cyrilzakka/clinical-trials huggingface dataset:
Digital Strategies to Advance Help-Seeking Aim 1 and 2

This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.

Aim 1: Characterize help-seeking patterns in 25,000 youth who score above Prodromal-Questionnaire (PQ-B) threshold. H1a: Youth will cluster into (1) pre-intenders (take the PQ-B and engage with educational content), (2) intenders (initiate a text exchange with a Strong365 peer navigator (3) actors (advance from texting to clinical assessment with a Strong365 clinician over phone/video) and (4) super-actors (advance from assessment to AMP-SCZ intake). Data will include online metadata (time spent online, # of resources viewed, time spent to complete the PQ-B, # of texts initiated/exchanged), self-report (demographics, symptom type and severity, PQ-B score, goals/needs, self-efficacy), and natural language. H1b (Strong365 only): Natural Language Processing (NLP) of data extracted from participant/provider interactions over text and video will identify linguistic markers of HAPA stages: intender, actor, super-actor. Models based on HAPA stages, along with behavioral features (i.e., message timing, frequency, response lag) will predict help-seeking advancement vs. disengagement. Top predictive features will be used to inform the crafting of help-seeking advancement strategies to be tested in MRTs (Aim 3).

Aim 2: To ensure that those who complete the PQ-B are directed appropriately, this study will establish the most accurate threshold for identifying CHR online. H2: Using data from population-based PQ-B screening, the investigators predict that a total distress score of 20+ will generate the highest diagnostic odds ratio with a sensitivity of at least 80% online, as determined by remote clinical assessment. For the remainder of the study, the threshold score that maximizes specificity and sensitivity will be used.

Eligibility Criteria:
Inclusion Criteria:

* Ages 12-29 years
* Living within a 50-mile radius of a US based AMP-SCZ site
* Able to complete the English language PQ-B on MHA's screening platform
Pocket Versus Tunnel ICRS for Treatment of Keratoconus

Keratoconus is a corneal degenerative disease associated with loss of best-corrected visual acuity. The use of intrastromal corneal ring segment implants is indicated to regularize the cornea and to reduce aberrations.

Keratoconus is a corneal degenerative disease characterized by corneal thinning and subsequent development of irregular astigmatism, diminution of vision and loss of best-corrected visual acuity.

Management of keratoconus includes halting disease progression through a corneal strengthening procedure called corneal collagen cross-linking (CXL) which usually results in stabilizing the condition but with no improvement in visual acuity or quality. Intrastromal corneal ring segment (ICRS) implantation is a well-established procedure for the management of moderate keratoconus with a corneal flattening effect that is associated with improvement of visual acuity and reduction of optical aberrations.

The aim of the study is to evaluate and compare the visual, refractive and topographic outcomes of two different femtosecond laser assisted surgical techniques to create a corneal stromal pocket or a tunnel for implantation of ICRS for the management of central keratoconus

Eligibility Criteria:
Inclusion Criteria:

1. Patients with progressive keratoconus with maximum keratometry (Kmax) between 50-65 diopters
2. Central keratoconus (Keratoconus with steepest corneal point within the central 3 mm zone).
3. Clear corneal with a minimum pachymetry of 400 μm.

Exclusion Criteria:

1. Corneal scars
2. Patients with advanced keratoconus with Kmax \> 65 diopters.
3. Non-central keratoconus (para-central or peripheral keratoconus with steepest corneal point outside the central 3 mm zone).
4. Previous corneal cross-linking and/or ocular surgery.
5. Systemic diseases such as diabetes mellitus and autoimmune diseases
Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography

Single-bolus computed tomography urography (CTU)is a recently developed one-stop imaging examination for diagnosis of urinary tract diseases, including urinary malignancies. However, single-bolus CTU uses two post- contrast phases (i.e.: nephrographic and excretory phases) for diagnosis of urinary tract diseases. A further-developed split-bolus CTU uses solitary post-contrast phase containing mixed information of nephrographic and excretory phases for diagnosis of urinary tract disease; however, whether split-bolus CTU has similar high diagnostic values for urinary malignancies remains unaddressed. Thus, the aim of this study is to compare the diagnostic performance between single-bolus and split-bolus CTU for diagnosing urinary malignancies. This study will enroll 352 patients from two hospitals if they fit the including criteria including aged \> 40 years old, presenting with gross hematuria or having urinary malignancies histories, normal renal function (i.e.: estimated glomerular filtration rate \> 60 mL/min/1.73 m2, no allergic history to iodinated contrast medium and no pregnancy). All enrolled patients will be randomized to undergo split-bolus and single-bolus CTU in 1: 1 manner. Two radiologists will read CTU images independently using a standardized recording sheet with Likert scales 1-5 representing higher probabilities of presence of urinary malignancies for larger number). The diagnostic values of split-bolus and single-bolus CTU will analyzed using reference standards by final diagnoses of urinary malignancies (i.e.: presence of urinary malignancies based on histological examinations of cytology examinations, biopsies or surgical specimens). The diagnostic performance of split-bolus CTU and single- bolus CTU for urinary malignancies will be compared using areas under receiver operating curve (ROC) to determine whether there is presence of significant difference .

