cyrilzakka/clinical-trials huggingface dataset:
Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.

Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However, some patients are ineligible for surgery because of their poor general health, concomitant anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.

Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment modality that has been approved in Europe for the treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease. However, currently, there is insufficient evidence to support the routine use of topical PDT for SCC.

Ablative fractional laser (AFL) ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones in the portion of the skin that the laser is applied to. Our previous studies showed that AFL-primed MAL-PDT (AFL-PDT) offered a higher efficacy than conventional MAL-PDT in the treatment of many other diseases, such as actinic keratosis, actinic cheilitis, and Bowen's disease.

Investigators recruited Korean patients with microinvasive SCC and compared the efficacy, recurrence rate, and cosmetic outcomes of AFL-PDT with those of standard MAL-PDT.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions:

  * tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and
  * difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems)

Exclusion Criteria:

* pregnancy or lactation
* active systemic infectious disease
* other inflammatory, infectious, or neoplastic skin diseases in the treated area
* allergy to MAL,other topical photosensitizers, or excipients of the cream
* history of photosensitivity
* use of immunosuppressive or photosensitizing drugs
* participation in any other investigational study in the preceding 30 days
* history or indicators of poor compliance
* Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria
"Working for You" Workplace Obesity Intervention

The purpose of this study is to test a workplace intervention program targeted at low SES workers. Working in partnership with BJC HealthCare, we will test an innovative multi-level intervention that includes an interactive obesity treatment program (iOTA) using SMS text messaging. The iOTA intervention will be embedded in a newly described Healthy Workplace Participatory Program, which incorporates employee participation in decision making to produce changes in the workplace environment that are acceptable, effective, and sustainable. These nested interventions will be tested a large delayed-start group-randomized trial. This study will rigorously test readily scalable interventions that can be translated to other work settings to reduce obesity and diabetes risk among low SES workers, a group at high risk for these disorders. This pragmatic clinical trial will advance the long-term goal of enabling employers and employees to reduce obesity and obesity-associated illnesses including diabetes.

Specific Aim: Test a multi-level worksite weight loss intervention to help workers attain and maintain healthy weight. Investigators propose a new group-level participatory wellness program engaging all employees within intervention work groups. The proposed workplace participatory program will assist work groups to adapt and deploy interventions that change their work environments to support healthy eating and physical activity. Nested within this group-level intervention for all workers, obese (BMI\>30) workers will be offered participation in an individual-level interactive obesity treatment approach (iOTA) intervention based on assessment of individual behavior risks, collaborative goal-setting with a health coach, and use of an interactive text system to provide ongoing support and self-monitoring of behavior change goals. Investigators will test these interventions in a delayed-start group randomized trial in 22 work groups (total workers = 990, obese workers = 308).

Specific Aim A: Implement and test a healthy workplace participatory program (HWPP) to promote healthy eating and healthy physical activity among all workers through changes in the work environment. Hypothesis: Workers in intervention groups will show improvements in healthy eating and activity compared to workers in control groups.

Specific Aim B: Implement and test an innovative Individual Obesity Treatment Approach (iOTA) in conjunction with changes in work environment. Hypothesis: Obese workers offered the iOTA intervention will lose weight over 24 month follow-up when compared to obese control group workers.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be a member of a chosen work group
* Speak English
* At least 18 years of age
* Sub-group (iOTA Intervention): BMI \>=30, cell phone with text messaging capability

Exclusion Criteria:

* Sub-group (iOTA Intervention): pregnant or nursing, weight-loss surgery in past 12 mths, currently receiving chemotherapy or radiation treatments
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer

The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.

Further study details as provided by Chinese Academy of Medical Sciences.

Eligibility Criteria:
Inclusion Criteria:

* 18 years \< age \< 80 years
* Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
* Pathological rectosigmoid adenocarcinoma
* Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
* Tumor size of 6 cm or less;
* Eastern Cooperative Oncology Group (ECOG) score is 0-1
* American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
* Informed consent

Exclusion Criteria:

* Body mass index (BMI) \>30 kg/m2
* Pregnant woman or lactating woman
* Severe mental disease
* Previous abdominal surgery
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
* Requirement of simultaneous surgery for other disease
Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure

The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.


