cyrilzakka/clinical-trials huggingface dataset:
Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis

The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound.

Recorded signals are stored on a laptop computer. The signals later undergo Fourier analysis are then compared to the findings on carotid ultrasoud as to degree of stenosis. Subjects with high grade stenosis in which no bruit was ascultated but in which carotid ultrasound data suggests a bruit may be present are studied for soft /inaudible bruits. When available, data will be correlated to CT/conventional angiographic studies.

Eligibility Criteria:
Inclusion Criteria:

* age 19-90 years
* having clinical ultrasound evaluation of carotid or femoral artery

Exclusion Criteria:

* under age 19; over age 90 years
Validation of Osmolarity System: Clinical Usability Study

Confirmatory trial to validate usability of a new portable osmolarity testing device.

Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing device.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide consent

Exclusion Criteria:

* Ocular pathology (other than Dry Eye)
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion and exclusion criteria include but are not limited to the following:

* Histologically or cytologically confirmed diagnosis of locally advanced/unresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
* PD-1/L1 refractory locally advanced or mUC as evidenced by:

EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.

* Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation.

Exclusion Criteria:

* Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
* Active infection requiring systemic therapy.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Known history of human immunodeficiency virus (HIV).
* Known history of hepatitis B or known hepatitis C virus infection.
Stability of Secondary Intraocular Lenses With no Capsular Support

Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support.

Acquired or congenital weakness of the zonules, either as part of a pseudoexfoliation syndrome (PEX), high myopia, past ocular trauma, post vitreoretinal surgery, and recurrent uveitis are the most common reasons for implantation of a secondary intraocular lenses (IOL) after cataract surgery. There are several techniques available to implant a secondary IOL in eyes with inadequate capsular support. Some of the most common techniques are the placement of a chamber angle-supported anterior chamber IOL (ACIOL), an iris-fixated IOL (IFIOL) and several different possibilities of scleral fixation of the IOL (SFIOL).

While those methods have all been found to show high safety and efficiency, there are certain procedure-specific limitations. One approach to sutureless implantation of a SFIOL is the "double needle flanged technique" described by Yamane et al. When using this technique, there is no need for extensive scleral incisions or distinct scleral manipulation, however, it may be challenging for the surgeon and may lead to complications such as "iris-optic-capture".

Past studies found no significant difference of postoperative best corrected visual acuity or rate of complications when comparing the three mentioned techniques, therefore, up to now choice of implantation and fixation technique lies with the surgeon's preferences and abilities. However, all three techniques have their drawbacks.

Hence, the aim of this study is to assess the centration, tilt, and wobble of secondary IOLs (comparing an IFIOL and a SFIOL) without capsular support.

Eligibility Criteria:
Inclusion Criteria:

* Secondary IOL implantation performed at the Hanusch Hospital
* IFIOL or SFIOL implanted
* Older than 21 years
* Written informed consent prior to recruitment

Exclusion Criteria:

* Concurrent participation in another drug or device clinical investigation
* Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
Gene Transfer for Cancer Pain

The primary purpose of this study is to examine the safety of NP2 (a nonreplicating HSV-based vector expressing enkephalin) in patients with cancer pain. The secondary purpose is to evaluate efficacy.

Therapeutic HSV-based vectors deliver genes from skin inoculation to sensory neurons to interrupt pain signaling at the spinal level. Side effects may be limited by the focal distribution of vector delivery and preproenkephalin expression. Preproenkephalin is a natural human gene that produces peptides that bind to opioid receptors in the body. The therapeutic being evaluated, NP2, is a replication defective herpes simplex type 1 virus (HSV-1) modified to express the human preproenkephalin gene that has demonstrated efficacy in numerous model of pain, including pain caused by cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with intractable pain from malignant disease with a 5 year projected survival of less than 25%.
2. Female patients of childbearing potential who have a negative pregnancy test and using birth control.
3. Patients who have not received recent treatment with a radiation, chemotherapeutic or immunotherapeutic agent and are not expected to undergo such treatment 28 days after injection of NP2.
4. Patients who have not had surgical stabilization/resection within 4 weeks of Screening and have no plans for additional surgical procedures.
5. Patients with adequate bone marrow function, IgG levels greater than 565 mg% and CD4 count greater than 500. .

Exclusion Criteria:

1. Patients with serious uncontrolled medical conditions other than malignancy.
2. Patients with severe liver or renal impairment
3. Patients currently or previously with positive serology for HIV, Hepatitis B or Hepatitis C.
4. Patients with a hemoglobin \<9 gm% or uncontrolled coagulopathy or bleeding diathesis.
5. Patients with a clinical diagnosis of any active herpes infection within the past 6 months.
6. Patients who have been vaccinated to prevent HSV infection or a history of shingles or the presence of active shingles.
Virtual 360°-Tour in Coronary Computed Tomography

The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and process time of the patients coming to CCTA (coronary computed tomography angiography). The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway.

The purpose of the study is to evaluate the effectiveness of the virtual 360° counselling environment in the anxiety and process time of the patients coming to CCTA (coronary computed tomography angiography).

The virtual, 360° environment 'Virtual 360°-tour in coronary computed tomography' uses 360°- technology based on spherical panorama images and resembles the spaces of the hospital according to the patient's pathway in CT-examination and provides information to the patient at various stages of the pathway. Patients who have referred first time to the coronary computed tomography can access the virtual CT examination environment via link before entering the hospital. Using the environment requires a network connection and is possible with a computer, tablet or phone. The environment has digital counselling materials in text, image, animation and video formats in three different virtual spaces/views, the environment and examination are presented via pathway of example 59-year female patient with arterial hypertension and exercise related chest pain (angina pectoris).

Eligibility Criteria:
Inclusion Criteria:

* coming to first coronary computed tomography examination
* adult patient
* able to independently fill in question forms

Exclusion Criteria:

* previous coronary computed tomography
* mental illness
Endotracheal Tube Securement Study

To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic, randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube fastener on complications including lip ulcers, facial skin tears, endotracheal tube dislodgement, and ventilator associated pneumonia among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

Background: The optimal securement method of endotracheal tubes is unknown, but should provide adequate security while minimizing complications. This study tests the hypothesis that use of an endotracheal tube fastener would reduce complications among critically ill adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic, single center, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patient intubated prior to admission to the MICU and the intubation time was less than 12 hours from the time of admission
* Patients intubated in the MICU for greater than 24 hours

Exclusion Criteria:

* intubated greater than 12 hours prior to admission to the MICU
* presence of oral mucosa or facial skin breakdown prior to enrollment
* required nasotracheal intubation,
* had a documented allergy to tape
* pregnant
* prisoners
Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants

Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, term infant from a singleton birth (=\>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour

Exclusion Criteria:

* Infants with known genetic syndromes; birth weight (\<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy
Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy

The purpose of this study is to learn about possible changes in brain anatomy and in thinking abilities, such as memory skills, in patients with cancer who receive treatment with chemotherapy alone or in combination with total body radiation before undergoing stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute undifferentiated or biphenotypic leukemia, myelodysplastic syndrome (MDS), Hodgkin's lymphoma, (HL) or non-Hodgkin's lymphoma (NHL), and in complete remission at the time of enrollment
* Are scheduled to undergo conditioning treatment with (1) total body radiation (TBI) and chemotherapy or (2) chemotherapy alone prior to receiving a myeloablative allogeneic HSCT
* Between 18 and 70 years of age.
* Are English speaking.
* Have capacity to give consent.

Healthy Control Inclusion Criteria:

* Have no diagnosis of cancer except basal cell carcinoma
* Between 18 and 70 years of age.
* Are English speaking.
* Have capacity to give consent

Exclusion Criteria:

* Patients with signs and/or symptoms of central nervous system disease as determined by their physician or by a brain MRI, either at the time of enrollment or during the study period.
* With disease progression at the time of enrollment or during the study period
* With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
* With a history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness
* With standard contraindications to MRI examinations

Healthy Control Exclusion Criteria:

* Exposure to chemotherapy or radiation therapy for any medical condition
* With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
* With a history of neurological disorders, neurodegenerative disease, or traumatic brain injury with loss of consciousness
* With standard contraindications to MRI examinations
Investigating Memory and Physical Activity After Cancer Treatment in Survivors of Adolescent and Young Adult Cancers

This study evaluates relationships among physical activity, thinking, and memory after cancer treatment in survivors of adolescent and young adult cancers.


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18+ years)
* Primary diagnosis of cancer when 15-39 years-old
* Access to a desktop computer or laptop with reliable internet access
* No gross motor impairments that prohibit ambulation
* Willing to complete study requirements
* English speaking

Exclusion Criteria:

* Diagnosed with nonmelanoma skin cancer only
* Not diagnosed with cancer in adolescent and young adult (AYA) age range of 15-39 years
* Scheduled travel during the study period that is not indicative of individual's normal schedule
Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconi's Anemia

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's bone marrow. The donated bone marrow stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before or after transplant may stop this from happening.

PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide in treating patients who are undergoing a donor bone marrow transplant for Fanconi's anemia.

OBJECTIVES:

* Decrease the conditioning-related toxicity of cyclophosphamide without decreasing the engraftment rate to \< 90% in patients undergoing allogeneic bone marrow transplantation for Fanconi's anemia.

OUTLINE: This is a multicenter, dose-finding study of cyclophosphamide.

* Nonmyeloablative conditioning regimen: Patients receive cyclophosphamide IV on days -5 to -2.

Cohorts of 5-10 patients receive decreasing doses of cyclophosphamide until the optimal dose (OD) is determined. The OD is defined as the dose at which ≥ 4 of 5 patients achieve engraftment and \< 1 of 10 patients experiences dose-limiting toxicity.

