cyrilzakka/clinical-trials huggingface dataset:
Study of Support Groups for African-American Breast Cancer Survivors

RATIONALE: A study that evaluates successful Los Angeles-based, peer-led African American breast cancer survivor support groups may help in developing a guide on how to organize and maintain breast cancer support groups.

PURPOSE: This clinical trial is studying support groups for African-American breast cancer survivors.

OBJECTIVES:

* Characterize five established Los Angeles (LA)-based, peer-led African American Breast Cancer Survivor (AABCS) support groups by identifying and evaluating the successful elements of structure and process that distinguish these groups: the purpose and goals; theories and techniques that are utilized; the structure of the group and implementation of specific goals; the cultural aspects that are incorporated to enhance the efficacy; and similarities and differences among these AABCS support groups.
* Develop a preliminary "Culturally Informed Breast Cancer Support Group Guide" on how to organize and maintain support groups, modeled on the "best model" experiences of the five established LA-based support groups for AABCS.
* Conduct three needs-assessment focus groups and 5 key informant interviews in the Inland Empire to evaluate the psychosocial needs and resources of AABCS in that region.

OUTLINE: At least 10 support group leaders (2 from each support group) undergo semi-structured interviews to elicit information about the needs of breast cancer survivors in their community and the cultural modes of support that are given. Eight to twelve African American Breast Cancer Survivors (AABCS) participate in 5 focus group discussions and complete a questionnaire about their breast cancer and experience with support groups for qualitative and quantitative analysis.

At least 5 Inland Empire community leaders undergo semi-structured interviews to elicit information about the needs of breast cancer survivors in their community. Eight to twelve AABCS from the Inland Empire participate in 3 focus group discussions and complete a questionnaire about their breast cancer and experience with support groups for qualitative and quantitative analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * African American Breast Cancer Survivor (AABCS) meeting 1 of the following criteria:

    * A member of 1 of the 5 support groups listed below
    * Live in the Inland Empire region of California
  * A cancer support group leader or facilitator of 1 of the 5 established support groups in Los Angeles:

    * Women of Essence (WOE)
    * Women of Color (WOC)
    * Support Sisters African American Breast Cancer Support Groups
    * Sisters
    * Celebrate Life
  * A community leader knowledgeable about breast cancer support services in the Inland Empire region

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome

The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.

The relationship between stress and infertility has remained a subject of controversy for many years. Recent research indicates that stress has a strong negative impact on pregnancy rates in women undergoing in vitro fertilization (IVF). In addition, stress is the most common reason given by women who voluntarily terminate treatment.

In a recent study, women who participated in a group mind/body treatment program had higher pregnancy rates than control subjects. The impact of an online stress management program has never been studied in the infertile population. An online intervention would be far more accessible for many infertility patients.

Eligibility Criteria:
Inclusion Criteria:

* female Boston IVF patients
* day three FSH 12 or below
* day three estradiol 80 pg/ml or below
* able to read, understand and sign the informed consent in English
* using own eggs (not egg donor)
* willing and able to comply with study requirements
* must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week

Exclusion Criteria:

* prescription antipsychotic medication
* previous diagnosis of borderline or narcissistic personality disorder
* previous or concurrent participation in a mind/body group
Comparing TR Band to Statseal in Conjunction With TR Band II

The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transradial procedures. It is believed that the use of both devices in combination compared to the hemostasis band (TR band) alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that you would need to wear the hemostasis band.

This study is a physician initiated, prospective, observational, two arm, randomized study to be performed at experienced 'Radial First' centers. Patients having undergone successful radial catheterization will be enrolled in the study. Enrollment with continue at each site with an initial goal of 800 patients enrolled, with each center contributing a minimum of 50 patients. Study will be have a single interim analysis after 400 patients are enrolled for efficacy and safety and continuation of the study. Clinicians will perform the catheterization in accordance with local standard practice, with no minimum amount of anticoagulation required.

Unlike the pilot trial of this device, the present study will have an identical time to first deflation of 60 minutes between the two groups, and have a larger sample size to detect any excess risk of hematoma or radial artery occlusion. The study may also help demonstrate a relatively low rate of radial artery occlusion with a rapid deflation protocol, even at lower doses of unfractionated heparin than currently recommended.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing diagnostic angiography or PCI via the radial artery
* Patients with a Barbeau test prior to the procedure showing pattern A,B,or C.

Exclusion Criteria: any one of the following...

* Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
* Use of a hemostasis method or device besides the TR Band.
* Patients undergoing catheterization from the femoral, brachial, ulnar, or distal radial (snuffbox) artery approach.
* Use of an anticoagulant other than unfractionated heparin or bivalirudin.
* Any use of glycoprotein inhibitors or cangrelor.
* Use of sheathless guides.
* Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
* Any active treatment with oral anticoagulants continued during course of procedure.
* Presence of arteriovenous dialysis fistula in the ipsilateral arm.
* Any physical deformity or trauma / injury of either wrist that would prevent proper placement or function of the hemostasis band.
* Raynaud's syndrome or known peripheral vascular disease of the forearm.
* Inability of the patient to personally consent for the study. (no surrogate consent)
* History or presence of Radial Artery Occlusion.
* Barbeau test showing Pattern D.
* Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.
Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery

The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure. The effects of the application of the Consensus Document "Stent and Surgery-2" on perioperative antiplatelet therapy will be assessed. The study will also assess ischemic and hemorrhagic events in relation to the application of the Consensus Document and length of any antiplatelet discontinuation and delay in performing surgical procedures.

The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. Centers will be divided into two groups: Centers that routinely follow the recommendations of the SAS 2 Document and Centers that do not. The relevant clinical, procedural and outcome data (within index admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF). The primary endpoint will be the rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy. The secondary end-point will be the composite of death, myocardial infarction, probable/definite stent thrombosis and bleeding events at 30 days; the type and the length of discontinuation of any antiplatelet therapy in patients undergoing surgery according to time from PCI to surgery; delay in performing surgical procedure; rate of surgical procedures within 12 months from PCI divided into quartiles (0-3, 3-6, 6-9, 9-12 months).

Eligibility Criteria:
Inclusion Criteria:

* Eligible will be male and female patients \> 18 years of age.
* Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery.
* Both candidates to elective and urgent/emergent surgical procedures will be included in the MONET registry.

Exclusion Criteria:

* Unwillingness/inability to sign the Informed Consent Form (ICF). Patients with an active bleeding requiring discontinuation of one or both antiplatelet agents will be also excluded. There are no other exclusion criteria.
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery

For patients with Crohn's diseases undergoing surgery，whether postoperative exclusive enteral nutrition(EEN) could delay the endoscopic relapse needs exploration.The trial will investigate the efficacy of postoperative EEN for maintaining disease remission.


Eligibility Criteria:
Inclusion Criteria:

- CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

* patients who received stoma creation
Young Pectus Excavatum Patients and Genetic Defects

In most pectus excavatum (PE) patients an underlying genetic defect is not found with molecular analysis, as a direct genetic link with PE has yet to be found and because potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are identified in the first decade of life and thus of congenital origin making younger PE patients a unique patient group. Therefore, the research question is; is early-onset pectus excavatum (PE) more likely to be part of a genetic defect than PE which became apparent during puberty or adolescence?

Importance: In most pectus excavatum (PE) patients an underlying genetic defect is not found with molecular analysis, as a direct genetic link with PE has yet to be found and because potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are identified in the first decade of life and thus of congenital origin making younger PE patients a unique patient group.

Objective: the investigators hypothesize that early-onset PE is more likely to be part of a genetic defect than PE which became apparent during puberty or adolescence.

Design: Cohort study Setting: Single center Participants: All pediatric PE patients aged younger than 11 years upon first visit of the outpatient clinic of the department of pediatric surgery at the Sophia Children's Hospital - Erasmus Medical Center between 2014 and 2020 were identified and informed consent was obtained for inclusion. Two clinical geneticists performed the anamnesis and physical examination. Molecular analysis was performed based on the differential diagnosis. All young PE patients which have been referred for genetic counseling already, were analyzed retrospectively.

Main Outcome: incidence of genetic defects

Eligibility Criteria:
Inclusion Criteria:

* Patients with pectus excavatum aged younger than 11 years upon first visit of our outpatient clinic

Exclusion Criteria:

* None
Therapeutic Drug Monitoring of Voriconazole

The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.

Voriconazole is an anti-fungal agent, which is used in the treatment of invasive fungal infection, especially aspergillosis. The serious side effects of voriconazole include liver function abnormality, encephalopathy, etc. Recently, the several studies showed that the blood level of voriconazole is variable and it is associated with drug side effect and treatment outcome. However, there is no randomized controlled study which proves that therapeutic drug monitoring of voriconazole can improve the clinical outcome in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* patients who were 16 years of age or older
* receiving voriconazole in order to treat invasive fungal infections or for empirical use

Exclusion Criteria:

* who experienced the serious side effect of voriconazole
* were hypersensitive to azoles
* had an aminotransferase, bilirubin, or alkaline phosphatase level higher than five times the upper limit of normal
Social Network Overdose Prevention and Education Intervention

The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs).

The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs). The investigators have utilized PEs for overdose prevention in interventions that have focused on training network members who use drugs to respond to an overdose. Yet, many overdoses are witnessed by people who do not use drugs. Additionally, many PWUO report using drugs at home and living with someone who does not use drugs, which highlights the importance of training non-using network members on overdose response. Based on pilot data, the investigators propose expanding an overdose peer education intervention to focus on non-using network members. The intervention seeks to prepare network members to respond to an overdose and normalize discussions about overdose prevention planning between index PWUO and non-using network members. The intervention condition consists of 3 individual sessions focused on overdose prevention and response. This condition is designed to train index study participants to be Peer Educators. In addition to the three sessions, the non-drug using network member will be offered one session. The control condition is only 1 session focused on overdose prevention and response. Both intervention and control participants will invite social network members to take part in data collection activities

Eligibility Criteria:
Inclusion Criteria:

* self-reported illicit opioid use at least 2 times in the past two weeks;
* age 18 and older;
* living in the Baltimore metropolitan region;
* willing to engage in peer education; and
* having and willing to recruit at least one non-using network member.

Exclusion Criteria:

Participants without the cognitive ability to provide informed consent and have the physical ability to participate in in-person intervention sessions.
The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation

This study is focused on the brain mechanisms and peripheral biological correlates of two different forms of meditation--mindfulness-based and compassion/loving-kindness. Project 1 is focused on the impact of compassion/loving-kindness meditation on emotional reactivity and emotion regulation. Project 2 is focused on the neural and behavioral correlates of mindfulness meditation and attention and pain regulation. In addition, Project 2 will examine the relations between changes in oscillatory rhythms during meditation and attention and pain processing. Project 3 will examine the impact of meditation on spontaneous brain activity during sleep. This project will also examine the impact of intensive meditation on regional changes in slow wave activity during subsequent sleep. Each of these projects will be conducted on the same participants so that interrelations among the various measures collected in the different projects can be examined. We believe that this study will dramatically advance the understanding of the mechanisms by which meditation produces changes in behavioral and biological processes.


Eligibility Criteria:
Inclusion Criteria:

* MRI safe

Exclusion Criteria:

* Not available for scheduled visits or applicable interventions
* Current medical conditions that may affect outcome measures, including chronic inflammatory diseases, asthma, serious mental health diagnoses, chronic pain conditions, a personal history of seizures
* Regularly taking medications that may affect outcome measures, including pain medications, corticosteroids, immuno-suppressants, prescription sleep medications, psychotropic medications
* Alcohol or non-prescription drug problems
* Night-shift worker
* Diagnosed sleep disorder or habits, such as late bedtime, that would prevent enough sleep in the laboratory
* Previous training related to one of the two active interventions for meditation naive participants
* Unwillingness or inability to engage in intervention activities as determined by participant or their primary care physician
* Currently pregnant or planning on becoming pregnant in the next year
* Currently nursing
* Current IUD
Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Subject implanted with the original Silimed gel-filled implant.

Exclusion Criteria:

* MR imaging is not possible because of the following:
* Metal implant
* Battery activated stimulator
* Pregnancy
* Tattoos
* Body weight \>300 pounds
* History of metal fragments in the eye
* Any other contraindication to MR exam.
A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature

This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Boys are between 4 and 9 years of age and girls are between 4 and 8 years of age.
* Height \<-2 SD for chronological age.
* Growth velocity\<5.0 cm/yr.
* GH peak concentration ≥10.0 ng/mL in two different stimulation tests.
* The difference of bone age (BA) and chronological age (CA) is within -2 to +2.
* IGF-1 concentration is between -2 SDS to +2 SDS.
* Prepubertal Status(Tanner Stage I).
* Birth weight within the normal range.
* Growth hormone treatment-naive.
* Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.

Exclusion Criteria:

* Subjects with abnormal liver and kidney functions (ALT \> upper limit of normal value; Cr \> upper limit of normal value).
* Subjects are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
* Subjects with known highly allergic constitution or allergy to investigational product or its excipient.
* Subjects with systemic chronic disease and immune deficiency.
* Patients diagnosed with tumor.
* Patients with mental disease.
* Patients with other types of abnormal growth and development.

  1. Growth hormone deficiency (GHD) (confirmed by GH stimulation test);
  2. Turner syndrome (confirmed by karyotype test of girls);
  3. Noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (PTPN11) gene on chromosome 12 for half of the patients, for both male and female patients);
  4. Laron sydrome (confirmed by IGF-1 generation test);
  5. Small for gestational age ( the birth height or weight is below the tenth percentile or 2 SD, with catch-up growth uncompleted at 2 years old).
* Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
* Congenital skeletal abnormalities or scoliosis, claudication.
* Subjects with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes).
* Subjects with abnormal electrolyte, blood gas analysis (vein), creatine kinase.
* Subjects who took part in other clinical trials within 3 months.
* Subjects who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.).
* For patients with potential high tumor risks such as tumor markers exceed normal range and some other relative information, they may be excluded from the treatment.
* Other conditions which is inappropriate for this study in the opinion of the investigator.