cyrilzakka/clinical-trials huggingface dataset:
Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

to determine if primary prophylaxis with Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) in unresectable cancer patients with the orifice of the cystic duct (OCD) involvement is superior to conservative management (Non EUS-guided gallbladder drainage).

Endoscopic biliary drainage with a self-expandable metal stent (SEMS) is an accepted form of palliative therapy for distal malignant biliary obstruction (MBO); it is a low invasive procedure with a long-term patency.

Covered SEMSs have a longer patency than uncovered SEMSs in patients with MBO, because covered SEMSs can prevent tumor ingrowth. However, complications of covered SEMSs include stent occlusion, migration, kinking, non-occlusion cholangitis, liver abscess, pancreatitis and cholecystitis.

Nonsurgical decompression of the gallbladder is urgently needs to prevent sepsis, perforation and death in patients with acute cholecystitis. Several risk factors of cholecystitis after SEMS placement for distal MBO have been reported: however, tumor involvement to the orifice of the cystic duct (OCD) is the major predictive factor for cholecystitis after endoscopic SEMSs placement for distal MBO palliative treatment .

Acute cholecystitis related to SEMSs deployment was evaluated in 2009, by using endoscopic trans-papillary gallbladder drainage (TPGBD) in 11 individuals in whom SEMSs covered the OCD. None episode of cholecystitis was reported, however TPGBD is a difficult technique with a high rate of stent dislodgement and reintervention needed.

EUS-GBD by using a lumen apposing metal stent have been proposed, but only for acute cholecystitis treatment or symptomatic gallbladder hydrops, never as a prophylactic technique.

The aim of this study if to determine if primary prophylaxis EUS-GBD in patients with distal malignant biliary obstruction and the OCD involvement is superior than conservative management. Also, a cost-effectiveness analysis will be done in both arm groups.

This would be the first trial to study the effect of prophylactic EUS-GBD prior SEMSs deployment in patients with distal malignant biliary obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old.
* Obtained written consent for procedures
* Unresectable malignant biliary obstruction diagnosed by Endoscopic Ultrasound and confirmed by confocal laser endomicroscopy (CLE) during cholangioscopy and histopathology.
* Tumor involvement to the orifice of the cystic duct.
* Self-expandable metallic plastic stent deployment as palliative therapy for distal biliary obstruction.

Exclusion Criteria:

* Under 18 years old.
* Refuse to sign written informed consent.
* Pregnancy
* Previous cholecystectomy
* Acute cholecystitis prior enrollment
* Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
* Large vessel between the gallbladder and gastric-duodenal wall.
* Coagulopathy
* Intrahepatic cholangiocarcinoma
* Previous gallbladder drainage by percutaneous or endoscopic techniques.
Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.

Patients with gynecologic malignancies often have a high prevalence of symptoms throughout their disease course including fatigue, pain, anxiety and depression. Palliative care is defined by the World Health Organization (WHO) as "an approach that improves the quality of life of patients and their families facing the problems associated with life threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual."

The University of Michigan Symptom Management and Supportive Care Program works together with patient's oncology team to manage cancer related and treatment related symptoms. They offer a wide range of services including: pain and symptom management, medication management, nutritional counseling, expedited access to psychiatric oncology, anesthesia pain service and physical medicine and rehabilitation. Studies have demonstrated an improvement in quality of life, symptom burden and patient/care giver satisfaction when palliative care is part of routine oncologic care. Currently, in gynecologic oncology, palliative care is incorporated on a case by case basis, instead of in a standardized approach. We hope this study will provide a standardized tool to identify gynecologic oncology patients receiving chemotherapy who would benefit from a referral to a symptom management clinic.

This study will provide a screening mechanism to identify advanced stage or recurrent gynecologic oncology chemotherapy patients with palliative care needs and determine which symptom management option provides the best improvement in symptom burden, that performed by a specialty clinic staffed by providers formally trained in palliative care or that provided by the patient's gynecologic oncologist. This study has the potential to change practice by providing a triage tool that will identify patients that will most benefit from specialty palliative care services and could result in improved quality of life for our patients.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Diagnosis of Stage III, IV, or recurrent gynecologic malignancy (Uterine, Ovarian, Cervical, Vulvar, Vaginal, Fallopian Tube, Primary Peritoneal)
* Receiving active intravenous, intraperitoneal, or oral chemotherapy
* Patient at University of Michigan Gynecologic Oncology Clinic

Exclusion Criteria:

* Male
* Less than 18 years of age
* Patients without a diagnosis of a gynecologic malignancy
* Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment
* Patients receiving radiation therapy with chemo-sensitization.
Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes

This study is designed to evaluate the safety and efficacy of PN2034 in insulin-dependent type 2 diabetics as measured by the change in average daily insulin dose from baseline to week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes mellitus
* 21 to 65 years of age
* on stable doses of insulin (\>/= 40 units/day) alone or with metformin for at least 3 months
* HbA1c level of \>/=7.5% but \</=10.0%
* fasting blood sugar level \>/= 125 mg/dL but \</= 279 mg/dL
* BMI 26-43 kg/m2
* direct bilirubin \< 1.5x the upper limit of normal (ULN)
* serum creatinine \< 1.5 mg/dL (males) or \< 1.4 mg/dL (females)
* blood urea nitrogen (BUN)\</=40 mg/dL
* all other clinical laboratory parameters (hematology, serum chemistry, and urinalysis) within normal limits or not clinically significant
* ECG normal, or abnormalities not clinically significant
* surgically sterile,postmenopausal,or using adequate contraception and have a negative pregnancy test at Screening
* able to perform daily self-monitoring of blood glucose (SMBG) tests
* willing and able to sign an informed consent form

Exclusion Criteria:

* diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis
* treatment with TZDs or any other oral antidiabetic (excluding metformin) within 3 months prior to screening or during study treatment
* change in lipid-lowering medication within 2 months of screening
* taken systemic corticosteroids within 1 month prior to screening or during study treatment
* history of or current/active cardiovascular disease
* significant current pulmonary conditions
* significant thyroid disease
* CPK value \> 3x ULN
* a female who is pregnant or lactating
* systolic BP \> 160 mm Hg or a diastolic BP \> 90 mm Hg at screening
* previous or current history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to randomization
* liver function tests (ALT, AST, ALP) \> 2 times ULN, or active liver disease at screening
* history of positive HIV
* positive hepatitis B test at screening
* weight loss or gain \>/= 15 lbs within 3 months of screening
* history of substance abuse (including alcohol abuse) within 2 years prior to screening
* donated and/or received any blood or blood products within 3 months prior to randomization
* taken an investigational study medication within 30 days prior to screening or during the study
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.


Eligibility Criteria:
Main Inclusion Criteria:

* General good health, other than perennial allergic rhinitis
* History and diagnosis of perennial allergic rhinitis by skin prick test
* Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)

Main Exclusion Criteria:

* Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
* Use of any prohibited concomitant medications as defined by the study protocol
* Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit
Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve

In this study, the investigators aim to use data identified through the hospital's integrated medical database and National Health Insurance database to explore the long-term performance and benefits of biological and mechanical valves. This research aims to provide more recommendations and references for valve replacement in different patient populations.

Long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most commonly discussed indicator. The choice of valves has evolved over the past 30 years, offering two options: biological valves and mechanical valves. Biological valves have seen advancements in the last 15 years, including new processes and improved valve preservation methods. The question of whether these new process valves offer better long-term effectiveness has become a hot research topic in recent years.

Mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects, abnormal clotting function, and bleeding. Biological valves, on the other hand, do not require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment. However, the risk of biological valve degeneration results in an average lifespan of 10 to 20 years, which cannot match the durability of mechanical valves. This is the drawback of using biological valves.

Therefore, the investigators hope to utilize the hospital's integrated medical database and the long-term National Health Insurance database for tracking. The investigators aim to observe valve performance in different patient groups, such as young people, the elderly, patients on dialysis, those with rheumatic autoimmune diseases, and those taking specific medications, among others.

Eligibility Criteria:
Inclusion Criteria:This is a retrospective study, and we plan to utilize data from the hospital's integrated medical database and the National Health Insurance database from January 2007 to December 2019. We will identify all patients within the data who were diagnosed with valve diseases and underwent valve replacement surgery.

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Exclusion Criteria:Individuals under 20 years of age.

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The Effect of Guided Imagery on the Third Stage of Labor

The purpose of this study was to evaluate the effect of guided imagery on the third stage of labor. Blood loss from hemorrhage during childbirth, most commonly due to uterine atony, is one of the leading causes of maternal mortality in the United States and the leading cause of maternal death worldwide. The hypothesis was that the use of physiologic guided imagery would reduce the amount of bleeding during the third stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older but less than 35 years
* English as her primary language
* fetus in a cephalic presentation
* singleton pregnancy
* 36 to 38 estimated gestational weeks
* no contraindications to vaginal delivery
* maternal weight less than 200 pounds prior to pregnancy

Exclusion Criteria:

* more than four previous children
* a history of postpartum hemorrhage
* bleeding disorder
* seizure disorder
* polyhydramnios
* diabetes (including gestational)
* hypertension
* cardiac disease
* uterine fibroids
* anemia (hematocrit less than 30)
* intrauterine fetal demise or tobacco use
Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes

Sports training aims to enhance an athlete's performance (overcompensation). To do that, the athlete must go through periods of fatigue and lower performance (overreaching). When the training plan is balanced, this fatigue is short and reversible.If the training load is too heavy or if recuperation periods are too short, it can lead to persistence fatigue that may only be reversible in the long term. This state of fatigue is part of the broader clinical picture of overtraining, which includes stark changes in performance as well as mood and sleep disorders. Many prediction and characterization methods based on biological markers have been evaluated, but they have not been put into practice in sports training due to obstacles such as reliability, interindividual variability and high costs. This study aims to evaluate a new approach based on the variability of an individual's heart rate (RR variability), which is a way of measuring autonomic nervous system (ASN) activity. It is non-invasive, low-cost, and has already proven useful in athlete health monitoring.

The investigators propose to describe the variation of these ANS regulation factors over a full year, in a population of high-level athletes, in order to measure changes in regulation which may be predictive of potential fatigue and intolerance to physical training, if such a syndrome came to be observed among the study group.

Eligibility Criteria:
Inclusion Criteria:

* High-level athlete, enrolled in a Ministry-recognized Pôle
* Participant signed the informed consent form

Exclusion Criteria:

* Confirmed current overtraining syndrome
* Known pregnancy on inclusion
* Athlete using cardio-inhibitor or cardio-accelerator drugs
Do Emotions Affect Mechanical Pain Thresholds?

The purpose of this study is to investigate if different emotional states could influence mechanical pain thresholds.

Participants will be randomized into 4 different groups watching different short video-clips (2.20 min). The negative emotions group will watch an uncomfortable short video containing violence and blood, the positive emotions group will watch a video containing a stand-up comedy show, the neutral emotions group will watch a video with Swedish nature, and the control group will just wait for 2.20 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clip interventions.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age, fluent in Swedish.

Exclusion Criteria:

* Pain anywhere in body during the test session, known neurological disease.
My Meal Plate - Promoting the Health Literacy of Patients

This study was to investigate the results on health literacy through the program of my meal plate.

Subjects were randomized to the intervention group and control group. The primary outcome was the Health Literacy on my Plate.

Eligibility Criteria:
Inclusion Criteria:

* patients who have ordered the general diet of the hospital and took more than three meals in a row.

Exclusion Criteria:

* pregnant woman
* unconscious
* people who cannot read
Three-Chamber Bags Retrospective Study in Spain

The primary study objective is to assess the rates of blood stream infection (BSI) from the use of Three-Chamber Bags (e.g., SmofKabiven®, Kabiven®, others) compared to Hospital Compounded Bags (HCBs) in patients requiring parenteral nutrition in Spanish hospitals.

This is a retrospective observational database study of patients receiving parenteral nutrition (PN) for at least 3 consecutive days with hospital admission date between January 1, 2013, and December 31, 2015 (study period).

The study will use an as treated approach, where patients will be followed from the index date (hospital admission day of the hospitalization during which PN is administered) up to patient discharge or death (observation period).

The study will be conducted using an initial EMR (Electronic Medical Record) data retrieval process, followed by manual data retrieval (chart review) that will complement data obtained from EMR. Data collection for manual data retrieval will be conducted through an eCRF.

The documentation of patient data will comprise two sequential steps. The initial step will include data of 30% of patients and then an interim analysis (IA) will be conducted. If IA shows positive results, data for the remaining 70% of patients (step II) will be gathered.

The study will be conducted in 10-14 sites in Spain.

Data analysis: Baseline demographics, co-morbidities, and hospitalization characteristics will be reported descriptively by means of mean with standard deviations and medians with ranges for continuous variables and by counts and percentages for categorical variables. Incidence rates for BSI will be reported by treatment group.

Eligibility Criteria:
Inclusion Criteria:

1. Adult hospital inpatients ≥ 18 years
2. Treatment with PN for at least 3 consecutive days
3. PN containing all three major macronutrients, delivered from 3CB or HCB
4. Patients with hospital admission between January 1, 2013, and December 31, 2015 (study period)

Exclusion Criteria:

1. Bloodstream infection before or at the same day of first PN administration
2. Immunosuppression due to concomitant therapy (e.g., immunosuppressive therapy due to transplantation, concomitant oral or intravenous administration of glucocorticoids) or disease (e.g., HIV, leukaemia)
3. Permanent vascular access (port, shunts for dialysis)
4. Femoral venous placement of central venous line used for PN
5. Burns, extensive skin injuries (e.g., Lyell´s disease)
6. Chemo-/radiotherapy for up to 3 months before hospital admission
7. Change of PN bag type during observation period, e.g., from HCBs to 3CBs or vice-versa
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer

This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries


Eligibility Criteria:
Inclusion Criteria:

* Patients with localized breast or gynecological cancer treated as curative adjuvant and/or neoadjuvant chemotherapy and/or adjuvant radiotherapy. These treatments must have been completed within 6 months of inclusion.

  * Patient reporting a chronic, stable fatigue state at investigator assessment, defined as a fatigue score ≥ 4 on the visual analog scale rated up to 10, experienced for at least one month
  * Maintenance therapy with hormone therapy or other maintenance therapy (trastuzumab, bevacizumab...) is allowed before and/or during the study (except for pembrolizumab, abemaciclib and PARP inhibitors, which are not authorized)
  * Patient 18 years of age or older
  * Effective contraception in women of childbearing age
  * Patient affiliated to a social security plan
  * Signed informed consent

Exclusion Criteria:

* Other identified causes of fatigue (anemia of grade \&gt; 2, underlying chronic disease known to be associated with fatigue)
* Ongoing chemotherapy (patients scheduled for oral capecitabine or trastuzumab-emtasin in the adjuvant setting are not eligible)
* Metastatic breast or gynecological cancer
* Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab or PARP inhibitors
* Patient requiring oral diabetes therapy
* Regular intake of Vitamin C (in addition to what is provided by the diet)
* Patients with chronic pain requiring daily treatment with analgesics, anti-inflammatory drugs or corticosteroids
* Consumption of ginseng-based products in the month prior to inclusion
* Hypersensitivity to any of the components of Qiseng or placebo
* Pregnant or breastfeeding patient
* Simultaneous participation in another therapeutic clinical trial (trial using an experimental product)
* Patient deprived of liberty, under guardianship or curatorship
* Patient unable to undergo the medical follow-up of the trial for geographical, social or psychopathological reasons
* History of any other malignant disease during the last 3 years, except for skin cancer other than melanoma, carcinoma in situ of the uterus. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no signs of recurrence for at least 3 years
Coping Skills Treatment for Smoking Cessation

The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.

1. 18-65 years of age,
2. a regular smoker for at least one year,
3. currently smoking 10 or more cigarettes per day,
4. report motivation to quit smoking in the next month.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* regular smoker for at least one year
* currently smoking 10 or more cigarettes per day

Exclusion Criteria:

* Current Axis I disorder
* Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
* Current suicidal risk
* Pregnancy or breast feeding
* Use of nicotine replacement products or bupropion
A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.


Eligibility Criteria:
Inclusion Criteria:

* Transitional cell carcinoma of the urothelium. Urothelial cell carcinoma (UCC) variants are allowed, that is, UCC with squamous and/or glandular differentiation, micropapillary, nested, plasmacytoid, neuroendocrine, and sarcomatoid
* Diagnosis of one of the following: a) Metastatic or surgically unresectable urothelial cancer (UC) (Stage IV) or, b) localized surgically-resectable or resected UC with a T classification of T2 or above or non-muscle-invasive urothelial carcinoma of the bladder (Ta, T1 and carcinoma in situ \[CIS\])
* Available archival tissue sample for fibroblast growth factor receptor (FGFR) aberration analysis

Exclusion Criteria:

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