cyrilzakka/clinical-trials huggingface dataset:
Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

During spinal anesthesia, sedation is performed using intravenous sedative for the patient's comfort and appropriate surgical environment. However, side effects of medications such as respiratory depression, hypotension, bradycardia and desaturation cannot be avoided. Recently, there have been developed a virtual reality experience equipment and a variety of virtual reality programs including visuo-haptic computer technology. There have been clinical studies that apply this technology to the pain medicine, sedation and medical education. However, no study has been reported for the purpose of replacing sedation during spinal anesthesia.

Therefore, we attempt to evaluate the efficacy and safety of sedation using virtual reality meditation program during spinal anesthesia for urologic surgery.

During spinal anesthesia, sedation is performed using intravenous sedative for the patient's comfort and appropriate surgical environment. However, side effects of medications such as respiratory depression, hypotension, bradycardia and desaturation cannot be avoided. Recently, there have been developed a virtual reality experience equipment and a variety of virtual reality programs including visuo-haptic computer technology. There have been clinical studies that apply this technology to the pain medicine, sedation and medical education. However, no study has been reported for the purpose of replacing sedation during spinal anesthesia.

Therefore, we attempt to evaluate the efficacy and safety of sedation using virtual reality meditation program during spinal anesthesia for urologic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing spinal anesthesia for urologic surgeries including Holmium Laser Enucleation of the Prostate or TransUrethral Resection of Bladder tumor).
* American Society of Anesthesiologists physical status classification 1, 2 or 3.
* Patients who voluntarily decides to participate in the trial and has given informed consent to this trial

Exclusion Criteria:

* History of chronic use of sedative, narcotics, alcohol or drug abuse
* Baseline oxygen saturation \< 90%
* Baseline hemodynamic or respiratory instability (initial systolic blood pressure \< 80 mmHg, respiratory rate \> 25 breaths/min or \< 10 breaths/min)
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons.

Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial.

In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as "open" proximal pancreatoduodenectomy (OPD).

Eligibility Criteria:
Inclusion Criteria:

* Age: 21-75 years
* Clinically/histologically established diagnosis of the cancer;
* Preoperative imaging assessment is resectable or borderline resectable

Exclusion Criteria:

* Benign tumors of the head of pancreas;
* Distant metastasis;
* Conversion to laparotomy;
* Instrumental findings of the tumor process prevalence;
* General somatic status on the ASA III-V scale;
* Acute pancreatitis;
* Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)).
* Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection
New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study

Alzheimer's disease (AD) is the most common neurodegenerative disorder afflicting the elderly. Currently, some biochemical tests performed on Cerebrospinal Fluid (CSF) samples have demonstrated to discriminate to some extend between AD and non-AD individuals based on the levels of tau, phospho-tau or Aβ42. We aim to investigate newly identified proteins whose levels increase during the Braak Stages of AD that are accessible in other body fluids such as blood, urine or saliva. The detection of these proteins would allow performing simple tests in case its levels were confirmed to be associated with the AD pathology.

We do not desire to provide a more extensive description

Eligibility Criteria:
Inclusion Criteria:

- mild to moderate AD

Exclusion Criteria:

-
CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)

The purpose of this study is to evaluate the safety and pharmacodynamic of CORETOX® in the treatment of post-stroke upper limb spasticity


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 19 years

  * 6 months since the last stroke
  * 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
* Informed consent has been obtained

Exclusion Criteria:

* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
* History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
* History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
* Fixed joint/muscle contracture
* Severe atrophy
* Concurrent treatment with an intrathecal baclofen
* Patients who have bleeding tendency or taking anti-coagulant
* Dysphagia and Breathing Difficulties
* History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
* Known allergy or sensitivity to study medication or its components
* Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
* Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study.
* Patient who are participating in other clinical trials at the screening
* Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception.
* Patients who are not eligible for this study at the discretion of the investigator.
Mass Closure vs Layer by Layer Closure

to assess two different ways of closure of laparotomy in children and infants

Introduction:

The technique of abdominal wall closure in infants subjected to abdominal transverse laparotomy incision may have an impact not only on the development of a future incisional hernia but also on the function of the anterior abdominal wall muscles.

There are two ways to close this laparotomy incision. These ways are either closure in mass or layer by layer closure. Neither of them is superior to the other.

The main issue that minds the pediatric surgeons is a safe and successful repair of the abdominal wall incision and the avoidance of the development of incisional hernia.

The aim of this work is to randomly compare the two different techniques of the closure of transverse laparotomy incision.

Patients and methods:

- Study design: The study was performed during the period from January 2020 to October 2024. It is a randomized control trial.

Inclusion criteria were infants younger than 3 years. We excluded infants with history of prematurity, previous abdominal operations and infants with congenital abdominal wall defects.

An informed consent was obtained from the parents or the care giver of every participant.

Randomization was obtained using closed envelop method. Patients were categorized into two groups A and B. Group A included patients that their exploratory wound was closed with mass closure method using Vicryl® 2/0 round needle. Group B included patients that their exploratory wound was closed layer by layer using the same suture material.

In both groups the ratio of the suture length to the wound was 3 to 1. - The measured variables: The variables that were addressed were

1. the mean operative time in minutes,
2. the incidence of wound dehiscence,
3. the occurrence of wound infection,
4. The development of an incisional hernia
5. Long term assessment of both abdominal wall structure and dynamics of abdominal muscles at the site of incision.

   * Follow up protocol:

All patients were scheduled on a follow up regimen. They were examined weekly for one month post-operative. Then monthly for one year. The anterior abdominal wall of these patients was examined by ultrasound at the 6th and 12th moth postoperatively. This helped assessment of the dynamics and structure of the muscles at the site of the incision.

- Statistical analysis: Statistical analysis was conducted using SPSS ™ statistical package ver. 21 (IBM SPSS, NY, USA). Numerical data were compared using an independent sample t-test, whereas categorical data were compared using the chi-square test. Statistical significance was set at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* all infants and children with transverse laparotomy

Exclusion Criteria:

* previous abdominal operations
* children and infants with congenital abdominal wall defects
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma

To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yo.
* Primary pigmented or amelanotic choroidal melanoma measurement of 16 mm or less in the largest vessel diameter and 6 mm or less in the apical height.
* Location of the tumor posterior to the equator.
* Documented growth by A/B scan.
* Risk factor for metastasis (thickness greater than 2 mm, symptoms, tumor margin at the optic disc)
* Ability to provide inform consent.
* Comply with the study assessment for the cooperation of the study.

Exclusion Criteria:

* Pregnancy or lactation.
* Premenopausal women not using adequate contraception; surgical sterilization or use of oral contraception, barrier contraception with either a condom or diaphragm or in conjunction with spermicidal gel, an IUD or contraceptive hormon implant or patch.
* Current infection or inflammation in either eye.
* Extension of tumor into the orbit.
* Retinal spread or metastatic disease.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Any known allergy to any of the components to be used in the study.
* Participation in another simultaneous medical investigation or trial.
Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Radiofrequency Stimulation in a Sporty Population.

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers and sport populations. Many factors have been proposed as the cause of pain, however there are no studies analysing possibilities of preventing shoulder injuries by using a radiofrequency stimulus.

The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.

The stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular, long thoracic or pectoralis nerves) and the thoracic region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50 years
* Sporty people with at least 3 days of training per week and presenting an upper limb dominance.

Exclusion Criteria:

* Suffer from any painful shoulder condition.
* History of significant shoulder trauma, such as fracture or ultrasonography
* Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.
* Recent shoulder dislocation in the past two years
Axial Ablation Versus Terminal Interruption of the Reflux Source

This randomised trial aims to compare the effect on ulcer healing of different means of managing venous reflux in the lower limb. It is a non-inferiority trial comparing endovenous ablation of the axial (Saphenous and other large veins) veins of the lowere limb, versus terminal interruption of the reflux source (TIRS). For the purposes of this trial TIRS will be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of the ulcer being treated.


Eligibility Criteria:
Inclusion Criteria

Primary or recurrent venous leg ulcer

Long or short saphenous vein reflux confirmed on ultrasound assessment, defined as retrograde flow lasting for \>0.5 seconds

Ankle-Brachial pressure Index (ABI) ≥ 0.8 (if ulceration prevents ABI Toe-Brachial Index(TBI) ≥ 0.5 acceptable), or a palpable pulse

Ulcer size between 1 and 200 cm2

Patient suitable for full compression bandaging

Exclusion criteria Pregnancy (or breastfeeding and needing to feed within 48 hours of treatment)

Active infection of ulcer, or infection within the last two weeks

Leg ulcer of non-venous aetiology as determined by clinical assessment

Isolated perforator vein reflux only

Evidence of deep venous insufficiency or thrombosis

Known hypersensitivity to Sotradecol or similar sclerosants

Previous inability to tolerate compression bandages

Presence of any contraindications for the use of compression bandages:

Absence of a palpable pulse, and Ankle Brachial Index (ABI) \<0.8

Decompensated congestive cardiac failure (NYHA Class IV)

Known hypersensitivity to any of the component materials

Patients unable to provide informed consent

Patients attending the leg ulcer clinic already will be excluded from enrolment with the same ulcer but will be eligible to enrol with a contralateral ulcer. Recurrent ipsilateral ulcers will not be excluded.
Methylphenidate in the Treatment of Cocaine Dependent Patients With Adult Attention Deficit Hyperactivity Disorder - 5

The purpose of this study is the use of Methylphenidate in the treatment of cocaine dependence and Attention Deficit Hyperactivity Disorder (ADHD) comorbidity.

The objective of this study is to determine the safety and efficacy of methylphenidate in a population of patients who are cocaine dependent and suffer from attention deficit hyperactivity disorder.

Eligibility Criteria:
Inclusion Criteria:

Cocaine-dependent. Meets the DSM-IV criteria for ADHD. Actively using cocaine within the past 30 days of screening.

Exclusion Criteria:

Symptoms of AIDS. Significant medical disorder. DSM-IV criteria for any substance other than cocaine, alcohol, nicotine, marijuana, caffeine. Requires detoxification from ETOH or benzos. History of seizures.
The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

The purpose of this study is to determine whether Intensity-modulated radiation therapy (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin and paclitaxel) is feasible and effective than current standard treatment for high-risk locally advanced NPC patients.

Meta-analysis showed chemotherapy when combined with conventional radiotherapy in locally advanced naso-pharyngeal carcinoma can improve 5-year overall survival with 6%, and beyond all concurrent chemotherapy with cisplatin benefits most. However, from Lin's (Lin JC, 2004) study, locally advanced NPC with high risk factors can not benefit from conventional concurrent chemoradiation. Failure pattern analysis revealed that local and distant failure accounted for 50% respectively. Large-scale data has demonstrated that with IMRT, local control can achieve 90%. Previous studies showed inductive chemotherapy can decrease distant metastasis. We need more effective and stronger chemotherapy, and we still need to testify concurrent chemotherapy combined with inductive chemotherapy.

A prospective trial would thus provide valuable information to help physicians and patients more precisely identify the feasibility and effectiveness of inductive + concurrent chemotherapy combined with IMRT for high-risk locally advanced NPC.

Eligibility Criteria:
Inclusion Criteria:

* biopsy-proved NPC
* N3 or T4N2 or multiple lymphnodes involved with at least one mass 4 cm or more in maximal diameter according to 7th UICC Staging
* provide written informed consent
* Kps\>70
* no dostant metastasis
* Life expectancy≥6 months
* Adequate renal function, defined as follows: Serum creatinine \< 2 x institutional upper limitof normal(ULN) within 2 weeks prior to registration or; creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CCrmale)
* The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin.

Exclusion Criteria:

* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Severe, active co-morbidity
Exocrine Pancreatic Function Testing in Cystic Fibrosis

Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit.

Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis.

New functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase.

MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.

Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients.

Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients.

Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.

Study design: Observational, cohort studies.

Patient characterization: Age, gender, and Genetic status from electronical records.

Exocrine function testing (EPF): Secretin stimulated ultrasound and short endoscopic secretin test (EST). Faecal Elastase.

Imaging: Transabdominal ultrasound of the liver and pancreas. secretin stimulated MRI. Contrast enhanced ultrasound (CEUS) of the pancreas using SonoVue contrast.

Endpoints:

Study 1: Exocrine pancreatic function by duodenal bicarbonate/ Enzymes related to Genetics and F elastase.

Study 2: Ultrasound parenchymal changes of the pancreas related to Genetics and EPF.

Study 3/4: Pancreatic secretion by ultrasound, MRI and EST related to EPF Study 5; Perfusion of the pancreas by CEUS related to EPF

Study 6: Genotype-phenotype conciderations of the CF pancreas.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis cystic fibrosis. Age over 15 years. Assigned to routine control at department of lung diseases, Haukeland university hospital.

Exclusion Criteria:

* Unable to concent, allergies to Sonovue ultrasound contrast, pregnant or breastfeeding, contraindications against endoscopy.
Latent Tuberculosis in Type 2 Diabetes

The patients with poorly controlled DM underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.

Poor control of diabetes mellitus (DM) increases active tuberculosis (TB) risk. Understanding risk factors for latent TB infection (LTBI) in this population is crucial for policy making. Under a collaborative multidisciplinary team consisting of endocrinologists and pulmonologists, patients with poorly controlled DM were enrolled; these patients underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥45 years
* poorly controlled DM (pDM), defined as HbA1c ≥9% within the preceding year

Exclusion Criteria:

* active TB
* immunocompromise (use of immunosuppressors
* current pregnancy