Eligibility Criteria:
Inclusion Criteria:

* Intensive care units patients intubated for at least 24 hours with at least on of the four following risk factor : aged of 65 years or more, any underlying chronic cardiac or lung disease, mechanical ventilation for more than 7 days.
* aged of 18 years or more

Exclusion Criteria:

* peripheral or central nervous system pathology
* known psychiatric pathology or agitation
* patient with decision of no reintubation
* patient refusal
* clinical worsening before polysomnography ( shock with vasopressors drugs, coma, PaO2/FiO2 ratio \< 150 with respiratory distress signs, coma with Glasgow scale \<8)
* pregnant or breastfeeding women
* patient under legal guardianship or protection
* patient with no health insurance coverage
* aged \< 18 years
Evaluation of the Bioavailability of Pramlintide

This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c value between 6-12%
* BMI \<= 27 kg/m2 or BMI \>=30 to \<= 45 kg/m2
* Consistent insulin regimen for 2 months prior to screening
A-protein Levels in Adult and Pediatric Brain Tumor Patients

The purpose of this study is to evaluate the sensitivity and specificity of "A-PROTEIN" levels in patients with brain tumors. A-PROTEIN levels will be analyzed both pre and post treatment. Levels in blood and/or cerebrospinal fluid (CSF) will be analyzed and correlated with the underlying diagnosis and outcome.

* Patients will be identified at the time of presentation to their neurologist, neurosurgeon or oncologist.
* Blood or cerebrospinal fluid will be collected for this study only when they are being collected for other reasons before and after each surgery. Samples will also be collected after any event such as significant change in symptoms or radiographic progression.
* Once the patients condition has been stabilized, samples will be take at regular intervals of \>= 1 month. The duration of this study is 24 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients with possible malignant or benign lesions of the central nervous system will be included.
* There are no restrictions with respect to treatment protocols or prior therapy.
* Patients will be identified after presentation to the neurosurgical, neurological or oncologic services at participating centers. Any patient with evidence of a central nervous system tumor will be eligible. Individuals without evidence of CNS tumors are also eligible, in order to provide blinded controls.
* A signed informed consent will be requested and required for participation.
* There is no age, sex, or ethnic origin restrictions in this protocol. Patients who choose not to participate in the study will continue to have their regular care as defined by their treating team. Patients who speak foreign languages are eligible as long a translator can be found to ensure proper consent has been obtained.

Exclusion Criteria: There are no exclusion criteria for this study.
The Relationship Between CES1 Genotype and Methylphenidate Response in Children With ADHD - INDICES Work Package 6

This is a prospective observational study of a cohort of children diagnosed with Attention Deficit Hyperactive Disorder (ADHD) and followed with weekly assessments during the first 12 weeks of Methylphenidate (MPH) treatment, and after three years.

The overall aim is to gain knowledge in order to develop guidelines for more individualized treatments with (MPH), obtain a better drug response, and reduce the risk of adverse reactions, in order to improve adherence and long-term outcome.

The study has three aims:

1. Examine the effect of carboxylesterase 1 (CES1) genotype in children with ADHD on the effectiveness and adverse reactions of treatment with MPH.
2. Study predictors for the short- and long-term outcome in childhood ADHD
3. Examine the long-term outcome with respect to ADHD symptoms, and impairment in daily functioning in the cohort

The specific aims are to:

* Describe the treatment response during the first 12 weeks after initiation of IR-MPH treatment, based on weekly clinician- rated ADHD core symptoms, the rate of normalisation/ borderline normalisation of ADHD core symptoms, adverse reactions, daily and social functioning, and measures of sustained attention.
* Describe the three-year outcome, based on parent rated ADHD core- and behavior symptoms, and level of impairment in daily functioning.
* Provide information about predictors for outcome after 12 weeks: clinical characteristics at entry (sex, age group, global severity of psychiatric disorder, psychiatric comorbidity, subtype of ADHD diagnoses), and predictors for outcome after three years: sex, age group, baseline severity of ADHD- and behavior symptoms, IQ, parental psychiatric disorder, maternal educational level, and time to treatment response.
* Determine the end-dose of IR-MPH after 12 weeks of treatment.
* Systematically sequence the CES1 gene and associate the identified genotypes of this gene with treatment responses, including dosage of IR-MPH

Eligibility Criteria:
Inclusion Criteria:

* MPH naïve
* recent ICD-10 diagnosis of hyperkinetic disorder (F90.0-90.9) or attention deficit disorder without hyperactivity (F98.8)
* clinical indication for treatment with IR-MPH

Exclusion Criteria:

* mental retardation (ICD-F70.X or IQ \< 70)
* previous treatment with drugs metabolised by carboxylesterase 1 (CES1)
* severe comorbid psychiatric or somatic disease that resulted in contraindication for treatment with MPH
* language barriers
* lack of informed consent.

Specific additional exclusion criteria for genetic analyses:

* Non-caucasian
* Lack of DNA
* Consanguine patients
* Variants with a minor allele frequency (MAF) above 0.05 or not in Hardy-Weinberg equilibrium
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations

Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.

The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.

Eligibility Criteria:
Inclusion Criteria:

1. patients of all ages;
2. diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;
3. with any operative indications as follows: (1) with stable hematoma or history of hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced deterioration of neurological functions;
4. with Spetzler-Martin Grades from I to IV;
5. who provide informed consent.

Exclusion Criteria:

1. \>70 years old with no significant hemorrhagic risk of bAVMs;
2. with Spetzler-Martin Grade ≥V;
3. accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation;
4. allergic to iodinated contrast agent;
5. unable to give informed consent.
Comparative Study for Medical Therapy for Lower Ureteral Stones

The goal of this clinical trial is to compare the efficacy and adverse effects of different drugs as a medical expulsive therapy for lower ureteral stones. The main questions it aims to answer are:

* Which of the following are more effective silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil as a therapy for lower ureteral stones?
* What medical problems do participants have when taking these drugs?

Researchers will compare silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil to see which drug works better to treat lower ureteral stones Participants will:

* Take silodosin, tamsulosin, silodosin plus tadalafil or tamsulosin plus tadalafil every day for 28 days
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were adult patients aged 18 years and older with lower ureteral stones measuring 5-10 mm in diameter, diagnosed through imaging techniques such as kidney-ureter-bladder (KUB) x-rays or computed tomography (CT) scans.

Exclusion Criteria:

* Exclusion criteria included pregnant and lactating women, renal insufficiency, congenital urinary tract abnormalities, associated kidney stones or contralateral ureteric stones, solitary kidneys, associated infected stones, uncontrolled pain, severe hydronephrosis, history of allergy to the study medications and recent treatment for ureteral stones within the past 3 months (e.g., lithotripsy or surgery) .
Leg Press Power Training with Visual Feedback Games Improves Physical, Cognitive, and Heart Health in Seniors

This study investigates the effects of lower limb leg press power training combined with visual feedback games on the physical performance, cognitive function, and heart rate variability (HRV) of older adults aged 65 and above. Participants were divided into an experimental group and a control group, with the experimental group engaging in leg press exercises combined with visual games twice a week for 12 weeks.

This study aims to investigate the effects of lower limb leg press power training combined with visual feedback games on the physical and cognitive health of the elderly. With the aging population increasing, the decline in muscle strength and cognitive function has become a significant challenge for older adults. To address these health issues, this study plans to recruit 40 participants aged 65 and above and randomly assign long-term care centers into an experimental group and a control group. The experimental group will perform leg press training combined with visual feedback games twice a week for 12 weeks, while the control group will continue their usual daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-80 years old
* Physical fitness and health assessment results are suitable for exercise
* Clear consciousness and no mental disorders .
* Able to walk independently for more than 10 meters.

Exclusion Criteria:

* Determined by doctors or other relevant professionals that they cannot accept cardiopulmonary testing and muscle strength training
* The resting heartbeat exceeds 120 beats per minute, the systolic blood pressure exceeds 160mmHg, and the diastolic blood pressure exceeds 100mmHg.
* Any stage of cancer and other hematologic diseases that affect research evaluation, such as: severe anemia.
* Diseases related to cardiac pacemakers and arrhythmias.
* Other neurological, muscular, or skeletal diseases that may affect the research assessment or severe contagious disease.
PRJ2203: Dolutegravir Post Authorization Safety Study (PASS)

Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg. One case of suspected DTG hypersensitivity (HSR) reaction from among over 1500 subjects exposed to the drug at the time of submission in 4Q2012, has been identified; this subject experienced a diffuse maculopapular rash with fever and elevated liver enzymes. Isolated rash was uncommon in the DTG programme with less than 1% of clinical trial subjects experiencing treatment related rash. The pharmacovigilance strategy for DTG and DTG-containing products is to implement a post-marketing risk management program to further quantify the risk of HSR and compare it to that of other integrase inhibitors, and to possibly determine associated risk factors. In addition, the post-authorization safety study will monitor and compare hepatotoxicity and severe skin rash following initiation of DTG or other integrase inhibitor (raltegravir (RAL) or elvitegravir (EGV) based antiretroviral regimens (ARV). Further to be able to distinguish the above symptoms and reactions caused by DTG or the other integrase inhibitor regimen from that of abacavir (ABC), known to cause hypersensitivity reaction, the integrase inhibitor groups will be compared in combinations with and without ABC. This five year-long safety study will be conducted through collaboration with EuroSIDA, a well established prospective observational cohort study of more than 18,200 subjects followed in 107 hospitals in 31 European countries, plus Israel and Argentina. This is a five year-long non-interventional prospective cohort study nested within the EuroSIDA study. The study population will include HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or other integrase inhibitors with and without ABC. Following initiation of DTG with ABC based antiretroviral regimen or DTG without ABC or regimens containing other integrase inhibitors (RAL, EGV) with or without ABC or any other DTG based ARV regimen as monotherapy or two-drug regimens, the study will aim to a) Monitor and compare hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare severe skin rash among all subjects discontinuing DTG or other integrase inhibitor regimens for any reason.


Eligibility Criteria:
Inclusion Criteria:

* New users of DTG or users of other integrase inhibitor regimens (RAL and EGV)

Exclusion Criteria:

* None
The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation

The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.

Objectives： The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.

Background： Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has similar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. Six-minute walking test (6-MWT) is a standardized laboratory tests to evaluate the endurance capacity in adult patients. It helps clinician to modify the treatment plan. Cirio, et at. has been shown HHHFNC may improve the exercise performance in severe chronic obstructive pulmonary disease (COPD) patients with ventilatory limitation.

Study Design： This is a prospective clinical trial in a pulmonary rehabilitation out-patient department (2018.08.01-2019.07.31).。 Methods： Patents with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD acute-exacerbation (AE) within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. The data will be collected for and analyzed.

Effect： Investigators expect the exercise performance; cardiopulmonary function will be improve under HHHFNC support. We hope the application of HHHFNC in adult patient with pulmonary rehabilitation could enhance the quality of life.

Key words： chronic obstructive pulmonary disease; heated humidified high-flow nasal cannula; pulmonary rehabilitation, six-minute walking test.

Eligibility Criteria:
Inclusion Criteria:

* COPD with performed pulmonary function test

Exclusion Criteria:

* Left-side heart failure
* COPD exacerbation within 3 month
* Diagnosed neuromuscular disease
* Unable to perform 6-MWT