Kornimate/medical-research-clean huggingface dataset:
evaluating the capacity of high-sensitivity serum crp levels to predict bronchial hyper responsiveness in school age children

Conditions: Hyperreactive Airway

Summary: background: bronchial hyper responsiveness (bhr) assessed by methacholine challenge test (mct) may aid in the diagnosis of asthma, while negative mct can help to exclude the diagnosis. laboratory measures that predict the results of mct are expected to reduce the number of procedures. the possible capacity of high sensitive c-reactive protein (hs-crp), a marker of systemic inflammation, to predict negative or positive mct in children has not been evaluated. aim: to evaluate the capacity of hs-crp to predict positive or negative mct in school aged children and to compare it with markers of airway inflammation: fractional exhaled nitric oxide (feno) and markers of allergic sensitization (ige and peripheral blood eosinophils). design: prospective study evaluating these parameters in patients with positive and negative mct. participant selection: the study population included subjects (age range 6 to 18 years) referred for methacholine challenge test (mct) sample size: 130 participants in the two groups. intervention: each subject will undergo evaluation including a respiratory questionnaire, methacholine challenge test with determination of pc20(the provocative concentration that reduced fev1 by 20% from baseline), exhaled nitric oxide (eno). venous blood will be analyzed for complete blood count + eosinophils, ige levels, hs-crp. all measurements will be evaluated in a single 3 hour visit, with no follow up study visits. primary end point: hs-crp levels as add on tool to predict negative or positive mct in children secondary outcome parameters: all other parameters are the secondary end points.


Eligibility criteria:
inclusion criteria: * age range 6 to 18 years * patient referred for methacholine challenge test (mct) exclusion criteria: * base line fev1(forced expiratory volume in the first second) \< 65% * the presence of other systemic or lung disease * anti-inflammatory drugs * upper respiratory tract infection in the last month

Keywords: c reactive protein airway hyperreactivity body mass index
nicotinamide riboside and mitochondrial metabolism

Conditions: Obesity

Summary: vitamin b3 has recently been found to be a potent modifier of energy metabolism, especially the function of mitochondria. mitochondria power up all cells in our bodies, by generating fuel, atp, for cellular functions. in previous studies, it has been discovered that mitochondrial biogenesis and oxidative metabolism in adipose tissue is severely impaired in obesity, already at a young adult age. here the investigators describe a proposal where they use nicotinamide riboside (nr), a form of vitamin b3 naturally found in milk, to activate dysfunctional mitochondria, in particular the sirt/nad+ pathway, and to rescue signs of obesity-related diseases. the investigators use a unique human study design: monozygotic twins either discordant or concordant for obesity, to examine the effects of nr on mitochondrial function in muscle, adipose tissue and the metabolism of the whole body. the upcoming upcoming results are important for understanding the links between mitochondrial dysfunction and chronic metabolic diseases in humans, as well as for clarifying mechanisms of the novel nutritional therapeutic approaches.


Eligibility criteria:
inclusion criteria: 1. bmi \>18.5 kg/m2 in both members of the twin pair 2. agreed to maintain current level of physical activity throughout the study 3. agreed to avoid vitamin supplementation or nutritional products with vitamin b3 14 days prior to the enrolment and during the study 4. written, informed consent to participate in the study exclusion criteria: 1. unstable medical conditions as determined by the principal investigator 2. clinically significant abnormal lab results at screening (e.g. ast and/or alt \> 2 x uln, and/or bilirubin \> 2 x uln) 3. subjects who have a planned surgery during the course of the trial 4. history of or a current diagnosis of any cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening). subjects with cancer in full remission more than 5 years after diagnosis are acceptable. 5. history of blood/bleeding disorders 6. immunocompromised individuals such as subjects that had undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (hiv) 7. hepatitis 8. blood donation in the previous 2 months 9. anemia (hemoglobin \<120) 10. participation in a clinical research trial within 30 days prior to randomization 11. allergy or sensitivity to study supplement ingredients 12. individuals who are cognitively impaired and/or who are unable to give informed consent. 13. any other condition, which in the principal investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may have posed significant risk to the subject.

Keywords: obesity metabolic syndrome vitamin b3 nicotinamide riboside mitochondrial dysfunction mitochondria adipose tissue skeletal muscle
medical weight loss on pelvic floor dysfunction

Conditions: Weight Loss; Pelvic Floor Disorders

Summary: the goal of this observational study is to learn about the effect of medical weight loss on the symptom of pelvic floor dysfunction in obese and overweight women. the main question it aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions in obese or overweight women.


