cyrilzakka/clinical-trials huggingface dataset:
Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Therapy-based Clinical Setting

The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm that has been designed to improve the effectiveness and safety of antidepressant medications by providing guidance in medication selection and appropriate dosing. This algorithm has been incorporated into a new genotyping interpretative report. This report is now available from AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.

The proposed pilot study is designed to evaluate the clinical impact of the interpretive report in an outpatient behavioral health clinic in St. Paul, Minnesota. While the ultimate goal of this project is to show an improvement in patient outcomes, this pilot study will be used to evaluate the feasibility of introducing the pharmacogenomic algorithm to a new setting that does not routinely use the algorithm. Secondary outcome data will be collected to generate meaningful estimates of the magnitude of potential treatment effects. The study will consist of two phases, each enrolling 2530 subjects. In Phase 1, consecutive patients will be prospectively monitored to observe standard practice. Patients will be given the option to receive genotyping and those that agree will have blood drawn. However, the results of the genotyping and algorithm will not be released until all phase 1 patients have completed study visits.. Subsequently, in Phase 2, also enrolling 3025 subjects, the results of the genotyping and algorithm will be made available immediately for additional consecutive prospectively monitored patients. Patients will be prospectively monitored in the same fashion as Phase 1. The results of the study will be used to perform preliminary analyses and subsequent fully powered multi-site trials will be planned based on the results of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is between the ages of 18 and 80.
2. Major depressive disorder or depressive disorder not otherwise specified (NOS) as ascertained by a physician or mental health professional licensed to diagnose.
3. Patient is an outpatient and not in imminent need of inpatient hospitalization
4. Patient's Hamilton Depression Rating score is \>14
5. Patient is being seen by a psychiatrist for optimum medication management.
6. Ability to read, understand and sign an informed consent document

Exclusion Criteria:

1. Serious medical illness (as ascertained via the initial triage screening process)
2. Patients with a diagnosis of Bipolar I disorder
3. Patients with a diagnosis of Schizophrenia or Schizoaffective disorder
4. Patients who are legally unable to consent to enrollment in the study (i.e. patients with legal guardians)
Enteral Nutrition and Amino Acid Absorption

The purpose of this study is to evaluate amino acid absorption with two different type of proteins.


Eligibility Criteria:
Inclusion Criteria:

* Patient with gastrointestinal disorder : citrulline plasma concentration \< 20 µmol/L and/or xylose plasma concentration \< 1,7 mmol/L
* Patient under enteral nutrition at home
* Patient already receiving 1 L by day

Exclusion Criteria:

* Obese patient BMI \> 30
* Diabetes
* Renal or liver failure
* Glucocorticoids treatment
Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder

Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study.


Eligibility Criteria:
Inclusion Criteria:

Symptoms of hypoglycemia such as palpitation, sweating and fatigue were found at the time of treatment. At the same time, the blood glucose of non-diabetic patients was less than 2.8mmol/L, and the blood glucose of diabetic patients was less than 3.9mmol/L

Exclusion Criteria:

Exclusion criteria: Although there were hypoglycemia symptoms at the time of treatment, the blood glucose of non-diabetic patients was more than 2.8mmol/L, and the blood glucose of diabetic patients was more than 3.9mmol/L.
Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study

The goal of this observational study is to optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. The main question it aims to answer is:When should immunosuppressive therapy be initiated?This study is a retrospective one. Participants will not receive any treatment.


Eligibility Criteria:
Inclusion Criteria:

* It meets one of the diagnostic criteria for PMN as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases: patients with a clear diagnosis of PMN based on renal biopsy pathology or presenting with nephrotic syndrome and positive anti-PLA2R antibody detection (\>14RU/mL), and excluding secondary factors such as tumors, infections, drugs, and systemic autoimmune diseases.

Exclusion Criteria:

* (1) Patients who have received treatment with immunosuppressive medications other than oral prednisolone.

  (2) The time interval between the renal biopsy and the baseline measurement is longer than 3 years.

  (3) Initiate the use of immunosuppressive agents within 1 week after the diagnosis of PMN.

  (4) Participate in the immunosuppressive treatment trial during the follow-up period and be in the intervention group.
A Head-to-head Comparison of [68Ga]Ga-FAPI and [68Ga]Ga-TATE PET/CT in Patients With Nasopharyngeal Carcinoma: a Single-center, Prospective Study

Both fibroblast activation protein (FAP)-targeted imaging and somatostatin receptors (SSTR)-targeted imaging were the promising imaging modalities for the diagnosis of primary and metastatic nasopharyngeal carcinoma (NPC). This prospective study is going to investigate to compare the diagnostic efficacy of 68Ga-FAPI and 68Ga-DOTATATE in detecting primary and metastatic NPC lesions, thereby obtaining a more accurate examination method of NPC.

Patients with newly diagnosed or previously treated NPC will be recruited in this study.

Each patient received an intravenous injection of 68Ga-DOTATATE (2-4mCi) on the first day and 68Ga-FAPI (2-4mCi) on the second day. Whole-body PET/CT scans were performed at 40-60 min after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender, aged ≥ 18 years.

  * Patients with newly diagnosed or previously treated NPC
  * A diagnostic magnetic resonance imaging (MRI) of the tumor region within the previous 1 weeks prior to dosing day is available.
  * signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Skills for Change: Nutrition Education Program for Emirati Adults With Type 2 Diabetes

The "Skills for Change" Diabetes Nutrition Education Program was a one-year, community-based conducted in Ambulatory Health Care Services health centers in Al Ain. The project involved nutrition education to improve blood glucose control, diet and physical activity levels of Emirati adults with type 2 diabetes.

Despite the high prevalence of diabetes and its complications in the UAE, very few diabetes education intervention studies have been conducted in a representative population in the country. The Skills for Change Program was a one-year, community-based, cluster randomized study involving Emirati adults with type 2 diabetes. We implemented a behavioral lifestyle intervention to improve glycemic control, food choices, and physical activity levels and to decrease sedentarity. The project was culturally adapted to Emirati adults with type 2 diabetes and was driven by theoretical principles of behavior change and education to enhance intervention effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* United Arab Emirates national
* Type 2 diabetes
* Adults: Male and female
* Age: 20-70 years
* Attending one of the 7 health centers in Al Ain managed by the Ambulatory Healthcare Services.

Exclusion Criteria:

* Type 1 diabetes
* Age \>70 Years
* Medical conditions that prevent active participation in the program, based on recommendation of the attending physicians
* Participating in other nutrition intervention programs
PDE5-Inhibition With Sildenafil in Chronic Heart Failure

To test the hypothesis that long-term PDE5-inhibition by overexpressing the nitric oxide pathway is beneficial in chronic heart failure patients.

Double-blind and placebo-controlled trial. Primary end-points: quality of life and exercise performance

In chronic heart failure (CHF), endothelial function (EF) deterioration and muscle underperfusion elicit ergoreflex exercise oversignaling, hyperventilation and breathlessness. PDE5 inhibition, by improving EF, might be beneficial. We tested this hypothesis in a long-term therapeutic trial. CHF patients were randomly assigned to placebo (23 cases, group 1) or sildenafil (23 cases, group 2) in addition to their current antifailure therapy, for 6 months. In group 2 and not in group 1, assessments at 3 and 6 months showed the following changes: reduction of systolic pulmonary artery pressure (-25.2 and -29.0 %), ergoreflex effect on ventilation (-66.6 and -72.5%), ventilation to CO2 production slope (VE/VCO2, -14.0 and -16.0%) and breathlessness (-29.6 and -27.1%); increase of brachial artery flow-mediated dilatation (FMD, +57.6 and +67.0%), peak exercise O2 uptake (peak VO2, +25.0 and +26.3%) and ratio of VO2 to work rate changes (VO2WR, +20.7 and +22.0%). These changes were significant at p\<0.01. In group 2 and not in group 1, a significant correlation was found, at 3 and 6 months, between changes in FMD and those in ergoreflex VE. Changes in ergoreflex correlated with those in peak VO2 and VE/VCO2 slope. No remarkable side effects were noted, but flushing in 3 patients.

In CHF, benefits of sildenafil are sustained and consist of improvement in EF, modulation in ergoreflex signaling, attenuation in exercise hyperventilation and breathlessness, increase in aerobic efficiency and exercise performance. Thus, sildenafil can affect peripheral mechanisms of breathlessness and may be viewed as an effective and safe adjunct to the therapeutic armamentarium of CHF.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility criteria were: consent to participate in the study after detailed information about procedures, possible clinical benefits and risks; ability to complete a maximal exercise test; forced expiratory volume in 1 sec/forced vital capacity ratio\>70%; left ventricular ejection fraction  45%, determined by echocardiography.

Exclusion Criteria:

* Patients were not recruited if they had systolic blood pressure \> 140 and \<110 mmHg, diabetes mellitus, therapy with nitrate preparations, history of sildenafil intolerance, significant lung or valvular diseases, neuromuscular disorders, exercise-induced myocardial ischemia, atrial fibrillation (6), claudication, peripheral vascular disease.
Outcome of ECMO and CRRT.

Background:

Although acute kidney injury (AKI) is a frequent complication in patients receiving extracorporeal membrane oxygenation (ECMO), and the CRRT impact is widely studied. The incidence of simultaneous use of ECMO and CRRT remain unclear.

Objective: The investigatore conducted this retrospective study to define the incidence of concomitant CRRT with ECMO therapy and to determine the overall impact of this strategy on patient outcomes such as mortality and renal recovery.

Methods:

The investigatore retrospectively analyzed data of patients of all ages, genders and ethnicities, admitted in the intensive care unit of Mohammed VI University Hospital, Oujda, Morocco, on a cumulative period of 2 years (January 2019 - December 2020). Were enrolled in the study patients who benefited from ECMO, and presented an acute kidney injury afterwards, using 'Microsoft Excel' as a software to utilize the information collected from the computerized patient database. 30 patients were included in the final study.


Eligibility Criteria:
Inclusion Criteria:

* benefited from ECMO .
* presented an acute kidney injury afterwards

Exclusion Criteria:

* patients who developed AKI before benefitting from ECMO and/or missing data
A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)

This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.


Eligibility Criteria:
Inclusion Criteria:

* Participant in a FTC/TDF PrEP demonstration project or FTC/TDF for PrEP clinical study
* HIV-1 negative adults (any sex/gender, including transgender) ≥ 18 years of age at time of enrollment in the demonstration project or clinical study.
* Evidence of seroconversion while receiving FTC/TDF for PrEP

Exclusion Criteria:

* This is an observational nested study and will monitor all reported seroconversions without intervention/exclusion.
The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)

The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).

Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.

The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.

Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 20 ≤ and \< 70 years
* History of OAB symptoms for ≥ 3 months
* International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
* An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary

Exclusion Criteria:

* Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
* Any condition that would contraindicate their usage of anticholinergics or alpha blockers
* History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
* History of stress urinary incontinence or urinary retention
* History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
* Pregnant or nursing women
* Current urinary tract infection
* Neurological bladder dysfunction
* Treatment with drugs that may interfere with CYP3A4 metabolic function
* Significant hepatic or renal disease
* Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
An Observational Study Called ROVER to Learn More About How Well Vericiguat Works in People Who Were Newly Treated With Vericiguat in Routine Medical Care in Germany

This is an observational study in which data already collected from people treated with vericiguat are studied.

In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.

Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death.

Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better.

Vericiguat is available in Germany for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. However, there is limited information available about the use of vericiguat for the treatment of HFrEF under real-world conditions in routine medical care.

The main purpose of this study is to collect information about how well vericiguat works in people with HFrEF who were newly treated with vericiguat. In addition, researchers will collect information about participants' basic characteristics, including their age, gender, other health conditions they might have, and the medicines they might be taking.

The data will come from 2 German health databases including people who newly started vericiguat treatment between September 2021 and September 2023.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an initial prescription of Vericiguat (index date) according to ATC Code C01DX22.
* At least 18 years or older on the initial prescription of Vericiguat.

Exclusion Criteria:

* No exclusion criteria for any population will be applied.
Physical Activity and Social Engagement for Persons With Disabilities in an Underserved Community

Using a community-based participatory approach, this project aims to evaluate the feasibility, acceptability, and preliminary efficacy of two technology-driven group activity programs on socioemotional health and physical activity in a local underserved community, Tarrant, Alabama. Participants will complete two six-week programs, specifically Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR).

This project will utilize a cross-over randomized design where participants will initially be randomized into either the Online or VR intervention group. After completing the initial six weeks of the assigned intervention, participants will cross over and complete six weeks of the other intervention. No washout period is included due to several reasons, including no known washout period for certain socioemotional outcomes have been established by prior literature, ethical concerns in requiring return to baseline levels during washout, and a prolonged washout period would negatively impact participant adherence and retention to the study. Psychosocial metrics will be collected at the end of each activity session through surveys.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Tarrant, Alabama
* 18 years or older with a physical disability or chronic health condition or older than 60 years
* Fluent in English

Exclusion Criteria:

* Visual impairment that interferes with television viewing
Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population

This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.

The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks

  * Subjects who are willing to be registered on the Merlin.net remote follow-up program
  * Subject ≥18 years
  * Subjects with life expectancy of at least 1 year
  * Subjects who agree to comply with the follow-up program included in this protocol

Exclusion Criteria:

* • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months

  * Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
  * Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
  * Functional NYHA Class IV
  * Subjects who are participating in another ICD or CRT-D study
  * Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
  * Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)