This study will enroll 352 patients. The calculation of sample size is according to the following equation:

n2=〖(Z∝+Zβ/2)〗\^2/〖(δ-\|ε\|)〗\^2 \[p1(1-p1)/k+p1(1-p2)\]

∝=0.05, β=0.2, δ=0.05, p1=0.96, p2=0.80 Then, the number of each arm patient should be ≥ 141 patients. However, if 20 % of the enrolled patients by fitting inclusion criteria are excluded by fitting exclusion criteria, the number of each arem should be ≥ 176 patients. Thus, this study plans to enroll 352 patients (for two arms). The enrolled patients are randomized to two groups (using single-bolus CTU versus using split-bolus CTU) using permuted block method.

Eligibility Criteria:
Inclusion Criteria: Fitting all of the followings

1. age ≥ 40 years old
2. presenting with gross hematuria or having a history of urothelial carcinomas
3. normal renal function (i.e.: estimated glomerular filtration rate ≧ 60 mL/min/1.73 m2)
4. no allergy history of iodinated contrast medium

Exclusion Criteria: Fitting any of the followings

1. pregnant or lactating woman
2. withdrawal of informed consent
HFNC and Prone Positioning in Awake Patients With Severe COVID-19

The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.

The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.

All patients with ARF related to Covid-19 and admitted to the ICU are turned in prone position whenever tolerated, while receiving oxygenation with HFNC.

Outcomes of interest are the rate of success or failure (defined as the need for intubation and mechanical ventilation)

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years, admitted to the medical ICU for confirmed Covid-19 and acute hypoxemic respiratory failure

Exclusion Criteria:

* patients already intubated at admission or those requiring immediate intubation
Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users

Anabolic androgenic steroids (AAS) abuse may have a toxic on myocardium that could lead to cardiac alterations. Clinical cases reported myocardial fibrosis in AAS users. However, recent studies did not find myocardial fibrosis in AAS users using T1-mapping technique. The aim of this study was to evaluate cardiac structure by cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). We also evaluated the cardiac contractility in AAS users.

Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.

Cardiac structure was assessed by LGE, T1-mapping and ECV. Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and echocardiography (speckle tracking)

Eligibility Criteria:
Inclusion Criteria:

* Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;
* Anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year;
* All anabolic androgenic steroids users were on a cycle over the course of the study;
* Sedentary control group: sedentary men without cardiovascular disease.

Exclusion Criteria:

* Smoking;
* Alcohol consumption;
* Use of diuretics and/or antihypertensive medications;
* Liver and kidney disease
Effect of Bacillus Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy

The purpose of the study is to determine the effect of bacillus coagulans and galactomannans (LactoWise®) administration on obese patients undergoing sleeve gastrectomy by observing standard protocol measurements in patients following sleeve gastrectomy: laboratory measurements, ideal body weight, and percent estimated weight loss, in addition incorporating the Gastrointestinal Quality of Life Index (GIQLI)

Loma Linda University's School of Allied Health Professions in collaboration with the Metabolic and Bariatric Surgery Department under the Surgery Division is conducting research to evaluate the influence of LactoWise® (a proprietary blend of probiotic and prebiotic - bacillus coagulans/galactomannans, respectively) on the normal microbiota of obese patients post bariatric sleeve gastrectomy. Pre-surgery, participants will be required to sign a consent form and to complete the Gastro-Intestinal Quality of Life Index (GIQLI). A total of 60 bariatric sleeve patients will be recruited for this investigation. Post-surgery participants will be randomized into two groups, one will receive LactoWise® and one be the control (placebo). The LactoWise® blend has 300 mg of the bacillus coagulans and galactomannans and contains around 4.5 billion live cells. Daily intake of capsules coupled with bariatric sleeve standard of care will be conducted for the duration of 3 months, which is the anticipated clinical timeline. Participants will also be asked to complete the quality of life questionnaire at each of the following follow-ups post-surgery: 2nd week, 6th week, and 3rd month.

Outcome measures will be the standard protocol for bariatric sleeve patients at the Metabolic and Bariatric Surgery Department which will include weight measurements, blood work. In addition to the standard of care procedures a research procedure to be added is the GIQLI. Pre and post clinical consults, administration of probiotic/prebiotic formulae, and follow-ups will be conducted at the Faculty Medical Offices - General Surgery - Bariatric Clinic at Loma Linda University Health.

Eligibility Criteria:
Inclusion Criteria:

* Patient of bariatric sleeve surgery
* Ages 18-70
* Consent to complete GIQOL questionnaire
* Commit to consistent use of LactoWise® or placebo assigned for study period

Exclusion Criteria:

* None sleeve bariatric surgery patient
* Have compromised immunity or poorly controlled systems
* Presence of any concurrent active infection
* Physically disabled
Effect of a Third COVID-19 Booster Among Health Care Workers

A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta variant. The pandemic also resulted in many infections among health care workers (HCWs) and their households. In this study, a retrospective analysis would perform on risk of COVID-19 infection and their outcome in relation to their COVID-19 vaccination history by using the data repository from one of the Hong Kong private hospitals.

