cyrilzakka/clinical-trials huggingface dataset:
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis

The primary objectives of this trial are:

In patients at high-risk for restenosis,

* To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
* To assess superiority of the BRS to the EES in TLF between 3 and 7 years


Eligibility Criteria:
Inclusion Criteria:

Patients (18-75 years old) with at least one of the followings:

* High-risk characteristics for restenosis

  * Medically treated Diabetes (oral medication or insulin)
  * Multivessel disease of which more than one de-novo target lesion to be treated with the study scaffold/stent
* Complex target lesion

  * Single de-novo target lesion satisfying at least one of the following:
  * Lesion length \>28 mm
  * Small vessels: Target lesion reference vessel diameter between ≥2.5 mm and ≤2.75mm
  * Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)
  * Bifurcation with single stent strategy

Exclusion Criteria:

* Patients are excluded from this study if they have:
* Age \<18 years or \>75 years
* Known comorbidities which make patients unable to complete 7-years follow-up
* Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
* Pregnant woman
* Breastfeeding woman
* Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
* Cardiogenic Shock (Killip \>2)
* PCI with implantation of stents/scaffolds within previous 30 days.
* Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
* Renal insufficiency (GFR \<45 ml/min)
* Life expectancy \< 7 years
* Known non-adherence to DAPT
* Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)
* LVEF \<30%
* Patients at high bleeding risk who are not suitable for long-term DAPT
* Following lesion characteristics:

  * Target lesion reference vessel diameter (RVD) \< 2.5 and \> 4 mm
  * STEMI with RVD of \>3.5mm of the culprit target lesion
  * Target lesion with in-stent/scaffold thrombosis
  * Graft lesions as target lesions
  * Aorto-ostial lesion(s)
  * Left main lesion
  * Severe tortuosity of target vessel
  * In-scaffold restenosis
  * Bifurcation target lesion with intended 2 stent/scaffold strategy
* Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)
Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population

The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.

A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.

Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.

The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent
2. Age \> or = to 65 years
3. Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
4. Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation

Exclusion Criteria:

1. Indication for closed reduction or percutaneous screw
2. Allergy to TXA
3. Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
4. Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S \& C deficiencies, prothrombin gene mutation)
Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction

Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.


Eligibility Criteria:
Inclusion Criteria:

* planned sequential both-sided lower third molar extraction (split-mouth) with osteotomy (with or without upper molar extraction in local anesthesia)
* able to understand the study and the NRS scale

Exclusion Criteria:

* simultaneous both sided extraction or only upper third molar extraction
* general anesthesia
* known or presumed abnormal coagulation status
* known or presumed liver or renal dysfunction
* contraindication against metamizole known or suspected (known or suspected allergy against novalgin or other pyrazolones, anaphylactic reaction against NSAIDS, decreased bone marrow function or hematopoesis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, and pregnancy/breastfeeding)
* contraindication against ibuprofen (known or suspected allergy against ibuprofen, anaphylactic reaction against Nonsteroidal anti-inflammatory drugs (NSAID), active or recurrent stomach or duodenal ulcera or bleeding, severe liver or renal insufficiency, inflammatory bowel syndrome, and pregnancy/breastfeeding)
* pregnancy and breast feeding mothers
Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Both epilepsy and depression also interact with stressful life events, but only some patients develop these disorders after a stressful event, indicating the possibility of a "vulnerable" population. Animal and human studies have looked at the role of brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF are associated with higher incidence of depression, and thus indicate the vulnerable population.

Animal studies of BDNF have looked specifically at the relation between epilepsy and depression using a novel "double hit" design. After chronic stress exposure, measurement of BDNF levels allowed identification of 2 sub-groups: a vulnerable population and non-vulnerable population. A "second hit" of kainic acid induced status epilepticus (SE) was then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable population exposed to SE developed a depression-like profile.

In a proof of concept approach we propose studying the relation between epilepsy, depression, anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in 150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for healthy subjects and for depressed subjects without epilepsy, we hope to identify whether risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels. In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and C-reactive protein will be measured in addition to BDNF.


Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage from diagnosis onwards
* Known or unknown etiology (symptomatic or cryptogenic epilepsy)

Exclusion Criteria:

* Psychogenic non-epileptic seizures
* Psychotic disorders and bipolar disorders
Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy

The aim of our study was to demonstrate the efficacy and feasibility of the medical consortium for screening upper gastrointestinal cancers with magnetically controlled capsule gastroscopy.

In this study, the investigators designed a propective cohort study to evaluate the the efficacy and feasibility of medical consortium for screening upper gastrointestinal cancers (MCSC) with magnetically controlled capsule gastroscopy (MCCG).

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic subjects undergong magnetically controlled capsule gastroscopy for health checkup in medical consotium;
* subjects able to give informed consent

Exclusion Criteria:

* suspected or known intestinal stenosis, obstruction, or fistula;
* inoperability of refusal to accept any abdominal surgery;
* dysphagia or gastric paralysis;
* previous history of gastrointestinal disease;
* with pacemaker, implanted-cardiac defibrillator or other implanted electromedical devices;
* need for standard magnetic resonance imaging examination within seven days after swallowing the MCCG, unless the capsule is confirmed to have been excreted;
* other factors that are not suitable for inclusion evaluated by medical stuff
Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?

The Swiss company mementor has recently developed an interactive self-help intervention for the treatment of insomnia entitled mementor somnium. This programme is based on the guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online sessions. An animated personal sleep coach provides relevant audio-information and asks questions to which the patient is invited to respond. The components of the programme flexibly adapt to the patient's responses. Aside from psycho-education, exercises and an instruction for sleep restriction, mementor somnium includes a cognitive restructuring intervention in terms of a Socratic dialogue. This Socratic dialogue, implemented by the animated sleep coach, is based on a complex algorithm in the shape of an decision tree. University of Zurich's Department of Psychology in Switzerland will test the effectiveness of mementor somnium in a randomised controlled trial with three assessment times (pre, 6-weeks post and 3-months follow-up). Patients suffering from insomnia will be allocated randomly to either the active intervention group or the waitlist control group. Participants will have access to the programme mementor somnium for six weeks. Primary outcome measure is the Insomnia Severity Index, secondary outcome measures are Beck Depressions-Inventory revised (BDI-II), Brief Symptom Inventory 18, and the SF-12 Health Survey. Additionally, sleep diary data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia Disorder (DSM-5)
* German language comprehension
* Internet-access

Exclusion Criteria:

* Other sleep disorder
* Suicidality
* Current psychotherapy
* Drug abuse or recent change in medication
Tele-patient-reported Outcomes (telePRO) in Clinical Practice

The aim of this study is to compare quality of care and patient experiences in two outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and 2) Open Access telePRO (patient-initiated telePRO follow-up)

The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.

Eligibility Criteria:
Inclusion Criteria:

* Males and females from Age 15 years
* Diagnosis of epilepsy
* Referred to standard telePRO by a clinician
* Access to internet (web-responders in standard telePRO)
* Can speak and understand Danish

Exclusion Criteria:

* Paper responders
* Referred to telePRO proxy questionnaire
NK Cell-based Immunotherapy as Maintenance Therapy for Small-Cell Lung Cancer.

Natural killer (NK) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the survival of patients with cancer. This study evaluates the efficacy and safety of NK cell-based immunotherapy for small-cell lung cancer (SCLC) after first-line chemotherapy. Half of the participants will receive autologous adoptive transfer of NK cells after the response from first-line chemotherapy, while the other half will be followed up in routine clinal practice.

The small-cell lung cancer (SCLC) is very sensitive to the standard-of-care first-line chemotherapy and/or radiotherapy, but it will ultimately progress or relapse and develop early resistance to conventional treatments. No effective maintenance therapy except for wath and wait after first-line therapy at present.

NK cells constitute the major component of the innate immune system and kill tumor cells in a non-MHC-restricted manner. In our previous pilot study and other reports, adoptive transfer of autologous NK cells expanded ex vivo was very well tolerant and effective.

There is no prospective trial on the maintenance therapy of SCLC after first-line chemotherapy based on autologous NK cells. The purpose of this phase II clinical research is to evaluate the efficacy and safety of autologous NK cells as the maintenance therapy after the first-line treatment, comparing with conventional observation group.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed small cell lung cancer.
* Having completed first-line therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) status.
* Age ≥18 years.
* Karnofsky Performance Status (KPS) ≥80.
* Important organs:cardiac ejection fraction \>50%; Pulse Oxygen Saturation(SpO2) \>90%; creatinine (Cr) ≤ 2.5 times the normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the normal range, total bilirubin (TBIL)≤2.0mg/dl (34.2umol/L);Hgb≥60g/L.
* Without contraindication of apheresis and cell isolation.
* Patients and their families having the willingness to participate in clinical trial with signed written informed consent.

Exclusion Criteria:

* Patient having an active rheumatic immunologic disease.
* Uncontrolled bacterial, fungal or viral infection.
* human immunodeficiency virus(HIV), hepatitis B virus infection(HBV), hepatitis C virus(HCV) infection.
* History of organ transplantation and hemopoietic stem cell transplantation.
* Pregnant or lactating women.
* Patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study.
* Patients receiving other immunotherapy after diagnosis.
IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE)

IMPROVE is an implementation study aiming to explore the effects of two bundled implementation strategies on the intervention fidelity of the Healthy School Start program (primary outcome) while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). Thirty schools in two municipalities will receive the HSS program reaching about 1400 families per school year, for two years.

IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effects of bundled implementation strategies on the intervention fidelity (primary outcome) of the Healthy School Start (HSS) program while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). The HSS is a 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parent risk of developing type 2 diabetes.

IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months. Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1+2 (Enhanced), consisting mainly of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include acceptability, appropriateness, feasibility, organisational readiness as perceived by school staff, child weight status and diet, and parents' risk of type 2 diabetes. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and stakeholder perceptions on sustainability.

This systematic approach to investigating the effects of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and the external supports needed for a school-based health program like the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools.

Eligibility Criteria:
Inclusion Criteria:

* All children and their parents at the included schools. All involved personnel at the included schools

Exclusion Criteria:

* No
Exercise Capacity and Daily Physical Activity in Obese Subjects With Treated Obstructive Sleep Apnea

Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea, OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early death from heart problems. They are also associated with lower levels of physical activity. Exercise strategies for weight loss, increasing physical activity and improving fitness are needed for obesity. In Obese individuals with OSA

1. The investigators will compare corridor walking tests compared to laboratory exercise tests. The null hypothesis is that the peak oxygen uptake achieved and the cardiopulmonary response during both the six-minute walk test and Incremental Shuttle Walk Test would not be different from that observed during an Incremental Treadmill Test.
2. The investigators will investigate whether cycling or walking uses more calories for the same intensity. We hypothesise that cycling (weight supported) will be endured for long.
3. The investigators will compare commonly used exercise tests with levels of daily physical activity.

The information from these three projects will help us set up the optimal exercise program for obese individuals.


Eligibility Criteria:
Inclusion Criteria:

* Obstructive Sleep Apnea
* Obesity BMI\>30
* Controlled on Continuous Positive Airway Pressure for three months

Exclusion Criteria:

* cardiac co-morbidity e.g ischaemic heart disease, chronic heart failure, valvular heart disease
* pulmonary co-morbidity
* neurological condition limiting the ability to perform walking or cycling
* orthopaedic condition limiting the ability to perform walking or cycling
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation

\[Pharmacokinetics Assessment\]

* Primary Parameter

  - AUC0-t
* Secondary Parameters - Cmax, tmax

\[Safety Assessment\]

- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged between 19-45
2. Body weight ≥ 50kg and in the range of ideal body weight ± 20%
3. Without congenital, or chronic diseases within recent 5 years
4. Subjects who are deemed eligible based on the screening tests
5. Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form
6. Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
7. Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.

Exclusion Criteria:

1. A subject with symptoms suspected of acute illness at the screening
2. A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
3. A history of gastrointestinal disease
4. Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
5. A history of drug abuse
6. Pregnant women or women who may be pregnant, and breastfeeding women
7. Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons