cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of RiMO-401 With Radiation in Advanced Tumors

This is a single arm study of RiMO-401 with radiation in patients with advanced tumors. A single escalation dose of RiMO-401 is intratumorally injected in a 3+3 study design to identify the recommended dose.

Primary Objectives:

• To determine the tolerability of RiMO-401 with palliative radiation as assessed by CTCAEv5

Secondary Objectives:

* To determine clinical response of RiMO-401 with palliative radiotherapy
* To characterize adverse events of RiMO-401 in patients with advanced cancers
* To characterize the pharmacokinetics of RiMO-401 with palliative radiation

The target population comprises patients with clinically accessible lesions that can be trated with palliative radiation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced or metastatic cancer not amenable to curative therapy
* Lesion that is amenable to palliative radiotherapy
* Lesion that is technically feasible for intratumoral injection
* Target tumor in region not in the field that was irradiated within the past six months
* Patients with advanced or metastatic HNSCC must have progressed on or been intolerant to standard of care therapies including platinum-based chemotherapy and anti-PD(L)1 therapy, prior to study enrollment
* Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment
* Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion
* ECOG score of 0-1
* Have a life expectancy of at least 12 weeks
* Have adequate bone marrow reserve and adequate liver function
* Both males and females and their partners of childbearing potential must agree to use adequate contraceptive measures
* Patients must sign a study-specific informed consent form prior to study entry
* Age 18 years or older.

Exclusion Criteria:

* Patients with a histological diagnosis of lymphomas and/or leukemias
* Patients with significant blood vessels (such as carotid artery encasement) or other major structures in the tumor region to be injected
* Patients may not have received chemotherapy, targeted therapies, immunotherapies, biologic response modifiers and/or hormonal therapy within the last 14 days
* Ongoing clinically significant infection at or near the incident lesion
* Major surgery over the target area (excluding placement of vascular access) \<21 days from beginning of the study drug or minor surgical procedures \<7 days
* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
* Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Pregnant and nursing women
* Patients with a target lesion located in a previously irradiated field
* Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation.
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy

This is a single-center, randomized, controlled trial (RCT), comparing bedside US-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy (PC). The study will randomize a total of 100 consecutive patients (50 in each group) undergoing PC at one large tertiary university hospital. The primary endpoints will be technical success and procedure-related complication rates. Secondary endpoints will be procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring PC, regardless of the underlying cause.
* Signed informed consent form

Exclusion Criteria:

* Age \<18 years or \>100 years
* The necessity for CT-guided PC catheter placement, according to the judgment of the performing physician
* Severe uncontrollable coagulopathy
Sweat and Gas Sensor for Healthy Skin and Atopic Dermatitis

Pilot study of a wearable gas and sweat skin sensor

The objective of this study is exploratory and deploys two wearable sweat and gas sensors which detect the composition of sweat proteins and volatile gases emitted from the skin in healthy subjects and patients with atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Subjects willing and able to comply with requirements of the protocol
* Healthy adults or subjects with atopic dermatitis

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and able to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape
* History of heat stroke, heat related or exercise related
* Non-English speaking subjects
A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India

The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their diabetes treatment and lab tests as part of their normal doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Diagnosed with type 2 diabetes (T2D).
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Available glycated haemoglobin A1c (HbA1c) value less than or equal to (\<=) 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.
* Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to (\<=) 14 days.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Any prior or current use of oral semaglutide.
* Hypersensitivity to oral semaglutide or to any of the excipients.
* Treatment with any investigational drug within 30 days prior to signing of informed consent.
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to signing of informed consent.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Early Detection of Glycocalyx Damage in Emergency Room Patients

Aim of the study is to evaluate to what extent a glycocalyx damage measured in the ER in patients presenting with sepsis correlates with their clinical course and if it can be used as a clinical stratification tool and mortality predictor.

The study will focus on the changes of the microcirculation and how they correlate with the macrocirculation, as well as microbiologic parameters. In the study will participate ca. 300 patients with sepsis, as well as 30 patients without sepsis and 30 healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

Patients with suspected sepsis

* Adult patients presenting to the ER with the clinical suspicion of infection
* Indication for hospital admission

Patients without sepsis

* Adult patients presenting to the ER with other conditions apart from sepsis/infection.

Healthy individuals

* Adult healthy individuals.

Exclusion Criteria (for all groups):

* Underage persons
* Pregnant women
* Oral mucosal injuries
Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

Recently, probe based confocal laser endomicroscopy showed to be able to distinguish malignant from benign pleura during medical thoracoscopy. However The clinical usefulness of this new tool remains to be determined.

The investigators believe that pCLE could be part of mini invasive pleural disease management and could be used during thoracentesis in order to increase the diagnostic yield of this procedure. The investigators are starting a prospective trial to recruit patients referred for medical thoracoscopy to the endoscopy unit.

First, the pCLE probe will be introduced through the Boutin's needle or the thoracentesis catheter, just before the thoracoscopy, in order to investigate the pleural pCLE features and to identify or exclude malignant infiltration. Second those features will be compared to the pCLE acquisition obtained during the medical thoracoscopy (the probe is introduced through the working chanel of the thoracoscope), under visual control. In order to compare the invasive and mini invasive acquisition, 10 criteria will be prospectively assessed.Third, These features will be compared to the histological samples performed during thoracoscopy. Finally, the interpretation of different investigators will be compared.

The 10 criteria are presented below:

1. Abnormal tissular architecture

   No: Correct identification of the previously described normal pleura characteristics Yes: identification of cellular/tissular structures which are not known to correspond to normal pleura (cellular clusters or dark clumps, glands, cells cordons, dysmorphic cells, papillar distribution....)
2. Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator

   yes no
3. Mean cellular size:

   Small: \< 10µm Moderate: 10 - 20µm Large: \> 20µm
4. Cellular density (with reference to the Chia seed sign)

   Low (lower than the Chia seed sign) Moderate High
5. Dysplastic vessels:

   Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia
6. Vascular density (on a full optical area)

   Low: 0 -2 vessels Moderate: 3 - 4 vessels High: \> 4 vessels
7. Organized or anarchic connective fibers

   Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture.
8. Chia seed sign on a full optical areal

yes No


Eligibility Criteria:
Inclusion Criteria:

* Every patient referred to the endoscopy unit for medical thoracoscopy

Exclusion Criteria:

* Pregnancy
* Known allergy to the fluorescein
Study About High Fat Meal and Postprandial Lipemia

The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.

These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.

Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.

Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.

Eligibility Criteria:
Inclusion Criteria:

* all patients should have obesity class I (BMI between 30 and 35kg/m2);
* Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
* Presenting the age between 19 to 40 years.
* Waist circumference\> 80 cm (IDF)

Exclusion Criteria:

* Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
* Presence of dyslipidemia;
* smokers;
* Significant loss of body weight six months prior to the study.
Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer

This trial studies nutritional preferences and product accessibility in oral nutritional supplements in participants with breast, colorectal, upper gastrointestinal, or prostate cancer. Learning what participants like and dislike about their current or past used nutritional supplements may help doctor know how to improve them.

PRIMARY OBJECTIVES:

I. Identify how patients with cancer are obtaining nutrition to support medical management.

SECONDARY OBJECTIVES:

I. Examine associations of gastrointestinal side effects with specific diagnoses and respective medical therapies.

II. Understand how patients access information regarding nutritional supplements.

III. Evaluate patient satisfaction with currently available oral nutritional supplements (ONS).

IV. Identify patient preferences in formulating a novel nutritional supplement.

OUTLINE:

Participants attend an interview over 15 minutes and complete surveys.

Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend English (both reading and writing)
* Subjects in the inpatient and outpatient setting with the diagnosis of breast cancer, colorectal cancer, upper gastrointestinal cancer (including gastric, pancreatic, and cholangiocarcinoma), or prostate cancer
* Receiving chemotherapy, biologic, or hormonal therapy in the University of Southern California (USC) Norris Comprehensive Cancer Center Day Hospital
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients with a mental disability that makes them unable to understand and respond to the questions
* Patients with reported non-oncologic associated deficits in taste and smell
Fasturtec TLS Treatment / Prophylysis

An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome


Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy planned for at least 3 cycles
* Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV
* With a minimum life expectancy of 3 months
* Uric acid \> 8 mg%
* Negative pregnancy test \< or =to 2 weeks and efficient contraceptive method.
* Negative HIV serology \< or =to 4 weeks
* Patient or legal guardian has signed a written informed consent

Exclusion Criteria:

* Hypersensitivity to uricases or any of the excipients
* Known history of G6PD deficiency.
* Previous treatment with Rasburicase or Uricozyme®
* Pregnancy or lactation
* Treatment with any investigational drug within 30 days before planned first Rasburicase administration
Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

* It has been shown that patients who undergo liver resection surgery are at high risk for postoperative acute kidney injury (AKI).
* Sevoflurane may increase the risk for postoperative AKI because of production of compound-A.
* Therefore, we have planned to investigate the effects of different anesthetic agents on postoperative renal function.
* Patients undergoing liver resection surgery are randomized into 2 groups.
* One of the groups receives sevoflurane and the other group receives desflurane.
* Blood and urine specimen are sampled both pre- and postoperatively, and several biomarkers are compared between the groups.

1. Design

   - This is a randomized, observer-blinded, controlled trial.
2. Study objectives and hypothesis

   - The aim of this study is to prove the hypothesis that desflurane is safer than sevoflurane in terms of the association with postoperative acute kidney injury (AKI) after liver resection surgery.
3. Inclusion and exclusion criteria

   * Inclusion criteria: Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included.
   * Exclusion criteria: Patients who undergo less invasive liver resection surgery under thoracoscopy or laparoscopy are excluded. Patients with chronic kidney disease, or allergic to any anesthetic agents used in the study (e.g., desflurane, sevoflurane, propofol, remifentanil, rocuronium) are also excluded.
4. Outcome definition

   - AKI is diagnosed based on RIFLE creatinine criteria within 72 hours postoperatively. Serum creatinine is measured preoperatively, on the day of the surgery, and 1st, 2nd, and 3rd postoperative days.
5. Methods

   * Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the agent administered during anesthesia
   * For the quantitative analysis for subclinical AKI, urine interleukin-6 (IL-6), plasma and urine neutrophil gelatinase-associated lipocalin (NGAL), serum cystatin C, urine liver-type fatty acid-binding protein (L-FABP), urine N-acetyl-β-D-Glucosaminidase (NAG), and urine albumin concentration are measured preoperatively, on the day of the surgery, and 1st postoperative day.
   * Demographic data, preoperative medication, past medical history, perioperative data related to anesthesia and surgery, and data related to outcome are also sampled.
   * Postoperative clinical course is followed until the patients are discharged.
   * Incidence rate of postoperative AKI and biomarkers are compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included.

Exclusion Criteria:

* Patients who undergo less invasive resection surgery under thoracoscopy or laparoscopy are excluded. Patients with chronic kidney disease, or allergic to any anesthetic agents used in the study are also excluded.
PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
* Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.

Exclusion Criteria:

* Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
* Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
* Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.
Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.

To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.

The efficacy of cabergoline is dose related and determined by percentage of Dopamine 2 receptor occupancy and prolonged receptor affinity. Activation of membrane receptors and target cell responses is proportional to the degree of receptor occupancy. Greater the drug concentration, greater is the binding and receptor occupancy and greater is the efficacy of the drug. Receptor occupancy can be increased either by using high dose of cabergoline or by rapid escalation of cabergoline. The patients, who respond to increasing dosages of cabergoline, probably do so by increased receptor occupancy with higher doses.

Rapid escalation of doses of cabergoline is another approach to increase the drug concentration and increase the occupancy of the receptor. Earlier decrease in serum prolactin levels with rapid escalation may help in reducing the cumulative dose of cabergoline and total duration of treatment. Though studies with high doses of cabergoline have been performed in prolactinomas with normalization of prolactin levels in almost 100%, but systematic studies using rapid escalation of cabergoline in prolactinomas are lacking except the one by Bhansali et al. In their study, serum prolactin became normal in 93 per cent of the patients with a mean duration of 8.2 wk. The mean decrease in serum prolactin was 99 per cent by four weeks, however a similar decrease (93 to 99%) in prolactin was achieved in other studies with a time lag of 48 to 160 wk. This supports the notion that rapid hike in doses of cabergoline decreases serum prolactin levels faster and it becomes normal in the majority of patients earlier6. However it was an uncontrolled study with limited number of subjects.

Therefore present study was planned to study the efficacy of rapid escalation of Cabergoline versus conventional dosing in patients with macroprolactinomas. Rapid escalation of cabergoline dose may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.

Eligibility Criteria:
Inclusion Criteria:

Males or females presenting with

1. Prolactin secreting macroadenomas (≥10 mm maximum diameter)
2. With/without visual complaints
3. With /without parasellar or suprasellar extension
4. Treatment Naïve

Exclusion Criteria:

1. On treatment with dopamine agonists.
2. Taking other drugs influencing prolactin Levels.
3. Systemic disease like Chronic Kidney Disease, Chronic Lung Disease
4. Other secondary causes of hyperprolactinemia.
5. Prolactin secreting microadenomas
6. Pregnancy during follow up
7. Prolactinoma as part of MEN-1 Syndrome
8. History suggestive of recent apoplexy (3 months)
9. Contraindication to cabergoline therapy like pre existing psychosis.