cyrilzakka/clinical-trials huggingface dataset:
Optimizing Drug Doses in Critically Ill

The primary objectives of this study are to examine whether augmented renal clearance (ARC) compromises renally eliminated drug therapeutic serum concentrations in patients with traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI.

Purpose: The primary objectives of this study are to examine whether augmented renal clearance compromises renally eliminated drug therapeutic serum concentrations in patients with traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI.

Participants: The population will be comprised of patients with traumatic brain injury requiring levetiracetam for seizure prophylaxis admitted to the neurosciences intensive care unit

Procedures (methods): This is a multi-center, prospective, non-randomized pharmacokinetic study in patients with TBI. In patients who meet the inclusion criteria, a 12-hour urine collection for measuring creatinine clearance levetiracetam urine concentrations will be performed daily for 7 days. Serum levetiracetam concentrations will be obtained twice daily for 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years
2. Patients with TBI requiring levetiracetam for seizure prophylaxis
3. Anticipated length of stay in the SICU or NSICU \> 48 hours
4. Informed consent provided by the patient's designated medical proxy

Exclusion Criteria:

1. Pregnancy
2. Patients with renal dysfunction (CKD stages 3 - 5 and/or SCr \> 1.4 mg/dL)
3. Patients receiving renal replacement therapy
4. Brain death or suspected imminent brain death within the next 48 hours
5. Patients with history of nephrectomy or renal transplant
Dyadic Approach To Active Living and Eating Healthy: The DATE Study

The purpose of the DATE study is to evaluate the feasibility and acceptability and a preliminary evaluation of the efficacy of a dyadic health behaviour change intervention to improve healthy eating, physical activity, and dyadic coping among older obese couples. This novel intervention will use a dyadic adaptation of common health behaviour change strategies and will promote a dyadic coping approach to health behaviour change that emphasize partners' interdependence and shared responsibility for the creation of a home environment conducive to a healthy lifestyle. For this project 35 obese older adults cohabiting dyads will be randomized to either the couples-based dyadic health behaviour change intervention or a couples-based nutrition counselling control condition.


Eligibility Criteria:
Inclusion Criteria:

* At least one of the partners is retired
* Partners cohabitating for at least 2 years.
* Obesity: BMI between 30-45 kg/m2

Exclusion Criteria:

1. Currently enrolled in a weight loss program
2. On a special diet
3. Eating disorder
4. Uncontrolled diabetes
5. Stroke
6. Heart problems (heart attack, heart failure, surgery of the heart or of the carotid arteries, pacemaker)
7. Other medical issues or medical treatment that would prevent doing physical activity
Comparison of PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast

The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for positron emission tomography (PET) scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/computed tomography (CT).

Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

If you agree to take part in this study, right after your already scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.

You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of your breast that has, or is suspected to have cancer. To take images using the PEMFlex Solo II, the breast is placed between two flat panels on the scanning machine and compressed (flattened). The position of the breast for this procedure is similar to getting a mammogram, but the PEMFlex Solo II uses about 50% less force to compress the breast(s). The compression will be repeated on the other breast if you are having scans of both breasts performed.

It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.

Length of Study:

After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.

This is an investigational study. The PEMFlex Solo II is commercially available for PET scan imaging of the breast.

Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. A signed informed consent.
2. Known or suspected malignancy involving the breast as determined by biopsy, physical examination or noninvasive imaging studies including plain films, CT, MR, ultrasound or nuclear medicine imaging.
3. Scheduled for routine clinical imaging at the ACB PET/CT facility.
4. Participant must be at least 18 years of age.

Exclusion Criteria:

1. Uncontrolled blood glucose levels (\>200 mg/dl).
2. Patient is unable to comprehend the requirements of the study.
3. Patient is unable to undergo scanning of the known or suspected lesion with the high-resolution PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study

Pycrinil® is a purified extract of the artichoke leaf. Artichoke leaf extract (ALE) has some clinical trial data suggesting benefit in the treatment of cholesterol disorders in several countries, but this effect has not been studied in a U.S. population. The investigators will give ALE or a placebo to overweight men and women with low "good" cholesterol to see if ALE increases their good cholesterol. The investigators will also make sure that ALE is safe.

Subjects will be divided into one of two groups: (1) Pycrinil®/flaxseed oil or (2) Placebo/flaxseed oil twice daily with food. The two formulations will be identical in appearance and standardized by Indena, S.p.A. Patients will be enrolled for a total of 3 months (± 1 week to allow for scheduling flexibility) with a 1 month (± 1 week to allow for scheduling flexibility) first follow-up visit in between enrollment and final visits. At all visits, patients will be asked to monitor for any symptomatic ADE. The first follow-up visit will focus on medication compliance (via pill count) and safety assessment (including laboratories). The final study visit will consist of brief clinical assessment (including anthropometrics), completed lifestyle and physical activity assessments, subjective ADE reporting, and donated blood and urine for clinical laboratory tests. Medication changes are not prohibited during the study period, but must be recorded. Medication bottles will be collected at the first follow-up and final visits; pill counts will be performed to assess compliance.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women
* BMI ≥25 kg/m2.

Exclusion Criteria:

* Patient on statins
* Triglycerides \>400 mg/dL
* Low density lipoprotein (LDL) \>190 mg/dL
* Significant hepatic disease (i.e., documented diagnosis of hepatic cancer, hepatitis, or cirrhosis)
* Significant renal disease (i.e., most recent glomerular filtration rate \<30 mL/min/1.73 m2)
* Significant gastrointestinal tract disease (documented diagnosis of malabsorption disorder, GI cancer, or uncontrolled inflammatory bowel disease)
* History of transplant
* Women of reproductive potential not receiving birth control
* Pregnant/nursing women
Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients

The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.

Several studies have shown that strength training can promote important benefits for the cardiovascular system in healthy subjects and patients with chronic diseases. However, the effects of resistance exercise on cardiovascular function in intermittent claudication patients are unclear. In addition, it also do not know the chronic effects on cardiovascular function in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Had a graded treadmill test that was limited by claudication (2 minutes)
* Had an ankle brachial index \<0.90
* Had systolic blood pressure ,160 mmHg and/or diastolic blood pressure,105 mmHg
* Were not performing any regular exercise program
* Were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers)
* Were nonobese
* Individuals who have not undergone bypass surgery or angioplasty least one year ago

Exclusion Criteria:

* Had no symptoms related to myocardial ischemia during the treadmill test
* Amputation
The Immediate Effects of Passive Hip Joint Mobilization on Hip Muscle Strength in Patients With Anterior Knee Pain

The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded cross-over study design. Patients with anterior knee pain and signs of impaired hip function will be recruited in Vienna and surrounding area, measurements/data collection will be conducted by two experienced physiotherapists in a physiotherapy group practice in 1150 Vienna.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis: anterior knee pain
* Prescription for physiotherapeutic treatment of anterior knee pain
* signs of functional hip impairment:
* impaired hip kinematics during single leg squat
* reduced passive hip joint mobility in comparison to the other, unaffected side
* manually weak tested hip abductors/external rota-tors in comparison to the other, unaffected side

Exclusion Criteria:

* intraarticular knee pathology
* preceding trauma/operation of lower extremity on affected side
* spinal disorders associated with low back pain, lumbar referred pain or nerve root irritation
* severe and/or recurring ankle sprains in recent history (significant enough, that it required a period of immobilization)
* other relevant comorbidities such as neurologic/rheumatologic/psychiatric diseases, osteoporosis and malign disorders
* pregnancy
Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery

Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Elective cardiac surgery under CEC with sternotomy
* Written informed consent from the patient.
* Women of childbearing age must have a negative urine HCG pregnancy test.

Exclusion Criteria:

* Thoracotomy approach
* Mini-sternotomy approach
* Opioid drug dependence or chronic opioid drug use
* Chronic benzodiazepine use (respiratory depressant treatment or treatment that may affect postoperative respiratory function)
* Contraindication or allergy to local anesthetics
* Emergency surgery
* Acute infective endocarditis
* Immunosuppressive or steroid treatment (prednisone \> 0.5mg/kg/day or equivalent)
* AIDS with CD4 count \<200/mm3
* Autoimmune disorder
* Transplant recipient
* Inclusion in another study within the last 30 days.
* Pregnancy
A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics

This is a single-center, randomized, double-blind, placebo-controlled, phase 1, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 in healthy participants and mild to moderate asthmatics. Subjects will be randomly assigned to different dosages of IBI3002 and matched placebo groups. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 5-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures.
2. Participants must be between 18 and 55 years old, inclusive.
3. Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive.
4. Participants of childbearing potential and their partners should use highly effective methods of birth control during the study and until 6 months after the study.
5. Participants with asthma must have:

   * Documented physician diagnosis of asthma for at least 12 months prior to screening and confirmed by the investigator;
   * Elevated FeNO defined as ≥ 25ppb;
   * Documented and stable GINA 2023 recommended Step 1\~3 controller treatment (defined as ≤ 250μg fluticasone propionate dry powder formulation equivalent total daily dose of ICS, alone or in combination with LABA) for the last 3 months prior to screening;
   * Pre-BD FEV1 ≥ 60% of prediction and Post-BD FEV1/forced vital capacity (FVC) \> 70%.

Exclusion Criteria:

1. History of allergies to any components of IBI3002 or placebo.
2. History of blood or needle sickness, or those who cannot tolerate venipuncture.
3. Female participants who are pregnant or breastfeeding at screening or randomization.
4. History of participating in a clinical trial within 1 month or 5 half-lives of the test drug (whichever is longer) prior to randomization, or those who are currently participating in a clinical trial.
5. History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening or randomization.
6. History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study.
7. For asthmatics only: history of a life-threatening asthma attack that required mechanical ventilation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years prior to randomization.
8. For asthmatics only: history of asthma worsen or exacerbation resulting in emergency room (ER) visits or overnight hospitalizations, or an increase in asthma maintenance therapy, or use of systemic glucocorticoids within the last 3 months prior to randomization.
Oral Contraceptives and Asthma Control

Asthma is a chronic inflammatory disorder of the airways affecting approximately 15 million individuals in the U.S. The rate of asthma exacerbations among women is twice that of men after adolescence, and a large proportion of females with asthma report worsened asthma symptoms during different phases of the menstrual cycle. Hormonal influences have been hypothesized to account for these differences. Decreased peak flow rates and increased symptoms have been found in females during the premenstrual phase of the menstrual cycle when estrogen and progesterone levels are low. Estrogen and progesterone have both been found to reduce smooth muscle contractility and increase bronchial smooth muscle relaxation. A perimenstrual shift toward a Th2 (allergic) phenotype characterized by a decreased interferon-gamma to interleukin-10 ratio has been demonstrated in healthy women not using oral contraceptives compared to midcycle; however, the effect was blunted in healthy oral contraceptive pill users, implying hormonal modulation of the allergic phenotype. Several case reports have demonstrated a therapeutic benefit of oral contraceptives in decreasing asthma exacerbations and corticosteroid requirements. Human studies have demonstrated that estrogen decreases pro-inflammatory cytokine generation, neutrophil recruitment, and inhibits inducible nitric oxide synthase activity, which could lead to lower exhaled nitric oxide levels.

The measurement of the fractional concentration of exhaled nitric oxide (FENO) is a non-invasive method to assess airway inflammation in adults and children with asthma. The hypotheses of the current study are that women using oral contraceptives will have lower FENO levels and better asthma control as assessed by the Asthma Control TestTM during different phases of the menstrual cycle. This study may identify clinically important changes in FENO levels and asthma control during the menstrual cycle and modification of these effects by oral contraceptive pills. This data may lead to future studies aimed at identifying therapeutic roles for hormones in asthma therapy in women.


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic
* Female
* Aged 18-45
* User of combination oral contraceptive pills OR non-user of any hormonal contraception

Exclusion Criteria:

* Smoker
* Other underlying lung disease (i.e., emphysema, cystic fibrosis, lung cancer)
* User of oral contraceptives that are not combination (estrogen + progesterone) pills
* User of non-oral hormonal contraception
* Have been treated in the prior 4 weeks with oral steroids
* Have had a respiratory infection in the prior 4 weeks
* Asthma under poor control at study entry
* Presence of severe asthma
Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab

This is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis.

This study is being conducted to evaluate the efficacy, safety, and molecular effects of abrocitinib in subjects with an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab. Approximately 60 subjects with atopic dermatitis will receive abrocitinib once daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject 18 years of age or older, at the time of consent.
2. Subject has clinically confirmed diagnosis of active atopic dermatitis (AD), according to Hanifin and Rajka criteria.
3. Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.
4. Subjects who had moderate to severe AD before initiating dupilumab treatment.
5. Subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows:

   1. A global vIGA-AD ≥ 2, at least 1% BSA with facial erythema, and a modified vIGA-AD for the face ≥2 at screening and Day 1 OR
   2. A global vIGA-AD ≥ 2, at least 3% BSA affected by AD on the trunk and/or limbs, and a modified vIGA-AD for the trunk/limbs ≥ 2 at screening and Day 1.

Exclusion Criteria:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. Subject has clinically infected AD.
3. Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
4. Subject has a history of cancer within 5 years prior to Day 1.
5. Subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
6. Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
7. Subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
8. Subject has a current or recent clinically serious infection.
9. Subject has used abrocitinib prior to Day 1.
10. Subject has a known hypersensitivity to abrocitinib or its excipients.
11. Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.
Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects.

This is an interventional, randomized, open-label, parallel-group, single-dose study investigating the safety, tolerability and pharmacokinetic properties of eptinezumab administered by intravenous (iv) infusion.

The study will consist of 20 healthy Chinese subjects, who will be randomized into two single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10 subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1.

Safety and tolerability will be assessed throughout the study. Blood samples for plasma quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day 84)/Withdrawal Visit.

Eligibility Criteria:
Inclusion Criteria:

* BMI of ≥ 19 and ≤ 25 kg/m2.
* The subject is Chinese, defined as being born in China and having four Chinese grandparents.
* The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The subject is pregnant or breastfeeding.
* The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Other inclusion and exclusion criteria may apply