cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Streamlined Heart Failure Optimization Protocol

The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.

The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial. It assesses whether an accelerated protocol leads to faster optimization and a greater degree of optimization.

Eligibility Criteria:
Inclusion Criteria:

* Ejection fraction of less than or equal to 40%
* Increased NT-proBNP level:
* ≥ 600 pg per milliliter or
* ≥400 pg per milliliter if they had been hospitalized for heart failure within the previous 12 months or
* patients with atrial fibrillation or atrial flutter on baseline electrocardiography were required to have an NT-pro BNP level of at least 900 pg per milliliter, regardless of their history of hospitalization for heart failure or
* recent heart failure admission or clinical diagnosis of heart failure.
* Patients who are either naïve to or taking no more than 25% target doses of Beta Blockers or ACEi or ARB before starting the trial.

Exclusion Criteria:

* Systolic BP of less than 100 mmHg on 2 consecutive measurements
* Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
* Type 1 diabetes mellitus
* Cognitive impairment that in the opinion of the investigator may lead the patient to be unable to understand and/or comply with the study medications, procedures and/or follow-up
* Uncorrected primary valvular disease
* Active malignancy treatment at time of visit 1
* Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is reliable in the judgement of the investigator\*
* Women who are pregnant or breastfeeding
* History of angioedema, or hereditary or idiopathic angioedema
* Severe hepatic impairment, biliary cirrhosis or cholestasis
* Patients who are receiving treatment with an aliskiren-containing product who have diabetes mellitus or renal impairment (eGFR \<60 ml/min/1.73 m2)

  * Highly effective methods of contraception include implants, injectables, combined oral contraceptives (the participant must have been on a stable dose for at least 3 months before entering the trial), intrauterine device, vasectomised partner, or true sexual abstinence (when this is the preferred and usual lifestyle of the patient and does not include periodic abstinence \[e.g. calendar, ovulation, symptothermal or post-ovulation methods\]). Use of such methods must be maintained throughout the trial and for 7 days after the end of the trial.
Dysthymia: Associated Costs, Treatment and Change Process

The study evaluates cost and effect of inpatient versus outpatient treatment of dysthymia, as well as investigates the processes through which psychotherapy works in treating dysthymia.

Inpatient treatment allows a more intensive treatment and allows the patient to be in a context where it is possible to focus on the processes in therapy with minimal interruption. Outpatient treatment is much less intensive but allows the treatment process to unfold in the context where the patient is experiencing the problems that brought them to therapy. It is not clear which of the contexts will be more effective in alleviating symptoms of dysthymia. Further, as dysthymia is a very costly disease for society it is of interest to know if the two treatments are cost-effective, and which one is the most cost effective.

A great paucity on dysthymia research ha left the psychotherapy field without an understanding of the processes through which dysthymia is changed. This study will investigate the change process through frequent assessments of common factors, psychological processes, symptoms, heart rate variability and cognitive attention bias.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site: Persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (DSM5); which includes an International classification of disorders-10 (ICD-10) diagnosis of depression, dysthymia, recurrent depression. unsuccessful previous treatments. living within driving distance from the treatment facilities.

Exclusion Criteria:

* current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.
A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* metastatic renal cell cancer (clear cell type);
* nephrectomy;
* absence of proteinuria.

Exclusion Criteria:

* prior systemic treatment for metastatic renal cell cancer;
* major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
* presence of brain metastases or spinal cord compression;
* ongoing need for full dose anticoagulants;
* uncontrolled hypertension;
* clinically significant cardiovascular disease.
Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis

The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life.

Eligibility Criteria:
Inclusion criteria

* Clinical diagnosis of severe sepsis
* At least 18 years old
* Patient or legally authorized representative able to provide informed consent

Exclusion criteria

* Severe lung injury (acute respiratory distress syndrome)
* Immunocompromised
* Severe liver disease
* Inflammation of the pancreas, organ rejection, or burns to more than 30% of body
* Enrolled in another clinical trial
* Already participated in this or other rPAF-AH study
* There is not a commitment to aggressive treatment
* Has a disease with life expectancy less than 6 months
Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia

This is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. Patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. The study will involve retrospective and prospective evaluations.

Safety will be assessed through reporting of serious adverse events (SAEs) related to study procedures.

The aim of this study is to identify and evaluate cardiotoxicity in patients with diagnosis of breast cancer, lymphoma or leukemia scheduled to receive anthracycline-based chemotherapy (Cohort A: prospective evaluation); and patients undergoing or having received within the last 5 years anthracycline-based chemotherapy (Cohort B: retrospective and prospective evaluations). Part A and B will be conducted in parallel. This study also has the objectif of identifying biomarkers of cardiotoxicity including inflammatory response proteins and clonal hematopoiesis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at time of CT initiation
* Signed informed consent
* Patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects)
* Planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline
* Left ventricular ejection fraction (LVEF) ≥50% pre-chemotherapy
* The participant is willing to undergo CMR scans and all other required study procedures

Exclusion Criteria:

* Known cardiomyopathy and/or LVEF \<50%
* Known heart failure
* History of myocardial infarction (MI)
* Clinically significant cardiac valvular disease
* Clinically significant pericardial effusion
* Allografted subjects
* Contraindications to CMR testing (Cohort A \& prospective evaluation for Cohort B):

  * Pacemakers, other metallic implants or severe claustrophobia
  * Weight \> 135 kg
  * Patients with a history of previous allergic reaction to gadolinium
  * Patients with history of seizure
  * Renal insufficiency (eGFR of \< 45ml/min/1.73m2 using the MDRD equation)
  * Pregnant or breastfeeding women
Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload

\&#34;Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function. This dysfunction exacerbates the hemodynamic burden on the right heart, leading to secondary pulmonary hypertension-a condition uniquely predisposed to myocardial fibrosis. The role of right ventricular (RV) fibrosis in pulmonary hypertension induced by bicuspid aortic stenosis remains an area of active investigation. Modifications in the extracellular matrix collagen network may mitigate excessive dilation of the pressure-overloaded right ventricle; however, fibrosis concurrently compromises cardiac performance. An increasing body of experimental evidence indicates that fibrosis is pivotal in both the onset and progression of right ventricular dysfunction. In cases of secondary pulmonary hypertension, the right ventricle endures a posterior load approximately five times greater than normal, rendering these circumstances an excellent model for examining pressure loading effects on RV structure. Notably, severe RV fibrosis persists even after hemodynamic normalization following mitral valve repair; thus, preoperative evaluation of RV fibrosis is essential for optimizing patient outcomes in individuals with secondary pulmonary hypertension attributable to bicuspid aortic stenosis.

In recent years, myocardial nuclear imaging has gained prominence as a tool for assessing myocardial fibrosis. Initial studies investigated FAPI myocardial nuclear imaging\&#39;s efficacy in evaluating left ventricular fibrosis among patients with aortic stenosis; subsequent research elucidated its correlation with sudden cardiac death risk in individuals suffering from obstructive hypertrophic cardiomyopathy.

The comprehension regarding how myocardial fibrosis impacts right ventricular function within patients experiencing pulmonary hypertension due to bicuspid aortic stenosis remains limited. The association between histological RV fibrosis and adverse prognostic indicators as well as outcomes related to right heart failure warrants further exploration.\&#34;


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Tricuspid valve insufficiency; must understand the purpose of the study and signed an informed consent form;

Exclusion Criteria:

Combined coronary artery stenosis; Combined with aortic aneurysm related diseases; Patients with congenital heart disease;
Effects of a Plyometric Training Program on Youths With Different Biological Maturity in Sport

This randomized controlled trial aims to assess the effectiveness of a 12-week plyometric training regimen on improving power, speed, and agility among boys aged 10 to 18 years who are actively engaged in sports and exhibit differing levels of biological maturity. The study seeks to determine how maturation affects the responsiveness to the training program, potentially influencing future sports training approaches for young athletes.

The main objective of this project is to assess the impact of a plyometric program on power, speed, agility, reactive strength index and stiffness in male athletes of different levels of maturation. The study takes the form of a short-term experiment (12 weeks), involving 30 young athletes with a minimum of two years of experience in systematic sports training. Participants are divided into an experimental group and a control group. The experimental group undergoes a 12-week plyometric training program, implemented twice a week within training sessions immediately following warm-ups. The control group engages in technical-tactical exercises. The program is developed by the authors of the research project based on current knowledge and requirements for creating an effective and safe plyometric program. Randomization is performed using a computer random generator. Participants undergo two testing sessions: one prior to the training intervention and the other one week after its completion. Age, height, weight, and body composition are measured using a personal scale with an integrated stadiometer. Tests include a 30-m sprint, countermovement jump, broad jump, unilateral triple jump, drop jump (reactive strength index), 20 submaximal vertical jumps (lower limb stiffness), BlazePod reaction test, and 505 agility test. The maturity status of the participants is evaluated using the Mirwald method and is used as a covariate in the subsequent statistical analysis. Findings of this research may provide crucial insights for targeted integration of plyometric methods during the developmental and maturation phases of young athletes.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 2 years of organized sports participation.
* Good health as confirmed by a pre-study medical screening.
* Signed informed consent from the legal representative and verbal assent from the participant.

Exclusion Criteria:

* Any serious lower limb injury in the past 6 months.
* Any current or historical mental health disorders.
* Any condition deemed by the medical screener as a contraindication to vigorous physical activity.
Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment

Checkpoint inhibitors like the PD-1 antibodies Pembrolizumab and Nivolumab represent standard of care for patients with metastasized melanoma. Numerous high quality studies demonstrate that endurance and resistance training in cancer patients is safe and elicits beneficial effects. However, there is no systematic experience with regard to exercise interventions in patients undergoing checkpoint inhibitor treatment. Therefore, the Sportivumab Study aimed to investigate safety, feasibility and effectivity of a 12 week combined resistance and endurance exercise intervention program during checkpoint inhibitor treatment. It is planned to enroll 40 patients. Participants will be randomized into an experimental and a wait-list control group (20 per group). The wait-list control group will receive the exercise intervention program after week 13 of enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Patients at age ≥ 18 years
* Diagnosed with melanoma stage (independent of stage)
* Assigned to receive an immunotherapeutic regimen (PD-1 antibody +/- Ipilimumab)
* Sufficient German language skills
* Willing to train at the exercise facilities twice per week and to take part in the scheduled testing at the National Center for Tumor Diseases
* Signed informed consent

Exclusion Criteria:

* Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
* Engaging in systematic intense exercise training (at least 1h twice per week)
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).

All patients who complete part 1 of the study have the option to enter the extension.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 and over
* Diagnosed with Interstitial Cystitis as defined by protocol
* Able and willing to complete questionnaires and diary
* Able to comply with visit schedule including Day 14 Removal visit
* Completion of blinded study prior to enrolling in unblinded part of study

Exclusion Criteria:

* Pregnant or lactating women
* Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
* History or presence of any condition that would make it difficult to evaluate symptoms
* Did not complete blinded study (unblinded part of study only)
TolerUp Enteral Feeding Protocol

This prospective, observational, multi-center study will follow children with cerebral palsy who decided to switch to an enteral product that contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy
* Fed with an enteral product that does not contain partially hydrolyzed protein and medium chain triglycerides and decided to be switched to an enteral product contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance
* Fed by tube, using enteral tube feeding as sole source of nutrition
* A signed and dated informed consent by subject's legally acceptable representative

Exclusion Criteria:

* Chronic diseases other than cerebral palsy (e.g. diabetes mellitus, renal, liver, endocrine diseases, malignancy)
* Intestinal obstruction
* Dialysis treatment
* Requirement of artificial ventilation
* Requirement of parenteral nutrition
* Normal nutrition in addition to enteral tube feeding
* Allergy or intolerance to any ingredient of the study product
* Currently participating in another clinical or non-clinical study
Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors

The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.

Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.

Eligibility Criteria:
Inclusion Criteria

* Male or female ≥18 years old
* Patients with histologically confirmed solid tumors who:

  o Part 1: have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapy
* Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug.
* All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤Grade 1 or Baseline) prior to study treatment administration
* Patients with stable, treated brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening.
* Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
* Karnofsky performance status ≥70%
* Life expectancy ≥3 months
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria

* Other than the primary malignancy, active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g., chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in-situ of the cervix
* Chemotherapy within 28 days prior to C1D1
* Biological therapy within 5 half-lives prior to C1D1
* Radiation therapy within 28 days or 5 half-lives prior to C1D1, whichever is longer
* Investigational drug use within 28 days or 5 half-lives, whichever is longer, prior to C1D1
* Part 1 only: (a) Patients with active or a history of glucose intolerance or diabetes mellitus and (b) Hemoglobin A1c ≥7%
* ≥Grade 2 sensory neuropathy at baseline
* Uncontrolled intercurrent illness (i.e., active infection) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the patient's ability to participate
* Refractory nausea and vomiting, malabsorption, small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption
* Mean QTcF ≥450 msec (for males) or ≥470 msec (for females) at Screening
* The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study