cyrilzakka/clinical-trials huggingface dataset:
Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)

This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.

This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The general procedures include the collection and testing of cancer tissue samples after surgery and chemoradiation therapy (radiation and temozolomide). For the patients randomized into the investigational study treatment group, they will also receive two vaccinations created from their own cancer cells, undergo leukapheresis to collect immune T-cells from their blood, and transfer of those activated effector T-cells after chemoradiation therapy. All patients are followed with MRIs at follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)
* Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines
* The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department
* Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits
* not currently receiving glucocorticoids and have been off glucocorticoids for at least 24 hours prior to vaccination as well as when they receive the T cell infusion.
* Patient function assessment (Karnofsky score is \> 60)
* a life expectancy of \> 12 weeks.
* Hemoglobin is \> 10 g/dL (may be transfused)
* White blood cell count is \> 3,000 cells/microliter (mcL) of blood.
* Platelet count is \> 100,000 platelets per mcL of blood (transfusion independent)
* Lymphocyte count is \> 1,000 cells/mcL of blood.

Exclusion Criteria:

* another concomitant life-threatening disease (not including glioblastoma multiforme)
* a second malignancy that is not in remission as determined by the clinical investigator. Exception: squamous or basal cell carcinoma of the skin.
* requirement for treatment with glucocorticoids to control brain swelling
* presence of active autoimmune disease that is currently being actively treated.
* psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
* Current pregnancy or a plan to become pregnant within 1-year following the study.
Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects

The inclusion of short periods of apnea (several seconds) during exercise (i.e. dynamic apnea) induces a significant decrease in blood oxygenation and muscle tissue. To date, the immediate effects ("acute apnea") of this decrease in the quantity of oxygen available at the muscle and brain level are poorly understood. Moreover, a physical training during which these short periods of apnea ("chronic apnea") would be included could lead to physiological adaptations and to improvement in physical performance similar to those obtained during altitude training.

The purpose of this study is to evaluate the effects of acute dynamic apnea on metabolism.


Eligibility Criteria:
Inclusion Criteria:

* The cutaneous thickness at the vastus lateralis level lower than 1.5 cm to obtain the reliable muscle oxygenation measurement
* Subjects will have to sign the inform consent before the beginning of the study

Exclusion Criteria:

* Contraindications to regular physical exercise practice
* To practice an endurance sport more than 1h/week
* Regular practice of apnea
* Chronic use of cannabis and/or alcohol
* Cardiac or metabolic pathology
* Asthma and/or bronchodilatator treatment
* ECG abnormality at rest
* Regular consumption of tobacco
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada

This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada.


Eligibility Criteria:
Key Inclusion Criteria:

* Participated in Study NBI-98854-HD3006 and completing dosing through the Week 156 visit; or were actively participating, receiving study treatment, and completed an early termination visit Study NBI-98854-HD3006 at the time of the study closure at sites in Canada.
* Participants of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment.

Key Exclusion Criteria:

* Have difficulty swallowing
* Are currently pregnant or breastfeeding
* Have a medically significant abnormality, physical examination finding, clinically significant laboratory abnormality
Prospective Cohort Study of Children Diagnosed with Type 1 Diabetes in Türkiye Between 2018 to 2022

Achieving glycemic targets with improved T1DM management reduces diabetes complications and the risk of progression. Thus, it is essential to identify the challenges in T1DM management within the country and develop strategies for improvement. In Türkiye, there is limited multicenter data regarding the clinical characteristics of children and adolescents with T1DM during the diagnosis and treatment process. This multicenter prospective cohort study aimed to determine the diagnostic and follow-up characteristics of children and adolescents with T1DM, assess the status of diabetes management in the country.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus can develop in individuals between the ages of 2 months and 18 years.

Exclusion Criteria:

* other types of diabetes mellitus
Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia


Eligibility Criteria:
Inclusion criteria

* 3-20 years old patients
* elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.

Exclusion criteria

* allergy to bupivacaine or ketamine
* coagulopathy
* endocrine, neuropsychiatric or cardiopulmonary dysfunction
* increase intracranial pressure (ICP)
* psychiatric illness, history of seizure, patients under chronic analgesic treatment
* history of peritonsillar abscess, tonsillar malignancy.
Specific Autoantibody Testing in Patients With Interstitial Lung Disease

The purpose of this study is to evaluate the clinical utility of specific autoantibody testing in unmasking an underlying connective tissue disorder in patients who present with interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease.

