cyrilzakka/clinical-trials huggingface dataset:
Nurse Specialist Intervention Promoting Altered Coping and Treatment for Chronic Pain

The aim of this study is to investigate of the implementation of an autonomous consultation with a nurse pain specialist for chronic pain patients has an influence on the behaviour towards the chronic pain. The trail will be done with patients that has planned an infiltration in a pain centre. Furthermore the pain intensity and patent satisfaction will be investigated as second outcomes.

During the consultation there will be explained what the patient can expect from the treatment in the pain clinic. What the patient expect from the infiltration will also be surveyed, so that it can be adjusted if necessary. In the end of the consultation there will be a brief explanation of chronic pain and the physiology as well als the different factors that have an influence on it.

This study is a monocentric randomised controlled trail of 172 participants, with an equal allocation (1:1). To collect the data there will be three different questionnaires for both groups. The first is a baseline measurement. The second will take place three weeks after the infiltration and the third ten weeks after the infiltration. This is in order to see if there is an evolution in the outcomes during time.


Eligibility Criteria:
Inclusion criteria:

* Patients that have an appointment for a treatment
* Patients with chronic pain, so 3 months or more and of functional dysfunction because of the pain.
* Patients that are receiving a spinal treatment form the cervical, thoracic or lumbar spine.
* The patient has to understand the Dutch language.

Exclusion criteria:

* Patients with a neurostimulator, an intrathecal medication pump or patients that already has an appointment at the consultation in the pain clinic. They have an doctor- patient relationship and that can cause bias.
* People who are legally incapable (persons younger then 18 years, persons with dementia, other cognitive diseases.
* People with facial pain. Here is the necessity of quick treatments. Or they already take place in other studies.
* People who are interned or detained. There is no possibility of follow-up.
* Palliative, oncologic or in hospital patients
* Patients who need a emergency treatment, because it is mostly acute or sub acute pain.
Internet-delivered Cognitive Behaviour Therapy for Chronic Conditions: Comparing Low Intensity Delivery Models

Chronic health conditions (e.g., heart disease, cancer, diabetes) represent any physical condition that persist for 3 months or more that requires ongoing management. Chronic health conditions are very common, and increase in prevalence with age. Internet-delivered Cognitive Behaviour Therapy (ICBT) is a promising approach for overcoming these barriers, and improving access to mental health care. In ICBT, clients receive content from traditional face-to-face CBT over the Internet, while receiving support and assistance from a guide through secure e-mail. The Chronic Conditions Course is an 8-week, 5 lesson ICBT program that consists of education and relapse prevention as well as cognitive, behavioural, and physical strategies for managing chronic conditions. This intervention has traditionally been delivered either with no support or with weekly brief (15 minute) individual therapist guidance via email and phone. However, in order to provide a faster response to clients using an on the demand (responding as quickly as possible and for sure within one business day team based approach (e.g., first available therapist responds) may be beneficial.

The proposed trial will examine the Chronic Conditions Course delivered by a team at the Online Therapy Unit based at the University of Regina versus a self-directed program. In the team based approach, participants will be able to contact the Online Therapy Unit if they have any questions regarding the content of the Chronic Conditions Course during the 8 week program. Participants in this group will receive a response from one of the members of the team within one business day. In the self-directed group, clients will receive automatic messages from the Online Therapy Unit that encourage participation during the 8 week program but otherwise will work on the course on their own. All participants will complete questionnaires prior to the start of the program, before each lesson of the program, once they have completed the program, and 3 months after completing the program. The primary outcome measures include anxiety and depression. Secondary outcomes include fatigue, pain, self-efficacy, disability, overall quality of life, and life satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* residing in Canada
* endorsing symptoms of anxiety or depression
* diagnosed with a chronic medical health condition
* chronic condition does not impact ability to complete treatment (ex. cognitive impairment)
* able to access a computer and internet service
* willing to provide a physician as emergency contact

Exclusion Criteria:

* high suicide risk
* suicide attempt or hospitalization in the last year
* primary problems with psychosis, alcohol or drug problems, mania
* currently receiving active psychological treatment for anxiety or depression
* not present in country during treatment
* concerns about online therapy
The Effect of Thoracic Manipulation on Upper Body Stability in Basketball Athletes

Basketball is the most popular sport in the world and has become even more popular as a result of the attention it has received.

The aim of our study was to see the effects of thoracic manipulation on upper body balance in addition to exercise programs of athletes.

Eligibility Criteria:
Inclusion Criteria:

* Male individuals aged 14-19 years
* Being a basketball athlete
* Regular participation in training

Exclusion Criteria:

* Known neurological disorder
* Serious orthopedic conditions that prevent exercise
* Cognitive impairment
Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.

The objectives of this study are to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment and to capture safety data of the procedure.

The safety assessment measure is the incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment.

Performance will be measure by assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the Numeric Rating Scale (NRS)

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 30 years or older
* Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG)
* Patient has a score of 6 or higher on the Numeric Rating Scale (NRS)
* Evidence that the subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes
* Evidence that the subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation

Exclusion Criteria:

* Subject diagnosed with a nociceptive chronic pain syndrome
* Subject does not agree to participate or is unlikely to participate for the entirety of the study
* Subject is currently participating in another clinical investigation with an active treatment arm
Development of a Model-based Working Memory Training and Investigation of Its Comparative Efficacy

This study is to investigate the efficacy of model-based Working Memory (WM) training using an appropriate control condition. The interventions are a model-based, a single-task and a multiple-task training on WM in order to compare the efficacies of these different training approaches for WM. A sham intervention acts as active control group. Each intervention will be presented on a tablet device.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature

Exclusion Criteria:

* Medical history of neurological or psychiatric disorders
* Any history of substance abuse
* Color vision deficiency
* Inability to used table devices
* Montreal Cognitive Assessment \< 26
A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines

A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.

Clarification regarding injection volumes for the different study groups:

Subjects will be randomized to Group A or Group B (1:1).

* Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be injected (equal to a dose of 10s.U.)
* Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be injected (equal to a dose of 10s.U.).

The two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A) will be compared as described under objectives.

Eligibility Criteria:
Key Inclusion Criteria:

* Women, 18 to 64 years of age
* Subjects seeking treatment for moderate to severe glabellar lines when the severity of these lines has an important psychological impact on the subject, as determined by the investigator.

Key Exclusion Criteria:

* Subjects previously treated with any botulinum toxin product.
* Pregnant or breast feeding women or women intending to get pregnant in the next 12 months.
* Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
* Subjects with clinical or subclinical neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert Eaton syndrome or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration.
* Subjects with previous or current diagnosis of Bell's paresis.
* Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
* Subjects who are taking anticholinergics or aminoglycoside antibiotics.
* Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results.
* Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening.
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes

The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.

Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.

Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.

The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-75 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.0 and 38.0 kg/m\^2 (both inclusive)
* HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening
* Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
* Oral or injectable GLP-1 Receptor Agonists

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)

Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35
* type 2 diabetes
* HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
* able to consent

Exclusion Criteria:

* pregnancy
* past esophageal, gastric or bariatric surgery
* irritable bowel, unexplained intermittent vomiting, severe abdominal pain, chronic diarrhea or constipation
* history of gastric or duodenal ulcers
* pre-operatory hypoalbuminemy
* history of renal, hepatic, cardiac or pulmonary severe disease
* taken of corticosteroid in the last month
* evidence of psycological problem that may affect the capacity to understand the project and to comply with the medical recommandations
* history of drug use or alcool abuse in the last 12 months
* history of gastro-intestinal inflammatory diseases
Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer

All patients will receive IL-2 (14 planned doses with an additional cycle 14 days after the first). Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to SBRT arm will receive two doses of SBRT on the Wednesday and Friday before the Monday on which IL-2 starts.

All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intraveneous bolus (IVB) every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gray (Gy) on the Wednesday and Friday before the Monday on which IL-2 starts.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of predominant conventional (clear cell) renal cancer
* Patients must be ≥ 18 years of age
* Tumors amenable to SBRT in lungs (central locations preferred), mediastinum, chest wall, bones with a soft tissue component (other than long bones), or liver, liver hilum and associated lymph nodes (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of protocol treatment. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy
* Patients must agree to participate in the Prometheus IL-2 patient registry (PROCLAIM registry)
* Patients must sign a study-specific consent form

Exclusion Criteria:

* No metastatic site amenable to SBRT
* Patients with brain metastases not candidates for radiosurgery alone
* Previous radiation to sites proposed for SBRT
* Patients with active systemic, pulmonary, or pericardial infection
* Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
* Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG
* Clinically significant underlying pulmonary disease as measured by pulmonary function tests
* Blood tests within protocol-specified range
* Need for chronic steroids
Glucose Control in Pre-Diabetic Renal Transplant Patients

Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system.

It is believed that in many patients the development of overt NODAT is preceded by a phase of impaired glucose tolerance that is called pre-diabetes.

This study aims at improving glucose metabolism in patients after kidney transplantation who are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for three months.

The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to improved glycemic control compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Time since renal transplantation \> 6 months
* Stable graft function
* Routine OGTT has been performed, and pre-diabetes has been diagnosed by pathological OGTT (2h, 75 g glucose, glucose level between 140 and 200 mg/dl)
* Informed consent of the patient

Exclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Patients with NODAT (2h glucose level at OGTT \>200 mg/dl)
* allergy against vildagliptin or pioglitazone
* pregnancy
* GFR\<15ml/min/1.73 with need for dialysis
* hepatic impairment
Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye

The primary objective of this study was to assess the efficacy and safety of different doses of rhNGF when administered as eye drops to patients with dry eye.

This is an open-label study evaluating safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops at different doses in patients with Dry Eye

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, ≥ 18 years old;
2. Required use of artificial tears for the treatment of Dry Eye within the 3 months prior to study enrolment;
3. Current use or recommended use of artificial tears for the treatment of Dry Eye;
4. Average VAS score for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm;
5. Corneal staining score with lissamine green \> 3 using the NEI corneal grading system in the worse eye (study eye);
6. Conjunctival staining score \> 3 using the NEI conjunctival grading system in the worse eye (study eye);
7. Schirmer test without anaesthesia ≤ 10 mm/5 minutes in the worse eye (study eye);
8. Tear film break-up time (TBUT) ≤ 10 seconds in the worse eye (study eye);
9. A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

1. Patient not suitable to participate in the study in the opinion of the investigator;
2. Patient with a mild or moderate Dry Eye condition (severity level less than 3 according to the Report of the International Dry Eye Workshop -DEWS, 2007) if fourteen (14) patients with mild or moderate dry eye condition have been already enrolled in the current treatment group (Group 1 and Group 2 separately);
3. Patient has had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or has a clinically significant allergy to drugs, foods, amide local anaesthetics or other materials including commercial artificial tears containing Hypromellose (in the opinion of the investigator);
4. Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment. Use of own artificial tears is allowed until Visit 2;
5. Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye within 30 days of study enrolment;
6. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye;
7. Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results;
8. Use of therapeutic or Refractive Contact lenses in either eye within 30 days of study enrolment;
9. History of ocular surgery in the study eye, including corneal refractive procedures, within 90 days of study enrolment;
10. Participation in another clinical study at the same time as the present and within 30 days of study enrolment;
11. History of drug, medication or alcohol abuse or addiction.