cyrilzakka/clinical-trials huggingface dataset:
Fish Oil (Omega 3), Immune Function, and Mood

This study is designed to examine the effects of fish oil on immune function and mood.

The beneficial effects of fish oil (or eating fish more frequently) include reductions in triglycerides, blood pressure, and heart rate, as well as increases in HDL cholesterol, the "good" type of cholesterol. In addition, certain aspects of immune function also appear to show favorable responses to fish oil supplementation, and some studies suggest that fish oil helps to improve mood and decrease depression.

This study is designed to examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects aspects of your immune response, and your mood; because some research suggests that people who eat more fish may do better during stressful times, the study will also examine how fish oil affects your immune response to stress, certain stress hormone responses, and your psychological response to stress.

For detailed information about the study, please visit our website at http://www.stressandhealth.org

Eligibility Criteria:
Recruiting men and women ages 40-88 from the Greater Columbus Ohio area. Participation involves taking capsules for 4 months and completing 6 appointments (for a total of 19.5 hours) at Ohio State.

Inclusion Criteria:

* Healthy men and women
* NOT currently taking any sort of fish oil or omega 3 supplement

Exclusion Criteria:

* Use of blood pressure medicines, cholesterol-lowering drugs, steroids, or antidepressants
* Certain lifestyle habits such as smoking or exercising vigorously for 2 or more hours a week may also exclude applicants from participating
Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship

We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.

We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. The aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.

Eligibility Criteria:
Inclusion Criteria:

* Patients candidate to coronary angiography and/or angioplasty and
* Baseline creatinine clearance \< 60 ml/min

Exclusion Criteria:

* Patients with STEMI
* Patients with shock
* Known allergy to contrast media
* Prior contrast administration within 1 month
* Current use of nonsteroidal anti-inflammatory drugs
Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma

The primary objective of the study is to measure the effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.

Asthma is a chronic inflammatory disease of the airways that affects 5 to 10% of adults and children. Despite current treatments that are often effective, 10% of patients are not controlled by inhaled therapies. These severe asthma require regular use of systemic corticosteroids in 30 to 40% of cases. In this context, the use of glucocorticoids is associated with many more or less serious adverse effects, but still affecting the patient's quality of life. Several treatments have already been proven to save systemic steroids (theophylline, anti-leukotrienes, golimumab ...). On the other hand, none is currently recommended because of a risk / benefit ratio that is too high.

Mepolizumab is a human monoclonal antibody that binds to and inactivates interleukin 5. It has recently been shown to be effective in reducing the daily dose of oral corticosteroids and in reducing exacerbations in these patients with severe eosinophilic asthma. It also reduces the number of eosinophils in the blood and sputum and improves the quality of life.

Patients will receive a subcutaneous injection of 100mg mepolizumab every 4 weeks for one year, for a total of 12 injections.

In France, this treatment was subject to a Temporary Authorization for Nominative Use in severe eosinophilic asthma and is reserved for hospital use.

The injections will be done in HDJ Pneumology CHU Grenoble Alpes and patients will be followed monthly during injections and one month after the end of injections.


Eligibility Criteria:
Inclusion Criteria:

* Severe eosinophilic asthma
* Patient on inhaled therapy with inhaled corticosteroid and long-acting bronchodilator for at least 6 months
* Patient under oral corticosteroid therapy (prednisolone or prednisone) for at least 6 months and unmodified in the last 4 weeks before the first injection
* Patient able to provide informed and written consent
* Obtaining the temporary authorization for nominative use for mepolizumab

Exclusion Criteria:

* Chronic pulmonary pathology other than asthma
* Active neoplasia
* Active liver disease
* Serious and uncontrolled cardiovascular pathology (LVEF less than 30%, NYHA IV, ...)
* Other eosinophilic pathology (Churg \& Strauss syndrome, parasitic infection, ...)
* Hypersensitivity to mepolizumab or excipient
* Immunity disorders
* Patient not affiliated to a social security system
A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy

REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.

The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
* Able to provide verbal consent
* Able to complete questionnaires in English or French

Exclusion Criteria:

* No access to pegfilgrastim or filgrastim prior to randomization
* Metastatic cancer
* Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women

This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a postmenopausal woman, 45-85 years old (inclusive).
2. Subject has had 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \>40 IU/L OR is 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
3. Subject is taking at least 500 mg of calcium supplement and 400 IU of vitamin D daily and has been following this regimen for at least 4 weeks prior to the first dose of study drug administration.
4. Subject has a body mass index (BMI) of ≥ 18.5 to \< 30.
5. Subject must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).

Exclusion Criteria:

1. Subject has a history of clinically significant major disease (as determined by the Investigator).
2. Subject has a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia.
3. Subject has had a long bone fracture within the past 6 months prior to enrollment, or an osteoporosis-related fracture within the previous 2 years.
4. Subject has a history of opportunistic infection, or has had a serious local or systemic infection within 3 months prior to screening.
5. Subject has a history of severe allergic or anaphylactic reactions.
6. Subject had major surgery within the previous 3 months.
7. Subject has a history of drug or alcohol abuse, or tests positive in a drug and alcohol screen at screening or on Day 1 prior to dosing.
8. Subject consumed any alcohol within 72 hours prior to dosing.
9. Subject gave a blood donation (one unit or more) within 1 month prior to dosing, or plans to give a blood donation during the course of the study.
10. Subject has taken any of the following bone active medications:

    * Teriparatide at any time in their lifetime.
    * Fluoride therapy for more than 3 months during the previous 2 years.
    * Estrogen, androgen, anabolic steroids, corticosteroids (excluding inhaled, topical or local injections for joint pain), calcitonin, or other bone active drugs (e.g. selective estrogen receptor modulators) within the 4 months prior to screening.

    Bisphosphonates:
    * If treated for more than 6 months at any time in their lifetime.
    * If treated for 3 to 6 months within 2 years of screening.
    * If treated for less than 3 months within 6 months of screening.
11. Subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry.
A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

This is a Phase 1 relative bioavailability study carried out in approximately 24 healthy male subjects and healthy female subjects of non childbearing potential to investigate the effects of formulation and food on the safety, tolerability, and pharmacokinetics (PK) of DNL343.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) ≥18.5 to \< 30 kg/m2 and body weight of at least 50 kg
* For women: Must have been surgically sterilized or be postmenopausal.

Key Exclusion Criteria:

* History of clinically significant endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
* History of malignancy, except fully resected basal cell carcinoma
* History of clinically significant neurologic or psychiatric diseases; head trauma with loss of consciousness; or clinically significant depression or suicidal ideation
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are able to use the German language, spoken and written
* Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
* Availability of a normal mammogram within 1 year prior to trial start
* Good general health
* No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician

Exclusion Criteria:

* Known or suspected allergy to estradiol or related products
* Known, suspected or past history of breast cancer
* Abnormal genital bleeding
* Previous oestrogen and/or progestin hormone replacement therapy
* Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
* Hot flushes which require systemic hormone replacement treatment
* Known insulin dependent or non-insulin dependent diabetes mellitus
* Systolic blood pressure (BP) of more than 160 mm Hg and/or diastolic BP or more than 100 mm Hg, currently treated or untreated
* Active deep venous thrombosis or thromboembolic disorders or a history of these conditions
* Active arterial thrombosis or a documented history of this condition
* Known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results
* Known HIV infection based on laboratory result
* Porphyria
* Body Mass Index (BMI) above 30.0 kg/m2
* Cervical smear presenting PAP of more than class II
* Known or suspected vaginal infection requiring further treatment
* Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
* Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine
* Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration
Effect of Diaphragmatic Release in Sleep Quality During Pregnancy

Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy.

The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will provide scientific basis for the clinical application of diaphragmatic release in sleep disordered breathing during pregnancy

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (at third trimester), diagnosed with sleep disordered breathing by the gynaecologist.
* Their ages will range from 30- 40 years old .
* Their BMI will be 25 to 30kg/m2.
* All are multipara.

Exclusion criteria:

Women will be excluded from the study if they have:

* Previous pulmonary surgery.
* any pulmonary diseases.
* Asthma.
* Neurological disorders
* Musculoskeletal disorders (severe osteoarthritis, osteoporosis)
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed melanoma
* Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
* A minimum of 1 measurable lesion by CT or MRI
* Provide a baseline tumor biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting
* Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
* Has an active infection requiring systemic therapy
* Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
* Has known history of or is positive for Hepatitis B or Hepatitis C
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions

To compare the relative bioavailability of Kali and Ortho-McNeil's products

To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg

Eligibility Criteria:
Inclusion Criteria:

* Healthy Males and females between 18 and 45 years of age inclusive
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.

Exclusion Criteria:

* Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
* Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
* Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
* Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
* This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
* Tobacco use(\>5 cigarettes per day)in the 3 months prior to study dosing.
* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
* Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
* Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
* females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
"Make It Fresh, For Less" Supermarket Pilot Study

The purpose of this study is to examine the impact of environmental modifications (choice architecture and a marketing campaign) in combination with weekly text messages on purchases of foods made by parents shopping in a large supermarket.

The "Make It Fresh, For Less" Supermarket Pilot Study is a supermarket-based intervention developed by the Harvard T.H. Chan School of Public Health in collaboration with the nonprofit organization ChopChop Magazine (chopchopmagazine.org) and a large Northeastern supermarket chain. A promotional campaign advertising low-cost, kid-friendly meals was piloted in one store selected by the supermarket partner, with promotions rotating every 4 weeks during a 16-week intervention period. Parent shoppers were recruited (n=401) at the store and given a study loyalty card to track their transactions. At the start of the intervention, half of the participants were additionally randomized to receive weekly behavioral messages via text message or email. Supermarket purchases were assessed at baseline, during the 16-week intervention, and up to 6-weeks post-intervention.

Primary Aim 1: to examine the impact of a choice architecture intervention in combination with a promotional campaign on food purchases of parents shopping in a large supermarket. It is hypothesized that there will be an increase in selection of foods targeted by the promotional campaign when physical modifications are made.

Primary Aim 2: to examine the impact of weekly behavioral messages in combination with an environmental change intervention on food purchases of parents shopping in a large supermarket. It is hypothesized that there will be a greater increase in selection of foods targeted by the promotional campaign among participants receiving the messages compared to participants exposed to the environmental change intervention alone.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English-speaking
* Live with a child 18 years of age or younger
* Do more than 50% of shopping at the study store
* Primary shopper in the household

Exclusion Criteria:

* None
A Clinical Study to Evaluate the Safety of Ospemifene

The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.


Eligibility Criteria:
Inclusion Criteria:

* Naturally or surgically menopausal
* Intact uterus
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

* Evidence of endometrial hyperplasia, cancer or other pathology
* Abnormal Pap smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication
* Use of hormonal medications
* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Maternal and Neonatal Outcome in Severe Preeclampsia

In normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue

Preeclampsia is considered severe if one or more of the following:

1. Blood pressure of 160mmHg systolic or high or 110mmHg diastolic or high on two occasions at least 6 hours a part while the patient on bed rest.
2. Proteinuria of 0.3gm. or high in 24 hours urine specimen or +1 or great on two random urine samples collected at least 4 hours apart.
3. Oliguria of less than 500ml in 24 hours.
4. Cerebral or visual disturbance.
5. Pulmonary edema or cyanosis.

Eligibility Criteria:
Inclusion Criteria:

* • All women with severe preeclampsia

Exclusion Criteria:

* • History of epilepsy.

  * Patients with chronic hypertension.
  * Patients with renal disease.