cyrilzakka/clinical-trials huggingface dataset:
GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors

This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.

This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.

This is 4 dose levels and increase dose level after confirm DLT of the previous dose.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of solid tumor, for which no standard therapy exists or is available any longer.
* Aged ≥19 years(Korean age).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥12 weeks.
* Adequate hematological and end organ function defined by the following
* laboratory results obtained within 14 days prior to Cycle 1 Day 1 (C1D1)
* Female subjects of childbearing potential (including a female who has undergone tubal ligation) requires a negative serum pregnancy test performed within 14 days prior to C1D1.
* Have an evaluable lesion(s) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Subjects to be enrolled in the Phase 2a stage must be able to provide pre-treatment tissue biopsy or archival tissue and must have a tumor lesion.
* Providing the signed informed consent form (ICF).

Exclusion Criteria:

* Unable to adhere to the study procedures and follow-up procedures.
* Pregnant or lactating subjects.
* Have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease.
* Have uncontrolled type 2 diabetes mellitus.
* Have history of a major surgery within 28 days prior to C1D1 or are anticipated to require a major surgery during the study.
* Have an evidence of severe or uncontrolled systemic disease, uncontrolled hypertension.
* Have received any other investigational or approved anticancer therapy within 3 weeks prior to C1D1.
* With a positive result of human immunodeficiency virus (HIV) infection.
Beta-glucan on Fecal Microflora in Polypectomized Patients

The aim of this study is to determine the effect of the potential prebiotic beta-glucan on the intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and beta-glucosidase) in the feces, the fecal pH and the concentration of fecal short-chain fatty acid in polypectomized patients. Also the in vitro anti-cyto- and anti-genotoxicity of fecal water will be examined on human cell culture (HT29). During the trial, patient's clinical symptoms (intestinal habits), physical activity, well-being and food intake will be recorded.

Prebiotics, such as short- and long-chain fructo-oligosaccharides are fermented by the microflora colonizing the gastrointestinal tract, and they selectively stimulate the growth or the activity of one or limited number of bacteria within the intestine. Beta-glucans are polysaccharides occurring in the bran of cereal grains, the cell wall of Saccharomyces cerevisiae and bacteria, certain types of fungi, seaweed and many kinds of mushrooms. The aim of this study is to determine the effect of the potential prebiotic beta-glucan on the intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and beta-glucosidase) in the faeces, the faecal pH, and the concentration of faecal short-chain fatty acid in polypectomized patients.

Eligibility Criteria:
Inclusion Criteria:

* The subjects must have biopsy and histologically confirmed adenomatous polyps ≥ 1cm in size or ≥ 3 in number with moderate or severe dysplasia

Exclusion Criteria:

* Subjects ≥ 75 years of age
* Subjects who are pregnant or desire to become pregnant during the study period
* Subjects who are considered to be poor clinic attendees
* Subjects who have been on antibiotics within the previous month or are likely to require antibiotics during the trial
* Subjects who consume prebiotics or probiotics within the previous month or are likely to require antibiotics during the trial
* Subjects with colon cancer
* Subjects with additional gastrointestinal disorders (e.g., Crohn's disease or ulcerative colitis)
* Subjects with malignancy or any end-stage organ disease
Diagnostic and Prognostic Value of Serial Procalcitonin (PCT) Measurements in Critically Ill Patients

In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with other laboratory markers to aid in the risk assessment of critically ill patients with severe infection (sepsis). Although considerable literature exists regarding the usefulness of Procalcitonin (PCT) as a marker of sepsis, there are still potential uses for PCT measurements that are not yet explored and its value among the critically ill patients remains unclear. This study seeks to better understand the usefulness of measuring PCT values in patients admitted to the Medical ICU for a variety of reasons and in particular with severe infection (sepsis).

Procalcitonin (PCT) is a 116 amino acid peptide that has an approximate MW of 14.5 kDa and belongs to the calcitonin (CT) superfamily of peptides. Transcription of the CALC-1 gene for PCT is usually suppressed in the non-neuroendocrine tissue, except in the C cells of the thyroid gland where its expression produces PCT, the precursor of CT in healthy individuals and in the absence of infection.

In the presence of microbial infection, circulating levels of calcitonin precursors (CTpr), including PCT, increase up to several thousand-fold.1 In addition to being a marker of microbial infection, PCT also acts as a modulator of the host inflammatory reaction. In an animal model of sepsis, administration of exogenous human PCT worsened outcome, whereas neutralization of endogenous PCT improved survival.

There are several inflammatory laboratory markers, like tumor necrosis factor (TNF)-α, interleukin (IL)-1, IL-6 and C-reactive protein (CRP), but they are non- specific for infection and can be caused by conditions like pancreatitis, burns, trauma or acute lung injury. The non-specific nature of clinical and laboratory parameters for microbial infection makes it difficult to evaluate patients with potential infection. In addition to the lack of specificity, traditional laboratory and clinical indicators of sepsis are not temporally concordant with the course of illness. As a result, these tests are not reliable to evaluate the response to therapeutic interventions in real time.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients admitted to the Medical Intensive Care Unit of the Cleveland Clinic with an anticipated MICU stay of ≥ 12hrs

Exclusion Criteria:

* Age less than 18-years of age and/or an expected MICU stay of less than 12-hrs
Seattle-PAP Bubble Nasal CPAP and Work of Breathing

The investigators propose to test the hypothesis that Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway pressure.

The primary outcome variable is work of breathing (WOB) over a two hour period, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles. The following endpoints would also be assessed: Oxygen saturations and Fraction of Inspired Oxygen (FiO2) needed to keep saturations in acceptable ranges, Heart Rates (HR), transcutaneous carbon dioxide (TcPCO2), and respiratory rates throughout the 6 hour study period.

Objective determination of when an infant requires more or less respiratory support is difficult, but measurements of pressure-rate products as estimates of work of breathing, using esophageal catheters, can estimate an infant's respiratory effort. However, objective, simple-to-use, low cost, and non-invasive methods and tools to determine an infant's respiratory effort do not exist currently.

This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.

Eligibility Criteria:
Inclusion Criteria:

* infant born less than 32 weeks gestation
* admitted to texas pavilion for women
* between 6 and 72 hours post delivery
* stable on standard bubble nasal CPAP
* informed consent

Exclusion Criteria:

* major congenital anomalies or suspected chromosomal anomalies
Functional MRI Evaluation in Pyeloureteral Junction Syndrome in Children

Pyelo-ureteral junction syndrome is the most common urological abnormality in children.

Functional MRI has been evaluated several times, and had shown good correlation with scintigraphy, but tends to over estimate results. Moreover, those studies included a small number of cases. Its sensitivity to detect crossing polar vessel is limited.

We aimed to evaluate, in patients between 0 and 1 year old, the correlation between MRI and scintigraphy differential renal function.

Our secondary objectives are : evaluation of MRI performances to detect polar vessel ; comparison of surgery times depending of MRI only realisation or MRI and scintigraphy realisation.


Eligibility Criteria:
Inclusion Criteria:

* children between 0 and 17 years old
* followed for pyelo-ureteral junction syndrome

Exclusion Criteria:

* none
Evaluate Breast Masses Using a New Method of Ultrasound Contrast to Detect Abnormal Blood Flow in Breasts

The purpose of this study is to determine if breast imaging with ultrasound can be improved by using 1) a ultrasound attachment with two transducers and 2) a contrast agent. These changes might allow smaller blood vessels to be seen than under the way breast ultrasound is usually performed.

The purpose of this study is to determine if performing ultrasound with an attachment made up of two transducers (rather than just a single transducer) will provide more information about the blood vessels in the breast than the current attachment.

The study will also examine the question of whether use of an ultrasound contrast agent will the scanner to see smaller blood vessels than are detected without the agent.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects who have breast masses and scheduled for core biopsy.

Exclusion Criteria:

* Pregnant or lactating females.
* Females who have heart problems or sensitivity to contrast agents.
* Females who have had previous surgery for breast cancer.
Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment

The prognosis in cancer patients has improved over the years. Survivor rates have increased significantly, and paternity has become an important concern in more than 50% of young male survivors. Sperm cryopreservation before cancer treatment is highly recommendable in these patients, as a strategy to preserve their fertility due to is not possible to predict how the chemo or radiotherapy treatment will affect the spermatogenesis.

The objective of this study is to evaluate if sperm after an antineoplastic treatment can be safely used. To determine the possible effects of oncological treatments in the spermatogenesis, three parameters will be analyzed, aneuploidy frequencies, DNA fragmentation in single and double-strand breaks and methylation levels to determine epigenetic changes before and after the therapy.

If cancer treatment affect sperm genetic integrity, it would have a clinical impact in the offspring of these patients. Identify the different side effects of antineoplastic treatments in DNA sperm will provide a clinical improvement in order to select the best sperm sample in an IVF treatment and it will facilitate genetic counseling


Eligibility Criteria:
Inclusion Criteria:

Patients with previous history of cancer Patients with several sperm samples cryopreserved to be able to thaw a part without damaging their future options, in case they need them.

Patients treated with chemotherapy and/or radiotherapy Patients have finished their oncological treatment. Patints recovered spermatogenesis after the oncological treatment to be able to obtain a sperm sample.

Exclusion Criteria:

Patients with only one sperm sample cryopreserved Patients that are not be able to obtain a fresh sample post treatment Patients with less than 3 million sperm per milliliter
An Open Label Positron Emission Tomography (PET) Study of GSK618334 in Healthy Male Subjects Using 11C-PHNO as PET Ligand

The purpose of this study is to investigate the relationship between the plasma concentrations of the study drug and the amount of the study drug bound to the D3 receptors of the brain after dosing of a new compound GSK618334.

This imaging study will be an open label, non-randomised PET receptor occupancy study using healthy male volunteers. The time course and degree of D3 receptor occupancy (RO) after single doses of GSK618334 will be determined using 11C-PHNO as a PET ligand labeling dopamine receptor. The PK/PD relationship between plasma concentrations of GSK618334 and D3 RO will be described. Potential relationships between D3 RO and functional magnetic resonance imaging (fMRI) endpoints will be assessed as an exploratory aim.

Eligibility Criteria:
Inclusion Criteria:

* healthy, male subjects aged between 30 and 55 old inclusive.
* normal body weight.
* normal ECG and vital signs.
* agree to use acceptable contraceptive methods required.
* capable of giving written informed consent.

Exclusion Criteria:

* smoker or uses other nicotine-containing products.
* certain medical conditions including heart disease, neurological disease, gastrointestinal disease, kidney or liver dysfunction - abnormal laboratory tests.
* certain psychiatric conditions and use of certain psychoactive drugs .
* positive blood alcohol or urine drug test.
* alcohol intake over 14 drinks per week.
* participation in another drug trial within 30 days or a study involving significant radiation exposure.
* donation of more than 450 mL blood within the 56 days.
* family history of cancer (one or more first-degree relative diagnosed before the age of 55 years old).
* having cardiac pacemaker or other electronic device.
* suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera.
The Role of Interferon-gamma in Immune Responses to Invasive Candidiasis

The purpose of the study is to investigate the role of the human immune response to candidemia/invasive candidiasis as it relates to the cytokine interferon-gamma.

In this study, patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema will be enrolled.

Persistent candidiasis confirmed by culture will be defined as follows: (i) Candida bloodstream infection present for \>48 hours after initiation of effective antifungal treatment and after removal of intravenous devices, (ii) Intra-abdominal infection (peritonitis or abscess) that persists for \>96 hours after source control intervention and effective antifungal treatment, (iii) Pleural empyema that persists for \>96 hours after placement of drainage catheter and effective antifungal treatment.

Outcomes in patients with and without persistent candidiasis will be assessed.

Eligibility Criteria:
Subjects must meet all following inclusion criteria to qualify for the study:

1. Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
2. Males or females ≥18 years of age
3. Patients having one or more systemic signs attributable to candidemia or invasive candidiasis (fever, hypothermia, hypotension, tachycardia, tachypnea, local signs of inflammation).
4. Isolation of Candida from blood, intra-abdominal abscess/peritoneal fluid or pleural fluid.

Exclusion Criteria

Subjects must NOT meet any of the following exclusion criteria to qualify for the study:

1. Severe neutropenia (absolute neutrophil count \<500 cells/microL)
2. Profound lymphopenia (\<300 cells/microL)
3. The Principal Investigator (PI) is of the opinion the subject should not participate in the study.
4. Females who are pregnant.
Trunk Rotation And Lateral Flexion Exercises In Stroke Patients

In this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors.

