Kornimate/medical-research-clean huggingface dataset:
evolution with cpap treatment of a cohort of type 2 diabetic patients with apnea-hypopnea syndrome

Conditions: Sleep Apnea; Type 2 Diabetes

Summary: the main purpose of this study is to measure the evolution of hemoglobin a1c level after treatment with cpap in a cohort of type 2 diabetes mellitus patients with poor glycemic control and associated moderate or severe obstructive sleep apnea.

subjects with poorly controlled type 2 diabetes are a high cardiovascular risk group in which a high prevalence of moderate to severe sleep apnea is expected. studies based on interstitial glycemic measurement demonstrate a reduction in glucose levels when treating sleep apnea with cpap. nevertheless, the effectiveness of cpap in improving glycemic control has been questioned as most studies have failed to demonstrate a reduction in hemoglobin a1c (hba1c) level over time. most of these studies have limitations such as a short follow-up or a suboptimal fulfillment of cpap treatment. we hypothesize that treating moderate to severe sleep apnea with cpap will improve glycemic control (measured by hba1c) at 14 weeks in good compliers and that this improvement will be sustained at one year. we aim to test this hypothesis in consecutive type 2 diabetes patients on stable treatment with hba1c ≥7% in routine outpatient visits in our diabetes, nutrition and endocrinology unit. after providing informed consent, patients will be screened for sleep apnea by nocturnal oximetry followed by a diagnostic respiratory polygraphy. those patients with obstructive sleep apnea with an apnea-hypopnea index ≥20 will be invited to enter the study. after a 3-month observation period without any intervention to rule out a potential influence of entering the study on hba1c levels, patients will be treated with cpap. hba1c levels will be measured at baseline, after 14 weeks, and thereafter every 14 weeks until completing one year of treatment. other endocrine, metabolic and cardiovascular risk variables will be determined at baseline and at 14 weeks of the intervention.

Eligibility criteria:
inclusion criteria: * type 2 diabetes on stable treatment for the last three months and hba1c ≥ 7% * obstructive sleep apnea with and apnea-hypopnea index ≥20 * acceptance of a therapeutic trial with cpap exclusion criteria: * race: non caucasic * blood level of hemoglobin \<10 in women or \<11 in men or iron defitiency or hemoglobinopathy * glomerular filtration rate \< 30 * habitual sleeping time \<6 hours per night * nocturnal work, shift work or unsual sleeping schedule * primary severe insomnia or secondary to restless legs syndrome * major or non stable psychiatric disorder * treatment with corticosteroids * chronic respiratory disorders that may require corticosteroids or cause respiratory insufficiency or fev1/fvc\<0.7 with fev1\<50 in spirometry * predominant nocturnal hypoventilation pattern * cardiac failure * alcohol abuse * active cpap treatment * previous surgery for sleep apnea * severe nasal obstruction * illiteracy
the effect of paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate tablets compared to placebo in subjects suffering from the common cold or influenza.

Conditions: Common Cold

Summary: this phase iv multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. each participant will be administered only once during each study period. participants will use a questionnaire to record the symptom severity scores as described, as well as time.


Eligibility criteria:
inclusion criteria: * aged at least 18 years and less than 65 years * good general and mental health in the opinion of the investigator * participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6: (i) at least one of pain symptoms: sore throat, headache, or extremities pain (ii) mandatory: nasal congestion (iii) at least one of catarrh symptoms: runny nose or sneezing * onset of first symptoms of cold must have occurred within 48 hours of screening. exclusion criteria: * pregnant or breast feeding women * history of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator * concurrent illness or medical history that is contraindicated or cautioned about in the drug label * anatomical factors causing nasal congestion * fever with body temperature \>38.5°c at baseline * have used any medication or herbal remedies to treat cold prior to screening (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours) * any medication that has potential drug-drug interactions with study medications * known or suspected intolerance or hypersensitivity to the study materials * have a positive drug urine test or recent history (within the last 2 years) of alcohol or other substance abuse
expanded access protocol for gbm patients with already manufactured dcvax®-l who have screen-failed protocol 020221

Conditions: GBM; Glioblastoma Multiforme

Summary: the study is an open-label expanded access study for patients for whom vaccine was manufactured during the northwest biotherapeutics' 020221 dcvax-l for gbm screening process, but who subsequently failed to meet specific enrollment criteria. patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. it is estimated that approximately 99 patients will enroll in this study.

patients who are being screened under protocol 020221 who are not eligible for enrollment due to a) evidence of disease progression or pseudo-progression post chemo-radiation or b) insufficient (\<5 doses) vaccine manufactured, and for whom the dcvax-l treatment was manufactured and released are eligible for this study. treatment schedule: open label vaccine injections will be give per the associated 020221 protocol. injections will be given at days 0, 10, 20, and at months 2, 4, 8, 12, 18, 24 and 30. there are no therapeutic restrictions, but guidelines for drug administration are recommended as per the 020221 protocol. data collected includes vaccine administration information, and any vaccine related adverse event. patient mris will be collected centrally for future review. patients will be followed for disease progression and survival.

Eligibility criteria:
inclusion criteria: 1. screen-fail for protocol 020221 due to either: * radiographic evidence of disease progression or pseudoprogression at the baseline visit under protocol 020221, as determined by central imaging review, or * insufficient vaccine manufactured for protocol 020221 (i.e. less than 5 doses). 2. patients must have a kps rating of ≥70 at the baseline visit (visit 5) (refer to appendix d, performance status scales). 3. patients may have received steroid therapy as part of their primary treatment. steroid treatment should preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone qd at least 7 days prior to the first immunization . 4. dcvax-l product manufactured and released. exclusion criteria: 1. active uncontrolled infection, or acute infection requiring antibiotic or antifungal therapy. antibiotic and antifungal therapy should be completed approximately 7 days prior to the first immunization. 2. fever ≥101.5of. if considered possibly transient, retesting is allowed. 3. unstable or severe intercurrent medical conditions. 4. females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm). 020221 baseline lab results and or local lab results are acceptable.

Keywords: gbm brain tumor glioblastoma brain tumor who grade iv
effect of extracorporeal shock wave therapy on ultrasonography changes in patients with palmar fibromatosis: a randomized controlled trial

Conditions: Palmar Fibromatosis

Summary: this study will be conducted to investigate the effect of extracorporeal shock wave therapy on ultrasonography chnges in patients with palmar fibromatosis

palmar fibromatosis, also known as dupuytren's contracture, is a condition that affects the hand and fingers. it is characterized by the thickening and tightening of the fascia, a layer of connective tissue beneath the skin of the palm. this thickening and tightening can lead to the formation of nodules or cords that restrict the movement of the affected fingers. the treatment options for palmar fibromatosis vary depending on the severity of the condition and its impact on hand function. mild cases may not require immediate treatment but should be regularly monitored. however, if the symptoms worsen or hinder hand function, there are several treatment options available. extracorporeal shock wave therapy (eswt) is a non-invasive physical therapy procedure that uses high-energy sound waves to treat various musculoskeletal conditions. it is commonly used to manage pain and promote healing in conditions such as plantar fasciitis, tendinitis, calcific tendinitis, and other similar disorders the eswt has shown promising results in reducing pain, improving function, and promoting healing in various musculoskeletal conditions. sixty patients with palmar fibromatosis will be assigned randomly to two groups; first one will receive extracorporeal shock wave with traditional therapy and the other one will receive traditional therapy only

Eligibility criteria:
inclusion criteria: * patients diagnosed with palmar fibromatosis. * adults aged 18 to 70 years. * patients of any stage of physiological change of the disease (nodules cords and contractures). exclusion criteria: * patients with contraindications to extracorporeal shock wave therapy. * patients with a history of previous surgery for palmar fibromatosis. * patients with comorbidities or conditions that may affect the outcomes of the study. * patients of ganglions and palmar tendon fibrosis. * patients of sever and morbid obesity. * end stage disease with psychological disturbance nature. * pregnant women. * cardiac and pulmonary unstable patients may affect results.

