cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases

The objective of this prospective, observational, controlled clinical study is to use magnetically-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases, to evaluate its clinical efficacy and safety.

Gastric cancer is the most common digestive tract malignancy in China, which severely impacts human health and quality of life. Currently, surgery is the main treatment for gastric cancer. Since the surgery removes part or all of the stomach for malignant tumor, various postoperative complications inevitably occur. The occurrence of postoperative complications is detrimental to the prognosis of patients. Therefore, regular follow-up after surgery is necessary to closely monitor for upper gastrointestinal symptoms and periodically examine intragastric lesions in order to make timely diagnosis and treatment, and improve quality of life. Standard endoscopy procedures often cause discomfort and poor compliance in elderly patients. Also, for patients with severe respiratory diseases, severe cardiocerebral vascular diseases, the risks of anesthesia are extremely high. Magnetic-controlled capsule gastroscopy has the advantages of being completely painless, convenient, highly accurate in diagnosis, and well-accepted by patients. It is more suitable for postoperative assessment in elderly patients and patients with underlying diseases.

Eligibility Criteria:
Inclusion Criteria:

* Planned to undergo magnetic-controlled capsule gastroscopy or conventional endoscopy, and have undergone surgery for gastric malignant tumors (including surgical resection and ESD), elderly patients (older than 65 years) or patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.);
* Agree to participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

* No surgical conditions or refuses abdominal surgery (Once the capsule is stuck it cannot be removed surgically);
* Cardiac pacemakers (except MRI-compatible ones);
* Electronic implants or metal foreign bodies;
* Pregnant women;
* Known or suspected GI obstruction, stenosis, fistula;
* Dysphagia.
Acute Kidney Injury After Elective Total Joint Arthroplasty

Total joint arthroplasty (TJA) is a common orthopedic procedure to treat patients with end-stage knee arthritis. Over 4,000 TJA were performed in the Hong Kong public hospitals in the past 12 months (July 2020 - June 2021) and the demand for this procedure is ever increasing with time. TJA are rehabilitative surgeries with an aim to accelerate patient ambulation and minimize hospital stay. To facilitate this process, multi-disciplinary enhanced recovery after surgery (ERAS) programs are implemented. This involves surgeons, anaesthetists, physiotherapists and nurses who follow an integrated care pathway to allow early patient mobilization and hospital discharge. The program reduces the hospital length of stay and this can reduce the risk of complications and mortality. One of the major challenges in TJA is postoperative pain. TJA is a very painful procedure with up to 50% of patients have moderate to severe pain (numeric rating scale \>4) immediately after surgery. This can delay patient mobilization and hinder postoperative recovery. Severe postoperative pain is also associated with an increased risk of infection, myocardial ischaemia, respiratory complications and the development of chronic pain. Therefore, an effective multimodal analgesia is an essential component in the ERAS program. It combines different oral analgesics to limit opioid use and its related side effects. Celecoxib has been shown to reduce pain and opioid use after TJA. It is therefore recommended to be used routinely. However, its potential nephrotoxic property has led to its judicious use, especially in patients with preoperative chronic renal failure. Postoperative acute kidney injury (AKI) is an independent risk factor for mortality, cardiovascular complications and hospital length of stay6. However, the studies assessing the incidence of AKI following TJA are scarce, and with conflicting results.

Therefore, the aim of our study is to retrospectively review the incidence and duration of AKI following elective TJA in a tertiary institution. We will evaluate the effect of celecoxib in our multimodal analgesia regimen on the risk of postoperative AKI and determine the risk factors associated.


Eligibility Criteria:
Inclusion Criteria:

* Patients data in our database who underwent elective primary and revision TJA in Queen Mary Hospital, Hong Kong from from January 2018 to December 2021.

Exclusion Criteria:

* Patients with rheumatoid arthritis.
* Missing of essential data.
Vitamin D and Type 2 Diabetes - a Cross Sectional Study

The purpose of the study is to describe vitamin D status among patients with type 2 diabetes and to determine the association between serum 25-hydroxyvitamin D and glycemic control, markers of inflammation and blood pressure

It has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency. It is well known that vitamin D deficiency causes osteoporosis, increases the risk of fracture and causes muscle weakness. But there is now evidence that calcium malnutrition and hypovitaminosis D are predisposing conditions for various common chronic diseases such as malignancies (particularly colon, breast and prostate) chronic inflammatory and autoimmune disease (inflammatory bowel disease, multiple sclerosis) as well as metabolic disorders (metabolic syndrome, hypertension).

It has also been reported that vitamin D deficiency may predispose to glucose intolerance, altered insulin secretion and type 2 diabetes mellitus.

The purpose of this study is to determine vitamin D status among type 2 diabetics in our outpatient clinic and examine the relationship between vitamin D status , calcium and phosphorous metabolism, inflammatory markers, glycemic control, blood pressure and lipid profile.

Moreover the patients are asked to answer a questionnaire regarding lifestyle, exercise, sun exposure and food intake.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Patients of Danish extraction
* Written consent

Exclusion Criteria:

* Renal failure (Urea \> 12 mmol/l)
* Age \< 18 years
* malabsorption
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and corticosteroids in patients receiving a kidney transplant


Eligibility Criteria:
Inclusion Criteria

* Completed the 12 month core study
* Informed consent Exclusion Criteria
* N/A Other protocol-defined exclusion criteria may apply.
Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment

This is a multicenter, interventional, randomized study among patients with a first lung or head \& neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)

* Study proposal at the first medical consultation for therapeutic management of a first upper aerodigestive tract cancer or lung cancer.
* Selection criteria validation
* Collection of an informed consent
* Randomization :

Arm A: Experimental arm : Addiction consultation to the overall cancer treatment

Arm B: standard of care

The completion of questionnaires , the measurement of exhaled carbone monoxide rate using a CO tester for all patients, and the integrated addiction treatment among patients randomized in Arm A will not interfere with the medical treatment of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a first upper aerodigestive tract cancer or a lung cancer
* Initial cancer treatment
* Aged ≥ 18 and ≤65 years
* Living within a radius of 20 km from the CHRU de Lille/Oscar Lambret Center
* Patient with tobacco addiction: regular smoker = at least 7 cigarettes /week or 1 cigarette/day or short-term ex-smoker = regular smoker who has stopped smoking for less than 1 year from the inclusion date
* Performance status (ECOG/WHO) ≤ 2
* Registered with a social security system
* Informed and signed consent collected before initiation of any study procedures

Exclusion Criteria:

* Previous lung cancer or upper aerodigestive tract cancer
* Previous other cancer \< 5 years, evoluting or treated at the inclusion (except uterine cervical carcinoma, basal cell or squamous cell skin carcinoma )
* Mesothelioma and esophageal cancer
* Occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day)
* Long-term ex-smokers who have stopped smoking for more than 1 year from the inclusion date
* Impossibility to comply with the study procedures due to geographic, social or mental reasons
* Patient under guardianship or tutorship
* Pregnant or breastfeeding women
Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
* The cancer is unresectable.
* All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Concurrent therapy with octreotide is permitted, when appropriate.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Age 18 years or older.
* Able to understand informed consent.

Exclusion Criteria:

* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

  * single TheraSphere administration; or
  * cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
* Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition.
* Previous radiation therapy to the lungs and/or to the upper abdomen
* Pregnancy
* Symptomatic lung disease.
* Significant extrahepatic disease representing an imminent life-threatening outcome.
* Active uncontrolled infection
* Any pre-treatment laboratory findings within 30 days of treatment demonstrating:

  * Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
  * Serum bilirubin greater than 2 mg/dl
  * Infiltrative tumor on imaging
  * Tumor volume greater than 70% of liver volume
  * Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses

EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's preference, EUS-FNA with suction or without suction technique has been used. To date, little is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15 to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the contamination of blood in specimen and possible adverse event may occur. To determine optimal number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction or without suction, this prospective single-blinded randomized trial was conducted.

For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.

First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.

Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA with suction or without suction/ different number of to-and-fro motion.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 19 years Solid pancreatic mass lesions

Exclusion Criteria:

* Age \< 19 years Coagulopathy Unable to consent
Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome

The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is:

Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome?

Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.


Eligibility Criteria:
Inclusion Criteria:

* Written consent to participate in the study.
* Persons aged 18 years and older.
* Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

Exclusion Criteria:

* Pregnant or nursing individuals.
* Cardiovascular diseases or orthopedic restrictions that prevent exercise.
* Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).
* Body weight greater than 200 kg (maximum capacity of training equipment).
* Individuals with mental illnesses that may impair their ability to understand or participate in the study.
Interaction Between Psychological States and Caregiver's Responses on Pain in Patients Suffering From Chronic Pain

Chronic pain is a major cause of disability, and given its negative impact on the functional, psychological, and social well-being of sufferers, it is crucial to identify the biopsychosocial factors that influence it. While biological and psychological factors have been extensively studied, the role of the patient's relational context has not been thoroughly investigated to date. The presence of pain affects both directly and indirectly the patient's family and social context, which could significantly influence the perception of pain itself. In particular, partners of chronic pain patients may experience high levels of stress, anxiety, and worry, and this may have an impact on couple satisfaction and the type of partner's responses with respect to the patient's pain manifestations. It is conceivable that the type of interaction between patient and partner is influenced by the intersection of the ways in which the patient expresses pain, such as by manifesting catastrophic experiences, with the type of responses provided by the partner, such as of criticism, distraction, or support. It can be hypothesized that both the partner's actual responses to the patient's manifestations of pain and the patient's satisfaction with these responses are important. This study therefore aims to understand the relationships between these factors. Specifically, it will assess whether attributions and catastrophizing behaviors of the patient influence pain intensity and interference over time through mediation by the responses given by the partner. It will also be assessed whether this mediation is moderated by the patient's satisfaction with the partner's responses.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of condition associated with chronic pain
* Presence of a caregiver associated by kinship and living together for at least six months
* Having given written consent at the time of treatment received at one of the OUs involved in the project to the possibility of being contacted to participate in research for scientific purposes.

Exclusion Criteria:

* Patients diagnosed with psychosis, dementia, or psychiatric comorbidities
* Patients who, at the time of recruitment, will be hospitalized or who will be undergoing inpatient rehabilitation treatment or who will have a scheduled surgery to be performed during the study period
The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；
* Barcelona Clinic Liver Cancer (BCLC) Stage B or C；
* Age ≥18 years or ≤75 years for both genders；
* ECOG performance status: 0-1；
* Child Pugh score≤7；
* LVEF≥50% or above LLN of the research institution；
* Enough organ function；
* Has at least one measurable lesion based on RECIST 1.1；
* Life expectancy ≥3 months；
* Patients must be able to understand and willing to sign a written informed consent document；

Exclusion Criteria:

* Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc;
* Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
* Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
* Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration;
* Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
* Any previous or current active autoimmune disease or history of autoimmune disease;
* History of hepatic encephalopathy or liver transplantation;
* History of interstitial lung disease or non-infectious pneumonia;
* History of allergic reactions to related drugs;
* Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
* With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable;
* Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months;
* Untreated hepatitis infection: HBV DNA\>2000IU/ml or10000 copies/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive;
* Evidence of active pulmonary tuberculosis (TB);
* Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
* Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;
Parkdale Infant Nutrition Security Targeted Evaluation Project: Chart Review

In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada.

It is important to know who is accessing community programs and what the drivers of program utilization are in order to better support the women who are enrolled and to target those who are not. The aim of this project is twofold: 1) to investigate what socio-demographic and psychosocial characteristics predict level of participation in a prenatal community outreach program targeting vulnerable mothers and 2) based on utilization of a prenatal program, are there differences in the use of a postnatal program? This study will be conducted through a retrospective chart review. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that more vulnerable women will not attend programming as frequently.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
* 5P's client signed the permission to release information on the 5P's intake form

Exclusion Criteria:

* Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally
* 5P's client did not sign the permission to release information on the 5P's intake form