cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Observational Study Of Chinese With NAFLD/NASH

This is a 10-year, longitudinal, observational study of patients with NAFLD/NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, the biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not.

This study aims to determine and elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications in Chinese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 and older;
* Adults being managed or treated for NAFL or NASH;
* Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.

Exclusion Criteria:

* Incompetent to understand and/or sign the informed consent;
* Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female;
* Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
* Diagnosis of liver cirrhosis and/or hepatocellular carcinoma;
* Diagnosis of chronic inflammatory disease (i.e. inflammatory bowel disease, rheumatoid arthritis, inflammatory lung disease, severe infectious diseases), other than NAFL/NASH.
Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection

Liver surgeries are high risk surgeries that might result in injuries in kidneys and heart. This study was planned to investigate the frequency of these injuries as well as the risk factors for their devolopment and its effect on patient outcomes.

Hepatic resections are highly invasive major surgical procedures and are associated with higher incidence of end-organ injuries, specifically acute kidney injury (AKI) and perioperative myocardial injury (PMI). This study was designed to determine the incidences of AKI and PMI, and reveal the risk factors for their development and investigate intraoperative labaratory predictors in patients undergoing hepatic resection. We also planned to evaluate the relationship between the occurrence of end-organ injury and length of hospital and intensive care unit (ICU) stay, and 90-day mortality.

Patients were identified from a prospectively maintained data file that involves the perioperative data of patients undergoing surgery at Hepatobiliary-Pancreas clinic of Başakşehir Çam\&Sakura City Hospital. All consequtive patients within the study period were evaluated for inclusion. 128 patients were eligible for statistical analysis. This sample size was sufficient to determine the incidence of perioperative organ injury with a margin error of 8.4%. Green formula revealed that the sample size was sufficient for evaluating 9 variables in a regression model.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent hepatic resection

Exclusion Criteria:

* presence of end stage kidney disease
* emergency surgery
* application of total vascular exclusion
* concomitant gastrointestinal resection
* duration of surgery less than 100 minutes
* non-oncologic procedures
Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)

Blood samples will be obtained from newly diagnosed GBM patients treated with combined radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The primary outcome is the shift in T reg cell fraction a defined by determining the proportion of CD4 cells that are CD4+ CD25.

Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor and it remains a lethal disease. Approximately 4 weeks post surgery for tumor resection, patients will proceed to standard of care treatment which currently consists of temozolomide (TMZ) with concurrent radiation therapy (RT) for 6 weeks. This study will add bevacizumab (BEV) to the standard of care regimen in newly diagnosed patients. The Bevacizumab will be added 2 weeks post start of RT/TMZ. Administration of bevacizumab will continue concurrently with TMZ every 2 weeks for 12 months. Blood samples will be obtained from these patients at 3 different time points during this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven GBM
* Karnofsky status equal to or greater than 60%

Exclusion Criteria:

* Inadequately controlled hypertension
* Prior history of hypertension crisis or hypertensive encephalopathy
* History of stroke or transient ischemic attach within 12 months
KT(KT Corporation)-SNUBH(Seoul National University Bundang Hospital) U-health Cooperative Research

The purpose of this study is to analyse utility and compatibility of U-health solution service based on mobile for chronic wound management.

In this study, 'the management of pressure ulcer' defined as procedures comprising wound assessment, wound dressing and infection control, visually evaluated the outcomes of 'the management of pressure ulcer' through the tele-consultation.

This study designed to draw service targets based on utility and compatibility of U-health solution service and to analyse whether health providers use U-health solution service.

Eligibility Criteria:
Inclusion Criteria:

* Subject who has pressure ulcer or Health care provider for wound management

Exclusion Criteria:

* Subject who have Osteomyelitis
* Subject who have suppuration
* Subject who participated in other clinical trial within 30 days from screening date
Virtual Reality Technology for Vasectomy Pain Modulation

This study will evaluate whether or not wearing a virtual reality (VR) headset reduces pain and anxiety in patients undergoing vasectomy. The headset being used is the SmileyScope virtual reality interface, a device already undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. In this study, the SmileyScope virtual reality interface is considered an investigational device because it is not yet approved for use in adult males undergoing vasectomy.

Vasectomy is a safe and effective procedure for permanent sterilization in males. More than 500,000 vasectomies are performed annually in the United States, and that number is expected to grow rapidly in the coming years. The procedure is safe and can be quickly performed in an outpatient setting. Complications of vasectomy are rare, and can include hematoma and infection, spermatic granulomas, and post-vasectomy pain syndrome in rare cases. Like all outpatient surgical procedures where the patient is not under general anesthesia, vasectomies involve intraoperative and immediate post-operative pain. While use of the no-scalpel technique and local anesthetic reduces intraoperative pain, expected operative pain is still one of the main reasons patients cite for not undergoing the procedure.

In our current study, the investigators aim to further modulate intraoperative pain using virtual reality goggles. In clinical trials, the SmileyScope device has been shown to reduce procedural pain in the pediatric population during venipuncture or intravenous cannulation. Results from those studies showed a statistically significant reduction in pain during intravenous procedures in the emergency department. This VR headset is undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. Currently, this device has been granted entrance to the FDA Safer Technologies Program. In this study, the SmileyScope virtual reality interface is considered an investigational device because it is not yet approved for use in adult males undergoing vasectomy. The aim of this study is to investigate whether this same virtual reality modality can be utilized to reduce pain during vasectomies.

Eligibility Criteria:
Inclusion Criteria:

* Adult males 18 years or older who are undergoing elective vasectomy

Exclusion Criteria:

* Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study
* History of chronic pain disorder or chronic narcotic use
* Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancer, etc. which could compromise the physical function of the headset.
Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery

The radio-guided technique offers both help with in-vivo identification and ex-vivo confirmation of parathyroid adenoma. In-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.

Despite the relatively accurate preoperative topographic information, minimally invasive parathyroid surgery can still be very challenging, especially in the case of small adenoma in ectopic localization. Radioguided technique offers both help with in-vivo identification and ex-vivo confirmation of adenoma. Excellent ex-vivo radio guidance results are referred. But, in-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* No history of thyroid or parathyroid surgery
* Diagnosis of primary hyperparathyroidism
* Indication for 99mTc-MIBI SPECT/CT examination

Exclusion Criteria:

* Minor patients
* Negative SPECT/CT findings
* Patients refusing surgery
* Previous combined surgery on the thyroid gland
* Patients in high risk of general anesthesia
* Patients who do not undergo surgery in the recommended time span
Acupuncture for Urinary Incontinence

This research study will evaluate the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo) acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not actually inserted into the body) on the frequency and volume of involuntary (accidental) urine loss after completing the intervention, and again one month later. Individuals participating in this study will be randomly assigned to receive either the actual or sham acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study participants will not know which group (actual or sham acupuncture) they were assigned to until one month after completing the 6-weeks of treatment. The sham acupuncture needles look similar to the real acupuncture needles and feel like they penetrate the skin, but do not actually do so. If individuals are assigned to the sham acupuncture group, they will be eligible to receive the actual acupuncture one month after completing the sham acupuncture if they wanted to. All individuals will be followed for 6 months after completing the acupuncture treatments.

See Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Urge or stress urinary incontinence at least twice a week on average for at least 3 months

Exclusion Criteria:

* History of previous acupuncture
* History of a neurologic problem such as Parkinson's disease or multiple sclerosis that could affect bladder function
* Current treatment with overactive bladder medications or medications that relax the bladder
* Urinary catheter
* Pregnancy
* Inability to empty the bladder effectively
* Inability to toilet independently
* Current treatment with steroid
* Interstitial cystitis
* Chronic pelvic pain
* Current treatment with warfarin
A RCT of a Fully-automated Self-help AEBT Website

Trichotillomania (TTM) is characterized by hair pulling that is repetitive in nature leading to notable hair loss, causing clinically significant distress and resulting in impairments across social and functional domains (APA, 2013). Trichotillomania causes significant social impairment including affecting close relationships, pursuing occupational changes or advancement, or interfering with schooling (Grant et al., 2017; Woods, Flessner, Franklin, Wetterneck, et al., 2006). The core of the treatment of trichotillomania has traditionally been Habit Reversal Training (HRT) (Twohig, Bluett, et al., 2014). Another form of treatment that is gaining empirical support is Acceptance and Commitment Therapy (ACT) which has been studied in four randomized controlled trials, one studying ACT as a standalone treatment (Lee, Homan, et al., 2018), and three examining ACT combined with HRT (Twohig et al., 2021; Lee, Haeger, et al., 2018; Woods, Wetterneck, et al., 2006) which demonstrated efficacy of the combined treatment in decreasing pulling symptom severity.

The prevalence of trichotillomania in the US is 1-2% of the population and yet treatment access is limited by many issues including processionals' lack of knowledge of the disorder and low treatment accessibility (Walther et al., 2010). ACT- enhanced behavior therapy has been implemented using telehealth to reach a larger population (42.2% decrease pre-to-post treatment), but telehealth still requires therapist time and incurs notable costs (Lee, Haeger, et al., 2018). The present study aims to address the gap in trichotillomania treatment accessibility by examining the role of check-ins on adherence and efficacy on afully automated, web-based ACT-enhanced HRT treatment for adults with trichotillomania across the United States. We predict that the condition with check-ins will increase adherence and efficacy of the treatment significantly more than the condition without check-ins. Additionally, we predict that hair pulling severity and psychological flexibility will be significantly improved by the condition with check-ins compared to the condition without check-ins.


Eligibility Criteria:
Inclusion Criteria:

1. Currently meet DSM-5 criteria for trichotillomania
2. searching for trichotillomania-based treatment
3. are atleast 18 years old
4. fluent English speakers
5. living in the U.S.

Exclusion Criteria:

1. currently receiving alternative therapy
2. currently modifying or starting psychotropic medication
3. previously met DSM-5 criteria for trichotillomania but are not, at the time of intake session, engaging in hair pulling
Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery

Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an adjuvant therapy in patients with myocardial infarction or in the patients undergoing valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known to prevent excretion of lactate and to increase the extraction of lactate after reperfusion with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury of myocardium after CPB, to improve myocardial contractility, insulin resistance and hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:

  1. congestive heart failure
  2. infective endocarditis
  3. redo valvular surgery
  4. surgery combined with coronary bypass graft
  5. multiple valvular surgery
  6. expected CPB duration longer than 2 hr 7\> preoperative serum creatinine over 1.4 mg/dl 8\> preoperative hemoglobin level less than 12 mg/dl 9\> left ventricular ejection fraction less than 40%

Exclusion Criteria:

1. emergency surgery
2. hemodynamic instability before surgery (mean arterial pressure \< 60 mmHg, heart rate \>100 /min
3. need for pharmacological or mechanical assist for hemodynamic stability before surgery
4. baseline blood lactate level more than 2 mmol/l
5. on steroid or NSAID
6. hepatic dysfunction
Effect of Weight and/or Obesity on Dapsone Drug Concentrations

This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, age \>18 years, of all racial and ethnic origins.
* Non-English speaking Spanish speakers will be included in the study.
* We are recruiting 12 normal or underweight (BMI \<25 kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI \> 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / \[height (in)\]2 x 703). Half of each group will be male; the other half will be female.

Exclusion Criteria:

* Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of dapsone on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of dapsone, so that the pregnancy and post-partum state would be a confounding variable.
* Abnormal liver function tests: transaminases\>10 times upper limit of normal, Alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal.
* History of allergies to dapsone, sulfones, or sulfonamides.
* Dapsone, sulfones, or sulfonamides are contraindicated for any reason.
* Volunteers unwilling to comply with study procedures.
* Current suspected or documented infection of any kind.
* Volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug.
* Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by PI.
* Donation of 450 milliliters (ml) (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
* Current use of zidovudine, amprenavir, rifabutin, rifapentine, or saquinavir.
* Creatinine clearance \< 70 ml/minute (min) as estimated by the Cockcroft-gault equation.
Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit

To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring.


Eligibility Criteria:
Inclusion Criteria:

For the "preoperative" arm:

* Signed informed consent form
* Arterial catheter for hemodynamic monitoring

For the "intraoperative" arm:

* Signed informed consent form
* Arterial catheter for hemodynamic monitoring
* The operation will presumably last for more than 2 hours

For the "intensive care unit" arm:

* Signed informed consent form
* PiCCO monitor for hemodynamic monitoring

Exclusion Criteria:

For the "preoperative" arm:

* Pregnancy
* Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student

For the "intraoperative" arm:

* Pregnancy
* Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
* Measuring blood pressure on both arms is not possible
* Insertion of an arterial catheter is not necessary or contraindicated
* Insertion of a central venous catheter is not necessary or contraindicated

For the "intensive care unit" arm:

* Pregnancy
* Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
iTBS on Negative Symptoms and Cognitive Function in Schizophrenia

The negative symptoms and cognitive deficits are common in patients with schizophrenia, and do not respond well to antipsychotics. The effective treatments for negative symptoms and cognitive impairment are still to be explored. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia. In this study, we explore the effects of iTBS on negative symptoms and cognitive function based on identifying the brain network connection of schizophrenia symptoms.

The negative symptoms and cognitive deficits are two core symptoms in patients with schizophrenia, and do not respond well to antipsychotics. There are many researches on the biological mechanism of these two symptoms, and some studies indicated that these two symptoms maybe related to the dysfunction of prefrontal cortex and deficiency of dopamine. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia.Therefore, this study explore the efficacy of iTBS on negative symptoms and cognitive deficits in schizophrenia based on identifying the brain network connection of schizophrenia symptoms.

Firstly, we have used neuroimaging to find the left prefrontal cortex that is responsible for negative symptoms and cognitive function in schizophrenia. Then,we design this randomized double-blind sham-controlled clinical trial. Patients with schizophrenia will be randomly treated with iTBS or sham condition to the left dorsolateral prefrontal cortex(L-DLPFC) for continuous 10 days, theL-DLPFC will be targeted utilizing the localite neuronavigation system. The follow-ups are set at baseline, the 11th day and the 30th day after the end of treatment. The main outcome measures include the change in MCCB score, PANSS score, SANS score, SAPS score and the resting-state functional magnetic resonance imaging data.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with schizophrenia in accordance with DSM-5
2. The disease duration ≤8 years
3. Received a steady dose of antipsychotic medication for least 4 weeks
4. The Global Deficit Score of MCCB ≥0.5 or the PANSS negative subscore ≥20
5. No obvious extrapyramidal side effects caused by antipsychotic drugs
6. Informed Consent

Exclusion Criteria:

1. Diagnosed with other mental disease in accordance with DSM-5
2. Combined with other severe physiological disease
3. Used antidepressants, mood stabilizer, or other psychoactive substances before
4. Drug or alcohol abuse
5. Pregnant or lactating
6. Contraindication to rTMS
7. Received rTMS or electroconvulsive therapy in the past 1 month