cyrilzakka/clinical-trials huggingface dataset:
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction

Less than 20% of patients with malignant distal bile duct (BD) obstruction (often pancreatic cancer) are suitable for resection surgery.In the rest,palliation treatment comes into focus. Jaundice caused by BD obstruction gives pain, infection (cholangitis), often itching and increased weight loss, and the patient is stigmatized by the deep yellow colour of the skin.Therefore palliation with endoscopic stenting by ERCP-technique is important. Modern self-expanding metal stents (SEMS) are now widely used in this context. Comparison in a RCT between steel and nitinol SEMS has never been performed.

The steel stent (Wallstent®) is the "original",is widely used, and has more expanding power. Nitinol stents are softer and claimed to be easier to insert,and are more and more popular.A newly developed nitinol stent (Wallflex®)may have these advantages, but is some 120 Euros more expensive.

Regarding the most important outcome measure, time to stent failure (obstruction), no one knows if there is any difference.Our hypothesis is that there is no difference in this main outcome endpoint.

Secondary outcome measures (compare above) are complications caused by the stent or stent insertion and technical ease to insert the stent. To discover a 12% difference between the 2 groups, regarding patency, 400 patients must be included in the trial, alfa 0.05, beta 0.8. Investigators know from previous trials (Single center trial South Hospital GIE 2006;63:986-995 and a newly finished similar swedish multicenter trial,prel data DDW- 09)that the 9 hospitals recruited will be able to include this no of patients in approximately 2.5 years.

Investigators will have a shortest follow-up period of 10 months, followup will be by phone with standard questions connected to stent failure, which is defined clinically AND by a new ERCP with intervention because of an obstructed stent.

Eligibility Criteria:
Inclusion Criteria:

* pt more than 20yrs.
* BD stenosis at least 2cm distal of the hepatic hilum, with typical malignant exposure radiologically.
* Clinically in accordance with tumour.s-bilirubin more than 50 micromol per litre.
* Radical surgery probably not possible(temporary-1month-plastic stenting for further investigation and then exchange to SEMS if estimated non-operable, after Rx is allowed).
* The patient must be fully informed by his doctor orally and in writing prior to the procedure, and give her/his informed consent. Ultrasound or CT examination must be performed prior to Rx.

Exclusion Criteria:

* Informed consent not obtained.
* Significant multiple intrahepatic stenosis by multiple tumour growth, not suitable for ERCP stenting.
* Radical Surgery will probably take place. Suspicion of non-malignant obstruction-further investigation must be performed.
* Not possible by anatomical reasons to reach the papilla, i.e because of prior operations.

prior BD stent inserted (metal stent or plastic stent \>1month).

* Previously included in this trial. Prothrombin index more than 1.5. (normal \<1.1).
Oat and Cholesterol

The primary objective is to assess the effect of an oat ingredient provided over 4 weeks on serum LDL cholesterol in men and women with elevated LDL-cholesterol compared to a placebo.

Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol, triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score


Eligibility Criteria:
Inclusion Criteria:

1. Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L)
2. Males and non-pregnant, non-lactating females 18-65 years
3. Agree to consume the investigational product three times daily for the duration of the study
4. BMI 18.5 to 39.9 kg/m2
5. Blood pressure \<160/100 mmHg
6. Fasting triglycerides \<4.0 mmol/L
7. Fasting serum glucose \<126mg/dL (\<7 mmol/L)
8. Serum urea and creatinine \< 1.8 times upper limit of normal (ULN)
9. Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) \< 2 times ULN
10. Hemoglobin \> 0.9 times lower limit of normal and \< 1.1 times ULN
11. Have a stable body weight (\<7 kg change) over the past 3-months
12. Absence of health conditions that would prevent fulfillment of study requirements

Exclusion Criteria:

1. Pregnancy, breastfeeding or planning to be pregnant
2. Allergy or sensitivity to study product ingredients
3. Dislike description of study product
4. Diet containing ≥15% of energy from saturated fat
5. Consuming \>20g fiber/per 1000 Kcal or \>40g fiber/day (including soluble fiber supplements)
6. Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week
7. Extreme dietary habits
8. Smoking \>5 cigarettes or equivalent per day
9. Use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization
10. Active major gastrointestinal disorder
11. Major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization
12. History of cancer within two years or randomization, except for non-melanoma skin cancer
13. Any condition or substance use which might, in the opinion of the PI, make participation dangerous for the participant, lead to poor attendance or compliance or affect the results
Leveraging Chatbot to Improve PrEP in the Southern United States

The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.

In the United States (US), the epicenter of the HIV epidemic is in the South. The HIV-related death rate in the US South is high, but engagement with quality HIV prevention services and care is low. Although only 38% of the US population lives in the South, the region accounts for 51% of new HIV infections. Gay, bisexual, and other men who have sex with men (MSM) account for 60% of new infections among African Americans in the South. Black MSM are one of the most vulnerable groups to HIV transmission in the US. HIV testing and PrEP uptake in Black MSM, however, remain low (10%) due to multiple factors including stigma, sexual-orientation based discrimination and low PrEP awareness among Black MSM. Innovative strategies that motivate and provide guidance for PrEP among Black MSM in the US South are therefore urgently needed. Chatbot technology should be tested and implemented to help improve PrEP awareness and uptake in the US South. In this project, the investigators aim to develop and pilot test to assess the acceptability and feasibility of a chatbot for PrEP awareness and uptake relative to treatment as usual (control).

Eligibility Criteria:
Inclusion Criteria:

* Being cisgender Black male
* Being aged ≥ 18 years
* Having Internet access
* Speaking English
* Self-reporting condomless sex with another man in the past 6 months
* HIV negative or untested.

Exclusion Criteria:

* Having lived in the US South less than 3 months
* Having received antiretroviral therapy (ART) treatment.
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older participants of VITAL.

Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set of participants: 1) among participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids modify agent effects.

Eligibility Criteria:
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:

1. are aged 60 or more
2. have no hearing impairment
3. indicate a willingness on the run-in phase to participate in a cognitive sub-study.
Super Skills for Life Effectiveness in the Online Modality

The study aims to evaluate the effectiveness of the transdiagnostic program Super Skills for Life (SSL). This protocol targets children aged 8 to 12 with emotional problems (anxiety, depression, low self-esteem, and lack of social skills). SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits, and coping strategies. The present research focuses on assessing the effectiveness of SSL applied online (through a virtual platform).

After selecting the children based on the online questionnaires completed by the parents (preintervention assessment) and inclusion/exclusion criteria, they were randomly allocated to the conditions of the intervention group and the wait-list control group. Parents and children from both groups completed the same measures at baseline, post-treatment, and 12 months follow-up. Children in the experimental group received the SSL program by the virtual platform.

The objective of the study is to evaluate the benefits of the Super Skills for Life protocol applied online. For this purpose, the researchers will test to what extent the experimental group decreases its anxiety symptoms, anxiety impairment, depressive symptoms, behavioral problems, hyperactivity/inattention, and peer relationship problems, and increase its self-esteem and prosocial behaviors, compared to the control group.

In conclusion, the purpose of the study is to explore whether SSL implemented online can be a cost-effective psychological intervention to prevent emotional problems in Spanish children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-12
* Presenting subclinical symptoms of emotional problems (anxiety, depression)
* Speaking, reading, writing, and understanding Spanish.
* Not receiving psychological or pharmacological treatment for emotional and/or behavioral problems

Exclusion Criteria:

* Had a psychiatric diagnosis already established
* Presenting a severe developmental disorder (intellectual disability, autism spectrum disorder, etc).
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates of very low birth weight infants.

The number of very low born weight infants increased every year.they are suffer from many questions.Recent studies have shown that Oropharyngeal administration of colostrum to very low birth weight infants can reduce the time reach full enteral nutrition .But there are no evidence support that it can promote infants' immune response. The hypothesis of the current study is that Oropharyngeal administration of colostrum to very low birth weight infants may increase the secretion of sIgA in urine and saliva.

The current study adopts randomized, double blind, controlled intervention trial, gives Oropharyngeal administration of colostrums to very low birth weight infants in intervention group and Oropharyngeal administration of Normal saline to control group. All indicators in this study are discrete traits, for sIgA、Lactoferrin number in Saliva and urine， number of CRP，time Begin oral feeding，time up to full enteral feeding， Person's chi-square tests were used for comparisons. For Blood culture results，The number of necrotizing enterocolitis (NEC) occurred， the investigators use Chi-square tests for comparisons between two groups. The study expects that Oropharyngeal administration of colostrum to very low birth weight infants can increase the secretion of sIgA in urine and saliva.

Eligibility Criteria:
Inclusion Criteria:

1. Born weight≤1500g
2. transferred to our hospital within 24 hours after birth
3. the mother can provide colostrum
4. parents of the infants agreed to participate in this study

Exclusion Criteria:

1. The infants suffering from life-threatening conditions ,such as severe heart disease,whose survival time are expected \<30d
2. The infants suffering from any kinds of disease,which impact they take human milk by mouth.(such as gastrointestinal malformations, NEC, etc.）
3. human milk is contraindicated

   * An infant whose mother :

     * Is infected with the human immunodeficiency virus (HIV)
     * Is taking antiretroviral medications
     * Has untreated active tuberculosis
     * Is infected with human T-cell lymphotropic virus type l or ll
     * Is using or dependent on an illicit drug except if the breastmilk is medically indicated
     * Is taking prescribed cancer chemotherapy agents contraindicated for breastfeeding
     * Is receiving any medications contraindicated in breast feeding
     * Is receiving diagnostic or therapeutic radioactive isotopes or exposure to radioactive materials (for as long as they are radioactive in the milk)
   * An infant diagnosed with galactosemia, a rare genetic metabolic disorder
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT


Eligibility Criteria:
Inclusion Criteria:

1. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
2. Negative or equivocal 99mTc Sestamibi SPECT/CT
3. Able to provide written consent
4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
6. Karnofsky performance status of \>50 (or ECOG/WHO equivalent)
7. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.

Exclusion Criteria:

1. Less than 18 years old at the time of radiotracer administration
2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 60 mL/min or serum creatinine \>1.5 x ULN
3. QTcF \>470 msec on electrocardiogram (ECG) or congenital long QT syndrome
Improving Learning in Hispanics With TBI or MS

The goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective.

A pilot study will be conducted to carry out this validation and resolve any methodological concerns in the translated protocol. 20 Spanish-speaking Hispanics at least one year post-traumatic brain injury (TBI) and 20 Spanish-speaking Hispanics with multiple sclerosis (MS), both with an objective deficit in learning and memory will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Subjects are randomly assigned to either the experimental or control groups. Experimental and control treatments includes two 45-60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on an objective measure of learning and memory.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 65
* Spanish is my dominant language, and I have had a traumatic brain injury or I have multiple sclerosis.

Exclusion Criteria:

* Participants with major depressive disorder, schizophrenia, bipolar disorder I or II
* MS subjects: Individuals with a history of head injury, stroke, seizures, or any other significant neurological history will not be included in the study.
* TBI subjects: Individuals must have sustained a TBI at least one year prior to enrollment in the study protocol. Individuals with a history of significant neurological insult other than TBI (e.g. premorbid epilepsy, multiple sclerosis, Alzheimer's disease) will not be included in the study.
Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

Predictive factors of osteoarthritis progression are not yet well understood. However, a growing role attaches importance to the subchondral bone. The aim of the present project is to determine predictive factors of progression of osteoarthritis at the knee by a multimodal characterization of subchondral bone by Medical Resonnance Imaging, direct high resolution digitization radiographs and bone texture analysis. At the end of the project, an innovative imaging device, combining semi-automatic softwares for texture analysis, control detection and image registration would be supplied. This will enable on the one hand a more accurate and reproducible way to measure the joint space width of the affected compartment and on the other hand, an assistance to better detect patients at risk of progression of their knee osteoarthritis. Identifying These "progressors" patients might permit their selection in clinical trials at baseline adapted to their severe disease, using for example biologic treatments targeting knee osteoarthritis. The main objective of this study is to analyze the predictive capacities of bone texture parameters measured on the high-resolution radiography of the knee on the structural evolution of the knee osteoarthritis at 3 years.


Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis according to the criteria of knee osteoarthritis of American College of Rheumatology.
* Having felt a painful push in the last 6 months.
* Visual Analogic Scale pain \> 4 on a 0 to 10 scale.
* having a Radiographic score of OARSI (Osteoarthritis Research Society International Score) from 2 to 3 whether it is for the presence of a joint space narrowing or the presence of an osteophyte

Exclusion Criteria:

* Patello-femoral degenerative osteoarthritis isolated.
* Incapacitated to consider the position in schuss for the realization of the radiography.
* Valgus \> in 5 °
* Secondary degenerative osteoarthritis
Isolated or Combined Use of NUTRIC Score and NRS-2002 to Predict Mortality in the Intensive Care Unit

The objective of this investigation was to assess the predictive capacity of the NUTRIC Score and NRS-2002, separately or combined, in forecasting hospital, 28-day and 3-month mortality in patients with respiratory failure admitted to the intensive care unit.

Malnutrition is a significant and widespread issue amongst hospitalized patients. Its prevalence is higher in critically ill patients who are admitted to Intensive Care Units (ICUs). Nutritional screening aims to estimate the probability of both positive and negative outcomes in patient treatment based on nutrition-related factors, and whether nutritional therapy can have a positive effect. The Nutritional Risk Score-2002 (NRS-2002) and Nutritional Risk Score in Critically Ill Patients (NUTRIC) are commonly used for nutritional risk assessment in critically ill patients. However, there is currently insufficient evidence in the literature to determine which scale should take precedence in the nutritional care protocol of critically ill patients with respiratory failure. Furthermore, there are no studies demonstrating the sensitivity of these scales varies based on the type of respiratory failure. This study aims to examine the effectiveness of the NUTRIC Score and NRS-2002, alone or combined, in predicting hospital, 28-day, and 3-month mortality in critically ill patients admitted to the intensive care unit with respiratory failure. Do the NUTRIC Score and NRS-2002 provide sufficient accuracy or is there a distinction when utilised singularly or together in forecasting mortality rates within the hospital, 28-day and 3-month time frames? Additionally, is there a defined threshold for predicting mortality in patients with respiratory failure when using the NUTRIC Score and NRS-2002 either by themselves or in conjunction? Does the efficacy of these prediction tools differ based on the type of respiratory failure?

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 and over
* Admission to the intensive care unit due to respiratory failure (respiratory distress is included in the complaints of patients when admitted to the intensive care unit).

Exclusion Criteria:

* Patients diagnosed with neurodegenerative diseases (Alzheimer's disease and other dementia diseases, Parkinson's disease, Prion disease, Motor neuron diseases, Huntington's Disease, Spinocerebellar ataxia, Spinal muscular atrophy)
* Pregnant patients
* Patients with a length of stay in the ICU of less than 72 hours
* Patients in the terminal period who were diagnosed with malignancy and whose treatment process was terminated due to lack of response to treatment.
Workshops for Veterans With Vision and Hearing Loss

This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.

This pilot study will enrolled 13 Veterans with Dual Sensory Loss (DSL), age 65 to over 89. The project headquarters in the Portland Oregon Veterans Affairs Medical Center will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators enrolled the 13 Veterans. Staff turnover reduced time available for enrollment and data collection. We therefore eliminated the original comparison group design and this study had only one experimental intervention arm and no control intervention or other arm. Veterans were chronologically enrolled who responded to recruitment letters and who passed telephone and onsite screening. The intervention consisted of six weekly two hour workshops providing information, skills training and exercises about self-managing DSL effects on daily life. Preliminary effectiveness data was collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach. This study data tracked pre and post intervention within subject changes.

Eligibility Criteria:
Inclusion Criteria:

* Veteran;
* Vision loss \> 20/70 better eye;
* Hearing loss \> 40 decibels better ear;
* Cognition Within Normal Limits (WNL);
* No behavioral flag or psychiatric diagnosis;
* Documented psychosocial restrictions secondary to vision and hearing loss

Exclusion Criteria:

* Vision and/or hearing can be corrected by surgical or pharmacological treatment;
* Requires use of sign language interpreter