cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of QIAstat-Dx® Gastrointestinal Panel 2

Performance evaluation of QIAstat-Dx® GI2 Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® GI2 Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment

The objective of the study is to demonstrate that the QIAstat-Dx® Gastrointestinal Panel 2 achieves its intended performance during normal conditions of use by the intended user in the intended environment.

The primary objective is to evaluate the performance of QIAstat-Dx® GI2 Panel in comparison with the results obtained from the reference methods.

The secondary objective of the study is to evaluate the safety of QIAstat-Dx® GI2 Panel with respect to users/operators.

The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® GI2 Panel and Reference Method(s). Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined

Eligibility Criteria:
Inclusion Criteria:

1. Stool specimen must have been collected from subjects/patients which meet the institute's criteria for a suspected enteric pathogen, such as individuals presenting with symptoms of gastrointestinal infection;
2. Stool specimen will be residual and obtained for completion of routine gastrointestinal testing;
3. Specimen for testing will consist of stool specimens preserved in Cary- Blair medium following the manufacturer's instructions for use;
4. Fresh, unpreserved stool must be transferred to Cary-Blair as soon as possible after specimen collection;
5. When fresh stool is transferred into the Cary-Blair container, the maximum fill line of the container should not be exceeded;
6. There is an adequate residual volume (minimum 1.0 mL) of Cary- Blair preserved stool specimens;
7. Cary- Blair preserved stool specimens should represent a homogenous suspension (easily vortexed);
8. Cary- Blair preserved stool specimens have been stored at the following conditions prior testing:

   * Up to 4 days at Room Temperature (15 to 25˚C).
   * Up to 4 days at 2 to 8˚C (refrigerated);
9. Samples should be tested on the QIAstat-Dx® system and the reference method FilmArray within 3 hours of each other.

Exclusion Criteria:

1. Whole stool specimen that had been frozen;
2. Specimen that had been centrifuged;
3. Lack of clear subject identification or label on residual stool specimen;
4. Obvious physical damage of residual stool specimen;
5. Repeated specimens from the same subject;
6. Specimens in preservative collection media other than Cary-Blair;
7. Specimen containing formalin or any other fixative;
8. Rectal swab specimens
9. Specimens not collected according to manufacturer's instructions (under-filled or overfilled specimens);
10. Specimen contaminated with urine or water;
11. Leaking container.
Evaluation of Wear Experience With Daily Contact Lenses

To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Currently wear Biofinity® monthly replacement spherical contact lenses.
* Distance visual acuity of 20/25 or better with current contact lenses.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
* Ability to give informed consent.
* Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.

Exclusion Criteria:

* No current ocular inflammation or infection.
* Not currently pregnant or lactating.
Investigating Composite Biomarkers for Pain Catastrophizing

Pain is a complex, multidimensional, and subjective experience; and although, investigators use a single word "pain", to describe our perception, multiple mechanisms contribute to the generation and maintenance of pain. To help diagnosing and improving pain management, there is a need for developing tools. These tools may include measurements of substances, or biomarkers, in the blood; e.g. small molecules called microRNA and proteins. In these experiments, the investigators would like to investigate how the psychological response to stress and pain alters the impulses in the brain and the content of microRNA and proteins in the blood. The future aim is to identify patients in high risk of developing and maintaining chronic pain and to be able to treat chronic pain efficiently.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women in the age 18-80 years
* Speak and understand English

Exclusion Criteria:

* Acute and chronic pain
* Pregnancy or breastfeeding
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.)
* Focal and generalized seizure
* Surgery or any other therapy for epilepsy
* Present or previous AEDs (anti-epileptic drugs) administration
* Present or previous use of epileptic devices (\<1 year prior the enrolment)
* Lack of ability to cooperate
* Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.


