cyrilzakka/clinical-trials huggingface dataset:
Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC

The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer-related death worldwide. The resection rate for HCC is approximately 10%-30% and the overall prognosis is very poor with a 5-year survival rate of 5%-6%. The recurrence rate is high after radical resection. In addition to surgery, radiofrequency ablation, transcatheter arterial chemoembolization (TACE), microwave ablation, cryoablation, radioactive seeds implantation, high-intensity-focused ultrasound, radiation therapy, chemotherapy and targeted drugs are available for patients with unresectable tumors; however, the efficacy of these treatments are limited and long-term prognosis in the patients is still poor. Moreover, due to serious side effects induced by treatments such as TACE, chemotherapy and targeted drugs, it may not be possible for patients to continue receiving these therapies. The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male aged 18 years and over, but no more than 75 years;
2. Histologic or cytologic confirmation of advanced hepatocellular carcinoma;
3. Patients with measurable lesions but can not be treated with surgery;
4. Patients with two or over measurable lesions;
5. ECOG≤0-2, Child-pugh A-B;
6. Patients had not received systemic venous chemotherapy ever before;
7. Hematology Index;
8. Neutrophile granulocyte greater than 1.5×10\^9/L;
9. Hemoglobin greater than 10g/dL;
10. Platelet greater than 90×10\^9/L;
11. Biochemical index
12. Serum bilirubin not greater than 1.5x upper limit of reference range （ULN）
13. ALT or AST not greater than 1.5x ULN
14. Creatinine clearance no less than 60ml/min;
15. Negative pregnancy test for women of childbearing potential;
16. Provision of informed consent;
17. Be able to follow the research program and follow up process;
18. Expected survival time 3 months or more.

Exclusion Criteria:

1. Chemotherapy with experimental drug within 3 months before the start of study therapy;
2. Have at least another primary malignant tumor;
3. Active infection with bacterial or fungal infection;
4. Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group;
5. Women who are pregnant or breast feeding;
6. Drug abuse, clinical or psychological or social factors which will influence the informed. consent or the study implementation;
7. May be allergic to immunotherapy;
8. Radiotherapy and immunotherapy may not be implemented due to social or geographical factors;
9. Weight loss greater 10% within 6 weeks before the start of study therapy;
10. influence the safety or compliance of the patients.
Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study

Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.

As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.

Eligibility Criteria:
Inclusion Criteria:

* Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient.
* Outpatients will be only in some hospitals which can get the patients' complete information.

Exclusion Criteria:

* Patients who are less than 24 months.
Family-based Outcome Results

Many obesity related risk factors are strikingly apparent in minority populations. Mexican-American children have the highest rates of overweight. The goals of this study are to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old children and their parents; 2) Estimate the effectiveness of a 14-week family-based intervention designed to show smaller changes, on average, in BMI appropriate for growth; 3) estimate the effectiveness of a 14-week family-based intervention designed to produce changes in television viewing, physical activity, fat, fiber, and fruit and vegetable intake in 3-5 year old Latino children and their parents at post-intervention and Year 1 follow-up.


Eligibility Criteria:
Inclusion Criteria:

* have received an annual physical
* parent or guardian willing to give consent
* parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child

Exclusion Criteria:

* requires a specialized diet outside of that served by the Chicago Public Schools
* has a chronic physical or behavioral disorder that requyires participant to be under close emdical psychologicagl supervision and routinely absent from the study
Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.

Type III collagen abundantly exists in the cardiovascular system including the aorta and heart. The aminoterminal propeptide of type III procollagen (PIIINP) is an extension peptide of type III procollagen, which is cleaved off stoichiometrically during conversion from type III procollagen to type III collagen and liberated to serum. Elevated serum concentrations of PIIINP are considered a marker of higher collagen turnover and tissue fibrosis including the heart and vascular system. In this study, the investigators prospectively examined whether serum levels of PIIINP could be a biomarker for predicting cardiovascular events in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* End-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in Toujinkai Hospital at the point of January 1, 2005

Exclusion Criteria:

* Histories of coronary events and/or interventions
* Congestive heart failure of New York Heart Association grades III to IV
* Moderate or worse valvular heart disease
* Permanent pacemaker implantation
* Idiopathic cardiomyopathy
* Chronic obstructive pulmonary disease
* Malignancy
* Acute hepatitis, chronic hepatitis, or liver cirrhosis including carrier of hepatitis virus
Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant

This study will investigate in-office ultrasound localization vs localization in radiology for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and aims to help establish best practices in this domain. Investigators will also create an ultrasound image gallery of palpable and non palpable as well as instructional video for non palpable ENG implant removal.

This is a descriptive study to establish best practices for ENG implant localization and non-palpable ENG implant removal.

Women presenting to UCLA Obstetrics and Gynecology service for ENG non-palpable and palpable implant removal or with ENG implant in place but desiring continuation will be enrolled. Investigators aim to enroll 20 women in each group. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria will be entered into the study.

Study duration for each participant is one visit for continuation group and two weeks for group desiring implant removal. Total study duration is expected to be 18 months.

1. For women desiring implant removal: document ENG implant using in-office imaging of ENG implant in the FP clinic with standard ob/gyn office ultrasound (abdominal 15 MHz linear probe with color doppler) and the same, using high frequency vascular probe (20+ MHz) in the radiology department.
2. Create an image gallery of office and radiology department obtained images of ENG implant localization. This will include:

   1. Ultrasound images obtained in women with palpable or non-palpable ENG implants in place at various time intervals after insertion who desire ENG implant continuation (office imaging only).
   2. Ultrasound images obtained in women seeking removal of non-palpable ENG implants, primarily referred patients who have either failed outside implant removal or have a non-palpable implant on presentation for removal.
3. Document and describe all cases of non palpable ENG implant removal with standard, in-office US versus radiology ultrasound equipment. Investigators will collect radiographic images, clinical findings, instruments used, patient characteristics (BMI, weight gain, time since of insertion), success of procedure, duration of procedure, number of attempts, final location of implant, and need for referral to general or vascular surgeon.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 - 50 years old
* English or Spanish speaking
* ENG implant in place
* Removal group

  o Women with non palpable ENG implant desiring ENG implant removal
* Continuation group o Women with palpable or non-palpable ENG implant desiring continuation

Exclusion Criteria:

* Known or suspected pregnancy
* Does not meet inclusion criteria
* Known ENG implant location outside of arm
* Current anticoagulation use (removal group only)
Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia

An observational study to evaluate the prevalence of US changes of gout in the joints and tendons of patients with different degrees of asymptomatic hyperuricemia. The investigators' findings may support the extension of the spectrum of urate disease, and define a subset of patients that may benefit from early urate-lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have at least one serum uric acid level l ≥ 7.0 mg/dL within the last two years without a clinical diagnosis of gout per American College of Rheumatology criteria30 (appendix A).
2. Patients, of matched gender and age, with normal uric acid levels will serve as controls.

Exclusion Criteria:

1. Patients who meet or have met the ACR criteria for Gout, unable to read English, and/or have terminal illness will not be eligible to participate in the study.
2. Patients with a diagnosis of skin psoriasis31, rheumatoid arthritis, or spondyloarthropathies will not be eligible to participate.
3. Patients who are on urate-lowering therapy.
4. Patients with 1 or 2 total knee replacements.
Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls, subacute and chronic patients will be assessed at two timepoints with 3 month standard rehabilitation inbetween. The specific assessments will require the participant to acitvely modulate their gait pattern to fullfill specific task constraints. Their performance will be assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the adaptive capacity that the patient retains. Sensitivity and specificity of these markers will be determined. With more sensitive descriptors of gait function and quality, locomotor rehabilitation for SCI can be better designed and smaller effects can be accurately measured.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Healthy controls
* Patients with an incomplete spinal cord injury in a chronic (at least 12 months post-injury) or subacute (3-6 months post-injury) stage of recovery
* Age: 18 years and older
* Able to stand without physical assistance and handrails for more than 120s
* preserved segmental and cutaneo-muscular reflexes in the lower limbs
* Bodyweight over 20 kg and under 120 kg
* Mini-Mental state examination score 26 (test only performed if cognitive deficits are suspected)

Exclusion Criteria:

* Current orthopedic problems
* Neurological impairment other than SCI
* Premorbid major depression or psychosis
* Metal implants in the cervical skull
* History of significant autonomic dysreflexia with treatment
* Dermatological issues (e.g. decubitus) at the harness attachment site (back, abdomen, upper legs)
* Malignant diseases
* Heart insufficiency NYHA III-IV
* Potential pregnancy
* Unlikely to complete the intervention or return for follow-up
* Participation in another training study
* Contraindications for training using the GRAIL (according the manual)
Rehabilitating Visual Deficits Caused by Stroke

This research aims to understand the efficacy of a visual training task to improve visual loss after stroke, also known as hemianopia. The investigators aim to understand whether training can improve vision and which areas or pathways in the brain are responsible for this improvement.

Damage to the primary visual cortex (V1) due to stroke usually results in loss of visual function in half of the visual world, this is known as hemianopia. This visual loss can negatively affect quality of life, as most stroke survivors are no longer permitted to drive and have difficulties with navigation and socialising. There are currently limited treatment options, although recent evidence suggests that visual training can be effective in improving visual function (Huxlin et al, 2009; Cavanaugh \& Huxlin, 2017). The aim of this research is to determine the capacity for visual rehabilitation after stroke using visual training and to understand the underlying brain mechanisms that might drive these improvements. This study will help the investigators to understand the brain mechanisms involved in visual rehabilitation and may allow the investigators to predict those most likely to benefit from visual rehabilitation in the future.

Twenty stroke survivors with hemi- or quadrantanopia will complete a 6-month visual motion discrimination training programme at home. Each participant will have three study visits; at baseline, 6-months and 9-months. At each visit the investigators will take measures of 1) visual fields 2) detailed tests of visual function 3) quality of life and 4) MRI scans of brain structure, function and neurochemistry. Between the baseline (0 month) and 6-month post-training session, participants will complete visual training at home. Between the 6-month post-training session and 9-month follow up, participants will not complete visual training at home. This study will therefore allow the investigators to determine whether rehabilitation improves conscious visual perception and quality of life as well as providing understanding of the neural mechanisms that underlie this improvement. The investigators will also determine whether improvements or neural changes persist after 3-months without training.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80
* Participant is willing and able to give informed consent for participation in the study
* Fluent English-speaking healthy adults
* Has suffered damage to the visual cortex at least 6 months before the study

Exclusion Criteria:

* Previous eye disease or impairment other than hemianopia
* Neurological or psychiatric illness
* Contraindication to MRI
* Pregnant or breast feeding
* Second stroke during training

Data quality assurance (participant data will be removed from analysis for the following reasons):

* Concurrent participation in other "vision therapy"
* Unreliable visual fields, indicated by greater than 20% fixation losses, false positives, or false negatives
* Inability to demonstrate fixation stability on eye movement monitored testing
* Failure to complete at least 100 training sessions over 6-months
Neuroplasticity in Maternal Opioid Use Disorder (OUD)

Opioid use disorder (OUD) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. The perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. OUD is also associated with neural reorganization, specifically neural circuitry implicated in stress regulation and reward processes. Interventions should therefore take advantage of this changing perinatal biology to enhance treatment response by targeting the aberrant neural circuitry compromised by maternal OUD. The investigators have developed and refined an evidence-based intervention for mothers with OUD designed to target these neural mechanisms and enhance the reward of caregiving; however, this has yet to be formally tested. Therefore, the investigators will examine maternal neuroplasticity using high-dense array electroencephalography (EEG) in mothers with OUD in response to our intervention. There will be 1 laboratory visit at pre-treatment, followed by 12 sessions of the evidence-based parenting intervention, and 1 laboratory visit at post-treatment. This study will attempt to validate the importance of taking advantage of the neuroplasticity in the perinatal period to optimize outcomes for mothers with OUD.

This is a study conducted at the Child Study Center (CSC) in the Yale School of Medicine. It involves mothers in treatment for OUD who are caring for infants who are 4-12 months old.

15 mothers will complete 1 study visit, which will last 2.5 hours. It will start with informed consent and then will include demographics, EEG/ERP, a multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).

Participants will then complete 12 treatment (Mothering from the Inside Out (MIO)) visits, and 1 post-treatment data collection visit.

Visits 2-13 (1 hour each) consist of participation in Mothering from the Inside Out (MIO).

Visit 14 (2.5 hours) includes participation in the ERP paradigm and the multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).

Eligibility Criteria:
Inclusion Criteria:

* Biological mother of infants between 4-months and 12-months of age
* 21-45 years of age at time of recruitment
* Enrolled in substance use treatment and on mediation for opioid use disorder (MOUD).

Exclusion Criteria:

* Incapable of giving informed consent
* Child spends less than 50% of time in mother's custody.
* Non-English-speaking
* Unable to complete the study because of pending legal cases or unable to supply two forms of contact for the purpose of follow-up
* Physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea).
Transinguinal Periperitoneal Technique in Inguinal Hernioplasty

evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide with approximately 20 million cases every year . The open Lichtenstein tension-free hernioplasty is most commonly performed and recognized for its low recurrence rate and short learning curve, but associated with an undesirably high level of postoperative chronic groin pain, up to 10-35% . Therefore, chronic groin pain is a common concern after inguinal hernia surgery. Treatment of chronic groin pain can be challenging and may require several interventions including, local anaesthesia , corticosteroids or additional surgery . Several studies showed that chronic groin pain might be dependent on the surgical technique, including identification and handling of inguinal nerves ,Preperitoneal techniques like the transinguinal preperitoneal patch (TIPP )have been developed to minimize these risks. The TIPP technique which introduced by prissier involves a standard anterior inguinal approach, with high dissection and preperitoneal reduction use of a PolySoft mesh have been proved to cause less chronic pain than the Lichtenstein technique. The PolySoft mesh is a lightweight polypropylene mesh, tailored in asymmetric oval shape that contains a recoil ring. Recent studies deficient in evaluation feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh in inguinal hernia repair . So the aim of our study to evaluate the use of conventional mesh in transinguinal preperitoneal technique in inguinal hernioplasty .

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years
* fit for surgery.

Exclusion Criteria:

* Patients less than 18 years
* American Society of Anesthesiologists (ASA) 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina \& implanted pacemaker ) .
An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.

This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female between 18-75 years old
* Diagnosed with type 2 diabetes for at least 3 months
* HbA1c of 7.5 to 10% inclusive
* BMI of 27 to 40 kg/m2
* If on any medication, treated with a stable dose for at least 90 days
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Willing and able to provide written informed consent
* Must have a Glucometer at home

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months
* Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study
* Allergies to any test product ingredients
* Has any of the following medical conditions:
* Oncological conditions
* Psychiatric disease
* Cardiovascular disease: any hospitalization within the past 3 months
* Multiple Sclerosis
* Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.
* Any other severe chronic disease
* History of drug or alcohol abuse
* Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study
* Participation in a clinical research trial within 30 days prior to screening
* Participating in an investigational health product research study
* Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol