cyrilzakka/clinical-trials huggingface dataset:
Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids

Interventional, prospective, randomized, double-blind, placebo-controlled and parallel assignment study, in which patients with Autism Spectrum Disorder (ASD) are two types of intervention by transcranial random noise stimulation (tRNS), to improve verbal fluency and empathy.

Interventional, prospective, randomized, double-blind, placebo-controlled and parallel assignment study, in which patients receive three types of intervention tRNS: one group received 35 sessions focused on the fronto-temporal cortex, another group received 35 sessions focused on the temporal fusiform cortex and last placebo group was operated with 35 sessions tRNS. After brain noninvasive stimulation sessions, a blind analysis of the improvement in verbal fluency and empathy in patients with autism spectrum disorder is made. For each patient included a follow up period of three months will be established.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 5 and 12 years.
* Meet DSM-IV criteria for autism spectrum disorder.
* Patients who have been diagnosed at least 2 years before inclusion in the study.

Exclusion Criteria:

* Acute visual or hearing loss.
* Traumatic brain injury.
* Other neurological disorders: migraine, epilepsy, tuberous sclerosis ...
* Trauma at birth.
* Mental retardation.
* Pregnancy.
Exploring the Value of Urine Proteomics-based Dynamic Surveillance for Early Recurrence After Radical Surgery for Hepatocellular Carcinoma: a Prospective Cohort Study

In this study, we explored and validated the predictive value of the longitudinal monitoring model of urinary proteomics for postoperative recurrence of hepatocellular carcinoma and the predictive value of minimal residual disease (MRD) status, verified whether it is earlier than the recurrence suggested by imaging tests, and initially explored its clinical feasibility in guiding the adjuvant treatment of hepatocellular carcinoma in the postoperative period, so as to provide a new idea for the strategy of early intervention in the postoperative period of hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatocellular carcinoma whose tumor stage at the time of initial diagnosis is consistent with BCLC staging 0/stage A/stage B, who can undergo radical surgical resection, and who have not received other antitumor therapy preoperatively.

Exclusion Criteria:

* Unable to provide specimens for testing such as urine proteomics; patients with a previous diagnosis of renal or urologic disease, two or more tumors at the same time; patients with non-primary foci of liver disease. Previously received anti-tumor therapy such as targeted immunotherapy.
Family Mediation Program For At-Risk Youth

The goal of this project is to conduct a pilot evaluation of a parent-child mediation program for at-risk youth. It is investigating whether families who receive parent-child mediation show greater improvement in family functioning, as well as adolescent substance use, academic performance, and delinquency, over a 6-week and 12-week period compared to a wait-list control sample.


Eligibility Criteria:
Inclusion Criteria:

1. Has a child referred to FARS due to having problems in any of the following areas: (a) poor grades; (b) truancy; (c) defiant behavior; (d) running away; (e) delinquency; (f) substance use
2. Agrees to participate in at least one FARS mediation session
3. Agrees to complete 3 surveys and be available over the next 3 months for follow-up
4. Fluent in English or Spanish

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   Exclusion Criteria: Families referred to FARS due to: (a) conflicts involving gang violence (e.g., shootings, killings); (b) conflicts involving weapons; (c) arson; (d) conflicts involving explicit sex activities; (e) conflicts involving domestic violence/child abuse; and (f) threats to harm self or others.

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Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)


Eligibility Criteria:
Inclusion Criteria:

1. Randomized in the parent study, PCYC-1115-CA
2. Informed consent for Study PCYC-1116-CA
3. Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study

Exclusion Criteria:

1. Disease progression involving the central nervous system (CNS) or transformation to another histology
2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
4. Requirement for treatment with a strong CYP3A inhibitor
5. Uncontrolled systemic infection or requirement for IV antibiotics
6. Noncompliance on the parent study(PCYC-1115-CA)
Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries

Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (K group and D group). Using computer generated randomization table; each group consists of 26 patients: K group (n=26): Patient will receive with 0.5 mg/kg/h ketamine infusion. D group (n=26): Patient will receive 0.1 ug/kg/h dexmedetomidine infusion.

Eligibility Criteria:
Inclusion Criteria:

Aged 18-60 years old.Body mass index of less than or equal 35.American Society of I and II.Duration of surgery not more than 3 hours.

Exclusion Criteria:

Known hypersensitivity to dexmedetomidine or ketamine. Hemorrhagic shock decompensation.History of alcohol or drug abuse.History of neurologic or psychiatric diseases Advanced renal ,liver or cardiovascular disorders.
A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults

This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks.

Hypothesis:

High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.


Eligibility Criteria:
Inclusion Criteria:

* adults
* non-obese
* healthy

Exclusion Criteria:

* diabetes
* diagnosed diseases of the intestine or cardiovacular system
Effects of TDCS for Enhancing Cognitive Function in Individuals with Persistent Post-Concussion Syndrome

Globally, 10 million new traumatic brain injury (TBI) cases are estimated annually, with mild traumatic brain injury (mTBI) accounting for 75-90% of all TBI cases. It is estimated that 40-80% of individuals with mTBI may experience the post-concussion syndrome (PCS), which is characterized by a range of physical, cognitive, and emotional symptoms. Although the underlying basis of cognitive dysfunction of patients with persistent PCS remains to be clarified, converging evidence shows that the clinical symptoms is underpinned by abnormal neural information processing as a result of axonal injury due to mTBI. Recent studies have demonstrated abnormalities in both structural and functional cortical connectivity, and a loss of cortical excitability-inhibitory (E/I) balance after TBI. Yet, there is no consensus for treating chronic symptoms of concussion, and PCS remains a chronic and highly disabling condition. One potential treatment option is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that has been shown to modify behavior by enhancing connectivity between targeted brain areas. However, research on the therapeutic effect of tDCS on PCS symptoms is limited, and the neurologic mechanisms underlying its effects are not well understood. The proposed study aims to address these knowledge gaps by examining the effects of tDCS on the central nervous system function in patients with PCS, with a specific focus on functional cortical connectivity and cognitive functions such as processing speed and executive function. The study also aims to add value to existing evidence by potentially opening new directions for designing intervention programs for the treatment of PCS after mTBI.


Eligibility Criteria:
Inclusion Criteria:

* being 18 years old or older;
* having a history of a mild TBI (less than 30 minutes loss of consciousness) 1-6 years prior to the study;
* able to communicate in Chinese.

Exclusion Criteria:

* being without a confirmed diagnosis from the medical practitioner;
* having a history of other neurological and psychiatric disorders, skull defect, recent medical instability (within 3 weeks);
* being pregnant;
* being medication for a psychiatric condition (e.g., major depression, anxiety, schizophrenia);
* with any implanted devices or suffering from real claustrophobia or feel uncomfortable in small, enclosed spaces, like MRI tunnel
Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-chamber Parenteral Nutrition Formulation

The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient but hospitalized \< 14 days prior to enrollment
* Requires PN because oral or enteral nutrition is not possible, insufficient, or contraindicated
* Has capability to complete at least 5 days of study treatment (i.e., PN)
* Has a useable peripheral vein for delivery of intravenous (IV) PN

Exclusion Criteria:

* Has a life expectancy of \< 6 days from initiation of study treatment, in the opinion of the Investigator
* Known hypersensitivity to the components of either of the investigational study treatments
* Use of prohibited medications (e.g. glucocorticosteroids or antitumor chemotherapeutic agents) within 30 days prior to enrollment
* Known serious clinically significant condition that would preclude participation in the study
* Known chronic active hepatitis, elevated liver function tests
* Known history of human immunodeficiency virus infection
* Known severe dyslipidemia, severe hyperglycemia,clinically significant abnormalities of plasma electrolytes
* Known pregnancy or lactation
Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs

The numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip or knee prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have his consent and signed the consent form.
* The patient must affiliated or a beneficiary of a health insurance plan.
* The patient is at least 18 years old
* Patient with an indication of total hip prosthesis or total knee replacement surgery set unilateral

Exclusion Criteria:

* The patient is participating in another interventional study.
* The patient is in an exclusion period determined by a previous study.
* Minor patients, people in emergency situations.
* The patient is under the protection of justice, guardianship or curatorship.
* The patient refuses to sign the consent.
* It is not possible to inform the patient.
* The patient is pregnant, parturient, or breastfeeding.
* The patient has a contraindication (or incompatible drug combination) to drug thromboprophylaxis applied according to good clinical practice and recommendations of learned societies
* Long-term anticoagulant therapy for personal thrombotic history.
* Known hemorrhagic disease.
* Haemorrhagic risk perceived during the consultation of preoperative anesthesia, leading to modify / develop the usual thromboprophylaxis.
* Chronic liver disease.
* Chronic renal failure with calculated clearance \<30 ml / min.
* Extreme body mass index: \<18 kg.m-2 or\> 40 kg.m-2
* total hip prosthesis or total knee prosthesis in the immediate aftermath of a bone fracture.
* total hip prosthesis resumption.
* Installation of more than one joint prosthesis.
* Surgery in the previous 3 months.
* Infective push in the previous 3 months.
* Indication of haemostatic treatment for abnormal haemorrhagic risk.
* Severe impairment of renal function with a calculated clearance \<30 ml / min.
* Contraindication (allergic, metabolic, other ...) to usual drug thromboprophylaxis.
* Condition requiring dosage adjustment of drug thromboprophylaxis.
* Indication to put in place intermittent pneumatic compression for perioperative thromboprophylaxis.
Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes


Eligibility Criteria:
Inclusion Criteria:

* male or female age 18 years or older
* Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
* Best correct visual acuity of greater than 24 and less than 80
* Presence of macular edema defined as OCT central subfield thickness of \>250

Exclusion Criteria:

* intravitreal anti-VEGF treatment in study eye within six weeks of baseline
* intravitreal steroid treatment in the study eye within eight weeks of baseline visit
* PRP in the study eye within 4 month of baseline visit
* Active iris neovascularization in study eye
* Uncontrolled systemic disease
* Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
* HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
* Agree to use two methods of birth control during the study;
* Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index \< 85%.

Exclusion Criteria:

* Donor and/or recipient HIV infection
* Subject pregnant or nursing
* Donor and/or recipient Hepatitis B surface antigen positive
* Kidney-pancreas transplant
* Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
* Kidney recipients: on dialysis for \> 5 years at time of Screening; subjects sensitized with panel reactive antibody \> 80%; for single organ kidney transplant, subjects with advanced liver fibrosis (Knodell stage 3) or cirrhosis
* Individuals being treated with and needing to continue rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton pump inhibitors (See Concomitant Medications).
* Individuals treated with amiodarone within 42 days of organ transplant.
Aortic Root Enlargement Versus Aortic Root Replacement in the Management of Cases With Small Aortic Root

Each type of Aortic valve surgery has its advantages and disadvantages; we aim to differentiate between two types of aortic valve surgery: aortic root replacement (using either Ross procedure or stentless bioprosthesis procedure) and mechanical aortic valve replacement.

Aortic valve replacement has been performed since the 1950s. Since then, the surgical procedure has been optimized to reduce the risk of procedure-related complications. In addition, technical advances in the design of valves have significantly improved long-term prognosis. After the initial use of mechanical ball-caged valves, numerous monoleaflet and bileaflet valves have been introduced and evaluated. Moreover, bioprosthetic valves came on the market in the 1960s as an alternative to mechanical valve.

The pulmonary autograft was introduced in clinical practice as a substitute for the diseased aortic valve by Donald Ross in 1967. The original implant technique, namely subcoronary freehand grafting, was associated with substantial prevalence of early and late valve dysfunction, thereby limiting widespread adoption of the operation. More recent experience with pulmonary autografts used for complete or partial aortic root replacement allowed for satisfactory functional behavior of the valve .

Homografts for aortic valve replacement were the first biologic stentless prostheses used in clinical practice in the 1960s. Binet introduced a stentless porcine bioprosthesis, but the valve was abandoned because of poor tissue fixation. Due to limited availability and a relatively difficult implantation technique, mechanical AVR became the popular therapeutic option. The disadvantage of life-long anticoagulation therapy in mechanical AVR prompted the development of xenogeneic bioprostheses. Although porcine aortic valves or pericardial tissue mounted on a stent made the implantation technique easier, these valves sacrificed orifice area and increased stress at the attachment of the stent, which caused earlier primary tissue failure. Optimizing hemodynamics to prevent patient-prosthetic mismatch and improve durability revived the use of stentless bioprostheses in the early 1990s.

Patients with an expected survival of less than 10 years (more than 65 years old, renal disease, lung disease, patients who are more than 60 years old), ejection fraction of less than 40%, or coronary disease would be reasonable candidates for aortic bioprostheses to avoid anticoagulation with an extremely low likelihood of aortic valve reoperation. Results tend to favor mechanical aortic valves in patients under age 65 years with a life expectancy of at least 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Aortic valve surgery.

Exclusion Criteria:

* Patients who have other procedure with aortic valve surgery.
Adult Asthmatics and Acid Reflux

The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma
* Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol
* Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months.
* Severe heartburn 3 days/week during the run-in period.

Exclusion Criteria:

* Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1.
* Any other significant disease or pathology judged to be clinically significant by the investigator
Digital Therapy in Self-management of COPD Patients

This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with COPD
2. Aged 40 and above
3. Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks
4. Can operate a smartphone proficiently
5. Take inhalation medication suits for the inhalation monitoring device as treatment
6. Fully understand and be willing to sign the informed consent form

Exclusion Criteria:

1. Certain comorbidities (e.g. unstable coronary complications)
2. Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months
3. Pregnant or lactating women
4. ABS allergy history
Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy

The purpose is to demonstrate that BLI800 is non-inferior, on overall colon cleansing, to Fortrans® (a reference colonic lavage in China) administered in adult subjects scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent signed prior to any study related procedures.
* Male or female, at least 18 years old undergoing colonoscopy for a routine diagnostic indication, such as: a. Routine cancer screening b. Polyp or neoplasm history c. Diagnostic procedure for occult bleeding or anaemia d. Diarrhoea or constipation of unknown aetiology e. Inflammatory Bowel Disease (IBD) not in severe active phase
* In good clinical condition (physical exam and medical history)
* Adequate fluid balance, and adequate electrolyte balance (measured during screening K, Na, Cl, anion gap/bicarbonate/carbon dioxide content within normal/within ±10% of normal range)

Exclusion Criteria:

* Abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
* Advanced carcinoma or any other colon disease leading to excessive mucosal fragility.
* Known or suspected gastrointestinal (GI) obstruction, gastric retention, gastroparesis, or disorder of gastric emptying.
* Known or suspected ileus.