cyrilzakka/clinical-trials huggingface dataset:
Goal Management Training for Parkinson Disease Mild Cognitive Impairment

Mild cognitive impairment is experienced by approximately 30% of patients with Parkinson's disease (PD-MCI), often affecting executive functions. There is currently no pharmacological treatment available for PD-MCI and non-pharmacological treatments are still scarce. The aim of this study was to test preliminary efficacy/effectiveness of two home-based cognitive interventions adapted for patients with PD-MCI: Goal Management Training, adapted for PD-MCI (Adapted-GMT), and a psychoeducation program combined with mindfulness exercises. Twelve persons with PD-MCI with executive dysfunctions, as measured by extensive neuropsychological evaluation, were randomly assigned to one of two intervention groups. Both groups received five sessions each lasting 60-90 minutes for five weeks, in presence of the caregiver. Measures were collected at baseline, mid-point, at one-week, four-week and 12-week follow-ups. Primary outcomes were executive functions assessed by subjective (DEX questionnaire patient- and caregiver-rated) and objective (Zoo Map Test) measures. Secondary outcomes included quality of life (PDQ-39), global cognition (DRS-II), and neuropsychiatric symptoms (NPI-12). Safety data (fatigue, medication change and compliance) were also recorded. Repeated measures ANCOVAs were applied to outcomes. Both groups significantly ameliorated executive functions overtime as indicated by improvements in DEX-patient and DEX-caregiver scores. PDQ-39 scores decreased at the four-week follow-up in the Psychoeducation/Mindfulness group whereas they were maintained in the Adapted-GMT group. All other measures were maintained over time in both groups. Adapted-GMT and Psychoeducation/Mindfulness groups both improved executive functioning. This is one of the first studies to test home-based approaches, tailored to the participant's cognitive needs, and involving caregivers.


Eligibility Criteria:
Inclusion Criteria:

1. PD diagnosis from the United Kingdom Research Brain Bank diagnostic criteria for PD (Hughes et al., 1992);
2. PD-MCI diagnosis from the Movement Disorder Society Task Force diagnostic criteria. Single and multiple-domain MCI were both included, only if executive functions were significantly impaired (-1 standard deviation on executive function tests according to age and education-adjusted norms);
3. Montreal Cognitive Assessment scores between 21 and 27;
4. Anti-Parkinson medication stable (at screening) since at least two months;
5. All other medications, including psychotropics, stable for at least three months.

Exclusion Criteria:

1. Participants with PD and dementia diagnosis
2. Patients with other neurological or psychiatric disorders.
Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

The purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. The investigators will assess feasibility and acceptability of the intervention, and explore preliminary efficacy of the intervention for reducing psychological distress and improving rates of optimal chemotherapy adherence.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 or older
* Verbal fluency in English
* Diagnosis of colon cancer
* Scheduled to initiate chemotherapy treatment for colon cancer

Exclusion Criteria:

* Active, unstable, untreated serious mental illness interfering with ability to participate
* Cognitive impairment interfering with ability to participate
* Receiving radiotherapy concomitant with chemotherapy
Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches using molecular tests allow the immune response of the patient to infection to be measured directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the whole genetic sequence of the bacteria to be obtained from a swab.

In this study the investigators will collect swabs from ulcers or rashes and a blood sample from patients with syphilis and measure both the response of the patient immune system and the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in the United Kingdom. Patients will receive standard medical care including standard treatment for syphilis in line with national guidelines. Standard management already includes collection of a swab and a blood sample. For this study an additional swab sample and an additional 5ml of blood will be collected for use in this research project. By better understanding host immune system responds to infection with syphilis the studies aims to gain better insights in to the pathogenesis of this important sexually transmitted disease.


Eligibility Criteria:
Inclusion Criteria:

* Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Exclusion Criteria:

* Age \<18 years
* Unable to provide consent
* Patients with other stages of syphilis apart from Primary or Secondary OR patients without a lesion from which swabs can be obtained
A Study of the Effect of Time-of-day of Training on Chronic Patellar Tendinopathy

The study is a 12-week human study where 60 participants with chronic patellar tendinopathy (more than 3 months symptoms duration) are randomised to undergo 12 weeks of targeted resistance exercise either in the morning or in the late afternoon. The overall aim is to investigate when the best time of the day to perform muscular strength training therapy towards tendinopathy is. The study will also include 10 healthy controls who will not perform any exercise training.


Eligibility Criteria:
Inclusion Criteria:

* Sports active men and women
* Age (18-55) years old
* BMI (18.5-30)
* Uni- or bilateral patellar tendinopathy
* Symptom onset \>90 days ago

Exclusion Criteria:

* Patellar tendinopathy longer than 24 months
* Previous surgery in the knee on the ipsilateral side
* Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months
* Any confounding diagnosis to the knee joint
* Known arthritis
* Known diabetes
* Known rheumatic disorders
* Inability to follow rehabilitation or complete follow-ups
* Enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous 3 months
* Have an occupation where it is not feasible to avoid pain provoking tasks
* Pregnancy
* Have sleeping disorders or disruptions, e.g., night shift work
* Use of medicines or supplements known to affect collagen synthesis or sleep
The Follow-up of Mesh/Native Tissue Complications Study(Part II)

To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. The investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the International Urogynecological AssociationInternational Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system) .

Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at 27 participating hospitals but also from other hospital. And the date of surgeries carried is not restricted in the study period.

This is a study of real world. The researchers focus to investigate the incidence of complications in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue.
* 2) Pelvic reconstructive surgeries include but not limited to open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh(commercial mesh kits or self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape).
* 3) Both primary and repeated pelvic surgery are included.

Exclusion Criteria:

* If the same patient who developed complications after pelvic floor reconstructive surgeries has been diagnosed and reported in 27 participating hospitals, and again treated for "the same code complication in other 26 hospitals, she will be ruled out.
Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol

The purpose of this pilot study is to explore whether there is a differential impact of verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation strategy for individuals with social anxiety disorder (SAD). Clients who have not demonstrated clinically significant change following group CBT for SAD will receive four additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that that individuals who receive imagery-based CBT will experience even stronger improvements and be more satisfied with their treatment than individuals who received traditional verbal-linguistic CBT.

Social Anxiety Disorder (SAD) is a debilitating disorder, marked by significant functional impairment and high personal distress for those who suffer. Psychological treatment for SAD has traditionally been verbal-linguistic cognitive behavioural therapy (CBT). However, a significant number of individuals who complete CBT for SAD do not achieve full response and continue to struggle with significant residual symptoms. One innovation that has received attention recently in the literature is using imagery-based CBT as a way to augment treatment outcome in SAD. Results from a pilot and benchmarking study suggest that participants who received imagery-based CBT were more likely to complete treatment than those who received traditional CBT and treatment outcome was strong for both groups, but stronger in the imagery-based CBT group.

However, before re-training hundreds of practitioners in using a completely novel treatment approach, it is important to see if a brief augmentation of traditional CBT programs is effective in producing further change for individuals with residual symptoms after group CBT. It is possible that individuals just require a few more sessions of the same verbal-linguistic CBT to consolidate treatment gains or work on lingering triggers of anxiety. It is also possible that more of the same is not as valuable as offering therapy using a different modality, such as imagery. Therefore, we propose to evaluate a brief imagery-based augmentation of traditional group CBT to explore its effects on further symptom reduction.

Eligibility Criteria:
Inclusion Criteria:

* Completed eight out of twelve sessions of standard verbal-linguistic group cognitive behavioural therapy for social anxiety disorder
* Presented with a Social Phobia Inventory (SPIN) score of greater than 19 post-treatment
* Interested in further treatment

Exclusion Criteria:

* Has another mental health concern of greater importance than social anxiety disorder
The Effect of Stress Ball Used During Endoscopy

Endoscopy procedure is a frequently used method in the evaluation of the gastrointestinal system. Upper gastrointestinal system endoscopy can be performed with and without sedation. Sedation is the controlled sleep of the patient with certain drugs (pharmacological methods). Non-pharmacological methods help reduce anxiety and pain. In this study, a non-pharmacological stress ball will be used. It is aimed to evaluate the effect of using a stress ball on pain, anxiety and satisfaction during upper gastrointestinal system endoscopy.

Patients do not want to think that an upper GIS endoscopy without sedation will be difficult. However, some complications can be seen like hypoxemia, allergic reaction, malignant hyperthermia, hypoventilation, respiratory depression, hypotension, bradycardia, apnea, hypoxia, etc. due to sedation applied during endoscopy.

Non-pharmacological methods help reduce anxiety and pain. Although sedative and analgesic medications reduce anxiety and relieve pain, endoscopy is still painful for patients. During the endoscopy process, non-pharmacological methods are used to draw attention to another direction, but it is not encountered that the stress ball is used as one of these methods in the endoscopy procedure.

This study was planned as a single-center prospective randomized controlled study for the treatment of the stress ball method used during the endoscopy procedure, pain in anxiety and satisfaction levels.

The data obtained in the study will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean, standard deviation will be used as descriptive statistical methods in the evaluation of data. In comparing the difference between two independent groups, Student's t test will be used for data conforming to normal distribution, and Mann-Whitney U test will be used for data that do not comply with normal distribution. The difference between two repeated measurements will be analyzed with dependent groups t-test for data conforming to normal distribution, and Wilcoxon test for data that do not conform to normal distribution. The difference between three and more measurements that do not comply with the normal distribution will be compared with the analysis of variance in repeated measures for data that do not fit the normal distribution, and with the Friedman test for data that do not comply with the normal distribution. A value of P \<0.05 will be considered as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* To have an upper gastrointestinal endoscopy for the first time
* Not wanting sedation during upper gastrointestinal endoscopy
* Being between the ages of 18-75
* Being willing to participate in research

Exclusion Criteria:

* Using analgesic or anesthetic drugs before or during the procedure
* Using antidepressants, anxiolytic and sedative drugs
* Having communication difficulties and mental disability
COVID-19 Surveillance Based on Smart Wearable Device

This is a prospective, multi-center cohort study. 200 subjects with COVID-19will be included . Wearable device's physiological parameters and clinical data will be continually collected , the investigators aim to explore whether using smart wearable devices is useful to early alerting deterioration of COVID-19.

This is a prospective cohort study. 200 subjects aged 18～75y with asymptomatic, mild, general-type COVID-19 will be recruited. The physiological parameters of wearable devices, including heart rate, sleep, blood oxygen saturation, electrocardiogram and exercise records, will be continuously collected from the day of admission / isolation to 14 days after discharge or out of quarantine. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. All clinical data of patients during hospitalization will be collected including demographic characteristics, onset time, visit time, hospitalization time, symptoms, physical examination, laboratory examination, imaging characteristics, disease severity, treatment and outcome. Primary outcome is the deterioration of disease, the correlation analysis between the change of wearable device physiological parameters and the deterioration of disease determined by the traditional disease evaluation system will be used to find it whether can early alert deterioration of COVID-19.

The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2020-055). Any protocol modifications will be submitted for the IRB review and approval.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years(both 18 and 75), either gender;
2. At the time of enrollment, patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh Edition)
3. Able to engage in daily activities;
4. Willing to participate in this research and willing to follow the research program, with the ability to sign informed consent;
5. having mobile communication equipment which can install APP of wearable device.

Exclusion Criteria:

1. Wear time of wearable devices \<50% during the whole study period
2. Wearable devices have faults, missing signals or errors throughout the study period, resulting in the proportion of analyzable information \<50%
3. Patients with incomplete outpatient and inpatient information and missing core information such as hospitalization / discharge time, symptoms, laboratory examination, disease progress record, etc.
4. Patients with serious underlying diseases (including serious mental diseases, mental disorders, nervous system diseases, malignant tumors, chronic liver diseases, heart failure, autoimmune diseases, chronic kidney diseases), or life expectancy less than 6 months
5. Unable to take care of themselves in daily life, unable to cooperate with medical history and data collection
6. participating in other clinical trials;
7. Pregnant women, women in puerperium
Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation

Recurrence rate remains high after radiofrequency ablation in patients with non-paroxysmal atrial fibrillation(AF). Prolonged use of anti-arrhythmic drugs (AAD) beyond the post-ablation blanking has been adopted as a solution but without sufficient clinical evidence. Dronedarone is an AAD valid to maintain sinus rhythm and has fewer side effect than other AAD for long-term use.We sought to investigate the effect of prolonged use of dronedarone on recurrence of non-paroxysmal AF patients beyond the post-blanking period within the first year after ablation.

In this multicenter, randomized, placebo-controlled trial, patients with non-paroxysmal AF will receive dronedarone for three months after radiofrequency ablation. Eligible Patients will then be randomly divided into dronedarone and placebo groups and followed up until one year after ablation. The primary endpoint is the cumulative nonrecurrence rate post three months and within one year after ablation. 7-day Holter monitoring (ECG patch) will be scheduled at 6,9, and 12 months after ablation for evaluating AA recurrence. Secondary endpoints include dronedarone withdrawal due to side effect or intolerance of AA recurrence, time to the first recurrence, repeat ablation, electrical cardioversion, unscheduled visit ,and rehospitalization.

This trial will evaluate whether prolonged use of dronedarone effectively reduces recurrence rate after ablation in non-paroxysmal AF patients. The result of this trial will provide evidence for optimizing post-ablation anti-arrhythmic therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years;
2. Diagnosis of non-paroxysmal AF
3. Undergoing AF ablation for the first time

Exclusion Criteria:

1. Unwilling to take or intolerant to dronedarone;
2. Hypersensitivity to the drug ingredient
3. Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40%
4. Bradycardia \<50 bpm
5. QTc Bazett interval ≥500ms or PR interval \>280ms
6. II or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemaker
7. Diagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 months
8. Patients with structural heart disease (moderate to severe aortic or mitral valve stenosis, interventricular septal thickness \>15mm, congenital heart disease)
9. Accepted cardiac surgery within the last 3 months
10. Left atrial diameter (LAD) \>55 mm
11. Patients with left atrial or left auricular thrombosis
12. Patients with Hyperthyroidism
13. Severe dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR\<30ml/min/1.73m2)
14. Abnormal blood coagulation
15. Concomitant use of dabigatran
16. Concomitant use of drugs that prolong QTc or may induce torsades de pointes
17. Concomitant use of strong CYP3A inhibitors
18. Concomitant use of another Class IA, IC, or III AADs
19. Patients suffering from serious infection, mental illness or malignant tumors
20. Pregnancy or breast-feeding
Nutrition for Asthmatics with Obesity

This study will test the effect of diet on asthma in individuals with obesity.

This is a crossover design pilot trial that will recruit 12 adults with obesity and asthma. Participants will undergo screening and a lead-in period before being randomized to a series of three, 7-day diets with a 7+ day washout period between each diet. Asthma control and lung function will be assessed at the completion of each diet.

The goal of this pilot trial is to understand the effect of diet on asthma and conduct an exploratory analysis on factors that may predict the response to diet.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* BMI: 30-45 kg/m2
* asthma diagnosed by medical specialist (confirmed in medical history)
* partly controlled or uncontrolled asthma by Asthma Control Test score ≤22
* owns a device compatible with ZEPHYRx platform
* stable asthma medication use (no change in the past 2 months).

Exclusion Criteria:

* Diabetes or using diabetes medications that may lower blood glucose levels
* point of care fasting blood glucose ≥126 mg/dl or triglycerides ≥400 mg/dl
* current smoking or smoking history of greater than 10 pack-years
* other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease; uncontrolled hypertension defined as systolic blood pressure ≥160 mm/Hg, or diastolic blood pressure ≥100 mm/Hg
* pregnant or nursing women
* food preferences or allergies inconsistent with study diet capabilities
* noncompliance with lead-in period requirements.