Kornimate/medical-research-clean huggingface dataset:
an elimination diet using a new amino acid based formula: immunological and clinical effects in cow's milk allergy

Conditions: Allergy; Food Allergy

Summary: the purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.

infants with cma cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. unlike standard infant formulas which are made from milk proteins, amino acid formulas (aaf) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.

Eligibility criteria:
inclusion criteria: * infants ≤ 8 months of age * infants sensitised to cow's milk and diagnosed with ige mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months exclusion criteria: * infants less than 2500 g at birth * infants less than 37 weeks gestation * infants with severe concurrent illness * use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs * infants consuming less than 500ml per day of their usual formula at study entry * investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Keywords: allergy cow's milk infants food allergy
myopia control using optimized optical defocus rcts

Conditions: Myopia

Summary: the aims of the study is to evaluate whether the disc3.5 plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

the purpose of the current study is to evaluate whether the disc3.5 plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses. the defocus incorporated soft 3.5 plus contact lens (disc3.5 plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas. the efficacy of the disc3.5 plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. the hypothesis of this study is that the disc3.5 plus will slow myopia progression more than spherical single vision soft contact lenses.

Eligibility criteria:
inclusion criteria: * age at enrolment: 8-13 year; hong kong chinese * spherical equivalent refractions (ser): -1.00 to -5.00d * astigmatism: -1.00d or less * anisometropia: 1.25d or less * spectacle corrected monocular visual acuity (va): 0.0 logmar or better * contact lens corrected monocular va: 0.1 logmar or better * normal binocular function * willingness to wear contact lenses regularly * parents' understanding and acceptance of random allocation of grouping and masking exclusion criteria: * prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc. * strabismus or decompensated phoria (checked by cover test at far and near in screening) * known contraindications for contact lens wear * have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development

Keywords: myopia myopic defocus contact lens myopia control
effect of a health pathway for people with persistent symptoms covid-19

Conditions: COVID-19

Summary: people with persistent symptoms of covid-19 have increased needs for needs for management of their overall health (physical, psychological and social). persistent covid-19 symptoms have a negative impact on quality of life. by proposing a follow-up and an intervention on the reduction of these symptoms, the symptoms, the study will improve quality of life.


Eligibility criteria:
inclusion criteria * persons who have been infected with covid-19. * person with persistent clinical signs of covid-19 for more than 12 weeks, referred by one of the partner structures of the project. the persistent signs of covid-19 are: fatigue which can be severe, neurological disorders neurological disorders (cognitive, sensory, headaches), cardio-thoracic disorders (pain and chest tightness, tachycardia, dyspnea, cough) and disorders of smell and taste. pain, digestive disorders and skin disorders are also common. * person who has agreed to participate and has given informed consent to participate in the study exclusion criteria: * refused to participate in the study * person under legal protection * person with severe cognitive impairment

Keywords: health pathway quality of life personalized multifactorial intervention
open-label phase 1/2 study of velcade for injection in patients with light-chain (al)-amyloidosis

Conditions: Amyloidosis

Summary: this is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with velcade in patients with previously treated systemic al-amyloidosis who require further treatment.


Eligibility criteria:
inclusion criteria: 1. male or female 18 y/o and older 2. female patients must be practicing an effective method of birth control 3. biopsy-proven al-amyloidosis 4. must have been previously treated (failed at least 1 previous treatment) and in the opinion of the physician, patient requires further treatment exclusion criteria: 1. hypersensitivity to boron or mannitol 2. prior treatment with velcade 3. patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational 4. uncontrolled infection
one-year trial of oral ziprasidone in patients with metabolic syndrome

Conditions: Schizophrenia and Disorders With Psychotic Features

Summary: the purpose of this study is to explore the impact of ziprasidone on the distribution of metabolic syndrome risk factors in a population of patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

the trial was terminated prematurely on may 24, 2012, due to changes in organizational strategy and resources. the decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * subject must present at least 2 of the following risk factors of ms at screening: elevated waist circumference: \>102 cm in men and \>88 cm in women; elevated triglycerides (tgs): ≥1.7 mmol/l (≥150 mg/dl); reduced hdl-cholesterol: \<1.03 mmol/l (\<40 mg/dl) in men and \<1.3 mmol/l (\<50 mg/dl) in women; elevated fasting glucose: ≥ 5.6 mmol/l. * according to the clinical judgment of the investigator, the risk factors for ms have developed in close temporal relationship to starting an antipsychotic medication. * substitution to a less metabolically disruptive antipsychotic medication is considered. exclusion criteria: * subjects with contraindication(s) to the use of ziprasidone according to canadian prescribing information. * subjects with a history of treatment resistance. * subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug. * body mass index ≥ 40 at baseline.

Keywords: ziprasidone metabolic syndrome risk factors schizophrenia psychotic disorders.
medical cannabis for treating pain related to fibromyalgia

Conditions: Fibromyalgia

Summary: the goal of this interventional study is to learn about the effect of medicinal cannabis (bedrocan®) on fibromyalgia patients with pain resistant to conventional therapy. the main question the trial aims to answer are: * is bedrocan® effective for treating fibromyalgia-related pain in patients resistant to conventional therapy? * can a low dosage of medical cannabis taken as a decoction reduce fibromyalgic pain? all patients were trained on how to make the decoction: therapy was started with 100 mg/day (1 folder) and increased to 200 mg/day (2 folders) in non-responders.

the study took place in the pain therapy unit of san carlo hospital (potenza, italy) between march 2021 and september 2021. over this period, 44 subjects visited the pain unit and underwent specialist evaluation. fibromyalgia syndrome was confirmed using the widespread pain index (wpi) and symptom severity (ss) scale criteria, resulting in the recruitment of 34 subjects. two participants discontinued therapy due to side effects, while 2 other patients were excluded for not initiating treatment within the required timeframe. therefore, the final number of recruited fibromyalgic subjects for the study was 30. among these subjects, those who provided informed written consent for starting the trial with medical cannabis were prescribed bedrocan® once a month, with a total of 30 prescriptions per month for a duration of 6 months. all patients were instructed on how to prepare the decoction; the therapy was started with 100 mg/day (1 chart) and increased to 200 mg/day (2 charts) in non-responsive subjects. the numerical rating scale (nrs) and sf-12 short form health questionnaire were used to evaluate pain intensity and the quality of life at the beginning of the study and 6th-month follow-up.

Eligibility criteria:
inclusion criteria: * informed written consent; * age \>18 years old; * diagnosis of fm confirmed by a rheumatologist; * persistent pain symptoms for at least three months without complaints that may otherwise explain the pain condition; * persistent pain syndrome on conventional therapy with opioids or non-steroidal anti- inflammatory drugs * not having taken medical cannabis in the previous year since the start of the study * stopping drug therapy during the trial with cannabis (bedrocan®). exclusion criteria: * specific contraindications to cannabinoid use; * pain syndrome not associated with fm * major comorbidities like renal impairment, severe liver disease, chronic hepatitis c, history of alcohol or drug addiction * the presence of cognitive deficits that could impair understanding of the study, completion of questionnaires, or adherence to therapy. * pregnant or planning pregnancy women and breastfeeding women

Keywords: fibromyalgia medical cannabis bedrocan® pain
endoscopy nurse participation in adenoma detection rate during colonoscopy

Conditions: Polyp; Adenomatous Polyp; Colonoscopy

Summary: colorectal cancer (crc) is the second most common cancer and the fourth leading cause of cancer death in korea. colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. however, significant lesions can be missed during colonoscopy. recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy. the aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. the primary outcome measure is the adenoma detection rate (adr).


Eligibility criteria:
inclusion criteria: * age over 50 * screening colonoscopy exclusion criteria: * history of colorectal surgery * history of hereditary colorectal cancers or polyposis syndrome * gastrointestinal bleeding * inflammatory bowel diseases * inability to provide informed consent * pregnancy

Keywords: polyp adenoma screening colonoscopy diagnosis
combination of the immune modulator dimethyl fumarate with alteplase in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the investigators conduct this study to investigate whether oral administration of dimethyl fumarate, a food and drug administration-approved drug for multiple sclerosis, is safe and effective in combination with alteplase in patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: 1. more than 18years old 2. nihss score≥5 3. mri shows anterior circulation infarction 4. patients who meet alteplase thrombolytic therapy within 4.5h 5. the time from onset to dmf application was less than 24 hours exclusion criteria: 1. hemorrhagic stroke 2. patients who have received or plan to receive endovascular therapy 3. other diseases of the central nervous system 4. pre-existing neurological disability (mrs score \>2) 5. vertebrobasilar artery obstruction 6. difficulty swallowing 7. patients who cannot accept mri examination 8. abnormal liver function (transaminase higher than 2 times the normal upper limit) 9. the lymphocyte count was lower than the lower limit of normal value 10. anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used 11. patients known to have hypersensitivity to dimethyl fumarate or any excipients 12. pregnant and lactating women

Keywords: dimethyl fumarate immune modulator alteplase acute ischemic stroke edema
safety, efficacy, dose-finding study of a monoclonal antibody in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine the highest tolerated dose, safety and activity of hcd122 in patients with multiple myeloma who are relapsed after receiving prior treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of mm requiring treatment * refractory or relapsed disease * at least one prior treatment regimen * male or female * \>18 years of age exclusion criteria: * prior allogeneic bone marrow transplant (prior autologous transplant allowed) * intracranial disease or epidural disease * clinically significant cardiac dysfunction or other significant organ dysfunction

Keywords: dose-finding monoclonal antibody multiple myeloma
pseudo continent perineal colostomy vs permanent left iliac colostomy after abdominoperineal resection for ultra low rectal adenocarcinoma

Conditions: Rectal Neoplasms; Colostomy Stoma; Quality of Life

Summary: aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (pcpc) and a permanent left iliac colostomy (plic) following an abdominoperineal resection (apr) for ultra low rectal cancer

the surgical treatment of ultra low rectal adenocarcinoma has known great changes, yet the abdominoperineal resection (apr) is still indicated in over 20% of these cases. a permanent left abdominal stoma is the standard salvage technique. the pseudo continent perineal colostomy (pcpc) is an alternative technique especially in low income countries where the stoma bag and stoma care is not covered by health insurances. furthermore, this technique allows the conservation of body image, which is frequently requested by muslim patients whenever it is possible. the aim of this study is to compare the cost effectiveness of both techniques as well as the quality of life of patients in the 6 first months following the surgery.

Eligibility criteria:
inclusion criteria: * patients of 18 years old or above * abdominoperineal resection for ultra low rectal cancer * creation of a definitive iliac colostomy or a pseudo continent perineal colostomy * patients willing to participate to this study (writting consent) exclusion criteria: -patients unable to respond to the quality of life questionnaires

Keywords: pseudocontinent perineal colostomy abdominoperineal resection colostomy cost effectiveness quality of life
effect of antigens or therapeutic agents on in vitro human intestinal organoids

Conditions: Intestine Disease

Summary: the study evaluates the effect of nutrient antigens or therapeutic agents on human small intestinal organoids.

small intestinal biopsies will be taken to establish human intestinal organoids in vitro. the organoids will be propagated and various antigens will be checked for their effects on proliferation, production of inflammatory components or signal cascade.

Eligibility criteria:
inclusion criteria: * patients with gastrointestinal disorders and therapeutical indication of gastroduodenoscopy or coloscopy * healthy controls for preventive medical check-up exclusion criteria: * pregnant women
recombinant human interleukin-11 combination low-dose rituximab in immune thrombocytopenia

Conditions: Purpura, Thrombocytopenic, Idiopathic

Summary: the purpose of this study is to determine whether recombinant human interleukin-11 (rhil-11) combination low-dose rituximab prednisone are effective and safe in the management of steroid-resistant/relapsed immune thrombocytopenia (itp).


Eligibility criteria:
inclusion criteria: 1. patients may be male or female, between the ages of 16 \~ 75 years old. 2. isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly. 3. to show a platelet count ≤ 30 × 109/l, or platelet count ≥ 30 × 109/l with bleeding manifestations at the moment of the first infusion with the study product. 4. ｅｃｏｇ performance status ≤ 2. 5. patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. some patients were also refractory to splenectomy. 6. patients must be willing and able to give written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received second-line itp-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit. 3. received high-dose steroids or ivig in the 3 weeks prior to the start of the study. 4. current hiv infection or hepatitis b virus or hepatitis c virus infections. 5. severe medical condition (lung, hepatic or renal disorder) other than chronic itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia). 6. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 7. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 8. patients who are deemed unsuitable for the study by the investigator (or coinvestigator).
understanding dexmedetomidine in infants post-operative from cardiac surgery

Conditions: Hypoplastic Left Heart; Tetralogy of Fallot; Tricuspid Atresia

Summary: this study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. this medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

this is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. three bolus doses and infusion doses will be administered to a total of 36 evaluable patients.

Eligibility criteria:
inclusion criteria: * patients must be greater or equal to one month or less than or equal to 24 months of age. * post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period. * planned tracheal extubation within 24 hours post-operatively. * adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dl and \>12 months to 24 months creatinine \< or= to 1.0mg/dl) * adequate liver function(total bilirubin \ 12 months to 24 months \< or = to 90 u/l) * isolated heart surgery * informed consent exclusion criteria: * patients who have received another investigational drug within the past 30 days. * receiving continuous infusions of muscle relaxants in the postoperative setting. * patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection. * patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. * patients who show signs or symptoms of elevated intracranial pressure. * post-operative hypotension based on age. * preexisting bradycardia based on age. * heart block * weight \< 5kg * patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.

Keywords: postoperative from cardiac surgery dexmedetomidine
efficacy of a psychoeducative program for improving quality of life in fibromyalgic patients [study protocol]

Conditions: Fibromyalgia

Summary: this research project pretends to demonstrate that a psychoeducative program implemented in the context of pc can produce a significant increase in the quality of life of patients with fm, as well as a decrease in the use of sanitary and social services, compared to usual care.

most fibromyalgic patients are attended at primary care (pc). however, the effectiveness of the treatments prescribed by general practitioners is usually scarce. the main objective of the present research is to assess the efficacy of a structured psychoeducative intervention, combined with relaxation, developed to improve the quality of life of patients suffering fibromyalgia (fm). the second objective is to assess the cost-effectiveness of this multimodal intervention.

Eligibility criteria:
inclusion criteria: * patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the american college of rheumatology (acr) exclusion criteria: * patients with a diagnosis not based on the acr criteria * those with cognitive impairment or suffering from physical mental/psychiatric limitations * severe concurrent rheumatologic illness that impede participation in the study evaluations * those who are not expected to live at least 12 months * those without schooling.

Keywords: fibromyalgia quality of life primary care non-pharmacological treatment cost / cost-efficacy