cyrilzakka/clinical-trials huggingface dataset:
Project STARFISH - PRJ0002679

This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.

The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (referred to below as "Starfish Test") aims to develop a multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).

The purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria. This Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US.

Eligibility Criteria:
Inclusion Criteria:

* Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study.

  * Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.
  * All-comers phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days.
  * Enrichment phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days, and with a standard of care positive PCR test result within three (3) days.

Exclusion Criteria:

* Participants meeting the following criterion will be excluded from the study:

  * Suspected to have respiratory tract infection for greater than seven (7) days.
  * Patients not suspected of having a respiratory tract infection.
Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects

The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male caucasian subjects as determined by results of screening
* Written informed consent in accordance with Good Clinical Practice and local legislation given
* Age \>= 18 and \<= 50 years
* Broca \>= -20% and \<= + 20%

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\<= 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation \> 100 ml (\<= 4 weeks prior to administration or during the trial)
* Excessive physical activities (\<= 10 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
Walking Dynamic Among Children With Brain Damge

The goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls.

leisure time physical activity by the Godin and Shephard (G\&S) questionnaire. Balance tests - the Timed Up and Go test (TUG) and functional reach test (FRT). Maximal isometric strength was assessed by using a hand held dynamometer; walking dynamics were recorded by an electronic mat, and the 6 minute walk test, energy expenditure index (EEI) and perceived exertion by the OMNI scale.

Eligibility Criteria:
Inclusion Criteria:

Post Traumatic Brain Injury

* Post severe closed head injury (Glasgow Coma Scale (GCS) score at admission to emergency room of ≤8
* At least one year post trauma
* Ages 7 to 13 years
* Independent ambulation (foot orthoses permitted)

Children with Cerebral palsy

* GMFCS 1 or 2
* Ages 7 to 13 years
* Able to stand up from a chair independently and maintain standing for more than 5 seconds without falling, without obvious limitation in the passive range of motion of lower extremities.

Typically Developed age and sex controls exclusion criteria:

* Children who could not fulfill simple instructions
Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer

In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in myeloma seems no more effective than that achieved with aspirin, while the effectiveness of the latter in the primary prevention of VTE has never been demonstrated regardless of the type of population considered. Meanwhile, a biological study showed that prophylactic doses of LMWH in patients with different types of cancer did not always optimal reduction of thrombin peak during the 24 hours following the injection of LMWH. These clinical and biological studies lead to the conclusion that patients with myeloma may be resistant to the usual doses of preventive LMWH, which may explain the failure of prevention.

Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is present in patient's biology and if this resistance is specific to myeloma in hematological cancers. For this, we propose to study the evolution of thrombin generation by Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin in 6 patients with de novo myeloma whit high thrombo embolic risk ie treated with thalidomide, lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not accumulate in patients with impaired renal function, and has a greater anti-biological activity thrombotic than other LMWH.

To assess whether the observed pattern of thrombin generation is particularly multiple myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical patients hospitalized for acute heart and respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

1. Body weight between 40 and 100 kg
2. Patient:

2a- With multiple myeloma indication with de novo standard treatment thalidomide or lenalidomide or erythropoietin (group 1) 2b- Or hospitalized for aggressive lymphoma treated with chemotherapy (group 2) 2c- Or older than 40 years and hospitalized at least three days for an acute medical pathology type of acute respiratory or cardiac (group 3) decompensation

Exclusion Criteria:

* Patient requiring anticoagulant therapy at curative doses
* Patients with a lower platelet count 80 G / L
* Subject with a history of heparin-induced thrombocytopenia
* Subject with a history of hemorrhagic disease
* History of severe trauma within 6 weeks prior to enrollment
* Organic lesion at risk of bleeding
* Poor renal with creatinine clearance \<30 ml / min
* Hypersensitivity to Tinzaparin
* Events or bleeding tendencies associated with coagulation disorders
* Subject on oral anticoagulant
* For group 3: Presence of hematological malignancy or active cancer
Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN

A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients with a diagnosis BPDCN according to World Health Organization (WHO) classification confirmed by hematopathology;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy

I wan to check the effects of Nintendo Wii balance board therapy in children with CP.

Evaluate the effects of Nintendo Wii balance board therapy in combination with conventional physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* children with age of 7-14 years. No history of falls. children able to stand independently. delays in gait development.

Exclusion Criteria:

* Children with hemiplegic CP. Comorbidities. children with lower limb contractures. hearing disorders. children with epilepsy.
The Relationship Between Fibromyalgia Syndrome Parameters With Disease-Pain Severity and the Quality Of Life

In this study, the investigators aim to evaluate the relationship between disease severity, quality of life, anxiety and pain level in patients diagnosed with Fibromyalgia Syndrome (FMS) with the parameters according to the American College of Rheumatology (ACR) 2016 diagnostic criteria. According to the 2016 ACR diagnostic criteria, there are 2 separate scales: Widespread Pain Index (WPI) and Symptom Severity (SS) . The relationship between these 2 parameters and the Fibromyalgia Impact Questionnaire, the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire will be examined.

The aim of this study is to observe the relationship between the WPI and SS parameters in the ACR 2016 criteria for fibromyalgia, separately, with the severity of the disease, pain level, quality of life and anxiety level. Accordingly, the investigators aim to evaluate whether WPI or SS has priority in assessing the severity of the disease. There is no study in the literature comparing the importance of the 2016 ACR diagnostic parameters on the disease effect. In this context, this study will be the first study in the literature and will be very valuable. Patients visiting the outpatient clinic with FMS diagnosis will be evaluated. Patients will be asked to fill the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire . The patients will be assed by an experienced Physical Medicine and Rehabilitation specialist for SS and WPI scores.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as FMS according to ACR 2016 criterias

Exclusion Criteria:

* History of Malignity
* History of Rheumatological Disease
Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions

The investigators hypothesize that in a real-world population undergoing percutaneous coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter \<3 mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents (DES).

Drug-eluting balloons are an established treatment for in-stent stenoses and showed good results in small vessels. Moreover, the available data suggest that DEB are a promising new technique for the treatment of de-novo stenoses in small vessels if pre-dilatation is performed and geographical mismatch is avoided.

The aim of this study is to demonstrate that DEB is non-inferior to DES in a real-world population with respect to the combined clinical endpoint Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Angina pectoris Canadian Cardiovascular Society (CCS) 2 to 4 or silent ischemia as assessed by stress echocardiography, stress cardiac magnetic resonance, myocardial perfusion scintigraphy, or fractional flow reserve
* PCI of de-novo stenosis in vessels ≥2.0 to \<3.0 mm in diameter irrespective of the indication (concomitant PCI of a vessel ≥3.0 mm in diameter is permitted if the stenosis is located in a coronary artery other than the culprit vessel)
* No flow-limiting dissection (TIMI ≤2) or residual stenosis \>30% after initial dilatation with a standard or non-compliant balloon, as assessed by the physician in charge
* Written informed consent

Exclusion Criteria:

* Concomitant large-diameter PCI in the same coronary artery (LAD, Ramus circumflexus (RCX), RCA)
* PCI of instent-restenosis (culprit lesion)
* Life expectancy \<12 months
* Pregnancy
* Enrolled in another coronary intervention study
* Unable to give informed consent
Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis

To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis.

The purpose of this study is to characterize the recovery and symptom relief following cryoablation of abdominal wall endometriosis. Patients undergoing clinically indicated ablation of abdominal wall endometriosis will receive an endometriosis-specific symptom survey (Endometriosis Health Profile - 30) prior to ablation and then at 3-, 6-, 12-, and 24-months following treatment. A 2 question survey related to pain at the treatment site will also be administered prior to ablation and then at 1-, 7-, and 30-days after ablation.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing ablation for abdominal wall endometriosis.

Exclusion Criteria:

* Decline to participate in research.
Normobaric Oxygen (NBO) Therapy in Acute Migraine

This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with frequent migraine (at least 1 attack per month)

Exclusion Criteria:

* Secondary (non-migraine) headache
* Chronic obstructive pulmonary disease
* Pregnant
Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma

It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.

The purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. It is a randomized phase II clinical trial with single phase and 2 experimental arms. Participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost); arm 2: particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). The short term response will be evaluated using RECIST criteria. And the acute and late toxicities will be evaluated according to NCI CTCAE v4.03.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed ACC
* Inoperable disease or postoperative residual disease detected by imaging studies
* Age ≥ 18 and ≤ 65 years of age
* ECOG \< 2, no significant active concurrent medical illnesses
* Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N \> 2000/mm\^3; PLT \> 100,000/mm\^3; total bilirubin \< 1.5mg/dl; AST/ALT \< 1.5 ULN; SCr \< 1.5mg/dl; CCR \> 60ml/min
* Willing to accept adequate contraception for women with childbearing potential
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

* Presence of distant metastasis
* Pregnant or lactating women
* A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
* Refusal of the patient to participate into the study
Fixed Dose Spinal Bupivacaine for Cesarean Delivery

The study is designed to compare the effectiveness of spinal anesthesia performed with fixed dose of hyperbaric bupivacaine regardless of patient's height and weight and anesthesia with the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined with opioid is very effective, regardless of parturient's weight and height, provides very good surgical conditions and assures patient's comfort while the rate of anesthesia - related complications is similar or less. Therefore, using height-adjusted protocols, although preferred in some centres, might not be necessary in order to provide good anaesthesia for cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric anesthesia settings, as many of cesareans are performed out of hours, giving less room for mistakes in less experienced hands.

Two groups of parturients undergoing cesarean section are to be compared: anesthetized with fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen (control group). Patients are going to be randomized to one of the above groups, two anesthetists will be involved in anesthetic procedure: anesthetist that looks after the patient throughout the procedure will be blinded to the dose of anesthetic given intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased and all patients will receive the same perioperative care in terms of fluid therapy, management of possible anesthesia - related complications and postoperative pain control.

Rate of effective spinal anesthetics, defined as adequate block level and no need for additional intraoperative analgesia has been established as primary outcome measure. Secondary outcome measures are rate of complications and amount of opioids used postoperatively. These are going to be statistically compared.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy above 37Hbd scheduled for elective cesarean section
* ASA 1 or 2

Exclusion Criteria:

* absolute contraindications to spinal anesthesia
* delivery in progress
* non-singleton pregnancy
* BMI\>35
* ultrasound - based estimation of fetal weight below 10 percentile
* pregnancy-induced hypertension
* more than 2 cesarean sections in patient's medical history
* significantly increased risk of obstetric hemorrhage (placenta previa)
Development of Novel Measures for Alzheimer's Disease Prevention Trials

This protocol focuses on novel measures of cognition and everyday function that have robust psychometrics and reduced practiced effects. They will be deployed in a parallel group study in which participants are randomized to assessment type (novel vs established) and receive serial assessments over a one year period in order to highlight contrasts between novel and established measures.

This protocol has the goal of validating novel cognitive and everyday functional measures that have sharply attenuated practice effects and are not prone to ceiling effects for use in preclinical Alzheimer's disease (AD) trials in which participants are cognitively within normal limits. To implement this, we will conduct an innovative parallel group study in which 400 healthy, non-cognitively impaired older subjects are randomized to one of two groups based on assessment type (novel instruments vs. established) and receive three serial assessments over a one year period. Novel cognitive measures include tests of executive function, episodic memory, and processing speed combined into a single composite. Novel functional measures involve computerized performance based, ecologically relevant instrumental activities. We will compare our novel No Practice Effects (NPE) cognitive battery and Miami Computerized Functional Assessment Scale (CFAS) against established measures that include the ADAS-COG in order to determine which battery (novel or established) has better psychometric properties and is less sensitive to practice effects in this clinical trials structure.

Eligibility Criteria:
Inclusion Criteria:

1. English speaking participants, ages 60-85 years
2. MMSE score of 24 or greater
3. Logical Memory II score of 9 or greater for subjects with 16 or more years of education, 5 or more for subjects with 8-15 years of education, and 3 or greater for subjects with 0-7 years of education
4. Presence of subjective memory complaints not exclusionary
5. A family member or other individual who is in contact with the subject and consents to serve as informant during the study.

Exclusion Criteria:

1. Diagnosis of stroke or excessive risk of CVD
2. Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loss of consciousness)
3. Untreated diabetes
4. Current DSM-5 Axis I psychiatric diagnosis of schizophrenia schizoaffective disorder or bipolar disorder; current major depression as determined by a Geriatric Depression Scale score of greater than 5. Current alcohol or substance use disorder
5. Active treatment of cancer
6. MMSE score below 24 and Logical Memory below 9 for subjects with 16 or more years of education, 5 for subjects with 8-15 years of education, and 3 for subjects with 0-7 years of education
7. Females who are pre-menopausal and are pregnant.
8. Use of antidepressants with large anticholinergic properties will be excluded. These include: amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine.
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant (Part 2)

The aim of the present study is determine the cost-effectiveness, clinical- effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.

A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.

This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.

Eligibility Criteria:
Inclusion Criteria:

* • Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).

Exclusion Criteria:

* Teeth will be excluded from the study if they had any of the following:

  * Dental caries in dentine
  * History of pain or swelling. Parents refused their children participate in the trial