cyrilzakka/clinical-trials huggingface dataset:
Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 24 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.

A prospective, longitudinal, randomized, double-blind study will be carried out in which all patients who come to the University Hospital "Dr. José Eleuterio González" with upper gastrointestinal tract bleeding, defined in our study as hematemesis or melena, including patients with this condition in the 24 hours prior to admission. Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale; which gives a score of 0-2 according to the percentage of mucosal vision; 0= \<25% visible surface, 1= 25%-75% visible surface and 2= \>75% visible surface, evaluating fundus, body, antrum and bulb, a score ≥ 6 will be considered a clean stomach and a score ≤ 5 will be considered full stomach. The diagnosis of origin of the upper gastrointestinal tract bleeding will be determined by the physician in charge of performing the endoscopy. All cases will be filmed and another physician will review the cases and validate the Avgerinos score, as well as the final diagnosis reported.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients ≥18 years of age with variceal and non-variceal upper gastrointestinal tract bleeding (hematemesis and/or melena).
* ≤12 hours of bleeding evolution.
* Hemodynamic stability at the time of upper endoscopy.

Exclusion Criteria:

* Patients \<18 years old.
* Pregnant patients.
* Metoclopramide allergy.
* Refusal to be part of the study protocol.
Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance

Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water) before and after ultramarathon.

Eligibility Criteria:
Inclusion Criteria:

* Participation to ultramarathon

Exclusion Criteria:

* pregnancy women
To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). The total duration of the study is approximately 33 Weeks including screening and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants ≥18 years of age.
* Receiving outpatient in-center hemodialysis for ESKD at least three times a week.
* Currently prescribed or meets criteria for ESA based on approved facility policy.
* Hb \> 8 grams per deciliter (g/dl).
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20%.
* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

* Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider.
* Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI).
* Known cirrhosis or active, acute liver disease.
* Unable to comply with study requirements or compliance with attending dialysis treatments as prescribed, or in the opinion of the treating physician or Investigator, not clinically stable to participate in the study.
* Pregnant at the time of consent (per participant self-report).
* Any other reason, which in the opinion of the Investigator, would make the participants unsuitable for participation in the study.
Better Understand End-of-life Emergencies' Management Among Elderly in Nursing Homes: a Pilot Study in Brittany, France

The purposes of this study are :

* To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes.
* To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use.
* To know and to understand the practical and organizational elements, in nursing homes, that can determine a (re) hospitalization or an end-of-life


Eligibility Criteria:
Inclusion Criteria:

* dead residents during the quarter preceding the date of the Survey Or
* Residents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of "terminal condition" contained in the guide of the CNSA (coding PATHOS - April 2011)).

Exclusion Criteria:

* patients opposing the study,
* patients aged below 18 year old
White Noise and Pacifier Use on Postoperative Pain and Crying in Newborns

The study was conducted to determine the effect of white noise and pacifier applications on pain and crying time during painful interventions in newborns who underwent surgery

Newborns most often experience painful procedures such as heel blood collection and peripheral venous catheter placement in the neonatal intensive care unit. Exposure to pain early in life has even been shown to increase the risk of developing problems (chronic pain, anxiety, and depressive disorders) in adulthood. This result implies that newborn or child pain should be adequately managed. Thus, pain in newborns or children should be prevented before it occurs, and if it cannot be prevented, it should be determined in the early period and the pain should be alleviated. Managing this pain in newborns should be one of the primary duties of newborn nurses. The first and most important determinant in relieving pain is determining the severity of pain, and non-pharmacological or pharmacological methods should be preferred according to the severity of the pain. Many non-pharmacological methods are used to manage pain that may occur in interventional procedures. Some of these methods are: giving sugar solution, kangaroo care, positioning (Kaşıkçıoğlu, 2014), breast milk and breastfeeding and swaddling, listening to music, lullaby. Two other effective methods are non-nutritive suction and white noise. As a result of studies, it was proven that the use of multiple non-pharmacological methods together was much more effective in reducing pain. Within the scope of the research, no research was found in the literature regarding which application - white noise or pacifier - could be more effective. By examining this information, the effects of the two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight over 1500 grams

  * Having passed the newborn hearing screening test
  * Having a history of previous surgery (excluding brain surgeries)
  * Not using sedative substances (dormicum, fentanyl)
  * Not using opioids
  * Having a full stomach 30 minutes before painful interventions
  * Having permission from their mothers
  * Newborns undergoing blood transfusion only

Exclusion Criteria:

* Being intubated

  * Having hiberbilirubinemia
  * Birth weight below 1500 grams
  * Having cerebral palsy
  * Having hydrocephalus
  * Having spina bifida
  * Having had brain surgery
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with advanced breast cancer that cannot be cured.
* Participant must have received at least one prior line of endocrine therapy for advanced/metastatic disease. Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.
* Up to 6 prior lines of therapy are allowed. Up to 2 prior chemotherapy and/or cytotoxic antibody-drug conjugates regimens in the advanced/metastatic setting is permitted.

Key Exclusion Criteria:

* New or active brain metastasis.
* Severe internal organ spread that could cause immediate life-threatening problems, including large uncontrolled fluid build-up or severe lung or liver involvement.

Note: Other inclusion/exclusion criteria may apply.
Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

This prospective, randomized, double-blind, placebo-controlled study is performed after obtaining written informed consent of patients who are scheduled for elective general surgery. After the admission to the preoperative unit 30 minutes before the surgery, The preoperative anxiety of patients is evaluated by The State-Trait Anxiety Inventory (STAI). Patients are randomly assigned to one of two groups in a 1:1 ratio by a computer-generated list. Patients receive midazolam IV at 0.04 mg/kg (group M) and an equal volume of saline IV (group C, control group). Anesthesia is induced with 2mg/kg of IV propofol. At a dose of 0.6 mg/kg, IV rocuronium bromide is given for neuromuscular blockade. Anesthesia is maintained at 2% sevoflurane. At the end of the surgery, anesthesia is terminated and the awake patients are extubated.

An equal depth of anesthesia is achieved by evaluating an entropy value of 40-50 during the operation. Heart rate, blood pressure, the amount of sevoflurane consumed (ml), end-tidal sevoflurane concentration (%), sevoflurane MAC, inspiratory sevoflurane (%) are recorded at baseline and 15-minute intervals.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 and 2
* patients who are scheduled for elective surgery
* BMI \<30

Exclusion Criteria:

* history of psychiatric disease
* use of psychotropic medications
* neurological disorders
* cancer
* chronic pain
* cardiovascular, respiratory, and hepatic diseases.
Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection

To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.

Primary Objectives:

Our study will investigate the feasibility of an accelerated recovery program to minimize length of stay (LOS) and facilitate outpatient surgery for patients undergoing minimally invasive, lower complexity (Kawaguchi-Gayet grade I) liver resection. This program (ARAMIS Hep) will combine minimally invasive surgical (MIS) approaches (robotic OR laparoscopic), enhanced recovery after surgery (ERAS) protocols, and Telehealth to liberalize discharge criteria in a safe manner.

Secondary Objectives:

In addition to demonstrating a reduction in LOS, our study will also provide preliminary data to aid in the broader implementation of this approach. Specifically, we will gain insight into the patient experience, measure patient-reported outcomes on recovery trajectories, and understand barriers to integrating a novel pathway into existing institutional frameworks.

Eligibility Criteria:
Inclusion Criteria:

* Tumor amenable to MIS Kawaguchi-Gayet grade I hepatectomy (see figure 1 below)
* No evidence of cirrhosis (based on imaging, evidence of portal hypertension, clinical features, or laboratory results)
* No significant cardiopulmonary disease that would prevent patients from undergoing MIS resection
* Ability to stay within 50 miles of medical center for immediate postop period
* Age of 18 years or above - because no adverse event data are currently available on enhanced recovery and early discharge after hepatic resection for patients \<18 years of age, children are excluded from this study
* Ability to understand and the willingness to sign a written informed consent document
* Non-English-speaking patients are eligible for participation

Exclusion Criteria:

Patients who will be excluded include those with:

* Tumors NOT amenable to MIS Kawaguchi-Gayet grade I hepatectomy
* Tumors not amenable to MIS or Robotic-assisted surgical resection
* Evidence of Cirrhosis on imaging, clinically, or lab testing
* Inability to stay within 50 miles of the Cancer Center in the immediate post-operative period
* Age below 18 years
* Inability to consent for trial/protocol
* Patients who are pregnant
A Study to Evaluate the Safety of K-755 in Healthy Volunteers

This is a Phase 1 study designed to explore the safety, tolerability and pharmacokinetics of K-755 following oral administration to healthy male and female volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
2. Males or females, of any race, between 18 and 45 years of age.
3. Body mass index (BMI) between 18.0 and 28.0 kg/m2.
4. Hematology, clinical chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.
5. No clinically significant abnormalities on the basis of medical history, physical examination findings, and vital signs.
6. All females must have a negative serum pregnancy test.
7. Able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

