cyrilzakka/clinical-trials huggingface dataset:
Stellate Ganglion Block and Cerebral Vasospasm

At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. But unfortunately, despite years of efforts, the prevention and treatment of cVS is still a major clinical dilemma and various ways of treatment are still being explored. Recent studies have shown that stellate ganglion block (SGB) can dilate cerebral vessels and alleviate the impact of existing cVS. However, there is no study to evaluate the effect of early application of SGB on the improvement and prevention of cVS after aSAH.

Cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after aSAH, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (DCI) or delayed ischemic neurological dysfunction (DIND). Past studies have shown that if cerebral vasospasm occurs in patients with aSAH, the proportion of ischemic brain injury can be as high as 20%-30%.Obviously, prevention and treatment of CVS are the key to reducing the disability and mortality of aSAH.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-65 years old;
* Within 48 hours after onset of aSAH,and planning surgical treatment(aneurysm clipping);
* Preoperative Hunt-Hess grade 2-3
* Sign informed consent.

Exclusion Criteria:

* ASA \> grade III;
* Patients with posterior circulation aneurysm, ophthalmic aneurysms or internal carotid aneurysms;
* patients with multiple aneurysms;
* Patients with severe coagulation dysfunction;
* Patients with trauma and local infection in the nerve block area;
* Local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery);
* MCA stenosis or infarction was found by preoperative imaging;
* Patients with poor temporal window signal revealed by preoperative TCD (clear waveform image could not be obtained);
* Allergy to known local anesthetics;
* Pregnant and lactating women.
Effectiveness of Combined Levetiracetam and Midazolam in Generalized Convulsive Status Epilepticus in Children

Generalized status epilepticus is a common pediatric neurological emergency with significant mortality and morbidity. Benzodiazepines remain the first anticonvulsive line but benzo-diazepines don't control seizures in about 30% of cases. GCSE may be more rapidly stopped and controlled through combining another drug with benzodiazepines such as Levetiracetam, acting by different pathways. This study aims to evaluate the effectiveness of combined levetiracetam and midazolam in treatment of generalized convulsive status epilepticus in children.

Generalized convulsive status epilepticus (GCSE) is a common pediatric neurological emergency with an annual incidence of up to 73 episodes per 100,000 children and is associated with mortality in 2.7% of cases and overall morbidity in 10% - 20% of cases, including hemodynamic instability and long-term neurological impairments.

The management of GCSE in children starts with emergency measures (stabilization phase) with monitoring and laboratory testing in the first 5 minutes. Benzodiazepines are used as first-line anticonvulsants for GCSE that persists for more than 5 minutes. However, studies have shown that benzo-diazepines don't control GCSE in about 30% of patients. GCSE may be more rapidly stopped and controlled through combining another drug with benzodiazepines, acting by different pathways.

Levetiracetam is a recent broad-spectrum antiepileptic drug with a relatively high safety profile. The effectiveness of intravenous levetiracetam has been demonstrated as a second-line anticonvulsant in GCSE. In this study, we aim to evaluate the effectiveness and safety of levetiracetam plus midazolam versus midazolam alone as first-line therapy of GCSE in children.

Eligibility Criteria:
Inclusion Criteria:

* Generalized convulsive status epilepticus, which is clinically defined at the time of presentation as continuous, generalized, tonic-clonic seizure activity or ≥ 2 generalized tonic-clonic seizures without recovery of consciousness for more than 5 minutes.

Exclusion Criteria:

* Failure to obtain informed consent.
* Prior therapy with any anticonvulsant for the presenting episode of generalized convulsive status epilepticus.
* Epileptic patients on levetiracetam therapy.
* Known allergy or contraindications to any of the study drugs.
* End-stage kidney disease.
* Severe liver disease.
* Cardiac diseases.
* Hypoglycemia or hyperglycemia.
* Inborn errors of metabolism.
* Known mood/behavioral disorder.
* Failure to obtain intravenous access in the first 5 minutes.
* Cessation of seizures during the stabilization phase (0 - 5 minutes).
* Traumatic brain injury
18F-FDG PET Radiomics of Diffuse Large B-cell Lymphoma

This study aims to investigate the prognostic value of 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) radiomics in diffuse large B-cell lymphoma (DLBCL) and its additional value to the International Prognostic Index (IPI).

Several studies have shown that 18F-FDG PET radiomics is predictive of survival in DLBCL. However, to the best of the investigator's knowledge, a multi-feature radiomic signature for prognosis assessment of DLBCL has not yet been described. Furthermore, it remains unclear whether PET-based radiomics could add more prognostic values to the IPI in DLBCL.

This study aims to develop 18F-FDG PET radiomic signature, and investigate whether the radiomic signature could improve the prognostic value of the IPI score in predicting progression-free survival (PFS) and overall survival (OS) in DLBCL.

Eligibility Criteria:
Inclusion Criteria:

1. histopathologically confirmed diffuse large B-cell lymphoma (DLBCL);
2. Over 18 years old when diagnosed;
3. Have undergone pre-treatment 18F-FDG PET/CT;
4. Have been initially treated with the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin).

