cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary rehabilitation will benefit patients with IPF as well.

The goals of this project are to assess the effect of PR on a number of important outcomes in patients with IPF. Once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient PR program (at National Jewish Medical and Research Center or other PR programs). Subjects will complete the same battery of questionnaires and tests immediately after completion of the PR program and again six months later.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 years or older
* Diagnosis of IPF according to American Thoracic Society criteria

Exclusion criteria:

* Patients who have completed a PR program within the last two years
* Patients with unstable medical conditions that would make PR unsafe
Time of Treatment in HALL Technique Vs ART

The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are:

* Does the Hall Technique provide a faster and pain-free treatment compared to ART?
* How do the outcomes of both techniques impact children's acceptance and behavior? Researchers will compare the Hall Technique, which uses preformed metal crowns without caries removal, to Atraumatic Restorative Treatment, which uses hand instruments to selectively remove carious tissue.

Participants will:

* Receive treatment using either the Hall Technique or ART in a single session.
* Attend follow-up visits to monitor the effectiveness and acceptance of the treatment.
* Complete assessments on their experience and comfort during and after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age: From 4 to 6 years.
* Caries in primary molars within enamel/dentin with vital pulp.
* Healthy children.
* Cooperative children

Exclusion Criteria:

* Presence of signs and symptoms of necrosis.
* Root caries.
* History of spontaneous pain.
"CuraMed" and "Curamin" in Osteoarthritis

This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will receive Curamin and one group will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of degenerative hypertrophic osteoarthritis of the knee (M17, according to International Classification of Diseases (ICD-10) of bone joints, verified by radiography (Grade 1-3 by Kellgren-Lawrence radiographic grades).

Exclusion Criteria:

* subjects with inflammatory and any secondary arthritis
* moderate and severe synovitis (grades 2 and 3)
* tear of meniscus
* chronic diseases of the kidneys, liver, gastrointestinal, cardiovascular, endocrine and nervous systems
* allergic anamnesis and drug intolerance
* pregnant or nursing
* history of substance abuse
* subjects taking non-steroidal anti-inflammatory drugs and analgesics within 2 weeks prior to the study
* subjects taking glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate, systemic or intra-articular glucocorticoids within three months prior to the study
Higher Irradiance in Keratoconus Ectasia

The purpose of the study is to see if brighter lights will allow for shortening of the treatment time required to stabilize the eyes of patients with keratoconus or a bulging cornea. The investigators will be comparing the therapeutic effects of two different higher brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as bright as the other and the exposure time of these brighter lights to deliver equivalent energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes. Riboflavin is vitamin B2 and the investigators are trying to determine if an identical clinical effect can be achieved the brighter treatment lights are used for shorter times. The investigators will also monitor the clinical effect and the status of the cornea to see if additional risks are associated with the brighter light.


Eligibility Criteria:
Inclusion Criteria:

Subjects who have one or both eyes that meet two of the following criteria will be considered candidates for this study:

1. 16 years of age or older
2. Having a diagnosis of progressive keratoconus or pellucid marginal degeneration.

   1. Characteristic pattern of deformity as analyzed by the Pentacam map.
   2. Minimal thickness of 350 microns
3. The ability to sign a written informed consent
4. States a willingness and ability to comply with schedule for follow-up visits
5. Subject willing to remove contact lenses prior to evaluation and treatment

Inclusion criteria for ectasia

1. History of having undergone a keratorefractive procedure and show:

   1. Steepening by Pentacam study
   2. Thinning of cornea
   3. Shift in the position of thinnest portion of cornea
   4. Unstable refraction with increasing myopia and astigmatism
   5. Development of irregular astigmatism
2. At least two of the above criteria must be present.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from this study:

Subjects meeting any of the following criteria will be excluded from this protocol:

1. Eyes classified as either normal or atypical normal,
2. Corneal pachymetry ≤ 350 microns at the thinnest point in treatment zone measured by Pentacam.
3. A history of delayed epithelial healing.
4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
5. A known sensitivity to study medications
6. Patients with nystagmus or any other condition that is severe enough to prevent steady gaze during the treatment
7. Inability to cooperate with diagnostic tests.
8. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
9. Patients who are unable to remain supine and tolerate a lid speculum.
Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.


Eligibility Criteria:
Inclusion Criteria:

1. adults (21+) who a) have been smoking at least 5 cigarettes daily for one year
2. usual brand (the brand used most often) is mentholated
3. have a smartphone that can receive text messages and access the internet (necessary for diary completion).

Exclusion Criteria:

1. other tobacco and pharmacotherapy criteria
2. health and safety criteria
3. planning to move out of the area within the next 3 months
The Study of the Effects of Vitamin A on Immune System in Patients With Atherosclerosis

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 3 months on immune system and Th1/Th2 balance in patients with and without atherosclerosis (documented with angiography).

Atherosclerosis, the leading cause of death and disability in the world, is considered an inflammatory disease with a complex etiology. The immune system has a prominent role in the formation, development and destabilization of atherosclerotic plaques. A whole range of identified cytokines have been shown to play a part in atherogenesis, some with proatherogenic properties while others having antiatherogenic properties. With increasing evidence for the significant role of inflammation and the cytokines involved together with the Th1/Th2 imbalance in atherosclerosis and its progression to Coronary artery diseases (CADs), the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.

Eligibility Criteria:
Inclusion Criteria:

* The criteria for enrollment of the patients and control subjects is consecutive patients of both sexes referred to the Division of Cardiology of the one of the Hospitals of Tehran University of Medical Sciences for coronary angiography for investigation of chest pain and/or suspected CAD.

Exclusion Criteria:

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* Patients who have allergy to vitamin A compounds, OR
* Patients who have used vitamin supplements in last 3 months.
Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal

The problem of root caries has been increasing in last decades as the an average life expectancy is rising. Due to progress of medicine and dentistry humans also maintain natural dentition longer.

The aim of the study is to determine the effectiveness of photoactivated disinfection / photodynamic therapy / photodynamic antimicrobial therapy in elimination of cariogenic bacteria after manual root caries removal.

If proved to be effective in eliminating bacteria from prepared cavity PAD could be incorporated in the protocol of treatment of root cavities.

Elimination of cariogenic bacteria is to be determined in this study - Mutans streptococci, Lactobacillus spp. and Actinomyces spp.

After manual preparation of the cavity with an excavator and taking a sample for a microbial analysis with a rose bur on micro motor (size 014) the cavity undergoes the procedure of photodynamic disinfection:

* application of photosensitizer 'Fotosan Agent' (CMS Dental, Denmark) for 5 minutes,
* radiation with low power laser, wavelength 635 nm power 200mW 120 s. ('Lasotronix', DiodeLX model SMART)
* rinsing with water and drying

After photodynamic disinfection another sample for microbial analysis is taken form the neighboring area to get the material for a comparison analysis.

Filling the cavity with a material for permanent fillings (glass-ionomer cement)

Samples are inoculated on:

* Mitis-Salivarius ('Difco') for Streptococci
* Rogosa SL 2% aqar ('Oxoid') for Lactobacillus
* Columbia with blood for Actinomyces (2 dilutions - 1:10 and 1:100)

Eligibility Criteria:
Inclusion Criteria:

* more than 10 teeth
* at least one tooth with primary caries lesion with contraindicated non-invasive treatment (lesion which needs to be prepared and filled with material for permanent fillings); tooth with no clinical and/or radiological symptoms of pulp involvement.
* no systemic disease

Exclusion Criteria:

* systemic diseases (may affect saliva flow and properties)
* antibiotic therapy in previous 3 months before the appointment
Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort

The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis
* the subjects were antiretroviral drug-naïve
* a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml

Exclusion Criteria:

* pregnancy or breastfeeding
* anticipated nonadherence
* AIDS-defining illness within 2 weeks of entry
* white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L
* transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range
Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures

The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2j 50hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as \> 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as \>10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates

Exclusion Criteria:

* Prostates measurements over 200g
* Patients who lack decisional capacity
* Patients who are non-english speakers
Myopia Control Effectiveness of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes

The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.

The variant of Defocus Incorporated Spectacle lenses (DG2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (DG2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months. In parallel, the DG2 treatment groups will continue their corresponding intervention for 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years. The changes in refractive errors and axial length in two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* SER: -0.75D or below in both eyes
* Documented history of fast progressing myopia, either in SER or AL

  * SER progression: 0.50D/year or more
  * AL elongation: 0.27mm/year or more
  * For children aged 4-6 years without past prescription forms,
  * 4-5 years old: myopia of -0.75D or below in both eyes
  * 6 years old: myopia of -1.25D or below in at least one eye, with the other eye -0.75D or below
* Best-corrected visual acuity (VA) in both eyes:

  * 4 - 6 years old: 0.20 logMAR (or its equivalent) or better
  * 7-12 years old: 0.00 logMAR (or its equivalent) or better
* Acceptance of random group allocation and the masked study design
* Anisometropia of 1.50 D or less
* Astigmatism of 2.00 D or less

Exclusion Criteria:

* Strabismus and binocular vision abnormalities
* Ocular and systemic abnormalities
* Prior experience of myopia control
Role of Immune Responses After Acute Myocardial Infarction

The fascinating role of lymphocyte subtypes in the development of coronary artery disease may be a new strategic target for understanding and therapy of acute myocardial infarction. The determinants of cell viability are unknown, postulating that they arise from factors not only related to microcirculation or energy expenditure, but also to inflammatory and immune responses. Furthermore, the intense mobilization of progenitor cells secondary to myocardial infarction triggers large lymphocyte proliferation that colonizes plaques in development, contributing to recurrent ischemic outcomes. This project aims to evaluate the immune and metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary disease progression.

Specifically, the investigators will study the innate and adaptive immunity, with emphasis on lymphocytes subtypes involved in the early and late surrogate outcomes of patients with acute myocardial infarction, their characterization (B1, B2 and T lymphocytes) in cell culture and by flow-cytometry, and immune responses (IgM and IgG for oxLDL and specific epitopes of apoB). In addition, the project will evaluate new biomarkers identified by studies of metabolomics, as well as the corresponding signaling pathways. Therapeutic pharmacological strategies and changes on intestinal microbiota will be evaluated since the acute phase of myocardial infarction up to 6 months.

In the study, the investigators will compared four arms of combined therapy: clopidogrel with rosuvastatin; or clopidogrel with simvastatin; or ticagrelor with rosuvastatin; or ticagrelor with simvastatin. The investigator's hypothesis is that the improvement of microcirculation with rosuvastatin and ticagrelor (synergic pleiotropic effects) may decrease the infarcted mass area, resulting in better left ventricular ejection fraction when compared to the other combined therapies.

The monitoring and genotype of microbiota will be examined together the metabolomics and cardiac MRIs obtained at the acute phase of MI and after 1-mo and 6-mo FU.

Eligibility Criteria:
Inclusion Criteria:

1. Stable patients with ST elevation myocardial infarction (STEMI) treated with thrombolytics in the first 6h or the initial of symptoms of MI.

Exclusion Criteria:

1. Contraindication or known intolerance to the study drug protocol
2. Those with comorbidities such as neoplasm, renal insufficiency (stage 4 or higher)

Patients should be randomized in the first 24 hours of AMI and treated by one of the four combined therapies at least 2h prior to coronary angiogram followed by percutaneous intervention when necessary.
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.

This is a open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study designed to show that 2 alternative dosing regimens, once weekly and once every-2-weeks (given at doses equivalent to 50 IU/kg 3 times a week) are not inferior to the 3-times-weekly dosing regimen. Approximately 375 patients with anemia will be enrolled in this study. Patients will be randomly assigned to receive epoetin alfa by subcutaneous (SC) injection according to one of the following 3 regimens: 3 times weekly (Group 1), once weekly (Group 2), or once every 2 weeks (Group 3) for 22 weeks. Thereafter, patients in Group 1 will be switched to the once-weekly dosing regimen for an additional 22 weeks, and patients in Groups 2 and 3 will continue their current treatment for an additional 22 weeks. The total duration of the open-label treatment phase is 44 weeks which will include initiation and maintenance treatment periods (with the goal of increasing, then maintaining, the hemoglobin level between 11.0 and 11.9 g/dL inclusive) and a safety period (to assess longer exposure to epoetin alfa treatment and any period of hemoglobin instability during the transition from 3-times-weekly to once-weekly dosing). Starting doses of epoetin alfa in the 3-times-weekly, once-weekly, and every-2-weeks groups will be 50 IU/kg, 10,000 IU, and 20,000 IU, respectively; thereafter adjusted according to weekly hemoglobin concentrations. Safety evaluations will include assessment of adverse events, laboratory tests, physical examinations, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
* Require support of an erythropoietin receptor agonist

Exclusion Criteria:

* Uncontrolled hypertension
* Serum ferritin level less than 50 ng/mL
* Serum iron overload
* Severe congestive heart failure
* Active infection
Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy

All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will be considered for inclusion. After written inform consent, psychometric tests in order to calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed before the TIPS procedure. After TIPS, patients will be followed during one year and the psychometric test and CFF will be performed every 3 months.

30 patients will be included.

The main endpoint is the success rate of CFF. The secondary end points are

* Correlation between CFF and PHES score
* Performance of CFF and PHES score to predict the occurrence of overt encephalopathy after TIPS procedure
* A sample collection during TIPS procedure is also performed for validation of biomarkers


Eligibility Criteria:
Inclusion Criteria:

* patients with cirrhosis in whom a TIPS is indicated
* patients have given their informed consent te be included

Exclusion Criteria:

* minor
* pregnant women
* patients who cannot see the red color
* refusal to participate