cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Accuracy,Feasibility,Safety of Continuous Glucose Monitoring System

Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU, but its feasibility, accuracy and confounding factors are controversial.

Acute glucose metabolic disorder (hyperglycemia, hypoglycemia and high glucose variability) is common during critical illness and associated with poor prognosis.Continuous glucose monitoring system (CGMS), which providing continuous glucose values, is promising to overcome these problems mentioned above and finally optimize glucose control.But its feasibility, accuracy and confounding factors are controversial.The aims of this study is to assess the accuracy, feasibility and safety of CGMS in daily routine in a general ICU in comparison with simultaneous laboratory arterial blood glucose (ABG) values

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: Critically ill patients who were older than 18 years old and expected length of ICU stay longer than 48 hours

Exclusion Criteria:

* 1) they were pregnant.2) had broken skin. 3) had a platelet count of less than 30 × 109/L 4) had participated in another trial.5) diabetic ketoacidosis or hyperosmotic coma.6) judged to be improper to complete this trial by the investigator
Characterization of Hamstring and Quadriceps Neuromuscular Fatigue After Soccer Game

This is a monocentric study comparing hamstring and quadriceps neuromuscular fatigue after simulated soccer game, anaerobic and aerobic training sessions. The purpose of this study was:

1. To quantify the decrease of isometric force immediately after a simulate soccer game.
2. To characterize peripheral and central fatigue between hamstring and quadriceps muscles and described the kinetics of recovery after specific tasks of soccer training.
3. To compare the level neuromuscular fatigue induced by anaerobic and aerobic training.
4. To highlight correlation between neuromuscular fatigue and performance markers.


Eligibility Criteria:
Inclusion Criteria:

* male
* age limits: minimum: 16 ; maximum: 40 years old
* to be a soccer player, licensed to the French Football Federation
* affiliation to the social health insurance scheme
* signing an informed consent form

Exclusion Criteria:

* impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, ...)
* subject under the protection of justice
* subject under guardianship or curatorship
* lower limbs musculotendinous or articular problems
* smoker or having been a smoker in the last 5 years
* subject wearing a pacemaker
* drug treatment in progress and impossibility to stop it within 7 days before the beginning of the study.
Left Ventricular Lead Position in Cardiac Resynchronization Therapy

Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.

In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.

Eligibility Criteria:
Inclusion Criteria:

* See above
* Males and females
* Ages 18 to 80 years

Exclusion Criteria:

* Patients who already have had a pacemaker device
* Patients with poor echocardiographic window
* Patients who are not able to understand the study and to give informed written consent
Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion

The main aim of the biomarkers to predict Hemorrhagic transformation(HT) after endovascular treatment in Acute Ischemic Stroke Patients.

The study has three main parts. During the first part, the investigators propose to conduct an enrollment of patients after thrombectomy in acute Ischemic Stroke and healthy controls. Serum biomarkers levels were analyzed (before and after) endovascular treatment patients and controls respectively.

During the second part, HT was evaluated and classified on cranial computed tomography and/or MRI post- treatment and was considered as symptomatic HT (sHT) if associated with neurological deterioration.

During the third part, the investigators aim to demonstrate the level of biomarkers can significant predict HT and outcomes in stroke patients undergoing revascularization.


Eligibility Criteria:
Inclusion Criteria:

1. be 18 or older;
2. have a clinical diagnosis of acute ischemic stroke
3. a score of 6 or more points on the NIHSS(the National Institutes of Health Stroke Scale);
4. be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke;
5. patients eligible for IV alteplase should receive IV alteplase;
6. Intracranial arterial occlusion of the distal intracranial carotid artery, middle (M1/M2) ,anterior (A1/A2) cerebral artery,vertebral artery,basilar artery or posterior cerebral artery,demonstrated with CTA, MRA or DSA;
7. begin intra-arterial therapy within 24 hours of symptom onset;
8. have provided informed consent.

