cyrilzakka/clinical-trials huggingface dataset:
Peri-operative Monitoring of Cerebral Oxygenation and the Onset of Delirium in Patients Undergoing Cardiac Surgery

Delirium is an acute brain syndrome characterized by a disturbance in consciousness accompanied by periods of inattention and changes in cognition. Memory impairment, irrelevant speech and disorientation are commonly observed signs and symptoms. Episodes of delirium have been associated with a prolonged hospital stay, functional and cognitive dysfunction and even an increased mortality. Delirium is a common complication in the postoperative setting where the incidence increases with the risk of surgery. The estimated incidence of postoperative delirium after cardiovascular surgery is remarkable, ranging from 31% up to 51%. Diverse preoperative risk factors have been documented for patients undergoing cardiac surgery: age, pre-existing cognitive dysfunction, a history of alcohol abuse and the severity of illness at admission.

An early diagnosis of postoperative delirium is of great importance to prevent long-term cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS) provides information on brain oxygenation by quantifying the regional cerebral oxygen saturation (SctO2) at the microvascular level. Recently, two studies showed that preoperative cerebral tissue oxygenation was lower in the cohort of patients that developed delirium postoperatively. Nevertheless, these studies did not investigate whether the onset of postoperative delirium coincided with a change of postoperative SctO2. A relationship between delirium and reduced cerebral blood flow has already been suggested. As such, the occurrence of a postoperative decrease of SctO2 might have been overlooked thus far. Hence, Investigators want to conduct a prospective, interventional study to determine the relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without Coronary artery bypass graft surgery (CABG))
* Surgery has to be performed under normothermic conditions
* Ability to perform the confusion assessment method for the intensive care unit (CAM-ICU)
* Patients willing to provide written informed consent

Exclusion Criteria:

* Age \< 70 years
* Off-pump cardiac surgery
* Surgery performed under hypothermic conditions
* Duration before extubation \> 36 hours
* Patients with insufficient knowledge of the Dutch language
* Patients using antipsychotics
* Patients with a known history of alcohol abuse (consuming two or more units a day)
Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand

Due to limited number of phototherapy centres and shortage of qualified phototherapy practitioners, heliotherapy has become a promising treatment alternative in Thailand where patients effortlessly receive supervised sun-bathing treatments from their homes whenever they are convenient. We used newly designed deep neural network UV forecasting model developed by using our 10 year-retrospective Solar UV irradiance (280-400 nm) retrieved from a ground based platform at Atmosperic laboratory, Silpakorn University, Nakhon Pathom, Thailand (13.82N 100.04E, 30 m above mean sea level). This model achieved a next-day forecast error of less than 12% which has been the most accurate prediction to date. We designed our 10week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values. We studied efficacy and safety of the 12-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand

We studied efficacy and safety of the 16-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand

Eligibility Criteria:
Inclusion Criteria:

* A psoriasis patient who indicate to have phototherapy and have lesional plagues systemically either on the front-back or left-right.
* A participant is based in Bangkok
* A participant is capable to understand and learn how to use our in-house assembled UV metre and web-based heliotherapy platform.

Exclusion Criteria:

* A participant has any sun-sensitive conditions including photo-aggravated photodermatoses and on photosentisitive drug treatments.
* Breast-feeding, pregnant individuals.
A Study to Objectively Measure Physical Activity and Sedentary Behavior During Cardiac Rehabilitation

The purpose of this study is to assess exercise patterns during home-based or center-based cardiac rehabilitation participation.

Participants enrolled in either home-based or center-based cardiac rehabilitation will be instructed to wear an accelerometer device for 7-days at baseline, 4-weeks, 8-weeks, and 12-weeks, to objectively measure their physical activity level during the cardiac rehabilitation program. A questionnaire will also be completed by the participant at baseline and 12-weeks to subjectively measure their physical activity level, based on self-report activities over the previous 7-days.

Enrollment in home-based versus center-based cardiac rehabilitation will be based on the availability of cardiac rehabilitation facilities and/or patient preference. There is no random allocation or assignment to groups by the study team.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and older.
* Able to provide consent.
* Has a qualifying indication for cardiac rehabilitation and able to participate in cardiac rehabilitation.

Exclusion Criteria:

* Unwilling or unable to participate in cardiac rehabilitation.
Operatively Treated Open Pilon Fractures

A chart review will be performed to extrapolate information including sex, height, weight, date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage, surgical history, wound history, fracture healing, and length of time to return to work. Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject, classifying all fractures according to the Orthopaedic Trauma Association classification guide. If a discrepancy in classification is found, then both will discuss together and come to a consensus.

After patients are identified with the Orthopaedic Surgical Database, letters will be sent to those patients who meet inclusion/exclusion criteria informing them of the study and that they will be contacted by the research associate in 1-2 weeks. The research associate will telephone the patient to discuss the study and answer any questions they may have. Dr. Goodspeed will also be available to answer any questions. The research associate with obtain verbal consent and proceed by asking questions from the Short Musculoskeletal Function Assessment Injury and Arthritis Survey, and the Foot and Ankle Outcomes Questionnaire. The medical student will then perform a chart review to extrapolate information including sex, height, weight, date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage, surgical history, wound history, fracture healing, and length of time to return to work. Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject, classifying all fractures according to the Orthopaedic Trauma Association classification guide. If a discrepancy in classification is found, then both will discuss together and come to a consensus.

Functional outcomes data will be measured by the Short Musculoskeletal Function Assessment Injury and Arthritis Survey and the Foot and Ankle Outcomes Questionnaire. Radiographic Classifications will be determined according to the Orthopaedic Trauma Association's classification guide.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Hershey Medical Center with a primary diagnosis of an open pilon fracture and surgically treated between 1/1/2000 and 12/31/2007.
* Temporization of the fracture may be performed elsewhere or by other orthopaedists at the Hershey Medical Center. Definitive surgery must be performed by Dr.'s David Goodspeed, J. Spence Reid, or Robert Simpson.

Exclusion Criteria:

* closed pilon fracture or pathological fracture; definitive fracture fixation performed outside the Hershey Medical center or by a surgeon other than Dr.'s David Goodspeed, J. Spence Reid, and Robert Simpson; patient is diagnosed with active infection at the time of first surgery at the Penn State Hershey Medical Center; patient is less than 18 years of age at the time of definitive surgery;
* patient is mentally compromised and unable to give consent;
* does not cooperate with survey data acquisition; patient is deceased;
* patient presented with significant ipsilateral leg fracture or injury at anytime within the time frame of the study.
Interrater Reliability of Subjective Pupillary Assessments

Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for this study if they have been diagnosed with some form of brain trauma (e.g., stroke, traumatic brain injury, aneurysm)

Exclusion Criteria:

* Prisoners
* Under 18 years of age
The Predictive Value of Cytokines on Response to Preoperative Chemoradiotherapy in Patients With Rectal Cancer

Rationale and background: Predictive factors are needed to discriminate chemoradiotherapy responders from non-responders and to individualize the treatment regime. Various cytokines play a role in processes affecting tumour growth and metastasis. Furthermore, cytokines might influence treatment response. Various cytokines are abnormally expressed in colorectal cancer patients, are associated with colorectal cancer or determine response to chemoradiotherapy. Therefore the investigators want to investigate whether levels of circulating cytokines could predict response to preoperative chemoradiotherapy in patients with rectal cancer.

Hypothesis: The investigators hypothesis is that the varying levels of circulating cytokines in the blood of rectal cancer patients may predict the response to preoperative chemoradiotherapy.

Study design: This study is an explorative clinical pilot study in which the investigators will collect 4 ml of blood from a selection of rectal cancer patients during a regular venipuncture before, during and after preoperative chemoradiotherapy and before and after surgery. Cytokines will be measured in blood plasma and in tumour and healthy tissue from the resection specimen using multiplex immunoassays. Plasma cytokine measurements will be linked to pathological response to identify which cytokines and corresponding levels can predict response to preoperative chemoradiotherapy for patients with locally advanced rectal cancer. Furthermore, blood plasma cytokine measurements before and after surgery will be compared to evaluate the effect of tumour resection on the immune response. In addition, preoperative blood plasma cytokine levels will be compared with cytokine levels in normal and tumour tissue to test whether circulating cytokine levels are representative for tissue cytokine levels.

Study population: Thirty patients (≥18 years) with locally advanced rectal adenocarcinoma eligible for preoperative chemoradiotherapy (oral capecitabine and 45-50 gray (Gy) in total; fractions of 1.8-2 Gy) and surgery.

Country of recruitment: The Netherlands


Eligibility Criteria:
Inclusion Criteria:

* Pathohistological diagnosis of locally advanced rectal adenocarcinoma (\<15 cm from the anal verge)
* Eligible for preoperative chemoradiotherapy (chemotherapy: oral capecitabine / radiotherapy: 45-50 Gy in total; fractions of 1.8-2 Gy) and surgery (stage 2 or 3 rectal cancer)
* Planned to undergo a venipuncture for a regular blood collection during preoperative chemoradiotherapy, before, and after surgery
* Written informed consent
* Age ≥18

Exclusion Criteria:

* Age \<18
* Serious adverse events during preoperative chemoradiotherapy
* Use of corticosteroids and/or immunosuppressive drugs during or 1 month prior to the study
* Other malignancies in medical history
* Previous pelvic radiotherapy and/or chemotherapy
* Confirmed bacterial or viral infection during the study or 3 months prior to the study
Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

Our primary objective is to develop a clinical pathway for care of patients having colorectal surgery at the Clinic. In particular, the investigators would like to determine what intraoperative concentration of oxygen is optimal in our patients.

The investigators therefore propose to test the primary hypothesis that supplemental oxygen (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially oxygen-related wound complications. Secondarily, the investigators will assess the incremental cost benefit of 80% versus 30% oxygen. As a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.

Eligibility Criteria:
Inclusion Criteria:

* adult colorectal surgical patients
Effect Of Supraglottic Airway Devices On The Tempromandibular Joint Function Following Prolonged General Anesthesia

Effect Of Supraglottic Airway Devices On The Tempromandibular Joint function Following Prolonged General Anesthesia

Supraglottic airway devices (SADs) are used for securing the airway in over 50% of general anesthetics; They are used for both spontaneously \& ventilated patients; They also used as conduits to aid endotracheal intubation when both positive mechanical ventilation ( PMV) \& tradional endotracheal intubation( ETT) have failed

All (SADs) consist of a tube that connected to a breathing circuit or a breathing bag which is attached to a hypopharengeal device that seals air flow to the glottis

There are many types of SADs including I-Gel, intubating laryngeal mask airway (LMA), LMA CTrash and LMA proseal Although considered relatively safe devices; and have many advantages as they are less invasive than EET, less incidence of bronchospasm, don't often require muscle relaxation or neck mobility

There are several potential complications \& disadvantages ; Include temporomandibular joint (TMJ) dysfunction, increases the risk of aspiration, more gas leak \&pollution, less safe in prone postion \& deeper anaethesia is required

This study will investigate (TMJ) dysfunction following the use of a (SAD) during general anesthesia, as There are a number of insertion maneuvers described for (SADs) \[2\] such as a jaw thrust may result in temporomandibular joint (TMJ) dysfunction by anteriorly displacing the mandible . In addition, other factors such as degree of muscle relaxation leading to hypotonicity of jaw muscles and passive mouth opening. In addition, for the duration of the operation the mouth is kept slightly open by a breathing tube may result in (TMJ) dislocation.

The inter-incisor distance will be measured using a Therabite â ruler (ATOS Medical, Nottingham, UK). This has a scale from 0 to 70 mm with 1-mm markings. The accuracy of this type of ruler is1.0 mm. The Therabite ruler was chosen as it routinely used by the investigators for (TMJ) assessment in the maxillofacial clinic.

Eligibility Criteria:
Inclusion The study will include 60 adult patients (\>18 years old) with ASA physical status class I and class II scheduled for elective surgery under general anesthesia where SADs ara planned to be used as airway devices

Exclusion Criteria:

1. Patient refusal
2. limited mouth opening(\<2 fingers)
3. Facial \&upper airway trauma
4. Patients with dentures or who were edentulous (as accurate objective measurements would be difficult to determine)
5. Head and neck surgery (as surgery may influence TMJ function)
6. GITsurgery (as SAD doesn't completely protect air way against aspiration )
7. Pt with preexisting tempromadibular joint dysfunction
8. Duration of anaethesia less than 1 h or more than 4hs-
Risk Factors for Type 2 Diabetes Mellitus With Cognitive Impairment: a Cohort Study

The aim of this study was to analyze the risk factors for the development of type 2 diabetes mellitus (T2DM) with mild cognitive impairment (MCI) and its pathogenesis associated with gut microbiota. A prospective cohort study was conducted to recruit 3820 participants aged 45 years and above who attended health checkups at the checkup center of Linyi City People's Hospital, Shandong Province. A follow-up survey was conducted identifying whether the participant had T2DM as an exposure factor group. Socio-demographic characteristics, blood, urine, and stool samples, lifestyle surveys, dietary status, and neuropsychological tests were collected at baseline and follow-up, exploring the association between clinical characteristics and gut microbiota and the risk for the development of T2DM with MCI.

The aim of this study was to analyze the risk factors for the development of type 2 diabetes mellitus (T2DM) with mild cognitive impairment (MCI) and its pathogenesis associated with gut microbiota. A prospective cohort study was conducted to recruit 3820 participants aged 45 years and above who attended health checkups at the checkup center of Linyi City People's Hospital, Shandong Province. A follow-up survey was conducted identifying whether the participant had T2DM as an exposure factor group. Socio-demographic characteristics, blood, urine, and stool samples, lifestyle surveys, dietary status, and neuropsychological tests were collected at baseline and follow-up, exploring the association between clinical characteristics and gut microbiota and the risk for the development of T2DM with MCI. Therefore, it is important to explore the factors affecting T2DM with MCI and screen for intervening factors, further elucidate its pathogenesis, and search for specific biological markers of early cognitive impairment in T2DM. This is socially and economically important for screening individuals susceptible to T2DM with MCI so that measures can be taken for early intervention and early treatment to improve the quality of life of patients while reducing medical costs.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 45 years old;
* no impairments in vision, hearing, language, etc., and can cooperate to complete the questionnaire;
* agree to follow-up.

Exclusion Criteria:

* have major systemic diseases, such as malignant tumors;
* have serious mental illnesses.
Diagnosis of Gastritis, H. Pylori Infection and Atrophic Gastritis in Dyspeptic Patients

Gastric cancer is the third most common cause of cancer-related death worldwide (1). Upper endoscopy is necessary to detect neoplastic macroscopic features at an early stage, but subtle abnormalities in the gastric mucosa are often missed or misdiagnosed (1). Helicobacter pylori (Hp) is involved in the pathogenesis of gastric diseases, such as, peptic ulcers, gastric lymphoma, and gastric cancer. Therefore, the necessity to recognize malignant gastric lesions at an early stage is imperative.

Previous I-SCAN™ technology uses white light as illumination light and digital post-processing of the reflection afterwards creates images yielding the virtual chromoendoscopic image. Emission of white light alone causes a potential limitation for the current I-SCAN™ technology to obtain high-quality images of microvascular patterns on the mucosal surface compared to narrow band imaging (NBI) with optical magnification.

Pentax Medical (HOYA, Tokyo, Japan) developed the Optical Enhancement™ (OE) System, which combines bandwidth-limited light with an endoscopy video system. The OE System combines digital signal processing with optical filters that limit the spectral characteristics of the illuminating light, connecting the peaks of the hemoglobin absorption spectrum (415 nm, 540 nm, and 570 nm) to create a continuous wavelength spectrum. This system has two modes that use different filters to optimize the visualization of specific features. Mode 1 is designed to improve visualization of microvessels with enough light. Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color (white color tone) with more light than Mode 1 filter.

In addition, high definition optical magnification endoscopes have been developed and can combine high-definition imaging with optical magnification to produce detailed images with magnification of up to 136×. This imaging technique facilitates the evaluation of the superficial vascular aspects of the mucosa, enabling the identification of early signs of inflammation or lesions not previously seen with conventional endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* above 18 years of age
* agreed to participate in the study
* patients with dyspepsia in accordance with Rome criteria

Exclusion Criteria:

* those taking NSAIDS, PPIs or antibiotics three weeks prior invitation
* severe uncontrolled coagulopathy
* prior history of gastric surgery
* those pregnant or nursing females
Linear Running Periodization x Nonlinear

In a competitive scenario, trainers and coaches seek to improve the performance of their athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training aimed at a specific moment of a competition. The organization variables, mainly the intensity of exercise in a training routine can stimulate important physiological pathways and uphold superior gains to VO2max, leading to a peak aerobic performance. However, due to lack of evidence, and the difficulty of control on a large scale, the effects of the intensity organization over a mesocycle periodization are still poorly investigated.

The objective of this study is compare two intensity blocks organization a) linear progression intensity (LP) and b) randomized or not intensity linaer (NLP) over five months running training, and a crossover design between subjects, on gains in VO2max, peak velocity (Vpeak) and critical power (CP). Furthermore, the relationship between the gains obtained with the training and the amount of exercise will be established. In our case all dependent variables will increase after training, with no significant differences between the two strategies on dependent variables.

Eligibility Criteria:
Inclusion Criteria:

* Minimum standards of physical activity proposed by the ACSM
* 18-45 years
* No metabolic or cardiovascular events
* No use ergogenic resources

Exclusion Criteria:

* Sedentary
* Diagnosis of cardiac, pulmonary or diabetes type I or II
* No injuries
Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer

The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.


Eligibility Criteria:
Inclusion Criteria

* Metastatic colorectal cancer
* Tumor classified WT KRAS
* At least 18 yrs of age
* ECOG PS 0,1 or 2
* Evidence of adequate organ function
* Measurable disease per RECIST criteria
* Have at least two of the following criteria:

  * Age \> 65 years
  * ECOG PS 1 or 2
  * Serum Albumin \< or equal to 3.5g/dL
  * Prior RT to abdomen or pelvis
  * Stopped first-line combination systemic chemotherapy \< 6 weeks duration

Exclusion Criteria

* Tumors classified as KRAS mutation
* Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
* Prior exposure to any biologic
* Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
* Known DPD deficiency
* Uncontrolled angina or a myocardial infarction within the previous 12 months
* Concurrent severe uncontrolled medical illness
* Known uncontrolled CNS metastases
* Bowel disease associated with chronic diarrhea
* Major surgery within 28 days