cyrilzakka/clinical-trials huggingface dataset:
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.


Eligibility Criteria:
Healthy volunteers:

1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

CHB patients:

1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg
2. Must have chronic hepatitis B with no history of clinical decompensation
3. Seropositive for HIV, HCV, or HDV antibody at Screen
4. Previous treatment with any HBV antiviral treatments within the last 3 months
5. Other known cause of liver disease, including NASH
Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement

The main purpose of the study is to find out if, after 4 weeks of dosing, signs of the investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee joint. A secondary purpose is to evaluate the safety of taking the drug either once a day or twice a day for 4 weeks.

This is a multicenter study of 2 dosing regimens of AGG-523, an investigational aggrecanase inhibitor that is taken orally. Potential study subjects are those with severe Osteoarthritis (OA) of the knee who are scheduled to undergo total joint replacement surgery.

Study subjects will be randomly assigned to 1 of 2 dosing regimens (once-daily or twice-daily dosing) of either 1800 mg AGG-523 or placebo, which will be taken during the 4-week period before having the total knee replacement. The treatments will be assigned using a 4:1 ratio of active to placebo treatment, which means that more subjects will receive the active treatment than the placebo (see below).

* AGG-523 1800 mg once a day (32 subjects)
* AGG-523 900 mg twice a day (32 subjects)
* Placebo once a day (8 subjects)
* Placebo twice a day (8 subjects)

Study subjects will have weekly evaluations as outpatients during the 4-week dosing period. The purpose of these evaluations is to monitor for potential complications, ensure compliance with taking the study drug, ask about the use of other medications, and, when necessary, replenish the supply of study drug. These assessments may be conducted by telephone, as a home visit, or by having the subject travel to the clinic for an outpatient office visit. A final (in person) visit will happen 2 weeks after having total knee replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, men or women, at least 55 years old
* Osteoarthritis of the knee requiring total knee replacement surgery

Exclusion Criteria:

* Other types of arthritis, like rheumatoid arthritis
* Recent major surgery (in past 3 months)
* Recent knee injections (in past 6 months)
National Health Interview Survey in Taiwan

The major elements of the survey were sampling, questionnaire design, field survey and database construction. This survey incorporated the multistage stratified sampling scheme. Questionnaires include health status, utilization of health care, health behaviors, quality of life, and social economic status.

This survey took a representative sample from each county and municipality in Taiwan using a stratified multi-stage systematic sampling procedure. Within each county/municipality (stratum), samples were selected with probability proportional to population size. Questionnaire design was based on the needs of the Department of Health and Welfare and the public health professionals. Due to different age has different health problems, the questionnaires were divided into 3 parts: under 12, 23-64, and 65+ years. The response rate was 75% in 2013.

Eligibility Criteria:
Inclusion Criteria:

* All the selected samples were to be interviewed.

Exclusion Criteria:

* severely ill or too frail to answer;
* having cognitive problems;
* having hearing or speaking problems; or
* dementia.
Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)

ADHD360 will be an innovative integrated platform for early ADHD diagnosis and intervention against its symptoms. In the core of the platform design there will be a serious game along with a mobile application to monitor behavior and to evaluate the intervention.

The ADHD360 project develop an integrated platform having as core elements a serious game along with a mobile application for monitoring of ADHD behaviors in a SMART (Specific, Measurable, Attainable, Realistic and Timely) way. The design of the serious game is based on both Diagnostic and Statistical Manual of Mental Disorders (version V(American Psychiatric Association, 2013)) along with neuropsychological tools, easily transferred to game, on a specific ADHD behavior. The primary objective of the project is to explore whether the game analytics along with the monitoring data could discriminate the ADHD from non-ADHD users. The secondary objective is to use the platform as an intervention. To this scope, a two-phase pilot study will be performed recruiting at least twenty (20) participants (10 ADHD; 10 non-ADHD) with ages ranging from 7 to 16 years. In the first stage, participants will undergo a neuropsychological evaluation as well as interact with the serious game two times (30-45 minutes/each time). After all participants have completed the first part of the pilot tests, a preliminary analysis of the data will be carried out using modern Machine Learning Methods in order to explore the discriminating capacity of the game. In the second stage, participants will interact with the platform for ten (10) weeks in total (2-3 times/30-45 minutes each). At the end of the second stage, the participants will undergo a neuropsychological evaluation following the procedures of the first one. The partners involved in the implementation of the project are the Intelligent Systems Lab (School of Computer Science, AUTH), the MEDPHYS Laboratory (School of Medicine, AUTH) and the Second Method (TSM) company. The partners cover the expertise required in data analysis, machine learning, medical record keeping, software development and game design (gamification). ADHD360 is co-financed by the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship and Innovation, under the call RESEARCH - CREATE - INNOVATE \[Τ1ΕΔΚ-01680\].

Eligibility Criteria:
Inclusion Criteria:

* (1) Participants should be between 7 and 16 years old
* (2) Diagnosed ADHD by an approved body of Ministry of Health
* (3) Participants willing to follow the study protocol and procedures
* (4) Participants with ADHD symptoms that they are not induced by an organic disease
* (5) Participants' parents voluntarily provided written consent for their children's participation in the study.

Exclusion Criteria:

* (1) Participants in ADHD group having other disorders apart from ADHD
* (2) Parents who refuse to give written consent for their children's participation in the study.
Predict Transpulmonary Pressure Through ZAM

Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable breathing pattern) and EAdi \>8 uV. Four modes of mechanical ventilation were performed under different support level for the measuring of EAdi, air way pressure and other parameters.

1. Mode NAVA spontaneous breathing select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM.

   Increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
2. Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.

   Make record of RR, Vt, Flow, Ti during both periods.
3. Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern observed during NAVA
4. Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Stable patient with acute respiratory failure on invasive mechanical ventilation Can tolerate pressure support ventilation light sedation with RASS between -2 and 1

Exclusion Criteria:

* EAdi\<8 uV contraindication for nasogastric tube insertion neuromuscular disease affecting spontaneous breathing lack of informed consent, and patients included in other intervention study
Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly, dosing schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
2. Patient has one or more radiographically measurable tumor.
3. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
4. Age ≥ 18 years.
5. Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
6. ECOG performance status 0 - 2 and an expected survival of at least 3 months.
7. Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:

   * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
   * Platelet count ≥ 100 x 10\^9/L
   * Hemoglobin (Hgb) ≥ 9g/dl
8. Patients with adequate organ function as measured by:

   A. Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

   B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.

   C. Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease.
9. Women must meet one of the following criteria:

   * Post-menopausal for at least one year
   * Surgically incapable of child-bearing
   * Utilizing a reliable form of contraception for the duration of study participation. Women of child-bearing potential must have a negative serum β-HCG within 7 days of study drug administration.

Exclusion Criteria:

1. Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.
2. Previous use of any chemotherapy or radiation therapy for metastatic disease.
3. Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
4. Other significant active or chronic infection.
5. History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
6. Pregnant or nursing females.
7. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
8. Major surgery, other than diagnostic surgery within 4 weeks of study entry.
9. Patient requires a legal authorized representative for consenting.
The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema

The aim of the work is to

1. Assess the incidence of weaning induced pulmonary adema(WIPO).
2. Assess the risk factors of WIPO.
3. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT).
4. Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.


Eligibility Criteria:
Inclusion Criteria:

* The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).

Exclusion Criteria:

* Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.
Czech Anesthesia Day 2019

Czech Anesthesia Day 2019 was designed as a prospective observational trial with the aim to evaluate the current anesthesiology practice in Czech Republic.

Anesthesiology centers in Czech Republic was screened for cooperation during the year 2018. Data from centers with previously confirmed cooperation will be screened and filled into the electronic database. The basic information about the centre, patient´s demography, American Society of Anesthesiologist classification (ASA), type of surgery/anesthesia, airway management, type of anesthesia induction, drugs for anesthesia induction a and anesthesia maintenance, used monitors of vital signs and functions, type and amount of infusions, temperature management, intravenous lines management, patient blood management, mechanical ventilation settings and postoperative admission will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients from confirmed Anesthesiology Centers - previously confirmed the cooperation (center is registered in the online database with the unique identification)

Exclusion Criteria:

* Data from centers with not confirmed cooperation
Emotion, Mood and Executive Function in Parkinson's Disease (PD)

The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct therapy to levodopa) on affect perception and emotional expressiveness in a double-blind placebo-controlled study.

Parkinson's disease (PD) is associated with a range of cognitive impairments, most notably deficits of higher order cognitive control mechanisms referred to as "executive dysfunction". These problems have consistently been related to dysfunction of fronto-striatal circuitry (summary see Stocchi \& Brusa, 2000). Executive function impairments may already be present in early stages of PD (Uekermann et al., 2004) and their severity may be exacerbated by affective changes such as depression (Uekermann et al., 2003). In addition to cognitive problems, PD patients frequently suffer from mood changes, in particular apathy (Kirsch-Darrow et al., 2006) and from affect processing impairments, relating to both the ability to decode the affective state of other people on the basis of facial expressions or prosody and to the ability to adequately express the patients' own emotions (e.g. Breitenstein et al., 1998; Zgaljardic et al., 2003, Pell \& Leonard, 2005). The capacity for emotion perception was found to be linked to the severity of executive dysfunction; affective and cognitive changes are thus not independent, at least in patients with moderate PD (Breitenstein et al., 2001).

In a recent drug monitoring study by Lundbeck GmbH/TEVA Pharma GmbH based on a small group of PD patients (n=29), introduction of Azilect (Rasagiline) therapy was associated with a significant improvement of PD patients' emotional expressiveness (e.g. facial expression, gestures, voice intonation) over an 8 week observation period. Significant improvements were observed for self-ratings of emotional expressiveness as well as ratings by physicians and relatives. The lack of a placebo-control group, however, does not allow any firm conclusions with regard to the specificity of these effects.

Intact affect recognition and an adequate ability to express emotions are of critical importance for social interaction. The therapeutic efficacy of drug treatment on non-motor symptoms in PD has so far only rarely been addressed. The documentation of a beneficial effect of Azilect on emotional processing would be of great relevance for the quality of life of PD patients and greatly enhance their ability to participate in social life.

The addition of a placebo control group is critical for the assessment of the specificity of the expected beneficial effects of Azilect.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic PD
* age range 30-75 yrs, HY I-III
* stable medication for at least 4 weeks prior to baseline
* Native speakers (German)
* signing of informed consent form

Exclusion Criteria:

* clinically significant depression (BDI\>13)
* freezing, pronounced fluctuations
* other neurological or psychiatric disorders
* dementia (MMSE\<25)
* treatment with the MAO-B-inhibitor Selegiline, antidepressants
* any contraindication according to SmPC
* participation in another interventional study
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer

This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work

RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

Overall Goals:

- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.

Primary Aim:

- to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work.

Secondary Aims:

to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read and understand the informed consent document; must sign the informed consent;
2. Aged 18 to 75 years old , sex is not limited;
3. must have undergone radical resection;AJCC TNM II、III、IV.
4. Availability of at least 1g tumor sample;
5. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] ), and adequate renal function (BUN and creatinine \<1.5 times IULNs)
6. Agree to Surgical indications of Heart \& lung and without the coagulation system disease
7. Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment；

Exclusion Criteria:

1. Inability to comply with study-related procedures
2. Unavailability of at least 6 doses of vaccine
3. Severe allergies
4. Unstable or severe intercurrent medical conditions
5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
7. Female patients who are pregnant or breastfeeding
8. Steroidal drugs are currently being used systemically.
Cyanoacrylate and Laser and Dentin Sensitivity

This study aimed to evaluate the effectiveness of two treatments for dental hypersensitivity: cyanoacrylate (Super Bonder®) compared with use of low intensity laser treatment (LILT). As the cyanoacrylate is a lower cost treatment, the hypothesis in investigation is if this product is equally effective as the laser treatment.

The present study included 62 patients (15 male and 47 females, aged 12 to 60 years). The initial cervical dentin hypersensitivity was checked throughout a thermal test (air blast). The 434 teeth included were that with a score ≥5 in a numerical scale rating of pain. Teeth were randomly assigned according quadrants (split mouth design) - 216 were allocated to LILT group and 218 for the Super Bonder® group. Thermal tests with a tetrafluoroethane spray (Endo-Ice®) and air blast were performed and considered as baseline. Pain parameters were recorded using a numerical scale rating with 24 hours, 30, 90 and 180 days after the interventions. Quality of life of the patients was also assessed with the use of OHIP-14 at baseline and after 180 days.

Eligibility Criteria:
Inclusion Criteria:

1. patients should be in good general and dental health;
2. present complaints of dental sensitivity to cold, sweet, acidic foods and brushing;
3. present complaints of pain in teeth located in different quadrants;
4. manifest pain or discomfort upon application of the triple syringe air jet;
5. not be in current use of desensitizing agents.

Exclusion Criteria:

1. presence of extensive restorations and carious lesions in the sensitive teeth;
2. undergoing orthodontic treatment;
3. frequent use of analgesics, antidepressants and anti-inflammatory drugs;
4. presence of gingival inflammation;
5. non-consent of patient.
SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala

This project plans to learn more about whether sending text messages to parents on their mobile phones to remind them when their child is due for his or her next vaccination will improve children getting vaccinated on time.

This project plans to learn more about whether sending text messages to parents on their mobile phones to remind them when their child is due for his or her next vaccination will improve children getting vaccinated on time. The vaccines that will be given are the same routine vaccinations registered in Guatemala and used by the Ministry of Health regardless of enrollment in the study.

Eligibility Criteria:
Inclusion Criteria:

* First dose of primary vaccination series
* Parents owning a mobile phone and able to decipher SMS messages
* Consent form signed

Exclusion Criteria:

* Moving away from the study site in the next 12 months
* Ineligible for primary vaccination series by the MOH