cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC

Immunotherapy for PD-L1 positive patients is still ineffective in some patients，which may be related to the complex immune microenvironment.In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.

There are still some patients with PD-L1 positive who are ineffective in immunotherapy, which may be related to the complex immune microenvironment. In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks.

Recently, studies have shown that the core elements of tumor microenvironment that have a significant impact on immunotherapy are:1. Infiltration abundance of specific killer T cells; 2. PD-L1 expression dependent on IFN - γ pathway, down-regulation of various active molecules and up-regulation of inhibitory molecules; 3. Activation and clearance of various inhibitory T cells.

Although the classification has achieved further refinement of immune cells and molecular level, there are still some problems to be solved urgently: first, the classification of TIL cells needs further refinement, and different types of TIL infiltration have different guiding significance for prognosis; second, the subjective second-order semi quantitative scoring is often used for til count scoring, with low repeatability and different centers It is not easy for different pathologists to reach an agreement on the results of reading and interpretation. Thirdly, conventional methods are difficult to meet the requirements of tumor microenvironment analysis. In conclusion, it is urgent to develop a multi molecular marker landscape analysis system for tumor microenvironment, and establish a standardized detection process for each molecule to meet the needs of clinical positioning, quantitative and qualitative analysis for key molecular markers of immune microenvironment.

In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Non small cell lung cancer was diagnosed by cytology or histopathology;
* Patients to be treated with PD-1 / PD-L1 inhibitors;
* Who signed the informed consent for participating in the research plan

Exclusion Criteria:

* History of other malignancies
* Cancer meningitis in subjects
* Incomplete clinical follow-up data
* Failure to sign informed consent to participate in the research program
Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata

* Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata.
* Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata.

Alopecia areata (AA) is the most common cause of non-scarring alopecia. (Hordinsky, 2013).

Although many patients improve spontaneously or respond to standard therapy, in patients with more severe and refractory disease, management can be quite challenging (Messenger et al., 2012 and Kranseler and Sidbury, 2017).

Corticosteroids either topical or intralesional are the most popular medications used to treat this condition. Other therapies such as topical minoxidil (MXD), anthralin, immunotherapy, systemic corticosteroids are also commonly used with variable success (Shumez et al., 2015).

Patients treated with MXD 5% have significant hair growth than placebo. Minoxidil was more effective for patchy alopecia than other types of AA such as ophiasis and alopecia totalis. It was ineffective in alopecia universalis (El-Taib et al., 2017).

In contrast, the incidence of adverse events associated with 10% MXD treatment was higher than with 5% MXD treatment. Therefore, new approaches are required to achieve both expected efficacy and safety (Oaku et al., 2022).

The combination of non-ablative laser and topical MXD can be a good alternative therapy for AA patients, including alopecia totalis and alopecia universalis, without systemic and local side effects (Wang et al., 2019) According to follicle deposition and diffusion experiments, minoxidil nanoemulsions penetrated hair follicles 26 times more efficiently than standard treatment (Cardoso and Barradas, 2020).

To the best our knowledge no previous research studied the effect of nanominoxidil solution in treatment of AA except in animal or compare transepidermal drug delivery versus topical nanominoxidil.

Eligibility Criteria:
Inclusion Criteria:

* The study will include patients with alopecia areata

Exclusion Criteria:

* Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients.

patient recieved any treatment for alopecia areata in the last 3 months before the study.

patients with extensive types (alopecia totalis, universalis and surface area \>50%).
Reflection and Feedback in Clinical Reasoning

Medical students' abilities to diagnose skin lesions after dermatology electives often remain unsatisfactory despite a dermatology elective being one of the most effective ways to improve their clinical reasoning. Feedback and reflection are two basic teaching methods used in clinical settings. This study aimed to investigate the effectiveness of structured reflection and immediate feedback in improving of medical students' evaluation of skin lesions.


Eligibility Criteria:
Inclusion Criteria:

* Fourth-year medical students at Seoul National University College of Medicine
* Students taking 2-week dermatology elective courses

Exclusion Criteria:

* Students who do not complete the whole course
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers

This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy RhD-negative volunteers
* Males and definitively sterile females
* No prior sensitization to RhD antigen

Exclusion Criteria:

* Healthy RhD-positive volunteers
Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

This is a pilot study evaluating an online cardiometabolic and weight loss program which is offered by The Wellness Institute. The program is 16 weeks and is developed by a multidisciplinary team and delivered by a degreed health professional (health coach) to assist participants in achieving their personal wellness goals. This study will also investigate the impact of Coronavirus Disease (COVID-19) on participants lifestyles and access to lifestyle programs and supports.

