cyrilzakka/clinical-trials huggingface dataset:
BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke

Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). To prevent clot particles migrating in other parts of the brain circulation during the thrombectomy, balloon guiding catheters are inserted. The aim of the study is to evaluate the safety and performance of the balloon guide catheter BOBBY™ by collecting information from patients, treated with a mechanical thrombectomy and the balloon guide catheter (BOBBY™) after acute ischemic stroke

The main objective of the STRAIT study is to assess the performance of the mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter (BGC) as adjunctive device for endovascular treatment of patients suffering from an anterior circulation acute ischemic stroke. Interventional procedures and clinical follow-up will be performed per standard of care. Patient health-related and imaging data will be collected as of stroke onset time up to 90 days follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 and ≤ 85 years of age
* Informed consent by the patient or legal authorized representative for data collection is obtained
* Patient eligible for the mechanical thrombectomy treatment with adjunctive use of the BOBBY™ BGC
* Patient presenting with an anterior circulation large-vessel occlusion of distal internal carotic artery (ICA ) through proximal M2 confirmed by computed tomograph angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
* Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging
* Treatment initiated (groin puncture) within 8 hours of symptom onset.
* Patient with a pre-treatment National Institutes of Health Stroke Scale (NIHSS) score ≥5
* Patient with no personal condition disabling the site to contact him/her at 90 days after procedure

Exclusion Criteria:

* Patient has evidence of cerebral ischemia in the posterior circulation
* Patient presents severe unilateral or bilateral carotid artery stenosis requiring stent treatment during the procedure
* Pregnancy or breastfeeding
* Patient presents other serious medical illness (e.g., cancer) with estimated life expectancy of less than 3 months
* Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation
* Patient is already participating in an investigational drug or device trial (change routine care of the patient)
* Patient has evidence of intracerebral hemorrhage on initial imaging
* Patient has a significant mass effect with midline shift
Study of Chiropractic and Neuromuscular Reeducation as a Treatment for Autism Symptoms

This study explores the effectiveness of chiropractic and neuromuscular reeducation as complementary and alternative medicine treatment approaches for autism. Our investigation maintains the following three hypotheses:

1. Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in children.
2. Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will reduce the presentation of autistic symptoms in children.
3. The presentation of autistic symptoms in children will significantly differ between the treatment groups of spinal manipulative therapy and spinal manipulative therapy in unification with neuromuscular reeducation.

We aim to describe and illustrate the roles of spinal manipulative therapy and neuromuscular reeducation in autistic children at a CAM university health center with regard to the following:

1. To measure the safety and efficacy of spinal manipulative therapy for the autism spectrum disorders
2. To measure the safety and efficacy of spinal manipulative therapy and neuromuscular reeducation for the treatment of the autism spectrum disorders
3. To begin to establish or debunk debated SMT treatment for autism
4. To evaluate, gauge, and improve current autism assessment tools by exploring face validity of the measures as indicated by ongoing data collection

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed by a physician with an Autism Spectrum Disorder between the ages of 5 and 15
* Children with parents able to bring their child to the university health center two times a week for 12 weeks
* Children assessed to have a level of functioning that is conducive to experiencing and undergoing chiropractic treatment at the university health center.
* Children without the presentation and diagnosis of comorbidity

Exclusion Criteria:

* Children with comorbidity or multiple diagnoses (mental retardation, chromosomal disorders)
* Children undergoing another treatment for their disorder, other than a form of behavioral therapy (ABA or DTT) by a trained or licensed mental health professional.
* Children taking medication that is not deemed to be stabilized by a primary care physician, including medication dosages that is likely to be shifted and changed during the 12 weeks of treatment in this investigation.
* Children assessed to have severe behavioral impediments not conducive to chiropractic treatment at the university health center.
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy

The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.

The study will be conducted on a group of 10 patients with head and neck cancer who have undergone radiation therapy and experience side effects such as discomfort/changes in the oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before and after the study, an assessment questionnaire related to the side effects of radiation therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Women and men, 18-75 years old
* Patients with head and neck cancer or other types of cancer after radiotherapy who suffer from oral mucositis
* Patients with dryness in mouth
* Signed informed consent.

Exclusion Criteria:

* Intake of supplements containing plant extracts, polyphenols or anthocyanins
* Participation in another clinical trial,
* Women who are pregnant, planning to become pregnant during the study or breastfeeding,
* Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation.
* Hypersensitivity/allergy to any of the ingredient
FH Detection in Children by Salivary Test

Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines.

International studies show treatment must be initiated early as at the age of eight years old.

In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test.

The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.


Eligibility Criteria:
Inclusion Criteria :

* children under 18 years old, with familial hypercholesterolemia
* children under 18 years old, intending surgery
* being able to spit

Exclusion Criteria:

* poor dental health
* for control patients: to have a known cholesterol disease
Chemotherapy in Treating Patients With Lung Cancer

This observational study was planned, with the primary objective to observe patient survival following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) with different platinum-based doublets under routine disease management conditions. Further secondary objectives of this study are to provide insights to what extent histologic subtyping and the use of additional prognostic or predictive biomarkers are currently considered for differential therapeutic decisions under routine conditions. All of these data are critical to evaluate the factors for differential therapeutic decisions and their effect on patient outcomes in a real life setting, and they can only be obtained through observational research.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) stage IIIB-IV
* Initiation of first-line treatment for advanced NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents
* 18 years of age or older

Exclusion Criteria:

* Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study
Cancer Occurrence and Outcome in Young Patients Undergoing Cancer Treatment at the Vanderbilt-Ingram Cancer Center

RATIONALE: Gathering information about the number of young patients with cancer and the outcome of these patients may help doctors learn more about cancer.

PURPOSE: This research study is looking at the medical records of young patients undergoing cancer treatment at the Vanderbilt-Ingram Cancer Center to determine how often cancer occurs and the outcome of these patients.

OBJECTIVES:

* To determine the number of patients between 15 and 30 years old who are treated for newly diagnosed cancer at the Vanderbilt-Ingram Cancer Center (VICC), in middle Tennessee, and in the state of Tennessee between 1990 and 2005.
* To determine the outcomes of these patients.
* To determine the number of these patients enrolled on clinical trials at VICC.
* To compare the outcomes of these patients when treated on a trial versus not treated on a trial provided they have the same disease.
* To compare the number of these patients who are treated on a clinical trial when they are first seen at Vanderbilt Children's Hospital vs Vanderbilt University Hospital.
* To determine referral patterns of these patients to VICC.
* To compare the outcomes of these patients who are treated at VICC vs middle Tennessee vs the state of Tennessee vs the entire nation.
* To determine the reason for not enrolling on a clinical trial.

OUTLINE: Cancer cases taken from the Vanderbilt-Ingram Cancer Center (VICC) Registry and the Tennessee Cancer Registry are examined for number and types of cancer, mortality rates broken down by county and health department region, electronic medical records, and treatment outcomes. Data is analyzed for comparison of number of new cancer patients, mortality rates, and referral patterns at VICC versus number of new cancer patients in the region, state, and country.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer

  * Newly diagnosed disease from 1990 to 2005
  * 15 to 30 years old at the time of cancer diagnosis
* Must live in the state of Tennessee

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old;
2. type 1 or type 2 diabetes.
3. proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
4. The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus

Exclusion Criteria:

1. Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
2. Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
3. anterior chamber neovascularization or neovascular glaucoma;
4. other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
5. received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.
Vit D and Peripheral Neuropathy in Taxane Naive Patients

To evaluate the efficacy of vit D supplement in cancer patients which receive taxane drugs with vit D deficiency and complaining from Peripheral neuropathy

Taxanes are a class of chemotherapy agents that promote the polymerization of tubulin into highly stable, intracellular microtubules. These microtubules cause cell death by interfering with normal cell division. (1,2) The first taxane developed and tested in the field of oncology was paclitaxel.(3,4 )The introduction of paclitaxel to the armamentarium of oncologic therapy in the early 1990s had a great impact on the standard of care in lung carcinoma, breast carcinoma, ovarian carcinoma, and other solid tumors. Subsequent to this development, another taxane, docetaxel was introduced. (5,6) Unfortunately, taxane therapy is associated with side effects such as peripheral neuropathy, myelosuppression, arthralgias, myalgias, and skin reactions that may adversely affect patient-reported quality of life (QOL). Peripheral neuropathy in particular can be severe. This toxicity is cumulative across the course of therapy, can be a dose-limiting toxicity, and may lead to dose reduction or cessation of therapy. (7) Peripheral neuropathies encompass disorders of peripheral nerve cells and fibers which manifest secondary to a wide range of pathologies. These nerves include cranial nerves, spinal nerve roots \& ganglia, nerve trunks \& division, along with nerves of the autonomic nervous system. The most frequently encountered symptoms of peripheral neuropathy include numbness and paresthesias , pain, weakness, and loss of deep tendon reflexes may accompany these symptoms. (8) Vitamin D is a fat-soluble vitamin that plays an important role in calcium homeostasis and bone metabolism, vitamin-D deficiency is associated with osteoporosis, increased risk of falls and fragility fractures. Many conflicting recent studies are now showing an association between vitamin D deficiency and cancer, cardiovascular disease, diabetes, autoimmune diseases, and depression. (9) Initial supplementation for 8 weeks with Vitamin D3 either 6,000 IU daily or 50,000 IU weekly can be considered. Once the serum 25-hydroxyvitamin D level exceeds 30 ng/mL, a daily maintenance dose of 1,000 to 2,000 IU is recommended. A higher-dose initial supplementation with vitamin D3 at 10,000 IU daily may be needed in high-risk adults who are vitamin D deficient (African Americans, Hispanics, obese, taking certain medications, malabsorption syndrome). Once serum 25-hydroxyvitamin D level exceeds 30ng/mL, 3000 to 6000 IU/day maintenance dose is recommended.(10) A 2022 ASCO meeting abstract by Chen et al reported that patients with vitamin D deficiency had more paclitaxel-induced neuropathy than those with normal vitamin D blood concentrations. (11)

Eligibility Criteria:
Inclusion Criteria:

* Any cancer patient \> 18 years old receive taxane treatment

Exclusion Criteria:

* Patient which receive any line of treatment cause Peripheral neuropathy before taxane.
* Chronic disease associated with neuropathy such as diabetes mellitus, Guillain-Barre syndrome and autoimmune disease.
Control of Periodontal Infections

The purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level "gain" in patients with chronic periodontitis.

In this 2x2x2 factorial design study, 229 moderate to advanced chronic periodontitis patients stratified according to current smoking status were recruited in USA and Sweden. Patients were randomly assigned to 8 groups, all of which were treated by SRP plus none, one, two or three adjunctive treatments. Thus, patients were assigned to groups that did or did not receive Surg, LAb, SAb or LAb+SAb (All) providing 8 treatment combinations (Surg + All, Surg + SAb, Surg + LAb, Surg alone, SRP + All, SRP + SAb, SRP + LAb, SRP alone). Clinical, microbiological and immunological measurements were taken for 2 years (at baseline, 3, 6, 12, 18 and 24 months). To focus on changes diseased sites, analysis was restricted to sites with baseline pocket depth greater than 5 mm. (also, these were the only sites treated by LAb). In this report, main effects and interactions were evaluated for PD reduction and AL gain two years post therapy for 187 of patients. Mean values were computed for each treatment group and averages after 2 years were compared to baseline by ANOVA. Factorial ANCOVA was used to examine significance of differences between Surg or not, SAb or not and LAb or not for PD reduction and AL gain using baseline attachment level or pocket depth as covariates and including current smoking as a factor.

Eligibility Criteria:
Inclusion Criteria:

* greater than 20 years of age
* had a least 15 natural teeth
* in good general health
* at least 4 teeth with pockets \> 6 mm
* at least 8 teeth with AL \> 3 mm at baseline

Exclusion Criteria:

* pregnant or nursing (if female)
* having antibiotic or periodontal therapy in the previous three months
* systemic conditions that would affect the course of periodontal disease
* systemic conditions that required antibiotic coverage
* allergic to drugs used in the study
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS

The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias.

The ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls \> 5 years with bladder exstrophy or isolated epispadias;
* sphincteric incontinence (leak point pressure \< 45 cm d'H20, open bladder neck during filling, stress urinary incontinence);
* normal renal function (eGFR \> 90ml/min);
* no (or stable) upper urinary tract dilatation in ultrasound.

Exclusion Criteria:

* under 5 years or more than 18 years old;
* renal insufficiency (acute or chronic);
* evolutive deterioration of the upper urinary tract (hydronephrosis);
* unmanageable detrusor instability;
* residual volume greater than 100 ml after voiding;
* bleeding disorders.
Lipid Profile in Acute Coronary Syndrome

This study aims to assess the TG/Hdl-c ratio in patients with acute coronary syndrome as a novel marker of atherosclerosis.

Cross sectional study to:

assess triglycerides/high density lipoprotein-cholesterol ratio as a novel atherogenic marker in patients presenting with acute coronary syndrome

Eligibility Criteria:
Inclusion Criteria:

* all patients presented with acute coronary syndrome

Exclusion Criteria:

* patients less than 18 years
* rheumatic heart disease
* congenital heart disease
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21 and over
* Able to read and write in English
* Smoker
* Heavy drinker

Exclusion Criteria:

* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine
* Significant hepatocellular injury
* Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* Women who are pregnant or nursing
* Suicidal, homicidal, or evidence of severe mental illness
* Prescription of any psychotropic drug in the 30 days prior to study enrollment
* Blood donation within the past 8 weeks
* Individuals who are seeking treatment for drinking or smoking who have attempted to quit drinking or smoking within the past 3 months
* Specific exclusions for administration of nicotine nasal spray not specified above including nasal polyps, chronic nasal congestion, allergies, sinusitis
* Specific exclusions for administration of nicotine patch not specified above including history of dermatoses
* Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior adverse reaction to nicotine spray
* Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study