cyrilzakka/clinical-trials huggingface dataset:
RFA Combined With Chemotherapy for Unresectable Cholangiocarcinoma

Extrahepatic cholangiocarcinoma is a malignant tumor that is highly malignant and difficult to diagnose and treat early. Endobiliary radiofrequency ablation (RFA) has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to compare the efficacy and safety of RAF combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma.

Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.

Radiofrequency ablation (RFA) is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.

The aim of this study is to compare the efficacy and safety of RAF combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma

Eligibility Criteria:
Inclusion Criteria:

* Obtention of a written informed consent.
* Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
* Patient with Karnofsky score \> 60， ECOG\>level 2
* Patient capable of fill in the quality of life questionnaire
* For the first time treatment
* CT, MRCP, EUS and other examinations indicate that the tumor has locally infiltrated large blood vessels and cannot be surgically removed

Exclusion Criteria

* No written informed consent
* Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
* Pregnant, parturient or breastfeeding women
* Serious abnormalities in liver and kidney function and coagulation function
* The ERCP guide wire cannot pass the stricture due to severe biliary stricture
* Merge with other malignant tumors
* Use other treatments that may affect the observation, such as radioactive particles or seed stent implantation, P53 injection, oral chemotherapy, interventional therapy, etc.
Collection of FUJIFILM's 3Dimensional Mammograms

This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.

This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography

Eligibility Criteria:
Inclusion Criteria:

* Female.
* Any ethnic or racial origin.
* Must come through the study via the screening or diagnostic pathway described above.
* Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
* Meet none of the exclusion criteria.

Exclusion Criteria:

* • Presence of a breast implant.

  * Women with only a single breast; for example, post mastectomy patients.
  * Is pregnant or believes she may be pregnant.
  * A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
  * A woman who has significant existing breast trauma.
  * Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate mammography examinations.
  * A woman who has had a mammogram performed for the purpose of therapy portal planning.
  * Inadequate technical quality mammography images, such as insufficient anatomical coverage or significant motion artifacts.
  * Cannot, for any known reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution.
  * Is an inmate (see US Code of Federal Regulations 45CFR46.306).
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.

Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 75 years
2. Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)

(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Rejection of laparoscopic resection
6. History of allergy to iodine agents
7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
8. History of other malignant disease within past five years
9. History of previous neoadjuvant chemotherapy or radiotherapy
10. History of unstable angina or myocardial infarction within the past six months
11. History of unstable angina or myocardial infarction within past six months
12. History of continuous systematic administration of corticosteroids within one month
13. Requirement of simultaneous surgery for another disease
14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
15. FEV1\<50% of the predicted values
16. Linitis plastica, Widespread
Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia

The purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50).

64 cases were randomly divided into four groups, In each group, dexmedetomidine target plasma concentration are 0, 0.4, 0.6, 0.8 ng/ml. Dexmedetomidine administered 15 min before target controlled infusion of propofol. The propofol infusion was started to provide a target effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness when the effect-site concentration and target concentration equilibrium.

Eligibility Criteria:
Inclusion Criteria:

1. Weight:18≦ BMI≦25
2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

1. A previous history of intolerance to the study drug or related compounds and additives.
2. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.
Endotracheal Tube Threading Over the Fiberoptic Bronchoscope

The goal of this study is to assess the ease of ETT threading over the FOB on the right or left labial commissures in patients aging between 18 and 70 years old with ASA score I-II and undergoing any type of surgery. The main question it aims to answer is whether threading the tube on the right labial commissure during FOB intubation has a better success rate than threading the tube on the left labial commissure. Participants will be randomized via a computerized system into 2 groups (Group 1: Patients intubated with FOB by threading the tube on the left labial commissure and Group 2: Patients intubated with FOB by threading the tube on the right labial commissure). Researchers will compare the success rate of threading the tube on first trial, number of ETT threading trials, time to success, and incidence of intra-procedural complication between the two groups to see if threading the tube on the right labial commissure during FOB intubation has a better success rate than threading the tube on the left labial commissure.

Fiberoptic bronchoscope (FOB) intubation is the gold standard technique for intubating patients with predicted difficult airway. Different maneuvers have been used to facilitate threading the endotracheal tube (ETT) over the fiberoptic bronchoscope including jaw thrust, stretching the tongue, rotating the ETT 90 degrees anticlockwise or using smaller tubes. To our knowledge threading the ETT with the FOB on the left or right lip commissures has not been investigated previously. Improving the ease of ETT threading on the right or left labial commissures could change our FOB intubation management.

The aim is to assess the ease of ETT threading over the FOB on the right or left labial commissures.

Patients between 18 and 70 years old with ASA score I-II and undergoing any type of surgery in the operating rooms at the American University of Beirut Medical Center will be randomized via a computerized system into 2 groups:

Group 1: Patients intubated with FOB by threading the tube on the left labial commissure Group 2: Patients intubated with FOB by threading the tube on the right labial commissure The primary outcome is the success rate of threading the tube on first trial. Secondary outcomes include number of ETT threading trials, time to success, and incidence of intra-procedural complications.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 70 years
* Any surgery requiring general anesthesia
* ASA 1 and 2

Exclusion Criteria:

* Patients aged less than 18 or more than 70 years old.
* ASA 3 and 4 patients.
* Patients who need a rapid sequence induction (including pregnant women) or those who have an increased risk of aspiration.
* Patients who need awake fiberoptic intubation for a difficult airway or any other reason
Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy

The aim of this study was to evaluate the effect of hyaluronic acid gel after photobiomodulation on the healing of surgical gingivectomy sites


Eligibility Criteria:
Inclusion Criteria:

* Chronic inflammatory gingival enlargement grade 2 and 3 according to the gingival overgrowth index by Miller and Damn.
* Adequate amount of keratinized tissue.
* Attachment loss= 0
* Well educated patients as post-operative instructions need to be followed precisely.

Exclusion Criteria:

* Patients with history of smoking
* Pregnant women
* Patients with bad oral hygiene
* Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing
* Patients who have any previous adverse reactions to the products (or similar products) used in this study
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial

This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures:

  * Lobectomy or pneumonectomy
  * Esophagectomy
  * Radical (total) cystectomy
  * Pancreatectomy
  * Partial hepatectomy
  * Hyperthermic intraperitoneal chemotherapy (HIPEC)
  * Gastrectomy (subtotal or total)
  * Cholecystectomy or bile duct resection

Exclusion Criteria:

* Age less than 18 years
* American Society of Anesthesiologist Class 5
* Projected life expectancy less than 30 days
* Known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or volatile general anesthetic agents
* Known or suspected history of malignant hyperthermia
Effects of Physical Training and Nutrition Education on Adipocytokines in Severely Obese Teenagers

Obesity is now becoming significantly prevalent of an environment characterized by easily available calorics foods combined with sedentary lifestyles. Moreover, it has been demonstrated that obesity is associated with metabolic complications such as disturbed adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose of this study is to assess the effects of a lifestyle intervention focused on various physical activities and nutrition education on adipocytokines hormones, in severely obese teenagers.


Eligibility Criteria:
Inclusion Criteria:

* to be aged from 12 to 17
* to have a body mass index \> 97 percentile for age and gender

Exclusion criteria:

* systemic disease
* endocrine disorder
* syndromic obesity
* subjects receiving medication with a history of recent intercurrent illness
A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

The aim of this exploratory study is to assess the ability of two test toothpastes containing 0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque bacteria using the plaque glycolysis regrowth model (PGRM).


Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
* Plaque sample acidogenicity in the pH range 5.0 to 5.7 at Visit.

Exclusion Criteria:

* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
* Women who are breast-feeding.
* Currently taking antibiotics or have taken antibiotics within 2 weeks of plaque assessment (Visit 2). A participant with any medical history that may prevent them from participating in the study until study conclusion (such as diabetes).
* Any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear.
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Current smokers, or smokers who have quit within 6 months of screening, or participants currently using smokeless forms of tobacco, e.g. Gutkha, Pan containing tobacco, Pan Masala.
* Current active caries or periodontitis that may compromise, in the opinion of the investigator, study outcomes or the health of the subject.
* Restorations in a poor state of repair that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
* Partial dentures or orthodontic appliances that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
* Recent history (within the last year) of alcohol or other substance abuse.
Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema

The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. The research aims to determine whether this digital solution is practical and acceptable for patients while identifying any unexpected challenges during implementation, ultimately establishing its potential for clinical integration into lymphedema care.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 70 years of age
* Diagnosed with breast cancer-related unilateral upper limb lymphedema
* Possessing an Android or iOS smartphone
* Voluntarily deciding to participate and providing written consent after receiving a detailed explanation of this study

Exclusion Criteria:

* Diagnosed with malignant lymphedema due to metastasis or recurrence
* Having severe comorbidities (underlying diseases, neuromusculoskeletal disorders, cognitive, mental, or visual impairments, etc.) that make it difficult to use the application and participate in exercise interventions

Discontinuation Criteria:

* Development of serious complications or cancer metastasis/recurrence during the study period
* Occurrence of a serious illness unrelated to study participation
* Failure to follow the instructions of the study physician
* Voluntary withdrawal from the study or development of circumstances preventing participation
Adaptive Hip Exoskeleton for Stroke Gait Enhancement

This work will focus on new algorithms for robotic exoskeletons and testing these in human subject tests. Individuals who have previously had a stroke will walk while wearing a robotic exoskeleton on a specialized treadmill as well as during other movement tasks (e.g. over ground, stairs, ramps). The study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

The focus of this work is a proposed novel artificial intelligence (AI) system to self-adapt control policy in powered exoskeletons to aid deployment systems that personalize to individual patient gait. Individuals post stroke have a broad range of mobility challenges including asymmetric gait, substantially decreased SSWS, and reduced stability, and therefore have greatly impaired overall mobility independence in the community. The investigators expect the proposed novel controller, capable of personalization to such variable and asymmetric gait patterns, will have significant benefits towards increasing community independence and mobility for patients post stroke. Patients post stroke will be fit with a hip exoskeleton (in a powered and/or unpowered state) and proceed to walk on a treadmill or perform various movement tasks. The same tasks will be performed by the patients without wearing the hip exoskeleton to serve as a baseline. The investigators expect improved outcomes in the powered hip exoskeleton compared to the unpowered hip exoskeleton and baseline conditions.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-85 years of age
* Had a stroke at least 6 months prior to study involvement
* Are community dwelling, which means the participant does not live in an assisted living facility
* Are able to provide informed consent to participate in the study activities
* Can safely participate in the study activities (per self-report)
* Must have a Functional Ambulation Category (FAC) score of 3 or above, which means the participant can walk without the assistance of another person

Exclusion Criteria:

* Require a walker to walk independently
* Have a shuffling gait pattern
* Have a Functional Ambulation Category (FAC) score of 2 or lower, which means the participant requires the assistance of another person in order to walk
* Have a significant secondary deficit beyond stroke (e.g. amputation, legal blindness or other severe impairment or condition) that in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results
Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting

The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG surgery


Eligibility Criteria:
Inclusion Criteria:

* Elective CABG surgery.
* Signed, documented informed consent prior to admission to the study.

Exclusion Criteria:

* Unstable angina, requiring intervention or CABG \<24 hrs after screening.
* Decompensated congestive heart failure.
* Chronic, persistent, paroxysmal atrial fibrillation.
* Uncorrected significant valvular heart disease
* Known hypersensitivity to the study drug
* Left ventricular dysfunction (ejection fraction \<35%)
* Use of anti-arrhythmic drugs other than beta blockers
* Non-cardiac illness with a life expectancy of less than 1 year
* Bleeding diathesis or history of coagulopathy
* Significant renal and liver insufficiency
* Significant thyroid, pulmonary disease
* Uncontrolled diabetes mellitus
* Patients on anti-arrhythmic drugs
* Patients with pacemaker
* Patients unable to provide/sign informed consent.
* Patients currently taking marine based omega-three fish oil supplements.
* Disturbances in lipid metabolism, serum triglyceride value \>3 mmol/l