cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Cyanoacrylate Obliteration vs. Nadolol Treatment in the Prevention of Gastric Variceal Rebleeding

Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized combination of GVO and BB can further decrease the rebleeding rate.

Gastric varies (GV) rarely rupture. However should it occur, the outcome would be worse than rupture of esophageal varies (EV). Rupture of GV is characteristic of a higher rebleeding rate, a requirement for a larger amount of blood transfusion and a higher mortality. Up to date, the treatment of GV bleeding (GVB) is still sub-optimal in contrast to the treatment of EV bleeding. The management of GV has been focused on treatment of acute GVB. Various specific methods are used to control GVB and prevent rebleeding; however they were far from ideal. It is because GV are usually larger vessels formed in deeper submucosa and connect to the spontaneous gastrorenal shunt which creates a fast blood flow. Therefore, voluminous blood in the larger diameter GV leads to exsanguine bleeding when ruptured. A variety of endoscopic methods, which include injection of sclerosants, tissue adhesive (cyanoacrylate), thrombin and ligation with rubber bands, detachable nylon loop and steel snares, are applied to control acute GV bleeding with variable successful rates (50\~100%) and rebleeding rates (20\~90%). The successful rate of endoscopic cyanoacrylate injection to arrest active GVB is more consistent around 90\~100% and rebleeding rate is around 30\~40%. The recent International Consensus Meeting endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute GVB. The embolic complications, either septic \& aseptic, are not uncommon. Expertise is also required to reduce the embolic complications and instrumental injuries. Therefore, the efficacy of specific treatment for GVB is sub-optimal, consecutive innovation of new methods are required to improve the prognosis of GVB. Non-selective beta-blocker is effective to reduce rebleeding from esophageal varices. However, its effect on gastric variceal hemorrhage has never been proven.

This is an important issues prompted by current portal hypertension experts. We have much experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journal. Therefore, we design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the secondary prevention of acute gastric variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of liver cirrhosis and/or HCC, endoscopically proven gastric variceal bleeding

Exclusion Criteria:

* younger than 18 y/o or older than 80 y/o, terminal illness, other major systemic disease or malignancy
A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients

This study is a 12-week, double-blind, placebo-controlled trial of L-methylfolate 15 mg/d supplementation in schizophrenia patients with mild or greater negative symptoms. L-methylfolate, a prescription medical food, is the activated form of folate required for conversion of homocysteine to methionine and hence is the optimal form of folate for supplementation, since it eliminates the need for activation by MTHFR. The purpose of this study is to examine the change in plasma L-methylfolate concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo.

Blood levels of L-methylfolate and biological activity will be evaluated by examining changes in plasma homocysteine concentrations, serum methionine concentrations and changes in brain activation as measured by fMRI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, any subtype
* Male of female
* Age 18-68 years
* Treated with an antipsychotic for at least 6 months at a stable dose for at least 6 weeks
* PANSS total score of at least 60, with at least 3 (moderate) on one negative symptom item or on one positive symptom item
* Simpson Angus Scale (SAS) for the EPS total score of 12 or less and
* A score of 2 (mild) or less on all items of the Calgary Depression Rating Scale (CDRS)
* Comprehension of English adequate to complete cognitive testing

Exclusion Criteria:

* Unable to provide informed consent
* CBC results consistent with megaloblastic anemia
* Serum creatinine concentration greater than 1.4
* Current use of folate supplementation \> 400mcg folate
* Alcohol or other substance abuse within 3 months (nicotine allowed)
* Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone or pyrimethamine
* Positive baseline urine toxic screen, (positive test for PCP, barbiturates, cannabinoids, amphetamines, benzodiazepines, opiates, or cocaine)
* Unstable medical illness (exclusionary lab values are listed in Appendix A)
* Unstable psychiatric illness
* Seizure disorder
* Pregnant or nursing, or planning/trying to get pregnant within the next 6 months, and
* DSM-IV diagnosis of major depressive disorder
Effect of High Dose Naloxone on Secondary Hyperalgesia

Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.

Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.

In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim therefore to show that latent sensitization is present in humans and is modulated by endogenous opioids.


Eligibility Criteria:
Inclusion Criteria:

* healthy man
* written informed consent
* ASA 1-2
* BMI 18 \< BMI \< 30
* normal ultrasound examination of the heart
* normal ECG
* urin sample without traces of opioids

Exclusion Criteria:

* volunteers, who do not understand the Danish language
* participation in another experimental trial in the previous 60 days
* nerve damage or skin lesions in the assessment areas
* neurological or psychiatric condition
* use of psycho-active drugs
* abuse of alcohol or drugs
* chronic pain
* regular use of pain-killers (\> 1 a week)
* allergy against morphine or other opioids (including naloxone)
* use of prescription drugs 1 week prior to the trial
* use of over-the-counter medication 48 hours prior to the trial
* urin sample with traces of opioids
* volunteer is not suitable for the trial according to the investigator's consideration
ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.


Eligibility Criteria:
Selected Inclusion Criteria:

* Weight ≥ 40 kg at screening
* Diagnosis of IPF based on modified American Thoracic Society-European Respiratory Society guidelines
* Diagnosis of PH based on the following hemodynamic requirements: mean pulmonary artery pressure (mPAP ≥ 25 mm Hg; pulmonary vascular resistance \> 240 dyne.sec/cm\^5; pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mm Hg
* Forced vital capacity (FVC) ≥ 40%
* Able to walk at least 50 meters during two 6-minute walk tests
* If receiving calcium channel blockers, low-dose oral corticosteroids, immunosuppressive, cytoxic, or antifibrotic drugs dose must have been stable.

Selected Exclusion Criteria:

* Diagnosis of PH primarily due to an etiology other than IPF
* Surgical lung biopsy diagnosis other than Usual Interstitial Pneumonia
* Other known cause of interstitial lung disease
* Evidence of significant obstructive lung disease
* Recent hospitalization for an acute exacerbation of IPF
* Recent active pulmonary or upper respiratory tract infection
* Left ventricular ejection fraction \< 40%
* Serum creatinine ≥ 2.5 mg/dL
* Required hemodialysis, peritoneal dialysis, or hemofiltration
* Female subject who was pregnant or breastfeeding
* Recent treatment for PH with an endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor, or prostacyclin derivative
* Recent treatment with high dose oral corticosteroids
* Recent treatment (within 4 weeks prior to screening) with imatinib mesylate (Gleevec)
* Alanine aminotransferase or aspartate aminotransferase lab value that was greater than 1.5 x the upper limit of the normal range
* Discontinued other ERA treatment for any adverse reaction other than those associated with liver function test abnormalities
Could Meditation Modulate the Neurobiology of Learning Not to Fear?

It is well-established that the practice of mindfulness meditation leads to improvements in mental health and well-being and the cultivation of positive emotions. However, the neural mechanisms of these improvements are largely unknown. A few recent studies suggest that mindfulness meditation impacts the structure and function of the ventromedial prefrontal cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that these regions are part of a brain circuit that is critical for the extinction of conditioned fear responses, and for the retention of fear extinction memory. Building on the overlap of these regions and on conceptual considerations, the project investigates whether mindfulness meditation could influence one's capacity to retain the memory of fear extinction. Meditation-naïve participants will be randomized to either a mindfulness-meditation based training or an active control training that controls for all mindfulness-unspecific components. Participants will undergo a fear conditioning, extinction and extinction recall protocol in an MRI scanner before and after the trainings. We hypothesize that participants who have practiced mindfulness meditation will show greater improvements in fear extinction memory after the course, and that these improvements will be correlated with anatomical and functional changes in the brain regions of interest. Improvements in fear extinction memory will also be related to improvements in self-reported psychological well-being. Merging the fields of an ancient spiritual tradition and a fundamental learning mechanism, the project investigates the underlying neural mechanisms of a practice for the enhancement of mental health and well-being.


Eligibility Criteria:
Inclusion Criteria:

18-65 years of age Proficient in English Right-handed Free of medication that affect cerebral metabolism Able to give informed consent High stress level (defined as a score of \>= 3 on the 4-item Perceived Stress Scale).

Exclusion Criteria:

More than 10 meditation sessions of any tradition in their lifetime, or more than 5 sessions within the last year.

More than 10 yoga sessions of any tradition in their lifetime, or more than 5 sessions within the last year.

History of neurologic or psychiatric disease, substance abuse or dependence that is current or within the last year.

Major/chronic medical conditions History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae History of seizures History of stroke Prior neurosurgical procedure Metal in the body, metal injury to the eyes Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt Pregnancy; breastfeeding or nursing Claustrophobia Weight \> 350 lbs.
Dexmedetomidine in Non-intubated VATS

This prospective study aims to evaluate the effectiveness of intraoperative DEX for postoperative analgesia and recovery after non-intubated VATS. In addition, the investigators observe the impact of DEX on anesthetic requirements, hemodynamic parameters, and adverse events during non-intubated VATS.

The non-intubated thoracoscopic approach has been adapted for use with major lung resections. The non-intubated VATS tries to minimize the adverse effects of tracheal intubation and general anesthesia, such as intubation-related airway trauma, ventilation-induced lung injury, residual neuromuscular blockade, and postoperative nausea and vomiting. An adequate analgesia allows VATS to be performed in sedated patients and the potential adverse effects related to general anesthesia and selective ventilation can be avoided. Dexmedetomidine (DEX), a highly selective alpha-2 receptor agonist, is increasingly used in anesthesia with sedative, hypnotic, anxiolytic, sympatholytic, and analgesic effects. It can also attenuate perioperative stress and inflammation and preserve the immunity of surgical patients, which may contribute to reduced postoperative complications and improved clinical outcomes. This study aims to evaluate the effectiveness of intraoperative DEX for postoperative analgesia and recovery after non-intubated VATS. In addition, the investigators observe the impact of DEX on anesthetic requirements, hemodynamic parameters, and adverse events during non-intubated VATS.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score of I-III patients receiving video-assisted thoracoscopic surgery

Exclusion Criteria:

* Age \< 18 or \> 80 years
* ASA classifications \> III
* Pregnancy
* Known allergies to any drugs used in the study
* Emergency surgery
* Patient refusal
* Chronic pain history
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial

The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastroesophageal reflux disease
* Long history of GERD symptoms
* Persistent or recurrent symptoms despite optimal medical treatment
* Persistent or recurrent complications of GERD
* Reduced quality of life owing to increasing esophageal exposure to gastric juice
* Pathological values in the preoperative evaluated functional parameters

Exclusion Criteria:

* Previous esophageal or gastric surgery
* Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)
* Pregnancy
Emergent Therapies in OBP. Pilot Study

Obstetric Brachial Palsy (OBP) produces functional limitations in the involvement of the affected upper limb within the child's natural environment. The therapeutic interventions of Conventional Mirror Therapy (MT) and Mirror Therapy Virtual Reality (VR) are aimed at the rehabilitation of the affected upper limb and the quality life improvement.

To quantify the increase in the affected upper limb spontaneous use and the quality of life of children with upper OBP from 6-12 years, when They are treated with Conventional MT or Mirror Therapy VR applying specific protocol: 20 min/day in 4 weeks.

The intervention protocol was permorfed for four weeks, three days per week applying Conventional Mirror Therapy or Mirror Therapy Virtual Reality, with 20-minute sessions in 4 weeks. Designed to be done at home.

Two measurements of the affected upper limb spontaneous use and quality of life were performed, a pre-treatment assessment corresponding to the baseline situation, and another post-treatment Assessment to observe the results after the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 6 and 12 years old, upper Obstetric Brachial Palsy type Erb-Duchenne (C5-C6) and extended Erb-Duchenne (C5-C7), preserved functionality to do the activities, adequate cognitive level to follow the proposed activities.

Exclusion Criteria:

* associated pathologies, medical complications or cognitive and / or visual impairment that prevent the activities performance, affected upper limb surgeries in the last year, treatment with botulinum toxin in the last three months, no possession of a device with Android operating system for the application of Virtual Reality therapy, families and children no partners.
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice

The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.


Eligibility Criteria:
Inclusion Criteria:

* patients that he must perform a diagnostic hysteroscopy
* acceptance to participate in the study signed informed consent

Exclusion Criteria prerandomization:

* hypersensitivity or allergy to anesthetics
* refusal of the patient
* patients under age 18 and pregnant

Exclusion Criteria postrandomization:

* dropout
* unbearable pain that involves other analgesic measures
* allergic reactions to topical anesthetics
Safety Analysis of Implantation of Stromal Vascular Fraction

Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The SVF includes a variety of different cells and growth factors where the adipocyte (fat cell) population has been removed. The use of SVF in the clinic for a variety of indications is analyzed for incidences of safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 97
* Able and willing to give written informed consent
* Up to date on all age and gender appropriate cancer screening

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease patients known to have tested positive for HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis. Will have an expert consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Primary objective is to answer the question "is two weeks doxycycline treatment (currently suggested treatment) at least as effective as six weeks doxycycline treatment in Lyme Neuroborreliosis?".Key secondary objectives are to provide a better understanding of the pathogenesis and long-term complaints, and to search for new biomarkers in Lyme Neuroborreliosis (LNB) by collecting clinical data, blood, and cerebrospinal fluid (CSF) in a biobank for future research

Endpoints:

Primary endpoint: Improvement on a composite clinical score from inclusion to six months after ended treatment defined as clinical score at inclusion minus clinical score at six months.

Secondary endpoints: Improvement on a composite clinical score 12 months after ended treatment. Fatigue Severity Scale (FSS),Patient Health Questionnaire (PHQ-15), Short Form 36 (SF-36) and blood and CSF findings at inclusion, after 6 and 12 months.

The study design is a multicenter, non-inferiority, randomized, penta-blind, placebo-controlled trial. 120 patients will be included from approximately 8 Norwegian hospitals.

Main inclusion criteria are neurological symptoms suggestive of LNB without other obvious reasons, one or both of a) Cerebrospinal fluid pleocytosis (\>5 leukocytes/mm3) b) intrathecal Bb antibody Production and signed informed consent. Safety assessments during the trial: Comparison of clinical outcome six months after end of treatment between the two treatment groups. Subjective experiences and blood tests including hematology and biochemistry for four weeks after ended treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Neurological symptoms suggestive of LNB without other obvious reasons and one or both of

   1. Cerebrospinal fluid pleocytosis ≥5 leukocytes pr mm3
   2. Intrathecal Bb antibody production
2. Signed informed consent

Exclusion Criteria:

* Age less than 18 years
* Pregnancy, breast-feeding
* Adverse reaction to tetracyclines
* Treatment with cephalosporin, penicillin, or tetracycline the last 14 days
* Serious liver or kidney disease that contraindicates use of doxycycline
* Lactose intolerance
* Need to use medications contraindicated according to Summary of Product Characteristics of the Investigational Medicinal Product
Pilot Study on Proteomics of Erythrocyte Proteins in Patients With COPD Based on TMT Technology

Chronic obstructive pulmonary disease (COPD), a common and complex disease characterized by persistent airflow limitation, is a leading cause of mortality worldwide. COPD and its comorbidity are associated with hypoxia condition. Further investigations on the cellular and molecular aspects of hypoxia in COPD should help to reveal the mechanisms underlying the development of this disease. Dysfunction of the erythrocyte, a main medium to transport oxygen through the blood, contributes to the prognosis and severity of COPD through hypoxia. It is proposed that dysregulated proteins in erythrocytes that impair oxygen transport may be involved in the development of COPD. However, a comprehensive study on altered proteins of erythrocytes in COPD is still lacking. Proteomics techniques and protein chip techniques provide a high throughput screening method to figure out characteristic inflammatory or metabolic markers of diseases. Therefore, this study is to evaluate the clinical significance of differential erythrocyte proteins in the course of COPD disease.


Eligibility Criteria:
1. case group

   Inclusion Criteria:
   1. Age from 40 to 80 years old; gender is not limited.
   2. Stable COPD
   3. Sign the informed consent with the willingness of obeying the protocol. -

   Exclusion Criteria:
   1. Subjects with known other chronic respiratory diseases except for COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
   2. Subjects had been accepted lung lobectomy or transplantation;
   3. Subjects be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al );
   4. Alcoholism, drug or solvents addition;
   5. Acute exacerbation COPD patients (AECOPD) -
2. control group Inclusion criteria

   1. Age from 40 to 80 years old; gender is not limited.
   2. Sign the informed consent with the willingness of obeying the protocol. - Exclusion criteria

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   1. Subjects with known other chronic respiratory diseases (such as COPD, asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
   2. Subjects had been accepted lung lobectomy or transplantation;
   3. Subjects be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al );
   4. Alcoholism, drug or solvents addition;