cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke

This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.

This is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. 45 to 75 years old patients;
2. Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;
3. Time from symptom onset to take the study assigned medication is within 24 hours;
4. Statin naïve or discontinued at least 3 month before stroke onset;
5. First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;
6. Moderate neurological deficit with baseline NIHSS scoring from 4-20;
7. MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset;
8. Consent form signed.

Exclusion Criteria:

-

Any of the following is regarded as a criterion for exclusion from the study:

1. Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;
2. Hemorrhagic transformation or intracranial hemorrhage on baseline MRI. MRI performed between 12-48 hours after the onset, if MRI provides evidences which met with the exclusion criteria, the patients will be excluded from the study;
3. Any circumstances under which MRI scans can't be performed;
4. Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;
5. Comatose with NIHSS 1a\>1;
6. Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse;
7. Suitable for rt-Plasminogen Activator thrombolysis treatment;
8. Receiving medication with possible neuroprotective functions after stroke onset;
9. Currently take steroids therapy;
10. Diagnosed with malignancy within 5 years;
11. Patients with myopathy or serum creatine kinase \> 3 times the upper limit of normal not caused by myocardial injury;
12. Severe renal function damage (eGFR\<30);
13. Concurrent use ciclosporin;
14. A history of hypersensitivity of statins and other severe complication;
15. Child-bearing women ;
16. Patients who are or may be pregnant;
17. Other conditions under which patients not pertinent to attend the study as judged by the investigators.
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer

The of this study is to explore the clinical outcomes of indocyanine green molecular fluorescence imaging in local resection of primary hepatocellular carcinoma (CNLC Ⅰa stage).

Indocyanine green molecular imaging technique is often used in the surgical treatment of primary liver cancer. Its application in hepatectomy of primary liver cancer is currently in the stage of case accumulation and clinical research. No prospective study has been conducted to determine the clinical efficacy of indocyanine green molecular imaging for local hepatectomy of primary liver cancer. On the basis of more than 1000 liver resection procedures, the investigators want to apply indocyanine green molecular imaging technology, a cheap, simple and radiation-free method, to guide surgical resection. The purpose is to assist surgical procedures and improve participants' tumor-free survival.

Eligibility Criteria:
Inclusion Criteria:

* First clinical diagnosis of primary liver cancer (China liver cancer staging, CNLC Ia stage);
* Child-Pugh grading standard of liver function was GRADE A or B;
* 18-66 years old;
* Complete clinical case data;
* limited surgical methods (local resection);
* Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

* There are basic diseases that cannot tolerate surgery (such as severe cardiopulmonary cerebral renal insufficiency);
* Tumor thrombus or distant metastasis was found in main portal vein and primary branch, main hepatic vein and branch, main hepatic vein and inferior vena cava by preoperative imaging examination;
* planned pregnancy, unplanned pregnancy and pregnancy;
* Preoperative child-Pugh grading standard of liver function was Grade C.
* Disease researchers that the investigator considers inappropriate to participate in this clinical trial.
Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy)

Evaluate the feasibility of performing a multi-elemental imaging analysis of lung specimens from patients with ILDs, with an technology named LIBS (Laser Induced-Breakdown Spectroscopy)

There is a major health problem due to the environmental and occupational related exposures to mineral particles, metals, and dust. The impact on health is considerable in terms of prevalence, morbidity and healthcare costs. Pathologists rarely report the presence of a possible mineral or metal-related etiology in a specimen by lack of available and convenient technology. Therefore, several respiratory diseases are considered idiopathic.

Interstitial lung disease (ILD), also known as diffuse parenchymal lung disease (DPLD) is a group of lung diseases affecting the interstitium (the tissue and space around the air sacs of the lungs). In France, 15.000 new cases of ILD are diagnosed each year. ILD may be classified according to the cause. Idiopathic ILD are ILD of unknown causes. The most frequent idiopathic ILD are sarcoidosis and idiopathic pulmonary fibrosis (IPF).These two diseases are the core topic of the present study since they may relate to important mineral or metal exposure.

The overall goal of this MEDICO-LIBS study is to evaluate the feasibility of using a laser-induced breakdown spectroscopy (LIBS)-based instrument to image(ie, identify, localize and possibly quantify) metals within selected human specimens with ILDs.

Eligibility Criteria:
Inclusion Criteria:

* Patient with ILD
* Patient informed, and agreed to participate

Exclusion Criteria:

* Patient opposed to participating in the study.
* Patient without available specimen.
* Patient under legal protection
An Investigational Device (Millar Mikro-Tip Catheter) and Imaging Scan (Shear Wave Elastography) in Measuring Tumor Pressure and Stiffness in Patients With Solid Tumors Undergoing Ultrasound-Guided Biopsy

This trial studies how well a Millar Mikro-tip catheter and shear wave elastography measure pressure and stiffness inside tumors among patients with solid tumors undergoing an ultrasound-guided biopsy. A Millar Mikro-tip catheter measures the pressure inside the tumor. Shear wave elastography is similar to an ultrasound and uses sound waves to vibrate the tissue in order to study tissue stiffness. These measurements may help doctors learn if pressure and stiffness are related to intratumoral fibrosis (the thickening and scarring of connective tissue).

PRIMARY OBJECTIVES:

I. To determine the feasibility of measuring tumor intratumoral pressures in vivo using a commercially available, sterile, single use, cardiovascular catheter device.

II. To determine the feasibility of measuring tumor intratumoral stiffness in vivo using a commercially available shear wave elastography with ultrasound.

SECONDARY OBJECTIVES:

I. To assess the relationship of tumor pressure, stiffness, and fibrosis.

OUTLINE:

Patients scheduled for an ultrasound-guided tumor biopsy undergo stiffness assessment of the tumor with shear wave elastography over 2 minutes and pressure measurements of the tumor using a Millar Mikro-tip catheter before and after the biopsy is collected.

After completion of the study, patients are followed up at 24-48 hours and at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for at least one biopsy (diagnostic or research) for solid organ tumors (excluding bone) at MD Anderson.
* Patients who are able to understand and give consent to participation in the study.

Exclusion Criteria:

* Tumor size \< 1.5 cm or \> 5 cm in size on pre-procedural imaging for 1st assessment and \< 1 cm for 2nd assessment
* Pregnant women (these patients will be tested for pregnancy before they are scheduled for a diagnostic or research biopsy per inclusion criteria #1).
* Tumors involving bone.
Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic

Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment.

We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo.

An interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.

Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians. The reported incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in retrospective surveys.

The pathogenesis of infantile colic remains elusive despite decades of research. It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.

Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy term infant 21-90 days of age
2. Birth weight ≥2500 g
3. Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
4. With colic symptoms (\>3 hours of crying on \>3 days per week) with debut 10 ± 5 days before enrollment
5. Gestational age between 37 and 42 weeks
6. Apgar score higher than 7 at 5 minutes
7. Written informed consent from a parent

Exclusion Criteria:

1. Any chronic illness or gastrointestinal disorder as judged by the pediatrician
2. Any history of antibiotic treatment or probiotic supplementation
3. Failure to obtain a written consent by parent/legal guardian
4. Participation in other clinical trials
5. Infants with acute illness
6. Subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo
PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

Atrial fibrillation ablation is the most common intervention performed worldwide. Up to 20 to 45% of patients show recurrence of AF within 12 month after catheter ablation, however its determinant are incompletely understood.

The aim of the PROSPECT-AF study is to assess the predictors of AF recurrence within the 3 years following ablation using clinical variables and innovative biomarkers in a prospective cohort of 750 patients undergoing atrial fibrillation catheter ablation.

The secondary aims are to assess the incidence of major adverse cardiovascular outcomes (MACE) and the incidence of major bleeding within the 3 years Wolfing catheter ablation.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing atrial fibrillation catheter ablation
* Able to give their consent

Exclusion Criteria:

* Childs
* Patient under guardianship
* Patients unable to give their consent
* Pregnancy
Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.

The development of acute kidney injury (AKI) during septic shock is frequent and is associated with a high mortality rate. The reason of this increased mortality despite the use of renal replacement therapy is still unknown. The deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. Among those solutes, indoxyl sulfate (IS) is associated with the development of cardiovascular complications and impairment of immune response. The role of uremic toxins and particularly IS in the prognostic of septic kidney injury is unknown. The investigators propose to analyze the relation between the serum concentration of IS and the mortality of patients hospitalized for a septic shock who developed an AKI.

During chronic kidney disease the uremic toxins have been widely described as potential harmful solutes targeting the cardiovascular system, immunologic system, endothelium and bone metabolism. However, nothing is known about the potential accumulation and pejorative effects of those uremic toxins during AKI (Acute Kidney Injury). The objective of this study is to explore the role of the uremic toxins and specially IS (Indoxyl Sulfate) in the mortality of patients hospitalized for a septic shock and AKI. This study will also describe for the first time the kinetic of the blood concentration of different uremic toxins and their relation with the mortality and the kidney function.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years hospitalized in the medical intensive care unit in Amiens university hospital
* Presence of a septic shock (sepsis associated with a persistent hypotension after fluid resuscitation and requiring vasopressors to maintain MAP \> 65 mmHg and/or serum lactate level \> 2 mmol/ L).
* Evidence of AKI (KDIGO \> or equal1) in the 72 hours following the admission in the ICU: diuresis \< 0.5ml / kg / h for 6 to12 hours or \> or equal 1.5 to1.9 fold increase or \> 26.5 micromol / l in serum creatinine from baseline
* signed written informed consent form
* covered by national health insurance

Exclusion Criteria:

* known pre hospitalization (in the last 3 month preceding the hospitalization) advanced chronic kidney disease defined by an estimated glomerular filtration rate \< 60 ml / min / 1.73m square
* Pregnancy
* Presence or strong clinical suspicion of renal obstruction
* Moribund patients (expected life \< 48h)
* Cardio respiratory arrest
* Hemoglobin level below 10 g / dl
Evoked Fields After Median and Ulnar Stimulation

In order to be able to study the effects of evoked fields with magnetoencephalography (MEG) in two groups of patients, comparison is made with a group of healthy volunteers.

This study is directed at the (central and / or peripheral) mechanisms of pain and the cortical changes (plasticity) due to chronic non-malignant pain in two groups of patients and one healthy volunteer group.

The aim of the study is further to evaluate cortical processes by MEG (and fMRI, if feasible) to quantify and qualify the responses, localise the generators and study the effects of a pain therapy.

To search for patterns that may result in diagnostic criteria and have an indicative value for the treatment and the monitoring of the effects.

Finally the study not only intends to support clinical diagnosis but also to provide tools to monitor treatment and support the choice (algorithm) between SCS and SAN. An algorithm, facilitating decision making between these two treatments, will be promoted. It should also provide a clinical decision tool for the use of SAN

Eligibility Criteria:
Inclusion Criteria:

CRPS I:

* (Absolute) functio laesa, secondary pain and cold sensations
* (Relative) abnormal skin colour, allodynia, hyperalgesia, hyperpathia, hyperhydrosis,oedema, increased nail growth, increased hair growth. (At least 4 need to be present).

CRPS II:

* All the previous but evidence of traumatic peripheral nerve injury.

Exclusion Criteria:

* General condition
* Pregnancy
* Technical implants (pacemaker, SCS: disturbs MEG)
Lateral Sinus Augmentation Using L-PRF as Sole Graft Material

Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. In this study, the ABC sinus classification was followed in case selection. A sinus augmentation is done with several techniques. Sinus membrane elevation is done with two different approaches, either the crestal approach or lateral window approach.

Using biofiller material for sinus membrane elevation has been tried by many researchers, using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or with implant tenting.

In this study, sinus augmentation was performed using a lateral window approach using L-PRF as sole biofiller material in one group, xenograft as only biofiller material in the second group and mixed xenograft with L-PRF in the third group. Histomorphometric analysis was done from the core biopsy after three months of augmentation, and implant placement was done.

After three months, prosthetic parts were placed. The results of this study show that the augmentation of the sinus using L-PRF mixed with bone graft is showing the best results followed by L-PRF only, and the least was xenograft.

From this point of discussion, it can be considered that using L-PRF as sole biofiller material in sinus augmentation.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult patients.
2. Both sex, males and females.
3. Age from 24 - 49 years old.
4. All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
5. Extraction done at posterior maxilla involved with the maxillary sinus.
6. Remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically.
7. Gingival biotype 1-2mm thickness.
8. Patient has no previous surgery in Maxillary antrum.

Exclusion Criteria:

1. Smokers.
2. Pregnant and breast-feeding females.
3. Mentally retarded Patients.
4. Presence of hematologic disease.
5. Previous radiation, chemotherapy, or immunosuppressive treatments.
6. Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
7. Patient with history of chronic sinus pathosis
8. Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure.
Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy

This study aims to assess whether transmusculr quadratus lomborum block (QL block) can reduce postoperative pain after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC). Patients will be randomly assigned to either QL block group or control group. Ultrasound-guided bilateral transmuscular quadratus lomborum block will be performed in QL block group using 0.375% ropivacaine. Multimodal analgesic regimen including acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), and rescue opioids will be used in every patient. Primary outcome is opioid consumption for 24 hours after surgery. Secondary outcomes included pain scores, time to first rescue analgesics, quality of recovery score, length of hospital stay.

Adult patients scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy will be screened for eligibility. After induction of general anesthesia, ultrasound-guided bilateral transmuscular quadratus lomborum block will be done in QL block group. 0.375% ropivacaine will be injected to each side. Patients in control group will receive no block. Multimodal analgesia will be applied to every patient for postoperative pain control. Multimodal analgesic regimen included scheduled administration of acetaminophen, NSAIDs, and rescue opioids. Blinded investigator will assess pain scores at rest and on movement at 6, 12, 24, 48, 72 hours after surgery, analgesic consumptions, nausea, vomiting, and quality of recovery questionnaire.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC)

Exclusion Criteria:

1. Allergy to local anesthetics or fentanyl
2. Chronic pain
3. Drug abuse
4. Patients who are unable to use patient-controlled analgesia
5. Skin infection at site for quadratus lomborum block
6. pregnant or breatfeeding women
7. Patients who are unable to communicate
Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation

This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for painless diagnostic procedures
* are ASA I or ASA II

Exclusion Criteria:

* have an indwelling central venous catheter
* have received an analgesic or sedative medication in the previous four hours prior to enrollment
* have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
* known hypersensitivity to lidocaine or any component of the formulation
* hypersensitivity to another local anesthetic of the amide type
* Adam-Stokes syndrome
* severe degrees of SA, AV, or intraventricular heart block
* allergy to corn-related products
* contraindication to propofol
Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.

Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Infants inborn below 28 weeks gestation

Exclusion Criteria:

* At birth, deemed not likely to survive 7 days or more
* Major intracranial congenital anomaly
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1

GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.


Eligibility Criteria:
Inclusion Criteria:

* refer to the GZPL master protocol for screening eligibility.

Exclusion Criteria:

* refer to the GZPL master protocol for screening eligibility.