cyrilzakka/clinical-trials huggingface dataset:
Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC

In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Potentially eligible patients will be screened by the research clinicians and requested to complete and sign a consent form before enrolment. Eligible patients who consent to participate will be randomly assigned to the intervention group (patients receive conventional treatment and Shenlingcao oral liquid) and the control group (patients only receive conventional treatment) designed dynamic stratified block randomized algorithm via a central randomization system for clinical research using 1:1 ratio.

The intervention and control group will be enrolled before the first chemoradiation. Non-allelic follow-up will be conducted in this study and terminated when the last enrolled patient follow up to 24 months. Prospectively collected information from patients, including baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older;
* Pathological diagnosis of patients with stage II, III A primary NSCLC;
* R0 resection has been accepted;
* Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
* Informed consent has been signed.

Exclusion Criteria:

* Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.);
* Patients with unclear pathological types;
* Patients with unclear pathological staging;
* Preserved Shenlingcao Oral Liquid before R0 resection surgery;
* Received immunotherapy or targeted therapy before R0 resection surgery;
* Radiotherapy and chemotherapy before R0 resection surgery.
A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence

This Phase I behavior therapy development study seeks to improve treatment outcomes for methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults ≥ 18 years who are seeking treatment for MA addiction.
* Own a cellular phone with SMS text messaging capability and have an unlimited text messaging plan.
* Available to attend CBT therapy groups.
* Agreeable to conditions of the study and signed an informed consent form.

Exclusion Criteria:

* Projected to be unavailable \> 12 hours/day to read and send text messages.
* Any medical or psychosocial condition that would preclude safe, useful, or consistent participation,
Does Social Buffering Continue to be Effective Over the Peripubertal Period When Friends Share the Stressor Experience?

The purpose of this experiment is to determine whether social buffering by friends of stress physiology remains effective later in puberty when friends share the load versus when they provide support but are not undergoing the stressor with the target child. There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

Adolescents experience social evaluation stress frequently. However, it is likely that often they are not alone, but with friends who are also going through the same experience. Thus, it is possible that under these conditions, social buffering by friends does not wane over the peripubertal period. Participants will be assigned to social conditions while engaging in an evaluative stressor task.

Eligibility Criteria:
Inclusion Criteria:

* sufficient vision, hearing, and language skills to provide verbal and written assent
* ability to see and read stimuli presented on the computer screen
* ability to hear verbal instructions provided by the experimenter and judges

Exclusion Criteria:

* premature birth (less than 37 weeks)
* congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
* Autism Spectrum Disorders
* history of serious medical illness (e.g., cancer, organ transplant)
* serious psychiatric illness
* systemic glucocorticoids or beta-adrenergic medication use
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study

Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Based on the current evidence, the role of OIN appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. Regarding not malnourished patients, there is still no clear correlation between OIN and decrease in post-operative complications. Furthermore, whether OIN increases immune response within the tumour microenvironment is based on studies with poor number of patients.

Randomized, controlled, open-label, single-centre study in patients candidate for elective curative surgery for colon-rectal cancer.

The study intervention consists of the oral nutritional supplementation enriched with immune-nutrients delivered before and after surgery in addition to standard dietary advice according to E.R.A.S. protocol.

All patients will follow low-fiber diet according to ERAS protocol during the study period. Patients assigned to the experimental arm will assume also Impact Oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by Nestlé Health Science S.p.a. It is a liquid drink packaged in a brick of 237 ml. Patients will assume Impact Oral® for 5 days before surgery and 5 day after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years or older;
* histologically confirmed adenocarcinoma of colon or rectum;
* Eligible for elective curative surgery with indication of colon and/or rectal resection in laparoscopy with mini-invasive technique;
* eligible for ERAS protocol;
* Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;

Exclusion Criteria:

* colon or rectal resection for benign disease;
* TNM Stage ≥4;
* neoadjuvant radio and/or chemotherapy
* ASA score \> 3;
* contraindications to oral nutrition (e.g. dysphagia, pyloric stenosis) or hypersensitivity to any ingredient of study product;
* albuminemia \< 3.0 g/l;
* weight loss \> 10% in the last 3-6 months;
* BMI \< 18.5 kg/m2;
* pregnant or breastfeeding;
* Not self-sufficient or with poor family compliance;
* Congenital or acquired immunodeficiency;
* Active uncontrolled pre-operative infections or other clinically relevant concomitant illness that preclude laparoscopic procedure;
* Bowel obstruction or parenteral nutrition or gastric tube;
Gluten Challenge in Celiac Disease

Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten containing cookies or bread for 3 days.

Questionnaires and sampling of blood is done before, during and after.

Before and 6 days after start of gluten challenge, blood samples will be collected and analysed by using HLA-tetramers to identify and purify CD4+ gluten-specific T cells by flow cytometry. T cells will undergo transcriptome analysis to get an insight in signalling of antigen-specific cells. Other cell populations like CD8+ T cells and γδ T cells will also be analyzed by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Celiac disease confirmed by biopsy
* Age 18 - 80 years
* Gluten free diet last 6 months
* Subject has received information and signed the informed consent form

Exclusion Criteria:

* Pregnant or breast feeding
* Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age)
* Drugs influencing immune system used last 3 months
* Current infectious disease of moderate or high severity
* Other chronic active intestinal disease
* Serious reaction on small amounts of gluten ingested
Bariatric Surgery and Pharmacokinetics of Atomoxetine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on atomoxetine are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty

This study evaluates the pathophysiological effects of a single dose methylprednisolone administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the effect on the endothelial glycocalyx shedding due to surgical trauma.

Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.

The investigators hypothesize that the group receiving methylprednisolone will experience reduction in glycocalyx degradation compared to the placebo-group, early after TKA.

The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.

Postoperatively, activation and / or dysregulation of the inflammatory system influence on the endothelial glycocalyx. Damage of the vascular endothelia increases the risk of cardiovascular and thromboembolic complications.

In animal studies glucocorticoids have been found to preserve the endothelial glycocalyx and the vascular barrier.

The effect of glucocorticoids on human endothelial glycocalyx after surgery is unknown and calls for further investigation.

This study is embedded in a primary study registrated as: NCT02319343

For further details please view the EudraCT registration:

EudraCT nr.: 2014-003395-23

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthrosis
* Undergoing total unilateral knee-arthroplasty surgery
* Speak and understand Danish
* Have given informed consent

Exclusion Criteria:

* Revision, bilateral og uni chamber knee-arthroplasty surgery
* General anaesthesia
* Allergy or intolerance towards Methylprednisolone
* Local or systemic infection
* Permanent systemic treatment with steroids within 30 days preoperatively
* Insulin-dependent diabetes
* Active treatment of ulcer within 3 months preoperatively
* Cancer disease
* Autoimmune disease incl. rheumatoid arthritis
* Pregnant or breast feeding women
* Menopause \<1 year
Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic

The purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture .

Bite force is one indicator of the functional state of the masticatory system that results from the action of jaw elevator muscles modified by the craniomandibular biomechanics .Determination of individual bite force level has been widely used in dentistry, mainly to understand the mechanics of mastication for evaluation of the therapeutic effects of prosthetic devices and to provide reference values for studies on the biomechanics of prosthetic devices. In addition, bite force has been considered important in the diagnosis of the disturbances of the stomatognathic system .

Twenty (20) single maxillary completely edentulous patients were selected from the out-patient clinic of the Removable Prosthodontics Department, Faculty of Oral and Dental Medicine, Cairo University.

The primary outcome is to measure the biting force of single maxillary complete denture by I Load star sensor .

Eligibility Criteria:
Inclusion Criteria:

* completely edentulous maxillary arch and full or partial dentate mandibular arch with adequate inter arch space
* edentuluos arches should be covered by firm healthy mucosa angle class 1 maxillomandibular relationship

Exclusion Criteria:

* patients with bad habits
* previous history of radiotherapy or chemotherapy
Vibration Exercise for Crohn's to Observe Response

Background: Crohn's disease (CD) is a long-term inflammatory condition of the digestive system. People with CD often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. In addition, they require long-term treatment with frequent negative effects and often need surgery and hospitalisations. Therefore, people with CD report a lower health-related quality of life (HRQOL) compared with other people. Doctors are constantly trying to find new treatments to improve HRQOL and control symptoms and whole body vibration exercise could be a potential treatment.

Exercise might be a simple, safe, and low-cost intervention for improving HRQOL in people with CD. This is because it has the potential to improve several aspects of physical, mental and social well-being simultaneously. Adults with CD have been shown to be less active than the general population and do not meet the recommended daily physical activity guidelines. One barrier to exercise is lack of time, however whole-body vibration exercise (where you stand and squat on a vibrating plate) can be done over a much shorter duration and at a lower intensity to gain potentially similar or at times greater benefits. More research is needed to understand the effects, both positive and negative of vibration exercise in people with CD.

Aim: This study begins to understand whether undertaking a supervised 6-week vibration exercise programme for adults with mild to moderately active Crohn's disease improves HRQoL and other symptoms such as fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18-65 years old
* Clinical diagnosis of CD for at least 4 weeks before randomization

  * Mild to moderate active CD (150-220 CDAI)
  * Stable medication for at least 4 weeks before randomization
  * Able to provide written consent, complete the study questionnaires and travel to the research centre for study assessment visits and exercise sessions
  * Be doing less than 60 minutes of purposeful exercise per week

Exclusion Criteria:

* Over 65 years old Severe or uncontrolled medical conditions that make it undesirable for the patient to participate

  * Coexistent serious autoimmune disease such as rheumatoid arthritis or systemic sclerosis
  * Planned major surgery within the first 3 months after randomization
  * Are pregnant, or are planning pregnancy within the first 3 months after randomization
  * Poor tolerability to venepuncture or lack of adequate venous access for required blood sampling
  * Current participation in \>60 min/week of purposeful exercise, such as jogging or cycling
  * Participation in another clinical trial for which concurrent participation is deemed inappropriate
  * Any orthopaedic implants (hip, knee, spine)
Amniotic Membrane Treatment for Hyposecretory Dry Eye

The goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye

Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th.

Researchers will compare against autologous serum eye drops effects

This was a randomized, active-controlled, parallel-group trial. The perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation.

During de initial 2 weeks screening period, the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops (ASED) or AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* dry eye related symptoms
* Fluorescein Corneal Staining score of 4 or more
* Lisamina Green Conjunctival score of 4 or more
* a no-anesthesia Schirmer test value at 5' of 10 mm or less

Exclusion Criteria:

* glaucoma treatment
* surgical procedures within 3 months of the baseline evaluation
* precense of punctal plug
* patients that were human immunodeficiency virus positive
Atrial Fibrillation: Risk and Benefits of Anti-coagulation in the Elderly

This study was designed to assess the effectiveness of oral anticoagulants in elderly patients (\>=75 years) with atrial fibrillation. All patients discharged from one large hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017 with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to mandatory and qualitative national registries and review of the medical records until december 31 2018.

The investigators established a prospective cohort of 2943 of elderly (\>=75 years old) discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st 2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital. Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial fibrillation and atrial flutter) according to the International Classification of Diseases, 10th revision. The first admission to the hospital during the study period is recorded as the index admission.

Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at admission and at discharge have been recorded for each patient through the screening of medical journals.

Eligibility Criteria:
Inclusion Criteria:

• All consecutive patients discharged with atrial fibrillation as main diagnosis from Danderyds Hospital from November 1st 2011 to December 31 2017 aged 75 years or more.

Exclusion Criteria:

* Patients who have not given their consensus to the use of medical journals for register based research.
* Patients who were discharged from the hospital with atrial fibrillation as main diagnosis but were admitted to the hospital for medical reasons unrelated to atrial fibrillation (as an example change of pacemakers batteries).
* Patients whose medical records are not consistent with the main diagnosis (as an example wrong ICD code).
Umbilical Cord Mesenchymal Stem Cell Improve Cardiac Function on ST-elevation Myocardial Infarction (STEMI) Patients

The goal of this clinical trial is to learn about the effectiveness of Umbilical Cord Mesenchymal Stem Cell (UC MSC) therapy in patients with STEMI against infarct myocardial size reduction and prevent the incidence of heart failure in the future

Participants who have already done Primary Percutaneous Coronary Intervention (PCI) will be informed about the procedure and risk of this clinical trial. After written consent, 60 participants will be check for their eligibility criteria and randomized into intervention (get UC MSC transplantation) and control group. All participants will be check for their biochemical blood analysis: Interleukin-10 (IL-10), Vascular Endothelial Growth Factor (VEGF), Galectin-3, GATA Binding Protein-4 (GATA-4), and Beclin 1 (1 day before transplantation, 7 dan 14 days after transplantation); infarct size and left ventricular ejection fraction (LVEF) through Cardiac MRI (7-10 days after Primary PCI and 6 months after transplantation) and echocardiography (every month); and major adverse cardiac events/MACE (every month). The result will be access after 6 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI treated with primary PCI maximum 12 hours after onset of chest pain

Exclusion Criteria:

* Patients with history of coronary artery bypass grafting surgery
* Patients with history of heart failure before admission
* Patients with cardiogenic shock
* Patients with cancer disease
* Patients with malignant arrythmia
* Patients with chronic kidney disease
* Patients with haemostasis disorder
* Patients with infection
* Patients with stroke
Effects of Low Level Laser Therapy (808nm) on Muscle Performance of Young Women Submitted to Physical Training

The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of young women submitted to chronic endurance training program associated to low level laser therapy when compared to chronic aerobic training alone.

The study assessed women muscle performance in isokinetic dynamometry, ventilatory parameters such as ventilatory threshold, VO2Peak, VO2Max, Ventilation. Maximal load in cycle ergometer test (Balke's protocol), Borg Scale and Heart rate were assessed too.

Eligibility Criteria:
Inclusion Criteria:

* healthy young women volunteers
* women with a beginner or moderately trained pattern of physical activity
* body Mass Index (BMI) between 18 and 25kg/m2

Exclusion Criteria:

* previous injury to the femoral quadriceps or hamstrings muscles (within 6 months prior to study)
* osseous or articular disorder in the lower limbs
* cardiovascular system disorders or systemic disease