cyrilzakka/clinical-trials huggingface dataset:
Preoperative Anemia in the Oncology Population and Associated Mortality

Anemia is a highly prevalent condition in the surgical population (1, 2). On the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy. Preoperative anemia has been associated with an increased risk of postoperative morbidity and even mortality (3). Despite this, the prevalence of preoperative anemia in the Chilean oncology population has not been quantified. To answer this question, a retrospective cohort study was designed between January and December 2022 to quantify the prevalence of anemia in the surgical population of the National Cancer Institute. In addition, the impact on morbidity and mortality at 30 days, 6 months, and 1 year will be evaluated. Statistical analysis will be performed using R. Studio Version 2023.09.1+494 (2023.09.1+494).

General Objective:

To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology surgical population and its impact on postoperative outcomes.

Specific Objectives:

1. To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology population.
2. To stratify the prevalence of preoperative anemia in the National Cancer Institute's oncology population by severity.
3. To assess 30-day, 6-month, and 1-year mortality in cancer patients with and without anemia in the National Cancer Institute's oncology population.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Oncologic surgery with curative intent

Exclusion Criteria:

* Emergency surgery
* Patients who received a preoperative transfusion
* Patients without a preoperative blood count
Forxiga CKD Japan Post-Marketing Surveillance (PMS)

To capture safety when Forxige is administrated to CKD patients in the real world setting

The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch for treatment of CKD.

1. ADRs which are unexpected from the precautions for use in our JPI
2. Understanding of incidence of ADRs during use of Forxiga in the real world setting
3. Factors (ie demography, treatment) possibly having an impact on the safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD except for dialysis and/or renal failure chronic

Exclusion Criteria:

* None
Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology

This study will be conducted to collect anatomical data in an ambulatory healthy population to aid in the development of a novel non-invasive technology to assess changes in lung hydration status. It will also help in developing reference ranges of lung hydration status in healthy subjects and their associated changes with time.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 30 years of age
* Subjects who are ambulatory not requiring assistance for ambulation
* Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB

Exclusion Criteria:

* Subjects with an active implantable medical device not cleared for use with the IMED-4 in the IMED- 4 Investigators Brochure.
* Subjects who are pregnant or lactating or who have been pregnant within the past three months
* Subjects who have a measured temperature of \>38° C at the time of screening
* Subjects who have tattoos and/or non-intact skin on the back in the electrode patch placement region
* Subjects who have had a past serious allergic reaction to adhesives
* Patients who decline to have their backs photographed with the IMED-4 device in position
* Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectance, etc.)
Efficacy of Pregabalin in Patients With Radicular Pain

The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.

Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pain in dermatomal distribution, in either cervical or lumbar region.
2. History of pain for more than 3 months.
3. History of herniated disc, spinal stenosis or failed back surgery.
4. A series of epidural steroid injections within the past 6 months.
5. Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.
6. Patients must be cognitively capable of completing the pain questionnaires.

Exclusion Criteria:

1. Patients below 18 or over 65 years of age.
2. Patients with mostly axial spinal pain.
3. Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
4. Workmen's compensation or disability issues.
5. Patients with chronic depression and on depression medications.
6. Addiction and/or substance abuse issues.
7. Patients using gabapentin or failure to respond to previous gabapentin use.
8. Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).
9. Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).
10. History of angioedema with pregabalin use.
11. Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.
12. Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).
13. Pregnant patients.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 27 kg/m\^2, inclusive

Exclusion Criteria:

* Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator or Sub-Investigator
* Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the Investigator
* Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmHg systolic or 40-90 mmHg diastolic
* Heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min
* Alcohol intake within 48 hours prior to the screening
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
* Clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the Investigator
* History of significant allergy or hypersensitivity
* Known or suspected allergy to trial product or related products
* History of drug or alcohol abuse
* Smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.


Eligibility Criteria:
Inclusion Criteria:

* endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal

Exclusion Criteria:

* concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation

This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who need tracheal intubation for mechanical ventilation and need 6-24 h of sedation after randomization, as anticipated;
2. The target RASS score is between +1 and -2;
3. 18 ≤ age \< 80 years old; with no restriction on gender;
4. 18 kg/m2 ≤ BMI ≤ 30 kg/m2;
5. The patients or their family members well understand the purpose and significance of the trial, voluntarily participate in this clinical trial, and sign the informed consent form.

Exclusion Criteria:

1. Patients known to be allergic to eggs, soy products, opioids and their antidotes, and propofol; patients having contraindications to propofol, opioids and their antidotes;
2. Patients having the following medical history or evidence at screening, which may increase sedation/anesthesia risk:

   1. Cardiovascular system: Class III and IV heart failure by New York Heart Association (NYHA), Adams-Stokes syndrome; acute coronary syndrome (ACS) within 6 months prior to screening; bradycardia requiring medications and/or heart rate ≤ 50 beats/min; serious arrhythmia history such as Degree II-III atrioventricular block (excluding patients with pacemakers); acute and chronic myocarditis; systolic pressure ≤ 90 mmHg even when large dose of vasoactive drug (such as norepinephrine ≥ 0.6 μg/kg/min) is used;
   2. Patients with mental disorders (such as schizophrenia, depression, etc.) and cognitive impairment; past abuse history of psychotropics and anesthetics, and long-term use of psychotropics;
   3. Patients with moderate to severe hepatic and renal dysfunctions (liver function: Child-Pugh Grade B and C, scale in Annex 9; renal function: glomerular filtration rate eGFR ≤ 60 mL/(min•1.73 m2) \[eGFR is calculated with the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 × serum creatinine (SCr)-1.154 × age-0.203 × 0.742 (female)\]; patients under dialysis;
   4. Epileptic seizures, convulsions; craniocerebral injury, intracranial hypertension, cerebral aneurysms; Glasgow Coma Score (GCS) ≤ 12 (scale in Annex 6); SOFA \> 9 (scale in Annex 7);
   5. Expected survival ≤ 72 h;
3. Laboratory measures at screening period meet the following criteria:

   1. Neutrophil count ≤ 1.0 × 10\^9/L;
   2. Platelet count ≤ 50 × 10\^9/L;
   3. Hemoglobin ≤ 70 g/L;
4. Pregnant or lactating females; fertile females or males reluctant to receive contraception through the study; any subject planning for pregnancy within 1 month after the study (including male subject);
5. Participated in other drug clinical trials within 1 month prior to screening; Other reasons rendering a subject unsuitable for participation in this study as per the judgment of the investigator.
Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices

Esophageal varices are common in patients with hepatocellular carcinoma (HCC), with an incidence rate of 63% at the time of HCC diagnosis. Following an acute variceal bleed, the 6-week mortality rate for HCC patients is as high as 26%. Mortality rates escalate notably in HCC patients experiencing acute variceal bleeding, especially with increasing cancer severity indicated by BLCL status. Research suggests that the cumulative incidence rate of variceal bleeding at one year in patients receiving primary prophylaxis is almost half that of patients not receiving any prophylaxis.

Beta blockers are the standard therapy for primary prophylaxis in patients with portal hypertension to prevent variceal bleeding. Endoscopic band ligation has also shown promising results in recent studies. However, the combined impact of beta blockers and esophageal band ligation on lowering the incidence of variceal bleeding remains unstudied.

The aim of this study is to compare the efficacy of carvedilol monotherapy versus combination therapy with carvedilol and endoscopic band ligation in patients with HCC for primary prophylaxis of high-risk esophageal varices.

Study population: All patients aged ≥ 18 years and ≤ 80 years admitted in Institute of Liver and Biliary Sciences, New Delhi with HCC of any cause and high risk esophageal varices and are giving written consent for participation in the study.

Study design - Single center, Open label, Randomized controlled trial Study period - 6 months Intervention - The patients will be randomized into Group -A (NSBB arm) and Group-B (EVL + NSBB arm). Both the group will receive the remaining treatment as per protocol Group A: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP\< 90 , H,R\<55) Group B: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP\< 90 , H,R\<55) + EVL every 3 weeks till eradication of varices followed by every 3 months.

Monitoring and assessment: Monitoring and evaluation would be done once a month for first 3 months then at 6th month.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. Cirrhosis with HCC
3. High risk oesophageal varices (\*large or small with RCS)
4. Valid consent

Exclusion Criteria:

1. Any contra-indication to beta-blockers
2. Any EVL or Sclerotherapy within last 3 months
3. Any past history of TIPS or surgery for portal hypertension
4. HCC with BCLC-D
5. Patients with past history of variceal bleed.
6. Patient With Liver transplant expected in next 2 weeks would be excluded
A "Window Trial" on Boswellia for Breast Cancer Primary Tumors

The purpose of this study is to determine whether oral administration of Boswellia causes biological changes in primary tumors of breast cancer patients.

To determine whether oral administration of Boswellia serrata causes biological changes related to angiogenesis (CD31), apoptosis (DNA fragmentation), and cell proliferation (Ki67) in primary tumors of breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer (stages I, II, or III) with primary tumor(s) ≥ 1.0 cm on mammogram, ultrasound, MRI, or physical exam
* 18 years of age or older
* Subject must understand risks and benefits of the protocol and be able to give informed consent
* Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result before and throughout the study
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic and end organ function
* Ability and capacity to comply with the study and follow-up procedure
* Subjects must be scheduled for surgery at MUSC no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1.
* At least 6 sections of unstained slides should be obtained. If sufficient slides or tissue is unavailable, the patient will be excluded from the trial.

Exclusion Criteria:

* Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
* Subjects with end-stage kidney disease and/or grade II liver dysfunction
* Subject has active or history of deep vein thrombosis (DVT)
* Subject has a history of coagulopathies or hematological disorders
* Subjects who are pregnant or are lactating.
* Subjects already taking drugs known to be 5-lipoxygenase inhibitors (Refer to section 5)
* Subjects taking drugs that interact with OATP1B3 (an anion transporter), MRP2 (a multidrug resistant protein), and/or P-Glycoprotein (P-Gp) (Refer to section 5.)
* Subjects taking anti-coagulants or platelet inhibitors (Refer to section 5)
* Subjects with bowel obstruction
* Subjects undergoing emergency surgery.
Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects

To evaluate serum levels of gamma tocopherol and it's metabolites after 3 doses, each separated by 12 hours.

In previous studies the investigators have demonstrated that gamma-tocopherol-enriched (yT) supplementation decreased systemic oxidative stress, increased serum levels of yT, and inhibited monocyte responses to LPS without any adverse health effects. Free Radic Biol Med. 2008 Jul 1;45(1):40-9. doi: 10.1016/j.freeradbiomed.2008.03.002. Epub 2008 Mar 12.

Oxidant stress plays an important role in mucosal inflammation. Oxidant stress occurs individuals after exposure to air pollution, including high levels of ozone, LPS exposure and woodsmoke particle exposure. Potential exposure to all of these are naturally occurring events. Previous studies have also shown that asthmatic individuals tend to have lower endogenous levels of antioxidants such a s vitamins E and C, and that supplementing antioxidants can decrease exacerbation's associated with ozone exposure in children. The investigators are interested in future studies to examine the benefits of a rapid gamma tocopherol supplement in individuals who will be exposed to air pollution, either in a controlled chamber study or in a real life event, such as during high O3 days or when a woodsmoke fire is in their neighborhood.

This study is to address the question: can the investigators see an increase in serum levels of gT with a shorter course of gT supplementation? Additionally, before embarking on other investigations of gT as a potential prophylactic supplement, it is prudent to determine is discernible levels can be achieved with a shorter dose of gT.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 and 50 years of age.
2. Vital signs within normal limits on admission to the study: SpO2 \> 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.

Exclusion Criteria:

1. Any chronic medical condition considered by the PI as a contraindication to receiving yT, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
2. Use of systemic or inhaled steroids.
3. Use of NSAID or ASA within 48 hours of dosing, and inability to withhold these medications for the duration of the study.
4. Use of anticoagulants including warfarin, heparin, clopidogrel or enoxaparin.
5. Diagnosis of anemia or abnormal blood counts at screening
6. Known vagal response to venipuncture
7. Abnormal PT or PTT values at screening.
8. BMI \> 35
9. Pregnant or breast feeding women will not be included.
Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of visual impairment in industrialized countries. Anatomical examination findings at the early and intermediate stages of AMD are not sufficient to determine any functional alterations at these stages (e.g., alterations in microperimetry, multifocal electroretinogram (mfERG) and contrast sensitivity). Identifying early functional markers of the disease is a necessary first step in the development and clinical validation of treatments to slow progression to advanced disease.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Corrected visual acuity 10/10 in each eye
* Presence of retinal alteration(s) compatible with early (presence of macular drusen \< 125 μm) or intermediate (macular drusen \> 125 μm or pigmentary abnormalities) AMD in at least one of the two eyes :

  * Conventional "soft" or "hard" drusen
  * Cuticular drusen
  * Reticulated pseudo-drusen

Exclusion Criteria:

* Presence of geographic atrophy, even incipient, in one or both eyes
* Presence of patent or latent neovascularization visible on OCT b-scan or OCT-A in one or both eyes
* Compatibility of retinal signs with a "probable" differential diagnosis (bestrophinopathies, familial drusen, fundus flavimaculatus, fundus albipunctatus, hypovitaminosis A) in one or both eyes.
* Oculomotor pathology that may prevent proper performance of functional tests: nystagmus, oculomotor paralysis, in one or both eyes
* Neurological/neurodegenerative pathology that may prevent adequate performance of functional tests: advanced Parkinsonian syndromes, Benson's disease, Alzheimer's disease with visuomotor apraxia
* Other ophthalmological pathology that may affect anatomical and functional measurements: hypertonia / glaucoma or other optic neuropathy, media disorder causing reduced visual acuity, refraction \< -6.00D or \> +6.00D
* Other medical conditions preventing examinations or imaging (tremors, etc.)
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block

This is a single center randomized, controlled, double-blinded, noninferiority study. Male pediatric patients who underwent inguinal herniotomy will be screened for eligibility. Patients will be randomly allocated to IINB and IINB/SCB groups with allocation ratio 1:1. The primary outcome measure will be the proportion of patients who needed rescue analgesia during the first postoperative 6 h. The secondary outcome measures will be intraoperative heart rate and mean arterial blood pressure (MAP), the postoperative pain FLACC pain scale, and intravenous paracetamol consumption, the incidence of adverse effects including hematoma, postoperative vomiting and fever.

Inguinal herniotomy in children is a frequent surgical procedure that require good postoperative analgesia. Ultrasound-guided ilioinguinal/iliohypogastric nerve block is a widely validated anesthetic technique for this procedureز

Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor hemodynamic changes and can be done in the presence of contraindications of the neuraxial block .

Ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) is commonly done in pediatric patients to control pain after lower abdominal surgeries and has been shown to be effective in controlling pain after inguinal hernia repair .

However IINB don't affect the genitofemoral neve that contributes the sensory innervation of the inguinal region. The spermatic cord (SC) is a unique male structure that contains the vas deferens, testicular arteries, the pampiniform plexus of veins, and the ilioinguinal nerve and genital branch of the genitofemoral nerve (GFN). To provide complete analgesia for inguinal hernia surgery, GFN should be blocked in addition to IINB .

Eligibility Criteria:
Inclusion Criteria:

* Male pediatric patients
* underwent elective open unilateral inguinal herniotomy
* Informed written consent will be obtained from the parents or the legal guardian.

Exclusion Criteria:

* local infection at the puncture site,
* bleeding disorder,
* allergy to amide local anesthetics,
* history of clinically significant cardiac, hepatic, or renal disorders.
* neurological dysfunction