cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.

Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years inclusive at the time of consent.
* Body mass index between 19.0 and 40.0 kg/m2 inclusive.
* Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
* Meets at minimum 1 of the criteria, as follows:

  * History of inadequate response to topical medications for AD
  * Subject intolerance to treatment with topical medications for AD, or
  * Topical medications are otherwise medically inadvisable
* AD that affects ≥ 10% of the body surface area (BSA).
* An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
* An IGA score of ≥ 3.

Exclusion Criteria:

* Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
* Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \[ECG\]) or from safety laboratory analysis.
* Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
* Known active allergic or irritant contact dermatitis.
Autonomic Involvement in Patient With Cognitive Decline

Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline


Eligibility Criteria:
Inclusion Criteria:

* male and females between 50 and 85 years
* cognitive decline (dementia, lewy's body dementia, Parkinson dementia, Alzheimer dementia)
* mild cognitive decline ( lewy's body MCI, Parkinson MCI and Alzheimer MCI)
* Ability to assume the upright position

Exclusion Criteria:

* diabetes mellitus
* eye problems
* severe cognitive decline
* heart disease
* peripheral neuropathy
* language barrier
* oncological disease
* medical pathologies associated with cognitive deficits
Effects of Multifocal Contact Lens on Ocular Tissue

The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 40 and 70 years of age.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye.
5. The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
6. The subject's refractive cylinder must be less than or equal to -0.75D in each eye.
7. The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye.
8. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
9. Subjects own a wearable pair of spectacles, if required for their distance vision.
10. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration).
11. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
2. Any ocular or systemic allergies that contraindicate contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear.
4. Any ocular abnormality that may interfere with contact lens wear.
5. Use of any ocular medications, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
8. History of herpetic keratitis.
9. Any ocular infection or inflammation.
10. Any corneal distortion or irregular cornea.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
13. History of diabetes.
14. Habitual wearer of etafilcon-A contact lens material.
15. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.

patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.

Eligibility Criteria:
Inclusion Criteria:

* patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017

Exclusion Criteria:

* (1) patients with ST-segment elevation myocardial infarction (STEMI)
* (2)a history of coronary artery bypass grafting (CABG)
* (3) cardiogenic shock
* (4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.
Badalona Major Depressive Disorder Database Study

A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care

Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study

Eligibility Criteria:
Inclusion Criteria:

* An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)
* At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009
* 18 months of enrollment with medical and pharmacy records after index episode date
Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal

SchistoVAN aims to study the role of schistosomiasis infection in the modulation of the immune response of children to childhood vaccine antigens, as well as the impact of this infection on their nutritional status and their haemoglobinaemia.

SchistoVAN aims to study the interactions between chronic parasite infections such as schistosomiasis and the immunological and nutritional status of children. In this scope, the investigators conducted a case-control study where one group of children is infected with schistosoma haematobium and the other is not infected with this parasite.

The investigators then stimulated whole blood of these children with various vaccine antigens to address their immune function and study the influence of schistosomiasis infectious state on their overall immune condition.

Aims of the study:

To evaluate the interaction between schistosomiasis and the nutritional status of children and their haemoglobinemia.

To evaluate the influence of schistosomiasis on children's specific immune response towards EPI vaccine antigens, the inflammatory status of children and nutritional serologic markers.

To compare schistosomiasis diagnostic tools (evaluation of circulating cathodic antigen (CCA) strip for diagnosis of urinary schistosomiasis in comparison with microscopy and urinary dipsticks)

To study prevalence of intestinal parasites such as Blastocystis hominis

Eligibility Criteria:
Inclusion Criteria:

* Members of AnoPalAnoVac cohort
* Age: between 6 and 10 years

Exclusion Criteria:

* body temperature \> 38.5 ºC
* malaria episode
Active Dads Healthy Families

The purpose of this study is to evaluate the feasibility of implementing a community-delivered physical activity program for fathers and their children ages 2-5 years.

The investigators will evaluate the feasibility of a community-based father-child physical activity promotion program. The investigators will work with a local Parks and Recreation department to recruit and deliver programming to three cohorts of fathers and their children 2-5 years old. To evaluate program feasibility, the investigators will assess recruitment efforts, program attendance, and participant engagement and satisfaction with the program. The investigators will also assess change in father-child outcomes post program including objectively measured physical activity, fathers' parenting, and father involvement.

