cyrilzakka/clinical-trials huggingface dataset:
Metronomic Therapy in Patients With Metastatic Melanoma

SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine.

Patients with measurable metastatic melanoma are eligible. All patients will be treated as outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease. A cycle will be defined as three weeks of continuous therapy with a one week rest.

Low dose continuous chemotherapy, called metronomic chemotherapy, is designed to target vascular cells and inhibit tumor growth and metastasises. A recent study in a melanoma mouse model has identified low dose vinblastine, cyclophosphamide and dacarbazine as a treatment which improves the animal's survival and is superior to full dose dacarbazine alone. This clinical trial seeks to translate this laboratory model directly into metastatic melanoma patients.

Eligibility Criteria:
* Metastatic melanoma with measurable disease
* Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosoureas) and recovered from all ill
* Karnofsky Performance Status ≥60%
* Life expectancy ≥ twelve weeks
* Adequate end organ function
* Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.
* Appropriate Contraception in both sexes
* The patient must be competent and signed informed consent.

EXCLUSION CRITERIA

* Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.
* In patients with a prior history of invasive malignancy, less than five years in complete remission.
* Have evidence of significant co-morbid illness such as uncontrolled diabetes - Uncontrolled brain metastasis: Patients with brain metastasis most have been treated with brain radiation therapy or surgery and remain clinically stable for a minimum of 4 weeks.
Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App

This study evaluates a self-help app in the treatment of shyness and social anxiety in adults. All participants will be assigned to the treatment group. It is expected that using this app will result in a reduction in social anxiety.

Over 2 million Canadians have suffered from social anxiety disorder (SAD) at some point in their lives. This disorder is characterized by a strong fear of negative evaluation in social situations and is associated with significant impairment in social interactions, educational/occupational achievement, and life satisfaction. Despite the fact that efficacious treatments have been developed and evaluated, both treatment effectiveness and treatment seeking behaviour remain below optimal levels. Combined with the many barriers to treatment (i.e., cost, stigma, access), researchers are investigating self-help modalities as an alternative to conventional psychotherapy.

The Defusion App is based on content from Fleming \& Kocovski's (2013) self-help book "The Mindfulness \& Acceptance Workbook for Social Anxiety \& Shyness." Specifically, the app teaches users about the tendency of socially anxious individuals to fuse with their anxious thoughts (i.e., cognitive fusion), and strategies to reduce it.

In this experimental research study, a smartphone app designed to help with social anxiety and shyness will be evaluated for both effectiveness and frequency of use. The objectives will be to determine whether participants use the app, and whether use of the app is associated with a reduction in social anxiety.

Preliminary evidence has indicated that smartphone apps for mental health are associated with promising results. It is expected that the use of the app in the present research will be associated with reductions in social anxiety symptom severity and a greater use of cognitive defusion strategies.

The participants will be a community sample of individuals interested in seeking help with social anxiety and shyness as recruited by the use of posters around the Wilfrid Laurier University campus and in the community, as well as online.

Eligibility Criteria:
Inclusion Criteria:

* must be seeking help for shyness/social anxiety
* must own a smartphone

Exclusion Criteria:

* none
Comparison of Different Exercise Trainings on Heart Rate Variability

The aims of this project are to compare the effects between 8-week moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) on improving HRV.

Background: Both heart rate variability (HRV) and visceral adipose tissue (VAT) are crucial factors predicting cardiovascular diseases, and both can be improved by exercise training. HRV can provide information regarding sympathetic and parasympathetic activity. Studies have demonstrated that HRV and VAT are correlated. VAT accumulation may dysregulate the balance of the sympathetic and parasympathetic nervous system. However, the correlation between sympathetic activation and VAT is controversial and limited by a paucity of studies, and the optimal exercise modality for improving HRV remains debatable. Therefore, the aims of this 1-year project are to compare the effects between 8-week moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) on improving HRV.

Methods: Purposive sampling will be used to enroll at least 72 community residents aged 40-64 years with VAT over 100 cm2. A two-phase crossover design will be used to understand the change patterns of HRV and VAT in the 8-week different exercise phase and with 8-week washout period insertion. Participants will initially be randomized into either the MICT or HIIT group for 8 weeks, and the groups will then be exchanged for the later 8 weeks. HRV parameters and VAT will be measured at four time points at baseline (T0), the end of the first phase (8-week later, T1), the initial of second phase (16-week later, T2), and the end of the second phase (24-week later, T2). Linear mixed models (LMMs) with random effects will be used to compare the effects of 8-week different exercise modalities on HRV and explore the effect of VAT changes on HRV over the 24-week intervention.

Relevance to clinical practice: The results of this study can reveal the optimal exercise modality for improving HRV among community residents with higher VAT and clarify HRV and VAT change patterns in exercise and rest phase and the correlation between HRV and VAT. These findings would provide evidence that clinical health professionals can use to promote health benefits through exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Community residents (a) who are 40-64 years old, (b) with a VAT of ≧ 100 cm2 measured using a body composition analyzer, and (c) who can communicate in Mandarin or Taiwanese will be included.

Exclusion Criteria:

* This study will exclude (a) residents with recent unstable conditions (stroke, cardiovascular and respiratory diseases, handicap, pregnancy, mental disorders, systolic blood pressure \> 200 mmHg, or diastolic blood pressure \> 110 mmHg), (b) residents with contraindications to body composition analyzer measurement (e.g., people with pacemakers, artificial metal joints, and amputated hands or feet) and residents who cannot stand during testing, and (c) residents with habits or lifestyles that may affect HRV (e.g., smoking or alcohol abuse and shift work).
Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.

This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 patients
* Scheduled for primary total knee arthroplasty
* Disposition to visits and scheduled tests

Exclusion Criteria:

* Previous surgery on knee to be operated
* Documented peripheral neuropathy
* Severe disease or condition that could potentially interfere with interpretation of tests.
Re-usable Respimat® Soft MistTM Inhaler Study

The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-experienced and Respimat SMI-naïve. This study also aims to examine patient preference for the re-usable Respimat SMI compared to the disposable Respimat SMI in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry.


Eligibility Criteria:
Inclusion Criteria:

Patients fulfilling all the following inclusion criteria will be eligible for participation in the study:

* Provision of signed informed consent prior to study data collection
* Patient with COPD aged 40 years or older
* Patient prescribed (or already receiving the disposable Respimat SMI and switched to) one of the following re-usable Respimat SMI products per the standard clinical practice: Spiriva 2.5 microgram inhalation solution; (2) Striverdi 2.5 microgram inhalation solution; and (3) Spiolto 2.5 microgram / 2.5 microgram inhalation solution
* Patient unlikely to change their Respimat therapy during the 4-6 week observation period (in the opinion of the investigator)

Exclusion Criteria:

Patients fulfilling any of the following exclusion criteria will not be eligible for participation in the study:

* Patient using a disposable Respimat SMI product during the study period
* Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry
* Patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment
* Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires
* Patient not fluent and literate in one of the main languages of the country
Mobile Intervention - Physical Activity in Cancer Treatment

Aim 1. Determine the feasibility and acceptability of the proposed mobile technology intervention to increase physical activity patients receiving treatment for renal cell carcinoma.

Aim 2. Evaluate the effect of the proposed intervention components (affective framing, intention planning, and goal-setting) on changes in physical activity.

Recent analyses have indicated that physical activity reduces mortality risk among patients with RCC.1. Physical activity also provides additional benefits for patients undergoing treatment for cancer such as improved quality of life and sleep, and reduced treatment-related fatigue. However, individuals receiving treatment for renal cell carcinoma (RCC) often fail to engage in sufficient physical activity. Many cancer survivors experience a decrease in their physical activity after diagnosis2 and the majority of RCC survivors do not meet the recommended guidelines for physical activity.3 Traditional physical activity interventions require significant resources and present substantial barriers for participants (travel, time commitments, etc.). In contrast, mobile technologies enable delivery of interventions with significantly fewer resources. These technologies also facilitate the delivery of just-in-time adaptive interventions (JITAIs) in which intervention support is provided at only at times when an opportunity for positive changes exists.4 The purpose of this support the development of a JITAI in RCC patients. Evaluation of the acceptability and efficacy of three intervention strategies (affective framing, intention planning, goal-setting, and savoring) will determine their inclusion in the JITAI.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 years or older
2. Diagnosed with RCC
3. \< 150 minutes of weekly moderate-to-vigorous physical activity
4. Own a smartphone (required for syncing the Fitbit device).

Exclusion Criteria:

1. Medical condition contraindicating exercise participation
2. Cognitively unable to give informed consent.
3. Unable to read and communicate in English
Drug Use-Results Survey of Betanis Tablets in Japan

This study is to determine the following information.

1. The occurrence of adverse drug reactions in clinical settings.
2. Factors potentially impacting safety, effectiveness, and other aspects.

This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron):

1. The occurrence of adverse drug reactions in clinical settings.
2. Factors potentially impacting safety, effectiveness, and other aspects.

Items of Particular Interest:

* Safety and effectiveness in patients with hepatic impairment and patients with renal impairment.
* Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs).
* The occurrence of cardiovascular adverse events.
* The occurrence of adverse events related to increased intraocular pressure.
* The occurrence of urinary retention

Eligibility Criteria:
Inclusion Criteria:

* Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.
The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub

The proposed study is to be carried out with 6000-7000 youths aged 12 - 24 in Hong Kong. The purpose of the study is to investigate the effectiveness and cost-effectiveness of a Hub project for young people: LevelMind@JC. This study is conducted by LevelMind@JC in collaboration with partnering NGOs including the Boys' \& Girls' Clubs Association of Hong Kong (BGCA), Caritas Hong Kong, Hong Kong Federation of Youth's Group (HKFYG), Hong Kong Playground Association (HKPA), Hong Kong Children and Youth Services (HKCYS) and St James' Settlement (SJS). It is a 1-year quasi experimental controlled study which aims to examine if these hubs can enhance young people's cognitive abilities, personal strengths and overall mental well-being. 1800 participants would be recruited, including 600 Hub users, 600 non-hub users (but receiving services from participating NGOs), and 600 community youth not receiving any youth services. Participants will be assessed at baseline and follow-ups (e.g., 3 months, 6 months, and 12 months); completing questionnaires and answering questions during a 3- hour interview. Hub users with mild to moderate mental distress will receive different psychological treatments according to their needs. For youths who are at risk for mental disorders, diagnostic and medical assessment services will be delivered by psychiatrists or clinical psychologists. Findings will allow us to better understand the effectiveness of this kind of community-based hubs for young people, improve mental wellness training of youth social workers; and in a long run, develop a community-based support model that is sustainable, scalable and replicable.


Eligibility Criteria:
Inclusion Criteria:

* For hub-user group (experimental group): 12 - 24 year- old hub users who receive community-based mental wellness youth hub services for young people.
* For non-hub user group (active control group): 12 -24 year- old youths who do not receive the community-based mental wellness youth hub services but other generic youth services in the community.
* For non-hub user group (passive control group): 12 -24 year- old community youth who do not receive any youth services in the community.

