cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.

For treatment of papillary thyroid microcarcinoma (PTMC), radiofrequency ablation (RFA) will be performed with the supine position and neck extended under ultrasonogrphic guidance. Before RFA, local anesthesia will be performed. RFA system including radiofrequency generator (VIVA RF system, STARmed, Goyang-si, Korea) and internally cooled electrode (star RF electrode, STARmed, Goyang-si, Korea) will be used. With regard to RFA procedure, moving shot technique and hydrodissection, if indicated, will be used. After RFA, follow-up will be performed using ultrasonography, serum thyroid function test, and questionnaire for quality of life by face-to-face interview at 2 months, 6, 12, 18, 24 months during the first 2 years after RFA, and yearly afterwards.

Eligibility Criteria:
Inclusion Criteria:

* who agrees to the consent form
* aged from 19 to 60 years old
* who has been diagnosed with Bethesda category V or VI by fine needle aspiration or needle biopsy
* whose thyroid cancer is 1 cm or smaller than 1 cm length
* who does not have lymph node or distant metastasis
* whose thyroid cancer does not have extrathyroidal extension
* in whom it seems technically possible to completely ablate thyroid cancer using RF

Exclusion Criteria:

* who cannot routinely followed up according to the study schedule
* who has been with Bethesda category I, II, III, or IV by fine needle aspiration or needle biopsy.
* who has hyperthyroidism that requires treatment
* who has bleeding tendency
* multifocal papillary thyroid microcarcinoma
* who is pregnant
A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

The purpose of the study is to assess the feasibility of a trial to test the effects of homocysteine (Hcy) lowering supplements in patients with NAFLD.

NAFLD patients will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits to complete activities such as physical exam, fibroscan, blood draws, and questionnaires.

The purpose of the study is to assess the feasibility of a trial to test the effects of homocysteine (Hcy) lowering supplements in patients with NAFLD.

NAFLD patients will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits. During the in person visits NAFLD participants will complete the following activities:

* Review medical history
* Physical examination
* Vital signs (blood pressure, heart rate, respiratory rate, body temperature)
* Measure height, weight, body mass index, and waist circumference
* Grip test
* Fasting blood tests
* Pregnancy test (if applicable)
* Fibroscan with CAP score
* QOL questionnaire

Eligibility Criteria:
We will enroll NAFLD patients, blocked by age 50 years (≤ 50; \> 50) and sex (M; F, four patients/subjects in each block).

Inclusion Criteria for NAFLD Group:

1. Increased hepatic fat accumulation diagnosed by either abdominal ultrasound or CT AND elevated CAP score of 280 dB/m or higher
2. HOMA-IR ≥ 2 or the diagnosis of metabolic syndrome
3. Chronic elevation of transaminases: ALT elevation (more than 2 times during the past 12 months, defined by 19 U/L for women and 30 U/L for men 31)
4. Stable use of any potential anti-NASH therapy (i.e., vitamin E, pioglitazone, glucagon like peptide 1 agonist, etc.) for 6 months prior to screening.
5. Aged 18+ years
6. Able to provide legal consent

Exclusion Criteria for NAFLD Group:

1. Any contraindication to the study supplements
2. Inability to obtain valid fibroscan measures at the screening
3. Pregnancy or lactation
4. Clinical diagnosis of cirrhosis or other chronic liver diseases
5. Recent use of steatogenic medications
6. Excess alcohol use (\>21/ \>14 drinks weekly in men/women)
7. Chronic kidney disease
8. Supplement use within 30 days, containing any of the study supplements
9. Total parenteral nutrition
10. Any clinical conditions associated with malabsorption
11. Any active diagnosis of malignancy
12. Use of immunosuppression
A Pharmacokinetic and Pharmacodynamic Study Comparing HLX01 And Rituximab in Patients With CD20-Positive, B-cell Lymphoma

Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01 and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. aged from 18 to 65 years;
2. CD20-positive non-Hodgkin's lymphoma (NHL);
3. having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
4. ECOG performance status of \<=1, expected survival of at least \>= 3 months;
5. Peripheral blood lymphocyte count \< 5×10\^9/L
6. signed an informed consent form which was approved by the institutional review board of the respective medical center .

Exclusion Criteria:

1. Other invasive malignancies within 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix;
2. Chemotherapy within 1 month;
3. Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 month before enrollment;
4. Had received rituximab or other anti-CD20(+) monoclonal antibody treatment 1 month ago but with ADA(+) before enrollment;
5. Blood concentration of Rituximab\> 24 μg/ml prior to study entry;
6. Had received hematopoitic growth factor within 1 week prior to study entry;
7. Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
8. Recent major surgery (within 8 weeks prior to screening, excluding lymph node biopsy);
9. Peripheral or central nervous system disease;
10. Serious hematologic dysfunction (white blood cell count of \<3.0×109/L; absolute neutrophil count of \<1.5×109/L; platelet count of \< 100×109/L; hemoglobin level of \< 9.0 g/dL);
11. Hepatic dysfunction (total bilirubin level of \> 1.5 × upper limit of normal (ULN); aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \> 2.0 × ULN; alkaline phosphatase \> 3.0 × ULN; renal dysfunction (serum creatinine level of \> 1.5×ULN );
12. Abnormal thyroid function;
13. Seropositive for HIV , HCV antibody; seropositive for hepatitis B virus surface antigen (HBsAg). HBV DNA\>1.0×103copies/ml;
14. Serious underlying medical conditions, could impair the ability of the patient to participate in the trial (including but not limited to ongoing active infection, uncontrolled diabetes mellitus, significant cardiac disease, uncontrolled angina, gastric ulcers, active autoimmune disease);
15. Pregnancy or breast feeding. For women of childbearing potential.
16. History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug.
17. Subjects had a history of alcoholism or drug abuse;
18. Researchers think that do not fit into the group.
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury

Traumatic brain injury (TBI) causes lifelong disability. Children with TBI often have difficulties in attention regulation and executive functions affecting their daily living. Need for rehabilitation is often long-lasting and there is an increasing demand for timely, cost-effective, and feasible rehabilitation methods, where the training is targeted to support daily life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.

The aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control, and executive functions by using a virtual environment that corresponds to typical everyday life. In this randomized control study, VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.

The researchers expect that; 1) Intensive training improves the attention regulation, activity control skills, and executive functions of the children in the intervention group 2)Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3)The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate traumatic brain injury (ICD-10: S06.0-S06.6 and S06.8-S06.9 and criteria defined in the Current Care Recommendation, 2021) and
* The challenges of attention and executive function identified in the assessment of a neuropsychologist/experienced psychologist and
* Age 8-12 years and
* Finnish as a native language

Exclusion Criteria:

* Sensitivity to flashing light,
* Epilepsy (ICD-10 G40),
* Mental retardation (ICD-10 F70-F79),
* Pervasive developmental disorders (ICD-10 F84),
* Inflammatory diseases of the central nervous system (ICD-10 G00-G09),
* Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),
* Brain tumour, and
* Multiple pregnancy
Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV

The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h)

After being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. Patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. ARTs will be switched to DTG dispersible tablet and ABC/3TC once daily will be prescribed according to weight band dosage. Total of 7 time point of blood sampling for plasma DTG concentrations will be measure at 7-14 day after medication switch. Patient will be follow up as schedule for total 24 week to assess safety, and efficacy of DTG dispersible tablet combine with ABC/3TC.

Eligibility Criteria:
Inclusion Criteria:

* Children living with HIV weighing 6 to below 20 kg
* Naïve to integrase inhibitors

Exclusion criteria:

* Currently active opportunistic infection
* Liver dysfunction (SGPT below 100 IU/mL)
* Renal dysfunction (GFR below 60 mL/min)
* Currently using medication that interacts with DTG
Child Asthma : What Parents Attitude During an Asthma Attack at Home Before Consulting the Pediatric Emergencies

prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home.

The main objective is to calculate the prevalence of placement of short-acting bronchodilators. The secondary objectives are to describe the factors associated with their implementation.


Eligibility Criteria:
Inclusion Criteria:

* child over 2 years emergency room consultant for asthma attack
* child whose parents did not express their opposition to participate and completed the non-objection form
* child consultant in pediatric emergencies of Quimper and Brest

Exclusion Criteria:

* child whose age is not between 2 and 15 years old
* cough equivalent of asthma
* history of cardiac or pulmonary pathology or prematurity
* refusal to participate
Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates

Children differ from adults with respect to growth and development but also immaturity of various pharmacological mechanisms. Dosing schemes in children are usually derived in an empirical manner from clinical trials in adult patient groups. All this poses neonates to an increased risk for therapeutic failure and adverse drug reactions.

Medicinal products studied during this project are among the ones with the highest needs for research in the pediatric intensive care. This project focuses on the necessity to integrate subject's individual characteristics to assist clinical decision-making in drug therapy. The investigators explore the mechanisms defining the dose response in pediatric populations. The results obtained with these studies will help to find safer drug dosing regimens in this delicate patient population.


Eligibility Criteria:
Inclusion Criteria:

* Given informed consent by the guardian of an eligible patient.
* Patient is more than 24 weeks old and has a body weight more than 500 g.
* Patient needs intensive care treatment based on a clinical decision by a neonatologist and receives propofol or oxycodone on their therapy. Attending neonatologist makes the decision to prescribe propofol for scheduled short procedural sedation or oxycodone for analgesia as well as all other treatment related decisions.

Exclusion Criteria:

* Eligible patients guardian declines to give informed consent.
* A previous history of intolerance to the study drugs or to related compounds and additives.
* History of any kind of drug allergy.
* Participation in any other studies concomitantly or within one month prior to the entry into this study.
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit'(V1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Predicting the Efficacy in Advanced Gastric Cancer.

With advances in chemotherapy for gastric cancer, it is important to identify patients who will respond effectively to specific therapies. This longitudinal study aimed to establish a liquid-biopsy assay that can predict response to ramucirumab plus paclitaxel therapy in patients with advanced gastric cancer.

The combination of paclitaxel and ramucirumab is a potent standard second-line therapy for patients with advanced gastric cancer, but approximately 30% of patients do not respond to treatment. Failure to respond to second-line therapy can lead not only to disease progression, but also to deterioration of the patient's health and loss of the opportunity to receive other treatments that originally had the potential to be curative. This study aims to predict the efficacy of second-line treatment (paclitaxel plus ramucirumab) in patients with gastric cancer using liquid biopsies (small RNA). Prediction using pre-treatment blood may allow patients who do not respond to treatment to choose other treatment options. This study aims to establish a tool that will enable noninvasive pre-treatment selection, which could lead to personalized treatment.

Eligibility Criteria:
Inclusion Criteria:

1. unresectable or recurrent GC histologically confirmed to be primary adenocarcinoma of the stomach.
2. age over 20 years.
3. Eastern Cooperative Oncology Group performance status score of 0-2.
4. written informed consent following full study information is provided to the patient.
5. progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
6. presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.

Exclusion Criteria:

1. Patients with a life expectancy of shorter than 3 months
2. Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
3. Patients with a history of serious allergic reactions or serious drug allergy.
4. Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
5. Patients for whom the attending physician considered that enrollment in the study is inappropriate.
Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thoracic central venous occlusion

Exclusion Criteria:

* pregnancy
A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.


Eligibility Criteria:
Key Inclusion Criteria:

1. ≥70 years of age at the time of informed consent, OR ≥60 and \<70 years of age with comorbidities precluding autologous stem cell transplantation
2. Histologically confirmed diagnosis of MCL
3. No prior systemic treatments for MCL
4. Measurable disease by CT/MRI
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
6. Adequate marrow and organ function

Key Exclusion Criteria:

1. Known central nervous system involvement by lymphoma
2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
3. Clinically significant cardiovascular disease
4. History of severe bleeding disorder
5. Unable to swallow capsules or disease significantly affecting gastrointestinal function
6. Active fungal, bacterial and/or viral infection requiring systemic therapy
7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exercise and Nutrition Intervention for Frail Older Patients

The objective of this study is to evaluate the effect of a person-centered training and nutrition intervention six month after discharge in acutely admitted frail old medical patients on physical function. Secondly, to evaluate the effect on frailty, quality of life, health literacy, nutrition, readmissions, death and consumption of home care costs.

Evidence on how to improve physical function and avoid unnecessary readmissions for frail hospitalized older medical patients is not established as yet. In Denmark, the few studies performed have not succeeded in showing a significant difference in physical function or quality of life, due to sector barriers, low compliance and uni-dimensional interventions and none of the studies addressed readmissions and or described a patient-centered approach.

This research project will address this serious individual and societal challenge by testing and evaluating a person-centered complex intervention with emphasis on the patients´ own focus and goals. To increase the probability of developing a successful intervention with the patient in focus we have completed two qualitative studies with patients and health professionals. The primary results from these studies indicate that the pedagogical approach of the involved healthcare professional is important for establishing a good relation. Patients had a desire of being more active, but after four week only a minority had their own expectations fulfilled. Furthermore, the patients expressed that social relations had the potential of increasing adherence to training sessions. Furthermore, a citizen's panel has been established, and possible elements important for the intervention were discussed on behalf of their own experiences with the healthcare system. The results of these qualitative studies and the latest evidence contributed to the development of the current intervention study.

Eligibility Criteria:
Inclusion Criteria:

* 65+ years old
* Acutely admitted with a medical focus at Aalborg University Hospital, South.
* Living in Aalborg Municipality (except 9230 Svenstrup, 9240 Nibe, 9293 Kongerslev, 9381 Sulsted, and 9382 Tylstrup)
* Able to walk (assistance is ok) before admission.
* Speak and understand Danish.

Exclusion Criteria:

* Discharged with rehabilitatinplan for physiotherapy within the last 30 days.
* Dementia or other cognitive impairments.
* Terminal ill.
Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population

Degenerative lesions of the shoulder occur very frequently and their incidence increases with age. The Constant-Murley score is currently considered the gold standard in Europe to assess the shoulder and is widely used by the orthopaedic community to follow up on shoulder pathologies. However, healthcare professionals are taking an increasing interest in self-administered patient-reported out-come measures. Several self-administered questionnaires are available to assess the shoulder. Among these questionnaires, the OSS (Oxford Shoulder Score) is considered to be quick, simple, and reliable for the English-speaking population. This score was initially developed at the University of Oxford in 1996. It is a self-administered questionnaire designed to evaluate pain and shoulder function through 12 questions. This score has since been adapted in different languages but not in French.

The aim was to develop a translation and a transcultural adaptation of the OSS and to assess its validity in native French-speaker patients with shoulder pain.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving chemotherapy for solid tumors in Ambulatory Medicine Unit of the Reims University Hospital (France) between May 14, 2012 and July 31, 2013
* native French speakers

Exclusion Criteria:

* Patients who presented shoulder's instability problems