cyrilzakka/clinical-trials huggingface dataset:
Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion

The purpose of this early study is to compare the clinical results of the new Conduit Interbody device to the traditional Concorde Bullet Device. The primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.

The demand for lumbar fusion continues to rise with the growing and aging population. Additionally, new and innovative technologies continue to bring new devices to the market. However, our understanding of how emerging constructs compare with existing technology is lacking. The purpose of this study is to compare the clinical results of the new Conduit Interbody device to the traditional Concorde Bullet Device in lumbar fusion, one or two levels between L2-S1 will be included. Both transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) approaches will be included in the patient cohort. The primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older with symptomatic degenerative lumbar spondylotic disease, either spondylosis, and/or spondylolisthesis
* who have failed conservative management of at least 6 weeks requiring 1 or 2 level lumbar interbody fusion (either PLIF or TLIF)
* All patients included will be index surgeries (no re-operations).

Exclusion Criteria:

* Patients who improve with consecutive management and do not undergo lumbar fusion surgery
* Surgery performed in the thoracic or cervical spine
* Surgery performed for tumor, infection, or trauma Patients who have an unstable fracture, tumor, and osteoporosis with T score exceeding -2.0
PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers

PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Healthy volunteers only

  -- Males ≥ 40 years of age
* Part 2: Prostate cancer patients

  * Males ≥ 18 years of age
  * Serum PSA (Prostate-Specific Antigen) value above normal.
  * Patients had an MRI and/or a positive \[11C\] - or \[18F\] -choline PET/CT for primary diagnosis (Note: MRI and \[11C\]-or \[18F\]-choline PET/CT are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed
  * Patients with primary prostate cancer have to be scheduled for prostatectomy
  * In patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a Gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate
  * Patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included
* Part 3: Prostate cancer patients -- The criteria for eligibility of part 3 are identical to the ones of part 2. Except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.

Exclusion Criteria:

* Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
* Active inflammatory bowel disease within the last 6 months
* Acute prostatitis requiring medical treatment within the last 6 months
* A non-urologic bacterial infection requiring active treatment with antibiotics within 3 months
* Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
* Patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment
* Subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
Longterm Outcome After Ventricular Septal Defect Closure

Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If discovered in infancy or early childhood surgical intervention can be of necessity depending on the size of the defect, to assure a healthy adulthood. The long-term results of surgical closure of VSD in childhood are good and after surgery the children are considered as equally healthy and physically fit as their peers. However, there is inconsistency in data regarding follow-up on this group of patients, in relation to exercise capacity as a measure of the cardiopulmonary function. To further approach this matter the post-operative cardiac factors of these patients have to be investigated.

With this study the investigators intend to examine the long-term outcome on cardiac output after heart surgery in VSD-patients. It presents an opportunity to also evaluate the correlation between cardiac output determined by gas-exchange and by MRI. The overall objectives of this study are to 1) examine whether VSD-operated patients have reduced cardiac output during exercise in comparison with matched controls, and furthermore 2) to evaluate a correlation between cardiac output measured by MRI and cardiac output determined by gas-exchange.

The project is designed as a long-term follow-up and method study. A cohort of 20 children who in the 1990's underwent surgical closure of a congenital VSD will be asked to participate in this study. An equal amount of healthy young adults, will function as control group. Each participant will complete two different exercise tests, a MRI of the heart during lower body exercise on a supine ergometer bicycle, and a Supine ergometer bicycle exercise test. This data can be used for comparing cardiac output between the test groups, and furthermore it allows an evaluation of the correlation between the two methods.

VSD is as described, the most common congenital heart anomaly. If not intervened with in childhood, it can cause severe heart complications later in life. It is unclear whether this intervention can cause long-term impact on patients exercise capacity, and for that reason it is of great importance that we strive for improving our knowledge of the long-term postsurgical outcome after VSD-closure.


Eligibility Criteria:
Inclusion Criteria:

* Patients: Surgical correction of VSD between 1990 and 1995
* Controls: 18-25 years old, with no medical records of heart disease

Exclusion Criteria:

* Missing journal
* Operation by ventriculotomy
* Other congenital anomalies
* Metallic implants or foreign objects
* Pregnancy
Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-Hemodiafiltration

study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.

Approximately 700 patients will be included.

This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.

Stable incident hemodialysis patients from hemodialysis in-hospital units and related satellite centers in Spain.

Eligibility Criteria:
Inclusion Criteria:

* End stage Renal Disease (ESRD) patients
* Age\> 18 years old
* HD therapy three times per week for 3 months at least and a maximum of 24 months.

