cyrilzakka/clinical-trials huggingface dataset:
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented squamous NSCLC.
* Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved targeted 1L therapies.
* Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
* Adequate organ and bone marrow function.

Exclusion Criteria:

* Presence of small cell and neuroendocrine histology components.
* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
* Any prior systemic therapy received for advanced or mNSCLC.
* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.
Medical Students and Risk of COVID-19 Infection

This study aims to estimate the prevalence of infected medical students with COVID-19 in the University of Jordan and to compare number of cases between students in clinical and basic years. In addition, this can provide insight into the awareness of infection control practices among students. Furthermore, to examine if hospital rotations increased risk of infection between clinical year medical students.


Eligibility Criteria:
Inclusion Criteria:

All medical Students

-

Exclusion Criteria:

* none
Effects of Smoking on Placenta and Lactation

Maternal smoking during pregnancy although it is known to be associated with fetal growth restriction, it's effect on postpartum breastfeeding is not yet clear. The aim of the present study was to examine the impacts of smoking in pregnancy on breastfeeding as well as its impacts on placental immunoreactivity.

The study was conducted on 70 women who gave birth via spontaneous vaginal delivery. Groups were classified as Smokers (n=35) and Non-smokers (n=35). The breastfeeding conditions of both groups were evaluated prior to discharge and after postpartum 10th day.

Cross-sections were taken from the placenta tissues after which their IGF-1 (insulin like growth factor-1), Leptin, HPL (human placental lactogen) immunoreactivities were examined.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who have started smoking at least 100 cigarettes in her lifetime and who now smokes every day,
* Pregnant women who have never smoked throughout their life, including pregnancy(16),
* Pregnant women who gave birth at term,
* Multiple pregnancy, preeclampsia, gestational diabetes, thyroid dysfunction, those who do not have a systemic disease and due to systemic disease during pregnancy those who do not use
* Pregnant women who had spontaneous vaginal delivery,
* In order not to encounter communication barriers and because cultural differences may vary, the pregnant woman is not a foreign national,
* Pregnant women who do not have any barriers to communication by phone,
* Those who do not have any health problems that prevent breastfeeding

Exclusion Criteria:

* multiple pregnancy
* insulin dependent diabetes
* pregnant women who have had a cesarean section
* preeclampsia
* thyroid disease
Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

Peri-implantitis is an inflammatory disease that leads to loss of jawbone around dental implants. Recent discoveries have identified increased release of Titanium (Ti) particles around implants as being associated to peri-implantitis. In this ancillary study to the Dental Hygiene and Peri-Implant Tissues Homeostasis trial the objective is to determine potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. Results from this study will determine whether there is a differential response to Ti particles across individuals, which may alter susceptibility to peri-implantitis.


Eligibility Criteria:
Inclusion Criteria:

* Is the subject ≥ 25 years of age?
* Does the subject have an implant with a probing depth ≥ 5mm, bleeding on probing, and radiographic bone loss of \> 2mm?
* Is the subject committed to the study and the required follow-up visits?

Exclusion Criteria:

- Is the subject immune compromised? Is the subject diabetic? Does the subject take steroid medication? Does the subject regularly use non-steroidal anti-inflammatories? Is the subject pregnant or intending to become pregnant during the duration of the study? Has the subject had previous implantoplasty? Did the subject take any antibiotics in the last 3 months?
A Prospective Study of NuCel® in Cervical Spine Fusion

The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.

The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine. Sixty subjects will participate in the study at a single clinical site. Participants will be at least 21 years of age. All subjects will have been established with cervical spine disease at one, two or three levels of the cervical spine that requires cervical interbody fusion per the opinion of the treating surgeon. The primary objective is to demonstrate that NuCel® is comparable to autograft bone graft in producing a successful, contiguous fusion at 6 months ±4 weeks post-operative when used in cervical fusion surgery. Success based on findings of cervical CT scan and plain radiographs. Additionally, Visual Analog Scale (VAS), Neck Disability Index (NDI) and patient satisfaction will be used as secondary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 21 years of age
2. Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
3. In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
4. Be likely to return for regular follow-ups until the end of the study period.
5. Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria:

1. Neck pain due to acute trauma.
2. Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).
3. Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
4. Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
5. Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
6. Currently a prisoner.
7. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
8. Pregnancy at the time of enrollment.
9. In order to confirm eligibility, subjects previously diagnosed with osteoporosis, osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal female subjects under the age of 65 with any of the risk factors for osteoporosis, and subjects at the investigator's discretion will have DEXA scans performed prior to study entry. If DEXA is required, exclusion will be defined as a DEXA bone density measurement T score ≤ -2.5
Predicting Peanut Anaphylaxis and Reducing Epinephrine

This research study is testing a new way to look for the early stages of anaphylaxis. Eligible participants will have a small monitor (transepidermal water loss) placed on the forearm during a food challenge (for peanut allergies). This monitor continuously records the amount of water lost through the skin.

In a previous study the team learned what values are associated with an anaphylactic reaction. These values are called "stopping rules." This study is looking at whether it can use these new stopping rules to end the oral food challenge before a person may show any symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Have a known history of food anaphylaxis to peanut confirmed by an allergist
* Have had skin and blood food allergy testing to peanut within the past 12 months. Meet the 80% likelihood positive predictive value threshold for peanut allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests per current literature corrected for age.
* Meet all clinical oral food challenge (OFC) requirements. This includes no asthma or atopic dermatitis exacerbations, no recent viral infections, no recent antibiotics, and no food allergy reactions in the past month.

Exclusion Criteria:

* Any known cardiovascular disease, cancer, pulmonary disease except well-controlled asthma, or other condition that would preclude an OFC otherwise.
* Any medication use that would interfere with an OFC result. Medications in this category include antihistamines (first or second generation) within 1 week, omalizumab within 3 months, and others listed in the protocol appendix.
* Any skin condition aside from well-controlled eczema that might impact TEWL measurement, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes.
Energy Expenditure

The purpose of this study is to standardize methods in measuring a person's energy expenditure. These methods may be used in a larger study in the future.


Eligibility Criteria:
Inclusion Criteria:

* adults must be 18 years of age or older
* children must be between 6 and 88 pounds

Exclusion Criteria:

* pulmonary or respiratory disorders
Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis

This is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in healthy subjects and patients with moderate to severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
* Body mass index (BMI) ranges from 18.0 to 26.0 kg/m2 (including boundary values).

Exclusion Criteria:

* Have participated in any clinical trials of drugs or medical devices within 3 months before the screening.
* Have severe infections, severe injuries, or undergone major surgical procedures within 3 months before screening.
* Have lost more than 400 mL of blood due to blood donation or other reasons within 3 months before screening.
* Positive drug abuse test or positive alcohol breath test result.
ROTEM® Obstetric Hemorrhage Pilot Study

This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor \&Delivery in spontaneous labor, for induction of labor, or for scheduled cesarean section.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and able to provide consent
2. Gestational age ≥ 34 weeks
3. ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:

   1. Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score \<5)
   2. Prior uterine surgery (\> 1 prior cesarean or myomectomy)
   3. Patients undergoing trial of labor after cesarean delivery
   4. History of postpartum hemorrhage
   5. ≥4 previous vaginal deliveries
   6. Multiple gestation
   7. The presence of \> 2 uterine fibroids or fibroid \> 5 cm on any ultrasound during the pregnancy
   8. Planned magnesium sulfate use
   9. Placenta previa/accreta/increta/percreta

Exclusion Criteria:

1. Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion)
2. Antepartum hemorrhage present on admission (\>500cc Estimated Blood Loss (EBL))
3. Coagulation defects
4. Thrombocytopenia with platelets count \<100,000
5. Enrolled in the "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA)" (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior to enrollment.
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease

This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.

Secondary objectives include:

* to characterize progression-free survival
* to characterize time to progression
* to determine response duration
* to characterize the effect of study drug on health-related quality of life
* to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population
* to characterize the immunogenicity response of MDX-060
* to characterize the safety of MDX-060, and
* to characterize the pharmacokinetic profile of MDX-060

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hodgkin's disease \[HD\] (excluding HIV-associated HD)
* Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
* Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
* ECOG Performance Status of 0-2
* Patients must have bi-measurable disease
* At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
* Life expectancy 12 weeks or greater
* Screening laboratory values must be met
* Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.

Exclusion Criteria:

* Previous treatment with any anti-CD30 antibody
* History of allogeneic transplant
* Any tumor lesion 10cm or greater in diameter
* Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
* Any significant active or chronic infection
* Apparent active or latent tuberculosis (TB) infection
* Patients who are pregnant or nursing
* Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
* Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy
CB-PRP in Retinitis Pigmentosa and Dry Age-related Macular Degeneration

The study will provides the enrollment of patients with genetic retinal dystrophies with primary rod impairment and dry age-related macular degeneration (Geographic type) A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group.

A complete morpho-functional ophthalmological evaluation will be performed in all patients at each control.

All patients underwent genetic evaluation and they reported different types of mutations that induce anatomic-functional impairment of the rods.

Patients affected by bilateral dry age-related macular degeneration (Geographic type) will be recruited as well.

After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) provided by the Umbilical Cord Bank according to the procedures provided for by the current legislation on blood components for non-transfusion use.

A complete ophthalmological examination will be performed at 1, 3, 6, and 12 months. They will include:

* Anterior segment biomicroscopy
* direct and indirect ophthalmoscopy
* ETDRS visual acuity assessment
* intraocular pressure measurement
* optical coherence tomography (OCT)
* OCT Angiography (OCTA)

The following assessments will be performed at baseline and at 6 and 12 months.

* Microperimetry
* Electroretinogram (ERG)
* Visually evoked potential (VEP)
* contrast sensitivity (MARS tables)
* Goldmann perimetry

Some morpho-functional data will also be collected in the contralateral eye and used as the control group.

To ensure the best safety for the patient, the first 5 eyes will be separated by a minimum of 20 days in order to observe the post-surgical evolution.

Eligibility Criteria:
Inclusion Criteria:

* Retinal dystrophies with compromised rods (only for RP patients)
* Visual Field (Manual Goldmann) V / 4e \< 30 ° (only for RP patients)
* Best corrected visual acuity \> Light perception
* Known genotype
* No or minimal opacity of ocular media
* No concomitant ocular (eg glaucoma, amblyopia)
* Dry Age-related Macular Degeneration (Geographic type)

Exclusion Criteria:

* Age\<18 years
* Pregnancy
* Previous inflammatory / infectious events involving the eyes
Treatment Results on Patients With Debridement and Prosthesis Retention in the Hip

This study presents the investigators results on patients treated for infection in the implemented hip prosthesis. Debridement and prosthesis retention is the method, followed by antibiotic treatment. The investigators present treatment results, predisposing factors and microbiological data.


Eligibility Criteria:
Inclusion Criteria:

* Infection in prothesis in hip treated with debridement and prosthesis retention

Exclusion Criteria:

* Other technique
A/H1N1 Immunogenicity and Safety in Adults

The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
* Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
* Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
* Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
* If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

* Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
* Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
* Subject has inherited or acquired immune deficiency
* Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
MBC Physical Activity Study

This clinical trial evaluates the impact of a tailored physical activity program on physical activity in patients with breast cancer that has spread from where it first started to other places in the body (metastatic). It has been shown that decreased physical activity contributes to poor performance and quality of life. Evidence has also shown that exercise could improve physical fitness, physical functioning, quality of life, and cancer-related fatigue, however, there is concern that it may not be available to those with physical limitations. The proposed physical activity program offers a comprehensive and individualized assessment for each metastatic breast cancer patient and includes a high quality, tailored exercise home-based program designed by an advanced qualified cancer exercise specialist. A tailored physical activity program may improve physical activity in metastatic breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 and older
* Able to read and speak English
* Diagnosed with metastatic breast cancer within 60 months of study enrollment
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
* Insufficiently inactive defined as answer "no" to screening question "On average, do you engage in at least 75 minutes a week of vigorous activity (like jogging) or at least 150 minutes a week of moderate activity (like a brisk walk)?"
* Able to comprehend and sign a written informed consent (no cognitive decline)
* Willing to comply with all study procedures and be available for the duration of the study through at least week 2 of 2Unstoppable
* Medically cleared by co-investigator or principal investigator (PI) to engage in aerobic and resistance exercise intervention
* Access to a smart device and have an active wi-fi connection at home

Exclusion Criteria:

* Severe or unstable cardiopulmonary, metabolic, or renal disease
* Unable to walk safely without physical assistance of another person or assistive device
* Any condition that may limit the ability to comply with behavioral and physical recommendations of the virtual exercise program
* Pregnancy