cyrilzakka/clinical-trials huggingface dataset:
Why Still in Neurosurgical Ward After Tumor Craniotomy?

The aim of this prospective observational study is to identify the specific reasons that prolong a hospital stay after elective tumor craniotomy. Optimal postoperative in-hospital stay is considered to be two days from surgery to discharge from the neurosurgical ward. However, a variable length of stay at a neurological department for follow-up of late recognized deficits of neurological consequences of the surgical procedure are common.

The concept of fast-track surgery and later enhanced recovery after surgery (ERAS) was first imputed in 1990s. Since then, ERAS protocols have been successfully adopted in many surgical fields, often with dramatic benefits for the patients. Length of hospital stay is one of the main questions addressed in many ERAS studies, as it by a simple approach address many of the complications encountered by the patients or the case flow in the perioperative period. Why patients have prolonged hospital stay after surgery has been investigated by Husted et al. in 2011 after hip and knee arthroplasty and P. Munk-Madsen et al. in 2019 after laparoscopic colorectal surgery. Both studies could isolate dominating factors prolonging hospital stay, some of them preventable. Existing length of stay studies on tumor craniotomy patients have focused on specific variables affecting hospital duration, but never explored the true cause of prolonged hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective brain tumor craniotomy

Exclusion Criteria:

* Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)
The Registration Program of BRCA1/2 Gene

Purpose:

1. Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
2. To build the breast cancer BRCA1/2 mutation database of Chinese group.
3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.

It is the first large-scale and systematic study that fully recognize and review on the mutation spectrum of BRCA1/2 and the risk of Breast cancer in Chinese high risk group, it will be a Landmark research of susceptibility genes in Chinese breast cancer.

Eligibility Criteria:
Chinese Genetic/Familial breast cancer patients, and its first or second degree relatives with breast cancer (female or male).

The selection will be based on NCCN Clinical Practice Guidelines in Oncology (Genetic/Familial High-Risk Assessment: Breast and Ovarian).

Inclusion Criteria:

Patients: it must be from independent family and meet the one or more of the following conditions.

1. Patients' age at diagnosis: 45 years or younger.
2. Patients' age at diagnosis: 50 years or younger.
3. Breast cancer patients: it must meet the one or more of the following family medical histories.

   3.1 Patients' age at diagnosis: 50 years or younger, and the one or more of the next of Kin has breast cancer.

   3.2 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has breast cancer that its age at diagnosis was 50 years or younger.

   3.3 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have breast cancer that its age at diagnosis was 50 years or younger.

   3.4 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has epithelial ovarian cancer.

   3.5 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have pancreatic cancer and/or prostate cancer (Gleason grading\>7, any of age).

   3.6 Patients' age at diagnosis: any of age, and the one or more of the close-male relatives has breast cancer.
4. Triple negative patients' age of onset: 60 years or younger.
5. Patients: male and have breast cancer.

Patients' first or second degree relatives are BRCA1/2 mutation carrier (1-5 people):

First or second degree female adult relatives of patients (age: 18 years or older), it will be selected from the same paternal or maternal side according to the family disease.

First or second degree male relatives of patients have breast cancer.

Exclusion Criteria:

N/A.
Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors

Evaluation and validation of metabolic markers for the prediction of drug-drug interaction of various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in healthy male subjects

Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they will be overnight-fasted from 9P of Day -1. Urine collection is scheduled from 12 hours before sildenafil administration to 12 hours after administration. Subjects will be administered sildenafil (oral) around at 9A of Day 1. Subjects will perform scheduled procedures including clinical laboratory tests, electrocardiograms and blood samplings for pharmacokinetic, pharmacometabolomic and mRNA assessment.

Subjects will be administered either erythromycin or itraconazole (oral) around at 9A on Day 3 and 9A/9P on Day 4. Urine collection is scheduled from 0 hour to 12 hours after Day 3 erythromycin or itraconazole administration. Subjects will perform scheduled procedures including clinical laboratory tests, electrocardiograms and blood samplings for pharmacokinetic, pharmacometabolomic and mRNA assessment.

On Day 5, sildenafil will be administered with erythromycin or itraconazole around at 9A. Urine collection is scheduled from 12 hours before Day 5 drug administration to 12 hours after administration. Subjects will perform scheduled procedures. After subjects perform scheduled procedure, the study will be discharged (around 9A of Day 6).

Study participation was terminated on post-study visit (Day 12-14).

Eligibility Criteria:
Inclusion Criteria:

* Age: Between 19 to 50 years of age, inclusive
* Weight: within 17-28 of Body Mass Index (BMI)
* Subject who are reliable and willing to make themselves available during the study period.
* Subject who are willing to follow the study protocol, and give their written informed consent voluntarily.

