cyrilzakka/clinical-trials huggingface dataset:
Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)

The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.


Eligibility Criteria:
Inclusion Criteria:

* • Male or female between 2 and 12 years of age

  * The subject suffers from moderate atopic dermatitis (SCORAD\<40) that is amenable to treatment
  * Diagnosis of atopic dermatitis meets Hanifin's criteria (at least 3 basic features and at least 3 minor features)
  * Atopic dermatitis is, in the opinion of the investigator, stable for the past 7 days
  * The subject's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 42 days
  * The subject's parents agree that the subject will not change his/her lifestyle during the study period (including: regular body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash clothes)
  * The subject's parents agree to use only the test product during the study period
  * The subject's legal guardian is able and willing to sign the informed consent form and to comply with the study regulations of this protocol

Exclusion Criteria:

* • The subject has another dermatological disease/condition that could interfere with the clinical evaluation, including infected atopic dermatitis lesions

  * The subject has a previous history of allergy to cosmetic products or to any of the ingredients included in the tested formulations (Appendices 1 and 2)
  * The subject received a topical or a systemic immune-modulator (such calcineurin inhibitors or cortico-steroids) for the treatment of atopic dermatitis, within 14 days prior to day 0
  * The subject underwent phototherapy within 28 days prior to day 0
  * The subject is expected to be extensively exposed to the sun during the trial
  * The subject underwent any experimental treatment within 14 days prior to day 0
Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa

This study evaluates whether the integration of an Economic Strengthening program with an HIV-prevention education program produce synergistic effects on economic and health outcomes for South African youth ages 14-17 years old.

In South Africa, the overall HIV prevalence of 12.2% can be reviewed based on a number of factors: age, province, type of locality, race, economic household conditions, and marital status. Those to be reached through the ASPIRES intervention and evaluation are economically disadvantaged Black African youth, male and female, located in urban localities in Gauteng province, and are situated within a setting of high risk and vulnerability for HIV. The ASPIRES project is providing technical assistance to provide economic strengthening (ES) and HIV prevention education programming for adolescents. The ASPIRES ES intervention includes financial capability building through the provision of financial education in combination with access to appropriate youth-friendly savings mechanisms. The HIV prevention education intervention Vhutshilo 2.2 will be used in this study.

This study will assess whether the integration of an ES intervention with an HIV-prevention education intervention improves economic and health outcomes beyond singular interventions, estimate the resources required at the program level to support the ES and HIV-prevention education interventions; and describe whether the interventions were perceived as effective in addressing economic and health outcomes and to describe how and why the interventions were perceived as effective or not.

This study will enroll up to 2000 youth ages 14-17 and randomly assign them to either 1) ES intervention only, 2) HIV prevention intervention only, 3) combined ES and HIV intervention, or 4) no intervention.

Eligibility Criteria:
Inclusion Criteria:

* Beneficiary of Future Families in a study community
* Parent or guardian consent allowing adolescent to participate in the study
* Willing to sign or make their mark on an assent form
* Willing to provide contact information
* Only one adolescent is eligible per household
Physical Activity Behavioral Change Intervention in Lung Cancer

Patients with lung cancer have poor physical activity and increased sedentary behavior, with the presence of high levels of fatigue.

A randomized controlled trial will be carried out to compare usual care versus a personalized exercise program in the community, in order to explore the changes on physical activity and sedentary behavior and its impact on cancer-related fatigue.

Patients with lung cancer are characterized by having low levels of physical activity (PA) and high sedentary behavior (SB), with direct impact on their quality of life, complications and survival. Previous studies have observed that PA programs have high dropout rates and are not very sustainable over time, making it necessary to incorporate models that consider the preferences and possibilities of patients.

Objectives: To compare the effects on PA levels and SB of a 6-month personalized program vs. conventional care, in community-dwelling lung cancer survivors.

Methods: Controlled and randomized pilot study, with intervention and control group, pilot study. 40 non-small cell lung cancer survivors (18 to 70 years old) will be included. The control group will receive the usual recommendations regarding an active and healthy lifestyle. The intervention group will follow a personalized PA and behavior change program in the community, supervised by a physiotherapist expert in therapeutic exercise.

PA and SB measurements will be carried out using accelerometry and self-reported questionnaires. As secondary variables, functional capacity, lung function, dyspnea and fatigue, as well as quality of life will be measured. A motivational interview will be conducted to personalize the intervention considering clinical characteristics, treatment, motivation and preferences. The intervention will be re-evaluated and adapted monthly, considering the results reported weekly.

Through covariance analysis, the levels of PA and SB, among other factors, measured at the beginning and at the end of the intervention will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of non-small cell lung cancer who are candidates for radical and/or metastatic treatment
* ages between 18 and 70
* ability to answer questionnaires in Spanish
* who have accepted participation and signed the informed consent

Exclusion Criteria:

* participants with a life expectancy of less than 6 months
* patients with levels of physical activity greater than 240 metabolic equivalents (MET) METs/day
* patients who have a contraindication to exercise
* patients with dementia or spatial disorientation or behavioral disorders
A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations

This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.


Eligibility Criteria:
Inclusion Criteria:

* Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
* Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy greater than or equal to (≥) 12 weeks
* Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
* Adequate hematological , liver and renal function

Exclusion Criteria:

* Known hypersensitivity to erlotinib or any of its excipients
* Squamous non-small cell or small cell tumors or absence of histological report
* Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
* Prior exposure to inhibitors of EGFR
* Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
* Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
* Radical radiotherapy with curative intent within 28 days prior to enrollment
* Any active non-controlled systemic disease
Biomarkers of Cognitive Impairment in Blood Cells

The aim of this study is to identify transcriptomic biomarkers in blood cells to diagnose early cognitive impairment. This would allow preventing the development of severe pathologies, such as Alzheimer Disease. In addition, this project will analyse the influence of adiposity, obesity, nutritional habits and physical activity on cognition.

Blood cells constitute a minimally invasive material, which is presented as potentially suitable for addressing the identification of clinical diagnostic biomarkers. This study will compare gene expression in blood cells of patients with various degrees of cognitive alteration (mild cognitive impairment due to Alzheimer's disease and dementia due to Alzheimer's Disease) compared to control individuals, to identify early biomarkers of impaired cognition. The availability of non-invasive early biomarkers of cognitive dysfunction is highly relevant in the field of public health, from the point of view of being able to prevent or delay the onset and/or progression of dementia and other cognitive disorders. In addition, it is intended to establish the association between the biomarkers identified with nutritional imbalances and increased adiposity/obesity.

Eligibility Criteria:
1. Control group

   Inclusion criteria:
   * Age between 55-80 years
   * Absence of cognitive symptoms
   * Normal neuropsychological examination, (Clinical Dementia Rating, CDR = 0)

   Exclusion criteria:
   * Any disease that could influence their cognitive performance or blood cell parameters.
2. Group with Mild Cognitive Impairment Due to Alzheimer's Disease (MCI group)

   Inclusion criteria:
   * Age between 55-80 years
   * Established diagnosis of MCI
   * Cognitive deficit of 1.5 standard deviation in at least one of the neuropsychological tests performed, with no relevant functional repercussion (Functional Activities Questionnaire, FAQ\<7 and CDR≤0.5)
3. Group with Dementia Due to Alzheimer Disease (AD)

Inclusion criteria:

* Age between 55-80 years
* Established diagnosis of Alzheimer's disease
* CDR ≥ 0.5 and positive AD markers in cerebrospinal fluid
Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer

The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

60 patients with stageⅠ\~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 18\~80 years old;
* Histologically confirmed with colorectal cancer at stage Ⅰ\~Ⅲ;
* Patients who can accept curative operations;
* Patients who have a life expectancy of at least 3 months;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times ;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* History of organ allograft;
* Patients who had distant metastases;
* Patients who had active infection;
* Prior use of any anti-cancer treatment in 30 days;
* Now or recently will join another experimental clinical study ;
* Other situations that the researchers considered unsuitable for this study.
Pain Relief Effect of Angiopuncture for Patients With Postoperative Pain

The study aimed to investigate the effectiveness of angiopuncture therapy in pain alleviation for postoperative pain patients. The study involved patients aged 20-65 with acute foot and ankle trauma and pain after surgery. Physicians used handheld ultrasound Doppler to measure perforators, puncture participants with a filiform needle, and monitor pain scores and heart rate data before and after acupuncture. The duration of therapy was 20 minutes per day for 72 hours, with pain measured using the numerical rating scale. The study aimed to compare the outcomes before and after angiopuncture.

In order to give therapeutic therapy, solid filiform needles are inserted into the skin during dry needling (DN), traditional acupuncture (TA), and western medical acupuncture (WMA). DN is a treatment used to treat painful musculoskeletal illnesses, whereas TA and WMA have a wider variety of indications, including musculoskeletal discomfort, gastrointestinal problems, and neurological concerns. While DN implants are used in trigger points, acupuncture is for acupoints.

In addition, common methods include injections of painkillers, oral medications, and nerve blocks. Angiopuncture therapy is being used for the first time as a method of pain management in this article. The aim was to investigate if skin perforating needling therapy could alleviate postoperative pain in patients.

Patients with recent foot and ankle surgery who have had acute foot and ankle injuries and pain. Doctors measured three to four perforators at the proximal end of the trauma site using a handheld ultrasound Doppler, punctured the perforators for 15 minutes with a filiform needle (size: 0.18mm gauge \* 25mm length), and then monitored the patient's pain level and heart rate data before and after acupuncture Variety. If pain relief is possible, they'll do it. Risks include becoming more painful.

To create numbers, investigators employed an internet table generator. Despite having just one group, investigators compared the results of angiopuncture before and after therapy lasts for 20 minutes per day for 72 hours. Numeric rating scale (NRS) pain score at baseline: 6, 12, 24, 36, 48, 60, and 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* aged 20-65 years
* acute foot or ankle trauma
* pain after foot or ankle surgery

Exclusion Criteria:

* Have scars and deformities on the lower extremity surface
* cannot cooperate with the locating method of angiopuncture
* allergy to any material
* pregnant women
* breastfeeding women
Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on X-ray

This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities.

In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.

In addition, to investigate the effect of Lunit INSIGHT CXR assistance on the interpreting physician's interpreting performance, a multi-reader, multi-case (MRMC) study was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Chest radiographs of aged 14 years or older
* Conventional PA or AP chest radiographs
* Chest radiographs with confirmed radiology reports

Exclusion Criteria:

* Chest radiographs taken in postures other than PA and AP e.g.) decubitus, oblique, lordotic, or lateral view
* Invert-grayscale chest radiographs
* Image quality not suitable for interpretation due to incorrect patient positioning, inadequate image collimation, severely damaged lung presence of external materials such as jewelry
Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer

Acetylsalicylic acid (ASA) seems the ideal colorectal cancer (CRC) chemoprevention agent. Several ongoing trials are testing the effect of ASA as co-therapy in CRC. The mechanisms of action, the appropriate dose and the ideal target population are unknown. The investigators have demonstrated that doses of 100 mg of ASA induce direct and partial but persistent acetylation of the cyclooxygenase (COX) isoenzyme COX-1 in the normal colorectal mucosa. The primary objective is to perform a study of aspirin by using a proteomic assay for comparing platelet COX-1 and CRC mucosal COX-1 after different doses of ASA. Secondary objectives are: the measurement of prostaglandin E2 (PGE2) and phosphorylated S6 protein (p-S6) levels in CRC mucosa, the assessment of indirect biomarker of aspirin action (serum thromboxane B2 (TXB2) and urinary levels of 11-dehydro-TXB2 (TX-M)), the evaluation of systemic biomarkers of inflammatory/tumorigenic COX-2 by assessing urinary levels of major metabolite of PGE2 (PGE-M). Methods: Phase II randomized clinical trial in 60 patients with newly diagnosed CRC in 3 groups of 20 patients receiving 100 or 300 mg/day, or 100 mg/12 hours of enteric-coated ASA for 3±1 weeks, prior to definitive treatment by surgery. Main outcome: Acetylation of COX-1 and COX-2. Eicosanoid levels in target organs. Expected results: Evidence for the current uncertainty about the mechanisms of action and the dose required to obtain the best chemopreventive effect with ASA in CRC. Confirm acetylation of COX as a key biomarker of efficacy with ASA.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 \< 80 years old
* recent diagnosis (\< 48h) of rectum or colon cancer, established by endoscopy and later confirmed by anatomo-pathologic study
* normal coagulation values and biochemical vales without clinically significant deviations that, at the discretion of the investigator, may interfere with the study procedures

Exclusion Criteria:

* Allergy to ASA or to any other NSAID.
* Rectal cancer requiring neoadjuvant treatment within the two weeks following the beginning of ASA treatment.
* Previous use of ASA, NSAIDs, antiplatelet agents, corticosteroids or misoprostol within the 15 days prior to diagnosis and/or anticipation of need for treatment with any of these drugs during the study period. History of peptic ulcer disease or active peptic ulcer or any other gastrointestinal disease that may be considered a contraindication to the use of ASA, without the concomitant use of proton pump inhibitors.
* Diagnosis of bleeding disorders.
* Diagnosis of cancer (excluding non-melanoma skin cancer) within the previous 3 years.
* Conditions supposing serious comorbidity, excluding diabetes, and including respiratory, cardiac, hepatic and renal diseases.
* Active smoking.
* Pregnancy or breastfeeding.
* History of drug or alcohol abuse.
Small/Middle Tier Cities and County Lung Cancer Quality Improvement Project (QIP) Study

To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.

The primary objective of this study is to assess the implementation of standardized diagnosis and treatment practice in oncology departments of Small/Middle tier cities and County hospitals, after standardized education and implementation of lung cancer clinical practice guidelines for oncology physicians.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, at the time of signing the informed consent.
* ECOG performance status 0-2.
* Newly pathologic diagnosed metastatic NSCLC (clinical stage IV) or recurrent metastatic NSCLC.

Exclusion Criteria:

* Be participating in other intervention clinical trials.
* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
* Previous enrolment in the other QIP study.
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).

This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast
* Fibroadenoma is palpable
* Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension
* Fibroadenoma volume is between 2 cc and 10 cc
* Patient must give written informed consent (personally signed and dated) before completing any study-related procedure

Exclusion Criteria:

* Patient is pregnant or nursing
* Patient with breast implants in the target breast
* Patient with a breast cyst within the fibroadenoma to be treated
* Patient participating in another clinical trial involving an investigational drug, device or biologic
An Follow-Up Study of Liver Cirrhosis

This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study.

Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
* Voluntary signed informed consent

Exclusion Criteria:

* Patients evaluated by investigators as inappropriate