cyrilzakka/clinical-trials huggingface dataset:
A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Ability to understand and comply with study procedures and give written informed consent
2. Following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period
3. Males or post-menopausal females
4. Aged ≥18 years at the time of informed consent
5. Fasting serum TG levels ≥200 mg/dL (≥2.26 mmol/L) and ≤500 mg/dL (5.65 mmol/L) at screening
6. Serum HDL-C \<50 mg/dL (\<1.30 mmol/L) if male or \<55 mg/dL (\<1.42 mmol/L) if female at screening.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

1. Current or planned use of any lipid-altering medications other than the study drugs, statins, or ezetimibe during the study.

   i. Subjects currently on statins or ezetimibe must be at high risk for atherosclerotic CV diseases, and the dose(s) must be stable for at least 4 weeks prior to screening

   ii. For subjects currently on lipid-altering medications other than statins or ezetimibe, at least 4-week washout period (or for subjects currently on probucol at least 8 week washout period) will be required prior to the first fasting blood sampling at Screening Visit
2. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by HbA1c (NGSP level) ≥8.0% at screening
3. Uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening
4. Uncontrolled thyroid disorder
5. Creatinine ≥1.5 mg/dL at screening
6. Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT \>2 × ULN at screening
7. History of pancreatitis
8. Gallbladder disorder, history of cholelithiasis, primary biliary cirrhosis, or history of disease or surgery that may affect the absorption, distribution, metabolism and excretion of drugs or the metabolism of bile salts
9. Unexplained creatine kinase (CK) \>5 × ULN at screening
10. Myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent
11. New York Heart Association Class III or IV heart failure
12. History of malignancy within 5 years
13. Participation in another clinical study at the time of informed consent or administration of an investigational drug other than placebo within 16 weeks prior to the informed consent for this study
H - Test Usage in Identification of Sexual Orientation Among People.

Using of H - test in identifying the sexual behavior of the human.

The test using videos and in the same time watching the vital signs of the participant to identify any changes in them align with the vides.

These videos contain +18 contents that can excite them and make them sexually active. So we can determine with type of vides that more excited to the human and select his or her sexual behavior type.

Eligibility Criteria:
Inclusion Criteria:

* All the people can be included

Exclusion Criteria:

* Have a psychological disorder
* Have a sexual disorder
Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study

ICU patients frequently face complicated recovery processes, including long-term anxiety disorders. Lung transplantation (LTx) offers people with terminal respiratory conditions both the hope of prolonged survival and a better quality of life related to health. Among the disorders usually encountered in the postoperative period of LTx are anxio-depressive disorders. These anxiety disorders affect the quality of life related to health and compromise the follow-up of the patient by phenomenon of psychological disinvestment. Other psychological disorders are also anchored in the patient's experience of this post-surgical ICU period (ie, depressive episodes and/or, at a distance, post-traumatic stress disorder (PTSD). Various models of management of anxio-depressive disorders and PTSD are proposed in the literature. To our knowledge, while many of them have shown their efficiency in the curative management of disorders, few have demonstrated their effectiveness in preventing them. Exposure therapies using virtual reality (ETVR) have in the past demonstrated their effectiveness in many areas of psychiatry. In our study, experimental arm patients will be offered ETRV support with a virtual reality headset. A scenario with progressively increasing stress levels linked to the ICU environment and different situational contexts (alarms, etc.) will be presented to patients. This habituation to the potentially anxiety context of ICU will reduce the occurrence of psycho-cognitive disorders by progressive extinction phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Registration on the lung transplant waiting list
* Signature of consent

Exclusion Criteria:

* Minor patient, pregnant or breastfeeding woman, or not affiliated to the social security scheme
* Patient under guardianship or curatorship
* Patient with a history of mental illness
* Patient not mastering the French language
* Patient deprived of liberty
* Patient carrying a transplanted organ (liver, kidney, heart ...)
* Lung re-transplantation
Iron Fortified Beverages and Application in Women Predisposed to Anemia

* The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia.
* A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.


Eligibility Criteria:
Inclusion Criteria:

* Women
* non-smoker
* non-pregnant
* non-breastfeeding
* serum ferritin \<40 ng/ml
* hemoglobin\>=11g/dl

Exclusion Criteria:

* Serum Ferritin \>=40 ng/ml
* Hemoglobin \<11g/dl
* Amenorrhea
* Menopause
* Iron deficiency anemia
* Thalassemia
* Hemochromatosis
* Blood donors
* Chronic gastric diseases
* Renal diseases
* Eating disorders
* Allergy to any component of the study juices
* Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study
Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence

The hospital where this study will be conducted is responsible for the one-year contingency management treatment for methamphetamine drug offenders referred from the Yunlin District Prosecutors Office. Completing the one-year treatment is prerequisite for offenders to get slow prosecutions.

It is an open-label, parallel-group trial comparing the combination of psychosocial intervention and slow prosecutions with psychosocial intervention alone in treating subjects with methamphetamine dependence

Study Hypothesis

1. Psychosocial interventions in combination with slow prosecutions is more effective than psychosocial interventions alone to achieve abstinence for subjects with methamphetamine abuse/dependance.
2. Inclusion of telephone reminding before each visit will enhance the retention rate and abstinence rate.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR criteria for amphetamine/methamphetamine abuse or dependence
* 18 - 65 years old
* For TSTSU-N and TSTSU-T arms: methamphetamine offenders referred by the Yunlin District Prosecutors Office
* For OPD arm: psychiatric outpatients referred from the psychiatry clinics in National Taiwan University Hospital, Yunlin Branch

Exclusion Criteria:

* Concurrent use of other illicit substances
* Co-morbidity with major psychotic disorders (schizophrenia, schizoaffective disorder, other psychotic disorder), mental retardation, acute episodes of major depressive disorder or bipolar affective disorder) or serious personality disorders.
Effects of Different Inhalation Oxygen Concentrations on Postoperative Atelectasis

This study was a single-center, prospective, randomized controlled, two-arm study. This study will be conducted in the First Hospital of China Medical University. the investigators aimed to investigate the effects of different inspired oxygen concentrations in lung protective ventilation strategies on immediate postoperative atelectasis and intraoperative changes of oxygenation index in patients undergoing neurosurgical surgery in the supine position.

This study was a single-center, prospective, randomized controlled, two-arm study. This study will be conducted in the First Hospital of China Medical University. the investigators aimed to investigate the effects of different inspired oxygen concentrations in lung protective ventilation strategies on immediate postoperative atelectasis and intraoperative changes of oxygenation index in patients undergoing neurosurgical surgery in the supine position. A total of 96 neurosurgical patients under supine position were selected with an estimated operation time of more than 2 hours. Patients were randomly assigned to low-oxygen concentration (30%FiO2) L group, or high-oxygen concentration (60%FiO2) H group, and both groups received lung protective ventilation strategies. The main outcome was the comparison of postoperative atelectasis volume between the two groups. Secondary outcomes were the comparison of intraoperative oxygenation index and postoperative changes in diaphragm height between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* patients with American Society of Anesthesiologist (ASA) physical status I-II;
* Older than 18 years; Patients with operation time more than 2 hours and plan to extubate in the operating room;
* Preoperative blood gas partial pressure of oxygen was more than 80mmHg;
* Patients scheduled for elective neurosurgery were operated in the supine position.

Exclusion Criteria:

* A history of acute lung injury with acute respiratory distress syndrome within three months;
* Heart failure (New York Heart Association class) greater than IV, severe liver and kidney dysfunction (Child B or C liver failure, glomerular filtration rate \<30ml/min);
* BMI \> 30 kg/m2.
* The operation time is more than 10 hours;
* The amount of bleeding was more than 500ml; The total fluid volume exceeded 3000ml.
Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation.

