cyrilzakka/clinical-trials huggingface dataset:
10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease

The ARCTIC-FORWARD study is a multi-center prospective observational study investigating the long-term outcomes of rheumatoid arthritis (RA) patients who received structured treat-to-target therapy early in their disease. The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs.

Rheumatoid arthritis (RA) is one of the most common autoimmune diseases. Recent developments in RA treatment has shown to change the outcome of RA for the early stages of the disease, with very limited loss of work participation and high rates of disease activity remission. The data on the long-term outcome for patients who received early optimal treatment is much more limited, and it is of special clinical interest to know to what extent these patients should be monitored with regards to slowly evolving joint damage, subclinical inflammation, loss of physical function and loss of work participation.

The aim of this study is to assess clinical, radiographic and functional long-term outcomes of modern RA care and to identify risk factors for progressive disease.The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs. We will perform an extensive evaluation of all patients participating in the ARCTIC study 10 years after the initiation of structured treat-to-target therapy. Outcomes include disease activity, radiographic damage, functional status, DMARD use, extra-articular manifestations including interstitial lung disease, comorbidities, survival, work participation, health care resource use, and health related quality of life.

Eligibility Criteria:
Inclusion Criteria: All patients that entered the ARCTIC study are eligible for the follow-up study. The main inclusion criteria in the ARCTIC study were age 18-75 years, fulfilment of the 2010 ACR classification criteria for RA, DMARD naivety with indication from DMARD therapy, and symptom duration of less than two years.

Exclusion Criteria: Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible
Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders

Objectives: The aim of this research is to compare the effectiveness of myofascial release therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction syndrome.

Material and Methods: A single-blind randomized clinical trial will be conducted in a university research clinic. Sixty-four subjects with temporomandibular disorders and myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group (myofascial release protocol and Rocabado exercise therapy) and control group (exercise therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and joint sounds will be collected at baseline, and forty-eight hours after the intervention phase.


Eligibility Criteria:
Inclusion Criteria:

* Presence of myofascial pain with or without jaw opening limitation (Ia and Ib) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD).
* A chief complaint of acute pain (duration \< 6 months) in the temporomandibular joint on at least one side.
* The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
* Agreement to attend evening therapy sessions.

Exclusion Criteria:

* Subjects with dental pain or tender muscles caused by systemic diseases.
* Major psychological disorders.
* A recent history of trauma in the face and neck area.
* Subjects wearing full or partial dentures.
* Edentulism.
* Therapeutic co-interventions during treatment.
* Indication for surgical treatment of temporomandibular joint.
OTTAPE : Observatory on the Use of New Therapies (LED Photobiomodulation, Radiofrequency, Laser and Injectable Hyaluronic Acid) in the Treatment of Women's Pelvic-perineal Pathologies After Failure, Partial or Total, of First-line Medical Treatment

Women's pelvic-perineal pathologies are a very frequent reason for consultation in gynaecology. The symptoms reported are diverse and range from the most frequent (genital prolapse, urinary or anal incontinence, dysuria, chronic pain) to new complaints (dyspareunia, vaginal laxity, perineum scarring, vulvo-vaginal atrophy).

Currently, first-line medical treatments are no longer sufficient to improve patients. New therapies have emerged, namely LED photobiomodulation, radio frequency, Erbium or fractionated CO2 laser and injectable hyaluronic acid.

These new treatments have been used in common practice for several years, but no studies have standardized practices. There are no recommendations regarding these new therapies to give specific indications for their use.

The aim is to standardise the indications for these new technologies.

* LED photobiomodulation: management of scar perineas with pain, scarring disorders or trophic disorders.
* The Erbium laser or fractionated CO2: treatment of vulvo-vaginal atrophy.
* radiofrequency: management of chronic pelvic-perineal and postpartum pain.
* injectable hyaluronic acid: treatment of vestibulodynia and trophic disorders. Non-validated indications are proposed for these therapies (urinary incontinence, vaginal laxity and prolapse)

Initially, this involves the follow-up of patients treated in the Gynaecology-Obstetrics department of the University Hospital of Nîmes and the Karis medical centre of Perpignan for a pelvi-perineal pathology. Other centres will be gradually incremented. Patients will have received a letter of information and no objection to the prospective collection of her data as part of routine management without any other intervention. These patients should not have any contraindications to the use of these new therapies.

At inclusion, the patient receives a pelvic-perineal clinical examination and a functional assessment (vaginal sampling), pain (EVA). The FSFI questionnaire will be administered.

During this visit, the investigator will set up a treatment with a new therapy. This treatment will be chosen by the operator before recommendations are made. The operator must detail the type of device and the protocol chosen.

The patient will be reviewed 4 weeks after the end of her treatment: she will benefit from an evaluation identical in all respects to the inclusion visit with the administration of the PGI-I questionnaire.

All information concerning the discontinuation, continuation or change of treatment will be documented in this follow-up phase.

In case of failure, second line treatment may be offered. Possible adverse reactions will be collected at all times.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pelvic-perineal pathology
* Patients who are not opposed to prospective data collection.

Exclusion Criteria:

* Patients with contraindications to these new therapies
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward,

The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health.

This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

All participants:

* Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study
* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2

Participants with moderate or mild HI:

* Diagnosis of chronic (\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause.
* Is generally in good health with the exception of HI.

Healthy Control Participants:

* Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

All participants:

* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery.
* History of cancer
* Consumes greater than 3 servings of alcoholic beverages per day.
* Is on statin background therapy.

Participants with moderate or mild HI:

* Severe complications of liver disease within 3 months of entering the study.
The Effect of Telehealth Ontario on Non-urgent Emergency Department Use at The Hospital for Sick Children

The purpose of this study is to compare the rate of non-urgent emergency department use between three groups of patients: those who were referred to the emergency department by Telehealth Ontario; those who were referred by a physician; and those who arrived without being advised by a nurse or a doctor.

Some studies have shown that certain telephone nursing advice lines are effective in reducing non-urgent emergency department use. However, to my knowledge, no study has investigated the efficacy of Telehealth Ontario in particular. There are important differences between Telehealth Ontario and other phone lines that have been evaluated, in terms of the method in which calls are handled, the diversity of the population served, and the place of the phone-in line within the health care system. These studies, the results of which cannot be extrapolated directly to Telehealth Ontario, should not replace the direct study of the impact and utility of Telehealth Ontario.

Currently Telehealth Ontario receives over 3000 calls daily from residents of Ontario who are concerned about their health. These callers rely on the advise of Telehealth nurses to direct the care they seek out for themselves and for their families. The provincial government also relies on Telehealth Ontario - to provide a useful service within the health care system, relieving the pressure on over-crowded emergency departments by directing patients with non-urgent medical complaints to more appropriate avenues of treatment. This will be the first study to examine the impact of Telehealth Ontario. Although only a small aspect of Telehealth's impact will be examined - the impact on non-urgent emergency department use at Sick Kids - it is an important first step. The results of this study may serve to guide modifications to Telehealth that will make it more accessible to specific groups within the community, more reliable in the advice it provides, and more effective in delivering its message to callers.

Eligibility Criteria:
Inclusion Criteria:

All children presenting to the ED between 0600 and 2400 during the study period

Exclusion Criteria:

1. Children arriving without an adult, as consent could not be obtained.
2. Children with whose parents communication was not possible in English, as it was not possible to provide translation services for this study.
3. Children arriving by direct transfer from another hospital.
4. Children arriving by ambulance summoned by someone other than the parent or guardian.
5. Children arriving at the ED for a pre-arranged visit/appointment.
6. Children requiring immediate resuscitation.
Individual Placement and Support for Patients With Offending Histories

The overall aim of the study is to assess the feasibility of conducting a Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations.

This is a feasibility trial which aims to assess the feasibility of conducting a full Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations.

Given that IPS is a complex intervention, the design of this study has drawn from the principles set out in the UK Medical Research Council (MRC) Guidance on developing and evaluating complex interventions by defining three major research strands in order to achieve the specific objectives of the study as follows:

A. Implementation of IPS in community forensic services: The specific objective of this strand is to embed the IPS model in the community forensic services in which the feasibility study will be carried out (aided by an IPS Expert), by bringing an employment specialist into clinical teams, raising awareness about IPS within the organization, forming links with IPS services in the area and developing links with employers, as well as conducting IPS fidelity reviews.

B. Feasibility Cluster Randomized Controlled Trial (RCT): The specific objectives of this strand are to estimate the parameters required to design a full RCT including:

1. Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations.
2. The feasibility of randomization, recruitment and retention rates to the IPS and controls;
3. The suitability of the key outcome measures with respect to: reliability, acceptability, and distribution of the scores.

C. Process Evaluation: This will be carried out in parallel with the other two strands to meet other specific objectives by using the following methods:

1. Qualitative interviews with staff to identify the structural, legal, organizational and individual-level to barriers and facilitators to implementation of IPS in community forensic services.
2. Fidelity Reviews to assess the extent to which the services follow the principles of IPS and to assess how well the employment specialist functions within the community forensic services.
3. Qualitative interviews with patients assigned to IPS in order to assess their general views of IPS, benefits from participating, disadvantages from or dislikes about participating and barriers and facilitators to implementation.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 years
* Patients (females and males) on the caseload of the community forensic services

Exclusion Criteria:

* Patients unable to provide informed consent
* Patients not eligible to work in the UK
* Patients currently in open employment
* Patients who do not wish to work
Real-Time Internet Evaluation of Swallowing

The purpose of this study is to determine whether real-time internet evaluations of swallowing, or x-ray swallow studies viewed over closed internet circuit, are a reliable method of evaluating swallowing function.

