cyrilzakka/clinical-trials huggingface dataset:
SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer

This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A\*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.


Eligibility Criteria:
Key Inclusion Criteria

* Age ≥18 and \<75 years
* Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by histology cytology.
* Checkpoint inhibitor naïve and indicated for pembrolizumab or currently receiving pembrolizumab (monotherapy). May have received prior platinum containing chemotherapy regimen or checkpoint inhibitor therapy.
* Subjects that have already received pembrolizumab (alone or in combination) and are progressing or have completed immune checkpoint inhibitor therapy for recurrent/metastatic disease, may still be enrolled and will skip Part A of the study.

These subjects will enroll into Part B when manufactured T cells are available.

* Measurable disease according to RECIST v1.1.
* HLA-A\*02 positive by central laboratory.
* Tumor shows MAGE-A4 expression confirmed by central laboratory.
* ECOG Performance Status of 0 or 1.
* Left ventricular ejection fraction (LVEF) ≥50%.

Note: other protocol defined Inclusion criteria may apply

Key Exclusion Criteria:

* Positive for any HLA-A\*02 allele other than: one of the inclusion alleles, HLA- A\*02:07P or HLA-A\*02 null alleles
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study or history of severe hypersensitivity to another monoclonal antibody.
* History of autoimmune or immune mediated disease
* Leptomeningeal disease, carcinomatous meningitis or CNS metastases.
* Other prior malignancy that is not considered by the Investigator to be in complete remission
* Clinically significant cardiovascular disease
* Uncontrolled intercurrent illness
* Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
* Pregnant or breastfeeding

Note: other protocol defined Exclusion criteria may apply.
Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases

Coronavirus 2019 (COVID-19) infection is associated with higher morbidity and mortality in adult patients on dialysis, and kidney transplant recipients (KTRs). Although children had lower morbidity and mortality, KTRs are more vulnerable than healthy children.

It has already known that the general immune responses to vaccines, which are currently in practice (attenuated, conjugated, or recombinant) were lower than healthy controls in children and adolescents on dialysis and with a kidney transplantation. Uremic milieu and immunosuppressive drugs are the factors causing impaired immune response in this group of patients. The new mRNA vaccine technology is used worldwide including children and adolescents during the pandemic. Studies have demonstrated lower immune response to new SARS-CoV-2 mRNA vaccine in adult KTRs. However, there is limited data about vaccine-induced immune response in children and adolescent with renal replacement therapy.

The aim of this study was to assess immune response to SARS-CoV-2 mRNA BNT162b2 and its clinical and laboratory correlates in children and adolescent KTRs. Humoral immune response was assessed by anti-SARS-CoV-2 immunoglobulin G (Anti-S IgG) and its clinical correlate neutralizing antibody (nAb). Cellular immune response was assessed with SARS-CoV-2 specific Interferon ɣ release assay (IGRA).

This is a prospective, multicenter case-control study performed between September 2021 and March 2022 in the Pediatric Nephrology Units of IU- Cerrahpaşa School of Medicine, Memorial Hospital, Marmara University School of Medicine, IU- Istanbul School of Medicine, Medeniyet University School of Medicine, and Istinye University School of Medicine. The control group has consisted of age and gender comparable 19 healthy children without any acute infection or chronic disease, who were admitted to Cerrahpasa School of Medicine, Pediatric out-patient unit for routine control.

When permitted by local guidelines, children and adolescents who were over 12 years old were notified of vaccine eligibility and encouraged to schedule an appointment. The SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) administered to all participants by intramuscular route in the deltoid region. At least one month after the second dose of the vaccine, serum samples and whole blood samples were collected from all patients and controls, to analyze the humoral and cellular immune response to the vaccine. All samples were stored at -20 ◦C until testing. SARS-CoV-2 PCR test results were recorded retrospectively to determine natural infection.

Eligibility Criteria:
Inclusion Criteria:

* 12-21 year-old chronic kidney diseases and dialysis patients

Exclusion Criteria:

* Patients with primary immune deficiencies and not vaccinated with SARS-CoV-2 mRNA BNT162b2 vaccine
* Patients who did not completed 2 series of SARS-CoV-2 mRNA BNT162b2 vaccine
First Safety Study in Humans of a Single Dose of CPG 52364

Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.


Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index and weight
* No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram

Exclusion Criteria:

* Current illness or history of medical condition affecting the body's function
* Use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days
* Use of any medications during the study
* Positive TB test
* Smoking within 6 months
* Pregnancy or risk of Pregnancy
* Alcohol or drug misuse within 60 days
* Sensitivity to quinazolines
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors

This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9MW3811 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants between 18 and 75 years of age, inclusive.
2. Histologically or cytologically confirmed advanced malignant solid tumors, for which standard therapy does not exist or has proven ineffective or intolerable.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Participants must have measurable disease according to RECIST (version 1.1).
6. Adequate organ functions.
7. Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.

Exclusion Criteria:

1. Participants with cancerous meningitis and/or central nervous system metastases with clinical symptoms.
2. History of other active malignant tumor within 3 years prior to screening.
3. Suffering from poorly controlled body cavity effusion.
4. Suffering from active autoimmune disease.
5. History of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or other respiratory diseases that require hospitalization within 4 weeks prior to the first dose of study drug.
6. History of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
7. History of other severe or uncontrolled systemic disease, i.e. poorly controlled diabetes.
8. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
9. Major surgery within 28 days prior to the first dose of study drug.
10. Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody.
11. Participants who have received treatment with biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy within 2 weeks prior to the first dose of study drug; Radical radiotherapy received within 3 weeks or palliative radiotherapy received within 2 weeks prior to the first dose of study drug; Received treatment with chemotherapy within 3 weeks prior to the first dose of study drug (6 weeks for nitrosourea or mitomycin); Received treatment with oral fluorouracil or small molecule targeted drugs within 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is shorter); Received treatment with anti-tumor traditional Chinese medicine within 1 week prior to the first dose of study drug; Participated in other clinical trials within 4 weeks prior to the first dose of study drug.
12. Participants who have received systemic treatment with immunosuppressants within 2 weeks prior to the first dose of study drug.
Polycythemia Vera, Myelofibrosis and Essential Thrombocythemia: Identification of PV, MF & ET Genes

The purpose of this project is to find genes whose mutations cause Polycythemia Vera, Essential Thrombocythemia and Primary Myelofibrosis.

Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF), also known as the Philadelphia Chromosome negative myeloproliferative disorders (MPDs), are not congenital, but acquired. The purpose of this project is to find genes whose mutations cause these disorders, as well as improve diagnostic measures for these diseases. When this is accomplished new therapies to control and eventually cure the disease can be designed.

All subjects will be asked to donate 4-6 teaspoons of blood. On occasion, if the blood cells from a particular sample do not grow well and the DNA from that sample is used up or other tests are needed, we may ask to collect additional samples. In patients who have undergone a bone marrow biopsy as part of their clinical evaluation, we will test the reproducibility between pathologists for the revised 2008 WHO diagnostic criteria to diagnose myeloproliferative disorders (MPD).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with an elevated hemoglobin concentration (\>18 in males and \>16 in females) and who are suspected to have congenital or acquired primary polycythemia
2. Patients with a persistent thrombocytosis (\>400,000) that does not have an obvious secondary cause
3. Patients with a bone marrow biopsy that shows increased cellularity and fibrosis
4. Patients where there is clinical concern for primary myelofibrosis, such as anemia in combination with leukocytosis, thrombocytosis, splenomegaly and/or a leukoerythroblastic blood smear
5. Patients with thrombosis at unusual sites, such as Budd-Chiari syndrome, can have early PV before hemoglobin is elevated, these patients will also be included.

Exclusion Criteria:

1. Subjects who have a known acquired cause of polycythemia (increased hemoglobin/hematocrit) such as people living in high altitudes (in excess of 14,000 feet), subjects with heart disease, left to right heart shunt, severe hypoxia or severe pulmonary disease will be excluded from this study.
2. Subjects with a known acquired cause of thrombocytosis.
3. Subjects will be excluded if they cannot demonstrate decision making capacity sufficient to agree or decline the blood drawing or use of their blood for the study.
Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of chronic migraine meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.

Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited

Exclusion Criteria:

1. Women: Pregnant, lactating or \<6 months post partum
2. For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period.
3. For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
4. Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
5. A Beck Depression Inventory score of \>24 at baseline
6. Psychiatric disorders that could have interfered with study participation
7. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)
Flamenco Music Therapy in Pregnant

The use of music as a therapy for the psychological and emotional improvement of pregnant women has been well studied. Our hypothesis is that flamenco music can also involve psycho-emotional improvements in pregnant women

The objective of the study is to analyze the effects of a flamenco musical intervention on the stress and anxiety of pregnant women in five Management Units of the Sanitary District in Bahía de Cádiz-La Janda (Spain).

50 pregnant women will voluntarily participate in this study (25 in a control group and 25 in the experimental group) The psychological health assessment will be measured through the Perceived Stress Scale (PSS), the State-Trait Anxiety Inventory (S-STAI) and the Edinburgh Postnatal Depression Scale (EDPS) pre and post exposure.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer
* Single pregnancy
* Uncomplicated pregnancy,
* Expectations of vaginal delivery without complications
* Gestational age between 18 and 33 weeks,

Exclusion Criteria:

* Visual disorders
* Hearing disorcers
* Mental or cognitive disorders
* Difficulties in pregnancy,
* Medical complications,
* Smoker during the gestation period
Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts

The efficacy of traditional therapeutic approaches for aneurysmal bone cysts (ABC), such as surgery, embolization, sclerotherapy and radiotherapy, are often compromised for lesions in axial skeletons and adolescents complicated with pathological fracture. Therefore, denosumab, a new drug that has been successfully used in giant cell tumor of bone but has seldom used in ABC, was used to treat ABC in this trial.

Patients with primary ABC treated with perioperative denosumab in the Musculoskeletal Tumor Center of Peking University People's Hospital between January 2014 and December 2016 will be reported in this trial.Approved by the Ethics Committee of Peking University People's Hospital and with the full informed consent from the patients or their families, all patients received surgery and treatment with denosumab perioperatively. Denosumab 120 mg was given subcutaneously (abdomen wall or upper arms) every 4 weeks (Q4W), with a loading dose on both Day 8 and Day 15 of the first cycle. Meanwhile, all patients were suggested to take 800mg oral calcium supplement every day and avoid any dental or oral surgery (tooth extraction, tooth filling, etc.). Patients were followed once a month since the date of surgery. On follow-up visits, patient-reported adverse reactions, X-ray image of jawbone, serum calcium, alkaline phosphatase, renal and hepatic function, hemoglobin, white blood cell, and platelet count were collected, and histological examinations, radiological examinations (such as X-ray, computed tomography (CT), magnetic resonance image (MRI) and positron emission tomography-computed tomography (PET-CT) and postoperative functional status evaluations by MSTS（Musculoskeletal tumor society） score were conducted.

Eligibility Criteria:
Inclusion Criteria:

1. pathologically diagnosed with primary aneurysmal bone cyst
2. lesions in axial skeletons (i.e. spine, pelvis) which are difficult to reach a satisfactory surgical margin, and surgery can lead to very high incidence of complications.
3. pathological fracture
4. recurrence cases

Exclusion Criteria:

1. metastases or multi-focal lesions
2. malignancy
A Single Group Study to Evaluate the Effects of a Supplement on Premenstrual Syndrome

This is a virtual single-group study that will last three menstrual cycles (approximately 12 weeks). During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating. For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle. Questionnaires will be completed at the following time points:

* Baseline
* Day 7 of their first cycle during the trial (After using the product PRN during their period)
* 4 days before their second period during the trial (After using the product PRN for the previous month)
* Day 3 of their second period during the trial (After using the product for 7 days straight)
* Day 3 of their third period of the trial (After using the product for 7 days straight)


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18-40
* Self-reported moderate discomfort during menstruation related to pelvic cramps, bloating, fatigue, or mood swings.
* Self-reported symptoms during their menstrual cycle with gas, heartburn, and acid reflux
* Generally healthy - don't live with any uncontrolled chronic disease
* Has a menstrual cycle between 21 and 35 days in length
* Able to predict their menstrual cycle and timing of their menstruation

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Current use of any blood thinning medication
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding, or attempting to become pregnant
* Unwilling to follow the study protocol.
* Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system? e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
* Anyone currently on hormonal birth control, or has been on hormonal birth control in the last 3 months
Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder

The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* subacromial bursitis
* tendinitis
* Calcific Tendonitis

Exclusion Criteria:

* rotator cuff tear
* osteoarthritis
* pregnancy
* local or systemic infection
* steroid or lidocaine sensitivity
Laparoscopic Complete Mesocolic Excision on Colon Cancer

Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically confirmed colon cancer
* Signed consent

Exclusion Criteria:

* History of malignancy
* Intestinal obstruction or perforation
* Evidence of metastasis by preoperative examinations
* Deformity of spine
* Emergency case
* BMI \> 29
Molecular Analysis of Thrombocytopenia and Cancer (MATAC): Investigating Antigenic Mimicry Between Platelets and Tumor Cells in Patients With Immune Thrombocytopenia (ITP) Associated With Cancer

The association between hematologic malignancies and ITP is well described, but this link is much less clear with solid cancers. In cases of ITP associated with cancers, specific cancer treatment can lead to remission or even cure of ITP. Thus, our hypothesis was that chronic expression of GPIIB by tumor cells could have initiated an autoimmune loop against GPIIB, leading to the onset and perpetuation of ITP.

Autoimmune thrombocytopenia, also known as immune thrombocytopenic purpura (ITP), is a rare autoimmune disease characterized by platelet destruction and impaired production, posing a life-threatening risk due to bleeding complications. The pathophysiology of ITP involves complex mechanisms, including both defective platelet production and auto-reactivity of B and T lymphocytes leading to the production of autoantibodies against platelets, found in 35 to 55% of cases. Additionally, in the context of neoplasia, some patients may develop varying degrees of thrombocytopenia, exacerbating morbidity and mortality. A multicenter, retrospective study will collect data from routine care, including birth date, gender, biological parameters related to ITP, dates of treatment initiation and diagnosis of ITP and cancer, types of treatments, and outcomes such as survival or death, without additional medical interventions or appointments.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a definite diagnosis of both ITP and cancer;
* Synchronous diagnosis of ITP and cancer;
* Onset of ITP occurring 6 months before or after the diagnosis of cancer.

Exclusion Criteria:

* None
High Fresh Gas Flow After Intubation

Atelectasis is common during and after general anesthesia. Atelectasis develops early if preoxygenation with 100% oxygen is used and continuously used during induction until endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation maneuver immediately after confirming a successful intubation, reduces the area of atelectasis as investigated by computed tomography compared to a standard procedure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients, American Society of Anesthesiology (ASA) I-II
* Patients scheduled for orthopaedic day case surgery in general anaesthesia

Exclusion Criteria:

* ASA class III or higher
* Body Mass Index (BMI) 30 or higher
* Arterial oxygen saturation (SpO2) \<94% breathing air
* Chronic Obstructive Pulmonary Disease (COPD)
* Ischemic heart disease
* Haemoglobin \<100g/L
* Known or anticipated difficult airway and/or intubation
* Active smokers and ex-smokers with a history of more than 6 pack years
* Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis