cyrilzakka/clinical-trials huggingface dataset:
Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People

The study looks at how the study medicine (NNC9204-1177) affects other medicines in the body. Participants will get the study medicine and 5 other medicines which have all been approved by the authorities. Participants will get 1 injection of the study medicine each week for 11 weeks. The study medicine is injected under the skin in the stomach area. All injections will be given by study staff. Participants will get 5 medicines as tablets, capsules or syrup to be taken with water at the beginning of the study and after 10 weeks of treatment with the study medicine. The study will last for about 4 months. Participants will have 14 visits to the clinic with the study staff and study doctor. Participants will have blood draws and 2 different kinds of electrocardiograms taken during the study. They will be asked about your mental health. People who use any medication, including herbal products, cannot take part in the study. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period or if they use birth control pills or other hormonal birth control products.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-60 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 23.0 and 29.9 kg/m\^2 (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (intra-uterine device (IUD), vasectomised partner or sexual abstinence)
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Use of prescription medicinal products or non-prescription drugs, except for IUDs, within 14 days prior to the day of screening.
* Use of any herbal medicine known to interfere with the metabolic CYP pathways, such as Hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days prior to the day of screening.
Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics (PD), immunogenicity, and efficacy of subcutaneous (SC) ALXN1830 in adults with generalized myasthenia gravis (gMG).

Participants have the option to enroll in an Open-label Extension (OLE) Period to receive ALXN1830 up to 58 weeks (including follow-up period).

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of myasthenia gravis.
* Positive serologic test for anti-acetylcholine receptor antibodies.
* Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at Screening.
* MG-ADL profile must be ≥ 5.
* Participants receiving stable treatment with azathioprine; other immunosuppressive therapies.
* Total IgG level at Screening ≥ 600 milligrams/deciliter.

Key Exclusion Criteria:

* History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to Screening.
* Any untreated thymic malignancy, carcinoma, or thymoma.
* Intravenous immunoglobulin within the 6 weeks, and/or use of plasmapheresis/plasma exchange prior to randomization (Day 1).
* Use of rituximab within the 3 months (90 days) prior to Screening.
* Participants who have received previous treatment with any biological agent or other anti-neonatal fragment crystallizable receptor therapy within 5 half-lives or 90 days after last dose (whichever is longer).
* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
Alternate Formula Feedings in Formula Intolerant Infants

This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.


Eligibility Criteria:
Inclusion Criteria:

* Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
* Infants whose physicians had made a recommendation that the parents change the infant's feeding.
* Full term infants at birth with a gestational age of 37 to 42 weeks.
* Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.

Exclusion Criteria:

* Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
* Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.
Evaluation of Three Different Anagesic Techniques in Patients Undergoing Lumbar Fixation Surgery

Lumbar spinal stenosis is a degenerative condition characterized by the narrowing of the space surrounding the neurovascular structures of the lumbar vertebrae, resulting from age-related changes in the intervertebral discs, ligamentum flavum, and facet joints. It commonly causes unilateral pain in the lower back, hips, and legs, often described as cramping or burning. Postoperative pain management in these cases frequently involves oral opioids or intravenous administration using patient-controlled analgesia devices. However, opioids are associated with side effects such as reduced gastrointestinal motility, urinary retention, and respiratory depression.

To mitigate these issues, local anesthetic wound infiltration is widely employed by surgeons to manage postoperative pain and reduce opioid consumption following lumbar spinal surgeries.

The primary aim of this study is to compare the postoperative efficacy of three different analgesic methods in patients undergoing elective lumbar fixation surgery, using the percentage change in salivary opiorphin levels as a marker. Additionally, the study seeks to evaluate the correlation between these changes and postoperative pain scores, as well as the amount of opioids consumed.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo lumbar fixation surgery under general anesthesia
* aged between 18 and 65 years,
* American Society of Anesthesiologists physical status classification of I-II

Exclusion Criteria:

* Patients with a known allergy to local anesthetics.
* Patients who used opioid analgesics within 48 hours prior to sample collection.
* Patients with a history of smoking or alcohol consumption.
* Patients with conditions affecting salivary flow, such as xerostomia or those who have undergone radiotherapy.
* Patients with infectious diseases known to be transmissible through saliva.
* Patients with an ASA physical status classification of III or higher.
* Patients unable to use a patient-controlled analgesia (PCA) device.
* Patients who do not consent to the study procedures.
Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates

Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm.

Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm. The aims of the study are: 1. To select the appropriate ventilation mode and parameters (for example, switch to NIV-NAVA mode); 2. To monitor intermittent apnea, bradycardia and the frequency of cyanosis, 3. To pay attention to the changes in maximum peak pressure, adjust appropriate pressure support, and avoid lung injury. The predicted outcomes of NAVA mode for premature neonate may include : 1. Measurement of the lower PIP value to maintain proper and synchronized ventilation; 2. Monitoring of the diaphragm activity (Edi) signal to evaluate the work of breathing and estimate the weaning time.

Eligibility Criteria:
Inclusion Criteria:

1. Premature \>30week
2. Respiratory distress

Exclusion Criteria:

1. Premature \< 30weeks
2. ENT contraindication: fistula
3. Contraindication with orogastric tube or nasogastric
Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers

Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Key project components include a new Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and two innovative support plans, the Breastfeeding Doula and Father Support Programs. The objective is to increase breastfeeding rates for high-risk inner-city mothers.

Research Questions to evaluate project feasibility and effectiveness are:

1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?

Low rates of breastfeeding among low-income inner-city mothers represent a challenging health disparity that adversely impacts child and maternal health. The overall objective of Breast for Success is to increase the rates of breastfeeding initiation, continuation and exclusivity among high-risk mothers in the City of Cleveland via home-based culturally appropriate interventions. Key project components include a new Curriculum with brief engaging modules utilizing games, teach-reteach strategies, and interactive learning to address specific barriers identified in focus groups (e.g. pain, low milk supply, breast "myths"), and two innovative support components, the Breastfeeding Doula and Father Support Programs. Breast for Success was developed in collaboration with and will be disseminated in partnership with the Cleveland Department of Public Health MomsFirst initiative (a Healthy Start Program), which delivers comprehensive services including twice-monthly Community Health Worker home visits prenatally through 2 years postpartum to 500 women annually. The investigators will measure program success via participation logs, satisfaction questionnaires and breastfeeding rates at 1, 3 and 6 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

* pregnant woman enrolled in MomsFirst Program of Greater Cleveland

Exclusion Criteria:

* incarceration

Other study populations include the Community Health Workers, the doulas and the fathers of the study mothers.
Treatment Settings for Those With an Alcohol Problem

A prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if they presented with high alcohol involvement and/or low cognitive functioning. This study sought to: (a) validate and extend these findings within the uncontrolled environment of a community-based treatment center, and (b) test whether inpatients had fewer days of involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need for inpatient treatment, using prior cut-points for alcohol involvement and cognitive functioning, participants were randomly assigned within inpatient need group (No Need for IP; Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted an 90-day intervals across 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for treatment through the Chemical Dependency treatment programs of a large, community-based healthcare network
* Drank alcoholic beverages within the last 90 days
* Have a current address (not homeless)
* Free of legal stipulations that would affect treatment decisions
* Have a past 3 months Alcohol Use Disorder
* Primary alcohol, or alcohol and drug problem

Exclusion Criteria:

* Homeless
* Drug problem only
Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)

This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary bladder contractions.

This is a Phase 2, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injuries (SCI) with autonomic dysreflexia (AD) triggered by neurogenic detrusor overactivity (NDO).

Eligibility Criteria:
The inclusion criteria include, but are not limited to, the following:

* Male or female, 18 - 60 years of age
* Chronic traumatic SCI at or above T6 spinal segment and \>1 year post injury
* Documented presence of AD and NDO during UDS
* Hand function sufficient to perform CIC or a committed caregiver to provide CIC for management of urinary bladder drainage
* Patients must have documented two weeks of bladder and bowel history prior to their baseline visit
* Willing and able to comply with all clinic visits and study-related procedures
* Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
* Women of childbearing potential must not be intended to become pregnant, currently pregnant, or lactating. The following conditions apply:
* Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
* Women of childbearign potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
* Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment
* Must Provide Informed Consent

The exclusion criteria include, but are not limited to, the following:

* Presence of severe acute medical issue that in the investigator's judgement would adversely affect the patient's participation in the study
* A hypersensitivity to tolterodine (available as Detrol, Detrol LA), soya, peanuts, or lactose
* Recent treatment with intravesical OnabotulinumtoxinA (within 9 months of the baseline visit)
* Recent treatment with other anticholinergics medications (within 3 weeks of the baseline visit)
* Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the patient to participate in this study
* Patient is a member of the investigational team or his /her immediate family
A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma

This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.

The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe.

In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group \[IMWG\] ).
* Age 18 years or older.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Life expectancy greater than 3 months.
* Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
* Measurable disease, as defined by at least one of the following: Serum M protein 0.5 g/dL or higher, Urine M protein 200 mg/24 hr or higher, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal SFLC ratio.
* Adequate hematologic, renal, and hepatic function
* A negative pregnancy test (for females of childbearing potential).
* Patients must provide written informed consent.

Exclusion Criteria:

* Other invasive malignancy within the past 3 years.
* Active cerebral/meningeal disease related to the underlying malignancy.
* Active Grade 3 or higher infection.
* Known to be positive for HIV or known to have active hepatitis B or C.
* Previous allogeneic stem cell transplant.
* Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
* Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
* Females who are pregnant or breastfeeding.
Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma prostate cancer
* No evidence of measurable metastatic disease
* An ECOG performance status of 0 or 1

Exclusion Criteria:

* Previous hormonal therapy of any type for prostate cancer
* Any previous chemotherapy, or prior investigational therapy for prostate cancer
* Prior Immunotherapy
* Prior treatment with gene therapy
The Critical Care Recovery Program: Use of a Structured Clinic Visit to Reduce Adverse Drug Events in ICU Survivors

Background and Objective: Intensive Care Units (ICUs) save lives, but many ICU survivors face ongoing health issues, including adverse drug events (ADEs) from medications started during their hospital stay. These ADEs lead to emergency department visits and hospital admissions. Our project aims to improve the health of ICU survivors by creating a clinic that focuses on managing post-ICU health. The clinic will track and address medical issues that arise after ICU discharge and focus on deprescribing, or safely stopping, medications that may no longer be needed or could be harmful.

Project Plan: The clinic will be set up within the CARES clinic at VGH. Patients will be enrolled when they leave the ICU and will have follow up visits after hospital discharge. During these visits, the team will review each patient's medications and develop a personalized plan to reduce or stop unnecessary medications. We will also monitor patients for any new health issues that arise and provide eduction to patients and caregivers about managing their health.

Research and Evaluation: We will collect and analyze data on patient health outcomes, including the incidence of ADEs, hospital reeadmissions, and emergency department visits. We hope to show that patients who receive follow up care have better health outcomes and use fewer healthcare resources than a historical cohort. This data will help us demonstrate the cost-effectiveness of the clinic and support the need for expanding ICU follow up programs in British Columbia.

Long-term goals: We plan to establish a post-ICU care working group and expand the clinic model to other hospitals. Over the long term, we hope to standardize post-ICU care across BC, ensuring that all ICU survivors have access to comprehensive follow up care. This project will also lay the groundwork for future research on deprescribing medications for ICU related complications, which tend to improve or resolve once critical illness has resolved. The CCRP clinic will provide a setting to conduct clinical deprescription trials to establish whether long-term treatment of these complications is necessary.

Conclusion: Establishing a post-ICU discharge follow up clinic with a focus on deprescription has the potential to improve the long-term health and quality of life for ICU survivors. By reducing unnecessary medications, we can prevent complications, reduce hospital readmissions and demonstrate the value of comprehensive post-ICU follow up care.


Eligibility Criteria:
Inclusion Criteria:

* Patient being discharged to ward, home or repatriated to local health centre AND ONE OR MORE OF

  * Duration of mechanical ventilation \>72 hours
  * Length of stay in critical care \>96 hours
  * Out of hospital arrest
  * Maternal critical illness
  * Trauma
  * Significant ICU delirium
  * Unexpected adverse outcomes of planned treatment

Exclusion Criteria:

* Patient discharged for palliative care or expected to die within the next two months