cyrilzakka/clinical-trials huggingface dataset:
Emotional Experiences in Fathers of NICU Infants

This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies.

Our primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.

Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of NICU infants.

It is well known that birth and hospitalization of a preterm infant is stressful for parents. Numerous studies have evaluated emotional factors such as maternal stress, parental role alteration, and maternal depression. Researchers have also investigated both maternal and paternal emotional responses in relation to their infant being hospitalized in the NICU. Studies examining paternal response alone have received less research attention. To date, no studies have compared the emotional response of fathers of medical NICU babies and fathers of surgical NICU babies.

The purpose of this study is to evaluate and compare perceived paternal stress and depressive symptomatology in fathers of preterm medical and surgical infants. Fathers who agree to participate will be given a questionnaire that is comprised of two self-report tools. Together these tools should take approximately 15-20 minutes to complete. Fathers who participate will be asked to complete these tools at three different times throughout their infants' stay in the NICU.

Eligibility Criteria:
Inclusion Criteria:

* consenting fathers who are English speaking
* fathers with preterm infants \< 30 weeks gestation and who are likely to survive
* Infants who lack congenital or genetic abnormalities likely to be associated with significant neurodevelopmental handicaps.

Exclusion Criteria:

* There are no specific exclusion criteria.
A Study to Evaluate PT-523 in Patients With Refractory Leukemia

This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with refractory leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
* Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II.
* ECOG performance status 0 - 2.
* Adequate organ function and bone marrow reserve.
* At least 4 weeks must have elapsed from the time of major surgery.
* Use of appropriate contraceptive method.
* Signed patient informed consent.

Exclusion Criteria:

* Known human immunodeficiency virus (HIV).
* Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
* Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
* Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
Neurotensin Infusions in Healthy Individuals -

Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.

In this study, after a 1h baseline period, three doses (2.5, 5.0 and 7.5pmol/kg/min) of NT will be administered in sequence each infusion lasting 1h. On a placebo day saline will be infused similarly 1h infusions. During the final infusion (7.5pmol/kg/min) an ad libitum meal will be ingested. During the experiments blood samples will be collected and subjective perceptions recorded using validated visual analogue scales.


Eligibility Criteria:
Inclusion Criteria:

* Age = or above 18 years
* normal haemoglobin levels
* male
* Informed consent

Exclusion Criteria:

* Diabetes mellitus (fasting plasma glucose or HbA1c)
* Familiy history of diabetes mellitus
* Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
* Family history of inflammatory bowel disease
* Previous intestinal resection
* Body mass index (BMI) over 25 kg/m2
* Smoker
* Nephropathy (S-creatinine\> 130 μM)
* Liver disease (ALAT and/or ASAT \> 2 × upper normal limit)
A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides

This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines \[crow's feet lines\]).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe forehead lines, glabellar lines, and crow's feet lines
* Willing to have facial photos taken

Exclusion Criteria:

* Prior exposure to botulinum toxin of any serotype for any indication
* Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
* Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
* Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
* Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation
Smartphone-based Ophthalmoscopy

A subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of the retina.


Eligibility Criteria:
Inclusion Criteria:

* type 1 or 2 diabetes
* ability to provide written informed consent

Exclusion Criteria:

* significant optic media opacities
Comparison of the Visual Quality of Traditional Ultrasound Biometrics and Lenstar on the Cataract After Pars Plana Vitrectomy

Comparison of the visual quality of traditional ultrasound biometrics and lenstar on the cataract patients with diabetic retinopathy after vitrectomy in the 3 months later.To evaluate the clinical value of lenstar in post-vitrectomy patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with cataract after vitrectomy because of diabetic retinopathy.
2. Patients with good fixation in order to cooperate with various examination.

