cyrilzakka/clinical-trials huggingface dataset:
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
* Presumed NASH based on clinical characteristics or prior liver biopsy
* ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
* MRI PDFF liver fat content ≥ 10 %
* Written informed consent

Exclusion Criteria:

* History or clinical evidence of chronic liver diseases other than NAFLD
* History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
* History of liver transplant, or current placement on a liver transplant list
* Total bilirubin \> 1.2 mg/dL
* Albumin \< 3.5 g/dL
* INR \> 1.1
* AST or ALT \> 5 x ULN
* ALP \> 156 IU/L
* Platelet count \< 150,000 /mm3
* eGFR \< 60 mL/min/1.73m2
* Weight loss \> 5% within past 3 months prior to Screening
* Uncontrolled diabetes
* Uncontrolled hyperlipidemia
* Active COVID-19 infection
* Other protocol-defined inclusion/exclusion criteria could apply
Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

The objective of the proposed study is to assess bone health and determinants of bone health among select subpopulations of rheumatoid arthritis patients.

The overall hypothesis of this study is that osteopenia and/or osteoporosis are common among African Americans and men with rheumatoid arthritis and there are identifiable genetic and environmental factors contributing to the pathogenesis of bone loss in these groups.

The Specific Aims of the study are to:

1. Determine baseline hip and lumbar spine bone density (BMD) values and osteopenia/osteoporosis prevalence among African American men and women with early RA and among male veterans with established RA.
2. Identify environmental factors and candidate alleles, which confer increased risk of reduced baseline BMD loss over time among African American men and women with early RA and among male veterans with established RA.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis per ACR guidelines

Exclusion Criteria:

* Patients with diagnosis \> 2yrs (CLEAR study)
Myocardial Biopsy in Congenital Cardiac Surgery

Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.

Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.

Eligibility Criteria:
Inclusion Criteria:

Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes.

Hemodynamic stability.

Exclusion Criteria:

Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.
Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.

The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.

The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication or placebo. In addition, pulse wave velocity will me measured non-invasively before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male
* healthy
* 18 - 40 years old
* non-smoker
* no additional medication

Exclusion Criteria:

* any relevant disease
* smokers
* elevated liver enzymes
* body weight different from Broca Norm \> 20%
* allergies
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.

The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.

The investigators approach relies on the FDA-approved iron supplement ferumoxytol (Feraheme), which is used off label as a contrast agent for MRI. Ferumoxytol is composed of iron oxide nanoparticles, which provide a strong T1- and T2-signal on magnetic resonance (MR) images and are taken up by cells in bone marrow.

20 patients will undergo MRI before and after decompression surgery and transplantation of bone marrow derived cells. 10 patients will receive a single intravenous injection of ferumoxytol prior to their surgery. 10 additional patients will serve as untreated controls. The investigators hypothesize that MR images after intravenous injection of ferumoxytol will improve lesion detection and allow to track transplanted bone marrow cells. MR imaging findings will be correlated with clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Osteonecrosis
* planned decompression surgery with autologous stem cell transplant

Exclusion Criteria:

* Contraindications for magnetic resonance imaging
* Hemosiderosis/hemochromatosis ( patients can still be included in the non-ferumoxytol arm)
Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting

Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy is recruited. The patient who meets the eligibility criteria and provides informed consent is randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by mouth during the first 5 days of chemotherapy cycle. The study drug will be switched on the subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice versa). The primary outcome is the nausea score and vomiting during the first 5 days of each chemotherapy cycle when receiving the study drug.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer patient
* Received AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) and has nausea score at least 40/100 VAS or has vomiting
* Expect to receive at least 2 further cycles of AC regimen chemotherapy
* Provide informed consent

Exclusion Criteria:

* Pregnancy or lactation
* Has nausea or vomiting during 24 hours before chemotherapy
* Has other causes of nausea or vomiting eg. brain metastasis, gut obstruction, hepatitis or recent abdominal or pelvic irradiation within 1 week before chemotherapy
* Received any chemotherapy regimen other than AC regimen
* Allergic or intolerance to ginger
Activity of the Auditory Cortex During Speech Perception and Speech Production in Stuttering

The goal of the study is to examine the cortical activity during speech perception and speech production in idiopathic stutterers compared to fluent speakers. Therefore, the noninvasive method of magnetoencephalography (MEG) is used. A better understanding for the complexity of speech perception and its pathology should be developed.

Fundamental properties of stuttering are repetitions, prolongations, and blocks. In most cases stuttering emerges between 2 and 5 years of age. The auditory feedback should become less important during development, as soon as information about mispronounced words does not occur anymore. During speech development this control function should be adopted by other systems. In stutterers the dominance of the acoustic control should remain.

Brain imaging studies with positron emission tomography (PET) or magnetic resonance imaging (MRI) show defects in the network of motor system, in the lateralization of speech areas, and functions of the auditory cortex. Magnetoencephalographic studies describe a similar variety as cause of stuttering. There may be defects in the auditory feedback, a modification of the lateralization of speech areas, or an alteration of co-action of motor planning and auditory system.

The benefit of magnetoencephalography is a very good temporal resolution in the range of milliseconds combined with good spatial resolution. Therefore, it is well suited to examine the dynamics of cortical processing during stuttering. In this study evoked components of the auditory systems related to complex sounds, vocals, consonant-vocal combinations, and single words are analyzed. Differences of these components in the auditory cortices of stutterers and fluent speakers are hypothesized as well in temporal structure as in localization and lateralization.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with idiopathic stuttering (for the group of stutterers)
* Fluently speaking subjects (for the control group)
* Right handed
* Normal hearing

Exclusion Criteria:

* Neurological diseases
* Psychiatric diseases
* Medication with neurological effective drugs
* Implants with magnetic impact
Tools to Improve Medication Continuity in Adolescents With ADHD

Medication is an efficacious treatment strategy for adolescents with attention-deficit/hyperactivity disorder (ADHD), however use significantly declines during adolescence when the consequences of ADHD are most severe (e.g. dropping out of school, delinquency, etc.). The Unified Theory of Behavior Change (UTBC) has been proposed as a conceptual model to explain the mechanism underlying ADHD medication adherence and to guide the development of interventions to improve the continuity of treatment. The UTBC is a well-established and empirically tested model that identifies factors that influence an individual's intention to perform a behavior as well as factors that influence whether a behavior is actually carried out. Indeed, the research team's preliminary data support the relevance of pre-intention factors and implementation factors for medication continuity among adolescents with ADHD. Currently, no evidence-based interventions target medication continuity for adolescents with ADHD. The objective of this study is to test a multi-component intervention that systematically identifies and targets aspects of the UTBC model most relevant for each adolescent with poor ADHD medication continuity. The central hypothesis is that the tailored intervention will support ADHD medication continuity. The study will conduct an open label trial among adolescents with poor medication continuity to test whether the intervention engages the mechanism underlying medication continuity and improves outcomes.


Eligibility Criteria:
Inclusion Criteria:

* First prescribed ADHD medicine more than one year prior to enrollment
* Registered on myADHDportal.com at practice participating in study
* Filled at least one prescription for a stimulant medication in the past year

Exclusion Criteria:

* More than 80% of days covered with medicine over past one year
* Poor understanding level: The participant and parent cannot understand or follow instructions given in the study.
Cavitation Ultrasound in Treatment of Patients With PCOS

The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.

Polycystic ovary syndrome (PCOS) affects 5 to 10% of women of childbearing age and is the most common cause of anovulatory infertility. Common clinical manifestations include menstrual irregularities and signs of androgen excess such as hirsutism, acne, and alopecia. Metformin, a biguanide, is the most widely used drug for the treatment of type 2 diabetes worldwide. Its primary action is to inhibit hepatic glucose production, but it also increases the sensitivity of peripheral tissues to insulin. The increase in insulin sensitivity, which contributes to the efficacy of metformin in the treatment of diabetes, has also been shown in non diabetic women with the polycystic ovary syndrome.In women with PCOS, long-term treatment with metformin may increase ovulation, improve menstrual cyclicity, and reduce serum androgen levels; the use of metformin may also improve hirsutism. If published data on the effects of metformin in the prevention of diabetes can be extrapolated to women with the PCOS, then the drug may actually retard progression to glucose intolerance in affected women, as reported in a small, retrospective study. Ultrasonic vibrations spread in the form of a wave in medium such as a liquid or a solid. When the particles of an elastic medium are under ultrasonic vibration, they act continuously in only one direction. The lipolytic range of ultrasounds is 30-70 Kilohertz (KHz), and the best effects are obtained in a range between30-35 KHz. The depth of the treatment in the tissues is generally2-3 cm, to avoid muscles involvement. Biological effects of ultrasounds on adipocytes are: micro-mechanical, thermal, micro-streaming and cavitation. Cavitation ultrasound means that ultrasounds produce an alternation of decompression and compression waves in a fluid media which progressively increase the tension of the adipocyte until it implodes and frees the emulsified fat. The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.

Eligibility Criteria:
Inclusion Criteria:

* Obese infertile polycystic ovarian syndrome (PCOS) women

Exclusion Criteria:

* Women 40 years or older
* Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months
* Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy
ADNP Syndrome: The Seaver Autism Center for Research and Treatment is Characterizing ADNP-related Neurodevelopmental Disorders Using Genetic, Medical, and Neuropsychological Measures.

ADNP, also known as Activity Dependent Neuroprotective Protein, is a rare neurodevelopmental disorder caused by mutations encompassing the ADNP gene on chromosome 20. Clinically, ADNP syndrome is characterized by intellectual disability and global developmental delay. This study seeks to characterize ADNP-related neurodevelopmental disorders using a number of genetic, medical and neuropsychological measures.

Subjects with a variant in the ADNP gene will be asked to complete a battery of developmental, behavioral and medical assessments to better characterize gene-related neurodevelopmental deficits. This series of assessments takes place over the course of a three-day period. It includes the Autism Diagnostic Observation Schedule (ADOS), parent interviews regarding developmental history and behavior, a psychiatric evaluation, a neurology assessment, as well as a clinical genetic evaluation that includes a physical and vitals exam. Affected individuals, as well as biologically related siblings, will also undergo a series of sensory assessments, including a research EEG, visual evoked potential, and an eyetracking assessment. Family members present for the visit will also be asked to provide a blood and/or saliva sample for research genetics.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must have a documented variant affecting the ADNP gene that the research team determines to be likely or definitely pathogenic.
* Eligible participants must be at least 2 years of age.

Exclusion Criteria:

* none
Effect and Mechanism of Brain Stimulation for Parkinson's Disease With Cognitive Impairment

This study intends to apply structural and functional brain network neuroimaging techniques combined with image post-processing methods to explore the differences in brain network changes in PD patients with cognitive impairment after DBS or TMS.

A variety of post-processing methods (VBM, SPM, CAT, LEAD-DBS, etc.) were used to analyze structural brain network images (sMRI, DTI) and functional brain network images (rs-fMRI, PET) based on connectomics, and combined with the changes of clinical symptoms before and after treatment. To study the mechanism of the influence of neural regulation on brain network, and further analyze how DBS and TMS improve the cognitive symptoms of PD patients from the perspective of brain connectomics, so as to explore the occurrence and development of Parkinson's disease with cognitive impairment and the possible improvement mechanism.According to the individual differences in clinical symptoms of different PD patients, better stimulation sites and the best brain network are sought to further guide the surgical plan, so as to obtain the best clinical treatment effect.

Eligibility Criteria:
Inclusion Criteria:

1. The clinical diagnosis of PD is consistent with the United Kingdom Parkinson's Disease Society Brain Bank criteria, with disease duration over 5 years, acute levodopa motor response ≥30%, and indication for STN-DBS.

Exclusion Criteria:

Exclusion criteria included patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery.
A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.

Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. However, there is very little information about effectiveness of various insulating materials used in the operating room.

Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative hypothermia in pediatric patients.

A randomized controlled trial was conducted in 42 pediatric patients (age 1 month-3 years, ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. The patients were randomly allocated into 2 groups. The patient's arms, legs and bodies were wrapped with either plastic (study group) or cotton (control group). All patients received standard general anesthesia with endotracheal tube and control ventilation with a fresh gas flow at 1 l/min. The core temperature (rectal temperature) was recorded every 10 minutes for 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 42 pediatric patients (age 1 month-3 years
* ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery.

Exclusion Criteria:
Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs.

ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico.

Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for generalized anxiety disorder (GAD) confirmed by the Mini International Neuropsychiatric Interview (MINI).
* Currently taking one of the Food and Drug Administration (FDA) approved antidepressant therapies (ADT) for GAD (i.e., escitalopram, paroxetine, duloxetine, or venlafaxine ER) with an inadequate response to an adequate dose (per label) and duration (\>= 8 weeks) as verified by a baseline Hamilton Anxiety Rating Scale (HAM-A) total score \>= 20 and Clinical Global Impression of Severity Scale (CGI-S GAD) \>= 4.

Exclusion Criteria:

* Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20.
* New diagnosis or exacerbation of major depression in the last 6 months.
Our Anesthesia Experiences in Hepatopancreatobiliary Surgery Practices: a Retrospective Study

Has the evolving anesthetic management in major abdominal surgeries had a positive impact on patients' one-year postoperative mortality and length of hospital stay? Which of the anesthetic management parameters have influenced mortality and hospital stay duration in these patients? To address these questions, we have planned to retrospectively review patients who underwent surgery at our center.

In our study, we aimed to compile our practices over the last 5 years by evaluating the impact of perioperative and postoperative anesthetic management on morbidity and mortality in hepatopancreatobiliary surgical patients. Our primary outcome was to form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group. Our secondary outcome was to assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.

Eligibility Criteria:
Inclusion Criteria:

* The study will include data from patients who have undergone their first operation with the diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy during the period from October 2017 to February 2022.

Exclusion Criteria:

* Data from patients who were deemed inoperable during the perioperative period after being taken into surgery with their current diagnosis, as well as data from patients who underwent repeat operations, were excluded from the study for their second and subsequent hospitalizations.