cyrilzakka/clinical-trials huggingface dataset:
Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy?

To date, there is a lack of large-scale randomized controlled study using AI assistance in the detection of polyps/adenoma in a screening population. The correlation of fecal occult blood test (FIT or FOBT) and the advantage of AI-assisted colonoscopy has not been investigated. There is also a lack of information of the benefit of AI-assisted colonoscopy in experienced colonoscopist versus trainee/resident.

There are several studies showing that AI-assisted colonoscopy can help in identifying and characterizing polyps found on colonoscopy.

* Byrne et al demonstrated that their AI model for real-time assessment of endoscopic video images of colorectal polyp can differentiate between hyperplastic diminutive polyps vs adenomatous polyps with sensitivity of 98% and specificity of 83% (Byrne et al. GUT 2019)
* Urban et al designed and trained deep CNNs to detect polyps in archived video with a ROC curve of 0.991 and accuracy of 96.4%. The total number of polyps identified is significantly higher but mainly in the small (1-3mm and 4-6mm polyps) (Urban et al. Gastroenterol 2018)
* Wang et al conducted an open, non-blinded trial consecutive patients (n=1058) prospectively randomized to undergo diagnostic colonoscopy with or without AI assistance. They found that AI system increased ADR from 20.3% to 29.1% and the mean number of adenomas per patients from 0.31 to 0.53. This was due to a higher number of diminutive polyps found while there was no statistic difference in larger adenoma. (Wang et al. GUT 2019). In this study, they excluded patients with IBD, CRC and colorectal surgery. The patients presented with symptoms to hospital for investigation.

To date, there is a lack of large-scale randomized controlled study using AI assistance in the detection of polyps/adenoma in a screening population. The correlation of fecal occult blood test (FIT or FOBT) and the advantage of AI-assisted colonoscopy has not been investigated. There is also a lack of information of the benefit of AI-assisted colonoscopy in experienced colonoscopist versus trainee/resident.

Eligibility Criteria:
Inclusion Criteria

* Patients receiving colonoscopy screening
* Patients aged 45-75 years
* Both patients who have or have not done a FIT test and both FIT +ve and FIT -ve subjects

Exclusion Criteria

* Patients who have symptom(s) suggestive of colorectal diseases
* Patients who have a history of inflammatory bowel disease, colorectal cancer or polyposis syndrome (anaemia, bloody stool, tenesmus and obstructive symptoms)
* Patients who had colonoscopy or other investigation of colon and rectum in the past 10 years
* Patients who had surgery for colorectal diseases
* Patients who cannot tolerate bowel preparation or have suboptimal bowel preparations (Boston Bowel Preparation Scale)
* Cannot reach caecum
* Patients who are incompetent in giving informed consent
Elastography in Boys With Epididymo-orchitis

The patients treated in our clinic for epididymoorchitis will be given scrotal shear wave elastography by the Department of Radiology and affected testis will be compared to non affected testis radiologically. Shear wave elastography is a method of ultrasonography, which allows the focused ultrasonographic wave to be directed to the selected tissue to produce deformation of the tissue and to obtain the numerical data on the tissue elasticity by measuring the speed of the wave when the tissue is recovered. The higher the wave velocity, the lower the elasticity of the tissue.

The data to be obtained by this method will be compared statistically.

Epididymo-orchitis is an inflammatory disease of the epididymis and / or testis. The clinical picture is manifested by sudden onset testicular pain and swelling. The differential diagnosis of testicular torsion should be made in the pediatric age group. While urgent surgery is required in testicular torsion, treatment with epididymo-orchitis consists of antiinflammatory and cold application. Scrotal ultrasonography is used in the differential diagnosis and epididymo-orchitis is diagnosed in epididymis.

The scrotal ultrasound for the control after the patient's symptoms have regressed gives an idea about the course of the inflammatory process. In recent years, the introduction of elastography, which is an advanced ultrasound technique, has begun to suggest the evaluation of the elasticity of testis and epididymis in various scrotal diseases.

In epididymo-orchitis, a disease that is known with inflammation of the testicular parenchyma, a study evaluating whether there is a permanent change in the testicular parenchyma after inflammation has regressed is not yet available in the English literature. In this study, it is planned to evaluate the pediatric patients from this perspective and contribute to the literature with the results to be obtained.

Eligibility Criteria:
Inclusion Criteria:

* To be followed-up and treated in the Department of Pediatric Surgery at Trakya University due to epidididymo-orchitis. (Inpatient and / or outpatient clinic)
* 18 years old or younger
* Approval by the legal guardian

Exclusion Criteria:

* Bilateral epididymo-orchitis
* Testicular pathology other than epididymo-orchitis (undescended testis, testicular torsion)
* Scrotal surgery (due to epididymoorchitis or not)
* Older than 18 years old
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Participants With Controlled Blood Pressure

This was a Phase 2, double-blind, randomized, placebo-controlled study of IONIS-AGT-LRx conducted in mild hypertensive participants.

Participants were randomized in a 2:1 ratio to receive a once-weekly subcutaneous treatment and an additional loading dose on Study Day 3 with either IONIS-AGT-LRx or placebo for 6 weeks.

All participants completed a 13-week Post-Treatment Period.

Eligibility Criteria:
Inclusion Criteria

1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method
3. Body Mass Index (BMI) ≤ 35.0 kg/m2
4. Participant must have been diagnosed with essential hypertension for a minimum of 3 months prior to screening
5. At Screening, on a stable regimen of antihypertensive medications for at least 1 month prior to screening
6. Agree to conduct at home Blood Pressure (BP) and Heart Rate (HR) monitoring three times weekly and document the average of the triplicate measurements assessed on a day in the patient diary

Exclusion Criteria

1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a participant unsuitable for inclusion
2. The use of the following at time of screening and during the course of the study:

   1. Other medications for the treatment of hypertension (e.g., clonidine, guanfacine, guanabenz, alpha-methyldopa, hydralazine, minoxidil, diazoxide, renin inhibitors)
   2. Medications that also may cause hyperkalemia (e.g., cyclosporine or tacrolimus, pentamidine, trimethoprim-sulfamethoxazole, all heparins)
   3. Oral or subcutaneous anticoagulants (e.g., warfarin, rivaroxaban, apixaban, heparin, lovenox)
   4. Organic nitrate preparations (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, or pentaerythritol)
   5. Sildenafil, tadalafil, vardenafil
3. Unwilling to discontinue antihypertensive mediations during Wash Out (WO) and Treatment Period of study
4. Participant has a history of secondary hypertension
5. Unstable/underlying cardiovascular disease defined as:

   1. Any history of congestive heart failure (NYHA class II-IV)
   2. Any history of previous stroke, transient ischemic attack, unstable or stable angina pectoris, or myocardial infarction prior to screening
   3. a history or evidence of long QT syndrome
   4. Any CS active atrial or ventricular arrhythmias
   5. Any history of coronary bypass or percutaneous coronary intervention
Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.

The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).

Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.

The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).

Both groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore.

Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between 18 and 65 years old;
* Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy;
* Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ;
* Presence of adipose degeneration ≤ 2 according to Goutallier;
* Written informed consent to participate in the study

Exclusion Criteria:

* Presence of a lesion of other rotator cuff tendons;
* Previous surgical procedures of the shoulder;
* Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI;
* Presence of relapsing shoulder dislocations;
* Presence of lesions of the glenoidine cercine that require intervention;
* Difficulties to follow the rehabilitation programs;
* Presence of neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases and immunosuppressed patients;
* State of pregnancy (presumed or established) or breastfeeding.
Stapler Versus Glue for Laparoscopic Groin Hernia Repair

Repair of inguinal hernia is the most common operation of the general surgeon. In recent years, it was recognized that chronic postoperative pain is as important for postoperative outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated patients. Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.

Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.

To perform a prospective randomized trial comparing pain after inguinal hernia repair using either fixation with stapler or histoacryl.

The standard TAPP procedure is performed under general anesthesia. Patients receive a single shot antibiotic prophylaxis, using Amoxicillin/Clavulanic Acids. Operations are performed by resident surgeons under supervision, consultants or senior consultants. After hernial sac dissection and retraction, preperitoneal fat is removed bluntly and Cooper's ligament is identified. A Vypro II ® (Ethicon ®) prosthetic mesh, 10x15 cm, is placed and fixed depending on randomization with either 5 mm Protack TM (Autosuture TM) or Glubran ® 2 (G.E.M., Viareggio, Italy). Randomization is performed in permutated block of 20 using sealed envelopes. Where tissue glue is used, meshs are additionally fixed caudally and laterocaudally. Peritoneal closure over the mesh is performed using resorptive sutures. Glubran ® 2 is a cyanoacrylate tissue adhesive. Follow up assessment: The use of analgesics in the postoperative period is standardized using paracetamol and morphine derivates. Following discharge patients are liberated of physical restrictions. Patient follow-up will be performed after 6 weeks, 6 and 12 months postoperatively. Patients are advised to mention pain in the operated groin area. In addition the Visual Analogue Scale is used to evaluate pain intensity.Statistical comparison is done using Mann-Whitney Test and Chi square Test (significance p \< 0,05).

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for laparoscopic primary inguinal hernia repair
* uni- or bilateral patients with recurrent hernias after anterior surgical technique
* written informed consent

Exclusion Criteria:

* general contradictions for laparoscopy
Effectiveness of Health Literacy Education

To determine the effect of health literacy education given to nursing students. The study was conducted at two university nursing departments in Turkey between December 2018 and March 2019. A total of 206 nursing students, 103 in the intervention and 103 in the control group, were included in the study. Health literacy education, consisting of four sessions, was given to the intervention group.


Eligibility Criteria:
Inclusion Criteria:

* Inadequate (0-25 points) health literacy level
* Problematic-limited (25-33 points) health literacy level
* Accepting to participate in the research
* Accepting to participate in the research

Exclusion Criteria:

* Adequate (33-42 points) health literacy level
* Excellent (42-50 points) health literacy level
* Foreign language students with limited language proficiency
* Visual-hearing disability
* Having a neuropsychiatric disease
Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.

MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥18 years of age.
2. Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which involves partial or complete mandibular bony impaction.
3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery in the eligibility assessment as well as in the baseline assessment immediately pre-dosing.
4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery.

Exclusion Criteria:

1. Previously dosed with MR-107A-02.
2. Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may affect coagulation.
4. Moderate or severe hypertension, prior stroke or transient ischemic attack.
5. Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.
6. Use of medications with the potential to interact with MR-107A-02.
7. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator.
Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery

The study aims to investigate whether tailoring limb lengths based on the 1/3rd and 2/3rd concept improves clinical outcomes in Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery compared to conventional limb lengths. In this study, two groups were described, first group involves patients who will undergo Lap RYGB with conventional limb lengths of 75cms and 125cms, while the second group is given tailored limb lengths according to the total small bowel length. In the follow up period, Total percentage weight loss, improvement in BMI along with the remission of co-morbidities were also assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years
2. Body Mass Index (BMI):

   BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea).
3. ASA - less than or equal to 3
4. Informed Consent: Ability and willingness to provide written informed consent and comply with procedures.
5. Previous Weight Loss Attempts: Documentation of previous attempts at weight loss through diet, exercise, or medical management.

Exclusion Criteria:

1. Previous Bariatric Surgery: Prior bariatric or major gastrointestinal surgery that might affect the outcome of RYGB.
2. Severe Cardiopulmonary Conditions: Significant cardiac or pulmonary conditions that pose a high surgical risk (e.g., severe congestive heart failure, severe chronic obstructive pulmonary disease).
3. Uncontrolled Psychiatric Disorders: Severe psychiatric illness or substance abuse issues that are not well-controlled, including eating disorders.
4. Pregnancy: Current pregnancy or plans to become pregnant within 12 months post-surgery.
5. Malignancy: Active malignancy or history of malignancy requiring treatment in the past 5 years (excluding non-melanoma skin cancer).
6. Severe Liver Disease: Cirrhosis or significant liver dysfunction (e.g., Child-Pugh B or C).
7. Inability to Comply: Patients who are unable or unwilling to comply with the postoperative follow-up schedule and dietary requirements.
8. Chronic Use of Medications: Chronic use of medications known to affect weight or metabolism significantly, such as corticosteroids or antipsychotics.
9. Other Medical Conditions: Any other medical condition or surgical finding that, in the opinion of the investigators, would make the patient unsuitable for the study.
Tabata vs Plyometric Training on Range of Motion, Agility and Vertical Jump in Taekwondo Players

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah Internatinal University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive tabata training. Group B will receive plyometric training.

the objective of the study is to determine the effects of tabata training versus plyometric training on range of motion of ap chagi, agility and vertical jump in taekwondo players. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah Internatinal University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive tabata training. Group B will receive plyometric training. The outcome measures will be assessed by goniometrer, quadrant jump test - agility and vertical jump test.

The data will be analyzed by SPSS, version 25. Statistical significance is P= 0.05.

Eligibility Criteria:
Inclusion Criteria:

Taekwondo players, Both male and female players., Players aged 12- 25 years, Players who are playing taekwondo from at least past six months, Individuals with BMI between 18.5- 24.9

Exclusion Criteria:

Out of practice players, Players with any musculoskeletal injury within past four weeks, Unwilling participants, Players with any systemic disease
Zero Heat Flux Thermometry System Comparison Trial

Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.

The core temperature of the body normally decreases in response to anesthesia. Deep tissue temperature can be used to estimate of body core temperature. Deep tissue temperature of the forehead will be measured using a new technology known as zero-heat-flux thermometry. The usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 17 years old
* patients undergoing surgery during which core temperature is estimated
* Willing to participate in trial
* Able to provide consent
* Adequate forehead surface area available for probe attachment
* Urology, orthopedic, or general abdominal surgery

Exclusion Criteria:

* Skin lesions at thermometer target site
* Infectious disease
* Bleeding disorder
* Prone intraoperative positioning anticipated
* Head and neck procedures
* Cardiothoracic procedures
* Tonsillectomy, cosmetic, or other brief surgical or nonsurgical procedures