cyrilzakka/clinical-trials huggingface dataset:
Omega-3 Supplementation for Pediatric Migraine

The purpose of the study is to assess the biochemical and clinical effects of omega-3 polyunsaturated fatty acid (PUFA) supplementation in youth suffering from migraine, including its effects on migraine disability, psychological distress, and overall quality of life. This study duration 12 weeks.

Omega-3 polyunsaturated fatty acids (PUFAs), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), hold potential therapeutic benefit for pediatric migraine due to their potent anti-inflammatory, anti-nociceptive, and neuromodulatory properties, which impact the pathophysiology of migraine. Dietary alteration and supplementation of omega-3 PUFAs have been shown to decrease the frequency, duration, and severity of headaches in adults with migraine, yet no rigorous clinical studies on omega-3 PUFA supplementation have been conducted in children and/or adolescents suffering from migraine. This study will establish feasibility of the intervention of omega-3 PUFA supplementation for pediatric migraine (i.e., provide proof-of-concept that the intervention raises omega-3 index levels compared to placebo).

The investigators will enroll 80 children and adolescents (ages 10-17 years) with a diagnosis of migraine and randomize participants 1:1 to receive an omega-3 PUFA dietary supplement intervention or placebo daily for 12 weeks, with assessments conducts at baseline and at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 10 and 17 years
* Parent consent and subject assent
* Diagnosis of migraine based on the third edition of the International Classification of Headache Disorders (ICHD-3) criteria

Exclusion Criteria:

* Known allergy to fish or seafood
* Current use of an omega-3 dietary supplement
* Significant neurological or psychiatric disorders or developmental delays
* Non-English speaking
* Allergy to coconut
* Pregnancy
Use of ΔIVC for Early Diagnosis of AHF in AECOPD

Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

This association is frequently underestimated with regard to the difficulty of clinical diagnosis.

The investigators expect that the application of the inferior vena cava collapsibility index (ΔIVC)could be useful in this issue.

Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very often underestimated. Until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the Swanganz catheter has been stated as reference. Other noninvasive diagnostic methods have been studied, such as systolic time intervals and Valsalva maneuver, but their application still difficult in patients with COPD exacerbation, especially in emergency department (ED) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the ΔIVC for the early identification of AHF in patients presenting to the ED with acute COPD exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* patient with history of COPD and admitted to the emergency departement for AECOPD

Exclusion Criteria:

* impossibility to give consent to participate in the study, non consent patients
* post traumatic dyspnea
* instable hemodynamic or neurological status
Patient Preferences of a Resect and Discard Paradigm

The investigators conducted a study "Resect and Discard Diminutive Polyps: a new paradigm" (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors performing colonoscopy are accurate enough at predicting histology of small colorectal polyps, such that these small polyps could be resected and discarded (instead of being sent to pathology). One of the main advantages of this approach is significant cost savings by reducing pathology costs associated with screening and surveillance colonoscopy. A disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no data regarding patient preferences toward this approach. The investigators therefore designed a patient survey to determine the patient's view toward this approach.

The American Society of Gastrointestinal Endoscopy (ASGE) published a review article on a new paradigm in colorectal cancer screening termed "resect and discard". This new paradigm challenges the current practice of sending all colorectal polyps, regardless of appearance or size, to pathology for analysis. "Resect and Discard" describes a new approach in which small polyps could be removed, but be discarded instead of sent for pathology analysis. This is based on data showing that gastroenterologists can predict the pathology of small colorectal polyps with 80-90% accuracy, and that discarding small polyps would not alter surveillance recommendations.

Neither the ASGE document nor published research, however, assessed patient attitudes toward this approach. This study surveyed patients prior to first time screening colonoscopy, in order to determine their preferences about the resect and discard approach; specifically would patients be willing to pay for pathology analysis of small colorectal polyps with their own money, and what factors influence their decision. We also inquired about factors that would influence their decision to pay/not pay pathology costs themselves.

Eligibility Criteria:
Inclusion Criteria:

• Indication for colonoscopy is screening or routine polyp surveillance

Exclusion Criteria:

* Indication for colonoscopy other than screening or surveillance
* Colon cancer identified at time of colonoscopy
* Known polyposis syndrome, or polyposis identified at colonoscopy
BMI and Lymph Node Count in Colorectal Cancer

Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.

Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS.


