Kornimate/medical-research-clean huggingface dataset:
study of hst5040 in subjects with propionic or methylmalonic acidemia

Conditions: Methylmalonic Acidemia; Propionic Acidemia

Summary: this is an interventional study to assess the safety, pk, and efficacy of hst5040 in 12 subjects - 6 with methylmalonic acidemia (mma) and 6 with propionic acidemia (pa). the study consists of 3 parts: * part a: open-label, within-subject, dose escalation study in pa and mma subjects ≥ 2 years old to identify a safe and pharmacologically active (optimal) dose of hst5040 for use in part b. subjects will continue in a part a open-label extension until all subjects complete part a and the optimal dose of hst5040 is identified for use in part b. * part b: 6-month, randomized, double-blind, placebo-controlled, 2-period crossover in the same subjects from part a to evaluate safety and efficacy of the optimal dose of hst5040 in addition to standard of care (soc). * part c: open-label long-term extension study in pa and mma subjects ≥ 2 years old (n = approximately 12, 6 each) to evaluate the long-term safety and efficacy of the optimal dose of hst5040. this study will determine whether hst5040 can improve levels of disease-associated toxins that accumulate in patients with pa and mma.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of symptomatic pa or mma (mutase) * ages ≥ 2 years old. * history of inadequate metabolic control while receiving standard of care (soc). * plasma mca concentration \> 3x upper limit of normal of the reference range at screening. * stable supplementation dose of carnitine for at least 1 week prior to the entry in the study. exclusion criteria: * moderate-to-severely impaired cardiac function with lvef \< 45% by echo. * clinically significant arrhythmia by holter monitor. * qtcf \> 450 msec * moderate to severe chronic kidney disease with estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2. * exposure to any investigational therapy, apart for a covid-19 vaccine, within the past 6 months prior to study entry. * exposure to gene therapy for pa or mma at any time prior to study entry. * history of organ transplantation (part a and b only) * history of severe allergic or anaphylactic reactions to any of the components of hst5040.

Keywords: methylmalonic acidemia propionic acidemia organic acidemia inborn errors of metabolism pcca pccb propionyl-coenzyme a carboxylase mmut methylmalonyl-coa mutase metabolic disease genetic disease hemoshear
a study to test the potential of brillouin microscopy for biomechanical properties measurements in human cornea

Conditions: Pellucid Marginal Corneal Degeneration; Keratoconus; Keratectasia

Summary: the purpose of this research study is to find out if the new brillouin ocular scanner can measure the variation (difference) of the corneal elastic changes involved in the onset of corneal ectasia, induced by lasik surgery and cornea collagen crosslinking (cxl) treatment. ectasia refers to the thinning and bulging of the cornea and results in severe vision degradation (loss), which may occur because of a progressive disease (keratoconus) or because of lasik surgery. it is believed that the structural weakening of the cornea plays a major role in developing ectasia. cxl is a treatment that is able to halt the progression of ectasia. the brillouin ocular scanner is a technique based on the principles used in the laser speed measuring of a car (radar gun). when laser light illuminates a moving sample, a portion of the light slightly changes color. in our body, e.g in eye and corneal tissue, very weak sound waves are naturally present and they can induce a similar color shift. measuring this color shift with a sensitive light color meter (spectrometer), we will measure the sound speed in the tissue.


Eligibility criteria:
inclusion criteria: * subjects with healthy cornea * patients with mild, moderate, or advanced keratoconus * subjects diagnosed with pmd * patients before and after lask surgery * patients with keratoconus before and after collagen crosslinking treatment exclusion criteria: * normal volunteer group: presbyopia and/or cataract * keratoconus subjects group: corneas with scars developed, received any ocular surgery, such as laser vision correction surgeries or cxl treatment * subjects diagnosed with pmd: excludes corneas received any ocular surgery, such as laser vision correction or cxl treatment * patients before and after lask surgery corneas received priori ocular surgeries, taking any ocular medications except season allergy medicine such as artificial tears
estrogen patch for covid-19 symptoms

Conditions: COVID

Summary: the purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of covid19 positive or presumptive positive patients for 7 days can reduce the severity of covid19 symptoms compared to regular care. this study has two study groups. one group will receive the study drug, a single-use climara 25cm2 estrogen patch. the other group will receive standard of care. participants will be asked questions about their symptoms for up 6 times in up to 45 days.

as the covid19 pandemic has spread, it has been observed that adult men of all ages and older women are at higher risk of developing serious complications from infection with the virus. animal model studies of sars suggest that the age and sex difference in covid19 symptom severity may be due to protective and acute actions of the female sex hormone estrogen. animal and human studies support immune modulating effects of estrogen that are acute acting in viral infections and wound repair processes that may reduce the damaging effects of the virus on the lung and symptom severity. our hypothesis is that a short 7 day course of estradiol delivered in a transdermal patch applied to the upper buttock in covid19+ or presumptive positive patients will be safe and will reduce symptom severity in adult men and older women when given prior to intubation. covid19+ and presumptive positive patients not requiring intubation will be enrolled to the study and randomized to receive an estrogen patch or standard of care. patients will be followed up at day 1, 7, 14 and 28 for clinical symptoms and disease outcomes.

Eligibility criteria:
inclusion criteria: * male ≥ 18 years of age or female ≥ 55 years of age * documentation of covid19 positivity or the presence of one or more of the following new onset (\<7 days) clinical features defining presumptive covid19 1. fever of \>100.5°f or 38°c 2. shortness of breath 3. cough 4. radiologic evidence of pneumonia * able to provide informed consent * able to be contacted by telephone for follow-up exclusion criteria: * currently receiving estrogen based hormonal therapy * abnormal genital bleeding * protein c or protein s deficiency * pre-existing liver impairment (e.g. hepatitis c, cirrhosis) * history of anaphylactic reaction or angioedema with climara * receiving lamotrigine therapy * subjects with known past diagnosis of estrogen receptor positive breast cancer or endometrial cancer * subjects with severe hypoxia at risk for acute intubation in ed * history of stroke * any history of thromboembolic event including deep vein thrombosis or pulmonary emboli * current use of st. john's wort * males on testosterone * history of myocardial infarction, cardiac stents, or active angina
transcutaneous bilirubinometry and phototherapy

Conditions: Neonatal Hyperbilirubinemia

Summary: a randomized controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age \> 32 weeks and \< 15 days of age treated with phototherapy for neonatal hyperbilrubinemia.

a randomized controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age \> 32 weeks and \< 15 days of age treated with phototherapy for neonatal hyperbilrubinemia. main outcome measurement is the number of blooddraws for measurement of bilirubin. secondary outcome measurements are duration of phototherapy and hospitalisation.

Eligibility criteria:
inclusion criteria: * neonates with indication for phototherapy for treatment of hyperbilirubinemia exclusion criteria: * skinlesions located on the sternum interfering with transcutaneous measurement * exchange transfusion

Keywords: transcutaneous bilirubinometry phototherapy neonatal icterus neonatal jaundice newborn
a study of endostar combined with chemotherapy followed by endostar maintenance therapy to treat advanced non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: this single arm study will assess the safety and efficacy of endostar combined with chemotherapy (gemcitabine plus platinum-based chemotherapy) followed by endostar maintenance therapy in patients with stage iiib/iv non-small cell lung cancer (nsclc).

all eligible patients will receive endostar in combination with gemcitabine plus platinum-based chemotherapy for 4 cycles (21 days for each cycle). endostar treatment will continue after completion of chemotherapy cycles until disease progression. efficacy will be evaluated every two cycles.

Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of inoperable stage iiib/iv nsclc * at least one measurable lesion * age of 18-75 years * life expectancy \> 3 months * ecog performance status 0-2 * adequate hematologic, renal, and hepatic function exclusion criteria: * prior systemic chemotherapy for nsclc * evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture) * concurrent anticoagulation therapy * evidence of bleeding diathesis or coagulopathy * pregnant or lactating women * allergic to e.coli preparation
diagnostic accuracy of surepath™ in eus-fna

Conditions: Submucosal Tumor of Gastrointestinal Tract

Summary: it is a prospective randomized controlled study to evaluate the diagnostic accuracy of surepath™ liquid-based cytology in endoscopic ultrasound-guided sampling.

the surepath™ has been approved by the fda since 1997. investigators want to compare the diagnostic accuracy of surepath™ liquid based cytology and conventional smear cytology(csc) in eus-fna sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes. the investigators randomly assigned (1:1) patients to the surepath™ group or the csc group. aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. the primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. the aim of this study is to confirm that the surepath™ is not inferior than the conventional smear test.

Eligibility criteria:
inclusion criteria: * patients who signed the agreement after the explanation * patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(ct, mr, ultrasound) or endoscopic examinations. exclusion criteria: * those who did not agree with the study * patients younger than 19 years of age * serious mental patients * patients with severe accompanying diseases (esrd, advanced copd, severe heart failure, sever mental illness) * pregnant women * if eus is difficult due to previous surgery (billroth ii or tg with r-en-y) * patient with blood clotting abnormality * if there is a risk of tract seeding after examination
h. pylori eradication for moderate itp

Conditions: Immune Thrombocytopenic Purpura; Helicobacter Pylori; Immune Thrombocytopenia

Summary: the purpose of this study is to determine the efficacy of h. pylori eradication for the treatment of chronic or persistent immune thrombocytopenic purpura (itp) patients with moderate thrombocytopenia. this is a multi-center, open label, prospective randomized phase iil study.

current treatment guideline of itp recommends corticosteroid as the first line treatment when patient has active bleeding or less than 30×10\^9/l of platelet, because of side effect and cost issues. since the first case report by italian study, several investigators have reported that secondary immune thrombocytopenia (itp) can occur in patients with helicobacter pylori (h. pylori) infection. we already reported the efficacy of h. pylori eradication in moderate itp patients with phase ii study (annals hematology 2015:94:739-46). to improve the evidence of this strategy for the treatment of moderate itp, we plan to start this multi-center, open label, prospective randomized phase 3 study.

Eligibility criteria:
inclusion criteria: * age ≥ 19 years * persistent or chronic itp patients defined by international working group * 30 x 10\^9/l ≤ platelet level ≤ 80 x 10\^9/l * h. pylori infection should be confirmed by at least one of tests: urea breath test (ubt), clo, stool h. pylori ag, h. pylori in gastric tissue (reported by a trained pathologist) * no history of any itp treatment for the past 3 months * no previous history of h. pylori eradication treatment * patients who voluntarily participate in this study and with informed consents exclusion criteria: * patients who have any cause of thrombocytopenia such as hiv, hcv infection, lymphoproliferative disease, malignant neoplasm, liver disease, definite sle and other autoimmune diseases, drugs, mds and leukemia * uncontrolled hypothyroidism or hyperthyroidism * active bleeding for the past 3 months or history of hemorrhagic gastric ulcer or brain hemorrhage * active infection * patients who are taking anticoagulant or aspirin * patients with penicillin allergy or side effects of macrolide * patients who are taking mizolastine, terfenadine, cisapride, pimozide, astemizole, ergot alkaloid and its derivatives (ergotamine and dihydroergotamine), bepridil or atazanavir * patients who have known allergy or severe side effect on study drugs * pregnant or lactating women

Keywords: immune thrombocytopenic purpura helicobacter pylori
thermal screening for early diabetic peripheral neuropathy (dpn)

Conditions: Diabetic Neuropathies; Diabetic Foot; Diabetic Retinopathy

Summary: the goal of this research is to develop better tools for diagnosing illness of the feet and legs of people who have diabetes. investigators will use thermal videos of the foot to aid in the refinement of a system designed to detect signs of diabetic peripheral neuropathy (dpn). the team of investigators will also look at diabetic eye disease and how it might relate to diabetic foot disease.

this study focuses on further development and testing of a microvascular functional imaging system, a computer-based system for screening thermal video images, designed to detect biomarkers of diabetic peripheral neuropathy (dpn). additionally, severity levels of diabetic retinopathy (dr) will be compared with those of dpn. all participants in this study will undergo foot exams, thermal imaging of the foot, and standard retinal imaging. these non-invasive assessments will be performed at an initial study visit. some of the participants will be offered additional study visits. one of the additional visits involves a standard nerve conduction velocity assessment by a neurologist, the other involves a dpn exam by a podiatrist. portions of the study take place at university of new mexico health sciences center (unm hsc). the research utilizes services of the clinical translational science center (ctsc). the study is approved by university of new mexico health sciences center's human research review committee (hrrc), which coordinates and supports the activities of the three federally mandated human research review committees (hrrcs) responsible for reviewing and approving all human research.

Eligibility criteria:
inclusion criteria: • must be non-diabetic or diagnosed as diabetic for at least 5 years exclusion criteria: history of chemotherapy * surgery below the knee within the last 2 years * fractures below the know within the last 2 years * history of stroke * body mass index (bmi) greater than 35 * history of heart failure * peacemaker or implantable cardiovascular defibrillator * high blood pressure (over 180/100) * end-stage renal (kidney) disease or renal (kidney) transplant * peripheral edema greater than 2+ (swelling of the feet or hands) * diabetic foot ulcers * foot sores * raynaud's phenomenon * tobacco use within the last month. * treatment with glucocorticoids, including: * beclomethasone * betamethasone * budesonide * cortisone * dexamethasone * hydrocortisone * methylprednisolone * prednisolone * prednisone * triamcinolone

Keywords: screen
assessment of implant fixation and sf-36 for short hip-stems - a prospective clinical study

Conditions: Primary and Secondary Coxarthrosis; Dysplasia Coxarthrosis; Post-traumatic Necrosis of the Femoral Head

Summary: the primary purpose of this study was to evaluate the implant fixation of the nanos™ neck preserving hip stem (ohst medizintechnik ag, distributed by smith \& nephew gmbh, marl, germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (mbrsa).


Eligibility criteria:
inclusion criteria: * subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. for bilateral subjects at least three months between surgical procedures were required. * subject was willing to consent to participate in the study and planned to be available for the follow-up examinations. * subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function. * subject was 30 to 65 (inclusive) years of age at time of surgery. exclusion criteria: * subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery. * subject had a local or systemic infection. * subject had previously diagnosed osteoporosis. * subject had a femoral neck angle of \>145°. * subject had a femoral neck angle of \<125°. * subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (american society of anaesthesiologists' (asa) score 3 or 4). * subject had a documented allergy against elements of the implanted device. * subject had a neurological disease with changed motor function. * subject was pregnant. * subject had a body mass index (bmi) \> 30. * subject suffered from alcoholism or addictive disorders. * subject needed a revision hip arthroplasty. * subject had an insufficient command of the language to understand patient information and consent.

Keywords: nanos tha mbrsa
intra-nasal vs. intra-venous ketamine administration

Conditions: Major Depressive Disorder

Summary: the current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the iv route.


Eligibility criteria:
inclusion criteria: 1. age 18-65 2. diagnosis of mdd (major depressive disorder), made or affirmed by a senior psychiatrist in shalvata 3. madrs score \> 20 4. treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist. exclusion criteria: 1. active or past psychotic disorder, including a history of psychotic affective state 2. mental retardation or autistic spectrum disorder 3. prominent personality disorder 4. cardiac or neurologic active medical condition, including past cva/tia (cardiovascular accident/transient ischemic attack) or any other unstable medical condition. 5. chronic nasal congestion 6. active or recent drug or alcohol abuse 7. substantial suicidality in a patient requiring admission but refuses to do so, and signs an "against medical advice" release form as part of clinical evaluation, and does not answer the terms for involuntary admission.
pinaverium and herbs for irritable bowel syndrome treatment: an onset and offset study (phibest)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to test the onset of action, offset of action, efficacy, and safety of pinaverium and an herbal medication for irritable bowel syndrome (ibs) for a long term (over one year). pinaverium has been in many countries, but there is no randomized, double-blind, large sample size, and placebo-controlled study on this medication yet. tong xie yao fang (formula for pain and diarrhea) is a historically and contemporarily used traditional chinese medicine that can be used for ibs. the hypothesis is that the two remedies are effective and safe for ibs treatment with no significant different onset and offset of actions when tested by modern clinical standards and criteria.

pinaverium bromide (pinaverium), an antispasmodics, is one of the most commonly used ibs medication worldwide. however, original clinical studies on pinaverium are scarce. only five original clinical studies from europe, one from latin america, and one from asian were found. these studies were single-centered and small sample sized (19 - 53 ibs patients) studies. tong xie yao fang has long been used in china. its efficacy and safety has not been evaluated by modern scientific method. effectiveness, onset and offset of actions are the most considered factors when physicians choose medications for ibs. yet, to our knowledge, there are no clinical studies studied the onset and offset of actions of pinaverium, which remains one of the most transcribed ibs medications, and herbs, which are becoming more popular for treating ibs. this study is designed to evaluate onset and offset of actions, efficacy, and safety over a long term (\>1 year) of pinaverium and tong xie yao fang for ibs treatment in a double-blind, randomized, and large sample size clinical trial using placebo as a control.

Eligibility criteria:
inclusion criteria: * 18 to 70 years old age group, male and female * in accordance with the above western medicine rome iii standards. * in accordance with the above description of deficient spleen qi and liver qi stagnation * informed consent for treatment * no change in appetite during treatments periods exclusion criteria: * pregnant or lactation female patients, and fertility male patients * present digestive system disease within current three months * take ibs medicines within ten days prior to treatment or during treatment * take depression medicine within ten days prior to treatment or during treatment * take pain reliever medicine within ten days prior to treatment or during treatment * have serious primary heart, liver, kidney, lung and blood system diseases, asthma, and lung and liver dysfunction patients * if an emergency occurs; a physician terminates the treatment * cannot comply with the rules and cannot cooperate

Keywords: irritable bowel syndrome, pinaverium herbal medication for ibs, tong xie yao fang (formula for pain and diarrhea)