cyrilzakka/clinical-trials huggingface dataset:
Fast Identification of Pathogen in the Setting of Pneumonia Using Multiplex PCR

With this study the investigators want to determine, if a fast identification of germs, causing infections of the lower respiratory tract, is possible through the use of Multiplex PCR technology - a method that allows on time detection of bacteria in medical specimen by identifying DNA sequences that are known to be specific for the respective microbe. Therefore aspiration samples from the respiratory tracts of ventilated patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR (polymerase chain reaction) application situated on the intensive care unit. The investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to conventional microbiological methods. The results of the Multiplex PCR analyses therefore will be compared with results of conventional microbiological methods.

In this clinical observational study it is to be investigated if Multiplex PCR analyses of clinical samples from ventilated critically ill patients could be a fast and accurate alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of pneumonia. Therefore aspiration samples from intubated and ventilated critically ill patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex PCR application situated on the intensive care unit. The samples will be investigated for DNA sequences that are known to be specific for pneumonia causing microbes. Analyses will take place in a point of care setting and will be carried out by intensive care physicians. According to the standard protocols of our intensive care units, conventional microbiological investigations, including MALDI-TOF, will be carried out parallel to the Multiplex PCR analyses.

Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion for an infection of the lower respiratory tract has been raised and decision for microbiological investigation of respiratory aspirate was made

Exclusion Criteria:

* patient has been recruited for a interventional clinical trial
* suspicion for an infection with a germ belonging to risk class 3 and 4 according to the german law (BioStoffV and TRBA, e.g. Mycobacterium tuberculosis)
Valuation in Depressed Mood, Anhedonia, and Anxiety

This study examines how people respond to rewards and losses, and the extent to which these responses are linked or distinct among people experiencing depressed mood, anhedonia, and/or anxiety.

This study tests relationships among neural and behavioral valuation mechanisms, and how these mechanisms change (or not) over time, with task instructions, and following cognitive behavior therapy.

Eligibility Criteria:
Inclusion Criteria:

* mood, anxiety, or anhedonia symptoms that affect functioning; fluent in English; able to see computer display; able to perform simple computer games.

Exclusion Criteria:

* history of seizure disorder, stroke, or head injury with more than 10 minutes of unconsciousness; hormone disorder; electroconvulsive therapy within 5 years; history of chemotherapy for cancer; current pregnancy; contraindications to MRI
InSeal VCD Large Bore Vascular Closure Device Safety and Effectiveness Clinical Study

The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.

The study hypothesis is that the VCD is safe and efficient in achieving hemostasis in the study population.

The increasing variety of arterial devices having a large crossing profile requiring the use of a large bore sheath is mandating focus on large bore closure. Such procedures include endovascular abdominal repair (EVAR), thoracic (TEVAR) aortic repairs and transcatheter aortic valve implantation (TAVI) typically involve sheaths and delivery catheters with 14-25Fr profiles.

Today, the typical closing technique (labeled in Europe) for such large sheath size is a one where sutures are deployed prior to the insertion of the large sheath with the sutures tied at the end of the procedure. This technique is cumbersome, hard to learn, complex to use and has relative high complications and failure rate.

The InSeal VCD device model 13-517, is easy to use, fast, affords immediate reliable hemostasis, and supports a wide range of sheath punctures size and artery's dia. 6-10 mm, while leaving a minimal amount material behind and will not limit re-access.

While each of these features may be found in one commercial device or another, to date there is no single device that meets all the market requirements.

Eligibility Criteria:
Inclusion Criteria:

1. Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
2. Femoral, axillary or subclavian artery diameter at sheath insertion site is between 5.5-10mm
3. Subject age is at least 18 years
4. Patient has signed most recent approved version of the Informed Consent
5. Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.

Exclusion Criteria:

1. Women Of Child Bearing Potential (WOCBP)
2. Legally non-competent patients
3. Patient participating in another clinical study at the time of the InSeal VCD study
4. Sheath insertion point is less than 12mm proximal to a bifurcation having a diameter greater than 2.5mm
5. Side branch of greater than 2.5mm in diameter less than 4cm proximal to the puncture site.
6. Known severe allergy to metal and membrane material
7. Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization
8. Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
9. Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment
10. Prior vascular surgery or vascular graft in region of access site
11. Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device
Pulse Pressure Variability With Position Before EPIdural Analgesia

Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in women with a low admission pulse pressure than those with a normal admission pulse. The aim of the present study is to look for a statistical link between the occurrence of a fetal heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions: dorsal decubitus position and in the left lateral decubitus.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* gestational age ≥ 36 weeks
* single eutrophic fetus
* wishing for epidural analgesia
* cervical dilatation less than or equal to 5 cm
* spontaneous labor
* scheduled for a vaginal delivery.

Non-inclusion Criteria:

* prematurity (\< 36 weeks of amenorrhea) or post-term birth
* intention of induction of labour using oxytocin before epidural analgesia or prostaglandin
* contraindication to epidural analgesia
* history of hypertension or gravidic hypertension or heart disorder
* gestational diabetes
* foetal malformation or oligohydramnios or fetal growth abnormality
* fœtal macrosomia diagnosed by ultrasonic scanning
* hematocrit less than 20%

Exclusion Criteria

* induction of labour using oxytocin before epidural analgesia
* newborn weight \> 4kg at birth
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease

This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing a pain crisis necessitating hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 years of age.
* Documented diagnosis of sickle cell disease.
* Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids.
* Able to receive the first dose of study drug within 24 hours from the administration of IV opioids.

Exclusion Criteria:

* Serious systemic infection
* Acute Chest Syndrome
* Serious concomitant medical problems (for example, stroke)
* SCD pain atypical of VOC
* Severe renal or hepatic impairment
* Chronic pain rather than a presentation of acute VOC
Cervical Repositioning Error in Chronic Migraine

This study examines cervical joint position sense in individuals with chronic migraine vs. healthy controls. The ability to reposition the cervical spine after active movement will be evaluated in different head positions. Impaired proprioception and motor control is hypothesized in the migraine group.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-65 years old
* Diagnosis of chronic migraine (for the chronic migraine group)
* No history of migraine (for the control group)

Exclusion Criteria:

* History of cervical spine pathology
* Neurological deficits unrelated to migraine
* Current pregnancy
Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and several POCT (point-of-care testing) devices against two laboratory methods will be performed. This evaluation will be performed according to ISO (International Organization for Standardization) 15197 System Accuracy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* People with diabetes Typ 1 or Typ 2 and people without diabetes
* for BG adjustment people with diabetes Typ 1 or Typ 2
* informed consent

Exclusion Criteria:

* pregnancy or lactation period
* severe acute diseases
* severe chronic diseases
Oocyte Activation: Revised or Initial AGT Technique, Which is Better?! A Sibling-oocytes-split Design

This study will be conducted to compare two different Assisted Gamete treatment (AGT) with oocyte-sibling-split design control group : AGT- initial protocol for activating oocytes by culturing oocytes in calcium ionophore after injection for two rounds of 10 minutes at 37 C, 30 minutes after injection.

sample group : AGT-revised protocol oocytes will be injected by sperm previously cultured in Ca ionophore and 0.4 pL of calcium ionophore then will be cultured in calcium ionophore after injection for 10 minutes

investigators performed ICSI then with one of two activation protocols added : AGT-initial or AGT-revised For the AGT initial protocol, Oocytes will be injected then will be incubated in 10 mM calcium ionophore (Sigma-Aldrich) for two rounds of 10 minutes at 37 C, 30 minutes after ICSI injection, and then will be rinsed and transferred into culture medium.

For the AGT-revised protocol, ejaculated spermatozoa will be exposed to calcium ionophore in a drop on the ICSI dish before injection. During the ICSI procedure, spermatozoa will be aspirated individually from the drop containing calcium ionophore and immobilized in a separate polyvinylpyrrolidone drop. Next, approximately 0.4 pL of calcium ionophore will be aspirated into the micropipette and will be injected into the oocyte with the spermatozoa. Post-ICSI oocytes will be then exposed to 50 mM calcium ionophore for 10 minutes at 37 C, and then will be washed and placed in culture medium.

Eligibility Criteria:
Inclusion Criteria:

* couples presented with an extremely poor fertilization (\<10%)
* couples with previous complete fertilization failure after undergoing ICSI cycles
* At least 4 MII oocytes
* Severe oligoasthinozoospermia
* Teratozoospermia
* testicular aspirated sperm

Exclusion Criteria:

* age \>40 years
* BMI \>34
* aspirated oocytes \< 4
* Normozoospermia
* subfertile patients
Evaluation of Compumedics "Somfit" Device

To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.

Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.

Eligibility Criteria:
Inclusion Criteria:

* Individuals age between 18 to 75
* Be able to give informed consent
* Individuals with diagnosed Obstructive Sleep Apnoea (OSA)

Exclusion Criteria:

* Less than 18 years of age
* Greater than 75 years of age
* Unable or not willing to provide informed consent
* Need for nursing care
* Currently working nightshift
Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities

* To investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11}
* to identify the associated clinical features and to better target neonatal CUS investigations.{11}

Preterm birth is associated with various brain injuries. The earlier the period of gestation, more is the incidence of brain injuries. Brain injuries are known to be one of the most important factors leading to significant morbidity and mortality in these vulnerable preterm babies.{1} Cranial ultrasound (CUS) examinations have been performed on preterm infants to diagnose various perinatal brain injuries and for the prediction of long term outcomes.{2} Cranial ultrasonography (CUS) is the preferred modality to image the neonatal brain.{3} The advantages of CUS are numerous: it can be performed at the bedside with little disturbance to the infant, it is relatively safe, and can be repeated whenever needed, enabling visualization of ongoing brain maturation and the evolution of lesions.{4,5}

Eligibility Criteria:
Inclusion Criteria:

* All neonates suspected clinically to be suffered from brain lesions at nursery unit at assiut university hospitals

Exclusion Criteria:

* Patients above the age of 28 days
Effects of Videolaryngoscope on Intraocular Pressure

This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.

The stability of the intraocular pressure plays an important role during ophthalmic surgery. The systemic blood pressure, aqueous humor dynamics, choroidal blood volume, central venous pressure, extra-ocular muscle tone, and also conventional laryngoscopy affect the intraocular pressure.It was shown that the new devices for laryngoscopy, such as video laryngoscopes provide minimal hemodynamic changes when compared to direct laryngoscopes. However there is no current data about the effects of the intubation with McGrath videolaryngoscope on intraocular pressure. The main objective of this study to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologist physical status I
* Non-ophthalmic elective surgery under general anesthesia

Exclusion Criteria:

* A history of pre-existing glaucoma or previous intraocular surgery
* Thyromental distance below 6cm
* Maximum mouth opening below 3cm
* Mallampati score of III or IV
* Pre-anesthetic intraocular pressure above 20 mmHg
* Number of intubation attempts more than 2
* Obstetric or laparoscopic surgery
A Study of MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma

This is a Phase I/II, single-arm, multicenter, open-label study which is divided into two portions: Phase I is dose escalation portion, in which subjects with relapsed or refractory B-cell lymphoma will be enrolled except malignant lymphoblastic lymphoma (LBL) and Burkitt lymphoma. After the RP2D is identified, Phase II of subjects with relapsed or refractory mantle cell lymphoma who previously received ≥ 2 and ≤ 4 different chemotherapy and/or targeted drug therapy will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients in Phase I study will be enrolled with refractory or relapsed B-cell non-Hodgkin lymphoma.
* 2) Patients enrolled in the phase I study failed two or more lines of treatment regimens; Patients with mantle cell lymphoma should also be patients with contraindications or failure of BTK inhibitor therapy.
* 3) Eastern Cooperative Oncology Group (ECOG) performance status score is 0\~2.
* 4) Have life expectancy ≥ 3 months.
* 5) Major organ functions meet the following criteria:

  * In the absence of growth factor support therapy or blood transfusion in the last 14 days: absolute neutrophil count ≥1.5×109/L, hemoglobin ≥80 g/L, platelets ≥75×109/L (no platelet transfusion within 14 days); if accompanied with bone marrow invasion, neutrophils ≥1.0×109/L, platelets ≥50×109/L.
  * Biochemistry: Total bilirubin ≤1.5×ULN or ≤3.0×ULN in Gilbert's syndrome, AST or ALT ≤2.5×ULN, serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
  * Coagulation function: International normalized ratio (INR) and activated partial thrombin time ≤ 1.5 × ULN.

Exclusion Criteria:

* 1) Present or prior history of other malignancies (except cured carcinoma in situ of cervix and basal cell carcinoma of skin), unless there is radical treatment and no evidence of recurrence or metastasis within the last 2 years.
* 2) Lymphomas involved the central nervous system.
* 3) Patients with history of organ transplantation or allogeneic hematopoietic stem cell transplantation; patients who have received autologous hematopoietic stem cell transplantation or CAR-T treatment within the past 3 months,
* 4) Patients who are suitable and ready for autologous stem cell transplantation.
* 5) History of eye surgery or trauma within 3 months before the screening visit, history of serious eye infection or the most recent eye surgery within 4 weeks before the screening visit.
* 6) Has had active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
* 7) Has had uncontrolled or significant cardiovascular diseases, including:
* 8) Women who are lactating or pregnant.
* 9) Women of child-bearing potential who do not agree to have two pregnancy tests prior to first dose (at least one of tests is serum pregnancy test) and the test result shall be negative.
* 10) Male patients who do not agree to the birth control measures.
* 11) Any conditions that in the opinion of the investigator considers inappropriate to participate in the study.
DEXINEURO® Tab on Blood Glucose Reduction in Patients With Type 2 Diabetes Accompanied by Diabetic Peripheral Neuropathy

This study is to evaluate the efficacy of DEXINEURO® tab on blood glucose reduction and assess the interaction with concomitantly administered insulin or oral antidiabetic agents in patients with type 2 diabetes accompanied by diabetic peripheral neuropathy.

This clinical trial is a multi-center, single-group, prospective observational study conducted to investigate the interaction with concomitant insulin or oral antidiabetic agents and assess the influence on blood glucose reduction when administering DEXINEURO® tab to patients with type 2 diabetes and diabetic peripheral neuropathy.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 years and older of both genders.
2. Type 2 diabetes patients with HbA1c ≤ 10% at screening.
3. Patients diagnosed with diabetic peripheral neuropathy who are scheduled to receive DEXINEURO® tab.
4. Individuals who have voluntarily provided written consent to participate in this study.

Exclusion Criteria:

1. Individuals who have taken or are currently taking alpha-lipoic acid (thioctic acid) within 1 month before screening.
2. Individuals contraindicated according to the approval conditions of DEXINEURO® tab.
3. Pregnant or breastfeeding women.
4. Individuals participating in other clinical trials (except for non-interventional observational studies, if they have not received investigational drugs, or are participating in other non-interventional observational studies).
5. Individuals whom the principal investigator deems inappropriate for participation in this study for reasons other than those mentioned above.
Comparison of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses

The purpose of this study is to demonstrate that the Centurion® Vision System (CVS) used with the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti® Vision System (IVS) used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction surgery via phacoemulsification of cataract grades NII- NIV \[Lens opacities classification system II (LOCSII)\].


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to consent for participation;
* Willing and able to attend postoperative examinations per protocol schedule;
* Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study;
* Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation;
* Untreated or uncontrolled Glaucoma;
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes;
* Poorly dilating pupil or other pupil defect;
* Current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1A adrenoceptor (eg, Flomax®, Hyntrin®, or Cardura®);
* Severe retinal disorders;
* Corneal disease or retinal detachment;
* Other protocol-specified exclusion criteria may apply.