Kornimate/medical-research-clean huggingface dataset:
extension study of zemaira® i.v. administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency.

Conditions: Emphysema; Alpha 1-proteinase Inhibitor Deficiency

Summary: this study is a continuation of the placebo-controlled study ce1226_4001 (nct00261833) to evaluate the efficacy and safety of zemaira® intravenous (i.v). administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. the long-term verification of a disease-modifying benefit of zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (ct).


Eligibility criteria:
inclusion criteria: * subjects who have completed the 2-year treatment and observation period in the phase 3/4 zemaira® ce1226_4001 study (nct00261833) and are willing to sign informed consent * males, and non-pregnant, non-lactating females, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator exclusion criteria: * individuals residing in the us * current evidence of alcohol abuse or abuse of drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids * history of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol * current tobacco smoker (smoking must be discontinued for at least 6 months prior to study participation) * conditions or behaviors that interfere with attending scheduled study visits in the opinion of the investigator * history of non-compliance * administration of any other experimental new drug or participation in an investigation of a marketed product * inability to perform necessary study procedures

Keywords: alpha1-proteinase inhibitor deficiency chronic augmentation and maintenance therapy emphysema emphysema due to alpha 1-proteinase inhibitor deficiency
effects of nightshift work and sleep disturbances on erectile function

Conditions: Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea

Summary: we aim to observe the unwanted effects of nightshift work and short term insomnia on erectile function of men aged between 25 to 60 years. we will also compare the levels of serum testosterone in the target group and compare it with the ones who don't work in hightshifts.


Eligibility criteria:
inclusion criteria: * suffering from erectile dysfunction * mainly psychogenic ed * employed exclusion criteria: * patients with major organic causes erectile dysfunction (radical pelvic surgery/radiation therapy, uncontrolled diabetis mellitus, uncontrolled hypertension, new york heart association class 3-4 heart failure, acute coronary syndrome within 3 months, dyslipidemia) * neet(not in employment, education, training) patients
assessment of cardiac sparing in fetal hypoxia

Conditions: Fetal Hypoxia

Summary: the fetal heart plays a central role in the adaptive mechanisms for hypoxemia and placental insufficiency. longitudinal data on the hemodynamic sequence of the natural history of fetal growth restriction show that the umbilical artery and middle cerebral artery are the first variables to become abnormal . these arterial doppler abnormalities are followed by abnormalities in the right cardiac diastolic indices, followed by the right cardiac systolic indices, and finally by both left diastolic and systolic cardiac indices . preserving the left systolic function as the last variable to become abnormal ensures an adequate left ventricular output , which supplies the cerebral and coronary circulations.this defence is contingent on the fetal cardiovascular system, which in late gestation adopts strategies to decrease oxygen consumption and redistribute the cardiac output away from peripheral vascular beds and towards essential circulations, such as those perfusing the brain. adding cardiac doppler may improve management of the iugr fetus(intrauterine growth retardation), doppler ultrasound is valuable in defining the degree of cardiovascular compromise in at-risk pregnancies. the severity of fetal blood flow redistribution shows the degree of fetal adaptation and provides information on how long the pregnancy can be continued safely. the aime of the study is assessment of cardiac output redistribution in fetal hypoxia by estimating relative right to left side cardiac output wich reflect cardiac sparing in (iugr).


Eligibility criteria:
inclusion criteria: 1. women aged 20-35 years. 2. women with bmi from 20-30 kg/m2. 3. pregnant women in singleton fetuses from 32 to 34 weeks gestation. 4. women with late fetal growth restriction fetuses. it refers to an estimated fetal weight or abdominal circumference \<10th centile. those women had increased the resistant index (ri) in umbilical arteries above the 95th percentile at the time of recruitment (case group). 5. normal pregnant women (control group). exclusion criteria: 1. women with estimated fetal weight below the 5th or 3rd percentile. 2. women with premature pre-labor rupture of membranes. 3. women with antepartum hemorrhage 4. women with fetal congenital anomalies. 5. women with absent or reversed diastolic flow in the umbilical artery at the time of recruitment. 6. women with preeclampsia or on anti-coagulant thereby. 7. women who refused to participate in our study.
imatinib mesylate in patients with refractory desmoplastic small round cell tumors

Conditions: Refractory Desmoplastic Small Round Cell Tumors

Summary: an open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing pdgf-r. patients will be treated up to 12 months, or to disease progression. tumor will be evaluated according to recist criteria


