cyrilzakka/clinical-trials huggingface dataset:
Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery

This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes.

Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for inclusion if the following criteria are fulfilled
* Informed consent obtained
* Scheduled for lower extremity open vascular surgery
* Diabetes treated with insulin or oral antidiabetic medicine
* Age ≥ 18 years

Exclusion Criteria:

* Contraindications to HBO therapy
* Pregnancy (women of childbearing potential will undergo pregnancy test before inclusion)
* Patients already in HBO treatment
* Vascular reoperation
* Creatinine \> 250 mmol/L
* NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
* Clinically significant chronic obstructive pulmonary disease.
* Acute sepsis.
* Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up.
* Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices.
* Mental condition making the subject unable to understand the concepts and risk of the study
A Multicenter Observational Study on Safety of the Herbal Medicines at Inpatient Setting

Prospective observations on safety of the herbal medicines regarding liver and kidney injuries at inpatient setting of four sites in South Korea which are located at each quadrant of the country. In a previous study (PMID 28634823), six women presented liver injuries by herbs and similar findings were also reported. That knowledge has been developed to design the observations of females (19-80 ages) at least 2 weeks' hospitalization with weekly routine lab tests to obtain the occurrence of liver or kidney injuries and the profiles on micro biomarkers throughout the hospitalization period, and then, the follow-up test will be conducted in outpatient setting.

Total 500 inpatients will be observed to assess safety of herbal medicines with the balance of 60 to 110 each site. After obtaining the informed consent from patient, blood draw and urine collection are conducted prior to intake of the herbal medicine, blood draw and urine collection are routinely done every week throughout the whole admission period. The primary outcomes are, 1) liver for alanine aminotransferase (ALT), RUCAM (in case of causality assessment when ALT≥3 upper normal limit) and new biomarker, mircoRNA-122 and 2) kidney for urine creatinine, blood urea nitrogen (BUN) and new biomarker, Neutrophil gelatinase-associated lipocalin (NGAL). The secondary outcomes are, 1) liver for aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyltransferase (γ-GT), total bilirubin and new biomarker, glutamate dehydrogenase (GLDH) and 2) kidney for serum creatinine and new biomarker, kidney injury molecule-1 (KIM-1). The follow-up will be done by the study doctors based on their decision on the inpatient after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Female whose age is between 19 and 80
* Inpatient expected to stay at least 2 weeks and to intake herbal medicine
* Who signed voluntarily informed consent.

Exclusion Criteria:

* Who were short of stay for 2 weeks or stopped intaking herbal medicine
* Who had problems physically or mentally by investigator
Low-Dose CT - Stage I Testicular Cancer

Patients with primary germ cell cancer of the testicles confined to the testis can avoid adjuvant treatment by entering a surveillance protocol. In the surveillance protocol, patients are followed for up to ten years with serial computed tomography scans to detect recurrence. Multiple CT scans expose patients to a significant amount of radiation, which may be associated with an increased risk of secondary malignancies. This study hypothesizes that low dose CT scans are as effective as standard dose CT scans in detecting disease recurrence in this setting and will significantly reduce radiation exposure in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Phase A:
* Newly diagnosed testicular germ cell testicular cancer (GCT) with no clinical or tumour marker evidence of metastases
* Stage I disease according to UICC stage groupings and currently on surveillance (in Year 1 of non-seminoma surveillance or year 1 or 2 of seminoma surveillance)
* ECOG performance status 0 or 1
* Phase B:
* Stage I disease according to UICC stage Groupings
* Initial Low dose CT considered by study radiologist to be of sufficient quality to allow surveillance using LDCT protocol

Exclusion Criteria:

* any medical conditions that render the patient ineligible to undergo the protocol or procedure
Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery

To compare the prognosis of elderly patients undergoing radical resection of colorectal cancer treated with general anesthesia and general anesthesia combined with transversus abdominis plane block and continuous infusion of dexmedetomidine. The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65-80 years,regardless of gender
* American Society of Anesthesiologists physical status I-III
* Undergoing elective radical resection of colorectal cancer
* Sign informed consent

Exclusion Criteria:

* Could not cooperate to complete the pain VAS evaluation
* Could not cooperate to complete the cognitive function assessment
Effect of Nigella Sativa on Lipid Profiles in Elderly

The purpose of this study is to determine whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.

Cardiovascular diseases are still common health problems worldwide. They are major causes of morbidity and mortality in many countries. Dyslipidemia is the main risk factor of cardiovascular events. Despite the invention of many conventional hypolipidemic drugs, the use of traditional medicine remains high, especially in elderly patients. However, evidence of the effectiveness of many herbs or other traditional drugs is lacking. Nigella sativa or black seeds are traditional herbs used for years in Middle East and India. They are believed to cure many diseases, including dyslipidemia. Therefore, a study is needed to prove their effectiveness as their use might improve our strategy to improve patients' compliance.

Eligibility Criteria:
Inclusion Criteria:

* age of 60 years or more
* having dyslipidemia (total cholesterol \>200 mg/dL or LDL \>100 mg/dL or triglyceride \> 150 mg/dL or HDL \< 40 mg/dL (male) or HDL \< 50 mg/dL (female)

Exclusion Criteria:

* ALT or AST are two times of upper normal limit
* creatinine clearance test is below 30
Propofol and Perioperative Inflammation

The inflammatory properties of propofol are still under debate. Apolipoprotein A-I (Apo A-I) is involved in the inflammatory process. This study was designed to determine whether and how propofol or its solvent modulate Apo A-I and the inflammatory response after surgical stress. The investigators study hypothesis was that propofol might modify the Apo A-I blood levels, and thus, modulate the postoperative inflammatory course.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I or II
* scheduled for uni- or bilateral elective laparoscopic totally extraperitoneal hernia repair

Exclusion Criteria:

* Body mass index (BMI) \< 18.5 or \> 39.9kg/m2
* treatments with steroids (\>5mg/d prednisone equivalent, for the last 30 days)
* with opioids/non-steroidal anti-inflammatory drugs (NSAIDs) for chronic pain during the last 30 days
* immunosuppression (AIDS, neutropenia \<1000 cells/ml, transplant surgery, chemotherapy)
* known lipid disorder (triglycerides \>2.00mmol/l, low-density lipoprotein (LDL)-cholesterol \>2.50mmol/l or high-density lipoprotein (HDL)-cholesterol \< 1.00mmol/l)
* hypolipemic treatment before admission
* thyroid metabolism disorder (thyroid-stimulating hormone \>6.0 mUI/l or \<0.4mUI/l)
* renal insufficiency (creatinine \>106umol/l)
* liver disorder (bilirubin \>20umol/l, thromboplastin time \<60%)
* insulin dependant diabetes
* parenteral nutrition or after any lipid-containing medication (propofol, intralipid, etomidate) during the last 30 days
* antihypertensive medication with diltiazem or other calcium channel blockers
* known chronic alcoholism (men: \>65-75 ml alcohol/day)
* multidrug abuse (cocaine, heroin, methadone, or other narcotics, sedatives or stimulants)
* mental illness
* known allergy to propofol after randomization:
* change of surgical strategy
* protocol violation
* major bleeding (\>0.5l)
Exercises on CIPN, Fatigue, and Quality of Life in Colon Cancer Patients Receiving Chemotherapy

Objective:

Cancer is one of the biggest global health threats. The incidence and mortality of colorectal cancer (CRC) are increasing. The treatment of CRC is mainly surgical resection, and the standard treatment of metastatic colorectal cancer is Oxaliplatin chemotherapy, which is mainly a platinum agent (Alkylating agent). Oxaliplatin can exert its anti-cancer therapeutic effect by binding to cell DNA, and become toxic to neurons, damaging large and small fibers outside the brain and spinal cord. Causes peripheral neuropathy, which seriously affects the quality of life of patients. The purpose to develop the interventional and investigate intervention by exercise program of CRC patients with regard to the improvement effect of peripheral neuropathy, fatigue and quality of life during the treatment.

Methods:

Experimental study designs were used, and samples were taken from a regional teaching hospital. The control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises, balance training and resistance exercises twice a week, 60 minutes each time, plus weekly 5 walking exercises, 30 minutes each time, for a total of 12 weeks, of which the exercise training during chemotherapy and hospitalization is performed under the supervision of the investigator, and 1 balance training and resistance exercise are performed for 60 minutes each time to ensure that the patient performs. The correctness and safety of exercises, and balance training and resistance exercises in combination with the home style. During the home exercises, the researchers will give weekly telephone interviews to understand the patient's exercise status, and indeed achieve the balance training and resistance exercises twice a week. All measurement tools and methods are implemented in accordance with consistent standard operations. The control group took pre-tests when the case was closed, without interventional measures, but also performed post-tests in the same way as the experimental group at 6 weeks, 8 weeks, 10 weeks, and 12 weeks in the interventional experimental group.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with colon cancer, were getting chemotherapeutic drugs with oxaliplatin.

Exclusion Criteria:

* bone metastasis, lower extremity lymphedema, cognitive dysfunction, musculoskeletal problems,and diabetic.
Metabolic Effects of Gastrointestinal Surgery in T2DM

Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in \~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated


Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled diabetes ( A1c\>8%)
* Less than 10 years of history
* Not taking insulin
* Ages between 20 and 65 years old
* BMI between 26-34

Exclusion Criteria:

* previous abdominal surgery
* LADA
* Using insulin
Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue

A retrospective and prospective study to determine if the use of ambient lighting during screening colonoscopy is well tolerated and if ambient lighting will help physicians maintain adenoma detection rates while decreasing symptoms of eye strain as the day progresses.

This study is a a single-center study at an independent community-based teaching hospital comparing adenoma detection rate in screening colonoscopies performed in low lighting with those performed with ambient lighting (75-150 lux). All cases included in the study involved adult patients undergoing screening colonoscopy with a participating gastroenterologist. Diagnostic colonoscopies, history of colon resection, colorectal cancer, and cases performed in children, pregnant women, and prisoners were excluded from analysis. Cases involving gastroenterology fellows were also excluded. Retrospective data was collected over a six month period from January 2017 to June 2017, followed by a prospective arm the during the same calendar months the subsequent year (January 2018 to June 2018).

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing screening colonoscopy
* Procedure performed by a participating gastroenterologist

Exclusion Criteria:

* Any diagnostic colonoscopies
* History of colon resection
* History of colorectal cancer
* Children
* Pregnant women
* Prisoners
* Cases involving trainees, including gastroenterology fellows
The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain

Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction.

Innovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation.

Project Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 or above
* Can understand Cantonese
* Scored \>6 in the Abbreviated Mental Test; a cut-off point of 6 is valid for differentiating between normal and abnormal cognitive functions in geriatric clients
* Have a history of non-cancer pain in the past 6 months
* Have a pain score of at least 2 on the Numeric Rating Scale
* Able to take part in light exercise and stretching
* Owns a smartphone and can access the Internet

Exclusion Criteria:

* Have severe visual and/or auditory deficits that affect that seeing and hearing
* Have a serious organic disease or malignant tumor
* Have a mental disorder diagnosed by neurologists or psychiatrists
* Had a surgical treatment in the past two months
* Experienced drug addiction
Endometrial Safety Study

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
* Non-hysterectomized women.

Exclusion Criteria:

* Usual exclusion criteria for hormone therapy apply.
The Degree, Development and Interrelationship of Structural and Functional Asymmetry in (Pre)Adolescent Elite Tennis Players

Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in structural (e.g. increased bone and muscle mass) and functional (e.g. increased strength) adaptations to the dominant side of the body. The corresponding structural and functional asymmetry can be further accentuated by (intensively) practicing a unilateral sport such as tennis, which is very popular. Yet, research on this particular topic is scarce, especially in (pre)adolescent players. Existing studies, which often face methodological shortcomings (e.g. crosssectional designs, small sample sizes, no link to field methods), mainly focus on adults and structural asymmetry of the upper extremity itself, with very little or no attention to whole body structural as well as functional asymmetry. Moreover, the link of both forms of asymmetry with growth and maturation, everyday locomotion, technical skill performance and whole body injury is currently not (fully) understood. Therefore, the main purpose of this research project is to gain comprehensive knowledge on the degree, development and implications of both structural and functional asymmetry during a critical period in life using a longitudinal approach. As such, this project among youth elite tennis players will provide insights on the extent to which structural and/or functional asymmetry is acceptable for being most successful but remaining injury free.


Eligibility Criteria:
Inclusion Criteria:

* Being enrolled in a Belgian high-performance tennis academy

Exclusion Criteria:

* Injury at the start of the data collection, any known musculoskeletal abnormality, developmental disorder or metabolic disease.
Tobacco Cessation in Postmenopausal Women (Part I) - 1

The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers.

Female subjects were screened and randomized. Following two weeks of medication monitoring, all participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks (the experimental period), participants were randomized to a continued smoking or smoking abstinence condition. The abstinent group was provided with cessation counseling and monitored for abstinence. For all participants, data were collected during five clinic visits on all dependent measures: MNWS, QSU, Beck Depression Inventory (BDI), Profile of Mood States, Motor Speed Tasks and Reaction Time Tests. Question of interest was whether hormone replacement therapy would improve these dependent measures as manifested during short-term smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

Female smokers ages 40-79, smoking at least 15 cigarettes per day for at least one year, have natural menopause, have a transvaginal ultrasound to confirm loss of follicular activitiy, have a normal baseline mammogram, a normal chemistry at baseline, willing to take hormone replacement therapy for the duration of the study, normal thyroid function, and have a normal TSH.

Exclusion Criteria:

Women who have had formal dieting with or without pharmacological methods within the last three months; a weight change greater than or equal to 10 pounds within the last three months, BMI greater than or equal to 40, severe menopausal symptoms, active medical problems, alcohol or drug abuse, other forms of nicotine use.
Feasibility of Using Webcams in Clinical Studies

This study tests the feasibility of having study participants use webcams to participate in research studies. The study scientists hypothesize (1) that webcams will be an adequate method of detecting a participant's ability to perform a tasks for a clinical trial (e.g., swallowing a pill, eating food) and (2) that a majority of study participants would be willing to use a webcam to participate in a research study.

In the first phase of this study, the study scientists will research and compare technologies that will be used in video monitoring via webcam. The study team will also develop a standardized protocol for using the webcam technology through hands-on testing (without the use of study participants).

In the second phase of this study, video monitoring via webcam will be tested. Specifically, the study scientists will see whether the video recordings can be used to assess compliance to clinical interventions. Study participants will be recruited from among Pennington Biomedical Research Center employees and assigned to be either evaluators or testers. Testers will act as if they were study participants in a clinical study who are supposed to adhere to an intervention such as swallowing a pill or consuming food. They will be video-recorded by webcam while performing these tasks. Evaluators will then try to detect how well the testers followed the instructions for the task through in-person observation and by watching video recordings. Data from these tests will then be used to see whether watching the video recordings is as effective as watching in-person.

In the third phase of this study, past, current, and potential study participants at Pennington Biomedical Research Center will be surveyed to determine their comfort with using webcams and their likeliness to opt to use webcams to participate in clinical studies.

Eligibility Criteria:
Inclusion Criteria:

* Pennington Biomedical Research Center employees and trainees
* Age 18 years and older

Exclusion Criteria:

* Any employees who directly report to and are directly employed by the study's principal investigator