cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity

Primary Objective:

To describe the safety profile and immunogenicity following each injection.


Eligibility Criteria:
Inclusion Criteria :

* Aged 18 to 40 years on day of inclusion
* Informed consent form signed
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman, inability to bear a child or negative urine pregnancy test.

Exclusion Criteria :

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
* Vaccination with an influenza vaccine during the past 6 months
* Any vaccination in the 4 weeks preceding the first trial vaccination
* Vaccination planned in the 4 weeks following any trial vaccination
* Breast-feeding.
* For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
* Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
* Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
* Blood or blood-derived products received in the past 3 months.
* Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
* Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
The Effect of Case Management in Complex Cancer Pathways

Introduction: Case management (CM) has been proposed as a method for optimizing the course of treatment for complicated cancer patients. However evidence of the effect of CM is limited and methodologically rigorous research is needed.

Aim: To analyze effects of Nurse CM in complicated cancer care.

Methods: The study is designed as a two-arm randomized controlled trial (RCT) including approximately 280 colorectal cancer patients.

Intervention group patients will be offered usual medical treatment plus supportive intervention from a case manager. Control group patients will receive usual medical and supportive treatment.

The intervention: Case managers are registered nurses and possess thorough knowledge of cancer treatment and pathways. Core intervention elements: Planned and ad hoc personal and telephone contacts, surveillance of care pathways, coordination and dissemination of care plan (including transfer of patient-specific information to other departments and general practice).

Primary outcomes: Patient evaluations of care pathways and "Quality of Life" (questionnaires).

Secondary outcomes: Use of health care services and care process measures (The National Health Insurance Service Registry and The National Patient Registry; and GPs' evaluations of continuity of care (questionnaire).

Schedule:

* "Case management used to optimize cancer care pathways: A systematic Review" has been published in BMC Health Services Research.
* The CM manual has been written. Questionnaires are under development and pilot testing.
* Two case managers have been appointed 1. January 2009.
* After training and pilot testing of the intervention the RCT will begin in March 2009. Inclusion period is 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Colon or rectal cancer are highly suspected and a course of treatment at Department P, Aarhus University Hospital is expected to follow.

Exclusion Criteria:

* Do not speak and understand Danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)
Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.

Giving chemotherapy directly into the abdomen is called intraperitoneal (IP) chemotherapy. Because ovarian, fallopian, primary peritoneal and uterine cancer spread in the abdominal cavity, giving chemotherapy drugs by infusion into the abdominal cavity may result in a greater dose of the drugs reaching the tumor cells. Intraperitoneal treatments will be administered through an implantable peritoneal catheter. These catheters are to be inserted into the peritoneal cavity, tunneled through the subcutaneous tissue, and connected to an implantable port, which is placed in the subcutaneous tissue of the anterior, inferior thorax.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage IA, IB, IC, II, III, IV and recurrent platinum sensitive epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma. Histologic subtypes which are eligible include serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma (not otherwise specified), and carcinosarcoma.
* Patients with advanced endometrial carcinoma, of any histology, including endometrioid adenocarcinoma, clear cell adenocarcinoma, and serous papillary carcinoma.
* Patients with uterine carcinosarcoma of any stage are eligible.

Exclusion Criteria:

* Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
* Patients with septicemia, severe infection, or acute hepatitis.
* Patients with prior malignancy or cancer treatment within the last five years.
Testing a Novel Community-based Occupational Therapy Model

This study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model.

In this project the investigators' overall objective is to implement a narrative medicine-based occupational therapy (OT) model of care that brings client voices to the forefront of treatment planning and intervention to enhance the existing interdisciplinary system of service delivery within Midtown Community Mental Health (MCMH). The investigators hope to accomplish this objective via the following specific aims:1) Assess current programming - particularly processes surrounding client assessment, treatment planning, intervention, care-coordination/residential placement, and discharge - within MCMH sites to better understand limitations/gaps previously identified by the site manager that impact equitable and effective treatment 2) Adapt an existing care model - the Art of Healing Wellness Model (AoHW) - to meet the needs of MCMH, implement the model using an OT practitioner, and track feasibility/acceptability outcomes. 3) Re-assess MCMH programming post implementation to identify/demonstrate change resulting from the model 4) Using OT in the role of consultant, offer training to current MCMH staff to enable implementation of the adapted AoHW by MCMH (baccalaureate level) care coordinators 5) Preliminarily evaluate usability of the adapted AoHW by MCMH staff via focus groups following training and staff implementation

Eligibility Criteria:
Inclusion Criteria

• Patient on a pre-determined treatment team at the outpatient mental health recruitment site

Exclusion Criteria

* Under 18
* Pregnant
Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults

This proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP behaviours among Chinese community-dwelling older adults. This is a mixed methods study with the quantitative paradigm being the main research approached used. The quantitative arm will be a randomized controlled trial (RCT). The qualitative arm will adopt focus group interviews for data collection. Recruited subjects from the community centres will be randomly allocated to the intervention and control group. The older adults in the experimental group will receive an ACP board game delivered by trained facilitators, whereas the older adults in the control group will receive another board game about healthy lifestyle. The outcome measures of the older adults will include the ACP Engagement scale, the Life-Support Preferences Questionnaire (LSPQ), a self-developed ACP knowledge questionnaire and those data will be collected at baseline (T0), immediately post-intervention(T1), at 1 month (T2), and 3 month (T3). The qualitative arm of this study will contribute to the understanding of issues and effects of ACP game as an intervention. Its finding will complement the results obtained from the RCT.


Eligibility Criteria:
Inclusion Criteria:

* aged 60 years or over;
* speak Chinese.

Exclusion Criteria:

* uncommunicable because of language barrier or sensory impairment;
* have been referred to the palliative care service at the time of recruitment.
Shared Decision-making and Antimicrobial Stewardship in Secondary Care

To identify opportunities for antibiotic prescribing shared decision making between patients and prescribers in secondary care.

This is a qualitative study with patients and clinicians in secondary care.

We will use semi-structured interviews with patients and clinicians to address the research question. Patients that have received antibiotics during a recent inpatient stay will be identified using the hospital electronic prescribing system and a letter inviting study participation will be included in their discharge medication pack. Senior prescribing decision makers will be recruited from participating hospitals. In total, we hope to carry out up to 50 interviews with patients and clinicians.

Eligibility Criteria:
Inclusion Criteria:

For clinicians:

* Participant is willing and able to give informed consent for participation in the study.
* Senior registrar or consultant medical or surgical doctor working at participating hospitals and caring for inpatients.
* Fluent in English.

For patients:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 16 years or above (no upper age limit).
* Good standard of speaking English and able to read and understand study materials.
* Received antibiotic for treatment of suspected or confirmed bacterial infection during inpatient stay.

Exclusion Criteria:

* For clinicians:

  * Prescribers not currently caring for inpatients

For patients:

• Patient who received prophylaxis antibiotics only
Blood Transfusion Management in Patients With Mitral Valve Replacement in China

The evaluation uses ΔHb as an independent factor combined with artificial intelligence (AI) to predict its impact on the prognosis and blood transfusion of patients undergoing cardiac surgery, thereby guiding perioperative clinical blood use and improving patient prognosis.

1. Select 8 hospitals to form a multi-center team, and enter the keyword "mitral valve replacement" in the case system of 8 hospitals to collect information on 2000 heart surgery patients.
2. Mainly collect information on preoperative, intraoperative and postoperative test indexes (blood routine, liver and kidney function, coagulation function, blood gas), cardiac color Doppler, blood transfusion and prognosis of patients undergoing cardiac surgery, using statistical methods for analysis. Identify key observations.
3. Gradually incorporate and exclude data, and use statistical methods to conduct preliminary analysis on the collected data.

The AI prediction model was established by machine learning algorithm to predict intraoperative blood transfusion, verify the specificity and sensitivity of the blood transfusion prediction model, and scientifically guide clinical blood use.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing "mitral valve replacement" surgery;
2. Age 18-75 years old;
3. 48h biochemical indicators before surgery, blood general indicators, coagulation indicators are complete.

Exclusion Criteria:

1. Lack of necessary tests and patient test information is not detailed, blood transfusion information is not detailed;
2. The blood transfusion information is not detailed in the same period as other cardiac operations (such as aortic valve surgery, coronary artery bypass grafting, etc.), but the tricuspid valvuloplasty is not ruled out at the same time;
3. Heart surgery or emergency surgery again.
Efficacy of Malaria Vaccines in Kenyan Adults

Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become more widely available. However, transmission still persists and it appears that additional control measures are required. The leading malaria vaccine candidate in development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the field. This partial protection might be enhanced by combination with other components. The other vaccination approach that has produced repeatable efficacy in humans is the use of viral vectors to induce T cell responses. Previous attempts with this vaccine approach have been effective in challenge studies in Oxford, but ineffective in the field, probably because of reduced immunogenicity.

Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with thrombospondin- related adhesion protein (ME-TRAP).

The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and partial protection in 5 out of 14 volunteers in challenge studies.

The investigators propose a Phase 2b study of 120 healthy adult men in Kenya. The investigators will assess the efficacy and further evaluate the immunogenicity and safety profile of the vaccine regimen. The investigators also intend to assess the correlates of efficacy and natural immunity.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adult males aged 18 - 50 years in good health.
* Will remain resident in the study area for the study duration.
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* Informed Consent

Exclusion Criteria:

* Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
* Hypersensitivity to Verorab, the trial vaccines or the antimalarial used.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, kathon, neomycin
* History of splenectomy.
* Haemoglobin less than 10.0 g/dl
* Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels).
* Blood transfusion within the month preceding enrolment.
* History of vaccination with previous experimental malaria vaccines or other vaccines likely to impact on findings of study (e.g. other MVA or adenovirus vectored vaccines)
* Administration of any other vaccine or immunoglobulin within 2 weeks before vaccination.
* HIV or Hepatitis B surface antigen seropositivity.
* Current participation in another clinical trial or recent participation within 12 weeks of this study.
* Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
* Likelihood of travel away from the study area
Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease

The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.

Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and endoscopic criteria.
* Males or females ages 11-17 years.
* Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \< 10
* Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for at least 2 months.
* Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent.

Exclusion Criteria:

* Patients with documented intestinal stricture.
* Patients with signs of symptoms of systemic or intestinal infection.
* Antibiotic use the previous 1 month.
* Probiotic use in the previous 2 months (excluding yogurt).
* Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus and Infliximab.
* Patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease.
* Patients with indwelling catheters.
* Patients with short bowel syndrome
* Positive urine pregnancy test for female subjects
Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease

Our study is a multi-site, prospective, observational study including patients with acute exacerbations of CLD. Approximately 1500 patients from 24 hospitals in diverse regions in China will be enrolled and followed for 3 months. Data about demographic data, laboratory tests, and clinical manifestations, collected through a mobile application, will inform real-time prognostic scores. The aim of this study is to validate the model's real-world applicability in non-specialist hospital settings.

The study is a multi-site, prospective, observational study conducted in 24 hospitals representing different regions across China. The choice of 24 hospitals was based on their representation of diverse geographical regions across China. These hospitals were selected to ensure a comprehensive validation of the screening model's efficacy in varied healthcare settings. Data will be collected through a mobile application, providing real-time prognostic scores for patients. The study is divided into three parts: patient recruitment, in-hospital follow-up, and post-discharge follow-up . Follow-up will last for 3 months. Endpoints will be considered for all-cause death, survival and liver transplantation. The study is planned to enroll 1500 patients from January 2024 to January 2026.

Eligibility Criteria:
Inclusion Criteria:

* Chronic liver disease with or without cirrhosis, including chronic viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, metabolic liver disease, chronic drug- induced liver disease and cryptogenic cirrhosis. The duration of underlying non-cirrhotic chronic liver disease should be longer than 6 months.
* Acute exacerbations of chronic liver disease, including acute decompensation (bacterial infection, hepatic encephalopathy, variceal bleeding, ascites and jaundice) in 1 month and liver injury (ALT or AST \>3 ULN , or TB\>2 ULN) in 1 week.
* Patients are informed of the study purpose and willing to sign the informed consent.

Exclusion Criteria:

* \<18 years old or \>75 years old
* with malignancy of liver or other organs
* with other serious comorbidities (such as circulatory failure, respiratory failure, chronic kidney disease with end-stage renal failure, stroke within 6 months before admission, severe systemic autoimmune diseases or severe metabolic disease )
* pregnant
* receiving immunosuppressive agents for non-hepatic diseases
A Randomized Controlled Double Blinding Study of Intradermal Acupuncture Treatment on Obesity

The purpose of this study is to determine whether intradermal acupuncture is effective and safe in the treatment of obesity.

Recently the Studies of auricular acupuncture or Common Acupuncture on obesity have been conducted. Saam acupuncture, the Korean unique acupuncture, is famous with its high efficacy but not established by the scientific way yet. Thus, we tried a double-blind study on the effect of sa-am acupuncture on obesity using intradermal acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>25, regular menstruation, volunteer

Exclusion Criteria:

* symptomatic obesity, acupuncture treatment within 3 months, \>120kg, pregnancy or breast-feeding, hemophilia, dementia, mental illness, arrhythmia, liver cirrhosis, renal failure, pace maker, diabete mellitus, tuberculosis, steroid taker,
Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit

This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay. This is a single center, non-interventional observatory study.

Patients admitted to the medical wards with a provisional diagnosis under "pneumonia","chest infection" or "fever" will be screened by research assistants.

Patients eligible with the inclusion criteria will be recruited into the study. Informed consent will be signed for those patients willing to participate in the study. Patient will be asked to save approximately 40 ml of urine. The urine sample will be processed in local laboratory and shipped out to a commercial lab for detection of any pneumococcal pneumoniae, and if present, serotyping will be performed at the same time using the same urine sample by urinary antigen assay. Meanwhile patients will be managed as usual by their clinical teams. Investigations and treatment will be offered by the clinical team as deemed necessary. The study team will only perform collection of urine and will not interfere the clinical management of the patients.

Positive results would be informed to the clinical teams for the appropriate action.

Eligibility Criteria:
Inclusion Criteria:

* Admitted with signs and symptoms suggestive of pneumonia

Exclusion Criteria:

* 1. Nosocomial pneumonia which is acquired \>= 48 hours after hospital admission. 2. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.