cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Mindfulness Intervention：Rumination Behavioral Experiments

This study hopes to explore whether the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress

In recent years, mindfulness-based interventions (MBIs) have seen extensive application in both clinical and non-clinical settings. Studies show that mindfulness training improves emotional regulation and processing, contributing to better emotional health. MBIs have proven effective in reducing anxiety and depression among patients with conditions like multiple sclerosis, enhancing personal well-being, and alleviating chronic pain. Given the mounting evidence supporting its benefits, MBIs have become widely adopted across various settings. Nonetheless, the precise mechanisms through which mindfulness alleviates emotional distress remain poorly understood.

Rumination, a transdiagnostic process, plays a critical role in the development and persistence of emotional distress. Empirical evidence supports the effectiveness of MBIs in reducing rumination. However, the role of rumination in mediating the effects of MBIs on emotional distress remains inconsistent across studies. Kazdin (2007, 2009) outlined criteria for evaluating mechanisms and mediators, yet existing studies lack sufficient evidence to meet these standards. This study aims to explore the mechanistic role of rumination using behavioral experiments, focusing on the consistency criterion

Eligibility Criteria:
Inclusion Criteria:

* - Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
* - Aged 18-55 years old.

Exclusion Criteria:

* - Subjects who could not access the Internet;
* - Subjects with insufficient Chinese ability;
* - Subjects who have participated in mindfulness based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week;
* - Subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
* - Subjects with high risk of suicide.
Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.

The proposed study is a sequential multiple assignment randomized trial (SMART) to identify an effective adaptive intervention (AI) for adolescents at elevated suicide risk transitioning from acute psychiatric care. Participants will be initially randomized to Motivational Interview (MI)-enhanced safety planning (MI-SP) or to MI-SP with supportive text messages delivered for four weeks after discharge (Texts) (Phase 1 intervention). Adolescents who are classified as Phase 1 non-responders at the end of the first or at the end of the second week post-discharge, based on their responses to daily surveys , will be re-randomized to either added booster call or portal follow-up (Phase 2 intervention). Those classified as Phase 1 responders at the end of the second week post discharge will continue with the initially assigned intervention options. Thus, participants will receive one of six treatment sequences resulting from the different intervention components or their combinations. These six treatment sequences, in turn, will form four AIs.

The study team anticipates that AIs that begin with MI-SP plus text-based support will have:

* lower odds of suicidal behavior 3 months post discharge
* longer time to suicidal behavior over the 6 month follow-up
* less severe suicidal ideation over the 6-month follow-up

Additionally, the study team anticipates that the AI that begins with MI-SP + Texts followed by portal follow-up for non-responders will lead to:

* lowest odds of suicidal behavior within 3 months
* longest time to suicidal behavior over the 6 month follow up
* least severe ideation over the 6-month follow-up

Eligibility Criteria:
Inclusion Criteria:

* A suicide attempt in the last month or (2) past-week suicidal ideation (based on the Columbia-Suicide Severity Rating Scale (C-SSRS). In the absence of C-SSRS ratings in the chart, attending physician indication in the chart of the presence of suicidal ideation within the last week or the presence of a suicide attempt in the last month will be used.

Exclusion Criteria:

* Adolescent presenting with severe cognitive impairment or with altered mental status (acute psychosis or acute manic state)
* Transfer to medical unit or residential placement
* No availability of a legal guardian
* Adolescent not owning a cell phone.
Cognitive Impairment and Upper Extremity Performance in COPD

Within the scope of this study, COPD patients will be divided into two groups according to cognitive dysfunction.

Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the groups.

Although the mechanism of cognitive dysfunction in COPD is not clear, the reasons focused on are; decreased oxygen use, high carbon dioxide levels, increased inflammation and oxidative stress, decreased physical activity, peripheral vascular diseases, atherosclerosis, high or low blood pressure, cerebral vasoconstriction, increased intracranial pressure, accompanying comorbidities, smoking and genetic predisposition, brain damage and exacerbations have been reported. Few studies have shown that cognitive dysfunction is associated with functional performance. There are no studies on the effect of cognitive function on upper extremity performance and mechanisms of action in COPD patients.

The aim of this study is to compare upper extremity functional capacities, respiratory functions, fatigue and quality of life in COPD patients with and without cognitive function impairment.

Within the scope of this study, COPD patients will be divided into two groups according to cognitive dysfunction.

Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the groups.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Stage 2-3-4 according to the GOLD classification in the 40-65 age range

Exclusion Criteria:

* Exacerbation of respiratory symptoms in the past 4 weeks (change in breathlessness and/or sputum volume/color, need for antibiotic treatment or need for hospitalization)
* Presence of asthma, unstable coronary heart disease, uncontrolled diabetes, hypertension, left-sided congestive heart failure, neoplasia, severe claudication, encephalitis or epilepsy
* Having a history of head trauma or brain tumor
* Having a significant psychiatric condition or the presence of defined dementia, according to the American Psychiatric Association
Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with patellofemoral pain. A set of psychosocial surveys assessing fear avoidance beliefs, kinesiophobia, and pain catastrophizing will be completed by the participant/parents. Participants will then complete an activity questionnaire, numeric pain rating scale, and a self-report questionnaire of functional ability. Participants will then be randomized into one of two groups (psychologically informed education group and a control group). Participants will view a series of educational videos (based upon group assignment) and complete physical therapy exercises for lower extremity strengthening, flexibility, and neuromuscular control. Participants with patellofemoral pain will then complete follow-up surveys of their psychosocial beliefs, pain and self-reported functional ability through REDcap at immediately post-intervention, 1 week, 3 weeks, 6 weeks, and 3 months.


Eligibility Criteria:
Inclusion Criteria:

• Having patellofemoral pain as defined as: Pain around or behind the patella, which is aggravated by at least one activity that loads the patellofemoral joint during weight bearing on a flexed knee (e.g., squatting, stair ambulation, jogging/running, hopping/jumping).

Exclusion Criteria:

* Prior history of patellar dislocation.
* Suspicion of other diagnosis of the knee by evaluating physical therapist or principal investigator.
* Other concomitant injury of the leg.
* Prior history of knee surgery.
* Red flags present for non-musculoskeletal involvement (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing).
* Numbness and tingling in any lumbar dermatome.
Robotic Assisted Colon and Rectal Surgery Prognostic and Outcome Analysis

To analysis surgical outcome between robotic and laparoscopy colon and rectal surgery. Retrospective case-control study of single institute.

Microinvasive surgery bring minor pain, faster recovery and comparable oncological outcome. Robotic surgery seems to be superior in precise dissection then before. This study compare robot assisted to laparoscopy surgery in colon and rectal disease. To analysis the surgical outcome and prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* for colon and rectal disease, using conventional laparoscopy and da Vinci Xi robot system.

Exclusion Criteria:

* emergent operation, combined other open surgery, for non-colorectal disease, carcinomatosis found to be unsuitable for surgery once peritoneum entered, taTME in laparoscopy group and other robot system in robotic surgery group.
Effects of Gua Sha and Thermotherapy on Chronic Neck Pain

Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a round-edged instrument until small petechiae appear. This so called "sha", considered as the removal of blood stasis by traditional practitioners, will fade within a few days. Normally, this treatment is not considered as painful, but as relaxing and easing tense muscles.

In this study, the investigators will investigate the effectivity of Gua Sha massage in treating chronic neck pain. The investigators will research effects on subjective pain intensity, neck pain specific disability and haptic perception.


Eligibility Criteria:
Inclusion Criteria:

* Chronic mechanical neck pain, at least 40 mm on a 100mm visual analog scale.
* Pain for at least 3 months.

Exclusion Criteria:

* radicular symptoms
* congenital spine deformity
* pregnancy
* rheumatic diseases
* oncologic diseases
* other severe psychiatric or somatic comorbidity
* recent invasive or surgical treatment of the spine
* participation in other studies
* skin diseases in the area to be treated
Danish Aspirin Resistance Trial - Pilot Study

Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. At present, no international consensus exists on how to measure "aspirin resistance". The purpose of this study is to compare different methods for detecting "aspirin resistance". A classic but cumbersome way of evaluating platelet function will be compared to newer, easy-handling point-of-care tests. We hypothesize that one or more point-of-care tests will prove to be superior to the classic platelet function test in detecting aspirin resistance.

Platelets play a major role in arterial thrombus formation - the cause of cardiovascular death, acute myocardial infarction and ischemic stroke and the number one killer in the Western World. Binding the COX enzyme platelet aggregation is inhibited by aspirin, and as prophylaxis against death, myocardial infarction and stroke aspirin is the most widely used drug worldwide. Low dose aspirin has been shown to improve outcome in patients with ischemic heart disease, but approximately 12% of these patients will suffer from a vascular event during a 2 year follow-up period despite aspirin therapy. It has been speculated that these patients might be "resistant" to the antiaggregatory effect of aspirin, and a diminished response to aspirin has been correlated with a less favourable outcome. However, at present no international consensus exists on how to measure "aspirin resistance".

Comparisons: The platelet aggregation in patients with ischemic heart disease on chronic, low dose aspirin is compared to platelet aggregation i healthy volunteers evaluated with different tests. The traditional way of evaluating platelet function, Platelet Aggregometry a.m. Born, will be compared to 3 point-of-care tests (VerifyNow, PFA-100 and Multiplate Whole Blood Aggregometer) and to urin- and serum thromboxane metabolites as a measure of COX inhibition.

Eligibility Criteria:
Inclusion Criteria:

* ischemic heart disease verified with a coronary angiogram
* treatment with 75 mg aspirin once daily

Exclusion Criteria:

* ischemic vascular event within the previous 12 months
* percutaneous coronary intervention or coronary artery by-pass grafting within the previous 12 months
* treatment with NSAID, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drug affecting platelet aggregation
* platelet count \< 120 x 10\^9/l
* not able to give informed consent
CryoSpray Ablation(tm)Thoracic Patient Registry

The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with the CryoSpray Ablation™ System post-510K approval.

The proposed registry is a prospective, multi-center study of patients that are currently undergoing CryoSpray Ablation™. A maximum of 50 investigational sites will participate in this study.

The study population consists of patients who are being treated with the CryoSpray Ablation™ System for thoracic diseases. Enrolled subjects must have a signed consent form for data collection.

Eligibility Criteria:
Inclusion Criteria:

Patients who are being treated with the CryoSpray Ablation™ System for lung and for thoracic diseases.

Exclusion Criteria:

* Subjects with thoracic or airway obstructions and diseases who were not treated with the CryoSpray Ablation™ System.
* Subjects under the age of 18 years.
* Subjects unable to provide consent.
Primary Health Management for Chronic Obstructive Pulmonary Disease

The core objective of the "Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease (COPD)" is to explore a primary health management model and service standards that are suitable for COPD patients and aligned with grassroots realities. It also aims to enhance the capability of primary healthcare institutions in the prevention and management of chronic respiratory diseases. The primary outcomes are to evaluate the efficacy and cost-effectiveness of COPD Essential Public Health Services (EPHS) intervention in communities in China.

Participants are already receiving intervention B, "Usual primary health care," as part of their regular medical care under the current health policy. Researchers will compare intervention A, which is"the EPHS for COPD", with intervention B to determine if intervention A performs better in COPD management.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 35 years.
2. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the 2024 GOLD guidelines.
3. Post-bronchodilator FEV1(Forced Expiratory Volume in one second) predicted ≥ 30%.

Exclusion Criteria:

1. Inability to provide informed consent.
2. Contraindications for pulmonary function tests, including:

   * Recent myocardial infarction, stroke, or shock within the past 3 months.
   * Severe heart failure, severe arrhythmias, or unstable angina within the past 4 weeks.
   * Recent major hemoptysis within the past 4 weeks.
   * Major thoracic, abdominal, or ophthalmic surgery within the past 3 months.
   * Psychiatric disorders requiring antipsychotic medication or with a history of seizures requiring medication.
   * Cognitive impairment, including dementia or severe comprehension deficits.
   * Uncontrolled hypertension (systolic blood pressure \> 200 mmHg, diastolic blood pressure \> 100 mmHg).
   * Resting heart rate \> 120 beats per minute.
   * Presence of aortic aneurysm.
   * Severe hyperthyroidism.
   * Pregnancy or lactation.
   * Respiratory tract infections (e.g., tuberculosis, influenza, pneumonia) within the past month.
   * Presence of pneumothorax, large pulmonary bullae not scheduled for surgery, or tympanic membrane perforation.
3. Currently participating in, or planning to participate in, any other COPD health management or clinical intervention projects during the study period.
Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants

The primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability of aducanumab administered via SC and IV routes in healthy participants and to characterize additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* A minimum weight of 45 kg, inclusive, at Day -1.
* All women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (Day 1).
* Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.

Key Exclusion Criteria:

* Mini mental state examination (MMSE) score of \<27 at Screening.
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of severe allergic or anaphylactic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
* History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised prior to study entry).
* History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
* Positive test result at Screening for hepatitis C virus antibody (HCVAb).
* Positive test result at Screening for hepatitis B virus (defined as positive for both, hepatitis B surface antigen \[HBsAg\] AND hepatitis B core antibody \[HBcAb\]).
* Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 90 days prior to Day -1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)

This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy.

After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase.

All subjects will receive 6 weeks of treatment at the established RP2D.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years of age or older at the time of signing the informed consent
* Subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
* Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with concomitant Ta) urothelial cell carcinoma of the bladder according to central review
* Subjects who are treatment naïve, unable to obtain intravesical BCG for the treatment of NMIBC, have received at least one dose of intravesical BCG, or at least one dose of intravesical chemotherapy

Exclusion Criteria:

* Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin allergy testing prior to inclusion in the study)
* Predominant (defined as \> 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review
* Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
* Nodal involvement or metastatic disease that existed at any time (past or present disease)
* Bladder cancer stage ≥ T1 within the last 36 months according to central histology review
* Bladder cancer stage CIS with concomitant T1

For more information on eligibility criteria, please contact the sponsor.
To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans

The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo control.

This study is the first to investigate the relative colonisation of the human GI tract by L Reuteri ATCC PTA 4659. Simple demonstration that they survive passage is the first step in development of potential new probiotics, which is necessary before these strains can be considered for continued testing in probiotic food matrices. The aim of this study will evaluate the safety and tolerability of Lactobacillus Reuteri in healthy adult subjects.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18-65 years
* BMI 19-33
* Hb 120 g/women 130 g/l for men
* Healthy assessed by screening tests and physical examination
* Signed informed consent and bio bank consent

Exclusion Criteria:

* Participation in a clinical study within 90 days prior screening use of antibiotics 2 weeks before baseline
* Pregnant or lactating