cyrilzakka/clinical-trials huggingface dataset:
Effect of PVE on Surgical Outcomes and Long-term Survival in Perihilar Cholangiocarcinoma

Portal vein embolization is often recommended to reduce the risk of postoperative liver failure and mortality. In this retrospective cohort study, researchers investigated the effect of portal vein embolization in patients with resectable perihilar cholangiocarcinoma bismuth type III and IV.


Eligibility Criteria:
Inclusion Criteria:

1. patients with Bismuth type III or IV stricture on radiological examination, including computed tomography (CT) or magnetic resonance cholangiography
2. patients with perihilar cholangiocarcinoma histologically confirmed by surgical resection or forceps biopsy/brush cytology under endoscopic retrograde cholangiopancreatography or through the percutaneous transhepatic biliary drainage tract.

Exclusion Criteria:

1. patients with unresectable perihilar cholangiocarcinoma
2. patients who refused treatment
3. patients with other concomitant malignancies.
Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial is studying protein biomarker levels in tissue samples from young patients with low-risk Hodgkin lymphoma.

OBJECTIVES:

* To investigate the variability of expression of human geminal-center-associated lymphoma (HGAL) protein in pediatric low-risk Hodgkin lymphoma.
* To assess the variability of HGAL staining between risk groups by comparing samples from subjects enrolled in the low-risk study AHOD0431 with subject samples enrolled in AHOD0031 for intermediate-risk classical Hodgkin Lymphoma (cHL).
* To assess the variability of HGAL staining by evaluating a tissue array created from subjects with intermediate-risk cHL.
* To correlate rapid or slow early-response in the intermediate-risk group with HGAL protein expression.

OUTLINE: Paraffin-embedded tissue samples and tissue microarrays are analyzed for protein expression by IHC.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with low-risk classical Hodgkin lymphoma (cHL)
* Samples available from patients enrolled in the low-risk study COG-AHOD0431 and in the intermediate-risk cHL study COG-AHOD0031

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis

This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.
* Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month
* Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area
* Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

Exclusion Criteria:

* Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants had previous treatment with any topical or systemic PDE-4 inhibitor.
Study of Eteplirsen in Young Participants With Duchenne Muscular Dystrophy (DMD) Amenable to Exon 51 Skipping

This is a multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, and PK of once-weekly IV infusions of eteplirsen in approximately 12 male participants, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD with a deletion mutation amenable to exon 51 skipping.


Eligibility Criteria:
Inclusion Criteria:

* Male between 6 months to 48 months of age (inclusive)
* Diagnosis of DMD with a deletion mutation amenable to exon 51 skipping
* Parent(s) or legal guardian(s) who is willing to provide written informed consent

Exclusion Criteria:

* Received treatment that might have an effect on muscle strength or function within 12 weeks prior to dosing
* Received previous or current treatment with any experimental treatment
* Clinically significant illness other than DMD
* Clinically significant laboratory abnormality
* Any other condition that could interfere with the participation in the study.
Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD

High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.


Eligibility Criteria:
Inclusion Criteria:

Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour)

Exclusion Criteria:

* other lung/pleural diseases or thoracic deformity
* severe heart failure (New York Heart Association class IV), severe dysrhythmia
* unstable angina, or malignant comorbidity
* obesity (BMI ≥ 35 kg/m²)
* severe obstructive sleep apnea syndrome
Quality Control of CE-Certified Phonak Hearing Aids - 2017_13

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders
Postmenopausal Progestins, MI and Stroke

To evaluate the cardiovascular effects of postmenopausal hormone replacement therapy and the suspected beneficial effects on myocardial infarction and stroke.

BACKGROUND:

Post-menopausal women who use estrogens generally experience at once a reduced risk of coronary heart disease and, at the same time, an increased risk of endometrial cancer. In order to protect the endometrium from unopposed estrogens, many physicians now recommend the addition of a progestin during 10-13 days of the cycle. Progestins may be implicated in the increased risk of myocardial infarction in women on oral contraceptives.

DESIGN NARRATIVE:

This was a case-control study. The computerized files of the Group Health Cooperative (GHC) in Seattle were used to identify cases. All postmenopausal women, aged 40 to 79, were eligible as cases if, according to World Health Organization criteria, they presented with a fatal or non-fatal myocardial infarction. A random sample of women listed in the enrollment files at GHC served as a source of potential controls. Review of the out-patient medical records, performed by an assistant blind to case-control status ensured that all study subjects met the same criteria. Telephone interviews were used to obtain information about exposure to postmenopausal hormones as well as known risk factors. The computerized pharmacy records at GHC provided additional information about exposure. Frequency matching controlled for the potential confounding effects of age and year of presentation. Stratification and logistic regression were used in data analysis.

The study was renewed in 1995 to make more precise some of the indeterminate findings related to current use, cumulative dose and duration of use but also to extend the assessment of the risk or benefit to incident strokes. The study ended in January, 1999.

Eligibility Criteria:
No eligibility criteria
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.


Eligibility Criteria:
Inclusion Criteria:

* Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

  * All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  * Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
  * Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  * Finasteride or dutasteride use at any time.
* Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
* Have prostate enlargement measured by ultrasound at screening.

Exclusion Criteria:

* Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer \[Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study\].
* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
* Have problems with kidneys, liver, or nervous system
* Have uncontrolled diabetes
* Have had a stroke or a significant injury to brain or spinal cord.
* Have scheduled or planned surgery during the course of the study.
Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)

this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term patency of each modality

End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline therapy for patients with ESRD. A proportion of hemodialysis patients exhaust all options for permanent vascular access (fistula or graft) in both upper extremities.ePTFE grafts are easily subjected to graft outflow tract intimal hyperplasia, which may lead to graft outlet stenosis and graft thrombosis after a certain period of usage. The commonest cause of PTFE graft failure is intimal hyperplasia (IH) at the venous anastomoses. our study aims to evaluate the influence of double cuffed ePTFE grafts with autologous vein cuffs on the long-term patency of dialysis access, and compare the clinical patency and the complications occurring with the usage of the double cuffed graft to that with standard non cuffed grafts in chronic renal hemodialysis therapy.

this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long term patency of each modality

Eligibility Criteria:
Inclusion Criteria:

1. Patients with end stage renal diseases and GFR less than 30
2. By clinical examination in ability to palpate distal or proximal upper limb veins 3. By duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible 4. Patients with previous history of failed attempts of autogenous vein creation 5. Patients with border line cephalic or basilica vein (3mm) and on intraoperative the vein diameter appears to be unsuitable (less than 3 mm).

Exclusion Criteria:

1. All patients with palpable suitable forearm or arm veins
2. Patients with baseline blood pressure less than 110/70
3. Brachial artery of diameter less than 4 mm
4. Patients with ligated brachial artery
5. Patients with history of central vein stenosis
6. Patients with immunodeficiency states
The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children

In this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200, on the severity of autism symptoms and the quality of life in children with Autism Spectrum Disorder aged 7 to 15.

This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and eight children aged 7 to 15 years diagnosed with Autism Spectrum Didorder will be randomly assigned in a 1:1 ratio to receive either a multispecies probiotics or a placebo for 12 weeks. The probiotic mixture contains 5 x 10\^9 colony forming units per dose consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200.

The two co-primary outcomes will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS) and quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A). The secondary outcomes will include evaluations of sleep impairments using Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A), parental stress levels using Parenting Stress Index-III (PSI-III), gastrointestinal symptoms using Gastrointestinal Symptom Rating Scale (GSRS), and urinary p-cresol levels. These outcomes will be assessed twice: at baseline and after 12 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-5) or International Classification of Diseases, Tenth Revision (ICD-10).
2. Children either not taking any medication or receiving the same medication for the last 2 months.
3. Patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study.

Exclusion Criteria:

1. Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics).
2. Use of probiotics or synbiotics within the previous 2 months.
3. History of intolerance or allergy to probiotics, synbiotics or any other study product component.
4. Surgery with bowel resection or short bowel syndrome.
5. Children with severe immunodeficiency.
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.

Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
* Lasting for 6 months since initial diagnosis
* Rated severe
* Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
* Refractory to topical steroids

Exclusion Criteria:

* Female patients who are pregnant or want to become pregnant
* Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
* Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy
Assessing Brain Metabolism Using MRS With Deuterated Glucose

This study will investigate the use of Hydrogen 1 (1H) magnetic resonance spectroscopy (MRS) with deuterated glucose (2H-glucose) to detect dynamic glucose uptake in the brain.

PRIMARY OBJECTIVE:

1. To define the most appropriate imaging parameters of 1H MRS for obtaining deuterium-labeled glucose metabolism (Cohorts 1 and 2).
2. To evaluate treatment induced metabolic changes after the administration of 2H-glucose in participants with glioma (Cohort 3).

OUTLINE:

Participants with and without glioma will be evaluated to develop a robust strategy for obtaining 2H-glucose metabolism in twenty healthy participants (cohort 1) and thirty participants with glioma (cohort 2), while the remaining thirty glioma participants will be studied at baseline and after completion of non-investigational therapy (cohort 3).

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be \>= 18 years old

   * Cohort 1: Healthy controls
   * Cohort 2: Participants with histological proven glioma who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion \> 4 cc) based on a prior MR scan, Karnofsky performance status of \>=70 and life expectancy \> 4 weeks.
   * Cohort 3: Participants with histologically proven glioma who will be undergoing any treatment, Karnofsky performance status of \>=70 and life expectancy \> 12 weeks.
2. Participants must not have any significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the subject's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
3. Participants must not have a history of any other cancer unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years.
4. Participants must not be pregnant or breast-feeding. Persons of childbearing potential are required to obtain a negative serum or urine pregnancy test within 14 days of the scan. Effective contraception (men and women) must be used in subjects of childbearing potentials.
5. Participants must sign an informed consent indicating that they are aware of the investigational nature of the study

Exclusion Criteria:

Participants must be excluded from participating in this study if they are not able to comply with the study and/or follow-up procedures.

1. Participants exceeding the weight limitations of the scanner (300 pounds)
2. Inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.)
3. Inability to complete the study due to other reasons (severe claustrophobia, MR incompatible medical implants or devices, inability to comply with pre-procedure fasting, etc.)
4. Pre-examination blood glucose level of \> 120 mg/dL as measured by point of care finger stick blood glucose test prior to MR examination.
5. Participants, either healthy volunteers (recruited for cohort 1) or participants with glioma (for cohorts 2 \&3), have history of diabetes mellitus.