cyrilzakka/clinical-trials huggingface dataset:
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment

This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.

The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in viremic chronic CHB-infected subjects not currently on treatment.

Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
* HBV DNA levels:

  * For subjects who are HBeAg positive at Screening, a Screening HBV DNA level in serum/plasma that is ≥20,000 IU/ml, or
  * For subjects who are HBeAg negative at Screening, a Screening HBV DNA level in serum/plasma that is ≥2,000 IU/mL, and
  * For all subjects, no HBV DNA serum/plasma test values \<1,000 IU/ml over the previous 12 months (using an approved test)
* CHB subjects must not have been on prescribed anti-HBV treatment for at least 12 months prior to Screening

Exclusion Criteria:

* A documented prior diagnosis of cirrhosis
* Pregnant or nursing females
* Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
* Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
Beta-glucan, Product Claims and Satiety

This is a digital clinical trial to investigate satiety and consumer preference in responses to three test breakfast bars with varying level of dietary fiber, beta-glucan, and product packages (with or without product claims) in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-70 years.
* Habitual snack bar consumers (consume bars at least 3 times a week).
* Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
* Understand the study procedures.
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Willing to follow study procedures on test days.
* Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day.
* Willing to provide informed consent to participate in the study.
* Willing to maintain confidentiality of the study and test products.

Exclusion Criteria:

* Pregnant or lactating women, or women who are planning to become pregnant during the study
* Known food allergies, sensitivity, or intolerance to any food or food ingredients
* Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
* Taking medications that affect appetite, metabolism, or blood pressure
* Taking supplements with dietary fiber
* Presence of acute diseases or infection
* Presence or history of chronic diseases
* Diagnosed with eating disorders
* Restraint eaters
* Lost or gained 5 pounds or more in the past 3 months
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.


Eligibility Criteria:
Inclusion Criteria:

Male and female children will be eligible for participation in this study if:

* they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old;
* they are clinically healthy;
* their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent;
* their legal representative agrees to keep a Volunteer Diary.

Exclusion Criteria:

Children will be excluded from participation in this study if they:

* have a history of any previous TBE vaccination;
* have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA \> 126 VIEU/ml and / or neutralization test \> 1:10);
* have a history of allergic reactions, in particular to one of the components of the vaccine;
* have received antipyretics within 4 hours prior to the first TBE vaccination;
* suffer from a disease that cannot be effectively treated or stabilized;
* suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
* suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
* are known to be HIV positive (a special HIV test is not required for the purpose of the study);
* suffer from a febrile illness at study entry;
* have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
* are participating simultaneously in another clinical trial.
Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy

Follow up of the patients at Ghent University Hospital treated with hippocampal DBS for refractory epilepsy.

Endpoints:

* Long term evaluation of the effects of hippocampal DBS on seizure frequency and cognition
* Evaluation of the satisfaction of patients and neurologist regarding the rechargeable DBS battery


Eligibility Criteria:
Inclusion Criteria:

* Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital

Exclusion Criteria:

* (none)
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Patient is older than 18 years
* Written informed consent is obtained from patient
* Patient with a primary or incisional ventral hernia

Exclusion Criteria:

* Patient with a recurrent ventral hernia
* Patient with ASA class 5 and 6
* Patient underwent emergency surgery
* Patient is pregnant
* Patient with a known allergy to components of the ePTFE prosthesis
* Patient has a life expectancy less than 1 year
* Patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors
The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution

Exposure to air pollution is an important risk factor for cardiovascular morbidity and mortality, and is associated with increased blood pressure, reduced heart rate variability, endothelial dysfunction and myocardial ischaemia. The study objectives were to assess the potential cardiovascular benefits of reducing personal particulate air pollution exposure by wearing a facemask in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Current smokers
* Significant occupational exposure to air pollution
* Regular medication use (except oral contraceptive pill)
* Intercurrent illness
Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years

Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing acute mountain sickness in lowlanders older than 40 years travelling from 760 m to 3'100 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of acute mountain sickness (AMS) in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, age 40-75 yrs, without any disease and need of medication.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.
* Kyrgyz ethnicity

Exclusion Criteria:

* Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
* Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
* Allergy to acetazolamide and other sulfonamides.
Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF)

The purpose of this study was to analyze the clinical factors associated with the effect of Granulocyte-Colony Stimulating Factor (G-CSF).

1. Granulocyte-Colony Stimulating Factor (G-CSF) G-CSF is known to be a synthetic cytokine that induces neutrophil differentiation and proliferation survival during leukocyte differentiation, and increases the activity in the periphery of mature neutrophils, which play an important role in human immunity. Cytotoxic chemotherapy inhibits bone marrow hematopoiesis. Inhibition of bone marrow hematopoiesis causes anemia, thrombocytopenia and leukopenia, and significant leukocytopenia causes opportunistic infection. G-CSF is an indispensable drug for the treatment of leukopenia caused by cytotoxic chemotherapy in solid and blood cancer patients receiving chemotherapy.
2. Chemotherapy with chemotherapy and G-CSF The severity of neutropenia induced by chemotherapy was grade 1 (\<1500 / mm3), grade 2 (\<1500-1000 / mm3) and grade 3 (\<1000) based on the Common Terminology Criteria for Adverse Events To 500 / mm3) and grade 4 (\<500 / mm3). Cytotoxic anticancer drugs used in general chemotherapy cause neutropenia, and febrile neutropenia occurs in 10-20% of patients. In order to recover this, grade 4 neutropenia with an absolute neutrophil count (ANC) of less than 500 and neutrophil to grade 2 or higher with G-CSF in case of febrile grade 3 neutropenia.
3. G-CSF dose and timing G-CSF (Renoglass team lenograstim 250 ug) was subcutaneously injected to a solid tumor (grade 3 or higher regardless of fever) with grade 3 or grade 4 neutropenia with fever Until then, take medication daily. It is used regardless of gender, age, weight, body mass index, method of using anticancer, and injection time.

However, the actual timing and extent of neutrophil recovery after G-CSF administration varies from patient to patient. G-CSF is a cytokine that is currently used in clinical trials. However, there are insufficient studies to investigate the clinical factors involved in the recovery of neutrophils in bone marrow after G-CSF administration in domestic cancer patients. Therefore, this study aims to analyze the clinical factors for the recovery of bone marrow hematopoietic function of G-CSF administered in neutropenia following cytotoxic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with solid cancer and blood cancer
2. Patients who received chemotherapy with moderate risk (Appendix 1, Appendix 2)
3. CTCAE version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), Decreased grade 3 neutrophils with fever (solid cancer)
4. Those who understand and agree with the purpose of the research

Exclusion Criteria:

* 1) Patients with hypersensitivity to G-CSF 2) Patients not diagnosed with hematologic tumor 3) grade 1, grade 2 or more neutropenia 4) Patients who did not sign a consent agreement
The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy

Capsule endoscopy is a non-invasive way to examine the small bowel, but its yield is limited by the battery life. In 20% of cases, the recording stops before the entire length of small bowel is examined. Capsule transit speed is dependent on bowel motility. When we eat, the brain sends signal to the bowel to speed up motility. In this study the investigators wish to determine if chewing bacon (sham feeding) can trick the brain to speed up bowel motility and improve the rate of complete small bowel examination.

This is a prospective, randomized, single-blinded controlled trial.

Subjects ages 19 years and older referred for capsule endoscopy (CE) at the GI Clinic, St. Paul's Hospital will be invited to participate in the study. We will be recruiting 122 subjects and will randomize them into 2 groups: control group and treatment group. Control subjects will undergo the standard capsule endoscopy procedure. Subjects in Treatment group will undergo sham feeding in addition to the standard capsule endoscopy procedure. Both control and treatment subjects in this study will be required to swallow a capsule (the size of a large pill) named Given Imaging SB3® Capsule.

The investigator and the video reader will be blinded (single-blinded study). Times will be recorded at: first gastric image, first duodenal image and first cecal image.

The diagnostic yield for controls and subjects will be calculated. The clarity of the images will be graded according to the ICCE 2005 consensus regarding bowel preparation and prokinetics in capsule endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients, 19 years or older referred to St. Paul's Hospital for capsule endoscopy

Exclusion Criteria:

* In-patients will be excluded
* Patients who have been taking taken medications that affect your bowel movement in the five days prior to the procedure
* Patients who are vegetarian or have dietary restrictions that do not allow bacon/pork products.
* Patients, who have proven or suspected obstruction of the bowel.
* Patients, who have had prior small bowel and/or stomach surgery.
* Patients who have a known and/or have a history suggestive of a swallowing disorder
* Patients with complicated diabetes diabetes with associated complications (bleeding in eyes, kidney disease, or numbness/tingling in hands/feet)
* Patient who have thyroid problem that is not being treated (for example, hypothyroid but not taking supplement)
* Patients who are pregnant, prisoners or an institutionalized individuals
* Patients whose capsule camera is placed using a traditional scope (instead of swallowing the capsule camera)
The Impact of the SCN9A Gene Polymorphism on Postoperative Pain

The purpose of this study to determine the association between postoperative pain after cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.

SCN9A gene encodes an alpha subunit of the voltage-gated sodium channel (Nav1.7) and polymorphisms of this gene are associated with severe pain disorders. The impact of the polymorphisms in SCN9A on postoperative pain and opioid consumption after cesarean section is unclear.

Eligibility Criteria:
Inclusion Criteria:

* The women aged 18 to 45,
* in 36 to 40 weeks of pregnancy
* undergoing cesarean section

Exclusion Criteria:

* History of chronic pain or pain disorders
* Psychiatric diseases
* Diabetes mellitus
* Severe cardiovascular, kidney or liver diseases
* Alcohol or drug abuse
* Heavy smoker
* Unable to use the Patient controlled analgesia (PCA) pump
Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible. The date of surgery must be known prior to registration. This trial aims to determine if image mapping techniques can improve the concordance between imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be identified on pre-operative scans and mapped by radiologists then shared with pathologists prior to processing the resected specimen. Patients will be managed at their local hospital with standard follow-up. Patients will be followed up for 5 years.

A prospective interventional multi-centre study, COMET aims to prove the accuracy of imaging diagnosis of extranodal tumour deposits (TD) and their adverse effect on prognosis of colorectal cancers. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected primary adenocarcinoma of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).
2. Amenable to surgical resection.
3. Disease spread assessed on imaging
4. Patients having primary surgery and those undergoing neoadjuvant treatment will be included.
5. All must have had baseline staging scans and those undergoing neoadjuvant therapy must also have had a post-treatment scan.
6. Patients aged 16 years and over

Exclusion Criteria:

1. Patients with recurrent tumours
2. Synchronous tumours
3. Under the age of 16 years
4. Unable to give informed consent.
Positive Appraisal Improve Trust Between Patients and Therapists, and Change Treatment Effects

The trust between patients and medical providers is the cornerstone to obtain success treatment. To boost the trust can increase medical prescription compliance, enhance patient satisfaction, and improve the effectiveness of treatment. Otherwise, mistrust between medical providers and patients will result in ineffective treatment and excessive defensive health care. This situation may cause medical dispute and medical resources wasting problems.

Most of treatment complete in a few times of admissions and interventions. So, how to improve the trust between patients and doctors quickly became a more knotty problem. Several studies found that speech (including listening, showing compassion, and take longer to explain), reputation, clothing, offer a newer therapy were more important than age, title, and sex.

However, past researches were restricted to an unclear causal relationship. That is they can't be determined whether good doctor-patient relationship and better trust conditions create a longer visit time, better satisfaction, and good reputation, or vice versa. They also unable to clarify whether the high degree of trust result in improved treatment effects, or good relationship result from good medical outcomes.

Investigators want to design a randomized control trial by giving patients recommendation and physical therapist introductions to enhance the trust of patients to therapists. And this study may verify whether enhance trust between therapists and patients will lead to changes in treatment effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. First time visit to Taoyuan general hospital rehabilitation ward at 2016/07/01\~2017/12/31
2. Diagnosis with L spine spondylosis, L spine Herniated Inter-vertebral Disc, or non-acute low back muscle strain
3. Suitable for physical therapy with ( Hot packing + interference current therapy + pelvic traction + therapeutic exercise )
4. most pain score \>2

Exclusion Criteria:

1. poor of follow oral order, or patients who can't understand Chinese, including patients with aphasia or dementia
2. patient who can not received 4 weeks of physical therapy
3. other cause of low back pain which can't treatment with physical therapy, including : (Urinary tract stones, infection, rapid progression disease which need immediately operation)
Blood Flow Restriction Exercise in Patients With Pancreatic, Biliary Tract, and Liver Cancer (PREV-Ex)

In patients with cancer, resistance training appears to be a safe and effective exercise modality to increase both lean muscle mass and strength, as well as attenuates cancer-related fatigue. It may serve as a feasible intervention in these patients to mitigate cachexia, especially if implemented before the onset of cancer cachexia or in a pre-cachectic state. This study is a multicenter randomized controlled trial that will compare a blood flow restricted resistance training intervention during the pre- (prehabilitation) and post-operative (rehabilitation) phase in patients with pancreatic, biliary tract and liver cancer, versus usual care on skeletal muscle and other health-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of resectable pancreatic cancer
* Diagnosis of resectable biliary tract cancer (includes cholangiocarcinoma and ampullary cancer)
* Diagnosis of resectable liver cancer
* ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2

Exclusion Criteria:

* Serious active infection
* Uncontrolled severe pain
* Severe neurologic or cardiac impairment according ACSM criteria
* Uncontrolled severe respiratory insufficiency as determined by the treating clinician
* Any other contraindications for exercise as determined by the treating physician
* Poor Swedish comprehension
* Pregnancy
Effects on Dementia Caregivers

The Three Good Things (3GT) is a gratitude list intervention that is empirically supported (Emmons \& McCullough, 2003; Seligman et al., 2005) and is a low-cost, easily accessible tool for medical and mental providers to recommend and dementia caregivers to implement independently. Thus, this study aims to investigate the feasibility of use of 3GT in the dementia caregiving population and investigate potential therapeutic mechanisms of the intervention.

The hypothesis predicts that Caregivers of persons diagnosed with dementia who are randomized into the intervention group (3GT) will report reduced levels of depression, burden, burnout, show an increase in levels of gratitude, increased positive emotion, and increased positive reframing (Brief COPE: Positive Reinterpretation scale and Positive Aspects of Caregiving measure) as compared to baseline levels, and post-follow up assessment in 15 days. The participants will be recruited from local community partners and Amazon MTurk. They will be randomized into 2 groups; one group will be asked to reflect on three good things that happened that day, and the other group will be asked to reflect on early memories. Participants will be reminded via text message daily for 15 days and asked to document their three good things or early memories on a Qualtrics link that will be provided in the text message. Additionally, they will be asked to answer 10 mood-related questions daily. An ANOVA will be used to assess the pre and post intervention differences between groups for depression, burden, burnout, gratitude, positive emotion, and positive reframing. Multilevel modeling will be used to assess the relationships between gratitude and depression at the within-subjects level and then between-subjects by intervention condition. Identified demographic factors will be added to covary at both levels of analysis. Data will be de-identified and stored on a University of Central Florida local hard drive, which requires special permission and password-protected profiles.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified caregivers of persons with dementia at least 18 years of age
* Identify English as their primary language
* Self-report current care for an older adult with dementia identified by a medical professional

Exclusion Criteria:

* Participants that are currently receiving psychotherapy, have a diagnosis of dementia, and/or severe mental illness
* Individuals under the age of 18 years old
* Adults who cannot consent in English
* Pregnant women and prisoners will not be included in the study.
* Participants who do not have access to a phone that can not receive text messages will not be able to participate, as equipment will not be provided to Participants.