cyrilzakka/clinical-trials huggingface dataset:
PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial

Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving success during therapeutic ERCP is selective biliary cannulation (SBC). Nevertheless, SBC doesn't consistently yield favorable outcomes, even among expert endoscopists, failing in around 25% to 50% of cases with standard ERCP approach (sphincterotome and guidewire).

In such situations, depending on the endoscopist's experience and preference, various advanced techniques come into play. These encompass the double guidewire cannulation approach, needle-knife precut papillotomy or fistulotomy, and transpancreatic sphincterotomy, serving as potential rescue methods.

In recent times, the EUS-guided approach has been gaining increasing significance. Initially, it was viewed as a rescue option in cases where advanced ERCP techniques failed (5-15% of cases). More recently, it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction.

Rationale of the study Patients with distal malignant biliary obstruction have a higher risk of ERCP failure, related to the difficulty of bile duct cannulation. These patients after standard ERCP strategies failure, undergo advanced ERCP rescue strategies and in case of failure to EUS guided biliary drainage. HoweverEUS guided biliary drainage performed following the attempted advanced ERCP strategies, it may carry the risk of adverse events of advance ERCP strategies. We hypothesize that, in this setting of patients, early EUS guided biliary drainage in case of difficult biliary cannulation has a lower risk of post-procedural adverse events, as well as better overall safety and efficacy profiles. This could imply better outcomes such as for those patients who are planned to receive a chemotherapy before surgery in which a complication, such as acute pancreatitis, could delay the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with distal malignant biliary obstruction
* Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct \> 15 mm diameter.
* Difficult biliary cannulation defined as ESGE guidelines
* Agree to receive follow up phone calls
* Able to provide written informed consent

Exclusion Criteria:

* Coagulation and/or platelets hereditary disorders and/or INR\>1.5, PLT\<50,000 103/mm3.
* Use of anticoagulants that cannot be discontinued
* Pregnant women
* Previous ERCP or EUS-BD attempt
* Inability to sign the informed consent
Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCEP III guidelines to achieve their LDL-C target goal of \<=3.0 mmol/L. As this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or type II diabetic patients \>30 years old with no CHD, was \<2.5 mmol/L.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and LDL-C levels of \> 2.5 mmol/L to \<=4.20 mmol/L (97 mg/dL to 160 mg/dL) at Visit 1.
* history of coronary heart disease (type II diabetic patients \> 30 years old with no CHD)
* triglycerides \<= 4.00 mmol/L drawn, and liver transaminases (ALT, AST) \<=50% above the upper limit of normal at Visit 2, with no active liver disease, and/or creatine kinase (CK) \<=50% above the upper limit of normal

Exclusion Criteria:

* subjects with Body Mass Index \>=35 kg/sqm at Visit 1
* alcohol consumption \> 14 drinks per week
* pregnant or lactating
* treated with any other investigational drug within 30 days prior Visit 1
* previously treated with ezetimibe or participated in a clinical study with ezetimibe
* any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study
Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

This protocol posting describes the booster phase of the study. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).

All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female who completed the primary vaccination phase of the study.
* Written informed consent obtained from the subject.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Pregnant or lactating female.
Can VAST Improve ACLS in Rwanda

Aim The purpose of this study is to determine if the addition of the VAST Course to technical resuscitation skills training enhances healthcare providers' resuscitation performance in a resource-limited setting.

Objectives

The aims of this research will be achieved by meeting the following objectives:

1. Quantitative evaluation of study participants' resuscitation performance during a simulation scenario before ACLS course, immediately following ACLS course, immediately following VAST course, and at 4 months post training.
2. Qualitative exploration of the barriers and supports identified by course participants to implementing resuscitation in the workplace after resuscitation skills training through focus groups.

New knowledge Lessons learned from this study will help inform the design and the implementation of resuscitation training programs in resource-limited settings. This has potential to improve resuscitation capacity in resource-limited settings leading to higher quality of care for patients.


Eligibility Criteria:
Inclusion Criteria:

* Full course participation
* Available for focus group interviews

Exclusion Criteria:

* Refusal to provide informed consent
* Participated in VAST or ACLS training in the four months prior to study
IUD Insertion Post First Trimester Abortion

The goal of this study is to provide better information about contraception to women having an abortion so that they are less likely to have another unintended unwanted pregnancy.

Participating subjects will receive their choice of contraception following their abortion and if this choice is an IUD they will be randomly assigned to one of two types of copper intrauterine devices.

All participating women will fill out a survey about their contraceptive choices at the time of their abortion as well as at 3, 6, and 12 months afterwards. The investigators will also follow pregnancy rates at 1 through 5 years after the abortion to see which form of contraception was most effective.

The investigators expect to find that IUDs are the most effective form of contraception but that the types of copper IUDs currently available in Canada are not known to be as effective as those available in other countries, for which high quality evidence is available. The investigators hope to use this data to determine the effectiveness of copper IUDs available in Canada.

This prospective randomized controlled trial will examine satisfaction and effectiveness of post abortion contraception by comparing the two types of copper IUDs currently available in Canada, and including a non-interventional group of other contraceptive options.

The primary outcome measure is one year expulsion rates of copper IUDs places post abortion. Secondary outcomes are satisfaction with current method at 3, 6, and 12 months post-abortion, retention rates and repeat abortion rate over one year. One and five year pregnancy rates will be analyzed using access to universal health care databases.

Our results will provide the first information on the effectiveness of post abortion contraceptive methods currently available in Canada.

Eligibility Criteria:
Inclusion Criteria:

* Residents of BC registered with the Medical Services Plan of British Columbia
* Women seeking abortions for pregnancies up to 11 weeks 6 days gestation

Key Exclusion Criteria:

* Women who plan to conceive within the next year
Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma

Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without.

Heat shock protein 70 (HSP 70) may be involved in various aspects of immune system including infection, autoimmunity, and tumor immunity. The relationship between HSP70 expression, disease activity and cancer prognosis varied according to type of cancer. The overexpression of HSP70 by tumor cells contributes to tumor behavior. HSP70 is present in normal and abnormal hepatocytes, and was reported to be over-expressed in both hepatoma cell lines and human hepatocellular carcinoma (HCC) tissue. Recent study indicated that HSP70 is a molecular marker during early hepatocarcinogenesis. It is also involved in anti-tumor immunity in HCC.We also investigate the polymorphism of tumor necrosis factor-alpha promoter, and correlated to clinical relevance.

Eligibility Criteria:
Inclusion Criteria:

* History proven HCC patients

Exclusion Criteria:

* No-definite diagnosed patients
A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer

This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer.

An accurate assessment of prognosis (life expectancy) is important for cancer patients, their carers, and their health care professionals. In the case of patients / their carers, it allows them to plan for the future, and to make more informed decisions about further anti-cancer treatments, and about referral to supportive and palliative care services. However, previous research suggests that health care professionals are not particularly good at estimating prognosis, and frequently over-estimate prognosis.

The aim of this project is to assess the usefulness of measuring physical activity, and differences between daytime and nighttime physical activity, in determining prognosis in patients with cancer. Studies suggest that these measures may be useful in determining prognosis in certain groups of patients with cancer (e.g. patients receiving chemotherapy for colon / rectum cancer). However, these studies need to be repeated in patients with different types of cancer, and also patients receiving other types of treatment (including supportive and palliative care). The aim of this small scale ("feasibility") study is to determine whether or not a large scale ("definitive") study can be done.

The feasibility study will include 50 patients with cancer, who will be asked to rate their performance status (physical activity) on a well-used scale, and then to wear a watch-like device for one week that measures physical activity and sleep patterns. The researcher will collect a blood sample: some of which will be used for analysis of parameters, which have previously been identified as prognostic indicators and will collect and store some blood for future transcriptome analysis. Participants will also be asked to complete a sleep diary during the week, and a questionnaire about their symptoms at the beginning and end of the week. The study will last one week in total and is collaboration between the Royal Surrey County Hospital, and the University of Surrey (Surrey Sleep Research Centre).

Eligibility Criteria:
Inclusion Criteria:

* Outpatients.
* Age ≥ 18 years.
* Diagnosis of locally advanced / metastatic cancer.
* No curative treatment available.
* Patient receiving supportive and palliative care.
* Negative response from palliative medicine physician to the "surprise" question (i.e. "would you be surprised if this patient were to die in the next 12 months").
* (Estimated) prognosis of \> 2 weeks.

Exclusion Criteria:

* Inpatients.
* Age \< 18 years.
* Diagnosis of local (non-advanced) cancer.
* Curative treatment available.
* Presence of a physical disability that affects daytime activity (e.g. metastatic spinal cord compression).
* Presence of a physical disability that affects movement of the non-dominant arm (e.g. lymphoedema).
* Cognitive impairment (clinical judgement).
Effect of St. John's Wort in the Treatment of Recurrent Aphthous Stomatitis

The aim of the treatment of Recurrent Aphthous Stomatitis (RAS) is to accelerate the healing of ulcers by reducing pain and inflammation, thus enabling patients to perform their oral functions comfortably. It has been said many times in the literature that St. John's wort is very effective in wound healing.In this study, the evaluation of the therapeutic effects of St. John's wort extract on the clinical symptoms and ulcer healing rate in patients with Recurrent Aphthous Stomatitis (RAS), a condition with no definitive treatment, was aimed.

he etiology of Recurrent Aphthous Stomatitis (RAS) remains incompletely understood. Various therapeutic approaches, including topical and systemic agents, have been employed to alleviate pain, reduce ulcer dimensions, and prolong disease-free intervals. First-line management of RAS typically involves topical pharmacological agents. Among these, triamcinolone acetonide (TA), a corticosteroid derivative, is extensively utilized in the treatment of moderate-to-severe RAS due to its anti-inflammatory properties.

Hyaluronic acid (HA) gel, a more recent therapeutic option, has been demonstrated to effectively mitigate pain associated with RAS without inducing systemic or local adverse effects. Furthermore, Hypericum perforatum (St. John's Wort) has gained significant attention in the scientific community owing to its pharmacological properties, including antiviral, antibacterial, antioxidant, and anti-inflammatory effects. Studies evaluating the topical application of Hypericum perforatum extract in wound healing have indicated that it significantly enhances tissue repair and regeneration.

This study aims to compare the efficacy of triamcinolone acetonide, hyaluronic acid gel, and Hypericum perforatum extract in pain management and ulcer size reduction in patients with RAS.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years and over
2. Having a history of RAS for at least 2 years
3. Having one in an easily accessible area in the mouth
4. RAS has not exceeded a period of 48 hours

Exclusion Criteria:

1. Having any allergic history to these substances to be applied
2. During pregnancy and lactation
3. Use of steroids, vitamins, antibiotics, antihistamines, oral retinoids or immune system regulating agents for ulcer treatment within 3 months
4. The patient has a history of systemic disease
Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

The evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care) in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).


Eligibility Criteria:
Inclusion Criteria:

* Age 2.0 - 9.0 years for females, 2.0 - 10.0 yrs for males.
* Prepubertal stage (Tanner 1 for breast (B1) in females, or Tanner 1 for genitals (G1) for males).
* Bone age \< 10 'years' (males) or \< 9 'years' (females) according to Greulich and Pyle. The bone age will be read by the pediatric endocrinologist responsible for the pre-study screening visit.
* Height SDS \< -2.5 for ethnically adequate references. For children of Dutch or Western European origin the 1997 nation-wide references for Dutch children will be used. For children of Moroccan or Turkish origin, the respective reference charts will be used. For children of other ethnicities, the 1977 North American (NCHS/WHO) reference will be used, as these charts have been accepted by WHO as world-wide standard from the age of 5 years.

Exclusion Criteria:

* Has a history of hypersensitivity to growth hormone or phenol (conservative added to GH in NutropinAq), or drugs with a similar chemical structure.
* Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
* Has a birth weight and/or length below -2 SDS for Swedish reference charts. Patients will not be excluded due to an unknown birth weight or length.
* Has a known cause of short stature, or any significant concomitant disease that is likely to interfere with growth or with the study schedule/objectives, or is a known contraindication to GH treatment.
Occupational Therapy for Adults Who Have Experienced Intimate Partner Violence (IPV)

The purpose of this graduate student research study is to understand the effectiveness of an occupational therapy program in a domestic violence shelter. It is expected that participation will last about 6 weeks. Subjects will complete pretests involving lifestyle assessments and a coping scale and then participate in 8 occupational therapy sessions during the 4 weeks of program implementation. The occupational therapy sessions will last approximately 90 minutes. After the program is completed, subjects will complete the posttests.

Procedures and Activities. You will be asked to:

Complete a series of questionnaires about your health, well-being, and daily activities.

Participate in 8 OT sessions that may include activities such as journaling, positive self-talk, coping skills methods, and grounding exercises.

Complete the posttests.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18 years of age or older receiving services from a domestic violence organization

Exclusion Criteria:

* None
Acceptability of HPV-self Sampling

This trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Acceptability will be evaluated using an anonymous questionnaire and the main outcome of the study will be the response acceptability " yes " or " no " for HPV self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the acceptability of HPV self-sampling.

These data will help to propose new strategies for cervical cancer screening in France, particularly to taget non-attenting populations

Women will be recruted in 8 centers located in 2 departments , Aude and Herault (in the Region of Occitanie in the south of France).The questionnaire will be proposed to the women attending one of these eight centers by an investigator, who will verify the inclusion and exclusion criteria. The same person will collect the filled questionnaire.

The questionnaire is anonymous and is composed of 15 questions evaluating the acceptability of HPV self-sampling and socio-economic determinants.

These questionnaires will be collected and statistical analysis will be performed using appropriate tools.

This study will bring informations on the acceptibility of HPV self sampling among french women eligible for cervical cancer screening in 2 Departements of the South of France. Self-sampling acceptability will be linked to socio-economic determinants.

These data will be important to propose and evaluate new strategies to improve screening coverage, particularly of the context of the organized cervical cancer screening that will take place in France in 2018.

Eligibility Criteria:
Inclusion Criteria:

* Women 25-65 years old
* Living in the Aude or Herault departments
* Informed patient Exclusion criteria
* Virgins
* Previous hysterectomy
* Present or previous cervical pathology
* Patient under guardianship or tutorship
To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.

Removal of uremic toxins is the main goal of HD, It was improved by using high volume convective technique with high flux (HF) dialyzer. This technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life.

This study will assess the effect of hemodiafiltration (HDF) versus high flux dialysis on free light chains (FLC) reduction as a marker of HD adequacy and its relation to albumin loss using dialyzer effective surface area 2.6m2.


Eligibility Criteria:
Inclusion Criteria:

* Prevalent HD patients on regular hemodialysis sessions for \>6 months 3 sessions/week of 4 hours duration.
* Patients with Arterio-venous fistula as dialysis access.

Exclusion Criteria:

* Patients with hemodialysis catheters.
* Patients with active inflammation or infection.
* Decompensated heart failure.
* Liver Cell Failure ( Child B,C)
* Patients with known malignancies.
Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma

This pilot study seeks to evaluate the feasibility of measuring the proximal effects of concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic target molecules in Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, this study proposes to evaluate the extent to which CRT induces the differential expression of components along two critical, and potentially interdependent, molecular pathways: the arachidonic acid and epidermal growth factor receptor (EGFR) signaling pathways.


Eligibility Criteria:
Inclusion Criteria:

* Untreated HNSCC (\> Stage I) amenable to transoral biopsy.
* Scheduled for concurrent CRT (Cisplatin or Carboplatin/5-FU based) as definitive primary treatment
* Older than 18 years of age.
* Understand and sign informed consent.

Exclusion Criteria:

* Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
* Breast-feeding, pregnancy or of childbearing potential (including those women who are less than two years post menopausal) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
* History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease, rheumatoid arthritis or pancreatitis).
* Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
* NSAID (including celecoxib) or aspirin (\> 81 mg/day) use within 1 week of enrollment.
* Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.