cyrilzakka/clinical-trials huggingface dataset:
Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic

Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation).

Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.


Eligibility Criteria:
Inclusion Criteria:

* Congenital or acquired knee joint defects/deformation
* Defects or malfunction of the knee joint
* Arthrosis (degenerative, rheumatic)
* Post-traumatic arthritis
* Symptomatic knee instability
* Reconstruction of flexibility
* Patients with metal hypersensitivity (ceramic tibia/femur)

Exclusion Criteria:

* Illnesses which can be treated without using a knee joint implant.
* Acute or chronic infections near the implantation
* Systemic diseases and metabolic disorders
* Serious osteoporosis
* Serious damage to the bone structures that impedes stable implantation of the implant components
* Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc.
* Bone tumors in the area of the implant anchoring
* Obesity or overweight of the patient
* Overload of the knee implant to be expected
* Abuse of medication, drug abuse, alcoholism or mental disease
* Pregnancy
* Lack of patient cooperation
* Sensitivity to foreign matter in the implant materials
* Patients under the age of 18
* Patients participating in another trial
Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest

Out-of-hospital cardiac arrest (OHCA) has multiple etiologies. In the absence of ST-elevation myocardial infarction, percutaneous coronary intervention (PCI) is delayed. This study aims to determine the diagnostic accuracy of Coronary Calcium Score (CCS) and Coronary CT Angiogram (CCTA) to rule out a coronary artery disease (CAD) in the first days after an OHCA.

Each year, 50.000 out-of-hospital cardiac arrest (OHCA) occur in France. Acute myocardial infarction (AMI) is one of the most frequent etiology of OHCA. When a cardiac arrest is due to a ST-elevation myocardial infarction (STEMI), a percutaneous coronary intervention (PCI) is realized in emergency. However, without ST-elevation, PCI timing is unclear. 2020 European Society Recommandations suggest that PCI should not be realized in emergency, based on Lemkes and al. clinical trial. But there is scarce evidence about the exact timing to realize PCI. Electrocardiogram, troponin level, and echocardiography are unprecise to rule-out an ischemic etiology of cardiac arrest.

A brain CT-scan and a CT-pulmonary angiogram are recommended in first place, to identify the etiology of the cardiac arrest if there is no ST-elevation nor obvious causes. Nevertheless, in the absence of scanographic abnormality, a differed coronary angiogram should be realized.

We suggest that coronary CT angiogram (CCTA) and coronary calcium score (CCS) are feasible in the first days of hospitalization, and could rule-out a coronary artery disease (CAD). The aim of the study is to avoid an invasive coronary exploration, and to have a quick answer about anti-thrombotic treatments management.

Eligibility Criteria:
Inclusion criteria :

* Patients hospitalized in intensive care unit after a resuscitated out-of-hospital cardiac arrest
* No obvious cause for sudden death on anamnestic information, CT brain and CT pulmonary angiogram.
* Absence of ST elevation myocardial infarction

Non-inclusion criteria :

* In-hospital cardiac arrest
* Refractory cardiac arrest
* Indication of immediate coronary angiography
* ST-elevation myocardial infarction or unknown left bundle branch block
* Dynamic or presumably new contiguous ST/T-segment changes
* Cardiogenic shock
* Life-threatening arrhythmias
* Coronary artery bypass graft
* Pregnancy
* Multiple organ failure syndrome
* Know severe chronic kidney disease (GFR \<30mL/min/1,73m²)

Exclusion criteria :

* During the Coronary computerized tomographic angiogram :
* Haemodynamic instability requiring high dose of vasopressors (\>1µg/kg/min of Norepinephrine)
* Non sinusal cardiac rhythm
* KDIGO 1 Acute kidney injury
Effect of Consumption of Caraway on Treatment of Obesity

This study aims to investigate the applicability of caraway (black cumin) intake on the treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to examine the applicability of caraway product in terms of safety and efficacy.

A randomized placebo-controlled clinical trial, was done on 120 healthy overweight and obese women aged 20-55 in Iran. data were collected trough questionaires, interview and physical examination. the required parameters including anthropometric indices, body composition vital parameters (heart rate and blood pressure)and full blood parameters, were measured before and after intervention. volunteers were randomized into test and control group and were asked to consume either caraway samples or placebo during 12 intervention weeks.

the outcome measure will be assessed for both primary and secondary data from baseline through week 12 (3 months).

Eligibility Criteria:
Inclusion Criteria:

* overweight and obese women (BMI\> 25)
* aged 20-55 years old
* healthy subjects

Exclusion Criteria:

* Pregnant and lactating women
* Thyroid disease
* type I or II diabetes mellitus
* hypertension (systolic BP 140 and/or diastolic BP 90)
* endocrine dysfunction
* impaired liver function
* chronic renal disease
* cardiovascular disease
* primary dyslipidemia
* myopathy
* patients using drugs which affect on metabolism or appetite
* a maintained weight loss in the preceding 3 months
* meals not eaten at regular intervals
* participation in another investigation study within the past 30 days
* a history of alcohol or drug abuse within the past year
* smoking
* a history of sleep disorders
* clinical depression or other psychiatric conditions
* abnormal obese
* allergy or sensitivity to any of the 'active' or 'placebo' product ingredients
PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or greater than 18 years
* Patients scheduled for primary elective implantation of TIAP

Exclusion Criteria:

* Participation in another clinical trial which could interfere with the primary endpoint of this study
* Lack of compliance
* Impaired mental state or language problem
* Patients with known allergy to contrast agent
Assessment of the Impact of Acquisition Time, Respiratory Gating and New Qclear Reconstruction Modalities on the Quantification of Dosimetry in Selective Internal Radiotherapy

Post-processing of Positron Emission Tomography (PET) acquired images, performed following radioembolization treatment with microspheres at 90Y in hepatocellular carcinoma patients, is subject to changes commercialized by General Electric : respiratory motion correction, specific reconstruction algorithms. We propose to test the possible combinations of these reconstruction parameters to determine which ones to apply for an optimal quality exam with the shortest scan time possible


Eligibility Criteria:
Inclusion Criteria:

* patient with hepatocellular carcinoma
* with radioembolization treatment decided
* over the age of 18

Exclusion Criteria:

* radiembolization not possible
* acquisition of PET/CT imaging at 90Y not possible
Creating a Virtual Village for People Aging With HIV During COVID-19

In a PCORI-funded project on HIV and aging engagement that was co-led by the study team, the topics of isolation and depressions were identified as priority areas of deep concern among older PLWH. The COVID-19 pandemic has enhanced the urgency to test interventions to mitigate depression and isolation among older PLWH. However, there is scant evidence on effective interventions that help mitigate depression and isolation among older PLWH. While physical distancing and stay at home orders are a necessary strategy to flatten the curve, ease pressure on the healthcare system, and protect the most vulnerable, the order further increases the isolation faced by people aging with HIV, and creates barriers to accessing medications, health services, and other resources. This project will include 6 virtual focus groups and 12 individual interviews with adults ages 50 or older in California (Palm Spring, Los Angeles) and the Tampa-Bay region, Florida to (1): further characterize issues related to depression, isolation, and basic needs of people aging with HIV during the COVID-19 pandemic (2) utilizing results from Aim 1, co-develop ideas for what to include in a virtual village, and (3) create and pilot the virtual village in a group of people aging with HIV. The overall goal of this study is to execute an innovative solution to address issues related to isolation for older PLWH which have been exacerbated during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking adults
* Living with HIV
* residing in Palm Springs, Los Angeles, or Tampa Bay Florida
* age 50 or older

Exclusion Criteria:

* not able to read English or Spanish
Establishing of the Inter-rater Reliability and Variability of Selected Standardized Tests Performed in Czech Language

The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test administered according to the new Czech extended versions of their manuals.

New Czech manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test were made by back-translation method. They were updated and extended by new rules for unification of their performing. The manuals include instructions for performing three trials of each subtest.

At least 30 occupational therapy students will be tested by those three tests according to those new Czech manuals. Video of students' performance will be obtained.

The inter-rater reliability, internal variability and variability of results got in two different ways will be established.

Eligibility Criteria:
Inclusion Criteria:

* Czech language as a mother tongue
* age from 20 to 65 years
* occupational therapy student

Exclusion Criteria:

* diagnosed pathology of the upper limbs or diseases that negatively affect the dexterity of their limbs
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion.

We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.

THRIVE is previously shown feasible as sole mode of ventilation in selected patients during general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation and a degree of ventilation was observed. However, a slowly developed respiratory acidosis was also observed over time.

Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth breathing enhance the effects of the high flows of oxygen levels applied by increasing the airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear whether the efficiency of THRIVE depends on the particular circumstances of airway management. Physiologic characterization of THRIVE performance under standardized conditions of airway management and under close monitoring by systematic analysis of blood gas dynamics over time during general anesthesia is needed.

We plan to study the blood gas dynamics during THRIVE apnea ventilation during general anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under 7.15 and/or PaCO2-rise \> 12 kPa will lead to cessation of THRIVE.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (age over 18 years)
2. Elective surgery where intubation is not mandatory
3. The patient can understand the information about the study and give their informed written consent of participation

Exclusion Criteria:

1. ASA (American Society of Anaesthesiologists class) \> 3
2. NYHA (New York Heart Association class) \> 2
3. BMI \> 30 kg/m2
4. Symptomatic respiratory disease
5. Symptomatic cardiac disease
6. Evidence of arteriosclerotic disease
7. Neuromuscular disease
8. Pregnancy
9. Presumed or predicted difficult airway (SARI - Simplified Airway Risk Index score \> 4)
10. Known or suspected nasal congestion/stenosis or catharalia
Prospective Study of oncRNA Stratification of Cancer by Size and Stage

Cancer strikes about one in three women and one in two men in the U.S. and more than 600,000 die from it each year. The best chance to reduce these numbers and save lives is through early detection and intervention.

The investigators are developing a blood test to detect cancer from a simple blood draw also referred to as a liquid biopsy. This test is based on orphan non-coding RNAs (oncRNAs) that are abundant in the blood of patients with cancer and largely absent in people without cancer. Using artificial intelligence (AI) and machine learning (ML) investigators are able to interpret the thousands of oncRNAs found in the blood of patients with cancer by identifying unique, cancer-specific patterns. oncRNA patterns can be used to detect several types of cancer and detect cancer at the earliest stages.

This is a prospective, observational study to collect blood samples and medical information from participants with and without cancer to represent the population in the USA. The investigators have designed the study to include participants without cancer, participants with conditions that are a predisposition for cancer, participants with pre-malignant lesions, and participants with cancer. Patients with a wide variety of cancers are going to be included i.e. bladder, breast, colorectal, esophageal, gastric, kidney, liver, lung, ovarian, pancreatic, prostate, and uterine cancer.

Each participant will be asked to donate a small blood sample and to share their medical information. The participant's medical information will be updated during the course of the study. The blood will be tested for oncRNA. The objective is to create a blood repository and associated medical database to develop a blood test for cancer, for different cancer types. The study is designed to be inclusive and represent the population in America.

If this study is successful, the results will enable a world where cancer can be detected early with a simple blood test and diagnosed accurately, with better chances of cure. The investigators believe this study has the potential to transform cancer detection in America.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Able and willing to provide informed consent
* Able and willing to have 35-40 mL of whole blood drawn

Exclusion Criteria:

* Age \<18 years
* Prior history of cancer, except for non-melanoma skin cancer
* Prior history of receipt of any blood products within 30 days of enrollment
* Receipt of any cancer therapy, e.g., surgical, radiation, or medical including neoadjuvant treatment, prior to study enrollment
* Prior history of receipt of any non-cancer system immune modulation therapy within the last 60 days (ex: monoclonal antibodies)
* Prior history of organ transplantation
* Current or prior pregnancy within the last 12 months
* Unable or unwilling to provide informed consent
A Feasibility Study of the Impact on Blood Pressure Control of Supplementing Community Pharmacist Services With Structured Information on Blood Pressure and Its Treatment

Hypertension is a major health problem, however its control is unsatisfactory. One of the reasons for such a high prevalence of this disease includes poor patient compliance to treatment. Approximately 30 % of newly diagnosed hypertensive patients stop taking their blood pressure medication by six months and 50% by 12 months.

The UK government is keen to encourage community pharmacists to play an active role in participation of services that can improve patient adherence to their medications. The New Medicines Service (NMS) and targeted Medicines Use Reviews (MUR) are established services which fund community pharmacists to review and explain medicine use to patients, with hypertension a common condition for which advice is given within these schemes. Within these schemes, advice is verbal and unstructured, with no specific written information provided on drugs or the disease being treated.

This study aims to determine whether structured information provided to participants verbally and in writing by community pharmacists about blood pressure and current medicine(s) within NMS and targeted MURs will be retained and will be associated with improved hypertension control. Participants will be recruited from people eligible for NMS and MURs and attending community pharmacies.


Eligibility Criteria:
Inclusion Criteria:

1)18 or over 2) male or female 3) Have been started on any blood pressure medication

Exclusion Criteria:

1)Patients with English language problems
Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.


Eligibility Criteria:
Inclusion Criteria:

* Age according to approved label and physician discretion
* Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Exclusion Criteria:

* Subjects who previously enrolled in this study
* Subjects who are unlikely to comply with protocol requirements
* Hypersensitivity to biphasic insulin aspart or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Effects of Neurofeedback Training on Attentional Deficits in Patients with Acquired Brain Injury

The goal of this study is to investigate new neuromodulation therapies for attention deficits following acquired brain injury. Brain damage can affect various domains, including motor and cognitive functions. However, cognitive deficits have many consequences on the functionality and independence of patients, and attention is an essential requirement for most of daily activities. After brain damage, cognitive rehabilitation is generally the first treatment option for attention deficits. Some studies have shown that cognitive rehabilitation is sometimes not very effective.

For this reason, new therapies such as neuromodulation techniques are being investigated. Neurofeedback is a non-invasive neuromodulation therapy involving a type of computer-based training and learning, and some studies have shown that it is a promising tool to treat cognitive deficits in patients with brain injuries.

In the present study, the investigators will evaluate the effects of neurofeedback as a therapy for attentional deficits after brain injury. Participants undergoing neurofeedback and cognitive therapy will be compared to participants only receiving cognitive therapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* ABI resulting from TBI, stroke, hypoxia and other etiologies
* attentional deficits that are among the objectives of neurorehabilitation as established by the clinical team (scores falling in the 90% percentiles on the Conner's Continuous Performance - CCPT, on the Digit and Spatial Span Tasks and Color Trail test)
* good cognitive condition (ie., scores of ≥23 in the Mini Mental State Examination
* MMSE or ≥75 in the Galveston Orientation \&amp; Amnesia Test - GOAT)

Exclusion Criteria:

* previous report of psychiatric and/or neurologic disorders
* contraindication to computerized activities
* blindness or severe visual impairments
Effects of Variety and Portion Size on Meal Intake of Adults

The primary purpose of this study is to gain a better understanding of the combined effects of meal variety and portion size on food intake at a meal. The study will also explore relationships with eating microstructure such as eating rate and bite size. Additionally, other individual characteristics will be examined for their influence on the effects of variety and portion size on meal intake.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to travel to Penn State University Park campus weekly for meals
* Be fully vaccinated against COVID-19
* Be a woman 20 - 65 years old
* Regularly eat 3 meals/day
* Be willing to refrain from drinking alcohol the day before and during test days
* Have a body mass index between 18.0 and 35.0 kg/m\*m
* Be willing to refrain from eating after 10 pm the evening before test sessions
* Be willing to participate in all study procedures

Exclusion Criteria:

* Must not be a smoker
* Must not be an athlete in training
* Must not be pregnant or breastfeeding at the time of screening
* Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
* Must not be currently dieting to gain or lose weight
* Must not have a health condition that affects appetite
* Must not have participated in a similar study in our lab in the past year
* Must not be a student, faculty, or staff member in nutritional sciences or psychology