cyrilzakka/clinical-trials huggingface dataset:
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma

The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and E) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham (UAB) Hospital
* Blunt or penetrating injury
* UAB highest trauma activation

Exclusion Criteria:

* Age \< 19 years of age
* Patients with known bleeding diathesis or who are concurrently taking anticoagulant medication
* Patients with known liver disease
* Minor patients
* Pregnant patients (known or suspected pregnancy)
* Patients who are incarcerated
* Patients who lack a surrogate
An Intervention to Improve End of Life Decision Making Among Homeless Persons

This project is a prospective, randomized controlled trial to improve the end of life experience for homeless persons by facilitating the expression of their wishes and enhancement of their dignity when facing serious illness, death, or the prospect of dying. Our main hypothesis is that homeless persons will engage in this intervention and increase rates of advance directive completion.

This project is a prospective, randomized controlled trial to improve the end of life experience for homeless persons by facilitating the expression of their wishes and enhancement of their dignity when facing serious illness, death, or the prospect of dying. Our main hypothesis is that homeless persons will engage in this intervention and increase rates of advance directive completion.

Participants were recruited from Listening House, a drop-in center for homeless individuals located in St. Paul, Minnesota and represent a convenience sample. Participants were required to speak English, not be overtly intoxicated, and have been homeless during the previous six months. The study was reviewed and approved by the institutional review board of the University of Minnesota. All participants who entered the study gave written and oral consent for randomization and data measurement and screening.

After recruitment and consent, participants were randomized into two intervention arms, minimal intervention (MI) and guided intervention (GI). All participants received educational materials about advance directives and advance care planning, pre-intervention surveys, and an advance care planning document, designated HELP, specifically designed for marginalized populations to preserve autonomy and elicit preferences of EOL care.

All participants completed a baseline written pre-test and survey. For this, they received compensation of $5. Those randomized to the minimal intervention were provided the opportunity to complete a HELP document if they so desired. Participants randomized to the GI group were provided with the written instructions and tools and asked to return to meet with investigators for one-on-one counseling and assistance in completion of the HELP document on one of several days later during the week of enrollment. Three months after enrollment, post-intervention evaluations were sought from both MI and GI subjects. There was no financial incentive offered for completion of the HELP form.

Measurement The primary outcome of interest was the completion of a legally valid advance directive, the HELP document, which was measured by inspection of HELP documents as well as self-report. Secondary outcomes include knowledge, attitude, and behavior variables measured through a questionnaire administered at baseline and at follow-up. Demographic information, including education and living situations, was also collected at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Homeless in last six months
* Speak English
* Age 18-65

Exclusion Criteria:

* Intoxicated
* Minor
TTE and Dysphagia in Anterior Cervical Surgery

The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed prior to anterior cervical spine surgery can result in a decreased rate of dysphagia.


Eligibility Criteria:
Inclusion Criteria:

* Elective Anterior cervical spine surgery (C2-C7) for degenerative disc disease or myelopathy

Exclusion Criteria:

* More than four levels of fusion
* Trauma or urgent cases of anterior cervical spine surgery
* Prior anterior cervical spine surgery (a known risk factor for dysphagia),
* Prior neck surgery (eg. Thyroidectomy)
* Tumors
* Infections
* Neurological disorders that can predispose to dysphagia such as Parkinson's, Cerebrovascular Accidents (CVA), Alzheimer's and Amyotrophic Lateral Sclerosis.
The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial

Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).


Eligibility Criteria:
Inclusion Criteria:

* Adults patients (20-50)
* Good oral hygiene (plaque index 0 or 1 )
* Patient approving to participate in the study
* Absence of parafunctional habits and/or bruxism
* No sign of irreversible pulpitis
* No periapical radiolucency
* Deep subgingival margin
* Molars class II with subgingival margin

Exclusion Criteria:

* • Patients with known allergic or adverse reaction to the tested materials.

  * Systematic disease that may affect participation.
  * Xerostomic patients.
  * Bad oral hygiene (plaque index 2 or 3 )
  * Heavy smokers
  * Patients undergoing or will start orthodontic treatment
  * Patients with removable prothesis
Effects of Vibration Training on Exercise Capacity in COPD-patients

The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
* Severe disease other than COPD, that could influence the results of the study
* Abuse of alcohol or drugs
* Simultaneously participation in another study
* Tachypnea (\>30/min)
* Severe exacerbation during rehabilitation
* Cardiac insufficiency (NYHA IV)
* Myocardial infarction during the last 6 weeks
* Mental-health problem
* Pregnancy
* Known HIV-infection
* Slipped disk
* Acute discopathy
* Acute thrombosis
* Implants in trained regions of the body (lower extremities)
* Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
* Acute tendinopathy in trained regions of the body
* Acute hernia
* Fresh fractures, wounds or scars in trained regions of the body
* Gallstones or stones in the urinary tract collection system
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for the subjects will be approximately 7 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.
* Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible Parkinson's disease dementia according to Movement Disorder Society's Clinical Diagnostic criteria.
* Score on the Montreal Cognitive Assessment (MoCA) of 13-25.
* Modified Hoehn and Yahr Stages 1-4.
* Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.

Exclusion Criteria:

* History of blood coagulation disorders or hypercoagulability.
* Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
* Prior hypersensitivity reaction to any human blood product or any IV infusion.
* Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
* History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins.
* Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing
* Hemoglobin \< 10 g/dL in women and \< 11 g/dL in men.
Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse

Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

330 patients with schizophrenia and cannabis abuse or dependence (according to DSM-IV criteria) are randomly assigned to 4 motivational interview during one month or usual intensive treatment. Treatment is conducted in outpatient which are evaluated at the inclusion and at 6 month with Time-Line Follow Bach for the consumption, PANSS score, number of relapse...). A outcome measure was urinalysis results providing an objective measure of cannabis use throughout the six month of the trial.

Eligibility Criteria:
INCLUSION CRITERIA:

* Schizophrenia or schizo-affective disorder according to DSM-IV criteria
* Meeting DSM-IV criteria for actual cannabis abuse or dependance
* in current and regular contact with mental health service
* with an age at interview of 18 years or more
* No evidence of organic brain disease or clinically significant concurrent medical illness or learning disability
* Written informed consent was obtained from all subjects (patients and parents).

EXCLUSION CRITERIA:

* Not membership to a regime of social security or to a CMU
Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

The overall goals of this study are to 1) assess awareness of interest in the use of pharmacotherapy for smoking cessation in Croatia and Slovenia, countries in Central Europe with very high smoking prevalence, and 2) investigate whether cytisine is at least as feasible and effective as varenicline in helping smokers to quit in a real-life setting: family medicine practices in Croatia and Slovenia. The investigators propose to survey patients from 40 primary care practices (20 in Croatia and 20 in Slovenia) to assess desire to quit smoking and awareness and interest in pharmacotherapy. Additionally, 380 patients with interest in quitting smoking will be randomly assigned to use varenicline or cytisine to help quit smoking.

The investigators hypothesize that cytisine is at least as feasible and effective as varenicline in helping smokers from primary care practices in Croatia and Slovenia to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Receive care in one of forty family medicine practices in Croatia and Slovenia
* Aged 18 or older
* Current smokers
* Indicate a desire to stop smoking and to use pharmacotherapy.

Exclusion Criteria:

* Mental illness who cannot provide informed consent for the study
* Pregnant or breastfeeding.
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii pneumonia (PCP) for whom this investigational compound could provide significant medical benefit.

Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral therapy (at the discretion of the treating physician and/or medical monitor).

Patients must have:

* Presumptive or definitive diagnosis of Pneumocystis carinii pneumonia (PCP).
* HIV positivity or be otherwise immunosuppressed.
* Demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, OR a documented history of such intolerance during a prior episode.
* Consent of parent or guardian if less than 18 years of age.

