cyrilzakka/clinical-trials huggingface dataset:
Effect of Moisturizing Creams on Skin Barrier Function

This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo.


Eligibility Criteria:
Inclusion Criteria:

* Dry skin barrier disorders such as atopic dermatitis or Malassezia eradicated head and neck dermatitis.
* Rough or clinically normal skin on the volar aspect of the forearm.
* Either gender
* Age between 18 and 65 years
* Written Informed Consent

Exclusion Criteria:

* Possible allergy to ingredients in the study medications.
* Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy.
* Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse).
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results.
* Pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study.
Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study

non-intervention、real world study； Effect of timing and regular treatment of zoledronic acid on the incidence of SREs in breast cancer patients

(1) Main Purpose: To observe the clinical efficacy of zoledronic acid regularly in the prevention of SREs in breast cancer patients with bone metastasis (2) Secondary Objectives:

1. To observe whether zoledronic acid prolonged the time of first SREs in patients with bone metastasis;
2. The clinical efficacy and influencing factors of zoledronic acid in different subgroups were observed by subgroup analysis of population baseline, clinical characteristics (such as different types of breast cancer), past history and complications.
3. To observe the clinical distribution, characteristics, timing and compliance of zoledronic acid administration in Chinese breast cancer patients with first bone metastasis.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years 2. Histologically confirmed breast cancer 3. Initial diagnosis of bone metastasis by MRI or CT and treatment with zoledronic acid 4. Serum creatinine ≤265mol/L or 3.0mg/dl 5. CrCl ≥ 30 ml/min 6. Serum Ca2+ concentration 2.0-3.0 mmonl/L 7.ECOG score ≤2 Voluntary research, informed consent

Exclusion Criteria:

* 1. Pregnant and lactating women 2. Severe liver insufficiency (ALT and/or AST higher than 3 times the upper limit of normal) 3. Patients with osteoarthritis or other bone related diseases need bone targeted therapy 4. Patients with uncontrolled dental problems or planned jaw surgery
PANGeA - Physical Activity and Nutrition for Quality Ageing

General objectives of the project

Defining healthy ageing factors; Setting up content-related bases of the international excellence centre (SLO-ITA) in the field of health of elderly citizens; Raising awareness on the significance of healthy ageing, social inclusion and mobility of less privileged populations (the elderly); Reducing the costs of health care; Connecting the existing health care, social and private entities and improving their mutual coordination.

Physical activity, dietary habits, social and private entities strongly affect the quality of health and quality of life of the elderly. The main object of this study will be to evaluate physical and cognitive performance in combination with physical activity and dietary habits of the elderly. The investigators are interested in longitudinal monitoring of the elderly that participated in measurements in 2013 and measurements after a decade. The results of this study will give important epidemiological information about physical and cognitive status, health status in combination with physical activity which occurs in a longer period of time.

Eligibility Criteria:
Inclusion Criteria:

* singed written consent
* age above 60
* healthy

Exclusion Criteria:

* severe musculoskeletal injuries
* inability to follow instructions when performing the test
A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients

The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment.

This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.

Patients within inclusion criteria are asked to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;

  1. Newly diagnosed with GHD according to the current medical standard.
  2. Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.
  3. Transition patients diagnosed with CO-GHD before 2013.
* Prescribed Genotropin at the time of inclusion.
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.
Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics

The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and/or females of non-childbearing potential between the ages of 18 (or 21 based on country-specific age of consent) and 60 years, inclusive, at Screening. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical/safety laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5 half-lives (whichever is longer) prior to Day 1.
* Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to simvastatin or other statins.
Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism

The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen.

The following study aims to understand the efficacy of the digital therapeutic, GuessWhat, in improving socialization outcomes in children with Autism Spectrum Disorder (ASD) after regular use over 8 weeks. We will use a cross-over, waitlist control design to examine outcomes after 8 weeks. GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen. The study will enroll parents who are at least 18 years old and have a child between 3 and 12 years old with a formal ASD diagnosis. Parents will be asked to complete two clinical outcome measure questionnaires immediately prior to and up to 1 week after playing GuessWhat with their child 3 times per week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Parent who is at least 18 years old of child with autism.
2. Child with autism is between 3 and 12 years old at time of baseline data collection.
3. A professional diagnosis of Autism that is able to be confirmed by negative score on a machine learning based algorithm using items from Mobile Autism Risk Assessment and video based classifier or by a copy of diagnostic report.

Exclusion Criteria:

1. Parent is unable to read the app in the offered languages (English, Spanish, Portuguese)
2. Parent does not have an Android or iOS smartphone compatible with GuessWhat App.
3. Child has additional psychiatric or neurologic diagnoses including genetic syndromes or epilepsy in addition to autism.
Endothelial Progenitor Cells and Pulmonary Idiopathic Arterial Hypertension

Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury and the capacity for repair.

Current evidence established that endothelial progenitor cells (EPC) participate in several models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery disease, etc. However EPC in the setting of PAH is less well established. The target of this study is to demonstrate if the number of EPC is increased in a mexican population of patients with PAH.


Eligibility Criteria:
Inclusion Criteria:

* Patients were included in the study if they were in The WHO functional class II to III, and had a mean pulmonary artery pressure \>30 mm Hg on right heart catheterization. The ability to walk \>50 m during a standardized 6-min walk test.

Exclusion Criteria:

* Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, major bleeding requiring blood transfusion,renal dysfunction, and evidence for malignant diseases were excluded.
Family-Based Prevention With Black and Latinx Children

The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.

This pilot project is novel in that it (a) interweaves positive parenting practices, ethnic-racial socialization, and healthy lifestyle behaviors into a prevention program for Black and Latinx families, and (b) targets preschool-aged children using a brief, universal prevention approach, which increases potential for dissemination and scalability. The guiding hypothesis is that incorporating these components into a parenting intervention will lead to improvements in children's health as compared to a control condition. A type 1 hybrid effectiveness-implementation design is used to simultaneously test intervention effectiveness while also gathering information on intervention delivery to inform future implementation trials. The specific aims are to: (a) test the preliminary effects of a preventive intervention on the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children, (b) identify the preliminary effects of the intervention on parenting outcomes, and (c) examine potential barriers and facilitators to intervention delivery.

Eligibility Criteria:
Inclusion Criteria:

Eligible children will:

* be between the ages of 3-6 years
* identify as Black/African American or Latinx/Hispanic
* have a parent or caregiver willing to participate in the intervention that: (a) lives in the same household as the child ≥50% of the time, (b) has primary responsibility for the child, and (c) speaks English or Spanish.

Exclusion Criteria:

Consistent with typical methods associated with a universal prevention approach, there are minimal exclusion criteria. Children will be excluded who:

* have a cognitive/psychological condition that limits the child's ability to communicate
* have a physical health condition that limits the child's ability to be physically active
Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke

The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted locomotor training on motor recovery of lower extremities and walking ability compared with the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.

72 first-ever stroke patients who could not walk independently (FAC \< 2), and suffered within 6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk independently before stroke attack were excluded.

Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment (NDT) basically. The robotic assisted locomotor training group received additional robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3), Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA), Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles were assessed before, during (2weeks) and after training. And the independent walking ability were followed until 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Hemiparesis as result of 1st stroke
2. No other neurologic or orthopedic disorder
3. Independent ambulation before the stroke
4. No severe medical illnesses
5. Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups
6. Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal assistance in ambulation
7. The interval between stroke and start of the treatment
8. Time since stroke onset \< 6 months
9. age: 20-80yrs old

Exclusion Criteria:

1. Unstable fractures
2. Severe osteoporosis
3. Severe skin problems
4. Severe joint problems
5. Major difference in leg length,
6. Body weight over 130 kg,
7. Orthostatic circulatory problem
8. Severe cognitive impairment
Experience and Feasibility of Methods for Early Sensory Training

The good effects of using guided plasticity for a rehabilitative purpose in case of nerve damage have been shown, but a problem that has been presented is that some individuals find it difficult to assimilate these effects due to difficulties in carrying out abstract training or due to a lack of motivation. In early sensory training, the plasticity of the brain is used. Methods for early sensory training that have been described are: 1) mental imagery of touch (mental imagery), 2) observation of touch, 3) mirror training, 4) use of images for visualization of touch. The method needs to be developed and refined to be able to offer individual training plans in order to find a motivating and meaningful form of training.


Eligibility Criteria:
Inclusion Criteria:

* \>= 50% injury of N. Medianus/ N. Ulnaris or 100% digital nerve injury dig I and/or dig II
* Ålder: ≥ 18 år

Exclusion Criteria:

* Impaired cognitive ability
* Documented psychiatric diagnosis
* Inability to master the Swedish language
Penile Lengthening Pre-Penile Prosthesis Implantation

This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.

Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint post-operatively that their penis length is shorter than what it was previously.

Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers several potential advantages in that it is minimally-invasive, does not increase the morbidity of surgery, and has not been shown to result in any long-term side effects.

A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and limited amount of data available, we sought to perform a clinical trial evaluating the effect of PTT on increasing the total length of prosthesis which can be inserted. We additionally sought to determine if PTT resulted in improved post-operative satisfaction on total penile length achieved.

To accomplish the study, a population of men from Mayo Clinic planning to undergo placement of an IPP will be enrolled and given the option to either join the control (no treatment) group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to publish in a scientific journal.

Eligibility Criteria:
Inclusion Criteria

* Men undergoing placement of a penile prosthesis
* Must be the first time a penile prosthesis is implanted
* Undergoing implantation of a 3-piece inflatable penile prosthesis

Exclusion Criteria

* Prior ischemic priapism
* Any prior penile prosthesis surgeries
* Any prior penile surgeries other than circumcision
* Undergoing malleable penile prosthesis or Ambicor device
China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)

INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.

INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 and over
* The femoral access vessel is adequate for the selected delivery system;
* Length of proximal aneurysmal neck ≥ 10mm;
* Aortic neck diameter ≥ 17mm and ≤ 31mm;
* The aortic neck is suitable for suprarenal fixation;
* The angle of the infrarenal and suprarenal neck is ≤60 degrees;
* Iliac fixation length ≥ 15mm;
* Iliac diameter ≥ 7mm and ≤ 22mm;
* Minimum total AAA treatment length (proximal landing point to distal landing point) ≥ 128mm;
* Morphology is suitable for aneurysm repair;
* Written informed consent form shall be provided prior to initiating any study protocol;
* The subject is willing to follow the prescribed follow-up schedule.

Exclusion Criteria:

* The subject has one of the following conditions:

  1. Aneurysm sac rupture or leaking abdominal aortic aneurysm
  2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
* Known to be allergic or intolerant to nickel titanium (Nitinol), polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE);
* Known contraindication to undergoing angiography or anticoagulation
* Existing AAA surgical graft and/or a AAA stent-graft system;
* Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial;
Adrenal Exhaustion Syndrome in Critically Ill Patients Without Improvement

We study the relationship between patient outcomes and sequential changes of serum cortisol level.

Elevated corticosteroid level to meet physiologic needs during acute illness is a protective response for stress. This homeostasis is maintained by the hypothalamic-pituitary-adrenal (HPA) axis. However, inadequate response as corticosteroid insufficiency in critically ill patients is reported with increasing frequency, especially in severe sepsis and septic shock. Thus, corticosteroids could be beneficial for septic shock or severe acute illness.

Once considered as normal adrenal function, adrenal insufficiency may developed later with chronic critical illness as adrenal exhaustion syndrome. It is easily overlooked and is possible due to the chronic secretion of systemic cytokines or other HPA axis-suppressive substances. There is still no consensus how often adrenal function testing should be repeated, although a re-evaluation should be considered if clinical symptoms and signs suggest adrenal insufficiency or deteriorating clinical condition.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* ICU admission
* had two cortisol data

Exclusion Criteria:

* first cortisol data abnormal
* cortisol data not checked in ICU
Circadian Rhythms and Cardiovascular Risk

The purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure.

People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian phase in some of the same key indices of CV risk. The investigators hypothesize that such changes, taken together, may explain the different timing of heart attack and sudden cardiac death in OSA.


Eligibility Criteria:
* BMI less than 40
* Moderate to severe OSA (AHI)\>15
* No current or previous pharmacological treatment for hypertension
WaveLight® Refractive Flap Accuracy Study

The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to understand and sign an informed consent form.
* Have refractive error (in both eyes) that requires refractive surgery.
* Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
* Myopia between 0.00 to -12.0 Diopters pre-operatively.
* Astigmatism between 0.00 to +6.00 Diopters pre-operatively.
* Willing and able to attend post-operative examinations per protocol schedule.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Participation in a clinical study within the last 30 days.
* History of previous corneal surgery in either eye.
* Multifocal ablations in either eye.
* PRK or PTK surgery in either eye.
* Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
* Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
* Unable to discontinue contact lens wear as specified in protocol.
* History of Herpes simplex or Herpes zoster keratitis.
* Active ocular rosacea.
* Lyme disease.
* Severe ocular allergies.
* Other medical conditions and use of medications as specified in protocol.
* Pregnant or planning to become pregnant during the study.
* Other protocol-specified exclusion criteria may apply.