cyrilzakka/clinical-trials huggingface dataset:
Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia

The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.

Thoracotomy is one of the most painful surgical incisions. It has been shown that 5-80% of patients still suffer from thoracic pain 2-3 months after surgery and the international association for the study of pain (IASP) defines postthoracotomy pain syndrome (PTTS)as pain that recurs or persists at least 2 months after surgical procedure. Previous reports have shown that the incidence of PTTS varies according to preoperative pain, pain intensity, sex, and types of procedure. However, little is known about the effect of the type of anesthesia to postthoracotomy pain.

Eligibility Criteria:
Inclusion Criteria:

* patients undergo elective thoracotomy of lung surgery

Exclusion Criteria:

* emergency operation age under 18 years patients with unstable hemodynamics
Effectiveness and Safety of Lidocaine for Scleroderma

Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen.

FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings.


Eligibility Criteria:
Inclusion Criteria:

* Scleroderma (diffuse or limited) at less than 5 years of the first symptom

Exclusion Criteria:

* Overlap with other connective tissue diseases
* Fibromyalgia
* Pregnancy
* Current use of ciclofosfamide ou D-penicillamine
Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

The investigators are testing to see if infusion of bupivicaine between the mesh and abdominal wall can reduce postoperative pain and decrease use of narcotics in the postoperative setting.

The primary objective of this study is to test different methods for pain management following laparoscopic ventral hernia repair. We hypothesize that local analgesic injection between the abdominal wall and mesh intraoperatively during laparoscopic ventral hernia repair will result in a 20% decrease in the use of post-surgery pain medication in the first four hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be scheduled for a laparoscopic ventral hernia repair at SBCH. If any additional procedure is performed, the subject will be excluded from the study
2. Age 18 or older
3. Patient must agree to complete pain journal postoperatively
4. Informed consent signed and dated by patient. Consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal

Exclusion Criteria:

1. Any surgical procedure occurring besides the study procedure
2. Any allergy or sensitivity to bupivicaine or its derivatives
3. Less than 18 years of age
4. Patient unable to self report in pain journal due to cognitive disabilities
5. Discharged less than 4 hours post-surgery
the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome

Evaluating any possible relationship between irritable bowel syndrome occurrence and Helicobacter pylori infection


Eligibility Criteria:
Inclusion Criteria:

* All patients will be selected according to Rome IV criteria for the diagnosis of IBS, which include:

Recurrent abdominal pain at least 1 day/week in the last 3 months, with two or more of the following criteria:

* Related to defecation
* Associated with a change in frequency of stool
* Associated with a change in form of stool. Criteria achieved for the last 3 months with symptom onset at least 6 months before diagnosis

Exclusion Criteria:

* • Rectal bleeding

  * Anemia
  * Weight loss
  * Onset after 50 years of age
  * Recent antibiotic use
  * Abnormal abdominal examination (organomegaly, lump)
  * Family history of colorectal cancer.
  * Family history of inflammatory bowel disease, or celiac disease.
Ventral Hernia Improvement of Treatment and Life

The goal of this clinical trial called the VITAL study is to learn if surgery has a positive impact on the quality of life in patients with incisional or parastomal hernia. The main questions it aims to answer are:

Does surgery alleviate patients from their initial problem? Does new discomfort arise after surgery? Do the symptoms worsen, and does quality of life deteriorate in patients who are not offered surgery? The project will also look at time to surgery and postoperative complications. Researchers will send questionnaires to the patients to answer.

Participants will:

Answer the baseline questionnaire. Answer the follow-up questionnaires at 1 month, 3 months, 6 months, 1 year, and 3 years after surgery or after the baseline questionnaire has been completed for those patients being managed conservatively with observation


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Incisional hernia or parastomal hernia

Exclusion Criteria:

- Can't understand or read Danish
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization

"Study on the effectiveness and safety of the coil system for the treatment of intracranial aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The trial design is: prospective, multi-center, randomized, open, parallel positive control, and non-inferiority test. Purpose: To compare the data obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms embolization.

"Study on the effectiveness and safety of the coil system for the treatment of intracranial aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The team leader is Shanghai Changhai Hospital and the Second Affiliated Hospital of Zhejiang University School of Medicine. The trial design is: prospective, multi-center, randomized, open, parallel positive control, and non-inferiority test. Purpose: To compare the data obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms embolization. Sample: 228 cases. The subjects will be randomly assigned to the test group or the control group, with 114 cases in each group.

Eligibility Criteria:
Inclusion Criteria:

* An intracranial aneurysm was diagnosed by DSA examination of whole cerebral blood vessels, and it is planned to use a coil for the embolization of the target aneurysm
* The subject can understand the purpose of the research, show sufficient compliance with the research protocol, and sign an informed consent form

Exclusion Criteria:

* Multiple aneurysms
* Blood alveolar aneurysm, fusiform aneurysm, pseudoaneurysm, dissecting aneurysm, infectious aneurysm with arteriovenous malformation
* mRS score ≥ 3
* Hunt and Hess rating≥4
* Emergency ruptured aneurysms who need stent
* The target aneurysm has previously been treated with vascular embolization or surgery
* Patients with severe stenosis of the tumor-bearing artery
* PLT\<60\*10⁹ or INR\>1.5
* Having vital organ failure or other serious diseases
* Received major surgery within 30 days before enrollment, or planned to undergo surgery within 90 days after enrollment
* History of allergy or contraindications to antiplatelet drugs, anticoagulant drugs, anesthetics, or contrast agents
* Patiens with a history of allergies to platinum and tungsten metals
* Life expectancy \<12 months
* Pregnant or breastfeeding women
* Participated in other drug or device clinical trials within 1 month before signing the informed consent
* Other situations that the researcher judges are not suitable for inclusion
Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it aims to answer are:

* Subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets.
* Diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices.

Participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Biliary atresia patients \> 6 years old
* Vital signs are stable
* Without acute gastrointestinal bleeding

Exclusion Criteria:

* Patients with metal implants, metal stent, artificial joints, bone plates, and bone screw
* Patients with electronic devices, such as pacemakers, cochlear implants, or other implanted electronic medical devices
* Throat or esophageal obstruction leading to dysphagia patients
* Consciousness disturbance patients unable to swallow
* Patients with acute upper gastrointestinal bleeding
* Patients with platelet lower than 40K or PT INR \> 1.5
Neuropsychological Assessment of Cognitive Decline in Patients With a Definite Parkinson's Disease

Cognitive disorders in Parkinson's disease (PD) are not as obvious as cognitive disorders in Alzheimer disease and their diagnosis tends to be delayed. If neuropsychological assessment of cognitive decline in Parkinson's disease is well established, the thresholds of cognitive testing corresponding to a dementia are unknown. Recently, new diagnosis criteria of dementia associated with PD have been proposed by the movement disorder society. In this study two groups of patients with idiopathic PD will be separated and compared according to their Mini Mental State Examination (MMSE) score (upper or lower than 26). Included patients will have clinically idiopathic PD, will be over 65 years old and will present cognitive complain. Cognitive and mood disorders as well as motor symptoms will be assessed using validated scales and a neuropsychological assessment dispatched in two visits will be performed . Differences in the distribution of data from the two groups of patients will be assessed in statistically analysis with non parametric tests. The purpose of this study is to determine the most effective tests and their threshold value corresponding to a pathological cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* MMSE ≥ 16
* impact of cognitive disorders in daily living
* criteria of the UKPDSBB for PD
* steady state in PD
* benign delusions or treated psychosis are tolerated
* informed consent obtained

Exclusion Criteria:

* dementia from other origin than PD
* cognitive decline without impact on daily living
* MMSE \< 16
* delirium in the last 3 months
* Severe Depression
* Central Anticholinergic medication
* inability to perform the cognitive testing
* major cerebrovascular disease
* inability to give an informed consent (patients with protective measures)
Ipsilateral and Contralateral Index for the Interpretation of Adrenal Vein Sampling (AVS) in Primary Aldosteronism

Adrenal vein sampling (AVS) is currently considered the gold standard for subtype diagnosis of primary aldosteronism (PA). However, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, and there is no general consensus on the criteria that should be used for the interpretation of the results of an AVS study in these specific cases.

The differentiation between subtypes of primary aldosteronism (PA) is fundamental to refer each patient to the most appropriate therapeutic approach (surgical in case of unilateral disease and medical in case of bilateral disease). Adrenal vein sampling (AVS) is currently considered the gold standard for such differentiation between subtypes.

However, despite significant progress in optimizing the AVS procedure, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, especially in less experienced centers.

It would therefore be important to identify criteria for the interpretation of the results of a suboptimal AVS study (i.e. with sampling of only one of the two adrenal veins). This problem has recently been addressed by some groups; however, there is still no general consensus on these criteria and all existing studies must be considered exploratory in this field.

In this study, therefore, all patients with PA followed by our center and who underwent a successful (i.e. with correct cannulation and sampling from both adrenal veins) unstimulated (i.e. without cosyntropin stimulation) AVS procedure will be retrospectively evaluated.

If a reliable unilateral index could be identified for subtype diagnosis, this tool could be used for the interpretation of suboptimal AVS data, thus preventing a certain percentage of patients from the necessity to repeat the procedure and allowing to refer each one, also on the basis of an incomplete dataset, to the most appropriate therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Diagnosis of Primary Aldosteronism
* Execution of Adrenal Vein Sampling (AVS) for Subtype Diagnosis

Exclusion Criteria:

* Execution of AVS in stimulated condition (i.e. with cosyntropin stimulation)
* Inability to achieve successful catheterization of one or both adrenal veins during AVS (as established by adrenal/peripheral vein cortisol ratio)
Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension

This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* ocular hypertension or glaucoma in both eyes
* currently treated with brimonidine
* requires IOP-lowering therapy in both eyes

Exclusion Criteria:

* uncontrolled systemic disease
* known allergy or sensitivity to brimonidine
Spinal Cord Stimulation for Chronic and Intractable Back Pain

The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery or who have chosen to seek alternative therapy.

Management of symptoms of chronic back pain and/or lumbar radiculopathy is often difficult and inadequate. Current treatment options include pharmacological treatments, physical therapy, nerve blocks, surgical interruption of the pain pathway, or back surgery. Many patients either do not have adequate pain management with conventional treatments or are not able to tolerate the treatments due to significant side effects. Similarly, many patients are either not candidates for surgical interventions, or are unwilling to undergo such procedures. Spinal cord stimulation has proven to be an effective treatment for patients with pain following a failed back surgery, and this study will investigate spinal cord stimulation as a treatment option for the treatment of chronic back pain in patients who have never had back surgery. A successful study outcome will establish spinal cord stimulation as a less-invasive treatment option to be considered prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment.
* Be 18 years of age or older.
* Be an appropriate candidate for the surgical procedures required for SCS implant.
* Be willing and able to comply with all study related procedures and visits.
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

* Have had any back or spine surgery.
* Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery.
* Have any other chronic pain conditions likely to confound evaluation of study endpoints.
* Are a current substance abuser (including alcohol and illicit drugs).
* Have a significant psychiatric disorder.
* Have a condition currently requiring or likely to require the use of MRI or diathermy.
* Have an active implantable device.
* Are pregnant or lactating or planning to become pregnant in the next year.
* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* COPD
* Asthma
* Smoking Pregnancy
Immune Microenvironment and Gene Expression Profiling in Mesothelioma

Pleural and peritoneal mesotheliomas (PPM) are rare cancers mostly related to asbestos-exposure, which are characterized by a complex histopathological diagnosis and staging, few therapeutic options and a dismal prognosis. The main unmet medical need in PPM is the lack of a treatment sequence for affected patients. The advent of immune checkpoint inhibitors has changed the first line treatment of PPM, thanks to the improvement in survival achieved by the combination of ipilimumab and nivolumab that are currently approved for non-epithelioid histology in our Country.

PPM is characterized by a large heterogeneity of the genomic landscape, which is mainly characterized by the loss of tumour suppressor genes and mutations in DNA repair genes and by an "altered- suppressed" or "excluded" tumor immune microenvironment (TIME).

The goal of this project is to improve the immune-biological and molecular stratification of PPM subgroups that can lead to the identification of different personalized treatment approaches. PPM patients (N=220) will be retrospectively (N=150) and prospectively (N=70) recruited from the coordinator center and 6 participating Italian centers. Treatment-naïve tumor samples will be collected and analyzed by bulk gene expression and spatial whole transcriptome analysis, and by 9-color multiplex immunofluorescence.

New targets or actionable pathways potentially emerging from such studies will be finally assessed and validated in patient-derived organoids/xenografts that accurately reflect PPM tumorigenesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Mesothelioma of the Pleura and Peritoneum
* Age greater than 18 years of age
* Patients undergoing surgery will require both biopsy and surgical sampling material
* Pathologist's confirmation of the presence of tumor sections in the excised specimens
* Patients in follow-up from active cancer treatment for at least 6 months

Exclusion Criteria:

* Inadequacy of biological material for analysis under study
* Patients not amenable to active oncologic treatment
* Patients lost to follow-up before 6 months after the end of active oncologic treatment
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.

This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with acromegaly
* Confirmed diagnosis of a growth hormone-secreting tumor
* Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening
* Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 \< 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL

Exclusion Criteria:

* Patients with pituitary surgery less than 3 months prior to screening
* Uncontrolled diabetes defined as having a fasting glucose \> 150 mg/dl and HbA1c \>= 9%
* Symptomatic cholelithiasis
* Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial
* Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening