cyrilzakka/clinical-trials huggingface dataset:
AI-assisted White Light Endoscopy to Identify the Kimura-Takemoto Classification of Atrophic Gastritis

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification.

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. The higher the score, the more severe the degree of atrophic gastritis. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification of atrophic gastritis to achieve gastric cancer risk assessment.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-80 years who undergo the white light endoscope examination Informed consent form provided by the patient.

Exclusion Criteria:

1. patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric;
2. disorders who cannot participate in gastroscopy;
3. Patients with progressive gastric cancer;
4. low quality pictures;
5. patients with previous surgical procedures on the stomach or esophageal;
6. patients who refuse to sign the informed consent form;
Usage of Procalcitonin to Reduce Antibiotics Duration in VAP in Neurosurgical ICU

Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia

Patients who are more than 18 years old who are admitted to Neurosurgical ICU will be recruited 48hours after ventilation if matches criteria for ventilator associated pneumonia. Patients will be randomised into 2 groups. first group will be procalcitonin guided in addition to conventionally guided sepsis assessment (TWC, CRP, body temperature). second group is only conventionally guided sepsis assessment. in procalcitonin guided group, blood sample will be taken on Day 1 of recruitment and day 5. On day 5 , the procalcitonin level will be compared to recommendations in PRORATA trial. If procalcitonin level is below the level to withhold antibiotics, recommendation will be made to the primary physician to off the antibiotics. Another Procalcitonin level will be repeated on Day 7 to rule out reinfection. This study aims to compare the duration of antibiotics and length of ICU stay among the 2 groups.

This study will fill up the gap among the lack of datas in neurosurgical patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Neuro-ICU \& Trauma ICU
* Patients aged \>18 years old.
* Ventilation for \>48 hours
* VAP and treated with antibiotics \<24hours prior to inclusion in trial.
* Patient with arterial line or central line

Exclusion Criteria:

* Patients who are on antibiotics but not assumed or proven to have VAP
* Expected short ICU stay (\<3 Days)
* Non-bacterial infections
* Long term antibiotic treatment (transplant or chemotherapy patients, endocarditis, osteomyelitis)
* Hospitalisation 48hours before enrolment
* Severe immunosuppression
* Pregnancy
* Primary team's decision to continue antibiotics for 14 days prior to trial
* DNAR or expected to die within 5 days
Evaluation of the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III-IV

Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.

The Main objective of this study is to evaluate the faisibility of chemotherapy with Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV and to determine principal predictive factors of this feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proven diagnosis of epithelial ovary cancer F.I.G.O stages III or IV (when only cytological proven diagnosis is available: malignant cells and pelvis tumoral mass and increased CA-125 must be diagnosed simultaneously)
* Patient aged \> 70 years
* Neutrophil polynuclears \> 1500/mm3 and Platelets \> 100 000/mm3
* No clinical icterus
* Life expectancy of at least 3 months

Exclusion Criteria:

* Previous diagnosis of malignancy
* Previous chemotherapy treatment
* Previous radiotherapy
* Hypersensitivity to products containing Cremophore EL
* Hepatic values: bilirubine \> 2\*LSN, SGOT-SGPT \> 2\*LSN and/or Alkalin phosphatase \> 3\*LSN
* Myocardiopathy with arrhythmia
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition

The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of taking megestrol
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma

Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.

Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.

ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).

Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with head and neck carcinoma
* Age 18-65

Exclusion Criteria:

* Recurrent head and neck carcinomas
* Previously diagnosed oesophageal cancer
Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

This is an observational study designed to determine whether veterans with PTSD have a higher risk of heart disease than those without PTSD. Cardiovascular risk will be assessed by interview and review of medical records, carotid artery ultrasound, and blood tests measuring markers of inflammation. Study participation is approximately 6 months. The eligible study population is veterans of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), age 28 through 38 years.


Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF veterans at the VASDHS
* Between 28 and 38 years of age
* Willing to complete structured diagnostic interview for PTSD, CIMT ultrasound and blood test
* Willing to have a review of their medical records
* Able to give informed consent
* Have a negative urine pregnancy test, if a woman of child-bearing age

Exclusion Criteria:

* Do not meet inclusion criteria
* History of schizophrenia, other neurocognitive illness (including severe TBI by INTRuST criteria)) or active alcohol and/or drug abuse determined by chart review, interview or AUDIT-C score
* Inability to complete study tests within 18 months of study start
* Pregnancy
Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia

The purpose of this placebo controlled interventional study is to collect preliminary data on administering dexmedetomidine in patients with Familial Dysautonomia (FD) during a rapid cessation of autonomic crisis. The primary aims are to assess the feasibility and evaluate if measurements of heart rate, blood pressure and oxygen saturation can predict the start of an autonomic crisis.

Funding Source- FDA OOPD


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Familial Dysautonomia.
* One or more autonomic crises during the last year.
* Our database shows evidence of autonomic crisis, previous treatment with IV dexmedetomidine, and registered medical data within the year preceding the study.
* Age 16 years or older
* The patient has a responsible caretaker to communicate with the medical providers.
* Provision of signed and dated informed consent form from the patient and responsible caregiver
* Able to state willingness to comply with all study procedures and availability for the duration of the study
* For males and females of reproductive age: use condoms for contraception if sexually active.

Exclusion Criteria:

* At the consideration of the principal investigator, the caregiver cannot fully understand the protocol, or communicate during the crisis with the Center.
* The patient during the crisis, before taking the medication, has any of the following:

  1. Oxygen saturation less than 92% on room air or baseline need for oxygen, change from baseline oxygen dependency.
  2. Respiratory rate \>25 breaths per minute.
  3. Supine blood pressure ≤ 90/860mmHg
  4. Febrile illness with temperature \>100.3 F.
  5. Serological signs of infection (WBC count \>10 g/dL, or CRP \>10 mg/L or ESR\>20, or above their steady historical baseline levels) in recent (less than one month) studies.
* The patient is a female and has a positive pregnancy test.
* The Montreal Cognitive Exam (MoCA) is below 25 points.
Outcomes on Teeth Prepared With BOPT

The aim of this study is to evaluate the clinical and biological behavior of full coverage restorations on teeth prepared without finish line in a prospective clinical study.

The purpose is to evaluate the clinical and biological behavior of full coverage restorations on teeth prepared without finish line.

This prospective study included 149 teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD). Restorations were fabricated with zirconium oxide cores and ceramic coverings. Patients attended regular annual check-ups when probe depth, presence of inflammation with bleeding on probing, presence of plaque, gingival thickness, marginal stability, biological or mechanical complications, and the patient's level of satisfaction were registered.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged over 18 years).
* non-smokers.
* periodontally healthy or periodontally managed.
* patients who had undergone restoration with fixed prostheses (one-piece crowns or fixed partial dentures FPDs) in the aesthetic zone (incisors, canines, premolars, first molars), which needed to be replaced due to biological, esthetic or some other type of problem.

Exclusion Criteria:

* patients who were smokers.
* patients who presented unmanaged parafunctional habits.
* patients with severe systemic diseases.
Evaluation of CO Intoxication Rate, by CAPillary HbCO

The main goal of COCAP is to compare COHb (carboxyhemoglobin) levels measured from venous or arterial samples with those measured from capillary samples in patients suspected of Carbon Monoxide intoxication.Patient participation in the study will be limited to capillary sampling (approx. 5-15 minutes).


Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted to emergency department
* Presenting one or more clinical signs (asthenia, headache, nausea, vomiting, loss of consciousness, etc.) and a history compatible with CO intoxication (collective symptoms, notion of smoke, activation of a detector, etc.).

Exclusion Criteria:

* Minors
* Patients under protective supervision (safeguard of justice, curatorship, guardianship)
* Incarcerated patients
* Pregnant or breast-feeding women
* Patients refusing to take part in the study
Effects of On-Line Hemodiafiltration(HDF) on Vascular Health in Chronic Hemodialysis Patients

The purpose of this study is to determine whether on-line hemodiafiltration ameliorate the endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease patients on maintenance hemodialysis.

1. On-line hemodiafiltration(OL-HDF) is a technique that combines diffusion with convection in which the large substitution fluid is produced directly from the dialysate. It offers many advantages aside from its safe inflammatory profile, which is attributable to the use of ultrapure dialysate and highly biocompatible dialysis membranes. Due to an improved convective clearance, significantly increased removal of large or protein-bound uremic retention solutes can be achieved, with a potential benefit on cardiovascular morbidity and mortality.
2. Endothelial dysfunction, almost universal in end stage renal disease, is important risk factor for cardiovascular events, and can be evaluated by brachial artery endothelium-dependent vasodilation (flow-mediated dilation) to reactive hyperemia following 5 min of forearm ischemia.
3. The stable HD patients will receive 8-week treatment on OL-HDF or conventional low flux HD and then crossed over to opposite treatment arm. The FMD will be measured by one sonographer, and at the same time whole blood and serum will be sampled and stored for further analysis. The timepoint for measurement is 4-week interval after baseline evaluation.

Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease on maintenance hemodialysis for more than 3 months

Exclusion Criteria:

* diagnosis of active cardiovascular diseases in 6 months
* elevation of liver enzymes over two fold of upper normal limit in 3 months
* admission for acute infection in 3 months
* untreatable stenosis of vascular access
Cerebello-thalamo-cortical Coupling in Essential Tremor

Essential tremor (ET) is a frequent and disabling disorder with progressive worsening of postural tremor of the upper limbs that impairs most of the manual activities of every day life (feeding, drinking, etc.). Although the pathophysiology of essential tremor (ET) is not fully elucidated, tremor is associated with abnormal activity within different brain regions, in particular the thalamus and the cerebellum. Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM-Thal) reverses the symptoms of tremor but is an invasive procedure. Transcranial stimulation of the cerebellum may represent a non-invasive therapeutic option for ET patients. Here, the investigators propose to test the efficacy of cerebellar stimulation in 15 ET patients previously operated for DBS of the thalamus. To further understand how this treatment provokes tremor reduction, the investigators will analyse the brain neuronal activity in 13 others ET patients candidate to thalamic DBS by using combined electrophysiological recordings of the thalamus (with the electrodes implanted), the cerebellum and the cortex with magnetoencephalography.


Eligibility Criteria:
Inclusion Criteria:

* age below 75 years
* diagnosis of essential tremor according to the criteria of the Tremor Investigation Group and the Consensus statement of the Movement Disorder Society Group (ref)
* health insurance
* signed informed written consent

Exclusion Criteria:

* other neurological disorders
* medications that interact with or influence brain excitability
* significant brain lesions detected in MRI
Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged from 20 to 80 years (at inclusion visit).
2. Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent.
3. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
4. And having signed a written informed consent.-

Exclusion Criteria:

1. Known Type 1 Diabetes, uncontrolled type 2 diabetes \[HbA1c \> 9.5 %, Fasting plasma glucose (FPG) \> 240 mg/dL (\> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)\].
2. TG \> 500 mg/dL (\> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
3. Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (\> 1 year since their last menstrual period).
4. Pregnant or lactating women.
Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.

This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study product daily for 10 weeks. The study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Body mass index between 18.5 through 39.9 kg/m2
3. At least three symptoms rated between 4 to 6 in severity (moderate to severe discomfort) on a 1 to 7 scale, one of which must be acid indigestion as determined by the "Reflux Syndrome" score
4. Self-reported "acid indigestion" symptoms (including pain/discomfort beneath the breastbone, bitter fluid in the mouth, or bloating/nausea after eating) at least 3 times per week over the previous 4 weeks
5. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
6. Able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects

Exclusion Criteria:

1. Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale
2. Diagnosed gastrointestinal disease/complication or functional bowel disorder (e.g. IBS, functional constipation, IBD, ulcer, etc.) based on physical examination or documented medical history that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
3. Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
4. Regular (\>3 days per week) prescription medication use for any gastrointestinal disease/condition
5. Recent (\<6 months) abdominal surgery for any reason
6. Immunodeficiency
7. Recent change in anti-psychotic medication within the previous 3 months
8. Systemic steroid use within the prior month, excluding regular use of asthma medication
9. Pregnant female or breastfeeding
10. Eating disorder
11. Recent (within 2 weeks) antibiotic administration
12. History of alcohol, drug, or medication abuse
13. Daily consumption of probiotics, fermented milk, and/or yogurt
14. Known allergies to any substance in the study product
15. Participation in another study with any investigational product within 30 days of screening
Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer

RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer will come back. It may also help the study of prostate cancer in the future.

PURPOSE: This clinical trial is studying whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer.

OBJECTIVES:

* Determine bone mineral density (BMD) in patients with clinically significant early stage prostate cancer.
* Determine whether patients who have a higher level of BMD and have had a radical prostatectomy for cure are less likely to have an early relapse (i.e., less than 3 years) than those patients with a low level of BMD.

OUTLINE: This is a case-controlled study followed by a prospective, longitudinal, cohort study.

Patients undergo bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry with a densitometer. Posteroanterior measurements of the total hip are also recorded.

Patients also undergo blood collection to examine markers that provide evidence of systemic disease.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-confirmed early stage prostate cancer

  * Disease localized within the capsule
  * No evidence of regional or distant spread (i.e., T1-2, N0, M0 disease)
  * A cohort of patients must have undergone a prior radical prostatectomy
* Prostate specific antigen \< 12 ng/mL
* Gleason score ≥ 6

PATIENT CHARACTERISTICS:

* Creatinine clearance ≤ 2.0 mg/dL
* No Paget's disease
* No hyperthyroidism or hypothyroidism
* No Cushing's disease
* No chronic liver disease
* No major health problems that would cause a significant reduction in mobility or activities of daily living

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior bisphosphonates, thyroxin, or calcitonin
* No prior agents that suppress PSA levels (e.g., finasteride)
* No prior androgen or estrogen therapy
* More than 12 months since prior glucocorticoids
* More than 12 months since prior herbal supplements that are known to lower PSA levels
A New Etiological Cause for Anterior Cruciate Ligament Injury: E-Scooter

The investigators aimed to find the relationship between e-scooter use and anterior cruciate ligament injury.

The incidence of injuries related to e-scooter use is increasing. There is no study in the literature investigating the relationship between anterior cruciate ligament injury and e-scooter use.

Eligibility Criteria:
Inclusion Criteria:

* Participants with e-scooter related ACL injury

Exclusion Criteria:

* Participants with other ACL injury etiology