cyrilzakka/clinical-trials huggingface dataset:
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
* Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
* Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
* Any abnormality preventing reliable applanation tonometry in either eye.
* Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
* Pregnant or lactating.
* Participation in any other investigational study within 30 days of screening visit.
* Other protocol-defined exclusion criteria may apply.
Large-Scale Implementation of a Decision Aid About Colorectal Cancer Screening

The goal of the project is to improve shared decision making and increase uptake of colorectal cancer (CRC) screening by facilitating the implementation of a decision aid about CRC and screening options in two healthcare systems in Indiana.

This implementation project is putting a shared decision making approach into routine practice to help patients make informed decisions about colorectal cancer(CRC) screening. Regular screening is recommended for adults ages 45 - 75 years old, and there are multiple approved tests for individuals at average risk for colorectal cancer. A video-based decision aid about CRC screening was developed and tested in a previous study by the project team. The study showed that viewing the decision aid had positive effects on measures directly related to shared decision making (knowledge, decision conflict) as well as intent to undergo CRC screening. The project team is working with two healthcare systems to provide patients who are eligible for CRC screening access to the decision aid, training staff and clinicians how to use the decision aid to support shared decision making for CRC screening, working with healthcare system leaders to support the staff and clinicians, and providing support for the ongoing use of the decision aid.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare system participants will be eligible if they are employed by one of the project team's partner healthcare systems
* Patient participants will be eligible if they are considered due for colorectal cancer screening by the healthcare systems' criteria.

Exclusion Criteria:

Patient participants will be excluded if they:

* are not between ages of 45 - 75 years old
* self-report that they no longer receive primary care at either of the project team's partner healthcare systems
* self-report that they are not due for colorectal cancer screening (had colonoscopy within the past 10 years, sigmoidoscopy in the last 5 years, FIT in the past year, or Cologuard in the past 3 years)
* are unable to speak or read English or Spanish
Self-help Forest Bathing (Shinrin-yoku) on Depression, Anxiety, and Stress

The objective of this pilot randomized controlled trial is to evaluate the efficacy and acceptability of self-help forest bathing on depression, anxiety, and stress in the Hong Kong adult population.

Prior to all study procedures, eligible participants will be required to complete an online informed consent form (with telephone support). Around 80 eligible participants aged between 18 to 65 years old with at least a mild level of depression, anxiety, or stress symptoms will be randomly assigned to either the self-help forest bathing intervention group (FB group) or the waitlist control group (WL group) in a ratio of 1:1.

Participants in the FB group will receive forest bathing guidance via an in-house smartphone app. The WL group will be asked to maintain their typical activity in week 1-7. This group will receive the guide upon trial completion in week 8.

The outcomes of the interest will include generalized anxiety symptoms, depressive symptoms, insomnia symptoms, wellbeing, health-related quality of life, functional impairment at baseline (week 0), immediate (week 7), and 1-month post-intervention assessments (week 10). Treatment credibility and acceptability will be collected at baseline and immediately after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents;
2. Aged between 18 to 65 years;
3. Meet the threshold for mild depression (score of \>5 on the Patient Health Questionnaire 9 \[PHQ-9\], anxiety (\>5 Generalized Anxiety Disorder 7 \[GAD-7\]), or stress (\>15 on the Depression, Anxiety, and Stress Scale \[DASS-21\] stress subscale, after multiplying score by 2);
4. Able to read and understand Chinese and type in Chinese or English
5. Have an Internet-enabled mobile device (iOS or Android operating system)
6. Willing to provide informed consent and comply with the trial protocol

Exclusion Criteria:

1. Received psychotherapy for depression, anxiety and stress in the past 6 months;
2. A change in psychotropic drugs or over-the-counter medications that target depression, anxiety, and stress within 2 weeks before the baseline assessment.
3. Patient Health Questionnaire-9 (PHQ-9) item 9 score \> 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided);
4. Currently participating in another intervention study that may potentially affect mental health;
5. Self-disclosure of having unsafe health conditions for which physical activity was contraindicated by physicians;
6. Self-disclosure of any psychiatric, medical, or neurocognitive disorder(s) that makes participation unfeasible;
7. Pregnancy;
8. Hospitalization.
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 60 to 64 years.
* Healthy.

Exclusion Criteria:

* Previous vaccination with any licensed or experimental pneumococcal vaccine.
* History of severe adverse reaction associated with a vaccine.
* Immunodeficiency.
Periodontal Condition in Pregnancy and Low Birth Delivery Incidence

The objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight.

This research was carried out in the following three centers: Samsun Birth and Children's Hospital, Department of Obstetrics and Gynecology of the Faculty of Medicine and Faculty of Dentistry of the University of Ondokuz Mayıs. 269 women in their first trimester were included in this study. Their ages ranged from 18-35 years, their height was above 150 cm and they have no history of any systemic disease. At the end of each trimester these measurements were performed: attachment level, probing depth, gingival index, plaque index, and bleeding on probing. According to the periodontal diagnosis the research population was divided into three groups: periodontally healthy women; periodontally diseased women, however rejection of treatment; periodontally diseased women, however acceptance of treatment.In this study one-way ANOVA, chi-square, conditional logistic regression analyses were used.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-35 years
* Sure of her dates

Exclusion Criteria:

* systemic diseases (i.e., diabetes mellitus, cancer, hypertension, urolithiasis, parathyroid disease, diseases that compromise pregnancy)
* Less than two pregnancy
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Signature of ICF
* Negative pregnancy test (women of child bearing potential)
* Patients who comply with at least one of the following (A or B):

A: One of the following criteria (major criteria):

* Re-transplant due to severe dysfunction of a previous hepatic graft
* Requirement of any renal substitutive therapy, including dialysis or hemofiltration
* Fulminant hepatitis requiring hepatic transplant

B: Two of the following criteria (minor criteria):

* Post-transplant renal impairment (defined as CrCl\< 50 mL/min) 30 days after transplantation
* Intra surgery blood transfusion of at least 40 units
* Choledochal jejunectomy
* 2 or more Candida sp cultures (nasal, pharynx, rectal) from 48 hours pre- to 48 hours post-hepatic transplant
* Post transplant re-intervention (laparotomy)

Exclusion Criteria:

* Hypersensibility to amphotericin B or candin
* Patients who have received any other antifungal (excluding fluconazole or oral nystatin for a maximum of 7 days)
* Documented or suspected fungal infection
* Pregnant women of women who do not accept to us a valid anticonceptive method
* Any other disease or medical condition that makes the patient not adequate to participate in the trial
The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF

Due to the complex nature of HF patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. With the increasing popularity of smartphones and the continuous development of medical technology, digital health intervention (DHI) has emerged as a new medical model in the treatment of diseases.

This study will establish a comprehensive post hospital management model of HF based on DHI, including cognitive behavioral therapy, digital self-monitoring and remote dielectric sensing (ReDS™) technology, etc., comprehensively strengthen the post hospital intervention and management of HF. Objective to explore the effect of comprehensive post hospital management based on DHI on cardiac function of patients with HF 6 months after discharge.


Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized for HF, NYHA classification II-IV upon admission
2. The patient's residence is within the urban area of each center, and ReDS™ technology can be performed at home or at the outpatient clinic
3. No difficulty using smartphones, with basic Chinese reading and writing skills
4. Accept the terms and conditions of the study and obtain informed consent from the subjects/their families

Exclusion Criteria:

1. Age\<21 years old
2. Patients with height\<155 cm or\>190 cm, BMI\<22 kg/m2 or\>36 kg/m2, chest circumference\<80 cm or\>115 cm, and flail chest or rib fractures
3. History of pulmonary embolism
4. chronic renal failure（Scr \> 443umol/L）
5. History of heart transplantation or pacemaker implantation
6. Severe pulmonary hypertension
7. Suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy
8. Massive pleural effusion
9. The subject is unable to complete the 6-minute walking test
10. Expected lifespan\<6 months
11. Researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.)
12. Individuals who are unable to understand and/or comply with this research procedure (such as those who are addicted to alcohol, substance abuse, or have mental illnesses)
13. Currently participating in clinical trials of other devices or drugs
14. Researchers involved in the design and execution of this study
PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma

Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.

Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone.

We desined prospective multicenter phase 2 study using these combination sequentially.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy.
* Presence of measureble disease : serum M-protein \> 1g/dL or urine M-protein \> 400mg/day
* Age \< 75
* Performance status \</= ECOG 2
* Expected survival \> 6 months
* who signs the informed consent

Exclusion Criteria:

* known hypersensitivity to thalidomide or dexamethasone
* known refractoriness to thalidomide + dexamethasone
* Previous Velcade therapy
* Sepsis
* Woman in reproductive age
* Serum creatinine \> 2 mg/dL ; 24 hour creatinine clearance \< 30 ml/min; past medical history of kidney transplatation
* Peripheral neuropathy \>/= grade 2
* Recurrent DVT or pulmonary embolism
* Cardiac ejection fraction \<0.5 : Severe conduction disorder
* Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis
* Active ulcers in gastrofiberscope
Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）

To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

Currently, there is little experience in the application of targeted drugs combined with immunotherapy. Through this study, we hope to explore the optimal population for the use of carelizumab combined with regorafenib in the second-line treatment of hepatocellular carcinoma (HCC), as well as the efficacy and safety.

This research is a single-center trials phase II second-line, single arm, explore the clinical outcome of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Not convenient to disclose

Exclusion Criteria:

* Not convenient to disclose
Exercise Training in Healthy Young Men

Resistance type exercise training has been shown to be a potent stimulus to increase skeletal muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to affect the muscle adaptive response following exercise. Whether timed protein intake could augment the increase in muscle fiber size and/or satellite cell content following long-term exercise intervention remains to be established.

We hypothesize that protein supplementation before sleep, on both training and non-training days, during a 12 week resistance training program further increases type II muscle fibre cross sectional area when compared to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy
* Age between 18 and 30 years
* BMI between 18.5 and 30 kg/m2
* Recreationally active, performing sports on a non-competitive basis between 2 and 5 hours p/wk
* Participants willing and able to give written informed consent and to understand, to participate and to comply with the biomedical research project requirements

Exclusion Criteria:

* HbA1C level above 6.5%
* Fasted blood glucose level above 7 mmol/L
* Serum creatinine level beneath 60 or above 120 µmol/L
* Participants with a recent history or current state of COPD
* Participants with a recent history or current state of rheumatoid arthritis
* Participants with a recent history or current state of musculoskeletal/orthopedic disorders
* Participants with a recent history or current state of renal disorder
* Participants with a recent history or current state of cognitive impairment
* Participants with orthopedic metal implants in the spine and/or upper/lower extremities
* Participants with lactose intolerance and/or dairy protein allergy
* Participants who are enrolled in an interventional biomedical research project or have received an investigational new drug or product with the last 30 days prior to screening.
* Participants on medication, including anticoagulants
Brief Motivational Intervention to Increase Physical Activity and Fruit/Vegetable Intake

Research has shown that a high percentage of college students do not meet recommended national guidelines for physical activity or fruit/vegetable intake. The purpose of this study was to pilot test the short-term efficacy of a one-on-one, brief motivational intervention (BMI) designed to increase physical activity and fruit/vegetable intake. It was hypothesized that participants in the BMI condition would report greater physical activity and fruit/vegetable intake at follow-up than those in an education-only control condition.


Eligibility Criteria:
Inclusion Criteria:

* Two or fewer days of 30+ minutes of moderate physical activity per week
* Zero days of 20+ minutes of vigorous physical activity per week

Exclusion Criteria:

* Three or more days of 30+ minutes of moderate physical activity per week
* One or more days of 20+ minutes of vigorous physical activity per week
Direct Peritoneal Resuscitation Effects in the Damage Control Patient

The purpose of this study is to find if direct peritoneal resuscitation helps blood flow through important organs in a person's body after they have had a traumatic injury with massive blood loss. Sometimes after severe injuries requiring operation, surgeons cannot close the muscles and skin of a patient's belly, because of swelling. This study will also try to find if direct peritoneal resuscitation decreases tissue swelling and allows for quicker closure of of a patient's belly.

Standard methods of controlling bleeding and increasing blood flow to vital organs will be used. These methods include giving blood and fluids and surgically repairing the vessels that are causing the bleeding which are standard ways physicians treat injuries with massive blood loss. A drain (a small plastic tube) will be placed inside the belly.

Subjects will randomly (like flipping a coin) be placed into a group of patients who either get a sugar solution dripped into the belly after surgery or do not get this treatment. The drain will be used to drip a high glucose solution into the abdomen in patients be part of that group. The fluid will continue to be dripped into the belly until it is possible to close the skin and underlying layers.

Eligibility Criteria:
Inclusion Criteria:

* All trauma patients age 18 years or greater with massive blood loss
* Patients requiring a damage control procedure
* Traumatic injury within the last 24 hours

Exclusion Criteria:

* Patients who are pregnant
* Less than 18 years of age
* Known chronic renal disease
* Moribund
Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System

DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes.

New cadmium-zinc-telluride (CZT) systems allow time and/or dose reduction. This can be interesting in DaTSCAN acquisitions as those are long-lasting, often on difficult patients.

This study will evaluate the diagnostic performances of a new 3D-ring CZT camera in DaTSCAN SPECT.

DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes, particularly for the diagnosis of Parkinson's disease or in the exploration of dementia-type neurodegenerative diseases.

The acquisition of tomoscintigraphic images is performed 3 hours after injection and lasts approximately 30 minutes on a conventional gamma camera.

Recently, the introduction of systems equipped with cadmium-zinc-telluride (CZT) technology has made it possible to reduce acquisition times and/or injected doses. Among these systems, some new 3D-ring CZT cameras allow tomoscintigraphic acquisitions to be carried out from the outset for the exploration of different organs.

Patients included in this study will be double scanned both on a conventional camera and on the new multipurpose CZT system, with CT.

The primary objective is to evaluate the diagnostic concordance between the DaTSCAN brain scintigraphy images from the new CZT SPECT/CT system and those from the conventional SPECT camera, when visually interpreted blindly by experienced observers (nuclear medicine physicians), according to a diagnostic scale.

Striatal binding ratios (SBR) will also be compared. Time reduction will also be evaluated on DaTSCAN SPECT data from the new multi-purpose CZT system.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to our Nuclear Medicine department for DaTSCAN scintigraphy.

Exclusion Criteria:

* Under 18 years-old patients.
* Pregnant women or at risk of pregnancy.
* Breast feeding.
* Painful patients.
* Patients under guardianship.
* Patients in whom a standard examination is not feasible (agitation).
Drug Use-Results Survey on Picoprep® Combination Powder

The purpose of this survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.