1. Female subject who are pregnant or breastfeeding.
2. Subject with presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
3. Subject with any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-755.
4. Subject with presence of an active malignancy or within the past 5 years a malignancy of any type, other than basal cell carcinoma of the skin.
5. Subject has a history of type 1 hypersensitivity to any medication and/or clinically relevant food allergies.
6. Subject has a history of drug addiction.
7. Subject has a positive screen for drugs of abuse, cotinine or alcohol.
8. Subject has a history of regular alcohol consumption within 6 months of the study.
9. Subject has smoked tobacco within 6 months prior to Check-in, or has used non-inhaled tobacco- or nicotine-containing products within 3 months prior to Check-in.
10. Subject has used prescription or over-the-counter medications, dietary/nutritional supplements (except paracetamol or vitamin supplements)
11. Subject has used steroid medications (oral, inhaled, parenteral, or topical) within 30 days or 5 half-lives (whichever is longer) before study drug administration.
12. Subject has participated in an investigational drug study within 30 days or 5 half-lives (whichever is longer) before study drug administration.
13. Subject has a positive screen for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antigens/antibodies.
14. Subject has had a clinically significant acute illness within 4 weeks or other illness within 5 days before the first study drug administration.
15. Subject or a family member of the subject is a member of the professional or ancillary personnel working at the investigative site involved in the study.
16. Not suitable for entry into the study in the opinion of the Investigator.
17. Receipt of blood products within 2 months prior to Check-in.
Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

1. To evaluate the effectiveness of Conbercept for PCV patients.
2. To describe the characteristics of PCV.
3. To describe the adverse events (AE) of Conbercept in the treatment of PCV.
4. Todescirbe the real situation and prognosis of PCV patients in our country.

1. To observe the visual changes in PCV patients receiving Conbercept treatment, so as to evaluate the effectiveness of the treatment. Changes of OCT, ICGA, quality of life and visual function would be observed and evaluated.
2. To observe and describe the characteristics of PCV.
3. To observe and describe the incidence of adverse events (AE) and serious adverse events (SAE) of Conbercept in the treatment of PCV, so as to evaluate the safety of this treatment.
4. To observe and descirbe the real situation and prognosis of PCV patients in our country.

Eligibility Criteria:
Inclusion Criteria:

* According to the current diagnostic criteria, diagnosed as PCV patients
* Conbercept is used for treatment, and the recommended treatment scheme is 3+PRN
* Local and systemic anti-VEGF therapy was not used for at least three months before enrollment
* The patient volunteers to take part in this observational study, and signs the informed consent
* The patient can follow-up regularly (at least 4 times of follow-up in one year)

Exclusion Criteria:

* The patient has serious systemic disease, and the current clinical treatment is contraindicated
* Local or systemic anti-VEGF therapy was used for less than three months before enrollment
* Existence of diseases unsuitable to accept intravitreal Conbercept, including uncontrolled hypertension and diabetes, AIDS, malignant tumors, active hepatitis, severe renal failure, severe mental, nerve, cardiovascular, respiratory and immune diseases
* During six months before screening, there were cardiovascular events such as stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure
* Ocular contraindications, including active intraocular inflammation, infectious endophthalmitis, corneal ulcer, scleritis, uncontrolled glaucoma and so on
* Patients who could not follow up regularly
* Patients who refuse to sign the informed consent
* Others
Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab (Avastin). They both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. It is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x).

In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.

see above

Eligibility Criteria:
Inclusion Criteria:

* patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated for the treatment of diabetic macular edema
* able to return for extra clinic visits according to study schedule

Exclusion Criteria:

* active malignancy
* previous retinal laser treatment
* previous anti-VEGF therapy
* previous vitrectomy
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury

PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.


Eligibility Criteria:
Inclusion Criteria:

* Blunt traumatic spinal cord injury
* Neurological level of injury from C0 to L2
* American Spinal Injury Association impairment scale grade A, B or C
* Spine surgery performed within 48 hours of injury

Exclusion Criteria:

* Condition limiting patient's ability to engage into cycling
* Medical condition that might interfere with patient's safety if cycling
* Moderate or severe brain injury
* Inability to walk independently prior to injury
* Pre-existing neurological disorder
* Complete spinal cord transection
* Unwilling or unable to comply with scheduled follow-up