cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)

The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LT-02 (delayed release phosphatidylcholine granules; administered orally via 1.6 g BID for up to 12 weeks) in subjects with active ulcerative colitis who are refractory to a standard dose of oral mesalamine therapy. Refractory to mesalamine is defined as active disease despite receiving at least ≥ 2.4g mesalamine (or equivalent dose) for at least 8 weeks with or without rectal 5-ASA.

Eligibility Criteria:
Key Inclusion Criteria:

1. Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
2. Active UC with disease confirmed by endoscopy findings and confirmed by central reader.
3. A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2 points.
4. Mesalamine (5-ASA) refractory.

Exclusion Criteria:

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
2. Toxic megacolon or fulminant colitis,
3. Prior colon resection,
4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening,
5. Known celiac disease
6. Other inflammatory or bleeding disorders of the colon and intestine, or diseases what may cause diarrhea or gastrointestinal bleeding
7. History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
8. Subjects with known hypersensitivity to soy,
9. Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists, vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8 weeks prior to screening,
10. Treatment with any (topical or systemic) corticosteroid formulation for the treatment of IBD within last 7 days prior to endoscopy,
11. Treatment with other investigational drug within last 8 weeks prior to screening,
Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms

It is well documented that the proportion of inappropriate transthoracic echocardiograms (TTEs) is highest in the ambulatory environment, where it has been reported as high as 30%. Therefore, the potential to improve TTE utilization may be greatest in the outpatient setting. However, no study to date has evaluated whether an Appropriate Use Criteria (AUC)-based educational intervention can reduce inappropriate TTEs in this setting. The investigators therefore designed the first randomized control trial of an AUC-based educational and feedback intervention aimed at reducing inappropriate outpatient TTEs ordered by cardiology and internal medicine physicians in training.

The investigators designed a randomized, control trial of an AUC-based educational and feedback intervention designed to reduce the proportion of inappropriate TTEs in the cardiology and internal medicine outpatient practices at Massachusetts General Hospital. A random number generator divided 24 cardiology fellows and 88 internal medicine residents into control and intervention arms.

During the study, physicians in the intervention arm receive the following multi-faceted educational intervention on TTE appropriateness: 1) a lecture at the beginning of the study period, which describes the AUC for echocardiography and highlights common clinical scenarios for which outpatient TTEs are ordered, 2) an electronic "pocket card" via email that provides tips on appropriate ordering of TTEs, and 3) an individualized monthly feedback report that categorizes TTEs ordered over the preceding month. The feedback reports contain the number of TTEs ordered during the month and how many are classified as appropriate, inappropriate, or uncertain based on the 2011 AUC. A description of all inappropriate TTEs and the rationale for the inappropriate classification is provided. The physicians in the control arm have their TTE orders tracked and classified, but do not receive any feedback on their ordering behavior. While study participants are not blinded to which arm of the study they are in, they were blinded to which arm of the study their colleagues are in.

Prior to the start of the intervention, all study participants receive a knowledge assessment survey. The survey includes five case-based questions designed to assess knowledge of the AUC for TTE and also questions regarding attitudes toward diagnostic testing. Each participant also receives a post-study knowledge assessment survey.

The primary outcome measures in this study are the rate of inappropriate and appropriate TTEs. Secondary outcome measures include the number of TTEs ordered, common appropriate and inappropriate TTE indications, and pre- and post-study knowledge assessment scores among the study physicians.

Eligibility Criteria:
Inclusion Criteria:

* Cardiovascular Medicine fellows at Massachusetts General Hospital
* Internal Medicine residents at Massachusetts General Hospital

Exclusion Criteria:

* Attending physicians
Effect of EA Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke

Most ischemic stroke patients are in recovery phase, often accompanied by motor impairment, but they lack effective treatment. The appearance of nerve growth factor (NGF) promotes the development of neuroprotective therapy, but it has little effect on stroke because of the blood-brain barrier (BBB). Electroacupuncture (EA) has been used for stroke, while there is no significant clinical effect for recovery phrase. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness and safety of EA combined with NGF treatment on ischemic stroke recovery.


Eligibility Criteria:
Inclusion Criteria:

* people with first-ever ischemic stroke confirmed by CT or/and MRI;
* 14 days to 6 months after stroke onset;
* 50 years≤aged≤80 years;
* 3≤modified Rankin Score (mRS)≤4;
* Patients can accept treatment with EA and have good compliance;
* Patients have clear consciousness, pain perception and resolution ability to complete basic communication;
* willing to participate and be randomized to one of the groups.

Exclusion Criteria:

* transient ischemic attack, subarachnoid hemorrhage, cerebral hemorrhage and other cerebrovascular diseases;
* severe heart, liver, kidney dysfunction and severe coagulation dysfunction; cerebral infarction caused by repeated recurrence of stroke, brain surgery or trauma, and brain tumors;
* severe neurological deficits before stroke, such as visual and auditory impairment, aphasia, agnosia, severe hemiplegia, or affected limb function before stroke, such as cerebral palsy, polio, fracture, and mRs≥1;
* diseases with affecting cognitive function such as congenital dementia, or alcohol, drug or substance abuse ;
* lactation, pregnancy or intend to be pregnant within 6 months;
* needlesickness, needle phobia and skin infection at acupuncture site;
* pacemaker, implantable cardioverter defibrillator carriers or conductive metallic foreign bodies in the body;
* allergy to NGF;
* currently enrolled in another clinical trial or participation in other clinical trials within the last 3 months.
The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)

The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)

Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase 2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .

Eligibility Criteria:
Inclusion Criteria:Only subjects fulfilling all of the following criteria will be eligible for the study:

* People aged from 2 months to 4 months old.
* The subjects or subjects' guardians are able to understand and sign the informed consent
* The subjects or subjects' guardians allow to comply with the requirements of the protocol
* Subjects with temperature \<=37.0°C on axillary setting
* The subjects have signed informed consent already

Exclusion Criteria:The subjects have never been vaccinated with any Poliomyelitis Vaccine.

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Macugen for Histoplasmosis

The purpose of this study is to evaluate the safety and effect on visual acuity of Macugen (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS).

Ocular histoplasmosis is a leading cause of severe and irreversible central vision loss in middle-aged adults living in the central and eastern US. OHS has been associated with the fungus Histoplasma capsulatum, a dimorphic soil mold found in 18 to 20 states in the central and eastern US. Annually, approximately 100,000 people are thought to be at risk of vision loss caused by OHS.

This study will include OHS patients with CNV lesions no larger than 5400 microns in greatest linear diameter with classic or occult CNV extending under the geometric center of the FAZ and best-corrected visual acuity letter score between 20/40-20/200. Twenty four patients will be enrolled and the study will have 2 treatment arms with 12 patients each. The first arm will consist of 12 patients who will receive 0.3 mg of Macugen intravitreally every 6 weeks for one year. The second arm will consist of 12 patients who will receive Photodynamic Therapy (PDT) with Visudyne every 3 months for one year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ocular histoplasmosis,
* Evidence of classic or occult choroidal neovascularization extending under the geometric center of the fovea,
* Greatest linear diameter of no greater than 5400 microns,
* Best-corrected visual acuity scores between 20/40-20/200,
* Ability to give informed consent,
* Limited child bearing potential and a negative pregnancy test

Exclusion Criteria:

* Features of any condition other than OHS such as AMD, or pathologic or myopic angioid streaks associated with CNV in the study eye,
* Area of CNV that is less than 50% of the total lesion not including area of prior laser treatment, previous rip of retinal pigment epithelium,
* Vitelliform-like lesion,
* Telangiectasia,
* Central serous retinopathy,
* Serous pigment epithelial detachment without CNV,
* Any significant ocular disease other than CNV that could compromise vision in the study eye, such as amblyopia, glaucoma, optic neuropathy, or diabetic retinopathy,
* Inability to obtain photographs to document CNV,
* Presence of atrophy/scar in the center of fovea,
* Presence of vitreo-retinal traction over the center of the fovea,
* History of treatment for CNV in the study eye other than non-foveal laser photocoagulation,within 12 weeks prior to enrollment
* Participation in another clinical trial or use of another investigational new drug within 12 weeks of the full extent of the study treatment,
* Intraocular surgery within the last two months,
* Capsulectomy within the last month in the study eye
Physical Deconditioning in COVID-19 Positive Patients and Non-Specific Low Back Pain

The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 to explore the relationship between physical fitness and low back pain (LBP). Level of physical fitness will be measured at baseline and incidence and intensity of LBP will be recoreded over 1 year.

Non-specific low back pain (LBP) is the worldwide number one cause for disease related years lived with disability. It is frequently assumed that a low physical fitness is a major risk factor for acute LBP as well as a factor for chronic LBP. However only few prospective observational study have been conducted.

The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 and assessing level of physical fitness and both incidence and intensity of LBP over a 1-year period.

The study aims to determine if a poor physical health, as measured by 6 minutes walk test (6MWT) and 30''seconds sit to stand test (30''STS), is a risk factor for LBP occurrence and for chronic LBP Secondary objectives aim to explore the respective weight of physical factors (i.e. physical fitness, BMI, smoking, physical activities) and psychological factors (i.e. depression, anxiety, catastrophism, fear-avoidance) on the occurrence and severity of LBP.

According to the literature, we expect that in the physically healthy population, 15% will developed back pain; whereas in the population in poor physical health the incidence at 1 year will be 30%. If alpha error is set at 0.05 then 236 patients are required to have a 80% chance to confirm our hypothesis. In order to account for drop out, and considering that the risk of drop out is high in this type of non-interventional study 350 persons will be recruited. Note that this amount of persons should yield approximately 70 persons with low back pain, which allow up to 7 independent variable in a logistic or cox regression. This is based on the rule of at least 10 events (low back pain) per variable.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, \<65 years old
* Confirmed or supected COVID19 test
* Informed Consent as documented by signature

Exclusion Criteria:

* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Previous enrolment into the current study.
* Any comorbidity which could impact on the physical test (6-minutes walking test), e.g hip or knee osteoarthritis, polyneuropathy, symptomatic coronary heart disease.
Evaluation of Factors in Human Brain Tumors

Presently, patients with primary malignant brain tumors have a life expectancy of 15 weeks following surgery unless they receive additional types of therapy (chemotherapy, radiotherapy, and/or immunotherapy). Patients that receive additional therapy can increase life expectancy to 50 weeks.

The statistics on the life expectancy and survival have increased efforts among researchers to develop new treatments for primary malignant brain tumors.

This research project involves the growth and study of human brain tumor cells outside the body in the laboratory as part of an attempt to better understand these tumors and to develop more effective treatments for them.

This protocol involves the study of human brain tumor cells outside the body in the laboratory as part of an attempt to better understand these tumors and to develop more effective therapeutic measures.

Malignant primary brain tumor patients at present have a life expectancy of approximately 15 weeks following surgery unless other adjunctive measures are taken. With currently available adjunctive therapy the life expectancy reaches 50 weeks.

These survival data have spurred extensive efforts to develop new treatment modalities. Radiation, chemotherapy and immunotherapy have been mildly helpful adjuncts but their use has been largely on empirical grounds or on the basis of experimentation on animal tumor models often quite different in nature from human brain tumors.

Our group has sought to develop data upon which to devise new treatment strategies for patients with malignant brain tumors.

The foundation of our approach rests upon the use of in vitro studies of the cell biology of each patient's tumor.

It is our plan to utilize these tumors for in vitro investigation of the immunology, biology, biochemistry and molecular biology of brain tumors. Optimal conventional therapy will be given to the patients as we seek to learn more of how the scientific information obtained can be used to help them.

Eligibility Criteria:
INCLUSION CRITERIA:

Patients to be studied will have either undergone surgical confirmation of a malignant primary brain tumor or be considered likely to have that diagnosis on the basis of diagnostic studies.

They should have survival likelihood of at least three months and be able to comprehend the nature of the proposed program.
Sensory Evaluation of Taste and Smell in Oncology

Nutritional status is a major issue in the management of cancer patients. Forty to 60% of patients are undernourished at diagnosis. This undernutrition has a direct impact on patients' health and quality of life, with a reduction in survival associated with an increase in the risk of toxicity from anti-cancer treatments (chemotherapy, radiotherapy, surgery), the risk of infection and the risk of hospitalization. Thus, it is estimated that 10-20% of cancer patients die from the consequences of their undernutrition rather than from the tumor itself (Muscaritoli et al. 2021).

It is therefore recommended to systematically implement a multimodal nutritional intervention in cancer patients (recommendations of the learned societies ESPEN, ESMO and ASCO), combining nutritional support (oral and/or enteral and/or parenteral) with physical exercise (Muscaritoli et al. 2021). However, despite the systematic provision of dietary management, the effectiveness of nutritional interventions varies from patient to patient in terms of nutritional status, quality of life and overall survival (Cintoni et al. 2023).

Among the factors impacting patient compliance with dietary measures and their efficacy, sensory alterations occurring under chemotherapy potentially have a major impact (Drareni et al., 2019).

Indeed, the vast majority of patients describe an alteration in tastes and smells after starting chemotherapy treatment. However, few studies have focused on the specific parameters associated with these alterations. The aim of this study is to prospectively assess changes in sensory perceptions and eating habits in patients undergoing chemotherapy for digestive cancer at the start of treatment and after the first cycle of chemotherapy, and to correlate these alterations with patients' nutritional profile and clinical course.


Eligibility Criteria:
Inclusion Criteria:

* Able to complete the proposed questionnaires
* Patients over 18 years of age
* Non-opposed patients
* Digestive cancers starting chemotherapy and/or immunotherapy
* Able to eat by mouth

Exclusion Criteria:

* Concomitant treatment for a non-digestive cancer (excluding basal/spinocellular carcinoma and chronic haemopathy)
* Previous ENT surgery (face/neck)
* Exclusive enteral feeding (nasogastric tube, gastrostomy) or parenteral nutrition
* Previous chemotherapy/immunotherapy \< 5 years
* Individuals deprived of liberty by a judicial or administrative decision
Non-contact Blood Pressure and SpO2 Measurement Based on Image Sensor

This study aims to develop an automated and real-time non-contact vital sign measurement system using cameras. It will collaborate with physicians from National Taiwan University Hospital to conduct measurements during outpatient visits or hospitalizations. This allows physicians to non-invasively measure multiple vital signs (such as heart rate, blood pressure, and oxygen saturation) upon your entry to the outpatient clinic or hospital. Simultaneously, the measurements will be verified using commercially available contact-based instruments. The research outcomes of this project aim to enhance the convenience, safety, and comfort of vital sign measurements for outpatient visits, hospitalizations, and long-term care in the future.

The experiment of this project is to use a camera to measure blood pressure, blood oxygen saturation and pulse, record images of the face and hands, and use the image processing algorithm we developed to extract the signals from the images to estimate blood pressure and blood oxygen Concentration and pulse values. The experimental process will be carried out in accordance with the "experimental setup, blood pressure measurement, and blood oxygen saturation measurement" process. At the same time, commercially available measurement instruments will be used to conduct clinical experiments and verification. The experimental setup diagram is shown in Figure 1. Blood pressure and blood pressure The oxygen saturation measurement process is shown in Figure 2. The blood pressure measurement process takes about 10 minutes, and the blood oxygen measurement process takes about 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-85 years old
* Install the physiological measurement device on people who do not feel any physical discomfort

Exclusion Criteria:

* Age \> 85 years, age \< 18 years
* Patients with arrhythmia
* Those with a history of severe heart disease
* Those who wear makeup on their face (for example: foundation cream, sunscreen lotion, foundation...etc.).
* The body will make involuntary, short-term, rapid or repetitive movements unconsciously, resulting in the inability to control the body to reach a stable and static state. For example: patients with motor-related Tourette Syndrome, etc.