cyrilzakka/clinical-trials huggingface dataset:
Risk Assessment of Indirect Exposure to the Environment in the Gastrointestinal Endoscopy Center

Study objective: To clarify the risk of exposure to indirect contact and transmission of environmental objects during digestive endoscopy diagnosis and treatment for patients and medical staff, simulating by using Vitamin B2 solution.

Study design: This is a case-only research.

In the study, the object surface of the digestive endoscopy room is preliminarily analyzed, and several key exposure units, such as potential high-frequency touch areas such as the surface of the bed unit, are screened and defined. A fluorescence photographing system is arranged in the digestive endoscopy room, and the exposure unit before treatment is photographed with the best excitation wavelength of the fluorescent marker as the light source, to get the experimental background reference. Then, patients undergoing digestive endoscopy in the same endoscopy work unit (usually half a day) are selected. Before entering the digestive center, the hands of patients are fluorescently marked with vitamin B2 mixed hand sanitizer 1ml (vitamin B2 0.12mg/ml). Meanwhile, the process of the gastroscopy is recorded by camera for the recognition of touch behaviors. Then, the doctors and nurses give routine care and procedure. Based on the fluorescence tracing and detection methods, the indoor light source is turned off after each selected endoscopy work unit, and the fluorescence residue on the surface of key exposed units is photographed. The environmental surfaces touched by the patient are sampled by the wiping method. Then the video of the gastroscopy process is analyzed for the recognition of touch behaviors. The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan), which is quantified as a cumulative mass (μg) over all the exposure time.

Eligibility Criteria:
Inclusion Criteria:

* During the study period, patients who were treated in the digestive endoscopy center of Beijing Union Medical College Hospital and planned to undergo gastroscopy. Age and gender are not limited temporarily.

Exclusion Criteria:

* Allergic to medical non-toxic fluorescent agent: Vitamin B2 aqueous solution.
* Poor general condition, including severe cardiopulmonary disease, difficult to tolerate examination, and coagulation disorders.
* Patients with contraindications to endoscopy.
Gabapentin in Phantom and Stump Pain

To investigate whether gabapentin can prevent phantom and stump pain after amputation.


Eligibility Criteria:
Inclusion Criteria:

1. Amputation of crus or femur

Exclusion Criteria:

1. Patients who cannot cooperate
2. Fertile women without sufficient contraceptives
3. Allergy to gabapentin
4. Earlier amputation of the same limb except toes
5. Serious lever, kidney, cardiac, respiratory, haematological disease.-
AI Based Real Time Detection of Endometriosis Lesions

Development of AI-based approaches for automated real-time detection of endometriosis lesions using endoscopic image and video material.

In the field of endometriosis, artificial intelligence (AI) has been used for diagnoses or even predictions of endometriosis before confirmation through laparoscopy. AI's significant potential in minimally invasive surgery lies in automatic image analysis, aiding in the detection of structures or anomalies based on image data. This offers the potential to detect endometriosis lesions during laparoscopy regardless of the indication. Training and creating such AI models are done using machine learning algorithms based on annotated data. These training data consist of image data with pixel-level annotations of the content that the model should detect. Deep learning (DL) algorithms have proven effective in image analysis, relying on neural networks to autonomously fill them with the most critical decision criteria for correct analysis of the image content. The trained AI model can then be applied to unknown data, providing the probability of detecting a structure for each pixel. Possible visual outputs of the model include outlining the detected content or segmenting, assigning predefined content to each pixel. The quality of the model depends crucially on a sufficiently large number and quality of training data. Quality includes correct annotation of data to prevent the model from learning errors. Diversifying image data by including negative examples in the training and test datasets is equally important. The F1-score is used as a measure of the model's quality, combining precision (P) with recall (R) to a value between 0 and 1, based on an annotated test dataset.

The goal is to achieve a high F1-score through the selection of training data and an appropriate DL algorithm. Parameters like image preparation optimization or DL algorithm parameters such as selecting different neural networks can improve the F1-score. The number of required training data for a good AI model depends on the complexity of the question and the number of contents to be detected, as the model can only recognize learned content. It is possible to iteratively adjust the selection of training data for different questions based on the achieved F1-scores after each training and testing. If necessary, the number of training data can be increased, and problematic image data, such as missing annotations, can be identified and corrected based on the results.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Written consent after explanation
* Indication for surgical treatment of endometriosis

Exclusion Criteria:

* Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
* Absence of patient consent
* Malignancies
Test of Chamber Pressure to Divers and Chamber Attendants

SCUBA divers and chamber inside attendants will undergo a brief hyperbaric chamber excursion and will be asked to what chamber pressure they were compressed and what gas they breathed.

In clinical trials evaluating hyperbaric oxygen, blinding can be challenging. Options for participant blinding include offering regular air at a lower pressure than the hyperbaric oxygen intervention, or compressing all participants to the same pressure but providing different gas mixes to the active and sham arms.

In some trials of hyperbaric oxygen for brain injury, investigators offer a sham chamber session (regular air at 1.2 atmospheres absolute \[atm abs\]) compared to the active intervention, hyperbaric oxygen (100% oxygen at 1.5 atm abs). It is unknown whether individuals familiar with pressure changes, such as divers and hyperbaric chamber inside attendants, could discern the difference between these pressures and thereby become unblinded to study allocation.

In this study, 80 experienced divers and chamber inside attendants will be enrolled and randomly assigned to one of four possible chamber pressures and one of two breathing gases. After a brief hyperbaric chamber excursion, they will be asked to what chamber pressure they were compressed and what gas they breathed. If participants can accurately report chamber pressure or breathing gas, pressure-familiar individuals should be excluded from blinded clinical trials of hyperbaric oxygen.

Eligibility Criteria:
Inclusion Criteria:

* Adult, age 18 - 65 years
* Completion of medical history questionnaire without concerns identified for exposure to increased pressure
* Familiarity with atmospheric pressure change:
* Experienced and active hyperbaric chamber inside attendant: more than 50 hyperbaric compressions, with more than 4 have been in the last 4 months; or
* Experienced and active SCUBA diver: more than 20 lifetime compressed gas open water (not swimming pool) dives, with more than 10 in the last 12 months
* Able to equalize middle ear pressure easily

Exclusion Criteria:

* Pregnancy
* Known risk for barotrauma, as identified on the medical history questionnaire, such as:
* Recent (within 12 months) inner ear or sinus surgery
* Spontaneous pneumothorax
* Pulmonary cysts
* Emphysema
* Bullous lung disease
* Chronic obstructive pulmonary disease needing chronic active therapy
* Inability to tolerate chamber confinement or pressure
* Presence of heart failure
* Presence of any implanted electrical device, except hyperbaric-approved pacemakers
* Presence of middle-ear tympanostomy tubes
Experiments to Test How and Why the Sense of Smell Differs Between People

The ability to smell varies greatly between different individuals. Some people are unable to detect an odor that most people can smell. It is not known what causes these individual differences. Humans have about 1000 genes for odorant receptors that bind and detect odor molecules. It has been shown that some of these genes exist in two forms: a functional one and one that has been mutated and is therefore no longer functional. We think that people who can not smell a specific odor may carry the non-functional form of the gene for the receptor that detects the odor molecule. To test this hypothesis we want to find people who can not detect a specific smell and then compare their odorant receptor genes with those of people who can smell the odor.

The enjoyment of a fine wine, the odor of a ripe cheese, the memory of a long-lost grandmother brought back by the scent of her perfume, or the alarm we feel when we smell smoke are all produced by a functioning olfactory system. Interestingly, there are enormous individual differences in how we interpret these smells. Given almost any odor, some people will find it pleasant, others unpleasant. Ripe cheese or garlic may smell delicious to some, but repulsive to others. The scientific basis of this variation has not been well-studied. Despite the clear evidence for culture-based preferences for food and aromas, the nature-versus-nurture debate for smell remains unresolved. We believe there may be a genetic basis for our unique senses of smell. For example, some of us can smell methanethiol, the metabolite that is excreted in our urine after eating asparagus, whereas other people cannot. The Rockefeller University Smell Study seeks to recruit 400 normal subjects to track down the genetic basis of how we perceive smells. The study consists of up to two visits, each lasting up to 4 hours, in which we will test your perception of a variety of smells. On your first visit there will be a small blood sample taken (8.5 millileters) and your height and weight will be measured. If you are a woman of child-bearing age, we will ask you to provide a urine sample to test for pregnancy. If you are pregnant, you will not be permitted to participate in our study. You will fill out a short survey that asks some questions about yourself, your household, your personal habits, and your sense of smell. You will perform three different types of smell tests. In the first, you will be given two vials at a time and asked to tell us which contains an odor. In the second type of test, you will be asked to describe carefully your impression of three different odors. In the third type of test, you will be asked to rate odors according to their strength and pleasantness. All odorants will be presented to you in glass jars. You will be asked to smell odors in several hundred jars.

Eligibility Criteria:
Inclusion Criteria:

18 years or older,

Male and Female

Normal sense of smell

-

Exclusion Criteria:

Not pregnant

No history of nasal illness or surgery

No seasonal allergies-
A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects

The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Chinese subjects between 18 and 55 years old (inclusive) at Screening
2. Free of any clinically significant disease or medical condition at screening as determinedby the Investigator
3. Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 32 kg/m2
4. Women must be of non-childbearing potential:Surgically sterile; no menses for ≥ 12 months AND a follicle-stimulating hormone level\>40 IU/L at screening; or meeting the definition of "postmenopausal range" based onscreening laboratory results
5. Willing and able to comply with all the study requirements and provide written informedconsent for the study

Exclusion Criteria:

1. Donated blood or experienced significant blood loss
2. Has inadequate venous access or unsuitable veins for venipuncture and IV administrationof the study drug
3. History of or have any evidence of diabetes mellitus
4. History of renal impairment or inflammatory bowel disease
5. History of clinically significant ear pathology, ear surgery, or hearing impairment
6. Active infection
7. History of malignancy
8. Have undergone a surgical procedure within 3 months prior to study entry or have anysurgical procedure anticipated to be required during the study.
9. Any clinically significant abnormality at screening that, inthe opinion of the Investigator, would exclude them from the study
10. Received the last dose of an investigational drug or treatment with a medical devicewithin 30 days or 5 half-lives prior to screening or currentlyparticipating in another study of an investigational drug or medical device
11. Previously participated in a study of IGF-1 or IGF-1R-related products
12. Any medical condition or laboratory abnormality, that in the opinion of the Investigator, would prevent the subject from completing the study, pose a risk to the subject, or confound the ability to interpret study results
Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy

It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal.

* Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common or even mandatory practice in most transplant centres.
* This serves to monitor the occurrence of postoperative intraabdominal bleeding and is used for the detection and drainage of any bile leakage.
* Below table mentions both advantages and disadvantages of prophylactic drain placement after hepatectomy.

Advantages

1. Early detection of haemorrhage
2. Early detection of bile leak
3. Early reintervention Disadvantages

1. Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3. Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.

* Our study in ILBS for ALF donors, the overall complication rate was 20% as per Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2 complications. Major complications (3b and above) were seen in 4 (1.0%) patients. Biliary complications were noted in 1.7% only.
* In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows for the early removal of the drain tube with minimum infection risk after liver resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin concentration is \<3 mg/dl on day 3 after operation.
* In our institute we remove drain routinely, when output is less than 100ml and serous. That is usually on postoperative day 5-7.
* There is no randomized control trail done in donor hepatectomy comparing early versus standard drain removal.

Eligibility Criteria:
Inclusion Criteria:

* • Donors evaluated as per institutional protocol for donor hepatectomy and found fit

  * Those who consent

Exclusion Criteria:

* Patients refusing to consent for inclusion in the study.
* Left lateral hepatectomy.
Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer

A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in patients with metastatic androgen independent prostate cancer where efficacy is measured by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed MAIPC
* Documented progressive disease in bone, soft tissue or PSA despite castrate levels of testosterone
* If LHRH agonist were used previously it must be kept
* Previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
* Previous DES should be held for at least 4 weeks before partcipating in the trial
* Chemotherapy naive patients
* No prior radioisotope
* Less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
* KPS\> 70%
* Adequate hematologic, hepatic and renal function

Exclusion Criteria:

* Patients with serious medical illness
* History of significant active cardiac disease
* History of gastrointestinal ulceration, bleeding or perforation
* History of myocardial infarctin within past 12 months
* Allergy to sulfonamides or to celecoxib or history of urticaria to any NSAID

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Audio-Recorded Discharge Instructions for LEP Parents

In this pilot study, limited English proficient (LEP) parents of children at Seattle Children's Hospital for day surgery will be randomized to usual discharge care or usual discharge plus language-concordant, audio-recorded instructions via recordable card. these cards are similar to recordable greeting cards, and can record up to 180 seconds of information. They can be played back over 100 times. We will follow-up with families 2-7 days later to assess satisfaction and comprehension of discharge instructions.


Eligibility Criteria:
Inclusion Criteria:

* Limited English proficient (LEP) parents of day surgery patients at Seattle Children's Hospital (main campus) who prefer one of the following languages for care: Spanish, Somali, Russian, Ukrainian, Vietnamese, Mandarin, or Cantonese. Eligible parents are those receiving condition-specific discharge instructions about one or more of the following: a new medication, wound care, diet advancement, return precautions, or more than 1 follow-up appointment

Exclusion Criteria:

* Child being kept overnight at hospital following surgery
Treatment of Anemia in Diabetic Subjects With CKD

The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRITÂ®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline by Week 17.

This is a prospective, randomized, double blind, placebo controlled, multi-center study in diabetic subjects with the anemia of chronic kidney disease. Subjects will be randomly assigned in a 1:1 ratio to receive either Epoetin alfa (PROCRIT®) or matching placebo for sixteen weeks. Epoetin alfa (PROCRIT®) is indicated for the treatment of anemia associated with chronic renal failure (pre-dialysis), non-myeloid malignancies receiving chemotherapy, in HIV-infected subjects receiving zidovudine therapy, and in anemic subjects undergoing elective non-cardiac, non-vascular surgery to reduce the need for allogenic blood transfusion during high-volume blood loss procedures. This study is being undertaken to assess, under well-controlled conditions, the effect of weekly Epoetin alfa (PROCRIT®) treatment on hemoglobin response in diabetic subjects with the anemia of chronic kidney disease. The study hypothesis is that weekly PROCRIT treatment will be effective in achieving a hemoglobin response than placebo, where hemoglobin response is defined by at least a 1 gram/deciliter increase from baseline by Week 17. The subjects are administered study drug (PROCRIT® or matching placebo) once weekly by subcutaneous injection by a health care professional for 16 weeks. The initial dose of study drug is either PROCRIT® 10,000 U (1.0 mL) or matching placebo. The maximum dose administered is 20,000 U (2.0 mL).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a clinical diagnosis of diabetes mellitus
* History of documented proteinuria or microalbuminuria
* A glomerular filtration rate between 15 and 90 mL/minute/1.73m2
* Subjects with hemoglobin greater than or equal to 9.0 /dL and less than or equal to 11.0 g/dL.

Exclusion Criteria:

* A current diagnosis of poorly controlled high blood pressure (hypertension) (systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 100 mm Hg) after adequate anti hypertensive therapy
* Subjects with severe neuropathy or peripheral vascular disease with gait instability
* Subjects scheduled to receive dialysis during the course of the study
* Subjects with a transferrin saturation \< 20% or ferritin level \< 50 ng/dL
* Subjects with active malignancy, defined as a malignancy requiring current therapy (surgery, chemotherapy, or radiotherapy) or a history of treatment for malignancy in the last 5 years.
Gilles de la Tourette Syndrome (TS) and Seasonality

This retrospective and prospective observational study intends to evaluate the correlation between seasons and the variation of the syndromic structure of the Tourette.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending the Tourette Center since January 2012.
* Males and females.
* Age between 6 and 50 (completed).
* Diagnosis of Tourette syndrome ascertained
* Presence of a value equal to or greater than 15/40 of the Y-BOCS.

Exclusion Criteria:

* Presence of allergic pathology.
* Presence of significant psychiatric symptoms, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD)
Faslodex Advanced Breast Cancer Local Chinese Study

This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal advanced breast cancer with oestrogen receptor positive
* Progression under first-line anti-oestrogen therapy.

Exclusion Criteria:

* Life-threatening metastasis; contraindication to anastrozole
* \>2 regimens of hormonotherapy for advanced breast cancer
Laryngeal Handshake for Identifying the Cricothyroid Membrane

The cricothyroid membrane is the most common position that the invasive airway secure is performed, but it is not easy to identify the cricothyroid membrane by tactile perception. Although it is recommended to use the laryngeal handshake method for identifying the cricothyroid membrane in difficult airway society 2015 guidelines for management of unanticipated difficult intubation in adults, there is only suggestion without clinical data about how much the laryngeal handshake method improves the accuracy of identification of the cricothyroid membrane So we made the hypothesis that the cricothyroid membrane is identified more correctly when the laryngeal handshake method is used than when that method is not used. And we try to find out whether there is actual difference about identification of the cricothyroid membrane between using the laryngeal handshake method and not using that method. By identifying the difference between them, we are going to support the recommendation of guidelines and make the evidence for educating the doctors who have any possibility to perform the criocthyroidotomy to use the laryngeal handshake method skillfully in the 'cannot intubate, cannot oxygenate' situation.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent nose or ear surgery in Seoul National University Hospital and Seoul Metropolitan Government Seoul National University Boramae Medical Center

Exclusion Criteria:

* those whose ASA class was over 3, those who rejected to participate study or had impaired capacity to agree, those who was going to undergo neck surgery, those who had anatomical anomaly or skin lesion at neck, and those who were pregnant were excluded.