cyrilzakka/clinical-trials huggingface dataset:
Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies..


Eligibility Criteria:
Inclusion Criteria:

* Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed
* Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required):

  * At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Rechallenge with the same anti-PD-(L)1 for disease considered sensitive to anti-PD-(L)1 therapy (e.g. after a treatment break) is considered 1 line
  * Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received adjuvant platinum-based therapy meet this criterion if disease progression occurred within 6 months from the last dose that the participant received that therapy. No additional cytotoxic therapies after progression on platinum-based therapy are allowed
  * Prior best overall response of stable disease or better with anti-PD-(L)1 therapy
  * Disease progression must have occurred while the participant has been receiving anti-PD-(L)1 therapy or within 16 weeks of the last dose of anti-PD-(L)1 therapy
* Participants with Measurable disease per RECIST v1.1
* Participants with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1
* Adequate hematological, hepatic, and renal function as defined in the protocol.
* Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with tumors harboring actionable epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic aberrations. Participants with tumors with other actionable aberrations are eligible and allowed to have received up to 1 line of available targeted therapy
* Participants with history of additional malignancy within 3 years before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years
* Participants with known brain metastases, unless clinically stable
* Participant with history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease
* Other protocol defined exclusion criteria could apply
XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.

The secondary objectives are safety and pharmacokinetic interaction


Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer (MBC)
* HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
* Adequate organs functions

Exclusion Criteria:

* More than one previous chemotherapy regimen for metastatic disease
* Cardiac dysfunction
Morphine in Acute Abdominal Pain

The investigators primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group. After follow up information was obtained and patients data were recorded on the SPSS data chart, two blinded coauthors (general surgeon and emergency physician) determined the clinically important diagnostic accuracy and change in physical examination. They firstly defined clinically important diagnostic errors, as any disagreement between the preliminary and final diagnosis that might be expected to have adverse effect on the patient's general status. If coauthors decided an instance of diagnostic error as clinically important, this was coded "diagnostic discordance" for statistical analysis. While the preliminary diagnosis was determined as accurate or not different from the final diagnosis, this was coded "diagnostic accuracy" for statistical analysis. Secondary outcome measures included the need for rescue drugs at 30 minutes, the presence of at least one adverse event, demographic features and final diagnosis of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Elderly (65 years or older) patients with non-traumatic UAP of less than 48 hours' duration were included in the study. Participants were required to have a UAP and report either "mild" or greater pain intensity on a four-point verbal rating scale (VRS) or at least 20 mm on a 100 mm visual analogue scale (VAS).

Exclusion Criteria:

* Exclusion criteria included known allergy or contraindication to morphine, or any opioid analgesic
* Hemodynamic instability (systolic blood pressure less than 100 mm-Hg)
* Use of any analgesic within 6 hours before ED presentation
* Patients refused to participate to the study
* Incooperated to the VAS
* Isolated flank pain or previous study enrollment
* Patients with known renal, pulmonary, cardiac or hepatic failure were also excluded.
Accuracy and Reliability of Ultra Low Dose CBCT Versus CBCT Imaging in Semi-automated Segmentation of the Mandibular Condyle (A Diagnostic Accuracy Study)

The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine \& Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.

The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine \& Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.

R (Reference standard): Physical real linear measurements of the condyles will be considered as reference standard, where distances will be measured by digital caliper on the dry human in millimeters as supported by García-Sanz et al. (2017) \& (Kim et al., 2020).

Volumetric measurements form the dry human condyles will be considered as reference standard where water displacement method will be used (according to Archimedes' principle), by immersion of the condyle under investigation in a water filled graduated transparent glass container, after being hangered from a L-shaped metal hanger by using a rope, till the complete immersion of the condylar volume (which was demarcated by using the gutta percha points) under the water level, this will provide more standardization. Then, the displaced amount of water, will be observed and then aspirated by a graduated pipette to calculate its volume in cubic millimeters. This technique was supported by García-Sanz et al. (2017).

Eligibility Criteria:
Inclusion Criteria:

1. mandibles with sound condyles
2. skulls with sound glenoid fossa.

Exclusion Criteria:

1. skulls with fractured glenoid fossa,
2. glenoid fossa with developmental deformities,
3. mandibles with fractured condylar neck or head,
4. presence of pathological lesions,
5. fracture,
6. Shipping,
7. developmental deformities in the condyle.
Decision Aid Development for Smokers

A decision aid tool will be developed using participatory research approach. The decision aid will be targeted to cigarette smokers scheduled for elective surgery.


Eligibility Criteria:
Inclusion:

* Current cigarette smoker having elective surgery at Mayo Clinic Rochester and is scheduled to be seen at Preoperative Evaluation Center.
Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma

The purpose of this study is to define the mechanisms that underlie the refractory pruritus (itch) in Cutaneous T-Cell Lymphoma (CTCL).

Little is known about the fundamental cause of pruritus in CTCL, however we do know the malignant CD4+ T-cells of CTCL accumulate in the epidermis and are in close proximity to the neural, immune and vascular systems that influence and regulate the biology of the skin. The close proximity of malignant CD4+ T-cells with the key mediators in the itch process could result in the pruritus experienced by patients with CTCL. To accomplish this we are collecting and examining skin biopsies for CTCL patients and healthy controls to identify itch-associated local biomarkers of the disease. In addition to these skin biopsies, we are retrospectively examining existing paraffin-embedded skin biopsy tissue blocks from CTCL patients. We are performing comparative and quantitative immunohistochemical analyses on the samples. This study will help to determine which components in the skin are potential key players in the manifestation and maintenance of recalcitrant pruritus in patients with CTCL.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CTCL

Exclusion Criteria:

* None
Genetic Susceptibility to Radiation Induced Thyroid Cancer

Case control on thyroid cancer occuring in a cohort of 7300 subjects treated during their childhood, mostly by radiotherapy, for a skin Angioma at Gustave Roussy, Villejuif France between 1947 and 1973.

This case control study, which is included in a larger european project, aims to investigate the DNA variant interacting with the risk of radiation induced thyroid cancer after irradiation.

The sutdy is planed to include about 30 cases and 30 controls. Matching criteria are date of birth, gender, and age at irradiation.


Eligibility Criteria:
Inclusion Criteria:

Diganosis of thyroid cancer during the followup or selected as a control matched on gender, date of birth and age at skin hemangioma diagnosis.

Exclusion Criteria:

No available adress Refusal
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.

Background:

Myoma is the most common gynecoid tumor and produces many vasoactive substances, which may be a cause for secondary hypertension. Early reports suggested the association of myoma and hypertension. We studied the effect of myoma removal on hypertension and erythropoietin level to evaluate this hypothesis.

Patients \& Methods:

In this single centered prospective cohort study, in twenty eight patients who were candidates for myomectomy due to myoma, 24 hour holter monitoring of blood pressure and serum erythropoietin were checked before and 6 weeks after hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* candidate for myoma removal by hysterectomy
* operable
* hysterectomy is indicated

Exclusion Criteria:

* patient refusal
* inoperable patients
* other secondary cases of hypertension
The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

To investigate the evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.

Pneumonia complicating stroke is very difficult to manage and has a very poor prognosis, leading to a significantly higher risk of death. Oral opportunistic pathogens have been reported to be associated with the incidence of pneumonia among non-stroke immunocompromised subjects. Preliminary studies found that patients with stroke had higher carriage rates of oral opportunistic pathogens than healthy subjects. Therefore, investigators hypothesize that pneumonia complicating stroke is associated with oral opportunistic pathogens, and oral health promotion interventions may reduce the incidence of pneumonia complicating stroke via its effects on the species and relative abundance of oral opportunistic pathogens. In order to prove this, investigators need to (1) firstly conduct a randomized controlled trial to confirm whether oral health promotion is able to reduce the levels of plaque, and the incidence of pneumonia complicating stroke at clinical level; (2) secondly employ metagenomics analysis to compare oral rinse samples and respiratory samples, and to identify pneumonia-associated "oral opportunistic pathogens group"; (3) finally elucidate how oral health promotion influences the species and relative abundance of oral opportunistic pathogens. This proposed study will provide evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* having onset of stroke within 3 days and free of any post-stroke complication
* having moderate to severe functional disability- Barthel Index (BI) scores of \<70
* being conscious and respiring voluntarily without ventilator
* not having any lung disease and lower respiratory infection
* not have an indwelling naso-gastric feeding tubes
* having dysphagia as showed by GUSS test (The Gugging Swallowing Screen, GUSS)
* having normal cognitive ability or mild impairment- Mini Mental State Examination (MMSE) \>18
* having ability to follow instruction (as an assessment of compliance of oral health intervention)
* not having systemic administration of antibiotics
* not being edentulous

Exclusion Criteria:

* mild disability (Barthel Index \> 70)
* having normal swallowing function
* edentulous
* having an indwelling naso-gastric feeding tubes
* having communication disorders, unable to cooperate with family caregivers for oral health promotion
Cardiovascular Assessment During COPD Exacerbation to Improve Diagnosis and Treatment

This is a research study involving patients hospitalized for COPD flare-ups. Patients will be randomly assigned to two groups: one group will only see a pulmonologist (lung doctor), and the other group will also be seen by a cardiologist (heart doctor) during their hospital stay. Both groups will fill out a questionnaire, and the pulmonologist will review their lung disease, adjust their treatment, and recommend follow-up care. The cardiologist will also assess the second group for heart diseases (like high cholesterol, diabetes, heart disease, high blood pressure, or heart failure) and start or adjust heart treatment if needed. Both groups will be followed up by phone 1, 3, 6 and 12 months later to check for changes in treatment, new heart problems, COPD flare-ups, or death.

This is a single-center, prospective, randomized study involving patients hospitalized for COPD exacerbation. Eligible patients will be identified either by the internal medicine department doctors or by reviewing the admission diagnoses of hospitalized patients in the hospital's database. After obtaining informed consent, the patients will be randomized into two groups.

Both groups will complete a background questionnaire and will be assessed by a pulmonologist during the hospitalization, who will focus on their lung disease, optimize basic treatment, and recommend follow-up as needed. The intervention group will undergo an additional evaluation by a cardiologist during the hospitalization, who will check for cardiovascular diseases (such as hyperlipidemia, diabetes, ischemic heart disease, hypertension, or heart failure) and adjust or start treatment according to new or existing diagnoses.

Both groups will receive follow-up phone calls about 1, 3, 6, and 12 months later to evaluate any changes in treatment following the intervention, new diagnoses or events of cardiovascular diseases, COPD exacerbations, and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Documented COPD (based on lung function tests, symptoms and relevant treatment).
* Aged 18-75 years.
* Mentally competent to understand and follow medical recommendations.

Exclusion Criteria:

* Under 18 years of age.
* Unable to provide consent.
* Unstable concurrent disease.
Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata

Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few.

The aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia areata


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration.

Exclusion Criteria:

* Alopecia totalis and alopecia universalis.
* Alopecia areata solely affecting the beard.
* Pregnant and lactating.
* Patients known to have autoimmune diseases e.g. autoimmune thyroid disease, vitiligo or SLE.
* Patients receiving systemic treatment relevant to alopecia areata within 3 months before enrollment into the study or topical treatment relevant to alopecia areata within 2 months before.
* Patients with a dermatological condition affecting the scalp other than AA: e.g. psoriasis, eczema.
* Patients with psychiatric illness or psychological state interfering with compliance or influencing the expectation of the patient.
Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy

Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs notwithstanding. In recent years have attempted to quantify the effect, and wider impact of intrapartum compromise, as well as the underlying mechanisms for it. After a poor outcome related to intrapartum care parents and healthcare practitioners often strive to understand whether the event could have been predicted and/or prevented. This can be difficult to answer, at least partly related to the heterogeneous fetal response to perinatal asphyxia. Mothers and the maternity service are increasingly encouraged to personalize care and their choices around the birth process, however the information required to guide these choices is most often missing. This makes it difficult for women and professionals to make an informed choice about their care, including the safest mode of birth for them and their baby.

Aim of the study: Identifying antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.

Antenatal, perinatal and postpartum data will be documented from the medical notes and from parental reports including;

* Booking factors (maternal age, smoking, parity, previous lower segment caesarean section (LSCS), multiple births)
* Antenatal factors (preeclampsia, gestational diabetes, prelabor abruption, placenta previa, oligohydramnios, polyhydramnios, threatened preterm labor, gender, concerns of IUGR infant)
* Labor factors (induction of labor, pre-labor rupture of membranes, planned LSCS, gestation at birth, presentation, prelabor breech, breech delivery, duration of ruptured membranes).
* Infant characteristics included GA, gender, birth weight (BW), head circumference, and multiplicity.
* Clinical signs, examination findings and laboratory data also will be included. Most covariates will be extracted from patient's notes, routine data collection or as part of a routine clinical database.

Data will be processed and analyzed using SPSS software and the results will be processed in tables and figures.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of neonatal encephalopathy(e.g. irritability, decreased responsiveness, coma, seizures, hypotonia, abnormal primitive reflexes, apnea, feeding disturbance, and abnormal cry), NICU admission, full-term infant with poor condition at birth (5-minute Apgar score \<7) and/or need for major resuscitation.

Exclusion Criteria:

* Preterm infant, full term infants with birth asphyxia but with congenital malformations or chromosomal abnormalities, infant of diabetic mother and CNS infections are excluded from the study.
Changing Patterns of Candida Infections in Urban Medical Centers

The purpose of this study is to determine the changing patterns of infection caused by Candida species in urban medical centers and its influence on patient outcomes. A retrospective cohort study design will be employed with the main outcome measure being hospital mortality. Secondary outcomes including microbiologic clearance of the infection, duration of hospitalization, and the intensive care unit (ICU) length of stay will also be assessed.

The following information that was collected as part of the patient's clinical treatment will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU, etc.), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* All hospitalized patients with a positive blood culture for Candida will be eligible.

Exclusion Criteria:

* None
is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?

. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital

we will manage all patients with vericose veins with injection sclerotherapy and will monitor there response in terms of relive in vsisble veins, swelling and pain.

we also want to evaluate hoe many sessions of injection sclerotherapy are required for complete resolution of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* All the patients who present with symptomatic varicose veins underwent a duplex scan by radiologist to identify site of reflux and condition of deep veins. If the patient is a candidate for intervention then he is offered surgery or foam sclerotherapy

Exclusion Criteria:

* recurrent and secondary varicose veins