cyrilzakka/clinical-trials huggingface dataset:
Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal Cancer

To determine the response to treatment with a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy versus a conventional covered stent in patients with advanced esophageal cancer.

Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The current study is designed to demonstrate the preliminary results with this irradiation stent in patients with inoperable esophageal cancer compared to those using a conventional covered stent.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary cancer of esophagus,
* Must be dysphagia caused by esophageal cancer,
* Surgically inoperable, but may be metastatic,
* Without esophageal fistulas,
* Must be an inpatient at Zhongda Hospital,
* Life expectancy is over 6 months,

Exclusion Criteria:

* Esophageal fistulas,
* Tracheal compression with symptoms,
* WBC \<2000/mm3 and Platelet count \<50,000/mm3,
* Concurrent therapies:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism

The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.

Pulmonary embolism (PE) is life threatening disease requiring early diagnosis and treatment. Thrombolytic therapy (TT) is required in patients with massive PE. PE has a high mortality but the in-hospital all-cause case mortality rates were lower in unstable patients who received TT than those who did not. However, it was reported that minority (nearly 30%) of unstable patients received thrombolytic therapy. The reason that majority of unstable patients failed to receive thrombolytic therapy is unclear. The higher rates of complications including the life threatening bleeding may be a reason of reluctance in the use of TT.

The lungs are the only organ receiving the entire cardiac output. Therefore, they are the point of convergence for the entire molecules of the thrombolytic agent, independent from the route of administration. So that lower doses of the TT might be effective in PE, with the additional benefits of enhancing its safety profile. The percutaneous endovenous intervention for deep venous thrombosis has suggested an exquisitely favorable pulmonary response to low-dose thrombolysis. The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.

The primary end points consisted of in hospital all cause mortality, major complications, pulmonary hypertension and right ventricular dysfunction. Secondary points are all cause mortality, pulmonary hypertension and right ventricular dysfunction at 6 month.

Eligibility Criteria:
Inclusion Criteria:

Patients with massive PE aged 18 years or older with confirmed PE and able to give informed consent will be included in the study. PE is defined according to current guidelines as adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomography angiography. Massive PE was defined as acute PE with sustained hypotension (systolic blood pressure\<90 mm Hg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or left ventricular \[LV\] dysfunction), pulselessness, or persistent profound bradycardia (heart rate\<40 bpm with signs or symptoms of shock).

Exclusion Criteria:

Patients with prior intracranial hemorrhage, known structural intracranial cerebrovascular disease (eg, arteriovenous malformation), known malignant intracranial neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent surgery encroaching on the spinal canal or brain, and recent significant closed-head or facial trauma with radiographic evidence of bony fracture or brain injury were excluded from the study.
The Cerebral-Respiratory Interaction in Controlled Mechanically Ventilated Neurosurgical Patients. (The CeRes-CMV Study)

The impact of mechanical ventilation on intracranial perfusion is still not completely clarified. It is often assumed that raising airway pressure will invariably elevate the intracranial pressure, but this is not always the case.

The effects of airway pressure on intracranial pressure can depend on several factors, and among others, an uncontrolled expiration and consequent lung collapse may have an influence on cerebral perfusion.

This study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in critically ill neurosurgical patients during controlled mechanical ventilation.

Electrical impedance tomography measurements , oesophagus and gastric pressure, electrical activity of the diaphragm and intracranial pressure will be acquired in a synchronised manner during controlled mechanical ventilation. Moreover, airway opening pressure, expiratory flow limitation and recruitment/inflation ratio will be determined during controlled mechanical ventilation, on a daily bases until the patient recover his/her own spontaneous breathing.


Eligibility Criteria:
The patients will be included within 48 hours from initiation of mechanical ventilation and insertion of an external ventricular drainage catheter

Inclusion Criteria:

* Age \>18 years;
* MV expected for more than 72 hours;
* Not pregnant;
* Informed consent from patient or next of kin.

Exclusion Criteria:

* Previously demonstrated paralysis of the diaphragm or know pathology of the phrenic nerve or neuromuscular disorder,
* Chest tube,
* Patients with clinical conditions that contraindicate the insertion of esophageal/gastric catheters (e.g., esophagus rupture, esophageal bleeding),
* Pacemaker and/or implantable cardioverter defibrillator, these last being a contraindication for EIT.
* Hemicraniectomy. In case of late hemicraniectomy (after patient inclusion), the patient will drop-out from the study.

