cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal

Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* with an inflammatory CNS pathology
* to benefit as part of care from an MRI with injection of gadolinium
* consent to participate in the study
* beneficiary of a social protection scheme

Exclusion Criteria:

* pregnant or breastfeeding woman
* patient benefiting from a legal protection measure
* Patient having performed more than 3 MRI exams with gadolinium injection during his life

Secondary exclusion criteria :

* motion artifact not allowing image interpretation
* patient who has not completed one of the following sequences: T1 anatomical, FLAIR, or QSM pre-gadolinium injection.

Secondarily excluded patients will be replaced up to a maximum of 25 patients.
A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects

This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels, in a fasted state and a fed state.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-55.
* Capable of giving written informed consent.
* Capable of completing study requirements.

Exclusion Criteria:

* Positive result for HIV, HBV, or HCV.
* History or medical condition which could impact patient safety.
* Current or past abuse of alcohol or illicit drugs.
* Participation in another clinical trial within the past 30 days.
BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

The aim of this preliminary study is to evaluate the safety and efficacy of bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) administration in type 2 diabetes patients

Type 2 diabetes (T2D) patients had peripheral insulin resistance accompanied by progressive pancreatic beta cell degeneration and dysfunction due to glucotoxicity and lipotoxicity. Several studies have shown that the immune system plays a significant role in the pathogenesis of T2D. Bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) via its immunomodulatory properties have the potential to improve insulin resistance condition and pancreatic beta-cells dysfunction thus improve the glycemic control and insulin requirement in T2D patients. In this pilot study, we plan to recruit 15 T2D patients with total daily dose of insulin \>= 0.5 unit/kgBW/day to receive BM-MNCs (5 subjects) or UC-MSCs injections (10 subjects). These subjects will be closely followed up for 12 months for evaluation of primary and secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients on insulin therapy with or without oral hypoglycemic agents, with total daily dose of insulin \>= 0,5 unit/kg body weight
* Stable HbA1C in the last six months (HbA1c \<= 8.5%)

Exclusion Criteria:

* Type 1 diabetes mellitus
* eGFR \< 45 mL/min/m2 (for BM-MNC)
* Liver disease (moderate- severe)
* Active infection
* Contrast hypersensitivity (for BM-MNC)
* History of Malignancy
* Acute coronary syndrome in last three months
* Coronary arterial diseases with significant stenosis and has not carried out revascularization
* Pregnancy (for women subjects)
The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration

We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT).

A fecal Hemoglobin concentration just below the cut-off of the fecal immunochemical test (FIT) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. Individuals with these higher fecal Hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal Hemoglobin concentrations could benefit from longer screening intervals.

A randomized controlled trial will be conducted within the national CRC screening program among individuals with a negative FIT in the previous screening round. Individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal Hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice.

The overall aim of this study is to improve the balance between harms and benefits of CRC screening, by using a personalized approach based on fecal Hemoglobin concentration at previous screening. More specifically, this study has three goals:

1. Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;
2. Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;
3. Estimate the long-term effect of personalized screening versus uniform screening.

To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Previous negative FIT (below the cut-off of 47 microgram per gram feces)

Exclusion Criteria:

* Previously tested with FIT cut-off of 15 microgram per gram feces
CRC Detection Reliable Assessment With Blood

The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.

The CRC DRAW study is a prospective, multi-center, observational study to validate the Next-Gen CRC Screening test for the detection of CRC. The study will collect blood samples from average-risk participants scheduled for screening colonoscopies.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is 45 years of age or older at time of enrollment.
2. Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria)
3. Participant is able and willing to undergo a screening colonoscopy
4. Participant is able and willing to sign informed consent and adhere to study requirements
5. Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy).

Exclusion Criteria:

1. Previous personal history of CRC or precancerous lesions
2. Positive result from non-invasive screening test within the associated recommended intervals:

   2.1 Fecal occult blood test or fecal immunochemical test within the previous 12 months 2.2 Epi proColon test within the previous 12 months 2.3 FIT-DNA (Cologuard) test within the previous 36 months
3. Diagnosed with condition associated with higher risk for colorectal cancer, such as:

   3.1 Inflammatory bowel disease (IBD) 3.2 Chronic ulcerative colitis (CUC) 3.3 Crohn's disease 3.4 Familial adenomatous polyposis (FAP) 3.5 Familial history for colorectal cancer 3.5.1 One or more first-degree relatives diagnosed with CRC or adenomatous polyps before 60 years of age 3.5.2 Two or more first degree relatives diagnosed at any age with CRC
4. Individuals with relevant familial (hereditary) cancer syndrome, such as:

   4.1 Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome) 4.2 Peutz-Jeghers Syndrome 4.3 MYH-Associated Polyposis (MAP) 4.4 Gardner's syndrome 4.5Turcot's (or Crail's) syndrome 4.6 Cowden's syndrome, 4.7Juvenile Polyposis 4.8 Cronkhite-Canada syndrome 4.9 Neurofibromatosis 4.10 Familial Hyperplastic Polyposis
5. Diagnosed with chronic gastritis or cirrhosis
6. Current diagnosis of any cancer, except non-melanoma skin cancer
7. Overt rectal bleeding or bleeding hemorrhoids within previous 30 days
8. A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation
9. Pregnancy
The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children

This research is a randomized controlled experimental study designed to determine the effect of the Quantum-Touch method applied during the vascular access procedure in children aged 7-12 years, on the level of pain, fear and anxiety in children.

Quantum-Touch was first described by Richard Gordon and Bob Rasmusson in 1978; it activates life force energy by combining various hand positions, various breathing techniques and body awareness exercises. It is applied by directing the formed high energy field to an area of pain, stress or illness through therapeutic touch. Tully found that Quantum Touch in reducing acute and chronic pain; Walton reported that Quantum-Touch application is effective in chronic musculoskeletal pain. It is important to conduct studies with a high level of evidence investigating the effect of Quantum Touch, which is a non-pharmacological method, on pain, fear and anxiety for children of different age groups, which is easily applied during invasive procedures. Based on this information, in this study, which was planned in a randomized controlled and experimental design, it was aimed to determine the effect of the Quantum-Touch method applied during the vascular access procedure in children between the ages of 7-12 on the level of pain, fear and anxiety in children.

Eligibility Criteria:
Inclusion Criteria:

* The child and family agree to participate in the research,
* The child's being literate,
* The child is between the ages of 7-12
* The child does not have a chronic and mental health problem.
* No history of sedative, analgesic or narcotic substance use within 24 hours before admission
* Not having a febrile illness at the time of application
* Previous vascular access

Exclusion Criteria:

* The child and family do not agree to participate in the research,
* The child's illiteracy,
* Having a visual and auditory problem,
* The child is less than 7 years old or older than 12 years old
* The child has a chronic and mental health problem
* Failure to open vascular access in a single attempt
* Having a phobia of pain
Healthy Adolescent Transitions (HAT)

Randomized trial of a rapid repeat pregnancy prevention program for adolescent mothers.

Five hundred adolescent mothers from central Ohio will be enrolled--half will be assigned to an intervention that features nurses and social workers providing extra assistance during late pregnancy and the early postnatal period and half will be assigned to a standard of care intervention.

OhioHealth is the lead entity. Nationwide Children's Hospital serves as the local independent evaluator.

This federally funded contract is supported by the Family and Youth Services Bureau.


Eligibility Criteria:
Inclusion Criteria (at baseline)

1. Age 14-19 years
2. 24-35 weeks gestation
3. Medicaid insurance
4. Central Ohio resident
5. English speaking
6. Ability to provide informed consent (18-19 years of age) or minor assent and parental consent (\<18 years of age)
7. Willingness to complete study-related surveys and coaching sessions
8. Patient must have her own smartphone, capable of running the study-related mobile application
9. Patient must have regular access to cellular or WiFi service

Exclusion Criteria

1. Patients \< 13 years or \>19 years
2. Non-English speaking
3. \<24 or \>35 weeks of gestation
4. Primary residence is located outside of central Ohio
5. Another adolescent from the household has already been enrolled in the program
Prevalence of Anxiety Symptoms Among French General Practitioners

Mental health is a major public health issue in the general population, but few studies seem to focus on the mental health of self-employed healthcare professionals, and GPs in particular. As front-line workers who are often called upon to manage complex situations, they are quite likely to suffer from anxiety-depressive symptoms or burnout. Nevertheless, general practice is vast, and there are many different ways of practising and organising it.

The primary objective is to describe the prevalence of clinically significant anxiety symptoms in French self-employed GPs.

The secondary objective is to investigate the factors associated with the presence of clinically significant anxiety symptoms in French self-employed GPs.

Eligibility Criteria:
Inclusion Criteria:

* general practitioners
* qualified and established
* practicing in France
* with at least some self-employed practice
* agreeing to participate in the study

Exclusion Criteria:

* salaried general practitioners
A Study of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma

This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered by intravenous (IV) infusion to patients with relapsed or refractory hematologic malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with rituximab.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 12 weeks
* History of histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent NHL (including Grades 1-3a FL; MZL \[including splenic, nodal, and extra-nodal\]; and SLL), Grade 3b FL, DLBCL, MCL, or CLL
* Must have at least one bi-dimensionally measurable lesion

Exclusion Criteria:

* Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks prior to study treatment
* Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to of study treatment
* Completion of autologous stem cell transplant within 100 days prior to study treatment
* Prior allogeneic stem cell transplant
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms:

* Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily)
* Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 and ≤70 years.
* ECOG performance status of 0 to 1.
* Life expectancy of more than 12 weeks.
* At least one measurable lesion exists.(RECIST 1.1).
* Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
* Required laboratory values including following parameters:

ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN;BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male.

* Signed informed consent

Exclusion Criteria:

* Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor.
* Received previous therapy with capecitabine within 3 months.
WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers

Whole grains, non-starchy vegetables, fruit, and beans are a consistent feature of diets associated with a lower risk of cancer and other diet-related diseases. For cancer risk reduction, the American Cancer Society recommendation is to consume at least 2.5 cups of a variety of fruits and vegetables daily. Other than dietary choices, weight control and physical activity levels are important modifiable determinants of cancer risk. This study finalized a novel, theory-driven farm-to-WIC intervention developed in preliminary work to promote vegetable intake among low-income adults served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). In New Jersey (the location of the study), WIC provides participants up to $30 in seasonal Farmers' Market Nutrition Program (FMNP) vouchers and monthly cash value vouchers or CVV (valued at $11 for adults and $8 for children at the time of the study) redeemable at farmers' markets. The program combined behaviorally focused nutrition education with the establishment of a WIC-based farmers' market (implemented in the summer of 2019 during the FMNP voucher issuance period). Content to address other modifiable determinants of cancer risk was added. To create additional opportunities for experiential and hands-on learning, monthly trips to an area farmers' market were held (between September 1, 2019 \[after the WIC-based market was discontinued\] and November 30, 2019 \[the end of the local growing season\]). The research employed an experimental design to initially test the intervention in 3 WIC agency sites (1 intervention and 2 control sites) with 297 urban, primarily Hispanic adults. Program effects on primary outcomes of vegetable intake (measured objectively using dermal carotenoids as a biomarker of intake and via self-report) and FMNP voucher redemption (objectively assessed using data provided by WIC) were examined at mid- and post-intervention (3 and 6 months post-baseline, respectively). Intervention effects on potential hypothesized mediators and the redemption of CVV at farmers' markets, participant satisfaction with the program, and the cost-effectiveness of the intervention also were examined.


Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish-speaking
* Farmers' Market Nutrition Program (FMNP) voucher recipient or caregiver of a child FMNP voucher recipient
* Not less than 3 months from expected delivery date (pregnant women)
* Eligible to receive WIC benefits for 6 months after study entry

Exclusion Criteria:

● Restrictions of food intake (has food allergies or foods that cannot be eaten)
Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders

The investigators investigated the effects of high frequency (10Hz) repetitive transcranial magnetic stimulation (rTMS) on the symptoms and cognitive functioning in patients with psychiatric disorders

OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency rTMS over left dorsolateral prefrontal cortex in the treatment of symptoms and cognitive functioning in 200 chronic patients with schizophrenia and 200 patients with major depressive disorders

METHODS:

1. Clinical Trial：The study consists of 4 weeks of treatment.
2. Assess Procedures:

2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS) or DSM-IV for depression, and repeatable battery for the assessment of neuropsychological status(RBANS).Patients are interviewed at screening, at at baseline, 4 weeks, 16 weeks.

2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4 weeks, and 16 weeks.

2.3 Weight gain measurement: weight gain every week

Eligibility Criteria:
Inclusion Criteria:

For Schizophrenia Patients:

* Diagnosis of schizophrenia by two senior psychiatrists
* Between 18 and 60 years and Han Chinese
* Duration of symptoms at least 12 months
* With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS \< 24)
* Smoking

For Major Depressive Disorder Patients:

* Diagnosis of Major depressive disorder by two senior psychiatrists
* Between 18 and 60 years and Han Chinese
* Duration of symptoms at least 12 months
* Smoking

Exclusion Criteria:

* Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
* Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
* Severe headache for unknown reasons and cardiovascular diseases, intracranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
* Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
* Education level less than 5 years by subject report
* Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study
* Subjects who suffered from alcohol or illegal drug abuse/dependence
Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM) surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.

Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane. However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM surgery, taking COST line into account as a new parameter

Eligibility Criteria:
Inclusion Criteria:

* Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center.
* Only eyes with postoperative follow-up period more than 6 months were included.

Exclusion Criteria:

* Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.