cyrilzakka/clinical-trials huggingface dataset:
Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant

The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 to 60 years inclusive
* Percentage of Panel Reactive Antibodies at transplantation \> 20%
* Estimated glomerular filtration rate using MDRD formula at inclusion \>29ml/min

Exclusion Criteria:

* Subjects with a history of cancer
* Subjects with a previous non kidney transplantation
* Subjects receiving any immunosuppression different of tacrolimus/prednisone/mycophenolate
* Subjects with a urinary protein/creatinine ratio greater than 0.3
* Subjects with active HBV, HCV and HIV infection
WeChat-based Intervention for Internet Addiction

The study aims to design an integrated model which combined self-initiated online learning and personalized interactive behavioral support delivered via WeChat for university students to reduce internet addiction level.

Internet addiction (IA), also described as pathological or problematic internet use, or internet addiction disorders, refers to a pattern of excessive internet use, and it is a new form of behavioral addiction. There are multiple subtypes of IA including excessive online gaming, sexual preoccupations and excessive messages. The excessive use of internet often generates distress or impairments, and evidence showing IA is accompanied by numerous negative impact physically, psychologically and socially such as ADHD, interpersonal sensitivity4, depression and anxiety, family discord, social problems. Pervious study also suggested IA has a significant correlation with academic performance decrement among students, who were considered as a particular vulnerable population being addicted to internet due to easy access to internet, flexible schedule, positive social atmosphere for computer/smartphone use and lack of parental supervision of internet use. IA is a relatively recent and widespread phenomenon. It was estimated 11% Chinese university students were addicted to internet, and an increase in internet use among Chinese children and adolescents was observed amid the COVID-19 epidemic.

IA is believed have some similarities with substance addiction (e.g. smoking, alcohol drinking and drug abuse) as subjects would undergo same symptoms such as depressed, anxious and lonely, affect neurobiology system with common mechanism, and both suffer from substance withdrawal. The interventions for substance addiction have been adopted to treat IA with promising effect including pharmacotherapy, Cognitive Behavior Therapy (CBT), family-based intervention and motivational interviewing, while the treatment for IA has not been standardized yet. In view of the similar characteristics of IA with substance addiction, brief advice and mobile phone-based personalized behavioral support could be feasible to treat IA which has been proven effective in our previous community-based smoking cessation trial, and the COVID-19 epidemic increased the acceptance of mHealth interventions.

The specific objectives are:

1. . To examine the effectiveness of the integrated model in reducing IA in university students;
2. . To assess the acceptability and feasibility of using the model.

Eligibility Criteria:
Inclusion Criteria:

* 1). Currently a full-time university student in HK;
* 2). Aged 18-25 years;
* 3). Internet Addiction Test (IAT) \> 50;
* 4). Able to understand and communicate in Chinese;
* 5). Own a smartphone can access internet and proficiency in using WeChat;

Exclusion Criteria:

* 1) Currently participating in other internet addiction controlling projects or services;
* 2) Experiencing psychiatric/psychological diseases or receiving regular psychotropic medication.
A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC

For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically/cytologically confirmed diagnosis of SCLC.
2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
3. Patients should be between 18 and 75 years old.
4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
6. With weight loss no more than 10% within 6 months before diagnosis.
7. Informed consent must be signed.

Exclusion Criteria:

1. Histology confirmed the mixed NSCLC components;
2. Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
3. Any disease or condition contraindicated by radiotherapy or chemotherapy;
4. Malignant pleural effusion and pericardial effusion;
5. Pregnant and lactating women;
6. The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.
Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of CKD

Control of blood pressure (BP) is the first thing to do in the management of chronic kidney disease (CKD). Although guidelines suggest the optimal blood pressure level, it is hard to assess BP correctly during the office visit. Often there is a discrepancy between office BP and out-of-office BP, including home BP and ambulatory BP. Recent study reported that as many as 34% of Korean CKD patients had masked hypertension, which means high BP by ambulatory BP monitoring but normal BP by conventional office BP measurement.

This study aims to evaluate the effect of ambulatory BP-guided BP management on the clinical outcome of CKD, compared to the conventional management using office BP.

We hypothesized that management of blood pressure using ambulatory BP monitoring would obtain more optimal BP control and thereby would influence positively on renal progression and CV outcomes.

In detail, when the eligibility criteria is met, all the subjects will undergo both ambulatory BP and office BP measurement at baseline.

After randomization, ARB (fimasartan) will be administered to drug-naive subjects or will replace the other RAS blockers in subjects with current uses. Dosing of fimasartan will be adjusted or additional drugs of other classes will be added sequentially over 3 months (titration phase).

At 3 months, ABPM will be performed in ABPM group to evaluate the adequacy of blood pressure control and dosing will be adjusted according to the ABPM results (target BP: daytime BP \< 135/85 mm Hg). This adjustment will be assessed at 6 months by ABPM once again.

For subjects in office BP group, conventional care will be provided according to current guidelines (target BP \< 140/90 mm Hg).

At 18 months, ABPM will be performed in all the subjects and outcome measures will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Office BP \> 130/80 mm Hg, irrespective of anti-hypertensive medication
* CKD stages 3-4 (or estimated GFR 15-59 ml/min per 1.73 m2)
* Random urine albumin-to-creatinine ratio \> 300 mg/g or protein-to-creatinine ration \> 300 mg/g or dipstick albumin \> 1+, in case of estimated GFR 45-59 ml/min per 1.73 m2

Exclusion Criteria:

* Systolic BP \> 180 mm Hg or diastolic BP \> 110 mm Hg
* Malignant hypertension
* Resistant hypertension (using more than three kind of anti-hypertensive drugs other than diuretics)
* Uncontrolled DM (Hb A1c \> 10.0% within 3 months of eligibility assessment)
* Use of immunosuppressive agents within 1 months or anticipated
* Atrial fibrillation or flutter
* Contraindication to renin-angiotensin system blockers (hypersensitivity, bilateral renal artery stenosis, single kidney, etc.)
* Pregnancy
* Kidney recipients
* Participating other clinical trials, except observational studies
Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease

The purpose of this study is to determine the safety of using a modified virus to transfer a gene called GAD into a region of the brain called the subthalamic nucleus in patients with advanced Parkinson's disease. The overall goal of this approach is to ultimately normalize the flow of information in several brain regions responsible for movement, to ultimately improve function in patients with this disorder. The current study is primarily designed to evaluate the safety of this approach, but patients are also being monitored for possible signs of effectiveness as well.

This study involves treatment of patients with medically refractory Parkinson's disease (PD) with gene therapy. The patients are chosen from a population of patients who would normally be candidates for standard deep brain stimulation (DBS) surgery for PD. These patients respond to medical therapy, but develop substantially reduced responses over time, often with severe fluctuations in their condition between a functional and severely non-functional state. Some patients also develop dose-limiting side effects from medication, including involuntary movements called dyskinesias and nightmares. When there are no medical contraindications, DBS is often performed in these patients to try to quiet hyperactive brain regions such as the subthalamic nucleus (STN). In PD, the STN is overactive due to a loss of GABA inputs to this region, which normally reduces neuronal firing. In turn, the STN drives other brain regions, including the globus pallidus (GPi) and substantia nigra (SNr), which are also hyperactive and which also have reduced GABA inputs. The goal of this gene therapy trial is to introduce the gene for glutamic acid decarboxylase (GAD) into the STN using an adeno-associated virus (AAV) vector, in order to permit the STN to produce it's own GABA, as well as release GABA into the GPi and SNr targets, which also have reduced GABA inputs. This is anticipated to restore a more normal pattern of information flow from this basal ganglia circuit to the thalamus and higher cortical structures in order to reduce the motor symptoms of PD, while eliminating complications arising from inserting DBS electrodes and batteries into the human body.

Eligibility Criteria:
Inclusion Criteria:

* Duration of disease: Greater than 5 years
* Idiopathic Parkinson's disease
* Parkinson's medication stable for 3 months
* Absence of dementia
* Hoehn and Yahr rating: 3 or greater and/or UPDRS: 30 or more in "off" state and/or Complications of l-dopa therapy limiting effective use

Exclusion Criteria:

* Poor candidate for any surgery
* Significant dementia
* Secondary parkinsonism
* Severe autonomic symptoms
* Atypical Parkinson's disease
* History of substance abuse
Progesterone Induced Blocking Factor Expression Levels in Endometrial Cancer Cells.

Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be questionable whether tumor cells express PIBF for escape of immune system. There are some studies in the literature that evaluate PIBF expression of different malign cells (e.g. glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF expression levels in the endometrial cancer cells.

This retrospective controlled study will be conducted at both Obstetrics and Gynecology clinics and Pathology clinics of Kayseri Training and Research Hospital. This study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the PIBF expression levels in the samples. There are three groups in this study; endometrial cancer, endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided form the Pathology clinic of Kayseri Training and Research Hospital archives.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed endometrial cancer
* diagnosed endometrial hyperplasia

Exclusion Criteria:

* diagnosed cancer except endometrial cancer
Motivational Interviewing to Reduce Substance Use Among Depression Patients

The study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug use and depression symptoms, improve functional status and promote appropriate health services utilization, in a sample of 300 adults seeking treatment for depression who also report hazardous drinking or drug use with depression.

This study addresses important questions regarding how to identify and treat patients in Psychiatry who present for services with alcohol or drug use that may exacerbate depression. The investigators propose a study of Brief Motivational Intervention (BMI) to reduce drug and alcohol use among patients with depression, and to enhance engagement with a Kaiser Chemical Dependency Recovery Program (CDRP) as needed. Patients with depression who use drugs or alcohol even at sub-diagnostic levels are at high risk for escalation of substance problems. BMI is an innovative, evidence-based approach that could decrease drug and alcohol use and improve outcomes. But it has not been tested among depression patients. This study sample will include 300 outpatients in treatment for depression in Kaiser Permanente Northern California Hayward/Fremont Psychiatry. Inclusion criteria are based on drug use (any illicit drug use and non-prescribed use of prescription drugs) and hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men), and moderate to severe depression symptoms at intake. Three hundred patients will be randomized to receive one in-person BMI session and two telephone BMI sessions within 6 weeks of intake (intervention) or a brochure on risks of drug and alcohol use (control). The investigators anticipate that the intervention will be effective in reducing frequency of drug use and hazardous drinking at 3-, 6-, and 12-month telephone follow-up interviews; improving mood and functional outcomes; increasing depression treatment retention (number of psychiatry visits, based on Healthcare Effectiveness Data and Information Set (HEDIS) standards); and facilitating patient initiation of chemical dependency program treatment if needed, and will be cost effective. For the improvement of patient care, it will also yield important information on integrating alcohol and drug intervention in Psychiatry and how best to help patients access specialty CDRP services when needed.

Eligibility Criteria:
Inclusion Criteria:

* Hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men)
* Drug use (including any illicit drug use and non-prescribed use of prescription drugs in the prior 30 days)
* Moderate or greater symptoms of depression based on a score of ≥ 5 on the Patient Health Questionnaire (PHQ-9)

Exclusion Criteria:

* Current mania or psychosis
The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease

The project will investigate the effect of pharmacological and electric modulation of N-methyl-D-aspartate (NMDA) pathway on the cognitive flexibility and volitional movement preparation in patients with Parkinson's disease (PD).

Sarcosine (also called N-methylglycine) is an endogenous GlyT-1 inhibitor. By blocking glycine uptake, sarcosine increases synaptic glycine concentration to enhance NMDA receptor function. NMDA receptor, a subtype of ionotropic glutamate receptors, serves important functions in the brain, including learning, memory, cognition, and neural plasticity under physiological conditions and contributes to neurodegeneration in pathophysiological processes. NMDA receptor represents collectively a group of heteromeric tetramers. Every NMDA receptor is a protein complex, typically composed of two NR1 subunits and two NR2 subunits that together form the NMDA receptor ion channel. It requires two receptor agonists (glutamate for the NR2 binding site and glycine for the NR1 binding site) to open the ion channel for NMDA receptor activation. Clinically, modulation through the NMDA-NR1-glycine site is preferred to avoid the excitotoxicity associated with the glutamate site activation.8 In addition, recent animal studies have shown that dopamine secretion can be enhanced by either blocking the striatal NR2 or by activation of the NMDA-receptor glycine site. In the project, we will focus on pharmacological enhancement of NMDA-glycine receptor function based on increasing synaptic glycine concentration by sarcosine administration to examine whether enhancing NMDA-glycine receptor activity can improve the neuropsychiatric symptoms, cognition and hopefully motor function in PD-D patients

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of PD-D will be based on the criteria proposed by 2007 movement disorders PD-D task force. (Emre M et.al. Mov Disord 2007; 22:1689-1707)

Exclusion Criteria:

* Acute confusion due to systemic illnesses or drug intoxication.
* Major depression
* Features compatible with "Probable Vascular dementia.
* Patient who is pregnant.
Deep Brain Stimulation (DBS) and Motor Evoked Potentials (MEP)

MEP onset latencies from the hand muscle using two different stimulus methods will be compared from each study participant. Conventional MEP data will be collected prior to skin incision. Following the DBS insertion hand muscle evoked responses will be generated via the DBS electrode. A hand held DBS programmer will be connected to the proximal end of the implanted DBS for delivery of electrical stimuli. Stimulus intensity will be adjusted until a hand muscle evoked potential is registered from the same recording electrodes used for the conventional MEP acquisition. A STN-implanted electrode can produce hand muscle responses due to it's close proximity to the motor fibres of the internal capsule. When the conventional and DBS-induced hand muscle responses have been acquired the study data objectives have been met. Data will be analyzed off-line.

Purpose: Hand muscle MEP generated via the DBS electrode will provide an onset latency standard from which we can compare conventional MEP from the same hand muscles. It is critical for validation of conventional MEP to know where in the brain the motor pathway is being stimulated. This will avoid false negative MEP test results.

Objectives: We will measure the onset latencies from hand muscle MEP generated via the DBS electrode as well as using conventional MEP methods. The DBS onset latency data will provide a known anatomical standard to compare with conventional hand MEP.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients scheduled for DBS surgery under general anesthesia; age 35-75 years; no history of stroke or peripheral nerve disease

Exclusion Criteria:

* peripheral nerve disease (e.g. type I diabetes); demyelinating disease (e.g. multiple sclerosis); previous stroke; allergy to propofol based anesthesia
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
2. patients must have confirmation of APL by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \&lt; 45 mL/min. Moderate hepatic impairment with total bilirubin \&gt; 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.

Exclusion Criteria:

1. Patient is ineligible for treatment with intensive chemotherapy
2. Patient with active infection not controlled, active bleeding from vital organs
3. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female aged 18-60 years.
* 2. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* 3. Chronic HBV infection for ≥ 6 months.
* 4. On NRTI therapy for ≥ 6 months.

Exclusion Criteria:

* 1. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
* 2. Significant liver fibrosis or cirrhosis.
* 3. History or evidence of drug or alcohol abuse.
* 4. History of intolerance to SC or IM injection.
* 5. History of chronic liver disease from any cause other than chronic HBV infection.
* 6. History of hepatic decompensation.
* 7. Contraindications to the use of PEG-IFNα.