Relative contraindication: in case of skull base fracture the patient can be included only if oesophageal/gastric and NAVA catheters can be inserted orally.
Artificial Intelligence in Categorizing the Severity of Oxygenation by Incorporating the PEEP Into the Definition of ARDS in Ventilated Patients

Artificial Intelligence in categorizing the severity of Oxygen in ventilated patients to predict initiation of treatment measures to improve mortality - P/FP ratio


Eligibility Criteria:
Inclusion Criteria:

1. Intubated patients

Exclusion Criteria:

1. pediatric and neonates
2. DNR patients
3. Non intubated patients
RefleXion PET/CT Imaging Performance in Patients With Various Malignancies

This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) fludeoxyglucose F-18 (\[18F\]-FDG)- positron emission tomography (PET)-computed tomography (CT) imaging in patients with various cancers (malignancies). PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, \[18F\]-FDG. Because some cancers take up \[18F\]-FDG, cancer cells can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RefleXion system is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The RMRS uses PET emissions to guide radiotherapy delivery in real-time and has been studied for use with FDG (which is an agent used in standard PET-CT scans that targets glucose). Information gathered from this study may help researchers to improve PET-CT imaging on the RefleXion system. This information will be used in the future to improve planning and delivery of radiotherapy that will target (in real time) the signal released from the \[18F\]-FDG-PET-CT tracer. Comparing the imaging from the standard of care \[18F\]-FDG-PET-CT with the \[18F\]-FDG imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for cancer.

PRIMARY OBJECTIVE:

I. To assess imaging performance of the \[18F\]-FDG PET-CT subsystem on the X1 RMRS to detect lesions (primary and metastatic) in patients with various types of malignancies.

SECONDARY OBJECTIVE:

I. To determine the feasibility of generating a BgRT plan using X1 RMRS-acquired \[18F\]-FDG PET data derived from the imaging-only session at the studied dose level.

OUTLINE:

Patients receive \[18F\]-FDG injection and undergo SOC \[18F\]-FDG PET-CT on study. Patients with at least one PET avid lesion then undergo X1 RMRS PET-CT imaging-only session on study.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative
* Age: \>= 21 years
* Patients with malignancies (abdominal/pelvic/thoracic/head and neck/breast tumors) undergoing SOC \[18F\]-FDG PET-CT for diagnostic and/or radiotherapy planning purposes
* Patients should be scheduled for \[18F\]-FDG PET-CT prior to study entry

Exclusion Criteria:

* Known psychiatric or substance abuse disorder that would interfere with conduct of the study
* Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
* Lung parenchymal and bone tumors will be excluded as their imaging characteristics were evaluated in a previous study
Intervention Effect of Transcranial Alternating Current Stimulation (tACS) on Disorder of Consciousness (DOC)

To investigate the effect of high definition-transcranial alternating current stimulation(HD-tACS) on consciousness promotion in patients with chronic consciousness disorders and the underlying neural mechanism by EEG.

Forty patients with chronic consciousness disorder who met the inclusion criteria were recruited with the informed consent of the family. All the participants were randomized to receive "active" or "sham" treatment protocol. Stimulation was performed using a alternating stimulator linked to one anodal electrode and four cathodal electrodes. The anodal electrode was placed over the left dorsolateral prefrontal cortex (DLPFC; F3 in the 10-20 international system of EEG placement), and the four cathodal electrodes (AFz, FCz, F7, and C5 in the 10-20 international system EEG placement) were placed around the anodal electrode to form a current loop. Twenty 2 milliampere (mA) sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 10 consecutive days, and the stimulus frequency was set as 6 Hertz (Hz). Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. Before and after the tACS treatment, the state of consciousness was assessed according to coma recovery scale-revised(CRS-R), and19-channel EEG data were collected.

Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed as chronic disorders of consciousness based on CRS-R assessment by at least two professional neurologists;
2. the age requirement is between 18 and 75;
3. vital signs need to be stable;
4. no neuromuscular blockers and sedatives have been used within 24 hours before the study and the entire protocol;
5. no improvement in the state of consciousness was observed within one week before the start of the study.

Exclusion Criteria:

1. previous or current diagnosis of severe neurocognitive degenerative diseases;
2. metal implantation in the head;
3. previous surgical procedures resulted in skull defect;
4. previous history of epilepsy.
Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease

To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.

This is a double-blind randomised placebo-controlled study investigating the efficacy of baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease. Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and female participants will be recruited to this study. Trial patients will be randomised to one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

This study will also include a second, parallel group of patients with alcohol dependence (non alcoholic-liver disease patients) that will undergo the trial protocol as described above. These patients will be randomised according to a separate list into one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

Eligibility Criteria:
Inclusion Criteria:

* ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for \>10 years.
* Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Willingness to give written informed consent
* Abstinence from alcohol for between 3 and 21 days
* Resolution of any clinically evident alcohol withdrawal (CIWA-AR)

Exclusion Criteria:

* Active major psychological disorder associated with psychosis or significant suicide risk
* Pregnancy or lactation
* Concurrent use of any psychotropic medication other than antidepressants
* Substance use other than nicotine if unstable
* Clinical evidence of persisting hepatic encephalopathy
* Pending incarceration
* Lack of stable housing
* Active peptic ulcers
* Unstable diabetes mellitus
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance

The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.


Eligibility Criteria:
Inclusion Criteria

Women will be enrolled in this study who:

1. Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
2. At least 18 years of age;
3. Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
4. ASA Classification I or II (Appendix II);
5. Have a negative serum pregnancy test (for women of childbearing potential); and
6. Absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation.