Exclusion Criteria:

1. Myopia of \>6 diopters
2. Ocular trauma and other eye disease accepted vitrectomy,such as branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO).
3. Vision acuity \<0.1
4. Silicone oil eye
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Switzerland, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit'(V1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients

To evaluate the effect and safety of mivacurium chloride in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* The parent/guardian must sign a parental permission consent document
* American Society of Anesthesiologists (ASA) physical status class 1-3
* Elective surgery patients with tracheal intubation, and the operation duration is expected to be longer than 30 min but no longer than 120 min(cleft lip and palate, orthopedic, bilateral hernia, bilateral cryptorchidism, hypospadias crack, and other ear, nose and throat surgery, etc)
* Age between 2 months to 14 Years

Exclusion Criteria:

* BMI\<18kg/m2 or BMI\>31kg/m2
* Patients with serious respiratory, cardiovascular disease, and liver and kidney dysfunction\[AST（glutamic oxalacetic transaminase）,ALT(glutamic-pyruvic transaminase)\>1.5 Normal;BUN(blood urea nitrogen)\>Normal)\]
* Patients with asthma or airway hyperresponsiveness, neuromuscular patients disease or cachexia
* Preoperative hemoglobin less than 10g/L
* Hypoproteinemia TP（total protein) \<45g/L
* Diabetic patients
* Patients with difficulty airway
* Patients with Known or suspected atypical plasma cholinesterase gene homozygous
* Burn patients
* Patients with serious acid-base imbalances, or severe electrolyte imbalance
* Patients with neuromuscular relaxants in a week
* Patients prohibited with muscle relaxants, or allergy to any component of mivacurium
* Patients participated in any drug clinical trial with 30 days before the start of the study
* Other situations not suitable for inclusion
* Blood loss more than 10 ml/kg in surgery
Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients

This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district.


Eligibility Criteria:
Inclusion criteria

* Patients diagnosed with metastatic melanoma (C43) during 01 January 2014 and 31 December 2021.
* Adult (18 years or older) at the time of diagnosis of metastatic melanoma.
* Resident in the corresponding hospital district(s) at the time of diagnosis of metastatic melanoma.

Exclusion criteria

* Metastasis recorded prior to 01 January 2014 (i.e. prevalent case).
* Record of any other cancer (The International Classification of Diseases, 10th Revision \[ICD-10\] diagnosis code starting with C, excluding C43, C77, C78, and C79) as last cancer diagnosis before metastasis.
* Participated in COBRA (vemurafenib, temozolomide, lomustine, vincristine) trial.
Paradigm Shift in Medical Education: Applications of High-Fidelity Simulation, Teamwork Model Development, and Concept of Flipped Classroom in Innovation and Revolution of Resuscitation Training

Medical education was transformed from mainly didactic class before 19th century to the clerkship and internship training based on the concept of "learning by doing" in 20th century. There are new challenges for medical education in the 21th century, including knowledge explosion, the importance of communication and teamwork in clinical care, and lack of comprehensive and systemic experiential learning. Therefore, another paradigm shift of medical education in this century is necessary. This research project, through applying high-fidelity simulation, resuscitation teamwork model, and concept of flipped classroom in resuscitation training, take the innovation and reform of resuscitation training as a pilot test for paradigm shift of medical education.

This research project is a 4-year project. Three innovative intervention for resuscitation training will be developed, implemented, and evaluated. There will be 4 phases in this project:

1. Development phase (1st year): establishment of structure, validity and reliability test, faculty development, and course preparation.
2. Experiment phase (2nd year): comparative studies will be conducted.
3. Implementation phase (3rd year): integration and implementation of innovative interventions.
4. Evaluation phase (4th year): effectiveness evaluation and analysis of learning retention.

Through innovation, development, implementation and effectiveness evaluation in this 4 phases, this research project hope to integrate high-fidelity simulation, resuscitation teamwork model, and concept of flipped classroom, into resuscitation training successfully and appropriately. Furthermore, these experiences can provide the bases of paradigm shift in medical education in the future.


Eligibility Criteria:
Inclusion Criteria:

Health care workers in the following department of National Taiwan University Hospital ward. The Department of surgery, the Department of internal medicine, the Department of Emergency Medicine, the Department of Ambulatory Service.

Exclusion Criteria:

Physical conditions are unsuitable for personnel to implement emergency skills training.
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure

The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)

The study was terminated early and the pediatric development of serelaxin in the treatment of acute heart failure (AHF) discontinued, following the results of the phase III study RELAX-AHF-2 (CRLX030A2301/NCT01870778) study in adult patients with AHF. Whilst no new safety concerns associated with serelaxin were observed, the study in adults did not meet either of its primary endpoints

Eligibility Criteria:
Key Inclusion criteria:

* Body weight ≥2.5 kg to ≤120 kg
* Hospitalized in an intensive care unit or step-down unit with the following:
* - Signs and symptoms of acute heart failure of any etiology
* - Stable dose of vasoactive and/or inotropic drugs
* - For non-surgical patients echocardiographic evidence of reduced ventricular function (ejection fraction \<50% or fractional shortening \<28%)
* Systolic blood pressure (SBP) ≥25th percentile SBP for age and gender.

Key Exclusion criteria:

* Moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction
* Single ventricle physiology
* Fixed pulmonary hypertension
* Blood lactate levels \>5 mmol/L at screening
* Birth \< 36 weeks post-conceptual age (for patients \<1year old)
* Confirmed or clinically suspected systemic infection or severe localized infection
* Dyspnea or acute lung injury primarily due to non-cardiac causes
* Patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy
* High use of inotropic and/or vasoactive agents at screening
* Electrocardiographic abnormalities
* Solid organ transplant recipient within 1 year of transplantation or one who presents with severe organ rejection
A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis

ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.

The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.

This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR)
* Must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month
* NSAID washout of at least 2 days before screening/baseline

Exclusion Criteria:

* Previous treatments acting on cartilage or bone metabolism
* Received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
* Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
* Kellgren-Lawrence Grade 1 or 4 in the index knee on any incidences.
* Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
* History of joint replacement of the knee or hip within the previous 12 months
Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime

Recent studies have shown that applying intermittent negative pressure (INP) with short negative pressure (-40 mmHg) pulses to the lower extremities increase arterial blood flow velocity and skin blood flow. However, the optimal magnitude of negative pressure to improve blood flow is not known, and needs further investigation. Peripheral arterial blood flow velocity, skin blood flow and skin temperature in the foot will be recorded at different levels of oscillating negative pressure to identify a pressure range which is practically, while at the same time induce clinically relevant changes in blood flow parameters. Heart rate and blood pressure will be recorded to monitor the effects on the central circulation.

Cross sectional study design. The equipment for physiological measurements will be attached to the patient, and the foot will then be placed in the pressure chamber. The device induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. Pressure levels of 0 mmHg, -10mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested.

Patients will be recruited from the out-patient clinic at Department of Vascular Surgery, Oslo University Hospital, Aker.

Inclusion criteria:

Diagnosed peripheral artery disease (PAD), Ankle-Brachial Index \<0.9 Outcome measures:

Arterial blood flow: Ultrasound Doppler from peripheral arteries in the foot.

Skin blood flow: Laser Doppler to measure acral skin blood perfusion.

Skin temperature

Systemic blood pressure: Finger arterial pressure will continuously be acquired by a photoplethysmographic pressure recording device (Finometer).

Ankle brachial index

Pressure recordings inside the pressure chamber: Continuously monitoring of pressure within the pressure chamber using a digital differential manometer.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed peripheral artery disease
* Ankle-Brachial Index \<0.9

Exclusion Criteria:

* Incapable to make an informed consent
* Diagnosis of severe psychiatric disease
* Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
* Systemic infection
* Use of vasoactive substances
Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in individuals with prodromal Alzheimer's disease.

The goal of the present study is to assess behavioral (primary) effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in pathological aging still need to be elucidated. Individuals with prodromal Alzheimer's disease, will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary) will be examined before, during and after the intervention, in order to draw conclusions about the effect of tDCS. In addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Follow-up sessions to assess long-term effects are planned four weeks and seven months after the post assessment. Furthermore, to assess potential predictors of tDCS effects, functional and structural parameters will be measured with MRI. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in individuals with prodromal stages of Alzheimer's disease. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for modulating cognitive decline in healthy and pathological aging.

Eligibility Criteria:
Inclusion Criteria:

* Older adults (60 - 80 years);
* Right handedness;
* subjective cognitive decline (SCD) or mild cognitive impairment (MCI)

Exclusion Criteria:

* Dementia or other neurodegenerative neurological disorders; epilepsy or history of seizures; close relatives with epilepsy or history of seizures; previous stroke;
* Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
* History of severe alcoholism or use of drugs;
* Severe psychiatric disorders such as depression (if not in remission) or psychosis