It has been well established that patients with connective tissue disease associated interstitial lung disease respond better to immunosuppressive therapy, and have a better outcome compared to patients with idiopathic interstitial pneumonias. This makes it imperative to identify this group of patients for management and prognostication. Unfortunately some of these patients do not demonstrate overt clinical manifestations of connective tissue disease and our current available autoantibody screen does not detect all potential autoantibodies present. We would like to test for specific autoantibodies in this group of patients to evaluate its clinical utility in identifying covert connective tissue diseases associated with interstitial lung disease.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 21 years old and older
2. Patients with interstitial lung disease who have been found to have weak positive ANA (1:400 titre) with no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease will be offered specific autoantibody testing

Exclusion Criteria:

1. Inability and unwillingness to sign informed consent
2. Patients who are pregnant or have underlying malignancy
Bitter Chocolate or Orange Juice for Non-reactive Non-stress Test (NST) Patterns

There are multiple factors affecting the variability and acceleration pattern of fetal heart rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any factor decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be stimulated by manual manipulation, sound, light, change in maternal position and maternal ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently practiced in outpatient settings. This is not only medical but also a social routine. In this study the investigators have chosen the two most popular so-called 'fetal accelerators', chocolate and orange juice against no intervention and tried to find any usefulness of these on non-reactive NST patterns.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancies at 36 to 41 completed gestational weeks that have a non-reactive NST pattern without decelerations.

Exclusion Criteria:

* multiple pregnancies, fetal anomaly, hypertension, intrauterine growth restriction, active labor, contractions or decelerations on NST, absence of a first or second trimester ultrasonography for accurate gestational dating, pre-gestational or gestational diabetes and known allergy to chocolate or orange
The Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell Carcinoma

Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors .Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.

Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors. Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.

About this study ,inclusion criteria were the following parts:

the patients of poor differentiated HNSCC ; T1-4aN0-2M0; pathological examination: poor differentiated squamous cell carcinoma; initial treatment(primary, without surgery, radiotherapy and chemotherapy); range:18-70 years old; KPS\>80; hemogram and the function of main organ such as heart, lung, liver and kidney were normal; having the endoscopy, CT and MRI before formed into different groups; sign the informed consent file, good compliance.

AND the exclusion criteria were:

uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis; serious and uncontrollable infection; main organ system failure (including heart ,lung ,liver and kidney); reject training; high and moderate differentiated squamous cell carcinoma

Eligibility Criteria:
Inclusion Criteria:

* Patients of poor differentiated HNSCC ;
* Patients within the stage of T1-4aN0-2M0;
* The pathological examination of the patients show poor differentiated squamous cell carcinoma;
* Patients with initial treatment(primary, without surgery, radiotherapy and chemotherapy);
* 18-70 years old;
* KPS\>80;
* Hemogram and the function of main organ such as heart, lung, liver and kidney were normal
* Having the endoscopy, CT and MRI Signed the informed consent file, good compliance.

Exclusion Criteria:

* Uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis;
* Serious and uncontrollable infection;
* Main organ system failure (including heart ,lung ,liver and kidney); reject training;
* High and moderate differentiated squamous cell carcinoma
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

Currently, there is limited evidence showing increased resolution of HS flares with higher doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile between the doses. The goal of this study is to determine the efficacy of treating HS flares with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each dose.

A double-blinded, randomized, placebo-controlled study examining the relative efficacy of ILTAC-10, ILTAC-20, and ILTAC-40 versus placebo for acute flares of HS in subjects with moderate to severe HS. The duration of the study will be approximately 4 weeks for each enrolled patient and will include an initial screening/randomization/treatment visit and a 4-week follow-up period. During the initial visit, subjects who meet the study's eligibility criteria will be randomized to receive either ILTAC-10, ILTAC-20, ILTAC-40, or placebo in a 1:1:1:1 ratio. Study subjects will then receive treatment or placebo. The follow-up period will be of 4 weeks and will consist of 3 phone calls and 1 live visit, including an end of study visit on week 4 after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 13 years old.
* Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.
* Subject is willing to comply with the procedures in this protocol.
* The subject must be diagnosed with HS and receiving care at HSC
* Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5
* The subject must have an inflamed nodule or abscess at the time of enrollment.

Exclusion Criteria:

* The subject has an HS-PGA score of 0 or 1
* The subject has received ILTAC less than 8 days prior to the initial visit.
* The subject does not have capacity to consent to the study.
* The subject is has taken systemic steroids at least 4 weeks prior to the time of enrollment.
* The subject has a known allergy or history of adverse reaction to steroids.
* The subject is pregnant.
* Subjects who have received a biologic therapy two weeks before and during the study period.
Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis

The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to improve joint functionality and reduce pain.

Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.


Eligibility Criteria:
Inclusion Criteria:

* Degenerative osteoarthritis of the knee confirmed radiologically
* Degenerative osteoarthritis of the knee replacement candidate
* Walking ability in patients with or without external support
* Baseline in pain VAS greater than 60

Exclusion Criteria:

* Neoplastic disease
* Immunosuppressive States
* Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months.
* Patients who have undergone arthroscopic surgery on the last 3 months
* Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia)
* Fibromyalgia or chronic fatigue syndrome
* Liver disease
* Deficit coagulation (blood dyscrasia)
* Thrombocytopenia
* Anticoagulant treatment
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)

This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.

IW-6463 tablets will be orally administered once-daily (QD) for up to 29 days

Eligibility Criteria:
Inclusion Criteria:

1. Prior genetic confirmation of a known mitochondrial disease mutation
2. Neurological features of MELAS (can be based on medical history)
3. Elevated plasma lactate levels at Screening Visit (≥1.0 mmol/L)
4. Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 90 days after the final dose of study drug.
5. Male participants must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception and agree to refrain from sperm donation from the Screening Visit through 90 days after the final dose of study drug.
6. Other inclusion criteria per protocol

Exclusion Criteria:

1. Positive pregnancy test at Screening or on Day 1
2. Hypotension defined as systolic blood pressure (BP) ≤90 mmHg or diastolic BP ≤60 mmHg at Screening or predose at Day 1
3. Hypertension defined as systolic BP \>160 mmHg or diastolic BP \>100 mmHg, at Screening or predose at Day 1
4. Uncontrolled diabetes
5. Severe gastrointestinal dysmotility as determined by the investigator that may impact compliance and/or oral drug administration, absorption and exposure.
6. Unable to fast for 3-4 hours after a meal
7. Unable or unwilling to adhere to the study schedule, lifestyle restrictions, assessment requirements or, in the clinical judgment of the investigator, is otherwise not suitable for study participation.
8. Current or past history of clinically significant cardiomyopathy and/or cardiac conduction abnormality
9. Used any nicotine-containing products (eg, cigarettes, e-cigarettes, vape pens, cigars) within 1 month of enrollment
10. Other exclusion criteria per protocol
Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

In this study, based on the conceptual framework of Pressure Injurie development, the risk factors for pressure injury in critically ill patients provided by the latest guidelines, and combined with the current relevant studies on mucosal pressure injury, we prospectively observed and collected clinical data related to tracheal intubation patients in the ICU, analyzed the risk factors for the occurrence of oral MPI, and established a risk prediction model to help clinical and nursing staff to detect and actively prevent oral MPI at an early stage The study aims to improve the quality of nursing management, enhance the level of nursing services and improve patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Duration of ICU admission ≥ 48h.

Exclusion Criteria:

1. radiotherapy oral mucositis;
2. Pressure injury to the mucosa, oral ulcers and erosions from other causes already present prior to tracheal intubation;
3. Patients undergoing oral surgery;
4. those who have been brought in from outside the hospital for \>48h for transoral tracheal intubation;
5. Common oral ulcers (not pressure/friction generated).
Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study

The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).

By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;
* Within 48 hours of onset of fever and rash symptom.
* Age of 1-13 years.
* Documented body temperature 37.4 °C-39.0°C
* Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

* Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.
* With history of allergies on traditional Chinese medicine.
* Attending other clinical studies on HFMD after diagnosed.
Cardiac MRI for Detection of Acute and Chronic Cardiac Involvement in Patients With Epilepsy

The aim of the study is to use multiparametric cardiac MRI to identify any abnormalities in myocardial structure and function in patients with epilepsy. A two-stage study design is planned as part of the study:

1. In the acute setting, cardiac MRI will be performed in patients before and after a tonic-clonic seizure and compared intraindividually. In this study arm, potential acute seizure-induced myocardial damage will be detected.
2. In the chronic setting, cardiac MRI will be performed in patients with known chronic epilepsy during the seizure-free interval to detect potential chronic myocardial damage (myocardial fibrosis) and compared with a control population. Within the group of epilepsy patients, possible associations with various epilepsy-specific characteristics (e.g., form, cause, onset, duration, and severity of epilepsy) will be investigated.


Eligibility Criteria:
Inclusion criteria:

1. diagnosed epilepsy
2. examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-EEG recording)
3. age between 18-60 years

Exclusion criteria:

1. underlying cardiac disease, e.g. coronary artery disease, previous myocardial infarction, previous myocarditis, complex congenital heart defect, known cardiomyopathy of other cause
2. pregnant and breastfeeding women
3. patients who use IUD for contraception
4. patients with a contraindication to contrast enhanced MRI