Exclusion Criteria:

* History of hypersensitive reaction to medication (midazolam, itraconazole, rifampicin)
* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
* History or evidence of drug abuse
* Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
* Participation in clinical trials of any drug within 3 months prior to the participation of the study
* Judged to be inappropriate for the study by the investigator
A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer

A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Localized Non-Metastatic Rectal Cancer

Exclusion Criteria:

* Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer
Fiber Health Benefits

The investigators hypothesize that fiber supplementation will provide measurable differences in indices of children's health (fewer complaints of abdominal pain and constipation, lower body mass index) compared to placebo.

This prospective study proposes supplementing children with fiber or placebo for four months. Children in elementary school, ages 5-12, will be randomized to receive fiber supplemented bars vs low-fiber snack bars (placebo).

Eligibility Criteria:
Inclusion Criteria:

-Children bewteen ages of 5-12 years

Exclusion Criteria:

* History of allergy/intolerance to components of the snack bars (e.g. celiac disease)
* History of Hisrchsprungs disease, abdominal surgery to intestine or colon
* Unable to take a fiber bar by mouth
Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles

Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying energy and density settings of the Fraxel Repair Laser to determine an optimal dose response.

Objective 2: To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.

To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.

This is a multi-site, non-randomized, non-controlled investigator initiated study designed to follow a total of 30 qualified and consenting subjects treated with one Fraxel Repair treatment in the course of clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults between 18-75 years of age.
* Subjects who can read, understand, and sign the Informed Consent Form.
* Subjects willing and able to comply with all study requirements.
* Fitzpatrick skin type I-IV (Although the systems are cleared for all skin types I- VI, it is recommended to use the Matrix applicators on skin types I- V).

Exclusion Criteria:

* Subjects with active localized or systemic infections.
* Immunocompromised subjects.
* Subjects with coagulation disorder.
* History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
* Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
* In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
* Use of Accutane® within the past 6 months.
* Subjects with a history of radiation therapy to the treatment area.
* Subject has a history of allergy to lidocaine or ester-based local anesthetics.
* Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
* Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.
Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study

The purpose of this study is to describe the effectiveness of the adjunctive ASM treatment on the clinical response, safety profile and quality of life of patients affected by focal onset seizures in a real-world setting.

The aim of the study is to assess the effectiveness and safety of adjunctive therapy in a real-world setting of patients affected by focal-onset seizures who are eligible to start the treatment with ASM as adjunctive therapy according to the physician's judgment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of any ethnic origin ≥18 years old at baseline.
* Patients with diagnosis of focal-onset seizures with or without secondary generalization.
* Patients should have been eligible to start treatment with ASM as adjunctive therapy according to the physician's judgement prior to the inclusion.
* Patients should have clinical history of treatment failure with at least 2 ASMs.
* Patients using their seizure diary as part of their standard of care for at least 3 months prior to -the study entry (diary can be paper or electronic, filled in by patient and/or family members).
* Written informed consent (including data privacy consent) signed by the patient, legal guardian, or legally authorized representative prior to entering the study in accordance with the ICH GCP guidelines

Exclusion Criteria:

* Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
* Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
* Patients with unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified assessments (e.g., in the judgement of the Investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months prior to enrollment, current psychotic disorder, acute mania).
* Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator could affect the participant's safety or interfere with study assessments.
* Patients with substance abuse or dependence (except for caffeine and nicotine).
* Patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.
Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity

Sleep is ubiquitous in animals and humans, and disruptions are of high clinical importance. Still, the neural basis of sleep perception is insufficiently understood, which limits the development of new treatments. The current project is designed to further contribute to the understanding of the neural basis of sleep perception and to the development of innovative treatments for disrupted sleep (insomnia).


Eligibility Criteria:
Inclusion Criteria:

* For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
* Age 18 to 65 years
* Written informed consent

Exclusion Criteria:

* Relevant current or past serious medical disorder, including but not limited to cardiac arrhythmia, diabetes mellitus, and chronic pain conditions.
* Neurological conditions including epilepsy, history of brain injury, encephalitis or any organic brain syndrome
* Current or past mental disorders (life time prevalence), e.g. depressive disorder, attention deficit disorder, psychotic disorders, anxiety disorder, posttraumatic stress disorder
* Sleep disorders (except ID for patients), including movement-related sleep disorders (PLMS index with arousal \> 5) or breathing-related sleep disorders (AHI \> 15)
* Intake of CNS active medication (except appropriate thyroid hormone substitution)
* Current or past substance abuse or dependency
* Smoking \> 5 cigarettes per day
* Excessive caffeine consumption (\> 500 mg or 5 cups coffee per day)
* Irregular sleep schedules resulting from shift work, travelling or personal habits, defined as a sleep/wake time deviation \> 4 hours in the weekly routine or as a habitual total sleep time \< 4.5 hours or \> 10 hours per night
* Known pregnancy
Patterns of Neurocircuitry Activation In Severe Asthma

The overall purpose of the study is to compare the patterns of neurocircuitry activation in severe asthmatics vs. mild to moderate and healthy controls. The Investigators hypothesize that neurocircuitry activation increases with asthma severity, producing different neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or non-asthmatics.

To begin to further address possible relationships of asthma and brain function, the investigators propose the following hypothesis, "patients with defined characteristics of severe asthma will have distinct patterns of persistent neurocircuitry activation. The investigators further propose that the detection of ongoing neurocircuitry activation occurs because of persistent and active airway inflammation in severe asthma. Finally, the investigators propose that the intensity of specific neurocircuitry activation will relate to the severity of underlying asthma.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in Severe Asthma Research Program III (2012-0571) study
* Has severe asthma
* Is a male or female with no health concerns that might affect the outcome of the study
* Provided a negative urine pregnancy test prior to visit (Females only)
* Capable and willing to grant written informed consent and cooperate with study procedures and requirements (investigator discretion)
* Is able to tolerate a simulated functional Magnetic Resonance Imaging brain scanning session
* Is able to give valid informed consent to participate by signing and dating a written consent form

Exclusion Criteria:

* Uses psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of a study physician or Co-Investigator)
* Has one or more contraindications for functional Magnetic Resonance Imaging
* Has needle phobia or claustrophobia
* Unable to distinguish specific colors used in Stroop task
* History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder
* Is a pregnant or lactating female
* Has had an upper or lower respiratory infection within 1 month of the visit
* Has unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the visit
* Is a current smoker (defined as smoked within the last year) or a former smoker with a history of \>5 pack years
* Any condition which, in the opinion of the investigator, might interfere with participation in the study
* Inability or unwillingness to perform required study procedures
A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia

The purpose of the study is to collect information on how Tresiba® works in real world patients with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Tresiba® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Diagnosed with type 2 diabetes and treated with any antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1).
* Available and documented HbA1c value 12 weeks or less prior to initiation of Tresiba® treatment.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Hypersensitivity to the active substance or to any of the excipients as specified in the Tresiba® local label
COVID-19 Pandemic and Medical Students

Little is known about changes in levels of academic, financial, psychological, \& hygienic impact on medical students during this pandemic.

this is a cross-sectional, questionnaire-based study. It is conducted on a random targeted sample of medical students at medical schools in Universities of Jordan, classified by their academic years (from the 1st to the 6th academic year). A score of 10 points was constructed to reflect the perspective about the items in each group of variables. SPSS version 25.0 was used for the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Medical students in the basic and clinical years

Exclusion Criteria:

* Inability to complete the questionnaire
Physical Therapy for Men Undergoing Prostatectomy

The purpose of this study is to determine if pelvic floor muscle training with a physical therapist before and after surgery will improve health-related quality of life following robot-assisted radical prostatectomy.

Goals of the present study will be to determine whether initiating pelvic floor muscle training preoperatively improves quality of life symptoms related specifically to urinary health following robot-assisted radical prostatectomy. Drawing definitive conclusions from past studies is challenging secondary to various inconsistencies including: variability of physical therapy intervention, poorly defined definitions of continence, as well as poorly defined quality of life measurements. Additionally, the vast majority of studies combined open and robotic prostatectomy increasing cohort heterogeneity and further blurring interpretation of results. The investigators' study will focus exclusively on patients undergoing robot-assisted radical prostatectomy. Standardized pelvic floor muscle therapy as well as clearly defined patient outcomes (ie: validated questionnaires) will be utilized to determine whether preoperative initiation of formal pelvic floor physical therapy can improve health-related quality of life following surgery.

In the era of robot-assisted radical prostatectomy does physical therapist initiated preoperative pelvic floor muscle training lessen the expected postoperative drop off in urinary related quality of life and/or improve patient's recovery of continence following surgery?

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduling to undergo robot-assisted radical prostatectomy
* Patients willing and able to complete the EPIC questionnaire in its entirety
* Ability to provide informed consent

Exclusion Criteria:

* Previous prostate surgery
* Radiation treatment
* History of incontinence defined as any pad use for urinary leakage in the past 6 months