cyrilzakka/clinical-trials huggingface dataset:
Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

This study is part of International Vaccine Institute (IVI)'s typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Hechi City in the Guangxhi province of China. The cost-effectiveness and safety of Vi vaccination will also be evaluated.

Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence, is given as a single dose, lacks patent protection and requires less strict cold chain requirements.

This project attempts to evaluate a new vaccination strategy for residents of endemic areas. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (meningococcal A vaccine) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 2 populous townships of Hechi City. The vaccines used in this study are locally produced and licensed in China. A 1 year pilot phase will precede the actual Vi-demonstration project. Surveillance for typhoid fever cases will continue after the mass immunization campaign. A passive surveillance system to evaluate adverse events following immunization will be implemented. Socio-economic studies will be conducted in parallel to the effectiveness evaluation. The knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention will be assessed. Logistic, feasibility and vaccine costs will also be determined.

Secondary objectives of this trial are:

* To estimate the logistic feasibility of a mass typhoid immunization campaign
* To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention
* To study typhoid fever risk factors in the population

Eligibility Criteria:
Inclusion Criteria:

* Registered in the project census

Exclusion Criteria:

* Pregnant
* Lactating
* Fever \> 37.5 degrees Celsius, axillary
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence

The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

To get the objective urodynamic and sonographic effects of IncontiLaseTM procedure on women with stress urinary incontinence; and its impact on urinary symptoms and female sexual function.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence

Exclusion Criteria:

* \< 20 years old female
INtravenous TNK for Acute isChemicsTroke in China

Acute ischemic stroke is the most common type of stroke, accounting for about 60%-80% of all stroke, with high incidence, high mortality, high disability rate, has become the first cause of death in China. At present, only ultra-early thrombolytic therapy, endovascular therapy and antiplatelet therapy have obtained evidence-based medical evidence in ischemic stroke treatment, but only thrombolytic therapy and endovascular therapy can improve the good prognosis of patients. Intravenous thrombolytic therapy within 4.5 hours after the onset of ischemic stroke symptoms has been shown to be effective, which is recommended in the guidelines.

In most countries, alteplase (R-tPA) is the only drug approved for the treatment of acute ischemic stroke. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) is a modified recombinant tissue-type plasminogen activator, with no procoagulant effect and a longer half life. In recent years, there are some studies on the comparison of therapeutic effects of TNK-tPA and RT-PA in patients with acute ischemic stroke, and TNK shows promising especially for large artery occlussion. At present, there are few reports on the application of rhTNK-tPA in Chinese stroke patients.

The aim of this study is to evaluate the efficacy and safety of rhTNK-tPA in Chinese patients with ischemic stroke in a prospective, multicenter registration study.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 ;
2. The time from onset to treatment was less than 4.5 hours;
3. Ischemic stroke confirmed by head CT or MRI;
4. There are measurable neurological deficits;
5. First onset or previous onset without obvious sequelae (Mrs ≤1 score) ;
6. signed informed consent.

Exclusion Criteria:

1. Severe neurologic deficits before onset (mRS ≥2) ;
2. Significant head trauma or stroke in the last 3 months;
3. Subarachnoid hemorrhage;
4. A history of intracranial hemorrhage or head injury or acute stroke within 3 months;
5. Intracranial tumors, arteriovenous malformations or aneurysms;
6. Intracranial or spinal cord surgery within 3 months;
7. Non-compressible arterial puncture within 7 days;
8. Gastrointestinal or urinary tract hemorrhage within last 21 days;
9. Major surgery within 1 month;
10. Thrombocytopenia (platelet count \<10×109/L);
11. Use of heparin or oral anticoagulation therapy within 48 hours;
12. Use of warfarin with an international normalised ratio \>1.7 or PT \>15 s;
13. Uncontrolled hypertension (SYSTOLIC \>180 mmHg OR DIASTOLIC\>110 mmHg) ;
14. The Blood Glucose concentration \<50 mg/dl (2.7 mmol/L);
15. Severe systemic disease with poor life expectancy (\<3 months); ;
16. Allergic to research drug;
17. Within 3 months or participating in other clinical trials;
18. Other conditions due to which investigators consider study participation inappropriate.
Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

This study will use a multi-center, prospective design, with a "Real World Study" model, to include 200 patients with nephrotic syndrome. based on the Population Pharmacokinetics (PPK) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the Pharmacokinetics/ Pharmacodynamics (PK/PD) relationship of Tacrolimus in patients with nephrotic syndrome, and develop an optimal medication regimen.