HCWs were required to submit a standardized online self-declaration form for report of 1) demographic of the HCWs, 2) symptoms related history and 3) COVID-19 exposure history once they were COVID-19 confirmed by rapid antigen test against COVID-19 and/or polymerase chain reaction (PCR) test for COVID-19. Subsequent follow up such as contact tracing, COVID-19 PCR testing results of these HCWs and status of return to work were captured by the infection control team in a systematic manner.


Eligibility Criteria:
Inclusion Criteria:

* All full time staff members of the private hospital

Exclusion Criteria:

* History of COVID-19 before 2022
Lumbar Discopathy Decompression with Lateral Interbody Fusion: Radiological and Clinical Outcomes

The aim of the study was to introduce a single-segment lumbar spine decompression and fusion with intervertebral implants through modified by the authors lateral lumbar approach. Functional, surgical and radiographic outcomes was evaluated.


Eligibility Criteria:
Inclusion Criteria:

Single-segment L1-L4 spine discopathy.

Exclusion Criteria:

Any other spinal diseases. More than one level of discopathy.
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the efficacy and safety in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Eligibility Criteria:
Criteria: Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification II to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Baseline blood pressure ≥180 mmHg
* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial

The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual symptom (PMS) symptoms, perceived stress level and pain intensity.

The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. The sample of the study consisted of people who scored above the mild level according to the Premenstrual Syndrome Scale (PMSS) score and volunteered to participate in the study. Participants will be divided into 2 groups as experimental group and control group by randomization method. Sociodemographic Information Form, Premenstrual Syndrome Scale (PMSS), Perceived Stress Scale (PSS) and Mcgill Melzack Pain Scale (MPQ) will be administered to the participants. Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Being a woman between the ages of 18-35.
* Not having a condition that prevents exercise (not having orthopedic, cardiopulmonary, mental diseases, etc. that will prevent exercise).
* Not having given birth.
* Volunteer to participate in the study.
* Having a score above the mild level on the PMSS score.
* Normal menstrual cycle.

Exclusion Criteria:

* Having a condition that prevents you from exercising.
* Having a chronic disease.
* Being on any medication regularly.
* Being pregnant.
* Being in the menopausal period.
* Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection, fibroid/uterine tumor etc.)
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo


Eligibility Criteria:
Inclusion Criteria:

* Male or female inpatients 18 to 65 years of age
* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode
* Having a total Young Mania Rating Scale (YMRS) score \>= 20 and a score of at least 4 on two of the following YMRS items:

  * Irritability,
  * Speech,
  * Content, and
  * Disruptive/Aggressive Behavior

Exclusion Criteria:

* Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values \[such as thyroid-stimulating hormone (TSH)\].
* Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score \>= 18 at Visit 2.
* Patients experiencing first manic episode.
* Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.
Neural and Psychiatric Consequences of Cannabis Use in Adolescents

The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.


Eligibility Criteria:
Inclusion Criteria:

Cannabis users 1) the study team will require majority of adolescents with cannabis use to have a significant cannabis use (self-reported use on ≥15 of the prior 30 days and positive tetrahydrocannabinol (THC) urine toxicology).

Depression Positive

1) participants with subthreshold depression, defined as a raw severity score of ≥30 on the Children's Depression Rating Scale-Revised (CDRS-R, for ages 14-17) and as a raw severity score of ≥12 on the Montgomery Asberg Depression Rating Scale (MADRS, for ages 18-20)

Exclusion Criteria:

1. MRI contraindications such as claustrophobia, metallic ink tattoos, orthodontic braces, or pacemakers
2. positive pregnancy tests
3. neurological illnesses and medical conditions such as unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis)
4. estimated full-scale Intelligence Quotient (IQ) ≤80 to ensure that participants have the ability to understand the study112
5. current Substance Use Disorder (SUD) other than cannabis or nicotine.
6. certified for or self-reported medical cannabis use, or intent to become certified
7. current stimulant use (methamphetamine or cocaine) by self-report or urine toxicology
8. oral contraceptives will be allowed and controlled for in order to maximize recruitment of older adolescents.

Depressed THC non-users:

1. psychotropic medication-free for \>1 month (or \>3 months for medications with a long half- life such as fluoxetine) prior to study enrollment.
2. Diagnostic and Statistical Manual 5 (DSM-5) diagnoses of bipolar disorder, psychotic disorders, autism spectrum all non-cannabis substance-related disorders will be exclusionary.
3. Self-injurious acts (e.g. cutting) and suicidal ideations (SI) without a specific as passive SI) are common in adolescent depression and will be allowed. constitutes an imminent risk to self or others (defined as active SI), the withdrawn from the study and emergency procedures will be initiated immediately,
Meal Enjoyment and Tolerance: Sex Differences

Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10 men and 10 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.


Eligibility Criteria:
Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders