirmed by instability chromosomal test with diepoxy-butane or mitomycin c * at least one of the following parameters must be higher than these values: hemoglobin:8,0 g/dl; neutrophils: 750/mm3; platelets: 30.000/mm3 * lansky index\> 60%. * left ventricular ejection fraction \>50%. * to grant informed consent in agreement with current law norms * women in childbearing age must obtain a negative result in the pregnancy test in serum or urine in the visit of selection and accept the use of suitable contraceptive methods since at least 14 days prior to the first dose of mobilizing treatment until the 14 days following the last exclusion criteria: * evidence of myelodysplastic syndromes or leukemia, or cytogenetic abnormalities predicted of these syndromes in bone marrow aspiration. cytogenetic analyses performed 2 months before starting study are accepted * patients with active infection process or any other underlaying severe medical process * severe functional alteration of organs (hepatic, renal, respiratory)(?3), according to national cancer institute (nci ctcae v3) criteria * haematopoietic transplant * any disease or concomitant process that is not compatible with the study as per investigator opinion * patients not elegible because of an psico-social evaluation * patients that received transfusional support during the last 3 months. * pregnant or breastfeeding women
efficacy and safety study of fibrin sealant with 4 iu/ml thrombin, vapor heated, solvent detergent treated (fs vh s/d 4) in face-lift procedures

Conditions: Facial Rhytidectomy (Face-lift)

Summary: the primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 iu/ml thrombin, vapor heated, solvent detergent treated (fs vh s/d 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).


Eligibility criteria:
inclusion criteria: * subjects planned for facial rhytidectomy * subjects who read, understand and sign the written informed consent * healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ecg * subjects 18-75 years old, inclusively * subjects who are able and willing to comply with the protocol requirements * female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery exclusion criteria: * pregnant or lactating women * subjects who have undergone previous face-lift surgery * subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension * subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.) * subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.) * subjects who had prior silicone injections to their face (botox and/or restylane are allowed) * subjects considered by the investigator to be smokers * subjects with ecchymosis and/or edema on the face on day 0, prior to surgery * subjects with known (documented) bleeding or coagulation disorders * subjects currently being treated with anti-coagulants * subjects treated with aspirin in the last 7 days or use of other non-steroidal anti-inflammatory drug (nsaids) within the last 7 days prior to surgery * subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension * subjects with diabetes mellitus * subjects with a history of bell´s palsy * subjects with connective tissue disorders * subjects with documented history of pathologically or pharmacologically induced immune deficiency * subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery * subjects with a known sensitivity to fibrin sealants * subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc) * subjects who have participated in another clinical study within 30 days prior to this study
evaluation of ttp399 in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to evaluate the safety and efficacy of ttp399 in type 1 diabetics. this study will be in 2 phases: phase 1 will evaluate the safety of different ttp399 dosage regimens over 1 week of daily dosing. phase 2 will evaluate the safety and efficacy of a ttp399 dosing regimen over 12 weeks of daily dosing.


Eligibility criteria:
inclusion criteria: * people diagnosed with t1dm, confirmed diagnosis prior to 40 years of age and a diagnosed for minimum of 1 year. * type 1 diabetics using either continuous subcutaneous insulin infusion (with lispro or aspart) or multiple daily doses of insulin * willing to use adequate contraception * no major surgeries or significant injuries within the past year and without an active infection. exclusion criteria: * diagnosis of t2dm, severely uncontrolled t1dm, maturity-onset diabetes of the young, insulin-requiring t2dm, other unusual or rare forms of diabetes mellitus, diabetes resulting from a secondary disease * receipt of an investigational product within 30 days of the screening visit or any therapeutic protein or antibody within 90 days prior to screening visit or any previous treatment with ttp399. * living in the same household or related to another participant in this study. * two severe episodes of hypoglycemia that required assistance by a third party within 3 months of screening visit * use of antidiabetic medications other than insulin 3 months prior to screening visit, systemic corticosteroids 1 month prior to screening visit, weight loss medication 2 weeks prior to screening visit, and antipsychotic medications 3 months prior to screening visit. * participation in any formal weight loss program or contemplating such therapy during the trial. * recent history of use of non-prescribed controlled substances or illicit drugs. * current alcoholism or a history of excessive alcohol consumption within 2 years prior to screening * history or presence of symptomatic autonomic neuropathy or chronic gastrointestinal disease. * personal history of long qt syndrome. * blood donation of approximately 1 pint (500 ml) within 8 weeks before screening visit * history of hemolytic anemia or chronic transfusion requirement. * history of cancer, other than non-melanoma skin cancer or uterine cervical cancer that required therapy in the past 5 years. * breastfeeding
ischemia modified albumin (ima) expression in the male and female population

Conditions: Group Identification

Summary: the study has as general objective to analyze in the adult population, (male and female) the presence of a very common protein, in its normal form and modified, isolated from the blood of patients and called albumin. the opportunity to observe the distribution of this protein in the population, provides the basis to be able to perform this type of assay also in the population of patients with pathologies, in the near future, with the aim of increasing knowledge on the subjective tolerability to orthopedic implants.

100 patients, waiting for elective surgical intervention (such as hip replacement or primary knee ligament reconstruction, arthroscopy), distributed evenly by gender and age (50 men, 50 women including 25 postmenopausal and 25 in bearing age) and afferent to the department of surgery prosthetic hip and knee of our institute, will be enrolled. at execution time of blood sampling routine, a further specimen of whole blood (7 ml) will be added which will be sent to the medical technology laboratory for ima dosage. in addition, total albumin, ferritin, transferrin and serum iron will be analyzed from clinical pathological laboratory. the investigators will be able to analyze the ima and normalized ima distributions with respect to gender factor and correlation with the three listed blood tests (ferritin, transferrin and serum iron).

Eligibility criteria:
* inclusion criteria: * caucasic * signed informative consensus * exclusion criteria: * patients wearing articular devices * pregnant (for female) * fractured patients * patients with oncologic diseases, hemochromatosis, hepatic diseases, thalassaemia, diabetes, anemia (hb\<9)
randomized controlled study comparing three different techniques for open hernia repair

Conditions: Inguinal Hernia

Summary: the primary aim is to evaluate if psh and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. the second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups


Eligibility criteria:
inclusion criteria: * 18-75 years * unilateral primary hernia * open surgery exclusion criteria: * recurrent hernia * bilateral hernia * laparoscopic surgery * female
acupuncture and escitalopram for treating major depression clinical study

Conditions: Depressive Disorder, Major

Summary: we will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.

this is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for major depression.

Eligibility criteria:
inclusion criteria: 1. between 18 and 75 years of age with no gender-based restriction. 2. fulfilling the diagnostic criteria of dsm-5 for major depressive disorder. 3. a hamilton rating scale for depression (hdrs-17) score ≥ 17 4. ability to read and understand mandarin chinese, at least nine years of education, and willingness to adhere to the study protocol. 5. the absence of acupuncture treatment within at least 1 year. 6. willingness to participate in the trial and provide written informed consent for the clinical trial. exclusion criteria: 1. lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth. 2. high suicide risk or presenting with suicidal ideation (a score of more than 2 points on the suicide question of the hdrs-17) at the time of entry. 3. medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram. 4. pregnancy or breastfeeding. 5. subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture. 6. candidates afraid of needles in general and reluctant to receive acupuncture in particular 7. known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency). 8. previous participation in other acupuncture trials.
non-invasive endopat increases diagnostic yield of cad by coronary angiography

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to assess the non-invasive, peripheral arterial tonometry (pat) testing as another way of predicting potential coronary artery blockages in the heart.

we are conducting a 16 minute, non-invasive endopat test on patients coming to our cath lab for a first-time angiogram. the angiogram results will be compared to the endopat results to determine if the endopat test, which generates a score, is successful in predicting who may have blockages in their coronary arteries.

Eligibility criteria:
inclusion criteria: * patients without known coronary disease who are referred for coronary angiography. * adults 18 years and older. exclusion criteria: * patients with known coronary disease, acute coronary syndrome, cardiac transplantation, and severe connective tissue disease.
non-invasive lung water monitoring in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the investigators conducted a prospective, convenience-sampled observational pilot study, enrolling adult patients with pulmonary hypertension who were either outpatients or inpatients in the cardiology department of our hospital. the measurement of remote dielectric sensing (reds) values was performed by reds™ pro. data were collected using the electronic medical record system of our hospital. participants were followed up within 6 months after discharge. the primary endpoints included all-cause mortality or clinical deterioration related to pulmonary hypertension.

the investigators conducted a prospective, convenience-sampled observational pilot study, enrolling adult patients with pulmonary hypertension who were either outpatients or inpatients in the cardiology department of our hospital. the measurement of remote dielectric sensing (reds) values was performed by reds™ pro. data were collected using the electronic medical record system of our hospital. participants were followed up within 6 months after discharge. the primary endpoints included all-cause mortality or clinical deterioration related to pulmonary hypertension. data were collected using the electronic medical record system of our hospital, including demographics, clinical diagnoses, past medical history, ancillary examinations and laboratory test, surgical procedures, and medication use. treatment and management of participants were in accordance with guideline recommendations. participants were followed up by telephone or outpatient visits within 6 months after discharge.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤85 years, with no gender restriction; * hemodynamic confirmation of ph via right heart catheterization (rhc) (mean pulmonary arterial pressure \[mpap\] \> 20 mmhg). exclusion criteria: * thoracic deformities or injuries precluding proper device fit (e.g., severe scoliosis, flail chest); * inability to use the reds™ pro non-invasive lung fluid monitor due to physical characteristics (height \ 190 cm; body mass index \[bmi\] \ 39 kg/m²); * prior implantation of a left ventricular assist device or cardiac transplantation; * congenital cardiac anomalies or intrathoracic masses affecting right lung anatomy; * hemodynamic profiles inconsistent with ph.
trial of tang-min-ling pills in the treatment of type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: tang-min-ling pills are made by chinese herbs extract, and data showed they had antidiabetic effects on the experimental rats and no obvious toxicity was found.this is a randomized, doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy and safety of tang-min-ling pills in the treatment of type 2 diabetic patients and explore the optimal dosage of tang-min-ling pills.

two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into 3 groups, and were given high-dosage (12g tang-min-ling pills every time), low-dosage (6g tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively. hemoglobin a1c (hba1c), fasting plasma glucose (fpg)、postprandial 2 hours plasma glucose(2hpg)、syndrome、symptoms、body mass index (bmi)、waist circumference (wc) of these groups were measured and analyzed. some safety indexes such blood and urine and stool routine examination, electrocardiogram (ecg)and liver and kidney function tests were measured and analyzed during the experiment. the treatment period is 12 week.

Eligibility criteria:
inclusion criteria: 1. patients with primary type 2 diabetes mellitus 2. bmi ≥ 24 kg•m-2 3. 30-70 years old 4. hba1c≥7.0%, and fpg\>7.0 mmol/l, but \ 11.1 mmol/l 5. informed consent has been signed 6. stagnated heat of liver and stomach syndrome according to tcm syndrome differentiation exclusion criteria: 1. the patients accepted diabetic treatment for more than a month continuously 2. the patients were treated by drugs in 3 week before they were given test drugs 3. diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month 4. the contractive pressure \>160 mmhg or diastolic pressure \>100 mmhg 5. pregnant, preparing for pregnancy or breast-feeding women 6. mental patients 7. the patients who have serious heart, lung, liver, kidney and brain or other primary complications 8. allergic persons 9. the patients who are attending other clinical trial 10. the patients who have serious diabetic complications 11. the patients who ever attended this clinical trial 12. alcohol and / or psychoactive substances, drug abuse and dependency 13. the person maybe loss for some reason such as work or life condition according to the investigator's judgement 14. the lipid-lowering or antihypertensive drug dosage and category which the patients are taking couldn't be kept stable 15. the patients who are eating some drugs or health food which can affect the body weight

Keywords: tang-min-ling pills; overweight type 2 diabetes mellitus; blood glucose traditional chinese medicine clinical trial intervention studies
platelet reactivity after receiving clopidogrel among moderate ckd patients undergoing pci

Conditions: Coronary Heart Disease

Summary: dual antiplatelet therapy (dapt) with standard doses of aspirin and clopidogrel has long been the cornerstone in patients undergoing percutaneous coronary intervention (pci). however, inhibition of platelet activation and aggregation after dapt varies greatly among patients. some clinical studies have demonstrated that patients with high on-treatment platelet reactivity are at increased risk of major adverse cardiovascular events. tailored antiplatelet therapy seems offer an opportunity to improve outcomes after coronary stenting by drug adjustment based on platelet function testing. unfortunately, the results of 3 major prospective trials (gravitas, arctic, trigger pci) of personalized antiplatelet therapy are neutral. in these studies, platelet function was only assessed by a single measurement and a single method early after the start of antiplatelet treatment. to test the stability of platelet reactivity measurements over time among patients undergoing pci, investigators use 3 methods (verifynow p2y12 assay, flow cytometric assessment of the phosphorylation status of vasp, light transmittance aggregometry) for platelet function testing in 2 periods (\~14days), with maintenance doses of clopidogrel.


Eligibility criteria:
inclusion criteria: 1. \>18 years old. 2.15 ≤ egfr \< 60 ml/min/1.73 m2. 3. clinically stable and following pci between 4 weeks and 1 year. 4. on clopidogrel (75mg/d) and aspirin (100mg/d) treatment at least 4 weeks. exclusion criteria: 1. conditions that alter platelet function. 2. conditions that increase bleeding risk.
engorgement study with a double electric breast pump

Conditions: Engorgement

Summary: the purpose of this study is to analyze the effectiveness of an fda approved class ii medical device, the simplisse double electric breast pump, in relieving the symptoms of engorgement.


Eligibility criteria:
inclusion criteria: * first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner. exclusion criteria: * greater than one week postpartum * less than 18 years of age * non-english speakers * not willing to use double electric breast pump

Keywords: breast pump engorgement lactation
video/audio distraction analgesia for simulated oncology procedure pain

Conditions: Pain

Summary: the purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. two of the distraction techniques include immersive virtual reality (vr). the most efficacious distraction technique will be used in a subsequent clinical study in cancer patients.


Eligibility criteria:
inclusion criteria: * healthy men and women * 18-21y, 40-60y, or older than 60y exclusion criteria: * a predisposition to motion sickness * unusual sensitivity or lack of sensitivity to pain * chronic pain * peripheral neuropathy * sensitive skin

Keywords: virtual reality oncology lumbar puncture