cyrilzakka/clinical-trials huggingface dataset:
Preoperative BNP and MINS in AAA Open Repair

The aim of this study was to investigate whether preoperative B-type natriuretic peptides serves as an independent predictor of myocardial injury after non-cardiac surgery (MINS) in abdominal aortic aneurysm open repair.

The incidence of MINS was compared between the lower BNP and higher BNP groups, and a stepwise logistic regression analysis was performed to evaluate the predictors for MINS.

Eligibility Criteria:
Inclusion Criteria:

patients who underwent open repair with AAA from September 2010 to October 2021

Exclusion Criteria:

1. Ruptured AAA
2. Traumatic aortic injury
3. Absence of troponin-T value within 30 days of surgery
4. Diagnosis of elevation of troponin-T due to non-ischemic cause (ex: sepsis, pulmonary embolism, atrial fibrillation, cardioversion, etc.)
5. Insufficient medical records
The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.

The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants. We hypothesize that exposure to appropriately designed womb-like sounds in the Neonatal Intensive Care Unit (NICU) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate.

This proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants 29-33 weeks gestational age at birth
* 34 weeks corrected age
* off respiratory support \>1.5 lpm

Exclusion Criteria:

* on respiratory support \>1.5 lpm
* congenital anomalies
A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults

This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.

This single ascending dose (SAD), randomized, single-blinded, placebo controlled study is the first study and it is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of KJ103 in healthy subjects after a single intravenous dose. It will include up to 34 healthy subjects in up to five dose groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the ages of 18 and 55 years, inclusive.
2. Male body weight ≥50kg, female body weight ≥45kg, body mass index (BMI) within 18 kg/m2to 35 kg/m2, inclusively.
3. Immunoglobulin (IgG) levels at screening is within the normal range.
4. Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, hematology, biochemistry, and urinalysis.

Exclusion Criteria:

1. History of or diagnosis at screening of any clinically significant immunodeficiency including but not limited to immunoglobulin A deficiency.
2. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
3. Any clinically significant illness in the 28 days prior to the first study drug administration.
4. Any history of tuberculosis.
5. Positive screening results to HIV Ag/Ab combo, syphilus, hepatitis A, hepatitis B surface antigen or hepatitis C virus tests.
6. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration.
7. Current use of tobacco or nicotine-containing products exceeding 10 cigarettes per day or equivalent.
8. Received an investigational drug (or was using an investigational device at the time) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever is longer.
9. Female who is lactating.
10. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration.
Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects

Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. Virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. It seems that the use of VR could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. This study aims at quantitatively investigating the effectiveness of an HMD immersive virtual reality system on the upper limb functioning in subacute stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week
* upper limb motor impairment defined by an upper extremity score \<55 on the Fugl-Meyer Assessment

Exclusion Criteria:

* neurological conditions in addition to stroke that may affect motor function
* other medical conditions likely to interfere with the ability to safely complete the study protocol
* impaired cognitive functioning that influences the ability to give informed consent
* severe neuropsychological disorders
* visual impairment
* severe upper-limb pain defined as \> 7 on the Visual Analogue Scale
Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

This study is intended to assess the effects of astaxanthin use on pain, physical function, and inflammation as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS) scores and levels of inflammatory biomarkers in subjects taking astaxanthin. If improvements in pain, function, and/or markers of inflammation could be demonstrated with the use of astaxanthin, this may suggest the potential for astaxanthin to be used in management of knee osteoarthritis (and possibly other forms of osteoarthritis) with less evident toxicity than seen with the presently available standard therapies (e.g. NSAIDS, opioids).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Symptoms of knee pain
* Radiographic evidence of mild to moderate arthritis
* Able to provide written consent on their own behalf

Exclusion Criteria:

* Pregnancy
* Current tobacco use
* Current substance abuse (alcohol or drug)
* Presence of significant cardiovascular, pulmonary, hepatic, or renal disease
* Prior history of knee trauma or surgery
* Gout or pseudogout
* Significant depression or anxiety scores on PHQ-9 and GAD-7, or pre-existing diagnosis of a significant mental health disorder
* Presence of other chronic pain syndromes such as chronic low back or neck pain, fibromyalgia, or complex regional pain syndrome
* Presence of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease
* Symptomatic involvement of multiple other joints with osteoarthritis
* Known allergy to fish or astaxanthin
* BMI greater than 35
* Participation in another clinical trial
Antigravity Treadmill Training on Gait Characteristics and Balance

Severe burn injuries are associated with hypermetabolic responses and increased catabolism. These generalized changes lead to a vast loss of muscle mass and cause reduced muscle strength and endurance, limited walking ability, and reduced functional mobility Recently, the antigravity treadmill or lower body positive pressure (LBPP) technology has been developed as a unique system of maintaining a participant's body weight all through treadmill training and developing low-load treadmill walking using a unique treadmill system that allows gaining the benefits of low-load treadmill walking without interrupting with locomotion dynamics

Objective: This single-blind randomized controlled trial aimed to examine the effects of antigravity treadmill training on gait characteristics and balance in healed adult burned patients.

Methods: Fifty-five adult burn patients were chosen to participate in this study, their ages ranged from 18 to 35 years. They were randomly allocated to Alter G (ALG) (n=22), and control (Cont) (n=23) groups. The control group received a traditional physical therapy program (TPTP), three times per week. In contrast, the experimental group received antigravity treadmill training (30 minutes,3 times/week, speed 0.1 m/sec, 75% body weight) in addition to the traditional physical therapy program given to the control group. All study participants followed the instructions recommended for the exercise performed (three days per week) in terms of intensity, type, and duration to limit any difference between groups, as well as instructions about not exercising the rest of the week. During the study period, both groups received standard medical care. outcome measures: gait characteristics and postural stability indices were measured at the baseline (pre) and end of 12 weeks of intervention (post). The Statistical Package for the Social Sciences (SPSS) software was used for statistical analysis. The Shapiro-Wilk test was used to determine the normality of the data. The paired t-test was used to test within-group comparisons of mean changes in muscle strength, gait characteristics, and postural stability indices. The unpaired t-test was used to compare between groups. P\<0.05 was chosen as the level of significance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with circumferential lower limb deep second to third-degree thermal injury
* Burns extending from the lower trunk to the foot were considered
* The total body surface area (TBSA) ranges from 35 to 50%
* All patients completed the same physical therapy program during hospitalization peroid

Exclusion Criteria:

* Lower limb prosthesis
* Severe musculoskeletal disorders
* Serious cardiovascular insult
* Participation in an outside physical training program
* Fracture
* Medication that negatively impacts the study's results
* Brain injury
* Vestibular disorders
* Visual disorders
* History of epilepsy
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.

This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.

Eligibility Criteria:
Inclusion Criteria:

* Must be healthy males or females between 18 to 45 years old, inclusive
* Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg

Exclusion Criteria:

* History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
* Female subjects who are pregnant or breastfeeding
* Any previous treatment with Human Albumin Interferon fusion protein

Other protocol-defined inclusion/exclusion criteria may apply
Direct Pulp Capping in Primary Molars

The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.

After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet.

Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method.

2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal.

All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.

Eligibility Criteria:
Inclusion Criteria:

* Cooperative child and compliant parent.
* Complete physical and mental health.
* Children who are known to be healthy and free from systemic diseases.
* Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.

Exclusion Criteria:

* A deep carious lesion in close proximity to the pulp with an intact lamina dura.
* Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region.
* Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.
Developing Methods for Completing Future Satiety Studies

Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is recognized a useful strategy for weight management. Recently, the category of foods marketed as having satiating effects has seen significant growth and this trend is expected to continue. The purpose of this project is to develop and validate methods for assessing the degree of satiety induced by foods and natural health products using commercially available food products.

This trial will examine the effects of a commercially available yogurt (containing added protein and fibre) on self-reported satiety and hunger, as well as food intake in both controlled and uncontrolled settings.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women with regular hormonal contraceptive use, aged between 20 and 35 years
* BMI of 20.0-24.9 kg/m2
* Regular yogurt consumers (i.e. \> 3 servings per week)

Exclusion Criteria:

* Taking any regular medications or herbal supplements other than a multivitamin or folic acid supplement.
* History of cardiovascular disease (including hypertension), diabetes, hypoglycemia, gum disease or any other medical condition
* Vegans or vegetarians who exclude dairy products
* Milk allergies or any other food allergies
* Anyone with known anaphylactic allergic reactions, food or otherwise
* Dislike or unwillingness to consume study foods
* Gastrointestinal disease or disorders, including Celiac disease, lactose intolerance, irritable bowel syndrome, etc.
* BMI \<20.0 or \> 25.0 kg/m2
* Current participation in diet/weight-loss programs and/or changes of \> 5 kg body weight within the past 6 months
* Unusual dietary patterns (i.e. routinely skipping breakfast or other meals)
* Unusual sleep patterns (i.e. shift workers)
* High habitual intake of caffeinated beverages or alcohol
* Restrained or disinhibited eaters, defined by the Three Factor Eating Questionnaire
* Smokers
Effect of Grape Seed Extract on Blood Pressure

The purpose of this study is to determine whether an 8-week intervention with grape seed extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal female with elevated daytime blood pressure values.

Background: High blood pressure is a major risk factor for morbidity and mortality from stroke, heart disease, and end-stage renal disease. Several studies have shown that dietary polyphenols derived from fruits and vegetables (including those from grape products) can lower blood pressure in both normotensive and hypertensive subjects.

Study objectives: Primary objective: To study, in subjects with elevated blood pressure levels, the effects of grape seed extract high in polyphenols, on daytime ambulatory systolic and diastolic blood pressure (SBP and DBP, respectively). Secondary objective: To explore mechanistic pathways responsible for the blood pressure lowering efficacy in case a blood pressure lowering effect is shown.

Study population: Each treatment group will consist of 35 men and postmenopausal women (35-75 years of age) with daytime SBP between 120 and 159 mmHg. The total number of subjects will be 70.

Study design: This study will have a randomized, double-blind, placebo-controlled parallel design with 2 treatments, a 1-week run-in period, and an 8-week intervention period. The 2 treatments will consist of placebo capsules and capsules with grape seed extract.

Study outcomes: Daytime ambulatory blood pressure (ABP) will be measured every 20 minutes for 2 x 12 hours at baseline and 2 x 12 hours at the end of intervention. Furthermore, before and after the intervention period, 24-hour urine will be collected and 2 blood samples will be taken in order to investigate mechanistic pathways and platelet function.

Eligibility Criteria:
Inclusion Criteria:

* Male and postmenopausal female subjects in the age ≥ 35 and ≤ 75 at start of the study
* BMI ≥ 18.5 and ≤ 30.0 kg/m2
* Apparently healthy: no reported diseases that may affect study results and pre-selected blood parameters within normal range
* Informed consent signed
* Willing to refrain from supplements, food products, diets and drugs that may interfere with the outcomes of the study

Exclusion Criteria:

* Mean of 6-hour ambulatory SBP \< 120 mmHg, \> 159 mmHg and/or DBP \> 99 mmHg
* 10-year risk mortality risk on CVD \> 10% according to NHG standard M84. For subjects \> 65 years of age and SBP ≥ 140 mmHg the study physician will assess eligibility
* Irregular pulse or pulse \< 50 or \> 100 bpm
* Intense exercise \>10 h/w
* Reported weight loss/gain \> 10% of body weight in the 6 month preceding pre-study examination
* The habit of smoking during the past year
Compensatory Cognitive Training in Clinical High Risk Latino Youth

This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.

Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.

This is a 12 week randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.

Study participants will be measured 3 times, at baseline, 12 and 24 weeks on all outcome measures. Study hypothesis: Study participants receiving CCT will show significant improvement at 12 and 24 weeks compared to baseline in 1) Neurocognition using the Global Cognitive Index z score derived from the MATRICS neurocognitive domain scores, 2) Functional Capacity as assessed by the UCSD Performance-based Skills Assessment (UPSA/UPSA-Adolescent), 3) Self-Rated Functioning as measured by the Specific Level of Functioning Scale (SLoF) and 4) Clinical symptom ratings as measured by the Scale of Prodromal Symptoms (SOPS) total score when compared to subjects receiving RT training across study time.

Eligibility Criteria:
Inclusion Criteria:

* Meet Clinical High Risk criteria
* Be of Latino descent
* Speak Spanish as their preferred language

Exclusion Criteria:

* Concomitant medical or neurological illness
* Brain injury with loss of consciousness \> 30 minutes
* Current substance abuse (excluding nicotine)
* IQ \< 80
* High suicidal risk
Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)

The primary aim of this study is to learn about who is most likely to benefit from guided self-help (GSH) for obsessive-compulsive disorder (OCD).

40 Participants with OCD will be recruited. They will be given access to OC Fighter, an internet OCD treatment program. During the 17 week program, participants will meet with a therapist 9 times. Assessments will occur at pretreatment, post-treatment, 3-month follow up and 6-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* Principal or co-principal diagnosis of OCD
* Clinical global impression score greater than or equal to 4
* Y-BOCS score great than or equal to 8
* Fluency in English
* Capacity to understand the nature of the study and willingness to sign informed consent form

Exclusion Criteria:

* Active manic episode, psychosis, pervasive developmental disorder, mental retardation
* Concurrent OCD psychotherapy
* Current threat of harm to self or others
* Previous adequate trial of therapist-administered or self-administered exposure and response prevention for OCD
Natural History, Diagnosis, and Outcomes for Leukodystrophies

The goals of this protocol is to diagnose, care for, and understand the clinical histories and outcomes of people with leukodystrophies.

Inherited leukodystrophies affect close to 1 in 7500 children with mortality greater than 30%. Affected patients face additional serious medical complications including epilepsy, developmental regression, and intellectual disabilities. Diagnosis is difficult and requires the assistance of a specialist. Finally, identifying treatments and improving outcomes is complex.

The Western Leukodystrophy Project, which is part of the University of Utah and of Primary Children's Hospital, and which is a certified Leukodystrophy Care Network Center, provides a specialized resource for patients with leukodystrophies.

This clinical study assists with diagnosis of leukodystrophies; suggesting treatment options and implementing care guidelines, and improving outcomes for all patients by understanding the clinical histories and outcomes of affected patients..

Eligibility Criteria:
Inclusion Criteria:

* evidence by clinical exam, radiological findings, and/or testing, of an inherited leukodystrophy.
* be able to travel to the leukodystrophy clinic (at Primary Children's Hospital, Salt Lake City, Utah);
* be able to tolerate a general physical exam, and a neurological exam.

Exclusion Criteria:

* unable to be evaluated at the University of Utah Hospital or Primary Children's Hospital;
* refusal to sign study consent form;
* evidence or finding of another non-genetic cause of their condition;
* Persons with known white matter disease or lesions related to: birth injury or prenatal injury, multiple sclerosis, trauma, infection, immunization, or post-infectious effects (e.g. ADEM- acute disseminated encephalomyelitis), metabolic disturbance (e.g. Central pontine myelinolysis), neoplasms, primary rheumatologic diseases (e.g. Systemic lupus erythematosis), stroke, hypoxic-ischemic injury, drug or toxin effect, seizures, or endocrine disturbance.
Transcriptomics Signature of Anti Vaccinia Memory B Cells

Analyse the transcriptomic signature of anti vaccinia memory B cells at a short time after vaccination as compared to the signature already established in long-lived memory B cells.


Eligibility Criteria:
Inclusion Criteria:

* Healthy donors vaccinated against smallpox

Exclusion Criteria:

* none