cyrilzakka/clinical-trials huggingface dataset:
SMC Radiation Oncology Breast Cancer Cohort Study

The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.

The main question it aims to answer are:

* Changes in breast skin
* Factors related to breast skin changes
* Patient-reported outcomes
* Cosmetic outcomes

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

* Photographs
* Fibrometer
* Questionnaires (BREAST-Q)
* CTCAE version 4.03 evaluated by treating physicians


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer treated with curative surgery

Exclusion Criteria:

* History of thoracic radiation therapy
A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects

The purpose of this trial is to compare the pharmacokinetics (PK), safety, tolerability and immunogenicity of a single dose of 300 mg tralokinumab administered as a 1 × X mL subcutaneous (SC) injection with Device A and 2 × Y mL consecutive SC injections with Device B.

This is a single center, randomized, open label, 2 period, 2 sequence cross over trial designed to compare the PK and to evaluate the safety, tolerability and immunogenicity of 300 mg tralokinumab administered as a 1 × X mL SC injection with Device A (test treatment \[T\]) and 2 × Y mL consecutive SC injections with Device B (reference treatment \[R\]) in healthy subjects. Additionally, the experience of tralokinumab being administered with Device A compared to Device B will be evaluated.

After being informed about the study and the potential risks, all subjects giving written informed consent will be enrolled and randomized to 1 of 2 treatment sequences, Sequence TR or Sequence RT in a 1:1 ratio (i.e., subjects receive the 2 treatments in the specified order).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female aged 18 to 55 years (both included) at the time of Screening.
* Female subjects of childbearing potential must use a highly effective form of birth control throughout the trial and at least for 16 weeks after last administration of the investigational medicinal product (IMP) and must have a negative serum pregnancy test at Screening.

Exclusion Criteria:

* Systemic (non biologic) or topical treatment within 21 days prior to first dose administration unless in the opinion of the Investigator the medication will not interfere with the trial procedures or compromise safety.
* Active tuberculosis or history of incompletely treated tuberculosis based on medical history or medical report.
* History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at Screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
* History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization.
* History of a helminth parasitic infection within 6 months prior to the date of informed consent that has not been treated with or has failed to respond to standard of care therapy.
* History of anaphylaxis or severe allergic reaction following any biologic therapy
Genomic Study in Non-small Cell Lung Cancer Brain Metastasis

The investigators collected the data from the investigators' center between January 2011 and October 2020. The study included all non-small cell lung cancer patients with surgically excised brain metastasis. The investigators analysis the correlation of gene mutation and the disease course.

The investigators collected the data from from the investigators' center between January 2011 and October 2020. The study included all non-small cell lung cancer patients with surgically excised brain metastasis. The investigators analysis the correlation of gene mutation and the disease course. The investigators use Kaplan-Meier regression to analyze the overall survival, and the difference between the groups was calculated using log rank test. Cox proportional hazards method was used to create the regression model and estimate the hazard ratios.

Eligibility Criteria:
Inclusion Criteria:

- patients diagnosed with non-small cell lung cancer who underwent craniectomy and subsequent whole brain radiotherapy and associated chemo or target therapy

Exclusion Criteria:

* patient who did not receive postoperative adjuvant therapy
Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures

This study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night.

Supracondylar humerus fractures are one of the most common traumatic fractures seen in children and their treatment usually requires immediate closed reduction and percutaneous pinning (CRPP). The presence of neurovascular complications associated with this fracture is considered an orthopedic emergency. For this reason, depending on the patient's operation time, the procedure should be performed at night under emergency conditions. Sleep deprivation, which is common in healthcare professionals, may affect patient safety due to disruptions in treatments and surgical procedures by reducing physician performance.

Eligibility Criteria:
Inclusion Criteria:

* aged 5 to 12 years
* had supracondylar humeral fractures,
* underwent CRPP
* under general anaesthesia
* American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria:

* Surgical procedures outside the operating room
* parental refusing the study protocol
Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation

The goal of this observational study is to evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum.

The negative impact that OASISs (Obstetric Anal Sphincter Injuries), and possible subsequent anal incontinence, have on women's quality of life has stimulated research in this field in recent decades. However, there are still few studies concerning the topic. The transperineal approach by means of the transvaginal probe in the study of the pelvic floor, anal sphincter and related lesions has helped us to make strides in our knowledge of the anatomy of the pelvic floor and in defining the lesions that may affect it.

The development of ultrasound techniques such as 3D and 4D and new reproducible and increasingly accurate volumetric acquisition modalities shows promise for improving the diagnosis of OASIS and the clinical management of OASIS and consequently the quality of life of women.

