cyrilzakka/clinical-trials huggingface dataset:
Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin

To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).

Approximately 240 patients will be randomized in this study, 60 to each of two MBX-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the Actos® group. Patients in the Actos® group will receive Actos® 30 mg/daily for the first eight weeks of the treatment phase and Actos® 45 mg/daily for the last 16 weeks of the treatment phase. Patients in the MBX-102 400 mg group and MBX-102 600 mg group will continue MBX-102 400 mg and 600 mg, respectively for the full 24 weeks. All study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, MBX-102 or Actos®. This sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in HbA1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
* Male or female, 18-70 years of age
* All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded.
* Female patients must not be pregnant or lactating
* BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2
* HbA1c ≥ 7.5%, ≤ 10.5%
* FPG ≥ 120 mg/dL, ≤ 240 mg/dL

Exclusion Criteria:

* History of diabetes secondary to pancreatitis or pancreatectomy
* Any history of ketoacidosis
* History of insulin use within last one year (insulin use while hospitalized is acceptable)
* Weight loss \> 10 pounds in the three months prior to screening visit
* History of TZD use (Actos® or Avandia®) within 6 months of screening visit
* History of TZD discontinuation due to side effect or lack of efficacy
Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.

"In-Clinic LVAT" feature is a non CE-marked feature designed to be activated by the physician during 2 hospital follow-ups:

* first visit: planned to be conducted 15 days maximum after inclusion
* second visit: planned to be conducted between 1 and 3 months after the first visit The evaluation consists in the comparison between the threshold value provided by the algorithm and the threshold value obtained manually by the physician.

Eligibility Criteria:
Inclusion Criteria:

* Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines \[1\]:

  * With IS1 Platinium SonR CRT-D (models 1811, 1841, CE-marked) for maximum of 5 days or;
  * With IS4 Platinium SonR CRT-D (model 1844, CE-marked).
* Right atrial, right and left ventricular leads must be implanted. Only bipolar and quadripolar for Left Ventricular lead.
* Reviewed, signed and dated informed consent.

Exclusion Criteria:

* Subject included in another clinical study that could confound the results of this study;
* Malfunction or dislodgment of right atrial, right and left ventricular implanted leads;
* Subject diagnosed with permanent atrial fibrillation;
* Known pregnancy;
* Minor age;
* Under protection or guardianship;
* Unavailability for scheduled follow-up or refusal to cooperate
Evaluation of Green Dot a Primary Prevention Intervention

The purpose of this study is to evaluate the statewide application of Green Dot among high schools students. We hypothesize that students in high schools with Green Dot will over time report lower rates of sexual violence (SV) compared with students in comparable high schools randomized not to have Green Dot. This reduction in sexual violence will be mediated through a reduction in social norms supporting sexual violence (measured with violence acceptance scales) and an increase in bystander behaviors.

"Green Dot" is a bystander intervention program that empowers students to actively question peer support for sexual violence (SV) and become change agents who play a significant role in preventing sexual violence. The purpose of this study is to evaluate the statewide application of Green Dot among high schools students. We hypothesize that students in high schools with Green Dot will over time report lower rates of SV compared with students in comparable high schools randomized not to have Green Dot. A high school based controlled intervention trial is being used to test the efficacy of Green Dot. Both panel and cohort survey methods will be used to provide baseline and prospective data on student's attitudes supporting SV, bystander behaviors and violence victimization and perpetration. In 13 Kentucky regions, 2 demographically comparable high schools were recruited to participate in Green Dot intervention either as the intervention or control site. Schools were randomly assigned to the intervention. Study Population includes all students in participating high schools invited to complete anonymous panel surveys beginning spring 2010 through 2014. This state-wide, population-based, multi-site controlled intervention trial provides an empirical test of a promising intervention, which, if proven effective, could result in the primary prevention of SV and a reduction in the health and academic consequences of SV.

Eligibility Criteria:
Inclusion Criteria:

Only high school students attending the intervention or comparison high schools will be eligible. Two groups will be recruited: those receiving bystanding training and those not receiving such training who may or may not be in the social network of those receiving bystanding training.

Exclusion Criteria:

All other high school students in Kentucky
A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers

This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
* Body Mass Index of 18 to 30 kg/m2, inclusive.
* For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
* For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy

This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.

Vaginal stenosis can occur as a result of treatment for pelvic malignancies. Women receiving pelvic radiation therapy using a vaginal dilator 5-7 times per week will have less vaginal stenosis than women using a vaginal dilator fewer times or not at all.

Eligibility Criteria:
Inclusion Criteria:

* Pre and post menopausal women undergoing definitive (not palliative) treatments for a pelvic malignancy, including rectal, endometrial, cervical, or anal canal carcinoma.
* Treatments include radiation therapy, chemotherapy, surgery, or a combination of therapies.
* May have early-stage or locally advanced (node positive) disease.
* Male partners of the female subjects are also consented for this study.

Exclusion Criteria:

* Subject may not have evidence of metastatic disease.
* Prior pelvic radiation therapy
* Prior hysterectomy (not for current diagnosis)
* Diagnosis of prior malignancy, except non-melanoma skin cancer.
Renal Outcomes Among Post Liver Transplantation Patients

To evaluate Renal outcomes among patients, post liver transplantation at Assiut university.

It is estimated that 1 in 4 liver transplantation (LT) recipients has an estimated glomerular filtration rate (eGFR) of \<60mL/minute/1.73 m2 at the time of LT Renal dysfunction, both before or after LT, is an important comorbidity associated with an increased risk of death, morbidity, and cost. Serum creatinine, a major component of the Model for End-Stage Liver Disease (MELD) score, has driven the increased incidence of renal dysfunction among patients undergoing LT End-stage liver disease (ESLD) is commonly complicated by kidney dysfunction, which in turn leads to a worse prognosis. The kidney dysfunction can be functional or structural, ranging from prerenal azotemia and hepatorenal syndrome causing acute kidney injury to immunoglobulin A (IgA) nephropathy (IgAN) and membranoproliferative glomerulonephritis causing chronic kidney disease Each condition carries a different presentation, treatment, prognosis, and risk of recurrence. Therefore, when ESLD patients undergo evaluation for liver transplant, it is critical to assess their kidney function and understand the cause of any underlying kidney dysfunction LT recipients will continue to worsen due to calcineurin inhibitor toxicity and lack of recovery from hepatorenal syndrome (HRS), necessitating renal replacement therapy Patients who are not expected to recover their kidney function after liver transplant usually benefit from combined liver and kidney transplant (CLKT). Others may need modified immunosuppressive regimens that minimize or avoid use of calcineurin inhibitors to preserve the remaining kidney function.

For assessment of kidney function, Equations that estimate GFR are most commonly used in daily practice. They have the advantage of being inexpensive and results are immediately available. Their disadvantage is that they rely on endogenous biomarkers, which are confounded by non-GFR determinants such as age, sex, muscle mass, drugs, certain chronic conditions, diet and presumably many more Creatinine, the most commonly used biomarker, depends heavily on muscle mass. Pre and intraoperative factors and postoperative complications were evaluated for their impact on development of AKI The preoperative factors MELD, SCr, Bilirubin and INR were highly associated with an increased risk for developing AKI requiring RRT for the post OLT complications, length of ICU stay was associated with the development of AKI Patients with a longer ventilation time and a higher amount of RPC transfusion were more likely to have AKI requiring RRT, whereas these parameters were not associated with milder forms of AKI.

Eligibility Criteria:
Inclusion Criteria:

* Data of all Patients underwent liver transplants with their reports available at El Raghy university hospital

Exclusion Criteria:

* Inadequate data
* Patients on dialysis more than 8 weeks pre liver transplant.
Radiomics Compared With Conventional Response Criteria for Predicting Progression of Desmoid Tumor After Cryoablation

Desmoid tumors (DT) are uncommon tumors that arise from musculoaponeurotic structures. Despite benign, they can cause pain and disability due to their tendency to be locally aggressive. Cryoablation, a technique used in interventional radiology, has gained popularity in recent years as a treatment option for sporadic DT. This involves repeated cycles of freezing, leading to cell death. Recent studies showed that percutaneous image-guided cryoablation appears to be safe and effective for local control for patients with extra-abdominal desmoid tumors.Although changes in the heterogeneity of tumors are commonly known, they are often ignored in response criteria that only evaluate tumor size in a single dimension, such as Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Nevertheless, MRI can reveal early changes in tumor heterogeneity in responding tumors, resulting from a reduction in cellular area and an increase in fibro-necrotic content, before any dimensional changes occur. These changes in heterogeneity can be quantified using a radiomics approach. The aim of this study is to develop radiomics response criteria dedicated to the evaluation of DT treated with cryoablation as a first line treatment and to compare their performance with those of alternative radiologic response criteria for predicting progression according to RECIST 1.1.


Eligibility Criteria:
Inclusion Criteria:

* desmoid tumor treated at Rizzoli Orthopaedic Institute with cryoablation
* baseline MRI
* clinical and radiologic follow-up until disease progression or the start of a new line of treatment performed every 3 months, with a minimum of 6 months follow-up

Exclusion Criteria:

- not meeting inclusion criteria
Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia

This study will determine the effectiveness of artemisinin plus risperidone in improving symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study addresses the Toxoplasma infection hypothesis of schizophrenia.

Evidences of high levels of Toxoplasma gondii antibodies in the serum and the cerebrospinal fluid (CSF) of individuals with schizophrenia have suggested that this organism might be involved in the etiopathogenesis of schizophrenia. The investigators hypothesize that antimicrobial therapy by using an add-on agent together with a well-proven neuroleptic may have favorable effects on a subgroup of schizophrenic patients.

Eligibility Criteria:
Inclusion Criteria:

* Currently resides in Beijing, China
* Diagnosis of schizophrenia or schizophreniform disorder
* Duration of symptoms is no longer than 60 months
* No history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
* Current psychotic symptoms are of moderate severity or greater as measured by one of the five psychotic items in the Brief Psychiatric Rating Scale (BPRS)

Exclusion Criteria:

* DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform psychosis
* Documented disease of the central nervous system that might interfere with the trial assessments (e.g., stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection)
* Acute, unstable, and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
* A clinically significant echocardiogram (ECG) abnormality in the opinion of the investigator
* Pregnant or breastfeeding
* Use of prohibited concomitant therapy
* History of severe allergy or hypersensitivity
* Dependence on alcohol or illegal drugs
* Use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants
Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice

A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.

The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Patients with indeterminate lung nodule
3. Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT
4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
5. Informed consent properly obtained per local regulations

Exclusion Criteria:

1. Known pregnancy or breastfeeding
2. Patients with pure ground-glass nodules on pre-procedural chest CT
3. Uncontrolled coagulopathy or bleeding disorders
4. Ongoing systemic infection
5. History of lobectomy or pneumonectomy
6. Patients with pacemakers or defibrillators
7. Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist
8. Patients with pleural effusion or diaphragmatic paralysis
Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms

Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular mechanisms

The latest definition of sepsis highlights the role of dysregulated host response to infection in organ dysfunction aggravation. Maintenance of immune homeostasis of septic patients through immunotherapy is the key breakthrough to improve success rate. Antigen-presenting cell (APC) is the bridge that connects the innate and adaptive immunity. Decrease of count and function of APC has been shown to be associated with worsened clinical outcomes in patients with sepsis. Gamma-delta T cells (γδ T cells) are the newly identified population of T lymphocytes. Recent studies have found that γδ T cells possess unique and powerful antigen-presenting function, making them the hot topic in infection and cancer research. Based on the results, the investigator plan to evaluate the antigen-presenting function changes of γδ T cells in septic status by analyzing the antigen-presenting related molecules on γδ T cells, antigen protein uptake ability, and their function on the proliferation and activation of CD8+ T lymphocytes. Furthermore, the investigator will explore the mechanism and signal pathways for the APC function changes of γδ T cells. Findings from this research could help explain the mechanism of sepsis induced immune dysfunction, enrich our understanding of the important role of γδ T cells, and build a good foundation for immunotherapy in sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 year old;
2. a known or suspected infection based on clinical data at the time of admission and sepsis-induced dysfunction of at least one organ.

Exclusion Criteria:

1. autoimmune disease,
2. history of transplantation,
3. acute tuberculosis,
4. chronic hepatitis B or C infection,
5. HIV infection,
6. active malignancy, and
7. long-term use of cortical steroids.
Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation

The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-36 years old with a body weight of more than 60 kg up to 90 kg
* BMI of 18-32 kg/m2
* Menstrual cycle length of 23-35 days
* An indication for controlled ovarian stimulation for IVF or ICSI

Exclusion Criteria:

* history of an endocrine abnormality
* abnormal outcome of blood biochemistry or hematology
* abnormal cervical smear
* chronic disease
* uterine pathology that interfering with the COS treatment (e.g. fibroids ≥ 5 cm)
The Prevalence of Hyper-Lp(a)-Emia in the PMMHRI-Lp(a) Registry

The PMMHRI-Lp(a)-Registry is a non-interventional, single-center registry conducted in the Polish Mother's Memorial Hospital Research Institute (PMMHRI). The PMMHRI-Lp(a)-Registry was established in January 2022. Since then, all consecutive patients of the Department of Cardiology and Adult Congenital Heart Diseases, Department of Endocrinology, and outpatient cardiology and endocrinology clinics with the measured Lp(a) concentration have been included.

The PMMHRI-Lp(a)-Registry is a non-interventional, single-center registry conducted in Poland's 2nd largest, supra-regional hospital - the Polish Mother's Memorial Hospital Research Institute (PMMHRI). The PMMHRI-Lp(a)-Registry was established in January 2022. Since then, all consecutive patients of the Departments of Cardiology, Endocrinology, and outpatient cardiology and endocrinology clinics have been included. The indications for Lp(a) measurement in the registry are based on the 2021 Polish Lipid Guidelines and new Polish recommendations on the management of elevated Lp(a) (2024). Lp(a) was determined using Sentinel's Lp(a) Ultra, an Immunoturbidimetric quantitative test (Sentinel, Milan, Italy), and the results are presented in mg/dl.

The following information was collected from the patient's medical records: demographic parameters; relevant comorbidities; concomitant medications including lipid-lowering therapy status, anticoagulation status; smoking status; post hoc calculated cardiovascular risk score; and laboratory parameters including i.e. Lp(a) and lipids profile.

Eligibility Criteria:
Inclusion Criteria:

* measured lipoprotein(a) concentration

Exclusion Criteria:

-
Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue), neurological complications and and mainly disorders of the respiratory system, such as respiratory muscle weakness after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation (tDCS) have been proposed to minimize functional and structural impairments. The aim of the present study is to evaluate the effects of inspiratory muscle training associated with stimulation of the diaphragmatic motor cortex through hd-tdcs in post-COVID-19 patients on inspiratory muscle strength, pulmonary function, inflammatory levels and functional capacity.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled.

Exclusion Criteria:

* Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.