Exclusion Criteria

Subjects will be excluded from the study for any of the following:

1. BMI \> 35;
2. Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
3. Suspicion of gallbladder cancer, tumor, polyps, or mass;
4. Acute cholecystitis or acute pancreatitis;
5. Presence of common bile duct stones;
6. History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test);
7. Pelvic Inflammatory Disease;
8. Evidence of abdominal abscess or mass;
9. Diffuse peritonitis;
10. Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
11. Clinical diagnosis of sepsis;
12. History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis;
13. History of peritoneal or vaginal trauma;
14. Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
15. Planned concurrent surgical procedure;
16. Prior or planned major surgical procedure within 30 days before or after study procedure;
17. History of transvaginal surgery;
18. History of (or symptomatic for) abdominal adhesions;
19. Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
20. Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox;
21. Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or
22. Any condition which precludes compliance with the study (Investigator discretion).
Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension

The purpose of this study is to determine the safety and maximum tolerated dose of inhaled NX1011 for the treatment of pulmonary arterial hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

* Patient must either:

  * meet the PAH diagnostic criteria at Screening (based on a documented history of diagnosis as outlined in the American College of Chest Physicians \[ACCP\] 2004 Evidence-Based Clinical Practices Guidelines)15; or
  * have elevated pulmonary pressure with a suspected PAH diagnosis based on a clinical referral at Screening for a RHC.
* Patient must have PAH as defined by a mean pulmonary artery pressure (PAP) \> 25 mmHg.
* Patient must have symptoms of pulmonary hypertension (PH) according to the World Health Organization (WHO) Functional Classification of Pulmonary Hypertension Class II through IV.
* Patient must consent to, be able to tolerate, and have adequate venous and arterial access for Swan-Ganz catheterization (SGC) and an arterial line.

Exclusion Criteria:

* Clinically significant right-to-left intracardiac shunts based on Doppler echocardiography with bubble study.
* History of pulmonary veno-occlusive disease or clinically significant aortic or mitral stenosis.
* History of sustained ventricular tachycardia (VT-S) or ventricular fibrillation (VF) and cardiac arrest, or presence of atrial fibrillation.
* Active cardiac disease meeting the following criteria:

  * Patient with elevated pulmonary capillary wedge pressures (PCWPs) \> 25 mmHg.
  * Patient with a history of myocardial infarction or coronary intervention within the last 60 days.
  * Patient with a history of pacemaker, cardiac defibrillator, or biventricular pacemaker insertion within 4 weeks of Baseline.
  * Patient who cannot be withdrawn from nitrate therapy.
A Study of the Novel Drug Dimebon in Patients With Huntington's Disease

This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
* Able to take medication (capsules) by mouth.

Exclusion Criteria:

* Clinical evidence of unstable medical illness;
* Females who are pregnant or lactating or who intend to become pregnant during the study period.
Probiotic Toothpaste for Microbial Colonization

The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults

This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18.

Participants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility Criteria:
Inclusion Criteria:

* In general good health
* Practise good oral hygiene

Exclusion Criteria:

1. Have a history of autoimmune disease or are immunocompromised.
2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
3. History of allergy (e.g. dairy).
Evaluation of Endovenous Sclerotherapy for Treatment of Varicose Veins

The overall objective will be to evaluate clinical predictors of outcomes in patients who undergo endovenous sclerotherapy for the treatment of varicose veins.

A prospective cohort study of patients who undergo endovenous sclerotherapy over 2 years. There are no deviations in usual clinical assessment and care of patients seeking varicose vein treatment. The purpose of this protocol is only to collect clinical and biomarker information related to this standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of varicose veins

Exclusion Criteria:

* None
Dextrose Concentration Decline Rate in Vivo

Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies

Rationale: In vitro studies of the potential mechanism of action of therapeutic dextrose injection commonly place human or animal cells in a dextrose (glucose) culture medium for a prolonged period of time, typically 24 hours, and expose them to high dextrose levels, typically 1-25% (1000- 25,000mg%). High glucose levels in culture media can cause cell death. Given that cellular apoptosis/death has not been shown to occur after therapeutic dextrose injection in vivo by histologic analysis, we expect that elevated glucose levels drop rapidly in vivo. In this study 12.5% dextrose will be injected intraarticularly (in the knee) and dextrose 5% will be injected subcutaneously, and dextrose level measurements will be obtained at timed intervals after each in order to produce a curve depicting the pattern and speed of decrease in dextrose levels after in vivo injection. In vitro studies can then utilize this information to alter the pattern and speed of decrease of dextrose levels to mimic in vivo conditions, and in so doing provide more useful data on potential mechanisms of therapeutic dextrose injection in soft tissue and joints.

Eligibility Criteria:
Inclusion Criteria:

Able to be relatively immobile for intermittent measurement of dextrose levels

Exclusion Criteria:

Diabetic