cyrilzakka/clinical-trials huggingface dataset:
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)

Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. Prediction of who will have these problems is challenging using traditional definitions of disease. It is believed that underdevelopment and injury occur in both lung tissue and the blood vessels in the lungs, with a sophisticated interplay between them that contributes to lung disease seen in prematurity. New magnetic resonance imaging (MRI) techniques can delineate tissue structure with unprecedented granularity, assessing lung tissue, blood vessels, and their interplay. The ability to identify, at an early stage, those infants destined for chronic lung disease with greater certainty will be useful in counseling families and critical for the effective introduction of promising new BPD therapies. 319 infants born less than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. Babies will be evaluated at 36 weeks post-conception with lung MRI, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. Lung health will be assessed every 3 months by phone questionnaire and chart review. At 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. The investigators will look at how well baseline MRI markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of BPD. The investigators anticipate that these new MRI markers will measure lung health safely and longitudinally in babies born extremely preterm. By identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. Further, The investigators envision that MRI will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Infants born at \<29 weeks gestation;
2. currently \<36 weeks PMA.

Exclusion Criteria:

1. Known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or structural heart disease (other than atrial septal defect/hemodynamically insignificant ventricular septal defect/patent ductus arteriosus);
2. genetic syndrome or congenital anomaly;
3. contraindications for MRI or transport;
4. invasive or non-invasive ventilation that cannot be safely removed for MRI;
5. current respiratory infection;
6. family cannot speak English/French;
7. transferred to another hospital prior to baseline study visit
8. not receiving follow-up at one of the study centres.
Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)

The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.

Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* hematological malignancy
* standard indication for allogeneic transplantation
* expected survival time over 12 weeks
* no related or unrelated donor
* availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Prior allogeneic transplantation
* Pregnant or nursing women
* Positive serology for hepatitis B or C
* HIV positive
* Left ventricular ejection fraction \< 50%
* DLCO \< 50%
* Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
* Treatment with other investigational drugs within 4 weeks of enrolling in this protocol
Local Paclitaxel Delivery for SFA Disease

To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.

Treatment of superficial femoral artery atherosclerosis with percutaneous techniques is hindered by high restenosis rates. Paclitaxel inhibits restenosis in coronary arteries, and a few studies suggest it may be effective in reducing restenosis rates in peripheral arteries. The investigators hypothesize that delivering paclitaxel through an irrigating catheter will be superior in preventing restenosis.

Eligibility Criteria:
Inclusion Criteria:

* All subjects between 18 and 80 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions will be invited to participate (23, 24).
* Patients must be on appropriate pharmacologic therapy for PAD including antiplatelet agents and lipid-lowering therapy.

Exclusion Criteria:

* Life expectancy \<1year
* Acute limb ischemia
* Anatomy not amenable to percutaneous revascularization
* Inability to provide informed consent
* Renal insufficiency (creatinine clearance \<40mL/min calculated using Cockcroft-Gault equation)
* Prisoners
* Pregnant or lactating women
Aquatic Training in Patients With Severe Scarring

Aim:

- to investigate the effects of an aquatic exercise program in patients with severe scars

Patient population:

* 10 patients of at least 18 years old
* patients with scars after burns or other severe skin injuries
* stratification into two groups: an intervention group and a control group

Method:

* 8 patients will participate in the aquatic exercise group and 2 patients in the control group
* assessment of physical fitness parameters, scar tissue and psychosocial impact

Hypothesis:

- patients of the aquatic exercise group will recover sooner and better (physically and psychologically) than patients of the control group

Intervention:

- during 6 weeks patients will performed an aquatic exercise program (2 to 3 sessions a week)

Assessment:

* T0: post-hospitalisation status: body mass index, physical fitness, strength and respiratory function
* T1: at baseline: body mass index, physical fitness, strength, respiratory function, exercise capacity, mobility, scar parameters and some questionnaires
* T2: after 6 weeks training: same measurements as T1
* T3: 3 months after end of aquatic training: idem T1
* T4: 6 months after end of aquatic training: questionnaires
* T5: 1 year after end of aquatic training: questionnaires

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* hospitalisation at the burn unit of at least 14 days
* patients with severe skin damage (like burns, deglovements, necrotic fasciitis, ...)

Exclusion Criteria:

* younger than 18 years
* psychiatric history (recommandation of psychiatrist not to participate in the study)
A Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors

The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing stroke self-management program on recovery of community-dwelling stroke survivors.

Previous systematic reviews showed that theory-based stroke self-management programs had potential benefits in improving stroke survivors' quality of life and self-efficacy. However there is a lack of evidence evaluating the effectiveness of a nurse-led theory-based stroke self-management program among community-dwelling Chinese stroke survivors.

This is a parallel group, single-blinded, randomized controlled trial to be held in a community center. All participants will be assessed at two time-points (baseline before randomization, and one month after program completion). Eligible participants will be randomly allocated to either the control group (receiving usual care) or the intervention group (receiving the self-efficacy enhancing stroke self-management program). Participants in the intervention group will receive an additional assessment on usefulness of the program immediately after program completion.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or above
* have a clinical diagnosis of stroke
* currently live at home or will be discharged from hospital to home within one week
* have a Mini Mental State Examination score \>18
* speak Cantonese
* capable of giving informed consent
* can attend sessions of the self-efficacy enhancing stroke self-management program
* can use a phone

Exclusion Criteria:

* diagnosed with transient ischemic attack, subdural or epidural hemorrhage
* have cerebrovascular events due to presence of malignancy or head trauma
* have limited comprehension and receptive aphasia
* have been diagnosed with schizophrenia, bipolar disorder, or dementia
* have received a stroke self-management program in the past 12 months as reported by the participants
Correlation Between Epistaxis and Cardiovascular Disease

Investigators examine blood-pressure variance, several cardiovascular risk factors of patient with epistaxis. As a result of collected data, investigators look into correlation between epistaxis and hypertensive cardiovascular disorder.

This study is prospective observational single blinded study.

A participant is visit in the ER who patient with epistaxis.

Investigators will enroll 50 patients with epistaxis. Exclusion criteria is that patient needs immediately treatment for hypertensive urgency or patient with nasal trauma.

Investigators examine blood-pressure (BP) at five times in Emergency Department (ED) and out-patient department (opd) of Otorhinolaryngology (OL) . Investigators explain this study and ask to write consent for participant. After proper management of epistaxis, investigators get blood sampling of the participant and, the participant has a reservation to "opd of cardiovascular division of Internal Medicine" (CV opd) in the hospital.

When the participant visit CV opd, the participant undergo 24-hours-BP-monitoring and Pulse wave velocity (PWV).

After that, the participant will be follow-up for 3 months.

Investigators collect 50 data from 50 participants as a registry and analyze the data.

Eligibility Criteria:
Group A

Inclusion Criteria:

* age is over 18 with spontaneous epistaxis

Exclusion Criteria:

* they needs immediately treatment for hypertensive urgency.
* they don't want to participate in this investigation.

Group B

Inclusion Criteria:

* age is over 18 with bleeding of wound

Exclusion Criteria:

* their wounds' condition is serious or their pain is much severe.
* they don't want to participate in this investigation.
Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial

Pregnancy-associated plasma protein A (PAPP-A), alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and inhibin A, are biochemical markers that are part of the first and second trimester screening test, for Down syndrome and neural tube defects in pregnancy. These biochemical markers have been shown also to be associated with slightly increased risk for adverse pregnancy outcomes in the absence of aneuploidy or neural tube defects, for example; preeclampsia, low birth weight, placental abruption, preterm labor, and intrauterine fetal death.

There are no guidelines regarding the management of these cases assuming a reassuring maternal and fetal status are normal, at term (38 - 39 weeks). However, adverse events may still develop between 38 to 42 weeks when calculated according to ongoing pregnancy.

Investigators aim in this randomized trial to examine the effect of induction of labor at 38 - 39 weeks compared to expectant management among women with abnormal first or second biochemical screening tests on maternal and perinatal outcomes.

Enrollment: 320 women in both groups. Interim analyses will be performed after enrolling 50% of the participants.

Eligibility Criteria:
Inclusion Criteria:

* HCG, AFP or Inhibin greater than 2 multiple of median (MOM) or PAPPA less than 0.15 MOM.
* Singleton.
* Appropriate for gestational age fetus.
* Reassuring fetal status including normal amniotic fluid index.

Exclusion Criteria:

* Any hypertensive disorder.
* Indication for induction of labour at enrollment.
* Any contraindication of induction of labour.
* Prior cesarean delivery.
* Any contraindication for a trial of vaginal delivery.
Effect of Herbal Extracts on Gingival Inflammation

The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients \[5 cycles\], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 -75.
2. Severe localized gingival inflammation \[GI index 2 or greater

Exclusion Criteria:

1. Pregnancy or a wish to become pregnant during the study.
2. History of periodontal treatment within the last month.
3. Antibiotic treatment within the last month
4. Use of any antimicrobial mouthrinse within the last month.
5. Participation in another trial one month prior to the study.
6. Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.
7. Systemic Disease.
8. Patients using salicylate
Bayston Multicenter Antimicrobial PD Catheter Safety Study

The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that is impregnated with a "cocktail" of three well known anti-microbials

The objective of this clinical investigation is to establish the safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD patients initiating CAPD.

The Bayston catheter is not expected to cause any safety related complications or reactions other than those described for not-impregnated peritoneal dialysis catheters. Thus the objective of this clinical investigation is to evaluate whether the Bayston catheter causes any unanticipated serious adverse device effects (USADE).

The primary hypothesis for this study is that the Bayston Antimicrobial Peritoneal Dialysis Catheter is a safe catheter for peritoneal dialysis.

No claims regarding efficacy will be verified during this clinical investigation.

This is a prospective, non-randomized, single-arm, multi-center study involving patients suffering from end stage renal disease who are eligible for treatment with peritoneal dialysis. Forty-three (43) patients will be enrolled who will be followed up to 6 months after implantation of the Bayston Antimicrobial Peritoneal Dialysis Catheter.

Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease documented by clinical symptoms and/or laboratory findings
* Patients scheduled for their first PD catheter implantation
* Eligible for peritoneal dialysis (CAPD)
* Willing and able to attend all study follow-up visits
* Willing and able to understand and sign the informed consent form

Exclusion Criteria:

* A history of allergy to rifampin, trimethoprim or triclosan
* Use contact lenses or have lens implants
* Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
* Recent abdominal surgery, abdominal adhesions, infected abdominal wall, diaphragmatic tears or ileus
* Respiratory insufficiency
* Infection:

  * Active infections from successful completion of antibiotic treatment for routine bacterial infection less than 4 weeks of entry into the clinical investigation (screening)
  * Febrile viral infection within 4 weeks of entry into the clinical investigation (screening)
  * Less than 12 weeks from conclusion of therapy for systemic fungal infections to screening
* Abnormal hematology parameters defined as severe anemia with hemoglobin \<8.5g/dL, white blood cell count of \<3,500/μl and a granulocyte count \<2,000/μl
* Have collagen-vascular, connective tissue, or bleeding disorders
* Used an investigational medicinal product, biologic or device within the last 30 days prior to enrollment
Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages

The purpose of this study is to properly analyse the visual and refractive outcomes of implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had keratoconus
* Contact lens intolerance and clear cornea.
* The maximum keratometric reading was less than 60.00 diopters (D)
* The minimum corneal thickness more than 300 μm.

Exclusion Criteria:

* Acute or grade IV keratoconus.
* Previous corneal or intraocular surgery.
* Cataract, history of glaucoma or retinal detachment, macular degeneration or retinopathy, neuro-ophthalmic diseases, and history of ocular inflammation
iPhone App Compared to Standard Riva-Rocci (RR)-Measurement During Stress Testing

The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the photoplethysmography signal of the inbuilt camera can measure blood pressure (BP) fluctuations with sufficient correlation compared to the goldstandard oscillometric BP measurements. Investigators will recruit patients who are scheduled for a routine treadmill stress test and assess their blood pressure before and right after the test with the smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR DELTA BP Study is the correlation of the absolute difference of subsequent measurements between both techniques. If the relative chances of BP fluctuations are sufficiently assessed with this new device, BP fluctuations could be monitored continuously after calibration.


Eligibility Criteria:
Inclusion Criteria:

- able to give informed consent

Exclusion Criteria:

* atrial fibrillation
* medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)
Microwave vs. Radiofrequency Ablation for Benign Thyroid Nodules: A Multicenter Randomized Controlled Trial Study

Compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. The study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide a basis for clinical treatment.

Ultrasound-guided minimally invasive treatment has accurate positioning, higher targeting, no need for general anesthesia, less trauma for patients, and more reliable efficacy.Currently, it mainly includes percutaneous anhydrous ethanol injection, radiofrequency ablation and microwave ablation for the treatment of thyroid nodules.Currently, radiofrequency ablation and microwave ablation are mainly used to treat thyroid nodules.

This study was a randomized, parallel, positive control, and non-inferiority multicenter clinical study.Radiofrequency ablation was used as the positive control.Follow-up was conducted at 1, 3, 6 and 12 months after ablation. The primary endpoint was the rate of nodule volume reduction at 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years and ≤75 years
* The pathological diagnosis was benign thyroid nodules within 6 months
* Diameter ≥2cm, solid \> 80%, the number of multiple nodules≤ 3
* Participate voluntarily and sign the informed consent

Exclusion Criteria:

* Coagulation mechanism disorder or bleeding tendency
* Patients with severe cardiopulmonary insufficiency
* Blood pressure cannot be effectively controlled
* abnormal liver function
* Blood glucose cannot be effectively controlled
* Abnormal thyroid function
* Allergic history of ultrasound contrast agent
* Suspicious lymph node metastasis in the cervical region
* Abnormal contralateral vocal cord function
* Pregnant and lactating women
* Have participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment
* The researchers believe that there are any other factors that are not suitable for inclusion or that affect participants' participation in the study.
* Patients with inner pacemaker, hearing aid, metal stent, titanium clip, internal (external) steel plate and other metal objects.
Blood-flow Restricted Exercise in Inclusion Body Myositis

This study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol on patient reported physical function, in patients with sporadic inclusion body myositis. The study is designed as a parallel group randomized controlled trial with a treatment group and a control group.

Sporadic inclusion body myositis (sIBM) is a disease characterized by skeletal muscle inflammation and severe muscle atrophy especially in the muscles in the thigh and the finger flexors. In time the muscle weakness will cause the affected person to become unable to walk and carry out basic tasks in the every day life.

Currently no effective treatment exist for sIBM patients, however several studies indicate that exercise may be beneficial for the patients.

In the resent years a lot of research attention has been directed toward low-intensity training with partial vascular occlusion as an alternative to the conventional high intensity strength training. Interestingly the low-intensity blood-flow occluded training is found to be at least as beneficial in causing muscle growth as the conventional strength training but with very little mechanical load on joints and tendons. Furthermore the blood-flow occluded training seem to result in a hyper-activation of muscle stem cells which play an important role in muscle regeneration.

This make the blood-flow restricted training modality a very interesting treatment possibility for sIBM patients because it might be able to restore and/or maintain the skeletal muscle tissue and therefore also muscle function.

Eligibility Criteria:
Inclusion Criteria:

Clinical features

* Duration of weakness \> 12 months
* Weakness of finger flexors \> shoulder abductors AND knee extension \> hip flexion

Pathologic features

* Invasion of nonnecrotic fibres of mononuclear cells or rimmed vacuoles or
* increased major histocompatibility complex I (MHC-1) but no intracellular amyloid deposits or 15-18nm filaments

Exclusion Criteria:

* Lack of gait function
* Co-morbidity contraindicating the use of blood-flow restricted training (previous deep vein thrombosis/pulmonary embolism or known peripheral ischemic disease).
* Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic \> 160mmHg, diastolic \> 100mmHg), severe knee/hip arthritis)