cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone Infusion in Community-acquired Pneumonia

The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

Community-acquired pneumonia (CAP) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring ICU admission.1 Especially elderly patients may have a severe illness with a high morbidity and mortality rate. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. However, this natural reaction can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung.

Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Hypothetically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 to 100 years with a community-acquired pneumonia.

Criteria to determine a community-acquired pneumonia:

* Chest radiograph showing new opacities
* In combination with two of the following findings:

  * Cough
  * Production of sputum
  * Temp \>38,0 °C or \<36,0 °C
  * Audible abnormalities by chest examination compatible with pneumonia
  * Leukocytosis (\>10.000 cells/mm3), leftward shift (\>10%) or leukopenia (\<4000 cells/mm3)
  * CRP \> 15 mg/dl (three times upper limit of normal)

Exclusion Criteria:

* o The following groups are excluded:

  * Immunocompromised patients:

    * Patients with a known congenital or achieved immunodeficiency.
    * Patients who received chemotherapy less than 6 weeks ago.
    * Patients who received corticosteroids in the last 6 weeks.
    * Patients who received immunosuppressive medication in the last 6 weeks. (like cyclosporine, cyclofosfamide, azathioprine)
    * Patients with COPD who are on systemic corticosteroids for COPD.
    * Patients who require ICU treatment.
The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.

The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).


Eligibility Criteria:
Inclusion Criteria

Subjects who meet all of the following criteria are candidates for this study:

1. Male or Female
2. Any race
3. Patient is at least 40 years old.
4. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
5. Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
6. Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
7. Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
8. Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \&lt; 0.70) in eye(s) to be treated.
9. Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
10. Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
11. Patient is not a contact lens (CL) wearer.
12. Patient has normal corneal topography.
13. Patient is willing and able to comply with all examinations.
14. Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria

Subjects who meet any of the following criteria are to be excluded from this study:

1. Corneal disease or corneal disorder in either eye.
2. Any active ocular surface disease of any severity.
3. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
4. Previous corneal surgery in the eye to be treated.
5. Conjunctivochalasis
6. Nystagnus
7. Diabetes
8. Pregnancy
9. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.

nclusion Criteria: -

Exclusion Criteria:

-
Single-dose Escalation Trial of M2ES in Healthy Volunteer

This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.

Randomized double-blinded placebo-controlled，single-dose escalation trial in health volunteer,to determine the safety and the max tolerate dose in health volunteer.

Eligibility Criteria:
Inclusion Criteria:

1. Physical and mental healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening.
2. 19 to 45 years of age.
3. Body mass index (19-25 kg/m2) ,the body weight ≥55kg for male subject,≥45kg for female.
4. Negative pregnant test, no menstrual period for female.
5. willing to comply with the protocol.

Exclusion Criteria:

1. Be allergic to endostatin
2. Have taken any drug during the last 2 weeks
3. Have Participated any clinical trail during the last 2 week
4. Cardiovasculre, respiratory, Liver, renal, gastro-intestinal hematologic endocrine and mental disease
5. HIV-1 infected
6. HBV, HBV infected ,Hepatitis B surface antigen positive
Diclofenac Gel in the Treatment of Cervicogenic Headache

The intervention will consist of the nursing staff applying 2 grams of diclofenac 1% gel topically to the posterior cervical region four times daily. The control group will receive petroleum jelly topically to the posterior cervical region four times daily. Patients will receive a pre-intervention and post-intervention survey incorporating the Numeric Assessment Scale and Headache Impact Test-6.


Eligibility Criteria:
Inclusion criteria:

1. 18-90 Years old
2. Subject must be able to consent for themselves
3. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
4. English or Spanish speaking
5. Complain of a headache, caused by a disorder of the cervical spine and/or it's component (i.e. bony, disc and/or soft tissue elements) usually but not invariably accompanied by neck pain (Avijgan et al, 2019)).

Exclusion criteria:

1. Primary headache secondary to intracranial pathology (i.e. tumors)

   a. While TBI and Stroke patients can suffer headaches as a sequalae of their intracranial pathologies, it is not always the case that their headache is primarily secondary to their pathology but due to other etiologies such as cervicogenic headache or myofascial pain syndrome. History and physical examination by the medical team will help aid in determining the headache's etiology.
2. Patients on dual antiplatelet therapy

   a. Aspirin 81mg daily or Clopidogrel (or antiplatelet monotherapy) is acceptable
3. History of cervical spine procedures

   a. Spinal cord injury patients with cervical neck injuries that have required operative repair will be excluded from the study.
4. Nerve blocks within past 4 weeks or steroid injections within past 6 months.
5. Patients with fibromyalgia
6. Pregnant women
7. Chronic pain on continuous opiate regimen (use of opioids on most days \>90 days)
8. Discharged in less than 14 days from acute inpatient rehabilitation
9. Any contraindication use per diclofenac gel package insert:

   1. Known hypersensitivity to diclofenac or any other components of the drug product
   2. History of asthma, uriticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
   3. In the setting of coronary artery bypass graft (CABG) surgery.
10. Development of adverse reaction resulting in discontinuation of diclofenac gel
Vestibular Balance Therapy Intervention for Children

The goal of this within groups clinical trial is to determine the feasibility of a home-based vestibular balance therapy program for children with vestibular hypofunction. The main questions to be answered are: 1) what is the intervention's feasibility and 2) what is the intervention's preliminary impact on function? Participants will receive a comprehensive battery of vestibular function and balance tests, then an 8-week home-based intervention to be done 5 times/week with weekly checks from the physical therapist. Data will be used to design a larger clinical trial with a comparison group.

Approximately 60-75% of children with severe/profound sensorineural hearing loss (SNHL) also have vestibular hypofunction (VH), resulting in delayed gross motor development, poor postural control, and gaze instability. Although clinical practice guidelines provide recommendations for adults with VH, no statements exist for children due to a paucity of high- level studies. The long-term objective of this proposal is to assess feasibility of a home-based vestibular balance therapy (VBT) program for children so that a larger well-powered controlled study can be designed. The specific aims are to assess the intervention's feasibility (Aim 1), estimate its preliminary impact on functional outcomes (Aim 2), and assess participant engagement (secondary Aim). To accomplish this, we will use a prospective single arm feasibility design. We will enroll 15 children with SNHL, aged 4-17 years; 12 with confirmed VH for the VBT, and 3 with normal vestibular function to test the sham intervention. All children will be tested on the functional outcomes: computerized dynamic visual acuity, modified functional gait assessment, and sensory organization test at baseline, 4, and 8 weeks. A physical therapist (PT) will train children/caregivers in the 8-week structured VBT home program consisting of 4 categories of exercises (Times 1 viewing, gaze shifting, static and dynamic balance) done 5 times/week, 5 minutes/exercise. The PT will meet weekly with the child/caregiver in person to systematically progress the exercises. The children in the sham intervention (10 minutes of reading, 10 minutes of play) will also receive weekly meetings with the PT to control for attention bias. To assess Aim 1 (Feasibility) metrics will include process (e.g., recruitment rates), resources (e.g., communication needs), management (e.g., data collection/entry), experience (e.g., barriers). To assess Aim 2 (impact) we will analyze within group changes and effect sizes to design the larger study.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of severe to profound SNHL
* age 4-17 years
* caregiver/child verbal willingness to commit to the home vestibular balance therapy or sham intervention
* vision screening/testing within 1 year or willingness to get a vision test.

Exclusion Criteria:

* neurologic condition other than SNHL
* inability to read at a kindergarten level or identify pictures
* currently receiving vestibular therapy
* uncorrected vision problems unrelated to a vestibular deficit
Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Primary:

·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer

Secondary:

·To evaluate the toxicity of the combination


Eligibility Criteria:
Inclusion Criteria:

* Non-small cell bronchopulmonary cancer established by histological and/or cytological methods;
* Advanced or metastatic disease (stage IIIB or IV);
* At least one measurable lesion with one dimension (\>= 20 mm by CT scan or \>=10 mm by CT scan) outside of the irradiated area;
* No prior chemotherapy;
* Previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks;
* Age \>= 18 years old;
* ECOG Performance Status (PS): 0-1;
* Life expectancy \>3 months;
* Hepatic and renal functions and blood count satisfactory:

  * Blood counts: white blood cells \>= 3.0 x 10\^9/l, neutrophils \>= 1.5 x 10\^9/l, platelets \>= 150 x 10\^9/l, haemoglobin \>= 9 g/dl,
  * Hepatic function: bilirubin within the limit of the normal upper value, aspartate transaminases (AST) or alanine transaminases (ALT) \<= 2.5 times the normal upper value
  * Renal function: creatinine clearance (calculated according to Cockroft and Gault) \>= 40 ml/min;
* Patients of reproductive age must use an effective contraceptive method;
* Informed consent form signed before any procedure undertaken connected with the study

Exclusion Criteria:

* Pregnant or breastfeeding patient;
* Past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix);
* Symptomatic cerebral or leptomeningeal metastases;
* Symptomatic peripheral neuropathy \> 1 (NCI-CTC grade);
* Presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator);
* Treatment with another test product or participation in another therapeutic trial in the 4 weeks preceding inclusion in the study;
* Concomitant treatment by any other anticancer therapy;
* Concomitant treatment with phenytoin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Transvenous Lead Removal Post-Market Clinical Study

This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years of age or older
2. Lead indwell time greater than 1 year

Exclusion Criteria:

1. Patient is unable or unwilling to provide informed consent (per the IRB/EC requirements) to participate in the clinical study
2. Patient presents with an extracardiac lead
Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego

A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.

A study that aims to quantify the state of DAA uptake and its impact on the HCV epidemic among PLWH in San Diego, and to characterize negative predictors of DAA treatment uptake among PLWH in San Diego. Retrospective and prospective data from UCSD Owen Clinic will be utilized to calculate HCV prevalence, primary incidence, and reinfection incidence. Using mathematical epidemic models, the study will assess levels of existing and scaled-up interventions necessary for HCV elimination from PLWH in San Diego.

Eligibility Criteria:
Inclusion Criteria:

* Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
* With history of acute or chronic HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody

Exclusion Criteria:

* With no history of or current HCV infection defined as having a negative HCV antibody from 2008 to 2020
Daily Routines, Executive Functioning & ADHD

The goal of this clinical trial is to learn adjusting daily or nightly routines improves executive functioning in youth with ADHD. It will also learn about the acceptability of the intervention.

The main questions it aims to answer are:

1. Does the intervention improve sleep for youth with ADHD?
2. Does the intervention improve areas of executive functioning for youth with ADHD?
3. Is this an acceptable intervention for youth with ADHD?

Researchers will compare the two intervention conditions to see if their are impacts in executive functioning and sleep.

Participants will:

Complete cognitive testing, executive function tasks, questionnaires, and an interview at baseline and at one month Wear an actigraph watch for one month Bring a parent with them to three meetings Complete daily sleep diaries for one month

The purpose of this study will be to examine if adolescents with ADHD with altered daily or nightly routines show improvements in EF, specifically working memory, cognitive flexibility, and inhibitory control. This will be a pilot study including up to 25 adolescents between the ages of 11 and 17 years old, with a diagnosis of ADHD (combined presentation, or predominantly inattentive presentation). Participants will be stratified by gender and randomly assigned to one of two conditions: 1) night routines or 2) daily routines. The intervention is ready to be implemented and adapted for an ADHD population. Though the intervention itself was not focused on sleep hygiene, the team incorporated strategies to increase the likelihood of extending sleep duration, such as reviewing actigraphy and sleep diary data with the participant, collaboration between the participant, caregiver and researcher to address obstacles to obtaining enough sleep, and instructing the participant to obtain a specific amount of sleep. The first study demonstrated that sleep extension in youth with type 1 diabetes (T1DM) was feasible, whereas the ongoing study has demonstrated that overall youth increase TST over a 3-month period. This latter study has a booster session approximately one month after the initial consultation. Thus, this study will last one month with two weeks of baseline to establish sleep patterns and the intervention portion for this study will last for two weeks to monitor whether the youth increase their sleep and ascertain an effect size of intervention impact.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of attention-deficit/hyperactivity disorder (ADHD)
* Located in the greater Tucson, AZ area
* Must have a guardian willing to participate

Exclusion Criteria:

* Clinical diagnosis of autism spectrum disorder
* Clinical diagnosis of an intellectual disability
* Clinical diagnosis of psychosis
* Clinical diagnosis of bipolar disorder
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study

This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively randomized fully resected stage III colon cancer patients to receive adjuvant treatment with either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.


Eligibility Criteria:
Inclusion Criteria:

* Patient included in PETACC08 study
* Signed informed consent for translational study
* FFPE tumor sample available for miR-31-3p and miR-31-5p expression testing

Exclusion Criteria:

* Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Evaluation of Comfort in Symptomatic Contact Lens Wearers

The purpose of this study is to evaluate the comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada.

The duration of individual participation is six days.

Eligibility Criteria:
Key Inclusion Criteria:

* Is able to understand and sign an approved information consent letter;
* Habitually wears daily disposable soft contact lenses in both eyes;
* Is able to achieve 20/40 or better monocular VA with habitual contact lenses;
* Has a pair of spectacles for vision correction.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Routinely sleeps in habitual contact lenses;
* Has any known active ocular disease and/or infection;
* Is pregnant or lactating;
* Other protocol-defined exclusion criteria may apply.
Implantation With the Nucleus CI532 Cochlear Implant in Adults

The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant.

The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.


Eligibility Criteria:
Inclusion Criteria:

* Meet current cochlear implant criteria at the implanting center
* 18 years or older with bilateral sensorineural hearing loss
* Limited benefit from appropriate binaural hearing aids
* Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies
* Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted
* Fluent speaker in the language used to assess clinical performance

Exclusion Criteria:

* Evidence of hearing loss prior to age 5
* Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz
* Simultaneous bilateral implantation prior to the study
* Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery
* Cochlear anomaly that might prevent complete insertion of the electrode array
* Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway
* Active middle ear infection
* Tympanic membrane perforation
* Unrealistic expectations
* Unwillingness or inability co comply with all investigational requirements
* Patients with existing cerebral shunts or drains
* Recurrent episodes of bacterial meningitis
The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed uterine sarcoma (rereading in reference centers)
* Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma
* All stages \<= stage III (FIGO modified for endometrial carcinoma)
* Full surgical exeresis
* Age \>= 18 years and physiological age \<= 65 years
* Negative extension check-up (thoracic and abdomino-pelvic TDM)
* Performance status (PS) \<= 2 (ECOG)
* Normal haematologic functions (absolute neutrophil count \> 1,500/mm3, platelets \> 100,000/mm3)
* Serum creatinine \< 1.25 x ULN
* Good hepatic check-up (total serum bilirubin \< 1.5 x ULN; AST or ALT \< 2.5 x ULN)
* Absence of neuropathy \> grade 1
* Left ventricular ejection fraction \> 50% (by isotopic or ultrasound scan determination)
* Written informed consent

Exclusion Criteria:

* Low grade endometrial stromal sarcoma
* Time since surgery \> 8 weeks
* Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones)
* Antecedents or evolutive psychiatric disorder
* Concurrent active infection or other serious uncontrolled systemic disease
* Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix