cyrilzakka/clinical-trials huggingface dataset:
Donepezil Memory Preservation Post ECT

This randomized, placebo-controlled trial will evaluate the use of donepezil compared to placebo to reduce the risk of memory impairment after electroconvulsive therapy (ECT).

Electroconvulsive therapy (ECT) is a method used to treat a variety of psychiatric conditions. An electrical current is distributed throughout the brain (Lisanby 2007) inducing seizure activity in a controlled setting using neuromuscular blocking agents (Mirzakhani 2012) while the patient is under anesthesia (Deiner 2009). ECT is approved by the Food and Drug Administration (FDA) for the following conditions: unipolar and bipolar depression, manic and mixed states in bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder and catatonia (FDA executive summary). ECT is often used after trials of psychotropic medications have failed (Kellner 2012).

Electroconvulsive therapy (ECT) is commonly associated with cognitive side effects that range from anterograde and retrograde amnesia to issues with executive function, attention and declines in information processing. Problems with autobiographical memory and recall for new information appear to be affected the most. In addition, data suggests that the loss of memory of autobiographical events may persist as long as six months. These issues may cause patient adherence problems and potential relapses into previous psychiatric conditions.

Donepezil is an acetylcholinesterase inhibitor indicated for Alzheimer's Dementia and has been shown to slow the progressive decline in cognition and memory in Alzheimer's Dementia. It is hypothesized that donepezil will help to preserve memory and minimize the decline in memory that is associated with the administration of ECT.

This study aims to determine if donepezil can minimize deficiencies in autobiographical memory 4-5 weeks after ECT treatment has been started.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder, anxiety disorders, bipolar depression who are receiving right unilateral ECT will be included.

Exclusion Criteria:

* Patients with previous use of alcohol or illicit drugs within seven days of randomization will be excluded. Preexisting unstable cardiovascular disease including uncontrolled hypertension will be excluded. Patients with a documented allergy to donepezil will also be excluded. Patients with axis I disorders (eg. schizophrenia, schizoaffective disorder) other than major depressive disorder, anxiety disorders and/or bipolar depression will be excluded. Patients on anticoagulant therapy or chronic NSAID therapy will be excluded. Patients who are pregnant or wish to become pregnant within one year from trial enrollment will also be excluded. Patients who have received ECT within 6 months of enrollment will be excluded. Baseline Mini Mental State Examination (MMSE) \< 24 will be excluded.
Assessment of Retinal Fundus Imaging Camera

The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy per ETDRS level 35 and higher with or without macular edema.

The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy (ETDRS level 35 and higher) with or without macular edema. Study subjects will sign the informed consent form, and data collection will involve being imaged by cameras.

Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older.
* Documented diagnosis of diabetes mellitus, as per any of the following: Having met the criteria established by the World Health Organization (WHO) and/or the American Diabetes Association (ADA), Hemoglobin A1c (HbA1c) ≥ 6.5%, Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L), Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75g anhydrous glucose dose dissolved in water, Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
* Ability to understand and the willingness to sign a written informed consent document.
* Diagnosis from a retinal specialist of ETDRS level of 35 or higher with or without DME or diagnosis from a retinal specialist of ETDRS level 20 or lower and no DME.
* Standard Corrected Visual Acuity of at least 20/40 or better in both eyes.

Exclusion Criteria:

* Currently participating in an interventional eye study (e.g., actively receiving the investigational product for Diabetic Retinopathy (DR) and/or Diabetic Macular Edema (DME)).
* Has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia, or previous enucleation).
* Pregnancy
* Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops.
* Any condition that is contraindicated for the use of study devices in the opinion of the investigator.
* Contraindication for imaging by devices used in the study due to any of the following:
* Subject is hypersensitive to light
* Subject recently underwent photodynamic therapy (PDT)
* Subject is taking medication that causes photosensitivity
Vitamin D and HbA1c Levels in Diabetic Patients With CKD

The purpose of this study is to determine the association between serum 25-hydroxyvitamin D and HbA1c levels in diabetic patients with chronic kidney disease. The investigators hypothesized that serum 25-hydroxyvitamin D levels were negatively correlated with HbA1c levels.

This was a cross sectional study using consecutive sampling methodology for participant recruitment. It was carried out at the specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.

Serum 25(OH)D levels were determined by using direct chemiluminesent immunoassay (ADVIA Centaur XP; Siemens Healthcare Diagnostics, Tarrytown, New York, USA). Serum HbA1c levels were determined using high-pressure liquid chromatography (Variant™ II Turbo; Bio-Rad, Hercules, California, USA).

Data collected will be analyzed using Statistical Package for Social Sciences SPSS version 23.0 for Windows, version 23.0 (IBM Corp., Armonk, New York, USA).

Eligibility Criteria:
Inclusion Criteria:

* eGFR 15-59 ml/min/1.73m2
* age ≥ 18 years old
* able to provide informed consent

Exclusion Criteria:

* active infections
* autoimmune diseases
* malignancies
* on immunosuppressive therapy
* on vitamin D supplements
The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children

Medical clowns are known to assist in relaxing children and allowing better cooperation during performance of medical procedures.

The ability of medical clowns to improve the motivation of children to perform active tasks was never examined to date.

The investigators would like to examine the influence of the clowns' presence on the performance of pulmonary function test.

The investigators would like to evaluate the performance of pulmonary function tests among preschool children aged 3-6 years.

Overall 200 children will participate.

The children will perform pulmonary function test without a clown present.

About an hour later half of them will perform the exam again with a medical clown assistance and the second half will repeat the examination without a clown present the differences between the performance will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* children visiting the pediatric pulmonology clinic
* parents signed informed consent

Exclusion Criteria:

* medical or neurological diseases not allowing performance of pulmonary function tests
* parents refusal
Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss worldwide, and nearly two million Australians have some signs of AMD. This proposed project is a prospective, observational study that seeks to to understand the underlying aetiology of AMD, factors associated with differences between age-related macular degeneration (AMD) phenotypes or severities, or between AMD and healthy individuals. It also seeks to understand the natural history of AMD progression and the factors associated with the rate of progression. In this project, the disease phenotype, genotype and severity and rate of progression will be determined based on non-invasive clinical imaging or functional assessment of the retina, from obtaining biological samples from the participants, or from patient-reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older; and
2. either AMD (defined as having at least a medium druse \>63 um), or having eyes with normal ageing changes (including small drusen ≤63 um) or no abnormalities as control participants

Exclusion Criteria:

1. ocular or systemic conditions other than AMD that could compromise retinal assessment or assessment of AMD and its progression; or
2. any participant with any mental or physical impairment that prevents them from signing an informed consent form or participating in this study.
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

Patients will be randomized in a 1:1 to receive treatment with durvalumab + tremelimumab combination therapy or SoC therapy. The primary objective of this study is to assess the efficacy of combination treatment compared with SoC in terms of Overall Survival (OS) in patients.

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

* Aged at least 18 years
* Documented evidence of Stage IV NSCLC
* No activating EGFR mutation or ALK rearrangement
* No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1
* No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

* Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant
* Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment.
* Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)
REVerse Intestinal Metaplasia in the Stomach (REVISE)

This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. Response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment.

A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.

The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium, an FDA-approved drug no longer in active use. The study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol (as described below). This initial screening research endoscopy is needed as current clinical care is variable (due to lack of guidelines for mapping and surveillance). The investigators anticipate enrolling 60 participants in the observational cohort for intensive gastric mapping, and then of these 60 participants, 32 eligible participants (after determining eligibility based on presence of high-risk features of the gastric intestinal metaplasia with confirmed extensive gastric intestinal metaplasia) will be included in the randomized control trial to receive either Pyrvinium (n=16) or placebo (n=16).

Treatment is planned as followed:

2 weeks of Pyrvinium vs placebo (within 3 months of initial research endoscopy).

Following the initial endoscopy, participants will receive placebo or Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days. The drug (or placebo) will be verified and dispensed from the investigational drug pharmacy using an IND with attention to safety and blinding to research participants and clinical research staff. The drug and placebo will be administered as liquid suspensions. Medication diary logs will be used and participants will be asked to return bottles that contained the medication.

All participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Adults (including men, women, and non-binary individuals) over age 18 with known GIM with at least one high-risk feature (extensive vs limited, incomplete or mixed-type GIM, family history of stomach cancer),
* Ability to provide informed consent,
* Evidence of prior but not active H. pylori infection

Exclusion Criteria:

* Active gastric cancer diagnosis,
* High-risk of bleeding complications due to anticoagulants or underlying medical condition,
* Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)
Compression Anastomosis Using the CAR™ 27

Purpose:

Evaluation of the CAR™ 27 for the creation of compression anastomoses.

Indication:

Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design:

Prospective, open labeled study.

Patient Population:

Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects:

15 patients estimated up to three months to enroll.

Duration of Treatment:

During the operation - creation of the anastomosis.

Duration of Follow-up:

Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints:

To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is over 18 years old.
2. Patient is scheduled for a non-emergency procedure.
3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Patient has an allergy to nickel.
2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
3. Patient is participating in another clinical trial which may affect this study's outcomes.
4. Patient has been taking regular steroid medication.
5. Patient has contraindications to general anesthesia.
6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
Brain Imaging Biomarkers in Patients With Brain Metastasis

A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.

Advances in medical imaging can provide useful information to guide and look at the response to treatment. Previous studies suggest early changes in the tumor after radiation treatment may be detectable using special MRI (Magnetic Resonance Imaging), and CT (Computed Tomography) scans. A biomarker is a measureable indicator of the severity or presence of some disease state. Previous studies suggest that the change in several imaging biomarkers can predict who will respond to radiation treatment. In this study, patients will undergo CT and MRI scans prior to and after radiation treatment to measure these biomarkers. The purpose of this study is to validate the predictive abilities of biomarkers in terms of determining how patients will respond to radiation treatment. This is a single-center phase II study, which will be conducted at the Princess Margaret Cancer Center. The study will be enrolling up to a total of 90 patients who will be receiving radiation treatment for brain metastases. Patients will be asked to participate within this study for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
* At least one index lesion with diameter \> 1cm and without imaging evidence of hemorrhage
* Patients age \> 18 years of age
* Patients planned for RT to brain metastases
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Previous Whole Brain Radiotherapy
* Previous radiosurgery to the index lesion
* Individuals unable to undergo contrasted MRI for whatever reason
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)

This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:

  * Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.
  * Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).
  * Male or female outpatients aged 5 to 15 years at the time of providing informed consent.

Exclusion Criteria:

* Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.

  * Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration
  * Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
  * Subjects with repeated epistaxis
  * Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
  * Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
  * Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
  * Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine if vitamin E could also prevent Ox-induced acute PN

This was a prospective, phase II, randomized pilot study. Patients were randomized 5 days before the start of Ox to receive either vitamin E at 400 mg daily or placebo, until after the end of the Ox-based chemotherapy regimen. The investigators evaluated PN intensity using the CTCAE version 3 and specific Ox PN gradation scales. The investigators included patients with colorectal and gastric cancers scheduled to receive Ox-based chemotherapy. Both groups received calcium and magnesium supplements before and after oxaliplatin infusions.

Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance status 0 or 1
* Older than 18 years
* New diagnose with colorectal or gastric cancer
* Scheduled to receive oxaliplatin-based regimens

Exclusion Criteria:

* Excluded patients with a previous history of PN or with symptomatic PN at entry into the study
* Excluded patients who received other chemotherapy regimens (except isolated 5-fluorouracil)
* Patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins
BoTox Into the Sternocleidomastoid Muscles (SCM)

Botulinum toxin injections have been used both in the face and neck for many years. However, injection into the sternocleidomastoid muscle (SCM) has only been done to treat neck spasms. In this study botulinum toxin will be injected into the SCM to determine if this will result in a temporary slimming effect on the neck and produce a more feminine, youthful neck contour.

The specific study objectives are to determine if:

* the neck circumference is decreased at 4 weeks after botulinum toxin (prabotulinumtoxinA-xvfs) injection.
* patients can appreciate a difference in their neck contour, self-confidence, and the way they perceive themselves post-injection via an aesthetics outcome and a neck perception survey.
* injection of the botulinum toxin into the sternocleidomastoid muscle is safe to perform based on adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age eligible individual seeking a more feminine neck appearance

Exclusion Criteria:

* Prior neuromodulator injections in the sternocleidomastoid muscles (SCM) within the past year
* Current anticoagulant use
* Body mass index (BMI) \>30
* Anticipation of significant weight gain or loss during the study period (e.g. patients taking or planning to take within the study period a semaglutide medication.)
* Prior allergy to botulinum toxin A
* Currently pregnant or breastfeeding