Eligibility Criteria:
Inclusion Criteria:

* General status (WHO) Karnofsky Performance Status ≥60
* Presumptive glioblastoma according to radiological criteria,
* Surgical indication decided in Multidisciplinary consultation meeting (RCP) of neuro oncology,
* Decision to treat the patient as part of the Clinical trial achieved in neuro-oncology RCP ("Multidisciplinary consultation meeting")
* Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
* Clinical neuro-oncological monitoring and long-term MRI/ TEP 11C MET scheduled at the hospital centers
* Patient able to understand and sign voluntarily Informed consent
* Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
* Women of child-bearing potential should benefit of an effective contraception
* For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA

Exclusion Criteria:

* Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
* Contraindications to 5-ALA

  * Porphyria
  * Taking photosensitizer treatment
  * Severe renal or hepatic impairment
  * Bilirubin\> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)\> 2.5 x Maximum. rates
  * Creatinine clearance \<30 mL / min;
  * Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
* Contraindications to surgery
* Contraindications to magnetic resonance imaging (MRI/TEP 11C MET
* Treatment with an experimental drug within 30 Days prior to the start of the study
* Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
* Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
* Pregnant or nursing women
* Refusal to participate or sign the consent of the study
* Soy allergy
Nighttime Communication Study

This study seeks to determine whether a family-centered nighttime communication intervention improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of nighttime medical care.


Eligibility Criteria:
Inclusion Criteria:

* Parents of patients admitted to the general pediatrics inpatient units
* Overnight nurses working on the general pediatrics inpatient units
* Overnight residents working on the general pediatrics inpatient units

Exclusion Criteria:

* Non-English speaking parents
Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every week in the treatment of patients with advanced ovarian cancer that is resistant to platinum-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria

* Histologic diagnosis of ovarian cancer
* Recurrent or persistent disease following primary therapy
* Measurable disease
* Prior treatment with at least one but no more than three prior chemotherapy regimens
* Resistant or refractory to platinum-based chemotherapy
* At least 18 years of age
* Good performance status (ECOG 0 to 1)
* Adequate liver, renal and bone marrow function

Exclusion criteria

* Pregnant or currently breast feeding
* Treatment with chemotherapy or immunotherapy within four weeks
* Prior radiation to the whole pelvis
PROM by AmnioQuick Duo+ in Egyptian Women

Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests.

Premature rupture of the fetal membranes (PROM) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. PROM may be subdivided into term -PROM (TPROM, i.e. PROM after 37 weeks of gestation) and preterm PROM (PPROM, i.e. PROM prior to 37 weeks of gestation). PPROM occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.The diagnosis of PPROM is made by examination , patient history and simple testing. Patient history has an accuracy of 90% for the diagnosis of PPROM

Eligibility Criteria:
Inclusion Criteria:

* pregnant ladies with PROM from 20- 37 weeks

Exclusion Criteria:

* Gestational Age \>37 wks Non reassuring CTG Signs of chorioamnonitis ( Fever , maternal or fetal tachycardia , Foul cervical discharge , uterine tenderness or high TLC ) Antepartum hemorrhage
GI Neuromuscular Pathology Prospective Registry

In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).

Biopsies will be collected from patients that have been diagnosed with gastroparesis (having nausea, retching, bloating and fullness of stomach) and are undergoing surgery for the GES implantation. These patients will serve as our study group population. Biopsy samples of those who do not have gastroparesis but are undergoing surgery on the digestive system will be collected after the patients consent to be on the trial. These patients will serve as our control group population. Detailed medical history will be collected and the study group patients will be asked to complete two questionnaire to assess the severity of the symptoms. They will be followed in the clinic at 6, 12, 18 and 24 months post implantation.

Eligibility Criteria:
Inclusion Criteria Study Group:

Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.

Inclusion Criteria Control Group:

Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery

Patients who are organ donors and undergoing surgery

Exclusion Criteria Study Group:

Contraindication for surgical full-thickness biopsy for any reason. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease.

Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident. Pregnant Unable to give own informed consent Prisoners

Exclusion Criteria Control Group:

Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor
Pancreatic Cancer Biomarker Study

This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.

This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.

Study participants will be recruited by physician referral or from a list of clinical patients being evaluated for a potential pancreatic abnormality or for potential treatment of pancreatic cancer. Additionally, a surveillance cohort will be recruited among individuals who are being monitored for recurrence following surgical or medical treatment for pancreatic cancer.

Peripheral blood specimens will be collected from all participants at time of enrollment. Additional specimens may be collected from surveillance cohort participants no more frequently than once every 3 months as clinically indicated.

The specimens will be sent to a clinical lab for sTRA biomarker and CA19-9 analysis. Participants will be followed for 36 months to track clinical outcomes. The performance of the investigation biomarker for the diagnosis, prognosis, or surveillance of pancreatic cancer will be compared to the performance of CA19-9.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis/Prognosis Cohort

* Patients being evaluated for possible pancreatic abnormality, via additional radiological test (endoscopic ultrasound, abdominal CT scan), blood test (CA19-9), or other diagnostic procedure.
* Patients being evaluated for medical or surgical treatment for pancreatic cancer or pancreatitis on the basis of previous clinical and radiological findings.

Surveillance Cohort

* Patients being monitored or who will be monitored for potential recurrence of pancreatic cancer following surgical or medical treatment of pancreatic adenocarcinoma.

Exclusion Criteria:

* The participant is unwilling or unable to provide written informed consent.
* In the investigator's opinion, the participant is unsuitable for the study.
* The participant does not speak English.
* The participant is a prisoner.
* The participant is known to be pregnant.
* The participant is less than 18 years of age.
Correlation of Cerebral State Index With the Richmond Agitation-Sedation Scale in Mechanically Ventilated ICU Patients

The purpose of this study is to correlate the cerebral state index obtained from a cerebral state monitor with the Richmond Agitation-Sedation Scale assessment performed on sedated and mechanically ventilated intensive care patients.

Currently there are no objective methods to measure levels of sedation in all ICU patient populations. This generally does not become problematic in most patients. However, certain populations cannot be assessed by standard means. These populations would include patients who are quadriplegic and those who are being treated with neuromuscular blocking agents. The current norm is to use a sedation scale such as the Richmond Agitation-Sedation Scale to assess the patient's level of sedation. An alternative to this would be to use an EEG based method that monitors brain activity. New methods of monitoring brain activity, using cerebral state monitors may provide an effective means of monitoring sedation. The cerebral state monitor, however, and the parameters it provides, the cerebral state index, has not been tested in an ICU setting. Correlating the measurements gained from the cerebral state monitor with the RASS assessment from sedated ICU patients may allow us to develop a method of monitoring sedation in populations that were impossible to monitor previously. Accurately monitoring the level of sedation in these patients may help decrease the incidence of over-sedation and under-sedation.

Eligibility Criteria:
Inclusion Criteria:

* Admission the surgical-trauma intensive care unit at the Charleston Area Medical Center General Hospital
* Adult (18-85 years of age)
* Anticipated duration of mechanical ventilation of at least 72 hours

Exclusion Criteria:

* Patients admitted with paralysis or a brain injury
* Patients who are deaf, blind, or have pre-existing dementia/delirium
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging

The study will be conducted under the following 3 sub-studies:

1. Scans within Scanner (Intra-scanner precision substudy),
2. Scanners within a site (Inter-scanner precision substudy),
3. Scanners between sites (Inter-site precision substudy)

Eligibility Criteria:
Inclusion Criteria:

Glass slides are screened for the known features and will be considered eligible for the study only if all of the following criteria apply:

* Slides are selected from cases in a consecutive manner starting with cases at least 1 year old since accessioning
* Slide is a glass cover-slipped surgical pathology slide of human tissue
* Slide is stained with hematoxylin and eosin (H\&E) or other stains
* Slide has the designated primary feature in the FOV, which is readily observable in its natural environment although the slide may also have one or more secondary features from the same magnification group in the FOV.
* Slide is available in the archives for use, or purchased commercially, is not damaged, has tissue on the slide which is still in good condition, has a stain that is not faded and otherwise passes all quality checks

Exclusion Criteria:

Slides are to be excluded from the study if any of the following criteria apply:

* Slide is unable to be scanned, contains damaged tissue or has indelible markings
* Slide comes from an active (less than 1 year old) case
* Slide is from a patient who already has a slide enrolled in the study, only 1 slide per patient to be enrolled
Trial of Iressa in Prostate Cancer Patients

This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Removal of prostate for prostate cancer
* Raised level of prostate specific antigen (PSA) post-surgery
* Can have received some radiation therapy

Exclusion Criteria:

* Any after surgery male hormone blocking therapy.
* Low white blood cell count
* Abnormal liver function test
Handling Comparison Between Two Contact Lens Types

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 40 and 70 years of age.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
7. The subject best corrected visual acuity of 20/20 -3 or better in each eye.
8. Subject must own a wearable pair of spectacles.
9. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
10. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any ocular abnormality that may interfere with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
7. Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
8. Any ocular infection or inflammation.
9. History of herpetic keratitis.
10. Any corneal distortion or irregular cornea.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
13. Current history of diabetes.
14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.