Eligibility Criteria:
Inclusion Criteria:

* （1）Patients with Nephrotic Syndrome：

  1. Proteinuria greater than 3.5 g/24 hour
  2. Serum albumin \<30 g/l
  3. Clinical evidence of peripheral oedema
  4. Hyperlipidemia 1) and 2) are necessary for diagnosis.
* （2）18-75years old（include 75），gender is not limited；
* （3）Voluntary signing informed consent。

Exclusion Criteria:

* （1）Secondary nephrotic syndrome；
* （2）Allergic to Tacrolimus or other unsuitable use of Tacrolimus；
* （3）With other immunosuppressive agents such as cyclosporin A, cyclophosphamide, mycophenolate mofetil, leflunomide, tripterygium wilfordii (hormone is not restricted)；
* （4）Severe liver dysfunction (transaminase \> 3 ULN, or bilirubin \> 3 ULN)；
* （5）Severe renal insufficiency（eGFR\<30 ml/min/1.73m2）
* （6）Joined other clinical trials within 1 month；
* （7）Missing clinical data；
* （8）Pregnancy, lactation or planning for pregnancy within 12 months；
* （9）Researchers believe that patients who are not suitable for this clinical trial。
STRucturation of Transcript Analysis of Genes Involved in Hereditary Cancers

Molecular diagnosis using high throughput sequencing has become an essential part of oncogenetic care, making it possible to identify people at risk, to guide surveillance, and to direct preventive surgery and treatment. The quality of this 'precision' care depends on the quality of the interpretation of the genomic variants identified. To be usable in oncogenetics, a genomic variant must be correctly interpreted: pathogenic, benign or of uncertain significance (VSI). The impact of these DNA variants (VSI) on RNA is particularly important for interpretation. Today, due to a lack of resources, joint and systematic DNA/RNA analysis is never carried out. This has inevitably meant that a number of situations of interest have been overlooked. It is now important to go a step further and organise a visible and reliable circuit, allowing routine access to these studies for patients.

Systematic DNA/RNA analysis is never carried out using the current approach, due to a lack of resources. Strategies recommend pre-screening variants using in silico analysis, followed by RNA studies targeting variants of interest.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Patients seen in oncogenetic consultations and who have given their informed consent for genetic analysis in the context of a major predisposition to breast, ovarian or digestive cancer.
* Person who has read and understood the information note and does not object to taking part in the study
* Membership of a social security scheme

Exclusion Criteria:

* Minors
* Persons deprived of their liberty or adults under guardianship or incapable of giving their consent
* Failure to obtain informed consent
Incidence of Pancreatic Fistula After Radical Gastrectomy

This study is designed to investigate the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients.

Pancreatic fistula, which can lead to fatal end, is one of the most serious complications after radical gastrectomy. It is usually treated as a key factor to evaluate the quality of gastrectomy. The incidence of pancreatic fistula is far different between different areas, knowing the prevalence of pancreatic fistula and risk factors can help us to prevent pancreatic fistula and improve the short time outcome of gastric cancer surgery treatment. So, we designed this perspective, multi-center study to investigate the incidence of pancreatic fistula and its outcome in China.

Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed stomach adenocarcinoma
* preoperative curatively resectable tumor

Exclusion Criteria:

* pancreas resection
* emergent surgery due to gastric cancer acute complications
* cancer of gastric remnant
RP% Measurement by FCM as a Diagnostic Test for ITP

Immature platelets-also termed reticulated platelets (RP)-are platelets newly released into the circulation, and have been associated with a variety of pathological bleeding events including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM) after staining with thiazole orange (TO) at low concentration and expressed as a fraction of the total platelet count (RP%). The diagnosis of primary ITP is based on differential diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are useful in daily practice. Our study aimed at distinguishing primary ITP from other thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen (MAIPA) were analyzed accordingly.

The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60\*10\^9/L from 4 medical centers in China. In brief, 15 μl aliquots of anti-coagulated whole blood were incubated for 70 min with 5 μl of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.

Clinical information of all participants including gender, age, platelet count and definitive diagnosis were recorded by an exclusive investigator. RP% results were revealed at the end of recruitment and after all FCM measurements were completed. The agreement between clinical diagnosis and RP% results were analyzed to identify primary ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Untreated adult patients of both gender between the ages of 18 and 75 years
2. Each participant showed a platelet count 60\*10\^9/L, with or without bleeding manifestations
3. Thrombocytopenic disorders including autoimmune-mediated, aplastic (hypoplastic) or chemotherapy-induced thrombocytopenia

Exclusion Criteria:

1. Received high-dose steroids or IVIG within 3 weeks prior to the test
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months prior to the test
3. Current HIV infection, hepatitis B virus or hepatitis C virus infections
4. Severe medical condition (liver and kidney function impairment). Unstable cardiovascular disease or uncontrolled hypertension.
5. Patients who are deemed unsuitable for the study by the investigator
Study on Hemodialysis: Illumination Effects

Previous research has shown that sleep quality in hemodialysis patients is disturbed. One of the possible explanations is an insufficient or disturbed melatonin rhythm. Melatonin rhythm is regulated by exposure to light. In this feasibility study, the investigators examine the effects of light therapy during dialysis on sleep, melatonin rhythm and mood.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* men/women aged 18-85 years
* knowledge of the dutch language
* hemodialysis patient
* subjective sleep problems (Epworth sleepiness score \>9)

Exclusion Criteria:

* known major illness, which interferes with patient's participation
* use of melatonin/hypnotics
* use of photosensitizing medication
* jet lag or travel \> 1 time zone
Visual Rehabilitation of Patients With Myopic Maculopathy

The Visual Pathfinder (LACE inc.) offers a non- invasive, patient- centered visual rehabilitation system based on an acoustic biofeedback. The investigators wanted to evaluate its usefulness in the improvement of visual function in visually impaired patients with high myopia.


Eligibility Criteria:
Inclusion Criteria:

* high myopia (range 9-15 D) visited at the Outpatient Medical Retina's Hospital A. Fiorini Terracina (LT), University of Rome "La Sapienza", Polo Pontino. The diagnosis of myopic maculopathy was made on the basis of a comprehensive ophthalmological evaluation which included: biomicroscopic examination of anterior and posterior segment, fluorescein angiography (FAG) (Heidelberg HRA-2, FA module Heidelberg, Germany), optical coherence tomography (OCT), Spectral Domain (Heidelberg HRA-2, OCT module Heidelberg, Germany) and microperimetry with microperimeter MP-1 (Nidek Technologies, Padova, Italy).

Exclusion Criteria:

* The investigators have excluded patients with other eye diseases (glaucoma, AMD, retinal detachment, etc.), uncooperative patients and persons with opacity of the dioptric media.
An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints

This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.


Eligibility Criteria:
Inclusion Criteria:

1. TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS
2. Patients who provided written informed consent prior to participation to this study
Study on the Influencing Mechanism and Promoting Strategies of Post-partum Nurses' Work Engagement

The goal of this observational study is to through the combination of longitudinal qualitative research and longitudinal quantitative research, the work experience changes of nurses returning to work after delivery were analyzed, and the changing trajectory and influencing mechanism of work involvement of nurses returning to work after delivery were explored.On this basis, combined with the existing literature, the promotion strategy of post-natal nurses' work involvement was constructed in order to improve the level of post-natal nurses' work involvement, help them better adapt to clinical nursing work, and improve the quality of nursing service.


Eligibility Criteria:
Inclusion Criteria:

* Nurses returning to work after childbirth are engaged in clinical nursing work in the hospital;
* The time to return to work after childbirth is less than 1 month;
* Informed and voluntary participation in the study.

Exclusion Criteria:

* Training, rotation, practice nurses;
* Give birth to abnormal children.
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.


Eligibility Criteria:
Inclusion criteria:

1. Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

Exclusion criteria:

1. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) \> 1.5 fold Upper Limit of Normal (ULN) (Patients who completed the parent trial with transaminase values \> 1.5 fold ULN but \< 3 fold ULN are considered eligible)
2. Bilirubin \> 1.5 fold ULN
3. Bleeding risk
4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
5. New major thrombo-embolic events developed after completion of the parent trial.
6. Time period \> 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
7. Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial.
8. A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients' ability to participate in this trial.
9. Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
10. Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it until 3 months after end of treatment.
Shinrin-Yoku (Forest Bathing) on Psychological Well-being

This study will examine the effects of Shinrin-Yoku (forest bathing) as an intervention for enhancing psychological well-being in Chinese population. The main component of Shinrin-Yoku is the use of 5 senses in various activities, which typically includes forest walking, meditation, yoga etc. While Shinrin-Yoku has been widely recognized in Japan as a means of preventative health and stress management, it is still a new concept in some countries. In the existing literature, there is increasing evidence demonstrating the efficacy of Shinrin-Yoku for improving for health promotion. However, there is very limited research examining the effectiveness of Shinrin-Yoku in different types of natural environment and the sustainability of its effects.

This study will be a pilot randomized controlled trial on the effects of Shinrin-Yoku (forest bathing) as an intervention for enhancing psychological well-being in Chinese population. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 30 eligible participants will be randomly assigned to either the natural forest group or the urban green area group in a ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Aged from 18 to 65
* Cantonese language fluency
* a willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

* Pregnant
* Have suicidal ideation
* Using medication or psychotherapy for depression
* Experiencing Depression, Anxiety and Stress
* Having unsafe conditions and are not recommended for physical activity by physicians
* Have major psychiatric, medical or neurocognitive disorders that make participation infeasible based on the research team's judgment.
Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management

Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.

Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.

Before inclusion,all eligibility criteria will be verified.

Sarcopenia in patients with inoperable, high-grade epithelial ovarian carcinoma will be evaluated at different times:

* before treatment, in the 30 days prior to their inclusion in the study,
* after 3 neoadjuvant chemotherapy cycles,
* after 3 adjuvant chemotherapy cycles,
* 9 months after surgery. The reference detection method is by CT-scan. This will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening.

On inclusion, the patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia.

This follow-up by a dietician and a physical fitness trainer will be recorded at each neoadjuvant chemotherapy session.

Dietary advice will be given each time along with personalised advice if weight loss were to be observed.

If undernutrition or a foreseeable risk of undernutrition are diagnosed, parenteral nutrition will be prescribed by the oncologist, the anaesthetist or the surgeon.

The objective of APA is to prevent the onset or aggravation of disease, to increase patient autonomy and quality-of-life, or even to help them return to social activities.

Respiratory preparation will also be offered to increase the patient's respiratory capacity in view of surgery, with exercises to be done using a respiratory training device.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Inoperable, high-grade, epithelial ovarian carcinoma requiring perioperative chemotherapy (neoadjuvant and adjuvant).
3. Optical medical treatment (carboplatin-taxol chemotherapy every 3 weeks) and surgery at Institut Bergonié.
4. Non-clinically undernourished patient, i.e. without loss of more than 10% bodyweight in 6 months
5. Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any tests required for the research).
6. Patient with social security cover in accordance with Article 1121-11 of the French code of public health.

Exclusion Criteria:

1. Contraindication to CT-scans.
2. Contraindication to bone mineral densitometry.
3. Patients over the age of 70 the G8 of whom requires oncogeriatric surgery.
4. Patients under guardianship, vulnerable patients or patients under any other legal protection measures.
5. Geographic, social or psychological factors meaning the patient is unable to commit to study follow-up and procedures.
6. Patient already included in this study or in another study evaluating the impact of sarcopenia.