cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, 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 would preclude contact lens wear, in the opinion of the investigator;
* Monovision contact lens wear;
* Other protocol-defined exclusion criteria may apply.
Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery

The investigators investigate the prevalence of PTPS in patients receiving with uniportal video-assisted thoracic surgery (VATS), and early identify neuropathic pain as well as treated with neural protective strategy to target intercostal nerve.

More than 30% of patients have persistent pain after thoracic surgery. Intercostal neuralgia is characterized by neuropathic pain in the distribution of affected intercostal nerve(s) (along the ribs, chest, or abdomen) that commonly manifests as a sharp, aching, radiating, burning, or stabbing pain and may be associated with paresthesia such as numbness and tingling. The pain may be intermittent or constant and typically presents as a band-like pain that is wrapped around the chest and back or in a thoracic dermatomal pattern. Pain may last for a prolonged period and may continue long after the disease process has subsided.

Hypertonic dextrose injection (prolotherapy) is reported to reduce pain, including non-surgical chronic low back pain (CLBP), and subcutaneous injection of 5% dextrose is said to minimize neurogenic pain hyperalgesia and allodynia. The mechanism in both cases is unclear, though a direct effect of dextrose on neurogenic pain has been proposed. This study assessed the short-term analgesic effects of epidural 5% dextrose injection compared with saline for non-surgical CLBP.

Intercostal nerve damage is a suspected pathogenic mechanism for developing post-thoracotomy pain syndrome (PTPS). Video-assisted thoracic surgery (VATS) is a minimally invasive procedure that potentially reduces PTPS. However, there was no specific outcome study for uniportal VATS.

In this study, the investigators investigate the prevalence of PTPS in patients receiving uniportal video-assisted thoracic surgery (VATS), identify neuropathic pain early, and treat it with a neural protective strategy to target intercostal pain nerve.

Eligibility Criteria:
Inclusion Criteria:

* PTPS after single port VATS

Exclusion Criteria:

* abnormal sensation
* can not complete questionnaire
* others cause of pain
Vitamin D Supplementation Can Improve Heart Function in Idiopathic Cardiomyopathy

Vitamin D deficiency could be a high risk for cardiovascular diseases. It has been recently reported that vitamin D deficiency is another cause of heart failure and cardiomyopathies. It was found that vitamin D supplementation improved the heart function. The purpose of this study is to evaluate patients with idiopathic cardiomyopathies and determine whether vitamin D supplementation in cases where there is a deficiency, improves heart functioning.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic cardiomyopathy

Exclusion Criteria:

* Post heart surgery
* Congenital heart disease
500mg Fulvestrant in HR+ MBC

To study the real world use of 500mg Fulvestrant in HR+ MBC.

An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with ER/PR+，HER2- advanced breast cancer
2. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.

3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015.

4.Available medical history

Exclusion Criteria:

1. Incomplete medical history
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
Clinical Feasibility Study of the BariTon™ System in Obese Patients

Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged between 25 and 60 years inclusive
2. A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program
3. Stable weight, i.e. \< 5% change in body weight for minimum of 3 months prior to enrolment
4. Willing and able to provide written informed consent
5. Willing and able to comply with the study procedures and follow-up schedule
The Effect of Motor Imagery and Action Observation on Motor Skill Acquisition

The aim of this study is to investigate the effects of Motor Imagery and Action Observation on Motor Skill Acquisition in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Right hand dominance

Exclusion Criteria:

* Individuals with neurological, orthopedic, or rheumatological disease (for example: stroke, essential tremor, tennis player, trigger finger, rheumatoid arthritis, etc.)
* Severe cognitive problems
Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy

The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.


Eligibility Criteria:
Inclusion Criteria:

* Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
* Further criteria as defined in the study protocol

Exclusion Criteria:

* Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments
* Clinically relevant perennial allergy/-ies other than house dust mites allergy
* Contraindication to any study test or procedure
* Further criteria as defined in the study protocol
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive Advanced Non-small Cell Lung Cancer

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*0201 or HLA-A\*0206 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.

The investigators previously identified three novel HLA-A\*0201 or HLA-A\*0206-restricted epitope peptides, which were derived from a cancer-testis antigen, URLC10, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HHLA-A\*0201 or HLA-A\*0206-positive advanced non-small cell lung cancer patients who failed to standard therapy.

Eligibility Criteria:
Inclusion Criteria:

1. NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
2. ECOG performance status 0-2
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*0201 or HLA-A\*0206
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
GIP/GLP-1 Co-Activity in Subjects With Obesity: Lowering of Food Intake

We aim to delineate the effects of separate and combined infusion of GIP and GLP-1 on food intake, appetite, bone health and fat metabolism in overweight/obese subjects.

The gut-derived incretin glucagon-like peptide-1 (GLP-1) is a potent regulator of gastric emptying, appetite and food intake in humans whereas its sister incretin hormone, glucose-dependent insulinotropic polypeptide (GIP), does not seem to have independent effects on these variables in humans. Interestingly, recent data from rodents have shown that concomitant activation of the GIP and the GLP-1 receptor may potentiate the satiety-promoting and body weight-reducing effects of GLP-1. Also, evidence suggests that GIP may be an important mediator of bone remodelling and lipid deposition. The effect of simultaneous activation of the GIP and GLP-1 receptors on appetite, food intake, fat metabolism and bone health has not been thoroughly examined in humans. The aim of this study is to delineate the effects of GIP/GLP-1 receptor co-activation on food intake, mechanisms regulating food intake, fat and bone metabolism in obese subjects.

Material and methods:

The investigators plan to include 18 obese/overweight men without diabetes. The primary endpoint of the study is food intake during continuous intravenous infusions of saline (placebo), GIP, GLP-1 and GIP+GLP-1, respectively. Secondary endpoints includes resting energy expenditure (measured by indirect calorimetry), appetite, satiety and hunger assessments (measured by visual analogue scales), plasma insulin, C-peptide and glucagon secretion, plasma triglycerides, cholesterols, and free fatty acid responses and changes in plasma bone turnover markers.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men
* Age between 25 and 70 years
* Body mass index (BMI) between 25 and 40 kg/m2

Exclusion Criteria:

* Diabetes or prediabetes (defined as glycated haemoglobin (HbA1c) ≥ 43 mmol/mol)
* Anaemia (defined as haemoglobin \< 8.3 mmol/l)
* Any gastrointestinal disease that may interfere with the endpoint variables
* Anorexia, bulimia or binge eating disorder
* Allergy or intolerance to ingredients included in the standardised meals
* Tobacco smoking
* Any regular drug treatment that cannot be discontinued for minimum 18 hours
* Any physical or psychological condition that the investigator feels would interfere with trial participation
Biopsychosocial Impact on Caregivers in Patients Undergoing Joint and Spine Surgery

The purpose of this study is to describe the biopsychosocial impact of caregivers in patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability to provide care following surgery on a loved one.

This is a pilot feasibility study with the goal of enrolling 50 caregivers in each surgical subgroup, with a total of 150 subjects. Caregivers for patients undergoing the above surgeries will be administered Patient Reported Outcome Measurement Information System (PROMIS) measures preoperatively, 7 days postoperatively, 14 days postoperatively, and 1 month postoperatively. PROMIS item banks will include Global Health, Anxiety, Fatigue, Depression, Self Efficacy, Social Satisfaction, and Sleep Disturbance. If the caregiver reports the presence of persistent pain, Pain Interference and Physical Function will be administered.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Are the primary person helping in the recovery of a patient undergoing one of the following surgeries below with in the first 30 days after surgery Total knee arthroplasty Total hip arthroplasty Cervical/Thoracic/Lumbar spine surgery
* Able to understand English and can verbalize their pain level

Exclusion Criteria:

* Younger than 18 years old
* Refuse participation
* Cannot understand English
* Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)
Early Intervention for Information Processing Speed Deficits in Acute SCI: A Pilot Study

This study seeks to conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.

Spinal cord injury (SCI) newly affects approximately 18,000 persons in the US per year. Decades of research have focused on the physical limitations associated with SCI, as well as therapies for addressing these physical problems. However, it is becoming better acknowledged that many individuals experience significant problems with their cognitive abilities, such as attention, memory, and the time it takes them to process information. Research has shown that people who have cognitive difficulties, compared to those with a purely physical disability, are less likely to be employed, engage in fewer social and work-related activities, have greater difficulties carrying out routine household tasks, and are at higher risk for mental illness. If cognitive issues arise after an SCI, it is more likely that a person would have a more challenging time adapting the many lifestyle changes brought about by their injury, would benefit less from their rehabilitation program, and have more difficulty rejoining the workforce. As it stands, cognitive assessment or rehabilitation is not part of the standard of care for individuals after their SCI because of the relative lack of research in this area. This study seeks to conduct a multisite pilot study to test whether a cognitive training program can improve processing speed abilities in individuals shortly after they experience their SCI, with the hopes that this early intervention will improve the trajectory of their overall health and well-being.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* recent traumatic SCI (approximately 6 months post-injury)

Exclusion Criteria:

* no other significant neurological, psychiatric or substance use history
* no significantly impairing visual disturbance
Risk and Protective Factors of Children and Adolescents Who Were Hospitalized Due to Alcohol Intoxication

The aim of the study is to improve the prognosis of the development of alcohol consumption by considering a variety of biological, psychological and social risk and protective factors. Therefore, young people who have been hospitalized due to acute alcohol intoxication within the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired psychosocial development. The study will also include a control group of young adults who were in hospital due to other medical conditions. The identification of relevant cases will be based on medical records of several children's hospitals. These records will be analysed with regard to potential predictors of developmental hazards and protective factors.


Eligibility Criteria:
experimental group:

Inclusion Criteria:

* male and female volunteers who were hospitalized due to acute alcohol intoxication from January 1, 2000 to December 31, 2006
* written informed consent by the subject
* minimum age of 20 years

Exclusion Criteria:

* incapability to conduct interview

control group:

Inclusion Criteria:

* male and female volunteers who were hospitalized due to other medical conditions but not acute alcohol intoxication from January 1, 2000 to December 31, 2006
* written informed consent by the subject
* minimum age of 20 years

Exclusion Criteria:

* incapability to conduct interview
The Impact of Different Simulator Characteristics on Transfer of Learning

This study aims to explore the impact of different simulator characteristics on transfer of learning.

During an ISUOG basic training course, participants will be randomly assigned to 30 minutes of simulator training during which time they will practice the 2nd trimester US scan. A total of four different simulators are being used for training. After completing the practical basic training session, they shift the type of simulator that they trained on to one of the remaining three simulators. On this simulator, they are required to perform selected planes for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine specialists using the ISUOG 20 planes checklist. The performances of participants coming from each of the four simulators are examined and the role of 1) type of simulator interaction (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image acquisition (real US images vs. computer-generated images) are examined.

Eligibility Criteria:
Inclusion Criteria:

ISUOG course participants

Exclusion Criteria:

More than 50 independent 2nd trimester US scan before attending the course.
Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

Fatigue is a common symptom and a leading concern in patients with inflammatory bowel disease (IBD) and often persists despite clinical and endoscopic remission.

This study evaluates the metabolomic profile of fatigued patients with IBD.

To date, there is only one non-published study using metabolomics in quiescent IBD patients with and without fatigue.

The investogators designed this study to examine if there are metabolomics factors associated to fatigue in IBD patients.

This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent. (1) IBD outpatients attending the Hospital de Sabadell Gastroenterology Day-care unit were consecutively included for analytical monitoring of immunosuppressant treatment or infliximab infusion.

The investigators recorded demographic data, IBD classification according to the Montreal classification, and history of drug administration. In addition, clinical activity of the disease was measured using the Harvey-Bradshaw score for Crohn's disease (CD) and the modified Mayo score for ulcerative colitis (UC). The "Functional Assessment of chronic Illness Therapy-Fatigue" (FACIT-F) was used to assess fatigue.

Eligibility Criteria:
Inclusion Criteria:

- Inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) .

Exclusion Criteria:

* Age below 18 years.
* Refusal to give written informed consent prior to participation
* Active infection at the time of inclusion.
* Concomitant diseases not related to IBD (e.g., cancer, heart disease, pulmonary disease) that might contribute to the presence or the severity of fatigue.
* Active flare of IBD in the last 3 months.
Can Technology-Assisted Toilets Improve Hygiene and Independence in Geriatric Rehabilitation? A Cohort Study

Toileting is a private activity of daily living. Geriatric rehabilitation patients are often unable to toilet themselves independently, leading to embarrassment and loss of self-esteem. Relationships with their caregivers may also become strained. Furthermore, improper toileting hygiene can lead to skin irritation, breakdown and infection.

Technology-assisted toilets (TATs) clean and dry the anal and vaginal regions using a stream of water and a fan. They can therefore potentially eliminate the need for patients to be able to wipe themselves. TATs are operated using wall-mounted remote controls. This study will examine the potential benefits of TAT use in geriatric rehabilitation patients.

Forty patients aged ≥65 years referred for treatment of physical impairments to the Geriatric Rehabilitation Unit (GRU) of the Elisabeth Bruyère Hospital (EBH) will be recruited for this study. Participants will have a bowel movement on two occasions, once using toilet paper and once using the TAT. The Psychosocial Impact of Assistive Devices Scale (PIADS), a validated questionnaire, will be used to analyze participants' toileting experience. Participants will be visually evaluated for cleanliness before and after each testing session.

The investigators hypothesize that participants will report that, in comparison with use of a standard toilet, toileting using the TAT: 1) is easier to use, 2) improves psychological well-being and 3) is more effective at cleaning than regular wiping techniques.


Eligibility Criteria:
Inclusion Criteria:

1. over the age of 65
2. inpatients at the EBH GRU
3. can communicate effectively in English or French
4. are able to remain balanced while sitting on a toilet
5. are able to physically use the remote control
6. are able to wipe themselves, but they do not need to be able to wipe themselves effectively

Exclusion Criteria:

1. are cognitively unable to provide informed consent
2. are severely aphasic
3. are undergoing treatment that interferes with toileting
4. have any conditions that increase perineal sensitivity such as ulcers, wounds, or infections
5. require two people to assist them in transferring to and from the toilet
6. are under isolation precautions