* Allogeneic bone marrow transplantation (BMT): Patients undergo allogeneic BMT on day 0.
* Graft-vs-host-disease (GVHD) prophylaxis: Patients receive cyclosporine orally or IV twice daily beginning on day -1 and continuing until day 49, followed by a taper on days 50-180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Fanconi's anemia by chromosome fragility with a diepoxybutane (DEB) or mitomycin C test

  * Hemoglobin ≤ 8.0 g/dL, absolute granulocyte count ≤ 1,000/mm\^3, or platelet count ≤ 50,000/mm\^3
* No refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or acute leukemia
* HLA-identical related donor available

PATIENT CHARACTERISTICS:

* Glomerular filtration rate ≥ 30% predicted for age
* No liver disease (e.g., active hepatitis or moderate to severe portal fibrosis/cirrhosis by biopsy)
* No symptomatic cardiac insufficiency or symptomatic arrhythmia
* No other diseases that would severely limit the probability of survival
* No HIV seropositivity
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* Not specified
Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke

The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.

Further study details as provided by M's Science Corporation:

Eligibility Criteria:
Key Inclusion Criteria:

* Males or females 18 years of age or older
* Experienced a stroke from 48 to 72 hours before randomization
* A total score of \>/=4 on the NIHSS, or \>/=2 on the upper or lower extremity motor scores of the NIHSS
* Medically and neurologically stable within 24 hours prior to randomization

Key Exclusion Criteria:

* Patients with transient ischemic attack
* Patients with stroke in progression
* Unstable cardiac, hepatic, or renal disease, or other major medical disorder
Suspicion of Hypoglycemic Effect of mRNA Based Covid-19 Vaccines (Polyethylene Glycol) Will Happen , Observational Study on Diabetic Patients at Saudia Arabia

vaccines for covid-19 are gold strategy and great achievement at this century for protection against complications of covid-19 , development of many vaccines with different technology represent a big challenge for this disease so the world live bad days and the vaccines save world to see the light once again , mRNA based vaccines have a new technology which designed before for cancer therapy, this technology is very effective , producible and fast for future disease targets but these vaccine must contain excipients for preservation of this technology mRNA so we now study these side effects of excipients and we suspect that polyethylene glycol as excipients have big role at hypoglycemic effects with antidiabetic medications like metformin and insulin especially at children and older age

diabetics patients as chronic diseases represent high percentage at all the world and high priority for vaccines against covid-19 so we will focus on these group as need more attention and need best health and quality of life so my study concentrate on diabetics patients from 12 years to 80 years who were taken mRNA based vaccines and suffer from recurrent hypoglycemia , i will check the blood glucose one month after the first or second injection of mRNA based vaccines Pfizer or moderna vaccines and study all medicines taken by patients and suspect what's happen is there is hypoglycemic effect or nor by following up the readings of blood glucose by glucometers or CGM

there are previous studies about relation of metformin and polyethylene glycol injection and this study conclude that The subcutaneous injection of PEX168 once a week can effectively, continuously and safely improve HbA1c levels in patients with T2D when combined with metformin ( Gao F, Lv X, Mo Z, Ma J, Zhang Q, Yang G, Liu W, Li Q, Zhou J, Bao Y, Jia W. Efficacy and safety of polyethylene glycol loxenatide as add-on to metformin in patients with type 2 diabetes: A multicentre, randomized, double-blind, placebo-controlled, phase 3b trial. Diabetes Obes Metab. 2020 Dec;22(12):2375-2383. doi: 10.1111/dom.14163. Epub 2020 Sep 6. PMID: 32744358.

Eligibility Criteria:
Inclusion Criteria:

- Male and female subjects between the ages of 12 and 80 years, inclusive, with Type 1 or 2 diabetes mellitus as defined by the American Diabetes Association (Diabetes care, Vol. 21: S5- S19, 1998) for more than one year.

Exclusion Criteria:

* under 12 years above 80 years undergone bariatric surgery no exercises during testing
NettOpp: The Development and Evaluation of an App-based Selective Intervention for Adolescents Exposed to Cyberbullying

The aim of the project is to develop and evaluate an app-based intervention for adolescents who have been exposed to cyberbullying. The overarching goal is to offer a low-threshold intervention, called NettOpp, that is easy accessible and free to use for every junior high school student who has experienced cyberbullying in Norway.

The main aim of the intervention is to increase coping strategies for adolescents who have been exposed to cyberbullying. More specifically the aims are to increase 1) knowledge about cyberbullying, 2) help-seeking behavior, 3) coping strategies with cyberbullying, 4) to reduce mental health problems, and 5) cyberbullying, and 6) to increase self-esteem and the 7) sleeping quality of the adolescents.

To evaluate the mobile application three studies will be conducted: A lab test, a pilot study, and a larger effectiveness study with a follow-up examination after 3 months. The lab test will be conducted to examine the quality of the prototype of the app in order to find out if adjustments have to be made. Thereafter, a pilot study will be conducted with adolescents that were exposed to cyberbullying in the past six months. The pilot study will use a pre-post design.The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents whose guardians have given consent and who agree to take part in the study

Exclusion Criteria:

* severe developmental or cognitive challenges