cyrilzakka/clinical-trials huggingface dataset:
Reducing Head Impact Exposure in Hawaii High School Football

This three-year study will determine the effectiveness of a helmetless tackling training intervention to decrease head impact exposure in Hawaiian high school football players.

High school football participants are reported to sustain an average of 600, and as many as 2000, head impacts in a single season. Impacts to the top and front of the helmet generate the greatest forces, and thus pose the highest risk for acute brain and spinal cord injury. Equally disconcerting is the potential relationship between the accumulation of concussive and sub-concussive impacts (head impact exposure, HIE) and the risk for developing long-term conditions such as cognitive impairment, early-onset Alzheimer's, and chronic traumatic encephalopathy (CTE). Tackling and blocking behaviors using the head as the point of first contact can be attributed, in part, to the fact that players wear a helmet, which influences behavior by increasing the perception of safety.

The central hypothesis is such that a football player who regularly practices tackling and blocking drills without a helmet in a controlled environment will naturally leave the head out of contact and is likely to continue to do so while wearing the helmet during games and full-contact practices. This learned motor behavior will reduce the number of head impacts a football player experiences throughout their playing career and thus reduces the risk of acute and chronic head and neck injury.

The investigation will be a pre-test, post-test quasi experimental design using an evidence-based helmetless tackling and blocking program (HuTT®) with football players (\~200) recruited from high school football teams in Oahu, Hawaii.

Year 1 will serve as a baseline and entail collecting only head impact data during regular football participation for two teams. After adding a third team for years 2 and 3, all subjects will then undergo the HuTT® Program intervention emphasizing proper tackling and blocking techniques under closely supervised drills where players participate without their helmets and shoulder pads in place.

From the outset, subjects will use a new Speedflex helmet outfitted with the InSite™ head impact sensor (Riddell, Co). The helmet and sensor will be worn in all practices and games and used to record head impact exposure (frequency, location, and magnitude). ImPACT tests will be conducted at pre- and post-season intervals to measure verbal and visual memory composite, visual motor speed composite, reaction time composite and symptoms scores. In addition, player self-efficacy for head-safe behavior will be scored each year using a self-reported survey.

A between-subjects ANOVAs will be used to compare outcome measures among teams. Significant interactions and main effects will be identified by appropriate t-tests with Bonferonni corrections at an alpha-level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams

Exclusion Criteria:

* none
COMFORT: A Multicenter, Open-label, Randomized, Crossover Study

The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.

A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women; age 18 to 75 years
2. Bilateral incompetence of SFJ (reflux \>1 second on duplex ultrasonography) associated with incompetence of the GSV in both legs
3. GSV diameter \>5 mm measured from the superficial epigastric vein to 10 cm below the SFJ while in a standing position in both legs
4. Eligible to receive RFA treatment and Varithena® treatment
5. CEAP C2-C5 (inclusive)
6. Patient is participating in usual work and home activities with no changes anticipated for the duration of the study
7. Ability to comprehend and sign an informed consent and complete study questionnaires written in English
8. Ability to reliably use an electronic diary to record pain and analgesic/opioid use in accordance with the protocol

Exclusion Criteria:

1. Prior GSV treatment in either leg
2. Non-venous source of pain in either leg that could confound the results of the study
3. Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study
4. History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound
5. Deep venous reflux unless clinically insignificant in comparison to superficial reflux
6. Inability to wear post-procedure compression bandaging and stockings
7. Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
9. Major co-existing disease (e.g., malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
10. Contraindications to Varithena® (e.g., acute thromboembolic disease) or RFA according to the manufacturer's prescribing information

    1. Varithena® contraindication due to known allergy to polidocanol
    2. RFA contraindication due to veins being too large
    3. RFA Contraindication due to veins being too tortuous
11. Known allergic response to polidocanol and/or multiple allergic reactions
12. Current or history of alcohol or drug abuse
13. Pregnant or lactating women
14. Women of childbearing potential not using effective contraception for at least one month prior to study treatment and/or unwilling to continue birth control for the duration of the study
15. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening
Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma

Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial

Study objective:

1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma.
3. Exploratory

   * To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent glioblastoma
   * To evaluate pharmacodynamic (PD) parameters by clinical biomarker test

Study Methodology

Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case.

A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. Patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (PD) or the withdrawal of consent.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients ≥19 years old
* Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable.
* At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria
* Karnofsky Performance Status (KPS) ≥ 80
* A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
* At least 12 weeks of expected survival time
* Signed informed consent

Exclusion Criteria:

* Diagnosed with other malignant tumor within 2years
* Uncontrolled HT or seizure, class III or IV heart failure, oxygen dependent disease, active psychiatric disorder
* Not recovered grade 2 AE due to previous CCRT
* Major surgery or other investigational drug treatment within 4 weeks
* Pregnant/lactating female and female/male potential childbearing without contraception
* Severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug
* Expectation of poor compliance
* Previous therapy with VEGF targeted agent
Effective Pain Management of Interscalene Blocks During Shoulder Surgery

Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient.

Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.

This is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.

Eligibility Criteria:
Inclusion Criteria:

* Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement
* patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and
* must be able to understand and agree to follow study protocol.

Exclusion Criteria:

* severe bronchopulmonary disease,
* oxygen dependent,
* existing nerve injury,
* BMI \> 40,
* coagulation disorders,
* allergy to ropivicaine,
* history of drug or alcohol abuse,
* American Academy of Anaesthesiologists physical status classification \> lll,
* pregnant women.
Vulnerability Markers in Pathological Gambling

Addictions without substances are an emergent problem giving rise to a recent and increasing request of care. Among these new addictions, pathological gambling and pathological online video gaming which are up. The purpose of this study is to identify vulnerability factors (personality traits, decision making strategies...), which are common or specific to each type of game (on line poker, casino, MMORPG, and no-gamers).


Eligibility Criteria:
Inclusion Criteria:

* arm 1: online poker gamblers who don't play another type of gamble/game
* arm 2: casino gamblers who don't play another type of gamble/game
* arm 3: MMORPG gamers who don't play another type of gamble/game
* arm 4: no-gamblers/gamers subjects
* step 2 : only right-handled subjects (due to registration of brain activity)

Exclusion Criteria:

-
A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients

To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* Zidovudine (AZT).
* Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
* Allowed ONLY with permission of the Wyeth-Ayerst medical monitor:
* Standard therapy for infections that develop during the study period.
* Oral acyclovir.
* Nystatin.
* Ketoconazole.
* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Patients must have the following:

* Diagnosis of AIDS or AIDS related complex (ARC).
* Provide informed written consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Active opportunistic infection or malignancy requiring treatment at study entry.
* Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
* Evidence of central nervous system (CNS) opportunistic infection or malignancy.
* Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results.
* Dementia.
* Evidence of = or \> 2 + proteinuria at study entry.

Concurrent Medication:

Excluded without permission of the Wyeth-Ayerst medical monitor:

* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Patients with the following are excluded:

* Active opportunistic infection or malignancy requiring treatment at study entry.
* Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
* Evidence of conditions listed in the Patient Exclusion Co-existing Conditions.
* Active substance abuse.
* Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 8 weeks of study entry:

* Immunomodulators.
* Antiviral therapy, except zidovudine.
* Excluded within 2 weeks of study entry:
* Intravenous or oral acyclovir.
* Excluded within 3 months of study entry:
* Ribavirin.

Required:

* Zidovudine at a dose of = or \> 1000 mg/day for at least 6 weeks prior to study entry.

Active substance abuse.
Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers

This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.


Eligibility Criteria:
Inclusion Criteria:

Healthy Control Subjects (Group 1)

* Must be in general good health.
* Must not have received interferons in the past.

All MS Subjects

* Clinical or laboratory-supported diagnosis of relapsing remitting MS (McDonald et al, criteria numbers 1-4).
* Either on AVONEX® or treatment-naïve.
* Have an EDSS score between 0.0 and 5.5, inclusive.

Exclusion Criteria:

* History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, to other components of the drug formulation.
* History of intolerance to acetaminophen, ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
* History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
* History of malignancy.
* The presence of any significant medical condition or psychiatric illness not due to MS that, in the investigator's opinion, would interfere with therapy
* History of uncontrolled seizures within the 3 months prior to enrollment.
* History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
* Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 8 weeks prior to enrollment.
* Positive for human immunodeficiency virus (HIV), hepatitis C antibody (HCV) or positive for hepatitis B surface antigen (HbsAg) at screening.

Other inclusion and exclusion criteria apply as per protocol
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)

This is an open-label, multi-center study designed to extend the evaluation of the safety, tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.

Patients who complete the Part 2 Week 28 visit in study KNS-760704-CL201 and patients with ALS who were actively receiving RTPB \[(6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydro-chloride monohydrate\] under Research IND #60,948 were eligible to participate in this study.

Eligible patients received 1 tablet of KNS-760704 (150 mg) every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has provided signed informed consent for this trial before the commencement of any study-related procedure
2. Patient is actively participating in Knopp Protocol KNS-760704-CL201 and has completed the Part 2 Week 28 visit in that study or patient is actively receiving RTPB under Research IND #60,948

Exclusion Criteria:

1. Patient did not participate in Knopp Protocol KNS-760704-CL201 or patient did not receive RTPB under Research IND #60,948.
2. Patient discontinued from KNS-760704-CL201 for any reason other than enrollment into this study (applies to patients enrolled in KNS-760704-CL201 only)
3. Patient was not taking RTPB under Research IND #60,948 prior to April 30, 2009 (applies to patients enrolled under Research IND #60,948 only)
EMEPIC : Value of a Mobile Team of Cardiologist Using Echocardiography for Managing Patients With Acute Heart Failure

The aim of the study is to compare clinical management of patients with acute decompensation of heart failure, hospitalized in non cardiological ward, with the use of a mobile team including a cardiologist with portable echocardiography and standard care. The hypothesis is that a mobile team will lead to shorter hospitalization.

Randomized, controlled, monocentric study comparing Standard care with the care provided by a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward on the duration of hospitalization, re-hospitalization rate à 30 days, emergency visit within 30 days, treatment at discharge, mortality within hospital stay and at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for suspected heart failure
* \> or = 18 years

Exclusion Criteria:

* Refuses to participate
Reliability of Kinovea in Gait Assessment in Multiple Sclerosis: a Pilot Study.

The objective of this observational study is to determine whether the Kinovea video analysis tool is valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis, comparing the data obtained from this system with those of the gold standard, the GaitRite system. The main question to be answered is:

Is the Kinovea system valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis?

Participants walked across the GAITRite platform four times without shoes and four times with shoes, while being recorded by two cameras simultaneously: one recorded gait from the sagittal plane and the other from the frontal plane.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for evaluation by the NeuroLab-Lázaro gait laboratory (Seville).
* Patients who have signed informed consent prior to the test.
* Patients between 18 and 55 years of age, diagnosed with MS according to the 2017 McDonald criteria.
* Patients with an EDSS score of less than 6.5 points.
* Patients who are willing to participate in the study and who do not object to being recorded while performing the gait test and to the use of images for educational and research purposes.

Exclusion Criteria:

* Patients who use walking aids and/or orthoses.
* Patients with comorbidity or decompensated systemic disease within the last month.
* Patients who have any physical impediment (excessive fatigue) to performing the gait test, as documented in their medical records reviewed on the Diraya platform.
* Patients who have suffered a relapse within 30 days prior to the start of the study.
An Efficacy and Safety Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 120 eligible patients with severe novel coronavirus pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 80 years old (including threshold), regardless of gender;
* There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1 week;
* HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
* Participants who voluntarily sign informed consent.

Exclusion Criteria:

* Participants who cannot take orally, or are suspected to be allergic to Jaktinib hydrochloride, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
* Critical pneumonia patients with other organ failure requiring ICU monitoring and treatment;
* Participants who have received the following treatments within the specified time window before randomization:

  1. participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid;
  2. Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random;
* Immune deficiency;
* Participants who have received novel coronavirus vaccine within 1 week before randomization;
* Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment;
* Renal diseases requiring dialysis treatment;
* Pregnant and lactating women;
* Any other participants that were considered unsuitable by the investigator.
Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After COVID- 2019 .

The goal of this observational study is to learn about sarcoidosis development after COVID-19 infection.

The main question it aims to answer is:

* prevalence of Sarcoidosis among patients previously infected with COVID-19.

Participants will:

* provide previous positive RT-PCR for COVID-19
* Have computed tomography of the Chest with suggestive findings of sarcoidosis
* Have bronchoscopic guided biopsies and pathological analysis to detect number of patients with sarcoidosis.

This prospective cross sectional study was performed on a total of 55 patients with mediastinal and /or hilar lymphadenopathy with or without lung infiltrates referred to Bronchoscopy unit , Chest department, Ain-Shams University hospital for biopsy taking and diagnosis.

All patients were subjected to the following : history taking , clinical examination , radiological assessment by computed tomography (CT )chest , fiberoptic bronchoscopy where biopsies were taken either by conventional-Trans-bronchial needle aspiration (c-TBNA) , endo-bronchial ultrasound (EBUS-TBNA) or direct forceps biopsies and sent for histopathological examination and if the patient had past history of COVID-19 infection with previous positive reverse transcriptase- polymerase chain reaction assay (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with previous positive RT-PCR for COVID -19 and CT chest findings of mediastinal and or hilar lymphadenopathy with or without lung infiltrate will be included. .

Exclusion Criteria:

* Patients younger than 18 years old Patients
* Patients refuse to participate in the study
* Patients previously diagnosed as sarcoidosis