cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C)

Regulation Focused Psychotherapy for Children (RFP-C) is a manualized, time-limited psychodynamic treatment for children with externalizing symptoms. RFP-C also holds the potential to treat a wider range of psychopathology, including comorbid internalizing conditions, because it aims to improve emotion regulation which is a transdiagnostic component of childhood mental health. This study will replicate previous findings supporting the efficacy of RFP-C. It will test the effectiveness of RFP-C in parallel groups via a pragmatic Randomized Controlled Trial (RCT) conducted at Istanbul Bilgi University's outpatient clinic in Istanbul, Turkey with a sample of 80 children with externalizing and comorbid internalizing/externalizing problems in comparison to a parental awareness and child social skills group. Primary outcomes will be child externalizing problems and oppositional defiance problems. The treatment's effectiveness and change mechanisms will be investigated both at the end of treatment (primary endpoint) and at 6-month follow-up (secondary endpoint). The project results will provide preliminary answers about the active ingredients of RFP-C, help improve therapeutic interventions, and design optimal treatments for externalizing problems.


Eligibility Criteria:
Inclusion Criteria:

1. Children must be between the ages of 6-12 years of age
2. Meet criteria for clinical levels of externalizing problems on the SDQ
3. Parent(s) able to attend four sessions of parent meetings

Exclusion Criteria:

1. Solely emotional problems and non-clinical problem levels (as assessed by the SDQ)
2. Primary diagnosis of psychosis or eating disorders (as assessed by KSADS-PL)
3. Risk for suicide and/or severe violence risk (as assessed by KSADS-PL)
4. Current enrollment in another psychosocial treatment
5. Intellectual disability or major developmental delay (e.g. moderate/severe autism spectrum disorder) (as assessed by KSADS-PL \& WASI)
6. Families with high risk of domestic abuse
7. Parents with acute psychosis (as assessed by SCID)
8. Parents with severe substance abuse and dependence (as assessed by SCID)
9. Parents with intellectual disability (as assessed by WASI)
10. Parents with acute risk of harm to self and others (as assessed by SCID)
Dislocated Stable Distal Both-Bone Forearm Fractures in Children

We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.

children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial.

After informed consent, a randomization between 2 kinds of treatment will be done: K-wire fixation or no K-wire fixation of the fracture after a stable reposition.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: the number of re-dislocations, re-operations, consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Eligibility Criteria:
Inclusion Criteria:

* both-bone forearm fracture
* distal
* dislocated
* stable after reposition
* age \< 16 years

Exclusion Criteria:

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)
* both fractures of type torus
Pulmonary MRI Using Ultra Short /Zero TE Sequences

Modern imaging modalities, especially magnetic resonance imaging (MRI) have greatly advanced in recent years. Through technical advances, proton-based magnetic resonance imaging (MRI) has steadily increased in use to assess pulmonary structures in the pediatric population especially in Europe. Such technical developments have advanced by overcoming rapid decaying of transverse relaxation time and cardiac/chest movement synchronization, showing MRI to be feasible with respect to morphological and functional assessment of pulmonary impairment, in chronic lung disease such as cystic fibrosis for disease progression and prediction of exacerbation. However pulmonary imaging with MRI has also been feasible to detect pulmonary nodules in malignancies (allowing for spatial resolution).

This prospective study will enable developing/ fine tuning for an optimized ultra-short echo/zero echo MRI sequence to enable pulmonary imaging with assessment of detailed lung structures which is important in patient with chronic lung disease. This will enable radiation sparing through x-ray and computed tomography, especially reduce the accumulation dose in long term follow up imaging of patients with chronic lung disease. Also, detailed pulmonary imaging enables more detailed imaging in comparison to the standard reference of care often using radiographs, can pick up disease prior to clinical symptoms, is a useful tool to assess treatment outcome and can sometimes even prevent chronic changes by early disease diagnosis and rapid treatment. This is of particular interest in patients with chronic lung disease, such as cystic fibrosis, but also other congenital lung diseases such as congenital pulmonary airway malformation (CPAM) or malignant diseases which will otherwise have a second CT imaging to assess the lung.

The investigators will recruit healthy volunteers to assess the available MR sequences on the 1.5 T MRI scanner at the IWK health Centre in the Department of Diagnostic Imaging and either fine tune/modify the existing protocol with the help of the MRI technologist and application specialists or build a new sequence according to the most recent literature. The aim is to recruit 15 patients of different age group (aged 3- 18 years old) to assure a robust imaging protocol for all age groups. Especially, the preschool age group can be more challenging due to increased cardiac and respiratory motion, but also the understanding of the diagnostic imaging with guidance of the in house child life support as well as parental guidance and support, the possibility to watch a video on the MRI scanner to distract the patient as best as possible since the aim is to conduct the short pulmonary MRI protocol without the need for sedation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants (without prior history of pulmonary disease)
* Ages 3 - 18 years old

Exclusion Criteria:

* prior history of pulmonary disease
* implants
* surgeries
* pregnancy
* metal devices
* braces
* anything that would exclude them from taking an MRI
Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying temozolomide to see how well it works in treating patients with mycosis fungoides or Sezary syndrome that has not responded to previous treatment.

OBJECTIVES:

* Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome.
* Determine the toxic effects of this drug in these patients.
* Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed mycosis fungoides or Sezary syndrome

  * Stage IB-IVB disease
  * Must have failed at least one prior systemic therapy
  * Generalized erythroderma allowed
* Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only

  * Prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2 OR
* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.2 mg/dL
* SGOT or SGPT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No New York Heart Association class III or IV heart disease
* No clinically significant peripheral venous insufficiency

Other:

* HIV negative
* No poorly controlled diabetes mellitus
* No acute infection requiring IV antibiotics
* No other medical condition that would prevent ingestion or absorption of oral medication
* No other neoplasm within the past 5 years except curatively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy and recovered
* No concurrent growth factors or epoetin alfa

Chemotherapy:

* At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

* At least 4 weeks since prior topical steroids

Radiotherapy:

* See Disease Characteristics
* At least 2 weeks since prior radiotherapy for local control or palliation and recovered

Surgery:

* Recovered from prior major surgery

Other:

* No other concurrent investigational drugs
Extension for Menopause Sample Collection

This study will provide urine samples from women going through the menopause transition in order to maintain the SPD sample bank.

Symptom information and cycle length will also be recorded to observe how these change through the menopause transition.

This is an extension to a previous sample collection (Protocol-1326) where additional samples will be collected from the women who continue to go through the menopausal transition (i.e. are not post-menopausal).

Three sets of 10 consecutive daily urine samples will be collected at three timepoints (month 0, month 6 and month 12).

Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚C until required.

Eligibility Criteria:
Inclusion Criteria:

* Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326

Exclusion Criteria:

* Post-menopausal volunteers (12 months since last menstrual period)
* Use of hormone replacement therapy (HRT)
* Use of hormone contraception
* Hysterectomy and/or oophorectomy
* Pregnant or breast feeding
* Other medical reason for amenorrhea (absence of menstruation)
A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis

The goal of this observational study is to compare patient outcomes between the groups of patients admitted before and after the full implementation of the novel surgical strategy in patients with necrotizing pancreatitis. The main question it aims to answer are:

• the efficacy and safety of the novel surgical strategy To assess the efficacy and safety of the novel surgical strategy, all included patients were divided into two groups according to the timing of receiving treatment: 1) the early period group: patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies; and 2) the late period group: patients admitted during and after January 2021 received the complete novel surgical strategy.


Eligibility Criteria:
Inclusion Criteria:

Consecutive patients older than 18 years with necrotizing pancreatitis were included.

Exclusion Criteria:

Patients who met one or more of the following criteria were excluded: (1) had a past medical history of acute pancreatitis; (2) had drainage or surgery for pancreatic necrosis in other hospitals before admission to our institute; and (3) did not complete the treatment strategy owing to nonmedical reasons.
Surgical Management for Suburethral Slings

This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.

The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.
4. Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion Criteria:

1. Patient has an associated or suspected neurological disease.
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
5. The subject has current urinary tract infection.
Nourishing the Community Through Culinary Medicine

The purpose of this study is to adapt existing Nourish Program curriculum for synchronous virtual delivery,to implement adapted virtual Culinary Medicine (CM)curriculum among target population, to assess if program participation improves participant dietary behaviors, nutrition knowledge, and cooking skills and behaviors above standard of care, to assess if program participation improves patient levels of HbA1c, Body Mass Index, Blood Pressure, HDL, LDL and Triglycerides above standard of care and to determine the feasibility and reproducibility of virtual synchronous CM classes in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes and glycosylated hemoglobin (HbA1c) \>7.0
* receiving care at Sanitas Medical Center clinics in August 2021 - August 2023
* English speaking or Spanish speaking.

Exclusion Criteria:

* Patients without the technological support needed to participate in the program (e.g., reliable internet and device - cell phone, tablet or laptop);
* Patients with terminal or late-stage conditions (e.g., advanced stage chronic kidney disease);
* Patients with uncontrolled mental disorder that interferes with participation in active programming;
* Patients with physical impairment that interferes with participation in active programming
Technology-Assisted Implementation of a Mobile Health Program for Serious Mental Illness

The goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. The main question this research aims to answer is whether patients obtain similar outcomes to previous FOCUS studies when using FOCUS with clinicians trained on a newly developed digital training platform.

Participants will be asked to use the FOCUS smartphone application and receive mobile health coaching from clinicians who have been trained using the digital training platform.

Widely available technologies can help overcome the capacity constraints of brick-and mortar community mental health centers (CMHCs), expand the reach of evidence-based mental healthcare, and provide much needed illness management skills and resources for people with serious mental illness (SMI). With funding from the NIMH, PCORI, and CMMI, the investigators developed and tested FOCUS--a multi-modal smartphone illness self-management system that is shown to be feasible, usable, highly engaging, and effective among people with SMI.

The current project facilitates translation of FOCUS into routine care at CMHCs using implementation strategies of practice facilitation, implementation resource teams, and the development of accessible training materials. The investigators are proposing a technology-assisted training and implementation model designed to address system needs that have emerged since the COVID-19 pandemic and enhance sustainability of FOCUS at CMHCs. The new tools and strategies used in the project will facilitate improved training and implementation in new treatment settings, reaching a far larger number of patients who otherwise would not receive FOCUS and improving the sustainability of this tool, even in high turnover settings.

This trial is a prospective multi-site site single arm implementation study in three community mental health centers located in New Hampshire and Missouri. The investigators will develop and evaluate a digital training platform to aid in the implementation of FOCUS and utilize the platform to improve the availability, reach, impact, and sustainability of the FOCUS intervention in CMHCs. Patient participants will utilize FOCUS for a 12-week period at CMHCs where clinicians have been trained using the digital training platform. Investigators will compare patient outcomes to results of previous trials where clinicians were trained using more traditional, in-person training and support methods.

Eligibility Criteria:
Inclusion Criteria:

* Chart diagnosis of a serious mental illness (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder)
* 18 years of age or older
* English-speaking
* Have access to a smartphone that can support FOCUS

Exclusion Criteria:

• Plan to move or discontinue services at the participating community mental health center in the next three months
Developing Resilience Skills and Social Competence in Youth in a School Setting

Our study aimed to answer the question: Can a resilience-based intervention improve the psychosocial and educational outcomes of students with psychosocial difficulties? We examined the effectiveness of a resilience-based group intervention, the Resilience Builder Program® (RBP), with students in low-SES school settings to determine if this treatment improves psychosocial and educational outcomes.

Enhancing resilience is valuable to youth from economically marginalized communities given that they often face greater challenges and hardships than their peers from more affluent communities.

Efforts to increase resilience skills in these youth are hampered because they disproportionately encounter barriers in access to mental health interventions. Implementing school-based services may be optimal to address these inequalities. This project explores the effectiveness of a school-based group intervention (the Resilience Builder Program®) related to resilience and academic functioning in a sample of children from economically marginalized communities. Students (N = 169) with social-emotional difficulties were recruited from five elementary schools and randomly assigned to participate in the Resilience Builder Program® (RBP) immediately or following a semester delay. Participants, their parents, and teachers completed measures of resilience and academic functioning. Repeated-measures analysis of variance compares groups across time (pre-, post-intervention) on psychosocial and academic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* psychosocial deficits

Exclusion Criteria:

* psychosis
* extreme aggression
* autism
Genetic Susceptibility to Bladder Cancer

This clinical research study will identify biologic and lifestyle factors which increase a person's risk of developing specific cancer. Researchers propose to conduct a case-control study examining interindividual differences in susceptibility to tobacco carcinogenesis as predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis and this will include studies of the genetic modulation of carcinogen activation and detoxification and of chromosome sensitivity to tobacco mutagens.

Researchers propose to conduct a case-control study examining interindividual differences in susceptibility to tobacco carcinogenesis as predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis and this will include studies of the genetic modulation of carcinogen activation and detoxification and of chromosome sensitivity to tobacco mutagens.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a histologically confirmed diagnosis of superficial or muscle-invasive bladder cancer
* Subject is a Texas resident.
* Subject can understand English or a qualified translator is available for the interview.
* Subjects of any age, gender, or ethnicity are eligible to participate in the study.
* Subject consents to participate in the study.

Exclusion Criteria:

* Subject has had prior treatment with systemic chemotherapy or radiotherapy in the past 6 months.
* Subject has been diagnosed with superficial or muscle-invasive bladder cancer more than twelve months ago.
Long-term Follow-up After Surgical Treatment for GERD (Gastroesophageal Reflux Disease)

10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires.

Long-term follow up with questionnaires after surgery with laparoscopic 270 degrees posterial partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux disease.

Quality of Life SF-36; physical and mental component scores. GSRS, five dimensions of abdominal symptoms; reflux, abdominal pain, indigestion, obstipation and diarrhea.

Reflux specificquestionnaries on various issues of reflux disease and frequency issues about reflux disease problems.

Eligibility Criteria:
Inclusion Criteria:

Gastroesophageal Reflux 10 years follow-up after surgery informed consent

Exclusion Criteria:

Deceased patients patients who declined participation
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.


Eligibility Criteria:
Main inclusion criteria:

* Patients with asthma disease
* Written informed consent
* Patients who completed the 24-week evaluation of study APTA-2217-05

Main exclusion criteria:

* % FEV1.0 \< 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05
* Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days
* Serious diseases