cyrilzakka/clinical-trials huggingface dataset:
Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis

The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Current diagnosis of AK, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead);
2. Female or male \>18 years of age;
3. Skin type I or II according to Fitzpatrick;
4. Patient has confirmed his/her willingness to participate in this study;.

Exclusion Criteria:

1. Topical drug therapy for AK within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected AK area during the previous month;
2. Suitable for surgical, photodynamic or any other topical treatment in the next 6 months;
3. Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer;
4. Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm;
5. Immunosuppression or current treatment for cancer;
6. Clinically unstable medical condition;
7. High risk group for HIV infection or presentation of other infectious diseases
8. Presentation of contact allergies or allergies to compounds of the test substances;
9. Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day);
10. Psychiatric disease that may interfere with follow up of study procedures;
11. Participation in other clinical trials up to 30 days prior to day 1 of the study
12. Prior treatment with study medication in the area to be treated;
13. Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients

This study aims to prospectively explore the effect of incentive-integrated E-IBD (electronic inflammatory bowel disease) chronic disease management model on the improvement of IBD quality of life, and provide a more effective chronic disease management model for improving the quality of life and social participation of IBD patients.The investigators firstly identify the IBD patients in need of empowerment disease activities through the questionnaire .Then, the investigators feedback the patients' education content according to their needs found.Based on the social support network of patient organization and the medical support network of tertiary medical institutions, the investigators complete the empowerment process of IBD patients' self-management initiative and self-management ability, through the internet. Finally ,the investigators evaluate the quality of life(QoL), social participation,disease self-management level via questionnaire . The primary outcome is the improvement of QoL score after three months' intervention.


Eligibility Criteria:
Inclusion Criteria:

* 1.Clinically diagnosed IBD patients,according to the criteria of the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018;
* 2.Aged 18 to 75 years old;
* 3.Understand and comply with the requirements of the program and sign informed consent.
* 4.Identified as need intervention according to the patient identification questionnaire screening;
* 5.Patients with the ability to complete all course training and/or follow-up work;
* 6.Enrolled at least one year ahead of end of this study(for garantee of enough folllow-up time).

Exclusion Criteria:

* 1.Unable or unwilling to sign the consent form, or unable to follow the research procedure;
* 2.Patients who have had a stoma or ileorectal anastomosis (partial scales are not available);
* 3.Patients who do not complete training on time or do not complete follow-up assessments in their entirety;
* 4.Patients with other malignancies or life-threatening complications；
* 5.Pregnancy or lactation；
* 6.Patients whose remaining follow-up time less than one year before the end of this study.
Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia

This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.

This study aims to determine whether behavioral word-retrieval therapy coupled with anodal tDCS will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition).

tDCS neuronal targets will be selected in this order:

1. left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension),
2. left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or
3. right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted.

The same areas will be stimulated during the first tDCS and sham periods. If the participant returns for a second period of tDCS and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). For cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits
* Premorbid speakers of English
* Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment
* Stroke size: any l
* Location: Left hemisphere strokes only from any etiology.
* Time since stroke onset: 1 day to 20 years.

Exclusion Criteria:

* uncorrected visual or hearing impairment by self report
* other premorbid neurological disorder affecting the brain
* any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia
* premorbidly diagnosed with a developmental language disorder
* Pregnant women will also be excluded
Risk Factors for Shoulder Joint Motion Restriction

In breast cancer patients, limitation of shoulder joint movement may occur following cancer treatment. Shoulder limitation causes a significant decrease in the patient's participation in activities of daily living. The aim of the study is to define these limitations, to evaluate in detail all the structures that cause the problem, and to determine the causes of the limitations in patients with shoulder joint movement limitation developed after breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 30-60
* Having breast cancer treatment within 5 years

Exclusion Criteria:

* Not having agreed to participate in the study
* Presence of additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect upper extremity functions
Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC

Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.

In this study, TNBC patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. The experimental group received 6 cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 + adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To compare the efficacy and safety of 6\*TP (docetaxel + cisplatin) regimen and traditional 6\*TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70.
2. Clinical stage Ⅱ-Ⅲ.
3. triple negative and invasive breast cancer confirmed by histopathology:

   Triple negative breast cancer is defined as:
   * negative for ER and PR (IHC nuclear staining \< 10%).
   * Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and without FISH amplification).
4. With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization.
5. Organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy:

   * neutrophils count absolute value ≥ 2.0×109/L
   * hemoglobin ≥ 100g/L
   * blood platelet ≥ 100×109/L
   * total bilirubin \< 1.5 ULN (upline of normal value)
   * creatinine \< 1.5×ULN
   * AST/ALT \< 1.5×ULN;
6. Cardiac ultrasound EF value ≥ 55%.
7. Females of childbearing age with negative serum pregnancy test 14 days before randomization.
8. ECOG score ≤1.
9. Sign informed consent.

Exclusion Criteria:

1. Evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest CT, abdominal ultrasound, or CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging examination mean) .
2. The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease.
3. The patient has a second primary malignant tumor, except for:

   - Thoroughly treated skin cancer
4. Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.
Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping

The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
* ETDRS visual acuity worse or equal to 20/30
* Adult able to give consent

Exclusion Criteria:

* Diagnosis of age-related macular degeneration
* Opacity blocking the fundus visualisation
* Presence of active intraocular inflammation
* Presence of intraocular tumor
* Presence of retinal detachment
Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors

The Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition.

The investigators will recruit 56 obese, older adult breast cancer survivors at least 1 year, and up to 10 years post-breast cancer treatment, and randomize them to either a 15 week light-intensity physical activity intervention, or usual care group.

Intervention: The participants will receive weekly support calls, and instructed to increase their light-intensity physical activity, to achieve at least 150 minutes per week. The frequency, intensity, time, and type of physical activity will be modified to maximize adherence and compliance. The support calls developed for this trial target older adults' capabilities, opportunities, and motivations for physical activity.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 65-84 years
3. 1-10 years post-breast cancer treatment
4. Body mass index ≥30
5. ≥1 drink per week over the last month
6. ≥21 on the Telephone Interview For Cognitive Status
7. ≤7 on the Alcohol Use Disorder Identification Test
8. Fluent in written and spoken English
9. Must be able to provide and understand informed consent
10. Primary physician approval

Exclusion Criteria:

1. Body mass index \<30
2. \< 21 on the Telephone Interview for Cognitive Status
3. \>7 on the Alcohol Use Disorder Inventory Test
4. Other neurological or major psychiatric disorders
5. Significant heart or lung disease
6. Limited life expectancy
7. Other factors that could potentially limit ability to participate fully in the intervention
8. Self-reporting achieving over 150 minutes of moderate-to-vigorous physical activity per week.
Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of non-Hodgkin's lymphoma
* Disease exclusively localised into the CNS at first diagnosis and failure
* Progressive or recurrent disease
* Previous treatment with HDMTX containing CHT and/or RT
* Presence of at least one target lesion, bidimensionally measurable
* Age 18 - 75 years
* ECOG performance status \< 3 (Appendix 1).
* No known HIV disease or immunodeficiency
* HBsAg-negative and Ab anti-HCV-negative patients.
* Adequate bone marrow function (plt \> 100000 mm3, Hb \> 9 g/dl, ANC \> 2.000 mm3)
* Adequate renal function (serum creatinine \< 2 times UNL)
* Adequate hepatic function (SGOT/SGPT \< 3 times UNL, bilirubin and alkaline phosphatase \< 2 times UNL)
* Adequate cardiac function (VEF ≥ 50%)
* Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
* No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
* No concurrent treatment with other experimental drugs.
* Informed consent signed by the patient before registration
Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

Despite early treatment, the deterioration and mortality of sepsis patients remains high. A possible explanation could be persistent tissue hypoperfusion, or undetected in the early phase despite the normalization of macro-hemodynamic parameters. This interventional study evaluates the impact of measuring microcirculation parameters by nurses on patient prognosis through early initiation of vascular filling.

Sepsis and its most serious form, septic shock, are a public health problem. Sepsis is defined by the presence of organ failure, including acute circulatory failure, which combines hypovolemia, vasoplegia and cardiac dysfunction. Vascular filling is therefore a pillar of the management of septic patients to correct hypovolemia and improve perfusion and tissue oxygenation. Following numerous studies, the evaluation of peripheral microcirculation is becoming a clinical "trigger" making it possible to identify patients at risk, particularly in emergency department. In a meta-analysis, it has been showed that alterations in microcirculatory perfusion predict deterioration and mortality during severe infections. Currently, no interventional study has evaluated the impact of measuring microcirculatory perfusion (peripheral perfusion index and marbling) by nurses on patient prognosis through early initiation of vascular filling.

In this study, patients will be assessed hemodynamically using peripheral perfusion index and/or presence of mottling. If peripheral perfusion index \> 3s and/or presence of marbling a first vascular filling test of 500 cc over 30 minutes will be started after a medical control.

Patient will be followed up 7 days to determine outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Admitted to the Emergency Department for suspected Sepsis for less than 6 hours according to international Sepsis-3 definitions (high probability of infection defined by a fever greater than or equal tol to 38.3°C with a suspected infectious source + Score NEWS 2 greater than or equal to 2)
3. Affiliated to a social security system
4. Having agreed to participate in this study

Exclusion Criteria:

1. Patient with arterial hypotension (SBP ≤ 100 mmHg) on admission
2. Patient having already received a 500mL filling test over 30 minutes
3. Patients moribund according to the investigator
4. Pregnancy or breastfeeding
5. Patient under guardianship, curatorship or safeguard of justice
The Use of Jet Injection Lidocaine for Blood Draws in Young Children

This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip noise.

No change since last report.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months-6 years seen in the Children's Hospital of Wisconsin outpatient laboratory that have an order for venipuncture for a blood draw

Exclusion Criteria:

* Previous adverse reaction to lidocaine or Pain Ease spray
* Pre-existing skin lesion at site of blood draw
* Needle stick for IV insertion or lab draw that has already occurred at current hospital visit
* Patients who are physically unable to move their arms or legs
* Patients who are unable to cry
* Patients with connective tissue disorders that predispose to easy bruising
* Patients with bleeding disorders
Strawberries and Knee Osteoarthritis (OA)

The proposed study aims to examine the hypothesis that strawberry supplementation will lower serum biomarkers of inflammation and improve knee function in patients with symptomatic osteoarthritis (OA).

The investigators propose the following two specific aims in a randomized crossover placebo-controlled trial in participants with two or more features of the metabolic syndrome and symptomatic osteoarthritis in this 12-week efficacy study:

Aim 1: To assess the effects of strawberries on biomarkers of inflammation \[serum levels of C-reactive protein: CRP; inflammatory cytokines: interleukin-6: IL-6; interleukin 1β: IL-1β; tumor necrosis factor-alpha: TNFα\] Aim 2: To assess the effects of strawberries on knee function as assessed by overall musculoskeletal examination and pain score (ICOAP, KOOS and HAQ-DI).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee osteoarthritis
* Must have waist circumference \>35 inches for women and \>40 inches for men

Exclusion Criteria:

* Cancer
* Heart disease
* Smoking
* Berry allergy
Investigating the Efficacy of Caloric Vestibular Stimulation in the Treatment of Substance Use Disorders

The purpose of this study is to determine efficacy and effect of CVS (caloric vestibular stimulation)

This study is designed as a nonrandomized, single-blind, sham-controlled trail in which willing participants will receive a 5 day course of twice daily caloric vestibular stimulation (CVS) or sham treatment. CVS involves twice daily sessions of CVS each lasting 15 minutes. The week before the intervention baseline characterization of mood and substance craving will be conducted using standard mood and substance use questionnaires. Prior to treatment beginning participants will undergo structural and functional MR imaging. Participants will also undergo a standard battery of questionnaires, including cognitive testing, mood and affect surveys, and surveys specific to SUD. During each of the 5 treatment days the participants will be asked to fill out questionnaires related to mood and craving symptoms. Participants will be blinded to sham stimulation or the standard CVS protocol. At the end of the 5 day course participants will be scanned again in MRI and asked to fill out the same battery of questions. Consistent with the existing standard of care participants will also receive two urine drug screens (UDS)

Eligibility Criteria:
Inclusion Criteria:

* Subjects will have a diagnosed SUD (including but not limited to Opiate, Alcohol, Cocaine, Nicotine, or Amphetamine Use Disorders).
* Subjects will be between the age of 17 and 50 years old
* Subjects will have been abstinent on a stable treatment regimen for at least 4 weeks
* Subjects will be able to sit still for MRI imaging
* Subjects will be able to read and complete survey questionnaires
* Subjects will reliably be abstinent from their drug of choice through the 5 day intervention as determined by the discretion of a clinician

Exclusion Criteria:

* Subjects will be excluded for comorbid neuropathology (eg history of stroke or TBI)
* Subjects will be excluded if they are at high risk for relapse as determined by a clinician
* Subjects will be excluded if they are unable to tolerate the CVS devise
* Subjects will be excluded if they have malformations of or existing trauma to the external auditory canal