cyrilzakka/clinical-trials huggingface dataset:
Investigating Health Impacts of Exposure to Harmful Algal Blooms

The goals of this project are to study the biological effects of environmental toxins (ET), in particular aquatic toxins such as brevetoxins (PbTx) and microcystin or their metabolites. This study is designed to examine the effects of the body from harmful algae blooms (HAB) as well as possibility of an association between exposure to the marine toxin, brevetoxin (PbTx), which is released from K. brevis during the red tide bloom, and the prevalence of neurological illnesses.

Exposure to environmental toxins present in local waters, such as brevetoxins released by Karenia brevis (K. brevis) or microcystin produced by cyanobacteria, is known to cause skin and eye irritation, gastrointestinal and respiratory distress. The ingestion of high levels of brevetoxins from eating contaminated shellfish can result in Neurotoxic Shellfish Poisoning (NSP), an acute gastroenteritis with accompanying neurologic symptoms. People are often exposed by direct skin contact with contaminated waters, drinking contaminated water, breathing in airborne droplets of the toxins, or eating contaminated shellfish. This condition usually resolves itself within 3 days as the brevetoxins are excreted from the body. Aerosolized brevetoxins are also known to cause a reversible upper respiratory syndrome, characterized by coughing, sneezing, and feelings of irritation to the airways. Once the exposure to the brevetoxin-laden air has ceased, symptoms usually go away within 15 minutes.

The main objective of this study is to determine if exposure to marine or similar environmental toxins can adversely affect CNS health, immune system, respiratory system and other biological processes which contribute to long-term cognitive dysfunction or illnesses in individuals exposed to these toxins.

Sponsor will be examining whether general health signs and symptoms that are reported are as associated with the exposure to harmful algal bloom toxins. Known symptoms of exposure to harmful algae bloom/red tide /shellfish include the following: Skin and eye irritation, gastrointestinal and respiratory distress, acute gastroenteritis with accompanying neurologic symptoms, respiratory distress, such as reversible upper respiratory syndrome with symptoms of coughing, sneezing, and feelings of irritation to the airways.

Eligibility Criteria:
Inclusion Criteria:

1. Subject should be able to provide written informed consent.
2. Adult aged 18 or older.
3. Resident (temporary or permanent) of one of the following five southwest Florida counties (Lee, Collier, Charlotte, Sarasota, or Manatee).
4. Any race or ethnicity.
5. Willing to return for at least a total of four study visits and participate in all required procedures for the duration of the study.

Exclusion Criteria:

1. Inability to speak or write in English.
2. Any medical condition for which the study investigator believes enrollment is medically inappropriate.
3. Unwilling/unable to provide biological samples or poor venous access.
Placement of Perineural Catheters in the Popliteal Region

The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.


Eligibility Criteria:
Inclusion Criteria:

* adults
* BMI less than 30

Exclusion Criteria:

* known allergies to local anesthetics or other drugs used
* patient refusal
* any local or systemic contraindication to the use of popliteal block
Glucose Metabolism in Sickle Cell Disease

The purpose of the study is to better understand how the body handles sugars glucose and fats, such as cholesterol and triglycerides in sickle cell disease, and what puts certain persons at risk to develop diabetes. This understanding may help us to find new treatments to control blood sugar and prevent diabetes in people with and without sickle cell disease (SCD).

In this research, DNA and RNA will be isolated from blood cells. DNA will be used to find genes that cause or protect from diabetes, high cholesterol and high triglyceride, and RNA will be used for studies designed to find out how genes are doing their job of eventually producing proteins.

Sickle cell disease (SCD) is due to homozygosity for a Glu6Val mutation in HBB (sickle cell anemia; hemoglobin SS) or to compound heterozygous forms like hemoglobin SC disease and hemoglobin S-β thalassemia. Past studies suggested a low prevalence of diabetes in patients with SCD.10 Improvements in treatment and care have increased the life span of patients. This, along with the wide availability of high calorie diets and increasing adiposity in SCD raises that possibility that the prevalence of diabetes is increasing in SCD. Our study is designed to characterize the changes in metabolism that occur in sickle cell disease and to identify clinical, genetic and genomic risk factors for the development of diabetes. Our hypothesis is that non-overweight subjects with SCD have relative protection from diabetes and metabolic syndrome, but that those individuals who do become overweight have a dramatic increase in the rates of diabetes and metabolic syndrome. Lean SCD subjects will not have simply a neutral, but an overtly anti-diabetic phenotype (e.g. better glucose tolerance and lower metabolic syndrome markers). The two main study aims are as follows; Aim 1. Define the metabolic status of adult SCD subjects according to normal or increased BMI.

Aim 2. Determine genetic and genomic predictors of overweight, metabolic syndrome and diabetes in SCD subjects.

Eligibility Criteria:
Inclusion Criteria:

* Major sickling genotype (hemoglobin SS, Sbeta0-thalassemia, SOarab, SDpunjab)
* Age \>35 years
* BMI \<25 kg/m2 or \>26 kg/m2
* Steady state, defined as \>two weeks from a hospitalization for vaso-occlusive crisis, infection or surgery and not requiring immediate parenteral medication for pain control
* Fasting state (\>8 hours since ingesting food or medication for diabetes)

Exclusion Criteria:

* Patients receiving insulin therapy
* Acute inflammatory or infectious illness or injury
TREAT (Telemedicine for Reach, Education, Access, and Treatment)

The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.

This study will assess whether a new care delivery model combining telemedicine videoconference diabetes consultations with diabetes self-management teaching is efficacious in reducing HbA1c in patients with type 2 diabetes in rural areas. The control group will consist of patients with type 2 diabetes receiving "usual care", i.e., who have not received a referral to the endocrinologist telemedicine team. Secondary outcomes include patient satisfaction, level of understanding of self-management skills, and hypoglycemia

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older with type 2 diabetes
* Referral by a primary care provider.
* HbA1c equal or greater than 7.0%.

Exclusion Criteria:

* Type 1 diabetes
* Gestational Diabetes
Comprehensive CBT (Cognitive Behavioral Therapy) Via reSET App

This research is being done to find out whether an app based cognitive behavior therapy called reSET improves the adherence to and outcome of buprenorphine treatment for opioid use disorder (OUD) in the setting of a Hub and Spoke implementation system.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Starting outpatient treatment for OUD within the PACMAT Hub and Spoke system (either the Hub or one of the Spokes)
* Planning maintenance treatment with buprenorphine
* Willing to participate in the study
* Can read, write and comprehend English

Exclusion Criteria:

* Planning an outpatient detoxification, or treatment other than buprenorphine maintenance (e.g. methadone maintenance, Vivitrol, or counseling with no medication)
* Judged by the evaluating physician or allied clinician to need a higher level of care (e.g. residential or inpatient treatment)
* Unwilling to participate in the study
* Under the age of 18
* Unable to read, write and comprehend English
The Efficacy of Automated Feedback After Internet-based Depression Screening

The DISCOVER randomized controlled trial is designed to evaluate the effect of automated feedback after internet-based depression screening in individuals with undetected depression. A total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ≥ 10 points) will be randomized into three groups to either receive a) no feedback (control group), b) standardised or c) tailored feedback on their depression screening results.The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious as compared to standard feedback.

Major depressive disorder (MDD) is a highly prevalent condition associated with substantial disease burden and economic costs. Still, it often remains undetected and untreated, which in turn increases the likelihood of a chronic course, treatment resistance and rising healthcare costs. One solution to address early detection and disease burden could be widely accessible depression screening. Our previous trial in cardiac patients provides first evidence that depression screening combined with written individual-targeted feedback on the screening results improves depression severity and encourages greater patient participation and engagement in mental health. To amplify these effects in a broader setting, the internet-based DISCOVER randomized controlled trial (RCT) now aims at addressing affected but yet undetected individuals on the internet. In order to evaluate the effect of feedback in this setting, a total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups. They either receive a) no feedback (control group), b) standardised or c) tailored feedback on their depression screening results. The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious as compared to standard feedback. Futher outcomes are guideline-based depression care, depression-related help-seeking behaviour, a health economic evaluation, clinical outcomes (somatic symptom severity and anxiety), health-related quality of life, illness beliefs, intervention acceptance, depression diagnosis and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* (Gender: male, female, diverse)
* Age ≥ 18 years; no maximum age
* Sufficient German language skills
* Informed consent
* Patient Health Questionnaire-9 \> 9 points
* Contact details
* Internet access
* Sufficient computer/internet literacy

Exclusion Criteria:

* Diagnosis of a depressive disorder within the past 12 months
* Depression treatment (current or within the past 12 months)
An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy

This main purpose of this study is to examine the effects of an exercise intervention to counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate cancer patients. Specifically, a supervised and home-based exercise program will be used to assess its impact on clinical and behavioral variables related to ADT in prostate cancer patients.

This study will assess the feasibility of an exercise intervention to counteract adverse side effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI), hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial, 40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching control group (n=20) with a follow-up at 8-weeks.

Eligibility Criteria:
Inclusion Criteria:

* (1) Caucasian or African-American/Black men; (2) histologically confirmed non-metastatic PCa; (3) receiving ADT treatment for 9-months or less upon recruitment (and continue to receive treatment during the duration of the study); (4) 40 to 75 years old; (5) sedentary defined as \<60 minutes of recreation or work requiring modest PA/week; (6) ability to perform the level of physical activity assessed by the Physical Activity Readiness Questionnaire (PAR-Q); (6) has access to a smartphone or computer with internet capabilities

Exclusion Criteria:

* (1) severe cardiac disease; (2) recent myocardial infarction; (3) treated for any other cancer; (4) any physical, psychological illness, and/or medical problems that restricted them from exercise; (5) and not willing or able to follow procedures specified by the study and/or instructions of the researcher.
Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy

This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy


Eligibility Criteria:
Inclusion Criteria:

* Age of 18-70 years (both inclusive) at the time of signing informed consent
* Body mass index of 25.0-40.0 kg/m\^2 (both inclusive)
* Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening
* Insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

Exclusion Criteria:

* Known or suspected hypersensitivity to the trial products or related products
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB

Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.

To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba

Eligibility Criteria:
Inclusion Criteria

1. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.

Exclusion Criteria

1. Patients with known hypersensitivity to Delamanid or any excipients of Deltyba®
2. Patients whose serum albumin \< 2.8 g/dL
3. Patients taking medicinal products that are strong inducers of CYP3A (e.g. carbamazepine).
4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors

Comparative analysis of available ILR devices models Abbot Confirm RxTM, Medtronic Reveal LINQTM, and Biotronik BIOMONITOR., evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

All devices have different algorithms for arrhythmia detection and structural design. Consequently, these devices vary in sensitivity of arrhythmia detection and data transmission.Therefore, we aim to expand a comparative analysis of available devices, evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Eligibility Criteria:
Inclusion Criteria:

Patients \> 18 years of age with appropriate indication for ILR for atrial arrhythmia management.

Exclusion Criteria:

Inability to give consent
Investigation of Peak Expiratory Flow and Physically Fitness in Obese and Overweight Adolescents

Due to the increasing prevalence of childhood obesity and overweight, health problems may begin to appear at an early age. The aim of this study is to examine physical activity level, core performance, anthropometric measurements and peak expiratory flow in overweight and obese adolescents compared to normal weight adolescents.

Due to the increasing prevalence of childhood obesity and overweight, health problems may begin to appear at an early age. Overweight and obese people are at risk for medical conditions that can lead to greater morbidity and mortality. Lack of physical activity is a well-known risk factor for obesity and the relationship between them has been supported by many studies. It has also been reported by studies that obesity affects respiratory parameters. In overweight and obese adolescents, a relationship is likely between the affected respiratory parameters and the weakened core region. There are not enough studies on this subject in the literature. Therefore, the aim of the study is to examine the physical activity level, core performance, anthropometric measurements and peak expiratory flow in overweight and obese adolescents in comparison with normal weight adolescents.

Eligibility Criteria:
* Inclusion Criteria for the Obese and Overweight Group:
* BMI percentile value is 85.-95. between and above the 95th,
* Do not have any chronic disease,
* Do not have orthopedic problems that would prevent them from participating in the study,
* Secondary school students who are willing to participate in the study and whose parents' consent has been obtained will be included.
* Inclusion Criteria for the Normal Weight Group:
* BMI percentile value is 5th-85th. between,
* Do not have any chronic disease,
* Having no orthopedic and neurological problems that would prevent them from participating in the study,
* Secondary school students who are willing to participate in the study and whose parents' consent has been obtained will be included.
* Exclusion Criteria:
* BMI percentile value below the 5th,
* With chronic cardiac and pulmonary disease,
* Having a diagnosis of neurological or other disease affecting cognitive functions,
* Individuals receiving medical treatment that will affect attention and concentration will not be included.
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study

Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.

Right ventricular (RV) pacing has long been the gold standard treatment for symptomatic brady arrhythmias. Right ventricular apical pacing has shown to cause electrical and mechanical desynchrony resulting in left ventricular (LV) dysfunction, and, in some cases, clinical heart failure together with other mechanical and arrhythmic complications. Hence, it was necessary to find a more physiologic method of pacing that ensures synchrony. His bundle pacing was first described in 2000, and is more recently adapted as a pacing method with less deleterious effects on the RV. However, lead dislodgement, high pacing thresholds, battery depletion, and difficulty identifying the exact location of His bundle were the most significant concerns related to this method. Subsequently, left bundle branch area pacing (LBB-AP), first described in 2017 by Huang et al, has emerged as safe alternative with excellent lead stability and capture threshold, and more ability to correct distal conduction disease as compared to His bundle pacing. Recent studies report promising mid-term outcome concerning left ventricular desynchrony. To the best of our knowledge, bi-ventricular activation was never studied in patients with LBB-AP.

Multiple tools have been used to assess biventricular (BiV) synchrony specially with chronic resynchronization therapy (CRT) including echocardiography and 12 lead ECG. Eschalier et al. found that epicardial noninvasive ECG mapping, was better at predicting clinical CRT response than QRS duration or the presence of LBBB. Activation patterns and timings with RV apical pacing, native LBBB, and BiV pacing have been well studied using this tool. With LBBP, however, these activation parameters have not yet been described.

This study aims to evaluate bi-ventricular activation in patients equipped with LBB-AP using non-invasive 3D mapping system in patients with or without baseline ventricular conduction disorder.

Eligibility Criteria:
Inclusion Criteria:

* 30 patients with a functional LBB-AP pacemaker

Exclusion Criteria:

* Age \< 18 years
* Previous cardiac surgery
* Cardiomyopathy with documented ventricular scar
* Patients with prior pacemaker
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma.

The study compares 1 stent versus 2 stents.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open-angle glaucoma (OAG)
* Subject on at least one glaucoma medication
* Signed informed consent

Exclusion Criteria:

* Angle closure glaucoma
* Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Fellow eye already enrolled