cyrilzakka/clinical-trials huggingface dataset:
A Deep Learning Approach to Identify Patients With Full Stomach on Ultrasonography

Preoperative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. And then build up effective clinical predictive models for identification of full stomach, which can predict the high aspiration risk.

Aspiration of gastric contents can be a serious anesthetic related complication. Preoperative fasting was a common practice to decrease perioperative aspiration risk. However，one of most important prescription of enhanced recovery after surgery protocols is the reduction of preoperative fasting time in opposition to the traditional recommendation of overnight fast. Gastric antral sonography prior to anesthesia may have a role in identifying patients at risk of aspiration. The aim of this study is to construct models using deep learning for identification of full stomach, which can predict the aspiration risk.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing surgery Age: 18\~85 yeas ASA 1\~3

Exclusion Criteria:

-Diabetes mellitus Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer Prior surgery to upper GI On medication that may affect gastric emptying time Pregnancy
A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers


Eligibility Criteria:
Inclusion Criteria for All Subjects:

1. Male and Female between 18 and 55 years old
2. BMI 18.0 to 32.0 kg/m\^2
3. Female subjects must have a negative serum pregnancy test at screening
4. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria

Exclusion Criteria for All Subjects:

1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
3. Subjects with a history of clinically significant drug allergy
4. Excessive use of alcohol defined as regular consumption of ≥14 units/week
5. Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up
6. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
7. Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section

The purpose of this study is to determine whether a single dose of gabapentin, given before cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of surgeries. We believe that it may be effective for treating pain after cesarean sections, but it has never been studied for this purpose.

A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive a single dose of a gabapentin before the surgery. We are also interested in whether or not the dose of gabapentin reduces the need for other pain-killing medication during this time.

Patients will be randomly assigned to receive either gabapentin or a placebo. In addition, all patients will receive the usual standard of care and medication for pain (intrathecal morphine,oral paracetamol and diclofenac). At 4, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The dose of gabapentin given is thought to be safe for the baby, and we plan to investigate whether the gabapentin has any effect on the baby's pain response when given his/her vitamin K injection. Gabapentin has also been shown to reduce long-term pain that can develop, and patients will be followed up at 6 weeks to be asked about their pain at that time.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing elective cesarean delivery

Exclusion Criteria:

* Patients unable to communicate in English
* Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
* Patients with contraindications to any of the medications used in the study
* Patients with contraindications to spinal anesthesia
* Patients who have taken any pain medication in the past week
* Patients with fetuses having congenital abnormalities
* Patients with severe mental disorders
* Patients with HIV or hepatitis infections
* Intravenous drug users
* Patients with uncontrolled hypertension and diabetes
* Patients with central nervous system tumours
Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome

To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls and women with Rett syndrome


Eligibility Criteria:
Inclusion Criteria:

1. Has completed the Week 12/End-of-treatment visit of the antecedent study, Study ACP-2566-003
2. Met all entry criteria for the antecedent study
3. May benefit from long-term treatment with open-label trofinetide in the judgment of the Investigator
4. Can still swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
5. The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
6. Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Baseline

Exclusion Criteria:

1. Began treatment with growth hormone during the antecedent study
2. Began treatment with IGF-1 during the antecedent study
3. Began treatment with insulin during the antecedent study
4. Has developed a clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
5. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study
6. Has a clinically significant abnormality in vital signs at Baseline
7. Has a QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of trofinetide is given in the present study
8. Has developed a clinically significant ECG finding during the antecedent study

Additional inclusion/exclusion criteria apply. Patients will be evaluated at baseline to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all prespecified entry criteria).
Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy

To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.

To date, no studies have compared the outcomes of thulium beam coagulation versus suture renorrhaphy for hemostasis of tumor bed in laparoscopic partial nephrectomy in patients with small renal messes (SRMs).

This study aims to compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.

The investigators hypothesize that:

Conducted well designed, randomized prospective comparative study can help to identify which technique is better.

Using thulium beam coagulation for hemostasis of the tumor bed in laparoscopic partial nephrectomy can improve the outcome, shorten intraoperative ischemia time and decrease blood loss.

Eligibility Criteria:
Inclusion Criteria:

* cT1 single renal mass.

Exclusion Criteria:

1. Absolute contraindication for laparoscopic surgery (e.g., severe cardiopulmonary insufficiency, and chronic obstructive lung disease).
2. Renal mass involving the hilum.
3. Renal mass in patients with chronic kidney disease.
Postoperative Oral Intake Trial

Complete fasting until resumed bowel function after upper abdominal surgery is not beneficial. Enteral feeding has been claimed to be the preferred way of delivering nutritional support postoperatively. Increasing evidence suggests that letting patients eat ("voluntary oral feeding" or "oral intake at will") from the day after the operation is safe. No prospective randomised trial has been undertaken to compare these two regimens. In this study, the investigators will randomise 444 patients, subject to major upper abdominal surgery, into receiving either continuous enteral feeding by needle catheter jejunostomy until resumed bowel function, or to oral intake at will from postoperative day 1. The main endpoints are the incidence rate of major complications and death, as well as a Quality of Life assessment.

Null-Hypothesis:

Routine postoperative feeding by needle catheter jejunostomy after major, upper abdominal surgery has no clinically relevant advantages over early oral intake at will.

Complete fasting until resumed bowel function after upper abdominal surgery is not beneficial. Enteral feeding has been claimed to be the preferred way of delivering nutritional support postoperatively. Increasing evidence suggests that letting patients eat ("voluntary oral feeding" or "oral intake at will") from the day after the operation is safe. No prospective randomised trial has been undertaken to compare these two regimens. In this study, we will randomise 444 patients, subject to major upper abdominal surgery, into receiving either continuous enteral feeding by needle catheter jejunostomy until resumed bowel function, or to oral intake at will from postoperative day 1. The main endpoints are the incidence rate of major complications and death, as well as a Quality of Life assessment.

Null-Hypothesis:

Routine postoperative feeding by needle catheter jejunostomy after major, upper abdominal surgery has no clinically relevant advantages over early oral intake at will.

Eligibility Criteria:
Inclusion Criteria:

* Adults subject to major, upper, open abdominal surgery (exceeding simple cholecystectomies and fundoplications)

Exclusion Criteria:

* Crohns disease
* Mentally disabled
* Pre-op dependency on intravenous (IV) nutrition
* Expected life duration of less than 3 months
Barrett's Esophagus in Olmsted County

To compare participation rates in screening for Barrett's Esophagus (BE) using sedated esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a population based cohort. An age and gender stratified random sample of 300 patients from a previously defined (in terms of the presence or absence of symptoms of gastroesophageal reflux using a validated questionnaire) population based cohort from Olmsted County11, 12 using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR conventional sedated endoscopy. The investigators will compare participation rates in the three arms.

To identify factors associated with non-participation in population screening for BE. The investigators will compare demographic and clinical factors in participants and non-participants, to help predict non-participation using data from prior surveys (data has been collected on patient demographics, bowel and reflux symptoms, employment, education, somatization behavior, psychological profiles using the validated Gastroesophageal Reflux questionnaire \[GERQ\] and the Bowel Disease Questionnaire \[BDQ\]) which have been completed by all targeted subjects. This preliminary will allow us to identify barriers to screening and develop interventions to increase participation in future larger studies.


Eligibility Criteria:
Inclusion Criteria:

* Olmsted county resident

Exclusion Criteria:

* History of known BE or endoscopy within the last 5 years;
* History of progressive dysphagia;
* Known Zenker's diverticulum;
* Known epiphrenic diverticulum;
* Known or suspected intestinal obstruction;
* Cardiac pacemakers or other implanted electro-medical devices;
* Pregnancy;
* Patient expected to undergo MRI examination within 7 days after ingestion of the capsule;
* History of prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or uncomplicated cholecystectomy) within the last six months; pregnancy;
* History of recurrent epistaxis, moved from Olmsted County or deceased;
* Significant illnesses that might impair ability to complete questionnaires (e.g. metastatic cancer, major stroke); and
* Any contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel \[Plavix\]).
Offering Free Fruits and Vegetables to Men at Risk of Poverty

The study aims to investigate whether the provision of free fresh fruits and vegetables to middle-aged men at risk of poverty increases their fruit and vegetable intake over a period of 4 weeks.

A total of 100 men (\> 30 years, living alone) with a low SES will be randomly assigned to a control or intervention group while controlling for food bank use. The intervention group will receive free fresh fruits and vegetables consisting of 2 daily portions of their favorite variety over a period of 4 weeks which will be provided to them once per week.

All participants will be asked to fill out a demographic questionnaire as well as a Food Frequency Questionnaire (FFQ), a questionnaire on variety of fruits and vegetables consumed and a 24-h-food-recall questionnaire. All questionnaires will be administered by trained interviewers. During the study period, the 24h-food recall questionnaire will be administered four more times; two times before the 4-week intervention period and two times after the intervention period. After the 4-week intervention period, interviewers will administered the FFQ and the questionnaire on variety.

Participants assigned to the control group will receive a fruit and vegetable basket after 4 weeks after baseline.

All participants will receive gift certificates for local supermarkets in the amount of 35,00 €.

Eligibility Criteria:
Inclusion Criteria:

* income below 980 € per month
* \> 30 years of age
* living alone
* without regular food delivery service (except for e.g. meals on wheels once a day)
* born in Germany
* speaks German

Exclusion Criteria:

* lives in assisted living accommodations
Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft

The correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. One of these chin repositioning techniques, called "Chin Wing", cuts the bone to optimize the functional and aesthetic result. While all genioplasty techniques expose the risk of nerve damage and lack of bone consolidation, these parameters are only rarely addressed in the literature in the specific context of this extensive bone cutting.

The objective of this work is to assess the satisfaction of patients who have benefited from chin advancement surgery using the "Chin Wing" technique.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥ 18 years old)
* having undergone "Chin Wing" type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022.
* Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed their opposition to the reuse of their data for scientific research purposes
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer

This study is PhaseⅠstudy to evaluate the tolerability and safety of ONO-4578 and ONO-4538 in combination with standard-of-care docetaxel and ramucirumab as second-line therapy in patients with advanced or recurrent NSCLC who were refractory to a combination therapy containing an anti-PD-(L)1 antibody and a platinum-based drug


Eligibility Criteria:
Inclusion Criteria:

1. Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer
2. Life expectancy of at least 3 months
3. Patients with ECOG performance status 0 or 1

Exclusion Criteria:

1. Patients with severe complication
2. Patients with multiple primary cancers
A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649

The purpose of this study in healthy elderly people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649- The pharmacodynamic activity of PF-06743649 will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 65 and 85 years, inclusive. Ideally at least 25% of the subjects enrolled in each cohort will be 75 years of age and above at Screening. Subjects must be healthy as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory test results. Subjects with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the investigator.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Evidence of gout/hyperuricemia, measured sUA \>8 mg/dL at screening.
* Experienced an episode of nephrolithiasis or ureterolithiasis.
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma

The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Clinical history of asthma
* Ability to perform spirometry

Exclusion Criteria:

* Chronic obstructive pulmonary disease or bronchiectasis
* Upper or lower respiratory infection
Expanded Access for Bromodomain and Extra-Terminal (BET) Inhibitor

This is an expanded access designed to provide access to Bromodomain and Extra-Terminal (BET) Inhibitor for eligible participants.


Eligibility Criteria:
Long Term Safety of the Sonitus SoundBite System

The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.

The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled calibration software for subject calibration. The Sonitus BCD picks up sounds from a microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the natural pinna and ear canal. The signal picked up by the microphone is then transmitted wirelessly to a removeable bone conduction oral appliance located on the upper molars. The oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory signal to the teeth that reaches the skull via bone conduction and routed transcranially to the contralateral cochlea.

Eligibility Criteria:
Inclusion Criteria:

* Must be \>18, \<80 years old
* Must be fluent in English, as determined by the PI
* Must not be a member of a vulnerable group (IRB defined)
* Must remain in geographic area during duration of the study
* Diagnosis of acquired SSD (Section 3.1), time since onset (≥3 mos)
* Must have a minimum of 6 posterior teeth remaining in the upper arch (3 teeth per side),third molars are acceptable if healthy, fully erupted and substituting for second molars

Exclusion Criteria:

* Must not be current users of devices such as Baha, CROS or TransEar
* Must not have known active medical causes of SSD

  * Active middle ear pathology
  * Conductive HL (Otosclerosis, otitis media, otitis externa and others)
  * Sudden hearing loss that is not stable
* Must not have known medical problems that might be life-threatening or is a contraindication for elective dental or medical procedures
* Must not have a history of seizures
* Must not have known problems that may interfere with the impression procedure, such as inability to breath through nose (e.g. severe flu, allergies or cold)
* Must not have allergies to polymers
* Must not have known dental abnormalities

  * Temporary crowns or undergoing dental treatment
  * Poor oral hygiene and/or rampant decay
  * Current orthodontics
  * Active caries in one or more of the possible abutment teeth for the device
  * Active moderate to severe periodontal disease around abutment teeth for the device
  * Suspicious oral/facial lesions or swelling of any type
  * Severe pain on palpation on any area of mouth, face or neck
  * Moderate to severe heat sensitivity on any of the upper teeth
  * Subject currently being treated for temporomandibular joint disorder (TMJ), pain, full mouth reconstruction or posterior dental implants
* Must not have known Audiological conditions

  * Conductive hearing loss (air-bone gap \>10dB HL at more than 3 frequencies)
  * Word recognition scores inconsistent with pure tone averages
  * Fluctuating hearing loss
* Must not have known psychological factors that interfere with their ability to comply, comprehend, consent and cooperate