cyrilzakka/clinical-trials huggingface dataset:
Chemokine Mechanisms in Chronic Pelvic Pain

The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of chronic pelvic pain syndrome in men.

Chronic pelvic pain is the hallmark of patients with chronic pelvic pain syndrome (CPPS), a non-bacterial category of prostatitis that is a significant source of morbidity in American men. The cause of CPPS is unknown and there is a lack of convenient biomarkers for diagnosis of this syndrome. This project will examine the expression of biomarkers in expressed prostatic fluid from adult men with and without a diagnosis of CPPS. Thus our specific aim is to validate the use of the chemokines MCP-1 and MIP-1alpha and mast cell tryptase as biomarkers for CPPS in humans and correlate their levels with CPPS symptoms.

Eligibility Criteria:
Inclusion Criteria:

* CP/CPPS group inclusion criteria

Patients are eligible for the study if they meet the following criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Agreed to participate in Study procedures.
* Participant is at least 18 years of age.
* Participant reports a response of at least 1 on the pain, pressure or discomfort scale (SYM-Q, Question #1).
* Participant reports pain or discomfort in any of the 8 domains of the Male Genitourinary Pain Index (MGUPI) (items 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d).
* These CP/CPPS symptoms been present for the majority of the time during any 3 months in the previous 6 months.

Exclusion Criteria:

* Participant has an on-going symptomatic urethral stricture.
* Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.

Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy.

* Participant has augmentation cystoplasty or cystectomy.
* Participant has a history of cancer (with the exception of skin cancer).
* Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
* Participant diagnosed with unilateral orchialgia, without pelvic symptoms.
* Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.

Control group exclusion criteria In addition to the exclusion criteria listed above additional criteria for control subjects are as follows.

1. In the past year, symptoms of discomfort or pain in the pelvic region for extended periods of time.
2. Volunteers who have had a urinary tract infection with a urine culture value of \>100,000 CFU/ml within the past three months.
3. Volunteers treated with intravesical chemotherapy or BCG.
4. Volunteers who have had any of the following sexually transmitted diseases (STDs) - gonorrhea, chlamydia, mycoplasma or trichomonas.
5. Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome)
Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy

(Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy

Exclusion Criteria:

* Incomplete treatment
A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies

The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736 (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469 in a set of participants with advanced solid tumors while rituximab will be tested with MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>/= 18 years old
* Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exists (Monotherapy and in Cohorts A and B)
* At least one lesion measurable by RECIST not previously irradiated (Monotherapy and in Cohorts A and B)
* Histologically confirmed DLBCL(Cohort C)
* Adequate organ and marrow function
* ECOG performance status of 0 or 1
* Willingness to provide consent for biopsy samples

Exclusion Criteria:

* Prior exposure to immunotherapy (either as a single agent or in combination) including but not limited to CD137 or OX40 agonists, anti-CTLA-4, anti-PD-1, or anti-PD-L1, anti-PD-L2 antibody or pathway-targeting agents
* History of organ transplant that requires use of immunosuppressives
* History of primary immunodeficiency or tuberculosis
* Active or prior documented autoimmune disease within the past 3 years
* Active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months
* Major surgical procedure within 30 days prior to the first dose of investigational product or still recovering from prior surgery
* Women who are pregnant or lactating
ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs

The goal of this clinical trial is to assess the feasibility and clinical value of acetylcholine (ACH) rechallenge after intracoronary verapamil +- nitroglycerine in a patient cohort with angina and non-obstructive coronary arteries (ANOCA).

The main questions it aims to answer are:

* to determine the efficacy of these drugs in treating ACH-induced coronary artery spasm
* to determine the efficacy of these drugs in preventing ACH-induced coronary artery spasm

The ACH rechallenge will take place during the index coronary function tests in patients with proven ACH-induced vasospastic angina. The study is considered a feasibility study, no control arm is included.


Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated coronary angiogram in the setting of angina with non-obstructive coronary artery disease (ANOCA)
* Non-obstructive coronary artery disease is defined as the absence of coronary artery stenosis ≥ 50%, or if ≥ 50% with non-ischemic resting (RFR \> 0.89) and hyperemic indices (FFR \> 0.80).
* ACH provoked epicardial and/or microvascular spasm
* Left ventricular ejection fraction (LVEF) \> 50%
* Renal function with eGFR ≥ 40 ml/min

Exclusion Criteria:

* Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)
* Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular disease
* LVEF \< 50%
* Long QT syndrome (LQTS) - genetic or acquired
* Ventricular paced rhythm
* Renal failure with eGFR \< 40 ml/min
* Thyroid stimulating hormone (TSH) \< lower limit of normal (LLN). A subject taking thyroid replacement therapy may be enrolled with TSH level below LLN if, in the opinion of the investigator, the subject is in a clinically euthyroid state.
* Known hypersensitivity or contra-indication for either acetylcholine, verapamil, nicorandil or nitroglycerine.
* Pregnant female subjects. Female subjects of child-bearing potential should be on adequate contraceptive measures or are to be screened with a urine pregnancy test.
Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome

This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.

This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.

The double-blind portion of this study is intended to end if statistical significance is reached at the interim analysis (accrual of 28 vEDS-related events requiring medical attention; estimated to take 24 months) or after accrual of 46 vEDS related clinical events requiring medical attention (estimated to take 40 months).

A total of approximately 150 patients who meet all the inclusion and none of the exclusion criteria will be enrolled and randomized 2:1 to receive either celiprolol or placebo, respectively.

Following the double-blind treatment period or occurrence of vEDS-related clinical event, patients have the option to participate in an open label extension period.

Eligibility Criteria:
Inclusion Criteria:

1. Willingness to obtain magnetic resonance angiogram (MRA) image at local imaging facility.
2. A genetic test confirming the presence of a pathogenic COL3A1 variant (classified as likely pathogenic or pathogenic according to ACMG/AMP Guidelines.
3. Patients must be ≥ 15 years of age at the time of randomization.
4. Able and willing to discontinue use of β-blockers prior to randomization.

Exclusion Criteria:

1. Lack of a COL3A1-positive test at screening (e.g., COL3A1 benign, likely benign, variant of unknown significance \[VUS\] or no variant) or presence of a COL3A1 variant but demonstration of a COL3A1 variant reported to be a haploinsufficiency variant.
2. Arterial rupture or dissection, uterine rupture, and/or intestinal rupture within 6 months prior to Screening.
3. Patients unable to discontinue β-blocker treatment prior to randomization.
4. Unable or unwilling to complete the study procedures.
5. Breastfeeding, pregnancy, or planned pregnancy during the trial.
6. Any medical condition that in the opinion of the Investigator may pose a safety risk to the patient in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
7. Use of any prohibited medications
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis

Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female with mildly to moderately active ulcerative colitis

Exclusion Criteria:

* Off prohibited medications for proscribed period of time
* Evidence of infectious colitis
* Labs outside of range
* Pregnancy or lactation
Maternal Serum Stathmin-1 Levels in Preeclampsia

The goal of this observational study is to investigate maternal serum Stathmin-1 levels in pregnancies affected by preeclampsia compared to healthy gestations.

The main questions it aims to answer are:

1. What are the maternal serum Stathmin-1 levels in pregnancies with preeclampsia?
2. How do Stathmin-1 levels differ between preeclampsia with severe features and uncomplicated pregnancies?

Researchers will compare Stathmin-1 levels in pregnancies with preeclampsia and preeclampsia with severe features to those in a control group of healthy pregnancies to assess differences in biomarker levels.

Participants will undergo blood sample collection at 32-34 weeks of gestation. Have their blood samples processed for Stathmin-1 level measurement using ELISA.


Eligibility Criteria:
Inclusion Criteria:

* Gestational Age: Pregnancies between 20 weeks and term (up to 40 weeks).
* Diagnosis of Preeclampsia (PE): New-onset hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
* Diagnosis of Severe Preeclampsia: Defined by criteria such as severe hypertension (systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg), organ dysfunction (renal insufficiency, liver involvement, neurological complications), thrombocytopenia, pulmonary edema, or fetal growth restriction.
* Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.

Exclusion Criteria:

* Multiple Pregnancies: Participants carrying more than one fetus.
* Pregestational Diabetes: Pre-existing diabetes mellitus diagnosed before pregnancy.
* Chronic Hypertension: Pre-existing hypertension diagnosed before pregnancy or before 20 weeks of gestation.
* Systemic Diseases: Chronic kidney disease, autoimmune diseases, or other significant systemic illnesses.
* Fetal Anomalies: Identified structural or genetic abnormalities in the fetus.
* Premature Rupture of Membranes: Spontaneous rupture of membranes before the onset of labor at term (37 weeks of gestation) or preterm (before 37 weeks of gestation).
Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.


Eligibility Criteria:
Inclusion Criteria:

Adult patient ≥ 18 years with cardiogenic shock defined by:

* Adequate intravascular volume
* Norepinephrine to maintain MAP at least at 65 mmHg for at least 3 hours and less than 24h. At inclusion the dose must be \<1 microgram/kg/min under norepinephrine base or \<2 microgram/kg/min under norepinephrine tartrate, OR/AND Dobutamine since at least 3h and less than 24h and at dose ≥ 5 microgram/kg/min at inclusion.
* Tissue hypoperfusion: at least 1 sign (lactate ≥ 2 mmol/l; mottling, capillary refeel time \> 3 seconds, oliguria \<500ml/24h or ≤ 20 ml/h during the last 2 hours, ScVO2 ≤ 60% or veno-arterial PCO2 gap ≥ 5 mmHg);

Exclusion Criteria:

* Myocardial sideration after cardiac arrest of non-cardiac etiology
* Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support
* Use of VA-ECMO or IMPELLA or LVAD;
* Cardiogenic choc post cardiac surgery under cardiopulmonary bypass (CPBP) weaned for less or equal of 6 hours.
* Chronic renal failure requiring hemodialysis
* Cardiotoxic poisoning
* Septic cardiomyopathy
* Previous levosimendan administration within 15 days
* Cardiac arrest with non-shockable rhythm;
* No flow time higher \> 3 minutes;
* Cardiac arrest with unknown no flow duration;
* Total duration of cardiac arrest (no flow plus low flow) \> 45 minutes;
* Cerebral deficit with fixed dilated pupils
* Patient moribund on the day of enrollment
* Irreversible neurological pathology
* Known hypersensitivity to levosimendan or placebo, or one of its excipients
* Pregnant woman, birthing or breastfeeding mother
* Minor (not emancipated)
* Person deprived of liberty for judicial or administrative decision;
* Adult subject to a legal protection measure (such as guardianship, conservatorship)
Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line

The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients.


Eligibility Criteria:
Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* Previously treated with a sulfonylurea for at least 3 months
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious cardiovascular complications
* Evidence of serious diabetic complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to glimepiride
* Other protocol-defined exclusion criteria may apply
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis

The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.

This is a phase 2, multi-part, three-year, randomized, open-label, assessor-blinded, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab in participants with severe refractory diffuse cutaneous systemic sclerosis (dcSSc) . This study comprises two cohorts:

* A Lead-in Cohort enrolling participants to receive rapcabtagene autoleucel.
* A Randomized Cohort enrolling participants to receive rapcabtagene autoleucel or rituximab.

After end of study, participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must fulfill the 2013 American College of Rheumatology/ European League Against Rheumatism classification criteria for systemic sclerosis and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy.
2. Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit.
3. Severe, progressive systemic sclerosis disease defined by at least one of the following:

   * Progressive systemic sclerosis-associated interstitial lung disease
   * Severe, progressive systemic sclerosis skin disease
   * Clinically significant systemic sclerosis-associated cardiac involvement at Screening

Exclusion Criteria:

1. Any condition during Screening that could prevent a complete washout of medications as required per protocol or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study, as judged by the Investigator.
2. Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab.
3. Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator.
4. Any medical conditions that are not related to SSc that, in the opinion of the Investigator, would jeopardize the ability of the participant to tolerate lymphodepletion and anti-CD19 CAR-T cell therapy.
5. Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy), limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening.
6. Participants with pre-existing pulmonary hypertension.
7. Significant renal pathology at Screening, including:

   * Active SSc renal crisis
   * Confirmed diagnosis of glomerulonephritis
8. Participants with uncontrolled stage II hypertension at Screening.
9. Vaccination with live attenuated vaccines within 6 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply.
A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.

Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize a minimum of 42 US cardiology clinics to an intervention arm vs. control arm. The clinic-level multi-faceted educational intervention will include strategies to develop cardiology and endocrinology partnerships and guideline-recommended care pathways with measurement and feedback to improve the care of patients with type 2 diabetes mellitus and cardiovascular disease.

Patients must be enrolled during a routine visit in a cardiology clinic, and the clinic must have at least 3 physicians and/or APPs on staff with independent patient populations.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosis of Type 2 diabetes mellitus (T2DM)
* History of at least one of the following conditions:

  1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
  2. Stroke and/or carotid artery stenosis (≥50%)
  3. Peripheral Arterial disease (defined as claudication with ABI\<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
* Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

* Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
* GFR\<30 mL/min/1.73m2
* Already on all guideline-recommended therapies for T2DM and CVD
* Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD