cyrilzakka/clinical-trials huggingface dataset:
Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan

This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily in subjects with type 2 diabetes mellitus before, during and after Ramadan.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing informed consent. Algeria: Male or female, age at least 19 years at the time of signing informed consent
* Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to day of screening (Visit 1)
* Treated with any pre-mix/self-mix or basal insulin regimen for at least 90 days prior to the day of screening (Visit 1)
* Subjects not on any OAD(s) (oral anti-diabetic drug) prior to trial participation OR subjects on fixed daily dose(s) of OAD(s) for at least 90 days prior to screening (Visit 1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen: Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject medical record) Insulin secretagogues (sulfonylureas (SU) and glinides), Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), a-glucosidase inhibitors, Sodium-glucose co-transporter 2- inhibitors (SGLT2 Inhibitors ) (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
* HbA1c 7.0%-10.0% (53-86 mmol/mol) (both inclusive, by central laboratory analysis)
* Intention to fast (daytime, i.e., between dawn and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting
* Willing to give blood during Ramadan

Exclusion Criteria:

* Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening (Visit 1), hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening (Visit), hyperosmolar hyperglycaemic coma within 90 days prior to screening (Visit 1), subjects performing intense physical labour)
Telemonitoring of Patients With COPD in Carinthia

Evaluation whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of reduced hospital readmissions, improved health related quality of life and health status. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility Criteria:
Inclusion Criteria:

* COPD 3 or 4
* Be able to use the system provided
* Life expectancy \> 12 months

Exclusion Criteria:
Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury

The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. Within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. Patients will be assigned to one of these groups at random and followed for one year. The hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Ability to implant device less than 12 weeks post-SCI
* Presence of acute SCI at or above T12
* ASIA Scale A or B
* Expectation to perform CIC personally or have caretaker perform CIC

Exclusion Criteria:

* Inability to perform CIC
* Pre-existing SCI
* Pre-existing progressive neurological disorder
* Autonomic dysreflexia
* Prior sacral back surgery
* Posterior pelvic fracture with distortion of the sacroiliac joint
* Prior urethral sphincter or bladder dysfunction
* Chronic urinary tract infections prior to SCI
* Pregnancy at the time of enrollment
* Presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure
* Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure
* Active untreated infection
* Traumatic injury to the genitourinary system
* Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology
Earlier Detection and Optimization of Treatment and Prognosis for Patients with Early-onset Colorectal Cancer

The study aims to collect high quality clinical data on lifestyle and patient biomaterials prior to start or during / after treatment of early-onset colorectal cancer (EOCRC) and to inform on treatment and survival outcomes of EOCRC patients.

The current study will be complementary to COMPRAYA, a prospective cohort study focused on risk factors of impaired medical and psychosocial outcomes of adolescents and young adults with cancer (AYA) and to GENAYA, focused on genetic testing of AYA. The collected data and materials will be essential for an in-depth analysis of the epidemiology, exposomes and pathophysiology of EOCRC and compare this with average-onset CRC (AOCRC) and healthy controls. These data will facilitate multiomics studies and the identification of high-risk profiles and blood- and/or stool-based biomarkers, which in turn will enable the development of prevention and early detection strategies to ultimately improve prognosis and the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among EOCRC patients wil be examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locoregional or metastatic colorectal cancer (CRC)
* Histologically proven CRC
* Age 18 - 49 years at time of first CRC diagnosis
* Able to understand the informed consent form
* Provide written informed consent.

Exclusion Criteria:

* Mentally incompetent patients based on the opinion of treating physician
* Inability to understand the Dutch language
Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years, male or female
* In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60.
* Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4

Exclusion Criteria:

* Patients with history of seizure or with alcohol or substance abuse in the last 6 months
* Diabetes, Parkinson's disease or phaeochromocytoma
* Patients with hypertension and current use of antihypertensive agents
* Women who are pregnant, lactating or intend to become pregnant during the study period
* Poor response to two different antipsychotics in full dose and full course or use of clozapine previously
* Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation
The Role of Macular Pigment in Patients With Age-related Macular Degeneration

In the industrialised world age-related macular degeneration (ARMD) is the leading cause for legal blindness beyond the age of 50 years. Recent studies indicate that the amount and status of the macular pigment (MP) may play a central role in the development and progression of the disease. It has been demonstrated that the MP density can be increased by dietary supplementation. First results of MP density measurements with a modified confocal laser scanning ophthalmoscope show that this method allows to quantify the MP in a clinical setting. The aim of this study is to assess the peak MP density as well as the MP distribution in relation to the risk for ARMD. We will establish reference values for MP density distribution in a normal population and compare these to values obtained from patients with age related maculopathy in a cross-sectional study. For all MP density measurements we will use a modified scanning laser ophthalmoscope and dietary intake of macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and autofluorescence imaging. The results of our study will help assess the relationship of macular pigment density and distribution with ARMD. Additionally, we will be able to identify patients with low MP density, and probably improve the early diagnosis of patients at high risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or zeaxanthin in patients with high risk for ARMD due to low macular pigment values.


Eligibility Criteria:
Inclusion Criteria:

* age related maculopathy

Exclusion Criteria:

* other macular diseases
Age-Related Changes and Cycloplegia-Induced Differences in the Human Crystalline Lens

The ocular biometric parameters of the human crystalline lens including anterior chamber depth (ACD), lens thickness (LT), radii of curvature of anterior and posterior lens (ALR and PLR), lens equatorial diameter (LED), and lens vault (LV), automatically quantified by the CASIA2 (SS-OCT; Tomey, Nagoya, Japan). Images of iridocorneal angle were obtained using CASIA2 and the Schlemm' s canal (SC) and trabecular meshwork (TM) were quantified manually. Both cycloplegia and non-cycloplegia images were obtained.

Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia), were consecutively included from April to May 2019. All participants underwent visual acuity, dry and wet refraction, anterior and posterior segment examination, intraocular pressure (IOP), and axial length (AL) using IOL-Master 700 (Carl Zeiss Meditec AG). Investigators recruited children under 18 years old at a refraction outpatient clinic, who were prescribed cyclopentolate hydrochloride eyedrops (S.A. Alcon-Couvreur N.V., Belguim) for cycloplegic refraction. For adults, they were prescribed compound tropicamide eyedrops (Mydrin-P, Santen Pharmaceutical Co., Ltd, Osaka, Japan), consisting of 0.5% tropicamide mixed with 0.5% phenylephrine hydrochloride, for pupillary dilation in order to perform fundus examination at an outpatient clinic. Exclusion criteria were as follow:ocular diseases other than cataracts; history of eye surgeries or injuries; shallow anterior chamber with a risk of angle closure. The data from right eye was selected for analysis.

Eligibility Criteria:
Inclusion Criteria:

Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia) Must be able to cooperate examination

Exclusion Criteria:

ocular diseases other than cataracts history of eye surgeries or injuries shallow anterior chamber with a risk of angle closure
Melatonin Supplements for Improving Sleep in Individuals With Hypertension

This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.

Hypertension, or high blood pressure, is a condition in which an individual's blood pressure is higher than the normal level. It is estimated that one in three individuals in the United States has high blood pressure, though many do not know it because there are usually no symptoms. Uncontrolled hypertension may lead to stroke, heart attack, heart failure, or kidney failure. Beta-blockers are one class of drugs that have been developed to help lower blood pressure, and thereby decrease the risk for these serious problems. Beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. Many individuals who take beta-blockers for hypertension complain that they have trouble sleeping, which may be related to the beta-blockers' effect on melatonin levels. This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers. In addition, the study will examine whether the melatonin supplements aid in lowering blood pressure.

Participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study. Participants will take part in two inpatient phases. Each inpatient stay will last 4 days and will be separated by 3 to 4 weeks. While in the clinic, participants' sleep patterns and core temperature will be recorded and plasma, saliva, and urine samples will be collected. Blood pressure will be measured before and after each inpatient stay, as well as at points during the stay. Throughout the study, participants' activity will be monitored by an accelerometer worn around the wrist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with uncomplicated hypertension
* Currently being treated with Atenolol (a beta-blocker)

Exclusion Criteria:

* History of medical illness other than essential hypertension
* Personal or family history of psychiatric illness
* Current use of any medication other than anti-hypertensive drugs
* Any recent travel across time zones
* History of working various shifts on an irregular basis
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.

The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
* Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
* Participants must require hospitalization for the acute exacerbation or relapse of mania.
* Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
* Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
* Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.

Exclusion Criteria:

* Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
* Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
* Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
* Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
* Other protocol-defined Inclusion/Exclusion criteria apply.
A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.


Eligibility Criteria:
Inclusion Criteria:

* Patients had sprained their ankle within 48 hours
* The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament
* At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
* Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms

Exclusion Criteria:

* Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator
* Patients with a similar injury of the same joint within the last 6 months
* Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side
* Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.
The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms

The French Ministry registered the Fenestrated Anaconda ™ on the List of Reimbursable Products and Services (LPPR) by the French Health Insurance on February 2018 for a duration of 5 years, while taking up the conditions for carrying out the act recommended by the CNEDiMTS (Committee in charge of medical device review), namely the carrying out of a post-registration study for the renewal of the authorization. This renewal of registration is conditioned by the set-up of a long-term follow-up study of all patients treated with the Fenestrated Anaconda ™ in France.

To do this, this study will be carried out in partnership with the Federation of Medical Specialties (FSM) and the National Professional Council (CNP) of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda ™ from the registry called Datavasc developed by the CNP and available online on the FSM's electronic platform.

EPI-EFA study: Post-registration study of the Fenestrated Anaconda™ in the management of a complex abdominal, juxtarenal, pararenal, suprarenal aortic aneurysm, whether or not associated with a distal common iliac artery or thoracoabdominal aneurysm type IV, in high-risk patients requiring treatment, for whom a surgical contraindication has been asked.

* Study type : observational, national, multi-centre, prospective, non-comparative study, as open registry
* Primary objective : To evaluate the long-term interest of Fenestrated Anaconda™ on all patients treated with in France. The data collected should be:
* 1-year mortality rate related to device, procedure, any cause = primary endpoint
* Stent-related adverse events (endoleak, migration, integrity of the device), renal events, ischemia (medullary (paraplegia / paraparesis), intestinal) = secondary endpoints
* Study timelines :
* Duration / follow-up :
* 1-year recruitment period from October 2019, with a minimum of 91 patients
* Mid-term follow-up : at 1 year
* Routine practice : until 5 years
* Reports to be submitted to French Health Authority :
* Interim report with mid-term follow-up data for renewal dossier
* Final report with long-term follow-up data

Eligibility Criteria:
At the request of the French Health Authority (HAS), no inclusion or exclusion criteria can be set as the study should be carried out on all patients treated with the device in France.
Naloxegol and Opioid-induced Constipation

This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.

This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital
* Admitted to Bethesda North TriHealth Hospital CVICU post-surgery

Exclusion Criteria:

* Medically unstable
* Cognitive deficits that impair the patient's ability to understand the informed consent
* Language barriers
* Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction
* Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil
* Patients on following medications prior to time of consent: Diltiazem, Verapamil, Amiodarone, Ketoconazole, Clarithromycin/ erythromycin, Antivirals
* Conditions that present an increased risk of bowel perforation (as determined by the physician)
* Pre-existing diagnosis of opioid-induced constipation AND receiving naloxegol as a treatment by their physician