cyrilzakka/clinical-trials huggingface dataset:
Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A \& MS bioassays on tumor control by radiotherapy.

For that purpose, this project is composed of 3 stages:

* A Calibration stage that will allow to evaluate the correlation between the clinical tumor response parameters (i.e. TV/AP features) and the radiobiological parameters issued from the A/MS bioassays in order to develop a mathematic model defining the UTCR parameter
* A Validation stage in order to assess the validity of A/MS bioassays towards clinical tumour response parameters (i.e. both TV/AP features and UTCR).
* A Precision stage will be performed either to improve the precision of the predictive performance of the A and MS bioassays or to establish a new mathematical model describing the correlation between clinical and radiobiological parameters. The objective of this precision stage will depend of the results of the calibration stage (see below).

This prospective clinical study will be conducted in a population of patients with different tumor types in order to explore a large range of tumor radiosensitivity including sarcomas, rectal carcinoma and esophagus tumor.

Eligibility Criteria:
Inclusion Criteria:

I1. Patients (male or female) ≥ 18 years of age. I2. Adult patients with a suspected, non-treated, non-metastatic retroperitoneal or limb soft tissue sarcoma, esophagus cancer or rectum cancer to be treated by pre-operative radiotherapy or radio-chemotherapy I3. At least one measurable lesion as per RECIST 1.1 I4. Documented negative serology tests (HVB, HIV, HVC) I5. PS ECOG 0 to 1 I6. Patient able and willing to provide informed consent. I7. Ability to understand and willingness for follow-up visits. I8. Covered by a medical insurance.

Exclusion Criteria:

E1. Contra-indication to radiotherapy E2. Contra-indication to skin biopsy
Preventive Medicine Study of Childhood Atopic Diseases

Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups.

Environmental intervention programs:

We will both interview by telephone and mail the health education leaflets, in order to achieve the following aims:

-Smokers living with the children will change where smoking takes place for reducing the children's ETS exposure.

Data collection:

We will contact participants individually to get informed consent before data collection. No matter what intervention, non-intervention or reference group, all participants will test as follows:

* Blood sample collection: We will test the total IgE, specific IgE, cytokines, such as IL-4, IL-13, TNF-α, ECP and EOS.
* Questionnaire collection
* Pulmonary function test

After intervention programs applied, all participants will test pulmonary function, and total IgE, specific IgE and cytokines by blood sample after six months by school approaches. Then, we can compare the pulmonary function, total IgE, specific IgE and cytokines before and after intervention programs.

Eligibility Criteria:
Inclusion Criteria:

* Only one smokers living in the same household
* Having smoking exposure during the past 12 months while questionnaire surveying
* Child without smoking habit

Exclusion Criteria:

* None of above
Ulcerative Colitis Mayo Score With Artificial Intelligence

This project will use deep learning to classify colonoscopy images of different severity of ulcerative colitis, so as to assist clinicians in the accurate diagnosis of ulcerative colitis.

In this project, artificial intelligence was used to colonoscopic images of patients with ulcerative colitis with different disease activity levels and classify them according to the evaluation standard Mayo score to assist endoscopists in identifying disease activity levels of patients with ulcerative colitis during colonoscopy. It can help clinical endoscopists to accurately identify, and the visualization technology of artificial intelligence category response map can comprehensively display the areas with high importance for deep network classification results, and visualize the experimental lesion sites, thus effectively verifying the reliability and interpretability of deep network. This study can provide strong support for accurate identification of disease activity in clinical ulcerative colitis, effectively reduce the workload of clinicians, and provide a convenient, effective and practical clinical teaching tool.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects were 18-72 years old, male and female;
2. Clinical diagnosis of ulcerative colitis;
3. The subjects underwent colonoscopy and the colonoscopy report was complete.

Exclusion Criteria:

1. Subjects are younger than 18 years old or older than 72 years old;
2. Subjects underwent colectomy, ileostomy, colostomy, ileostomy, or other intestinal resection;
3. subjects with ambiguous diagnosis.
Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery

LMA Protector is a recently developed second generation laryngeal mask several kinds of different laryngeal masks were used for the airway management during laparoscopic surgeries. However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery .In this study researchers aim to determine the effectivity of LMA Protector and plan to analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .

Tracheal intubation may have more complications than laryngeal masks. In this study researchers aim to determine the effectivity of LMA Protector and on the otherside the heamodynamic variables and the complication rates between tracheal ıntubation and laryngeal mask insertion will be compared.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I-III patients
* Patients undergo laparoscopic surgeries
* Laparoscopic surgeries duration of less than 2 hours

Exclusion Criteria:

* Difficult intubation history
* BMI\>35
* Open cholesistectomies
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).

The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants birth weigh \>2000 g, 11 -17 weeks old at Dose 1 with written informed consent.

Exclusion Criteria:

* Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.
Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.

Retained CBD stone after ERCP is a common problem in clinical practice. This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome.

This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome. Patients with CBD stone who received endoscopic stone removal were included after complete stone clearance was seen on occluded cholangiogram. One arm received saline irrigation of CBD at least 50 ml until clear effluent seen and another arm as control. Both group received endoscopic ultrasound to evaluation for residual stone and followed up for complication and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with common bile duct stone
* Complete stone removal by endoscopy as seen in occluded cholangiogram

Exclusion Criteria:

* unstable vital sign
* failed complete stone remval
* assciated biliary malignancy or history of bile duct surgery
* associated bile duct stricture or choledochal cyst
* Toxic cholangitis
* pregnancy or unable to give informed consent
Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection

Spontaneous isolated superior mesenteric artery dissection(SISMAD) is an increasingly diagnosed disease. However, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. This study aims to compare the therapeutic efficacy of conservative and endovascular treatment for SISMAD.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 and above;
2. Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA
3. Signed informed consent forms, willing to receive treatments

Exclusion Criteria:

1. Symptoms are severe and patients need exploratory laparotomy;
2. Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;
3. Patients with mental illness cannot cooperate subjectively;
4. Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;
5. Pregnancy and breastfeeding women, or patients who have recent birth plans;
6. Patients who are participating in other clinical projects;
7. Patients are not suitable to participate in this study.
Effect of Acute Caffeine and Beetroot Juice Intake on Strength, Power, and Muscular Endurance

Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine and beetroot juice intake on sports performance. However, there are few studies focused on the production of strength, power, and muscle endurance, particularly when both supplements are ingested together.

Objectives: Evaluate the acute effect of combined and isolated intake of caffeine and beetroot juice on the production of strength, power, and muscle endurance in young adults, analyzing the effect of circadian rhythms (morning vs. afternoon) on the exercise performed (bench press vs. squat).

Methods: A total of 12 healthy and physically active participants will be recruited for the study. Through a double-blind, crossover, randomized, and controlled design, participants will ingest: a) Caffeine (3 mg/kg body mass); b) Beetroot juice (70 ml, 6.5 mmol of nitrates); c) Caffeine + Beetroot juice; d) Placebo (maltodextrin, 3 mg/kg). The supplements will be ingested 120 minutes (beetroot juice or placebo) and 60 minutes before (caffeine or placebo), the latter dissolved in 200 ml of water. After the ingestion period, strength, power, and muscle endurance will be analyzed with 1RM tests, strength and power tests at 25%, 50%, 75%, and 90% 1RM, and muscle endurance tests at 65% 1RM, in all cases for squat and bench press exercises. Additionally, dynamometry (manual and the isometric mid-thigh pull test) and vertical jump (squat jump and countermovement jump) will be analyzed. The four experimental conditions will be conducted in the morning (8:00 am to 10:00 am) and in the afternoon (4:30 pm to 6:30 pm).


Eligibility Criteria:
Inclusion Criteria:

* Age between ≥ 18 and ≤ 35 years.
* Body Mass Index (BMI) \&amp;lt; 25 kg/m².
* Resistance-trained individuals (\&amp;gt; 2 years of structured trained).
* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.
* Participants must be able to perform the tests described in the following section.

Exclusion Criteria:

* History of neuromuscular diseases, heart diseases, or diseases that may affect liver or muscle metabolism.
* Use of drugs, other stimulants or sport supplements that interfere with the intake of the study\&amp;#39;s dietary supplements.
* Sedentary habits (\&amp;lt; 150 min/week of moderate exercise).
* Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.
* Performing strenuous exercise during the 48 hours prior to the tests.
* Failure to replicate the same food intake on the two days of the experiments.
* Consuming caffeine or any other stimulant after 6 pm the day before the training or tests, to avoid headaches, discomfort, or lethargy among regular caffeine consumers.
* Consuming foods rich in NO3- (e.g., beetroot, spinach, or celery) during the 48 hours prior to each experimental condition.
Power Lung Versus Acapella After Coronary Artery Bypass Graft Surgery

The purpose of the study is to compare between the power lung versus acapella on airway clearance after coronary artery bypass graft surgery.

In this part of the study the materials and methods will be presented under the following headings: subjects, equipments, procedures of the study and statistical procedures

1. Subjects. Ninty patients of both sexes will participate in this study with an age range of 40 to 50 years old. They will be chosen from outpatient clinic, Qena University Hospital.

   Patients will be randomely assigned into three groups:

   Group A: patients will receive a two supervised sessions using acapella device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration.

   Group B: patients will receive a two supervised session using power lung device three sets for 10 repetitions two times daily from first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, Percussion and vibration).

   Group C. Patients will receive only routine physical Therapy program.
2. Equipment:

1. For evaluation: Arterial blood gases including: - paO2, paCO2, PH and O2 saturation. Spirometry measurements: - as forced vital capacity (FVC) andbforced expiratory volume in the first second (FEV1).

The incidence of PPCs and the length of postoperative stay: - using the Melbourne Group Scale Dyspnea. According to the revised or modified Borg scale or rating of perceived exersion.

The Rand SF 36 health survey questionnaire. 2. For treatment The power lung device. Acapella device.

Eligibility Criteria:
Inclusion Criteria:

* They will be from 40-50 years old.
* They will be patients undergo elective CABG surgery.
* Non productive cough postoperatively.
* Cough pain intensity \> 5 as rated on a visual analogue scale (VAS) on postoperative day 1.

Exclusion Criteria:

* Patients with chronic chest diseases.
* Patients with an intensive postoperative care (ICU) stay \> 48 hrs.
* Uncooperative patients.
Role of the Sympathetic Nervous System in Rosacea

Rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. This project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy males and non-pregnant/non-lactating females with mild to moderate erythematotelangiectactic rosacea, as well as age-sex matched healthy control subjects.

Exclusion Criteria:

* Neurological, cardiovascular, respiratory, metabolic, muscular, or other dermatological disorders
* Current history of alcohol and/or drug abuse
* Known allergies or hypersensitivities to medications/drugs that are used in the protocol
* Current smoking or regular smoking within the last 2 years
* Body mass index \> 35 kg/m2
* Medications or supplements which are known to affect neural, cardiovascular, or muscular responses
Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval

Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.

HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.

Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.

Consent female patients between 18 and 43 years old scheduled for oocyte retrieval will be enrolled in this study and their anxiety level will be collected via a questionnaire.

After randomization, patients will either benefit from audiovisual distraction using HappyMed Video Glasses, (medical device with CE marking), or from the usual management during procedure. The anaesthesiologist will check that no anxiolytic or sedative drug was given 12 hours before anaesthesia. The patients will be stratified according to whether or not a previous intervention was performed. Anaesthesia will be started and maintained with administration of sufentanil (0.1 μg/kg) and propofol (using the Dixon's up-and-down method). The aim is a patient who spontaneously ventilates and does not react to gynaecological stimulation. Prevention of postoperative pain and nausea/vomiting will be carried out at the initiation of the surgical procedure. The effect of these drugs is longer than the intervention duration and will not influence the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing oocyte retrieval requiring a sedation associating sufentanil and propofol
* Contactable by phone the day after the procedure.
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Corneal or conjunctival diseases in progress,
* Claustrophobia
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties or neuropsychiatric disorder
Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer

The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).

This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of EGFR mutation (including T790M positivity) using cobas real-time PCR and droplet digital PCR (DDPCR) in patients with NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years
* Obtained written informed consent
* Patients diagnosed with NSCLC by histology or cytology and inoperable stage IV at the time of study enrollment
* Patients with the following EGFR gene mutations: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)
* Patients previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib as first line therapy
* Patients who had shown clinical benefits (CR, PR, SD) from EGFR-TKIs and had been confirmed PD on those therapy according to RECIST v 1.1.
* Patients who underwent liquid biopsy (plasma) for EGFR mutation at the time of PD on EGFR-TKIs
* Patients who plan to undergo tissue biopsy for EGFR mutation at the time of PD on EGFR-TKIs

Exclusion Criteria:

* Patients who withdraw informed consent
* Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for EGFR mutation based on the investigator's judgement
Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH

36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum, (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3) represents control group where participants are exposed to paraffin pellet chewing. The pH of saliva will be evaluated according to time in relation to the gum chewing (T) where (T0) represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of the day (in the morning from 10 to 11 am).

Direct benefit of the research to the human volunteer:

It is important for high caries risk patients to decrease caries susceptibility as this will eventually decrease their dental treatments and subsequently the treatment cost.

Scientific value and social benefits:

This study will benefit the dentist as the main goal of a dentist is to prevent rather than cure. Also, it will decrease the restorative work carried out by dentist and save this time for educating more patients about caries prevention methods.

Expected risk to the human subjects:

Allergic reactions due to any of the components of the materials used which is rare to occur.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for the trial must comply with all of the following at randomization.

  1. Age range from 20-50 years
  2. High caries risk patients defined according to American Dental Association (ADA)
  3. Acidic baseline saliva pH
  4. Systematically healthy
  5. Not taking any medication interfering with saliva secretion
  6. Subjects who signed informed consent

Exclusion Criteria:

* (1) Subjects who wore orthodontic appliances or removable prosthesis (2) Subjects suffering from any medical or systematic disease (3) Smokers (4) Pregnant females (5) Allergy to any of chewing gum ingredients