cyrilzakka/clinical-trials huggingface dataset:
A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to learn more about the safety and side effects of tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also measure how much tirzepatide gets into the bloodstream and how long it takes the body to remove it. The study will last about six or eight months for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are stable on a single oral antihyperglycemic medication (OAM), metformin, acarbose, or sulphonylureas only (other types of OAM \[dipeptidyl peptidase IV inhibitors, sodium-glucose cotransporter-2 inhibitors, and thiazolidinediones\] are not allowed in this study), for at least 3 months
* Have a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Have type 1 diabetes mellitus
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Visit 1
* Have a history of heart block or PR interval greater than (\>)220 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or a GI disease that impacts gastric emptying or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
* Have known allergies to tirzepatide, GLP-1 analogs, or related compounds or any components of the formulation
Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010

The interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by STAR and ASTRAL clinical trials in 2009, confirmed by the CORAL study in 2014.

These studies did not show any benefit of the gesture on renal function, morbidity and cardiovascular mortality or the tension control. The aim of the study is to evaluate renal angioplasty on atherosclerotic stenosis.

Previous studies did not concern the indication of renal angioplasty in some high-risk situations, such as malignant or resistant renal vascular hypertension, OAP (Acute pulmonary oedema) flash or acute renal failure of ischemic origin.

There is no work in the literature that has studied retrospectively the evolution of angioplasty practices renal artery disease on atherosclerotic stenosis since 2009, nor their remote results of the gesture.

Eligibility Criteria:
Inclusion Criteria:

* OAP flash: hospitalization for Acute congestive heart failure without any other identified etiology than renal artery stenosis
* Resistant arterial hypertension under treatment including a diuretic
* Acute renal failure or ischemic renal failure quickly progressive
* Radiological criteria: renal ischemia visualized at arterial time of angio-CT or renal angio-MRI

Exclusion Criteria:

* Renal transplant patients
* Patients with another etiology of secondary hypertension, including fibro-muscular dysplasia of renal artery
* Restenosis on stent, angioplasty of accessory renal artery
* Patients subject to legal protection (safeguard of justice, guardianship) and persons deprived of liberty
* Patients objecting to participate to the study
Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial

The goal of clinical trial is to compare using pedometer in sarcopenic cirrhotic patients. The main questions it aims to answer are:

1. Did the encourage using pedometer group had higher change of skeletal muscle index (SMI) than discourage using pedometer group?
2. How many of patients who had sarcopenic improvement in both groups at 6 months after enrollment?
3. What is the mortality rate and hospital admission in both groups at 12 months after enrollment?


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 - 75 years old
* 2. Cirrhotic patient with diagnosed sarcopenia
* 3. Patients or caregiver who can write and announce Thai language
* 4. Cirrhotic patient who was post liver transplantation \> 1 year

Exclusion Criteria:

* 1. Cirrhosis Child-Turcotte-Pugh (CTP) C \> 10 2. Refractory ascites 3. Decompensated comorbidity: heart failure NYHA III-IV, ESRD with dialysis, COPD Gold D 4. Performance status ECOG 3-4 5. Bone fracture within 4 weeks or limitation of activity 6. Pregnancy and breastfeeding 7. HCC during treatment with TACE or microwave ablation or radiofrequency ablation within 6 months before enrollment 8. Advanced stage malignancy 9. Received chemotherapy 10. Muscle weakness disease 11. Recent cerebrovascular disease within 6 months and motor weakness grade \< II 12. Age 65-75 years old with history of falling \> 2 times/year
Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects

This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis).

Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 75 years of age
* PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired \>/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
* Baseline six-minute walk distance (6MWD) \>/= 250 meters
* Currently receiving Ventavis and be stable at current dose for 30 days prior to Baseline
* If currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to Baseline
* Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

* Nursing or pregnant
* Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
* History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
* Use of investigational drug within 30 days of Baseline
Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study

The primary aim of this study is to investigate, whether higher intake of selenium rich food items such as fish and shellfish, is associated with higher selenium blood levels.

The secondary aim is to investigate the uptake of selenium from fish and shellfish and the incorporation of selenium from those foods into proteins in the human body. Furthermore, the impact of the natural variation in the genes that are responsible for the accumulation of selenium in the proteins will be investigated.

Selenium is an essential trace element that is incorporated into proteins in the human body and it hereby plays a major role in several important cellular processes. Previous studies have indicated that the selenium status of the Danish population is below the levels required to optimize the suggested protective effects of selenium towards major diseases including cancer. In Denmark, important natural sources of selenium are fish and shellfish.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* 50-74 years
* BMI 18.5-28 kg/m2
* non-smokers

Exclusion Criteria:

* strenuous exercise \> 10 h/week
* excessive intake of alcohol
* frequent intake of fish and shellfish \> 200-300 g/week
* intake of dietary supplements 3 months before or during the study
* frequent use of medication except antihypertensive medicine, cholesterol lowering medicine and hormone replacement medicine
* simultaneous participation in other research projects
* cancer diagnosis within the past 5 years
* severe chronic diseases
Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus

Immediate release (IR) tacrolimus peaks in the first two hours after administration. These peak levels are influenced by CYP3A5 expression with expressors requiring higher total daily doses with higher peak levels compared to non-expressors. Tacrolimus XR (Envarsus) is a once daily formulation with delayed absorption and lower peak levels while maintaining similar trough levels as seen with IR tacrolimus. A randomized trial of conversion from IR tacrolimus to tacrolimus XR in kidney transplant recipients have shown similar efficacy and adverse events between the two groups but no improvement in estimated GFR. However, urinary biomarkers of acute kidney injury associated with changes in tacrolimus dosing may be more sensitive then serum creatinine. The objective of this study is to assess renal tubular injury in heart transplant recipients who are converted from immediate release to tacrolimus XR. The hypothesis is that the delayed absorption and lower peak levels of tacrolimus XR will lead to less tubular injury and improved renal function without increased risk to the heart allograft.

The primary outcome is change in urinary NGAL expression with conversion from IR tacrolimus to tacrolimus XR. In aim 1, changes in urinary biomarkers of tubular injury at 4 weeks after conversion to tacrolimus XR with stable trough levels will be assessed. These changes will be assessed by CYP3A5 expressor category that will be determined by genotyping of a single gene for variants. The changes in GFR using the creatinine-cystatin C CKD-EPI equation will be assessed. In aim 2, the rate of rejection as defined as treated rejection within the last 30 days for any grade \> 1R or AMR or acute graft dysfunction (LV ejection fraction drop \> 10%) will be looked. The cardiac allograft vasculopathy based on coronary angiography +/- IVUS and right heart catheterization hemodynamics at baseline and 1 year post conversion will also be evaluated. In addition to changes in cardiac function, the changes in blood pressure, serum glucose, and cholesterol in the first year after conversion will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Stable, heart-only transplant recipient within 10 years of transplantation
* 18 -80 years old
* Currently taking IR Tacrolimus
* Baseline eGFR\> 30mL/min/1.73m2

Exclusion Criteria:

* Multiple organ transplant recipients
* Less than 18 years old
* Greater than 80 years old
* Heart-only transplants recipients with active malignancy, rejection, or greater than 10 years from transplantation
Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.

Partial epilepsies are refractory to medical treatment in 30% of the cases (Refractory Partial Epilepsy or RPE). Patients with RPE suffer from social and occupational disability, an increased risk associated with seizures (traumatic brain injury, accidents), but also a higher risk of sudden unexplained death (2 to 3 times higher) than the general population. Moreover, the medical and social burden of these patients is heavy, representing a significant cost to society.

