cyrilzakka/clinical-trials huggingface dataset:
Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Patients With Stroke

Introduction: An optimal combination of antidiabetic drugs for diabetic patients with ischemic stroke is not well-established. The objective of this randomized trial is to evaluate whether combination of pioglitazone and a sodium glucose cotransporter 2 (SGLT-2) inhibitor, compared with a dipeptidyl peptidase-4 (DPP-4) inhibitor, reduces recurrent stroke in diabetic patients with recent ischemic stroke.

Methods and analysis: The trial is a randomized, parallel-group study conducted at 7 hospitals in Taiwan. Inclusion criteria are adult patients with a history of ischemic stroke within 3 months, diabetes mellitus with Hba1C \> 7%, taking metformin currently or previously, and estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2. Eligible patients who sign the informed consent forms will be randomly assigned in a 1:1 ratio to receive either combination of pioglitazone and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) vs. a DPP4 inhibitor. Primary outcome is change in HbA1C between 6 months and baseline in active vs comparator groups. Additional biomarker outcomes are change in hs-CRP insulin resistance, B type natriuretic peptide, and urine albumin creatinine ratio between 6 months and baseline.

Ethics and dissemination Study protocol was approved by the Institutional Review Board of Chang Gung Memorial Hospital, Chiayi Branch, Taiwan (201702353A3, 201802340A3 and 201902176A3). All participants will be required to sign and date an informed consent form. Study findings will be disseminated via a peer-reviewed journal.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke within 3 months of randomization
2. Type 2 diabetes mellitus and Hba1C \> 7.0% and under metformin therapy currently or previously
3. Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2
4. Age ≥ 20 y at study entry
5. Ability and willingness to provide informed consent

Exclusion Criteria:

1. History of congestive heart failure (NYHA class 1-4)
2. History of bladder cancer
3. History of repeated (\> 2 episodes) urinary tract infection or genital tract infection
4. Irreversible medical conditions with predicted survival \< 1 years
5. Current use of an insulin
6. Current use of a glucagon-like peptide-1 receptor agonist
7. Current use of pioglitazone or an SGLT-2 inhibitor
Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer.

The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.

Although it seems as more non-invasive there is still lack of data especially on efficacy of nasal mask use in NIV for newborns. By using esophageal pressure transducers we will evaluate the pressure supplied by the ventilation mode and compare it with more commonly used nasal prongs. The investigators will test the hypothesis of equivalence of nasal mask in comparison to prongs with better safety parameters.

Eligibility Criteria:
Inclusion Criteria:

* all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit

Exclusion Criteria:

* who are intubated in delivery room or neonatal intensive care unit before randomization
* with congenital anomaly
* patients who require NIV more than 3 days
Effect of Intraoperative Fluid Management on Morbidity

The purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity


Eligibility Criteria:
Inclusion Criteria:

* epidural anesthesia
* ASA I-III

Exclusion Criteria:

* metastasized cancer
* pregnancy
The Pharmacokinetics Study of Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans

The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional decoction.


Eligibility Criteria:
Inclusion Criteria:

* The volunteers about 6\~8 persons should be aged from 20 to 35 years old with a body weight between 50\~80 kg, no marriage and have a healthy body condition.
A Multidrug-resistant (MDR) and Extensively Drug- Resistant (XDR) Tuberculosis Study in Alsace

The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of the treatments with WHO recommendations. During years 2006-2016, all new cases of MDR TB or XDR TB diagnosed Strasbourg University Hospital will be included in the study (22 cases). Data were collected from the Center for Tuberculosis Control (CLAT) records, the patient's medical records.


Eligibility Criteria:
Inclusion Criteria:

* Major patient (≥18 years old)
* Patient hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis

Exclusion Criteria:

- Refusal of the patient to participate in the study
Microbiome Changes in Travelers to Tropical Destinations

The human gut contain a wide range of microorganisms creating the gut microbiome. The microbiome has great impact on metabolic and immunologic processes and responses. Travelers who travel to tropical destinations where the intestinal infection risk is high are prone to microbiome changes. During the current study the travelers will give feces specimen before and after the travel and their microbiome will be analyzed.

Individual differences in the microorganisms variety are affected by external factors such as food, age, geographic location, medication consumption, host genetics and exposure to microorganisms in early stages of life. During the current study the geographic location affect will be tested by comparing the microorganism environment before and after traveling to tropical destinations.

Eligibility Criteria:
Inclusion Criteria:

* Travelers who intended to travel to tropical areas
* Good general health

Exclusion Criteria:

* Medication consumption
* Background diseases
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

This is a global, prospective, multi-center, long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

There will be no study treatment administered to participants in this study. Participants will have visits every 6-8 months for monitoring of selected AEs and laboratory parameters. The study periods include a Baseline and Follow-up Period (up to 10 years after first dose of AAA617 in parent treatment study).

