cyrilzakka/clinical-trials huggingface dataset:
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

Preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. Gene expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The expression of PGP9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of PGP9.5. These data will be correlated to stage evaluation (TNM) and survival.


Eligibility Criteria:
Inclusion Criteria:

* Fifteen patients evaluated- or treated for suspected or verified gastric adenocarcinoma at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital
* informed consent

Exclusion Criteria:

* General contraindications for endoscopy with biopsies (i.e. bleeding disorders or use of anticoagulants).
A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed NMOSD patients;
2. Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
3. The blood pregnancy tests were negative within 7 days before the first dose in fertile female subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;
4. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures.

Exclusion Criteria:

1. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
2. Subjects with chronic active immune system diseases undergoing systematic treatment;
3. Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
4. Received the prescribed drug treatment at the prescribed time before first dose;
5. Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
6. Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
7. Pregnant or lactating women; Subjects with birth plans during the trial;
8. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
9. Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
10. A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period;
12. Subjects with severe or persistent infection currently or within the 1 months prior to screening;
13. Subjects with positive gamma interferon release test;
14. Subjects who currently have active hepatitis or have a history of severe liver disease;
15. Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
16. Abnormal laboratory test results;
17. Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
18. Subjects with symptoms of severe mental illness who are clinically uncooperative;
19. Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.
Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm

Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm.

Secondary To investigate the impact of peripheral preconditioning on perioperative inflammatory response.

To investigate whether peripheral preconditoning can protect against perioperative myocardial infarction and reduced cardiac pump function.


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years, hospitalized for elective surgery of abdominal aortic aneurysm

Exclusion Criteria:

* Lack of informed consent.
* Hemiparetic patient.
* Pregnancy or nursing patient.
Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.

The study aims to mimic the treatment Danish patients receive when admitted to the hospital with a ST-elevation myocardial infarction since these patients are refereed to acute Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic inhibition.

Current guidelines recommend the administration of Efient right before the PCI procedure, while the patient is lying down, either in the ambulance or in the operating room. We, the investigators, believe that this is suboptimal for the patient, since any sort of prolonged inhibition time will possibly worsen the patients prognosis and make the patient more prone to later clotting issues.

Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright position and making them sit up for 2 minutes after ingestion, the effect of the pills will commence faster than if taken in a supine position. This will possibly lead to faster inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting issues during and after the procedure.

The study will be divided into two sessions: first session will be the control arm- ingestion of Efient in supine position.

14 days later, the same test-persons will be doing the intervention- ingestion of Efient sitting upright for 2 minutes. Besides this, the second session will be exactly the same as the control arm.

Eligibility Criteria:
Inclusion Criteria:

* 20-30 years of age
* Healthy
* Male
* Ability to give informed consent
* Non-Smoker

Exclusion Criteria:

* Known with reflux or dysphagia
* Ingestion of medicine, beside Paracetamol \<14 prior to the trial
* Hematological diseases
* Diabetes
* Known kidney disease
* Known liver disease
* Recent trauma
* Scheduled operation within 7 days after the trial
* Former apoplexia
* Known gastro-intestinal disease
* Weight \<60 kg
Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults

The aim of the present randomized controlled clinical trial will compare Insignia orthodontic treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment by measuring the treatment duration in both groups. The secondary objectives will be to compare periodontal health, alveolar crest changes, bone and gingival healing, analgesic intake and patient-centered outcomes between the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring maxillary and mandible orthodontic treatment (both arches)
* Adult patients with completed growth based on the cervical vertebral maturation method as described by Baccetti et al. (Baccetti et al. 2002)
* Minimal to moderate maxillary and mandibular anterior crowding at baseline (irregularity index \<6;(Little 1975));
* American Society of Anesthesiology I or II (I = nor- mal healthy patient; II = patient with mild systemic disease);
* Adequate dento-oral health (i.e., the absence of periodontal diseases, periapical infection, or untreated caries).

Exclusion Criteria:

* controlled periodontitis with a loss of alveolar support \>10%
* gingival recession \>2 mm
* smokers
* altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use)
* mental or motor disabilities; and 6) pregnancy.
This Research Project Studies the Relationship Between OSA and Nocturia.

The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.

The observation study will be performed on patients diagnosed with obstructive sleep apnoea. Patients will undergo routine examination for sleep apnoea and will be asked to fill in voiding diaries for 48 hours. The main goal of the study is to find whether there are any parameters of sleep apnoea associated with occurrence of the nocturia.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed obstructive sleep apnoea (OSA )
* Apnea-Hypopnea Index (AHI) \> 15
* ability to fill in the voiding diaries
* signed informed consent

Exclusion Criteria:

* patients using diuretics
* patients with malignancies
* pregnancy
Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

The major goal of this project is to determine whether the use of physiologic doses of corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and alters microcirculatory flow in post-cardiac arrest patients.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old
* Either pre-hospital cardiac arrest and ROSC or Inpatient Cardiac Arrest with resultant ROSC
* Vasopressor dependent for a minimum of 1 hour post-arrest

Exclusion Criteria:

* Pregnant
* Indication for Corticosteroids outside of current research proposal
* DNR or comfort care measures
* Presence of septic shock
* Chronic Use (\>1week) of oral Corticosteroids in the last year
Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA

Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA.

Fifty patients with any severity of OSA will be recruited according to the indications for oral appliance therapy in the practice parameters of the American Academy of Sleep Medicine (AASM)2006.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years with OSA
* AHI \> 5
* Refused CPAP therapy

Exclusion Criteria:

* Poor oral hygiene
* Untreated TMD
* Inadequate healthy teeth (\< 6)
* Severe or unstable medical problems.
Complications of Transurethral Resection of the Bladder Tumour

This is a prospective study enrolling consecutive patients who undergo transurethral resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure. Study end-points are incidence, severity and predictive factors of surgical complications. The study secondary aim is a validation of Clavien Dindo scoring system for reporting complication of TURBT.


Eligibility Criteria:
Inclusion Criteria:

* primary or recurrent bladder tumour
* informed consent to undergo the surgery

Exclusion Criteria:

* age \<18 years
Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia

Index computed in real time from Auditory Evoked Potentials have been described parallel to depth of anesthesia. The goal of the study was to compare general anesthesia guided on Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I : AEP guided anesthesia, Group II: Blind AEP record, standard practice.


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-II patients
* aged 18 - 65 years
* scheduled for general surgery (except laparoscopic interventions) lasting longer than 1 hour.

Exclusion Criteria:

* Body weight \< 70% or \> 150% ideal body weight
* neurological disorder and hearing disorders (being not able to communicate with the patient in a normal tone)
* use of any medication interfering with pharmacological effect of the study including alcohol misuse or drugs.
Compassion-Based Intervention for Lung Cancer Caregivers (CBI-LCC)

Objectives: This 3-year study aims to develop, refine, and evaluate a brief compassion-based intervention specifically designed for family caregivers of lung cancer patients. In the first year, the primary focus will be on developing the intervention content and assessing its feasibility and acceptability. In the second and third years, the goal will be to assess the intervention's effects on depression and anxiety.

Method: In the first year, the intervention will be developed in three stages. Initially, the intervention will be created based on compassion-focused theory and evidence-based exercises, incorporating feedback from family caregivers in previous studies and insights from professionals to ensure its relevance to lung cancer caregivers. Next, a pilot study will test the intervention's feasibility and acceptability with 30 family caregivers, using mixed methods to gather session-by-session feedback and assess recruitment, retention, and adherence. Following the pilot, the intervention will be revised based on participant and researcher feedback, preparing it for further study. In the second and third years, a randomized controlled trial (RCT) will be conducted with 84 participants randomly assigned to either the 4-session Brief Compassion-Based Intervention (BCI) or a single-session Telephone-Based Support and Education (TSE) control group. Outcomes, including depression, anxiety, caregiver stress, mindfulness, self-compassion, and self-efficacy, will be measured at baseline, immediately post-intervention, and at 3- and 6-month follow-ups. For data analysis, long-term follow-up quantitative data will be analyzed using the Generalized Estimating Equation (GEE) to examine group differences. Moderation and mediation analyses will be conducted to explore potential moderators and mechanisms of the intervention. Qualitative data from interviews will be analyzed using content analysis.

Expected Results: This study is expected to provide a comprehensive understanding of the feasibility, acceptability, and effectiveness of compassion-based interventions for lung cancer caregivers, contributing to their application in clinical care practice.


Eligibility Criteria:
Inclusion Criteria:

* Primary family caregiver of a person with newly diagnosed lung cancer (within one year of diagnosis)
* Aged 20 years or older
* Access to a computer or smartphone with internet connection at home

Exclusion Criteria:

* Currently receiving psychological therapy
* Diagnosed with a severe mental illness and taking medication for it (e.g.,psychosis, bipolar disorder)
* Previous experience with mindfulness or self-compassion training
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for attention deficit hyperactivity disorder
* Have voluntarily signed an informed consent form
* Are between 18 and 60 years of age
* Will use contraceptive methods during the study
* Women must not be pregnant or breast-feeding
* Must be in generally good health
* Are fluent in English

Exclusion Criteria:

* They have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation
* They have a current diagnosis of major depressive episode, generalized anxiety disorder (GAD), or post-traumatic stress disorder (PTSD) or have a clinically significant sleep disorder requiring treatment
* They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers
* They failed to respond to two or more adequate trials of FDA-approved ADHD medication
* They have violent, homicidal or suicidal ideation
* They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome or a central nervous system (CNS) disease, excluding ADHD
* They have a urine drug screen that is positive for alcohol or drugs of abuse
* They have a history of substance or alcohol disorder (abuse/dependence) during the last 3 months
Lidocaine Gel 2% and Muscle Traction Pain During Squint Surgery in Pediatrics

Assessing the efficacy of lidocaine gel 2% application 10 minutes before surgery on post operative pain and the use of analgesics postoperatively

After inhalational induction of anesthesia and applying the pulse oximeter to the patient's finger but and before cannulating or managing the patient's airway lidocaine gel 2% is efficiently applied to the surgical eye (to give more time for the gel to act without delaying the surgery) then cannulation and laryngeal mask inserted to maintain ventilation properly.

Applying lidocaine gel 2% should be filling the upper and lower 10 minute fornices before disinfecting the eye and starting the surgery

The primary outcome is assessing postoperative pain and need for postoperative systemic analgesia The secondary outcome is to monitor the oculocardiac reflex intraoperatively and the need for intraoperative atropine.

Eligibility Criteria:
Inclusion Criteria:

* age 3 to 12 years
* squint surgery

Exclusion Criteria:

* below 2 years or more than 13
Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain

Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain during labor or following a caesarean section. The perineal pain associated with the realization of an episiotomy has been much less studied and often undervalued.

Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during laparoscopy). This product has the advantage of being well tolerated, easy access and administration. Three recent studies compared the post-episiotomy analgesic efficacy of local ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of these studies showed statistically significant results. However, they focused on the results at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.


Eligibility Criteria:
Inclusion Criteria:

* Major Patient (≥ 18 years)
* Term ≥ 37 weeks of amenorrhea
* Right medio-lateral episiotomy performed for medical need
* Delivery of a single fetus in a cephalic presentation with or without instrumental extraction
* Delivery under epidural anesthesia
* Patient to be monitored over 6 months of study
* Patient in ability to understand protocol
* Patient having given consent and signed informed consent
* Patient with social coverage

Exclusion Criteria:

* Hypersensitivity or known allergy to Ropivacaine or to other amide-linked local anesthetics or to any of the excipients
* General contraindication specific to local anesthesia, irrespective of the local anesthetic used
* Contraindication for Ropivacaine- Obstetric paracervical anesthesia
* Hypovolemia
* Weight \<50 kg
* Contra-indication or refusal of the epidural
* Poor understanding of the French language
* Substance addiction.
* Chronic pain syndrome.
* Severe hepatic or renal impairment.
* Acute porphyria.
* Caesarean section programmed.
* Tear of the 3rd degree according to the associated French classification.
* Refusal to participate in the study
* Patient under tutelage, curatorship, or deprived of liberty
Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases

Multiplex respiratory polymerase chain reaction (PCR) test has gained wide acceptance as an alternative to conventional culture methods for the detection of the causative agent of community-acquired pneumonia (CAP). The aim of this study is to evaluate the positivity and to determine the causative agent of CAP using multiplex respiratory PCR test in patients with diabetes mellitus.

A total of 151 adults diagnosed with CAP were enrolled. Group 1 composed of patients who had diabetes (n=42) and group 2 consisted of patients who did not have diabetes (n=109). Demographic and clinical data of the subjects were collected and compared statistically.

The multiplex respiratory PCR test positivity of group 1 was statistically higher than group 2 (p=0.004). The most identified nasopharyngeal pathogen was SARSCoV2 in group 1, whereas in group 2, the most prevalent agent was Streptococcus pneumoniae (p=0.002, p=0.628). Furthermore, the amount of procalcitonin, CRP, neutrophil counts and the ratio of neutrophil-to-lymphocyte ratio (NLR) and CRP-to-lymphocyte (CLR) ratio on admission were statistically higher in group 1 than groups 2 (p=0.012, p=0.002, p\<\<0.001, p=0.001, p=0.001).

Diabetic patients are at greater risk for developing CAP. Therefore, early detection and prompt treatment is crucial for diabetic patients with CAP to avoid morbidity and mortality. Multiplex respiratory PCR test is an important method for identifying the causative agent of CAP rapidly.

Eligibility Criteria:
Inclusion Criteria:

In this study, a population of 190 people over the age of 18 were searched in terms of suitability for this work , who diagnosed with CAP after admission to the Department of Chest Diseases by using a multiplex respiratory PCR test.

Exclusion Criteria:

Subjects who had an infection other than pneumonia, and had a diagnosis of malignancy, transferred to intensive care unit and pregnant women were excluded.