cyrilzakka/clinical-trials huggingface dataset:
A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velaglucerase Alfa (VPRIV) Home Infusion

The main purpose of this survey is to determine participants', caregivers', and nurses' understanding and use of educational materials (EM) on VPRIV home treatment. EM includes an infusion diary and guide and an emergency plan related to VPRIV infusion given at home for Gaucher disease. The survey is conducted in European countries.

Data will be collected directly from participants, caregivers, and nurses in form of a questionnaire, electronic or paper.

The participants diagnosed with Gaucher disease receiving VPRIV® home infusion, their caregivers and home infusion nurses were observed in this study. This cross-sectional study will determine and assess the understanding of the educational material (EM), including infusion diary and emergency plan associated with VPRIV® home infusion in participants diagnosed with Gaucher disease, their caregivers and home infusion nurses.

The study will recruit approximately 30 participants/caregivers and 30 home infusion nurses. The survey will be conducted through non-nominative web-based questionnaires that will be completed in approximately 10-15 minutes. All participants will be enrolled in a single observational group:

• VPRIV® Home Infusion

The trial will be conducted in home-based setting in Austria, Belgium, Finland, France, Germany, Italy, the Netherlands, and Spain.

Eligibility Criteria:
Inclusion criteria:

1. Gaucher disease participants who receive VPRIV® for home infusion and their caregivers.
2. Home infusion nurses administering VPRIV® to participants with Gaucher disease at home.

Exclusion criteria:

Potential respondents will be excluded if they have conflicts of interest with the survey (e.g., if they are employed by regulatory bodies, or pharmaceutical industry).
Treatment of Patients With Blepharitis and Facial Rosacea

To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea


Eligibility Criteria:
Inclusion Criteria:

* blepharitis
* facial rosacea

Exclusion Criteria:

* pregnant or nursing women
* allergy to tetracyclines
* recent eye surgery
* past or current use of isotretinoin
* patients who are achlorhydric
* patients who have had gastric by-pass surgery
Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment

This project is proposed to be a three-year project. The purposes of this project are to develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

Aim. develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

Background. Mild cognitive impairment (MCI) is a common clinical syndrome that identifies people at high risk of developing dementia, and the prevalence range from 7.7 to 51.7%. Although treatments for MCI are currently unavailable, preliminary evidence has identified potential neuro-protective effects of exercise program and cognitive rehabilitation, which may lead to improved outcomes. However, the design and delivery of an appropriate program for people with MCI is challenging for having physical, psychological, cognitive, and social barriers.

Design. A prospective randomized control trial. We developed a Physical activity stage-matched intervention (SMI) (1st year), cognitive rehabilitation (2nd year) and New lifestyle program

Eligibility Criteria:
Inclusion Criteria:

* had a subjective memory complaint
* MMSE score\<16, 21 or 24, based on their years of education (illiterate, 6 or \>9 years, respectively, Yeh et al., 2000), but needed \>13 or objective memory impairment: AQ\>5 or at least one item of IADL dependence
* able to carry out activities in daily life

Exclusion Criteria:

* using walking devices
* depression or dementia diagnosis
Effects of a Personalized Physical Training to Reduce Fatigue

Chronic fatigue (CF) is a pathological fatigue over at least 6 months, without improvement after rest or sleep. In primary care, it is the major complaint in 5 to 10% of the consultations. Physical activity is an efficient therapy to help reducing this fatigue in addition to the improvement of muscular and cardiorespiratory functions. However, it remains little exploited. Yet the studies focus mainly on precise chronic pathologies with general trainings, without considering the fatigue status and reveal a large heterogeneity. Personalizing the physical training appears to be the next step in order to improve chronic fatigue patients care.

The objective of this study will be to investigate the relevance and the effects of a personalized physical training to reduce fatigue in chronic fatigue patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18
* Men or women
* FACIT-F score ≤ 34
* Ability to walk during 10 minutes without stopping
* Ability to receive the Myocene® stimulation protocol
* Have given written consent
* Members or beneficiaries of a social security program

Exclusion Criteria:

* Contraindication to experimental procedures
* Important health issues that would compromise the participant security during the study
* Persistent atrial fibrillation or 2nd or 3rd degree atrioventricular block
* Currently participating in an other interventional study or having so in the past thirty days
* Patient is pregnant
* Patient is unable to give an informed consent
* Patient is deprived of liberty or under guardianship
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer

Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
* Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
* Signing of informed consent by the patient or relative in charge.
* Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).

Exclusion Criteria:

* Patients \<18 years
* Pregnancy or breastfeeding
* Epithelial ovarian tumors stage FIGO III or IV.
* Impossibility to obtain a biopsy from the tumor.
* History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
* Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.
* Patient not able to undergo surgery.
* Hypersensitivity to active principle, to sodium iodide or iodine allergy.
* Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland
Retinal Nerve Fiber Layer Thickness Measurements in Patients With Sleep Apnea Syndrome

The purpose of this study was to measure the retinal nerve fiber layer (RNFL) thickness in eyes of Obstructive Sleep Apnea/hypopnea syndrome (OSAHS) using optical coherence tomography (OCT), and assess whether it is decreased. The investigators then compared the results with healthy subjects database of RNFL thickness from another retrospective study.

An association between glaucoma and OSAHS has been reported in several studies. Glaucoma is a progressive optic neuropathy involving loss of retinal ganglion cells and their axons at the level of the optic nerve head.Computerized technologies have now been successfully used in evaluating retinal nerve fiber layer (RNFL) thickness in glaucoma.Given the evidence of a possible link between OSAHS and glaucoma, it is reasonable that structural losses in retinal nerve fiber layer (RNFL) thickness would be present in OSAHS.Indeed,decreased retinal nerve fiber layers was found in patients with OSAHS, the severity of which correlated with the severity of the patients' OSAHS using scanning laser Polarimetry (SLP).Optical coherence tomography (OCT) provides quantitative RNFL thickness data by measuring the difference in the temporal delay of back-scattered light from the RNFL and a reference mirror.During the past decade, OCT has been used widely in clinical practice to discriminate glaucomatous eyes and eyes with early perimetric glaucoma from normal eyes. Several studies confirmed the accuracy and reproducibility of the RNFL thickness measurements by OCT. The thickness of the peripapillary RNFL was measured with the Stratus OCT(Carl Zeiss Meditec, Inc, Dublin,CA)using the fast scan protocol(3.4).Only good quality images, as judged by the well-focused and centered scans,no artifacts showing distorted anatomy, no missing parts and a signal strength ≥6, were used for further analysis. The considered OCT parameters were overall average RNFL thickness and the average RNFL thickness in 4 quadrants (superior, nasal,inferior,and temporal)extracted from the standard RNFL thickness analysis report(RNFL Thickness Average Analysis Protocol).

Eligibility Criteria:
Inclusion Criteria:

* formal diagnosis of moderate or severe OSAHS
* eligibility to sign informed consent form
* older than 18 years

Exclusion Criteria:

* known glaucoma
* not eligible to sign informed consent form
* younger than 18 years
* incompetent persons who lack decision making capability
Glycaemic Index Determination in Oral Nutrition Supplements

The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response.

The determination of the glycemic index will be conducted following the protocol described in the International Standard Organization 26642. Specifically, the glycemic response of each food will be determined in 15 healthy volunteers, using a glucose-containing beverage with 25 g of glucose in 200 mL as a control for glycemic response measurement. The amount of food each volunteer will test will be equivalent to an intake of 25 g of digestible carbohydrates in a single intake. Subsequently, increases in blood glucose levels will be recorded at 15, 30, 45, 60, 90, and 120 minutes after initiating the food intake. Blood glucose measurements will be performed using a portable glucometer via capillary blood. The area under the curve of the increase in glucemia will be estimated using the trapezoidal method, and these will be compared with the glucose increases provided by the glucose-containing beverage.

Eligibility Criteria:
Inclusion Criteria:

• Healthy volunteers with no known food allergy or intolerance and pharmacological treatments known to affect glucose tolerance (excluding oral contraceptives)

Exclusion Criteria:

* Known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
* Any acute, chronic disease or any other serious complications that may interfere with glucose metabolism.
* Subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.
* Subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion
* A major medical or surgical event requiring hospitalization within the preceding 3 months.
* Pregnancy
Therapy Online Plus (TOP+) - Comparing Two Online Interventions for Dealing With Challenging Life Circumstances

Psychotherapy interventions can roughly be grouped into compensation-oriented strategies (compensating for and and modifying personal deficits of patients) versus capitalization-oriented strategies (building on patients' personal strengths). Improvement of emotion regulation (compensation-oriented) as well as the activation of resilience (capitalisation-oriented) have been identified as important transdiagnostic factors in the treatment of mental disorders. The study aims to compare compensation vs. capitalization strategies by using two online programs, centered either on emotion-regulation ("REMOTION") or on activating resilience ("Res-Up!"). Res-Up! and REMOTION are administered as stand-alone intervention or as add-on treatment to standard psychotherapy.

Participants will be randomly assigned to three study conditions (Res-Up!, REMOTION, waiting control group). Outcomes are assessed at baseline, after six weeks and after twelve weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a mental disorder according to DSM-5
* Recruited at the training centers of the German Association for Behavior Therapy (Deutsche Gesellschaft für Verhaltenstherapie, DGVT) at Muenster, Bielefeld and Dortmund or at the Center of Mental Health and Psychotherapy, Witten/Herdecke University (all outpatients clinics

Exclusion Criteria:

* Insufficient German language skills
* Current severe episode of major depression
* Psychotic disorder
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants

This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.


Eligibility Criteria:
Inclusion Criteria:

* Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
* Infant must be stable on NAVA for at least 24 hours prior to the study

Exclusion Criteria:

* Infants with congenital heart disease (CHD)
* Infants with persistent pulmonary hypertension (PPHN)
* Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?

Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be easily removed and have been treated in a number of different ways. Two of the simplest and most successful ways to remove seborrheic keratoses are cryosurgery and curettage.

The investigators are conducting this study to see which of these two treatments has the best result.

Approximately 24-30 people will take part in this research study at the Hershey Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* have at least 1 seborrheic keratosis on each side of his/her trunk or proximal extremities.
* be able to understand the consent form and evaluation of treatment questionnaire.

Exclusion Criteria:

* Children \<18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone.

II. Assess the toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no).

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed transitional cell carcinoma (TCC) of the urothelium(renal pelvis, ureter, bladder, or urethra)

  * Mixed histology carcinoma with a TCC component allowed
* Progressive regional disease
* Metastatic disease
* Failed 1 and only 1 prior systemic chemotherapy regimen containing cisplatin or carboplatin in the adjuvant, neoadjuvant, or metastatic setting

  * May have included taxane-based therapy
* Measurable disease outside prior irradiation field
* Previously resected and irradiated CNS metastases with evidence of stable disease allowed
* Performance status - ECOG 0-2
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL
* No prior severe cardiovascular disease (American Heart Association class III or IV heart disease)
* No uncontrolled congestive heart failure
* No ventricular dysrhythmia
* No active unresolved infection requiring parenteral antibiotics within the past week
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or clinically unsuspected organ-confined prostate cancer treated with prior prostatectomy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior systemic biologic response modifier therapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior major surgery and recovered
A Study for the Identification of Biomarker Signatures for Diagnosis of Pulmonary Hypertension (PH) in Participants at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance Imaging

The primary purpose of this study is to estimate the percentage of participants in the population considered clinically as not having pulmonary hypertension (PH) that are positive for PH biomarker (micro ribonucleic acid \[RNA\]); estimate the percentage of participants in the population considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) and compare results of the MRI to the biomarker results; to determine the performance of the biomarker signatures identified in the CIPHER (NAPUH0001) study in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), in a population considered clinically as not having PH.


Eligibility Criteria:
Inclusion Criteria:

* Referred for diagnostic work-up for pulmonary hypertension (PH)
* With low or intermediate (but not high) probability of PH by transthoracic echocardiography (TTE) according to European Society of Cardiology (ESC)/ European Respiratory Society (ERS) Guidelines if at the time of enrollment Right Heart Catheterization (RHC) is not deemed to be clinically indicated
* Medically stable on the basis of physical examination, medical history and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Must sign an Informed consent (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must sign a separate approval in the ICF if he or she agrees to provide an optional (DNA) sample for research. Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study

Exclusion Criteria:

* Undergone RHC within 2 years
* Participants requiring renal dialysis
* Participants post-lung or heart transplant
* Severe left ventricular dysfunction: left ventricular ejection fraction less then (\<) 35 percent
* Ongoing Contagious respiratory disease
Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium

During delirium patients are at risk of severe harm due to unattended bed-exits resulting in falls. This research intends to explore how effective alarming contact mats (CareMat®) in comparison to contactless bed-exit alarming devices (Qumea®) are to reduce the risk of unattended bed-exits and falls.

Delirium is a neuropsychiatric disorder with a sudden and reversible decline in attention and cognition due to a medical condition.8 Delirium is associated with emotional distress for patients, their relatives and medical staff.3-5 During delirium, patients are at risk of severe harm due to unattended bed-exits and subsequent falls.6, 7 As worldwide strategy, sitters are used for the prevention of harm in patients with delirium. However, evidence of the effectiveness of sitters is scant.9 A newly designed specialised acute care unit for older patients with delirium, the FELIX PLATTER delirium unit (DelirUnit), strives to overcome the aforementioned shortcomings. On the DelirUnit there are no physical barriers such as bed rails to prevent patients from bed-exits. Floor beds minimize injuries when patients leave their beds unattended. Specialised nurses and nursing aides care for this vulnerable patient group. Sitters are banned. As an alternative to sitters, nurses are informed about patients' intended bed-exit by electronic alarming contact mats at the bedside or in front of beds (CareMat®) or by a novel contactless radar-based bed-exit monitoring system (Qumea®). Up until now, evidence for the effectiveness of technical devices for fall risk prevention is low. This research intends to explore how effective contact mats (CareMat®) or contactless bed-exit alarming devices (Qumea®) are in fall risk detection and fall prevention.

Eligibility Criteria:
Inclusion Criteria:

Admission at or transferal to DelirUnit. During Covid pandemic, patients will be enrolled into the study after the second negative Covid swab (PCR).

Exclusion Criteria:

Patients who have been sectioned and must be treated in a facility, whether they agree or not (under the mental health act) (Fürsorgliche Unterbringung).

No proxy consent available due to language barriers;

Missing legal proxy in case of lacking family network