cyrilzakka/clinical-trials huggingface dataset:
A Pre-Operative Screening Questionnaire (AMS-Q) for Ambulatory Orthopedic Surgery Patients

We are studying whether providing patients undergoing day surgery the opportunity to have their medical history reviewed by an hospital internist before surgery leads to better results after surgery. These doctors are internal medicine specialists who are experienced in assessing patients going to surgery, making sure they are "fine-tuned" before their operation. We believe this will ensure the safest and best surgical outcomes. The study involves the patient filling out a 3 page questionnaire for review by the internist prior to surgery. Additionally, patients will receive a follow-up phone call one week after surgery asking about the experience at the hospital and a questionnaire in the mail three months later to see if the patient had any medical problems after leaving the hospital.


Eligibility Criteria:
Inclusion Criteria:

* All patients having ambulatory surgery performed by one of our participating surgeons during the study period.

Exclusion Criteria:

* Patients who speak neither English nor Spanish.
* Patients who have had any surgery in the previous 6 months.
Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent

This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old
2. De novo or re-stenotic significant stenosis in at least one native coronary artery
3. Patients with silent ischemia, stable angina, unstable angina or non-STEMI eligible for PCI (no limitation of the number of treated lesions and vessels, except higher tercile of Syntax score assessed by the site)
4. Target lesions suitable for PCI with Drug-eluting Stent (DES) diameter between 2.00 and 4.50 mm
5. Total lesion length should be from 15 to 120 mm
6. Patient is willing and capable to sign the written informed consent and comply with all requirements of the registry
7. Planned staged procedures are allowed within 3 months using Supraflex Cruz stent only

Exclusion Criteria:

1. SYNTAX Score \> 32
2. Hemodynamic instability or cardiogenic shock
3. Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by current practice
4. Subject is pregnant, nursing or is a woman with child-bearing potential
5. Any co-morbid condition with life expectancy \< 1 year or that may result in protocol non-compliance
6. Patients who are participating in another drug or device investigational study, which has not reached its primary endpoint
7. Patients under judicial protection, tutorship or curatorship
Model of Predicting Biochemical Recurrence After Radical Prostate Cancer Based on Pre-treatment PSMA PET / MR Image Features

The purpose of this study is to investigate the predictive value of preoperative 18F-PSMA-1007 PET/MR in the predictive effect of biological recurrence (BCR) after radical prostatectomy (RP) for localized prostate cancer (PCa).

Construct a predictive model for biochemical recurrence (BCR) in patients after radical prostatectomy using imaging parameters from preoperative 18F-PSMA-1007 PET/MRI, and compare the predictive performance of this model with existing clinical models. Data from three centers will be collected, with datasets from two centers used as the training set for the selection of predictive factors and model construction, while the dataset from the remaining center will serve as the validation set to assess the predictive performance of the model for BCR after prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically confirmed prostate cancer without other types of malignancy -

Exclusion Criteria:

1.Surgery or endocrine therapy is performed prior to the examination

-
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures

The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at the time of surgery for pilon fractures, will improve ankle range-of-motion and functionality.

To determine if the use of Botulinum toxin A intramuscular injections of the gastrocsoleus complex in patients with operatively treated tibial plafond fractures will result in:

1. increased ankle dorsiflexion when compared to controls
2. increased ankle functionality as measured by the FAAM, and quality of life as measured by the SF-36, when compared to controls
3. a higher proportion of patients achieving at least 10 degrees of dorsiflexion when compared to controls

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and older with a tibial plafond fracture to be treated by a staged protocol involving primary external fixation and definitive fixation within 3 weeks from the injury.

(Non-definitive, interval procedures such as repeat irrigation and debridement and fibular fixation are allowed.)

