cyrilzakka/clinical-trials huggingface dataset:
Adaptive Immune Response to COVID-19 Vaccination

AICOVI (Adaptive Immune Response to COVID-19 Vaccination) is a prospective clinical cohort study aiming at studying the kinetics of vaccine-specific antibody production after COVID-19 vaccination in health care workers.

AICOVI (Adaptive Immune Response to COVID-19 Vaccination) is a prospective clinical cohort study aiming at elucidating the kinetics of vaccine-specific antibody production after COVID-19 vaccination in health care workers at the Greifswald University hospital.

Participants were recruited before their intended vaccination. Participants received the basic immunization with either two i. m. doses of BNT162b2 (Comirnaty®, tozinameran (INN), BioNTech/Pfizer) with a time interval of 21 days or two i. m. dose of AZD 1222 (Vaxzevria®, Covishield®, ChadOx1 nCoV-19, Oxford University/Astra-Zeneca) with a time interval of 12 weeks (homologous vaccination), or one i. m. dose of AZD 1222 as the first vaccination and one i. m. dose of BNT162b2 or mRNA-1273 (Spikevax®, elasomeran (INN), Moderna) as the second vaccination with a time interval of at least 4 weeks (heterologous vaccination). Approximately 6 months later, participants received a booster vaccination with BNT162b2.

Within the study, volunteers donate peripheral blood by venipuncture on each day of vaccination as well as 7 and 14 days after each vaccination. EDTA plasma and peripheral mononuclear cells (PBMCs) are prepared and stored at -20 °C.

Volunteers are also asked to complete a standardized questionnaire on each day of blood sampling. Questionnaires collect data about physical characteristics, COVID-19 vaccination, previous SARS-CoV-2 infection as well as current infections, medication, immune relevant diseases and side effects of the vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Planned participation in COVID-19 vaccination
* Completion of the 18th year of life
* verbal and written consent given

Exclusion Criteria:

* current infectious diseases
* underweight (BMI\<18,5)
* blood coagulation disorders, anemia or similar diseases
* known congenital or acquired immunodeficiencies

Inclusion criteria for control/validation group of TRP participants:

* informed written consent
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)

The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

The duration of treatment is 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery).
* Patient is scheduled to receive general anesthesia.
* Patient is scheduled to receive postoperative medication.
Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry for Off-Label Transplant Use of Plerixafor

Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of plerixafor will be collected for data entered over a 5 year time span (i.e., data entered into the registry between the date of European Union (EU) marketing authorization \[31 July 2009\] and 31 July 2014).

The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database.

The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor shall provide information of a substantial number of patients who are representative of the patient population receiving plerixafor off-label.


Eligibility Criteria:
Inclusion Criteria: Patients treated with plerixafor who have 1 or more of the following:

* Background disease other than lymphoma or multiple myeloma (MM)
* Are younger than 18 years of age.
* Received transplant using ex vivo plerixafor-mobilised cells (umbilical cord cell, peripheral blood (PB), bone marrow (BM) cell collection)
* Received treatment with plerixafor alone (i.e., without granulocyte colony stimulating factor (G-CSF))
* Contraindication for G-CSF
* Transplants using plerixafor-mobilised cells from allogeneic donor
* Received transplant using plerixafor-mobilised bone marrow cells
* Routes of plerixafor administration other than subcutaneous
* Patients whose cells do not mobilize poorly
* Other

Exclusion Criteria:

* Adults diagnosed with lymphoma or multiple myeloma (MM) and have been treated with plerixafor according to the European Union (EU) label.
A Study Evaluating AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Solid Tumors

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age at the time consent is signed.
* Has adequate end organ function per laboratory testing.
* Pregnancy prevention requirements
* Has measurable disease per RECIST 1.1 as assessed by the local site Investigator/radiology.
* Has a performance status of 0 or 1 on Eastern Cooperative Oncology Group scale.
* Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts

Exclusion Criteria:

* Has a diagnosis of immunodeficiency.
* Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years.
* Has known active CNS metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has an active infection requiring systemic therapy.
* Inability to comply with study and follow-up procedures.
* Has had a severe hypersensitivity reaction (Grade ≥3) to treatment with pembrolizumab, another monoclonal antibody, or has history of any hypersensitivity to any components of the study treatments or any of their excipients.
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks (or, if shorter, within 5 half-lives for kinase inhibitors) prior to first dose of study treatment.
* Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis.
* Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
* Has received previous treatment with another agent targeting the IL-2, IL-7, or IL-15 receptors.
* Is expected to require any other form of antineoplastic therapy while on study
Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea in Patients Requiring Anterior Lamellar Keratoplasty

In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating networks of recombinant human type III collagen and synthetic phospholipid - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection, trauma or keratoconus. Control group will consist of patients with the same condition who will undergo corneal transplantation - current standard of care.

Recently developed and passed extensive pre-clinical testing collagen-phosphorylcholine(RHCIII-MPC) corneal substitute will be implanted in patient's corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of cornea is removed, either manually or with assistance of femtosecond laser, it will be substituted with proposed transparent implant. Control patients with same condition will be grafted with human donor cornea using the same surgical technique.

The investigators will test the safety and the effectiveness of developed biosynthetic corneas. Overall 20 patients are planned to recruit. They will be randomized in two groups - 10 patients will undergo RHCIII-MPC cornea implantation, another 10 will be impanted with human donor cornea. The patients will be follow-uped for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must sign and be given a copy of the written Informed Consent form.
* Subjects with best corrected distance visual acuity +1.0 LogMAR or worse as a result of corneal scar due to infection, injury or keratoconus in the operative eye.
* Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

Exclusion Criteria:

* Subjects with severe or life-threatening systemic disease.
* Subjects with uncontrolled hypertension.
* Subjects with uncontrolled diabetes or insulin-dependent diabetes.
* Subjects with glaucoma in either eye.
* Subjects with marked microphthalmos or aniridia in either eye.
* Subjects with any other serious ocular pathology, serious ocular complications at the time of surgery underlying serious medical conditions, based on the investigator's medical judgment.
* Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.
Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing

Breast cancer is the most common malignancy among women worldwide. For early stage breast cancer, adjuvant radiotherapy is essential to minimize loco-regional disease recurrence. However, significant portions of the heart and the lungs are exposed to low dose radiation during radiotherapy, which result in stochastic side effects among breast cancer survivors. Inspired by 3D printing technology, we approached this issue with an in-house made PERSonalized BReAst holder system (PERSBRA). PERSBRA is composed of a 3D-printed plastic holder covering the whole breast and an air-filled interface. Its main function is to reproducibly adjust the breast position to decrease heart and lung radiation exposure in tangential fields. Here we propose to measure the performance of PERSBR in terms of radiation dosimetry in 50 patients receiving scheduled whole breast irradiation. For customized PERSBRA, body shape of the patient with or without a bustier corset will be captured with a handheld 3D scanner and input into a 3D printer for PERSBRA design and manufacturing. A participant will receive two more CT scans in addition to the simulation scan with PERSBRA in place before the first and the sixth fractions of irradiation. These images will be analyzed for dosimetric parameters in the presence/absence of PERSBRA as well as position reproducibility. The data will provide proof-of-principle evidence for the clinical utility of PERSBRA and will facilitate its further refinement.

1. Patients with early breast cancer or ductal carcinoma in situ treated with breast conservation surgery.
2. Adjuvant radiotherapy to the breast is part of the patient's initial treatment plan.
3. Non-contrast CT scan is a routine procedure for the patient's radiotherapy treatment planning.

Eligibility Criteria:
Inclusion Criteria:

* Patients with early breast cancer or carcinoma in situ after partial mastectomy have decided to receive adjuvant radiation therapy for the breast on the affected side, and use non-contrast computed tomography to obtain localized images is part of the original treatment plan.

Exclusion Criteria:

* Clinical diagnosis or pathological diagnosis has lymph node metastasis, lymph node micrometastasis, or lymph node tumor cells.
* The clinical diagnosis is likely to have metastatic cancer.
* Pregnant women.
* Be younger than 20 years old.
* The subject was unable to read and understand the subject consent form written in Chinese and complete the informed consent procedure.
Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean

Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly effective, their use is not without problems. One is the increasing requirement of these address the same nociceptive stimulus.

Opioid induced hyperalgesia could be an explanation studies in animal models. Through mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and changes in intracellular calcium regulation involved.

The hyperalgesia induced by intrathecal opioids is controversial. The investigators propose a model study in patients undergoing cesarean section to study the secondary hyperalgesia induced based on the study of nociceptive thresholds with two methods opioids: Von Frey filaments and digital algometer.

If intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an increase in sensitivity will occur. This increase can be measured by von Frey filaments, expressed in increased requirement clinically opioids.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant 37 to 41 weeks.
* American Society of Anesthesiologists classificationI or II.
* Between 18 and 40 years.
* Scheduled for elective cesarean section under spinal anesthesia in the Maternity Service of the Clinical Hospital of the Catholic University.

Exclusion Criteria:

* Background Of high risk pregnancy. Twin-pregnancy.
* Obesity\> 30 kg / m 2 before pregnancy.
* Background Of psychiatric illness.
* Using Chronic analgesic.
* AllergyDrug used in protocol.
* require General anesthesia during surgery
Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound

To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.

Objectives:

1. To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.
2. To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure.

Methods:

1. The study design is prospective observational study.
2. We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured.
3. The data will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for cardiac surgery
* need central venous catheterization intraoperatively
* elective surgery
* age \> 18

Exclusion Criteria:

* neck pathology
* history of internal jugular or SVC thrombosis
* limited neck mobility
* severe valvular lesion
* decompensated heart failure
Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport

The purpose of the study is to assess the usability and tolerability of this jugular vein compression device in a population of helmeted and non-helmeted competitive high school, collegiate and professional athletes in the sports of football and rugby. This study differs from previous work in that it is designed to capture additional data related to the athlete experience wearing the jugular vein compression device in older and more elite playing levels.

Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs incurred for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Sports Science, LLC (Q30). Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities. Regarding safety, the externally worn collar is meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn or the mere act of just lying down. This study will investigate the tolerability of this device in athletes participating in the competitive sports of football and rugby at the high school, collegiate or professional levels.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteer
* Able to provide written consent
* Must be 14 years or older and a participant in collegiate/professional sports of football or rugby

Exclusion Criteria:

* Unable to provide written consent
* History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
* Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
* Glaucoma (Narrow Angle or Normal Tension)
* Hydrocephalus
* Recent penetrating brain trauma (within 6 months)
* Known carotid hypersensitivity
* Known increased intracranial pressure
* Central vein thrombosis
* Any known airway obstruction
* Any known seizure disorder
Effect of Smartphone Overuse on Hand Strength and Function in Physical Therapy Students

The present study aimed to measure wrist flexor and extensor muscle strength, hand grip strength, wrist pain and function in smartphone addicts and non-addicts

Smartphones have become ubiquitous worldwide, offering significant potential for medical applications by providing healthcare professionals and students with instant access to resources for informed decision-making. However, despite their benefits, overuse of smartphones can lead to physical health issues. Grip strength is recognized as an indicator of overall muscle strength, upper limb function, and various health conditions. Isokinetic testing, a reliable method for measuring muscle performance, has been widely used in studying low back pain but less commonly applied to wrist strength assessment.

Currently, there is a lack of evidence regarding the impact of smartphone overuse on wrist flexor and extensor peak torque, handgrip strength, and function. This research aims to investigate these aspects, providing insights into upper extremity function and potentially aiding ergonomists in addressing musculoskeletal disorders. The study's findings could contribute to the biomechanical evaluation and design of upper extremity tasks, enhance understanding of wrist functioning, and inform ergonomic design considerations. Additionally, the results may help smartphone users adopt better postures and grasping techniques to minimize injuries and maintain hand function, ultimately improving their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age of subjects 18 to 25 years.
* Body mass index from 18, but less than 25 kg/m2.
* Experimental group, healthy subjects who are smartphone users for at least two years prior to study.

Exclusion Criteria:

* Subjects with a history of neurological disorder affecting the upper extremities, vestibular dysfunction, or balance disorder.
* Deformities of elbow or hand.
* Any recent upper limb fracture or trauma.
* Disorders like carpal tunnel syndrome, radiculopathy or tendinopathy.
* Individuals going to the gym or athletes.
* Individuals who smoke.
* Subjects who had cognitive, linguistic or vision impairment which limited their use of instruments and questionnaire.
Postpartum Intra-caesarean Intrauterine Device Insertion Using a Novel Technique

The assessment of efficacy and patient safety of immediate postpartum IUD insertion using a novel technique.

The postpartum period is so critical time for both the mother and newborn that needs special health care because there are high morbidity and mortality rates during it (1).

The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes (2, 3).

A woman's fertility may begin to return rapidly and ovulate within 4:6 weeks postpartum particularly if she is not exclusively breastfeeding. In addition , more than 50% of women become sexually active by 6 weeks postpartum (4, 5).

So, it is important to provide highly effective contraception immediately after delivery before leaving the delivery setting especially in communities where women cannot return easily for follow up visits due to financial and social barriers or who have limited access to medical service (6, 7).

The use of effective postpartum contraception particularly longـacting reversible contraception (LARC) methods like the intrauterine device (IUD) has been shown to decrease the risk of unintended pregnancy and its complications and avoid repeated caesarean sections with higher continuation rates of use than other methods 6 months after delivery (8-10).

Immediate post placental intraـcaesarean IUD insertion has many advantages as it is effective reversible longـterm contraception, doesn't interfere with breastfeeding, is coitus independent and the woman can avoid discomfort and pain during the standard insertion and bleeding from insertion will be masked by lochia (11-14).

Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery (15, 16).

By using a novel technique in this study, these complications would be decreased.

Eligibility Criteria:
Inclusion Criteria:

1. Women admitted to undergo CS.
2. Singleton pregnancy.
3. Delivery of a liveـborn infant with gestational age \< 36 weeks.
4. Informed and written consent to participate in the study.

Exclusion Criteria:

1. History of dysmenorrhea, menorrhagia or coagulopathies.
2. Uterine anomalies or fibroids.
3. Antepartum or intrapartum hemorrhage.
4. Prolonged rupture of membranes \<24 hours with or without chorioamnionitis.
5. Intrapartum fever.
6. History of current, recent (within previous 3 months) or recurrent pelvic infilammatory diseases (PID).
7. History of ectopic pregnancy.
8. Multiple pregnancy.
9. Active cervicitis, vaginitis or sexual transmitted diseases (STD) on gyaecological examination.
10. Allergy to any component of the IUD or Wilson's disease.