cyrilzakka/clinical-trials huggingface dataset:
Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction

Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. The purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of PDP. Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the PDP intervention or a control condition. The PDP intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. Control mothers will receive usual care plus depression monitoring by phone. Data will be collected at baseline, post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.


Eligibility Criteria:
Inclusion Criteria:

* First-time, English-speaking mothers of healthy singleton newborns
* Positive screen (\> 10) on Edinburgh Postnatal Depression Scale

Exclusion Criteria:

* Suicidal ideation
* Currently receiving depression treatment
* Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder
Ventilator Associated Pneumonia Care Bundle Prevention on Internship Students' Knowledge and Clinical Performance

The goal of this clinical trial is to determine the effect of a self-instructional module regarding ventilator-associated pneumonia care bundle prevention on internship students' knowledge and clinical performance in pediatric intensive care unit.The hypotheses of this study were as follows:

1. Internship students who are taught by VAP care bundle prevention self-instructional module exhibit higher scores in knowledge test about VAP care bundle prevention than those who are not.
2. Internship students who are taught by VAP care bundle prevention self-instructional module exhibit higher scores in performing the VAP care bundle prevention procedure than those who are not.
3. Internship students who are taught by VAP care bundle prevention self-instructional module exhibit more positive feedback about it than those who are not.


Eligibility Criteria:
Inclusion Criteria:

* Nursing intern students at Faculty of Nursing, Alexandria university, Egypt.

Exclusion Criteria:

* No
Nitrite Infusion in Islet Cell Transplantation

This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.

Patients diagnosed with chronic pancreatitis or recurrent acute pancreatitis may acquire insulin-dependent diabetes due to islet cell destruction. Therefore, islet cell autotransplantation is the optimal therapeutic approach for many of these patients. Islet cell autotransplantation is typically done by excision of the pancreas, followed by isolation of the islet cells and then infusion of these cells into the sinusoids of the liver. Isolation of the islet cells occurs in an ischemic and hypoxic environment, resulting in ischemia reperfusion (IR) injury and destruction of islet cells following infusion into the sinusoids. Hence, strategies to prevent IR injury and subsequent islet cell destruction, such as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) could enhance islet cell survival following reperfusion, also decreasing long-term insulin requirement. The purpose of this study is to determine if NO administered by infusion in patients undergoing islet cell auto transplantation, will inhibit islet cell destruction, increase diabetes cure rate (decrease the amount of and/or the need for long-term insulin requirement), decrease the ischemic injury (reduces the injury to the islet cells from a decrease in oxygen levels during procurement of the islet cells) during islet cell procurement, and decrease IR injury following islet cell infusion. The primary endpoints of the study are exogenous insulin use, HgbA1c levels post-operatively, and blood glucose levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 18 years of age
* Scheduled to undergo Islet Cell auto-transplantation by Dr. Jared White or Dr. Bart Rose
* Subjects who can provide informed written consent and are willing to do so

Exclusion Criteria:

-Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)
Fentanyl for Treatment Pain Caused by Radiotherapy

The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.

The study is a phase IV, open label, single arm study. The purpose of this study is to assess the clinical utility and safety of fentanyl transdermal therapeutic system (patch) for treatment of pain caused by radiotherapy. The patients increase or even decrease the amount of study medication in order to achieve pain relief, 48 to 72 hours or 3 days are required after the first patch application. The study medication will be used for 4 weeks. VAS (visual analog scale), BPI Q9 (quality of life) and global assessment have been used to assess the effectiveness. VAS will be assessed every week. BPI Q9 will be assessed at week 1 and week 4. Global assessment will be assessed at week 4. The safety of the study drug will be evaluated using adverse event (AE) report.

The investigator will assess the pain intensity of patients and increase or even decrease Fentanyl dosage every week. Fentanyl will be started on 25 or 50 ug per hr depending on investigator's judgement. Fentanyl will be administered for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients have the history of head and neck tumor
* Patients who are proceeding radiotherapy
* Patients who are administered weak opioids and pain score (Visual analog scale) of 4

Exclusion Criteria:

* Patients who have been administered Fentanyl for pain treatment within 2 weeks before the study
* Patients who will have surgery within 1 month
* Known presence of distant metastasis
Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC)

The purpose of this study is to determine whether a relationship exists between a previously established diagnosis of endometriosis and the consecutive risk of developing a clear cell or endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer registry data will be assessed to investigate differences in survival of women with endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without previous diagnosis of endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* endometrioid ovarian carcinoma
* clear cell ovarian carcinoma
* endometriosis, atypical endometriosis
* borderline tumors with endometriosis

Exclusion Criteria:

* undifferentiated carcinomas
* germ cell tumors
* sex cord-stromal tumors
Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma

The purpose of this study is to determine the safety of this new treatment offered in this study. PCNSL can be cured in less than half of patients with standard treatment, a combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and brain radiation may result in serious lasting side effects. Most patients older than age 60 develop memory problems, difficulty walking or inability to control their bladder. Some patients younger than age 60 also develop these side effects.


Eligibility Criteria:
Inclusion Criteria:

* All patients must have non-Hodgkin's lymphoma involving the brain, as demonstrated by CT or MRI and histologic confirmation by one of the following: A positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.

A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy.

* Patients must be HIV-1 negative.
* Patient must have left ventricular ejection fraction ≥ 50%.
* Patients must have no evidence of systemic lymphoma. This must be demonstrated by a CT scan of the chest, abdomen and pelvis prior to registration.
* Patients must have adequate bone marrow function (defined as peripheral leucocyte count \>3000 cells/mm3 and platelet count \> 100,000 cells/mm3), liver function (bilirubin \< 2.0 mg%), and adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance \> 50cc/min/1.73M2).
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
* Patients must be between 18 and 72 years-old.
* Patients must sign an informed consent.

Exclusion Criteria:

* Prior cranial irradiation
* Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
* Pre-existing immunodeficiency such as renal transplant recipient.
* Prior treatment with chemotherapy for CNS lymphoma.
Phase 4 IOP Signals Associated With ILUVIEN®

This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.

The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.

Exclusion Criteria:

* Patients who are unable to understand and sign the Informed Consent Form.
Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer

The pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral cell isolation by size) in patients with bronchial cancer was previously demonstrated.

However, no kinetic study was ever realized to study the value of the CTC as predictive indicator of answer to the therapy. This project plans to study patients in an early stage and patients at advance stage locally moved forward or metastatic of the disease by evaluation of the presence and the number of CTC before every cure. This collaborative and original study should allow to refine the diagnoses of answer and to plan the possible relapses what would allow a premature institution of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients with non-small cell lung cancer
* accepting participation

Exclusion Criteria:

* refusing participation
A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Adequate hematological function

Exclusion Criteria:

* Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
* Exposure to bendamustine within the 180 days before study enrollment
* Prior autologous or allogeneic stem cell transplantation (SCT);
* Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor;
* History of other invasive malignancy within 5 years except for localized/in situ carcinomas;
* Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;
ABLATOR Ablation Observational Registry

The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

The objectives of this registry are the following:

* To confirm patient safety as part of the post market surveillance study.
* To assess performance of a combination of SJM products during procedures.
* To assess the learning curve with a combination of SJM products.
* To collect operator feedback on a combination of SJM products.

All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.

In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Eligibility Criteria:
Inclusion Criteria:

All patients who are indicated for an atrial fibrillation ablation procedure.

Exclusion Criteria:

Pregnant women.
Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients

The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.

Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles). A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients. Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Solid organ transplant recipient.
* Age ≥18 years
* VZV-seronegative at time of transplant
* ≥90 days post-transplant
* Able to provide informed consent

Exclusion Criteria:

* Has already received the recombinant subunit Herpes zoster vaccine in the past
* Ongoing CMV viremia \> 200 IU/mL
* HIV infection
* Diagnosis of malignancy (e.g. PTLD)
* History of a severe allergic reaction (anaphylactic reaction) after any vaccine
* Documented Chickenpox or Shingles after transplantation
* Congenital immunodeficiency (e.g., CVID)
* Treatment for rejection in the past 30 days
* Immunoglobulin in the past 30 days or anticipated to receive immunoglobulin
* Anti-CD20 monoclonal antibody in the past 6 months or anticipated to receive Anti-CD20 monoclonal antibody
* Plasmapheresis in the past 30 days or anticipated to receive plasmapheresis
* Febrile illness in the past one week
* Unable to comply with the study protocol
Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation

The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were included to the study. For each patient, ulceration were randomly assigned to the test or the control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact mode. In the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain was evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a clinician.


Eligibility Criteria:
Inclusion Criteria:

* For inclusion every patient had to have one pairs of minor RAS duration of 3 days or less, in the buccal or labial nonkeratinized oral mucosa.

Exclusion Criteria:

* Patients with a known systemic disease that predisposed them to RAS (e.g., Behçet disease), presence of any major herpetic lesions, traumatic ulcers, ulcers caused due to topical or systemic medications, or undergoing systemic or local treatment for RAS were excluded.
Study on the Feasibility of Continuous Glucose Monitoring(CGM) for Improving Blood Glucose Control in Severe Patients

Compared to traditional blood glucose monitoring (TGM), CGM can accurately capture asymptomatic hyperglycemia and hypoglycemia events that are missed by TGM, accounting for 33% and 90% of cases, respectively. Real-time CGM provides instantaneous glucose levels and can also generate alarms for hypoglycemia and hyperglycemia based on preset glucose ranges, assisting patients in making timely adjustments to their glucose levels. Clinical studies have found that glucose control guided by real-time CGM is better, and the decrease in glycosylated hemoglobin levels is positively correlated with the frequency of CGM use. More importantly, although glucose variability can be calculated using conventional blood glucose measurements taken every four to six hours, to further assess precise changes in glucose levels, more detailed and accurate continuous data are required. In this respect, CGM has unparalleled advantages over traditional blood glucose monitoring.While the use of CGM in critically ill patients is still controversial.

We conducted this clinical study to compare the effectiveness of CGM and traditional blood glucose monitoring in guiding blood glucose control in critically ill patients, and to clarify the feasibility of using CGM for critically ill patients. We also aimed to explore the possible factors that affect CGM in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years and \< 80 years
* ICU stay ≤48 hours
* Expected ICU stay \> 24 hours
* APACHE II score≥ 8

Exclusion Criteria:

* local infection within the sensor placement area
* Laparotomy within lower abdomen
* Participated in this study before
* In other clinical trails.
Ultrasound (US)-Guided Versus Sham Ultrasound Corticosteroid (CS) Knee Injections

To determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 89.
* Meet the American College of Rheumatology criteria for knee OA with knee pain, aching or stiffness on most of the past 30 days and have evidence on radiograph of a definite osteophyte.
* Have a pain score of at least 4 out of 10 on an 11 point numeric rating scale.
* For participants with bilateral knee OA, the most symptomatic knee will be considered the study knee. If both knees are symptomatic, the subject will choose the one they want treated.
* Be able to speak and understand English.
* Have a telephone.

Exclusion Criteria:

* Prior hyaluronic acid injection.
* Scheduled knee hyaluronic acid injections, arthroscopy, or knee surgery.
* Comorbid conditions including: known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain, knee instability defined as report of knee buckling or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent
* Current involvement in litigation or receiving workmen's compensation. These patients are to be excluded because they are expected to bias results. This group will be expected to over-report pain symptoms. This bias cannot be corrected for in the analysis.
* Contraindications to intra-articular injections: known bleeding disorder/diathesis.
* Prosthesis in the painful knee.
* Bilateral total knee replacements.
* Pregnancy if no recent knee x-rays are available.
* Wheelchair bound.
* BMI greater than 40.
Compassionate Use Treatment for a Single Patient With a Custom Made Branched/Fenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm

The FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE H\&L-B ONE-SHOT™ INTRODUCTION SYSTEM is neither commercially available or available as part of a clinical trial. IRB approval of this protocol was requested so that Cook, Incorporated may apply to the FDA for approval for one-time use of this patient-specific device for compassionate use for patient AO. It is a custom made endovascular device consisting of4 fenestrations for the celiac, SMA (superior mesenteric) and left and right renal arteries.

The Custom Made Branched/Fenestrated Endovascular Device to be used in this treatment plan is not Food and Drug Administration (FDA)-approved, and is approved for use only in a clinical study. However, the FDA has allowed the use of this device for compassionate use.

The devices used are tubular grafts made of polyester fabric sewn to metal stents. The upper part of the grafts includes fenestrations (holes) that allow the grafts to be located above or near major arteries that branch off of the aorta (celiac artery, superior mesenteric artery (SMA), and renal arteries) without blocking blood flow to them. The celiac artery supplies blood to internal organs including the liver and stomach. The SMA supplies blood to internal organs as well, including parts of the large and small intestines. The renal arteries supply blood to the kidneys. Grafts with branches and/or fenestrations are needed when the aneurysm is located near these major arteries. The major arteries that branch off of the aorta (celiac artery, SMA, and renal arteries) may also be treated using stents (small tubular metal structures) to help keep the arteries open and aligned with the graft fenestrations (holes).

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Prenatal PCB Exposure

This project is designed to investigate the association between prenatal exposure to environmental contaminants on cognitive development of school-age children


Eligibility Criteria:
Pregnant mothers carrying full-term infants between 1991 and 1994. No longer recruiting. This is not a clinical trial. This is an epidemiological study.
Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with four arms involving a control group.


Eligibility Criteria:
Inclusion Criteria:

* Men diagnosed with erectile dysfunction
* Must be in the age range of 18 to 40 years
* Must be in a stable heterosexual relationship
* Must not be suffering from any medical or psychiatric illness

Exclusion Criteria:

* Men not meeting criteria of diagnosis of erectile dysfunction
* Men not in a heterosexual relationship
* Men above the age of 40 years
* Men diagnosed with any medical or psychiatric illness