cyrilzakka/clinical-trials huggingface dataset:
Socioeconomic Factors and Mortality in the Intensive Care Population

It is important to find out how much of the socioeconomic factors´ impact on mortality on ICU patient´s can be explained by the presence of comorbidity. The aim of this study is to clarify the impact of socioeconomic factors on mortality and how much of this effect are due to comorbidity in the intensive care population.

The first ICU admissions of patients aged 30 years and older, registered in the Swedish Intensive Care Registry (SIR) from 2009 to 2012 were included. SIR was linked to the National Patient Register, Statistics Sweden and the Cause of Death Register using unique person identity numbers. Educational level and disposable income was reported in the year preceding the admission to intensive care to not be affected by the current illness.

Eligibility Criteria:
Inclusion Criteria:

* Registered in the Swedish Intensive Care Registry (SIR) from 2009 to 2012.
* The first ICU admission
* Patients aged 30 years and older

Exclusion Criteria:

* Missing registration of educational level
* Missing registration of income
Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma

Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are currently participating in a clinical trial which is closing. This research study is studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657

This research study is an Expanded Access Trial, which is a way to provide an investigational therapy to individuals who are not eligible to receive that therapy in a clinical trial, but have a serious or life-threatening illness for which other treatments are not available.

The purpose of this expanded access program is to treat participants diagnosed with relapsed or refractory multiple myeloma with an investigational drug called ulocuplumab.

Participants enrolled in the program will receive ulocuplumab with lenalidomide and dexamethasone or ulocuplumab with bortezomib and dexamethasone. Ulocuplumab is supposed to kill myeloma cells.

Lenalidomide, which is also known as Revlimid® and Bortezomib, which is also known as Velcade®, are approved by the FDA for treatment of Multiple Myeloma. Dexamethasone, also known as Decadron®, is also approved by the FDA for other treatments. It is a type of steroid medication that fights inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent document
* Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment.

Exclusion Criteria:

* Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks).
Pain and Hemodynamics in Peripheral Arterial Disease: Response to Pulsed Electromagnetic Treatment

patients with peripheral arterial disease are recommended to perform all exercise forms including elliptical type. electromagnetic treatment addition to exercise may increase benefits of this exercise

patients (40 elderly) with peripheral arterial disease who take their medications will be divided to older patients group that receive one hour elliptical exercise (n=20 patients, exercise will be applied 3 times per the week for eight week) and a group (n=20) that receive 3 sessions per weeks of 8-week electromagnetic one-hour therapy and one hour elliptical exercise (exercise will be applied 3 times per the week for eight week)

Eligibility Criteria:
Inclusion Criteria:

* older patients
* peripheral arterial disease patients

Exclusion Criteria:

* cardiac elders
* respiratory elders
* renal elders
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

* Have primary progressive multiple sclerosis (MS)
* Have secondary progressive MS without superimposed relapses
* Relevant cardiac, hepatic and renal diseases as specified in the protocol
* Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
* Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
* Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.
Health and Aging Brain Study: Health Disparities Tau Positron Emission Tomography (PET) Scan Study

The purpose of this project is to study the aging brain among participants enrolled in the Health and Aging Brain Study: Health Disparities project . There are a number of things that can influence how people think as they age, including diabetes, depression, as well as our biology. In this study, the investigators seek to study the aging brain by using brain PET scans that create detailed pictures of the brain.

There are a number of things that can influence how we think as people age, including diabetes, depression, as well as our biology. In this study, the investigators are using PET scans with a tracer to create detailed pictures of the brain. This information will be used to help the investigators understand how the brain ages and in the future could be used to develop better diagnostics and treatments for Alzheimer's disease and memory loss in Mexican Americans, African Americans, and non-Hispanic whites. The goal of this study is to address this disparity by enrolling ethnically diverse participants in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in the Health and Aging Brain Study HD: Health Disparities project
2. Provided consent to re-contact
3. Willing and capable of undergoing PET scan of the head

Exclusion Criteria:

1. Inability to provide informed consent by self or by proxy.
2. Pregnant or breast feeding women\*
3. History of alcoholism or drug dependency/abuse within the last 2 years before screening
4. Hypersensitivity to the active substance or to any of the following excipients is contraindicated: sodium dihydrogen phosphate, phosphoric acid, sodium ascorbate, ethanol (anhydrous), water for injection
5. Participants may not be in this study if they do not meet the safety criteria to undergo imaging procedures.
The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE

The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:

1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo.

Objectives: The investigators aimed to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with HIE.

Methods: This prospective, randomized controlled study was conducted between September 2020 to August 2022. The infants receiving MEN during hypothermia (n =30) and those who were not fed (n=30) constituted the study and control groups. Infants were monitored continuously with NIRS and mesenteric arterial blood flow velocities were measured with Doppler USG before and after feeding.

Eligibility Criteria:
Inclusion Criteria:

* The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and/or 2. base deficit \&amp;gt;-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat \&amp;amp; Sarnat classification based on neurological examination were treated with TH.

Exclusion Criteria:

* Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease (ENGAGE)

This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease Type 1.

Gaucher disease is characterized by lysosomal accumulation of glucosylceramide due to impaired glucosylceramide hydrolysis. Type 1 Gaucher disease, the most common form accounts for greater than (\>) 90% of cases and does not involve the central nervous system (CNS). Typical manifestations of Type 1 Gaucher disease include splenomegaly, hepatomegaly, thrombocytopenia, anemia, skeletal pathology and decreased quality of life. The disease manifestations are caused by the accumulations of glucosylceramide (storage material) in Gaucher cells which have infiltrated the spleen and liver as well as other tissue. Eliglustat tartrate is a small molecule developed as an oral therapy which acts to specifically inhibit production of this storage material in Gaucher cells.

This study was designed to determine the efficacy, safety, and pharmacokinetics (PK) of eliglustat tartrate in adult participants (\>16 years) with Gaucher disease Type 1. The study consisted of 2 periods: The Double-Blind Primary Analysis Period (PAP \[Day 1 to Week 39\]) and the Long Term Treatment Period (LTTP/Open-Label Period (post-Week 39 \[Day 1 of the Open-Label Period\] through study completion).

Eligibility Criteria:
Inclusion Criteria:

* The participant (and/or their parent/legal guardian) was willing and able to provide signed informed consent prior to any study-related procedures to be performed;
* The participant was at least 16 years old at the time of randomization;
* The participant had a confirmed diagnosis of Gaucher disease Type 1;
* Female participants of childbearing potential must had a documented negative pregnancy test prior to dosing. In addition all female participants of childbearing potential must use a medically accepted form of contraception throughout the study.

Exclusion Criteria:

* The participant has had a partial or total splenectomy;
* The participant had received pharmacological chaperones or miglustat within 6 months prior to randomization;
* The participant had received enzyme replacement therapy within 9 months prior to randomization;
* The participant had Type 2 or 3 Gaucher disease or was suspected of having Type 3 Gaucher disease;
* The participant had any clinically significant disease, other than Gaucher disease, including cardiovascular, renal, hepatic, gastrointestinal (GI), pulmonary, neurologic, endocrine, metabolic, (for example, hypokalemia, hypomagnesemia), or psychiatric disease, other medical conditions, or serious intercurrent illness that might confound the study results, or, on the opinion of the investigator, might preclude participation in the study;
* The participant had tested positive for the human immunodeficiency virus (HIV) antibody, Hepatitis C antibody, or Hepatitis B surface antigen;
* The participant had received an investigational product within 30 days prior to randomization;
* The participant was pregnant or lactating.
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening
* Good mental health in the opinion of the investigator.
* Normal spirometry (FEV1 of \>80% of predicted and FVC of \>80% of predicted value) at screening.

Exclusion Criteria:

* Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.
* Has received any investigational medication, including investigational vaccines, in the 3 months prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.
* Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.
Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues

Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of soft tissue diode laser application versus conventional root canal treatment using CBCT

Sample size is 24 24 Patients were randomly distributed in 2 groups , one group of patients received soft tissue laser therapy after root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not have a laser session following root canal treatment Group A Soft tissue laser application : Endodontically treated teeth were targeted by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe were applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in continuous wave mode Group B : Placebo : conventional root canal treatment : mock laser intervention A CBCT was taken preoperative and after 12 month postoperative, both linear and volumetric measurements were calculated

Eligibility Criteria:
Inclusion Criteria:

* Adult patients age between 18-50 years
* Medically free patients.
* Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
* Preoperative Pain
* Sensitivity to percussion
* Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal
* Occlusal contact with opposing teeth

Exclusion Criteria:

* Pregnant females.
* Patients having a significant systemic disorder or history of drug abuse
* Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
* Patients having bruxism or clenching
* Teeth having:

  * No occlusal contact
  * No sensitivity to percussion
  * Greater than grade I mobility.
  * Pocket depth greater than 5mm.
  * No possible restorability
  * Procedural errors
  * Previous Root canal treatment
  * Open apex
Prevention of Eating Habits Associated With Obesity

This study evaluates the effectiveness of a Wise Intervention based on a values alignment approach to improve obesity-related eating habits in Spanish adolescents. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.

Obesity in adolescence is associated with physical and mental health problems and predicts obesity in adulthood. Adolescence may be an ideal time to target interventions, as this is when numerous health-related habits are consolidated. Several universal preventive interventions have been carried out in educational centers for the promotion of healthy eating habits. However, the results of reviews and meta-analyses have concluded that most are not cost-effective for producing long-term changes in the dietary preferences of young people. The so-called wise interventions paradigm is an innovative approach to interventions that involve a set of rigorous techniques grounded in research to help people improve in a variety of life settings. Recently, it has been developed a wise intervention aimed at improving adolescents' daily dietary choices. This intervention, called the values alignment intervention, focused on the role of marketing on the behavior of children and adolescents who are exposed to a relentless barrage of marketing from the food industry. The values alignment intervention seeks to neutralize the positive emotional associations with junk food that marketing generates and presents the rejection of unhealthy foods in favor of healthy alternatives as a way to live up to two values that are important to adolescents: (1) the desire to be autonomous from adult control, and (2) the desire for social justice. In two randomized controlled trials, it has been demonstrated that the intervention reduced implicit positive associations with junk food and substantially improved dietary choices, especially in boys. In addition, there were significant differences in attitudinal variables related to healthy eating. These promising results suggest that reframing unhealthy eating as incompatible with important youth values could be a low-cost solution to produce changes in adolescent attitudes and dietary choices. Therefore, the general objective of this project is to adapt the values alignment intervention to improve obesity-related eating habits in Spanish adolescents and evaluates its effectiveness. It is therefore a highly innovative project with great potential for social impact in the field of health promotion.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by the adolescents and their parents.
* To be fluent in Spanish and/or Euskera.

Exclusion Criteria:

* Lack of permission by parents and the adolescent.
* Lack of understanding of the instructions.
Epigenetic Evaluation of HAT/HDAC Activity in PBMC From Patients With Clinically Isolated Syndrome

The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group) and healthy controls (control group).

Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating disease of the central nervous system (CNS). Clinically isolated syndrome (CIS) is often a sign of multiple sclerosis and the term refers to the first episode of neurologic symptoms experienced by a patient. Possible presentations of CIS include optic neuritis, a brain stem and/or cerebellar syndrome, a spinal cord syndrome, or occasionally cerebral hemispheric dysfunction. An accurate diagnosis at this time is important because people with a high risk of developing MS are encouraged to begin treatment in order to delay or prevent a second neurologic episode and, therefore, the onset of MS.

The innate and adaptative immune systems play an important role in pathophysiology of MS, acting in interaction with environmental, genetic, and epigenetic factors.

Epigenetic modifications, such as DNA methylation and histone modification, alter DNA accessibility and chromatin structure, thereby regulating patterns of gene expression. These processes are crucial to normal development and differentiation of distinct cell lineages in the adult organism. Histone acetylation, through the family of histone acetyl transferase (HAT), is most consistently associated with promoting transcription. Deacetylation of histones correlates with CpG methylation and the inactive state of chromatin. There are 4 classes of histone deacetylase enzymes (HDACs), with members capable of deacetylation of histones and/or other protein targets. Acetylation homeostasis is a key regulator of both immune cell activation. Of note, potent histone deacetylase inhibitors (HDACi) endowed with antiinflammatory and neuroprotective properties have been identified. Efficacy of HDACi in experimental models of MS has been reported consistently. This study could provide information on the mechanisms involved.

Eligibility Criteria:
Inclusion Criteria:

* Clinically isolated syndrome within the last 6 weeks (CIS group)
* Healthy volunteer, free of any inflammatory disease (control group)
* Patient able to understand the reason of the study
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Systemic corticosteroid therapy (\>1mg/kg)
* Immunosuppressive/immunomodulatory therapy (prior or ongoing) (CIS group)
* Patient with ongoing infection (Control group)
Study of Recombinant Human N-Acetylgalactosamine 4-Sulfatase in Patients With MPS VI

The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose levels of weekly intravenous infusions of recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.


Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Patient must be five years of age or older
* Patient must have documented diagnosis of MPS VI, confirmed at screening by measurable clinical signs and symptoms of MPS VI
* Leukocyte ASB enzyme activity level less than 20% of the normal range
* Clinical evidence of significant MPS VI disease that provides adequate opportunity to achieve quantitative, short-term therapeutic benefit in three or more of the following parameters: endurance (as measured by a six-minute walk test), forced vital capacity (as measured by spirometry), joint range of motion, urinary glycosaminoglycans, and hepatomegaly.
* Ability to perform all protocol tests
* Ability to stand independently for six minutes
* Sexually active subjects must agree to use an adequate form of contraception

Exclusion Criteria:

* History of bone marrow transplantation
* Pregnant or lactating patient
* Use of an investigational drug or device within 30 days prior to study participation.
* A medical condition, serious intercurrent illness, or other extenuating circumstances that may significantly decrease study compliance including prescribed follow-up
* Known hypersensitivity to rhASB or to components of the study drug
* History of cancer (except low grade and fully resolved skin malignancy)