cyrilzakka/clinical-trials huggingface dataset:
Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).

The study design consists of 4 study visits, two performed before (V1 at day -7 and V2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatment (V3 at day 49 and V4 at day 56). Biometrics, fasting blood samples and a standard mixed meal test are performed at V2 and V4. 75Se-HCAT scintigraphy is carried out between V1 to V2 and V3 to V4, respectively. Between V2 and V3 the subjects will have two telephone calls and one visit at the Endocrine Research Unit for fasting blood samples to make sure they do not experience any adverse events and are compliant.

The control groups will only participate in V1 and V2. The aim with the control groups is to have baseline values for unoperated subjects with and without diabetes to compare with the values in the intervention group after 8 weeks of depletion of endogenous bile acids.

Eligibility Criteria:
Inclusion Criteria:

Intervention group

* RYGB-operated ≥ 18 months prior to inclusion
* History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
* HbA1c \<58 mmol/mol on no antidiabetic medication or metformin alone
* Weight change \< ±3 kg for \>3 months at time of inclusion

Control group A

* No history of diabetes
* HbA1c \<48 mmol/mol at time of inclusion
* Fasting plasma glucose \< 7.0 mmol/L at time of inclusion
* Weight change \< ±3 kg for \>3 months at time of inclusion Control group B
* Type 2 diabetes (HbA1c ≥48 mmol/mol or use of antidiabetic medication at time of inclusion)
* Weight change \< ±3 kg for \>3 months at time of inclusion

Exclusion Criteria:

* Pregnancy or breastfeeding
* Haemoglobin \< 6.5 mmol/L at time of inclusion
* Fasting plasma glucose \> 10.0 mmol/L at time of inclusion
* Prior cholecystectomy
* Chronic or tendency to diarrhoea
Medicine Abuse Headache

In patients with MOH, we will evaluate the impact of educative telephone coaching on the number of days with headache over the month preceding the appointment. The educative coaching will be administered by a nurse, during a single phone call and prior to the medical visit

In tertiary centers, it is not unusual for patients to wait for 6 months for a medical appointment. This clinical trial is monocentric, open, randomised. In the first arm, the patients will receive educative telephone coaching at Month 2 by the nurses, over the phone. In the second arm, the patients will not receive any educative telephone coaching before the appointment with the neurologist.

All patients will complete "Quality of life" questionnaires at Month 1 and Months 6, complete a migraine agenda during the length of the study and have a medical appointment around Month 6.

The primary outcome will be the efficacy of such educative telephone coaching, administered before the medical appointment in the Chronic Pain Center, in Bordeaux. It will be measured by the number of days with headache over the month preceding the appointment.

Eligibility Criteria:
Inclusion Criteria:

* Adults, male or female, \> 18 years old
* Patients with a presumptive medication overuse headache diagnostic (\>15 days/month with migraines, \> 10 days/month intake of crisis treatment)
* Persons calling the Chronic Pain Center in Bordeaux and asking for a medical appointment
* Informed and written consent, dated and signed by the patient and the investigator prior to any study related procedure

Exclusion Criteria:

* Patients with a differential diagnostic (other primitive headaches and secondary headaches)
* Persons non affiliated to a social security system
* Persons who refuse to participate in the study.
Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients

The purpose of this study is to compare X-ray images obtained using the GM85 digital radiography machine at the standard full dose to X-ray images obtained using the GM85 digital radiography machine along with the Samsung S-Vue system, which is a image post-processing engine that allows images to be obtained using a lower dose. The study also aims to determine the lowest dose of radiation that can be used to get a good, readable x-ray of the chest in pediatric patients using Samsung S-Vue system.


Eligibility Criteria:
Inclusion Criteria:

* Standard weight/height outpatients who require two X-ray exams within 3 months in the US
* BMI is \>5% and \< 85% for participants over the age of 2;for participants less than 2 weight for length will be measured

Exclusion Criteria:

* Obese and underweight children as defined as BMI ,\<5% or \>85% according the World Health Organization growth chart for participants over 2 years of age; and for participants less than 2 years of age,weight for length will be measured
Preoperative Bevacizumab for Vitreous Hemorrhage

The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss lasting more than three months in patients not previously treated and four months in those previously LASER treated.

Exclusion Criteria:

* Previous intra-ocular surgery other than cataract surgery
* Retinal detachment
* Use of anticoagulants drugs other than aspirin
* Vitreous hemorrhage clearance at week-3 study period
* History of previous thromboembolic events
Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer

The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of old.
* Have been diagnosed with breast cancer
* At least one year disease-free interval after initial treatment.
* Have pre-study laboratory tests that are within the requirements of this study.
* Be able to visit the doctor's office weekly during the treatment period.

Exclusion Criteria:

* To be pregnant or breastfeeding.
* To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy.
* To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment.
* To have another illness that your doctor thinks would make you unable to participate.
* To be unable or not willing to take folic acid and vitamin B12.
Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients

The site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. Transradial access (TRA) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (RAO) that limits the radial artery for future needs.

Distal radial access (dTRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dTRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort.

This study aims to reveal the feasibility and safety of dTRA and routine TRA procedures in acute coronary syndrome patients. The primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (MACEs) in the two groups, respectively. Investigators will also focus on puncture success in diagnostic and interventional cases, rate of One attempt success, access time, procedure time, crossover rate, contrast dose of patients, fluoroscopy time and dose, and healthcare cost of each group.


Eligibility Criteria:
Inclusion Criteria:

* presence of a pulse in the snuffbox

Exclusion Criteria:

* Absence of pulse
* Ultrasound indication of arterial occlusion or severe calcification
* Severe forearm artery malformation
* Patients with severe liver and renal failure, or abnormal coagulation function
* Established cardiogenic shock
* History of previous coronary artery bypass grafting and radial artery use.
* Raynaud's disease in the medical history
Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma

Phase III randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2 to 4 months after the end of treatment. The randomization ratio is 1:1.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged superior to 35 years
* Current or previous smokers (smoked more than 10 packs year) or alcohol drinkers (current or previous, more than 140 g alcohol per week) or both
* Histologically proven invasive HNSCC stage 0 to IVa, excluding T4b and nasopharynx. Patients with in situ carcinoma are eligible.
* Treated with curative intent
* Free of cancer at the post-treatment clinical and radiological examination (negative PET-CT for N≥2) at least 2 months after the end of the last treatment and no later than 4 months after. If there is a strong doubt of lack of complete remission (for example if more exams or longer follow-up are needed to affirm or deny complete remission), the patient is not eligible for the trial.
* Remark: Patients with several head and neck squamous cell carcinoma (concomitant or successive), all treated with curative intent and all in complete remission, are eligible.
* Agree to have a long term follow-up
* Signed informed consent
* Patient affiliated to a social security system or beneficiary of the same

Exclusion Criteria:

* Pregnant or breastfeeding women
* Severe psychiatric condition that may inhibit protocol participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
* Impossibility to perform the planned exams of the intensive strategy
* Nasopharyngeal carcinoma
* Other malignancies within 5 years prior to randomization that needs followup by PET-scan or chest CT or head and neck CT/MRI
* Any disease that needs follow-up by regular upper digestive endoscopy
Real World Perspectives on Advancements in Hearing Aid Technology

This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.

Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.

This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.

Eligibility Criteria:
Inclusion Criteria:

* Moderate sensorineural hearing loss
* Experienced hearing aid user
* Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial
* Smartphone user for receiving study alerts

Exclusion Criteria:

* Cognitive impairment
* Not willing to wear hearing aid
The Effect of Rifaximin on Portal Vein Thrombosis

The aim of this study is to evaluate the efficacy of rifaximin in the treatment of portal vein thrombosis in cirrhotic patients

Portal vein thrombosis is not an uncommon complication in cirrhotic portal hypertension, which lead to a poor prognosis in endoscopic management of variceal bleeding. Evidence indicated that enoxaparin prevented PVT and liver decompensation via decreased rates of bacterial infections and lowered the potent inflammatory mediators such as interleukin-6. Rifaximin is a broad-spectrum antibiotic that exerts endotoxin-lowering and anti-inflammatory effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 y.o. ≤age≤75 y.o
* Cirrhotic patients had CTA confirmed portal vein trombosis
* D-dimer no more than five times the normal upper limit

Exclusion Criteria:

* age \<18 y.o. or age \> 75 y.o.
* had portal cavernoma
* received anticoagulation treatment in the past 6 months
* splenectomy
* Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
* Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.
* Acute variceal bleeding within 5 days.
* Use of other antibiotics in the past 2 weeks
* Acute portal vein thrombosis
Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer

RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.

OBJECTIVES:

* Evaluate the value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death in patients who have undergone radiotherapy for localized prostate cancer.

OUTLINE: This is a multicenter study.

Patient medical records are reviewed to collect data about pre-treatment prostate biopsy, assigned Gleason score, prostate-specific antigen level, and radionucleotide bone scan.

Patients complete a Bowel Toxicity questionnaire to assess quality of life related to acute and long-term bowel toxicity after radiotherapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of localized adenocarcinoma of the prostate
* Has undergone radiotherapy (external beam radiotherapy and/or brachytherapy) with or without hormonal therapy for adenocarcinoma of the prostate in the University of California, San Francisco (UCSF) Radiation Oncology Department at San Francisco General Hospital or Veterans Administration Medical Center of San Francisco between 1987 and 2006

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia

The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that treatment will decrease symptom severity and will not have any significant side effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of torticollis with noticeable symptoms for at least 6 months
* Total TWSTRS score greater or equal to 20, TWSTRS severity score greater than or equal to 10 and TWSTRS Disability score greater than or equal to 3 (must meet all 3 criteria)

Exclusion Criteria:

* Diagnosis of isolated anterocollis
* Concurrent myopathic disease, myotonic dystrophy (or other form of muscular dystrophy), myasthenia gravis
* Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymixins, anticholinesterases, magnesium sulfate, or lincosamides
* Any illness that is considered by the Investigator to make the subject an inappropriate candidate
* Cervical spine injury within 18 months or head and neck surgery within 6 months prior to screening
* Pre-existing dysphagia
* History of active autoimmune disease
* Exposure to botulinum toxin based pharmaceutical within 3 months prior to screening
* History of primary non-response or secondary resistance with prior exposure to botulinum based pharmaceuticals
* History of chemotherapy/radiation for malignant disease within 24 months
* Any investigational drug/device during the 30 days prior to screening
Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.

Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.

Eligibility Criteria:
Inclusion Criteria:

* Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR thimerosal.
* All subjects must be adults (18 years of age or older) and otherwise in good health.
* Pre-menopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.
* Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

Exclusion Criteria:

* Subjects unable to meet inclusion requirements.
* Women who are breastfeeding or pregnant.
* Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
* Systemic treatment during the last 7 days with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents.
* Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
* Acute dermatitis outbreak or dermatitis on or near the test area on the back.
* Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
* Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study.
Social Media, Teen Moms and PPD

Approximately 400,000 live births occur to adolescents in the United States annually. Of the 50% of adolescent mothers who experience depressive symptoms, less than 25% comply with referrals for depression evaluation and treatment due to lack of knowledge of depression symptoms (literacy), negative attitude towards mental health treatment, perception that individuals with depression are stigmatized (subjective norms), lack of understanding of health resources that are available to her and under her control (perceived control), and lack of time. Social media is a promising vehicle to reach and educate adolescent mothers since most adolescent mothers use social media for communication and to search for health information. Based upon the Theory of Planned Behavior, the investigators will target 11 counties in Kentucky with a social media ad campaign that will result in adolescent mothers (n=140) from those counties enrolling in an internet based intervention related to postpartum depression. The previously tested intervention includes vignettes from other adolescent mothers, questions and answers, resources, and an option to enroll in text message service. Before the intervention, after the intervention, and two weeks later the adolescent mothers will complete established questionnaires to determine if the intervention improved attitude and subjective norms towards depression and depression treatment, perceived control and intention related to seeking depression treatment, and the number of adolescent mothers with symptoms of depression who receive depression treatment. Data will be compared to scores on the same instruments from adolescent mothers (n=140) from the control group (18 other counties in Kentucky) that have not been targeted with the social media ad campaign or participated in the intervention. Data from the adolescent mothers in the control group will be collected in partnership with community agencies. The overall purpose of this trial is to test a cost effective and feasible method for reducing the cognitive and emotional barriers to accessing depression treatment in adolescent mothers. The specific aims are to (1) measure the extent to which a social media ad campaign is effective as a recruitment strategy; (2) test the effectiveness of an internet based social marketing intervention on both intention to seek treatment and rates of depression treatment, and (3) examine the dose effect of the intervention.


Eligibility Criteria:
Inclusion Criteria:

Adolescent mothers, 13-21 years of age, who delivered a live child within the last 12 months, and has their baby residing with them. For the adolescent mothers enrolled in the Internet-based social marketing intervention, they must reside in Kentucky counties of Fayette, Jefferson, Bullitt, Henry, Oldham, Shelby, Spencer, Trimble, Christian, Warren or Barren. The adolescent mothers enrolled in the control group must reside in Kentucky counties of Campbell, Casey, Daviess, Boone, Nelson, Russell, Carroll, Kenton, Hardin, Hancock, Henderson, McClean, Meade, Ohio, Union, Webster, Meade or Marion

Exclusion Criteria:
Capnography Monitoring in Ventilated Children

End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.

End-tidal and arterial CO2 measurements will be performed in invasively and non-invasively ventilated critically ill children. The endtidal CO2 values will assessed for their accuracy with respect to different underlying diseases and conditions of the children.

Eligibility Criteria:
Inclusion Criteria:

* Children on pressure controlled mechanical invasive or non-invasive ventilation on the Paediatric Intensive Care Unit of the University Children's Hospital Zurich
* Newborns with a birthweight of at least 2.0 kg
* Newborns with an age of at least 1 hour (age \> 60 minutes)
* Children up to the last day of the 13th year of living
* Ability of care taker or patient to understand verbal and written instructions and the general consent or informed consent in German or English
* Obtained written general or informed consent as documented by signature
* Available arterial line, i.e. a specific catheter inserted in an artery

Exclusion Criteria:

* Care taker or participant unable for linguistic, mental or other reasons or unwilling to understand verbal or written information and to give written informed consent in German or English
* Care taker not available
* Newborns with a birthweight below 2.0 kg
* Newborns younger than 1 hour (age \<60 minutes)
* Children with an age of 14 years onwards
* Missing arterial line
* Patients dependent on any other kind of respiratory support that is not compatible with the PcCO2-sensor or where a high leakage in the respiratory circuit makes PcCO2 measurements impossible (nasal mask ventilation, low-flow-/high-flow-ventilation, rebreathing mask, high- frequency-oscillation)
* Patients where the investigators act on the assumption that mechanical ventilation will be discontinued and/or the arterial line will be removed within 6 hours or where only one pair of values (arterial and endtidal CO2) can be compared
* Patients with a cyanotic shunt lesion with a weight of 15 kg or above