cyrilzakka/clinical-trials huggingface dataset:
Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)

The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis (eczema) over two consecutive six-week periods.

The study will aim for a sample size of approximately 150 participants (equally distributed between 3 international sites) between the ages of 3 months and 5 years referred to the respective Dermatology Departments for management of moderate to severe atopic dermatitis. They will be sequentially recruited and randomized to the wool-to-standard clothing arm or standard clothing-to-wool arm.

The study will run for 12 weeks for each participant with two consecutive 6-week periods for each intervention, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks post commencement of the first intervention.

The primary outcome is the severity of atopic dermatitis at 6 weeks post commencement of each intervention i.e.at week 6 and week 12. Severity of atopic eczema will be measured using the Eczema Area and Severity Index (EASI).

Secondary outcomes include the severity and change in the severity of eczema using the EASI at 3 weeks, the validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score and quality of life assessment using the children's Dermatology Life Quality Index (cDLQI) at 3 and 6 weeks of each 6 week intervention period, as well as weekly Patient Oriented SCORing Atopic Dermatitis index (PO-SCORAD) scores.

Eligibility Criteria:
Inclusion Criteria:

* Is aged between 3 months and 5 years of age at the time of recruitment
* Has moderate to severe eczema as determined by an EASI score of 7 or above at their initial visit
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf

Exclusion Criteria:

* Has a known allergic contact dermatitis to wool or merino wool
* Is unable to attend all scheduled visits
* Has unstable eczema defined by an escalation of treatment requirements during the preceding 6 weeks. This would include flares of AD for any reason including infection, food allergy etc.
* Use of systemic corticosteroids within 6 weeks of study start.
* Any medical reason that is considered by the principal investigator to preclude enrolment.
GAPcare: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department

GAPcare (Geriatric Acute \& Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that enrolls older adults who present to the Emergency Department after a fall to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults.

Falls are the leading cause of fatal and non-fatal injury among older adults. EDs frequently evaluate older adults after their falls, but the typical evaluation consists of an injury assessment alone. There is a critical need for an ED-based intervention that addresses reasons for the fall and provides on-the-spot assessment and guidance to prevent subsequent falls. Failure to prevent subsequent falls will result in increased morbidity, mortality, healthcare utilization, loss of independence, and rising health care costs as the population of older adults increases.

Participants in GAPcare will be older adults (≥65 years-old) who present to the ED for a fall. We will pursue the following specific aims to test and further refine the GAPcare intervention: (1) Examine the feasibility of recruitment and retention of eligible patients into the GAPcare intervention, (2) determine the initial efficacy of the GAPcare intervention in reducing subsequent falls and healthcare utilization at 6 months. Our long-term goal is to prevent the early morbidity and mortality of older adults who present to the ED after a fall. The overall objective of this survey is to gather preliminary data on the feasibility of an ED based fall prevention project.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
* Able to communicate in English
* Fall not due to syncope or external force (i.e., struck by car or assault)
* Fall not due to serious illness (i.e. stroke, acute myocardial infarction)
* Will be discharged to home, assisted living, or rehabilitation at completion of ED visit (i.e., not admitted)
* Legally authorized representative present to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four)

Exclusion Criteria:

* Unable to give informed consent due to intoxication or altered mental status
* Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)
Observational Study of Infants Fed With Dairy and Plant Based Infant Formula

A study to assess and evaluate adequate growth in infants receiving a dairy and plant based infant formula in a real-world setting, and parents' and infants' experiences with this infant formula.

The study collects growth data from 58 participating infants whose parents autonomously decided to use the dairy and plant based infant formula for their infant daily within the first three months of their infant's life, either supplemental to breastfeeding or as sole source of feeding. Parents are asked to complete 2-3 online questionnaires in which data is collected on infant growth (as assessed during regular visits to the Municipal Child Healthcare Clinic), feeding characteristics, parent and infant experience with the product, and whether their infant has been to a doctor or is taking medication.

