cyrilzakka/clinical-trials huggingface dataset:
Simplification and Test and Treat Strategies Towards Hepatitis C Eliminationplatform" in China(STAT)

The present study aims to establish a " one-sample testing platform " and assess the prevalence of hepatitis C in individuals taking routine physical examination or outpatient visit in mainland China.

Investigators intend to establish a one-sample testing platform to improve diagnosis and linkage to care process in participants under routine physical examination or outpatient visit. The platform is based on rapid diagnostic tests (RDTs) for HCV screening and HCV core antigen for confirmation. RDTs was used to screen for anti-HCV antibodies. The result of RDT will be interpreted within 15 minutes with the sensitivity of 98.9% (95%CI, 94.5% to 99.8%) and specificity of 98.9% (95%CI, 97.5% to 99.9%) using whole blood or finger-stick blood sample \[3-5\]. HCV core antigen is a marker of HCV replication and has a good correlation with HCV RNA in HCV-positive patients (R=0.98). A recent study suggested HCV core antigen testing could be used alternative testing for HCV RNA testing for diagnosis when HCV RNA testing was unavailable. The process of HCV core antigen test only takes 2-3 hours. "one-sample" means only one drop (10ul) of finger-stick blood or residual blood samples from other routine tests collected from patients was needed for anti-HCV antibody testing and HCV core antigen testing, which means they will not have to take another venepuncture. In addition, the use of RDT and HCV core antigen are also less costly. This approach might improve access to care, particularly in low-income and middle-income countries.

The present study aims to establish a " one-sample testing platform " in several medical institution to assess the prevalence of hepatitis C in individuals taking routine physical examination and further promote rapid diagnosis platform in mainland China, so as to achieve the goal in 2030.

Eligibility Criteria:
Inclusion Criteria:

* 1) 18 years of age and older, regardless of age or gender.
* 2) The residual blood sample needs to be not less than 1ml.
* 3) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

* 1) Pregnant, lactating female and who is planning pregnancy during study period.
* 2) History of tumor or other severe, life-threating diseases.
* 3) Samples not meet collection requirements.
* 4) repeated enrollment.
* 5) HCV infection has been diagnosed.
* 6) Recent HCV RNA testing confirmed that there is no HCV infection.

Termination criteria:

* 1) Subject asked to withdraw consent.
* 2) Subjects may suffer adverse impact from the study at investigator's discretion.
Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer

The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.

This study include a multi-center, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 310 patients. Participants will be randomly divided into experimental (n=155) and placebo groups (n=155).Patients in the experimental group was treated with Qizhu Yuling prescription within 6 months after esophagus cancer R0. Patients in the control group will receive the placebo.The primary endpoint is 1-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 1 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Eligibility Criteria:
Inclusion Criteria:

* 1. Esophageal cancer without esophagogastric junction pT1-4aN + M0 (stage IIB-IVA) meeting the diagnostic criteria without recurrence or metastasis;

  2. Patients who have completed adjuvant therapy (including adjuvant radiotherapy, adjuvant chemotherapy, adjuvant chemotherapy + radiotherapy) within 6 months after R0 resection for esophageal cancer;

  3. ECOG score 0-2;

  4. 18-75 years old;

  5. Expected survival ≥ 3 months;

  6. Subjects voluntarily signed informed consent.

Exclusion Criteria:

* 1. Combined with primary tumor at other sites;

  2. Patients complicated with severe primary diseases of heart, cerebral vessels, liver, kidney and hematopoietic system;

  3. Patients with mental illness and mental and language disorders;

  4. Participation in other clinical trials within 3 months;

  5. Patients with known hypersensitivity or intolerance to study drug.
Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months

The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries

Exclusion Criteria:

* BMI greater than 40
Simplified Versus Conventional Technique for Complete Denture Fabrication.

The purpose of this study is to evaluate the effectiveness of a simplified technique of conventional dentures fabrication, comparing it to a traditional technique, by evaluating the impact of oral health on quality of life, satisfaction of individuals and chewing efficiency as well assessing the quality of prosthetics and TMD. Furthermore, the cost involved in the manufacture of dentures through technique simplified will be compared to the cost involved in the traditional technique.

