cyrilzakka/clinical-trials huggingface dataset:
Evaluating a Peer-Facilitated Skills-Based Intervention for Caregivers of Concurrent Disordered Youth

Families of adolescents struggling with comorbid mental illness and addiction problems typically experience considerable emotional, financial and social burdens. Concurrent disorders (CDs) within families contribute to added stress and interpersonal conflict, as well as disrupt normal routines such as social and occupational activities. Despite the difficulties associated with being a family member of youth with CD, current mental health and addictions practices neglect to address this population. The overall purpose of this project is to assess the feasibility and clinical effectiveness of a Dialectical Behaviour Therapy skills (DBT) based training group for families of youth with CDs. The following main hypothesis will be examined: Family members of youth with concurrent disorders who participate in a 12-week skills group led by therapists and/or peer facilitators will show reduced caregiver burden and parenting stress from pre to post treatment.

This study is designed to assess whether a 12-week skills based intervention is feasible and effective in addressing issues experienced by families of youth with concurrent mental health and addiction problems. Eligible subjects will be invited to participate in the following intervention:

The intervention is based on a DBT skills training model for families, the Family Connections© model. This model was originally developed for families of individuals with Borderline Personality Disorder (BPD) and later adapted for this study for CD.The Family Connections model is a 12-week (90-minute once-weekly sessions) skills training group designed to be led by therapists and/or peer support facilitators. The family groups in this study will be facilitated by two family members with experience being part of a family group and training and they will work with or without a professional therapist. Groups will consist of a maximum of 16 family members. Family members will receive a manual which describes the skills to be covered.

The skills-training will be delivered in two cities in collaboration with two organizations: CAMH, Toronto and the Children's Centre Thunder Bay. Participants will be recruited through advertisements posted on flyers and relevant websites.

The family intervention will evaluate change over time and use a mixed between/within subject, pre/post and follow-up design. Assessments will occur at baseline, mid-skills training (4 weeks), after 12-week skills training (post intervention), and at 12-week post intervention follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* literacy in English,
* are family members of an adolescent scoring in the clinical range on at least one subscale of the Child Behavior Checklist (CBCL)

Exclusion Criteria:

* has adolescent children participating in the sister youth intervention protocol #069-2011.
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects
* Age ≥ 18 years, \<85 years
* Subject has failed standard conservative therapy for fecal incontinence (at least 6 months)
* Subject is a surgical candidate
* Subject is willing and able to cooperate with follow-up examinations
* Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.

Exclusion Criteria:

* Treatment with another investigational drug or investigational device
* Unable to understand study requirements or is unable to comply with follow-up schedule
* Contraindicated according to the instruction for use of the device
* Pregnancy or nursing, or plans to become pregnant
* History of significant obstructed defecation or other significant chronic defecatory motility disorders
* Current, external full thickness rectal prolapse or vaginal prolapse
* Inflammatory Bowel Disease
* Irritable Bowel Syndrome
* Systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)
* Active pelvic infection
* Chronic diarrhea
* Medical history of anal, rectal, or colon cancer
* Prior anterior resection of the rectum
* Medical history of pelvic radiation therapy
* Significant scarring of the recto-vaginal septum, a permanent implant in the rectovaginal septum, or a history of recto-vaginal fistula
* Previous anorectal posterior compartment surgery
* History of complex anal fistula
Study of Donated Amnion, Fetal Placental Membrane, as Skin Substitute for Burn Patients

Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious.

Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Pregnant, delivery expected within the month

Exclusion Criteria:

* Known history of hepatitis, HIV, or active transmissable diseases
DNA Repair in Patients With Stable Angina.

Markers of DNA damage and repair are present in both atherosclerotic plaques and peripheral blood mononuclear cells of patients with coronary artery disease. A positive correlation has been observed between the level of DNA damage and the severity of atherosclerotic lesions, as well as atherogenic risk factors such as smoking, hypertension and hyperlipidaemia. A number of in-vitro studies have implicated defective DNA repair in the development and progression of atherosclerotic lesions. In mouse models of atherosclerosis, the DNA repair signalling cascade has been shown to be amenable to pharmacological intervention and overexpression of specific repair proteins attenuate the development of atherosclerotic plaques. However, data regarding the role of DNA repair in the pathogenesis of atherosclerosis in humans are lacking. We have preliminary data indicating reduced DNA repair activity in patients with stable angina. This study will determine the molecular basis and the biological consequences of this observation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Ability to provide written informed consent

Exclusion Criteria:

* Age ≥ 80 years
* Inability to provide written informed consent
* Presentation with an acute coronary syndrome
* Severe valvular heart disease
* Hypertrophic cardiomyopathy
* Left ventricular ejection fraction ≤ 35%
* Prior coronary revascularisation (surgical or percutaneous)
* Diabetes Mellitus
* Clinical evidence of peripheral vascular disease
* Prior history of cerebrovascular disease
* Malignancy
* Active inflammatory disorders (e.g. rheumatoid arthritis/connective tissue disorder)
* Renal impairment eGFR \<60ml/min/1.73m2
* Anaemia (Hb \<100g/dL)
EVALUATION of GINGIVAL CREVICULAR FLUID and SERUM ASPROSIN LEVELS in OBESE and NORMAL-WEIGHT INDIVIDUALS with PERIODONTITIS

Obesity and periodontitis are chronic inflammatory diseases that share common pathological mechanisms. Asprosin, a novel adipokine discovered in 2016, has not been extensively studied in relation to periodontal tissues. In our study, we investigate the levels of asprosin in both serum and gingival crevicular fluid of patients with obesity and those of normal weight who have periodontitis. Additionally, our research aims to clarify the pathophysiological mechanisms linking periodontitis and obesity by examining local and systemic levels of TNF-α, IL-6, and asprosin, alongside clinical periodontal parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Willingness to participate in the study.
2. Weight classification:

   * Obese individuals: Body mass index (BMI) of 30 kg/m² or higher.
   * Normal-weight individuals: BMI between 18.5 and 24.9 kg/m².
3. Periodontal health status:

   * Bleeding on probing: less than 10%.
   * Periodontal pocket depth: less than 3 mm.
   * No sites showing attachment loss or alveolar bone loss on radiographs.
4. For individuals with periodontitis:

   * At least two non-adjacent teeth must show signs of interdental attachment loss.
   * Periodontal pocket depth greater than 3 mm.

Exclusion Criteria:

1. Individuals who have received periodontal therapy, any oral decontamination treatment, or antibiotics or steroids in the six months prior to the start of the study.
2. Individuals who are pregnant or breastfeeding.
3. Individuals diagnosed with rheumatoid arthritis or lupus erythematosus.
4. Individuals with a medical history of radiation or cancer therapy.
5. Patients with diabetes, defined by:

   * Hemoglobin A1c (HbA1c) level greater than 6.5%.
   * Fasting blood glucose (FBG) greater than 126 mg/dL.
   * An abnormal oral glucose tolerance test (OGTT).
6. Smokers.
Covered Stents in Treatment of Coronary Artery Perforation

Covered stents have been mainly used for treatment of potentially life-threatening coronary artery perforation and coronary artery aneurysm. Prior studies suggest that the use of covered stents improves event-free survival, enabling a life-threatening situation to be managed without emergency surgery and with significantly reduced rates of mortality, cardiac tamponade, and major adverse cardiac events. Although the devices are used for a long time, very limited study has described procedural-related outcomes with this specific technology. We therefore want to report procedural, in-hospital and long term outcomes among patients treated with the covered stents.


Eligibility Criteria:
Inclusion Criteria:

* Iatrogenic, peri-PCI CAP treated with covered stent implantation

Exclusion Criteria:

* CAP caused due to other cause than PCI
* PCI of other vascular territories during the same procedure
Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin

The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes.

Non-randomized, retrospective, observational study

Eligibility Criteria:
Inclusion Criteria:

Patients will be enrolled in the study if they fulfill the following three inclusion criteria:

1. Protocol criteria for HAP/VAP: Criteria for making a correct diagnosis of HAP will be met if the patient develops a new or progressive pulmonary infiltrate associated with at least two of the following: new or increased respiratory symptomatology (cough, sputum or tracheal secretions, shortness of breath), fever or hypothermia, leukocytosis, left shift, or leukopenia, or deterioration of pulmonary function.
2. Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP
3. Treatment of MRSA HAP/VAP with either vancomycin or linezolid with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm

Exclusion Criteria:

Patients not meeting enrollment criteria.
International Study of Biofield Therapy

Participants from 14 different countries received a single session of biofield therapy (Okada Purifying Therapy) lasting 30 minutes or longer from the volunteer practitioners. Before and after the therapy, they reported the severity of physical pain, anxiety/depression, dizziness/palpitation, and overall symptoms. The team compared the effectiveness/safety of biofield therapy between countries and analyzed the factors associated with the outcomes.

Participants aged 16 or older from 14 different countries (Japan, USA, Argentina, Brazil, Chile, Mexico, Peru, Taiwan, Thai, South Korea, Belgium, France, Portugal, and Spain) received a single session of biofield therapy (Okada Purifying Therapy) lasting 30 minutes or longer from the volunteer practitioners in their country of residence. Before and after the intervention, they reported each severity level of physical pain, anxiety/depression, dizziness/palpitation, and overall symptoms. The team compared the improvement/exacerbation rate of a single session of biofield therapy between the countries, and examined the adjusted odds ratio of the variables associated with the changes in each category of symptoms in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals who agreed to receive a single session of biofield therapy for 30 minutes or longer from the volunteer investigators.
2. Individuals who were able to self-evaluate the change of their symptoms.
3. Individuals who were competent to answer the questionnaires.
4. Individuals who were aged 16 or older.

Exclusion Criteria:

* no specific exclusion criteria
Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.

Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.

Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.

Intervention: Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out.

Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B disease.
* Over 18 years.
* Diagnosed with hemophilic arthropathy of the ankle (by clinical assessment with the Hemophilia Joint Health Score).
* On prophylactic or on demand treatment with FVIII / FIX concentrates.

Exclusion Criteria:

* Patients without ambulation ability.
* Patients with inhibitors (antibodies to FVIII or FIX).
* Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests.
* Not signed the informed consent document.
Relation of the Area of Cerclage With Preterm Birth

This study is planned prospectively in pregnancies who applied to Etlik Zübeyde Hanım Women's Health Care, Training and Research Hospital which is a teritiary hospital with 15.000 births anually, between January 2022 and January 2023. Cerclage treatment will be performed with the McDonald technique (the type of cerclage suture will be mersilene) between the 16-23 weeks of gestation in pregnant women with a diagnosis of cervical insufficiency based on the history , physical examination or ultrasound findings according to ACOG. The investigators will measure cerclage area after cerclage treatment (within 0-4 weeks) and different parameters besides it by transvaginal ultrasound. It will be whether the collected data is related to the incidence of preterm birth.

The parameters that will be measured with transvaginal ultrasound are:

* Cerclage area in the axial plane of the cervix
* Angle between anterior uterine wall and internal os
* Angle between anterior uterine wall and external os
* Anterior and posterior cervical widht at level of stitch
* Anterior and posterior stitch depth (stitch to canal )
* Cervical length above and below cerclage stitch

Before the data collection phase ,the required sample number for the research was determined using the G\*power (Faul, Erdfelder, Buchner, \& Lang, 2009) 3.1 program. When the alpha level is .05 and the power is %95 , the total number of samples was found o be 22.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy between 16-23 weeks of gestation and between the ages of 18-45
* According to ACOG based on history (Having one or more painless abortions between 16-22 weeks of gestation , a history of cerclage
* According to ACOG based on physical examination ( fetal membranes prolapsed from endocervical canal or not, cervical dilation present )
* Accoding to ACOG based on ultrasound examination ( if there is no previous history of preterm birth , if the cervical length is 10mm or less, if the cervical length is less than 25mm with a history of preterm birth )

Exclusion Criteria:

* Multiple pregnancies
* Pregnant women with premature rupture of membranes
* Pregnant women with uterine anomalies
* Pregnant women with fetal anomalies
* Pregnant women with Gestational diabetes mellitus, Chronic or gestational hypertension , fetal growth restriction , oligohydroamnios or polihydroamnios
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.

This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.

Eligibility Criteria:
Inclusion Criteria:

1. Aortic aneurysm involving the visceral vessels requiring treatment
2. Adequate access for TAMBE Device components
3. Appropriate aortic anatomy to receive the TAMBE Device
4. Age ≥ 18 years at the time of informed consent signature
5. Male or infertile female
6. The patient is considered high risk for open repair as deemed by the treating physician
7. Capable of complying with protocol requirements, including follow-up
8. An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

1. Prior aortic surgery
2. Ruptured or leaking aortic aneurysm
3. Aneurysmal dilatation due to chronic aortic dissection
4. Infected aorta
5. Mycotic aneurysm
6. Life expectancy \<2 years
7. Myocardial infarction or stroke within 6 weeks of treatment
8. Systemic infection which may increase risk of endovascular graft infection
9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
10. Participation in another drug or medical device study within 1 year of study enrollment
11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
13. Known sensitivities or allergies to the device materials
14. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
15. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
16. Renal Insufficiency Note: Additional Exclusion Criteria may apply
Sleep Quality, Job Satisfaction, Quality of Life, Occupational Burnout Levels in Individuals

The aim of this study is to compare sleep quality, job satisfaction, quality of life, occupational burnout levels among individuals who do or do not do exercise.

Physical activity is very important in terms of healthy growth and development, protection from unwanted bad habits, socialization, protection from chronic diseases, and providing an active aging period. At the same time it increases the quality of life throughout life.Especially in individuals who work in sitting position, the risk of physical activity decrease due to intensive working hours, time constraint, social insufficiency is even more risk.Therefore, it is aimed to compare sleep quality, job satisfaction, quality of life, occupational burnout levels among individuals who do or do not do exercise.

Eligibility Criteria:
Inclusion Criteria:

Healthy individuals;

* Between the ages of 25-65 years,
* Those who are in the profession group working for at least 8 hours,
* who do the same job for at least 5 years,
* Individuals with no doctor-diagnosed skeletal system disease will be included.

Exclusion Criteria:

Individuals;

* Below the age of 25 years and above the age of 65 years,
* Individuals with doctor-diagnosed skeletal system disease will be excluded.
Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue

This retrospective study is to collect and analyze the data from medical records within the period that breast cancer patient is receiving NHI-covered CRF treatment. This study will evaluate the clinical use, fatigue improvement, and treatment satisfaction of breast cancer patients with CRF treatment.

This is a single arm, multicenter, and retrospective study. About 200 breast cancer patients' data from medical records are expected to collect and analyze in this retrospective study. The data collection from medical records of breast cancer patients who approved to use NHI to pay for CRF treatment drug will include the demographic information, disease characteristics and cancer treatment information, fatigue score by visual analog fatigue scale, fatigue clinical global impression, CRF pharmacological treatment record, hematological lab data, ECOG, cancer drug compliance record, overall clinical evaluation after CRF treatment by physicians and patient's expectation to continue CRF treatment etc. Data of three return visits (i.e. at the time of before CRF treatment, after 4 times of CRF treatment and CRF treatment completed) per patient will be collected from medical records to analysis within the period that patient is receiving NHI-covered CRF treatment.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug

Exclusion Criteria:

* N/A