Stroke is a neurological deficit and acute focal injury of the by a vascular cause, including cerebral infarction, intracerebral hemorrhage and subarachnoid hemorrhage and is a major cause of disability and death worldwide. 2nd most deadly cause of death and disability in patients. This disease have long lasting effect on human body and also cause complication of lung function like pneumonia and respiratory distress function syndrome for this purpose to reduce chest complication and neurological defect use of chest physiotherapy and chest mobilization exercises are introduce so that hospital stay of patients reduces and recovery at high speed according to previous studies there is very strong relationship between trunk muscles and respiratory muscle with pulmonary function and physiotherapist can develop target rehabilitation strategies for stroke survivors.however in previous studies age group of patients acute subacute or chronic and diaphragmatic breathing are not included for the improvement of effective cough.

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* Age \> 50
* Right or left hemiplegic acute stroke patients
* Diagnosed cases of stroke patient
* Duration: 4 weeks being diagnosed
* Can sit with at least 10sec
* Can perform exercises with Active Assistance
* Patients who easily perform exercises
* Patients who response to commands

Exclusion Criteria:

* Patients with serious comorbidities like cancer
* Uncontrolled hypertension SBP \> 140mmhg and DBP \> 90mmhg
* Vitally unstable patient's
* Red flags for physiotherapy i.e. sudden dizziness, unexplained pain during exercise, chest pain.
* DVT Deep Vein Thrombosis
The Influence of Mother Nutrition on Breast Milk Microbiome

The research subject

Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. A mother's breast milk contains unique nutritious components and other nonnutritive elements that help promote healthy baby growth and development (1, 2). Recent studies show that a mother's breast milk contains components that vary from each specimen. There are great evidences that maternal and environmental factors have a strong influence on the composition of breast milk. Fatty acids, the second most common component found in breast milk, show extreme sensitivity to maternal nutrition (3, 4).

Latest studies show that breast milk also contains bacterial communities that may have health implications of newborn. The structure of these bacterial communities also varied greatly between subjects (5) .

In the research, we propose to investigate the connection between maternal nutrition, different fatty acids and their role in the growth and development of bacterial populations existing in breast milk.


Eligibility Criteria:
Inclusion Criteria:Healthy lactating women, breast feeding for the first 3 months after delivery

Exclusion Criteria: No compliance, sickness, drug consumption

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Optive Brand For Day And Night Dry Eye Management

This is an open label study of Optive eyedrops and gel combination for day and night dry eye management


Eligibility Criteria:
Inclusion Criteria:

* OSDI score of ≥ 23
* Ocular comfort at waking \<65 on 100-point scale
* Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye
* Use of eyedrops for the relief of dry eye symptoms for at least one month
* Best corrected visual acuity in each eye of at least 20/25
* Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study
* Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion Criteria:

* Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month
* Use of Optive brand eyedrops in the last month
* Monocular participants (only one eye with functional vision).
* Contact lens wear during the study
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Known pregnancy or lactation during the study period
* Participation in any clinical trial within 30 days of the enrollment visit
Keeping It Simple - Implementing Pain Education for All

Pain education has proven difficult to implement into clinical practice. In Denmark 4 out of 10 adults has inadequate health literacy levels. To avoid inequality in health care we need a new and accurate method to provide pain education to all who need it.

In this study, existing concept of pain education is implemented into clinical practice for a group of chronic pain patients including those with low degrees of health literacy, and then evaluate its use from both patient and physiotherapist perspective.

The focus of this is project is to implement existing knowledge into clinical practice and to adapt and test a tool (i.e., PNE4Kids) that was initially developed to explain pain to children and their parents, for its potential to teach adults in pain about contemporary pain science in a way that takes into consideration those with low degrees of health literacy. Further, we want to test its feasibility in adult pain patients at a community-based rehabilitation center. It is expected that adult patients suffering from chronic pain will find the adapted PNE4Kids, named PNE4Adults, comprehendible, will benefit from this type of pain education in terms of increased pain knowledge and self-efficacy, and decreased pain-intensity and pain catastrophizing thoughts. It is also expected that physiotherapists will find the pain education program easy to engage with and to transfer into a clinical setting.

Eligibility Criteria:
Eligible patients are; Danish speaking adult patients (≥18 years) Patients with chronic musculoskeletal pain (pain ≥ 3 months).