cyrilzakka/clinical-trials huggingface dataset:
4-week Mindfulness Program for Adults With Chronic Pain

The objective of this study is to determine the feasibility and acceptability of a 4-week mindfulness training program for adults with chronic pain (noncancer related). The intervention is based on the MIndfulness-based Stress Reduction Program, an 8-week mindfulness training program developed to help people manage stress-related and chronic conditions. The adapted mindfulness intervention will consist of four, weekly 1 hour and 30 minute group sessions that are modified from the original program to fit the shorter length and to directly address chronic pain management. Participants will complete pre- and post-intervention surveys and daily mindfulness practice diaries, all online. The surveys will help us determine if participants experience decreased pain interference, increased quality-of-life, and increased psychological well-being over the course of the intervention. Participants will also complete a post-intervention telephone interview to help determine satisfaction with the intervention and areas where the intervention can be improved.


Eligibility Criteria:
Inclusion Criteria:

* One or more chronic noncancer pain diagnoses (daily pain for at least 3 months)
* Has a pain management provider
* Reports more than minimal pain bothersomeness and interference in general activities
* Able to read and understand English

Exclusion Criteria:

* Diagnosis of mental illness with psychotic features
* History of inpatient admission for psychiatric disorder in past 2 years
* Active alcohol or substance abuse within the past year
* Has completed a mindfulness-based stress reduction or other mindfulness course; has or previously had a regular mindfulness meditation practice.
* Unable or unwilling to comply with study procedures (online questionnaires and practice diaries, 4 weekly intervention sessions, home practice, and one semi-structured phone interview).
Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects

The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different modified-release formulations of lersivirine and compare it to the PK of the immediate-release tablet. The effect of food on the PK of one of the modified-release tablets will also be assess along with the safety and tolerability of each treatment.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening;
* Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication;
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Gait Characteristics and Cognitive Evolution in Parkinson Disease

Parkinson's disease (PD) is a chronic progressive nervous system disease with gradual motor impairment. Cognitive dysfunction is common in PD, even in the early stages, and it is characterized by impairments in executive, attention, memory, language and visuospatial function. Motor symptoms, in particular, alterations in gait, have been studied in clinical practice to assess disease progression, and its response to treatments, both farmacological and physiotherapeutic.

Recent research on wearable technology in PD has shown that motor tests can be automated using wearable technology to eliminate human supervision and patient-reported data. Particularly, the quantitative gait analysis by using inertial devices has been proposed as a sensitive tool to longitudinally monitor gait worsening, response to dopaminergic treatment over time and cognitive dysfunction in PD patients.

The aim of this prospective multicente observational study is to investigate whether the dysfunction of specific gait parameters may be correlated to cognitive impairment (Attention/Executive Function Domain) in a cohort of ambulatory PD patients followed for 3 years.

This is a prospective multicenter observational study with annual follow-up assessments over 3 years.

Gait is assessed by an inertial device (BTS G-WALK). G- WALK is an easy-to-use solution to obtain accurate, objective and quantitative spatial-temporal gait data. The device is a wireless system consisting of an inertial sensor composed by a triaxial accelerometer, a magnetic sensor, and a triaxial gyroscope that positioned on lumbar/ or sacral segments allows a functional gait analysis.

Cognitive performance is evaluated with a neuropsychological battery designed to assess memory, executive /attention, and visuospatial domains.

Eligibility Criteria:
Inclusion Criteria:

* Both sex
* Aged between 55-74 years
* Diagnosis of idiopathic PD based on MDS clinical diagnostic criteria
* Hoehn \& Yahr (H\&Y) stages 2 to 3 at enrollment, independently by PD duration
* Clinical-pharmacological stabilization until 3 months before the enrollment
* DBS treatment (stable stimulation parameters until 6 months before the enrollment)

Exclusion Criteria:

* Evidence of neurodegenerative and secondary parkinsonism
* Dementia ( (score \<25 on the Mini Mental State Examination - MMSE)
* Psychiatric disorder (Beck Depression Inventory-II - BDI-II Score \>19)
* Presence of organ failure (Modified Cumulative Illness Rating Scale - CIRS \> 2)
* Orthopedic disorder or co-morbidities that may affect gait
* Drug and alcohol use
Social and Cognitive Factors in Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain, tingling sensation and paresthesia in the territory of the median nerve, symptoms modulated by psychosocial factors (eg, catastrophic thinking, depression, anxiety).

The objective of the study is to determine those psychological and social components that influence the symptoms and function of patients with CTS.

An observational cross-sectional design will be performed in patients with CTS. The patients will be selected consecutively in two hospitals of the South East Metropolitan Health Service (Santiago, Chile). The study variables will include: Perception of pain using the Visual Analogue Scale (VAS), the extent of symptoms will be evaluated using the Katz diagram; Functional assessment using the abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH); Catastrophic thinking as a response to pain using the Pain Catastrophizing Scale (PCS), fear of movement using the Tampa Scale for Kinesiophobia (TSK-11), and emotional state was assessed using the Hospital Anxiety and Depression Scale (HADS). Both are valid and reliable measures used to evaluate the influence of psychosocial factors in patients with CTS. Individual subject factors including duration of symptoms, type of work (desk / non-desk), BMI, age, gender, educational level and economic income will be collected through an interview process.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age, moderate or severe CTS medical diagnosis, duration of symptoms for more than three months, acceptance to participate in the study.

Exclusion Criteria:

* Inability to understand instructions, non-controlled mental health pathology, cognitive problems, and previous surgery in the upper limb.
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"

Multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma. Continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years
2. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
3. Longest tumor diameter measures 4.1-7cm
4. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation
6. Provision of signed and dated informed consent form
7. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Pregnancy
2. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) \<30
3. Renal cell carcinoma as part of a syndrome
4. Horseshoe kidney
5. Patient unable to undergo renal mass protocol CT or MRI
6. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
7. Uncorrectable coagulopathy, including a platelet count of \<30,000/μL and/or an international normalized ratio (INR) \>2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
8. Performance status precludes enrollment as determined by the investigators
Identification and Assessment of Risk Factors for the Development of Osteoporosis in Adults and Children Living in the Abay Region of the Republic of Kazakhstan Using the Method of Dual-energy X-ray Absorptiometry and Clinical and Epidemiological Research

A survey of people to identify risk factors for osteoporosis, which include age, gender, lifestyle, diet, physical activity, the presence or absence of somatic pathology. Diagnosis of osteoporosis by dual-energy X-ray absorptiometry. Conducting a correlation analysis of the relationship of the data obtained.

Successful diagnosis of osteoporosis is possible with the complex use of clinical, laboratory and radiological methods. In the complex of diagnostic methods, a special place has given to dual-energy X-ray absorptiometry, which is the "gold standard". The research area contains the following tasks:

Risk factors for the development of osteoporosis will be identified and quantified in the formed study groups of adults; to determine the diagnostic value of the risk factors for the development of osteoporosis obtained during the examination.

to assess the state of BMD in adults using X-ray absorptiometry (DXA) To carry out a correlation analysis of the relationship between the obtained data in adults of the Abay region of of the Republic of Kazakhstan

Eligibility Criteria:
Inclusion Criteria: adults and children without a history of pathological fractures and congenital pathology of the musculoskeletal system.

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Exclusion Criteria: adults and children with congenital pathology of the musculoskeletal system

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the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy

A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach Intestinal reactions, small bleeding events are recorded.

A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (\> 160 / 100mmHg),hemoglobin concentration \<100g /L, hemorrhagic disease or a history of bleeding tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor, active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate, plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1month,6months and1 year. The stomach Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are recorded.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of coronary atherosclerosis without indications for stent implantation .

Patient aged \>18 years and ≤75years. Must be able to swallow tablets

Exclusion Criteria:

Aspirin resistance; uncontrolled hypertension (\> 160 / 100mmHg); hemoglobin \<100g / L; hemorrhagic disease or bleeding tendency history; taking other non-steroidal drugs; severe liver disease history; malignant neoplasms; active gastric mucosa bleeding; PCI history; coronary artery bypass surgery; cardiac function grade Ⅳ.
Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation

In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.

After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.

Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.

In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18
* Patient registered on the lung transplant list at Hôpital Foch for a single or double-lung transplant
* Patient who did not object to inclusion in the study
* Patient affiliated to a French health insurance plan

Exclusion Criteria:

* Patient listed for a combined transplant (heart-lung, liver-lung, lung-kidney)
* Patient on national priority list (super-emergency)
* Pregnant or breast-feeding patient
* Patient under guardianship
Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training

The current study aims to examine the impact of booster sessions of cognitive control training (CCT) on indicators of depression vulnerability. Remitted depressed individuals (RMD) will be randomized over two groups, each receiving 10 sessions of the adaptive Paced Auditory Serial Addition Task, a well-established CCT procedure (Koster et al., 2017; Siegle et al., 2007). During and following completion of the training procedure, functioning will be monitored on a weekly basis over a period of 15 weeks. During this period, one group will be offered booster sessions based on early warning signs for possible recurrence of depression, whilst the other group will not receive booster sessions.

Cognitive impairments are closely associated with depression and recent studies have found that these cognitive problems can persist following remission of depression. Internet-delivered cognitive control training (CCT), and the adaptive Paced Auditory Serial Addition Task (aPASAT) in particular, has shown to be an effective preventative intervention for remitted depressed individuals (RMD), where beneficial effects have been found for rumination, depressive symptomatology (Hoorelbeke \& Koster, 2017), and risk for recurrence of depression (Hoorelbeke et al., 2021). At the same time, prior studies suggest significant heterogeneity in response to CCT, where RMD individuals can show strong fluctuations in functioning in the months following completion of aPASAT training. In line with this, recent findings suggest that, for individuals with high-risk profiles, initial training gains may diminish over time, resulting in recurrence of internalizing symptomatology (Hoorelbeke et al., 2022). As such, there may be merit in the use of CCT booster sessions.

Currently, it is unclear whether offering additional CCT sessions when RMD individuals are reporting increased symptomatology (i.e., adding booster sessions based on early warning signs for possible recurrence of depression) can increase the long-term effectiveness of CCT. In this study, two groups of RMD individuals will perform 10 CCT sessions, after which one group will be offered booster sessions (contingent on indicators of functioning). For this purpose, we will rely on 15 weekly mobile assessments, using the PHQ-9 questionnaire. In addition, functioning will be assessed using a more extensive assessment battery at baseline, post-training (2 weeks after baseline) and follow-up (15 weeks after baseline).

Eligibility Criteria:
Inclusion Criteria:

* History of ≥ 1 depressive episode(s)
* Currently in remission (≥ 3 months)
* Access to a computer with an internet connection
* Access to a smartphone

Exclusion Criteria:

* Ongoing depressive episode
* Psychotic disorder (current and/or previous)
* Neurological impairments (current and/or previous)
* Excessive substance abuse (current and/or previous)
* Use of antidepressant medication is allowed if kept at a constant level
Effects of Farinelli's Breathing Exercise in COPD Patients

This study was to investigate the effect of Farinelli's breathing exercise on pulmonary function, respiratory muscle strength, aerobic capacity, impact of COPD questionnaires, cytokines, and oxidative stress in patients with Chronic Obstructive Pulmonary Disease (COPD).

Sixteen patients with COPD (GOLD I) with mild and moderate (GOLD II) severity aged 51 - 80 years old who visited at the outpatient examination room, Phramongkutklao Hospital divided into 2 groups; diaphragmatic breathing group (DB; n=8) and Farinelli's breathing group (FB; n=8). Participants in each group were administered to complete breathing exercise 5 times per week for 8 weeks. Physiological data and pulmonary function (FVC, FEV1, PEF, FEV1/FVC, FEF25-75%, MVV, VC, TV, IRV, ERV and IC), respiratory muscle strength (MIP and MEP), aerobic capacity (6-MWD and VO2max), impact of COPD questionnaire (mMRC and CAT), cytokine (TNF-α and IL-6), and oxidative stress (MDA) were analyzed during Pre- and Post-test.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD who treated in Phramongkutklao Hospital
* Have a history of smoking
* FEV1 predicted after bronchodilator more than 50%
* No change in medication in 4 weeks
* No history of acute exacerbation in 4 weeks
* No history of cardiac disease.

Exclusion Criteria:

* Recurrent of acute exacerbation
* Cannot participate at least 80% of training program (≤ 32 sessions of 40 sessions)
* Unwilling to continue practicing.
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.

Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Eligibility Criteria:
Key Inclusion Criteria:

* Sign an approved Informed Consent Form.
* Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study.
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
* Routinely sleeps in contact lenses at least 1 night per week.
* Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
* Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
* Other protocol-defined exclusion criteria may apply.
Postoperative VEGF and Recurrence After Colon Cancer Surgery

The purpose of this trial is to study the relationship between the angiogenic response to surgical aggression, determined through the serum levels of vascular endothelial growth factor (VEGF) on postoperative day four, and the tumor recurrence in patients with colon cancer operated with a curative intention.

DESIGN: Prospective multicentric study.

PARTICIPATION: Colorectal Surgery Units of Hospital del Mar, Barcelona; Hospital Universitari Joan XXIII, Tarragona; Hospital Universitari La Fe, Valencia; Hospital Clínico San Carlos, Madrid; Hospital General de Granollers, Granollers; Hospital Germans Trias i Pujol, Badalona; Athalaia, Xarxa Assistencial Universitària de Manresa, Manresa

STUDY SUBJECTS: 280 consecutive patients with non-metastatic colon cancer in whom a curative intent resection is performed.

DETERMINATIONS: Determination of the proangiogenic cytokine VEGF in serum on the postoperative day four to assess its relationship with oncological results on long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study,
* Patients who will undergo elective surgical resection with potentially curative intention

Exclusion Criteria:

* Patients with metastatic disease
* Patients with synchronous colon neoplasia or in the previous five years
* Patients undergoing emergency surgery
* Patients who do not sign the informed consent.