Eligibility criteria:
inclusion criteria: 1. patients \> 16 years of age. 2. histologically documented diagnosis of dsrct, unresponsive or in no complete remission after any conventional multimodality approach. 3. immunohistochemical documentation of activated pdgf-r expression by tumor 4. at least one measurable site of disease 5. performance status 0,1, 2 or 3 (eastern cooperative oncology group) 6. adequate end organ function exclusion criteria: 1. patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing. 2. patient is \< 5 years free of another primary malignancy 3. patient with congestive heart failure or myocardial infarction within 6 months of study 4. female patients who are pregnant or breast-feeding. 5. severe and/or uncontrolled medical disease 6. known brain metastasis. 7. chronic active hepatitis or cirrhosis 8. known diagnosis of human immunodeficiency virus (hiv) infection. 9. chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing. 10. previous radiotherapy to \> 25 % of the bone marrow 11. major surgery within 2 weeks prior to study entry. other protocol defined inclusion/exclusion criteria may apply.

Keywords: refractory desmoplastic small round cell tumors pdgf-r
effect of selexipag on daily life physical activity of patients with pulmonary arterial hypertension.

Conditions: Pulmonary Arterial Hypertension

Summary: the primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (pah) in their daily life, by using a wearable wrist device (actigraph). the actigraph will collect data on daily life physical activity in the patient's real environment. in addition, the pah symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. patients will be assigned randomly to either selexipag or placebo.

this study is designed as exploratory with the purpose to generate hypotheses on new endpoints

Eligibility criteria:
inclusion criteria: * male or female between 18 and 75 years old inclusive. * women of childbearing potential must have a negative serum pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment discontinuation. * symptomatic pulmonary arterial hypertension (pah) belonging to one of the following subgroups only: * idiopathic * heritable * drug or toxin induced * associated with one of the following: connective tissue disease; hiv infection; corrected simple congenital heart disease. * with the following hemodynamic characteristics assessed by right heart catheterization (rhc) prior to randomization: * mean pulmonary artery pressure (mpap) ≥ 25 mmhg * pulmonary vascular resistance (pvr) ≥ 240 dyn•sec/cm5 (or 3 wood units) * pulmonary artery wedge pressure (pcwp) or left ventricular end-diastolic pressure (lvedp) ≤ 15 mmhg. * treatment with an endothelin receptor antagonist (era) for at least 90 days and on a stable dose for 30 days prior to randomization. * if an era is given in combination with a phosphodiesterase-5 (pde-5) inhibitor or soluble guanylate cyclase (sgc) stimulator, these treatments must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization. * who functional class (fc) ii or iii at randomization * 6-minute walk distance (6mwd) ≥ 100 m at screening. * ability to walk without a walking aid. * valid baseline data for daily life physical activity (dlpa) and pah-sympact®. exclusion criteria: * patients on a pah-specific monotherapy targeting the nitric oxide pathway (i.e. pde-5 inhibitor or sgc stimulator). * patients treated with prostacyclin, prostacyclin analog or selexipag within 3 months prior to screening. * any hospitalization during the last 30 days prior to screening. * severe coronary heart disease or unstable angina. * documented severe hepatic impairment or severe renal insufficiency at screening. * participation in a cardio-pulmonary rehabilitation program based on exercise training within 8 weeks prior to screening * any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.

Keywords: daily life physical activity actigraphy pah-sympact
influence of manual relaxation of the diaphragm on the tension of the posterior superficial fascia

Conditions: Diaphragm; Relaxation; Low Back Pain

Summary: the diaphragm performs many functions that are vital to the body as a whole. some of them are not related only to ventilation. the diaphragm is part of the myofascial system in the human body. therefore, the proper functioning of the diaphragm should be a significant element of physiotherapy, e.g. in patients reporting pain in the lumbosacral spine. considering the complex role of the diaphragm, it seems reasonable to investigate the influence of the mobilization of the diaphragm (aimed at reducing diaphragm tension) on the tension of the extensor muscles of the lumbar spine. the assumption of this reserach is to investigate the correlation between the tension of the fascia in the area of the diaphragm to the tension of the muscles in the area of the lumbar spine. the fascial connections between the diaphragm and the muscles in the lumbar spine presented above suggest that the manual therapy performed within the diaphragm can effectively prevent the occurrence of pain, and might be a supportive measure in the treatment of pain in the spine. the aim of the study is to investigate the corellation between the tension of the fascia within the diaphragm and the tension of the posterior superficial tape. research questions: 1. how does manual therapy in the area of the tendon attachments of the diaphragm affect the relaxation of the extensor muscles of the lumbar spine? 2. how can the therapy conducted only within the diaphragm, without interfering with the structures surrounding the spine, reduce the tension of the extensor muscles of the lumbar spine and, consequently, increase the range of its mobility in all planes? 3. how will the introduced therapy change the tidal volume of the lungs?


Eligibility criteria:
inclusion criteria: * age within 20-40 yrs, * bmi within normal range (18.5-24.9) * lack of abdominal obesity * lack of chronic musculoskeletal conditions * written, conscious consent exclusion criteria: * former abdominal surgery * abdominal diseases (i.e. (np. kidney stones, ulcers, irritative bowel sindrome, etc.), * pregnancy * fever, * tumors, * blood hypertension, * former surgery of respiratory system , * condition after surgical procedures in the area of the spine, * the occurrence of pain in the spine in the 3 months preceding the research experiment, * lack of conscious consent

Keywords: diaphragm low back pain deep tissue massage diaphragm relaxation
phase iii study to assess the efficacy and safety of sk3530 in patients with erectile dysfunction and hypertension

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to evaluate the efficacy and safety of sk3530 in men with ed and hypertension who were taking antihypertensive medication.

sk3530 is a potent and selective phosphdiesterase type 5(pde 5) inhibitor developed for the treatment of erectile dysfunction(ed). since ed is common in men with hypertension, it is important to determine the efficacy and safety of sk3530 in men with ed taking antihypertensive medication.

Eligibility criteria:
inclusion criteria: * hypertension patient taking stable hypertensive medication for at least 4 weeks * score below 25 from iief ef domain during 4 weeks of treatment run-in period * failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period exclusion criteria: * lab abnormality * uncontrolled diabetic mellitus * high or low blood pressure, orthostatic hypotension * hyper- or hypo-thyroidism

Keywords: erectile dysfunction hypertension sk3530
effects of extracorporeal cytokine elimination on hemodynamia and mortality in critical patients

Conditions: Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock

Summary: observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings in the intensive care unit.

observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings and met the inclusion criteria in the intensive care unit between 01.08.2023 and 01.02.2024

Eligibility criteria:
inclusion criteria: * c-reactive protein (crp) ≥ 100 mg/l * procalcitonin (pct) \< 2 ng/l * patients aged 18-80 years who were treated with cytokine adsorption due to vasoplegic shock exclusion criteria: * patients under 18 years of age * patients with suspected or proven bacterial cause of vasoplegic shock. * those who did not approve to participate in the study * patients without vasoplegic shock * patients with crp \< 100 mg/l, pct ≥ 2 μg/l

Keywords: vasoplegic shock, cytokine hemadsorption, hemodynamics, mortality, cytokine storm
randomized study of intravenous immunoglobulin (ivig) in patients with subacute proximal diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: objectives: i. determine the effect of intravenous immunoglobulin on recovery time of patients with proximal diabetic neuropathy. ii. determine whether rate of response is dose dependent in these patients.

protocol outline: this is a randomized, double blind, placebo controlled study. patients are randomized to treatment with low dose intravenous immunoglobulin (ivig), high dose ivig, or placebo. patients must first complete baseline evaluation. patients receive ivig or placebo on days 1, 2, 3, and 5, biweekly at weeks 2-4, weekly at weeks 5-8, and every other week at weeks 9-12. patients are assessed at 6, 12, 36, 52, and 104 weeks. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnostically proven non-insulin dependent diabetes mellitus as defined by the following criteria: presence of classic symptoms, such as polyuria, polydipsia, ketonuria, and rapid weight loss, together with plasma glucose elevations elevated fasting glucose concentration on more than one occasion * diagnostically proven proximal diabetic neuropathy with any of the following symptoms: severe thigh, hip, or leg pain greater than 20% weight loss progressive proximal weakness in the painful leg weakness in the contralateral lower limb thoracic or cervical root distribution symmetric distal polyneuropathy or autonomic neuropathy may be mild or absent --prior/concurrent therapy-- * at least 6 months since prior immunosuppression or plasma exchange * no history of prior renal transplant --patient characteristics-- * age: 18 and over * performance status: gait impairment at least grade 2 * hematopoietic: not specified * hepatic: not specified * renal: creatinine no greater than 1.4 mg/dl (women) creatinine no greater than 1.5 mg/dl (men) no history of renal failure * cardiovascular: no history of cardiac failure * neurologic: normal nerve conduction studies or changes compatible with distal symmetric diabetic neuropathy or diabetic lumbosacral radioplexus neuropathy spinal fluid cell count less than 5 cells/mm3 normal cerebral spinal fluid cytology no structural spine disease no inherited neuropathy * other: electromyographic evidence of proximal lower limb plexus or radicular denervation compatible with proximal diabetic neuropathy no other systemic disease or malignancy normal iga levels no chronic inflammatory demyelinating polyradiculoneuropathy (cidp) no systemic amyloidosis no monoclonal gammopathy associated neuropathy no history of allergy to serum products no selective cervical or root involvement without lower limb weakness no evidence of secondary diabetes

Keywords: diabetic amyotrophy diabetic lumbosacral radiculoplexus neuropathy diabetic neuropathy diabetic proximal neuropathy neurologic and psychiatric disorders rare disease
investigation of validity and reliability of the minnesota manual dexterity test in parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a disease that affects upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia, and causes limitations in patients' daily life activities. the impairment of upper extremity functional skills is related to the deficiency in planning both voluntary and complex movements, as well as the deficiency in multiple motor planning. in particular; fine manual dexterity, reaching, and grasping movements are affected, greatly affecting patients' daily activities. therefore, upper extremity evaluations are an important issue to consider for training upper extremity motor skills in pd. there are minimal assessment tools for evaluating the upper extremity functions of individuals with pd. the nine-hole peg test and the jebsen hand function evaluation test are the most commonly used scales in the evaluation of the upper extremity in pd, and their validity and reliability have been demonstrated. these scales roughly evaluate both extremities separately. however, these scales are not suitable assessment tools for testing activities in which both extremities are frequently used in daily life. therefore, there is a need for valid and reliable scales that can evaluate upper extremity activities both in isolation and bilaterally. the minnesota manual dexterity test (mmdt) allows both hands to be evaluated together. it also evaluates hand-eye coordination and gross motor skills in addition to manual dexterity. mmdt is used in individuals with pd, but there is no study in the literature examining the validity and reliability of the scale. therefore, this study aims to evaluate the reliability and validity of mmdt in individuals with pd.

at baseline, the mmdt, 9-hole peg test, and jebsen-taylor hand function test (jthft) will be applied to the ms group. the mmdt will be repeated seven days after the first application in ms. healthy controls are going to perform only the mmdt.

Eligibility criteria:
inclusion criteria: * between 40-80 years old * diagnosed with only "parkinson's disease" by a neurologist * between 1-3 values of your thoughts according to hoehn and yahr manufacturers exclusion criteria: * having any vision, hearing or perception problems that may affect the research results, * having an orthopedic problem that may affect manual skills in the upper extremity, * having a cardiovascular, pulmonary disorder

Keywords: parkinson's disease minnesota manual dexterity validity reliability upper limb function
the effect of retrolaminar block on postoperative pain

Conditions: Postoperative Pain

Summary: in recent years, as a part of multimodal analgesia, paravertebral blocks are replacing epidural analgesia due to the less side effects. although the risk of pneumothorax is the most feared complication in paravertebral blocks, retrolaminar block (rlb) -which is a paravertebral block- significantly reduces this risk due to the anatomical technique of procedure. the investigators aim to investigate the effect of retrolaminar block with ultrasound- guided on perioperative analgesia for patients undergoing lumbar vertebra surgery.

retrolaminar block will applie before general anesthesia induction when patients will be awake and under midazolam (0.03 mg/kg) sedation and standardized monitoring at the preoperative block area in sitting position using in-plane approach. after sterilising the skin, the investigators will perform block by using 7-18 mhz convex ultrasound probe ( esaote my lab 6 us machine, florance, italy) and a 22-gauge, 100-mm stimuplex needle (b. braun, germany). the investigators will pass in a sagittal plane from medial to lateral at the mid-lomber level, and identified the hyperechoic laminae, transverse processes, ribs and pleura. the l3 laminae will be identified approximately lateral of the spinous process. the needle will insert in-plane, cephalad to caudad. after lamina contact and negative aspiration, 20 ml bupivacaine 0.25% will be injected at low pressure with intermittent negative aspiration on each side and spread of local anesthetic between laminae and paraspinous muscles will be seen without pain or paresthesia. then 30 minutes later, the patient will be taken to the operating room. after general anesthesia prosedure, the patients will evaluate whether they have pain throughout 24 hours after the operation. the pain scores will be evaluated with visuel analogue scale.

Eligibility criteria:
inclusion criteria: 1. 18-75 years old 2. asa 1, 2, 3 patients 3. undergoing lumvar vertyebra surgery exclusion criteria: 1. pregnant woman 2. child 3. patint wiht cognitive disfunction