cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.

Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.

The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.


Eligibility Criteria:
Inclusion Criteria:

* Athletes Ages 10-19, both genders, enrolled in Nazareth Academy , Deerfield High School or the Deerfield young warriors youth Football program .

Exclusion Criteria:

* Self-reported history of central nervous system injury or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale \< 13), epilepsy, seizures, brain surgery, or any positive neuroimaging results)
* Active head lice infection, open scalp wound
* deafness, and/or blindness
* Sustained a concussion within six months
* Residual symptoms or deficits related to a previous concussion
* Long and thick hair that prevents the proper administration of an EEG cap.
Ticagrelor and Anti-inflammatory Effects

Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD) is still challenging because of bleeding and thrombotic complications. The investigators hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared with ticagrelor twice a day dose in ESRD patients on HD.

Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. The investigators recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted whether platelet reactivity during ticagrelor treatment is associated with endothelial function, platelet activation markers and inflammation status in ESRD patients on HD. Additionally, the dose dependent effects of ticagrelor have been rarely evaluated.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients undergoing regular (≥ 6 months) maintenance HD
* ongoing (≥ 2 months) treatment with clopidogrel
* P2Y12 reaction units (PRUs) were more than 235

Exclusion Criteria:

* known allergies to aspirin, clopidogrel, or ticagrelor
* concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
* thrombocytopenia (platelet count \<100,000/mm3)
* hematocrit \<25%
* uncontrolled hyperglycemia (hemoglobin A1c \>10%)
* liver disease (bilirubin level \>2 mg/dl)
* symptomatic severe pulmonary disease
* active bleeding or bleeding diathesis
* gastrointestinal bleeding within the last 6 months
* hemodynamic instability
* acute coronary or cerebrovascular event within the last 3 months
* pregnancy
* any malignancy
* concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
* recent treatment (\<30 days) with a glycoprotein IIb/IIIa antagonist
ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer

This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria for inclusion in the study:

1. Age ≥18 years old.
2. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
3. Ineligible to participate in a clinical trial using rMBCG or geographically unable to access a rMBCG clinical trial site.
4. Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations.

Exclusion Criteria:

Participants with any of the following criteria are excluded from participation in the study:

1. Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.
2. Women who are pregnant or nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers

Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers, female and male
* age 21 - 50
* BMI 18 - 30 kg/m2
* experienced drivers with a valid driver's license and at least 3 years of driving practice

Exclusion Criteria:

* any clinically relevant finding on physical examination affecting the study objectives
* clinically relevant abnormalities in the ECG laboratory values
* history or present evidence of clinically relevant metabolic, renal, hepatic, pulmonary or cardiovascular disease, CNS disorders, or disturbance of bleeding diagnosis of malignancy
* females who are pregnant or breastfeeding
Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin

Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible.

It has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. The analgesic effect occurred even prior to the release muscular. Several randomized studies have been published about it. The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent
* Active social care
* Compliant patient with protocol
* Patient more than 18 years
* Positive Neer Test

Exclusion Criteria:

* Prior study exclusion period
* Protected patient
* Study refusal
* Deficient patient
* Rheumatoid arthritis, osteoarthritis, chondrocalcinosis.
* Microcrystalline arthritis.
* Active infection .
* History of hypersensitivity reaction during a previous injection of botulinum toxin
* Bilateral involvement
* Neurological deficit
* Depression
* History of shoulder surgery
* Pregnant or breast feeding women
* Systemic disease (diabeta, vascularitis)
* Known neurological disease
* Intraarticular associate disease
* Acromioclavicular associate disease
* Myasthenia
* Botulinum toxin is not recommended in combination with aminoglycosides
Comparison of SensaScope Intuboscope and McGrath Series 5 for Endotracheal Intubation

A randomized controlled prospective study of laryngoscopy and intubation time comparing SensaScope and the McGrath® Series 5 video laryngoscope.

The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to semi-rigid stylet. An national, mono center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® Series 5 versus SensaScope in adult patients under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Participation in another study
Effect of Mulberry Fruit Powder in Metabolic Syndrome

Metabolic syndrome is a raising concern globally, especially in developing countries such as Pakistan. To prevent its risk factors diet and lifestyle modification is major solution. Functional foods have additional benefits of treating disease while providing basic nutrients. Mulberry is a native fruit with the properties of functional food, it is rich in anthocyanin and different anti-obesity,anti-diabetic, and anti-hyperlipidemic treating potential antioxidants. Mulberry will prove its therapeutic potential against the risk factors of metabolic syndrome.

Metabolic syndrome, which is characterized by a number of concurrent risk factors. These risk factors include dysglycemia, high blood pressure, high triglyceride levels, low levels of HDL cholesterol, and obesity (particularly central adiposity). It is rapidly increasing the burden of non-communicable diseases (NCDs) in Pakistan. The prevalence of MetS in Pakistan is 28.6%, and suburban areas from the province of Punjab showed a high prevalence. Females are more prone to metabolic syndrome. Dietary and lifestyle modification can prevent MetS from converting into CVD, T2DM, and stroke. There is limited documented research in Pakistan related to the therapeutic roles of mulberry fruit powder. With respect to these limitations, the present study aims to assess the therapeutic roles of mulberry fruit powder consumption on metabolic syndrome.

The utilization of dried mulberry fruit powder (MFP) as a component of nutritional supplementation will effectively ameliorate the clinical markers associated with metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Subjects having fasting total cholesterol level of ≥ 200 mg/dl or LDL cholesterol ≥ 130 mg/dl.
* Fasting Blood Glucose ≥110mg/dl.
* SBP ≥ 130/ ≥ 85 mmHg
* Waist Circumference of ≥40 inches in males and ≥35 inches for females

Exclusion Criteria:

* Participants of age 55 or above
* Participants who have less than two risk factors
Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA

There are several types of circulating DNA: DNA from patient's existing cells, foetal DNA in the case of pregnant woman, and tumoral DNA in the case of patients with cancer. These circulating tumoral DNA (ctDNA) can be obtained from a blood test called liquid biopsy and be detected by the latest generation of very high throughput sequencers with the Massive Parallel Sequencing technique (MPS).

This study focus on using this technique on breast and colorectal cancers in which no analysis of CNV (tumor origin marker) with this technique has been performed yet. It is a prospective, pilot, monocentric, feasibility study on genomic profile. The study aim is to show the possibility to realize in a reproductive way a molecular karyotype on ctDNA with the MPS approach from a liquid biopsy taken from patients with cancer and to compare this profile with the one obtained by CGH array (Comparative Genomic Hybridization) from primitive tumor.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Signed consent
* Women with invasive breast carcinoma, NOS, with a radiologically measurable tumor of more than 10 mm (stade I to III)
* Patients with invasive colorectal adenocarcinoma with a radiologically measurable tumor of more than 10 mm (stade I to III)
* Patients who primary surgery is planned

Exclusion Criteria:

* Neoadjuvant chemotherapy or neoadjuvant radiotherapy
* Other cancer
* BMI \> 30
* Pregnant woman
* Patients under protective administration or deprived of liberty
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
* Patients whose caregiver can properly collect the necessary information.

Exclusion Criteria:

* Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
* Patients who had delirium during the double-blind trial.
Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the start of treatment.

To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic neuropathy

Exclusion Criteria:

* Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.
Comprehensive Management of Rectal Cancer

study on the strategy we have adopted for rectal cancer treated with chemoradiotherapy in the case of a complete reponse ( surveillance vs. surgery) Particular Case of Patients with Complete Response After CRT. Traditionally, for patients with mid or lower rectal cancer, a protocol involving chemoradiotherapy followed by surgery 8 to 10 weeks after the end of radiotherapy and chemotherapy is systematically indicated after a post-chemoradiotherapy reassessment using pelvic MRI.

In a certain number of patients (25%), it was noted that the reevaluation through pelvic MRI after chemoradiotherapy shows complete tumor disappearance.

However, these patients were still operated on according to the standard procedure, and pathologists found no tumor in the surgical specimen (sterile specimen).

These are patients with a complete radiological and pathological response. In such cases, it is possible to resect the scar that remains at the site of the tumor (radiotherapy sequelae) and closely monitor the patient to detect recurrence in the short and medium term, thus avoiding mutilating surgery that impacts quality of life (fecal and gas incontinence, increased bowel movements, urinary and gynecological sexual disorders). This is known as the "Watch and Wait" strategy.

"Watch and Wait" Strategy. An initial opportunistic approach, also called Watch and Wait (W\&W), involves monitoring patients who are considered to have a complete response after CRT or total neoadjuvant treatment, regardless of the initial stage. This approach was developed by Habr-Gama et al. in Brazil and published in 18 different articles, involving a cohort of 361 patients, with complete response rates ranging from 20% to 30%. Local recurrence rates varied from 5% to 25% depending on the articles and the timing of complete clinical response evaluation, while maintaining a 5-year disease-free survival rate of 52% and an overall survival rate of 85%. These series primarily included cT2 or cT3 tumors, but also cT4 tumors. Complete clinical response was defined as the absence of any clinical tumor residue (no tumor, no ulcer, and negative biopsy), and patients were monitored monthly.

However, the evaluation timeline for complete response varied across the articles, ranging from 8 weeks to 14 months.

At present, no official recommendations validate this strategy; it remains an expert opinion. The aim is to demonstrate that we could avoid surgery in patients with a complete response (we have favored rectal surgery for the majority of our patients due to organizational obstacles, patient-related issues, and the difficulty in applying rigorous surveillance in certain cases).

The purpose of this research is to improve our practices in managing rectal cancer in patients with a complete response.


Eligibility Criteria:
Inclusion Criteria:

* All patients managed in our facility who achieved a complete response after preoperative radio-chemotherapy.

Exclusion Criteria:

* Minor patients
* Non-responding patients, or partial responders.
* Anal canal cancer
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants

This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg.m2; and a total body weight \>50 kg (110 lbs)
* Female participants must have a negative pregnancy test

Exclusion Criteria:

* Positive test for SARS-Co-V2 at the time of screening or Day -1
* Active pathological bleeding or risk of bleeding
* Positive urine drug test
* History of sensitivity to heparin or heparin induced thrombocytopenia
* Participants who have been vaccinated for COVID-19 in the past 7 days
Resistant Bacterial Infections in the Early Post LDLT Period

The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy

This prospective descriptive study has been done at Tropical Medicine department in the period between January 2014 to November 2015.

After the approval of the scientific and ethical committee of Ain Shams University Hospital, Patients with HCV positive end stage liver disease (ESLD) eligible for liver transplantation Ain Shams Center for Organ Transplant (ASCOT); Ain Shams University, (fulfilling the inclusion criteria) were included in the current study. Forty five patients were recruited and each one was followed-up during a period of 3 months following transplantation.

Included patients were divided into 2 groups:

Group 1 included patients who had a postoperative single episode of infection. Group 2 included those patients who had more than 1 episode of postoperative bacterial infection whom were further evaluated for the presence of emerging strains and/or antibiotic resistance.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian nationality.
* Accepting participation in the current study and signing a written consent form
* Age between 18-60 Years, including males and females.

Exclusion Criteria:

* Patients who refused to be enrolled in the study.
* Patients with other etiologies for end-stage liver disease (HBV, PBC...)
* Patients with preoperative infections, infections within 48 h after transplantation or early post-operative death