cyrilzakka/clinical-trials huggingface dataset:
Korean College of Rheumatology Biologics and Targeted Therapy Registry

We established a nationwide biologics and targeted synthetic DMARDs registry (in the form of an inception cohort) to study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis patients receiving biologics or targeted synthetic DMARDs. As this registry is to observe the "real world" use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is planned.

This registry is a multi-center, prospective, observational program that will gather and analyze data on patients being treated with biologics and targeted synthetic DMARDs in Korea. In contrast to a controlled clinical trial, there is no imposed experimental intervention and solely the patients' physicians will determine the patient's treatment. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment with biologics or targeted synthetic DMARDs. There will be no additional visit or laboratory test done outside the routine clinical practice. The selection of the agent, dosing, and treatment duration is determined by the investigator. Informed consent will be obtained from the patient prior to the collection of any data.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with RA, AS or PsA
* RA deemed by their rheumatologist to require treatment with a biologic or targeted synthetic DMARDs or a conventional DMARD(s)
* AS or PsA patients who are to initiate, restart or switch to a biologic agent or a targeted synthetic DMARD
* Patients who provide a written consent of participating in this registry (data collection and review).

Exclusion Criteria:

* RA, AS, PsA patients who are already on biologics or targeted synthetic DMARDs upon screening
Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

The purpose of this protocol is to provide continued acess to immunosuppressive medications to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.

Study acronym: EXIIST - Extended Immunosuppression in Islet Transplantation

Islet transplantation is an experimental therapy in people with difficult to control Type 1 diabetes (T1D). Insulin producing cells (islets) are isolated from a pancreas. After the cells are prepared, the islets are put into the subject's liver. These transplanted islets may produce insulin that the subject's islets can no longer make. In order to help keep up the function of the transplanted islets, immunosuppressive medications must be given indefinitely or for as long as the study doctor determines is necessary. The medications serve to modify the immune system that normally tries to destroy (reject) new islets.

Participants in this study have received up to three islet cell infusions as a previous participant in the ITN005CT (NIS01) protocol. They also received a maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (Prograf®), sirolimus (Rapamune®), mycophenolate mofetil (MMF, Cellcept®), and/or mycophenolic acid (MPA, Myfortic®).) This protocol provides a way to supply these immunosuppressive medications to subjects whose islets continue to function and make C-peptide.

Routine study follow-up visits will occur on an annual and -as warranted basis.

Eligibility Criteria:
Inclusion Criteria:

* Participation in clinical trial ITN005CT (reference: ClinicalTrials.gov record NCT00014911) at Harvard University (Massachusetts General Hospital), Washington University, or University of Miami.
* Immunosuppressive regimen consisting of a single agent or some combination from among the following: tacrolimus, sirolimus, mycophenolate mofetil, and mycophenolic acid.
* Willingness of participants to use an approved method of contraception before, during, and 12 weeks after study participation.
* Peak C-peptide \>0.1 pmol/mL during a mixed meal tolerance test (MMTT) within 12 months of the screening visit.

Exclusion Criteria:

* Inability to understand and sign the informed consent document for this study.
* Any medical condition which in the opinion of the investigator should preclude participation.
* Serum creatinine \> 1.6 mg/dL
* Insulin requirement \> 1.0 IU/kg/day
* Hemoglobin A1C (HbA1C) result \> 12%
* Hypoglycemia unawareness defined as the absence of adequate autonomic symptoms at plasma glucose levels of \< 54 mg/dL requiring treatment with glucagon, outside assistance, or treatment in an emergency room or hospital within a 12-month period
Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

The aim of this study is to investigate the impact of cognitive behavioural therapy for insomnia on adherence to endocrine therapy medication in breast cancer survivors.

Approximately 70% of breast cancer cases are hormone-receptor positive, therefore treatable with endocrine therapy medication. When taken as prescribed, this is effective in reducing the risk of breast cancer recurrence following primary treatment. However, research indicates that nonadherence (not taking medication as prescribed, whether due to forgetfulness or deliberately missing a dose) is an issue, with side effects being a consistent predictor of nonadherence. Sleep problems are one of the most common endocrine therapy side effects. The aim of this study is to explore the influence of cognitive behavioural therapy for insomnia (CBT-I) on endocrine therapy adherence in breast cancer survivors.

Participants will be randomised to 1 of 2 groups: intervention, or waitlist control. Both groups will complete measures of sleep and other endocrine therapy side effects (depression, anxiety, fatigue, musculoskeletal pain, and vasomotor symptoms) at baseline, post-intervention, and 12-week post-randomisation follow-up. Following randomisation, the intervention group will receive 4 weekly group CBT-I sessions remotely through videoconferencing, whereas waitlist control participants will receive the intervention after 12 weeks, once all measures are completed.

Primary outcome will be self-reported endocrine therapy adherence, with secondary outcomes including insomnia symptoms and other endocrine therapy side effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer
* Aged 18 or over
* Currently prescribed endocrine therapy medication
* Experience symptoms of insomnia
* Self-reported nonadherent to ET medication (e.g. forgetting to take, or deliberately taking a break from medication)
* Proficient in English language
* Access to videoconferencing

Exclusion Criteria:

* Undertaking shift work (i.e., irregular or night shifts)
* Pregnancy or breastfeeding
* Other unstable physical or mental health problem (including substance misuse)
* Received CBT-I within past 12 months
* Received chemotherapy or radiotherapy within past 4 weeks
Female Experiences and Brain Activity

The Female Experiences and Brain Activity study will investigate how different groups of people process information in different ways. Using electro-physiological methods it will investigate differences in brain activity between women with ADHD, women with bipolar disorder and those without a psychiatric illness. It will also investigate the relationship between patterns of brain activity, mood and functioning.

Attention deficit hyperactivity disorder (ADHD) and bipolar disorder (BD) affect approximately 2.5% and 1%, respectively, of the adult population in the UK. They represent a major clinical and economic burden on society. Genetic and environmental risk factors (such as life events for BD); have been identified for each disorder. Despite the highly different symptom presentations for ADHD and BD, it has recently become clear that they share a cognitive characteristic, observed in high response time variability (RTV). This has led to the question of whether the increased RTV, which reflects short-term fluctuations in performance, is a non-specific marker for psychopathology or whether the causes for the higher RTV could differ across disorders. RTV has been identified as a possible early marker of psychopathology; therefore a better understanding of the underlying mechanisms could lead to improved diagnosis and prevention of negative consequences. Further, it will give insight into the comorbidity observed between ADHD and BD. This study will use cognitive-electrophysiological methods to investigate the causes for RTV and its association with other cognitive and neurophysiological impairments observed in each disorder (aim 1). The second question will address whether, within each disorder, current cognitive functioning relates to the patients' current social functioning (aim 2). Adverse life events and other psychosocial risk factors can contribute to high variability in the level of social functioning observed, within and between individuals, in each disorder; yet our understanding of the association between current social functioning and cognitive functioning is limited. Finally the study will explore if any cognitive differences detected by electrophysiological investigation are associated with any candidate gene markers for either disorder (aim 3).

Eligibility Criteria:
Inclusion Criteria:

* current clinical diagnosis of adult ADHD
* or current clinical diagnosis of Bipolar Disorder
* or no history of psychiatric illness
* white European descent

Exclusion Criteria:

* presence of a neurodevelopmental disorder
* epilepsy
* brain injury
* dyslexia
* limited proficiency in English language
* IQ\<70
* any current psychiatric medication use (with the exception of mood stabilisers or stimulant medication in the clinical groups)
Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

A prospective randomized study included 210 patients with Unexplained infertility subjected to coupled ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained infertility (UI)

Exclusion Criteria:

* body mass index (BMI) ≥35 kg/m2,
* Follicle Stimulating Hormone \>10 International Unit /Litter in early follicular phase,
* diagnosed cause of infertility, menstrual cycle irregularity,
* ovarian cysts,
* sever cervical stenosis,
* former IUI,
* ongoing pregnancy and
* renal or hepatic diseases were all the exclusion criteria.
Air Barrier System for the Prevention of Prosthesis-related Infections

This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.

This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis-related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision.

This research will evaluate ABS performance in a prospective, randomized, blinded multi-center trial. The surgical procedures studied will include total hip arthroplasty, trauma-related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic vascular graft procedures. Patients will be enrolled during the first two years of the study, and CDC guidelines require a one year follow-up period to monitor patients for potential prosthesis-related infections.

Eligibility Criteria:
Inclusion Criteria:

* Total hip arthroplasty;
* Acetabular repair with instrumentation;
* Posterior lumbar, cervical, or thoracic (up to and including 6 vertebral levels) spine fusion with instrumentation and vascular prosthetic graft implantation.

Exclusion Criteria:

* History of prior prosthesis infection;
* Active infection;
* Open traumatic wounds as is the case after some acetabular fractures.
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys

Study design:

Double blind, randomized, placebo controlled study. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1.

The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo


Eligibility Criteria:
Inclusion Criteria:

* Boys aged ≥10years old
* Prepubertal - Tanner stage 1 (gonadarche) (testicular volume\<4)
* Height and weight ≤ 10th percentile for age and gender.
* Height-SDS ≥ -2.5 SDS
* BMI-SDS\>-3 SDS
* Low proportion between weight and height
* Signing inform consent forms

Exclusion Criteria:

* Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH
* Any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
* Any known gastrointestinal disease including malabsorption
* Any known organic reason for growth retardation
Evaluation and Medico-Economic Study of FIBROSCAN in Patients With Viral Hepatitis

A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. This transversal study aims to compare the evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550 consecutive patients taken in charge for a liver biopsy. The results of the study will compare the respective performances of these techniques in the prediction of the METAVIR score, and help in the recommendation of the care of patients with viral hepatitis B and C; these methods will undergo a medico-economic study.

The gold standard for the evaluation of fibrosis is considered as the METAVIR score by the clinicians. The results of this score are currently used for clinical decisions and description of the evolution of the disease. FIBROSCAN would be interesting in avoiding liver biopsies, if it was able to predict accurately the METAVIR score obtained if a liver biopsy was performed. The data available on diagnostic performances of FIBROSCAN are incomplete, the number of patients studied and the methods selection (blindness of the results of other techniques) are not precise in some of them. The main objective of this study is therefore to evaluate the performance of FIBROSCAN in the prediction of METAVIR score \> 2 (vs F0 or F1). An ancillary study will try to evaluate the diagnostic performance of FIBROSCAN in the global prediction of METAVIR score. A statistical method will be tested using the reference method as an ordinal polytropic variable. Half of the sample (1250 patients) will be used to determine the best THERSHOLD of FIBROSCAN in each of the clinical subgroups of patients, in order to obtain a high sensibility. The second half will be used as the validation sample, and the threshold will be used to estimate the sensibility, specificity and other diagnostic parameters of the FIBROSCAN. The secondary objectives are:

1. to evaluate the performance of FIBROSCAN in the prediction of METAVIR score in adjacent classes of fibrosis (F0-F1, F1-F2, F2-F3, F3-F4), and
2. to study the association between elastometry and fibrosis surface obtained by morphometry (considered as the best evaluation of global liver fibrosis).

This technique will be applied to a restricted number of biopsies (consecutive biopsies \> 2cm).

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B or C
* With liver biopsy indication
* Patient information

Exclusion Criteria:

* Drug hepatitis
* Metabolic hepatology
* Steatosis or non-alcoholic steatohepatitis
* Autoimmune hepatopathy
* Non-contraindication to liver biopsy
* Non-contraindication to FIBROSCAN examination
* Ascites
* Obesity
Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Dental fear and anxiety remain common problems that should be managed by both the dentist and the anesthetist. The currently available evidence for safe and effective sedative drugs for children undergoing the dental procedure is scarce The aim of this study was to compare the safety and efficacy of intravenous ketofol versus dexmedetomidine (Dex) as premedications a sedative in anxious children undergoing dental pulp therapy

This double-blind, parallel-group, randomized clinical study will recruiter anxious children who will undergo dental pulp therapy. The study participants will be allocated into two equal groups. Subjects in group I will receive ketofol solution (ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in group II will receive the Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h. Non-invasive blood pressure (mean ABP), peripheral oxygen saturation, heart rate, and respiratory rate will be assessed at baseline, at 2 minutes, then at 5 minutes intervals till 60 minutes. Ramsay sedation and Aldrete's recovery rating scores will be assessed before, during, and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* ASA-I children,
* aged 5-10 years-old,
* requiring dental pulp therapy

Exclusion Criteria:

* ASA class ≥ II;
* previous experience with GA or Conscious sedation (CS);
* dental treatment expected to exceed 45 minutes;
* history of allergy to local anesthetics, Dex, propofol, ketamine, eggs, or soya;
* respiratory tract infections
Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola

The goal of this retrospective study is to compare the safety and efficiacy of endoscopic thyroidectomy via retro-auricular single-site approach, transoral endoscopic thyroidectomy vestibular approach and transareola approach.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, no gender restrictions.
2. Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC).
3. Early stage PTC (stage T1N0M0).
4. Preoperative ultrasonography showed unilateral glandular lobe malignant tumor and the largest diameter was not more than 2cm, without cervical lymph node metastasis and extensive metastasis.
5. Patients undergoing thyroid lobectomy and central lymph node dissection.
6. Patients who have signed an approved Informed Consent.

Exclusion Criteria:

1. Patients who do not accept case data collection for various reasons.
2. The clinical data unfit this study (at the discretion of the investigator).
3. Patients who have undergone neck surgery or radiotherapy before this trail.
4. Patients who have uncontrolled hyperthyroidism.
Home-visits From geRiatric tEam aFter hIp fracTure

The primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of satisfaction and quality of life.

Among older individuals, falling is a strong predictor of frailty, morbidity, and mortality and may cause a fracture. Many older patients experience recurrent falls, further functional decline, and readmission within the first three months. Hence, fall-related visits to the hospital represent a "red flag" but are also an opportunity for targeted intervention and prevention of future falls. However, many older patients are only treated for fall-related injuries and discharged without fall risk assessment or evaluation, hence there is a need for follow-up with targeted fall assessment and intervention to prevent further falls.

Thus, the present project aims to examine the effect of home-visit follow-up of older frail patients discharged from the orthopedic ward with a hip fracture. Furthermore, we will explore the effect of a cross-sectorial collaboration between hospital and municipality in the patients' homes to prevent falls, readmissions, medicine-associated adverse effects, and physical deconditioning in old frail patients.

The present study is a interventional trial. The intervention will consist of a home visit within ten weekdays of the discharge, where a comprehensive geriatric assessment (CGA) will be performed. The team performing the CGA consist of a Geriatrician and an experienced geriatric nurse. CGA is an overall assessment of the patient taking account of; the presence and severity of comorbidity, the nutritional state, cognitive and functional status, review of current medications, and social measures. The purpose is to stabilize and optimize current as well as chronic conditions, and reduce the probability of adverse events and falls, and to secure interventions or changes persist through the transition from the secondary to the primary health care system. The assessment may lead to several interventions, including; medicine review (new medicine, change in current or discontinuation), initiation of a nutritional effort or contact to a dietitian, referral to other health care services (outpatient clinics, hospitals, or general practitioner), referral to physiotherapy and/or occupational therapy or optimization of home care.

Patients randomized to the control group will receive standard care, where the subsequent need for medical service or increased home care will require contact with the general practitioner or the municipality, at the patient's initiative.

Eligibility Criteria:
Inclusion Criteria:

* Age of 70 years or older
* Hip fracture
* Ability to provide informed consent
* Residence in one of three following municipalities: Gladsaxe, Rudersdal or Lyngby-Taarbæk

Exclusion Criteria:

* No ability to provide informed consent
* Patients, who dies within 48 hours of discharge
* Terminal patients

Nursing home residents