The aim of the COMIX-R study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Invasive mechanical ventilation on tracheal probe
* Acute respiratory distress syndrome, as defined by Berlin conference consensus, during hospitalization in intensive care,
* Recovery phase of acute respiratory distress syndrome: spontaneous ventilation representing from 20 to 30% of ventilation in APRV mode.
* No severe acidosis (pH\> 7.30)
* Patient affiliated to or beneficiary of a health care plan
* Express consent of the patient or his/her SDM

Exclusion Criteria:

* Pneumothorax
* Contraindication to the insertion of a nasogastric tube with an esophageal balloon
* Contraindication to the use of Electrical impedance tomography (pacemaker)
* Pregnancy, lactating or parturient woman
Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology

This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. In a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. Neurologists first reviewed the AI's recommendations using clinical records and then assessed its performance directly with patients. The findings were as follows: neurologists agreed with the AI's decisions nearly all the time, and the AI outperformed earlier versions of Chat GPT in every tested aspect. Patients and doctors found the AI to be highly effective, rating it as excellent or very good in most cases. This suggests the AI could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used.

Background and Objectives: Neurological emergencies pose significant challenges in medical care, especially in resource-limited countries. Artificial Intelligence (AI), particularly health chatbots, offers a promising solution. However, rigorous validation is required to ensure safety and accuracy. The objective of our work is to evaluate the diagnostic accuracy and resolution effectiveness of an AI-powered virtual assistant designed for the triage of emergency neurological pathologies, to ensure the minimum standard of safety that allows for the progression to successive validation tests.

Methods: This Phase 1 trial evaluates the performance of an AI-powered virtual assistant for emergency neurological triage. Ten patients over 18 years old with urgent neurological pathologies were selected. In the first stage, nine neurologists assessed the safety of the virtual assistant using their clinical records. In the second part, the assistant's accuracy when used by patients was evaluated. Finally, its performance was compared with Chat GPT 3.5 and 4.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old consulting in the ER due to a neurological emergency

Exclusion Criteria:

* Pregnancy
AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2)

This pilot study will test a digital care planning decision support system for patients with dementia.

he clinical study is part of an EU-funded project on the use of artificial intelligence for patients with dementia. This study will test a digital toolkit for advance care planning and decision making for patients with dementia and pilot-test this digital support system for feasibility and acceptability.

Other workpackages of the AI4HOPE project will design a digital technology platform to provide relevant, timely and appropriate information for people with dementia and their carers, and to facilitate them to document their goals, wishes, and preferences for future care.

Patients with mild to moderate dementia will be recruited for the pilot study in the six participating countries. The study population includes all types of dementia without stratification, as the aim of the study is to develop a digital technology platform to facilitate ACP for clinical practice in any patient with cognitive impairment from any type of dementia.

Even though the digital platform could be adapted to be useful for patients with advanced dementia and more severe cognitive impairment, or for use just by their families, the pilot study will recruit only patients with mild or moderate dementia, who will still be able to provide informed consent, and who will be able to self-assess for patient-related outcome or patient-related experience measures to inform the assessment of the digital technology platform.

Patients with dementia treated in the participating study centers will be screened for inclusion criteria and, if suitable will be invited to participate. The study will be performed for up to 90 days, with optional extension to 180 days according to patients' preferences.

Patients with baseline data and at least one interaction with the digital platform and data completed before and after that interaction will be included in the evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate dementia of any type
* Able to provide informed consent, or consent from surrogate decision maker
* Able to self-assess patient-related outcome (PROM) or experience (PREM) measures

Exclusion Criteria:

* Ongoing delir
* Severe cognitive impairment (MMSE \< 10 \[22\])
* Unable to provide informed consent
* Life expectancy estimated less than 3 month
Pilates-based Core Strengthening on Patellofemoral Pain Syndrome

Patellofemoral pain syndrome (PFPS) is one of the most common musculoskeletal pain conditions that tend to become a chronic problem. PFPS is common among young adolescents, particularly in physically active individuals aged 12 to 17 years old with more prevalence among females, as it affects females 1.5 - 3 times when compared to males.

Adolescents with PFPS usually complain of retro-patellar pain (behind the kneecap) or peripatellar pain (around the kneecap) and crepitation in the knee joint, and also there is discomfort while sitting with a flexed knee for a long time. Symptoms are usually exacerbated by activities that increase the load on patellofemoral joints such as weight-bearing activities, squatting, walking up or downstairs, and running.

PFPS takes place whenever the muscles around the knee fail to keep the kneecap properly aligned, leading to abnormal lateral tracking of the patella.Overuse such as running and jumping sports, the trauma of kneecaps such as fracture, dislocation, or knee surgery may also predispose to PFPS.

Eligibility Criteria:
Inclusion Criteria:

* Pain felt anterior to knee joint.
* Pain felt retro-patellar.
* Pain felt during rest and increased with activities like prolonged sitting, squatting, running, and stair climbing.
* Insidious onset lasting for more than 6 weeks.
* Without any traumatic incidence.
* Not participating in a physical therapy program for the past three months.

Exclusion Criteria:

* If they had a meniscal tear.
* Cruciate/collateral ligaments involvement.
* Knee osteoarthritis.
* Rheumatoid arthritis.
* A history of knee or hip surgery.
* Patellar dislocation/subluxation.
* Traction apophysitis encompassing the patellofemoral complex.
* Any pathology in the patellar tendon.
* Spinal referred pain.
Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers

The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.

Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female aged between 20 to 35 years
* BMI:18.0-26.0

Exclusion Criteria:

* Females who are pregnant
* Drug use affecting sex hormone secretion
Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan

The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0-2

Exclusion Criteria:

* Subject has uncontrolled intercurrent illness
CMV Intensive Care Units

Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection.


Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the study
* Age of at least 18 years
* Admission to the MHS-ICU for at least 72 hours

Exclusion Criteria:

* Inability to give informed consent
* Age younger than 18 years
* AIDS
* Pregnancy
* Organ or bone marrow transplant, receipt of immunosuppressive therapy including corticosteroids within 30 days, and cancer or hematologic malignancy treated with radiotherapy or chemotherapy
Postoperative Positioning After Surgery for Macular Holes

Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.

Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic macular hole stage II-IV
* Informed consent
* Duration of symptoms ≤ 24 months

Exclusion Criteria:

* Previous vitreomacular surgery
* Myopia ≥ 8 diopters
* Ocular trauma
* Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
MRI Neurofeedback and Brain Circuits Related to Motivation in Healthy Participants

The purpose of this research study is to understand how healthy individuals self-regulate motivation by observing brain activity using magnetic resonance imaging (MRI).

Neuromodulatory nuclei detect and transform brain network activity into simpler signals, then send neurotransmitters back out to large-scale brain networks to change their function. Such nuclei are centrally implicated in mental disorders and adaptive resilience, and their regulation remains an untapped resource for interventions. The purpose of this study is to understand how neuromodulatory nuclei detect and in turn influence distributed patterns of brain activity to impact behavior. In order to understand their regulation and effects on brain function, the investigative team has developed novel neuroimaging, behavioral, and analytic methods. These methods include: training participants to endogenously self-regulate dopaminergic midbrain and then relating midbrain activation to memory-conducive states, effort exertion, and decision making.

If the aims of this project are achieved, the investigators will have methods for regulating midbrain noninvasively, an improved understanding of its impact on learning and motivated behavior, and reliable cognitive strategies for a wide array of interventions across educational and clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years
* Male or female
* Right-handed
* In good general health
* Women of childbearing capacity: use of effective method of birth control

Exclusion Criteria:

* Current or diagnosis within past six months of an DSM-V Axis I or Axis II disorder (self-reported)
* Current or past six month use of prescription medications indicated for psychiatric conditions (e.g.,depression, anxiety)
* Current serious medical illness (self-reported)
* Head injury resulting in loss of consciousness
* For participants age \> 59 years, a total scaled score \< 8 on the Dementia Rating Scale-2.
* A clinically-defined neurological disorder including, but not limited to:
* Any condition likely to be associated with increased intracranial pressure
* Space occupying brain lesion
* History of stroke
* Transient ischemic attack within two years
* Cerebral aneurysm
* Dementia
* Mini Mental Status Exam (MMSE) score of \<24
* Parkinson's disease
* Huntington's disease
* Multiple sclerosis
* Presence of cochlear implants or other implanted electronic devices or non-removable metal (e.g., non-removable piercing, IUD)
* History of an eye injury involving metal. Participants who worked with metal may be allowed to participate on a case-by-case basis with prior written approval from BIAC.
* Claustrophobia or unwillingness to tolerate the confinement associated with being in the MRI scanner.
* Weight of more than 250 pounds