Eligibility Criteria:
Inclusion Criteria:

* Father or father figure to child between the ages 2-5 years
* Father or father figure 18+ years
* Can speak and read in English

Exclusion Criteria:

* Father or child has a physical disability precluding them from being physically active
Feasibility of a Train-the-Trainer Delivered Exercise Intervention in Firefighters

Purpose: To collect and report feasibility data for conducting a future cluster randomized trial to evaluate the efficacy of a TRAINER delivered integrated exercise program in career firefighters, and to determine intervention fidelity and preliminary effects of a TRAINER delivered integrated exercise program in career firefighters.

Participants: 52 career firefighters 18 - 60 years old (40 trainees, 6 trainers, 6 administrators).

Procedures (methods): Enrolled fire stations will be randomly assigned (3:2 allocation ratio) to a TRAINER or wait-list control (CON) group, stratified by city, using computer-generated random numbers. All enrolled firefighters will undergo a series of assessments at baseline (week 0) and post-testing (week 7) following the TRAINER delivered 6-week intervention.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent prior to any study procedures are performed
* Medically cleared for fire suppression duties
* A career firefighter from a local department (Carrboro, Chapel Hill, and Durham)

Exclusion Criteria:

* Highly active firefighters, defined as performing 4 or more days/week of vigorous exercise
* Pregnancy
* Recent injury preventing their participation in the exercise routine
* Involved in an active workers' compensation or personal injury case
Peritoneal Dialysis Fluid Cooling and Cardio-Protective Effects

The study team aimed to investigate the relationship between occlusive coronary artery disease, myocardial perfusion, and peritoneal dialysate temperature. In addition, the study team aimed to identify how abnormal myocardial perfusion in peritoneal dialysis (PD) patients is related to occlusive coronary artery disease, to identify factors associated with occlusive coronary artery disease in end-stage renal failure patients on PD. Finally, the study team identified factors associated with PD induced cardiac injury in end-stage renal failure patients on this dialysis modality.

In order to assess the patients response to physiological stress and the functional relevance of their coronary artery disease, patients underwent assessment using dual energy contrast enhanced (DCE) CT assessment of coronary arteries and myocardial perfusion. An initial CT scan with administration of contrast established baseline information regarding the extent of coronary artery disease, fibrosis, and myocardial perfusion at rest. Following this, patients underwent pharmacological stress with the administration of adenosine and a repeat CT scan established the response to stress in terms of myocardial perfusion. On the second study visit patients were started on C-CAPD using peritoneal dialysate cooled to between 32-33 degrees centigrade, at a pre-determined and precisely controlled temperature for the 4 hour duration of C-CAPD. Subsequently, patients were injected with a pharmacological stressor in the form of adenosine. They then underwent DCE CT assessment of coronary arteries and myocardial perfusion as done in the first visit. The second CT scan took place following a PD dwell.


Eligibility Criteria:
Inclusion Criteria:

* Patients having peritoneal dialysis treatment at least 6 times per week at home and followed at the London Health Sciences Centre
* Male and female, age=16 years old
* Patients listed for renal transplantation
* Residual renal function less than or equal to 750 mls per 24 hour period

Exclusion Criteria:

* Not meeting inclusion criteria
* Previous adverse reaction to intravenous contrast
* Allergy to adenosine - Patients with significant residual renal function (greater than 750mL/24 hours)
* Exposure to peritoneal dialysis for \<90 days prior to recruitment
* Ongoing spontaneous bacterial peritonitis (SBP)
* Severe heart failure (New York Heart Association grade IV) - Cardiac transplant recipients
* Mental incapacity to consent
Brain Blood Vessel Responses to Changes in Blood Flow: Younger Cohort

Brain blood flow will be measured during a simulated postural change test and while breathing increased levels of carbon dioxide using magnetic resonance imaging.

Global cerebral blood flow (CBF) decreases with advancing age; however, some adults have accelerated declines in CBF, placing them at a greater risk of cognitive impairment. However, there is a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain. This study will systematically address this gap in knowledge by examining cerebrovascular control in adults during acute physiological challenges (simulated postural change test and breathing increased carbon dioxide) that stimulate a change in CBF.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20-40 years
* Have a BMI ≤34.5 kg/m2
* Nonsmoker

Exclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease (AD)
* History or evidence of hepatic disease, hematological disease, or peripheral vascular disease; severe kidney injury requiring hemodialysis
* History of cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
* Uncontrolled hypertension
* History of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease
* Severe untreated obstructive sleep apnea
* History of diabetes with HbA1c greater than 9.5%
* Major neurologic disorders other than dementia (e.g., MS, ALS, brain surgery, etc.)
* Current or recent (\&lt;1 year) major psychiatric condition (Axis I) or addictive disorders
* Significant surgical history
* Other significant medical conditions at investigators' discretion
* Contraindications to MRI
* Prescribed medications that interfere with prazosin
* Lactose allergy
Assessing the Repeatability of a Psychological Stress Test

To establish the efficacy and repeatability of a suitable psychological stress test. The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. Despite the test increasing self-reported levels of stress, meaningful changes in saliva cortisol are typically observed in only half of all participants. In addition, the MMST is susceptible to habituation of the cortisol response upon repeated exposures, limiting its current usefulness for repeated measures. Given the multicomponent nature of the MMST, there is potential for components of the test to be manipulated to overcome these limitations i.e., increase the magnitude of the saliva cortisol response and mitigate against habituation effects. In addition, a supplementary topic of interest is to what extent cortisol responses to acute laboratory stress tests, like the MMST, relate to the well described rise in morning cortisol \~30 minutes after awakening. This may be of clinical relevance given that blunted cortisol response upon awakening and in response to acute psychological stress tests have been associated with poor health outcomes.

The primary objective of the current study is to investigate if the MMST elicits a meaningful increase in saliva cortisol.

The secondary objective is to investigate the efficacy of mitigation strategies to overcome habituation to the MMST.

A supplementary objective is to to investigate the relationship between the saliva cortisol response upon awakening and the saliva cortisol response to the MMST.


Eligibility Criteria:
Inclusion Criteria:

Participants who...

* have read and signed the study informed consent
* are healthy, recreationally active men and women aged 18-35 years
* test negative for coronavirus (COVID-19)
* are willing to provide saliva samples throughout and complete the MMST through the duration of the study
* are using monophasic birth control (women only)

Exclusion Criteria:

Participants who...

* have a recent history or are a current smoker
* are currently taking prescription/Over-the-counter medication
* consume ≥ 91 units of alcohol per month
* have a clinically diagnosed history of cardiovascular and/or metabolic disease including diabetes and abnormal blood pressure
* are pregnant
* have a recent or ongoing viral or bacterial illness in past 4 weeks
* test positive for coronavirus (COVID-19)
* have a clinically diagnosed psychiatric disorder
* have a clinically diagnosed sleeping disorder
* have a clinically diagnosed gambling addiction
* BMI ≥ 30 kg/m2 - calculated in the online health screening questionnaire
* report unusually high levels of recent or ongoing life stress over the last month; as assessed by the perceived stress scale (PSS) i.e. rating ≥ 13 indicates high perception of recent and ongoing life stress
* Endurance trained or engage in ≥3.5 hours of physical activity a week
Nasal Fentanyl for Chronic Cancer Pain

Today, patients with cancer pain in need of opioids for moderate to severe pain get long-acting morphine twice a day and morphine tablets taken on demand in addition. This procedure might be based on the assumption that cancer pain is persistent, although the evidence to support whether this assumption applies to all cancer patients is lacking. Some cancer patients might not need a fixed dose of long-acting morphine.

Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an opioid on demand when pain occurs.

A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl nasal spray taken on demand, showed that this treatment was apparently feasible and safe for these patients.

This approach is studied further in NFCP-II. The participants will be treated with rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary outcome will be patient satisfaction.

The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day. After 10 days of treatment there is a crossover and the opposite drug is used for the same participant. Morphine tablets can be taken on demand in all phases of the study.

The participants will meet the investigator at inclusion, at the crossover and at the end of treatment. During the study, a diary is filled in by the participants every morning. Questions about pain and side effects are answered. Satisfaction is measured at the crossover and at end of treatment while preference is measured at the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Cancer disease
2. Adult (older than 18 years)
3. Cancer-related pain \> 4 on an 11 point Numerical Rating Scale (NRS)
4. In the need of opioids (step II or III)
5. Able to use nasal drugs.
6. Life expectancy of \> 6 months
7. Karnofsky status \> = 60
8. Women of child bearing potential must use adequate contraception
9. Informed consent given according to applicable requirements before any trial-related activities.

Exclusion Criteria:

1. Use of opioids for moderate and severe pain
2. History of substance abuse.\*
3. Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
4. Renal- or liver- failure, defined as creatinin \> 150 and alanine-amino transferase (ALAT) \> x 1.5 reference value
5. Sleep apnoea syndrome, severe chronic obstructive lung disease or illnesses leading to severe respiratory depression.
6. Psychiatric disease
7. Neurological disease giving dizziness or sedation
8. Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures.
9. Previous or ongoing facial radiotherapy
10. Recurrent nose bleeding
11. Known hypersensitivity to the active substances or excipients of the study drugs
12. Pregnant or breastfeeding women
13. Treated with monoamine oxidase (MAO) inhibitor within the last 14 days