cyrilzakka/clinical-trials huggingface dataset:
Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease
* Prostate cancer progression documented by PSA progression or radiographic progression
* Asymptomatic or mildly symptomatic from prostate cancer
* Surgically or medically castrated, with testosterone levels of \<50 ng/dL
* Previous anti-androgen therapy and progression after withdrawal
* ECOG performance status score of 0 or 1
* If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1
* If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1
* If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days
* Life expectancy of at least 6 months

Exclusion Criteria:

* Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
* Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily
* Pathological finding consistent with small cell carcinoma of the prostate
* Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months
* Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
* Radiation or radionuclide therapy for treatment of mCRPC
* Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment
* History of pituitary or adrenal dysfunction
Testing Strategies for Increasing Exercise

The purpose of the study is to learn more about effective ways to motivate people to increase their non-exercise energy expenditure exercise. This is an important research question because obesity and weight-related issues are increasingly becoming a problem in America. This project will address this research question by testing the effect of group dynamics in motivating employees who are predominantly sedentary to use Walkstations at work. The Walkstations are treadmills that move at a very slow rate (maximum 2miles / hour) and are attached to a work station (i.e. with computer and telephone); they therefore are designed to increase energy spent not through heavy exercise, but through small changes in posture and movement associated with routines in daily life (called nonexercise activity thermogenesis or NEAT). The proposed study is designed to build upon previous research (Levine et al., 2005) suggesting the role of NEAT-enhanced behaviors in weight loss.

In this study, the investigators are interested in the impact of group dynamics on the propensity to use the Walkstations. Participants in the active arms will be asked to use the Walkstations for at least 3 hours per week. They will do so by signing up for a time slot. During their session, they will be asked to log into the scheduling system to indicate that they are using the Walkstation. Walkstation usage will be assessed by log-in data: employees will log-in to the phone and computer when they use the Walkstation. This log-in data is work-station specific; therefore the investigators will be able to tell when a given subject used the Walkstation.

Subjects will be randomly assigned to one of three conditions:

1. Individual. In the individual condition, participants will not be part of a team. They will receive weekly email feedback on their Walkstation performance (e.g. number of time slots they signed up for, and number of times they showed up for the time slot.) Participants will also receive a wellness tip in each email. (see appendix for a sample email)
2. Pairs. In the pair condition, participants will be randomly assigned to a partner. They will receive the same feedback as those in the individual condition, for both themselves AND their partner.
3. Group. In the group condition, participants will be randomly assigned to a group of 5 people. They will receive the same feedback as those in the individual condition, for both themselves AND each member of their group.


Eligibility Criteria:
Inclusion Criteria:

* Must pass the ParQ
* Must be employee of BCBS Massachusetts

Exclusion Criteria:

* Failing the ParQ
* Not being an employee of BCBS Massachusetts
Investigating the Correlations Between Dysphagia Symptoms and Swallowing Muscle Groups by HRPM-I

Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by high resolution pharyngeal manometry with impedance

Backgrounds: Some patients would experience dysphagia symptoms before the elective surgery. These patients usually do not have a history of head and neck surgery or cerebrovascular diseases. They are common causes of dysphagia. The anesthetics and airway manipulation can exacerbate dysphagia. However, research is limited on the specific weak muscle groups in patients with dysphagia symptoms, as well as on the existence of associated malnutrition.

Aims: The Eating Assessment Tool (EAT-10) questionnaire will be used to assess dysphagia symptoms. A score of ≥4 on the EAT-10 indicates the presence of dysphagia symptoms, while a score of \<4 indicates the absence. This study aims to (1) investigate which specific muscle groups are particularly weak in patients with dysphagia symptoms (EAT-10≥4); (2) to examine whether patients with dysphagia symptoms (EAT-10≥4) have poorer nutritional status than patients without dysphagia symptoms (EAT-10\<4).

Methods: This is a cross-sectional study. The investigators will recruit patients undergoing elective orthopedic surgery on the lower extremities, with the age range of 18 to 90 years. On the day of admission, patients will be examined by the EAT-10 questionnaire for dysphagia symptoms. High-resolution pharyngeal manometry with impedance will be conducted to measure the functional of swallowing muscles. Additionally, patients will be given the Mini Nutritional Assessment (MNA) questionnaire (a total score of 30 points). The higher scores indicate the better nutritional status. The albumin level will also be collected. The bioelectrical impedance analysis will be used to measure the patients' body composition, specifically skeletal muscle mass.

Eligibility Criteria:
Inclusion Criteria:

* age from 20 to 80 years

Exclusion Criteria:

* bleeding tendency
* pregnancy
* heart failure
* chronic kidney disease
Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.

The study has enrolled so far 3012 biopsies from 2313 participants and the results are analyzed for these biopsies. Follow-up data is, and will be collected.

Eligibility Criteria:
Inclusion Criteria:

* All kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study.

Exclusion Criteria:

* Patients will be excluded from the study if they decline participation or are unable to give informed consent.
Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-17;
* ASA Class I-II;
* Sign the informed consent form.

Exclusion Criteria:

* Patients with high risk of stomach satiety and reflux aspiration;
* Patients allergic to the study drug;
* Obesity or severe malnutrition;
* Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
* Hypertension without treatment;
* Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range);
* Other congenital diseases or acute and chronic diseases that affect the observation of curative effect;
* Participate in other clinical studies within 4 weeks.
Compuls-BED-Severity

* Binge Eating Disorder (BED) has been fairly recently introduced into the Diagnostic and Statistical Manual 5 psychiatric classification and its severity criteria are still not well established.
* Moreover, it remains unclear whether BED is associated with greater metabolic severity or more somatic comorbidities, especially in obesity.
* Improved BED severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care.

The investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of BED (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated).


Eligibility Criteria:
Inclusion Criteria:

* men or women aged 1
* participants eligible for bariatric surgery (BMI\>40, or BMI\>35 with severe comorbidities)
* participants scheduled for medical evaluation and treatment of obesity at the IUCPQ Obesity Clinic (BMI≥30)
* participants scheduled for evaluation and treatment of BED at the CEPIA with obesity (BMI≥30)
* for the group with BED: positive BEDS-7 screen and Binge Eating Scale score \>16;
* for the control group: have a negative BEDS-7 screen and Binge Eating Scale score\<12
* be fluent in French and able to consent.

Exclusion criteria :

* participants with severe neurological disorder and/or major neurocognitive deficits;
* participants with previous bariatric surgery or with introduction or change of anti-obesity medication (liraglutide or naltrexone/bupropion) in the previous 3 months;
* participants who cannot read and/or understand French;
* participants under guardianship or curatorship;
* participants already included in a study with a conflict of interest with this study;
* inability to use a computer or iPad;
* inability to access an Internet connection or to visit one of the inclusion sites.

Secondary exclusion criteria:

* participants with a discordance between BEDS-7 (positive) and Binge Eating Scale (score ≤ 16) results found secondarily
* participants who did not participate in part of the assessments (e.g., self-questionnaires or neurocognitive tests) and participants with a rate of missing data\>10%.
Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy

Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic. Recent studies have demonstrated that a large majority of children with a penicillin allergy label do not have a true IgE-mediated allergy. Appropriately delabeling antibiotic allergies has been shown to improve patient care outcomes and lower health care costs. However, efforts to implement these assessments in practice are lacking, particularly in the hospital setting. Therefore, there is a need for hospital-based risk assessment and delabeling strategies for hospitalized children. The investigator's objective is to determine the feasibility of implementing a hospital-based approach to penicillin allergy risk stratification and evaluation of patients at low-risk for true allergy.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Vanderbilt children's hospital admitted to a Pediatric Hospital Medicine service with a penicillin allergy reported in their chart who are medically stable

Exclusion Criteria:

* Known pregnancy
* Patients without a primary care provider
Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)

This study aims to evaluate both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal-NRP (TA-NRP) techniques, proving that brain blood flow is not resumed during NRP. This will be assessed through the use of two modalities: CT angiogram of the brain and continuous Hb02 readings. The study group hypothesise that such assessment methods will provide evidence to indicate that brain blood flow is not present during NRP and promote trust in the use of such novel techniques in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* DCD donors in Cambridge University Hospital
* Planned A-NRP
* Consent for study has been obtained
* Those who meet the appropriate criteria for DCD donation following WOLST
* ≥ 18 years of age
* ≤ 75 years of age

Exclusion Criteria:

* DBD organ donors
* DCD organ donations outside of Cambridge University Hospital
* DCD donors without planned A-NRP
* DCD donors whose family have withheld consent for brain blood flow investigations.
* Patients who do not meet the appropriate criteria for DCD donation following WOLST
* Patients with injuries that will physically prevent use of the necessary assessment methods
Diagnostic Survey of Mental and Substance Use Disorders in HUNT (PsykHUNT)

The aims of this observational survey are to i) gather experience on how to conduct a prevalence study of mental disorders in the Norwegian setting, ii) collect data on the prevalence, risk factors and consequences of mental and substance use disorders, iii) collect data on treatment coverage for mental and substance use disorders, iv) conduct a thorough nonparticipation analysis.

The psychiatric survey was a sub-project in the fourth wave of the Trøndelag Health Study (HUNT4), conducted on HUNT4 participants aged 20 to 65 years from the geographical areas Nord-Trøndelag and the city of Trondheim. The targeted sample size was 4,000 participants, and 16,602 persons from the study population of HUNT4 participants were invited to reach this goal. The only exclusion criterion was insufficient understanding of Norwegian or English. The investigators had complete lists with postal addresses and mobile phone numbers for all eligible participants as well as information about date of birth and gender. Potential participants were sampled in repeated probability sampling draws over the course of the data-collection period, which lasted from November 2nd 2018 to September 18th 2020. Younger persons were oversampled to adjust for the expected larger nonparticipation among these age-groups. The predesignated participants were informed about the project through postal letters. A week after receipt of the letter, each received an SMS with information on how to sign up for the psychiatric interview. One SMS reminder was sent to persons who did not respond to the initial invitation. The investigators made four contact attempts to schedule the interview amongst those who registered; three by phone and one final by SMS. All participants received a $30 gift card as a token of appreciation. Computer assisted face-to-face or telephone interviews were conducted by trained and certified interviewers at local field stations. The World Health Organization (WHO) Composite International Diagnostic Interview, fifth version (CIDI 5.0) was used as instrument in the data-collection.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient understanding of Norwegian or English to conduct the interview

Exclusion Criteria:

* None
NextGen - Clinical Implication of Next Generation Sequencing

Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.

Bacterial sensitivity test for different antibiotics are the most important guide for treatment of patients with UTI. Unfortunately, for patients with less than 10,000 Colony Count (CC), usually no sensitivity test is done and there is not any guide for appropriate antibiotic therapy for this group.

Eligibility Criteria:
Inclusion Criteria:

* Female at least 18 years of age
* U/C (Urinary Culture) growth of \<10,000 Colony-Forming Units (CFU)
* Understanding and acceptance of the need to return for all scheduled follow-up visits
* Able to give informed consent

Exclusion Criteria:

* Catheter in use (Foley or suprapubic or intermittent)
* Not able to provide clean midstream urine
* Antibiotic consumption in the past 2 weeks before signing the consent
* Pregnant or Planning to Conceive
* Incarcerated
the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence

Enrolled patients with urinary incontinence in Peking University People's Hospital, Wuhan People's Hospital, Zhongshan People's Hospital, and Jiangsu Maternity and Child Health Hospital in the Department of Gynecology, and collected baseline data. The random number table was used to divide the period into observation group and control group. The observation group was treated with a new type of pelvic floor rehabilitation therapy device PHENIX U4+, and the control group was treated with a traditional pelvic floor electrical stimulation therapy device. Follow-up observations during the treatment period and at the end of the treatment, 3 months and 6 months, the main follow-up content includes 1h pad test, 72-hour urination diary, modified Oxford muscle strength classification diagnosis, urinary incontinence-related questionnaires, new equipment inspections, etc. , Track and compare the treatment effect.

Use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.

Eligibility Criteria:
Inclusion Criteria:1) 18 years old and above; 2) Have a history of sexual life; 3) Plan to live locally for a long time; 4) Mild to moderate pressure, urgency or mixed urinary incontinence; 5) The patient agrees to conduct the study and signs an informed consent form.

Exclusion Criteria:

1. Combined pelvic organ prolapse (with extrahymen bulging);
2. Obesity (BMI\>28kg/m2, BMI=weight (kg)/height square (m2));
3. Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
4. Combined connective tissue disease;
5. Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
6. Malignant tumors;
7. Combined neurological diseases (patients with epilepsy and dementia);
8. Those with a synchronized pacemaker on their chest (biofeedback can be done).