In some cases, surgical treatment with resection of the epileptogenic zone (EZ) can be proposed. The presurgical evaluation includes various investigations seeking to clarify the location of the EZ; but this approach is sometimes insufficient and the definition of the EZ then requires invasive exploration through intracerebral EEG recording (stereo-EEG, SEEG). This latter technique is currently the preferred standard to define the EZ. It involves implanting electrodes in the brain areas suspected to belong to the seizure network. 50 to 70% of patients investigated with this technique will have epilepsy surgery.

In recent years, a series of studies in animals and humans have suggested that some oscillations, very short and at very high frequency (\> 250 Hz), called "fast ripples" (FRs) could be a good biomarker of the EZ (for a review see Zijlmans et al, 2012). The FRs are more easily recorded from microelectrode (diameter: 20-40 microns).

The purpose of this study is to evaluate a new medical device designed by DixiMedical to record FRs, combining micro and regular clinical electrodes.

Eligibility Criteria:
Inclusion Criteria:

* Patient with RPE in whom SEEG is required to precisely localize the seizure focus

Exclusion Criteria:

Patients with SEEG contra-indication:

* severe psychiatric disorders,
* severe agitation during their crisis
* contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system,
* contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women,
* anti thrombotic ongoing treatment.
The Effect of Yoga and Stabilization Exercises in Individuals With Chronic Low Back Pain

Although exercise has been shown to be effective in low back pain in the literature, there is no conclusion about which exercise is superior to the other. Although there are studies showing positive effects of spinal stabilization exercises and yoga approach on pain level, disability level and quality of life in patients with chronic low back pain, studies evaluating the effectiveness in many other aspects are insufficient. Therefore, this study aimed to investigate the effects of spinal stabilization and yoga exercises on pain, functional status, metabolic capacity, kinesophobia and sleep quality in patients with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific low back pain diagnosis
* Having pain that persists for at least 12 weeks
* 25-65 age range

Exclusion Criteria:

* Scoliosis with a cobb angle of more than 20º
* History of previous surgery for the lumbal region
* Having an additional diagnosis such as spondylolisthesis, spinal stenosis, spondylolysis
* Presence of neurological deficits
* Metastatic state presence
* Presence of neurological deficits due to diabetes
* Presence of metabolic problems such as thyroid, hypertension, coronary artery disease
* The presence of inflammatory problems involving the spine
In-School Evaluation of Bystander: A Game-Based Intervention for Sexual Violence Prevention

The investigators have developed a game-based sexual violence prevention program that uses a bystander intervention approach. This program is called Bystander and was designed for use with high school students in grades 9-12. The goal of this research is to evaluate the efficacy and feasibility of Bystander when implemented in a school setting. The research will capture data on knowledge about sexual violence and harassment, as well as attitudes, self-efficacy, perceived social norms and behavioral intentions around bystander behaviors. This research will consist of a baseline survey, program participation, a immediate post-program survey, and a 3-month follow up survey with youth participants. It will also involve qualitative in-depth interviews with school staff and administration about the program.

Using the investigators' experience in game-based learning, digital media, behavior theory, and adolescent sexual and reproductive health, the investigators have developed a digital game-based sexual violence prevention program-Bystander-to be used with high school students to teach them about prosocial bystander behaviors and decrease acceptance of common rape myths. The goal of this research is to evaluate the efficacy and feasibility of Bystander when implemented in a school setting.

This study will evaluate Bystander, a four-module intervention program. Each module is designed to last one school class period. It includes 20 minutes of individual gameplay through an interactive narrative featuring prosocial bystander behaviors and discussions dispelling rape myths. Each module also includes facilitated class discussion about the topics covered that day.

The research team will conduct a pre/post efficacy and feasibility study that will capture data through a pre-, immediate post-, and 3-month follow up survey on knowledge about sexual violence and harassment, as well as attitudes, self-efficacy, perceived social norms and behavioral intentions around bystander behaviors (all measured at pre-, immediate post- and follow-up time points). It will also capture demographic information and previous bystander behaviors at baseline. It will finally involve qualitative in-depth interviews with school staff and administration about the program.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-19 years
* A student in grades 9-12 at one of three identified study site schools
* Able to speak and read English at a 7th grade level
* Provide informed consent and express willingness to complete the follow-up survey.
MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age ≥18
* Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
* Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
* Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
* Radiographic progression on post-SRS imaging at previously treated SRS site(s)
* Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team
* Patients must sign study-specific informed consent prior to study entry

Exclusion Criteria:

* Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
* Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
* Small cell lung cancer (SCLC) or lymphoma histology
Analgesic Effects of Intrathecal Morphine and Bilateral Erector Spina Plane Block in Elective Cesarean Section

Cesarean section cause severe pain due to surgical incision, abdominal wall retraction and visceral organ movements. Cesarean section can be performed with general anesthesia, spinal anesthesia, epidural anesthesia and combined spinal epidural anesthesia methods.

Because of the possibility of aspiration pneumonia in pregnant women are under general anesthesia, the awareness of anesthesia in the mother during the operation due to insufficient anesthesia, unsuccessful intubation, respiratory complications in the mother and newborn and low APGAR scores, regional anesthesia is superior to general anesthesia in elective cesarean section operations.

Spinal anesthesia, abdominal wall blocks such as erector spinae plane block, parenteral and intrathecal opioids may be used for postoperative analgesia in cesarean section operations.

Intrathecal morphine can cause postoperative nausea-vomiting, itching, respiratory depression. Erector spina plane block can provide effective pain control and reduce opioid consumption.

The primary implication of this study is to compare postoperative pain scores and opioid consumption on elective cesarean section patients under spinal anesthesia with intrathecal morphine or erector spina block in addition to spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 40 years old, ASA (American Society of Anesthesiologists) score I-II, undergoing elective cesarean section

Exclusion Criteria:

* Emergency cesarean section
* The patients with major hepatic, cardiovascular or renal disease
* The patients for whom spinal anesthesia is contraindicated
* The patients who is allergic to any drugs that we use for this study
* Patients who declined to participate in the study
Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa

Adolescent girls and young women (AGYW) between the ages of 15-24 years continue to bear the brunt of Human Immunodeficiency Virus (HIV) infections in South Africa despite progress recorded in prevention and treatment programmes. The ongoing susceptibility of young women to HIV infection and the sub-optimal uptake of prevention options such as Pre-Exposure Prophylaxis (PrEP) that are highly effective creates a need for an HIV vaccine to benefit populations at substantial risk of HIV infection. However, lessons from previous vaccine studies and the recent COVID-19 vaccine have highlighted significant barriers to vaccine uptake, such as widespread misinformation and vaccine hesitancy. These challenges threaten the successful implementation of a future HIV vaccine. Building on these insights, this study will utilise psychological inoculation theory to develop and evaluate HIV vaccine messages among adolescent girls and young women. Primary objective: To compare changes in intentions to receive HIV vaccine following misinformation exposure in groups with and without psychological inoculation and behavioural economics boost. Secondary objectives: (1) To compare believability and persuasiveness of misinformation claims and motivational threat associated with misinformation in groups with and without psychological inoculation and behavioral economics boost. (2) To explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine hesitancy, and information avoidance. The investigators will conduct a three-arm randomized controlled trial of 2-3 inoculation messages that address emerging myths and misinformation about the HIV vaccine in South Africa. Participants will be randomly assigned to a control group or one of two intervention arms: (1) inoculation message arm, or (2) enhance inoculation message with insights from behavioural economics.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-24 years
* Self-reported history of sexual activity in the past 12 months
* Self-reported HIV-negative status or unknown HIV status at enrolment
* Willing and able to provide written informed consent
* Able to read and understand English

Exclusion Criteria:

* Unwilling or unable to provide consent for study participation.