Eligibility Criteria:
Inclusion Criteria:

1. Parents autonomously decided to feed their infant with at least one bottle per day of dairy and plant based infant formula in combination with breastfeeding or as sole source of feeding.
2. Parents' intention to feed their infant with dairy and plant based infant formula for at least 2 months as of start with product
3. Infant started feeding with dairy and plant based infant formula ≤ 4 months of age
4. Infant is being fed daily with dairy and plant based infant formula at time of enrolment

Exclusion Criteria:

1. Infant started feeding with dairy and plant based infant formula \>3 months ago at time of enrolment
2. Participation of the infant in any other studies involving infant formula feeding (products) concomitantly
Cocoa Extract for Migraine Trial

The goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. The main questions it aims to answer are:

* Will we be able to enroll 114 participants during the recruitment period?
* Will participants take study pills daily during the pill-taking period?

Researchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population.

Participants will be asked to:

* Provide two urine samples
* Complete daily questionnaires
* Take four study pills a day for 12 weeks


Eligibility Criteria:
Inclusion Criteria:

* Women and men aged ≥18 years
* Self-reported clinician diagnosis of migraine with or without aura which does not meet criteria for chronic migraine (according to the International Classification of Headache Disorders 3rd edition)

  * Individuals with self-reported migraine will need to report a clinician diagnosis of migraine and be classified as having migraine or probable migraine by the American Migraine Study (AMS) migraine screener. The AMS migraine screener, which has a sensitivity of 100% and a specificity of 82% for the diagnosis of migraine will be used to confirm self-reported migraine status.
  * History of migraine dating for at least one year
* Self-report of 4 to 14 migraine attacks during the 30 days prior to enrollment in the study
* Completion of at least 22 headache diary days during the 28 day run-in period

  o Report migraine frequency between 4 to 14 days during the 28 day run-in period
* If currently using medications to prevent or treat migraine, no new medication use within the past 3 months
* No new use of behavioral interventions within the past 3 months and/or agree to not begin new behavioral interventions during this trial
* Be willing to complete all study procedures and be randomized to all interventional groups
* Be fluent in English
* Own an iPhone or Android device and be willing to download MyCap to the device

Exclusion Criteria:

* Self-reported history of stroke or transient ischemic attack; history of brain surgery or spine surgery; currently receiving treatment for a concussion; and self-reported diagnosis of cluster headache, brain tumor, brain aneurysm, traumatic brain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder
* Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol
* Current alcohol or substance abuse (self-reported)
* Self-reported clinician diagnosis of medication overuse headache
* Currently or recently (past 6 months) received Botox treatment for migraine
* Failure to return the baseline urine sample
* Currently pregnant, nursing, or intending to become pregnant during the study period.
* Unwilling to forgo use of out-of-study supplements of cocoa extract during the trial
* Extreme sensitivity to caffeine
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of prednisolone after single dose administration of prednisone. This study will also assess the safety and tolerability of isavuconazole alone and in combination with prednisone.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
* Results for aspartate aminotransferase (ALT) must be ≤ upper limit of normal and total bilirubin must be ≤ 1.5 mg/dL
* The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1
* The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study

Exclusion Criteria:

* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death or a close relative at a young age due to possible or probably cardiac causes
* The subject has a history of tuberculosis or exposure to anyone known or suspected to have tuberculosis or any illness that might confound the results of the study or pose additional risk in administering study drug to the subject
* The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen, or QuantiFERON®-TB Gold test at Screening or is known to be positive for human immunodeficiency virus (HIV)
* The subject has a known or suspected allergy to any of the components of the trial products including prednisone or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions
* The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse or a positive drug and/or alcohol screen
A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial, patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, aged ≥18 years;
* Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
* At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);
* Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
* Life expectancy of more than 3 months;
* Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
* Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 109/L, neutrophil ≥1.5 × 109/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);

Exclusion Criteria:

* Pregnant or lactating women;
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
* Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); Uncontrolled hypertension;
* Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
* Urine protein\>grade 1;
* Any factors that influence the usage of oral administration;
* patients with a clear tendency of gastrointestinal bleeding;
* Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
* Abuse of alcohol or drugs;
* Less than 4 weeks from the last clinical trial;
* Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
* Evidence of central nervous system(CNS) metastasis;
* Disability of serious uncontrolled intercurrence infection.
Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30 kg/m2
* moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
* serum triglycerides \< 3 mmol/l.
* normal liver, kidney and thyroid function
* subjects must voluntarily sign the informed consent

Exclusion Criteria:

* use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
* lipid lowering medication
* history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
* pregnancy or lactation
* alcohol abuse
* subjects with intolerance to any ingredient of the test products
An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc. This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 3.1
* Patient who has not had any major protocol violation in Study CT-P13 3.1
* Patient is permitted to enter the extension study if, in the option of their general practitioner or the investigator, the patient will continue to gain benefit from treatment in the extension study. Local guidelines for patient treatment will be followed

Exclusion Criteria:

* Patient who has been withdrawn from Study CT-P13 3.1 for any reason
* Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events (SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the opinion of the investigator
* Patient who plans to participate in a study with an investigational drug during the period of this extension study
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva

To evaluate acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in comparison to placebo when given to COPD patients on pharmacodynamic steady state of tiotropium (Spiriva)

In case mono-bronchodilator therapy does not control symptoms of COPD adequately or if regular maintenance therapy is desired, a therapeutic intervention with a combination of bronchodilators is recommended. The risks of side-effects increases with increasing dose of any drug and, therefore, the most important rationale for combination therapy is a very favourable ratio of efficacy and safety. Knowing that anticholinergic and beta-adrenergic agents achieve their bronchodilating effects by different mechanisms, in particular the combination of these agents has proven to be beneficial in the management of COPD. Based on the established clinical benefits, tiotropium is an attractive and promising agent for the first-line long-term maintenance therapy in COPD. This also implies that a therapeutic intervention with other bronchodilators will be prescribed in daily practice. At present no studies on combination therapy with short-acting agents are available. Therefore, using a double-blind, randomised, crossover design, the bronchodilator effects of single doses of ipratropium or fenoterol were compared with placebo when added on top of steady state tiotropium. Patients were pre-treated with tiotropium to achieve this pharmacodynamic steady state. Serial lung function tests (FEV1, FVC, Raw, sGaw) were conducted following add-on of the short-acting bronchodilators or placebo.

Study Hypothesis:

H0: there is no difference between treatments in mean peak FEV1 H1: there is a difference between treatments in mean peak FEV1

Comparison(s):

Add-on of placebo was compared to add-on of ipratropium or add-on of fenoterol. The comparison of ipratropium with placebo was primary. The other 2 pair-wise comparisons were secondary.

Eligibility Criteria:
Inclusion:

* diagnosis of COPD
* FEV1 \< 60% of predicted
* FEV1 \< 70% of FVC
* smoking history of 10 pack-years

Exclusion:

* significant other disease than COPD
* history of asthma, allergic rhinitis or blood eosinophil count \> 600mm3
* cardiac arrhythmia requiring drug therapy
* symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
* recent history of MI (within past year)
* history of cancer within past 5 years
* life-threatening pulmonary obstruction
* cystic fibrosis or bronchiectasis; tuberculosis
* pulmonary resection
Electrical Stimulation Effect on Ankle Instability During Walking in Virtual Reality Setup

The purpose of the study is to investigate whether electrical stimulation to leg muscles and joints can help with balance in people with ankle instability. Participants will be asked to walk on a treadmill in a virtual reality cave. They will receive light electrical stimulation at the legs to improve your balance. The virtual reality image will sometimes shift in unexpected ways to challenge your balance. During the session, we will conduct a series of clinical assessments, including tests of functional performance and balance. Additionally, participants will be asked to fill out some questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 39 years.
* Having at least one significant ankle sprain in the past year, which causes a minimum of one interrupted day of physical activity.
* Having a history of at least two ankle sprains or "giving way" sensations at the injured ankle and/or a history of general feeling of ankle joint instability associated with the fear of getting another acute ankle sprain.
* Score \< 24 in the Cumberland Ankle Instability Tool (CAIT), and/or \> 11 in the Identification of Functional Ankle Instability (IdFAI), and/or answer ''yes'' to at least 5 yes/no questions in the Ankle Instability Instrument (AII).

Exclusion Criteria:

* Any head, neck, or face injury in the six months prior to the study (e.g., concussion, eye injury).
* History of vestibular or ocular dysfunction.
* Currently taking any medications affecting balance (i.e. antibiotics).
* History of injuries to lower extremities including fractures, knee injuries, and hip injuries.
* Sustaining an ankle sprain injury in the last 6 weeks.
* Pregnancy
* Any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
* Unstable cardiac or pulmonary disease.
* Clinically obese (BMI 30 or above).
* Any metal implant in the feet or legs that is close to the stimulating electrodes.
* A known allergy to medical-grade adhesives.
* Any other comorbidity affecting the ability to safely walk without assistance for at least 2 minutes