Eligibility Criteria:
Inclusion Criteria:

* colorectal carcinoma
* treated at the Klinik Favoriten between 1998 and 2011
* elective or acute surgical setting
* curative intent
* older than 18 years

Exclusion Criteria:

* other carcinoma (anal, metastases, ...)
* treated before 1998 or after 2011
* palliative intent
* younger than 18 years
A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient's written informed consent obtained prior to any study-related procedures.
* Male or female aged between 18 and 65 years inclusive;
* Evidence for "partially controlled" or "uncontrolled" asthma;
* Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
* FEV1 between 60% and 85% of the predicted normal values;
* A documented positive response to the reversibility test;
* Non-smokers or ex-smokers;
* A cooperative attitude and ability to be trained in the proper use of a DPI.

Exclusion Criteria:

* Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
* Significant seasonal variation in asthma occurring or expected to occur during study participation;
* History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;
* Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;
* Diagnosis of Chronic Obstructive Pulmonary Disease;
* History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency;
* Diagnosis of restrictive lung disease;
* Patients treated with oral or parenteral corticosteroids in the previous 8 weeks;
* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
* Allergy, sensitivity or intolerance to study drugs or excipients;
* Patients who received any investigational drug within the last 8 weeks before the screening;
* Patients taking any of the non-permitted concomitant medication;
* Subjects unlikely to comply with the study protocol;
* Any clinically relevant abnormal value or physical finding at screening;
* Significant medical history;
* Abnormal and clinically significant 12-lead electrocardiogram;
* Patients with low compliance of QVAR intake.
Puberty, Testosterone, and Brain Development

Transmasculine youth (female sex assigned at birth, male gender identity) who begin clinical gender affirming hormone therapy (GAHT) with testosterone (T) may experience changes in headache. Researchers think this because studies published on effects of giving testosterone to cisgender females (female sex, female gender identity) and transmasculine adults seem to show an effect on pain.

This research will help us learn more about changes in headache and in brain structure and function in transmasculine youth during the first two years of T. Youth who will be starting T within 6 months, either on puberty blocker or not, as part of their regular medical care can participate and will be asked to attend 4 visits:

* before starting T
* after 6 months on T
* after 1 year on T
* after 2 years on T

At the visits, they will be asked to:

* answer questions and surveys about their health
* have a brain MRI done
* give a small sample of blood

and at their first visit, complete a physical exam. Some participants can also do a brief test of pain sensitivity. All participants will be asked to complete a headache diary for the first 6 months, for 1 month after the 1 year visit, and for 1 month after the 2 year visit.

This will be conducted at Childrens Hospital Colorado (CHCO) Clinical \& Translational Research Centers (CTRC) facilities. Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging, as applicable, by a medical provider.

Visits will be in the morning to capture peak hormone levels.

The following questionnaires will be administered: PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, and PedMIDAS form (headache disability measure).

The daily headache diary is tailored to be brief on days when no headache occurs, and to capture more detail including medications taken and headache and aura characteristics on days a headache does occur.

The medical chart will be reviewed for relevant health information and medications.

MR-based imaging will be conducted at the Brain Imaging Center at the University of Colorado Anschutz Medical Campus.

Eligibility Criteria:
Inclusion Criteria:

1. transmasculine and gender diverse
2. assigned female at birth
3. age 12-20 years at the time of enrollment
4. plan to start testosterone clinically in \< 6 months
5. if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment

Exclusion Criteria:

1. cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures
2. known history of stroke, multiple sclerosis, or other serious neurologic condition
3. prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
4. prior diagnosis of polycystic ovarian syndrome (PCOS)
5. uncontrolled or untreated hypothyroidism
6. MRI-specific exclusion criteria: (Weight \> 500 lbs, severe claustrophobia, certain type of metal in body)
Internet-based A-CRA for Young Adults With Problematic Alcohol Use

The primary aim of the study is to evaluate the feasibility and acceptability of an internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) with therapist support for young adults (aged 18-24 years) with problematic alcohol use and their caregiver/significant other. Secondary aims include investigating the role of comorbid emotional symptoms, emotion regulation and prosocial behavior in treatment outcomes for the young adults. In a randomized controlled pilot trial, participants (n = 60 young adults as well as an optional accompanying caregiver/significant other) will be recruited from the community through advertisements as well as through clinic referrals in Stockholm, Sweden. Eligible participants will be randomized either to the 10-week I-A-CRA treatment or to an active control group (receiving psychoeducation about alcohol use over the same time frame). In both conditions an optionally accompanying caregiver/significant other will receive a support program in conjunction with the young adult's treatment. Participating young adults will be evaluated with regards to their alcohol use, psychiatric symptoms, emotion regulation, and prosocial behavior at pre-treatment, weekly during treatment, post-treatment, and at a 3-month follow-up. The primary outcome will be feasibility (measured as number of treatment completers; i.e., having completed 5 out of 8 treatment modules), and acceptability (measured by patient satisfaction). Secondary outcomes will include pre- and post-treatment self-rated binge drinking episodes, levels of depression, anxiety and stress, emotion dysregulation, and prosocial behavior. Self-reports regarding stress, emotion dysregulation, and prosocial behavior will be complemented by behavioral measures (computerized tasks).


Eligibility Criteria:
Inclusion Criteria:

* Young adult between 18-24 years of age
* Reporting ongoing substance use (alcohol), heavy drinking measured as risky use according to recommendations: 5/4 (male/female) standard drinks on a minimum of two occasions in the last month, or AUDIT-C ≥ 4 points indicating harmful consumption
* Access to internet via computer or other similar device, as well as access to smartphone
* If on psychiatric medication, it should have been a stable dosage during the past 3 months prior to pre-treatment assessment
* Adequate knowledge in the Swedish language and a Swedish personal identification number

Exclusion Criteria:

* Current DSM-5 diagnosis for any other substance use disorder except nicotine dependence
* Current (including last 12 months) DSM-5 diagnosis for other major psychiatric disorder (bipolar disorder, psychosis)
* Recent initiation of psychiatric medication or psychotherapy (within the last 3 months)
* Suicidal ideation at screening
* Serious somatic diagnosis requiring medical attention, such as uncontrolled diabetes mellitus, epilepsy or heart conditions
* Traces of any psychoactive substance (e.g., central stimulant amines, THC, benzodiazepines, opiates, cocaine) in urine sample at baseline assessment
* Pregnancy
Metabolomic Profiling of Novel Mediators of Vascular Function

The purpose of this study is to identify and characterize specific chemicals and metabolic pathways that change with forearm ischemia. These changes will be compared with forearm blood flow and flow-mediated vasodilation of the brachial artery.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or older
* Type 2 diabetes mellitus

Exclusion Criteria:

* Type 1 diabetes mellitus
* Type 2 diabetics taking insulin, thiazolidinediones (rosiglitazone or pioglitazone), an amylin analog (Symlin \[pramlintide\]), or incretin mimetics (Byetta \[exenatide\])
* Pregnancy
* Uncontrolled hypertension, \> 180/100 mmHg
Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients

The purpose of this research study is to understand the effects of therapy in lowering anxiety and improving quality of life in patients with IBD who are undergoing surgery

Pre- and post- surgery scores on the State Trait Anxiety Inventory will be used to measure levels of state-based anxiety as the primary outcome. Our hypothesis is that patients in the experimental group, will show a decrease in anxiety levels over the course of the four sessions, while the same group in the control group will not change significantly in their anxiety levels. It is hypothesized that this would be due to the psychotherapeutic intervention mitigating the inherent emotional stress and negative behavioral changes associated with surgery. It will be important to differentiate between the inpatient and outpatient groups, as their anxiety levels may inherently be discrepant. For patients with a three-step ileal pouch-anal anastomosis (IPAA), the three sessions subsequent to surgery will be conducted only after the first surgery. This is an exploratory study in which we are investigating the possibility of a range of potential outcomes to the intervention, including overall reduction of anxiety, depression, body image and improvement in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients age18 years or older.
* Patients with documented diagnosis of Inflammatory Bowel Disease.
* Patients with documented need for IBD surgery

Exclusion Criteria:

* Patients younger than 18 years of age.
* Patient who has any condition, including physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data and renders the patient an unsuitable candidate for the study.
Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players

This study of soccer skill performance has three objectives:

1. Compare effects of coffeeberry (300mg) and placebo ingestion on dribbling speed and precision, passing speed and accuracy, and sprint speed during a full simulated soccer match.
2. Compare effects of coffeeberry (300mg) and placebo ingestion on subjective measures (mental / physical energy and activation-deactivation (feelings or mood) during a full simulated soccer match.
3. Compare effects of coffeeberry (300mg) and placebo ingestion on chlorogenic acid (CGA) and caffeine metabolites in the blood 1-hour post ingestion, and other blood metabolites (glucose/lactate) throughout the simulated soccer match.


Eligibility Criteria:
Inclusion Criteria:

* Provide valid informed consent prior to any study procedure
* Male soccer players age 16 to 28 years.
* \>= 5-year soccer playing experience
* \>= 1-year regularly soccer training
* Free of injuries
* Willing to avoid alcohol in the 48-h period prior to all visits
* Willing to avoid caffeinated products and apples, berries/cherries for 24-h prior to all visits
* Willing to record food intake over the 48-h period prior to the first trial and replicate for second trial
* Willing to abstain from strenuous physical activity for 24-h before all visits

Exclusion Criteria:

* Smoking
* Cardiovascular diseases
* Diabetes or other metabolic disease • Hypertension (\>140/\>90 mm Hg)
* Presence of injuries
* Major illnesses or surgery in prior 90 days
* Participation in another clinical trial in the past month
Exercise Effects on Insulin, Gut Peptides, and Appetite

Determine whether the mid-day suppression of hunger and amplified increase in the release of glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following morning exercise is due to increased fat content of the diet per se or a combination of high fat diet after morning exercise. The action of gut peptides, particularly GLP-1, on gastric emptying is likely to be important in mediating its effects on postprandial appetite and glycemia (Nauck et al. 1997). Our hypothesis is that exercise amplifies gut peptide secretion when diet is enriched with fat, and that this stimulus suppresses the hunger sensation.

Specific aim: Determine whether a change in macronutrient composition from 60% carbohydrate and 25% fat to 30% carbohydrate and 45% fat is responsible by itself for suppression of hunger and increased secretory response of glucose-dependent insulinotropic hormone (GIP) and glucagon-like peptide-1 (GLP-1), or whether these changes depend on preceding exercise. We will measure (a) concentrations of plasma GIP and GLP-1 by chemiluminescent multiplex assay, (b) concentrations of plasma ancetaminophen to assess the gastric emptying rate, (c) concentrations of plasma insulin, and glucagon by radioimmunoassay, and glucose, ketone bodies, and free fatty acids with appropriate spectrophotometric methods, (d) hourly appetite responses with visual analog scale under two conditions: sedentary (SED) and exercise (EX).

Hypothesis: Hunger suppression and secretion of GIP and GLP-1 after the morning meal will be greater with slower gastric emptying rate when a meal consisting of 45% fat and 30% carbohydrate follows three hours after a 2-hour bout of moderate-intensity exercise than in the absence of exercise.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal status
* Age 50 to 65 years
* BMI between 20 and 30 kg/m2.
* Good health status (normotensive, fasting glucose \< 100 mg/dl, , hematocrit \> 32%, hemoglobin \>12 mg/dl)
* Absence of restricted food intake
* Absence of endocrine and metabolic disorders requiring medication other than hormonally corrected hypothyroidism
* Absence of musculoskeletal disabilities that would prevent walking

Exclusion Criteria:

* Presence of endocrine and metabolic disease requiring medication, other than hormonally corrected hypothyroidism
* Presence of musculoskeletal disabilities that would prevent walking
* Smoking
* Active dieting
* Absence of listed inclusion criteria
* Unwillingness to follow study protocol.
Internet-based Guided Self-help for Chronic Tinnitus

The purpose of this study is to determine the efficacy of a cognitive behavioral guided self-help training provided via the internet on tinnitus distress in a German sample.

Long waiting periods and the deficiency of outpatient therapies stimulated the development of internet-based interventions for a variety of mental disorders during the last years. A Swedish research group developed an internet-based self-help training for patients with chronic tinnitus showing promising results (Andersson et al., 2002; Kaldo et al., 2007; Kaldo et al., 2008). This self-help training was now adapted for German-speaking patients. The present study evaluates the efficacy of this treatment in a randomized controlled trial conducted in Germany. Further aims are a process evaluation of the treatment and the identification of predictors of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Chronic tinnitus for at least 6 months
* Medical examination of tinnitus by an ear, nose and throat physician (ENT)
* Scoring 38 or above on the Tinnitus Handicap Inventory (THI) or scoring 13 or above on the Mini-Tinnitus Questionnaire (Mini-TQ)
* Not currently receiving psychological treatment for tinnitus
* Being able to access the Internet and print instructions
* Sufficient knowledge of the German language to read and follow the Internet-based self-help program

Exclusion Criteria:

* Tinnitus caused by any other general medical condition or otologic disease (e.g., active Meniere's Disease)
* Clinical diagnosis of any severe mental disorder (especially a severe depressive disorder, suicidality, acute psychosis)
* Clinical diagnosis of Dementia or another severe organic cerebral disorder
* Clinical diagnosis of substance-related addiction/abuse