cyrilzakka/clinical-trials huggingface dataset:
Cohort of Heart Failure Patients

This is a prospective cohort study of patients with Heart Failure with an eighteen-month follow-up aimed to collect all demographic, clinical, biological and para-clinical data to study population characteristics, assess prognosis markers and occurrence of HF treatment side effects.

Congestive Heart failure is a frequent pathology and its prevalence increases with age. Its prognosis stays pejorative despite years of major therapeutical progress. In recent trials, all-cause mortality rates at 1-year reach up to 20% and 50% at 5 years.

Medical care of congestive heart failure is based on precise international recommendations. The association of Beta-Blockers, renin-angiotensin system blockers, mineralocorticoid receptor antagonists, represent the basis of the pharmacological treatment.

Cardiac resynchronization treatment and implantable cardioverter-defibrillator are additional efficient treatments that reduce events in appropriately selected patients.

Despite these improvements, the prognostic of congestive heart failure in registers is worse than those observed in randomized trials. This can be explained by differences in congestive heart failure patient populations and/or by a less rigorous medical care where treatments are not optimized.

The evaluation of medical care in congestive heart failure is today of utmost importance.

Integrating new pharmacological molecules, medical devices and the application of new recommendations have major interest for documentation and practical changes.

The main objective of this cohort will be to evaluate the evolution of the 12-month quality of life score of a HF patient and the characteristics and treatments associated with it.


Eligibility Criteria:
Inclusion Criteria:

* Patients with congestive heart failure confirmed during

  * Hospitalization for cardiac decompensation
  * A medical follow-up for stable congestive heart failure with at least one cardiac decompensation event
* NT-proBNP \> 500 ng/l in the month before Baseline (or BNP \> 150 ng/l)
* NYHA ≥ 2
* Aged over 18
* Signature of the informed consent

Exclusion Criteria:

* Life expectancy shorter than a month
* Patients on long term assistance or with heart transplant
* Impossibility to give patients clear information
* Loss of autonomy, dementia, major dependence
* Patients without health coverage
* Patient with no legal protection
* Pregnant woman
The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes

The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are:

1. What are the effects of the tested regimens on the level of IL-1 and IL-15.
2. What are the effects of the tested regimens on the Fasting Blood glucose?
3. What are the effects of the tested regimens on the HbA1C?
4. What are the effects of the tested regimens on the Body Mass Index?
5. What are the effects of the tested regimens on the Lipid profile?
6. What are the effects of the tested regimens on C-reactive protein?
7. What are the effects of the tested regimens on Hematological indices?
8. What are the effects of the tested regimens on Rate pressure product?

Participants will be separated into four groups:

1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days
2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.
3. Group 3 (Diabetes Type 2): 23 Pateins, will be receiving Placebo Capsule per oral once daily for 60 days
4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.

Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on Fasting Blood Glucose, HbA1c, Lipid profile, Rate pressure product, C-reactive protein, Hematological indices, and Body Mass Index. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Apperantly Healthy patients for control
* Patients diagnosed with T2DM
* Age between 18-70

Exclusion Criteria:

* Patients with T1DM
* Patients with a drug history of anabolic substances for more than 14 days duration.
* Patients with co-morbidities (e.g. CVS, renal, hepatic, and endocrine disorders)
* Pregnancy, lactation, or female patient willing for conception.
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly

The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a central laboratory) as outlined below:

  * A serum level for IGF-1 ≥1.3 x upper limit of normal range (ULN) during the screening period (applicable to both treatment naïve subjects and subjects who have stopped treatment and undergone a washout period prior to Visit 1(Week -4).
  * Subjects must have mean serum GH concentration ≥2.5 μg/L in a GH cycle (5 samples taken at 0, 30, 60, 90 and 120 minutes) during the screening period.
* The subject has undergone surgical removal of an adenoma for acromegaly at least 3 months prior to Screening, or is likely to require pituitary surgery in the future but not before completing at least 32 weeks of study treatment plus an additional follow up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for whom pituitary surgery is not an option (due to contraindications, refusal etc.) and is therefore never likely to undergo pituitary surgery.

Exclusion Criteria:

* The subject has been treated with radiotherapy within 10 years prior to Screening.
* The subject has been treated with lanreotide Autogel, lanreotide PR, pegvisomant, cabergoline or octreotide LAR within 3 months of Screening or octreotide immediate release (IR) or bromocriptin within 2 weeks of Screening.
* The subject has a history of or currently presents with clinically significant ventricular or atrial dysrhythmias ≥Grade 2, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
* The subject has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) \>8.5%).
Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria (Individuals with spinal cord injury):

* Spinal cord injury resulting in the need of a wheelchair
* BMI: 16-32 kg/m2

Inclusion Criteria (Healthy controls):

* Intact spinal cord
* Matched on gender, age and BMI to the group with spinal cord injury

Exclusion Criteria:

* Treatment with antidiabetics
* Treatment with anti-resorptive agents
* Gastrointestinal disease
* Smoking
* Long term steroid treatment
* Weight change more than 3 kg within the last 3 months.
* Overweight or intestinal surgery
Dronabinol On the Pain Experience

The purpose of this study is to identify the effect dronabinol has on opioid exposure when used as an adjunct to the current standard multi-modal pain regimen (MMPR)


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)

Exclusion Criteria:

* Pregnant
* Prisoner
* Patients placed in observation unit
* Non-acute trauma
* Admitted with primary burn injury
* Expired prior to admission
* Moribund
* Discharge from emergency department
* Left against medical advice
Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function

Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.

There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 45-65 years old (Jeong et al., 2019)
* Both genders will be included (Jeong et al., 2019)
* Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
* Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)

Exclusion Criteria:

* Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
* Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
* Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
* Neurological conditions affecting leg function (Peterson et al., 2022)
* Pregnancy (Jeong et al., 2019)
Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission

Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 and January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol.

Exclusion Criteria:

* Neonates \<34 weeks gestational age or with birth weight less than 2000 grams.
* Infants with serious congenital malformation
* Infants with a terminal disorder.
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed and evaluable locally advanced or metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose
* Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
* Prior radiotherapy must have been completed 2 weeks prior to first dose
* Adequate safety laboratory tests
* Willingness to use effective contraception

Exclusion Criteria:

* Gastrointestinal disease
* Significant hepatic disease
* Significant cardiovascular disease
* Significant ECG abnormalities
* History of pulmonary embolism or high risk of thrombosis
* Known HIV infection
* Active infection (requiring antimicrobial therapy)
* Pregnant
A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash

Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor inhibitor (EGFRi)/mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK) kinase inhibitor (MEKi)-associated acneiform Rash

This study is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in cancer participants with EGFRi/MEKi-associated acneiform rash. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with EGFRi/MEKi-associated acneiform rash.

Eligibility Criteria:
Inclusion Criteria:

* Participant has cancer
* Participant is treated with an oral or injectable Food and Drug Administration (FDA)-approved EGFRi or MEKi therapy
* Participant has EGFRi/MEKi-related acneiform rash of Grade ≥ 2 as per common terminology criteria for adverse events (CTCAE) version 5.0, and ≥ 20 inflammatory lesions on the face at screening and Day 1.

Exclusion Criteria:

* Participant has infected EGFRi/MEKi-associated acneiform rash according to investigator's evaluation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass

The purpose of this study is to measure blood levels of TXA in children having cardiac surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery. This study will help determine if the current dosing of TXA results in therapeutic blood levels.


Eligibility Criteria:
Inclusion Criteria:

* congenital heart disease requiring surgical repair with cardiopulmonary bypass

Exclusion Criteria:

* children weighing over 20 kg
* family does not want to participate in the study
Outcomes of Patients Not Responding to Antibiotics in the Community

A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community

To document and describe the clinical, microbiological, and pharmacoeconomic outcomes of two hundred patients who failed to respond to outpatient macrolide or beta-lactam therapy. Evaluable patients must have a positive culture obtained after they failed their initial macrolide or beta-lactam. The isolated pathogen must have a known MIC to the antibiotic class they failed to respond to (i.e. macrolide or b-lactam). The isolate must be available to be sent to the central laboratory for MIC testing

Eligibility Criteria:
Inclusion Criteria:

Patients who have failed to respond to at least three (ABECB and CAP) or five (AMS/ABRS/AECRS) days of macrolide or b-lactam therapy meeting all of the protocol criteria for acute bacterial exacerbations on chronic bronchitis(ABECB), community acquired pneumonia(CAP) and acute maxillary sinusitis(AMS) will be eligible for enrollment. All patients, whether enrolled retrospectively or concurrently, must have a positive culture. The pathogenic bacteria must be identified by a local laboratory and have a known susceptibility to the antibiotic class the patient failed to respond to (i.e. macrolide or b-lactam). The isolate must be sent to the Study Coordinating Center for precise MIC determination.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

1. Life expectancy \<3 months from underlying disease
2. Underlying lung carcinoma
3. Cystic fibrosis
Psycho-social Determinant for Sport Practised During Cancer

The litterature has demonstrates that physical activity can play an important role in decreasing patient mortality rates and increasing its well-being at all time of cancer. Despite this evidence, there is a weak adhesion in patients. It is therefore appropriate to look and see which may explain the high prevalence of physical inactivity in patients with cancer. The main objective of this study will be to recognize psychological and social factors which could explain the commitment or not to a physical activity in cancer patients. Besides the physical limitations related to the cancer and its treatment, socio-economic and psycho-social factors can often play an extremely important role in engagement or maintenance of sporting activity.

Different individual factors have been identified as playing an important role in physical activity (PA) practice. For example, sex, age, education level, socio-professional category, ethnicity, overweight seemed to impact PA level in general population and among cancer patient.

Beyond the disease's effect, as well as its treatment, the socio-ecological approach has identified five group of factors associated to PA practice: individual factors, interpersonal factors, environmental factors, political factors and global factors.

The aim of this mixed methods study is to identify the variables of the socioecological model facilitating PA practice, as well as PA level and preferences at different time during cancer (at diagnose, during treatment, after treatment).

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* With an histollogically confirmed non-metastatic (breast, prostate or colorectal) cancer diagnosis
* To be addressed to an oncologist before the beginning of any treatment
* Informed and having agreed to participate in the study
* Operated patient without adjuvant therapy

Exclusion Criteria:

* Presence of threatening bone lesion
* physical, cognitive or linguistics incapacity to fulfil the questionnaire
* With a life expectancy of less than 6 months
* Pregnant woman
* Under legal protection or deprived of liberty
DurAVR™ THV EU-EFS

A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.

The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve.

The study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Subjects will be consented for follow-up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
2. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
3. Eligible for transfemoral delivery of the DurAVR™ THV
4. Anatomy appropriate to accommodate safe placement of DurAVR™ THV
5. Understands the study requirements and the treatment procedures and provides written informed consent
6. Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria:

1. Anatomy precluding safe placement of DurAVR™ THV
2. Pre-existing prosthetic mitral or tricuspid valve
3. Unicuspid, bicuspid or non-calcified aortic valve
4. Severe mitral or severe tricuspid regurgitation requiring intervention
5. Moderate to severe mitral stenosis
6. Hypertrophic obstructive cardiomyopathy
7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
8. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
9. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
10. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
11. End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min
12. GI bleeding within the past 3 months
13. Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
14. Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions
Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects

Open-label, parallel, 2-arm, fixed-sequence study to investigate the effect of coadministration of a CYP3A4 inhibitor (Cohort 1, itraconazole multiple dose) and CYP3A4 inducer (Cohort 2, rifampin multiple dose) on the plasma PK of a single dose of KBP-5074 in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations

Exclusion Criteria:

* Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
* Use of any drugs or substances known to be strong or moderate inhibitors or inducers of CYP3A4 within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study.
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media


Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria:

* Children \>= 2 months and =\< 5 years
* Spontaneous draining AOM =\< 2 days Main

Exclusion Criteria:

exclusion criteria:

* Previous operation of the ear
* Chronic otitis media or tube placement with drainage \>= 3 days
* Chronic disease/immune deficiency
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT

This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Children (1-17) and adults (18-75 years old);
* Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
* Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
* No evidence of overall aGVHD \> Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
* No longer taking immunosuppressive agents for at least 30 days prior to enrollment;

Exclusion Criteria:

* Patients with GVHD Grades II-IV;
* Any cell therapy in the last 30 days;