cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Transcranial Electrical Stimulation (tES) on Emotion Processing

The aim of this study is to assess the efficacy of transcranial Electrical Stimulation (tES) on emotion processing of healthy participants. Meanwhile, the investigators evaluate the effect of tES on electroencephalography (EEG) of both resting and task-related signal. The hypothesis of this study is that tES can improve the cognitive function of emotion by modulating brain activity.

This is a randomized, single-blind, sham-controlled study using transcranial Electrical Stimulation (tES) for 7-day treatment. Participants were randomly assigned to transcranial alternating current stimulation (tACS) group, transcranial direct current stimulation (tDCS) group or sham-control group. Active tES comprised 20 min sessions of 1.5 mA peak-to-peak current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days. Sham group was administered similarly, but with current turned off after 30s. Apart from studying the effects of tES on physiology signals, subjective scale assessments and behavioral data are performed before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 35 years
* with normal or corrected to normal vision
* participant or guardian need to sign informed consent

Exclusion Criteria:

* reported neurological or psychiatric disorders
* history of any form of transcranial electrical stimulation experience
* use of mood stabilizer
* history of substance abuse or dependence
* severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma
* use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
* use of immunosuppressive medication such as oral steroid hormones women in pregnancy or lactation period
The Effects of a Yoga Program in Heart Failure Patients

The proposed research will investigate the clinical outcomes associated with a modified yoga training program in patients with heart failure (HF). HF patients (15-20) will participate in a modified yoga program during an 8 week period, two times per week with instruction for home practice. Baseline measures and follow-up will be taken after 8 weeks. The underlying hypothesis to be tested is that yoga-induced improvements in nervous system and skeletal muscle function will yield positive effects on clinical outcomes, functional ability, and health-related quality of life in patients with HF.

The effect of combined yoga and breathing training on the natural history of HF and its potential to decrease negative clinical outcomes and improve symptoms is unknown. The relevance of this research is related to the important information it will provide to clinicians caring for patients with HF and will be the basis for pilot data for future NIH funding applications.

The proposed research project is a pilot study designed to delineate the clinical outcomes associated with a modified yoga program in a population of adults with ventricular dysfunction and clinical heart failure (HF). The researchers hypothesize that patients in a modified yoga training program will have a significant improvement in clinical outcomes, functional ability, and health-related quality of life (HRQOL). The researchers propose to evaluate 15-20 subjects with chronic HF and New York Heart Association Functional Class (NYHA) II-III and obtain baseline physiological, functional, and HRQOL measurements. After obtaining baseline measurements, patients will participate in a modified yoga program with instruction for home practice for 8 weeks. Baseline measurements include: Vital signs, oxygen saturation, heart rate variability, exercise distance, muscular strength and flexibility determination, and various indices of HRQOL. At the conclusion of 8 weeks of yoga training the same measurements will be obtained.

In a group of chronic HF patients, the specific aims are the following:

1. To develop a safe and feasible yoga program;
2. To determine whether clinical outcomes (vital signs, oxygen saturation, heart rate variability), functional ability (exercise distance, muscular strength and flexibility determination), and HRQOL are positively affected by a modified yoga program.

Eligibility Criteria:
Inclusion Criteria:

* NYHA class I-III
* normal sinus rhythm
* able to walk
* ability to read or understand English
* age 30-75

Exclusion Criteria:

* cognitive impairment
* inability to consent
* 100% paced with pacemaker
* hospitalization within 3 months
* MI or recurrent angina within 6 months
* severe stenotic valve disease
* history of sudden cardiac death
* history of uncontrolled ventricular tachyarrhythmias
* pulmonary hypertension
* FEV1 less than 1 liter by spirometry
* orthopedic impediments to yoga
* medication noncompliance
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects

In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.

