cyrilzakka/clinical-trials huggingface dataset:
Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal

The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12 to 33%. The occurrence of delirium on the surgical ward after intensive care unit (ICU) dismissal in AAA patients remains unclear. Differences in outcomes between a delirium on the ICU and a delirium on the surgical ward have not been previously investigated.

Delirium is a frequent complication in patients who underwent open AAA surgery. This study demonstrated that patients on the surgical ward remain at risk for developing a delirium after ICU dismissal. Physicians should therefore maintain a high level of awareness for delirium in AAA patients who return to the surgical ward after ICU dismissal. This simultaneously emphasises the necessity of delirium preventive measures and early recognition on the surgical ward in order to improve clinical outcomes.

The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12 to 33%. The occurrence of delirium on the surgical ward after intensive care unit (ICU) dismissal in AAA patients remains unclear. Differences in outcomes between a delirium on the ICU and a delirium on the surgical ward have not been previously investigated.

An observational cohort study was conducted that included all patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018. The diagnosis of delirium was verified by a psychiatrist or geriatrician using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. Cox proportional hazards regression analysis was used to analyse 6- and 12-months survival rate.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018.

Exclusion Criteria:

* Patients that did not survive surgery
* Patients that did not go to the intensive care unit postoperatively.
A Clinical and Radiographic Evaluation of Low-Level Diode Laser Full Pulpotomy in Vital Permanent Teeth

In this study, patients with symptoms of irreversible pulpitis in mature permanent molars were treated with two pulpotomies techniques after random allocation in either 2 groups: Diode laser pulpotomy and traditional pulpotomy using bioactive materials (retro mineral trioxide aggregate ) with each group.The null hypothesis of the study was there would be no difference in success rate between Diode laser and traditional methods of adult pulpotomy .

In this study, 40 patients with symptoms of irreversible pulpitis in mature permanent 1st and 2nd molars were treated with two pulpotomy techniques after random allocation in either 2 groups: traditional pulpotomy and low-level diode laser pulpotomy. The pulp in each group was capped with Retro MTA . In the traditional pulpotomy group, the coronal pulp was removed by the traditional method while in the low-level diode laser pulpotomy group, the radicular pulp was biostimulated using low-level diode laser beam with parameters (970nm, power .5Watt, duty cycle 50%, and frequency 5H) 10 sec for each pulp stump in non-contact mode. After that, the capping material was prepared as manufacturer's instructions and applied over the pulp stamp, the final restoration was then placed in both groups. Patients were followed up after 6, 12, and 18 months to evaluate success and failure.

Eligibility Criteria:
Inclusion criteria:

* permanent 1st and 2nd molar
* irreversible pulpitis
* restorable

Exclusion criteria:

* Non-restorable teeth.
* Teeth with buccal restoration.
* Non-vital teeth that are not responsive to thermal stimuli or electric pulp test.
* Presence of swelling or sinus tracts.
* Teeth which showed sensitivity to percussion.
* Teeth with grade Ⅱ and Ⅲ mobility.
* Teeth with immature apices.
* Teeth with internal or external resorption or teeth with periapical pathosis.
A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension

Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents grant permission to participate.


Eligibility Criteria:
Inclusion Criteria:

* CHILDREN HAVE BLOOD PRESSURE LEVEL =\>95TH PERCENTILE FOR AGE,GENDER \& HEIGHT
* PARENTAL CONSENT MUST BE GRANTED

Exclusion Criteria:

* BLOOD PESSURE IS =\>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER \& HEIGHT
* SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS

Other protocol-defined exclusion criteria will apply.
Bioequivalency Study of Sertraline Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* Treatment with any triptan within 30 days prior to or during the study.
* History of allergic or adverse response to sertraline or any comparable or similar product.
Analysis of Circulating Tumor Markers in the Blood (ALCINA)

Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.

Exploratory multi-cohort study including different types of cancer (different organs and/or different histological types).

Each kind of blood-borne biological markers analyses corresponds to a cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with any tumoral disease (proven or suspected), of any type and stage
2. More than18 years old
3. Signed informed consent form

   Additional inclusion criteria if a tumor sample is needed:
4. Tumor considered as accessible by biopsy
5. Normal blood coagulation tests on the last blood analysis

Non-inclusion Criteria:

1. Patient in detention or protected by the law
2. Patient who cannot comply with the study follow up for geographical, social or psychological reasons

   Additional non-inclusion criteria if a tumor sample is needed:
3. Anticoagulant or antiaggregant that cannot be interrupted for the biopsy
4. central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)
Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)

Safety and Efficacy Study of BBM-P002 in subjects with primary advanced Parkinson's disease

Parkinson's disease is a neurodegenerative disorder involving loss of dopaminergic neurons in the substantia nigra. This study is a single-center, single-arm, open-label, treatment clinical study to evaluate the safety, tolerability and efficacy of an adeno-associated virus (AAV)-based gene therapy, termed BBM-P002, will be injected into the brain via a neurosurgical procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with idiopathic Parkinson's disease.
2. Males and females, 40 to 70 years of age (inclusive).
3. Disease duration from diagnosis of ≥5 years. Responsiveness to dopamine.
4. Good compliance and regular follow-up. Completion of Parkinson's disease patient diary accurately during follow-up, and family members, guardians or caregivers can help subjects fill in patient diary.

Exclusion Criteria:

1. Atypical or secondary parkinsonism.
2. History of coagulopathy, abnormal bleeding or hemopathy family history. Other bleeding risk which increases risk of surgery determined by investigator.
3. Any type of prior gene therapy.
4. Clinically significant electrocardiogram (ECG) abnormalities.
5. Concomitant disease including unstable cardiovascular and cerebrovascular diseases within 3 months, uncontrolled hypertension, sever postural hypotension, poorly controlled diabetes, history of malignancy.
6. Acute or chronic: hepatitis B (HBV); hepatitis C (HCV) infection must have completed curative antiviral treatment with HBV/HCV viral load below the limit of quantification or be negative due to prior treatment or natural resolution to be eligible for enrollment. Subject with Human Immunodeficiency Virus (HIV) or Syphilitic serum positive should be excluded.
Effect of Enteral Genistein Supplementation in Sepsis

To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis

Sepsis is a state develops as a response to severe infection with high mortality rate. Incidence of sepsis among patients admitted to hospitals is 2%. Annual incidence of sepsis is 50-95 for 100.000 population and incidence is increasing approximately 9% each year. Severe sepsis and septic shock is the most frequent reason for mortality in intensive care units (ICU). There is exaggerated and irregular host response in sepsis. Cytokines such as interleukin-1, interleukin-6, interleukin-8, tumor necrosis factor-α, Interferon-γ and high mobility group box-1 are released as response to invading microorganisms and they play a major role in sepsis pathogenesis.

Soybean proteins are used for prevention and treatment of cardiovascular diseases, osteoporosis and different cancer types.

Soy isoflavones such as genistein, daidzein and glycitein are the main components for cancer prevention. Genistein is the dominant isoflavones.

The main mechanism for anti-inflammatory effect of genistein is related to transcription nuclear factor (NF-kB) and inhibition of chemokine-8. The risk for prostate cancer was proven to decrease in epidemiological studies.

NF-kB plays a central role for inflammatory cytokine release, prevents apoptosis and induces tumor cell growth. The effect of topoisomerase II inhibitory chemotherapeutic agents is increased with NF-kB inhibition.

Hypothesis

1. Addition of genistein to enteral nutrition in patients with sepsis can play an important role to decrease inflammatory cytokines.
2. Morbidity can be decreased with lower levels of inflammatory cytokines in patients with sepsis.

Eligibility Criteria:
Criteria: inclusion criteria:

* Patients with sepsis above 18 years of age.
* Expected duration of ICU survival more than 48 hours.
* Patients receiving enteral nutrition (EN)
* Sepsis diagnosis within first 12 hours

Exclusion Criteria:

* Presence of thyroid dysfunction
* Presence of hyperlipidemia
* Patients with nill by mouth and not receiving enteral nutrition
The Munich Cardiovascular Adaptation in Young Athletes Plus Study

The aim of the 3-year longitudinal study is to investigate the cardiovascular system's response to training loads in young athletes. For the first time, these parameters will be examined alongside biochemical and metabolic laboratory measures, as well as body composition. The study focuses on the impact of training frequency and intensity, as well as performance, on cardiovascular structure and function.

The following research questions are being investigated:

What structural and functional cardiovascular changes can be observed in young athletes compared to the norm?

What is the relationship between cardiac and vascular parameters depending on the athletic load (training frequency and intensity) as well as athletic performance?

Do cardiac/vascular parameters change over the course of the study, and what role do athletic load (training frequency and intensity) as well as athletic performance play?

What laboratory chemical changes can be observed in young athletes depending on the athletic load (training frequency and intensity) as well as athletic performance?

What connections exist between laboratory chemical parameters and cardiac and vascular parameters in young athletes?

Is there a correlation between structural and functional cardiovascular changes and body composition as well as eating behavior?


Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥7 and \<18 years, presenting for sports medical examination and meeting the criteria mentioned for a period of 3 years
* Athletes participating in competitions, engaging in regular training in a primary sport, being members of a club or association, and training ≥3 hours per week
* The last intensive training must have occurred 12 hours ago to ensure sufficient recovery
* No acute infection, confirmed by a medical examination on the day of testing
* No orthopedic injury, confirmed by a medical examination on the day of testing
* No chronic disease, confirmed by a medical examination on the day of testing
* Clearance for cardiopulmonary stress testing after a medical examination on the day of testing
* Annual participation (1 time per year) in the sports medical examination for 3 years
* Maintaining regular training, training duration ≥3 hours per week, and participation in competitions

Exclusion Criteria:

* Presence of an acute infection, acute orthopedic injury, or chronic disease
* Missing consent from the participant and/or legal guardian
Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria

The University of North Carolina (UNC) and Partners for Development (PFD), an American non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for increasing the proportion of participants who exclusively breastfeed their infants until 6 months. The investigators will build upon PFD's existing microcredit and reproductive health program by adding face-to-face breastfeeding education during borrowers' meetings and bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention group will increase by 15%. The investigators will measure the effectiveness of the intervention by conducting baseline and final surveys with a cohort of 485 female borrowers who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be analyzed using logistic regression adjusting for possible confounders and the effect of clustering.


