cyrilzakka/clinical-trials huggingface dataset:
Hamburg City Health Study - a German Cohort Study

The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases.

A random sample of 45.000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, will take part in an extensive baseline assessment at a dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting cardiac, arterio-venous and cerebral function and structure including extensive imaging examinations. The protocol includes self-ratings of life style and environmental conditions, , dietary habits, physical activity, professional life, psychosocial context, , digital media use, medical and family history as well as health care utilization patterns. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to develop complex models predicting health outcomes based on a multitude of examination data, imaging data and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia will be invited for a visit to conduct additional MRI examination either of heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and data from involved health and pension insurances.

Eligibility Criteria:
Inclusion Criteria:

* Inhabitant of the city of Hamburg at the time of inclusion into the study (Inclusion is time of written consent)
* Age 45 to 74 years
* Personally signed informed consent

Exclusion Criteria:

* Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation
* Physical or psychological incapability to travel to the study center and to cooperate in the investigations
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol

In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
* Post-bronchodilator forced expiratory volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70%
* Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)

Exclusion Criteria:

* Patients with a history of asthma
* Patients who are currently being treated for COPD with tiotropium (Spiriva®)
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply
Egyptian Arthroplasty Surgeons' Antibiotics Usage Awareness

Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are procedures successfully applied to manage various end-stage chronic hip and knee diseases, such as osteoarthritis, rheumatoid arthritis, and femoral head avascular necrosis, as well as acute conditions, such as the neck of femur fractures, with excellent long-term functional outcomes. One of the devastating complications after such a procedure is periprosthetic joint infection (PJI). Various precautions are proposed to guard against such complications; one is the administration of perioperative antibiotics. However, injudicious or misuse of antibiotics could lead to the emergence of antimicrobial resistance, further complicating this matter. This is why various scientific and research organizations have proposed guidelines and a consensus for proper antibiotic use in perioperative THA and TKA surgery.

Antibiotic prophylaxis during primary THA and TKA can reduce the risk of PJI and surgical site infections. However, there is a lack of consensus on the optimal dosages and duration of prophylaxis, and guidelines vary among institutions. Alternatives such as extended oral antibiotic prophylaxis and different antibiotic regimens are being explored. International research is needed to establish best practices and determine the potential risks of antibiotic prophylaxis during primary THA and TKA. Unfortunately, the investigators are unaware of such guidelines proposed by any Egyptian health authority to guide and control the proper utilization of antibiotics during orthoapedic practice in general and joint replacement surgeries (THA and TKA) in particular.

This study will be an Online-based questionnaire investigating surgeons' perspectives on antibiotics utilization during primary total hip and knee arthroplasty surgeries and investigate their thoughts about the necessity for developing local guidelines.

Eligibility Criteria:
Inclusion criteria:

All Egyptian registered members of the Egyptian Pelvis and Hip Society, practicing Egyptian joint replacement surgeons (performing surgeries as a leading surgeon) who are willing to participate

Exclusion criteria:

* Members not listed in the E-mail directory of the society
* Surgeons refusing to participate
* Young surgeons who are not practicing independently
Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors

This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region and measure effects on compulsive behaviors and related measures. This work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.


Eligibility Criteria:
Inclusion Criteria:

Participants will:

1. Be between the ages of 18 and 60 years
2. Endorse problematic compulsive behaviors, per self-report and clinician-administered measures.
3. Agree to video taping of structured clinical interview
4. Report that they will reside in the Pittsburgh area for at least 5 weeks

Exclusion Criteria:

1. Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.
2. Medical contraindications for Transcranial Magnetic Stimulation (TMS):

   1. Presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches)
   2. Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy
   3. Pregnancy
   4. Metallic implants in body or other devices that may be affected by magnetic field
   5. Significant heart disease or cerebrovascular disease
   6. Medications with strong seizure threshold lowering potential or which may interfere with the efficacy of TMS (e.g., clozapine, stimulants)
3. Acute suicidality or other psychiatric crises requiring treatment escalation
4. Changes made to treatment regimen within 4 weeks of baseline assessment
5. Reading level \<6th grade as per participant self-report
6. Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current problematic use of mood altering drugs such as cocaine, opiates, amphetamines, and barbiturates)
7. Presence of movement disorder or tics affecting manual responses
8. Inability to read text from 2 feet away (corrective lenses allowed)
Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

The purpose of this study is to gather information regarding the use of Myfortic, Prograf, and corticosteroids in new liver transplant recipients. These three medicines help to prevent the body from rejecting the transplanted liver. The information the investigators are obtaining is data relating to the process of Myfortic absorption by the body, its distribution in the body, the breakdown of Myfortic in the body, and its elimination from the body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.

Myfortic is approved for use in kidney transplant recipients, and has been prescribed by doctors for liver transplant recipients. No study has been reported to date evaluating the pharmacokinetics of Myfortic in new liver transplant recipients who also take Prograf and corticosteroids. During this six month study, a series of blood samples will be obtained after subjects take Myfortic, Prograf, and corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> or equal to age 18 years
* Planned to receive tacrolimus and corticosteroid therapy posttransplant
* Serum creatinine at transplant \< or equal to 2.5mg/dL
* UCSF tumor staging \< 8cm total
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the baseline visit and are required to practice a reliable method of contraception for the duration of the study and for no fewer than 6 weeks after completing the study.
* Signed informed consent form prior to any research assessment

Exclusion Criteria:

* Induction therapy
* Requiring dialysis at the time of transplant
* Organ transplant other than liver
* Pregnant or nursing females
* Women of childbearing potential not practicing reliable methods of contraception. Reliable methods for contraception include surgical sterilization (hysterectomy, bilateral tubal ligation), double-barrier method (such as condom and diaphragm). To be considered as post-menopausal and not of childbearing potential, female subjects must have experienced 12 consecutive months of amenorrhea.
* Require any medications that interfere with metabolism of Myfortic (other than corticosteroids)
* Have a known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or any of its excipients
* Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug
SH-LPS System in Preoperative Planning for Liver Resection

Effective preoperative planning and real-time intraoperative guidance are crucial for performing accurate liver resections. To address this need, the researchers have designed advanced 3D-printed liver models using a self-healing elastomer, created through the copolymerization of 4-acryloylmorpholine (ACMO) and methoxy poly(ethylene glycol) acrylate (mPEGA). These models demonstrate outstanding healing properties, swiftly restoring their structure within minutes at room temperature, and quickly recovering after incisions.

In previous studies, Professor Yuhua Zhang, the project applicant, collaborated with a team from Zhejiang University to develop a 3D-printed liver model that is self-healing and reusable for repeated cutting. They preliminarily explored the feasibility of applying this model for preoperative planning and surgical training for liver surgeries. The results were published in Nature Communications (Lu et al., Nat Commun. Dec 19;14(1):8447). Building on this, the applicant intends to establish a personalized liver surgery planning system (Personalized Liver Surgery Planning System Based on High-Fidelity 3D Printed Self-Healing Liver Models, SH-LPS), which will assess, through a randomized controlled trial, the value of SH-LPS in improving liver surgery efficiency and safety.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old;
* Patients with a resectable tumor in the liver;
* Eastern Cooperative Oncology Group Performance status score: 0;
* Child-Pugh classification: A;
* The Laboratory test results meet the following criteria and patients can tolerate surgery: Haemoglobin≥90g/L, Neutrophil count≥1.5×10⁹/L, Platelet count≥100×10⁹/L, Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN）, alkaline phosphatase≤2.5 ULN, Serum albumin≥30g/L, serum creatinine\<1.5 ULN, International normalized ratios（INR）≤2 or rothrombin time（PT）exceed ULN≤6s, Creatinine clearance≥60 mL/min.

Exclusion Criteria:

* Patients with extra-hepatic metastasis;
* Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery;
* Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy;
* Severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L);
* There are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.
Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.

The improvement of imaging techniques in ophthalmology has made it possible to carry out a precise non-invasive study of the retinal microvascular network and to detect early abnormalities in retinal disorders. The presence of such early retinal abnormalities remains poorly known during type 1 diabetes and may be detected with OCT-angiography. Furthermore, the association with glycemic variability, likely to have deleterious effects on microvessels, has never been studied.


Eligibility Criteria:
Inclusion Criteria:

For the patient group

* Patient who has given consent

  * Type 1 diabetic patient, no retinopathy For the healthy control group
* Patient who has given consent
* Non-diabetic patient

For dyslipidemic control group:

* Person who has given consent
* Person with familial dyslipidemia

Exclusion Criteria:

For the patient group

* Presence of diabetic retinopathy
* Protected patient:

  * Minor patient
  * Pregnant, parturient or breastfeeding woman
  * Patient under legal protection (guardianship, curatorship, court decision)
  * Patient unable to express consent Person not affiliated to a health insurance scheme

For the healthy control group

* Ophthalmological history (vascular and degenerative macular conditions)
* Protected patient:

  * Minor patient
  * Pregnant, parturient or breastfeeding woman
  * Patient under legal protection (guardianship, curatorship, court decision)
  * Patient unable to express consent Person not affiliated to a social security scheme

For dyslipidemic control group:

* Ophthalmological history (vascular and degenerative macular conditions)
* Protected patient:

  * Minor patient
  * Pregnant, parturient or breastfeeding woman
  * Patient under legal protection (guardianship, curatorship, court decision)
  * Patient unable to express consent Person not affiliated to a social security scheme
Switching From Cardiac Troponin I to T

Cardiac troponin is central to the diagnosis of myocardial infarction and high-sensitivity cardiac troponin (hs-cTn) assays are the preferred choice for the assessment of patients with suspected acute coronary syndrome.

Since the introduction of hs-cTn assays in Europe in 2010, most hospitals have switched from contemporary sensitive cardiac troponin assays to a hs-cTn assay. The implementation of hs-cTn assays has led to an increase in the number of patients identified with myocardial injury. Although both hs-cTnI and hs-cTnT assays are recommended in current guidelines, the impact of switching from a hs-cTnI assay to a hs-cTnT assay on clinical practice is unknown. At this point, no studies have evaluated the impact of implementing sex-specific hs-cTnT thresholds on the diagnosis of myocardial infarction and outcome in clinical practice.

The investigators propose to determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of a hs-cTnT assay and to evaluate the impact on investigations, care and clinical outcomes in consecutive patients with suspected acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and over
* Symptoms of possible acute coronary syndrome
* High-sensitivity cardiac troponin measured at presentation

Exclusion Criteria:

* Insufficient clinical information to perform record linkage
* Previous enrolment in the study
* Patients with ST-segment elevation myocardial infarction (STEMI)
Early Feasibility Study: Application of OCT Imaging in Dermatology

Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture biological images from within optical scattering media (e.g., biological tissue). A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use.

AMO has developed an in-vivo OCT scanning system prototype based on the clinical needs and potential applications. This study is designed as an early feasibility study aiming for validation of AMO's in-vivo OCT scanning system in dermatology through collaboration with Mackay Memorial Hospital. The OCT can provide cellular-resolution (\<1μm in lateral and axial directions) images which can be utilized to identify organelles. A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use.

The proposed scenario in this study is to collecting OCT images of skins with suspicious lesion including tumor, inflammatory diseases or pigment alteration as well as normal skin by using AMO's in vivo OCT imaging system. By using traditional pathological biopsy images or dermoscopic images as gold standard references, investigators will try to identify different characteristics in OCT images of skin with suspicious lesion including tumor, inflammatory diseases, or pigment alteration as well as normal skins.


Eligibility Criteria:
Inclusion Criteria:

* A patient who is fully aware of the trial and can sign the inform consent form himself/herself
* Patients with suspected skin tumors or skin inflammations
* Patients diagnosed for biopsy
* Patients with no open wounds in the tumor or inflamed position

Exclusion Criteria:

* Patients with a transcutaneous infectious disease
* Patients under the age of 20
* Vulnerable populations, including: pregnant women, handicapped, and homelessness
* Patient cannot cooperate in examination
* Patients with skin tumors that are in the subcutaneous tissue
Digital Storytelling-role Play for Ethical Behaviours to Protect Patient Rights and Ethical Sensitivity

This study aimed to investigate the effect of an ethics education using role-play and digital storytelling, on nursing students' ethical behaviours to protect patient's rights and ethical sensitivity.

* Is role-playing in ethics education effective in improving students' behaviours to protect patients' rights?
* Is role-playing in ethics education effective in improving students' ethical sensitivity?
* Is digital storytelling in ethics education effective in improving students' behaviours towards protecting patients' rights?
* Is digital storytelling in ethics education effective in developing students' ethical sensitivity? The researchers will compare the mean scores of the ethical behaviours toward protecting patient rights scale and ethical sensitivity scale to see whether role-playing and digital storytelling methods in ethics education have an effect on nursing students' ethical behaviours and ethical sensitivity towards protecting patient rights.
* All groups will participate in the theoretical lectures of ethics education for a total of five weeks, three hours a week.
* The theoretical lectures will consist of examination of ethics and related concepts, ethical principles, professional values in nursing, relationship between care and ethics, ethical problems and ethical approaches.
* One week after the theoretical lecture, all groups will participate in a two-week practice phase, three hours a week.
* Each group will be divided into small groups of 6-7 people.
* The Intervention I group will conduct an ethical case analysis involving an ethical problem given to them by the researchers in the classroom environment every week and will discuss the analysis using the role-play method in the ethics committee to be formed after the session.
* Intervention II group will discuss the ethical case analyses with ethical problems written by themselves by coming together outside the classroom environment.
* Each small group of 6-7 people will present their ethical case analyses to other group members in the classroom through digital storytelling.
* The control group will continue the standard education.


Eligibility Criteria:
Inclusion Criteria:

* First-time registration in the course
* Being a volunteer

Exclusion Criteria:

* Non-native speakers of the country's native language
* Previous graduation from any health-related university
Melody® Transcatheter Pulmonary Valve Post-Approval Study

The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.


Eligibility Criteria:
Inclusion Criteria:

* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
* Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)

Exclusion Criteria:

* Implantation in the aortic or mitral position
* Venous anatomy unable to accommodate a 22-fr size introducer sheath
* Obstruction of the central veins
* Clinical or biological signs of infection including active endocarditis
* Unwilling or unable to provide written informed consent or comply with the follow-up requirements
The Effect of the Mobile Application Developed for Home Care of Preterm

mobile application will be developed to support the post-discharge home care of mothers of premature babies. With the developed mobile application, the effect of the education given to the mothers on the knowledge and skills of infant care, mother-infant attachment, and the mother's self-efficacy will be evaluated.

This research aims to examine the effect of the mobile application developed for the home care of the babies of the mothers of premature babies on their baby care knowledge and skills, mother-infant attachment and mother self-efficacy. A mobile application will be developed to support mothers who care for their premature babies at home after discharge. The application will be installed on the phones of mothers whose babies are discharged from the neonatal intensive care unit. After the babies are discharged, mothers will be trained at home with a mobile application. Maternal self-efficacy and mother-infant supplementation will be measured when infants admitted the NICU and one month after discharge the NICU.

Eligibility Criteria:
Inclusion Criteria:

For mothers;

* Being over the age of 18,
* Having a premature baby
* At least primary school graduate,
* Smart mobile app can be installed have a phone,
* Being able to understand and speak Turkish,
* Residing in Ankara

For babies;

* 32-37 weeks of gestation of the baby (middle and borderline premature)
* Baby in neonatal intensive care unit to stay
* Not having undergone a surgical operation,
* Absence of physical anomalies

Exclusion Criteria:

For Mothers;

* Diagnosed with postpartum depression
* unwillingness to participate in the study

For babies;

- Very small preterm (born below 28 weeks of gestation) and small preterm (between 28 and 31 weeks of gestation)