The Wellness Institute is offering a new cardiometabolic and weight loss program. It is a digital behavior change program designed to help clients achieve healthy weight reduction, thereby improving cardiometabolic risk. The target population is overweight or obese individuals at risk for or living with health conditions such as pre-diabetes, diabetes, hypertension and high cholesterol. The purpose of this study is to evaluate the program following a mixed methods quasi-experimental approach using focus groups, questionnaires, and data collected over the 16 week duration of the program. Participants will be asked to fill in a set of questionnaires to measure physical activity, diet, sleep and stress at the start and end of the program. Other outcomes include changes in body weight, body mass index (BMI), blood pressure, clinical chemistry, and medication intake over the 16 week program. At the end of the program, adherence will be measured though attendance and platform usage and acceptability will be measured by an exit questionnaire and virtual focus groups. This study will investigate the impact of COVID-19 on participants lifestyles and access to lifestyle programs and support. The impact of COVID-19 will be assessed through a Covid-19 questionnaire and virtual focus groups.

Eligibility Criteria:
Program inclusion criteria:

• Male or female, aged 18 years or above, have one or more of the following conditions: pre-diabetes, diabetes, high blood pressure, high triglycerides, low HDL, abdominal obesity, and BMI \>25 kg/m2.

Program exclusion criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
* Recent heart attack, stroke, heart surgery, and congestive heart failure.
* Participants who have unmanaged diabetes, chest pain or difficulty breathing.
Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs

16p13.11 copy number variations are considered as predisposition factors for neurodevelopmental disorders but can be inherited from normal parents. SEESIC aims at identifying seond molecular events by exome sequencing that could modulate the phenotype and explain familial discrepancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting intellectual disability
* Patients carrying a 16p13.11 copy number variant
* Blood DNA available without re sampling for the patient and his parents.
* Consent for genetics analysis already for the patient and his parents.

Exclusion Criteria:

- Other diagnosis for intellectual disability (apart 16p13.11 copy number variant) already posed
TAFF-Psychological Treatment of Separation Anxiety Disorder

The purpose of this study is to determine whether a specific family based cognitive behavioral treatment program is effective in the treatment of children with separation anxiety disorder.

Anxiety disorders are the most common mental disorders both in adulthood and childhood. Recent research indicates that anxiety disorders in childhood and in particular Separation Anxiety Disorder (SAD) increase the risk of mental disorders in adulthood. Despite these results research on SAD is still limited compared to the vast research activity on adult anxiety disorders. The proposed research program will close a gap of current international research: It will test the efficacy of a family based cognitive behavioral treatment program specific for SAD.

The research program consists of two parts. One study is aimed at children with SAD aged 5 to 7. 40 children are randomly allocated immediately to SAD-specific family-based treatment or to a wait list. For the second study 60 children with SAD (8 to 13 years old) are randomly allocated to either SAD-specific family-based treatment ("SAD-CBT") or a well established global CBT program for childhood anxiety disorders ("global CBT").

In both studies treatment success is tested at the end of treatment as well as 4 weeks and 1, 2 and 3 years after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of SAD
* Age 5 to 13 years
* Knowledge of German language
* Consent to randomization and psychological testing

Exclusion Criteria:

* Comorbid Pervasive Developmental Disorders
* Active psychotropic drugs
Non Surgical Treatment of Periimplantitis

20 consecutive adult implant patients, presenting the signs of peri-implant mucositis (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of supporting bone ≤30% compared with the situation after implant placement) will be included.

Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5 minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.

At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).


Eligibility Criteria:
Inclusion Criteria:

* adult patients suffering from peri-implant mucositis or peri-implantitis

Exclusion Criteria:

* Heavy smokers current pregnant history of malignancy long-term steroidal or antibiotic therapy
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Written informed consent prior to any study-related procedures
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2,
* Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated World Health Organisation 2019 grade 1-2 GEP NET
* Documented radiological disease progression on first-line SSA treatment at label dose or higher
* For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator
* For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator

Exclusion Criteria:

* Indication for chemotherapy treatment of GEP NET in second-line
* Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET
* Prior treatment with everolimus, sunitinib or PRRT
* Contra-indication, proven allergy or other indication than functional NET for the use of a SSA
* Patient showing progressive disease while being on a lower than the registered dose
* Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome
* Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET
* Concurrent anti-cancer treatment in another investigational trial
* Any abnormal findings at screening, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
* Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial
A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools

This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
* Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prior to the day of screening.
* Abuse or intake of alcohol, defined as any of the below: a) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women. b) Positive alcohol test at screening.
* Abuse or intake of drugs, defined as any of the below: a) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening. b) Positive drug of abuse test at screening.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.
Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls

This study has two research arms:

The purpose of the 1st is to determine if a smaller particle size calcium carbonate supplement (than that which is now commercially available) improves calcium absorption and retention in adolescents girls.

The purpose of the 2nd is to determine if vitamin D supplementation improves calcium absorption and retention in adolescents girls.

An important strategy to reducing the risk for osteoporosis and fracture in later life is to optimize the development of peak bone mass during adolescence. Because calcium is the main mineral component of bone, maximizing calcium absorption and retention during adolescence is important to maximize peak bone mass.

Our two research arms address two different mechanisms by which calcium absorption and retention may be increased:

1. We hypothesize that a smaller particle size calcium carbonate supplement (than that which is now commercially available) may be better absorbed and lead to higher calcium retention in adolescents.
2. We hypothesize that vitamin D supplementation will increased calcium absorption and retention in adolescents.

Subjects will be assigned to one of the two research arms.

1)Small and large particle size calcium supplements or placebo or 2) calcium supplements with or without vitamin D supplements will be given to subjects during two 3-week study periods in which subjects live on-site.

Calcium absorption will be measured by parathyroid hormone suppression after a calcium load and by stable calcium isotope in some subjects.

Calcium retention will be measured by calcium intake minus calcium excretion.

Eligibility Criteria:
Inclusion Criteria:

* 12-14 year old girls
* Generally Healthy

Exclusion Criteria:

* History of alcohol, smoking, or non-prescription drug use
* Malabsorptive disorders, bone, liver, or kidney disease that may affect calcium metabolism
* Oral contraceptive use
* Pregnancy
Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome

Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are depleted particularly in those patients with intense inflammatory response. The hypothesis tested is that early I:V: administration of a combination of AOX micronutrient supplements (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill patients, by reinforcing the endogenous AOX defenses and reducing organ failure.

Prospective randomized, double-blind, placebo-controlled, single-center trial. Patients admitted to ICU after complicated cardiac surgery, major trauma with or without brain injury, subarachnoid hemorrhage, and predicted by the clinicians to require \>48 hours of ICU treatment.

Supplements: provided IV for 5 days

Eligibility Criteria:
Inclusion Criteria:

* adult patients admitted for above diagnosis assessed on admission by the medical team likely to require more than 48 hours of ICU

Exclusion Criteria:

* absence of consent, participation in another study, liver cirrhosis or major burns and life expectancy \< 24 hours or a lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the 48 hours
The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill

Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high as 74% despite the use of analgesics. The highest pain intensity is experienced in the first 24 hours post surgery when patients are still in the ICU, and represents a strong predictor for the presence and severity of persistent postoperative pain. To maximize pain relief, massage has been suggested in the recent clinical practice guidelines of the Society of Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed promising pain relief effects of massage when administered to cardiac surgery patients in acute care units, however, its effects on pain relief while patients are still in the ICU and when pain severity is highest remain unknown.

This study aims to compare the effect of three 20-minute hand massage administrations within 24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding (i.e., simple touch) and standard care. Other objectives are to describe the location and quality of pain of cardiac surgery ICU patients.

Hypothesis:

Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity, unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients receiving hand holding and to those in the standard care group.


Eligibility Criteria:
Inclusion Criteria:

* able to speak French or English
* elective cardiac surgery requiring sternal incision (e.g., coronary artery bypass graft, valve replacement)
* able to answer questions and self-report symptoms

Exclusion Criteria:

* previous cardiac surgery
* diagnostic of cognitive or psychiatric disorder
* pulmonary artery pressure \>50 mmHg
* right ventricular failure
* systolic left ventricular dysfunction (ejection fraction 35% or less)
* body mass index \> 30
* prolonged bleeding from the chest drainage tubes (i.e., \>200 ml/h)
* having mechanical blood pressure support (e.g., intra-aortic balloon pump)
* receiving cardiac pacing with complete control of HR
* peripheral intravenous line in the hands
* suppurating/infective/inflammatory skin condition of the hands
* hypersensitivity to touch.