cyrilzakka/clinical-trials huggingface dataset:
Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.

OBJECTIVES:

Primary

* To determine if mRNA present in circulating tumor cells will help predict response in patients with hormone-refractory prostate cancer treated with docetaxel.
* In parallel with this, based on discoveries made since our protocol was initially submitted to ICORG, here we also propose to analyse serum specimens from these consenting patients for the presence of EC miRNA, mRNA and protein predictive of response to Taxotere.

Secondary

* To develop a predictive model based on the most accurate and sensitive combination of these biomarkers.

OUTLINE: This is a multicenter study.

Treatment Plan:

All patients will be treated with Docetaxel on a weekly, biweekly or three weekly schedule, dose and schedule at the discretion of the treating physician.

Blood samples are collected for biomarker laboratory studies at baseline, every 3-4 weeks during study, and at disease progression or every 12 weeks after completion of study. Samples are analyzed for mRNA via RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

Patients must satisfy the following criteria:

1. Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule.
2. Patients must be aged 18 years or over.
3. Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland.
4. Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases).
5. Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure.
6. Patients must not have received prior treatment with chemotherapy.
7. Patients must be able to give written informed consent.
8. Prior radiotherapy is allowed.
9. Concomitant use of bisphosphonates is allowed.

Exclusion Criteria:

1. Patients who have received previous cytotoxic therapy for prostate cancer are ineligible.
2. Patients who in the judgement of their treating physician will not be able to receive therapy and follow-up according to the protocol guidelines will be ineligible.
3. Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
4. History of other primary cancer, unless:

   * Curatively resected non-melanomatous skin cancer
   * Other primary solid tumour curatively treated with no known active disease present and no curative treatment for the last year.
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.

Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.

Eligibility Criteria:
Inclusion Criteria:

1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed

Exclusion Criteria:

1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders
Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin and/or folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously.

PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic acid in preventing the recurrence of colorectal polyps.

OBJECTIVES:

* Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive oral aspirin and oral folic acid daily.
* Arm II: Patients receive oral aspirin and oral placebo daily.
* Arm III: Patients receive oral placebo and oral folic acid daily.
* Arm IV: Patients receive 2 oral placebos daily. In all arms, treatment continues for 3 years in the absence of unacceptable toxicity.

After completion of the 3-year intervention, all patients undergo a surveillance colonoscopy.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal adenoma removed within the past 6 months

  * Greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal

    * OR
  * Any size with a history of prior colorectal adenoma removal(s)
* Removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery
* Removal must be considered complete with follow-up to be done within 6 months
* No prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy)

PATIENT CHARACTERISTICS:

Age:

* 75 and under

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* No active bleeding disorders

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* No unstable heart conditions

Pulmonary:

* No unstable asthma

Other:

* Not pregnant and no potential to become pregnant within the next 3 years
* No unstable diabetes
* No active upper gastrointestinal ulceration
* No known aspirin intolerance or sensitivity
* No other serious medical conditions that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* No other concurrent folic acid
* No concurrent anticoagulants
* No other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)
Development and Validation of the Client Centered Occupational Therapy Service Model

The purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services.

Occupational Therapy (OT) is one of the mental health services. The service phase includes acute/chronic hospitalization, daycare centers (adolescents, adults, and the elderly), community mental rehabilitation institutions, psychiatric nursing home, and outpatient assessment/treatments. OT provides holistic and continuous mental rehabilitation services at each stage of mental health care. During the acute hospitalization and based on the Model of Human Occupation (MOHO) model, the occupational therapist provides daily activities to assist acute patients with mental illness to develop occupation adaptation to enable and prepare for discharge.

However, the lack of a client-centered OT service model limits the interpretation of the treatment effect and the process of change. This will seriously affect the integrity and continuity of OT services and will limit the development of OT professions. Thus, the purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services.

This project consists of 2 stages. First, based on the MOHO model we use 5 stages with 6 weeks program to develop the OT@tcpc service model. Second, validate the to indicate the occupation identity and competence to validate the OT@tcpc service model. We will recruit 70 inpatients with schizophrenia and divided into intervention group, based on MOHO theory, and control group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria.
2. Over 20 years old.
3. Agree to participate in the study

Exclusion Criteria:

* 1. Diagnosis of intellectual developmental disorders 2. History of severe brain injury 3. Cannot complete the study due to poor cognitive, vision or hand function
Metacognitive Training as a Serious Game

The project aims to evaluate the efficacy of a therapeutic video game that incorporates elements from metacognitive training on delusions and jumping-to-conclusions in patients with psychotic disorders.

The study is an international, multicenter study and is being conducted in Switzerland (University of Basel) as well as in Germany (University of Lübeck). A total of 36 participants will be included. The estimated duration of the study is 15 months. All participants play a video game from the genre "Third Person Adventure". A character is navigated through a fantasy world using a keyboard and mouse. In the fantasy world, "stations" in the form of glowing gems are sought where players have to solve different tasks.

Participants are randomized to receive either the therapeutic video game with metacognitive training content or another video game with attention and memory tasks ("control intervention"). The control intervention does not include metacognitive tasks. Metacognitive training is an approach for the treatment of psychotic disorders, particularly delusions. The focus of metacognitive training is on thought distortions (so-called "cognitive biases") that are more pronounced in people with psychosis. The control intervention includes easily understandable, playful tasks. The intervention will take 4 appointments within 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 40
* diagnosis of a psychotic disorder and current delusions or a history of delusions

Exclusion Criteria:

* Language skills insufficient for assessments
* IQ \< 70
* Secondary psychotic disorders that are clearly induced by general medical conditions or substance use.
* Previous participation in meta-cognitive training for psychosis
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be willing and able to give written informed consent/Assent.
2. Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
3. Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Exclusion Criteria:

1. Known complement regulatory mutation or family history of complement regulatory mutation
2. Unresolved systemic meningococcal disease
3. 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient

Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.

The aim of the study is to assess the safety and tolerability of the oral administration of Salvia haenkei in a healthy population. Furthermore, Salvia haenkei has been identified as a potential anti-senescence agent and may counteract aging and aging-associated disorders. In this scenario, the current study aims also at exploring the effects of this supplementation on muscular and other organ functions (kidney, liver, heart, etc.) and on systemic inflammation and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Male or female
* Age 55-65 years, inclusive
* In good general health as evidenced by medical history and current health status
* Willingness to maintain dietary and sports habits as of baseline
* Willingness and ability to comply with the requirements of the study

Exclusion Criteria:

* Body Mass Index \< 18.5 or ≥ 30
* Difficulty in swallowing (dysphagia)
* Known allergy or sensitivity to any ingredient of the study intervention
* Any medical condition or clinically significant abnormalities in laboratory values (hematology, blood chemistry, urinalysis) at screening which in the judgment of the Investigator makes the subject unsuitable for the study
* Planned or anticipated major surgical procedure during the subject's participation in this study
* Inability or contraindications to undergo the study intervention
* Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
* Use of any new vitamins, herbal or dietary supplements, functional foods and sports drink, of any kind, liable or presented as liable to enhance physical performances within one month prior to the start and during the study
Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients

1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
2. Can the improved debilitating index predict the delusion after non-cardiac surgery
3. Which of the debilitating index are independent risk factors associated with postoperative delusions

Early identification of frailty patients is of great clinical significance for preoperative decision making and prognosis assessment. To date, the incidence of postoperative delirium in elderly patients undergoing noncardiac surgery has not been assessed. This study aimed to investigate the relationship between preoperative frailty assessment and the incidence of postoperative delirium after noncardiac surgery.

1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
2. Can the improved debilitating index predict the delusion after non-cardiac surgery
3. Which of the debilitating index are independent risk factors associated with postoperative delusions

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 70 years old;
2. ASA: Grade Ⅰ～Ⅳ;
3. Signed informed consent；
4. Scheduled non-cardiac surgery.

Exclusion Criteria:

1. Refuse to participate;
2. Expected length of stay \<3 days;
3. The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause;
4. Emergency surgery patients;
5. Inability to communicate due to illiteracy, language impairment, severe hearing or visual impairment;
6. Central nervous system diseases, including various types of dementia and depression
7. Severe renal insufficiency (requiring dialysis treatment);
8. Severe liver dysfunction (Child-Pugh score ≥10);
9. Patients who have participated in other relevant clinical studies within 3 months MMSE examination has confirmed the existence of cognitive dysfunction: illiteracy ≤17 points, primary school degree ≤20 points, middle school degree (including technical secondary school) ≤22 points, university degree (including junior college) ≤23 points
Improving Oral Health With Serious Games

This study investigated if computer games can be effective at changing the way children take care of their teeth. We a museum exhibit with 3D virtual reality games called "Attack of the S. Mutans!" Our hypothesis was that children who played the games and visited the exhibit would show improved attitudes about oral health, which would translate into improved brushing and self-care habits.

In this randomized controlled study with school children aged 8-12, we compared the outcomes for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on classroom presentation about virtual reality being used for healthcare; Group 3) Received no-treatment.


Eligibility Criteria:
Inclusion Criteria:

For participation in the study, enrollment criteria are as follows: 1) a dentist's diagnosis of tooth decay, or restorative dental work in the previous year; and 2) Parents or guardians provide usable baseline data, including contact information for follow-up questionnaires.

Exclusion Criteria:

None
PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia

Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.

This is an open-label, single-centre, randomised study, looking at a series of 40 patients up to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously treated. Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed WM according to the second 2002 WM international working group
* Not previously treated, apart from not regularly received by Chlorambucil
* Aged from 18 to 75 years, both male and female
* Ability to give signed informed consent
* Negative pregnancy test at inclusion (if necessary)
* ECOG from 0 to 2

Exclusion Criteria:

* Known hypersensitivity to rituximab or velcade or cyclophosphamide
* Uncontrolled infection including bacteria, virus and fungus, including active HBV infection
* Organic dysfunction: Bilirubin \> 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) \> 2.5 x normal above
* Positive HIV serology
* Serious psychiatric item in the history
Cognitive Dysfunction in COPD Patients : Role in the Performance of Cognitive-motor Dual Task Situation?

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point characterized by multiple systemic effects as cognitive dysfunction. This one seems to have an impact in activity daily living, considered mainly as a cognitive-motor dual task situations. Yet to date, no study has specifically focused in the cognitive-motor performance in patients with COPD or on the effects during a rehabilitation program. The main objective of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing performance between COPD patients and healthy subjects in a single and dual task cognitive-motor situation. The secondary objective was to assess the impact of a rehabilitation program on these performances.


Eligibility Criteria:
Inclusion Criteria:

* Male or female about 40 to 80 years old
* COPD patient (Tiffeneau \<70%); stage moderate to severe (Stage 2,3 and 4) with or without oxygen therapy (\>15h/day)
* Written and informed consent of the subject
* Authorization to physical activity referring doctor in the clinic
* Comorbidities no dominating

Exclusion Criteria:

* Subject with neurological pathology, cognitive or psychiatric
* Subject with pain and / or plantar injuries
* Subject has a prosthetic knee and / or hip.
* Subject requiring walking aid (cane, walker, etc.)
Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size
* Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

* Less than 20 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy
To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
2. Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).
3. Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken

Exclusion Criteria:

1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)