cyrilzakka/clinical-trials huggingface dataset:
Digital Youth-Nominated Support Team (YST) Program

The Electronic Youth-Nominated Support Team (eYST), is experimental. The purpose of this study is to get feedback from users about eYST. Another purpose of this study is to learn how well eYST helps youth.

Assessment data from multiple stakeholders (i.e., youth, parents, and support adults) will be collected at baseline, 4 weeks, 8 weeks, and 12 weeks via self-report and semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatient psychiatric patients who have attempted suicide or have documented Suicide ideation (SI) and a plan to harm themselves at admission.
2. Understand written and spoken English.
3. Own a smartphone or mobile phone.
4. Willing and able to complete enrollment procedures.
5. Parent or guardian and youth able to understand the nature of the study and provide written informed consent and assent for youth
6. Patients who are able to provide at least one verifiable contact for emergency or tracking purposes.

Exclusion Criteria:

1. Patients with active psychosis.
2. Patients experiencing substance withdrawal.
3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted.
4. Patient unwilling or unable to wear a mask during in person study procedures, if mandated due to current COVID/health safety guidelines.
5. Patients who in the judgment of the investigator would have an unfavorable risk or benefit profile with respect to eYST.
6. Any other psychiatric or medical condition or custody arrangement that in the investigators' opinion would preclude informed consent or assent or participation in the trial.
DEB-TACE+HAIC vs. HAIC for Large HCC

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC alone for unresectable large hepatocellular carcinoma (HCC).

This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of DEB-TACE (with CalliSpheres) plus HAIC compared with HAIC alone for unresectable large HCC (\>7cm).

230 patients with initially unresectable large HCC (\> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE plus HAIC (dTACE-HAIC) or HAIC as the primary treatment using an 1:1 randomization scheme. In the dTACE-HAIC arm, the microcatheter will be reserved at the proper/left/right hepatic artery and chemotherapy drugs (FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. The treatment can be repeated on demand (at a 4-6-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the HAIC arm, treatment will repeated once every 3 weeks for up to six cycles. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.

The primary end point of this study is overall survival (OS). The secondary endpoints are tumor response (objective response rate and disease control rate), success rate of conversion to resection, progression-free survival (PFS), and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* Patients with HCC confirmed by histology/cytology or diagnosed clinically.
* The maximum HCC lesion \> 7 cm.
* Unresectable HCC evaluated by the surgeon team.
* At least one measurable intrahepatic target lesion.
* Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
* ECOG score of performance status ≤ 1 point.
* Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range.
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein.
* Accompanied with vena cava tumor thrombus.
* Extrahepatic metastasis.
* Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy.
* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
* Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment.
* History of other malignancies.
* Uncontrollable infection.
* History of HIV.
* Allergic to the drugs involved in the research.
* Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
* History of organ or cells transplantation.
* Those with bleeding tendency.
Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To evaluate benefit of post-surgical stereotactic radiosurgery (SRS) on the resection bed in providing 6 month local control (decreasing the risk of local tumor recurrence) when compared to surgical resection alone.

SECONDARY OBJECTIVES:

I. Overall survival, development of distant brain metastases and complications related to treatment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.

ARM II: Patients undergo clinical observation after craniotomy.

After completion of study treatment, patients are followed up at 5-8 weeks, every 6-9 weeks for 1 year, every 3-4 months for 1 year, and then every 6 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).
2. Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined the study neuroradiologist.
3. The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist.
4. Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.
5. Patients must be considered candidates for SRS within 30 days of surgical resection.
6. Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first post operative visit. Patients under 18 years of age must have a Lansky Performance Score of of at least 70.
7. Patients must be able to undergo an MRI scan.
8. Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form.

Exclusion Criteria:

1. Patients who have received prior radiation therapy to the brain for any reason.
2. There is radiographic evidence of leptomeningeal disease prior to study entry.
3. The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
4. For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).
Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study

This randomized prospective quantitative pilot study compared teach-back method to standardized educational method in patient and caregiver to improve cancer pain management

Even though there are comprehensive guidelines for cancer pain management, pain control among cancer patients and survivors is often suboptimal due to undertreatment. According to recent studies, the addition of educational interventions could improve pain relief in cancer patients. Both patients and family caregivers play an important role in delivering cancer pain self-management, especially at home. Providing knowledge for cancer pain management with optimal intervention could improve patient and caregiver outcomes.

The Teach-back method, where patients and family caregivers are asked to repeat the instruction they've received from their health care professionals, can assess patients' understanding, repeat or modify the educational material if comprehension is not demonstrated. This pilot study compared the addition of the Teach-back method for cancer patients and their caregivers and its relation to cancer pain management.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe pain (pain scale 4 and above)
* ≥18 years old
* Signed the informed consent
* Willing to cooperate until the end of studies
* The patient is fully conscious and able to communicate well
* Cared by a family caregiver
* Family caregiver able to fully function as a caregiver

Exclusion Criteria:

* Near-death (dying) stage
* Not willing to cooperate until the end of studies
* Altered mental status and communication difficulties
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
* Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX).
* Participants must have an inadequate response or intolerance to MTX.
* Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening.
* Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product.

Exclusion Criteria:

* Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
* Participants must not have any contraindications to adalimumab.

  * Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib.
* Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant.
* Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
* Participants must not have a current or recent (\<4 weeks prior to baseline) infection.
* Participants must not have a positive test for hepatitis B virus (HBV) at screening.
* Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.
Screening for Poverty And Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK)

The SPARK RCT will test the impact of engagement with a Community Health Worker who is embedded in interprofessional primary care teams on change in estimated annual income at 6 months for people living in poverty.

Population: Patients seen by interprofessional primary care teams who are living on estimated annual incomes that are below the Canadian Low-Income Cut-Off (LICO)

Intervention: A Community Health Worker who implements an intervention that addresses a number of social needs, including improving income security, access to prescription medications, access to housing, reducing social isolation, paying for utilities and access to transportation

Control: Information on community resources on social needs

Outcome: Change in estimated annual income between baseline and at 6 months

Eligibility Criteria:
Inclusion Criteria:

* 18+ years old AND live in a household with an income below the Low-Income Cut-OFF AND agree to receive assistance with social needs

Exclusion Criteria:

* Has worked with a similar CHW or intervention in the past 1 year.
Goal-directed and Cue-dependent Behavior in Severe Obesity

The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior in participants with severe obesity before and after bariatric surgery as well as in a control group with normal weight.

Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Bariatric surgery is a very effective procedure to reduce weight fundamentally.

Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. The aim of the current study is to investigate cue-dependent and goal-directed nutritional behavior as well as the effect of a health mindset induction in severe obesity as well as changes in such behaviors due to bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* experimental: severe obesity
* control: normal weight

Exclusion Criteria:

* impaired cognitive functions, which might conflict with the task
* appropriate German
Post-Market Clinical Follow-up Study of A-SPINE's Products

This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.

The purpose of study is to confirm the safety and and performance of the A-SPINE's products for using 2 years. This post-market clinical follow-up study use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to evaluate the clinical improvement effects. Subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. Finally, analyze the clinical outcome, fusion rate, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Subject is above 20 years of age;
* Subject is indicated for A-SPINE Spinal Fixation System;
* Subject is willing and able to provide informed consent to participate in the study;
* Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits.

Exclusion Criteria:

* Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion Criteria.
Study of Ketorolac Versus Opioid for Pain After Endoscopy

A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.

Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.

Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution
* Patients who post-operatively receive a unilateral ureteral stent
* Capable of giving informed consent
* Capable and willing to fulfill requirements of the study

Exclusion Criteria:

* Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation
* History of coronary artery bypass graft surgery
* History of a bleeding disorder
* GFR less than 60 mL/min/1.73m2 (MDRD equation)
* Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks)
* Known allergy to either ketorolac or oxycodone
* Known or suspected pregnancy
* Solitary kidney
* Patients taking anticoagulant medication or antiplatelet medication (e.g. warfarin, clopidogrel, pradaxa, rivaroxaban, apixaban etc).
* Inability to give informed consent or unable to meet requirements of the study for any reason
Bioavailability Study of Sirolimus Tablets 2 mg Under Fasting Condition

This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fasting conditions.

Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Sirolimus tablets 2 mg under Fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

i. Provide written informed consent

ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg

iii. Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2

iv. Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance)

v. Female Subjects

* Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence
* Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

i. Incapable of understanding the informed consent

ii. Systolic blood pressure less than 90 mm of 140 mm of Hg

iii. Diastolic blood pressure less than 60 mm of 90 mm of Hg

iv. Oral temperature is below 95.0°F or above 98.6°F

v. Pulse rate below 50/min or above 100/min

vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs

vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function

viii. Consumption of grapefruit for the past ten days prior to the check-in, in each period

ix. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period

x. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period

xi. Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period

xii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing

xiii. Clinically significant abnormalities and / or with significant diseases

xiv. Confirmed positive in alcohol screening

xv. Confirmed positive in selected drug of abuse

xvi. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study

xvii. Confirmed positive in urine pregnancy test

xviii. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study
Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease

Herein, the investigators study the safety and efficacy of transplanting purified autologous bone marrow-derived stem cells transplanted via the intrathecal route by interventional radiology and the intravenous route.

A motor neuron disease (MND) is any of several neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. They include amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), progressive muscular atrophy (PMA), progressive bulbar palsy (PBP) and pseudobulbar palsy; spinal muscular atrophies are also sometimes included in the group.They are neurodegenerative diseases that cause increasing disability and eventually, death.

In spite of intensive research, motor neuron diseases (MNDs) are still incurable. Some of the key factors in this failure to find a cure have been the lack of human cell-based disease models for molecular analysis and drug screening and the difficulty of obtaining homogeneous populations of specific cell types for clinical applications. Stem cell biology has the potential to transform our understanding of disease processes and to revolutionize our approach to develop novel therapies for MNDs.

In this study, the investigators suggest a protocol for the treatment of MND by transplantation of purified autologous bone marrow-derived stem cells via the intrathecal and intravenous route.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 24-20 years old
* Patients with the diagnosis of definite Motor Neuron Disease

Exclusion Criteria:

* HIV/HBV/HCV
* Malignancies
* Bleeding
* Pneumonia
* Renal failure
* liver dysfunction
* Severe anemia (hb \< 8)
* Bone Marrow diseases
* Pregnancy and lactation
* Acute medical conditions/infections such as respiratory infections
* ventilatory support
Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. The aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective.

Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.


Eligibility Criteria:
Inclusion Criteria:

* given informed consent for transvaginal hybrid cholecystectomy

Exclusion Criteria:

* pregnancy
* malignoma
* present choledocholithiasis