cyrilzakka/clinical-trials huggingface dataset:
Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors

This study aims to test the potential of group metacognitive therapy in alleviating emotional distress in cancer survivors. The investigators aim to find out if a group based approach is acceptable to patients and feasible to deliver in a routine clinical health psychology service.

Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. Current pharmacological treatments are not very effective and are not well tolerated by patients, who prefer psychological treatments. However, meta-analyses of well-controlled studies of psychological treatments indicate that these achieve only small effect sizes. Reflecting this limited efficacy in the face of the need for psychological treatment, the National Cancer Survivorship Research Initiative highlighted development and evaluation of practically feasible interventions for depression and anxiety in cancer survivors as an urgent research priority. It is recognised that current influential psychotherapeutic approaches need to be modified to meet the specific needs associated with cancer. However modifications have been pragmatic rather than theory-driven and have not improved efficacy.

The study addresses the stages of 'development' and 'piloting and feasibility' in Medical Research Council guidance on intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of metacognitive therapy (MCT) in other settings and promising preliminary evidence of applicability in cancer. The investigators will conduct a phase I open trial to test the potential efficacy of group MCT in cancer survivors and the hypothesised causal metacognitive mechanisms underpinning treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis at least 6 months previously
* A score of at least 15 on the Total scale score of the Hospital Anxiety and Depression Scale (HADS)
* Sufficient understanding of English to consent and engage in therapy
* Stable on, or free from, psychotropic medication
* Minimum of 18 years old

Exclusion Criteria:

* History of psychotic disorder, learning disability, or organic mental disorder
* Risk of self-harm or suicide warranting immediate intervention
* In palliative phase of treatment
* Being considered for risk-reducing or reconstructive surgery within 1 year
* Concurrent psychological intervention for emotional distress
* Cognitive impairment precluding informed consent or participation
* Undergoing acute medical treatment (e.g. chemotherapy, radiotherapy)
* Current drug/alcohol abuse
Pogejiuxin Decoction Combination of Conventional Western Medicine for the Treatment of Heart Failure with Preserved Ejection Fraction

The objective of this study is to investigate the potential of Pogejiuxin Decoction to enhance the efficacy and mitigate the adverse effects associated with conventional treatment in patients with heart failure and preserved ejection fraction(HFpEF), thereby establishing a foundation for its clinical application in managing HFpEF.

This study recruits patients with heart failure and preserved ejection fraction(HFpEF), randomly assigning them to either the intervention group or the control group. The control group will receive the standard heart failure treatment protocol, while the intervention group will take Pogejiuxin Decoction orally in addition to the control group\&amp;#39;s treatment. The study will compare the degree of symptom improvement, relevant auxiliary examination indicators, traditional Chinese medicine syndrome scores, and adverse reaction differences between the two groups, providing a clinical basis for the further enhancement of HFpEF treatment with the combination of Pogejiuxin Decoction and conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatients with heart failure who meet the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Heart Failure 2018 and have grade II-IV heart function;
2. Inpatients who meet the diagnostic criteria for heart failure in TCM Internal Medicine(2012 edition);
3. Patients who meet the diagnostic criteria for HfpEF by heart color ultrasound;
4. Patients who sign informed consent and take the test voluntarily.

Exclusion Criteria:

1. Patients who do not meet the inclusion criteria.
2. Patients with severe hepatic or renal impairment (ALT/AST \&gt; 3 times the upper limit or serum creatinine levels \&gt; 265 umol/L or serum potassium \&gt; 5.5 mmol/L).
3. Patients with severe cerebrovascular, hematological, neurological diseases, or malignant tumors that require special treatment during the study period and may affect the judgment of heart failure treatment efficacy.
4. Patients with severe pneumonia, serious infections, or acute exacerbation of chronic obstructive pulmonary disease.
5. Pregnant or nursing women.
6. Patients with psychiatric abnormalities or unwilling to cooperate.
7. Patients allergic to the components of Pogejiuxin Decoction.
8. Patients undergoing coronary intervention, cardiac pacemaker implantation, placement of cardiac assist devices, or other treatments during the trial period.
Taichi for Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)

The present study is a randomized pilot study, overweight/obese adolescent and young PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile and metabolic profile will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 19 and 35 years;
* Diagnosis of PCOS according to the modified Rotterdam criteria;
* 2 years after menarche;
* Body mass index (BMI) equal to or greater than 23 kg/m\*m.

Exclusion Criteria:

* Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
* Patients with other endocrine disorder including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
* Patients with known severe organ dysfunction or mental illness.
Turkish Validity and Reliability Study of Hospital for Special Surgery Shoulder Surgery Expectations Survey

This study aims to evaluate the Turkish validity and reliability of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. By translating the original survey into Turkish and administering it to a sample of patients who have undergone shoulder surgery, the research seeks to determine whether the survey maintains its accuracy and consistency in the Turkish context. The study will involve statistical analyses to assess the survey's reliability, internal consistency, and construct validity, ensuring that the tool is culturally appropriate and effective for Turkish-speaking patients.

The process begins with the translation of the original survey into Turkish, followed by a back-translation to ensure accuracy. The adapted survey is then reviewed by a panel of experts to confirm its cultural relevance and clarity.

Once finalized, the Turkish version of the survey is administered to a cohort of Turkish-speaking patients who have undergone shoulder surgery. Participants complete the survey at a designated time point, typically postoperatively, to assess their expectations and outcomes related to the surgery. The collected data are then analyzed to evaluate the survey's reliability (internal consistency, test-retest reliability) and validity (content, construct, and criterion validity) within this specific population.

The goal of the intervention is to ensure that the Turkish version of the survey is a reliable and valid tool for assessing patient expectations and satisfaction following shoulder surgery, making it suitable for use in clinical practice and research in Turkey.

Eligibility Criteria:
Inclusion Criteria:

* Underwent Shoulder Surgery
* Native Turkish Speakers
* Adults (18 years and older)
* Consent to Participate

Exclusion Criteria:

-
Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder

The specific aim of this cluster-randomized (site) comparative effectiveness research study is to determine whether children who are (1) 5-12 years of age, (2) cared for in ePROS practices or clinics using an electronic health record (EHR), (3) have attention-deficit hyperactivity disorder (ADHD), and (4) are to receive treatment with stimulant medication for the first time in these practices, have superior clinical outcomes if their clinicians have access to an EHR-guided clinical decision support system (intervention group) than if their clinicians have no such access (control group).

In this cluster (site)-randomized trial of clinical decision support for ADHD medication titration, clinicians caring for children with ADHD whose families are initiating stimulant medication at that practice will be followed.

Two groups will be compared; an intervention group, which will receive the intervention-the clinical decision support (CDS)--, and a control group, who will not receive CDS. Over a 6-month period, the CDS will support guideline-based medication titration to achieve optimal symptom control with minimal side effects. The study will track the care delivered to affected children by the practitioners and will assess the endpoints of symptom reduction and side effects. There will also be a sub-study within the larger study which will give the team a better understanding about the pros and cons of consenting parents over the phone.

Eligibility Criteria:
Practice Eligibility Criteria

* Willing to offer the possibility of study enrollment to their patients who have ADHD
* Willing to use the Vanderbilt Assessment Rating Scale to assess and potentially, to monitor ADHD for study subjects
* Utilize Integrated Health Connect as a means to collect the Vanderbilt Assessment Rating Scale
* Use point-of-care reports for subjects enrolled in the study.

Patient Eligibility Criteria

* The child must be between the ages of 5-12 years old
* The child must be starting stimulant medication for the first time
* Parent must be able to speak and read English
* The child must not be diagnosed with a current manic episode, a psychotic disorder, or a pervasive developmental disorder (e.g. autism, Asperger's, Rett's disorder)
* The child must not have reported suicidality or have conduct disorder, per parent/guardian report
Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression

The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of reliability, to test whether the generic version has similar psychometric performance to the original, and to extend generalizability of the findings to younger adults.

The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of psychometric performance of the scale, compare performance of different wording for items, and to extend generalizability of the findings to younger adults.

Subjects are randomly assigned to one of the two versions of the Shared Decision Making Process scale and complete a set of measures regarding their experiences with decision making for depression, demographics, and health status. A subset of respondents will complete the Shared Decision Making Process scale and selected other items again 1 week later to examine short term test-retest reliability.

Staff will work with a national sampling firm to recruit subjects and obtain 500 responses to the baseline survey (n=250 for each version) and a subset will complete a retest survey (n=200; 50 from each age and survey type group). Eligible subjects are adults aged 18-75 who talked with a health care provider about treatment for depression in the preceding 12 months. The sample is not a national probability sample; however, the recruitment efforts will ensure about 50% of respondents aged 18-39 and 50% aged 40-75, and to ensure at least 25% of the sample is racial/ethnic minorities (Black or African American, Asian, Hispanic or Latino).

The investigators will examine validity and reliability of the different versions. The sample size was determined to ensure sufficient power to detect differences in key subgroups, including age (younger adults vs. older adults) and version (A vs. B). To detect a difference of about 0.33 standard deviations at 0.05 significance with 80% power would require 125 per group.

Eligibility Criteria:
Inclusion Criteria:

* Must have spoken to a healthcare provider about treatment for depression in the past 12 months
* Must have started or stopped medication for depression between January 2018 and their surveyed date.

Exclusion Criteria:

* None
System Accuracy of the Blood Glucose Monitor for Personal Use BG-709b

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

This study assesses the system accuracy the blood glucose monitoring systems for personal use BG-709b as outlined in DIN EN ISO 15197:2015.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent
MUTYH-associated Polyposis

This is single-center, prospective, non-randomized study

The study will include patients with more than 3 polyps, without mutations in the APC gene. Using molecular genetic research methods (polymerase chain reaction, SSCP, sequencing by Sanger method) mutations in the MutYH gene will be studied. For all patients with mutations in the MutYH gene, an optimal diagnostic algorithm will be developed. The significance of monoallelic mutations in the MutYH gene will be determined. Clinical monitoring will be defined. Optimal amount of surgical intervention will be suggested.

Eligibility Criteria:
Inclusion Criteria:

1. patients with multiple colon polyps (n polyps = 4+)
2. patient consent to participate in the study

Exclusion Criteria:

1. presence of mutations in the APC gene
2. patient's refusal to participate in the study
A Mindfulness-Based Intervention to Improve CPAP

The main purpose of this study is to assess the effectiveness of a mindfulness-based intervention in improving CPAP use compared to online peer support


Eligibility Criteria:
Inclusion Criteria:

* Adolescent age (13-18 years)
* Confirmed diagnosis of moderate or severe OSA
* Adolescent should have the capacity to consent themselves

Exclusion Criteria:

* Known developmental delay such that they are not able to participate in the study;
* Neuromuscular disorders
* Central sleep apnea
* Known diagnosis of severe psychiatric illnesses (e.g. suicidal ideation)
* Limited knowledge and proficiency in English to complete the study as judged by the clinical team
PMCF Study for Peripheral Arteries Above the Knee (ATK)

The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is \>18 years old at conduction of the procedure.
2. Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.
3. Target Lesion is located in the ilio-femoropopliteal vessels.

Exclusion Criteria:

1. Anatomy or size of vessels that did not allow appropriate usage of the devices, following IFU of the devices.
2. Known contraindication and/or allergy to (a component of) the device as described in the IFU of the devices.
3. Women who were pregnant or lactating at the time of the procedure.
4. Life expectancy of less than 12 months at the time of procedure.
5. Any patient who was hemodynamically unstable at onset of procedure.
Immune Modulation by Ischemic Pre-conditioning in Healthy Individuals: Intracellular Signalling in Regulatory Cells

The aim of the study is to investigate how phosphorylation of STAT3, p38 mitogen-activated protein kinase (MAPK), extracellular signal-regulated kinase (ERK) and protein kinase B (AKT) reacts to remote ischemic conditioning (rIC) in healthy humans, which could point to mechanisms by which rIC may protect against ischemia-reperfusion injury (IRI), and if rIC affects immune reactivity.

In rIC brief episodes of non-lethal ischemia and reperfusion in one vascular bed, tissue or organ, has shown to have protective effects against IRI in various organs. The protective effect of rIC seems convincing, but to date it is not clear which mechanisms give rIC its effects, and why effects are absent in some situations. Effects of rIC on the immune system are also not clear, but important if rIC is used in transplantation and autoimmunity settings, and also in regards to infection risk. Patients studied have often been given medical treatment and/or have comorbidities affecting the results.

This project will measure how intracellular phosphorylation of STAT3, p38 MAPK, ERK and AKT, inflammatory cell patterns and cytokine production react to rIC in healthy humans, and potentially give a better understanding of the mechanisms that mediate the protective effects of rIC. The intracellular mediators studied are involved in the initiation of cytokine production and regulate apoptosis and activation of the inflammatory cells. An altered balance between leucocytes and their mediators could be of importance for rIC effects, particularly in transplantation and autoimmunity, and this will be elucidated in our study.

As a secondary end point the investigators will measure the effect of rIC on pulse variability and blood pressure using a non-invasive device, since evidence regarding these aspects is sparse, although documented positive effects of rIC have primarily been on the heart and vascular system.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and well

Exclusion Criteria:

* Smoker.
* Taking regular medication.
* Any acute, chronic or systemic disease
* No hard physical exercise 72 hours prior to study participation.
* No alcohol or caffein-containing drinks 24 hours prior to study participation.
* Fasted for at least 6 hours prior to study participation.
Buprenorphine and Integrated HIV Care

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials.

From September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.

Eligibility Criteria:
Inclusion Criteria:

* HIV disease
* DSM-IV criteria for opioid dependence, as assessed by SCID
* Documented opioid positive urine toxicology testing

Exclusion criteria:

* Desire to remain enrolled in opioid agonist treatment at an opioid treatment program
* Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded)
* Current suicide or homicide risk
* Current psychotic disorder or major depression
* Inability to read or understand English
* Dementia
* Life-threatening or unstable medical problems requiring inpatient medical care or nursing home placement
* Currently enrolled in other studies involving the provision of psychosocial treatment.