cyrilzakka/clinical-trials huggingface dataset:
Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers

This is a 2-part Phase 1 cross-over study to assess the effects of food on the pharmacokinetics of PC14586 in healthy volunteers. The pharmacokinetics of PC14586 at a clinically relevant dose in Japanese participants will also be studied.

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the p53 Y220C mutation. This Phase 1 trial will be conducted in 2 parts (Part 1 - pilot and Part 2 - pivotal) to assess the pharmacokinetics of PC14586 in healthy volunteers including Japanese participants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male and female Caucasian/ non-Asian or Japanese human volunteers
* 18 to 55 years of age
* Able to swallow tablets.

Inclusion criteria for Japanese participants only:

* Japanese and born in Japan (1st generation)
* The parents and grandparents of the participant are ethnically Japanese and born in Japan
* Has undergone no significant change in lifestyle since leaving Japan
* Has lived \< 10 years outside of Japan

Exclusion Criteria:

* Clinically significant medical history as determined by the PI.
* Any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
* A p53 Y220C mutation.
* Blood pressure \>140 mm systolic or \>90 diastolic.
* Smoked or used other nicotine-containing products during the previous 3 months.
* History of alcohol and/or illicit drug abuse within the previous 5 years.
* Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV).
* Positive blood test for ethanol.
* Positive urine drug test.
* Pregnancy or breastfeeding.
* Unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site.
* Has donated blood within 2 months prior to admission.
* Has used over-the-counter (OTC) medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission.
* Has used an investigational drug within 30 days prior to Screening.
Study of Incidence, of Mechanisms and Prognosis of the Thrombopenia From Patients of Reanimation.

About 40 % of the patients in reanimation are thrombopenics and the causes are not well known (reduction in platelet's production, increase in their destruction...). This protocol studies the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in order to bring patients best medical cares.

About 40 % of the patients in reanimation are thrombopenics and the causes are not well known (reduction in platelet's production, increase in their destruction...). This protocol studies the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in order to bring patients best medical cares.

Eligibility Criteria:
Inclusion Criteria:

* Thrombopenia in reanimation

Exclusion Criteria:

* Pregnancy
* Contraindication of myelogram
Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure

The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.


Eligibility Criteria:
Key Inclusion Criteria:

1. Hospitalized for acute decompensated heart failure.
2. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
3. Renally compromised.
4. Female patients must be post-menopausal or surgically sterile.

Key Exclusion Criteria:

1. Acute or suspected acute myocardial infarction (AMI) or troponin levels \> 3X the upper limit of normal at the institution's local laboratory
2. Cardiogenic shock
3. Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
4. Clinically significant aortic or mitral valve stenosis
5. Temperature \>38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
6. ADHF due to significant arrhythmias
7. Severe renal failure defined as creatinine clearance \< 30 mL/min
8. Current or planned ultrafiltration, hemofiltration, or dialysis
9. Significant pulmonary disease
10. Major neurologic event, including cerebrovascular events in the prior 60 days.
11. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
12. Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.


Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infants \< 1500 gr
* Gestational age \< 32 weeks

Exclusion Criteria:

* Genetic anomalies
* Short bowel syndrome
* Not willing to participate
* Allergy to Lactobacillus reuteri components
Odense Fallers and Osteoporosis Study

Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and fall increases the risk of fracture. Falls in the elderly are associated with a high morbidity and mortality with potentially life-threatening consequences of falls including fractures. Besides fracture fall may cause long term problems such as disability fear of falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip and spine. The investigators want to investigate whether other more accessible and less expensive testing methods can be used to diagnose osteoporosis. Additionally, the investigators will examine the incidence of osteoporosis among the elderly in the municipality of Odense. Finally, the investigators would like to investigate the association between factors that can lead to falls and to investigate the performance of older and whether there are changes in functional ability over time.

Study Objectives

1. To define the prevalence of osteoporosis in a falls clinic population, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.
2. To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
3. To determine the prevalence of vertebral fractures in a falls clinic population and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers
4. To investigate functioning, disability, health related quality of life and perceived need for rehabilitation in a falls clinic population including variation in a one year period, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 65 years or over attending the falls clinic

  \*(There will be no upper age limit to recruitment).
* Those capable of giving Informed consent.

Exclusion Criteria:

* Patients under the age of 65 years.
* Men.
* Patients unwilling to give informed consent.
* Cognitively impaired people who are not capable of giving consent.
* Patients who are not mobile enough to be helped onto a DXA scan table with help
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease

In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery . Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.


Eligibility Criteria:
1. Inclusion criteria:

   * Age˃18 years, scheduled for upper abdominal surgery under general anesthesia.
   * Moderate to very severe COPD (GOLD II to IV).
   * ASA functional status II or greater.
2. Exclusion criteria:

   * Contraindications to the application of NIV.
   * Sleep apnea syndrome.
   * Facial deformation.
   * Inability to follow the study.
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response

The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ 40 years
* Patients must have a tissue diagnosis of HER2+ breast cancer
* Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy
* Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist
* Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection.
* Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis)

Exclusion Criteria:

* Breastfeeding
* Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast
* Prior adjuvant radiation therapy
* Patients with diagnosis of inflammatory breast cancer
* Patients with known BRCA mutation or other known breast cancer related deleterious mutations
Does Adding Milk to Coffee Change Gastric Volume?

The intention of this study is to determine wether coffee added milk change gastric volume in comparison with gastric volume after drinking black coffee

Thirty participants - divided in tree groups - drink coffee with or without milk after six hours fast for solid food. Each group drinks both coffee with or without milk in different order. Two hours after drinking coffee gastric volume is measured by Magnetic Resonance Imagining.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Former or present gastric history, pregnancy, claustrophobia, metal implants
Evaluation of the Influence of Body Position on the Inferior Vena Cava (IVC) Diameter

To determine if laying down or standing up changes the diameter of the inferior vena cava.

Patients are referred for IVC(inferior vena cava)filter placement secondary to trauma, surgery, a fractured pelvis or known blood clots in the lower extremities. The filter is placed to prevent blood clots from traveling into the lungs. The filters are placed during a interventional radiology procedure. During the procedure the diameter of the IVC(inferior vena cava)is measured with the patient in a horizontal position (laying down). The blood pressure in the IVC when a patient is in this position is relatively low in normal circumstances, but may increase substantially when the patient is vertical with secondary dilation of the IVC(inferior vena cava).

Migration of IVC(inferior vena cava)filters is not frequent; however it is a serious complication, which may be caused by changes in the diameter of the IVC(inferior vena cava)related to changes in the position of the body and/or increased pressure in the abdomen.

The purpose of this study is to evaluate how much postural changes of the body affect the diameter of the IVC(inferior vena cava).

For research purposes patients will have an intravascular ultrasound (IVUS) performed to measure the IVC diameter before and after a Valsalva maneuver (having the subject hold their breath and bear down as if they were having a bowel movement). The angiographic table will be elevated and the measurements will be repeated.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older
2. Subjects who will have a clinically indicated IVC filter placement procedure scheduled.
3. Only subjects with no contraindications to being elevated up to a standing or near standing position on the angiography table.

   -

Exclusion Criteria:

1. Pregnant
2. Have a broken leg or any other physical condition that won't allow you to stand.
3. If you are in a traction device
4. If you have a brain injury and require special monitoring of the pressure in the brain.
5. Patients on a ventilator cannot participate in this study.

   -
eRT Remote Health Monitoring

Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).

Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.


Eligibility Criteria:
Inclusion Criteria:

* Age \>40 years.
* Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9
* Smoking history \>10 pack-years.
* Postbronchodilator FEV1/FVC\<70% and FEV1\<70% based on NHANES III reference values
* Domestic situation felt to be supportive of remote health monitoring.
* Ability to give informed consent.

Exclusion Criteria:

* Clinical diagnosis of asthma.
* Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction.
* Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke).
* Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit.
* Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial.
* Myocardial infarction within 6 weeks of enrolment.
* Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day.
* A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.
Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant

This will be a prospective, randomized clinical trial, comparing the sternal alignment between the fixation with rigid plate X steel wires. Patients over 18 years of age, belonging to the lung transplant line in the State of São Paulo, who will undergo bilateral lung transplantation will be studied.


Eligibility Criteria:
Inclusion Criteria:

1. Above 18 years of age;
2. Belonging to the transplant queue of InCor;
3. Eligible for sequential bilateral lung transplantation submitted to clamshell incision;

Exclusion Criteria:

1. Patients undergoing a new surgical procedure after lung transplantation with the need to manipulate the steel wires or the sternal fixation plate other than for osteomyelitis;
2. Intraoperative death;
3. Patients who have undergone unilateral lung transplantation or have not undergone a clamshell incision.
Pilot Study on the Use of the Matrix Radiofrequencyfor Treatment of Port Wine Stain Birthmarks

Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular malformation involving post-capillary venules which produces a light pink to red to dark-red-violet discoloration of the skin. It is estimated that Port wine stain occurs in 3 children per 1,000 live births. Approximately 900,000 individuals in the United States and twenty million people worldwide have Port wine stain birthmarks .

The purpose of this research study is to improve port wine stain treatment after Matrix Radiofrequency device treatment. The Matrix Radiofrequency device energy generates fractional deep dermal heating in the region of the electrode matrix to induce skin injury, thus eliciting a wound healing response. Less affected tissue surrounding the matrix points may be stimulated by heat which helps accelerate the healing process, while at the same time minimizing adverse effects such as scarring or changes in the normal skin pigmentation.

The researcher can determine Port wine stain areas treated with the Matrix Radiofrequency device will have improved Port wine stain blanching responses as compared to those areas treated by pulsed dye laser.

Eligibility Criteria:
Inclusion Criteria:

* Port Wine Stain Birthmarks suitable for comparison testing
* Age \> 18 years of age

Exclusion Criteria:

* Less than 18 years old
* Are pregnant or breastfeeding
* Other history assess by the investigator
Pneumatic Displacement of Subretinal Hemorrhage With Perfluorocarbon Gases

Subretinal hemorrhage in the macula causes a significant loss of vision. This hemorrhage can be displaced by the use of a small volume of pure perfluorocarbon gas injected into the vitreous, which expands to a 40% gas bubble in the eye. When the patient gazes 40 to 60 degree below the horizontal, the gas bubble covers the hemorrhage and gravity displaces it rapidly. This position of gaze is easier for the patient than the face down position traditionally recommended.A vector of gravity force tangential to the sclera brings about this displacement. The procedure can improve vision quickly, reduce unwanted degenerative changes in the macula because of the persistent macular hemorrhage and improves the chances of treating of the underlying cause for the subretinal hemorrhage by laser or other means.

This protocol was designed to determine the optimum position of the gaze for pneumatic displacement of subretinal hemorrhage (SRH) in the macula. A geometrical analysis of the forces that act upon a SRH in the presence of an intraocular gas bubble was analyzed and it was concluded that the displacement was due to the effect of gravity on the SRH immersed in gas. This was followed by a prospective trial of positions of gaze and volumes of gas calculated to be optimum for displacement. The eyes of consecutive patients with SRH in the macula will had an intravitreal injection of pure perfluorocarbon gas sufficient to provide a 40% bubble after expansion. The patients are instructed to gaze down 40° or 60° below the horizontal depending on the volume of gas for 20 minutes every hour. The SRH is displaced rapidly in the first week. Visual acuity usually improves but recovery can be limited by the presence of sub pigment epithelial hemorrhage, exudate or proliferation. A vector of the gravity force tangential to the sclera is the largest force acting to displace a subretinal hemorrhage within a gas bubble. 79% of the vertical gravity component is obtained at gaze 40° below the horizontal and requires volumes of intraocular gas not requiring prior removal of vitreous. Face down positioning in common practice has been an error and succeeds only if the patient has been non compliant.

5- STATUS

Eligibility Criteria:
Inclusion Criteria:

* Diminished vision secondary to subretinal hemorrhage in the macula or exudative maculopathy.

Exclusion Criteria:

* Patient unable to maintain gaze position for 20 minutes every waking hour for 7 days.
* Patient unable to sleep on their side or with head elevated 40 degrees.
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer

The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.

Try a new drug association on this advanced cancer

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients must sign informed consent prior to study entry
* Patients has Karnofsky performance status of more than 50%
* No prior chemotherapy
* Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
* No previous radiotherapy for locally advanced or metastases.
* Hematopoietic: WBC \> 3000/mm2, Absolute neutrophile count \> 1500/mm2, Hemoglobin \> 9g/dl, Platelet count \> 100 000/mm2

Exclusion Criteria:

* No intracerebral or meningeal metastases
* Pregnant
* Fertile patient must use effective contraception
* No other serious medical condition or illness that would preclude study participation
* Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT \> 3.5 times upper limit of normal(ULN) alkaline phosphatase \> 6 times upper limit of normal(ULN)
* More than 30 days since prior investigational therapy
Novel Imaging Technique to Assess Gynecologic Cancer

This study will test a new type of DCE (dynamic contrast-enhanced) MRI (magnetic resonance imaging) to see whether, compared with traditional MRI, it produces better images that provide more information about tumors, which may help doctors make better decisions about treating women who have gynecologic cancer.

MRI is commonly used to detect and evaluate many types of cancer, but its slow processing speed and the risk that images will be blurred if the patient moves inside the scanner can limit its use in clinical practice. DCE MRI is a new imaging technique that uses additional computer processing to collect information continuously during scanning, which produces more detailed images faster than traditional MRI, which reduces the risk of movement-related blurring and provides important information about tumor activity.

The DCE MRI scan in this study will be done in a standard MRI scanner, using a contrast agent (gadobutrol; Gadavist®) that has been approved by the FDA.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers (for SA1) will be entered into the study if they meet the following criteria:

* Women aged 18 years or older.
* Willing and able to provide informed consent

Patients (for SA2) will be entered into the study if they meet the following criteria:

* Women aged 18 years or older.
* Gynecologic cancer undergoing standard of care pelvic MRI prior to treatment
* Planned treatment with chemoradiation (for SA2b only)
* Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol.

Exclusion Criteria:

Healthy volunteers (SA1) and patients (SA2) exclusion criteria:

* History of allergic reactions to gadolinium-based contrast agents (GBCAs)
* Women of childbearing potential (WOCBP) must not be pregnant.
* Women must not be breastfeeding.
* Contraindications/risk factors to 3T MRI as per assessed by our departmental "Comprehensive MRI Screening Questionnaire" and "MRI Contrast Dye Questionnaire" (e.g. risk factors associated with magnetic field such as cardiac pacemakers, defibrillators or other devices as per standard institutional policy; and risk factors associated with GBCM such as diabetes, dialysis, breastfeeding)