cyrilzakka/clinical-trials huggingface dataset:
InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.

Gastric cancer (GC) is a complex disease that represents the fifth most common malignancy in the world and the third leading cause of cancer death in both sexes. Chemotherapy (CT) combined with surgery represents the standard of care for stages II-III GC, but the efficacy of such treatments is still limited for many patients. It is mandatory to develop novel strategies aimed at identifying predictive markers, as well as deciphering the impact of the psychological-social and cultural environment of each patient on the outcome. GRAMMY study proposes a novel interdisciplinary approach integrating high impact basic, translational and psychological/sociological research towards developing an optimized patient stratification tool for the early prediction of therapy-resistant GC patient groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +/- Docetaxel)
* Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable
* Male or Female, aged \>18 years
* Availability of tissue samples and clinico-pathological data for retrospective cohort

Exclusion Criteria:

* Age \< 18 years
* Early Gastric Cancer and T2 (if N0)
* Linitis plastica
* Positive peritoneal cytology or peritoneal involvement
* Distant metastases
* Patient refusal to participate
* Patient refusal to the use of their own samples for research
* Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling
* Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable
* Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan

The purpose of this study is to determine the efficacy, safety and pharmacokinetics of Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG.
* Subjects with status epilepticus accompanied by generalized seizure, partial seizure or secondarily generalized seizure lasting 5 minutes or longer
* Subjects with repetitive status epilepticus / cluster seizure accompanied by not less than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour.
* Subjects not younger than 3 months (either gender is eligible for the study)

Exclusion Criteria:

* Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal
* Subjects with known history of hypersensitivity to lorazepam or benzodiazepine
* Subjects with a known history of benzodiazepine abuse.
* Subjects currently receiving lorazepam
* Subjects with angle-closure glaucoma
* Subjects with myasthenia gravis
* Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available)
* Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than 1500/mm3 at screening visit (if the data is available)
Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease

Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.

The proposed study is be a randomized, double-blind, placebo-controlled trial of supplementation with oral vitamin D3.

Each subject will take a once-weekly capsule containing vitamin D3 or a an identical-appearing placebo for a treatment period of 15 weeks.

Subjects will be assessed for Bone pain and tenderness, Neuromuscular function, physical performance score, and Quality of life assessment.

A subset of subjects will have bone biopsies performed before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* On dialysis
* Likely to be able to complete the study
* At least minimally ambulatory, with or without a walking aid (i.e., cane or walker)
* Able to complete the various questionnaires interactively with the research nurse
* Venous access that can be accomplished without unusual difficulty.
Case Management and Environmental Control in Asthma

Asthma among low-income, minority children remains a prime example of health disparities that are resistant to change. Controlled demonstrations of reductions in disproportionate hospital or emergency care are limited. We performed a controlled clinical trial of an "Asthma Coach" to reduce hospitalizations among low-income, African American children.


Eligibility Criteria:
Inclusion Criteria:

* 2-8 years of age
* Admitted to hospital for acute asthma
* African American ethnicity
* Medicaid coverage

Exclusion Criteria:

* Parent refusal to sign consent
* Living outside service area
Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)

The aim of this project is the prospective data collection of a new device used for trochanteric fractures of the femur. It should be answered how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and postoperative complications.

In comparison to previous implants, the TFNA has been improved substantially. Therefore the purpose of this focused registry is to investigate how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.

All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Pertrochanteric femoral fracture (31-A1 and 31-A2), intertrochanteric fracture (31-A3), fracture of the trochanteric area (31-A1/A2/A3) with diaphyseal extension or combined fracture of the trochanteric area and the femoral shaft (32-A/B/C) treated with the TFNA system according to the technique guide
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the registry according to the registry plan (RP)
* Signed and dated IRB/EC-approved written informed consent or assent from a family member

Exclusion Criteria:

* Additional acute fracture
* Any not medically managed severe systemic disease
* Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the registry period
* Prisoner
* Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry
* Intraoperative decision to use implants other than the devices under investigation
A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions.

The pathological classification of the prostate following radical prostatectomy provides important prognostic information; an accurate pathology report is the cornerstone to cancer treatment and follow-up. In addition to the preoperative serum PSA, Gleason score on pathology specimens, seminal vesicle invasion and lymph node status, and a positive surgical margin with extraprostatic extension (EPE) are significant predictors of clinical and biochemical recurrence. However, the prognostic implication of a capsular incision, a tumor extending to the inked margins without a histologically documented EPE, remains to be defined.

Eligibility Criteria:
Inclusion Criteria:

* pathologically proven prostate cancer
* follow-up for at least 6 months

Exclusion Criteria:

* insufficient biopsy data
* seminal vesicle invasion or lymph node involvement on pathology
* neoadjuvant or adjuvant therapy
Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions

Some educational researchers deliberately induce stress upon learners to in order to enhance retention; this practice is controversial and its utility must be weighed against the negative emotional effects it may have on participants. In this study we investigate the effect of the unexpected death of a simulation mannequin on the retention of non-technical and technical crisis resource management skills and consider the emotional impact of this acute stressor.

Background High-fidelity simulation is an increasingly used teaching tool that is proven to be effective for learning. According to the literature, by gradually increasing stress and emotions, more effective learning can be achieved. However, allowing the simulated patient to "die", as a deliberate stressor, is controversial. There is no previous research on the educational effect of letting a simulated patient die. We aim to evaluate the effects of simulated unexpected death on skill retention, stress levels, and emotions. We hypothesize that the occurrence of unexpected death will impact skill retention, and will be associated with higher stress levels and stronger emotions.

Methods After Institutional Research Ethics Board approval, 56 residents and fellows of different medical specialties will be randomized to either the intervention (unexpected death) or control (survive) group. Participants from both groups will have to individually manage a simulated cardiac arrest crisis. In the intervention group, the scenario will end by the death of the simulated patient, whilst in the control group the simulated patient will survive. Each participant will be immediately debriefed by a trained instructor. Three months later, skill retention will be assessed in a similar scenario. Crisis management performance of all scenarios will be rated by 2 blinded raters. Biological stress, cognitive appraisal, and emotions will be measured during both scenarios.

Implications The impact of simulated unexpected death on skill retention of residents and fellows will provide instructors with evidence to optimize scenario design and approach the role of stress and emotions in simulation-based education.

Eligibility Criteria:
Inclusion Criteria:

* Must be a resident or a fellow in the department of anesthesiology, critical care, emergency medicine, medicine, obstetrics and gynecology, surgery or family medicine at the University of Ottawa or the University of Toronto
* Participants are requested to refrain from physical strains, smoking, drinking caffeinated or low pH beverages and eating for at least one hour before enrollment
* Participants will be included between 11 AM and 8 PM, when cortisol levels are most stable

Exclusion Criteria:

* Not a resident or fellow in one of the departments indicated above
Stereotactic Body Radiotherapy for Prostate Cancer

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.

This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \>= 18 years
* Zubrod performance status of 0-3
* T1-3 N0 M0 adenocarcinoma of the prostate
* Prostate volume ≤ 100 cc
* Signed study-specific consent form

Exclusion Criteria

* Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
* Prostate volume \> 100 cc
* Nodal involvement
* Metastatic disease
* Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
* History of scleroderma
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* colorectal cancer;
* advanced or recurrent disease;
* \>=1 measurable lesion;
* \>=6 months since prior adjuvant therapy, and \>=4 weeks since prior radiotherapy.

Exclusion Criteria:

* previous treatment for colorectal cancer;
* significant history of cardiac disease in past 6 months;
* other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.


Eligibility Criteria:
Inclusion Criteria:

* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
* Has low-risk of HIV infection
* Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse

Exclusion Criteria:

* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid \[RNA\])
* Prior use of MK-8527 or islatravir (MK-8591)
Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis

osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.

Ethics statement This study was approved by the institutional review board of the faculty of physical therapy, Cairo university, Egypt (no.P.T. REC/012/003867) and strictly adhered to the criteria proclaimed in the latest version of the declaration of Helsinki code of ethics. each woman freely consents to participate in this research study.

study design. A prospective double-masked randomized controlled trial.

sample size calculation. Based on a pilot study, sample size was calculated according to the significant difference in the value of mean difference (pretreatments - posttreatment values) of ODI between control (16.60 ± 2.22) and study (26.50 ± 4.09) groups in two tailed unpaired t test, with α=0.05, power of 80%, and an effect size of 0.74. So, a sample size of 30 patients/per group would be required and increased to 35 women to allow for a 15% dropout rate (Power 301 http: www.psycho.uni-duesseldorf.de) Randomization. Randomization of sample selection were achieved using closed envelop way to allocate study participants to either intervention group (medication and treatment exercises) control group (medication only). all postmenopausal women and examiners were unaware of group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Their ages were ranged from 50-60 years.
* Their BMI not exceeded 30 kg/m2.
* All postmenopausal women past of at least one year after menopause.
* Had no regular physical activities during the past 6 months.