Exclusion Criteria:

* Younger than 18 years of age
* Significant traumatic brain injury or cognitive disability that would interfere with post-operative rehabilitation and study questionnaires
* Nerve, vascular, or tendon injury of the lower leg: injury to the tibial or peroneal motor nerves, injury to the posterior tibial artery requiring repair, or laceration of tendons that are involved in plantar flexion or dorsiflexion of the ankle which require repair
* History of prior lower extremity fracture to the tibia or ankle of the affected limb.
* Incarcerated patients.
* Patients unable or unwilling to return for follow-up examination.
* Pregnant or lactating patients.
* History of disease affecting the neuromuscular junction (ex: myasthenia gravis).
* Use of aminoglycoside antibiotics at the time of definitive fixation.
* Ipsilateral foot injury that will impair dorsiflexion exercises: Lisfranc injuries, fractures or dislocations of the talus, calcaneus, navicular, cuboid, cuneiforms, or metatarsals (phalanx fractures or dislocations will not be excluded).
* Patients receiving Botulinum Toxin A for other reasons.
* Patients with a known hypersensitivity to Botulinum toxin A.
* Gustilo Anderson type III B and C.
* Patients with a weight greater than 115 kg - to ensure proper injection locations
Little NIRVANA for Pediatric Pain and Anxiety

The aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. The investigators hypothesize that Little NIRVANA plus a numbing cream will reduce pain and anxiety for patients undergoing PIV placement in the emergency department (ED) when compared to the cream alone. It is anticipated that using the Little NIRVANA will not increase the ED length of stay, failed PIV placement attempts, or the need for additional intervention.

This is a two-group randomized clinical trial of 65 dyads of subjects and their parent and 65 proceduralists. Children will be randomly assigned to either the Little NIRVANA intervention group or a standard of care control group. Legal guardians of children in both groups will answer questions about their child's prior history of needle procedures, current pain/anxiety, medications taken prior to ED arrival, and video game experience. Children assigned to the intervention will play the game during the PIV placement, while children in the control group will receive the standard of care. The proceduralist performing the PIV placement and the parent will answer questions after the PIV placement about their perception of the child's pain and anxiety and questions about the Little NIRVANA experience for those children who were in the intervention group. This study has one visit that is completed during their ED stay.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing PIV line placement (peripheral IV order placed while patient is in the ED);
* Patients 2-8 years of age (inclusive)

Exclusion Criteria:

* Non-English speaking (Little NIRVANA is currently only available in English and Dutch);
* those for whom utilizing AR is deemed not feasible by the attending ED physician (e.g., critical illness)
Antiplatelet Drug Resistances and Ischemic Events

The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

Main objective:

* to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of ischemic events during the 3-year follow-up.

Secondary objectives:

* primary outcome in each pre-specified sub-group : patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry,
* to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of bleeding events during the 3-year follow-up,
* to investigate potential determinants of platelet reactivity at entry in the study

Eligibility Criteria:
Inclusion Criteria:

* Documented symptomatic ischemic atherothrombotic disease treated by aspirin, clopidogrel or both.

Exclusion Criteria:

* Known platelet disorder
* Chronic treatment by antiplatelet drugs other than aspirin or clopidogrel.
* Chronic anticoagulant treatment
* Chronic non steroid anti inflammatory drug treatment
* Active cancer
* Ongoing aspirin or clopidogrel treatment taken for more than 5 years prior to inclusion
Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network

At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. The study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.

This is a prospective cohort study of healthy term and near-term infants. The mobile network screening and follow-up of neonatal jaundice consists of two parts, one is the screening and follow-up program for healthy neonatal jaundice by using on parents' mobile phones, the other is the online registry of severe hyperbilirubinemia. Firstly，the TCB values of healthy term and near-term infants in delivery institutions will be prospectively recorded and followed up until jaundice subsided by using screening and follow-up program, so as to clarify the natural history of jaundice of healthy newborns in China. Secondly, by establishing an online registry for severe hyperbilirubinemia and "Follow up of jaundice" on Wechat applet, the investigators will find the specific problems of jaundice management in infants with severe hyperbilirubinemia. Lastly, through the follow-up of severe hyperbilirubinemia cases, the investigators will have a better understanding of their prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.

Exclusion Criteria:

* Biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on.
Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects

The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).


Eligibility Criteria:
Inclusion Criteria:

* Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

* Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator or sponsor may place the subject at risk or interfere with outcome variables, including drug absorption, distribution, metabolism, and excretion
* History of serious mental disorder
* History of drug or alcohol abuse within 2 years prior to screening
* History of any significant drug allergy
* Use of an investigational drug within 120 days prior to the first dosing of trial drug
* Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
* Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
* Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
* History of major surgery of the digestive tract (excluding appendectomy)
* Any subject who, in the opinion of the investigator, should not participate in the trial
Low-dose Maximal-intent Versus Controlled-tempo Resistance Training on Quality-of-life in Older Adults

The aims of this study were to:

1. Compare the effects of low-dose Maximal Intent and Controlled Tempo Resistance Training on untrained healthy older adults' quality-of-life, functional capacity, and strength.
2. Qualitatively explore perceptions of Maximal Intent and Controlled Tempo Resistance Training in older adults.

Older adults are defined as being 60 or more years of age.


Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible if they were between 30-60 years old
* Uninjured
* Had no cardiovascular or neuromuscular conditions
* Had not participated in lower-limb resistance training in the previous six months.

Exclusion Criteria:

* Participants were excluded if they had either taken part in any lower-limb resistance training in the last six months
* Had underlying health condition(s) that prevented them from participating in resistance training
* Regularly met or exceeded the UK recommended physical activity guideline of 150-minutes of moderate to intense physical activity per week.
Comparing Pain Relief Between Two Methods of Freezing Injections in Children Having Their Appendix Removed

Laparoscopic appendectomies are the most common emergency surgeries performed in children. Despite being considered minimally invasive surgeries, they can result in substantial postoperative pain and 2 of 3 patients require postoperative opioids. Increased postoperative pain can delay recovery, increase hospital admission time, lead to chronic pain, and cause patient distress. This study aims to reduce postoperative pain in this population by comparing the recovery outcomes associated with the administration of (1) an RSB with coadministration of IV dexamethasone as an LA adjunct (RSB+dex group) prior to the incision with (2) LA infiltration alone by the surgeon (LA group).


Eligibility Criteria:
Inclusion Criteria:

* Age 4-18 years old
* Diagnosed with acute appendicitis.
* Undergoing a laparoscopic appendectomy

Exclusion Criteria:

* Perforated/complicated appendicitis diagnosis
* Previous abdominal surgery
* Allergy to bupivacaine or dexamethasone
* Severe developmental delay preventing patients from using pain scales or adequately communicating pain
* Patients with Type 1 or 2 diabetes mellitus
* Patients with steroid dependence
A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis

The purpose of this study was to evaluate the safety and clinical activity of long-term dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being followed-up for safety.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who previously received and tolerated revusiran (ALN-TTRSC) in the ALN-TTRSC-002 study
* Adequate liver function
* Not Pregnant or nursing

Exclusion Criteria:

* Inadequate renal function
* Uncontrolled hypertension, ischemic heart disease or clinically significant cardiac arrhythmia
* Untreated hypo- or hyperthyroidism
* Prior major organ transplant
Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

The objective of this study was to evaluate the efficacy of topical 0.2% loteprednol etabonate, a 'soft steroid', compared with topical 0.1% dexamethasone, which is widely used in postoperative pterygium excision to prevent the recurrence of pterygium. If 0.2% loteprednol etabonate is non-inferior in efficacy compared with 0.1% dexamethasone, it may be used postoperatively in pterygium excision patients with the benefit of a low incidence of ocular hypertension or secondary glaucoma.

A prospective randomized control trial was performed from October 2015 to April 2019 at the Department of Ophthalmology, Thammasat Hospital, Thailand and Panyananthaphikkhu Chonprathan Medical Center, Thailand.

Subjects Patients who had pterygium excision with amniotic membrane transplantation (AMT) and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea were included.

Then the participants were randomized into 2 groups. Both groups received subconjunctival 5-fluorouracil (5-FU) injection 5mg/0.1 mL with 27-gauge needle in the area of fibrovascular tissue, and then the eyes were irrigated with 30 mL of normal saline. 0.2% loteprednol etabonate was prescribed in group 1, and 0.1% dexamethasone (CD-oph) was prescribed in group 2 every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months. 5-FU was repeatedly injected monthly in the presence of marked inflammation and not more than 3 times to prevent complications.

All patients were followed-up at 1, 3, 6, and 9 months to assess the impending recurrent pterygium severity score, intraocular pressure, complications, detection of true recurrent pterygium, and time to recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had pterygium excision with amniotic membrane transplantation and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea

Exclusion Criteria:

* recurrent pterygium
* received adjunctive treatment with beta radiation, mitomycin C or 5-fluorouracil
* glaucoma or intraocular pressure \> 21 mmHg
* history of 5-fluorouracil or chloramphenicol allergy
Effects Of Caffeine On Cognitive Performance

Caffeine is a potent central nervous system stimulant that increases the activity in the prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills can lead to further benefits in athletic performance. Therefore, it is necessary to clarify the dose-response of caffeine on cognitive performance.The aim of this research will be to determine the effects of different doses of caffeine on sport-related cognitive aspects.

The investigators will require healthy, physically active young adults to complete three trials under the conditions: a) placebo, b) 3 mg/kg, or c) 6 mg/kg body mass of caffeine. In each trial, different cognitive abilities will be assessed using the following test batteries: reaction time (DynavisionTM D2), anticipation (Bassin Anticipation Timer), sustained attention (Go/No-Go and Eriksen Flanker Test) and memory tests. In addition, side effects and the perceived sensation index will be recorded 24 h after each test.

Eligibility Criteria:
Inclusion Criteria:

* Physically active individuals ( \>150 min/week moderate physical activity or \>75 min/week vigorous physical activity)
* Individuals without serious and undiagnosed health problems.

Exclusion Criteria:

* Individuals with color blindness.
* Regular caffeine consumers (\>3 cups of coffee/day).
Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery

Temporary pacing with an external pacemaker after open heart surgery - besides preventing arrhythmias and AV-conduction disorders - is used to improve cardiac output. In theory, postoperative stunning temporarily limits stroke volume and SA-node dysfunction compromises an adequate compensatory rise in heartrate to ensure sufficient cardiac output. There is a lack of consensus regarding the use of this form of pacing. Protocols vary widely between hospitals. Moreover, the scientific base for this form of pacing mainly comprises studies dating back to the nineteen sixties and seventies. Major changes in (operating) techniques have taken place since then. Also, the role of the right ventricle in this context has not been studied specifically. The current study aims to investigate the effects of atrial pacing on right ventricular function specifically and hemodynamics in general, in today's postoperative setting. We hypothesize that a reduction in heart rate may lead to decreased right ventricular function.

When a hemodynamically stable state is achieved, the external pacemaker will be switched off for 30 minutes. Hemodynamic parameters will be acquired directly prior to switching off, 15 respectively 30 minutes after switching off, and 15 minutes after switching back on. To gain insight in the natural course of stunning, this routine will be repeated the next morning. No additional hemodynamic interventions will be allowed in these periods.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* admitted to the ICU after onpump open heart surgery
* Swan Ganz thermodilurion catheter in situ

Exclusion Criteria:

* participation other trials
* off pump cardiac surgery
QRS Microfragmentation in ECG as Predictor of Mortality and Morbidity - a Retrospective Analysis

Over the past decades, several ECG-based parameters have been identified as independent predictors of worsened prognosis in affected patients. In addition to visual assessment of morphology, methods of computer-based machine ECG analysis have gained importance in recent years. These methods allow the detection of systemic abnormalities in ECGs that are not visible to the naked eye. An example of this is provided by the so-called "QRS microfragmentations".

The aim of this evaluation is to retrospectively collect all established as well as new quantitative and qualitative ECG parameters (such as QRS microfragmentation) in a large patient collective. Subsequently, after characterization of the patients, an independent multivariate risk prediction model should be developed based on computer-based ECG analysis using maschnine learning algorithms.


Eligibility Criteria:
Inclusion Criteria:

* Patients who presented to the Department of Internal Medicine at the Medical University in Innsbruck between 01.01.2000 and 31.07.2022 and received an ECG recording as part of routine clinical practice.
* Age ≥ 18 years
* Residence in Austria

Exclusion Criteria:

* Insuffizient ECG Recording quality