Eligibility Criteria:
Inclusion Criteria:

* Participation in a microcredit borrower group sponsored by Partners for Development in Bauchi, Dass, or Ganjuwa Local Government Authority in Bauchi State, Nigeria
* Female (15-45 years)
* Pregnant at baseline

Exclusion Criteria:

* Female (\<15 years)
* Not pregnant
Aminoglycosides and Duct

The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms


Eligibility Criteria:
Inclusion Criteria:

infants born at or above 32 weeks of gestation

-

Exclusion Criteria:

* infants who are unlikely to survive or have congenital heart defects
[18F]FES PET/CT in Endocrine Refractory Breast Cancer

In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluoroestradiol (FES).

This study will evaluate \[18F\]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy. Imaging will occur prior to starting new therapy. Some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures. This is an observational study in that \[18F\]FES PET/CT will not be used to direct therapy decisions.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Recurrent or metastatic cancer that is of known or suspected breast origin - may be biopsy proven or identified on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT)
3. History of ER+ pathology (ER+ may be confirmed from surgery or biopsy of primary breast cancer or lymph nodes, and/or surgery or biopsy of a metastatic site, metastatic biopsy is not required)
4. At least one site of disease outside of the liver that is seen on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT); patients with measurable or nonmeasurable disease are allowed.
5. History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
6. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion Criteria:

1. Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
4. History of HER2/neu positive cancer (IHC 3+ and/or FISH positive) as assessed by medical record review at screening
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).

This is a two-part (1 year double-blind inclisiran versus placebo/ 1 year open-label inclisiran) multicenter study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C) on stable standard of care background lipid-lowering therapy. The primary objective is to evaluate the effect of inclisiran compared to placebo in reducing LDL-C (percent change) at Day 330.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous Familial Hypercholesterolemia (HoFH) diagnosed by genetic confirmation
* Fasting LDL-C \>130 mg/dL (3.4 mmol/L) at screening
* On maximally tolerated dose of statin (investigator's discretion) with or without other lipid-lowering therapy; stable for ≥ 30 days before screening
* Estimated glomerular filtration rate (eGFR) \>30 mL/min/1.73 m2 at screening

Exclusion Criteria:

* Documented evidence of a null (negative) mutation in both LDLR alleles
* Heterozygous familial hypercholesterolemia (HeFH)
* Active liver disease
* Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
* Major adverse cardiovascular events within 1 month prior to randomization
* Previous treatment with monoclonal antibodies directed towards PCSK9 (within 90 days of screening)
* Treatment with mipomersen or lomitapide (within 5 months of screening)
* Recent and/or planned use of other investigational medicinal products or devices

Other protocol-defined inclusion/exclusion criteria may apply
Pancreas Volume and Diabetes Status Following Pancreatectomy

This study will enroll 100 patients scheduled to undergo a pancreatectomy.

The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves.

The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves. Patients will be followed up to one year to track their diabetes status, postoperative outcomes and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing pancreatectomy at our institution (e.g., pancreaticoduodenectomy, distal pancreatectomy, distal pancreatectomy and splenectomy, central pancreatectomy).

Exclusion Criteria:

* All patients who are on steroids or other medications whose potential side effects include development of diabetes mellitus or elevated blood glucose.
* Pregnant or nursing women.
* Patients with uncontrolled diabetes (HbA1c \>8%).
3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).

Radical radiation therapy plays an important role in the management of prostate cancer, yielding comparable long-term outcomes to surgery. Unfortunately, long term disease free survival data using PSA criteria have shown that less than 50% of high-risk patients are free of disease at 10 years. To improve on the results of conventional dose radiotherapy dose escalation with three-dimensional conformal radiation has been employed. Due to the irregular shape of the prostate and the variable motion of this organ there is substantial radiation of adjacent normal surrounding tissue during treatment which results in radiation-induced toxicity. Intensity-modulated radiation therapy (IMRT) is a new form of radiation therapy. Preliminary evidence suggests that IMRT improves the dose distribution during radiation therapy of the prostate. The hypothesis of this study is that IMRT delivered using Helical Tomotherapy can reduce late toxicity of radical radiotherapy as compared to three-dimensional conformal radiation (3DCRT) in high-risk prostate cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. A pathologic diagnosis of adenocarcinoma of the prostate
2. Age greater than 18 years
3. ECOG performance status of 2 or less.
4. Presence of any of the following high risk features:

   * Clinical stage cT3-4 or
   * Gleason score 8-10 or
   * Pre-treatment PSA \&gt; 20ng/ml or
   * Clinical N1/N2 or pathologic N1/N2

Exclusion Criteria:

1. Patients with contraindication to radical radiation therapy including inflammatory bowel disease
2. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
3. Prior pelvic radiotherapy for other malignancies
4. Prior cytotoxic chemotherapy
5. Prior orchiectomy, radical prostatectomy, cryotherapy or thermal ablation therapy for prostate cancer