cyrilzakka/clinical-trials huggingface dataset:
Effect of Food on the Pharmacokinetics of ORIC-114

A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult subjects.

The study will be performed in two parts. Part 1 will assess the effect of food at a lower dose of ORIC-114 to first ascertain the degree of food effect (if any) on ORIC-114 exposure as a way to ensure the safety of the participating subjects. Part 2 will further assess the food effect at a higher dose of ORIC-114.

If the preliminary Part 1 results clearly show no food effect, Part 2 may not need to be conducted upon assessment by the Sponsor.

If Part 2 is conducted, the dose of ORIC-114 will be selected within the anticipated efficacious clinical dose range based on results from Part 1.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, adult, male or female (of nonchildbearing potential only), 18-55 years of age
2. Continuous nonsmoker who has not used nicotine and tobacco containing products for at least 30 days
3. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
5. Able to swallow multiple tablets.

Exclusion Criteria:

1. Mentally or legally incapacitated or has significant emotional problems
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
3. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
4. History or presence of clinically significant GI disorder (
5. Female subjects of childbearing potential.
6. Positive urine drug screen or alcohol breath test results
7. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
8. Lactose intolerant.
DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 18 years of age in sinus rhythm
2. Able to communicate effectively with trial personnel
3. LVEF measurements obtained via 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
4. Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial

Exclusion Criteria:

1. Female subjects who are pregnant or lactating. All women of child bearing potential \[WOCBP\] must have a negative urine pregnancy test at screening regardless of contraceptive use history.
2. Women of child-bearing potential are excluded unless they:

   1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
   2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
   3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
3. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
4. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).
5. Unstable cardiovascular status defined as:

   1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
   2. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
   3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
   4. clinically significant congenital heart defects
   5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
   6. acute pulmonary embolus or pulmonary infarction
   7. acute myocarditis or pericarditis
   8. acute aortic dissection
   9. atrial fibrillation
6. any major surgery within 4 weeks prior to screening
7. known contraindications to undergoing CMR (e.g. implanted pacemakers, cardioverter, defibrillators) or claustrophobia
8. participation in any investigational drug, device, or placebo study within 30 days prior to screening
9. known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease).
The Effects of Inhaled Iloprost on Congenital Heart Disease With Eisenmenger Syndrome

Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted therapy used in patients with Eisenmenger's syndrome. The purpose of our study is to assess the effects of inhaled iloprost on patients with Eisenmenger's syndrome.


Eligibility Criteria:
Inclusion Criteria:

* patients with Eisenmenger's syndrome diagnosed by right side cardiac catheterization

Exclusion Criteria:
Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy

The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference between these two treatment modalities in terms of glycemic control in diabetes.

The experimental method will be a randomized controlled trial performed at Roosevelt Hospital in our Diabetes in Pregnancy Program (DIPP). Perinatologists managing the patient in DIPP determine when patients need further treatment with medical therapy. Patients undergoing care at DIPP may require medical intervention in the following clinical scenarios: failure of diet alone to control glycemic indices and grossly abnormal glucose tolerance screening test results suggesting disease of such severity that diet alone would not be sufficient. After verbally counseling the patient, she will be recruited for the study by the investigators. An extensive explanation of the objectives of the study will be presented to the patient, as well as written copies of the protocol and consent. After informed consent is given, patients will be randomized to management with either insulin NPH or detemir together with rapid acting insulin aspart (Novolog) with meals, as necessary. The primary outcome will be level of glycemic control defined as overall mean blood glucose in pregnancy. This is a well established measure of overall glycemic control that has been used in numerous publications in the obstetric literature on diabetes in pregnancy. Participants will be followed until they deliver, with an expected range of 6-16 weeks depending on when the patient was enrolled in the study. The mean glucose will be determined by the sum of average glucose at each visit divided by the number of visits).

Eligibility Criteria:
Inclusion criteria:

* All pregnant women with a viable singleton or multiple gestation at ≤34 weeks with gestational diabetes diagnosed in their current pregnancy requiring medical therapy. "Early diagnosis" GDM patients will also be included; which is defined as a diagnosis made prior to 24 weeks.
* Women with known preexisting type 2 diabetes that are in need of medical therapy.

Exclusion criteria:

* Patients \<18 years of age
* a diagnosis of GDM outside of the gestational age stated above
* known allergy/prior adverse reaction to insulin NPH or insulin detemir.
* type 1 diabetes
Efficacy of Cotton as a Dampener for Vibration Anesthetic Device

The study aims to determine the effectiveness of cotton as a dampener for vibratory anesthetic devices (VADs) for dermatologic patients. It will compare patient preferences for VAD use with and without cotton across different anatomical sites and identify factors, such as chronic pain or neuropathy status, that may influence these preferences. Finally, the study seeks to generate preliminary data to inform potential modifications to VAD use, optimizing patient comfort in dermatologic procedures


Eligibility Criteria:
Inclusion Criteria:

1. Age range: from 18+
2. Dermatologic patients at Westlake Clinic
3. Consent: Must provide informed consent to participate in the study.
4. Availability: Able to complete the entire study session, which includes testing all sites in a single session

Exclusion Criteria:

1. Broken skin or known peripheral neuropathy on anatomical site of vibration.
2. Allergies: Known allergy or sensitivity to nitrile gloves or cotton
Study to Compare CAUTI Rates Following ERASE CAUTI Tray Non-Silver vs Silver Coated Foley Catheters

The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Received Either silver coated Foley catheter or ERASE CAUTI non-silver coated catheter

Exclusion Criteria:

* UTI present upon current hospital admission
* Burn patients, transplant patients, or immune-compromised patients.
Clinical Outcomes of Patients With COVID19

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with COVID19

Exclusion Criteria:

* Suspected patients with COVID19, not confirmed by the laboratory
* Patients who are refused to receive medical treatments
Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation

The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
2. Responsive to levodopa
3. Hoehn \& Yahr stages II-IV
4. Age range 55-85 years old
5. self-report of one or more falls in past 12 months
6. willing and able to attend exercise intervention sessions at OHSU campus, and also refrain from changes in anti-parkinson medications and exercise levels.

Exclusion Criteria:

1. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
2. no medical condition that precludes exercise
3. MoCA ≤ 21 or inability to follow directions
4. excessive use of alcohol or recreational drugs
5. recent change in medication
6. inability to stand and walk for 2 minutes without an assistive device
The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3

The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.

Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.

Eligibility Criteria:
Inclusion Criteria:

* Ten men and women in each group,
* aged 20-60.

Exclusion Criteria:

* History of hypercalcemia,
* vitamin D supplement use \> 800 IU daily,
* BMI \> 30,
* gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
* use of steroids in any form,
* anticonvulsants,
* antibiotics,
* acute illness, or
* vacation planned to "sunny climate"
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.

PRIMARY OBJECTIVES:

I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.

SECONDARY OBJECTIVES:

I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years.

TERTIARY OBJECTIVES:

I. To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index.

OUTLINE:

Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants undergo collection of breast tissue samples at any breast biopsy or breast surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
* Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
* Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
* Documented informed consent of the participant

Exclusion Criteria:

* Allergy or intolerance to gadolinium
* Inability to undergo breast MRI (e.g. claustrophobia)
* Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
* Previous diagnosis of stage 4 cancer
* Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
* Participants who have received endocrine therapy within 1 year prior to screening breast MRI
* Participants who have received breast radiation within 1 year prior to screening breast MRI
* Radiation to both breasts
* Pregnant and/or lactating within 1 year prior to screening breast MRI
* Receives screening breast MRIs at an outside facility other than the consenting institution
Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study

Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed.

Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension

Eligibility Criteria:
Inclusion Criteria:

* Papillary adenoma which seems suitable for curative endoscopic resection.
* 18 years or older.
* Capable of providing written and oral informed consent.

Exclusion Criteria:

* Patients with intraductal extension of \>1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.(16)
* Failure to place a PD stent in patients with normal pancreatic duct anatomy.
* Refusal to provide informed consent.
Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers

Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient.

The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with solid tumors. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects. Since immunologically based treatment of various solid tumors is under intense review with so called "immune checkpoint inhibitors" this trial will also provide valuable information on how imILT, in the future, could be combined with these new and, for some patients, very effective treatment regimens.

The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes.

This trial is explorative, prospective, open and non-randomized. Thirty patients diagnosed with solid tumors will be treated in this trial, which is estimated to be carried out during a time period of 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female \> 18 years of age
* Have histologically confirmed, locally uncontrolled, solid cancer, with or without metastases, that cannot be treated surgically due to unresectability or inoperability
* Have one or more tumours assessable by MRI/CT or ultrasound and situated in such a way that at least a part of the tumour can be treated with IMILT without damage to surrounding vital structures or the skin
* Are candidates for ablative intervention also outside this study
* Have given informed verbal and written consent to participation in the trial
* Have an ECOG performance status \< 2 (Karnofsky \> 60%)
* Have stable haematologic, renal and hepatic functions

Exclusion Criteria:

* Are HIV positive
* Have an active autoimmune disease
* Are on systemic corticosteroid medication (local treatment with aerosol's and ointment is allowed)
* Have known bleeding disorders or are treated with anticoagulant medication
* Are pregnant or nursing
A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD

The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring disease activity and predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD). The cohort of participants with COPD will be followed for 3 months. A calibration cohort with non-COPD participants will be included and followed for 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

For participants with COPD:

* Participants ≥40 and ≤80 years at baseline
* Diagnosis of COPD stage II to IV
* History of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to Covid-19 measures)

For participants in the calibration cohort:

• Participants ≥40 and ≤80 years at baseline

Exclusion Criteria:

For participants with COPD:

* Clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia \[esp. atrial fibrillation and conduction blocks\]), lung cancer (currently treated) that in the opinion of the Investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the study
* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
* Participants with known allergies or sensitivity to silicon or hydrogel
* Less than 6 weeks since previous moderate/severe exacerbation

For participants in the calibration cohort:

* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
* Participants with known allergies or sensitivity to silicon or hydrogel
* Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity