cyrilzakka/clinical-trials huggingface dataset:
Obstructive Sleep Apnea Treatment in Serious Mental Illness

Serious mental illnesses (SMI) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. A high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (OSA), but tend to be underdiagnosed and undertreated compared to the general population. This study aims to examine feasibility, acceptance, and impact of OSA treatment and how it affects cognitive function in people with SMI.

Sleep disturbances are central to many psychiatric disorders, including schizophrenia and bipolar disorder, with clear implications for cognition, brain health, physical health and aging. Obstructive sleep apnea (OSA) is typically underdiagnosed and undertreated due to impairment from psychiatric symptoms, limited resources, and stigma. In turn, consequences of untreated OSA in SMI are dire: in particular, worsening cardiometabolic health, cognitive decline, and death. Few studies have examined the impact of treatments for obstructive sleep apnea on cognitive problems in a high-risk group, such as older adults with SMI. The goals of the proposed study are to assess the acceptance and effectiveness of positive airway pressure (PAP) treatment for OSA, and its impact on cognitive and cardiometabolic outcomes as well as biological processes over a 3-month period. In order to determine eligibility, participants will be asked to complete a diagnostic test either at home or overnight in-lab. If diagnosed with sleep apnea, the participant will be offered a 3-month treatment with an automatic PAP. In addition, eligible participants will complete weekly check-ins with study staff and a series of detailed interviews, physical and neuropsychological tests, instrumental and clinical assessments, and blood draws every month for a total of 3 months.

Eligibility Criteria:
Inclusion Criteria:

Control participants:

* lifetime absence of major psychiatric illness
* 40 to 70 years old
* be at risk for or have a diagnosis of obstructive sleep apnea

For participants with serious mental illness:

* diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
* must not be conservatized
* 40 - 70 years old
* be at risk or have a diagnosis of obstructive sleep apnea.

Exclusion Criteria:

* DSM-IV-TR diagnosis of active alcohol or other substance abuse or dependence in the 3 months preceding enrollment. This will be self-report.
* Diagnosis of dementia, mental retardation, or other neurological or medical conditions known to affect neurophysiologic or neurocognitive functioning, or autoimmune disease
* Other major DSM-IV-TR Axis I Disorder
* Medical problems that interfere with a participant's ability to complete the assessments
* Plans to move out of the San Diego county area within the following 6 months
* Diagnosis of OSA and currently receiving APAP, CPAP, or any treatment from a physician.
Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization

According to INTERNATIONAL STANDARD (hereafter ISO) blood pressure (BP) monitor clinical evaluation protocol (ISO 81060-2:2018, Non-invasive sphygmomanometers- Part2: Clinical investigation of intermittent automated measurement type) for BN1 (BNiBP), an electronic sphygmomanometer module newly developed by Bionet Co., Ltd., the clinical group and evaluation criteria presented in, the effectiveness of blood pressure measurement performance was evaluated.

The auscultation method used as a reference (gold standard) of a non-invasive blood pressure (NIBP) measurement method was used. The first blood pressure measurement was performed once each (reference BP not used for evaluation, R0; test BP not used for evaluation, T0) with auscultation and the test medical device (BM5 equipped with BN1 (BNiBP)). The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each blood pressure measurement.

Three data pairs (mean value of R1, R2 \& T1 / R2, mean value of R3 \& T2 / R3, mean value of R4 \& T3) were obtained from one study subject. This study aims to verify that the mean value of the differences and standard deviations of data pairs meet the criteria of ISO 81060-2:2018.


Eligibility Criteria:
Inclusion Criteria:

* Recruitment is made through the recruitment notice for patients and their guardians who visit Hanyang University Hospital. Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject requirements are recruited.

Exclusion Criteria:

* Emergency surgery patient
* Persons who have mental disorders such as mental retardation, autism, etc. and who have difficulty measuring blood pressure or are expected to have difficulties
* A person who disagreed with the study
Detecting Lung Cancer Based on Exhaled Breath

Early detection is critical to improve the overall survival of lung cancer. Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On the other hand, cancer cells have different metabolism patterns compared with normal cells. Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a promising approach for lung cancer detection.

Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. VOCs can be transported to the alveoli through the blood circulation and expelled by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many clinical studies have found that VOCs in exhaled breath are closely related to disease status. Specific VOCs alterations have been identified in many tumors, especially lung cancer.

In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry data and support vector machine will be initially established and validated.

Eligibility Criteria:
Inclusion Criteria for inpatient :

* pulmonary nodules in competed tomography images
* plan to receive thoracic surgery

Inclusion Criteria for controls :

* have planned physical examination every year
* plan to receive low-dose computed tomography

Exclusion Criteria:

* history of malignant tumors.
* receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy before surgery
* with infections or liver disease
Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy

This study aims to evaluate the effects of a 12-week protein-rich individualized nutritional therapy combined with different time-efficient exercise programs on overall physical fitness (cardiorespiratory fitness and muscular fitness), inflammation, and muscle mass/body composition in patients with malignant disease undergoing curative or palliative anti-cancer treatment


Eligibility Criteria:
Inclusion Criteria:

* malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
* ongoing or planned curative or palliative anti-cancer therapy
* ECOG-Status 0-2

Exclusion Criteria:

* simultaneous participation in other nutritional or exercise intervention Trials
* bone metastases with high fracture risk
* cardiovascular disease
* use of anabolic medications
* epilepsy
* severe neurological or rheumatic diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis
AI-ECG Screening for Left Ventricular Systolic Dysfunction

The purpose of the current study is to verify the effectiveness of the artificial intelligence algorithm applied to the electrocardiogram as a potential screening tool for left ventricular systolic dysfunction.

The current investigators have developed an artificial intelligence (AI) algorithm based on 12-lead electrocardiogram (ECG) detecting left ventricular systolic dysfunction, through 364,845 ECGs from 148,547 patients. Then, when the model was tested retrospectively on 59,805 ECGs of 24,376 patients, the model performance expressed as an area under the receiver operating characteristic curve was 0.889 (95% CI 0.887-0.891).

The investigators are planning to prospectively validate the model's effectiveness as a potential screening tool for left ventricular systolic dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Individuals or those whose legal representative agree to participate in the study, and sign the consent form
* Can complete both 12-lead electrocardiogram and transthoracic echocardiography

Exclusion Criteria:

* Individuals whose age is less than 18 year-old.
* Individuals who do not agree to participate in the study
* Patients who are unable to participate in clinical trials at the discretion of the investigator
MIS Hematoma Evacuation

The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve \<15 ml residual hematoma volume following surgery.

Additionally, the study aims to compare the mortality and complication rate of patients who undergo minimally invasive, navigation guided endoport based evacuation of intracerebral hematoma with NICO BrainPath™ System as compared to non-operative, supportive standard of care.

The study is a prospective, non-randomized cohort study. 50 patients will be enrolled in Group A (NICO BrainPath™ system) and 50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care from Epic). 50 patients will undergo minimally invasive, navigation guided endport based evacuation of intracerebral hematoma with NICO BrainPath™ System. The patient population receiving non-operative supportive care will be matched to the surgical patients based on age, gender, and location of hemorrhage.

Approximately 100 patients will participate in this study. Patients with significant intraparenchymal hemorrhage who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for eligibility.

A repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH will determine eligibility in the trial. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPath™ system.

At baseline, the Glasgow Coma Scale (GCS) and the Modified Rankin Score (mRS) will be captured, along with baseline demographics. The GCS and mRS will be recorded at 1-, 3, and 6-month post-operatively. A follow-up CT will be captured at 3 months. Mortality and adverse events will be reviewed at each timepoint.

Eligibility Criteria:
Inclusion Criteria:

1. 18 and 80 years of age, inclusive
2. Spontaneous supratentorial, intracerebral hematoma ICH \>30 ml measured by the ABC/2 method.
3. Location of Hemorrhage: Lobar, Putaminal and/or Caudate
4. A Glasgow Coma Scale (GCS) of 4 or greater
5. Historical Modified Rankin Score (mRS) of 0 (no symptoms of neurological disability) or 1 (no significant disability despite symptoms, able to carry out usual duties and activities).

Exclusion Criteria:

1. Pupils dilated and fixed
2. Rapidly deteriorating patient (at the discretion of the surgeon)
3. Primary Thalamic Bleed
4. Intraventricular Blood (more than 50 % of either ventricle, visual estimate)
5. ICH secondary to aneurysm
6. Arteriovenous malformation (AVM)
7. Tumor
8. Moya-Moya
9. Sinus thrombosis
10. Platelet count \<100,000, INR \>1.4
11. Known coagulopathy, on anticoagulants that cannot be reversed
Carbohydrate and Metabolism: a Pilot Study

The optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. However, the metabolic consequences have not been examined.

In a pilot study, the investigators will assess the postprandial metabolic response to a meal of formula with either lactose or maltodextrins. A breastfed reference group is also included.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Term infants (gestational age 37-42 weeks)
* Birth weight 2500-4500g

Exclusion Criteria:

* Infant illness
* Maternal diabetes
* Maternal pregnancy complications
PET Imaging of Systemic Sclerosis Using FDG and 68Ga-DOTA-Siglec-9

This study evaluates the potential of positron emission tomography (PET)/computed tomography (CT) imaging to monitor disease activity in patients with systemic sclerosis (SSc). PET/CT imaging will focus on two pathological features of SSc, i.e. metabolic activity evaluated by glucose analog 18F-FDG, and expression of inflammation-inducible vascular adhesion protein 1 (VAP-1) evaluated by 68Ga-DOTA-Siglec-9 tracer.

In patients with systemic sclerosis (SSc), the quantitative assessment of disease activity is still difficult. Identification of patients who unlikely respond to therapy before or early in a course of the treatment could reduce morbidity and produce cost-savings. This project will evaluate the potential of advanced functional imaging techniques to monitor disease activity. Functional imaging will focus on two pathological features of SSc, i.e. metabolic activity evaluated by glucose analog 18F-FDG positron emission tomography (PET)/computed tomography (CT), and expression of inflammation-inducible vascular adhesion protein 1 (VAP-1) evaluated by new 68Ga-DOTA-Siglec-9 tracer. If successful, the resulting techniques may prove invaluable as tools in the clinical practice and in drug research aiming to find new targets to the treatment of SSc.

Eligibility Criteria:
Inclusion Criteria:

* Adults with active systemic sclerosis (SSc).
* Onset of SSc (defined as first non-Raynaud symptom) not more than 5 years ago.
* Clinically active disease with proximal nailfold capillary abnormalities detected with videocapillaroscopy and/or raised inflammatory markers (CRP or ESR).

Exclusion Criteria:

* Underage, pregnant, breastfeeding, handicapped or prisoner
* History of or current inflammatory joint disease or autoimmune disease other than SSc.
* History of treatment with, prior to this study, immunosuppressives or disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, leflunomide, azathioprine, mycophenolate, cyclophosphamide or biologic agents such as anti-TNF inhibitors, abatacept, or rituximab. Hydroxychloroquine is allowed in the history (≥3 months prior to PET study).
* Intra-articular or parenteral corticosteroids ≤4 weeks prior to PET/CT study.
* Prostanoids or other vasoactive treatments like phosphodiesterase-5 inhibitors or endothelin receptor antagonists ≤4 weeks prior to PET/CT study (the use of calcium channel inhibitors is allowed).
Study Assessing Pain Relief After Replacement of the Knee

This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)


Eligibility Criteria:
Inclusion Criteria:

* Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis.
* Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted).
* American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2 or 3.

Exclusion Criteria:

* Has a planned concurrent surgical procedure.
* Has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening.
* Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee.
* Immunocompromised or has a known history of Hepatitis B, human immunodeficiency virus (HIV), or Hepatitis C.
* Routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial.
* Unable to abstain from opioid use for knee pain within 14 days of surgery.
* Has been administered systemic steroids within 14 days prior to surgery.
* Has been administered any local anesthetic within 5 days prior to the scheduled surgery.
* Screening electrocardiogram (ECG) with significant abnormalities associated with significant heart disease.
* Has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications.
* Has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments.
* Has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome.
* Has a known or suspected history of drug or alcohol abuse. A subject with a history of alcohol use disorder that has ≥10 years sobriety will be permitted.
* Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine.
* Has a Body Mass Index (BMI) ≥45 kg/m2
The Modulatory Effect of Oxytocin on Interoception

This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.

The present study will use a double-blind, between-subject, placebo-controlled design to investigate the modulatory effect of oxytocin on interoception and whether this effect will vary as a function of emotional valence. In Experiment 1, subjects will perform a heartbeat detection task and the group differences between oxytocin and placebo groups of the interoceptive accuracy and neural activity in the core interoceptive network will be investigated. In Experiment 2, subjects will be asked to watch emotional faces while perform the heartbeat detection task. Investigators will examine whether oxytocin's effects on interoception will be varied as a function of different emotional valence.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Subjects reported having any neurological problems, psychiatric illness or drug or alcohol abuse and none were currently taking any form of medication and had not drunk any caffeine-containing beverages on the day of the experiment.
A Prediction Model and Assisted Decision-making System of Fertilization Disorders

The goal of this clinical trial is to test the accuracy of the forecasting system we develop. The main question it aims to answer is:

* Whether the clinical prediction system predicts the incidence of fertilization disorders accurately.
* The fertilization disorder prediction system predicts whether and how much the outcome differs from the doctor.

Participants will receive treatment assisted by a predictive system or receive general treatment.

Researchers will compare incidence of fertilization disorders to see if the fertilization disorder prediction system makes correct predictions.

Through the design method of single-center randomized controlled trial, 260 infertility patients were recruited, and they were divided into two groups of 130 cases in each group according to the method of block randomization, one of which was the intervention group, with the help of accurate prediction of fertilization disorders and clinical decision support systems, clinicians predicted and judged the probability and key factors of fertilization disorders of patients, and formulated and implemented personalized diagnosis and treatment plans based on the prediction results; The other group is the control group, which is treated by clinicians according to the conventional diagnosis and treatment plan, and the system performs parallel simulation operation to predict the outcome of fertilization disorders in patients without affecting any diagnosis and treatment decisions of clinicians. Through the comparison of the two groups, the predictive ability of the system for fertilization disorders was evaluated, and the effectiveness and safety of the personalized diagnosis and treatment plan formulated with the assistance of the system were observed, the primary observation outcomes were the incidence of fertilization disorders, and the secondary observation outcomes were embryo transfer rate, biochemical pregnancy rate, clinical pregnancy rate, etc.

Eligibility Criteria:
Inclusion Criteria:

1. infertile couples
2. have indications for acceptance of IVF or ICSI
3. Both parties sign an informed consent form and can complete the follow-up visit

Exclusion Criteria:

1. At least one of the spouses has contraindics to IVF or ICSI
2. Major diseases
3. Fresh cycle, PGT, IVM