cyrilzakka/clinical-trials huggingface dataset:
Multidimensional Examination of Patients with Colorectal and Anal Cancer

The aim of our cross-sectional research is to assess changes in physical activity, functional capacity, and health status in individuals with colorectal and anal carcinoma using subjective measurement tools, with particular focus on those suffering from incontinence, through a cross-sectional study. Additionally, the research involves the Hungarian adaptation and validation of the quality of life questionnaire for colorectal cancer (EORTC QLQ-CR29), quality of life questionnaire for anal cancer (EORTC QLQ-AN27), and Fecal Incontinence Severity Index (FISI)" questionnaires.

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide. The incidence of CRC is known to be high in developed countries and increases with socioeconomic development. Well-known risk factors include aging, alcohol consumption, smoking, and obesity. In addition to family history, lifestyle changes in diet, occupation, or physical activity may also emerge as risk factors for CRC. Previous research findings have shown a significant association between reduced physical activity and an increased risk of CRC. With improved patient survival rates, functional outcomes such as fecal incontinence, urinary, and sexual dysfunction are becoming increasingly important, as they are known to significantly impact quality of life (QoL). Reviewing the functional outcomes of rectal cancer surgeries, it is observed that even years after surgery, one-third of patients suffer from fecal incontinence. In contrast, studies on the functional outcomes following colon cancer surgeries are rare and often involve relatively small study populations. Previous studies have shown that physical activity in cancer survivors can have numerous beneficial health effects and is associated with a reduced risk of cancer recurrence and mortality in cases of colon and rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* adult (18-80 years) patients with a diagnosis of colorectal or anal carcinoma

Exclusion Criteria:

* Neuromuscular diseases
* severe congenital musculoskeletal and other disorders,
* severe psychiatric illness, lack of cooperation,
* undergone other surgical procedures within the past year.
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam

The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* Written and signed or thumb-printed informed consent obtained from the parent(s)/LAR of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Acute disease and/or fever at the time of enrolment.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
* Hypersensitivity to latex.
* Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
Opioid-Free Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series

Cranio-cervical instability (CCI) has been well identified in diseases regarding connective tissue, such as Ehlers-Danlos Syndrome/Hipermobility Type (EDS-HT). These patients frequently suffer from severe widespread pain with very difficult management and control. Chronic neuroinflamation, opioid-induced hyperalgesia, and central sensitization phenomena may explain this complex painful condition. A retrospective, observational, consecutive case series study is designed to determine if opioid-free anesthetic management shows a reduction in postoperative pain and opioid rescues needs in comparison with opioid-based anesthesia management for patients with EDS-HT undergoing crano-cervical fixation.

Cranio-cervical instability (CCI) has been well identified in diseases regarding connective tissue, such as Ehlers-Danlos Syndrome/Hipermobility Type (EDS-HT). These patients frequently suffer from severe widespread pain with very difficult management and control. Chronic neuroinflamation, opioid-induced hyperalgesia, and central sensitization phenomena may explain this complex painful condition. A retrospective, observational, consecutive case series study is designed to determine if opioid-free anesthetic management shows a reduction in postoperative pain and opioid rescues needs in comparison with opioid-based anesthesia management for patients with EDS-HT undergoing craneo-cervical fixation.

Main Aim: To determine if the administration of opioid-free anesthesia with propofol, lidocaine, ketamine, and dexmedetomidine shows reduction of postoperative pain, and postoperative needs of opioids rescue in patients undergoing CCF.

Secondary Aims:

* To determine if the administration of opioid-free anesthesia in patients undergoing CCF, and postoperative Lidocaine, Ketamine, and Dexmedetomidine infusions can reduce the preoperative needs of opioids treatment at discharge time.
* To determine if the administration of opioid-free anesthesia in patients undergoing CCF reduces the postoperative gastrointestinal complications.
* To determine if the administration of postoperative Lidocaine, Ketamine, and Dexmedetomidine infusions in patients underwent CCF can reduce the preoperative needs of postoperative anxiolytic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Hypermobility Syndrome undergoing Craneo-cervical fixation (CCF)
* Patients between 18-60 years.
* Patients enrolled in CCF surgery between September 2018 to March 2020 to get stabilized craneo-cervical instability (CCI).
* Patients under opioid-based total intravenous anesthesia or opioid-free total intravenous anesthesia with lidocaine, ketamine and dexmedetomidine (LKD).

Exclusion Criteria:

* CCF to stabilized post-traumatic or oncologic CCI.
* Lidocaine allergy.
* Advances heart-block.
* Epilepsy or convulsive syndrome non-medicated.
Postural Instability in Progressive Supranuclear Palsy

The purpose of this study is to better understand why individuals with Progressive Supranuclear Palsy (PSP) fall. Understanding the mechanism of gait and balance dysfunction in individuals with PSP may provide us with important early diagnostic tools, allowing for earlier identification of mobility problems and to better evaluate medical therapies aimed at improving motor disability.

The investigators will recruit 10 PSP, 10 PD and 10 healthy controls for the study. All subjects will be asked to come to the OHSU clinic at the Center for Health and Healing for an initial screening visit. They will meet with the primary investigator to conduct a brief interview and physical examination. In addition, they will be asked to answer questions regarding current and past medical illness, how often they fall and what kinds of medications they are on.

Subjects who agree to participate will come to the Oregon Clinical and Translational Research Institute (OCTRI) at OHSU for balance testing. Subjects will be asked to stand or sit on a movable platform with eyes open or closed. Prior to standing on the platform, the investigators will place 6 small sensors on body which are held in place by velcro straps (one on each wrist, ankles, chest and lower back). The platform will then be moved (tilt or slide) while subjects try to keep their balance. During all of the balance tests described above, body movements will be recorded from the sensors on the subjects' body. This data is directly recorded by a computer and analyzed to help us gain better understanding of the subjects' posture and their ability to remain up right.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of probable or possible PSP as defined by the National Institute of Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy (NINDS-SPSP) diagnostic criteria.
2. Be able to ambulate and stand unassisted for 5 minutes
3. Be able to cooperate with gait and balance testing
4. Be able to give informed consent.

Exclusion Criteria:

1. Cannot exhibit behavior or have dementia that precludes participation in the protocol
2. Cannot have medical or orthopedic illness that, in the investigator's opinion, would impact the patient's postural control or ability to participate in the study.
Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis

The purpose of this study is to determine whether a home-based cycling program for patients with lumbar spinal stenosis is a feasible and acceptable

Lumbar spinal stenosis is a prevalent and disabling condition in elderly individuals. Lumbar spinal stenosis results in lumbar and/or radicular leg pain when standing and walking, while symptoms regress in lumbar flexion positions and at rest. The inability to stand or walk impairs functioning and health-related quality of life of elders, and has an important healthcare cost. The 2 main treatment options for lumbar spinal stenosis are conservative or surgical. Laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option to avoid or delay surgery. Data regarding exercise therapy are scarce. Lumbar-flexion-based exercises are usually recommended. A pilot study suggested that lumbar-flexion-based endurance training, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly patients with chronic low back pain but barriers to adhering to the program were detected. Investigators aim to assess barriers and facilitators to a 3-month home-based cycling program in lumbar spinal stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilment of International Society for the Study of Lumbar Spine clinical diagnosis criteria for lumbar spinal stenosis with the presence of at least 6 out of the 7 following criteria: "pain in the buttocks or legs while walking"; "flex forward to relieve symptoms"; "feel relief when using a shopping cart or bicycle"; "motor or sensory disturbance while walking"; "normal and symmetric foot pulses"; "lower extremity weakness"; and "low back pain"
* Lumbar spinal stenosis qualitatively detected on MRI or CT-scan

Exclusion Criteria:

* Inability to speak or read French
* Impossibility or refusal to have an ergometric bicycle at home
* Ongoing lumbar-flexion-based endurance training
* History of spinal surgery
* Cognitive impairment
* Neurological or vascular disorder involving the lower limbs
* Contraindication to cycling
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)

The purpose of this study is to assess the effect of pioglitazone on stress- and alcohol-related measures in treatment-seeking individuals with alcohol use disorder (AUD) and elevated levels of stress and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* treatment-seeking individuals diagnosed with AUD diagnostic statistical manual 5 (DSM-5)
* fluent in English
* past month excessive alcohol use (\>7 drinks/week for woman, \>14 drinks/week for men, \>3 drinks/occasion for women\>4 drinks/occasion for men)14
* baseline Hamilton Anxiety Rating Scale (HAM-A) or Perceived Stress Scale (PSS) core indicative of mild to moderate anxiety (score 8 to 23) or moderate stress (score 14 to 26), respectively
* increase in alcohol craving following the baseline stress reactivity assessment.

Exclusion Criteria:

* Individuals will be excluded for exhibiting severe scores on the HAM-A, PSS, or post-traumatic (PTSD) checklist (PCL-5) at the discretion of the admitting physician
* physical dependence on alcohol Alcohol Use Disorders Inventory (AUDIT) score indicative of severe alcohol dependence (≥13 for women, ≥15 for men)
* greater than mild substance use disorder on drugs other than alcohol, nicotine, and marijuana
* contraindications for taking pioglitazone; medical conditions contraindicating pioglitazone pharmacotherapy or taking contraindicated medications
* be pregnant, nursing, or planning on becoming pregnant during the course of the study
* have any other illness, condition, or use of medications, which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study.
Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes after kidney transplantation. The association is examined by comparing the difference in oxidative modifications before and after 90 days treatment with 25 mg empagliflozin plus insulin compared to insulin treatment. The study is randomised and double-blinded. Each treatment group consists of 20 patients. Oxidative stress markers are measured by serum level of superoxide dismutase activity ,lipid peroxidation assay kit, glutathione assay, glutathione peroxidase activity , total antioxidant capacity assay oxidant status , carbonyl content assay and bca protein assay . . A student t-test will be performed to compare adding empagliflozin . The results will be published in a peer-review journal.

With the purpose of studying the antioxidant activity of empagloflozin 25mg will add on insulin in 20 patients after kidney transplant and will compare with 20 diabetic recipient of kidney transplant on insulin therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* HbA1c: 6.5-9.0%
* post kidney transplant
* stable graft function

Exclusion Criteria:

* pancreas and kidney transplant
* history of recurrent urinary tract infection
Efficacy and Safety of Pulsed Field Ablation in Refractory Mitral Isthmus-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study

Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study

This study aims to compare the effectiveness of pulse field ablation (PFA) versus radiofrequency ablation (RFCA) in improving mitral valve commissural block rate and atrial tachycardia recurrence rate in patients with refractory mitral valve commissural-dependent atrial flutter.

Study Design:

Randomized Groups: Patients will be randomly assigned to two groups:

Pulse Field Ablation (PFA) Group Radiofrequency Ablation (RFCA) Group

Eligibility Criteria:
Inclusion Criteria:

1.Patients aged ≥18 years. 2.Diagnosed with persistent symptomatic refractory mitral valve commissural-dependent atrial flutter. Refractory mitral valve commissural-dependent atrial tachycardia is defined as:

1. Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes.
2. Failure of catheter ablation: At least one previous attempt at radiofrequency catheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional block at the commissure).

3.Intolerant to at least one antiarrhythmic drug (AAD). 4.The patient must be capable of and willing to provide written informed consent to participate in this study.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Presence of left atrial thrombus on preoperative imaging.
3. Life expectancy less than 1 year.
4. Coagulation disorders or contraindications to anticoagulant therapy.
Stomatognathic System Assesment, After Different Methods of Establishing the Centric Relation

Patients with complete dentures were examined after the prosthoddontic treatment with two methods of establishing a centric relation: wax rims and gothic arch tracing method. The effectiveness of establishing a centric relation was evaluated.

In the study subjective experiences of patients, wearing complete dentures, were compared. Two different methods of determining a centric relation were performed: the traditional method using wax occlusal rims and the Gerber method, based on gothic arch tracings. The success rate of establishing a centric relation in both methods was evaluated (rentgenodiagnostics). The influence of the method used to obtain the centric relation on patients stomatognathic system (condyle centralization, pain) was also evaluated. The comparison between two methods was performed and results were analyzed. A centric relation was analyzed in temporomandibular joints and a corelation between TMD symptoms and centric relation was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* TMD according to RDC/TMD group I ,II
* Edentulous patients wearing complete dentures
* Patients agreement for taking part in the study

Exclusion Criteria:

* Analgesic drug addicted patients
* Neurological diseases with headache (migraine, cluster headache)
* Trauma in the head and neck region in the past 2 years
The ECEALT Chronic Low Back Pain Study

The primary objective of this double-blind randomized control trial (RCT) is to evaluate the clinical effectiveness of LLLT as adjunctive therapy to standard exercise treatment in patients with non-specific chronic LBP. Specifically, the study will aim to evaluate the effectiveness of adjunct LLLT in the reduction of pain in patients as well as determine its long-term functional outcomes.

Low back pain (LBP) is one of the most common musculoskeletal disorders and the leading cause of years lived with disability worldwide with significant socioeconomic impacts. Around 10-15 % of LBP patients develop chronic symptoms lasting more than 3 months, and this is considered chronic, with the causes often being "non-specific" with no identifiable causes. Despite the availability of medication-based protocols, the management of non-specific chronic LBP (NSCLBP) is an increasing challenge to clinicians and their patients. Adjunctive therapy can play an important role in the treatment of NSCLBP. In recent decades, low-level laser therapy (LLLT) has been widely used to relieve pain caused by different musculoskeletal disorders. Though widely used and reported as a safe, non-invasive treatment with minimal side effects; reported therapeutic outcomes of LLLT are varied and conflicting, due in part to methodological concerns, lack of data and unclear results.

Eligibility Criteria:
Inclusion Criteria:

* are 18-65 years with the ability to give informed consent
* report with non - specific chronic low back pain, which is defined as pain of \>3 months duration that occurs in the lumbosacral area of the spine, which may or not have the characteristics of limiting the patient's range of movements, and is not attributable to a recognizable, known pathology (e.g., infection, tumor, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome).
* are experiencing pain measured using the Quadruple Visual Analogue Scale between 4 and 7 at the time of assessment will be included to keep homogeneity of pain.

Exclusion Criteria:

* are under 18 years, and those over 65 years of age
* have had past fractures of the bone structures of the spine
* have had previous surgery of the spine
* have a history of previous surgery of the spine or vertebra; spondylosis, spinal stenosis, lumbar disc herniation
* use pacemakers (cardiac or brain)
* are pregnant, or those who plan to become pregnant during the course of the study
* have acute and/or chronic cardiovascular diseases
* have dermatological conditions in the area of irradiation and/or inflammatory skin lesions
* have tattoo/tattoos around the area of irradiation
* have any sensory deficits as defined by the World Health Organization's working definition
* are sensitive/allergic to phototherapy
* have neurological disorders as defined by the World Health Organization's working definition
* are taking anti-inflammatories or analgesic or psychotropic medications
* have any current infections
* have a history of drug abuse, either recreational, over the counter or prescription over the last 3 months