cyrilzakka/clinical-trials huggingface dataset:
An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
2. Written informed consent is obtained.
3. The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
4. The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
5. The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
6. The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.

   * Other criteria may apply, please contact the investigator for more information.

Exclusion Criteria:

1. The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
2. The patient has another confounding underlying lung disorder.
3. The patient has a known hypereosinophilic syndrome.
4. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
5. The patient is pregnant or intends to become pregnant during the study or is lactating.
6. The patient required treatment for an asthma exacerbation within 4 weeks of screening.
7. The patient is a current smoker or has a smoking history ≥10 pack-years.
8. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
9. The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
10. The patient was previously exposed to benralizumab within 12 months of screening.
11. The patient was previously exposed to reslizumab.
12. The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
13. The patient has current suspected drug and/or alcohol abuse.
14. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
15. The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.

    * Other criteria may apply, please contact the investigator for more information.
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)

The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.

Up to 40 patients will be prospectively enrolled in this multi-centre (up to 5 centres) single arm study. After given consent, patients will undergo minimally invasive cholecystectomy with da Vinci Fluorescence Imaging using Indocynine green (ICG) and near infra-red light (NIR) to identify the surgically relevant anatomy of the biliary tree during this procedure.

Efficacy endpoints The efficacy of the da Vinci Fluorescence Imaging Vision System to identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct (CBD).

Safety endpoints To observe and report peri-operative safety outcomes, including but not limited to incidence of adverse events and allergic reactions (rare according to the current knowledge and applications). Safety endpoints will be met by affirming the safety profile of the procedure, compared to currently available literature.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Ages of 18 to 80 years.
* Symptoms consistent with gallbladder disease including biliary colic or chronic right upper quadrant pain.
* Ultrasound confirming gallstones

Exclusion Criteria:

* Acute cholecystitis
* Biliary pancreatitis
* Suspicion of common bile duct stones.
* Pregnancy.
* Previous upper abdominal open surgeries.
* Severe lack of cooperation by patient due to psychological or severe systemic illness.
* The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
* Subject has a previous history of adverse reaction or allergy to ICG, iodine products (or excipient), shellfish or iodine dyes
* Surgery converted to non-robotic procedures, such as open surgery or laparoscopic surgery
Micro-Doppler Radar: A Gold Standard Comparison

The purpose of this study is to see if the study team can use micro-Doppler signal (MDS) technology to determine if someone has had an anterior cruciate ligament (ACL) reconstruction. The investigators will do this by comparing the movement data from a group of people who have had the surgery with a group who has not had the surgery to see if the micro-Doppler radar technology can accurately and predictably tell the difference.

The objective of this research is to validate that radar MDS can accurately and predictably differentiate individuals at high-risk for MSKI from those who are low risk. The investigators hypothesize that MDS will identify individuals at a high-risk for MSKI more accurately than the gold-standard MC technologies. To test this hypothesis, the investigators propose a case control study that will compare adults who have undergone ACL reconstruction to a control group of healthy adults that has not. Patients who have undergone ACL reconstruction have a 6-24% chance of either re-tearing their ACL or having a subsequent knee surgery on either side within two years of successful completion of surgery and post-surgical rehabilitation. Despite being released for full activities, little is known about what makes this group at high-risk for re-tear. As such, the investigators will use this patient population as a model for identifying an at-risk population for musculoskeletal injury (MSKI). The researchers will simultaneously collect radar micro-Doppler signals and biomechanical motion capture (MC) data in a state-of-the-art human movement lab. Participants will be asked to perform a series of functional activities that will be captured by both the MDS radar and MC systems. The data sets will then be analyzed independently.

Eligibility Criteria:
Inclusion Criteria:

High risk cohort

* age 18-40
* history of ACL reconstruction
* no current musculoskeletal injuries
* ACL repair between 9 and 24 months prior to recruitment

Control cohort

* age 18-40
* never had lower extremity surgery

Exclusion Criteria:

High risk cohort

* age \<18 or \>40
* pregnancy
* institutionalization
* history of cerebral vascular accident
* unable to provide informed consent
* inability to perform study activities
* history of hip or knee replacement
* inability to walk or jump without a limp
* current neuromuscular disease
* any surgery in the last 6 months

Control cohort

* age \< 18 or \> 40
* pregnancy
* institutionalization
* history of Cerebral Vascular Accident
* unable to provide informed consent
* inability to perform study activities
* history of knee or hip replacement
* inability to walk or jump without a limp
* current neuromuscular disease
* history of lower extremity surgery
* any surgery in the last 6 months
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.

