cyrilzakka/clinical-trials huggingface dataset:
HITT Device Pilot Testing for Traumatic Brain Injury

The purpose of this research study is to collect data from the eyes of traumatic brain injury (TBI) patients. Patients will look at a green target that will measure the fixation of the eye for 30 seconds. In that 30 seconds, the location of the green target will change and the participant is to track, with their eyes, the light as best they can. The device will measure how well fixation was maintained and the speed of the saccadic movements of the eye. Data will then be used to determine whether there is correlation between these measures and known TBI.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18-40
2. Documented/ verified mild TBI
3. Mild traumatic brain injury will be defined as Glasgow Coma Scale (GCS) of ≥13 at time of study enrollment
4. Injury occurred \< 24 hours ago
5. Positive acute brain CT for clinical care
6. Visual acuity/ hearing adequate for testing
7. Fluency in English or Spanish
8. Ability to provide informed consent
9. Enrolled in TRACK-TBI (IRB #: 825503)

Exclusion Criteria:

1. Catastrophic polytrauma that would interfere with follow-up and outcome assessment
2. Prisoners or patients in custody
3. Pregnancy in female subjects
4. Patients on psychiatric hold (e.g. 5150, 5250)
5. Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessment
6. Major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
7. Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g. substance abuse, alcoholism, HIV/AIDS, major transmittable diseases that may interfere with consent, end-stage cancers, learning disabilities, developmental disorders)
8. Low likelihood of follow-up (e.g. participant or family indicating low interest, homelessness or lack of reliable contacts)
9. Penetrating TBI
10. Spinal cord injury with ASIA (American Spinal Injury Assoc.) score of C or worse
11. Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
12. History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
13. Intoxication or chemical impairment at time of examination (upon initial presentation)
14. Evidence on hand-light examination of obvious ocular anomaly or misalignment
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
2. Women ≥ 18 years of age
3. Estimated life expectancy of more than six months

Exclusion Criteria:

1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
2. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success

The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations \& Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.

The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations \& Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.

Eligibility Criteria:
Inclusion Criteria:

Age 13-19; enrolled in participating high school health class; passive consent received;

Exclusion Criteria:

Students who enrolled in classes post baseline. Students who had previously failed the HS course and was already exposed to DREAMS curriculum.
Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

COVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for study participation:

* Men ≥ 36 years old diagnosed with at least one temperature elevation ≥ 100.4 F., OR new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay
* Men ≥ 18 years but \< 36 years old must exhibit EITHER new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay.
* Access to working telephone or other form of communication such as email.
* Randomization within 7 days of COVID-positive study result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a positive test is required to stay on study
* Written informed consent obtained from the subject and the subject agrees to comply with all study-related procedures

Exclusion Criteria:

Subjects with any of the following will not be eligible for study participation:

* Randomization greater than 7 days from a positive COVID test result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a negative test will result in a screen-fail and removal from study
* Admission to hospital at time of screening
* Inclusion in another randomized trial for COVID therapy
* Diagnosis of prostate cancer and/or treatment with anti-androgen in the past 3 months
* Current treatment with any androgen replacement products
* Prior allergic reaction or intolerance to Bicalutamide or other Androgen receptor Inhibitors
* Requirement for coumarin product or warfarin products due to potential displacement by bicalutamide
* Subject unable to take oral bicalutamide
* Known Hepatitis B or C
* Liver Cirrhosis
* AST/ALT greater than or equal to 3 X institutional ULN
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.

This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.

Eligibility Criteria:
Inclusion Criteria:

* Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol
* Body mass index of 18 to 32 kg/m\^2, inclusive

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect the absorption, distribution, metabolism and excretion of study drug
* Any other medical, psychiatric and/or social reason as determined by the Investigator

Other protocol-defined inclusion/exclusion criteria apply
The Effect of Ingesting a Novel Algae Protein Source on Rested and Exercised Muscle Protein Synthesis Rates in Older Adults.

To assess the rested and postexercise muscle protein synthetic response following the ingestion of a flavourless algae protein source compared with whey protein in older adults.


Eligibility Criteria:
Inclusion Criteria:

Males and Females BMI 18.5 - 30 kg/m2 Aged 65-80 years Recreationally Active

Exclusion Criteria:

Body mass index (BMI) \<18.5 or \>30 kg/m2 Any metabolic impairments Any cardiovascular impairments High blood pressure (≥140/90 mmHg) Any gastrointestinal disorders Any medications known to affect protein and/or amino acid metabolism A personal or family history of epilepsy, seizures or schizophrenia, motor disorder Chronic over the counter use of pharmaceuticals (\> 1 month) Allergic to any of the whole foods included in the study
DAPRE Exercises Technique and CKC Exercises on Extensor Lag in Post Knee Stiffness

This project was a Randomized clinical trial conducted on extensor lag in post-operative knee stiffness patient to compare the effects of The Daily Adjustable Progressive Resistive Exercise (DAPRE) technique versus Close kinetic chain (CKC) exercise training in people who had undergone knee stiffness, m so that we can have best treatment option for patients with extensor lag.

Probability Convenient sampling was done. Patients following eligibility criteria from Physiotherapy department of PSRD, Lahore, were considered. Sample size was calculated with Epi-tool calculator. 22 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A, 11 participants will receive Conventional physiotherapy treatment in addition to DAPRE technique by leg extension machine. In DAPRE technique, four sets of exercises were performed. The first two sets of exercise consisted of ten and then six repetitions, per- formed against one-half and three-fourths of the previously established working weight. Working weight is the amount of weight a patient uses during an individual session. The full working weight was used on the third set, and the patient performed as many repetitions as possible. After performing each of the third and fourth sets, patients rested for 1 min. 6 weeks (3 sessions per week)• Hot pack: 10 min• Stretching of calf and hamstring muscle: 10 min. Group B, 11 participants will receive Conventional physiotherapy treatment in addition to close kinetic chain exercises. Close kinetic chain exercises for extensor lag is seated leg press, double or single one third knee bend, step up and down exercise, wall slide with weight. Treatment time will be 30 minutes and three session per week will be applied on alternate day for up to 6 weeks. Pre interventional readings will be taken at baseline \& post interventional readings at 6th week. 6 weeks (3 sessions per week) • Hot pack: 10 min • Stretching of calf and hamstring muscle: 10 min. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.

Eligibility Criteria:
Inclusion Criteria:

* Post-operative knee stiffness (patients with 1-3 month stiffness).
* Both male and female , age 30-60 years.
* Willing to participate in research.

Exclusion Criteria:

Pre-operative knee stiffness

* Severe cardiopulmonary disease
* Patients undergoing chemotherapy
* Any traumatic injury/ Acute inflammatory muscular pathology
* TKR \& hip pathology and replacement
* Meniscal tear
Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the project is to investigate changes in the quadriceps muscle and cardiovascular regulation during exercise in relation to improved lung function after lung transplantation in patients with COPD.

Dysfunctional skeletal musculature of the lower limbs is related to low quality of life, exercise intolerance and higher mortality in patients with COPD. Limb muscle dysfunction in COPD consists of muscle atrophy and reduced muscle strength but also intra-muscular alterations in oxidative capacity and mitochondrial function are often present. Moreover, reduced blood flow to exercising muscle may also contribute to the muscle dysfunction in COPD. The mechanisms responsible for muscle dysfunction in COPD patients remain unclear but could be a consequence of reduced lung function, inflammation, medications or low physical activity. Loss of lung function with COPD is normally irreversible so the transition to near-normal lung function after lung transplantation is a unique model to investigate the adaptation of the limb muscle to improved lung function. Thus, the purpose of this project is to investigate the effect of lung transplantation on limb muscle function (mitochondrial function, oxidative enzyme capacity, fiber type distribution, oxygen delivery/uptake) and daily physical activity level in patients with COPD. The project has a translational focus on muscle dysfunction in COPD and uses methodologies from clinical medicine, integrative physiology and molecular biochemistry in order to gain knowledge of mechanisms behind limb muscle dysfunction and exercise intolerance in COPD.

Eligibility Criteria:
Inclusion Criteria:

* COPD with or without alpha 1-antitrypsin deficiency on the waiting list for a lung transplantation
* Single or double lung transplantation
* ≥ 18 years
* Ability to give informed consent

Exclusion Criteria:

* Retransplantation
* Multiple-organ transplantation (heart-lung transplantation)
* Musculoskeletal disorders which substantially inhibits physical activity
* Need for crossmatching in connection with lung transplantation
* Anticoagulant therapy before lung transplantation (except acetylsalicylic acid)
Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)
* Women can only be included, if a test has excluded pregnancy
* Only women can be included, who use a reliable means of contraception during the observational study

Exclusion Criteria:

* Known sensitivity to Viramune or one of its excipients
* Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
* Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
* For females:

  * Pregnancy
  * Breast-feeding
  * Insufficient or unreliable contraception
Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials

The purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain

Myofascial pain syndrome is a common musculoskeletal pain disorder affecting almost 95% of people with chronic pain disorders and is a common finding in especially pain management centres.It is characterized by trigger points, defined as hyperirritable spots within taut bands of skeletal muscle fibers. The syndrome is associated with tenderness in the muscle, referred pain, spasm and restriction of motion. Patients with MPS begin with one active MTrP (called the primary MTrP) in the affected muscles due to chronic repetitive minor muscle strain, poor posture, systemic diseases, or neuro-musculoskeletal lesions. When not treated correctly, expansion of the pain region and additional active MTrPs (called secondary or satellite MTrPs) will develop one of the most appropriate treatments for trigger points ultrasound therapy. The high-power pain threshold ultrasound (HPPTUS) technique is one of the ultrasound modifications used to treat trigger points In 2004, Majlesi et al. performed the first clinical study to compare this technique with the traditional ultrasound technique in patients with myofascial trigger points. The results showed that HPPTUS was much more effective than the traditional technique, and pain reduction and improved range of motion (ROM) were significant in a smaller number of sessions.sixty patients with mechanical neck pain will be assigned randomly to two equal group. one group will receive high power pain threshold ultrasound and traditional therapy and the other receive traditional therapy alone for four weeks.

.

Eligibility Criteria:
Inclusion Criteria:

* patients with mechanical neck pain from both genders.
* age between 19 and 38 years
* patients will be required to have active TrPs in the upper trapezius and levator muscle and neck pain

Exclusion Criteria:

* Patients will be excluded if they have History of whiplash injury,
* History of cervical spine surgery,
* Cervical radiculopathy or myelopathy,
* Having undergone physical therapy within the past 3 months before the study
* Non- rheumatologic diseases as multiple sclerosis,
* thyroid dysfunction and chronic infection and Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.
Extension Study of Ataluren (PTC124) in Cystic Fibrosis

Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.

This Phase 3, open-label, safety and efficacy study will be performed at sites in North America, Europe, and Israel. The study will enroll up to approximately 208 participants with nmCF who participated in a previous Phase 3 study of ataluren (PTC124-GD-009-CF \[Study 009\], NCT00803205). Participants will receive study drug 3 times per day (TID) (at breakfast, lunch, and dinner) for approximately 48 weeks (approximately 1 year). Study assessments will be performed at clinic visits every 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Completion of blinded study drug treatment in the previous Phase 3 study (PTC124-GD-009-CF).
* Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if \<18 years of age).
* In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during ataluren administration and the 4-week follow up period.
* Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.

Exclusion Criteria:

* Known hypersensitivity to any of the ingredients or excipients of the study drug (list provided at study sites).
* Current pregnancy or lactating, or pregnancy or lactating during the previous Phase 3 study.
* Ongoing participation in any other therapeutic clinical trial.
* Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results.