With new, simpler techniques of 3D/4D volume analysis of the anal sphincter, the number of operators able to objectively and accurately assess anal sphincter integrity, both in the delivery room and postpartum, could increase. The application and dissemination of an accurate and reproducible technique in the subjective assessment of the anal sphincter could help operators improve and refine the technique of surgical correction of anal sphincter injuries.

The primary objective of the study is to evaluate the reproducibility of novel 3D/4D ultrasound volume analysis techniques, using curvilinear reconstruction of the coronal plane of the anal sphincter combined with contrast enhancement technique (optic OMNIVIEW), in the assessment of anal sphincter integrity and thickness, both in pregnancy and immediate postpartum.

Secondary objectives include:

* Evaluation of the feasibility of new off-line analysis techniques.
* Evaluation of the correlation between thickness and ultrasound integrity of the anal sphincter at the postpartum visit and women's symptomatology in the postpartum.

To reduce bias as much as possible, each operator during each assessment will be "blinded" to the patient's history and all other measurements.

Clinicians who perform more than one measurement per volume will do so at least one month apart between each measurement.

The patient will be treated according to common clinical practice ensuring the standard of care. Patients will not undertake additional visits to those routinely performed. This is an evaluation of new techniques for off-line (in the absence of the patient) analysis of ultrasound volumes that are currently part of routine visits in both pre and postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant nulliparous or primiparous women;
* Age between 18 and 44 years
* Acquisition of informed consent form

Exclusion Criteria:

None
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Eligibility Criteria:
Inclusion Criteria:

* Adult women age ≥ 18 years
* Capable of informed consent
* Able to collaborate with planned follow-up (transportation, compliance history, etc)
* Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.
* Positive HPV test at study entry (any genotype).
* Women of childbearing potential agree to use birth control during the dosing phase (through week 8).
* Laboratory values at Screening of:

  * Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
  * Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
  * Serum Bilirubin (total) \< 2.5 x ULN
  * Serum Creatinine ≤ 1.5 x ULN
* Weight ≥ 50kg

Exclusion Criteria:

* Pregnant and nursing women
* Concurrent anal, vulvar, or cervical cancer
* HIV-positive participants with a CD4 count \< 200
* Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.
* Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry.
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Concomitant use of Efavirenz for HIV antiretroviral treatment
* Concomitant use of strong UGT inhibitors
* Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study
* Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy).
* Concurrent treatment with systemic corticosteroids
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo. The primary study objective was to compare the efficacy of XP13512 1200 mg taken once daily for 12 weeks versus placebo. The secondary study objectives were to assess the efficacy of XP13512 600 mg taken once daily for the reatment of RLS and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both XP13512 1200 mg and 600 mg.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.

Exclusion Criteria:

* A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
* Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
* Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
* Pregnant or lactating women;
* Women of childbearing potential who are not practicing an acceptable method of birth control.
PWV for Cardiovascular Complication After Cardiac Surgery

Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Therefore, we try to investigate the correlation between PWV values and cardiovascular complications like stroke, acute renal failure, or perioperative myocardial infarction after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery patients who sign the informed consent

Exclusion Criteria:

* Chronic renal failure (Cr\>1.5mg/dL), Dialysis patients
* Previous stroke
* Left ventricular dysfunction (EF \<50%)
* ASO with claudication
* \< 40 years
Nicotine's Potential Abuse With Menthol

To examine if switching from menthol to non-menthol cigarettes will change the dose-effect curves for positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate in smokers.

A placebo-controlled study that will recruit male and female menthol nicotine dependent smokers. Following screening and evaluation as described above, eligible participants will be enrolled in the study which will last about 4 weeks. Eligible, participants will be randomized to menthol or non-menthol smoking condition for 2 weeks (Phase 1) and then will be switched to the alternative condition for another 2 weeks (Phase 2). The smoking condition will be open label. Participants will be provided with free cigarettes in Phases 1 and 2. For the menthol condition, participants will be provided their usual brand of menthol cigarettes and for the non-menthol condition, they will be provided a matched-brand non-menthol cigarette (e.g., Newport Non-Menthol Gold 100s for those who smoke Newport Menthol Gold 100s). In week 2 of each Phase, participants will have a test session. Each session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. Once the participants complete the test session, participants will be crossed-over to the alternative treatment. The period between the 2 Phases will not be longer than one week.

Eligibility Criteria:
Inclusion Criteria:

* 1) Female and male smokers, aged 21 to 35 years, who have been smoking tobacco cigarettes for at least a year;
* 2) smoke ≥ 5 and less than 20 cigarettes per day;
* 3) urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker
* 4) not seeking treatment at the time of the study for nicotine dependence;
* 5) in good health as verified by medical history, screening examination, and screening laboratory tests;
* 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* 1) history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study;
* 2) regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics);
* 3) current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine;
* 4) use of e-cigarettes more than 10 days in the past 30 days;
* 5) urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients

A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.

The main purpose of this research study is to investigate the prevalence of inadequate health literacy and hepatitis C knowledge and their determinants among people living with HIV/AIDS co-infected with hepatitis C. The observation will determine if health literacy and/or hepatitis C knowledge are predictors of patient willingness and intention to be treated for HCV in the overall cohort and stratified according to study groups as noted above.

Eligibility Criteria:
Inclusion Criteria:

* Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
* Regardless of ethnic background
* English or Spanish speaking
* With active HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody

Exclusion Criteria:

* Neurocognitive impairment precluding participation
* Physical illness precluding participation
Effect of Midazolam Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Models

No trials have evaluated the effect of a Midazolam bolus (routinely used for premedication before general anesthesia) on the Concnetration at the effector site of Propofol (CeP) of Eleveld and Schnider TCI models, routinely used for general anesthesia delivery.

During recent years Eleveld and colleagues ideated a new propofol pharmacokinetic/pharmacodynamic (PK/PD) model for total intravenous anaesthesia with target controlled infusion (TIVA-TCI) pumps that has been proposed to have slightly better predictive performance for measured propofol plasma concentrations compared with those of the Marsh and Schnider models, and suitable for children, adults, older subjects, and obese adults, being considered as a "General purpose" model.

However, no trials have compared the Eleveld to the Schnidermodel after a premedication with Midazolam bolus (0.03 mg/kg) from a clinical point of view; so, this study aimed toevaluate midazolam effect on the estimated effector site concentration of the two models (CePE and CePS, respectively) at loss of responsiveness (LoR), during anaesthesia maintenance (Bispectral Index \[BIS\] 40-60) and return of responsiveness (RoR). The study also compared the incidence of deepening or superficializing anaesthesia (defined respectively as lowering or increasing in out-of-target BIS after initial CeP detection), as well as unwanted anaesthesia events: burst suppression (BSupp, identified as a burst suppression ratio \[BSR\] \>0) and unwanted spontaneous responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Undergo general anaesthsia with Targted Controlld Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)after midazolam premedication

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
A Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of BR3006 and Co-administration of BR3006A, BR3006B and BR3006C in Healthy Adult Volunteers Under Fasting Conditions

The purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of BR3006 and co-administration of BR3006A, BR3006B and BR3006C in healthy adult volunteers under fasting conditions


Eligibility Criteria:
Inclusion Criteria:

* Those who have body mass index (BMI) of 18.0kg/m2 to 30.0kg/m2 at screening visit.

  * For men, Those who weigh 55 kg or more
  * For women, Those who weigh 50 kg or more
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ethical drugs, over the counter drugs, herbal medicines, health functional foods concerned about affecting this clinical trial within 10 days before the first administration date. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have a medical history of gastrointestinal resection (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first administration date(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
Nasal Problems in Neonates and Infants Subjected to CPAP

The goal of this study is to Detect and Screen different nasal complications of using CPAP in neonates and infants and reach a consensus about minimizing nasal problems of CPAP in neonates and infants

Continuous Positive Airway Pressure (CPAP) is a means of providing respiratory support to neonates with either upper airway obstruction or respiratory failure. Respiratory failure constitutes either failure of ventilation or failure of lung function.

Nasal CPAP can be delivered through various devices, of which a nasal mask and binasal prongs are the most commonly used. However, earlier studies have described the development of Pressure Injuries (PI) on the nasal skin caused by these nCPAP devices

Nasal complications of nasal CPAP vary from external nasal complications such as columellar hyperemia, columellar necrosis to intranasal complications such as intranasal ulceration, granulation, vestibular stenosis and intranasal synechiae

Aims of the Study:

* Detection and Screening of different nasal complications of using CPAP in neonates and infants
* reach a consensus about minimizing nasal problems of CPAP in neonates and infants

Patients and Methods:

* Type of the study: prospective study.
* Place of the study:

  * Pediatric department and its units (Neonatal intensive care unit (NICU), Pediatric intensive care unit (PICU), Critical care unit)
  * Otorhinolaryngology department In Sohag university hospitals (old and new)
* Study period: One year from date of acceptance of the protocol.
* Patient:

Neonates and infants subjected to CPAP and presented to ENT department for assessment of nasal condition

• Methods:

All cases will be subjected to:

1. Full medical history: Name, age, sex, date of birth
2. Indications and duration of CPAP
3. Complete Ear,nose and throat (ENT) examination including endoscopic examination

Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants subjected to CPAP and presented to ENT department for assessment of nasal condition

Exclusion Criteria:

* Failure to obtain consent.
* Children above 1 year
* Adults