Study periods for the intervention-specific appendix (ISA) will be as follows:

* A 12-week induction period
* A maintenance period from Week 12 to Week 52, and
* A safety follow-up period up to 16 weeks.

The study will last about 74 weeks and may include up to 19 visits.

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
* Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).
* Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
* Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

Exclusion Criteria:

* Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
* Participants must not have an abscess.
* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II

This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.


Eligibility Criteria:
Inclusion Criteria:

* Males 18 to 64 years
* Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
* Stable heterosexual relationship for more than 6 months
* The subject must make at least four attempts at sexual intercourse
* Documented, dated, written Informed Consent Inclusion Criteria Partner
* Females 18 years, and older
* Stable, heterosexual relationship for more than 6 months with male ED subject
* Documented, dated, written Informed Consent
* Motivated to support treatment for male partner's ED
* Absence of significant sexual dysfunction as assessed by the total score on the FSFI16 \> 23.55

Exclusion Criteria:

* Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
* Subjects who are taking nitrates or nitric oxide donors
* Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents traconazole and ketoconazole (topical forms are allowed) or erythromycin
* Known hypersensitivity to vardenafil
* Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
* History of retinitis pigmentosa
* Unstable angina pectoris
* Severe chronic or acute liver disease
* Premature ejaculator (defined as IELT \< 2 minutes)
* Subjects who were taking alpha blockers
* Lost of vision of one eye because of NAION Exclusion Criteria Partner
* Presence of sexual dysfunction as assessed by the FSFI16 \< 23.55
* Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the partner's ability to complete the study or precludes the partner's participation in the study
Memesto Wearable Repetitive Message and Music Therapy Device Music Therapy Device That Senses and Reduces Agitation in People With AD,

This is a 12-week proof-of-concept study to evaluate the efficacy of Memesto in reducing agitation in persons with Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) currently living in a residential care facility. It is hypothesized that Memesto use will result in a reduction in agitation.

After informed consent is obtained and preliminary eligibility established, participants will be trained and issued the Memesto device for use over a 2-week screening/training phase. Participants successfully completing this phase will proceed into a 10-week open label treatment phase (via telephone and/or in-person data collection).

Eligibility Criteria:
Inclusion Criteria: Given that people living with ADRD can be of any adult age, people meeting criteria for ADRD diagnosis will be regardless of age. Younger-onset people living with ADRD, which may be smaller, will be considered for participation along with adults older than age 65 that make up the largest portion of persons living with ADRD. The family and professional caregivers can be any age greater than eighteen. We anticipate that 5% of the People living with ADRD will be less than age 65 with 70% being greater than age 75 and 25% being between ages 65 and 74. For family caregivers, we envision most will be spouses with the same age distributions as the parents with a skew to a slightly younger age group for caregivers who are children of the person living with ADRD and/or the spouses of children. For professional caregivers, we anticipate they will be between the residential care workforce ages of 20 and 65 with a skew toward persons over age 40.

Inclusion/Exclusion Criteria: Eligible participants will be adults with a dementia diagnosis who have clinically significant agitation, defined as a state of poorly organized and purposeless psychomotor activity characterized by at least one of the following: aggressive verbal (screaming, cursing), aggressive physical (destroying objects, grabbing, fighting), or non-aggressive physical (restlessness, pacing) behaviors. The behavioral symptoms must be severe enough to warrant pharmacological treatment. A family caregiver must be willing to participate along with a professional caregiver from the resident living facility.

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Diabetes Care for Breast Cancer Patients

The goal of this study is to find a new way to make diabetes care better for patients with breast cancer and diabetes who are currently receiving cancer treatment. We will have two groups, the researchers will decide who is in which group. One group will be working with a nurse who is trained in diabetes care while the other does not. This will allow the investigators to see if having a trained nurse as part of the care team can help improve the care the patients receive.

The present study aims to develop a stakeholder-engaged nurse practitioner (NP)-led intervention to improve diabetes care for patients with breast cancer and diabetes who are undergoing cancer treatment.

This is a pilot feasibility study, in which we will use a quasi-experimental pre-post design with non-randomized intervention and control groups. In this feasibility study, the investigators will first enroll 38 eligible patients for the control group and collect effectiveness measures at baseline and follow-up (end of chemotherapy or other cancer treatment, \~12 weeks). Through chart review, the investigators will document cancer treatment regimen completion at follow-up. The investigators will then enroll 38 patients for the intervention group, collecting the effectiveness and implementation outcomes at the end of their treatment (\~12 weeks).

The main hypothesis that will be tested in this pilot study is that a nurse practitioner embedded in the oncology team who is trained in diabetes management may successfully manage diabetes during active cancer care for patients undergoing cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed invasive cancer
* Plan to receive neo-adjuvant or adjuvant chemotherapy, targeted therapy, hormonal therapy, or radiation at Weill Cornell Medicine (WCM)

  * Age 18+ years
  * Pre-diabetes OR type 2 diabetes. Treatment with antidiabetic medication OR
* HbA1c greater than or equal to 5.7 OR
* Random glucose greater than or equal to OR
* Fasting blood glucose greater than or equal to 100

Exclusion Criteria:

* Patients receiving hospice care
* Type 1 diabetes
Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus
* Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening
* Fasting C-peptide must be \> 0.5 ng/mL
* HbA1c at screening in Patients who are treated with insulin alone must be \>=7.5% and \<=10.0%
* HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD) must be \>=7.0% and \<=9.5% at screening, and \>=7.5% and \<=10.0% at placebo run-in period
* Age at informed consent must be \>=20 and \<75 years
* BMI at screening must be \>22 and \<=40 kg/m2
* Further inclusion criteria apply

Exclusion criteria:

* Patients who experience uncontrolled hyperglycaemia before randomization
* Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor
* Patients with recent cardiovascular and/or stroke events
* Patients with hepatic and/or renal dysfunction
* Patients who received anti-obesity drugs or other treatment leading to unstable body weight
* Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin
* Pre-menopausal women who are nursing or pregnant
* Further exclusion criteria apply
The Effect of Action Control Based Intervention on Adherence After Cardiac Rehabilitaiton

This will be a pilot study of the effect of an Action Control-based intervention (ACBI) on adherence to prescribed diet and exercise programs after cardaic rehabilitation. The purposes of this study are to:

1. determine if an ACBI has an effect on adherence to prescribed home exercise and diet regimens for individuals 6 weeks after participating in a cardiac rehabilitation program
2. examine whether there is a difference in response to the ACBI between state-oriented individuals and action-oriented individuals.
3. test the interaction effect between action-orientation disposition and the intervention.

Patients with cardiac problems are burdened with complex lifestyle changes involving medication, diet and exercise. Non-adherence to prescribed treatment protocols is a major contributor to morbidity and mortality for these indiviudals. Rehabbilitation programs provide the necessary education and supervision needed to promote health, however, non-adherence occurs even for those indiviudals with appropriate resources and motivation. Most of the research up to this point deals with preparing indiviudals to be adherent. Action Control theory is focused on the mental processes that occur between the time an individual makes a decision to adhere and the moment when the appropriate activty either occurs or does not occur.

This interventions tudy will compare rates of adherece between indivudals who receive an action control based educational intervention and those who do not.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be a convenience sample of English literate men and women over the age of 21 enrolled in a cardiac rehabilitation program and accessible by phone for follow-up. All participants are referred to rehabilitation by their physician. Being enrolled in the program indicates the participants have experienced a serious cardiac event, either myocardial infarction and/or coronary surgery

Exclusion Criteria:

* Non-English literate, uner teh age of 21
Colorectal Surgical Site Infection

Surgical site infection (SSI) is one of the most common postoperative complications in surgery, with high morbidity. In the tertiary-center that the investigators evaluated they had a significant rate of surgical site infection. Because of that the investigators created a care bundle of measures in order to improve the outcomes.

Prospectively the investigators implemented a care bundle of measures with retrospective analysis, to decrease SSI . The superficial, deep and organ/space infections were evaluated and compared before and after care bundle implementation.

Between january 1, 2016 and December 31, 2020, 1139 patient records relating to surgical incisions were submitted for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31
* Age \> 18 years
* At least 30 days of follow-up

Exclusion Criteria:

* Patients submitted to urgent colorectal surgery
A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants

The main purpose of this study is to assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 46 days, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
* Must have comply with all study procedures, including the 8-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion Criteria:

History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor

* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening
* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening or Check-in (Day -1)
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
* Have previously completed or withdrawn from any other study investigating Pirtobrutinib (LOXO-305) and have previously received the investigational product