Exclusion Criteria:

1. have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;
2. patients with known infectious, inflammatory, or neoplastic diseases at the time of treatment and non-availability of blood samples;
3. are pregnant.
Nutritious Eating With Soul (The NEW Soul Study)

This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in:

1. Risk factors for CVD, including LDL cholesterol and blood pressure; and
2. Body weight.

   Secondary Aim
3. Examine long-term changes in CVD risk factors and body weight at 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as African American
* Be between the ages of 18-65 years
* Body Mass Index between 25- 49.9 kg/m2
* Live in the Columbia, SC/Midlands area
* Be able to attend all monitoring and weekly class visits
* Be willing to be randomized to either diet

Exclusion Criteria:

* Currently following a vegan diet
* Diagnosed with diabetes that is controlled by medication
* Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
* Under the age of 18 years old
* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Diagnosed with stroke or heart attack
Maraviroc Compassionate Use

The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

This study was cancelled prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.
* Have only CCR5-tropic HIV-1 virus
* CD4+ cell count \< 200 cells/mm3

Exclusion Criteria:

* CXCR4- or dual/mixed-tropic HIV-1 virus
* Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness
* Patients who are pregnant or breast feeding an infant or planning to become pregnant.
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight

The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Ages =\>7 y.o.
3. Subjects that are minors (\<18 years old) must have a parent or legal guardian.
4. Binocular vision
5. Willing and able to give informed consent and follow all study procedures and requirements
6. Fluent in English
7. Be treated for myopia with Ortho-K, day contacts, or night contacts

Exclusion Criteria:

1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
2. Has traveled outside the country within the last 4 weeks
3. Medications:

   a. Taking medications that may affect ability to follow instructions.
4. Eye Disease:

   a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection, keratoconus, etc.
5. Subjects that:

   1. Lack physical dexterity to properly operate the EyeQue App on the smartphone
   2. Lack the ability to follow instruction
   3. Lack binocular vision
   4. Lack the ability to maintain both eyes open
   5. Had eye surgery within the last 12 months (including Lasik)
A Study of Baclofen ER

This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine brain mechanisms of relapse/recovery, participants will complete fMRI sessions before, during, and after treatment. Brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Physically healthy cocaine-dependent (based on DSM-IV- TR criteria) male or female aged 18-60 yrs, voluntarily seeking treatment for cocaine dependence.
2. Females must be non-pregnant, non- lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, a levonorgestrel implant, intrauterine progesterone contraceptive system, medroxyprogesterone acetate contraceptive injection, and abstinence.
3. Reading level at or above eighth grade.
4. Participants provide voluntary informed consent.
5. Smoking is primary route of cocaine administration.
6. Available for an inpatient stay.

Exclusion Criteria:

1. Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator.
2. Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities.
3. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
4. Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). An x-ray may be obtained to determine eligibility.
5. Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes.
6. Current or prior gambling problems (assessed by participants self-report)
7. Non-removable skin patches
8. Have received medication that could interact adversely with baclofen, including muscle relaxants (including tricyclic antidepressants), antiseizure medication, CNS depressants (tranquilizers, sleeping pills), MAO inhibitors), within the time of administration of study agent based on the study physician's guidance (e.g. 5 half lives)
9. Have known or suspected hypersensitivity to baclofen.
10. Be taking baclofen for any reason currently or during the past year.
Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement

The purpose of this study is to assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield

Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. Optic Enhancement is a novel image-enhanced endoscopy system. Targeted biopsy protocol based on high definition endoscopy with Optic Enhancement will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from high definition endoscopy with Optic Enhancement targeted biopsies and a standard biopsy protocol and assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Eligibility Criteria:
Inclusion Criteria:

* patients with dyspeptic symptoms and aged 40 years or older
* or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
* or patients with family history of gastric cancer

Exclusion Criteria:

* presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
* presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
* inability to provide informed consent
Preoperative Pain Control in Liver Surgery Patients

Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score.

Methods: In this Randomized Controlled Trial, patients undergoing partial hepatectomy will be administered a single pre-operative dose of Pregabalin or a placebo. Primary endpoints are as follows:

* Post-operative analgesic requirements
* Post-operative VAS scale (rated 0-10)
* Complications
* Post-operative antiemetic requirement
* Length of stay

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing partial hepatectomy

Exclusion Criteria:

* contraindication against pregabalin
* creatinine \> 2.0 mg/dl
* GGT \>165, AST \>105, ALT \>135
* peptic Ulcus
* haemorrhagic diathesis
* angina pectoris, myocardial infarction
* stroke
* bronchial asthma
* opioid abuse
Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants

To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars.


Eligibility Criteria:
Inclusion Criteria:

1. Systematically healthy patient (ASA I and II).
2. Age between 20 and 45 years with no sex predilection
3. Mandibular permanent premolar teeth:

   * Diagnosed clinically with pulp necrosis.
   * Absence of spontaneous pain.
   * Radiographic evidence of root and root canal.
   * Slight widening in the periodontal membrane space or with periapical radiolucency.
   * No response to cold pulp tester (ethyl chloride spray)
4. Patients who can understand and interpret Numerical rating scale (NRS).
5. Patients' acceptance to participate in the trial

Exclusion Criteria:

* 1- Medically compromised patients having significant systemic disorders. (ASA III or IV).

  2- History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.

  4- Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.

  v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
* Immature teeth.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Expanded Access to NanoPac

NanOlogy may consider offering expanded access to NanoPac for patients who do not meet the enrollment criteria of clinical trials in progress.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction

Objective: To examine the effects of three commonly applied treatments of disordered phosphorus homeostasis on biochemical markers and vascular characteristics in patients with moderate and advanced non-dialysis dependent chronic kidney disease.

Approximately 120 qualified patients from our medical center, who have been diagnosed with mild to moderate chronic kidney disease (estimated GFR 15-60 ml/min), will be enrolled. After informed consent, qualified subjects will be randomized into 3 arms in a 1:1:1 ratio: lanthanum carbonate, calcium acetate, and dietary modification. The maximum length of treatment is 12 months. Dose of intervention will be adjusted based on changes in biochemical parameters. Primary end points are changes in serum phosphorus, urine phosphorus, serum parathyroid hormone, coronary artery calcification, aortic pulse velocity and flow mediated vasodilation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female CKD patients \> 18 years old
* Patients should be willing and able to provide written informed consent and HIPAA authorization to participate in study
* Chronic kidney disease Stage 3 or 4 per K-DOQI Guidelines: estimated glomerular filtration rate (eGFR) of 15-60 ml/.min/1.73m2 by using modified MDRD equation.
* Serum phosphorus \>4.6 mg/dl or plasma intact PTH (iPTH) level above 65 pg/ml or tubular reabsorption of phosphorus (TRP) \<80%.
* A negative pregnancy test prior to enrollment in female patients, unless the patient is 2 years postmenopausal, or has had a documented tubal ligation or total hysterectomy.
* Patients need to be off any phosphorus binders for 4 weeks prior to screening
* Stable dose of vitamin D products for 4 weeks in patients receiving such agents. Dose changes in patients receiving stable and initiation of vitamin D products in patients previously not treated will not be permitted during study

Exclusion Criteria:

* Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding
* Patients currently participating in a clinical trial with another investigational drug or device or who have receiving an investigational drug or device within 30 days of enrollment in this study
* Major surgery within 2 month prior to enrollment in study or planned surgery while the patient is in the study, other than dialysis vascular access surgery.
* Presence of coronary stents, artificial heart valves or pacemakers, and history of CABG
* Patients with active infections requiring ongoing treatment
* Patients who have had a malignancy (except for non-melanoma cancer of the skin) unless the patient has received curative treatment and has been disease free for \>2 years
* Patient who the Investigator determines has a medical status that would preclude the patient's participation in the study
* Patients on hemodialysis (HD) or peritoneal dialysis (PD)
* Patients with a functional renal transplant
* Patients with allergies to study drugs
* Patients with serum calcium \>10.7 mg/dl.