The objective of this proposal is to establish the validity of an Internet based protocol for real-time, remote, telefluoroscopic evaluation of oropharyngeal swallowing function. The investigators will achieve this goal by testing the hypothesis that oropharyngeal swallowing function evaluated by an experienced speech-language pathologist (SLP) using a remote, interactive, real-time, dynamic Internet telefluoroscopic procedure, which was developed in the PI's laboratory, has an acceptable level of agreement with the evaluations performed by an experienced SLP who is present in the fluoroscopy suite and using the traditional videofluoroscopic methodology. In other words, the primary aim of this investigation is to determine whether the telemedicine approach to evaluation of swallowing function is reliable relative to the traditional method by which a clinician is in direct contact with a patient for a pre-examination interview, clinical examination, and videofluoroscopic evaluation of swallowing function. Confirmation of the reliability of the telefluoroscopic evaluation of oropharyngeal dysphagia (hereafter referred to as dysphagia) can result in equity of access for underserved groups for whom SLPs with expertise in evaluating swallowing function are locally unavailable. Ultimately, the success of this project could translate specialty services into routine clinical practice across the United States and globally.

Eligibility Criteria:
Inclusion Criteria:

* Stroke, Head \& neck cancer, referred for swallowing evaluation.

Exclusion Criteria:

* No stroke or no head and neck cancer, or not referred for swallowing evaluation.
DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure

The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure

The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent DMEK combined or not with cataract surgery

Exclusion Criteria:

* patients with other ocular comorbidity, and those who had graft after a first graft failure
Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have unresectable or metastatic biliary tract or gallbladder cancer.

OBJECTIVES: I. Determine the 6-month survival and overall survival of patients with unresectable or metastatic biliary tract carcinoma or gallbladder cancer treated with gemcitabine, fluorouracil, and leucovorin calcium. II. Determine the tumor response in these patients treated with this regimen. III. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes followed by leucovorin calcium IV and fluorouracil IV over 5-10 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed unresectable or metastatic biliary tract carcinoma (extrahepatic, intrahepatic, or ampulla of Vater) or gallbladder carcinoma Not amenable to combined chemotherapy and radiotherapy CNS metastases that are locally treatable (i.e., lesions treatable with surgery or radiotherapy) allowed if no evidence of progression for at least 4 weeks after completion of treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 times upper limit of normal (ULN) AST no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic or immunologic therapy No prior biologic or immunologic therapy for metastatic disease No concurrent immunotherapy No colony stimulating factors administered concurrently with first course of study therapy, or within 24 hours prior to subsequent courses Chemotherapy: See Disease Characteristics No prior gemcitabine No prior chemotherapy for metastatic disease At least 6 months since prior chemotherapy used as radiosensitization either in the adjuvant setting or for locally advanced disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: See Disease Characteristics
Long-term Results of Pediatric Flexor Tendon Injuries

Hand and upper extremity injuries are among the most common causes of admission of children to the emergency department since they are the most frequently injured part of body following head in pediatric and adolescent population. Although upper extremity fractures and contusions are the main reasons of pediatric hand injuries, tendon injuries are not also uncommon. There are limited data in the literature about the long-term results of children with flexor tendon injury. Therefore, the aim of this study was to evaluate the long-term functional outcomes of children with flexor tendon injury.

Hand and upper extremity injuries are among the most common causes of admission of children to the emergency department since they are the most frequently injured part of body following head in pediatric and adolescent population. Although upper extremity fractures and contusions are the main reasons of pediatric hand injuries, tendon injuries are not also uncommon. While extensor tendon injuries have been reported to be most frequent than flexor tendon injuries for all age groups, the ratio of flexor to extensor tendon injuries is higher in pediatric population than adults and in children younger than 10 years old flexor tendon injuries are more common than extensor tendon injuries.Despite some challenges in the treatment of flexor tendon injuries of children, the outcomes have been reported to be better in children than adults since they have better blood supply, more rapid tendon healing and better remodeling ability of scars and adhesions. However, there is still a risk of permanent morbidities such as significant scarring and stiffness which can cause worse functional outcomes.There are limited data in the literature about the long-term results of children with flexor tendon injury. Therefore, the aim of this study was to evaluate the long-term functional outcomes of children with flexor tendon injury.

Eligibility Criteria:
Inclusion Criteria:

* . Patients between the ages of 6-18 who have applied to orthopedics emergency department due to hand injury and have been operated with flexor tendon injury, for the last 3 years

Exclusion Criteria:

* The patients who had history of bilateral hand injury, delayed surgery, accompanying extensor tendon injury and a follow-up less than six months after injury were excluded from the study.