cyrilzakka/clinical-trials huggingface dataset:
Oral Dexamethasone for Treatment of Migraine

The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the emergency department (ED) \[after successful treatment\] prevents rebound headache.

Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.

Migraine headache can be a debilitating condition. A small but significant proportion of sufferers seek treatment in emergency departments \[ED\], accounting for 2-5% of ED visits.Available data suggests that up to 66% of these patients may experience rebound headache after discharge that affects their ability to function normally \[eg work, social, etc\].It appears that inflammation plays a key role in recurrences. A number of small studies suggest that a single dose of corticosteroids at the time of discharge might prevent rebound headache. To date these studies have used intravenous dexamethasone. The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the ED \[after successful treatment\] prevents rebound headache.

Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.

Aims: The primary aim is to compare the proportion of patients who experience rebound headache within 48 hours after ED treatment of migraine between a group treated with single dose oral dexamethasone 8mg and a group treated with placebo. Secondary aims are to compare headache severity, analgesia/ health service use, adverse events and return to normal functioning between the groups.

Methods:

Study design: Double blind, randomised placebo controlled clinical trial. Setting: Emergency Department, Western Hospital. Participants: Adult patients \[age \>17 years\] with physician-diagnosed migraine treated in the ED.

Inclusion criteria: Consenting adult patients \[age \>17 years\] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up.

Sample size: 76 patients. Note: The study was stopped early for operational reasons. 63 patients were analysed.

Eligibility Criteria:
Inclusion Criteria:

* Consenting adult patients \[age \>17 years\] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up

Exclusion Criteria:

* Failure to consent
* Pregnancy
* Allergy to study medication
* Findings inconsistent with migraine
* Patients requiring hospital admission for further investigation and treatment
* Patients with active peptic ulcer disease
* Patients with Type 1 diabetes
* Patients taking corticosteroids for another condition within 7 days
* Active systemic fungal infection
* Patients previously enrolled in the study
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan

Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.

Intensity of conditioning regimen plays a important role in allogeneic stem cell transplantation (allo-HSCT) for patents with AML and MDS. IN our previous prospective study, we demonstrated that condoning regimen of dual alkylating agents with melphalan-busulfan and fludarabine (MBF) achieved a very low relapse rate (\~6%) in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In that study, adult patients received melphalan 140mg/m2 while patients \>=60 or with high transplantation risk in terms of HCT-CI received reduced dose of melphalan (100mg/m2). Overall, it was shown that 100 or 140mg/m2 melphalan had similar incidence of relapse while the 100mg/m2 melphalan presented lower incidence of toxicities.In this prospective randomize study, we aim to compare the transplantation toxicities and outcomes in young adults (18\~55) with AML/MDS receiving either 100 or 140 mg/m2 melphalan as conditioning regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AML in first remission
* Patients with MDS with bone marrow blast \>5% but remain less than 20% before transplantation
* Donor available: HLA matched sibling donor, 9\~10/10 matched unrelated donor or haplo-identical donor
* Inform consent provided

Exclusion Criteria:

* Patients with active infection (bacteria, fungal or viral)
* Patients with abnormal liver, renal and cardiac function
Recruiting All Strictly Breast-fed Babies With Blood In Stool

Breast feeding is the most nutritious form of nourishment in infants and is recommended for at least the first four months of life. Breast fed infants may develop milk protein intolerance. The management of breast milk protein intolerance differs from that of cow's milk protein intolerance in formula fed infants. Because breast milk is considered by many to be nutritionally superior to formula and results in maternal infant bonding mothers are often told to continue breast feeding. Despite the lack of evidence based data to support or refute the modification of the mother's diet, it is suggested that they eliminate their own intake of dairy products strictly and avoid supplementing with a cow's milk based formula. Investigators are doing this study to demonstrate that the deletion of dairy from the diet of a breast feeding mother will not cause breast milk protein intolerance to resolve.

Breast feeding is the most nutritious form of nourishment in infants and is recommended for at least the first four months of life. Breast fed infants may develop milk protein intolerance. The management of breast milk protein intolerance differs from that of cow's milk protein intolerance in formula fed infants. Because breast milk is considered by many to be nutritionally superior to formula and results in maternal infant bonding mothers are often told to continue breast feeding. Despite the lack of evidence based data to support or refute the modification of the mother's diet, it is suggested that they eliminate their own intake of dairy products strictly and avoid supplementing with a cow's milk based formula. The investigators are doing this study to demonstrate that the deletion of dairy from the diet of a breast feeding mother will not cause breast milk protein intolerance to resolve.Some infants have difficulty digesting breast milk. When this happens, the doctor may advise the mother to eliminate dairy from her diet as long as the mother continues breast feeding or until the baby is 12 months old. However, no studies have proven that this change in a mother's diet actually solves the baby's problem with breast milk. The purpose of this study is to find an answer to this question.

Eligibility Criteria:
Inclusion Criteria:

* Women with exclusively breast fed infants less than 4 months of age
* Infant that has a positive stool guaiac

Exclusion Criteria:

* Formula fed infants
Radical Surgery for Advanced Gastric- or GEJ-cancer With Oligometastatic Dissmination to the Liver

Offering treatment with potential to cure for participants with no such offer in today's standard treatment options, by offering metastatectomia and standard treatment with intention to cure i.e., neoadjuvant chemotherapy and gastrectomy for participants with gastric- og gastroeusofageal junction cancer. Including 20 participants from all 4 centres in Denmark able to perform the surgical procedures in question.

Endpoints: 2-year overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18.
* Presence of primary T1-T4N0-N3M1 adenocarcinoma of the stomach or GEJ and max. 30% liver involvement.
* Primary tumour resectable, based on imaging workup.
* Surgical operable patients with ASA-score36 ≤ III and WHO performance status37 0-1.
* Patients eligible for treatment with systemic chemotherapy by FLOT regimen.
* Informed consent is obtained.

Exclusion Criteria:

* Patient with non-resectable cancer.
* Direct growth involving adjacent organs, i.e., pancreas, colon, blood vessels or bones.
* Other malignant disease diagnosed or treated up to 2 years prior to inclusion, except non-aggressive cancers such as non-melanoma sin cancer.
* Altered anatomy of the upper gastrointestinal tract due to previous surgery of the oesophagus, stomach, and duodenum.
* BMI ≤ 18
* The patient is unable to understand and/or read the consent form.
* Other serious illness or acute infections.
* Pregnant or breastfeeding.
A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber

An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age of either gender and any race
* have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
* have a positive skin prick test to ragweed pollen within the past year of screening

Exclusion Criteria:

* known contraindication or hypersensitivities to any components of the investigational product medication or components
* history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
* presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
* presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
* presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
* diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
* woman of childbearing potential who is pregnant or nursing
COVID - AirPollution

Epidemiological data have related particulate matter (PM), nitrogen dioxide (NO2) and ozone (O3) to COVID-19 morbidity and mortality at the population level. Air pollution may be related to an increase in the COVID-19 severity and lethality through its impact on chronic diseases such as cardiovascular and respiratory diseases and diabetes that are also the main comorbidities associated with COVID-19. Epidemiological studies using individual data are needed to provide more precise estimate of the association between air pollution exposure and COVID-19. In this multicenter prospective study, the investigators will analyze the number of deaths in COVID-19 confirmed cases in geriatric patients according to long-term exposure to air pollution, taking into account confounders such as diabetes, hypertension, age, and BMI. Exposure to air pollution will be estimated as the mean concentration of air pollutants at the residential address during the previous two years. In addition, the investigators will explore the relationship between short-term variations in air pollutants, relative humidity, temperature, UV radiations, pollen and the occurrence of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 60 years old (or dementia patient over 50 years old)
* Patient hospitalized in a geriatric department over the period from 2020/01/01 to 2020/06/01
* Patient who underwent RT-PCR SARS-CoV-2
* Patient (or trusted person/ legal guardian/curator, if applicable) who has given consent to the re-use of his/her data (patient data) for research purposes

Exclusion Criteria:

None
Bariatric Surgery and Pharmacokinetics of Ramipril

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on ramipril.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide Combination Chemotherapy in Ewing's Sarcoma

Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide combination chemotherapy in Ewing's Sarcoma


Eligibility Criteria:
Inclusion Criteria:

* Patients with Ewing's Sarcoma
Adjunctive Glycine for Obsessive Compulsive Disorder

The purpose of this study is to determine whether individuals with obsessive compulsive disorder who will take a preparation of the amino acid glycine in addition to their current treatment, may experience improvement in their symptoms.

Individuals with obsessive compulsive disorder (OCD) often find inadequate relief, even with the best of currently available treatments. Some evidence suggests the the neurotransmitter glutamate may be a useful target for new treatments for OCD. The amino acid glycine, if given orally in adequate dosages, can have specific effects on one particular glutamate receptor molecule in the brain, that might be helpful with OC symptoms. This randomized, double-blind protocol will have study participants who suffer with OCD take either a glycine preparation or placebo for 12 weeks. Clinical measures (e.g., Y-BOCS, NIMH-OC) will be recorded at each visit to determine whether those taking the glycine experience clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OCD present for at least 1 year
* Male or female, age 18 to 65
* Stable medication regimen for 12 weeks prior to study entry
* at least moderately severe OC symptoms

Exclusion Criteria:

* Active substance use disorder within the last 6 months
* Comorbid schizophrenia, schizoaffective disorder, bipolar disorder, tic disorder, Tourette Disorder, schizotypal personality disorder
* Hoarding as the principal OCD symptom
* Insulin-dependent diabetes mellitus
* Pregnant or breastfeeding
Cell Free DNA in Mature B-cell Lymphoma

The purpose of this study is to assess whether plasma cell free DNA is an accurate tool that can early and dynamically inform on treatment outcome and an accessible source of tumor DNA to track tumor clonal evolution.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria
* 18 years or older

Exclusion Criteria:

* Chemotherapy before
* Other tumors
Childbirth Education on Upright Positions Mobility During Labor

Background and study aims: A prospective quasi-experimental study will be conducted among nulliparous women from the ultra-orthodox Jewish community.

Study design: While the control group participated in routine childbirth education, the intervention group learned with childbirth education that included interactive and constructive cognitive engagement activities. Participants in both groups completed a set of questionnaires regarding knowledge, attitudes, and self-efficacy.

Background: Upright labor positions and movement during labor have a positive effect on childbirth, yet the predominant labor positions are still horizontal. Therefore, it is important to explore how it is possible to improve childbirth education, particularly its instructional design, to strengthen women's self-efficacy toward the use of upright positions and mobility during labor. The aim of the study was to evaluate the impact of an instructional approach based on a cognitive engagement ICAP (Interactive, Constructive, Active, Passive) framework on the development of knowledge, attitudes, and self-efficacy expectations toward upright positions and mobility during labor.

Methods: A prospective quasi-experimental study was conducted among nulliparous women from the ultra-orthodox Jewish community (n=74). While the control group (n = 34) participated in routine childbirth education, the intervention group (n = 36) learned with childbirth education that included interactive and constructive cognitive engagement activities. Participants in both groups completed a set of questionnaires regarding knowledge, attitudes, and self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women

Exclusion Criteria:

\*High-risk pregnancy
Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.

The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.

The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese subjects \[according to body mass index (BMI)\]
* Fasting plasma glucose value between 100 and 125 mg/dl, with impaired fasting glucose or impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT)
* Total cholesterol values ≥ 200 mg/dl

Exclusion Criteria:

* Patients with neoplastic and liver diseases, renal failure
* Patients with type 1 or 2 diabetes mellitus
* Pregnant or breastfeeding women
* Hypersensitivity to any of the ingredients
* Therapy with lipid-lowering drugs
* Use of products containing red yeast rice
Cloud-Based Mapping for Personalized Ablation

Atrial fibrillation is a serious public health issue that affects over 5 million Americans in whom it may cause skipped beats, dizziness, stroke and even death. This study seeks to improve our understanding of the causes of atrial fibrillation and to design new and more effective therapy for this heart rhythm disorder.

This project will focus on the development of a novel paradigm for electrophysiologic data analysis and interpretation using cloud-based computing resources and mobile technology. Currently, electrophysiologic data gathered during a procedure is analyzed by the operator using multiple separate desk-based computer systems in the electrophysiology laboratory. The investigators propose that advances in cloud-based computing resources and network connectivity should apply a mobile paradigm to apply to invasive electrophysiologic procedures.

This project will provide proof-of-concept that open-access software the investigators have developed and made available online could be used, via a mobile phone interface, to identify sites in the heart where therapy is effective. At no time will patient therapy be guided by this system. The investigators will pursue therapy using only clinical means. In parallel, a double-blinded team will analyze data in real time using our online software visualized on a smartphone. Only when the case is concluded will the data be unblinded, to determine if the mobile system was accurate in real time.

Thus, development and testing of the cloud-based computing system is designed only to establish feasibility of the paradigm, followed by improvement of computational modeling algorithms. The data that is collected will add to the investigators' existing unique catalogue of multimodal (structural, clinical, and electrophysiologic) data.

The importance of this novel paradigm is to move from analyzing large volumes of data in isolation to creating a mobile platform, and to allow scalability to increase access, such as to underdeveloped medical centers.

Eligibility Criteria:
Inclusion Criteria:

* men and women of any ethnicity
* aged 21-80 years
* undergoing ablation of atrial fibrillation at Stanford University
* failed or be intolerant of ≥ 1 anti-arrhythmic drug or not willing to accept antiarrhythmic drug therapy.

Exclusion Criteria:

* active coronary ischemia or decompensated heart failure
* atrial or ventricular clot on trans-esophageal echocardiography
* pregnancy (to minimize fluoroscopic exposure)
* inability or unwillingness to provide informed consent
* rheumatic valve disease (because it results in a unique AF phenotype)
* thrombotic disease or venous filters
* significantly reduced kidney function
Importance of Cytokines in Peptic Ulcer Disease: Implications for Treatment

Although all PPIs are effective, there are some differences in their clinical performance, particularly in terms of the degree and speed of gastric acid suppression. Few data are also available about their effect of the pathophysiological mechanisms of gastritis and peptic ulcer disease. Aim of the present study is to investigate the effect of therapy with esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on the pattern of release of pro- and anti- inflammatory cytokines associated to peptic ulcerative process by the gastric mucosa.

Although all PPIs are effective, there are some differences in their clinical performance, particularly in terms of the degree and speed of gastric acid suppression. Few data are also available about their effect of the pathophysiological mechanisms of gastritis and peptic ulcer disease.

Triggering receptor expressed on myeloid cells (TREM)-1 is a recently discovered receptor expressed on the surface of neutrophils and monocytes. Engagement of TREM-1 has been reported to trigger the synthesis of proinflammatory cytokines. A soluble form of TREM-1, named sTREM-1, was observed and identified at significant levels in serum samples from patients with disease of the gastrointestinal tract inflammatory bowel disease. rendering interest about the implication of sTREM-1 in their pathogenesis.

sTREM-1 was also found elevated in the gastric juice of patients with peptic ulcer disease being correlated to the degree of the infiltration of the gastric mucosa by neutrophils.

Published data of our group elicit that sTREM-1 secretion is a crucial parameter for evolution from chronic gastritis to peptic ulcer disease. Samples of biopsies of gastric mucosa were cultured in the absence/presence of endotoxins showing that the inflamed mucosa was a potent secretor of sTREM-1 whatever ceased to exist post-antisecretory treatment.

Aim of the present study is to investigate the effect of therapy with esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on the pattern of release of pro- and anti- inflammatory cytokines associated to peptic ulcerative process by the gastric mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Abdominal pain or discomfort and/or
* Epigastric pain with nausea and vomiting and/or
* Dyspepsia.

Exclusion Criteria:

* Recent upper GI bleeding
* Gastric carcinoma
* Diabetes mellitus
* Liver cirrhosis
* Acute or chronic renal failure
* The ingestion of any antimicrobial or antisecretory medication for at least 15 days prior to endoscopy.