cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.


Eligibility Criteria:
Inclusion Criteria:

* Is an adult 18 years of age or older
* Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
* Has a life expectancy of at least 1 month.
* Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
* Has constipation that is caused by opioid medications.

Exclusion Criteria:

* Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
* Has a known or suspected mechanical gastrointestinal obstruction.
* Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
* Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
* Receiving opioid antagonist or partial antagonist products.
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease

Crohn\&#39;s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Risankizumab is a human monoclonal antibody against IL23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to its receptor. Primary non-response to risankizumab is high in both CD and UC. Currently, there are no predictors of response to risankizumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of risankizumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled risankizumab (risankizumab-800CW). This study aims to assess the safety and the optimal dose of risankizumab-800CW to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).


Eligibility Criteria:
Inclusion Criteria for part A:

* Established IBD diagnosis
* Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \&gt; 60 μg/g
* Patients must be eligible for risankizumab therapy
* Minimum age of 18 years
* Written informed consent
* Clinical indication for an endoscopic procedure

Inclusion Criteria for part B:

* Established IBD diagnosis
* Patients must be on risankizumab therapy for at least 14 weeks
* Minimum age of 18 years
* Written informed consent
* Clinical indication for an endoscopic procedure

Exclusion Criteria for part A:

* A female study patient who is pregnant or provides breastfeeding
* A female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800CW administration and the following 10 weeks
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Prior anti-IL23-specific therapy (IL23/IL12 combination therapy is not an exclusion criteria)
* Active extra gastrointestinal manifestations of Crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations)

Exclusion Criteria for part B:

* A female study patient who is pregnant or provides breastfeeding
* A female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800CW administration and the following 10 weeks
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Active extra gastrointestinal manifestations of Crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations)
Companion for CAR-T Web App During Chimeric Antigen Receptor T-cell Therapy

The complex logistics and unique toxicities of chimeric antigen receptor T-cell (CAR-T) therapy require intensive patient education and careful monitoring. The Companion for CAR-T (CC) web app may be able to assist with patient education and preparation, communication between patients and their multidisciplinary teams, and home-based toxicity monitoring.

This is a single-arm pilot study assessing the feasibility and acceptability of the Companion for CAR-T (CC) web app among patients receiving commercially available CAR-T therapies.

Primary Objectives:

I. To evaluate the feasibility of the CC web app. II. To evaluate the acceptability of the CC web app to patients.

Secondary Objectives:

I. To quantify the incidence of fevers being reported via the CC web app. II. To quantify the incidence of electronic Immune Effector Cell-Associated Encephalopathy (eICE) deficits being recorded via the CC web app.

Exploratory Objectives:

I. To explore patient perceptions regarding the CC web app. II. To explore usage patterns regarding the CC web app. III. To explore trends in patient-reported quality of life (QOL), values, and stressors over time during CAR-T therapy.

IV. To explore responses to abnormal findings reported or recorded using the CC web app

Participants will be given access to the web application from beginning at the day of study enrollment through Day +100 following CAR-T therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a hematologic malignancy (including any plasma cell dyscrasia, any type of lymphoma, or any type of leukemia).
* Planned receipt of an FDA-approved CAR-T therapy at University of California, San Francisco (UCSF) as standard of care.
* Patient proficiency in spoken and written English.
* Caregiver proficiency in spoken and written English.
* Age \>= 18 years old

Exclusion Criteria:

* FDA-approved CAR-T therapy being administered as part of a prospective industry-sponsored trial, for example registrational trials of CAR-T therapy versus salvage chemotherapy or CAR-T therapy as an off-label line of therapy.

  \*However, patients who receive an FDA-approved CAR-T therapy through an Expanded Access Program for non-conforming products (or any observational, non-interventional analysis of CAR-T products) are eligible.
* Lack of ownership of a personal computing device, tablet device, or smartphone.
* Refusal of patient and/or caregiver to sign up for a UCSF MyChart account.

  \*Participants and caregivers who do not have a MyChart account at enrollment but are willing to create one will receive assistance from the study team to do so.
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could - in the opinion of the study's Principal Investigator (PI) - interfere with provision of informed consent or compliance with study procedures.
Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity

The purpose of this study is to examine the feasibility and acceptability of a family-based program to improve physical activity and tobacco outcomes in a small pilot of middle school students and their families.

Low income ethnic minority youth tend to be at greater risk for obesity, physical inactivity, high risk behaviors such as tobacco and substance use and resulting cardiovascular and chronic disease. In this study we modified a tobacco and substance use risk prevention program to develop a tailored intervention (Healthy Families DC) that also included promotion of physical activity (PA) for DC middle-school students referred by school staff as over-weight and at risk for problem behaviors. The program included an initial family assessment, a family feedback session with family PA goal setting and 6 phone/text based booster sessions. A pilot study with 18 families, comprised of at least one caregiver and target child, was conducted to examine feasibility, acceptability, and trends in preliminary outcomes such as PA via self-report and accelerometry, health risk behaviors (e.g., tobacco use), health goal setting, and changes in family functioning (e.g., youth positive behaviors, parenting).

Eligibility Criteria:
Inclusion Criteria:

* Students aged 12-16 years
* Attending regular education classes at three urban DC public middle schools. -Students must currently reside with at least one parent or guardian who wishes to also participate in this study.
* Students and at least one guardian must be fluent in English

Exclusion Criteria:

* Adolescents, who are outside the study age range
* Patients/parents unable to speak/read English
* Are wards of the state
* Not attending regular education classes at the public middle schools -Furthermore, adolescents and guardians not assenting/consenting to be in the study will be excluded.
A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents with Spinal Muscular Atrophy

This is a multisite randomized controlled registry-based trial to evaluate the efficacy of an 8-week home-based exergaming intervention as compared to usual care on occupational satisfaction of children and youth (8-18 years old age) with spinal muscular atrophy (SMA).

This multisite randomized controlled registry-based trial will evaluate the efficacy of a home-based exergaming intervention, as compared to usual care, on occupational satisfaction of children and youth (aged 8-18 years old) with SMA. Participants in the intervention arm will play the exergame, Tales from the Magic Keep™ on the Azure Kinect platform, 3 times per week, for at least 20 minutes, over 8 weeks (total 8 hours), and continue to access their regular physical activities and rehabilitation services. Those in the usual care arm will continue to access their regular physical activities and rehabilitation services. Occupational satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM) at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed genetic diagnosis of 5q SMA
* Age at screening: Aged 8-18 years old
* Participant is able to stay seated independently without support for at least 10 seconds
* Participants has a score of at least 2 points in entry item A of the RULM (i.e., "Can raise 1 or 2 hands to the mouth but cannot raise a 200 g weight in it to the mouth")
* Treated with disease-modifying therapy
* Signed ICF

Exclusion Criteria:

* Inability to comply with study procedures according to the site investigator, prior to randomization
* Severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator
* Planned orthopedic surgery 6 months prior to or throughout intervention and follow-up period (16 weeks post randomization)
* Inability to read in English or French
Predictive Value of Coronary Heart Disease (CHD) Biomarkers for CHD Death

The overall objective of this research proposal is to determine whether the predictive value of using plasma concentrations of selected nutrient biomarkers of food intake determined using a single plasma sample either alone or in combination are stronger, objective predictors of subsequent death from coronary heart disease (CHD) or myocardial infarct (MI) compared to selected food intake data derived from subjective, self-reported food frequency questionnaires.

The overall objective is to determine whether the predictive value of plasma concentrations of selected nutrient biomarker(s) of food intake determined using a single plasma sample either alone or in combination are stronger, objective predictors of subsequent death from CHD or MI compared to selected food intake data derived from subjective, self-reported food frequency questionnaires. The nutrient biomarkers (phospholipid \[PL\] eicosapentaenoic acid \[EPA\], PL docosahexaenoic acid \[DHA\], PL trans fatty acids, phylloquinone, dihydrophylloquinone) and foods (fish, dark fish and tuna, vegetables, fruits, and whole grains, and unsaturated fat rich foods) targeted have previously been either directly or indirectly associated with CVD risk. We propose to test our overall objective by conducting a nested case-control study using plasma samples and food frequency data from the observational cohort of the Women's Health Initiative (WHI). Our cases (n=1200) will be selected from the subset of women who did not report dietary supplement use and who died of CHD or MI (collectively referred to as WHI CHD cases). The control subjects (n=1200) will be selected from the subset that were free of CHD or MI events and matched with cases for standard National Cholesterol Education Program (NCEP) risk factors (WHI controls). Nutrient biomarker data will be newly generated using stored specimens whereas the selected food intake data have previously been collected by the WHI investigators.

Eligibility Criteria:
Inclusion Criteria:

Cases, defined as women with centrally confirmed CHD and fatal or non-fatal myocardial infarction (MI).

Control subjects were matched on the basis of age, enrollment date, race/ethnicity and absence of CHD, MI, angina, coronary artery by-pass graft/ percutaneous transluminal coronary angioplasty, congestive heart failure, stroke or peripheral vascular disease at baseline.

Exclusion Criteria:

none
Switch of AndroidAPS to Commercially Available AID Systems

The aim of the study was to investigate the switch between open-source automated insulin delivery system (OS-AID) - AndroidAPS (AAPS) and commercially available AID systems - Control-IQ (CIQ) and MiniMed 780G (780G) in extended follow-up study.


Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes diagnosed \>2 years
* ≥ 18 years old
* written informed consent prior to starting study related activity
* previous user of AndroidAPS at least for 3 months

Exclusion Criteria:

* nonadherence to the current treatment regimen
* lactation
* pregnancy
* intending to become pregnant during study
* concomitant therapy influencing glucose metabolism
Lactobacillus Johnsonii in Children and Adolescents With T1D

While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the T1D population thereby preserving beta cell function.


Eligibility Criteria:
Inclusion Criteria:

* have confirmed T1D by physician diagnosis
* have normal values at screening for complete blood count (CBC) and complete metabolic profiles (with the exception of fasting glucose and HbA1c)
* are able to swallow a capsule
* are willing to complete weekly online questionnaires
* are willing to consume a probiotic
* are willing to provide stool samples throughout the study
* are willing to provide blood samples throughout the study
* are willing to take three stimulated C-peptide tests
* are able to access a computer with Internet throughout the study

Exclusion Criteria:

* being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
* being treated for chronic kidney disease
* have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, organ transplant, Lupus, DiGeorge syndrome, selective deficiency of IgA, Bruton's disease etc.)
* have an underlying structural heart disease
* currently live with an immunocompromised person
* are currently taking medications for constipation and/or diarrhea
* have taken antibiotics within the past 2 weeks prior to randomization
* are currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start
* are a current smoker
* are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months
* have a known allergy to milk or milk protein.
Caffeinol Hypothermia Protocol

Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. Clinical presentation of acute ischemic stroke
3. Computed tomography (CT) scan compatible with acute ischemic stroke.
4. Time to caffeinol treatment \< 240 minutes from stroke onset.
5. Time to hypothermia initiation \< 300 minutes from stroke onset.
6. Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut)
7. National Institutes of Health Stroke Scale (NIHSS) \> 8 at time of each treatment.
8. Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA.

Exclusion Criteria:

1. Etiology other than ischemic stroke.
2. Item 1a on NIHSS \> 1
3. Signs/symptoms of subcortical, brainstem or cerebellar stroke.
4. Symptoms resolving or NIHSS \< 8 at time of each treatment.
5. NIHSS \> 20 if right hemisphere or \>25 if left hemisphere
6. Known alcoholic
7. Clinical or laboratory evidence of alcohol intoxication.
8. Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks.
9. Known hematologic dyscrasias that affect thrombosis.
10. Comorbid conditions likely to complicate therapy:

    1. End-stage cardiomyopathy
    2. Uncompensated or clinically significant arrhythmia
    3. Myopathy
    4. Liver disease
    5. History of pelvic or abdominal mass likely to compress inferior vena cava.
    6. End-stage AIDS
    7. History of clinically significant gastrointestinal (GI) bleeding
    8. Impaired renal function with creatinine clearance, 50 ml/min
11. Intracerebral / intraventricular hemorrhage
12. Systolic blood pressure (SBP) \> 210 or \< 100; diastolic blood pressure (DBP) \> 100 or \< 50 mmHg
13. Severe coagulopathy
14. Pregnancy
15. Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks
16. Known history of epilepsy.
Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma

Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with high grade, operable, metastatic osteosarcoma (OST) of the extremities. The primary end point is event-free survival (EFS) from randomization

The study design includes backbone of 10 weeks of preoperative therapy using MAP (high-dose methotrexate, cisplatin, doxorubicin and dexrazoxane). Metastatic patients were randomized to high-dose chemotherapy for 31 weeks (arm 1) or concomitant metronomic therapy (MTX plus cyclophosphamide) such as 31 weeks of high-dose chemotherapy, followed by 73 weeks of metronomic therapy after completion of high-dose chemotherapy, totaling 104 weeks of metronomic therapy (arm 2).

Eligibility Criteria:
Inclusion Criteria:

* A newly diagnosed patient, previously untreated, with a high degree of malignancy, confirmed by biopsy. Participant with OST as a neoplasm are also eligible
* Participant with staging imaging studies performed less than four weeks. Otherwise, it should be re-staged
* If pre-chemotherapy amputation is necessary, the participant will enter the study being excluded from the evaluation of tumor necrosis grade according to Huvos, but eligible for survival analysis
* Participant aged ≥ 16 years should have a Karnofsky performance score\> 50 or WHO / ECOG ≥ 2 and patients \<16 years should have a Lansky performance score\> 50. Participant with a performance score impaired by the presence of a pathological fracture are eligible
* Patients with normal organic function
* Sexually active participant should agree to use contraceptive methods throughout the treatment
* Female participant should have a negative pregnancy test

Exclusion Criteria:

* If the participant or their legal guardian refuses to sign the informed consent form / consent term it will not be included in the study.
Continuous Use of COCs

The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.

Family Health International has recently initiated a USAID funded study to investigate the pregnancy rates, continuation rates, and acceptability of COCs in women taking COCs by the 21/7 cyclic regimen compared with the continuous use of COCs with bleeding-signaled hormone-free intervals. The primary objective is to determine whether continuous COC use leads to higher 12-month continuation rates than use of the standard 28-day COC regimen. Secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months between the continuous use group and the 28-day group 2) compare COC continuation rates through 6 months between the continuous use group and the 28-day group 3) compare acceptability of the two COC regimens 4) to compare bleeding and other side effects between the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the continuous use group and the 28-day group

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30
* Currently has menstrual periods every 21-35 days
* Willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements
* Has signed the informed consent form
* Has a negative urine pregnancy test at enrollment

Exclusion Criteria:

* Has contraindications to COC use (see WHO MEC-3rd edition)
* Is in any other research study
* Has been pregnant in the past 3 months
* Is breastfeeding or has breastfed in the past 3 months
* Is currently using an IUD (women who agree to IUD removal are eligible once the IUD is removed)
* Has had an injection of DMPA in the past 6 months
* Has had an injection of NET-EN in the past 3 months
* Has used combined injectables, oral contraceptive pills, implants, or a hormonal IUD in the past 2 months
* Has had any of the following conditions since her last pregnancy, or since menarche if never pregnant:

  * Pelvic infection treated with antibiotics
  * Diagnosis of infertility
  * Endometriosis