Participants should enroll into the LTFU study after parent treatment study requirements are fulfilled (refer to the parent treatment study protocol for requirements, including any additional requirements after participant enters this LTFU safety study).

The schedule of activities for this LTFU study is designed to start from date of informed consent for this LTFU study. Participants should be followed every 6 to 8 months for up to a total of 10 years starting from first dose of AAA617 in the parent treatment study. Participants entering the LTFU study will have already completed a variable portion of the required 10-year follow-up within the parent treatment study. The specific number of visits required in this LTFU study will depend upon the time of enrollment into this LTFU study following the first dose of AAA617 in the parent treatment study.

The total number of participants to be enrolled and the duration of this LTFU study will depend upon the total number treated in the parent treatment studies and their duration.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study
* Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.

Exclusion Criteria:

- Inability to complete the needed investigational examinations due to any reason.
Efficacy of Topical Cysteamine in Nephropathic Cyctinosis

The aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.

A total of 26 patients with nephropathic cystinosis were included in this prospective study. Patients were evaluated for improvement of corneal cysteine deposits crystals and photophobia following treatment with topical 0.55% cysteamine eye drops.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed diagnosis of nephropathic cystinosis
* leucocyte cystine concentration level of more than 2.0 nmol half-cystine/ mg protein
* clinical evidence of tissue deposition of cystine and tissue damage due to cystinosis

Exclusion Criteria:

* Allergy to cysteamine
Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention

This is a three phase study designed to examine clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human Immunodeficiency Virus (HIV) prevention strategy, and to identify knowledge-related and attitudinal factors associated with these behaviors. Each phase consists of the following:

Phase 1: Semi-structured face-to-face or telephone interviews of ATN-affiliated clinicians. Approximately 10 clinicians will be interviewed.

Phase 2: Development of a new theory-based survey instrument and cognitive interview testing of this survey. Approximately five clinicians (of those who participated in Phase 1) will be interviewed.

Phase 3: Administration of the newly developed survey to ATN-affiliated clinicians. Approximately 60 clinicians will be interviewed.


Eligibility Criteria:
Inclusion Criteria:

* Clinicians (including physicians, nurse practitioners, and physician assistants) that EITHER: Provide primary HIV care for HIV-infected and primary care for HIV-uninfected adolescents; OR Provide primary HIV care to HIV-infected adolescents only;
* Provides services to adolescents and young adults at ATN sites or one of their community partners;
* Ability to understand spoken English; and
* For Phase 2 only: prior participation in Phase 1.

Exclusion Criteria:

* Intoxicated or under the influence of alcohol or other substances at the time of consent;
* Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) and in the opinion of the protocol chair would interfere with the ability to give true informed consent; and
* For Phase 3 only: prior participation in Phase 1 or 2 of this study.
Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium

Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. Supposedly, the tip of a GDD tube with a thinner diameter, such as the Paul implant, will remain at a larger distance from the cornea and, thereby, cause less damage.

Objective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD.

Study design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise, both GDDs will probably have a similar risk/benefit profile. The risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Informed consent.
* Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Ethnicity will be based on self-reported origin of subject and/or parents.
* Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.

Exclusion Criteria:

* History of intraocular surgery (e.g. vitrectomy, cataract surgery, cyclodestructive procedures etc).
* History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy).
* Pseudophakia.
* Functionally monocular patients.
* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery.
* Narrow anterior chamber angle.
* Best corrected visual acuity less than 0.1.
* Severe blepharitis.
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease

A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.
* Clinically meaningful response to L-Dopa with well-defined early morning "OFF" episodes, as determined by the Investigator.
* Receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit
* No planned medication change(s) or surgical intervention anticipated during the course of study.
* Patients must experience at least one well defined "OFF" episode per day with a total daily "OFF" time duration of ≥ 2 hours during the waking day, based on patient self-assessment.
* Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
* MMSE score \> 25.

Exclusion Criteria:

A patient will not be eligible for study entry if any of the following exclusion criteria are met:

* Atypical or secondary parkinsonism.
* Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; or Duodopa/Duopa.
* Treatment with any form of s.c. apomorphine within 7 days prior to the initial Screening Visit (SV1). Patients that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered.
* Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite); Tigan® (trimethobenzamide hydrochloride; patients from US sites only); or domperidone (patients from non-US sites only).
* Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1).
* Currently taking selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents.
* Drug or alcohol dependency in the past 12 months.
* History of malignant melanoma.
* Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
* Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
* History of clinically significant hallucinations during the past 6 months.
* History of clinically significant impulse control disorder(s).
* Dementia that precludes providing informed consent or would interfere with participation in the study.
Fetal Anomalies Scan at the Time of Nuchal Translucency Study

Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study.