We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age 20-65 years
* BMI equal to higher than 25 kg/m2

Exclusion Criteria:

* under anti-obesity medication
* uncontrolled diabetes
* uncontrolled hypertension
* any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics
* thyroid function test abnormality
* malignancy within 5 years
* immune compromised hosts or under immune suppressants
* antibiotics or probiotics withing 2 weeks
* any intervention to reduce body weight within 6 months
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological, neurobiological and genetic data was collected. After the completion of the baseline assessment and examination, the patients were given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment. Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this study aimed to provide some guidance for the use of antidepressants in patients with bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* age 18-55 years old, bipolar depression

Exclusion Criteria:

* other mental illness, serious somatic illnesses, MRI contradictions.
Low Frequency TMS for Depression in Epilepsy

The purpose of this study is to determine if low-frequency transcranial magnetic stimulation (TMS) is safe and feasible for treating depressive symptoms in patients with epilepsy. Patients will receive an accelerated protocol of TMS consisting of three consecutive days of treatment. Patients will have in-person follow up visits after one month and again after six months.

This is a pilot study designed primarily to assess whether patients with epilepsy can safely tolerate low-frequency transcranial magnetic stimulation in an accelerated protocol to treat depression. The investigators aim to treat 12 patients with epilepsy and comorbid depression to receive a total of 15 hours of transcranial magnetic stimulation over 3 days at Dartmouth-Hitchcock Medical Center (DHMC). The investigators will assess safety of this protocol with regards to seizure frequency and other side effects of TMS treatment and the feasibility of using an accelerated protocol in this patient population. In addition to these primary aims, our secondary goal is to determine if dense array EEG can provide a useful biomarker for depression and its treatment in focal epilepsy. A structural and functional MRI will be obtained before treatment and a dense array EEG before and after TMS treatment to assess for changes in specific dense array EEG based biomarkers.

In addition to recruiting patients, the study staff will likewise request that family members or friends of the patient accompany the patient monitor him/her for increased seizure frequency. The recruited family member will bring the patient to the treatment and stay with the patient overnight at a local hotel and monitor for possible seizures or other adverse events of treatment. Family members will be instructed in seizure safety and be given emergency phone numbers to call if the patient is experiencing adverse effects of TMS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able and willing to provide informed consent.
* Diagnosis of epilepsy confirmed by the study neurologist (KB).
* English-speaking
* Not pregnant
* Able to safely undergo MRI (as assessed by MRI safety form).
* Have a family member or friend (proxy) who will be able to bring the patient to the hospital and serve as a safety monitor during stay in study hotel for two consecutive nights.
* Patients on stable doses of current antiepileptic and antidepressant medications for 1 month.

Exclusion Criteria:

* Significant cognitive impairment measured by the Montreal Cognitive Assessment (MOCA) \<23.
* History of other major psychiatric disorders (e.g., schizophrenia, bipolar disorder, substance use disorder (except caffeine and nicotine) or presence of unstable medical comorbidities.
* Actively/imminently suicidal (QIDS item 12 score \> 2 or Mini-International Neuropsychiatric Interview (MINI) Suicidality module score \> 16)
* Greater than 10 seizures per week during 1 month prior.
* History of stroke, moderate-severe traumatic brain injury or other major neurological disorder.
* Any magnetic or implanted device that will interfere with ability to safely receive MRI and/or TMS treatment.
Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Diabetes Patients

The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in patients with diabetes.

Depression is a common co-morbidity of diabetes, negatively affecting physical performance, glycemic control, adherence to medication, and dietary, and exercise recommendations. Modalities of psychotherapy like cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) can reduce depressive symptoms in patients with medical conditions. However, proper designed randomized trials assessing and comparing effectiveness of these psychological interventions are rare.

This longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in diabetes patients. Furthermore, potential moderators and mediators of treatment effect will be explored, as well as the role of common factors and treatment integrity.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 1 or 2 for at least three months prior to inclusion
* Written informed consent
* Age ≥ 18 and ≤ 70
* Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression)

Exclusion Criteria:

* Not being able to read and write Dutch
* Severe (psychiatric) co-morbidity
* Acute suicidal ideations or behavior
* Pregnancy
* Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study

Using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study
The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression

This is an observational study that will be conducted on pregnant women under vaginal delivery or cesarean section. The magnesium sulfate will be given to appropriate participants with a protocol that obstetrician are already using in our hospital. After delivery, participants are asked to answer sequential questionnaires to assess postpartum depression.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who will do delivery.
* Gestational week \>= 30 week
* Singleton

Exclusion Criteria:

* History of depression
EC-MOTION : ExtraCorporeal Membrane Oxygenation and Therapeutic Drug Monitoring of Drugs of infectION

The objective of the study is to investigate the exposure difference between antibiotic studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients without Extracorporeal Membrane Oxygenation.

The exhibition is evaluated by population pharmacokinetic modeling.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Hospitalisation in intensive care
* Treatment with ECMO or without ECMO
* Introducing sepsis treated with an anti-infective molecule studied (piperacillin) for less than 48 hours
* With an arterial catheter
* Patient Information or their next of kin according to the patients status.

Exclusion Criteria:

* Pregnancy
* Major person under legal protection (backup justice, trusteeship, quardianship), person deprived of liberty
Safety and Efficacy of UC-MSCs in Patients With Plaque Psoriasis

This is a study in patients with moderate to severe chronic plaque psoriasis.All the participants will be randomized into three groups, high-dose UC-MSCs, low-dose UC-MSCs, or methotrexate group.This study is designed to prove that UC-MSCs is safe and effective.

Psoriasis is a chronic, incurable, immune-mediated dermatological disease, and it is considered that immune system dysregulation is the important cause of the disease.Umbilical cord derived mesenchymal stem cells (UC-MSCs) have be proven safe and effective for the treatment of various intractable autoimmune and inflammatory disorders because of their distinct immunomodulatory properties.

Patients will be randomized into three groups.In one group patients will be treated with 1x10\^6 cells/kg in 0,1,2,3,5,7 week, in the second group patients will be treated with 3x10\^6 cells/kg in 0,1,2,3,5,7 week,in the third group patients will be treated with 5-25mg Methotrexate from 0 to 15 week In this study, researchers will determine the safety of UC-MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be assess the efficacy and sustainability of UC-MSCs in 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years old with moderate-to-severe psoriasis.
* Diagnosis of plaque psoriasis at least 6 months before entering the study.
* Moderate-to-severe plaque psoriasis(PASI≥10，or BSA≥10% and DLQI score≥10).
* Failure after conventional therapy.
* No other treatment for psoriasis during the period of the trial.
* Willing and able to comply with all study requirements and provide informed consent.

Exclusion Criteria:

* Other types of psoriasis,such as pustular, erythrodermic and guttate psoriasis).
* Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
* Ongoing use of other psoriasis treatments.
* Ever use of any biologic drug directly targeting IL-17,IL-23,TNFa etc.
* Active systemic infections during the last two weeks (exception: common cold) prior to initiation of the trial and any infections that reoccur on a regular basis.
* History of malignancy .
* Evidence of infection with HIV, hepatitis B or hepatitis C.
* Pregnant or lactating females, or willing to have a baby during the trial.
* Can not be traced on time.
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected adults or adolescents \>=16 years of age;
* HIV-1 RNA \>=5000 copies/mL;
* prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

Exclusion Criteria:

* history of prior use of Fuzeon or T-1249;
* female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
* current severe illness;
* currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.
Non-invasive Methods for Predicting Decompensation of Chronic Liver Disease

Preliminary studies have suggested that non-invasive methods can not only be applied to CSPH but also to predict the risk of decompensation in cirrhosis. However, there is a lack of clinical evidence, and more research is needed to provide such evidence. Especially in China, where the etiology of cirrhosis is prevalent, there is a large population of patients with hepatitis B cirrhosis undergoing antiviral treatment. Exploring the value of non-invasive methods in predicting decompensation events in these patients can not only expand the clinical application of non-invasive methods but also provide effective non-invasive screening and management strategies for patients with cirrhosis at different risk levels.

Primary Objective: The main purpose of this study is to evaluate the predictive effectiveness of non-invasive methods (based on liver and spleen stiffness) for the occurrence of decompensation in chronic liver disease (CLD).

Secondary Objectives: To establish different predictive models for the occurrence of decompensation in CLD and to assess their predictive effectiveness as non-invasive methods for decompensation in CLD.

Approximately 2334 individuals will participate in this study at 17 different health care Setting.The study will last for 4 years, including 1 year of enrollment and 3 years of follow-up. Patients will be seen at 6-month intervals, and all examination results of patients as well as decompensation events, liver cancer, and death will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years and under 80 years; ② Underlying chronic liver disease (etiology not specified);

  * Liver stiffness measurement (LSM) greater than 10 kPa or cirrhosis (diagnosed by imaging or histology);

    * Voluntarily signing an informed consent form.

Exclusion Criteria:

* Have undergone orthotopic liver transplantation or Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure;

  * History of liver cancer or other types of cancer diagnosed in the past or currently;

    * Acute or chronic portal vein thrombosis; ④ History of splenectomy or splenic embolization; ⑤ Currently in a decompensated stage (with complications such as variceal bleeding, moderate to severe ascites, hepatic encephalopathy, etc.).
Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation

This project aims to develop and evaluate a next-generation photon-counting CT prototype, and assess whether next-generation photon-counting CT--which enables reduced radiation dose, high spatial resolution, and spectral imaging--would facilitate improved diagnostic performance for abdominal, cardiothoracic, musculoskeletal, and neuroimaging.

This protocol aims to assess the diagnostic benefits of a next-generation Photon-Counting Computed Tomography (PCCT) system in patients undergoing routine CT imaging.

Recruitment will be conducted among patients scheduled for CT scans (with or without contrast agent) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans.

The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation.

This a total of 250 patients for the initial study.

Analyses will be conducted as needed, based on the specific validation or quantitative measures required for each clinical CT scan. This study will involve three radiologists for each cohort, selected based on their training in the specific anatomical region of interest, analyzing images from PCCT scanning. They will interpret both conventional CT slices and the additional spectral and high-resolution data provided by the PCCT. The images will be reviewed on a state-of-the-art workstation with a high-resolution monitor. Performance metrics will be set individually for each anatomical region.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 89.
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
* Not pregnant (based on attestation)

Exclusion Criteria:

* Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant before CT imaging.
* Participants with a known contrast allergy.
* Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)

This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects.

Granisetron is a well tested and established 5-HT3 receptor antagonist used in both oral and intravenous (IV) forms. A transdermal form of granisetron (Sancuso®) was approved by the United States (US) Food and Drug Administration (FDA) in September 2008.

Many of the 5-HT3 antagonists were developed and approved before the adoption of the International Conference on Harmonisation (ICH) E14 standard on QTc and cardiac testing. The association of non-cardiac medicinal products with the potential to prolong the QT interval and induce torsades des pointes (TdP) has significant implications for the future development of medicinal products.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects
* Aged between 18 and 50 years, inclusive, at screening
* BMI between 18.0 and 32.0 kg/m², inclusive

Exclusion Criteria:

* History of drug abuse
* Known hypersensitivity to granisetron, moxifloxacin, or related compounds, such as ciprofloxacin and levofloxacin
* Sustained supine systolic blood pressure \>140 mmHg or \<100 mmHg or a diastolic blood pressure \>95 mmHg at Screening or baseline
* Pulse rate at rest of \< 45 bpm or \> 100 bpm
* Abnormal Screening ECG indicating a second- or third degree AV block, or one or more of the following: QRS \>120 milliseconds (ms); QTcF \> 430 (males) or 450 (females) ms; PR interval \>240 ms; any rhythm, other than sinus rhythm, interpreted to be clinically significant by the Investigator
* Known history of long-QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, chest pain or dyspnea on exertion
* Electrolyte disturbances (such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, hypocalcemia, or hypophosphatemia), idiopathic cardiomyopathy, unexplained syncope, hypertrophic cardiomyopathy, or sudden unexplained death at a young age (\< 40 years) in a first-degree relative.
* Has used any medications or consumed any foods contraindicated in the protocol.