Kornimate/medical-research-clean huggingface dataset:
tcr alpha/beta depletion for hsct from haploidentical and unrelated donors in the treatment of pid

Conditions: Primary Immune Deficiency Disorder; Hematopoietic Stem Cell Transplantation

Summary: treatment study to assess of safety and efficiency of t cells receptor (tcr) alfa beta depleted graft for hematopoietic stem cell transplantation (hsct) from haploidentical and unrelated donors in patients with primary immunodeficiency diseases

infections, graft versus host diseases (gvhd) and associated morbidity and mortality remains significant problems after unrelated and haploidentical hematopoietic stem sell transplantation (hsct) in patients with primary immunodeficiency diseases (pid). in this study the hypothesis is that the transplantation of tcr alfa beta depleted peripheral blood stem cells (pbsc) would offers advantages over the use of positively selected cd34+ stem cells in haploidentical hsct and non-manipulated graft in unrelated hsct. the purpose of this study is to evaluate the safety and efficiency of the selective infusion of tcr alfa beta t cell depleted graft in pediatric patients with pid receiving hsct from haploidentical and unrelated donors.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 1 months and \< 19 years * patients diagnosed with primary immunodeficiency diseases eligible for an allogeneic transplantation and lacking a related hla-matched donor * lansky/karnofsky score \> 40, who \> 4 * signed written informed consent exclusion criteria: * dysfunction of liver (alt/ast \> 5 times normal value, or bilirubin \> 3 times normal value), or of renal function (creatinine clearance \< 30 ml / min) * severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \<40%) * serious concurrent uncontrolled medical disorder * pregnant or breast feeding female patient * lack of parents' informed consent.
application of ectoine containing nasal spray and eye drops in patients with allergic rhinitis

Conditions: Allergic Rhinoconjunctivitis

Summary: this is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of ectoin allergy nasal spray and eye drops. in addition the effectiveness and safety shall be compared to azelastine containing nasal sprays and eye drops. the patient applied ectoin® rhinitis nasal spray / eye drops or takes azelastine nasals spray and eye drops according to the instructions for use. the observation takes place over a period of 7 days. response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.


Eligibility criteria:
inclusion criteria: * male or female patients * aged 18-70 years * patients with proven allergy and acute symptoms in nose and eye which are treated with ectoin allergy nasal spray and ectoin allergy eye drops or azelastine nasal spray and azelastine eye drops during the observational period exclusion criteria: * pregnancy and nursing women, * drug addicts and persons unable to give consent to study participation, * patients with intolerance against ingredients of any of the study treatments, * previous eye or nose surgery, * concomitant treatment with anti-allergic drugs, and * diseases which might influence the output of the study according to the physicians' judgment. * contra indications according to the label

Keywords: ectoine allergic rhinitis bitop
a study to assess the efficacy, safety and tolerability of tegaserod alone and in combination with omeprazole given orally in patients with symptoms of symptomatic gastroesophageal reflux disease (sgerd)

Conditions: Symptomatic Gastroespohageal Reflux Disease

Summary: gastroesophageal reflux disease (gerd) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. the exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. the symptoms of gerd include heartburn and acid regurgitation this study will determine if tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.


Eligibility criteria:
inclusion criteria: * history of physician diagnosed gerd * heartburn and regurgitation 3 days during the week prior to screening exclusion criteria: * history of erosive esophagitis, barrett's esophagus, esophageal stricture, scleroderma, zollinger-ellison syndrome, known primary disorder * history or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper gi surgery * use of ppi during the last four weeks prior to screening other protocol-defined inclusion/exclusion criteria may apply.

Keywords: gerd, heartburn, regurgitation, reflux disease
prophylaxis versus treatment for turp syndrome.

Conditions: Transurethral Resection of Prostate Syndrome

Summary: this study is designed to investigate the usage \& effects of prophylactic hs preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of turp syndrome with its potential complications

the study will be conducted on 60 patients asa class i - iii bph patients, candidates for turp surgery using monopolar electronic resectoscope. eligible patients will be allocated into one of three study groups (n=20 in each). group a patients will receive nacl 3% hs at a dose of 4 ml/kg/hr; group b patients will receive nacl 3% hs at a dose of 2 ml/kg/hr; while group c patients will receive nacl 0.9% normal saline(ns) at a dose of 6 ml/kg/hr. all intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. vital signs \[mean bp, hr, cvp \& oxygen saturation (spo2)\] will be recorded. plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mosm) will be measured. incidence of tur syndrome, need for icu admission, post-operative ventilation and total hospital stay will be noted.

Eligibility criteria:
inclusion criteria: * asa class i - iii bph patients exclusion criteria: * patients having any condition contra-indicating regional anesthesia e.g impaired coagulation. * electrolyte imbalance, * uncontrolled hypertension, * congestive heart failure or being allergic to local anesthetics.

Keywords: turp hypertonic saline turp syndrome hyponatraemia
fatigue self-management in primary care

Conditions: Medically Unexplained Chronic Fatigue; Chronic Fatigue Syndrome

Summary: this study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. the hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.


Eligibility criteria:
inclusion criteria: * diagnosis of unexplained chronic fatigue * diagnosis of chronic fatigue syndrome exclusion criteria: * medically explained fatigue * any psychosis or dementia

Keywords: medically unexplained chronic fatigue chronic fatigue syndrome cognitive-behavior therapy self-management primary care nurses economic analysis cost effectiveness one year follow-up
chronic pain, life style factors and quality of life

Conditions: Chronic Pain

Summary: chronic pain, life style factors and quality of life (krokieta) is a multicenter study that aims to analyze life style factors, socioeconomic and psychometric properties, metabolic problems, drug use, quality of life and biochemical variables in chronic non-cancer pain patients. the life style factors will be compared to those of normal population. at baseline, the study patients fill in questionnaires (a-e), the patients´ weight, length, waist and blood pressure are measured, pain-related factors are recorded and blood samples taken. changes in the quality of life of the study patients will be evaluated by questionnaires during follow-up at 2 years and 5 years.

chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and sleep problems. nutrition and low physical activity may predispose to chronic pain. to gain information on the life style factors of adult chronic pain patients referred to university hospital or central hospital pain clinics in finland, 477 patients have been recruited to the study. the patients fill in questionnaires on sociodemographic factors, pain, medication, use of health services, physical activity, smoking, use of alcohol or other substances, sleep, quality of life, nutrition and psychological factors at their first visit to the pain clinic. height, weight, waist circumference, blood pressure and pulse are measured by the study nurse. a blood sample for analysis of blood sugar, cholesterol (total, ldl, hdl), triglycerides, hba1c and sensitive c-reactive protein (crp) is taken. the pain clinician records the pain diagnosis, medication and other methods of pain management chosen. the patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years * chronic non-cancer pain * finnish-speaking * referred to a multidisciplinary pain management center exclusion criteria: * inability to fill in questionnaires in finnish * cancer pain
dietary impacts on oral health in autistic children: a cross-sectional analysis

Conditions: Dental Caries in Children; Autistic Disorder; Dietary Habits

Summary: the study aims to explore how dietary habits affect oral health in children with autism. by examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. this observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism.

the study investigates oral health implications of dietary preferences in autistic children, revealing diverse oral statuses and emphasizing tailored interventions. key findings include significant associations between hygiene practices, periodontal disease, and dietary choices. the research highlights the need for personalized dental care, influenced by factors like age, gender, family income, parental education, and asd severity. the study contributes to understanding oral health challenges in autistic children, suggesting dietary factors play a crucial role in oral health outcomes, calling for targeted strategies to improve their dental well-being.

Eligibility criteria:
inclusion criteria: * children between the ages of 2 and 12 diagnosed with autism spectrum disorder are eligible to participate in the study. * informed consent from parents or legal guardians is a prerequisite. exclusion criteria: * challenges that may impact study outcomes include coexisting medical conditions. * severe behavioral issues that may impede participation. * difficulties in obtaining informed consent, posing obstacles to comprehensive research endeavors.

Keywords: oral health dietary preferences autistic paediatric population oral hygiene
prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic cd patients

Conditions: Celiac Disease

Summary: this is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a gfd for at least one year prior to screening.

this is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a gfd for at least one year prior to screening. seropositive patients (blood test confirmed at visit 0) will be scheduled for a screening visit (visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). patients who meet visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.

Eligibility criteria:
inclusion criteria: * biopsy confirmed cd diagnosis * seropositive * gluten free diet (12 months minimum) * experienced at least one self reported moderate or greater severity symptom during the last 28 day period * willing to take study treatment daily * must sign informed consent exclusion criteria: * wheat allergy * history of peptic ulcer disease, esophagitis, ibs, ibd * active colitis, dermatitis herpetiformis * diagnosed with type 1 diabetes * patients with known rapid gastric emptying (post-bariatric surgery, billroth i or ii surgery) * chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening * known refractory celiac disease (rcd1 or rcd2) * inability to give informed consent

Keywords: celiac
efficacy and safety of continuous versus intermittent linezolid infusion in critically ill patients with septic shock

Conditions: Treatment Efficacy

Summary: the aim of study is this to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the icu

it is prospective randomized controlled study on one hundred forty patients to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the icu, initially, each patient will be evaluated for septic shock based on the clinical criteria. baseline microbiologic specimens will be obtained for all recruited patients through the day of diagnosis including blood c\&s. then, empirical treatment with antibiotics according to expected source of sepsis. patients with gram-positive cultures sensitive to linezolid will be randomly allocated to receive linezolid in the continuous infusion group (group a) or conventional intermittent infusion group (group b) in a 1:1 ratio. group a: seventy patients in the continuous infusion group will receive an intravenous loading dose of 600 mg for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h). group b: seventy patients in the intermittent infusion group will administrate 600 mg of linezolid iv every 12 h for 60 min. the treatment period will be 8-10 days in both groups but might decrease or increase based on the patients' clinical response. at the beginning of the study, simple randomization will be used to assign patients using the random numbers set offered by the icu coordinator. each patient will be assigned a randomized code consisting of two letters that indicate the intensive care unit and two digits indicating the randomization sequence. the end point of the study is occurrence of thrombocytopenia (decrease in platelet count ≥ 50% from baseline or a decrease in platelet count ≤ 100 × 103/mm3).

Eligibility criteria:
inclusion criteria: * adult patients aged \> 18 years old * diagnosis of septic shock (patient with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm hg or greater and serum lactate level greater than 2 mmol\\l (\>18 mg\\dl) in the absence of hypovolemia). * positive culture confirming linezolid susceptibility. exclusion criteria: * patient refusal. * known allergy to linezolid. * pregnancy and lactation. * severe hepatic failure (child-pugh c). * thrombocytopenia (platelet count \< 80,000/mm3). * disseminated intravascular coagulation (dic). * hematologic disease, and concurrent use of other medications that may interact with linezolid (i.e., macrolides, serotonin modulators), or drug-associated thrombocytopenia.
imaging the vesicular acetylcholine transporter using 18f-feobv pet in parkinsons disease

Conditions: Parkinson Disease

Summary: patients with parkinson's disease (pd) often display symptoms, such as constipation, due to denervation of the cholinergic nerves in the gut. it has been hypothesized that pd initiates in the gut years prior to diagnosis. to gain a detailed understanding of the early stages of pd, techniques for quantification of cholinergic nerves are needed. the pet tracer 18f-feobv binds specifically to the vesicular acetylcholine transporter, situated in presynaptic cholinergic nerve terminals. the investigators will investigate 18f-feobv uptake in the brain and internal organs of 15 patients with moderate-stage pd and compare to 15 healthy controls. furthermore, findings are correlated to validated clinical tests of the autonomic nervous system. the aim is to validate 18f-feobv pet/ct as a clinical imaging modality to diagnose parasympathetic denervation in pd.


Eligibility criteria:
inclusion criteria: * parkinsons disease, disease duration \> 4 years, hoehn \& yahr stage 2-3 exclusion criteria: * significant neurological diseases (e.g. stroke, tumor) * significant psychiatric disease * previous major surgery on thoracic and/or abdominal organs * significant medical disease (e.g. heart- or liver failure) * inflammatory bowel disease * gluten intolerance * diabetes * magnetic resonance (mr) contraindications (metal in body, claustrophobia) * allergy to ct-contrast fluid * pacemaker * any current or previous cancer involving internal organs * peripheral neuropathy (except parkinsons disease related)

Keywords: parasympathetic
clot formation and coagulation factors consumption in the clearing fluid after arterial catheter blood sampling.

Conditions: Intensive Care Units; Arterial Lines

Summary: after blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. however, the status of coagulation in this clearing liquid remains poorly documented.

in the intensive care unit, blood sampling is mainly performed through an arterial catheter (radial or femoral artery). in addition to continuous arterial pressure monitoring, this provides an easy access to arterial blood without the need for venipuncture. it is standard practice to first clear the arterial sampling line before drawing blood for biological tests, to prevent the blood sample from being diluted by the arterial catheter's perfusion solution. this clearing fluid (i.e., a mixture of saline solution and blood) is usually discarded. it has been reported that the clearing fluid volume alone represents 24 to 30% of the total blood volume required for blood sampling. devices for reinjecting this clearing fluid are already on the market. the advantages of these devices include blood saving, reduced risk of blood exposure, reduced biological waste and lower infection rates associated with catheter handling. the main drawback of these devices is their cost and the need for frequent replacement. moreover, their impact on the decrease of blood transfusion remains unclear. furthermore, there are too few published data on the potential coagulation of clearing fluid reinjected into the patient nor the maximum time it can be safely reinjected. the aim of this study is to assess the activation of coagulation over time in the clearing fluid during arterial catheter blood sampling

Eligibility criteria:
inclusion criteria: * patient older than 18 years old * admitted to the icu * with a radial or femoral arterial catheter * requiring blood sampling exclusion criteria: * presence of a non-standard extension line: any tubing other than an arterial line intended for this purpose. * constitutional or acquired hemorrhagic disease, * major biological thrombophilia (anti-phospholipid syndrome, homozygous mutation of factor ii or v, protein c, s or antithrombin deficiency), * thromboembolic event in progress or \< 6 months, * bacteremia within the last 48 hours, * previous study participation, * pregnant or breast-feeding patient * moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment * patient with no health insurance * patient under guardianship
orthostatic dysregulation and associated gastrointestinal dysfunction in parkinson's disease - evolution

Conditions: Parkinson's Disease - Autonomic Dysregulation

Summary: symptoms of blood pressure dysregulation, impaired swallowing and digestion are common amongst parkinson patients. the overall aim of this study is to examine blood pressure regulation and esophageal motility and gastric emptying in parkinson's disease (pd) patients. the investigators hypothesize that - compared to age-matched controls - pd patients display an altered regulation of blood pressure, altered gastroesophageal motility, and delayed gastric emptying. these symptoms occur already early in the disease process, but aggravate with progression of the disease. the investigators will perform a 7-day blood pressure measurement, measurement of central blood pressure and pulse wave velocity, assessment of pulse variability, schellong tests to assess orthostatic function, high resolution manometry assessments during swallowing acts, and a 13c-sodium octanoate breath test to assess gastric emptying, in 18 pd patients (9 each hoehn\&yahr stages 1,2) and 12 age- and gender-matched healthy controls. results will be interpreted in relation to the severity of pd motor symptoms. the investigators anticipate that blood pressure dysregulation and gastroesophageal motility disturbances will be present only in pd subjects, but not in matched controls without neurological disorders and without any extrapyramidal motor signs. furthermore, the investigators expect to find an association between motor impairment and the severity of these autonomic symptoms, however, that according to the braak staging, subtle disturbances must already be present in the early stages of pd.


Eligibility criteria:
inclusion criteria: - informed, written \& formal consent for participation * male/female subjects, aged 50-70 years * pd patients (9 subjects each in hoehn \& yahr stage 1 \& 2) exclusion criteria: - antihypertensive treatment * medication influencing gastrointestinal motility for at least the elimination half life of the drug * medication interfering with blood-pressure regulation for at least the elimination half life of the drug * significant systemic illness * bmi \ 30kg/m2 * symptoms or a history of gi disease or surgery * with any evidence of infectious disease * evidence or history of drug or alcohol abuse * diabetes mellitus
muscle activity and sensation during upright partitioned leg exercise in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to determine if: the large muscles of the leg, activated during walking, are also active during scooting; whether scooting alters the relationship between leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.


Eligibility criteria:
inclusion criteria: * diagnosis of copd: fev1 \< 80 % and fev1/fvc \< 0.7; * able to communicate in english * clinically stable exclusion criteria: * predominant co-morbidities or treatments that might influence the results of exercise testing

Keywords: exercise tolerance lung diseases, obstructive