Exclusion Criteria:

1. Have primary central nervous system (CNS) lymphoma or second primary cancer;
2. Have undergone surgical resection;
3. With an incomplete follow-up.
Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation (European trade name: Champix(R); US trade name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 30-70 years at screening
2. Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)
3. ≥ 20 heavy drinking days (men: ≥ 5 drinks/day, women: ≥4 drinks/day, where 1 std. drink is defined as 12 g ethanol) during the last 60 days
4. Participants must have signed the informed consent

Exclusion Criteria:

1. Subject to treatment of alcohol withdrawal within 30 days of study initiation
2. Subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, SSRIs, varenicline, mirtazapine, rimonabant, methylphenidate or atomoxetine within 3 months of study initiation
3. Subject to treatment of depression within 3 months of study initiation
4. The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)
5. Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial
6. History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures
7. Laboratory hepatic values of more than 3 times the upper limit of the normal range or other clinically significant abnormalities in the screening laboratory values.
8. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
9. Any ongoing serious psychiatric or somatic disorder
10. Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)
11. The concurrent use of illicit drugs based on urine-toxicity test
12. The need for detoxification
13. Diabetes Mellitus Type 1
14. Suicidal risk
15. Homelessness
16. Additional factors that implies to the investigator/physician that the participant will not be completing the study
Esophageal Cytology With FISH in Detecting Esophageal Cancer

This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.

PRIMARY OBJECTIVES:

I. Determine if sponge cytology with FISH is a reliable screening tool for esophageal dysplasia/cancer, and determine its sensitivity and specificity, compared to the gold standard procedure (upper endoscopy).

SECONDARY OBJECTIVES:

I. Determine if the cytology screening with FISH biomarkers is more cost effective than upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal metaplasia and dysplasia.

II. Determine the limitations and future needs to improve this technique.

OUTLINE:

Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with known esophageal cancer diagnosed by previous endoscopy

  * Adenocarcinoma
  * Squamous cell carcinoma
* Patients determined to be at risk for esophageal cancer:

  * Subjects with a history of Barrett's esophagus
  * Subjects with a history of low or high grade dysplasia
  * Subjects with a history of gastroesophageal reflux disease (GERD)
  * Subjects with a history of esophagitis
  * Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
* Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:

  * Upper endoscopy
  * Surgical esophagectomy
* Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 (Karnofsky \>= 30%) will be included
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Subjects with severe, symptomatic dysphagia (unable to pass solids)
* Subjects that are unable to swallow a tablet/pill for any reason
* Subjects with a previous esophagectomy
* Subjects with esophageal varices
* Subjects unable to provide consent
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Participants With HER 2-Negative Aggressive Metastatic Breast Cancer

This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Participants with HER2-negative metastatic breast cancer. Mandatory to have the HER2/estrogen receptor (ER)/progesterone receptor (PR) status
* Participant who met criteria for first-line treatment with chemotherapy plus bevacizumab (standard doses) by local, regional or national guidelines or authorities
* Participants with measurable disease (RECIST criteria v1.1) or participants with no measurable but assessable disease
* Molecular phenotype as triple negative metastatic breast cancer; and ER-positive tumors need to fulfill at least one of the two clinical criteria: metastatic relapse on adjuvant endocrine therapy or progression to at least one prior line of endocrine therapy for advanced disease; or aggressive disease criteria (at least two criteria): taxane based regimen in the (neo) adjuvant setting; metastatic relapse within 2 years from the end of chemotherapy for early breast cancer; liver metastasis; three or more organs with metastatic involvement; symptomatic visceral disease
* Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* Participant has received prior chemotherapy for metastatic disease
* Participant requiring major/minor surgery within 3 weeks prior to administration of the first dose of study treatment
* Participant has received an investigational therapy within 4 weeks prior to study entry
* Participant has known symptomatic brain metastases
* Participant with non-measurable or assessable disease: exclusive blastic bone disease; pleural, pericardial or abdominal effusion as only evidence of disease
* Participant in chronic daily treatment with corticosteroids (doses greater than \[\>\]10 milligrams per day \[mg/day\] of methylprednisolone or equivalent), except inhaled steroids
* Pregnant or breastfeeding participant
* Women of childbearing potential who are not using hormonal contraceptives or highly effective birth control during the study
* Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Participant with significant renal, hematological or liver function alteration according to investigator's criteria
* Participant has serious medical risk factors involving any of the major organ systems
Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults

The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).

This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive therapy.

Eligibility Criteria:
Inclusion Criteria:

* HSV-2 seropositive
* A minimum of 1 year of reported history of genital herpes and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy

Exclusion Criteria:

* History of receiving an investigational HSV vaccine
* Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
* Pregnant or breastfeeding
Pulmonic SAPIEN S3™ THV Registry

Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.

The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN S3 transcatheter heart valve in the pulmonic position

A malfunction or dysplasia of the pulmonary valve or the right ventricular outflow tract (RVOT) is one of the major components of the cardiac physiology in many congenital heart defects. Surgical correction of complex heart defects often includes some form of surgical repair or replacement of the native RVOT by biological valves such as homograft, bioprosthesis or Xenografts (i.e., Contegra conduits). Typical examples are tetralogy of Fallot (TOF) or double outlet right ventricle (DORV), pulmonary stenosis (PS), pulmonary atresia (PA), truncus arteriosus (TA), transposition of the great arteries (TGA) with PS (Rastelli's operation), absent pulmonary valve syndrome (Miller-Lev-Paul), Ross surgery for aortic valve disease and others. The repaired or replaced pulmonary valve however often becomes dysfunctional later on and many patients require surgical revisions of the RVOT with pulmonary valve replacement within 10 years of primary intervention.

TPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Early results of percutaneous pulmonary valve implantation (PPVI) showed that it is a promising procedure compared to a conventional surgical intervention. Meanwhile, pre-stenting of the RVOT before PPVI is routinely performed, enabling PPVI in various anatomies.

Eligibility Criteria:
Inclusion criteria

* Clinical indication and decision for the implantation of an Edwards SAPIEN 3 THV made
* Data release form

Exclusion Criteria:

* none
Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.


Eligibility Criteria:
Inclusion Criteria:

* • All women at term(\>or =37 weeks of gestation)

  * Healthy
  * American Society of Anesthesiologists(ASA) class1 and 2
  * Women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl

Exclusion Criteria:

* • Women with American society of anesthesiologist physical status\>2

  * Body mass index \>or =40 kg per square meter
  * Height \<150 cm
  * Any contraindication to the spinal anesthesia
  * History of substance abuse
  * History of hallucinations
  * Chronic opioid therapy
  * Chronic pain or on any pain medication currently
  * Patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality
  * Cases with severely compromised fetus where immediate administration of general anesthesia is required.
Near-Infrared Spectroscopic (NIRS) Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients

Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to determine whether changes in VOT measurements occur in patients during cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult, elective cardiac surgery patients
* Procedure using cardiopulmonary bypass

Exclusion Criteria:

* Contraindication to pneumatic cuff inflation
* Pregnant
* Significant peripheral vascular disease of the arms
* Emergency surgery
An Open-label Study of a Gene Therapy Product (Vebeglogene Autotemcel) in Transfusion Dependent Beta-Thalassemia

This is an interventional study to evaluate the safety and efficacy of autologous Hematopoietic Stem and Progenitor Cells (HSPCs) transduced with lentiviral vector encoding functional hemoglobin subunit beta (HBB) gene in patients with transfusion-dependent beta-thalassemia.

The participant's autologous HSPCs will be transduced with the self-inactivating lentiviral vector, carrying the functional HBB gene.

Study duration per participant is approximately 27 months including an approximately 30-day screening/baseline period, an approximately 60-day mobilization and product manufacture, an approximately 10-day myeloablative conditioning, 1 treatment day, and an approximately 24-month study observation period.

The endpoints will be used to assess the safety and efficacy profiles in patients with transfusion-dependent beta-thalassemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients or parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedules.
* Diagnosis of beta-thalassemia and a history of RBCs transfusions.
* Documented baseline, or pretransfusion, Hb≤7 g/dL.
* Availability of an adequate and well-documented transfusion history.

Exclusion Criteria:

* Active bacterial, viral, fungal, or parasitic infection.
* A white blood cell (WBC) counts\<3×10\^9/L, and/or platelet counts\<100×10\^9/L not related to hypersplenism.
* Uncorrected bleeding disorder.
* Presence of severe diseases that judged not compatible with the study procedures, such as severe hepatic disease, kidney disease, lung disease, and/or cardiovascular disease.
* Uncontrolled seizure disorder.
* Any evidence of severe iron overload that, in the investigator's opinion, warrants exclusion.
* Prior autologous hematopoietic stem cell transplantation.
* Prior receipt of gene therapy.
To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis

The purpose of this study is to:

* To access the efficacy of TW compared to Aza in the maintenance therapy for lupus nephritis
* To investigate the safety and tolerability of TW versus Aza in the maintenance therapy for lupus nephritis

Tripterygium (TW) is a Chinese traditional patent drugs in treating chronic glomerulonephritis. It has been used to treat lupus nephritis for many years with less side effects. We compare the efficacy and safety of TW vs Aza in the maintenance therapy of lupus nephritis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who signed written informed consent form;
2. SLE patient, aged between 18-60 years, female or male;
3. Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy;
4. All patients received induction therapy for 6-12 months, including MMF, CTX, FK506 or multi-target therapy;
5. When recruited in the study, patients received partial remission or complete remission for 3 months;

   * Complete remission: proteinuria \< 0.4 g/24h, negative urine sediment, serum albumin \> 35 g/L, elevated scr \< 0.3 mg/dl, no extra-renal complications;
   * Partial remission: proteinuria \< 1.0 g/24h, urine RBC \< 500000/ml without casts, serum albumin \> 35 g/L, elevated scr \<0.3 mg/dl, no extra-renal complications.

Exclusion Criteria:

1. Patients who didn't sign written informed consent form or could not obey the protocol;
2. Patients who didn't received the CR or PR criterion;
3. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit;
4. WBC \< 3000/mm3 in peripheral blood;
5. Patients with abnormal of central nervous system.