cyrilzakka/clinical-trials huggingface dataset:
Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms

The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing temporary relief of tinnitus symptoms in adults 18 years and older.

Eligibility Criteria:
Inclusion Criteria:

* Subjective tinnitus
* Tonal tinnitus.
* Constant tinnitus on-going at least half the time over at least the past 6 months.
* Willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration.
* Willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation.
* 18 years of age or older
* Primary language is English

Exclusion Criteria:

* Objective tinnitus
* Atonal, pulsatile, intermittent, or occasional tinnitus
* Severe or profound hearing loss in one or both ears
* Current or prior surgically removed acoustic neuroma
* Consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days:

NSAIDS (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates Lasix and other "loop" diuretics "mycin" antibiotics such as vancomycin quinine and related drugs Chemotherapy agents such as cis-platin

* Acute or chronic vertigo/dizziness
* Ménière's disease
* Prior stapendectomy
* Prior mastoidectomy
* Auditory nerve tumor (acoustic neuroma), current or surgically removed in the past
* Active infection/wound/external trauma to the areas to be treated with the laser
* Medical, physical or other contraindications for, or sensitivity to, light therapy
* Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
* Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors

This phase I study will characterize the safety, tolerability, and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the combination regimen.

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Upon determination of eligibility, patients will be receive:

* Docetaxel + Topotecan

In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of Topotecan and docetaxel will be utilized.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Adult \> 18 years of age
* ECOG performance status 0 or 1
* Received 3 or less chemotherapy regimens in the metastatic setting
* Adequate bone marrow, liver and kidney function
* Prior brain metastases must be inactive and asymptomatic
* No previous treatment with Topotecan or docetaxel
* Understand the nature of the study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Moderate or severe peripheral neuropathy
* Active concurrent infection or serious underlying medical condition
* Known HIV positivity
* Pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic RLS
* Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
* In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time

Exclusion Criteria:

* Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS
no Antibiotics for Elective Cesarean With Low Risk of Infection

The purpose of this study is to discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved.


Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean
* With normal temperature;
* No signs of infection;
* Normal degree of cleanliness in vaginal; .Normal amniotic fluid.

Exclusion Criteria:

* Failure of vaginal delivery and emergency cesarean;
* Premature rupture of membranes;
* Antibiotics having been applied to 3 days before cesarean;
* Having inflammation before cesarean: such as vaginitis, pelvic inflammatory disease, chorioamnionitis;
* Having infections in respiratory or urinary system before cesarean;
* Placenta previa or placental abruption;
* With medical and surgical complications;
* BMI ≥ 30kg/m2;
* Total blood loss more than 1000ml within 2 hours after cesarean
Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking.

Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for healthy subjects:

* Men and women aged over 18 years
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 Dpt
* Schirmer I test \> 10 mm and BUT \> 10 sec

Inclusion criteria for patients with dry eye syndrome:

* Men and women aged over 18 years
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant except DES
* Normal ophthalmic findings, ametropia \< 6 Dpt
* History of dry eye syndrome for at least 3 months
* Tear Break Up Time (BUT) \< 10 seconds or Schirmer I test \< 7 mm
* At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching)
* Normal ophthalmic findings except dry eye syndrome

Exclusion Criteria:

* Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Ametropia \>= 6 Dpt
* Pregnancy
* Difference of more than 3 mm in Schirmer I test or difference of \> 3 sec in BUT between the two eyes
* Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study
Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome

Repetitive transcranial stimulation (rTMS) of the posterior parietal cortex will be applied daily over five days in adult Gilles de la Tourette patients. This approach aims at reducing premonitory sensations believed to induce tics. Patients will be randomized to an active or placebo (sham) group in a crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Gilles de la Tourette syndrome as defined by DSM IV-R
* Yale Global Tics Severity Scale (YGTSS) score between 30 et 60
* Premonitory sensations (" urge to move ")
* Affiliated to the French social security regime
* Ability to give informed consent

Exclusion Criteria:

* rTMS : epilepsy, craniotomy scar, pacemaker or neural stimulator, metal implants or foreign bodies, claustrophobia, pregnancy
* Cognitive impairment (MMS ≤ 24/30)
* Axis I disorders according to DSM IV-R : psychosis or history of psychosis, bipolar illness, major depressive disorder, addictions (except to nicotine)
* Impulse control disorders
* Other chronic debilitating illnesses
* Unability to give informed consent
* Participation in another clinical trial
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP

The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.

The primary efficacy endpoint of evaluation is defined by the post-operative time back to prior work or life through patient diary.

The primary safety endpoint of evaluation is defined by the incidence rate of sternal complications (DSWI \& SSWI) at 30 days post-op.

The secondary endpoints of evaluation up to 60-days post-operative are defined by:

* Quality of recovery after surgery (QoR-15)
* Days alive out of the hospital and at home (DAH)
* Disability-free survival (WHODAS 2.0.)
* Pain scores: Likert scale 1-10
* Opioid pain medication usage
* Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* ≥ 18 years of age, no upper limit
* Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\] and closed with the SternaLock XP Rigid Fixation System
* Willing to sign Informed Consent prior to the cardiac surgical procedure
* Willing and able to provide follow-up information up to 60-days post-operative

Exclusion Criteria:

Inclusion Criteria

* Male and female
* ≥ 18 years of age, no upper limit
* Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\] and closed with the SternaLock XP Rigid Fixation System
* Willing to sign Informed Consent prior to the cardiac surgical procedure
* Willing and able to provide follow-up information up to 60-days post-operative Exclusion Criteria

Pre-operative

* Emergent or salvage cardiac acuity, i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
* Active or latent infection (with positive culture)
* Documented foreign body sensitivity, allergy, or intolerance to metals.
* Rapid bone absorption condition, metabolic bone disease, cancer, tumor, or tumor like condition of the bone, end-stage malignant disease, or other unexplained disease.
* Mental/ neurologic conditions rendering patients unwilling or incapable of following post-operative care instructions.
* Functional disability affecting gait, balance or mobility.

Operative

* Delayed sternal closure required for any reason (e.g., sent to ICU with open chest wound)
* Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation.
* Insufficient quantity of sternal bone or limited blood supply as assessed by the operating surgeon using his or her professional judgment at the time of closure.
* Intraoperative death prior to device placement
Novel Screening Strategies for Scleroderma PAH

Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 30 years or older;
* diagnosis of limited or diffuse scleroderma (American College of Rheumatology criteria)
* for the "high risk" group, one of the following features:

  * resting transthoracic echocardiogram showing elevated right-sided pressures within previous 3 months \[tricuspid regurgitation (TR) jet \>2.8 m/s or evidence of right ventricular dysfunction\]
  * pulmonary function testing (PFT) showing abnormal diffusing capacity of carbon monoxide (DLCO) not due to significant interstitial lung disease (DLCO\<60% predicted or FVC: DLCO ratio \>1.4)

Exclusion Criteria:

* Pregnancy
* prior diagnosis of pulmonary hypertension
* treatment with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogues
* previous diagnosis of obstructive lung disease or pulmonary thromboembolic disease
* current smoker
* significant valvular disease
* resting echocardiogram showing left ventricular ejection fraction\<50% within previous 3 months
* resting echocardiogram showing significant (greater than Grade I) diastolic dysfunction
* pulmonary emboli (past or present).
Financial Incentives for Smoking Treatment

The investigators plan to compare the impact of two approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse population of patients at the Manhattan campus of the VA New York Harbor Healthcare System, which serves a critical safety-net role for urban veterans. During hospitalization, all smokers will receive usual care. Patients will be randomized to one of two arms: financial incentives plus usual care vs. usual care alone, which includes referral to the state Quitline. All patients enrolled in the study will be offered nicotine replacement therapy. The investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12 months after discharge. The primary study outcome is smoking abstinence at 6-month follow-up, verified by salivary/urinary cotinine.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years,
2. smoked tobacco during the prior 30 days,
3. have an active U.S. phone number and address,
4. can provide consent in English and
5. are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit

Exclusion Criteria:

1. use only smokeless tobacco,
2. are pregnant or breastfeeding,
3. are discharged to an institution (e.g., nursing home, long-term care facility),
4. are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study
Development and Validation of Family Adjustment Inventory

A diagnosis of chronic disease in childhood may be disruptive for families. Some parents show good adjustment, while others may have more difficulties.

Aim of this study is to develop and validate a new psychometric instrument to help precociously detect parents' vulnerability in the process of adjustment to their child's chronic disease at different times of care.

FAI was developed in two different forms:

1. for parents with one children suffering from a chronic disease or ill children who has siblings younger than 3 years old - FAI-O (only child);
2. for parents with at least two children, the brother/sister of the ill child has 3 years or more- FAS-S (siblings) The two forms are identical, with the exception that FAI-S has an additional dimension with respect to FAI-O, that specifically regards the involvement of siblings in the illness path of the sick brother/sister.

Development of FAI followed several steps:

* definition of initial instrument dimensions
* item wording for each dimension
* definition of scoring
* focus group with parents of patients suffering from a chronic disease to evaluate item content and linguistic clarity

Validation of FAI for each form (FAI-O and FAI-S):

Validation consists in several steps, identical for the two versions but in different in timing, depending on the number of admnistration.

* first phase: the FAI is administered to parents of patients with different chronic disease (each form needs to reach the total of 300 administrations).
* second phase: statistical analysis aimed to obtain the final version of each FAI form (define actual dimensions and most adequate items)
* third phase: administration to a new sample of parents of children suffering from a chronic disease (each form needs to reach the total of 150 administrations).
* fourth phase: statistical analysis aimed to confirm the adequacy of the instrument

Eligibility Criteria:
Inclusion Criteria:

* consent for participating in the study
* having a child suffering from a chronic illness and treated in the hospital in the following specialties: onco-hematology, neuro-oncology, diabetology, cystic fibrosis, metabolic disease, gastroenterology, cardiology, nephrology, rheumatology, allergology, pneumology, immunology, intensive care unit
* italian speaking

Exclusion Criteria:

* cognitive impairment
* no good knowledge of italian language
Asthma Education and Emergency Department Visits by Asthmatic Children

This study will be conducted to evaluate the effects of an educational asthma program on the frequency of emergency department visits and identifying factors associated with frequent emergency department visits by asthmatic children and determine its effect on asthma severity and quality of life among asthmatic children and their caregivers.

This one-arm interventional clinical trial study will be conducted at pediatric chest clinics and the emergency department of the children's hospital of Ain Shams University located in Cairo during the period from September 2021 to the end of December 2021.

The study will be conducted on 30 asthmatic pediatric patients aged from 1-15 years old with documented asthma diagnoses (intermittent wheezes, breathlessness, dry cough, etc)

Inclusion criteria:

: Objective asthma diagnostic testing consists of 2 components: (1) demonstration of airway obstruction and (2) documentation of variability in the degree of obstruction.

Exclusion criteria:

1. Underlying chronic lung diseases like: (Cystic fibrosis, tuberculosis, childhood interstitial lung diseases).
2. Asthmatic patients with major systemic illness (diabetes, chronic renal failure, chronic liver disease).

All the study participants will be subjected to an educational asthma program for 3 months to provide parents and children with information and skills to manage their asthma, through avoiding triggers, training in the correct use of medicines, including inhaler technique, information, and support to maximize adherence. All patients will be followed up by a phone call every 2 weeks and a follow-up visit monthly to confirm compliance with the educational program.

Eligibility Criteria:
Inclusion Criteria:

* Children with a documented asthma diagnosis Children aged from 1 to 15 years

Exclusion Criteria:

* Children with underlying chronic lung diseases
Assessing CPR Quality During In-Hospital Cardiac Arrest

Using an investigational monitor/defibrillator that passively records CPR quality parameters, including chest compression rate and depth and ventilation rate and volume, we are prospectively recording CPR quality during sequential in-hospital cardiac arrests at the University of Chicago Hospitals. Using an audio feedback system linked to this device, we are studying whether such audio feedback improves CPR quality when provided to rescuers trained in the use of the device.

Patients who suffer cardiac arrest during their hospitalization at the University of Chicago hospitals are given CPR and other resuscitation measures by trained physician and nurse teams. This care is given with the use of defibrillators to monitor cardiac rhythm as well as provide defibrillation as needed.

We have worked closely with engineers at Laerdal Medical Corporation to develop a defibrillator that passively monitors the quality of CPR via additional external sensors (see details in the following reference: Abella BS, Alvarado JP, Myklebust H, Edelson DP, Barry A, O'Hearn N, Vanden Hoek TL, Becker LB. Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. JAMA. 2005;293:305-10).

Patients who suffer in-hospital arrest are enrolled (provided they are over 16 years of age, are not pregnant, and are not in the operating room or emergency room setting) with mechanisms to satisfy IRB waiver of consent provisions. These patients receive the same care as before the study, but CPR parameters are recorded by the device. In addition, the device provides audio/visual "coaching" in CPR, based on the actual performance of CPR as measured.

We hypothesize that this coaching will improve CPR quality and hopefully improve survival from cardiac arrest.

The first phase of investigation is now complete, where patients were enrolled and studied without feedback ("baseline" group). Now we are enrolling patients into a second group with feedback provided. Enrollment is nearly complete for this second group. We will then evaluate the baseline and feedback groups to ascertain whether CPR improved over the two cohorts.

Eligibility Criteria:
Inclusion Criteria:

* adult patient with cardiac arrest hospitalized at University of Chicago Hospitals

Exclusion Criteria:

* pregnant
* arrest in ER or OR
* pediatric patient
* patient DNR, no CPR given
* no CPR given for other reasons (e.g. shock only)