Prospective study of patients at 12-14 weeks gestation that are coming for NT examination is conducted. Meticulous ultrasound examination will be done to the fetuses using trans vaginal and transabdominal techniques. The patients will receive only the NT information. Only in cases of detection of severe fetal anomalies the patient will get the information of the examination and counseling according to the findings. All patients will be asked to provide information of the 15 weeks early comprehensive ultrasound examination. The NT examination will be compared to the 15 weeks ultrasound. All patients will be asked to give information after delivery of the baby's health condition.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at 12-14 weeks

Exclusion Criteria:

-
Kinetics of B Cell Response in Infants Menjugate Vaccination

Kinetics of B cell response in infants Menjugate vaccination


Eligibility Criteria:
Inclusion Criteria:

* healthy infants

Exclusion Criteria:

* previously ascertained or suspected disease caused by N. meningitidis
* previous household contact with an individual with a positive culture of N. meningitidis serogroup C
Prevalence and Risk Factors of HIV Infections in Transgender and Non-binary People in Flanders and Brussels (Belgium)

Background: HIV prevalence and sexual risk have been estimated very high for transgender people. However, the limited sampling and data collection methods used in current research on transgender people potentially led to overrepresentation and generalisation of people at risk for HIV. Current HIV prevalence estimates in transgender populations are generalised from studies mainly focusing on transgender women who engage in sex work. Moreover, current research remains cisnormative, and studies focusing on non-binary people, who identify with a broad range of identities beyond the traditional male and female gender identities, are scarce.

Objective: This study aims to estimate the HIV prevalence rate in the Flemish and Brussels (Belgium) transgender population, including transgender women as well as transgender men and non-binary people, and identifying the associated individual and community-level risk factors.

Methods: In this community-based cross-sectional study, self-identified transgender and non-binary (TGNB) people will be recruited through a two-stage time-location sampling approach to minimize selection bias. In a first part, community settings in which TGNB people gather will be mapped using qualitative and ethnographic research methods, to reveal how the TGNB community in Flanders and Brussels is structured and to develop an accurate sampling frame. In a second part, to select the respondents, a multistage sampling design is applied involving a stratification based on setting type (healthcare facilities vs outreach events), a selection of clusters by systematic sampling and a simple random selection of TGNB people within each cluster. Participants will complete an electronic self-reported survey to measure sociological, sexual and drug-using behaviors (risk factors) and, at the same time, oral fluid aliquots will be collected and tested for HIV antibodies. Logistic regression models will be used to evaluate risk factors independently associated with HIV infection.

Conclusion: To the best of our knowledge, this study will be the first to investigate the HIV prevalence rates and behaviors that increase risk and vulnerability for HIV infection in an accurate representation of the TGNB population in a West European country. The findings of this study will globally serve as a knowledge base for identifying subgroups at risk for becoming infected with HIV within TGNB people and to set up targeted prevention programs on sexual health.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) self-identified transgender and non-binary people
* Able to read, write and understand the survey
* Consent to participate in the survey and to self-collect an oral fluid sample

Exclusion Criteria:

* Cisgender people
* People who have no understanding of the multilingual survey
Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)

The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Early feasibility study - multi-center, prospective, single-arm, and non-randomized study without concurrent or historical controls.

The primary objective of the study is to generate early feasibility data for the CardiAQ™ Transcatheter Mitral Valve Implant System with the Transfemoral and Transapical Delivery Systems for the treatment of moderate to severe mitral valve regurgitation in patients who are considered high risk for mortality and morbidity from conventional open-heart surgery.

The secondary objectives of the study are to evaluate the long-term safety of the device and the effects of the device on performance, functional, quality of life parameters, and technical, device, procedural, and individual patient successes.

The study is to be performed at a maximum of 5 investigational sites in the US.

Eligibility Criteria:
Key Inclusion Criteria:

* NYHA Classification ≥ III
* Left Ventricular Ejection Fraction ≥ 30%
* Mitral Regurgitation ≥ Grade 3+
* Subject meets anatomical and eligibility criteria for the investigational device

Exclusion Criteria:

* See Protocol
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH

Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age \>18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis

Eligibility Criteria:
Inclusion Criteria:

* Patiens newly diagnosed having Hereditary Hemochromatosis

Exclusion Criteria:

* Age \< 18 yrs.
* Not obese (BMI \<30)
* Not consuming alchol beverages,
* Not affected by systemic diseases and known hepatic viruses