cyrilzakka/clinical-trials huggingface dataset:
Tailoring Mindfulness Interventions for Families Managing Chronic Health Conditions

This is not an intervention or treatment study. It is an observational qualitative data study about tailoring a mindfulness intervention to assist families managing chronic health conditions.

This is not an intervention or treatment study. It is an observational qualitative data study. Collecting information from virtual audio only interviews from between 30 and 40 US adults about whether a mindfulness intervention would assist families managing chronic health conditions; and if so, how should it be tailored to meet their needs.

Eligibility Criteria:
Inclusion Criteria:

* English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member

Exclusion Criteria:

* unable to complete an audio interview in English lasting 30-60 minutes
IV Dexketoprofen vs Placebo in Migranie Attack

H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in emergency department.

H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine attack in emergency department.

Migraine attack is one of the most leading causes presentations to emergency department. Patients with migraine attack seek urgent care to cease their pain. There are so many interventions defined in the medical literature that can be used in migraine attacks. However, as a IV drug, dexketoprofen; little known whether IV dexketoprofen is superior to placebo or not. In the present study we aimed to determine the effects of IV dexketoprofen in migraine attack in emergency department.

Eligibility Criteria:
Inclusion Criteria:

* patients presented with headache who diagnosed as migraine attack according to the international headache society

Exclusion Criteria:

* denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy
Increasing Colorectal Cancer (CRC) Screening In Primary Care

Colorectal cancer screening remains lower than optimal. The purpose of this study was to test the efficacy of phone-based motivational interviewing versus tailored communication versus usual care in increasing CRC screening in primary care clinics.

Regular screening reduces both morbidity and mortality from colorectal cancer (CRC). Screening rates, however, remain low suggesting the need for innovative research designed to increase screening behavior. The purpose of this study is to compare the effectiveness of two interventions (Tailored Health Communication \[THC\] and Motivational Interviewing \[MI\]) in increasing CRC screening behavior. Both interventions are based on a strong conceptual framework derived from the Health Belief Model (HBM) and Transtheoretical Model (TTM), allowing us to explore the underlying mechanisms through which these interventions impact behavior change.

The primary aim of this study is to compare CRC screening test use among 804 participants randomly allocated to control or intervention conditions; participants will be recruited from the two sites (Chicago, IL, and Nashville, TN). The 3 study groups will receive (1) standard care, (2) tailored health communication, and (3) motivational interviewing. Eligibility criteria for study participants includes being 50 years or older, not having CRC, and being of average or moderate risk for CRC. Study participants will be surveyed by telephone about CRC-related beliefs pre-intervention (Time 1), 1 month postintervention (Time 2), and at 6 months postintervention (Times 3 and 4, respectively). Dichotomous behavioral outcomes (had screening test or not) and stages of CRC screening test adoption (based on the TTM) will be assessed, as well as sociodemographic and belief predictors of screening behavior. Binomial and multinomial logistic regression models will be used to evaluate screening test use and stage of test adoption. Sociodemographic and belief variables will be used as covariates, with intervention group as the primary independent predictor. Descriptive statistics and ANOVA will be employed to assess between intervention differences in amenable beliefs. Path (mediation) analysis will be performed to further explore the underlying mechanisms through which THC and MI may differentially affect CRC screening behavior.

Eligibility Criteria:
Inclusion Criteria:

* all genders
* can speak, read, write English
* no diagnosis of colorectal cancer
* non-adherent with screening
* age 50 or older

Exclusion Criteria:

* had colorectal cancer
* adherent with screening
Evaluation of Magnetic Resonance Imaging (MRI) vs Molecular Breast Imaging (Tc-MBI) in Breast Cancer Patients

The objective of this study is to evaluate the usefulness of Tc-99m Sestamibi Molecular Breast Imaging as an imaging modality for breast cancer screening.

Tc-MBI has shown significantly higher sensitivity and equivalent specificity in the detection of breast cancer among high risk women when compared to mammography. However, there is little published data comparing Tc-MBI to MRI for evaluating extent of disease in women with known breast cancer.

The study will target twenty (20) women with newly diagnosed breast cancer who are scheduled to undergo biopsy of additional suspicious lesions that were identified on standard of care contrast- enhanced breast MRI. Prior to the biopsy, these subjects will receive a Tc-MBI scan of the breast. The results from both imaging methods will be compared to histological findings. These results may be used to design larger and more comprehensive studies with an overarching goal to determine if there is a role for Tc-MBI in the pre-operative evaluation of patients with known breast cancer.


Eligibility Criteria:
Inclusion Criteria:

Women Patients must be 18 years of age or older. Patients will have biopsy proven unilateral breast cancer with ipsilateral or contralateral suspicious lesions on contrast-enhanced breast MRI and be a candidate for additional tissue biopsy.

Patients must be able to remain still for Tc-MBI scanning Patients must be able to provide written informed consent

Exclusion Criteria:

Men, age less than 18, inability to remain still for Tc-MBI scanning, cannot provide written informed consent, known untreated bilateral breast cancer, evidence of distant metastasis disease (M=1), pregnancy.
Clinical Application of Breast Blood-oxygen Functional Imaging Technology

This trial is going to evaluate the value of blood-oxygen functional imaging technology in the diagnosis of breast diseases.


Eligibility Criteria:
Inclusion Criteria:

* female older than 18 years breast lump received breast ultrasound and mammography

Exclusion Criteria:

* After core-needle biopsy or resection After neoadjuvant chemotherapy, radiotherapy or endocrine therapy
EZN-2279 in Patients With ADA-SCID

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated with Adagen.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ADA-deficient combined immunodeficiency
2. Stable clinical status while receiving therapy with Adagen®. Patients previously receiving gene therapy or undergoing hematopoietic stem cell transplantation who still require Adagen® treatment are eligible. The dose of Adagen® must be stable for at least 6 months prior to study entry.
3. Have both of the following during the Adagen® Lead-in phase of the study prior to EZN-2279 transition:

   1. Trough plasma ADA activity \>15 μmol/h/mL while receiving Adagen® and
   2. Total erythrocyte dAXP ≤0.02 μmol/mL from a trough blood sample
4. Patients or parent/guardian must be capable of understanding the protocol requirements and risks and providing written informed assent/consent

Exclusion Criteria:

1. Autoimmunity requiring immunosuppressive treatment
2. Patients with detectable neutralizing anti-Adagen® antibodies at screening evaluation
3. Severe thrombocytopenia (platelet count \<50 x 10\^9/L)
4. Current participation in other therapeutic protocols for ADA-deficient combined immunodeficiency
5. Current or prior participation in another clinical study with an investigational agent and/or use of an investigational drug in the 30 days before study entry
6. Known planned participation in a gene-therapy study for the planned duration of this study
7. Any condition that, in the opinion of the PI, makes the patient unsuitable for the study
8. Inability or unwillingness to administer Adagen® or EZN-2279 on a one-time-per-week regimen
9. Inability to comply with the study protocol
10. Female patients who are pregnant or lactating
11. Female patients who are breast-feeding
12. Female subjects of childbearing potential who are not using an FDA approved birth control method
Vision-based Ultrasonic Robot Autonomous Scanning Research

MGIR3-US is a remote scanning robot which can perform ultrasound exam. The aim of the study is to evaluate the feasibility and the application of MGIR3-US.


Eligibility Criteria:
Inclusion Criteria:

* patients who agree using MGIR3 to do ultrasonic examinations
* age from 18 to 65

Exclusion Criteria:

* Patients who has trauma on the inspection site or on the body surface
* Pregnant patients.
* Patients who are afraid of MGIR3-US
Induced-T Cell Like NK Cells for B Cell Malignancies

Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimeric antigen receptor (CAR-ITNK cells) is a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of CAR-ITNK cells infusions in patients with relapsed and refractory B cell malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patient with CD19 positive B-cell acute leukemia
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* ALT/ AST \<3 x normal
* Bilirubin \< 2.0 mg/dl
* Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
* LVEF\< 45%
* Accept white blood cell collection
* Provide informed consent

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* Active hepatitis B , hepatitis C or HIV infection
* Uncontrolled active infection
* Presence of grade 2-4 acute or extensive chronic GVHD
* Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
* Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Received non-diagnostic purposes major surgery within the past 4 weeks
* Participated in any other clinical study within the past 4 weeks
* Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
* Pregnancy or breast-feeding women
* Use of prohibited drugs:
* Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to ITNK Cells infusion
* Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to ITNK Cells infusion
* GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to ITNK Cells infusion
* Any situation that may increase the risk of the test or interfere with the test results
The Fibrin Pad Liver Study

The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 18 years of age, requiring elective or urgent, open hepatic surgery
* Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
* Subjects must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
* TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product
* TBS with major arterial bleeding requiring suture or mechanical ligation
* Subjects admitted for trauma surgery
* Subject is a transplant patient for fulminant hepatic failure
* Subject with TBS within an actively infected field
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
* Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products
* Subjects who are known, current alcohol and / or drug abusers
* Subjects who have participated in another investigational drug or device research study within 30 days of surgery
* Female subjects who are pregnant or nursing
Nis Register Study Comparing Seroquel and Seroquel Prolong

The general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The primary objectives of the study are:1.To collect information on the used Quetiapine Immediate Release or Quetiapine Extended Release medication 2.To collect information on duration and number of hospitalisation days 3.Change of GAF points


Eligibility Criteria:
Inclusion Criteria:

* Medication: Seroquel or Seroquel Prolong
* Diagnosis: F20-F29 or F30-F31 (ICD-10)
* In-patient

Exclusion Criteria:

* None
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B

This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
* 18 through 69 years of age, inclusive.
* Active hepatitis B e-antigen (HBeAg) negative chronic HBV infection, with all of the following:

  * HBeAg negative and HBeAb positive at screening
  * Alanine aminotransferase (ALT) levels \> the upper limit of the normal range (ULN) and ≤ 10 x ULN
  * Serum HBV DNA \> 100,000 copies/mL at screening
  * Creatinine clearance ≥ 70 mL/min
  * Hemoglobin ≥ 8 g/dL
  * Neutrophils ≥ 1,000 /mL
* Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score \< 4; however, up to 120 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
* Negative serum β-human chorionic gonadotropin (hCG)
* Nucleotide naive, ie, no prior nucleotide (TDF or ADV) therapy for greater than 12 weeks
* Nucleoside naive, ie, no prior nucleoside (any nucleoside) therapy for greater than 12 weeks. However, up to 120 patients with \> 12 weeks prior lamivudine experience will be eligible
* Willing and able to provide written informed consent
* Had a liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline

Key Exclusion Criteria:

* Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
* Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
* Decompensated liver disease defined as conjugated bilirubin \> 1.5 x ULN, prothrombin time (PT) \> 1.5 x ULN, platelets \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
* Received any nucleoside, nucleotide (TDF or ADV) or interferon (pegylated or not) therapy within 6 months prior to the pre treatment biopsy
* Evidence of hepatocellular carcinoma (HCC)
* Coinfection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
* Significant renal, cardiovascular, pulmonary, or neurological disease
* Received solid organ or bone marrow transplantation
* Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
* Has proximal tubulopathy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Practical Approaches to Exercise in Moms

This project aims to test the feasibility of a practical physical activity intervention for postpartum women, incorporating the use of body weights worn during typical daily activities.

We are piloting a 3-arm, unblinded, randomized controlled trial in postpartum women; with 10 participants in each study group. Women will be recruited at 2-6 months postpartum, with the intervention lasting through 12 months postpartum. Data collection will include:1) Physical activity; 2) Maternal body composition; 3) Questionnaires to assess:motivation to adopt healthy behaviors, body attitudes, infant feeding practices; 4) Process evaluation to assess: likes and dislikes about the intervention program, suggestions for improving the intervention, reasons for leaving the study. The proposed study time period is 6 months for study recruitment, 18 months to carry out the study, and 6 months for data analysis (total 2 years).

Eligibility Criteria:
Inclusion Criteria:

* 2-6 months postpartum women

Exclusion Criteria:

* Premature birth
* History of serious illness
* Medically incapable of low-intensity exercise
* Currently taking medications that cause weight loss
Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm

The aim of this study is to study the combined impact of mechanical ventilation and sepsis on the human diaphragm in order to establish the neutral, protective or destructive character of mechanical ventilation by studying the diameter of the fibers, activation of proteolytic systems, inhibition of protein synthesis, tissue inflammation as well as contractile function.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years of age, male or female requiring abdominal or thoracic surgery or multi-organ sampling;
* Affiliated to a social security or similar system;
* Not subject to legal protection;
* Having given consent to participate in the study (or consent from the trusted person)
* Control group (C): non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy
* Sepsis group (S): Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
* Group Mechanical Ventilation (MV): Patient in brain death for which a multi organ sample is planned
* Mechanical Ventilation + Sepsis (S-MV) group: Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)

Exclusion Criteria:

* Pregnant woman (diagnosis of interrogation)
* severe and / or unbalanced chronic respiratory disease; severe malnutrition
* Long-term corticosteroids\> 5mg / day for more than 1 month
* Myopathy
* surgery by laparoscopic

By group:

* Control group: Sepsis, preoperative controlled mechanical ventilation and preoperative hemodynamic instability
* Mechanical Ventilation Group: Sepsis, duration of controlled mechanical ventilation \<24 hours or\> 7 days
* Sepsis Group: Preoperatively controlled mechanical ventilation
* Mechanical Ventilation - Sepsis Group: duration of controlled mechanical ventilation \<24 hours or\> 7 days
Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection

The purpose of this study is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount.

Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental.

This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> or = 18 years
* Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy.

Exclusion Criteria:

* Pregnancy
* History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal LV function within 30 days of operation
* MI within 3 months
* History of stroke
* History of congestive heart failure and ejection fraction less than 35%
* History of severe COPD and resting oxygen saturation (SpO2) \< 90%
* Renal dysfunction (Cr \> 1.8)
* Abnormal coagulation parameters (INR \> 1.5 not on Coumadin, or platelet
* Presence of active infection including HIV
* BMI \> 35
* American Society of Anesthesiologists Status \> III, assigned at time of preoperative visit
* Corticosteroid use \> 10 mg Prednisone/day
* Bilirubin \> 10.0
Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema

The Endurance Trial is a Phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days

The Endurance3 Trial is a Phase IV open label study to assess the need for ongoing intravitreal aflibercept injections after the 3 year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) upon the presence of CR-DME (Clinically Relevant DME) as noted by OCT (Optical Coherence Tomography) imaging and examination. In addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled and completed VISTA DME (VGFT-OD-1009) clinical trial
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
* Enrollment in the trial within 12 weeks of trial activation

Exclusion Criteria:

* Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
* Pregnant or breast-feeding women
* Sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study