Kornimate/medical-research-clean huggingface dataset:
gammanorm quality of life study in immunodeficient patients using rapid push or pumps

Conditions: Primary Immunodeficiency (PID)

Summary: the purpose of this study is to compare satisfaction (lqi questionnaire, factor i: treatment interference) in pid patients receiving subcutaneous injections of gammanorm® 165 mg/ml according to the delivery device.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) * presenting with primary immunodeficiency * having received subcutaneous injections of immunoglobulin at home using an automatic pump for at least 1 month at the time of inclusion * for whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of gammanorm® 165 mg/ml at home * having signed an informed consent form exclusion criteria: * patient currently participating in another interventional study at the time of inclusion

Keywords: primary immunodeficiency, pid
a trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease

Conditions: Non-diabetic Chronic Kidney Disease

Summary: researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic ckd). the trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (ckd). it works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in ckd. in this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic ckd compared to a placebo. a placebo looks like a trial treatment but does not have any medicine in it. the trial will include about 1,580 men and women who are at least 18 years old. the participants will take finerenone or a placebo once a day as tablets by mouth. all of the participants will also continue to take their current medicine for their ckd. the participants will be in the trial for up to about 50 months. during the trial, the doctors will collect blood and urine samples and check the participants' health. the participants will also answer questions about how they are feeling and what adverse events they are having. an adverse event is a medical problem that happens during the trial. doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of chronic kidney disease and: * urine albumin/creatinine ratio (uacr) of ≥ 200 but ≤ 3500 mg/g and estimated glomerular filtration rate (egfr) ≥ 25 but \< 90 ml/min/1.73m\^2 at screening, and * documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening. * stable and maximum tolerated labeled dose of an angiotensin-converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) for at least 4 weeks prior to screening * k+ ≤ 4.8 mmol/l at screening exclusion criteria: * established diagnosis of type 1 or 2 diabetes mellitus, or hba1c ≥ 6.5% (48 mmol/mol) * autosomal dominant or autosomal recessive polycystic kidney disease * lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (anca) -associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening * symptomatic heart failure with reduced ejection fraction with class 1a indication for mineralocorticoid receptor antagonists (mras)
ucb therapy in acquired brain injury

Conditions: Acquired Brain Injury

Summary: this open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (ucb) therapy for patients with acquired brain injury.

acquired brain injury (abi) means brain damage caused by events after birth, rather than as part of a genetic or congenital disorders. those with abi suffer from cognitive, physical, or behavioral impairments limiting their activity and participation in society. abi results from traumatic or non-traumatic brain injury due to internal or external source (e.g. infection, brain tumor, hypoxia). preclinical studies regarding cell therapy in animal models of abi showed improvements of neurological dysfunction. ucb possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. this clinical research aims to determine the safety and efficacy of allogeneic ucb for patients with abi.

Eligibility criteria:
inclusion criteria: * acquired brain injury * duration: over 12 months * willing to comply with all study procedure exclusion criteria: * medical instability including pneumonia or renal function at enrollment * uncontrolled persistent epilepsy * poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up * not eligible according to the principal investigator

Keywords: umbilical cord blood acquired brain injury
inorganic nitrate and osa

Conditions: Obstructive Sleep Apnea

Summary: the main purpose of this study is to determine if acute beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. all subjects will consume low-dose (brl), higher-dose (brh), and placebo (brp) beetroot juice randomly on three independent study visits. beetroot juice also improves blood flow thus, the investigators will also measure blood flow to the carotid chemoreceptors.

four-weeks of daily beetroot juice supplementation reduces peripheral chemoreflex sensitivity in healthy older adults who have 'normal' responses to acute hypoxia. patients with obstructive sleep apnea have exaggerated peripheral chemoreflex sensitivity. it remains unknown if beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. additionally, increasing blood flow to the peripheral chemoreceptors reduces sensitivity. given that beetroot juice improves blood flow, the investigators will also measure common carotid artery blood flow at rest and during hypoxia.

Eligibility criteria:
inclusion criteria: * osa group: patients recently diagnosed with mild-to-moderate osa * control group: healthy individuals exclusion criteria: * diagnosis of heart disease * diagnosis of diabetes * diagnosis of any autonomic disorders * diagnosis of kidney disease * diagnosis of central sleep apnea * regular physical activity exceeding 30 minutes 3 days/week * a body mass index ≥40 kg/m2 * current or former use of a continuous positive airway pressure machine * current tobacco use * currently prescribed hormone replacement therapy

Keywords: inorganic nitrate blood flow peripheral chemoreflex common carotid artery
single dose omeprazole versus high dose in high-risk critically ill patients.

Conditions: Critical Illness

Summary: upper gastrointestinal (git) bleeding is common in high risk critically ill patients. hyperacidity has been identified as one of the main reasons for bleeding.1 2 antacids with different treatment modalities have been studied to establish the best regimen for prophylaxis against bleeding.3 4 proton pump inhibitors (ppi) are the most common drugs used in the medical field as antacids. the present study was carried out to investigate the beneficial effects of high dose omeprazole versus standard low dose as a prophylaxis against upper git bleeding in high risk critically ill patients.

a hundred and ten high risk critically ill patients were divided into two groups, fify five patients each. group a received intravenous (iv) omeprazole 40mg bolus dose once daily followed by normal saline infusion. group b received iv bolus of 80 mg omeprazole followed by 8mg/h infusion. the treatment was for the whole period of icu stay. gastric ph, residual gastric volume, signs of significant upper git bleeding, icu stay hb, number of ventilator free days, icu stay haemoglobin (hb), number of red cell units transfused in icu, icu stay, and numbers of icu survivors were recorded.

Eligibility criteria:
inclusion criteria: * mechanically ventilated patients were identified as high risk patients. patients with nasogastric tube inserted as part of their medical care were included in the study. exclusion criteria: * patients admitted because of upper gastrointestinal bleeding, patients who were not scheduled for early enteral nutrition during the first 24 hours of intensive care unit (icu) admission, patients with bleeding disorders, renal replacement therapy, history of gastric ulcer, gastric surgery, and the use of gastric antacids before icu admission.
tpo-mimetics before splenectomy in adult primary immune thrombocytopenia patients.

Conditions: Adult Patients; Immune Primary Thrombocytopenia; Splenectomy; TPO-mimetics

Summary: this study aims at analyzing the therapeutic activity of tpo-mimetics eltrombopag and romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.

adult immune primary thrombocytopenia is an autoimmune malignancy characterized by platelet destruction and inadequate platelet production. its incidence is of three cases per 100,000 people a year, with a prevalence in women in young and older adults. splenectomy is, still today, the therapeutic approach that offers a bigger guarantee of a long term response (around 60+70%). nevertheless, splenectomy may be accompanied by peri-operative complications in almost 10% of patients, which in rare cases may be fatal. these are normally hemorrhagic complications due to low platelet count. thus, a previous therapy to increase platelets is advisable before any splenectomy. in patients who are refractory to corticosteroids and immunoglobulins or when its use is not indicated, splenectomy has a potential risk of more complications. since the last few years, we count with tpo-mimetic drugs, specific for c-mpl receptor, able to stimulate platelet production, such as romiplostim and eltrombopag. nowadays, tpo-mimetics are allowed in italy when patients refuse splenectomy or when splenectomy is not contraindicated, but being itp with a low platelet count (\< 20-50.000/mmc) a potential contraindication to splenectomy due to hemorrhagic events, these drugs should be considered. nevertheless, there are no data on therapeutic risks and safety of these agents when used for this indication. the aim of the present study is to verify, on an italian national scale, the frequency of use, its impact and the safety profile.

Eligibility criteria:
inclusion criteria: * persistent or chronic itp in symtomatic phase. * 18 years of age or older. * indication for splenectomy due to refractory response to a previous therapy. * have used eltrombopag or romiplostim to increase platelet count before splenectomy. * have undergone splenectomy. exclusion criteria: * no informed consent.

Keywords: adult patients immune primary thrombocytopenia splenectomy tpo-mimetics eltrombopag romiplostim
double-blind, multiple dose study of tezepelumab (amg 157) in adults with mild atopic asthma

Conditions: Asthma

Summary: the purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (amg 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.


Eligibility criteria:
inclusion criteria: * male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age * body mass index (bmi) between 18 and 35 kg/m\^2 * normal or clinically acceptable physical examination (pe), clinical laboratory values, and electrocardiogram (ecg); clinically acceptable pe includes history of mild atopic asthma * used only inhaled short-acting β2-agonists infrequently to treat asthma * no current exposure to allergens to which subject experiences asthmatic responses * no other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening * positive skin prick test to common aeroallergens at screening * additional inclusion criteria apply exclusion criteria: * history or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; * history or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm * evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks * subject has know type i/ii diabetes * history of residential exposure to tuberculosis or has a positive purified protein derivative (ppd) or quantiferon test within 4 weeks before randomization * subject who has history of malignancy of any type within 5 years prior to enrollment * subjects tested positive for drugs/alcohol or nicotine use at screening * subjects tested positive for human immunodeficiency virus (hiv), hepatitis b or hepatitis c * additional exclusion criteria apply

Keywords: amgen amg 157 asthma
assessment of the effect of pap on energy and vitality in mild osa patients: the merge study

Conditions: Obstructive Sleep Apnea

Summary: the investigators wish to prospectively determine the response to cpap in patients presenting with mild osa. in many healthcare systems, patients with mild osa (ahi 5-15) are not reimbursed for treatment. although some evidence exists of the benefits of treating mild osa when scoring as per aasm 2007 criteria, more evidence is needed. the investigators wish to add to this pool of knowledge and also increase the inclusion criteria to include the aasm 2012 definition of mild osa. by including the 2012 aasm definition of mild osa, the investigators will add novel information to the field by assessing the benefits of treatment in both sub-groups of mild osa.

patients who visit their local sleep service for osa investigation, and are found to have mild osa (ahi ≤ 15) from an apnealink polygraphy (pg) home sleep test, scored as per aasm 2007 and/or aasm 2012, will be invited to take part in the study (pre-screening). at the study visit, informed consent, baseline demographics, and standardised questionnaires will be administered. participants will then be randomised to a cpap treatment group or control group. after 3 months, participants will be asked to repeat the standardised questionnaires, the trial will then be complete and they will return to routine clinical care.

Eligibility criteria:
study inclusion criteria * aged ≥ 18 and ≤ 80 * ability and willingness to provide written informed consent * ahi ≤ 15 as per aasm 2007 scoring criteria * ability to tolerate a cpap one hour long run in test exclusion criteria: * the presence of unstable cardiac disease * inability to give fully informed consent * supplemental oxygen * secondary sleep pathology e.g. periodic limb movement syndrome, narcolepsy, circadian disorder, obesity hypoventilation syndrome * ess ≥ 15, or concerns about sleepy driving from physician/ sleep lab staff * bmi ≥ 40
study of the experience of patients with osteoporosis using the forteo b pen to self administer once daily teriparatide therapy

Conditions: Osteoporosis

Summary: this study is being conducted to collect information from subjects with osteoporosis regarding their experience using the forteo b pen to self-administer teriparatide in the community setting. information collected during this study will be used to assess the need for changes to the forteo b-pen user manual and patient educational tools. additionally, the information generated from patients during this trial will be reviewed to assess the acceptability of the forteo b pen for commercial launch.


Eligibility criteria:
inclusion criteria: 1. men with primary or hypogonadal osteoporosis or postmenopausal women with osteoporosis in the opinion of the investigator. subjects must be at high risk for fracture in the opinion of the investigator. 2. willing to be trained and use the pen-injector daily to the satisfaction of study site personnel. 3. able to read, understand, and respond to self-administered questionnaires. 4. without language barrier, cooperative, and expected to return for all follow-up procedures. 5. have provided written informed consent to participate in this study, according to local regulations after being informed of the risks, medications, and procedures to be used in the study. exclusion criteria: 6. any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator. 7. having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator. 8. subjects who have an increased baseline risk of osteosarcoma, including those with: paget's disease of the bone or unexplained elevations of alkaline phosphatase, children and young adults with open epiphyses, and subjects who have received external beam or implant radiation therapy involving the skeleton. 9. history of malignant neoplasms in the 5 years prior to study entry, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated, or history of carcinoma in situ of the cervix or uterus.
the role of milk derived peptides on glycaemic control

Conditions: Insulin Resistance

Summary: this study aims to ascertain the potential of novel milk derived hydrolysates to improve glycaemic control to promote metabolic health. a comprehensive characterisation of the metabolic response to these milk derived hydrolysates will ascertain the effect of the hydrolysates in terms of insulin sensitivity. these hydrolysates have been shown to improve insulin resistance in cell and animal models. therefore the investigators aim is to test their efficacy in overweight, insulin resistant individuals at risk of developing type 2 diabetes.

recent figures estimate 60% of irish adults are overweight or obese. as obesity is associated with the development of insulin resistance, which precedes type 2 diabetes development by decades, novel food based solutions are required to improve glycaemic control and attenuate insulin resistance. in the current study insulin resistant individuals will undergo 4 study visits, 1 screening visit and 3 subsequent visits. at each of the 3 visits they will receive an oral lipid load consisting of 100ml soya bean oil, followed by either a water control; the hydrolysate being tested or the parent protein from which the hydrolysate was derived. after which they will undergo a 4 hour hyperinsulinemic-euglycaemic clamp at each visit to assess their insulin sensitivity.

Eligibility criteria:
inclusion criteria: * age 18 - 65 years * bmi \> 26 kg/m2 * prepared to maintain a constant body weight for the duration of the study * free of any chronic or infectious disease * not taking any medication for the regulation of blood sugars * diet controlled type 2 diabetes * free of any milk allergies or lactose intolerance * without anaemia exclusion criteria: * \ 65 years * diabetes (pharmacologically treated) or other endocrine disorders. * chronic inflammatory conditions. * kidney or liver dysfunction. * anaemia (haemoglobin \<12g/dl men, \< 11g/dl women). * taking any medication for the regulation of blood sugars.

Keywords: insulin sensitivity obesity insulin resistance milk derived hydrolysate hyperinsulinemic-euglycaemic clamp
suprasorb® cnpendo used for negative pressure therapy in the oesophagus and rectum to support defect and wound healing

Conditions: Esophagus Injury; Rectal Lesion

Summary: a post-market clinical follow-up (pmcf) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding instruction for use (ifu) in the intended patient population. patients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. they will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations. the study protocol does not define specific study procedures for patients enrolled. therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (index defect) * indication of treatment with suprasorb® cnpendo system according to ifu and medical guidelines * signed informed consent for usage of data exclusion criteria: * pre-existing coagulation disorders with increased risk of bleeding * defects involving the bronchial system (bronchus/trachea/pulmo) * any foreseeable deviation from ifu of suprasorb® cnp endo * known intolerance or allergy to one or more components of suprasorb® cnpendo
miofascial release and exercises therapy in the treatment of temporomandibular disorders

Conditions: Temporomandibular Joint Disorders

Summary: objectives: the aim of this research is to compare the effectiveness of myofascial release therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction syndrome. material and methods: a single-blind randomized clinical trial will be conducted in a university research clinic. sixty-four subjects with temporomandibular disorders and myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group (myofascial release protocol and rocabado exercise therapy) and control group (exercise therapy). intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and joint sounds will be collected at baseline, and forty-eight hours after the intervention phase.


Eligibility criteria:
inclusion criteria: * presence of myofascial pain with or without jaw opening limitation (ia and ib) according to the research diagnostic criteria for temporomandibular disorders (rdc / tmd). * a chief complaint of acute pain (duration \< 6 months) in the temporomandibular joint on at least one side. * the presence of joint clicking during jaw opening that was eliminated on protrusive opening. * agreement to attend evening therapy sessions. exclusion criteria: * subjects with dental pain or tender muscles caused by systemic diseases. * major psychological disorders. * a recent history of trauma in the face and neck area. * subjects wearing full or partial dentures. * edentulism. * therapeutic co-interventions during treatment. * indication for surgical treatment of temporomandibular joint.

Keywords: myofascial pain syndrome exercise therapy randomized controlled trial