Exclusion Criteria:

* Patients didn't take any drug before the study (e.g. calcium tablets, multivitamins containing calcium and vitamin D) that affects bone metabolism.
* Patients that were smoking or having alcohol consumption.
* Histories of fracture and surgery, or severe injuries
Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study

An association between periodontitis and endothelial dysfunction has been reported, suggesting that periodontitis presents an inflammatory burden to the cardiovascular system, that might lead to AVD. The study aims aim to assess whether non-surgical periodontal therapy enhances endothelial function in periodontitis patients using a non-invasive diagnostic device to assess endothelial function through PWA and the assessment of levels of salivary Endothelin-1, in a population of people in the UAE.


Eligibility Criteria:
Inclusion Criteria:

* Group 1: periodontally healthy subjects.
* Group 2: patients with periodontitis stage III or IV and grades A,B or C.

Exclusion Criteria:

* Medical conditions: Diabetes,pregnancy,obesity,renal disease,patients with cardiovascular diseases including hypertension,recent myocardial infarction or unstable angina (within 3 months),congestive heart failure,valvular heart disease
* Heavy smokers(\>10 cigarettes per day),
* Regular administration of drugs resulting in gingival hyperplasia,root planning in the past 6 months
* Regular administration of drugs resulting in gingival hyperplasia (such as cyclosporine and phenytoin)
* Recent antibiotic use (in the past 3 months)
* Non-surgical periodontal therapy in the past 6 monthsp
Estimation of the Minimal Important Difference and Validation of Foot and Ankle Instruments

The present study investigates the minimal important change and validity of foot and ankle measures.

Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided.

The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments.

Eligibility Criteria:
Inclusion Criteria:

* Full understanding of Finnish language
* Undergoing foot or ankle surgery
* At least 18 years old

Exclusion Criteria:

* Unbalanced mental disorder such as schizophrenia or depression
* Age under 18
* Does not understand Finnish
* Undergoing operation other than foot or ankle
Topical Allstate and Nasal Allergen Challenge

The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).


Eligibility Criteria:
Inclusion Criteria

1. Males and females between 18 and 55 years of age.
2. History of grass and/or ragweed allergic rhinitis for at least 2 years.
3. Positive skin test to grass and/or ragweed antigen within prior 12 months.
4. Positive response to screening nasal challenge.

Exclusion Criteria

1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
2. Use of nasal steroids, antihistamines in the last 2 weeks.
3. Upper respiratory infection, sinusitis less than 2 weeks before screening.
4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
5. Having poorly tolerated previous administration of allergens
6. Nasolacrimal drainage system malfunctions.
7. Participation in other investigational therapy in the last 30 days.
8. Any systemic disorder or medication interfering with the study.
9. FEV1\<80% of predicted at screening for subjects with mild asthma.
10. Presence of allergic rhinitis symptoms in the screening period with TNSS \>3 at baseline)
11. Undergoing allergen desensitization therapy.
12. Current smokers or recent ex-smokers.
13. Not willing to give informed consent
14. Inability to understand the nature and requirements of the study, or to comply with the study procedures.
15. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients

In this prospective, multicenter observational study the investigators capture the perioperative course of peripheral cholinesterase activity. The focus is the perioperative inflammation causing postoperative delirium. Therefore we measure the activity of Acetylcholine-Esterase and Butyrylcholine-Esterase in whole blood of adults in the perioperative context. Early postoperative delirium will be detected by Nu-DESC in the Recovery Room or the Postanaesthesia-Care-Unit. The course of the peripheral cholinesterase activity will be compared with the incidence of postoperative delirium and other clinical dysfunctions.

We follow up the patients for up to five years regarding Delirum, comorbidities and mortality data.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with age 18 years and above scheduled for surgery with planned stay in Recovery Room or Postanesthesia-Care-Unit
* Offered patient information and written informed consent
* In-hospital stay for at least 24 hours

Exclusion Criteria:

* Patients with known pseudocholinesterase deficiency
* Participation in prospective intervention studies during the study period
* Analphabetism
* Unability of German and English language use
* Anacusis or Hypoacusis with hearing aid device, Amaurosis
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* Coworker of the clinic (study center)