The traditional technique will be conducted through a protocol used by most dental schools in Brazil and described in some clinical trials as a conventional technique for dentures fabrication. On simplified technical functional molding step is deleted, and thus the orientation planes are made directly on the resulting models of the initial molding alginate, and the mounting of the models is performed in semiadjustable articulators random with the aid of an auxiliary table 15 degrees with semiadjustable articulators fixed to the slope. To evaluate the impact on oral health quality of life of individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent) for evaluation of patient satisfaction will use a specific questionnaire assessing the quality of the prostheses will be carried out through a specific exam, to assess the presence of TMD, all subjects will be evaluated through the RDC / TMD, for assessing the efficiency masticatory chewing capsules are used, the costs involved in the manufacture of prostheses will be calculated according to the material consumption used during the making of the prosthesis. All subjects will be assessed before making the prostheses and 90 days after installation of new dentures during this period will be held regular control visits. The data will be evaluated in order descriptive by numbers and proportions, moreover, it will be statistically evaluated by means of suitable tests.

Eligibility Criteria:
Inclusion Criteria:

Edentulous individuals for more than one year and total bimaxillary prosthesis users that need a couple of new prostheses.

Exclusion Criteria:

Pathological changes of alveolar ridges, motor problems and systemic diseases that may influence on the individual's adaptation to the prosthesis.
Family Lifestyle Overweight Prevention Program-Physical Activity Only

This randomized control trial evaluates the physical activity component of the Family Lifestyle Overweight Prevention Program compared to physical education class as usual among Hispanic middle school students.

Family Lifestyle Overweight Prevention Program (FLOW) is an intensive, multi-component obesity intervention designed to take place during physical education class. This intervention has established efficacy at improving standardized BMI among low income, Hispanic middle school students with overweight classification or obesity. However, the efficacy of individual components of the intervention have not been investigated. The purpose of this study was to compare only the physical activity component of FLOW to a physical education class as usual. The primary outcome of the study is time spent in moderate-vigorous physical activity. Secondarily the study evaluated the impact of the intervention on standardized BMI.

Eligibility Criteria:
Inclusion Criteria:

* age 10-17 years old
* enrolled in a middle school PE class at YES Prep Brays Oaks

Exclusion Criteria:

* pregnant
* cognitive impairment significantly below average age or grade level
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients

This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing adenoidectomy ± bilateral ear tube placement
2. Have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with IRB regulations

Exclusion Criteria:

1. An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
2. A known hypersensitivity or allergy to any of the study medications;
3. A history of chronic opioid use prior to surgery;
4. Coexisting renal or hepatic disease;
5. Morbid obesity (BMI% ≥ 99).
The Effect of Wearing Masks on End-tidal Carbon Dioxide and Pulse Oximetry

An Interventional Study is planned with the primary purpose of screening for changes in end-tidal carbon dioxide (ETCO2), inspired carbon dioxide (ICO2), and other vital signs that may develop after donning a disposable surgical mask.

Measurements will be taken and recorded during a 5-minute control period without a mask, recording non-invasive ETCO2 and ICO2 levels by way of a nasal cannula (NC), oxygen saturation (SpO2), breaths per minute (RR), and heart rate (HR) via anesthesia equipment. This will be followed by a 15-minute intervention of wearing a disposable surgical mask and repeating measurements of ETCO2, ICO2, SpO2, RR, and HR, recorded each minute.

Data will be collected from adults and children as young as 2 years of age. Age groups will include children aged 2-14 and adults aged 18 to 80, as described in the details of the research protocol. Parents and their children are invited to participate together.


Eligibility Criteria:
Inclusion Criteria:

* Good health
* Aged 2 - 14 years (inclusive) or 18 - 80 years (inclusive)

Exclusion Criteria:

* Significant cardiopulmonary diseases
* Intolerance to wearing nasal canula
* Intolerance to wearing a surgical mask
Tailored Anti-Inflammatory (A-I) Diet for Hispanics with Ulcerative Colitis (UC)

The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the Hispanics/Latino (H/L) diet on disease remission in H/L patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis with ulcerative colitis from medical records.
* Self-Identify as Hispanic /Latino
* Ages 16-75
* SCCAI between 3-9 (no greater than 12 bowel movements a day)
* Fecal calprotectin \> 150mg/dl.
* On stable medications for their disease for the past 3 months
* Likeability of Latin foods (starchy vegetables, rice, tropical fruits, plantains)
* No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.

Exclusion Criteria:

* Diagnosis of Crohn's Disease (CD).
* Prior ileoanal anastomosis (J-pouch) or diversion
* No recent hospitalizations on the last 4 weeks
* No Clostridium difficile or enteric infections on the last 4 weeks
* No use of probiotics on the last 4 weeks
* Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
* No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
* Pregnancy, breastfeeding or planning to become pregnant during study period
* Use of Total Parenteral Nutrition at the time of screening and during the study period
* Other significant or life-threatening co-morbidities
* The need for antibiotic use during the study period
* Adults unable to consent
* Ages less than 16 and \> 75 years old
* Prisoners
Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX

This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with congenital haemophilia A or B and inhibitors with spontaneous bleeds which require on-demand treatment
* Subjects prescribed NovoSeven® as the first line or recommended bypass agent
* History of on average at least 4 bleeds of any type over a 3 month period
* Subject or caregiver able and willing to complete daily journal for 3 months
* Informed consent obtained from all subjects or legal representative
First Responder Resiliency Program During COVID-19

Evaluating a wellness program developed to provide effective sustainable solutions for medical professionals providing care to COVID-19 pandemic patients.

Providing mindfulness training at specific time points during study participation with an emphasis on integrating physical and mental health management. The phase-based program delivers individualized, data-driven and quantifiable solutions that directly address pain points impacting healthcare professionals and organizations.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older at the time of consent
2. Frontline healthcare professional
3. Have access to an Apple or Android device
4. Not pregnant by subject self-report at time of consent
5. Have the ability to provide informed consent
6. Have no contraindicating comorbid health condition as determined by the clinical investigators

Exclusion Criteria:

1. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
2. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life or sleep
3. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, stress or sleep
4. An unstable medical or mental health condition as determined by the physician investigator
Community-based Complex Exercise for Stroke Patients

A lot of physical and social effects of exercise programs and daily physical education have already been proven for stroke patients after discharge. However, stroke patients have shown a passive attitude in participating in physical education or exercise programs for life, and the local community lacked appropriate guidelines or experience in guiding exercise and physical education for stroke patients, so they had a burden on instructing exercise. In this study, an appropriate complex exercise program was established for patients after discharge through analysis of domestic and foreign research data to provide an environment and opportunity to exercise in the community, and based on the results, stroke patients actively exercise in the community in the future. The goal is to provide a basis for doing so.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients aged 30 years or older residing in the community
* Those who can walk independently and have a score of 3 or higher in the Functional Ambulation Category (FAC)
* The daily life dependence of the stroke patient is a person who can perform simple tasks necessary for daily life, Those who scored 2 points or less on the Modified Rankin Scale (mRS)
* Subjects with no or mild stiffness of the affected upper and lower limbs, with a score of 1 or less on the Modified Ashworth Scale (MAS)
* All 3 major joints of the affected upper and lower limbs (Manual Muscle Test (MMT)) are 3 points (F grade) or higher ruler

Exclusion Criteria:

* With moderate or severe cognitive dysfunction, Korean-Mini Mental state test (Korean-Mini Mental state test) Those who scored less than 18 points in the Examination (K-MMSE)
* A person with a moderate or higher fall risk and less than 41 points on the Berg Balance Scale (BBS)
* Those who have difficulty understanding the intervention exercise program or expressing symptoms due to severe language impairment
* Those who cannot apply this intervention exercise program due to serious cardiovascular disease
* Those who have musculoskeletal disorders that make it impossible to exercise
* Those who are judged unsuitable for this study under the judgment of a specialist in rehabilitation medicine due to other diseases
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children

Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.

To get an understanding of the Hp infection general situation and provide evidence for Hp control, we are planning to run a free physical examination and lab test for a group of children. We are going to proceed with Hp-IgG test, 13C urea breath test and salivary Hp urea antigen test together to screening and diagnosing it.

Eligibility Criteria:
Inclusion Criteria:

* Age 3\~18
* Not been Clinical diagnosis of

Exclusion Criteria:

* Had antibiotics in the past week
* Had Bismuth or PPI
Juvenile Inflammatory Rheumatism (JIR) Cohorte

The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.

The JIR-cohort has to be filled by an authorized investigator during or after the consultation. Each patient much be followed at least once a year.

Different data are requested in the JIR-cohort: diagnosis, treatment, adverse events and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with juvenile inflammatory diseases
* Age at onset up to 18 years old
* Consent according national codes of ethics and current laws

Exclusion Criteria:

* Non-consent from patients and/or legal representative
A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD)

The main aim of this study is to check the disease activity in people with moderate to severe ulcerative colitis and Crohn's disease.

Participants will complete questionnaires about their disease and quality of life on Day 1 clinic visit. They will do this during a standard scheduled appointment with their doctor. Some of this study will also involve collecting information about participants from their medical records.

This is a retrospective, cross-sectional, and non-interventional study of participants with moderate to severe IBD (UC or CD). The study will have a cross-sectional evaluation on Day 1 to provide the real-world data of disease activity, treatment patterns, burden of disease and quality of life in participants with moderate to severe UC or CD.

The study will involve an additional retrospective review of medical charts of participants of previous 3 years to describe the IBD treatments and use of other healthcare resources related with the management of UC or DC.

The study will enroll approximately 335 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Mexico. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with moderate to severe CD or UC established for at least 6 months prior to Day 1 appointment, based on clinical, endoscopic or image criteria.
2. Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD).

Exclusion Criteria:

1. Has indeterminate or not classified colitis.
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Safety Study for Beta Thalassemia Subjects on PTG-300

In this study will investigate long term safety and use of the PTG-300 in Beta Thalassemia patients.

The PTG-300-03 study will study beta thalassemia patients on PTG-300 for two years. The dose and dose frequency for each subject enrolling in the PTG-300-03 study will be based on the last dose and frequency received by the subject in the previous study PTG-300-02 and the subject's response at that dose. Patients dose will be increased in a manner similar to that used on PTG-300-02 study. The maximum PTG-300 dose allowed is 80 mg/week.

Eligibility Criteria:
Inclusion Criteria:

* NTD and TD β-thalassemia subjects who completed Week 12 and Week 16 respectively in Study PTG-300-02.

Exclusion Criteria:

* Subjects who discontinued prematurely from study 300-02 (before Week 12 in NTD and Week 16 in TD).
Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer

The purpose of this study is to see whether three new types of MRI techniques used during magnetic resonance imaging (MRI) of the pelvis to look at rectal cancer can help doctors to tell if the tumor is getting better in response to the radiation and/or chemotherapy treatments.

This is a pilot study of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI, aka perfusion MRI) and diffusion-weighted MRI (DWI-MRI), herein referred to in combination as advanced MRI (aMRI) in the investigation of early tumor response to standard multi-dose, fractionated external beam radiotherapy (EBRT) of the pelvis given in the neoadjuvant setting concurrent with chemotherapy as well as induction chemotherapy prior to chemoradiotherapy or consolidation chemotherapy after chemoradiotherapy for primary rectal adenocarcinoma. This protocol aims to expand upon the growing body of knowledge concerning early changes in tumor neovascularity and cellular density as a potential biomarker of therapy efficacy. It further aims to address the trend towards more refined treatment stratification for lower risk tumors to avoid morbidity from potentially unnecessary radiation, chemotherapy or even radical surgery, by assessing the earliest changes that occur in microvasculature and perfusion and diffusion of water during this treatment to see if these can be predictive of long-term efficacy of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary locally advanced rectal adenocarcinoma (0-18cm from the anal verge) confirmed by MSKCC pathologist and eligible to undergo chemoradiation and surgical resection at MSKCC.
* Written informed consent
* Age equal to or greater than 21 years
* Willing and able to undergo all study procedures
* Patients must have a planned surgical resection of the rectum

Exclusion Criteria:

* Patients younger than 21 years
* Pregnant and nursing women
* Contraindications for MRI (such as claustrophobia, pacemaker, non MR-compatible artificial heart valves, cochlear implants, surgical clips in the brain, metal fragments in eye)
* Estimated GFR (using Cockcroft formula Appendix 2) less than 30 ml/min/1.73m2 (FDA advises caution in using gadolinium-based contrast agents in patients with severe renal impairment).
* History of allergic reaction to MR contrast media
* Inability to give informed consent in person