Exclusion Criteria:

* Youths with known diagnosis of psychiatric disorders (including Depression, Generalized Anxiety Disorder, Panic Disorder, Phobia, Obsessive Compulsive Disorder, Bipolar Disorder, Eating Disorder, Personality Disorder, Post-Traumatic Stress Disorder and Psychotic Disorder)
* Youths who receive psychiatric medication (including antidepressants, antipsychotics and antiepileptic drugs)
* Youths who have limited comprehension due to epilepsy or mental retardation.
Study to Demonstrate the Efficacy and Safety of Convatec ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings to Protect Against Skin Breakdown

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive to protect against skin breakdown


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over
* Patients able and willing to provide informed consent/Personal Consultee/Nominated consultee/ Their nominated consultee
* Intact healthy skin
* Stage I pressure ulcer/injury
* Patients who are at risk of developing skin breakdown (injury), in any clinical setting, with at least one clinically vulnerable area (including but not limited to sacrum, heel, elbows, hips, ischial tuberosity and spine)
* Braden score of 12 or less

Exclusion Criteria:

* Patients with known allergies to any of the materials used in the dressing
* Subjects requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
* Patients who are at high risk of unavoidable skin breakdown for example caused by a medical device (for example, under ventilation or faecal management systems)
* Patients with a wound of any aetiology on the area under investigation Patients who, in the opinion of the investigator, are considered unsuitable for any other reason
* Patients with a history of previous healed pressure ulcer/ injury in the area under investigation
* Patients who demonstrate a deterioration of skin from baseline skin assessment
Comparison Between Pericapsular Nerve Group (PENG) Block and Interscalene Brachial Plexus Block for Postoperative Analgesia Following Shoulder Arthroscopy

The study aimed to compare ultrasound guided pericapsular nerve group (PENG) block versus interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy.

Shoulder arthroscopy can effectively treat a number of injuries and diseases of the shoulder on an ambulatory basis. Although shoulder arthroscopy is considered minimally invasive, it is related to severe postoperative pain. The use of arthroscopy is popular because it decreases pain, shortens hospital stay, and improves patient satisfaction. However, immediate postoperative pain remains to be a problem in more than 40% of patients.

Regional anesthesia, especially peripheral nerve blocks have various advantages like decreased need for postoperative analgesics, decreased incidence of nausea and vomiting, shortened recovery time and hospital stay, Early ambulation and discharge.

Interscalene brachial plexus (ISB) block is considered the gold standard technique for pain management in shoulder surgery as it provides the most reliable analgesia. However, it has the potential for many complications. The most common of these complications is phrenic nerve palsy, which is reversible but may result in significant respiratory distress especially in patients with compromised respiratory function. Other less common yet serious complications include Horner's syndrome, recurrent laryngeal nerve block that may result in hoarseness of voice, vascular puncture, brachial plexus neuropathy, and unintended injection of local anesthetic into the subarachnoid space, epidural space, or vertebral artery.

Pericapsular nerve group (PENG) block is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia by reaching the sensory nerve branches of the glenohumeral joint.

Eligibility Criteria:
Inclusion Criteria:

- Age from 18 to 60 years old. - Both genders. - BMI ≤35 kg/m2. - American Society of Anesthesiologists Physical Status (ASA-PS) Class I and II. - Patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery.

Exclusion Criteria:

* Refusal of procedure or participation in the study
* Patient under age of 18 years old or above 60 years' old
* Physical status: ASA-PS III or above.
* Pregnancy or lactation.
* Infection at site of injection.
* Psychiatric illness.
* CNS Diseases like (epilepsy, stroke ...etc.) or neurological disease affecting patient's upper limb.
* Evidence of coagulopathy or anticoagulation.
* Patients with respiratory disease, renal or hepatic insufficiency.
* infection of the skin in the puncture area.
* Allergy against any of the drugs to be used.
* Obesity (BMI \>35 kg/m2).
Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF.

This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.

The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems.

Secondary objectives are to :

* study long term patient satisfaction with their hip prosthesis,
* confirm the long-term safety of these implants by studying the possible complications observed,
* evaluate the performance of these implants using clinical scores.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old at the time of surgery,
* Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2010 and 31/12/2015,
* Affiliated to French health insurance system

Exclusion Criteria:

* Patient who has rejected to the use of his/her personal data,
* Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.