cyrilzakka/clinical-trials huggingface dataset:
Clinical Re-evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

In order to investigate the time window of acute intracerebral hemorrhage(AICH) by "Blood Activating and Stasis Dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the therapy lasts two weeks, and the follow up should last three months. The main indexes are mortality rate, disability rate and the brain hematoma situation. The review is made by the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.

objective: to investigate the safety and effect of acute cerebral hemorrhage treated with "Blood Activating and Stasis Dispersing" therapy and to verify the traditional methods can influence the brain hematoma enlargement or not.

Methods: from 2013.8 to 2015.12, 360 cases of AICH will be included in 13 research centers. Patients are randomly into 3 groups within 6hrs from onset,such as, group A, blood activating herbal medicine (8 herbals), Group B, herbal medicine without blood activating herbal(6 herbals), Group C, placebo for 10days. All the patients will be treated according AHA guideline of AICH. All patients will be set to the CT at the onset, 24h later and 10-14days after treatment. So the rate of enlargement of brain hematoma in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* no younger than 18 yrs
* acute cerebral hemorrhage confirmed by brain CT scan
* within 6 hours from onset
* GCS≥6
* Sign the informed consent form

Exclusion Criteria:

* Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc;
* patients with Severe heart, liver and renal insufficiency.
* Intolerance to traditional Chinese medicine (TCM), allergic constitution.
* patients with severe cerebral hernia in the early onset
* Compliance is poor.
Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation.

Pulmonary regurgitation is a common complication late after complete correction of a tetralogy of Fallot. It progressively leads to a right ventricular dilatation that has been strongly associated with ventricular arrhythmia, sudden death and right ventricular insufficiency. Pulmonary valve replacement reduces the rate of complications but the precise timing for this procedure remains unknown. Moreover, pulmonary valve replacement, even before the occurrence of symptoms, doesn't allow for a total recovery in all patients. Reasons are not known, but cardiopulmonary bypass as well as late referral to surgery have been incriminated to explain the persistence of right ventricular dysfunction after surgical valvular. Therefore, a strategy avoiding cardiopulmonary bypass could potentially preserve the right ventricular function and in the meantime reduce the hospitalisation length and morbid-mortality. For the last six years, we and others have developed a technique of percutaneous pulmonary valve implantation. Encouraging results were reported in the treatment of failing right ventricular to pulmonary artery conduit, but presents indications are limited and the innovative technique could not be offered to most of patients requiring pulmonary valve replacement. In particular, to date, conventional surgery is the only approach for patients with large pulmonary trunk over 22 mm in diameter. We had the idea of collaborating with the surgeons to try to improve the outcome of valvular in these patients. We would like to investigate a hybrid strategy in those patients with large right ventricular outflow tract inaccessible to solely transcatheter technique. The studied technique will associate a surgical pulmonary artery banding without cardiopulmonary bypass immediately followed by a transventricular or a transvenous pulmonary valve insertion using a conventional valved stent. The purpose of this randomized study is to evaluate benefits and risks of the medico-surgical hybrid strategy, and to compare both strategies hybrid approach and conventional surgery with extracorporeal circulation in term of right ventricular function recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with surgical indication of pulmonary valve replacement for significant pulmonary regurgitation
2. Pulmonary trunk diameter \> 22mm
3. Age \> 5 years old or weight \> 20kg
4. Acceptance of protocol
5. Social regimen security

Exclusion Criteria:

1. No indication of pulmonary valve replacement
2. Age \< 5 years old or weight \< 20kg
3. Extra-cardiac disease with a vital prognosis under 6 months
4. Heparin and contrast allergy
5. Clinical or biological signs of infection
6. Pregnancy
7. Patients in emergency state
8. Patients included in an another research protocol during the last months
Tailored H. Pylori Eradication Based on Clarithromycin Resistance

The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant.

Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Helicobacter pylori infection

Exclusion Criteria:

* H. pylori eradication therapy within 1 year,
* antibiotics within 4 weeks,
* surgery for gastric cancer
* malignant tumors other than gastric cancer
* end-stage renal disease
* liver cirrhosis,
* pregnancy
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hepatic and Renal Dysfunction After Pneumoperitoneum

The purpose of this study is to compare the effect of TEAS pretreatment and treatment on hepatic and renal dysfunction induced by pneumoperitoneum in patients undergoing laparoscopic surgeries.

Patients were randomly assigned to three groups, control group and two intervention groups, receiving TEAS before and after general anesthesia induction respectively. TEAS was given through electrodes attached to acupoints. The time for TEAS was 30min. Venous blood samples were collected before and 20min after pneumoperitoneum. Hepatic and renal function index including AST, ALT, ALP, BUN, Cr were measured.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18yrs,\<60yrs；
* ASA 1-2；
* Scheduled for laparoscopic surgery under general anesthesia；
* Informed consented

Exclusion Criteria:

* Patients with hepatic or renal dysfunction；
* Patients with severe hypertension or cardiac dysfunction；
* Patients with severe pulmonary disease；
* Patients with hemoglobin\<100g/L
Exosome as the Prognostic and Predictive Biomarker in EBC Patients

This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients


Eligibility Criteria:
Inclusion Criteria:

* Early breast cancer
* Planned neoadjuvant chemotherapy
* Triple negative breast cancer or HER2-positive breast cancer

Exclusion Criteria:

* Stage IV breast cancer
* Hormone receptor positive breast cancer
Hippocampal Radiation Exposure and Memory

Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. There is a need to evaluate changes in memory function that may be associated with such exposures.

In this pilot study, we will investigate changes in hippocampal-dependent memory function in 10 patients receiving a low SRS dose to the hippocampus. We will also investigate such changes in a no-dose control group and a high-dose control group. This study will provide preliminary estimates of variance in memory changes associated with radiation exposure, and will then permit us to design future studies with the appropriate sample size justification.


Eligibility Criteria:
Inclusion Criteria:

* Patients planned for radiosurgery for benign disorders (Groups 1\&2).
* Patients planned for prophylactic cranial irradiation (Group 3)

Exclusion Criteria:

* Previous cranial radiation
* Severe psychiatric disorder
* Severe cognitive or memory impairment (MMSE \< 21)
* Non-English speaking, which will potentially make memory testing difficult and unreliable.
* Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures
* Patients on steroid medications.
* Left hand dominant patients
* Dose exposure to left hippocampus \>0.5Gy and \<2Gy. We will attempt to estimate dose to hippocampus prior to enrollment using pre-planning on diagnostic imaging to minimize exclusion of patients due to dose exposure \>0.5 Gy and \< 2Gy following baseline memory testing.
* Benzodiazepine or narcotics given on the day of radiotherapy/radiosurgery prior to completion of the study procedures
* Previous brain surgery within one year prior to radiosurgery
* Pregnant women
Postoperative Relapses in MS Patients

The aim of the study is to record any relapses during one year postoperatively in patients and parturients diagnosed with MS who received general or regional anesthesia


Eligibility Criteria:
Inclusion Criteria: diagnosed MS -

Exclusion Criteria: refuse to participate

-
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.

Demonstrate that the use of benchmarking improves quality of patient care, in particular the control of diabetes, lipids and blood pressure, by determining the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed Consent
* Patients suffering from diabetes type II, insulin dependent or not insulin dependent.

Exclusion Criteria:

* Type I diabetes
* Pregnancy diabetes
* Hospitalisation, as this is a primary care study
* Patients who are member of the Belgian Diabetes Convention
ctDNA for Early Detection of Recurrence in Melanoma

This study examines circulating tumor DNA (ctDNA) as a biomarker for early detection of recurrence in high-risk patients, following treatment of primary melanoma. The hypothesis is that ctDNA can provide accurate detection of recurrence or metastasis, at the time of or earlier than current methods, leading to improved management and hopefully prognosis, based on earlier detection.

This prospective, single-institution study will recruit patients attending follow-up for primary melanoma with high risk of recurrence, at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University.

Enrolled patients will undergo regular blood sampling. Samples will be centrifuged and plasma will be harvested and stored. In cases of metastasis or recurrence, tumor tissue samples will be analyzed using NGS to determine their mutational profile. Plasma samples will be analyzed for ctDNA corresponding to identified mutations. If ctDNA is detected, previous samples will be analyzed in reverse sequential order, until no ctDNA is detected.

Follow-up time after inclusion is five years or end of clinical-follow up, with an interim sample and data analysis scheduled for 2024 and final analysis scheduled for 2027-2028.

Eligibility Criteria:
Inclusion Criteria:

* Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV

Exclusion Criteria:

* Pregnancy
* Previous history of melanoma
Impact of Pulmonary Follow-up After Stem Cell Graft

Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many malignant and non-malignant hemopathies. The graft-versus-host immunological reaction (GvH) is a frequent and sometimes serious complication. The objective is to study whether a systematic and early follow-up by a lung specialist of allografted patients would allow an earlier diagnosis of GvH with pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* patients with a hematopoietic stem cell transplantation

Exclusion Criteria:

* Death within 100 days post-surgery
Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With NSCLC or MPM

Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant Pleural Mesothelioma, but all the studies published thus far were based upon a variety of empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modeling showed by simulation that a new metronomic protocol could lead to a better safety and efficacy profile.

Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical Protocol) with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is two-staged as 12 patients are planned to participate in the phase Ia, to confirm safety and consolidate the calibration of the average parameters of the model. Depending the phase Ia result, and after favorable decision of a consultative committee, the extension phase (phase Ib) will be an efficacy study and will include a number of 20 patients receiving the Optimal Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the phase Ia and the objective response according to RECIST 1.1 for the phase Ib.

An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.

Discussion: this ongoing trial is the first to prospectively test a mathematical optimized schedule in metronomic chemotherapy. As such, this trial can be considered as a proof-of-concept study demonstrating the feasibility to run a computational-driven protocol to ensure an optimal efficacy/toxicity balance in patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) ≥ 18 years of age.
* Patients with histologically documented, locally advanced or recurrent (stage IIIB) or metastatic (Stage IV) non-small cell lung Cancer or malignant pleural mesothelioma, for which no standard exits.
* Presence of at least one measurable lesion according to RECIST v.1.1 for NSCLC and modified RECIST 1.1 for MPM
* ECOG performance status ≤2

Exclusion Criteria:

* ECOG performance status \>2
* Patients with significant or uncontrolled cardiovascular disease (eg, congestive heart failure, angor, arrhythmia) within 6 months of starting study treatment
* Any neurological or psychiatric condition interfering with the understanding of study
* Infectious condition uncontrolled
* Any other medical condition that would jeopardize the subject participation
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis

The investigators' aim is to study the effects of mechanical expression of meibomian glands on eyelid disease, ocular surface health in the subacute phase of SJS/TEN.

The primary outcome is to use meibomian gland imaging to assess the health and caliber of the meibomian glands of both lower eyelids, between the treated and non-treated eyes before and after the intervention. Monitoring of outcomes will be measured by comparing the results of meibography at the initial visit and at the 6-month follow-up.

The secondary outcome assessed will be patient symptoms. The Ocular Surface Disease Index survey will be administered before each treatment and patients will be asked to differentiate their symptoms between the two eyes, both before and after the intervention.

The investigators hypothesize that mechanical expression of meibomian glands within the first 6 months of SJS/TEN onset will significantly improve ocular surface disease and symptoms in those patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with SJS/TEN presenting to the Massachusetts Eye and Ear Infirmary (MEEI) ophthalmology clinic or who were seen by the ophthalmology team acutely at the Massachusetts General Hospital (MGH).
* Patients must be in the Sub-acute phase of ocular SJS (within 6 months)
* Patients must have evidence of Meibomitis
* Patients must be adults (18 years of age or older)

Exclusion Criteria:

* Patients with unconfirmed diagnosis of SJS vs. Erythema multiforme (or other condition).
* Patients beyond the sub-acute phase of SJS
* Patients without evidence of Meibomitis (See above criteria)
* Patients under the age of 18
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2
* Patients treated with canakinumab in the core studies or subsequent extensions

Exclusion Criteria:

- Pregnant or nursing (lactating) women
SpotLight-19 Research & Development Study

In this study, we will use the SpotLight-19 device in patients presenting to a coronavirus disease (COVID-19) Assessment Centre for polymerase chain reaction (PCR) testing. Consenting patients will undergo a Spotlight-19 scan. We will link the scan to PCR results, age, vaccination status, and COVID-19 symptoms in order to calibrate the SpotLight-19 prediction algorithm of a state of COVID-19 infection.

Implementation of rapid, accessible, and accurate COVID-19 testing is a cornerstone of public health efforts to contain and respond to the spreading virus. To respond to this need, ISBRG Corp is applying its SpotLight-19 device to the challenge of developing a non-invasive screening test for COVID-19. The SpotLight-19 device is designed to use non-invasive visible and near-infrared (NIR) spectroscopic measurements of an individual's fingertip and an artificial intelligence technology platform calibrated using viral diagnostic measurements to identify and recognize a spectral fingerprint specific to COVID-19.

All individuals (3yrs or older) presenting to designated hospital COVID-19 Assessment Centres in Ottawa will be recruited to participate. Only people with extreme fingertip scarring will be excluded. Consenting participants will undergo a scan using the SpotLight-19 device - this includes a Fitzpatrick Skin Assessment and 10-20 second scans of the fingertip with the SpotLight-19 device. Following the scan participants will undergo a PCR test as per usual care. The PCR result, participant age, COVID-19 vaccination status, and presence of COVID-19 symptoms will be collected from the medical record and shared with ISBRG Corp. A minimum of 250 COVID-19 positive and a minimum of 250 COVID-19 negative as determined by PCR will be sought. The number of enrolled participants to achieve the sample size will depend on the COVID-19 positivity rate.

Eligibility Criteria:
Inclusion Criteria:

* Qualifies for COVID-19 testing as per Assessment Site protocol; or
* Is capable of cooperating with testing
* Is clinically stable such that the testing protocol may be completed safely

Exclusion Criteria:

* Extreme fingertip scarring or other physical condition that prevents use of the device
Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.

Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.

Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone

Eligibility Criteria:
Inclusion Criteria:

* Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm

Exclusion Criteria:

1. Previous percutaneous nephrolithotripsy at the same side.
2. Previous renal exploration for stones at the same side.
3. Positive urinary culture.
4. Calyceal stones
Sustainability of a Research Program in Risk Management (PeRENNITe)

Sustainability can be defined by several dimensions: the pursuit of program elements, the maintenance of its effectiveness, its integration into work processes, the adaptation of the program to the local context, its integration into the organizational culture, the dissemination of the program to other centres. Studies show that the continuation of the entire intervention is rare once the research stops.

The PRisM study (Pluriprofessionality and Risk Management through a Multifaceted Program in Primary Care) was a primary care risk management (RM) research project. Its purpose was to develop a safety culture within the participating multi-professional primary care structures. From 2015 to 2017, multi-professional primary care offices participated in the study, half of which implemented a RM program consisting of: 1) Training on RM in the context of primary care; 2) The appointment of a RM referent; 3) The conduct of six meetings of systematic analysis of incidents.

The PRisM study represents a favorable ground for the development of a methodology for evaluating the sustainability of a RM program in primary care.


Eligibility Criteria:
Inclusion Criteria:

* Volontary pluriprofessional primary care offices
* Having participated in the PRiSM study

Exclusion Criteria:

* office that waived participation in the PRisM study course
* office with a participation rate in the first PRisM safety climate survey \< 30%.
* office of the PRisM study intervention group that did not implement the program as planned