cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) is not inferior to 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

This study will be a phase Ⅲ open label interventional case series. Patients with unilateral Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles every 21 days. Patients will be followed for 60 months.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
* Received enucleation in the study eye.
* Monocular retinoblastoma.

Exclusion Criteria:

* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* History of chemical intervention for retinoblastoma in the study eye.
Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 12 to 17 years of age, inclusive
* Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
* AD in treatable areas (excludes the scalp and venous access areas) involving

  ≥10% and ≤35% of the total body surface area(BSA)
* Investigator's Static Global Assessment (ISGA) score of 2 or 3
* Normal or not clinically significant screening laboratory results
* Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site
* Willing and able to comply with study instructions and commit to attending all visits
* Females must use a highly effective method of birth control.
* Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Exclusion Criteria:

* Significant confounding conditions as assessed by study doctor
* Unstable or actively infected AD
* Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
* Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
* Current pregnancy or lactation, or intent to become pregnant during the study
* Known sensitivity to any of the components of the study drug
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Participated in a previous AN2728 clinical study
Evaluation of Postoperative Pain After Endodontic Retreatment Using Different Working Length Determination Methods: A Randomized Clinical Trial

The aim of this study is to compare the effects of two different working length determination methods on the incidence of postoperative pain in single-rooted, single-canal teeth undergoing root canal retreatment (RCR). Sixty-four previously treated, single-rooted, single-canal teeth, which were determined to require RCR based on clinical symptoms and radiographic findings, were randomly and equally divided into two groups and included in the study. Two distinct working mechanisms of an integrated endodontic motor with an apex locator were used in our study. One method involved simultaneous determination of the working length during canal shaping, while the other method determined the working length with a hand file after the canal filling was removed. After the session in which the methods were applied and the working length was determined, participants' pain levels were recorded using a visual analog scale (VAS) at 6-12 hours and on days 1-2-3-4-5-6-7.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers aged between 18 and 65 with no systemic diseases. Teeth without acute apical abscess. Single-rooted and single-canal teeth that have previously undergone root canal treatment, failed, and require re-treatment (diagnosed based on clinical symptoms and radiographic findings).

Individuals with preoperative pain rated 50 or lower on the 100 mm VAS scale

Exclusion Criteria:

Individuals with systemic diseases or allergic reactions. Pregnancy and breastfeeding. Teeth with open apex. Teeth with internal or external root resorption. Patients who have taken analgesic, anti-inflammatory, or antibiotic medications within the last twelve hours.

Teeth with broken instruments in the canal. Individuals with bruxism problems.
Use of Telehealth Technology by Mental Health Care Professionals in Times of COVID-19 Pandemic

A brief online survey to be completed by clinical therapists.

A brief online survey to be completed by clinical therapists. This brief 28 question online survey asks mental health care providers questions about their use of technology.

Eligibility Criteria:
Inclusion Criteria:

• Must be 18 years old, and must be a licensed mental healthcare provider actively treating patients within the past year.

Exclusion Criteria:

• Less than 18 years old, or if you are not a licensed mental healthcare provider actively treating patients within the past year.
Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of type 2 diabetes mellitus
* patients with hypertension (seated office SBP of \>=130 mmHg and \<160 mmHg and seated office DBP of \>= 70 mmHg at screening and at Week -2
* patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
* patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening

Exclusion Criteria:

* a history of diabetic ketoacidosis
* type 1 diabetes mellitus (T1DM)
* pancreas or beta-cell transplantation
* fasting C-peptide \<0.70 ng/mL (0.23 nmol/L)
* body mass index \<30 kg/m2
* has ongoing, inadequately controlled thyroid disorder
* has a history of cardio-renal disease that required treatment with immunosuppressive therapy.
Cognitive Frailty in Older Adults: The Role of Technology in Physical Activity Enhancement

This study intends to determine if smart watches and mobile phone application prompts can complement physical activity as a preventive intervention by motivating participants to exercise, so as to improve their physical and cognitive outcomes.

The investigators hypothesize that technology will help increase engagement in physical activity for the intervention group relative to the control group and subsequently improve cognitive and physical outcomes.

This study aims to explore the role of technology -- in the form of smart watches and mobile phone application -- in physical activity enhancement on cognitive frailty outcomes. Cognitive frailty is defined here as having both physical frailty and cognitive impairment but does not satisfy criteria for Major Neurocognitive Disorder. The investigators postulate that for older adults, such technology will help increase engagement in physical activity with subsequent improvement in cognitive and physical outcomes at follow up. This is with the aim of preventing this particular group from deteriorating to cognitive frailty because of the accompanying increased risk for adverse outcomes and morbidity.

This pilot study will be a randomized control trial with 2 treatment arms. Assessments will be done prior to and following the intervention period. During the period of intervention, the wearable will act as a tracking device and will be paired with a mobile application to issue prompts to the participant when necessary. The independent variable explored in the study is the use of the wearable while the levels of physical and cognitive improvements are the dependent measures. These will be tracked at baseline, 3 months and 6 months. Additionally, the mediating variable measured is the levels of physical activity to ensure that the proposed outcomes are affected through an increased level of physical activity encouraged by the use of the device.

If innovations like technology and the role of self-management proves efficacious, the future of healthcare in the context of a rapidly aging population will be more sustainable. Furthermore, this supporting role of technology in positive behavioral modification amongst older adults can have a multitude of applications in subsequent healthcare interventions.

Eligibility Criteria:
Inclusion Criteria:

* Older adults aged 60 to 85 years

Exclusion Criteria:

* Engages in vigorous exercises as determined by having more than 0 minutes of vigorous exercise on the International Physical Activity Questionnaire (IPAQ).
* Has medical contraindications for exercising, including but not limited to: physical disabilities or heart conditions where the primary doctor disallows exercising at moderate intensity.
* Does not own an Android phone which can support at least a version 6.0 Operating System
Feasibility of RUS Lung in MITS

This sponsor-initiated prospective observational study aims to demonstrate the feasibility and efficacy of RUS Lung Surgical Navigation System in patients undergoing minimally invasive thoracic surgery(MITS). The trial will enroll 36 patients who undergo video-assisted or robot-assisted thoracoscopic surgery using RUS Lung. The study will be conducted across two medical centers."

* Investigational Medical Device: RUS Lung (Endoscopic Imaging Treatment Planning Software)
* Clinical Trial duration: 12 months from IRB approval
* Target number of subjects: Total of 36 participants

Patients will be enrolled after being selected based on the inclusion and exclusion criteria and after obtaining informed consent. Video-assisted or robot-assisted thoracic surgery (VATS/RATS) will be performed using RUS Lung.Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 2 weeks after discharge. The operative outcomes including operative time, estimated blood loss, complication rates, and hospital length were compared with the historical control underwent VATS and RATS without using RUS Lung.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were diagnosed with lung caner (tumor size≤3cm)
* Individuals aged 19 or older
* Individuals who who are able to undergo CT imaging according to the established protocol
* Individuals who have voluntarily given written consent to participate in this clinical trial

Exclusion Criteria:

* Vulnerable subjects
* Individuals who who are not able to undergo CT imaging according to the established protocol
* Individuals who are expected to have severe adhesions
* Individuals who are unable to follow the study procedures and are deemed inappropriate for participation
The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain

Background: Low back pain (LBP) is still a frequent health problem. Recurrance of symptoms leads to high absence at work. It was proved in previous studies that low back manual massage has a significant impact on pain reduction. Trabert current (TC) is common physical modality used in rehabilitation of patients with LBP. The aim of study was to assess the effectiveness of manual massage in comparison to TC in patients with LBP.

Methods: Sixty patients with LBP were enrolled in to the study. In all patients discopathy and spondyloarthrosis were diagnosed. The subjects were randomly assigned to two groups: massage (I=30) and TC (II=30) therapy. The procedures were performed for ten days. Pain intensity was assessed by Numerical Rating Scale. Quality of life and the degree of disability were evaluated by Oswestry Disability Index and Roland-Morris Disability Questionnaire.

Results: In both groups pain reduction and functional improvement were observed after therapy. However, better results were noticed in group I.


Eligibility Criteria:
Inclusion Criteria:

* confirmed in X-ray spondyloarthrotic changes in lumbar area of spine
* pain of lumbar area lasting than 1 year

Exclusion Criteria:

* cardiac rythm disturbances
* cardiac pacemaker
* heart failure
* pulmonary embolism
* atherosclerosis
* neoplasmatic diseases
* skin lesions or purulent changes in the area of procedure
* pregnancy
* advanced osteoporosis
* spine fractures
* fever
Trajectory of Body Composition Identifies LAGC with Cachexia Following NACT

This longitudinal, multicentre cohort study included LAGC patients treated with NACT between 01/2010-12/2021. BC measurements including skeletal muscle mass (SMM) and total adipose tissue area (TATA) were evaluated by computed tomography at the third lumbar vertebra at baseline and follow-up imaging. Unsupervised latent class growth mixed models were applied to distinguish potential longitudinal SMM and TATA trajectories for identifying cachexia. The primary study endpoint was overall survival (OS), with secondary endpoints including Recurrence-free survival (RFS), objective response rate (ORR) and safety. Multiple Cox proportional hazards models were used to calculate adjusted hazard ratios (HRs) for survival.

This is a retrospective, longitudinal, multicenter, real-world cohort study

Eligibility Criteria:
Inclusion Criteria:(1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy.

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Exclusion Criteria: (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.

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Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer

Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. The main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in ES SCLC patients receiving carboplatin/etoposide/durvalumab.

Studies show that adding ICI therapy to standard chemotherapy prolongs survival in ES SCLC. The survival benefit, however, is modest, and there is a need for more effective therapy. It has been hypothesized that there is a synergistic effect of combining ICI with radiotherapy. In this randomized phase III study, the main aim is to investigate whether concurrent thoracic radiotherapy of 30 Gy/10 fractions improves survival in ES SCLC patients receiving carboplatin/etoposide/durvalumab.

It is currently not possible to classify the patients who benefit from ICIs in SCLC. In this study, biological material (tissue, blood, feces) which will be analyzed for potential predictive and prognostic biomarkers.

Prophylactic cranial irradiation in ES SCLC is debated, mainly due to the potentially detrimental effect on cognition. Thus, frequency and timing of brain metastases and cognitive function will be assessed before, during and after study treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years at time of study entry
2. ECOG performance status of 0 or 1
3. Body weight \>30 kg
4. Adequate bone marrow, liver and kidney function
5. Life expectancy of at least 3 months
6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 30 Gy/10 fractions
7. Histologically or cytologically confirmed SCLC
8. Stage III-IV disease (TNM v8)
9. FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
10. Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment

Exclusion Criteria:

1. Previous chemo-, immuno- or radiotherapy for SCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women
Molecular Diagnosis of Systemic Autoinflammatory Diseases

Systemic autoinflammatory diseases (SAIDs) are a set of rare clinically and genetically heterogeneous conditions. The project proposes to identify novel genes and specific signatures in subgroups of patients with SAIDs.

SAIDs are characterized by long dormant periods with no or only minor clinical symptoms interrupted by febrile crises accompanied by serous and synovial membrane inflammation that spontaneously resolves. Over the last decades, more than 50 genes encoding key components of the innate immune system have been identified to be involved in the pathophysiology of SAIDs, with both germline and somatic mosaic variations. When disease-causing variations are identified, specific biotherapies are proposed depending on the involved gene and pathway. However, despite these scientific advances, most SAIDs (70%) are of unknown etiology, the diagnosis is made with significant delay, and no targeted therapy can be suggested. This project aims to generate specific understanding and develop strategies for SAID patients with unknown etiology. The investigators aim to advance our understanding of SAIDs pathophysiology, find the disease-causing gene variations and identify the involved cellular pathways that should accelerate correct diagnosis and personalize treatment.

Eligibility Criteria:
Inclusion Criteria:

* A patient presenting with a clinical and biological aseptic inflammatory syndrome associating one or more of the following signs: spontaneously resolving fever, abdominal (pain, diarrhea), locomotor (arthralgia, myalgia), thoracic (pain, pericarditis), cutaneous, sensory (uveitis, deafness), or renal (amyloidosis) involvement.

Exclusion Criteria:

* Adult subject to legal protection measures (guardianship, curatorship, safeguard of justice).
Traditional Chinese Medicine for Complications in Critically Ill Patients

The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.

Introduction: Intensive care unit is a special department in the health care facility. Although with highly development of modern medicine nowadays, the average mortality rate in Intensive care unit is still around 7 to 20 %. There are a few tricky problems that intensivists and intensive care nurses faced very often, including intensive care unit delirium, arrythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Traditional Chinese Medicine can possibly provide a series of interventions that can alleviate those conditions.

Methods: A randomized control trial will examine the effect of traditional Chinese Medicine interventions vs. routine intensive care unit care. The patients will be randomly divided 1:1 into one of two groups. A total of 80 intensive care patient will have to meet the following criteria: age 20-90, two or less inotropic medicine use. Interventions such as: Chinese herbal medicine decoction, acupuncture, laser acupuncture, Chinese Tuina massage, herbal medicinal cake applied on acupoint, health education and diet education, will be given based on the patients needs and Traditional Chinese Medicine doctor decision. The main outcomes will be the incidence of arrythmia, delirium, and poor digestion and the severity of pain. The investigators will also record intensive care unit mortality, intensive care unit stays and hospital days.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-90
* newly intensive care unit admission (\<48 hours)
* Two or less inotropic medicine prescribed

Exclusion Criteria:

* Clinically unstable: receiving more than inotropic agents.
* Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times