Exclusion Criteria:

* No informed consent provided
* Synthetic membrane allergy
* Pregnant, breastfeeding, or planning to become pregnant
* Active systemic diseases: liver cirrhosis, malignancy prior to enrollment (except basal cell skin or similar) and / or immunosuppressive treatment in the 3 months before the recruitment.
* Scheduled for living-donor transplantation within the study period
* Patients with a significant residual renal function (defined as Urea clearance \>2,5 ml/min.
* Currently participating in another interventional clinical study or has participated in another interventional clinical study in the last 3 months that may interfere with this study.
PhotobiomoduLation for pAtientS With Advanced hEart failuRe

The objective of the study is to examine the effectiveness of photobiomodulation therapy in patients with advanced-stage heart failure with reduced ejection fraction (HFrEF), who have been referred but ineligible for a heart transplantation. The primary endpoint is a 15% relative reduction in left ventricular end-systolic volume (LV ESV) as determined by echocardiography over a 12-month follow-up period. The secondary objective is to determine the change in NT-proBNP, a biomarker for heart failure, the change in heart failure symptoms based on the NYHA functional classification, the change in quality of life questionnaire (KCCQ), additional echocardiographic parameters, and the detection of changes in heart failure and fibrosis biomarkers. Additionally, the study aims to examine hospitalization due to heart failure and overall mortality.


Eligibility Criteria:
Inclusion Criteria:

Advanced-stage HFrEF patients who were ineligible for heart transplantation Patients over 18 years of age The expected lifespan exceeds 1 year Consent form

Exclusion Criteria:

Non-compliant patient Pregnant women Drug or alcohol abuse The patient is participating in another clinical trial
The Profile of the Depression and it's Intervention Strategy in Patients With Parkinson's Disease in China

Depression is considered to be the most common neuropsychiatric disturbance of PD. In this study, investigators will summarize the treatment profile of PD depression to see if PD depression is properly treated according to guideline.

Depression is considered to be the most common neuropsychiatric disturbance of PD. Prevalence rates of depressive disorders in Parkinson's disease(PD) vary widely across studies, ranging from 2.7% to more than 90%. A systematic review of the 36 articles concerning PD and depression indicates that the weighted frequency of depressive PD was 52%.

Investigators' previous study on non-motor symptoms in 81 Chinese PD patients demonstrated that prevalence of loss of interest and depression(sadness) were 48.7% and 36.7% by Non-motor symptoms questionnaire (NMSQuest) separately, which was similar to average global data. But another Chinese data published in 2008 showed that the prevalence of depression in PD patients was only 12%, no statistical difference with controls(2%). Thus, investigators plan to initiate a larger study to understand if PD depression in China is similar to it in western countries.

Depression would occur at the early stage of the disease or proceed the motor symptoms, usually accompanied with other non-motor symptoms including apathy, sleep disorder, cognitive impairment, and etc. The effects of depression on quality of life might refer to a wider range. There is lack of solid data to reveal the harm of depression on quality of life of PD patients and caregivers. In clinical practice, the disease burden of PD depression is usually underestimated by physicians and patients.

Although PD depression affects QoL of patients and caregivers, PD depression would be relieved by medication, which was clearly recommended by international and Chinese PD guidelines. But the PD depression treatment status in Chinese clinical practice is not systematically analyzed before. In this study, investigator will summarize the treatment profile of PD depression to see if PD depression is properly treated according to guideline.

Eligibility Criteria:
Inclusion Criteria:

* The incidence of depression in patients of Parkinson's disease (DSM-5 diagnostic criteria for depression)

Exclusion Criteria:

* Inability to understand or answer questions for any reason，that would interfere our assessment.
* Participate in a concurrent clinical trial.
The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Patients with CS often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (V-A ECMO) is an effective tool to support refractory CS while ensuring continuous organ perfusion. Patients with CS present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including C-reactive protein (CRP), Interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα). As data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using Oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with CS requiring VA ECMO.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with more than 18 years old
2. CS is defined as the presence of the following:

   2-1) Systolic blood pressure is less than 90 mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg.

   2-2) Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.

   2-3) Causes of CS include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during percutaneous coronary intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
3. Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3.
4. Written informed consent from patient or legal surrogates

Exclusion Criteria:

1. Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure.
2. Shock with unwitnessed cardiac arrest outside the hospital
3. Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
4. Suspicious of brain death
5. Those who refused active treatment
6. Body weight under 30 kg
7. Heparin allergy
8. Pregnancy
ExerCube Training on Executive Functions in Young Athletes

Competitive game sports require the existence of several sport-specific skills. In particular, game sport athletes need a good set of skills in order to perform well on the field. Therefore, it is important for athletes, especially young athletes, not only perform their sport, but also perform variable trainings, which differently train/trigger sport-specific skills. One skill set that is important in competitive game sports are so-called executive functions. Executive functions are needed for action planning and adaptation to the individual environmental situation, e.g. inhibition, flexibility and divided attention. A form of training that is very promising in this respect is exergaming as nowadays coaches are using virtual reality simulations to create realistic training environments. An exergame that combines this cognitive stimulation with whole-body movements in a motivating training environment is the ExerCube. Until now, however, evidence is lacking how an additional holistic exergame training can influence executive functioning in young athletes. Therefore, this study aims to get preliminary insight into the effects of the ExerCube performance on the executive function in young athletes (primary objective). The participants will be allocated into either the intervention group (ExerCube training) or the control group (no additional ExerCube training). The intervention group will train 2 times per week for about 30 minutes over a time frame of 10 weeks. Additionally, to consider the effects of the training environment, the secondary objectives include training motivation, enjoyment and flow as well as mental well-being.


Eligibility Criteria:
Inclusion Criteria:

* Female and male
* Age between 15 to 20 years
* Young athletes (game sports)
* Healthy (self-reported)
* Able to provide written informed consent and understand instructions

Exclusion Criteria:

* History of cardiovascular issue that would prevent training participation
* Asthma (not controllable)
* Musculosceletal injuries that would prevent training participation
* Pain that would be reinforced by sportive activities
* Pregnancy
Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects of either gender, 18 years of age or older
* Subject is able to read, understand and sign an informed consent form
* Subject is willing to comply with all study procedures

Exclusion Criteria:

* Subjects taking medicines that increase skin sensitivity to heat
* Subjects taking medicines that change skin metabolism
* Cancer or any pigmentary or vascular lesions in the planned treatment area
* Subjects with Herpes simplex in the area to be treated
* Pregnant women
* Subjects wearing pacemakers and/or any other type of implanted electronics
* Subjects with any inflammatory skin conditions
* Subjects with active cold sores, open lacerations, abrasions
* Chronic or acute skin infections
* Subjects with active local or systemic infections
* Subjects with any disease in which an increase of skin temperature is contraindicated
* Subjects wearing piercing in the area to be treated
* Subjects have nerve insensitivity to heat in the area to be treated
* Subjects have metal implants in the area to be treated, excluding dental implants
* Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile
* Any condition where the study investigator determined that the subject is not adequate for this study
* Subjects participating in other studies
Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis (Sonic)

This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

Implant associated infections in orthopaedics and trauma surgery are a well-known and feared complication. Prosthetic-joint infection (PJI) is caused by a biofilm which is located atop the surface of the implant which as growing with the duration of the PJI. This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent a revision surgery of hip, knee and shoulder arthroplasties operated at the university hospital of Basel between 2011 and 2021,
* patients who had a PJI as a suspected diagnosis and
* have microbiological cultures from sonication fluid from removed prosthesis.

Exclusion Criteria:

* patients in the database who

  1. have non-bacterial microbiological positive cultures (e.g. fungal infection) and
  2. have not received a sonication of the removed prosthesis during the diagnostic process
Helmet CPAP Versus HFNC in COVID-19

We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.

A detailed description can be found in the study protocol published in Trials in Dec 2020:

Tverring, J., Åkesson, A. \& Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5

Eligibility Criteria:
Inclusion Criteria (all of the following):

1. Age ≥ 18 years
2. Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current disease episode
3. Peripheral oxygen saturation (SpO2) \< 92 % despite conventional low-flow oxygen therapy of at least 6 L /min for at least 15 min
4. A decision to initiate HFNC or Helmet CPAP by the attending ward physician
5. The patient has given written informed consent to participate.

Exclusion Criteria (any of the following):

1. Need for direct admission to the intensive care unit for mechanical ventilation
2. Unconsciousness or drowsiness
3. Pneumothorax
4. Carbon dioxide pressure (pCO2) \> 6 kPa in venous blood gas (VBG)
5. Underlying chronic obstructive pulmonary disease stage III-IV
6. A decision not to participate
7. Inability to comprehend the study content and give informed consent
Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups

The aim of the study is to apply and adapt device specific body composition formulas to various ethnic groups. Bases are prediction equations that are generated in the clinical investigation "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)". The study bears the code BCA-01.


Eligibility Criteria:
Inclusion Criteria:

The study will cover 130 healthy adults. 65 men and 65 women in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.

Exclusion Criteria:

* acute and chronic diseases
* regular intake of medications (except for contraceptives)
* amputation of limbs
* electrical implant as cardiac pacemaker
* insulin pumps
* artificial joints
* metallic implants (except tooth implants)
* claustrophobia
* pregnancy or breastfeeding period
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the inv. site
* current alcohol abuse
* frequent hypersensitivity reactions/allergies determ. anamnestically
* body weight of more than 150 kg
* extensive tattoos at arms or legs