Keywords: extracorporeal shock wave therapy ultrasonography changes palmar fibromatosis
a phase 1, 2-part, single ascending dose assessment of the safety, tolerability, and pharmacokinetics of rolapitant intravenous in healthy volunteers

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: the purpose of this study is to assess the safety and tolerability of single increasing doses of intravenously administered rolapitant in healthy male and female subjects.

part 1 of the study is designed to evaluate the safety and tolerability of a sad, up to 6 cohorts,of rolapitant iv (2 mg/ml solution) administered as an iv infusion over 30 minutes. in part 2 of the study, the safety and tolerability of the highest safe and well-tolerated dose established in part 1 will be evaluated in an expanded cohort. the highest safe and well-tolerated dose established in part 1 will be ascertained by the following criteria: an upper limit of 90% confidence interval (ci) for cmax. a minimum of 40 subjects will be enrolled in part 2.

Eligibility criteria:
main inclusion criteria: * subject must be a healthy male or female aged 18 to 55 years at screening * a female subject must have a negative pregnancy test at screening and on day -1. * a female subject of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from screening through 30 days after final study drug administration. * subject must have a body mass index (bmi) from 18.5 to 32.0 kg/m2 and a weight of ≥ 50 kg at screening. * subject must be able to provide informed consent after risks and benefits have been explained. subject must also be willing and able to comply with the protocol requirements. * subject must be in general good health as determined by the investigator based on pre-study medical, medication, and surgical history; physical examination; and clinical laboratory tests. main exclusion criteria: * subject must not have been dosed with test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose. * subject must not have a history of hypersensitivity to rolapitant iv or any of its excipients or who have completed a study visit as part of a previous rolapitant study within the 6 months prior to first study drug administration (day * subject must not have poor venous access or consider venipuncture intolerable. * subject must not have a history of significant complications or anxiety associated with the iv administration of medications that, in the opinion of the investigator, could make the subject unable to complete dosing requirements. * subject must not be pregnant or lactating.
the effect of tranexamic acid for total hip arthroplasty

Conditions: Hemorrhage

Summary: the aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. blood banks regularly undergo blood shortages. for these reasons, there is a need to reduce allogeneic blood transfusions. a number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (eaca) could reduce perioperative blood loss by interfering with fibrinolysis.

Eligibility criteria:
inclusion criteria: * asa 2-3 * 18-75 age * total hip arthroplasty surgery * regional anesthesia exclusion criteria: * allergies to drug * liver and kidney failure * ischemic heart disease * coagulopathy

Keywords: tranexamic acid total hip arthroplasty
respiratory muscle function after thyroid hormone replacement therapy in nonthyroidal illness syndrome

Conditions: Thyroid Diseases; Respiratory Failure

Summary: although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome (ntis) remains to be clarified. the ntis has been found to be an independent risk factor for prolonged (\> 13 days) mechanical ventilation. it is unclear, however, whether the ntis is only a biochemical prognostic marker or it actually contributes to the development and progression of respiratory failure. the aim of this study will be to assess respiratory muscle function after thyroid hormone substitution therapy in mechanically ventilated patients with the ntis.


Eligibility criteria:
inclusion criteria: * patients under mechanical ventilation for more than 48 hours who experience a spontaneous breathing trial and have a diagnosis of nonthyroidal illness syndrome exclusion criteria: * • age \<18 yr; * pregnancy or estro-progestinic therapy; * tracheostomy; * neurological or neuromuscular pathology and/or known phrenic nerve dysfunction; * previously diagnosed intrinsic thyroid disease; known or suspected pituitary-hypothalamic disease; * severe obesity; * ischemic cardiopathy; complex ventricular arrhythmias; * serum cortisol level below 80 ng/ml; renal or hepatic failure (respectively, creatininemia ≥ 3.5 mg/dl and bilirubinemia ≥ 6.0 mg/dl); * transfusion of plasma within 48 h prior to thyroid hormone assessment; use of amiodarone in the previous 8 weeks; * use of iodine contrast agents in the previous 8 weeks; * hemodialysis; * expected poor outcomes
evaluate the safety and efficacy of tgr 1202 in patients with relapsed or refractory hematologic malignancies

Conditions: Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Peripheral T-Cell Lymphoma; Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate the safety and effectiveness of tgr-1202 in patients with advanced hematologic malignancies.


Eligibility criteria:
inclusion criteria: * refractory to or relapsed after at least 1 prior treatment regimen; * eastern cooperative oncology group (ecog) score of 0 to 2; * at least 18 years of age. exclusion criteria: * any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks); * autologous hematologic stem cell transplant within 3 months of study entry or allogeneic hematologic stem cell transplant within 12 months; * known hepatitis b virus, hepatitis c virus or hiv infection; * previous therapy with gs-1101 (cal-101), ipi-145 or any drug that specifically inhibits the pi3k or mtor pathway;
preoperative intraarticular injection of methylprednisolone in patients scheduled for total knee-arthroplasty

Conditions: Knee Joint Osteoarthrosis; Hyperalgesia; Severe Movement Related Pain

Summary: despite improvements in analgesic treatment following total knee arthroplasty (tka) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. it has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain. the aim of this study is to investigate the effect of a preoperative intraarticular injection of methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.


Eligibility criteria:
inclusion criteria: * age 50 -80 * osteoarthrosis * scheduled for primary unilateral tka * preoperative pain report with nrs \> 5 upon walking * signs of sensitisation in knee exclusion criteria: * allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment * deficient written or spoken danish * impairment from psychological or neurological disease * local og systemic infection * immunodeficiency * treatment with corticosteroid within 30 days of inclusion * insulin treated diabetes mellitus * anticoagulant therapy * asa (american society of anaesthesia) class \> 3 * general anaesthesia * alchohol use \> 21 units / week * pregnancy
iron sucrose in patients with iron deficiency and pots

Conditions: Iron-deficiency; Postural Orthostatic Tachycardia Syndrome

Summary: this study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with postural orthostatic tachycardia syndrome (pots).


Eligibility criteria:
inclusion criteria: * patients (age 12 to years and older) with chronic (\>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations. * symptomatic orthostatic heart rate increment ≥30 bpm if \>19 years old or ≥40 bpm if \<19 years old during a 10 minute 70 degree head up tilt study * presence of non-anemic iron deficiency, defined as serum ferritin levels \<20 ug/l with hemoglobin no less than 1 gm/dl below the normal reference range as defined for age and gender * consent obtained from responsible guardian and from subjects, 12-17 years of age * consent obtained for subjects 18 years of age and older exclusion criteria: * orthostatic hypotension (decrease of systolic bp\>30 mmhg and/or diastolic bp\>15mmhg within 3 minutes of 70 degree head up tilt study) * pregnant or lactating females * the presence of failure of other organ systems or systemic illness that can affect autonomic function * concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. patients may participate if the potentially interfering medication is held for five half-lives prior to the study * laboratory evidence of anemia or iron overload * personal history of hematochromatosis or first degree relative with hematochromatosis * known sensitivity to venofer® (iron sucrose injection, usp) or other intravenous iron preparation
a study to explore the impact of lumacaftor/ivacaftor on disease progression in subjects aged 2 through 5 years with cystic fibrosis, homozygous for f508del

Conditions: Cystic Fibrosis

Summary: this study will explore the impact of lumacaftor/ivacaftor (lum/iva) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (cf), homozygous for f508del (f/f).


Eligibility criteria:
key inclusion criteria: * subjects with confirmed diagnosis of cf. * homozygous for f508del (f/f). * subjects who weigh ≥8 kg without shoes and wearing light clothing at the screening visit. key exclusion criteria: * any clinically significant laboratory abnormalities at the screening visit that would interfere with the study assessments or pose an undue risk for the subject. * solid organ or hematological transplantation. * history of any illness or comorbidity reviewed at the screening visit that, in the opinion of the investigator, might confound the results of the study. other protocol defined inclusion/exclusion criteria may apply.