Eligibility criteria:
inclusion criteria: * age 18 or higher * bmi 24 kg/m2 or higher * willing to follow the weight loss plan set by the physician follow-up and complete this study exclusion criteria: * urinary tract infection or gynecologic reproductive system infection in the past month * treatment history of pelvic floor disorders * pregnancy or delivery in the past half year * women with severe systemic disease * no follow-up conditions
evaluation study: obsessive-compulsive disorders in childhood and young adulthood

Conditions: Obsessive-compulsive Disorder

Summary: obsessive-compulsive disorders are very damaging illnesses that can already manifest in childhood and adolescence. with an average prevalence from 1 - 3%, they are one of the most frequently diagnosed psychiatric illness in these age groups. with the further use of data, the treatment success can be significantly improved; causal variables/predictors can be recognized, understood and taken carefully into account. the anticipated incremental knowledge will ultimately help children and young people with obsessive-compulsive disorders to receive faster and more effective treatment.


Eligibility criteria:
inclusion criteria: * children and young people from 8-18 years of age who fulfill the international classification of diseases tenth edition (icd-10) , obsessive-compulsive disorder handled in our clinic. * good german language speaking skills * iq \> 75 * all study participants or their legal representative have given written permission for their experiences to be documented in the study. exclusion criteria: * schizophrenia-related disorders (psychoses) * missing data * data sets without confirmed diagnosis * purely consultaive patient interview (no therapy intervention prescribed)
ustekinumab plus uvb-311nm in psoriasis

Conditions: Psoriasis

Summary: ustekinumab, an il-12/23 antibody has been approved in the e.c. and u.s.a. for the treatment of moderate to severe psoriasis. the aim of this study is to determine in a randomized half-side comparison whether additional narrowband uvb-311nm phototherapy accelerates and improves the clearance of skin lesions in ustekinumab-treated patients.

patients with moderate to severe psoriasis who receive standard treatment with ustekinumab (45 mg at week 0, 4, and every 12 weeks) are exposed to uvb-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in pasi to \ 90%, \> 75% and/or 50% between body sites.

Eligibility criteria:
inclusion criteria: * age \> 18 years * psoriasis patients who receive treatment with ustekinumab exclusion criteria: * age below 18 years * pregnancy or lactation * history of malignant melanoma * history of invasive squamous cell carcinoma of the skin * dysplastic melanocytic nevus syndrome * antinuclear antibodies (ds-dna, ro/ssa, la/ssb) * autoimmune disorders such as lupus erythematosus or dermatomyositis * photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, basal cell nevus syndrome, and others * general poor health status

Keywords: psoriasis biologic ustekinumab uvb-311nm narrowband phototherapy half-side comparison
ovarian fragmentation study (crespo medical team)

Conditions: Ovarian Failure; Premature Ovarian Failure; IVF

Summary: this is a study designed to validate kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after ivf.


Eligibility criteria:
inclusion criteria: * abdominal surgery need for fertility cause. * bad embryo quality (\>2 cycles with \< 1 embryo a-b quality. with: a. poor ovarian responders (previous ≤ 3 retrieved metaphase ii oocytes) in a conventional cycle. b. decreased ovarian reserve (antral follicle count (afc) ≤ 5 or antimullerian hormone (amh) ≤ 0.5 ng/ml). c.premature ovarian insufficiency according to: * patients \< 40 years old. * at least 1 year of amenorrhea. * follitropin serum levels (fsh) \>35 iu/ml in two serum samples separated by at least 1 month. * estradiol serum levels (e2) \< 20 pg/ml. exclusion criteria: 1. clinical/ultrasonographical signs of severe endometriosis ( or endometrioma). 2. age over 45 years (emc) 3. previous ovarian/pelvic surgery. unilateral oophorectomy. 4. body mass index \> 30 5. previous gonadotoxic treatment. 6. genito-urinary tract malformations. 7. inform consent unsigned.

Keywords: ovarian fragmentation kawamura ovarian rejuvenation
effect of intranasal oxytocin on dysphagia in children and adolescents with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: this phase 2b is designed to test the effectiveness of intranasal oxytocin on prader willi syndrome (pws). this is a prospective, multicentre, randomised, double-blind, phase 2b clinical study planned to include around 24 pws patients aged 2-17 years and 5 months.


Eligibility criteria:
inclusion criteria: 1. male or female patients between 2 years and 17 years and 5 months at inclusion. 2. genetically confirmed diagnosis of pws. 3. parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures. exclusion criteria: 1. a history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex; 2. intolerance of intranasal administrations (including when due to a major behavioural problem); 3. hyponatremia (clinically relevant at the discretion of the investigator); 4. hypokalaemia (clinically relevant at the discretion of the investigator); 5. prolongation of the qt interval and/or family history of prolongation of the qt interval; 6. concomitant treatment prolonging the qt interval; 7. start of growth hormone (gh) treatment within the last 4 weeks before inclusion; 8. history of abnormal electrocardiogram (ecg) (validated by a cardiologist); 9. pregnant girls; (for girls with childbearing potential who do not have contraception and are sexually active, a negative pregnancy test will be required) 10. patient with clinical signs in the context of contact with covid-19 infected person. 11. patient included in another study protocol on a medicinal product within the last 6 months; 12. administrative problems: 1. inability to give parents (or legal representatives) expert medical information; 2. no coverage by a social security regime.

Keywords: prader-willi syndrome oxytocin
efficacy study of metadoxine sr formulation in attention deficit hyperactivity disorder (adhd) subjects

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this clinical study is designed to evaluate the safety and tolerability of a single oral administration of a metadoxine slow release formulation to subjects diagnosed as having adhd. study also assess cognitive effects of such drug administration.

primary outcome measure is the safety and tolerability of study drug after a single dosing. additional outcomes include commission error rate from the tova test. the result is measured as standard score in % compared to the values of the normal population. exploratory outcome measures include: 1. tova measures like response time , variability, omissions etc. 2. subtests from wechsler: digit memory, digit-number signs etc

Eligibility criteria:
inclusion criteria: * age 18-45 * diagnosed as adhd exclusion criteria: * pdd patients * head injured patients * patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin b

Keywords: adhd add tova metadoxine
forecasting seizures using intelligent wearable technology for health tracking

Conditions: Epilepsy; Seizure

Summary: the goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy. the main questions it aims to answer are: * can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (gtcs) events, as well as changes in physiological and behavioral variables. * does this tool improve the lives of people with epilepsy? researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.

the primary goal of the study is to demonstrate the accuracy of seizurewise in predicting the timing of future convulsive seizures using data collected by the wearable embraceplus device and data provided by patients with gtcs monitored in outpatient settings. the secondary goals are: to assess the clinical impact of seizurewise on quality of life (qol), psychological health indicators, and economic and clinical outcomes to assess the clinical impact of visualizing behavioral and physiologic data without forecasting predictions on quality of life (qol), psychological health indicators, and economic and clinical outcomes a non-significant risk, open-label, prospective, randomized clinical investigation designed to evaluate the ability of seizurewise to forecast gtcs occurrence and to assess impact on qol and seizure management outcomes. the study will include two phases during which an algorithm based on sensor derived physiological measures is developed and tested with output blinded to the participant. in a final phase participants will be randomized to two arms, one of which will have access to a seizure forecasting risk score.

Eligibility criteria:
inclusion criteria: * subjects must be diagnosed with or be at risk of epilepsy * subjects or their parents or guardians must understand and consent to be in the study; * subjects or their parents or guardians must be able to read and communicate in english; * subjects or their parents or guardians must be willing and able to comply with study procedures and duration; * subjects must have a wrist circumference suitable for wearing the embraceplus device. exclusion criteria: * subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks; * subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary); * subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or * subjects that are empatica employees and actively participated in the development of this protocol or development of the seizure wise algorithms.

Keywords: forecasting
a study of ramosetron plus dx, dexamethasone, compared to granisetron plus dx for the prevention of vomiting and nausea

Conditions: Vomiting; Nausea

Summary: the purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.


Eligibility criteria:
inclusion criteria: * subject with age between 20-74 years old (inclusive) of either sex * cancer subject is scheduled to receive the designated chemotherapy programs * subject without symptoms of vomiting for at least one week before dosing trial medication * subject with ecog performance status scale no greater than 2 * subject has signed the written informed consent form exclusion criteria: * subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study * subject has received the designated chemotherapy programs within 6 months before entering the study * subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening * subject has known concurrent diseases that may cause vomiting * subject has taken medications that could influence the outcome of the study within 3 days before entering the study * subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone * female subject who is pregnant or breastfeeding * subject with life expectancy less than 3 months * subject participated other investigational drug trial within 1 month before entering this study

Keywords: serotonin antagonists randomized controlled trial combination drug therapy double-blind method
feasibility study of genomic profiling methods and timing in tumor samples

Conditions: Colorectal Cancer; Breast Cancer; Gynecological Cancer; Metastatic; Eligible for Phase I or Phase II Study; Melanoma Cancer

Summary: this is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

as part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. the samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. if patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy. * at least one biopsiable lesion deemed medically accessible and safe to biopsy. * candidate for one or more phase i or ii clinical trials at the time of study enrollment or at a later time point. * fulfills local institution's laboratory parameters for tumor biopsy. * willingness and ability of patient to provide signed voluntary informed consent. exclusion criteria: * any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment. * any contraindication to undergoing a biopsy procedure.

Keywords: genomic analysis genome tumor tissue archival biopsy core needle fine needle dna gene expression sequencing
effect of the rehabilitation effort at home in patients with head and neck tumor treated with curative intent

Conditions: Head and Neck Cancer

Summary: improvement exercise tolerance

this study allows improved exercise tolerance in patients undergoing rehabilitation effort

Eligibility criteria:
inclusion criteria: * tumor squamous cell head and neck (excluding nasopharynx) nonmetastatic including cervical lymphadenopathy primitives * patient to be treated with curative radiotherapy monofractionnée for at least 6 weeks, with or without concurrent chemotherapy (including targeted therapies) * kps ≥ 60 exclusion criteria: * cancer of the nasopharynx * metastatic patient * patients who received neoadjuvant chemotherapy or induction * patient parenteral nutrition * non-compliant patient treatment * patient with a cons-indication to the achievement of an effort: clinical signs of pulmonary arterial hypertension (pah) uncontrolled heart failure, recent myocardial infarction, arrhythmias, unstable angina. * patient desaturation in the stress test * patient already included in another clinical trial with an experimental molecule * pacemaker or defibrillator or neurostimulator * contraindications to treatment with standard radiotherapy with or without concurrent chemotherapy
effects of dronabinol (oral thc) on cannabis use

Conditions: Marijuana Smoking

Summary: study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. during each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.


Eligibility criteria:
inclusion criteria: * current use of marijuana * able to give informed consent exclusion criteria: * daily use of psychoactive medication * current axis i psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol * women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months * those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder * uncontrolled or unstable cardiovascular disease * allergy to sesame oil

Keywords: marijuana dronabinol pharmacotherapy
comparison of sita-standard compared to sita-fast visual fields.

Conditions: Glaucoma

Summary: this study will compare sita-standard and sita-fast tests in patients newly referred to the glaucoma screening clinic at the rd\&e hospital.

this study will compare sita-standard and sita-fast tests in patients newly referred to the glaucoma screening clinic at the rd\&e hospital. in addition to standard care (sita-fast) each person who agrees to take part in the trial will undertake one extra visual field test (sita-standard). by comparing the results of the two types of visual field test the investigators aim to provide information on which of the two tests is more specific for glaucoma and which test is better tolerated by patients. the investigators anticipate that this study will generate sufficient data to support a grant application for a longitudinal study to examine the relative merits of different visual field tests in patients with glaucoma and those suspected of developing the disease.

Eligibility criteria:
inclusion criteria: * patients over 18 years old attending the west of england eye unit glaucoma service who have been newly referred for suspected glaucoma. exclusion criteria: * 1. patients who are unable to perform visual field tests. 2. patients who are unable to have a full glaucoma assessment. 3. patients who have undertaken visual field tests in hospital eye departments in the last 2 years.
dronabinol on the pain experience

Conditions: Trauma Injury

Summary: the purpose of this study is to identify the effect dronabinol has on opioid exposure when used as an adjunct to the current standard multi-modal pain regimen (mmpr)


Eligibility criteria:
inclusion criteria: * patients admitted to the floor, surgical intermediate medical unit (simu), shock-trauma icu (sticu) at memorial herman hospital-texas medical center(mhh-tmc) exclusion criteria: * pregnant * prisoner * patients placed in observation unit * non-acute trauma * admitted with primary burn injury * expired prior to admission * moribund * discharge from emergency department * left against medical advice