NOTE:

* In general, patients who meet the eligibility criteria for other U.S. Bioscience-sponsored clinical trials for trimetrexate would not be eligible for this Compassionate Use protocol.

Exclusion Criteria

Patients with the following prior conditions are excluded:

History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions to trimetrexate.
A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART)

The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 Infection
* CD4 Tcell count \>350
* HIV-1 RNA levels to \<400 copies
* Negative HbsAg and anti-HCV antibody

Exclusion Criteria:

* Recent receipt of experimental HIV-1 vaccines
* Recent use of immunomodulatory agents
* Hypersensitivity or serious reactions to study vaccine components
* Active opportunistic infections
Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis

Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will prevent infections with this bacteria in patients with Cystic fibrosis (CF).

"Anti-pseudomonas IgY" is prepared from eggs of hens that have been vaccinated with Pseudomonas aeruginosa. The hens farm is under veterinary control according to Swedish rules. The drug is prepared with a water dilution method according to GMP standards (approved by Swedish MPA). Patients with CF who are intermittently but not chronically infected with P. aeruginosa get a short course of antibiotics to eradicate the bacteria. Thereafter they start to gargle with a solution of "anti-pseudomonas IgY" every night to prevent a new infection. Preliminary results have shown that it takes a significantly longer time to get a new infection and that the patients get fewer infections than control patients. In addition, results tentatively indicate that: patients have not got any new opportunistic bacteria or fungi (B. Cepacia, S. Maltophilia, A. Xylosoxidans, atypical Mycobacteria, Aspergillus Fumigatus); that use of antibiotics is greatly diminished; that the lung functions and nutritional conditions are maintained.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cystic fibrosis
* Colonized with Pseudomonas aeruginosa
* informed consent

Exclusion Criteria:

* Egg allergy
Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)

The primary objective in this study is to collect post-marketing information on Riociguat safety.Thus, the information on adverse events (AEs) and adverse drug reactions (ADRs) that occur within the first 12 months and in the following 6 -year observation at most, after starting Riociguat treatment under the routine clinical practice will be collected.

The secondary objectives are collecting information on Riociguat effectiveness, such as 6-Minute Walking Distance (6MWD) Test. Since it is assumed that Riociguat is for long-term use, information on Pulmonary Arterial Hypertension (PAH) clinical worsening will also be surveyed once a year.

This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for PAH. A total of 600 patients (valid for safety analysis) is planned to be included in 4 years. This study is performed as an "all-case investigation" therefore; all patients who receive Riociguat treatment for PAH need to be registered, in principle. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Riociguat treatment. Safety and effectiveness will be evaluated at the 3rd and 12th month of treatment. In addition, the extension observation period will be carried out as long as Riociguat treatment continues or at most for more 6 years. The purpose is to collect information on safety and effectiveness, such as adverse events and clinical worsening of PAH, once a year. Combining the standard observation and the extension observation period the patient could be followed for at most 7 years. When Riociguat treatment is terminated, the observation of the patient ends. The investigator should record data for each patient, as defined in the protocol, using the Electronic Data Capture (EDC) system. The duration of the study is of approximately 8 years from PAH indication approval.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with Riociguat for PAH

Exclusion Criteria:

* N/A
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants

The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.


Eligibility Criteria:
Inclusion Criteria:

* Age: 5 - 14 days since birth
* Fetal gestational age: ≥23 weeks and \<29 weeks
* Birth weight: ≥500g and ≤1250g
* Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of \> 12 breath/min and \> 25% oxygen
* Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment
* Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria:

* Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus
* Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
* Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
* Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
* Patient withCRP \> 30 mg/dL; Severe sepsis or shock
* Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug
* Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug
* Patient with severe intracranial hemorrhage ≥ grade 3 or 4
* Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening
* Patient with a history of participating in other clinical studies
* Patient who is allergic to Gentamicin
* Patient who is considered inappropriate to participate in the study by the investigator