cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood

This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign lesions.

RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

RF ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods.

To be eligible for this study, patients must have acquired lesions at \< 21 years of age (central nervous system lesions are excluded from this study). Study participants will have the RFA procedure performed at Seattle Children's and will have follow-up evaluations at various time points post-RFA.


Eligibility Criteria:
Inclusion Criteria:

* Lesion acquired in childhood (at \<21 years of age)
* Any lesion location except CNS
* Any malignant tumor or metastasis
* Any benign lesion (e.g. desmoids, venous or lymphatic vascular anomalies, aneurysmal bone cysts, osteoid osteoma, tongue hypertrophy, or painful neuropathy)
* Patients with malignant disease have had histologic confirmation of disease at initial diagnosis.
* ≥ 90 day life expectancy
* Potential benefit of RFA outweighs risk as determined by PI
* Other local tumor control measures are not recommended for malignant lesion based on review in multidisciplinary team conference or the patient refuses recommended local tumor control measures
* The patient is not expected to become short of breath at rest after RFA (forced vital capacity ≥33% of normal by pulmonary function tests) if pulmonary RFA is considered

Exclusion Criteria:

* Patients with uncontrolled infection.
* Patients with co-morbidities affecting inclusion criteria above.
* Patients who are pregnant and/or breastfeeding.
* Patients who had a change in chemotherapy within one month before RFA
* Patients who have planned change in chemotherapy and/or radiation therapy (to same site as RFA) interventions within the first three months following RFA.
* Patients should not be considered for pulmonary RFA if they have poorly compliant lungs (recently required mechanical ventilation) or require supplemental oxygen.
Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)

The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.

This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17 years, 4 months with ASD who are currently taking atypical antipsychotic medication. A 16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by age will be conducted. A secondary study aim will be to assess the long-term safety and efficacy of metformin by conducting a 16-week open label continuation.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.
2. Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.
3. A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
4. Age 6 years to 17 years, 4 months.
5. Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.
6. Prior to the conduct of any study-specific procedures, the subject must provide assent to participate in the study (if developmentally appropriate), and their parents (guardians) must provide written informed consent.

Exclusion Criteria:

1. History of intolerable adverse effects with metformin.
2. Prior history of an exposure to metformin of sufficient dose or duration to determine response status.
3. History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.
4. Use of cationic drugs excreted by the kidneys.
5. Planned surgery or procedure requiring contrast.
6. Pregnant at screening contact.
7. On other psychotropic concomitant medications for less than 2 months.
8. Treatment or planned treatment with concomitant medications with unacceptable interactions with metformin, including topiramate, levetiracetam, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, diuretics, or histamine H2 receptor antagonists.
9. Unable to tolerate blood work.
10. Current use of medication for target symptoms of appetite or weight loss.
11. Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.
Growth Factor Signature (GFS) Pilot Study (MK0000-098)(COMPLETED)

This study will evaluate a gene expression signature (Growth Factor Signature \[GFS\]) as a biomarker for response/resistance to BRC-ABL oncogene inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a histologically or cytopathologically confirmed blast phase Ph+ CML or Ph+ ALL.
* Participant is 18 years of age on the day of signing informed consent
* Participant must have performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Participant has at least 30 percent blasts in peripheral blood; or at least 30 percent lymphoblasts in peripheral blood or bone marrow

  * For Part II:
* Participant has progressed while taking imatinib or is unable to tolerate imatinib, being defined as discontinuing imatinib treatment as a result of nonhematologic toxic effects of any grade
* If female, participant is either post-menopausal, free from menses for \>2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with Visit 1
* Female participants of childbearing potential must have a negative serum or urine pregnancy test (beta hCG) at screening
* If male, participant is surgically sterilized, agrees to use an adequate method of contraception, or agrees to abstain from heterosexual activity for the duration of the study
* Participant or the patrticipant's legal representative has voluntarily agreed to participate by giving written informed consent
* Participant must be available for periodic blood sampling, study related assessments, and management at the treating institution for the duration of the study

Exclusion Criteria:

* Participant is currently participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives, whichever is longer, of the start of treatment
* Participant has known human immunodeficiency virus (HIV) infection or HIV-related malignancy
* Participant is a female who is pregnant or breastfeeding, or is expecting to conceive within the projected duration of the study
* Participant has a known allergy or hypersensitivity to imatinib, dasatinib or nilotinib
* Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate
* Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason, the investigator considers the participant inappropriate for participation in the study
Aminophylline in Bradyasystolic Cardiac Arrest

The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.

Out-of-hospital cardiac arrest treated by emergency medical services has an estimated incidence of 54.99 per 100,000 person years, which translates to some 155,000 episodes annually in the United States. Bradyasystole is the first recorded rhythm in up to 52 percent of cardiac arrests, and many additional patients with an initial cardiac arrest rhythm of ventricular fibrillation deteriorate to bradyasystole after defibrillation efforts. Survival to hospital discharge occurs in less than 3 percent of patients presenting with bradyasystole; however, due to its frequency, this rhythm accounts for over 17 percent of all cardiac arrest survivors. As a result, even a small improvement in survival from bradyasystolic cardiac arrest would result in thousands of lives saved annually.

Adenosine is an endogenous purine nucleoside that depresses the sinoatrial node, blocks atrioventricular conduction, inhibits the pacemaker activity of the His-Purkinje system and attenuates the effects of catecholamines. Since adenosine is produced and released by myocardial cells during ischemia and hypoxia, it may be a reversible factor in the etiology or perpetuation of bradyasystole. Aminophylline is a competitive antagonist of adenosine. The use of aminophylline for bradycardia and heart block has been described, and a number of anecdotal reports and small studies have been published on the use of aminophylline in cardiac arrest. We undertook this study to evaluate the effect of aminophylline during cardiopulmonary resuscitation (CPR) of patients with out-of-hospital bradyasystolic cardiac arrest unresponsive to initial therapy.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest
* Bradyasystole either as the presenting rhythm or as a rhythm developing during the course of the resuscitation
* Endotracheally intubated and ventilated with 100% oxygen
* Intravenous (IV) access established
* Bradyasystolic without palpable pulses after 1 mg of epinephrine and 3 mg of atropine.

Exclusion Criteria:

* A do-not-resuscitate directive
* Pregnancy
* Evidence of hemorrhage, trauma or hypothermia as a cause of the cardiac arrest
* Renal dialysis
* Theophylline hypersensitivity
* Patients taking an oral theophylline product
* Resuscitations directed by a paramedic student under practicum supervision
Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female who completed the primary vaccination phase of the HAB-160 study (NCT 00603252).
* Written informed consent obtained from the subject.
* If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
* History of any hepatitis A or hepatitis B vaccination or infection since the primary vaccination study.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Pregnant or lactating female.
The Arteriovenous Vascular (AV) ACCESS Trial

This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions

This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* End-stage kidney disease on hemodialysis via a central venous catheter
* Hemodialysis is the long-term modality of treatment for end-stage kidney disease
* Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
* Referred by patient's nephrologist for placement of arteriovenous access
* At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus
* Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
* Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
* Patient agreed to study participation and signed the informed consent

Exclusion Criteria:

* Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device
* Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
* Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
* Anticipated kidney transplant within 12 months
* Anticipated conversion to peritoneal dialysis within 12 months
* Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
* Anticipated non-compliance with medical care based on physician judgment
* A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.
GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression

The third/fourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and/or soluble TGFβ (GPC3/TGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3/TGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/TGFβ-CAR-T cell immunotherapy on human will firstly be tested.

1. Choose appropriate patients with advanced hepatocellular carcinoma,with written consent for this study;
2. Perform biopsy to determine the expression of GPC3 of the tumor by western blotting or IHC;
3. Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with GPC3/TGFβ targeting CAR (or/and scfv/cytokines-secreting), amplify the number of transfected T cells as needed, test the quality and killing activity of the GPC3/TGFβ-CART cells and then transplant back the patients via systemic or local infusions (via artery or intra-tumor), and follow up closely to collect related results as needed;
4. To enhance the killing capability, CD4+ T cells are genetically engineered to express TGFβ-CAR and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Tigit; CD8+T cells are constructed to express GPC3-DAP10-CAR with knockdown of PD1/HPK1;
5. Evaluate the clinical results as needed.
6. Will also perform the similar clinical trial on lung squamous carcinoma with the GPC3 expression.

Eligibility Criteria:
Inclusion Criteria:

1. patients with advanced HCC,which express GPC3 protein.
2. Life expectancy \>12 weeks
3. Child-Pugh-Turcotte score \<7
4. Adequate heart,lung,liver,kidney function
5. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3 CAR determined by flow-cytometry and killing of GPC3-positive targets greater than or equal to 20% in cytotoxicity assay
6. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Tumor size more than 25cm;
3. Severe virus infection such as HBV,HCV,HIV,et al
4. Known HIV positivity
5. History of liver transplantation
6. Active infectious disease related to bacteria, virus,fungi,et al
7. Other severe diseases that the investigators consider not appropriate;
8. Pregnant or lactating women
9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
10. Other conditions that the investigators consider not appropriate. -
Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain

This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the time of cesarean delivery may decrease post-operative pain scores.

This study is a randomized controlled trial. A total of 80 patients will be randomized 1:1 to intervention (liposomal bupivacaine) versus control (placebo solution).

The planned intervention is the infiltration of liposomal bupivacaine (or control) at the time of fascial closure at a Pfannenstiel incision, after the delivery of the infant and repair of the hysterotomy. The procedure to instill the drug is as follows: Once the patient is in the operating room, neuraxial anesthesia will be administered per routine practice. A Pfannenstiel skin incision will be made. The usual cesarean delivery procedure will be performed at the discretion of the surgeon. Once the surgical team is about to begin fascial closure, the study drug will then be infiltrated by a member of the study team, with 50% of the study solution in subcutaneous space and 50% in the fascial plane, taking care to evenly spread the drug in the superior and inferior aspects of the incision. For the fascial infiltration, liposomal bupivacaine will be preferentially infiltrated laterally. The remainder of the cesarean delivery will proceed according to the usual fashion. At any point in the cesarean delivery, the surgeon may chose to administer or withhold ketorolac.

Post-operative pain management will be: intrathecal morphine, scheduled ketorolac 30mg IV x 24h followed by ibuprofen 600mg q6h x 24h, scheduled Tylenol 650mg q6h x 48h, and prn oxycodone 5-10mg q4h. This is the current pain management protocol for postoperative women after cesarean delivery. If Tylenol or NSAIDs are contraindicated, either due to the discretion of the clinical team or pre-existing patient contraindication, these will not be administered but are not a reason for study exclusion.

The investigators plan to enroll 80 patients into this pilot study, 40 per group. This sample size is based on prior data among women who had a cesarean delivery at this institution, and were asked to report their pain scores with activity at 48- and 72- hours after operation. With this sample size, the investigators have 80% power to detect a 1.5 point difference in pain at 48 hours, and 90% power to detect a 1.5 point difference in pain at 72 hours, and account for any protocol violations or loss to follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled cesarean delivery via Pfannenstiel incision;
2. Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.

Exclusion Criteria:

1. Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
2. Contraindication to neuraxial anesthetic;
3. Allergy to local anesthetic;
4. Planned general anesthetic.
The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis

The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.

After hysteroscopic adhesiolysis, patients with moderate to severe intrauterine adhesions will be allocated into 2 groups randomly, with COOK ballon and estrogen and progesterone sequential therapy given to prevent adhesion routinely. 7 day later, G-CSF or normal saline will be injected into the uterine cavity by Tom catheter after removing the balloon respectively. A second hysteroscopic examination will be performed in 2 months to check up the adhesion reformation. In addition, the endometrial thickness after surgery and fertility outcome will be followed up.

Eligibility Criteria:
Inclusion Criteria:

* Moderate and severe intrauterine adhesion patients(AFS score ≥5)
* age 18-40
* first time receiving hysteroscopic adhesiolysis
* provided COOK balloon as adjuvant adhesion prevention treatment
* accepting randomized trial

Exclusion Criteria:

* Mild adhesion patients
* uterine shape can't be restored in the end of surgery
* abnormal chromosome phenotype
* systemic disease
* no fertility desire
* contradiction of G-CSF injection.