cyrilzakka/clinical-trials huggingface dataset:
A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Serum antibody to HIV with or without evidence of HIV antigenemia.
* White blood cells (WBC) = or \< 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
* Qualifying indications for AZT therapy.
* Life expectancy = or \> 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Current or past history of malignancy including Kaposi's sarcoma.
* Excessive diarrhea or significant malabsorption.
* If patients have had \> 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene \< 75 IU/ml, serum vitamin A \< 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
* Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
* Active OI requiring systemic treatment.
* Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Concurrent Medication:

Excluded within 4 weeks of study entry:

* Zidovudine (AZT).
* Other antiviral agent associated with leukopenia.
* Investigational drug.
* Immunomodulators.
* Interferon.
* Steroids.
* Excluded within 8 weeks of study entry:
* Ribavirin.
* Excluded within 4 months of study entry:
* Suramin.

Patients with the following are excluded:

* Current or past history of malignancy including Kaposi's sarcoma.
* Excessive diarrhea or significant malabsorption.
* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).
* Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
* Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Prior Medication:

Excluded:

* Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.

Risk Behavior:

Excluded:

* Current drug or alcohol abusers.
* Unprotected sexual contact or other activities that may result in reinfection with HIV.

Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies

This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged \>40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; \>60-day gap between medication fills; or end of study period.

This study is a non descriptive hypothesis testing study. Key study hypotheses are listed below.

Specifically the study hypotheses for the primary outcome being tested were:

Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT

Hypothesis for the key secondary outcome of COPD-related costs that was tested was:

Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a difference in COPD-related costs between FSC and OMT


Eligibility Criteria:
Inclusion Criteria:

* At least one hospitalization with a primary or secondary diagnosis of COPD or at least one ER visit with a primary diagnosis of COPD
* Initiatiation (prescription) of FSC or non-FSC (i.e. TIO, ICS, LABA, IPR) during peri-index period
* At least 40 years of age
* Continuous eligibility in the pre-index, peri-index, and follow-up periods

Exclusion Criteria

* Presence of exclusionary comorbid conditions during pre-index, peri-index, and follow-up periods: respiratory cancer, cystic fibrosis, fibrosis due to TB, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis
* Controller medication use during peri-index period
* COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days of visit during the peri-index period
Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera

This study evaluates SPECT image data acquired from Spectrum Dynamics' multi-purpose CZT SPECT-CT camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT camera. Additionally some subjects will undergo CT on the CZT SPECT-CT camera. The quality of images from each device will be compared.

The Spectrum Dynamics Multi-purpose CZT SPECT camera is a whole body SPECT (single photon emission computed tomography) scanner which utilises solid-state cadmium zinc telluride (CZT) detectors to visualise injected, or otherwise introduced, radioactivity in the human body. The CZT SPECT camera detects the location and distribution of gamma-emitting radionuclides in the body and produces 3 dimensional cross-sectional images through computed reconstruction of the data for the purpose of determining various metabolic and physiologic functions in the human body. In comparison to conventional sodium iodide (NaI) gamma camera (or Anger camera) technology, solid state CZT technology offers improved energy, spatial and temporal resolution, and higher count rates. Improvements in energy resolution and sensitivity thus enable the potential capability for enhanced quantification, simultaneous dual isotope imaging and dynamic imaging acquisition. The camera system also incorporates a multi-slice CT gantry and acquired SPECT and CT images can be combined to improve image reconstruction by allowing fusion of CT and SPECT image data for anatomic localisation referencing and CT attenuation correction of the SPECT image data.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is clinically referred for scintigraphy using a radiopharmaceutical in the energy range of 40 - 220 keV emission
2. Patient is aged ≥18 years
3. Patient condition is stable
4. Patient is willing and able to undergo image acquisition on the MPC CZT SPECT camera with integrated CT in addition to standard clinical scintigraphy procedure
5. Patient must be willing and able to provide written informed consent
6. Patient must be affiliated to a social security scheme

Exclusion Criteria:

1. Patient with unstable medical condition
2. Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
3. Patient is contra-indicated to undergo the scintigraphy imaging procedure for which they have been clinically referred
Examining the Effect of Metaverse-Based Epilepsy Education

The research is a randomized controlled experimental study and was planned to examine the effect of metaverse-based epilepsy education on the epilepsy knowledge level of parents.

Developments in the field of technology, patient density in polyclinic services, limited number of nurses specialized in the field and the desire to carry out effective workforce planning bring different education methods to the agenda in the field of nursing. Creating the metaverse universe, which has been used in many technological fields in recent years, is among the newest of these technological developments. When the content created in Metaverse-based training is presented to the user, the user has the opportunity to enter the universe, choose the avatar the participant wants, and navigate and gain information by entering the desired module among the training modules created for participant. At the same time, since it offers an interactive training module to the participant, there are no limitations such as time, place or subject as in other training models. When the literature was examined, no study was found in which metaverse-based education was used in the field of epilepsy. In this context, our research aimed to examine the usability of metaverse-based epilepsy education and its effect on parents' epilepsy knowledge level.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to use a smartphone with internet access
* Having a child diagnosed with epilepsy

Exclusion Criteria:

* Having an additional chronic disease (diabetes, chronic kidney failure, cancer, etc.) other than epilepsy
Reading Problems Associated With Central Nervous System (CNS) Pathologies.

This project aims to analyse eye movements, their alterations and influence in reading performance in patients with acquired CNS diseases and compare them with people of the same age, without neurological or ocular pathology and with normal reading speed and pattern.

The exploration is focused on the oculomotor system in patients with CNS diseases, even without involvement of the primary visual pathway, and reveals more involvement than the one obtained by a simple ophthalmological examination.

The following protocol will be applied:

Neuropsychological function Clock Test- Clock Drawing, whose score corresponds to a scale of 1 to 6, from perfect organization to severe disorder respectively, with a cognitive deficit being a result greater than 3. This test is used to detect signs of heminegligence in addition to the Line Bisection Test. It will consider the displacement of the central mark to the right side as a positive sign.

Mini-Cognitive Exam, whose cut-off score corresponds to 23 out of the 30 total, equal to or less than this figure, would indicate the presence of a cognitive deficit.

Far and near Best corrected visual acuity Primary gaze position Cover test (far and near) Extrinsic ocular motility Nystagmus presence Intrinsic ocular motility Biomicroscopy of the anterior pole Computerized visual field 30-2 Intraocular pressure Ocular fundus examination Records with Tobii Pro Nano Hardware Package eye-tracking system and Tobii Pro Lab - Full Edition software.

Reading performance assessment: International Reading Speed Texts (IReST) Attentional questionnaire based on the IReST, two simple answer questions (one word) will be formulated for each text, at the end of the reading to check the reading comprehension of the patient Evaluation of the speed and quality of horizontal and vertical reading: Test DEM (Developmental Eye Movement).

Eye-tracking test: with an animation of a moving circle.

Eligibility Criteria:
Inclusion Criteria:

* Patients and normal volunteers with ages between 18 and 80 years old.
* Clinical radiological neurological stability in acute CNS diseases (≥ 3 months after ACD).
* Best distant binocular visual acuity, equal or greater than 0.5 (Decimal Scale). Best close binocular visual acuity, equal or greater than 20/40.Glasses or soft contact lenses users.

Exclusion Criteria:

* Presence of visual heminegligence evaluated with clock drawing test and line bisection test.
* Presence of visual agnosia: Poppelreuter-Ghent © test.
* Presence of cognitive deficit: mini mental state examination (MMSE), with sufficient residual hearing capacity.
* Medical history, or presence after ophthalmic examination of: maculopathy, advanced cataracts, ophthalmological diseases affecting central visual acuity or macular fixation.
* Healthy control subjects should have normal monocular perimetry using standard Swedish interactive threshold algorithm (SITA) Central 30-2 Humphrey® Perimeter Test .
Family Caregiver Role in Decreasing Delirium in Older Patients With Fractured Femur Using HELP Principles.

The Hospital Elder Life Program (HELP) has been shown to reduce delirium in hospitalized patients. In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.

Approximately 30% of those aged 65 years and over will fall at least once a year. As many as 38% of all older people hospitalized following a fall are admitted with hip fractures and 93% of these will undergo surgical repair of the fracture (Ministry of Health, 2015). Fractured femur is associated with many complications. Delirium (acute confusional state) following surgery is one of the most common of these complications, it often results in adverse outcomes for both patients and caregivers (Tieges et al., 2021), and places great financial burden on the health system. It must be emphasized that delirium can be prevented, and when it occurs should be recognized and treated appropriately. The HELP (Hospital Elder Life Program) is an accepted evidence-based model that has been proven to be effective in reducing delirium at the time of acute hospitalization (Inouye et al., 1999). HELP (which has been implemented at the Rambam Healthcare Campus) is a volunteer-based program using non-pharmacological interventions that include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility (Inouye, 2000). The HELP program has been shown to reduce delirium by one-fifth in previous studies (Wang et al., 2020). In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 65 years and older
* Acute hospitalization in the orthopedic unit for fractured femur post-fall
* Expected or actual surgical intervention for treatment of fracture
* At least one family caregiver involved in supporting the patient during hospitalization

Exclusion Criteria:

* Documented conditions that have been clinically active during the previous 6 months: including psychiatric illness; cerebrovascular disease; brain malignancy; alcohol abuse; drug abuse
* Terminal disease
* Delirium
* Inability to assess for delirium due to advanced dementia or sensory deprivation (marked impairment of vision or hearing) or any other condition that limits communication with the patient
Treatment of Displaced Radial Neck Combined With Olecranon Fractures

This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children.

The most common fracture in children is the elbow fracture, and the three most common elbow fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow fractures are easy to diagnose and the treatment modalities are studied often. However, proximal radius fractures, which include radial neck and head fractures, remain challenging to diagnose and manage. In addition, proximal radius fractures are often combined with other fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated conservatively if the displacement is less than 3 mm and the angle is less than 30º. However, for severe Judet type III and type IV radial neck fractures, surgery is inevitable.

This study focused on radial neck fractures combined with an olecranon fracture. In this study, absorbable rods were used for fixation of radial head fractures, and with no need for removal of the inner fixation, we performed anatomy reduction via the same incision with direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe displaced radial neck combined with olecranon fractures in children using a Boyd incision, absorbable rods, and K-wires.

Eligibility Criteria:
Inclusion Criteria:

* open reduction of severe radial neck fractures combined with an olecranon fractures in the same elbow
* fixation performed using absorbable rods and K-wires

Exclusion Criteria:

* single radial head fractures or single olecranon fractures
* fixation performed with bands
* old fractures,
* Boyd incision was not used,
* guardians did not agree with the surgery
Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms

Endovascular techniques for the treatment of intracranial aneurysms are growing.

Retrospective analysis of the investigators experience in the last 8 years with the airway management in endovascular therapy for unruptured aneurysms. A total of 206 participants will be included from 2010 to 2018. Airway management (anticipated difficult airway, need for LM repositioning, orotracheal intubation because of failed laryngeal mask insertion, airway complication), intraoperative monitoring, aneurism size and location, intraoperative and perioperative complications will be registered.

Statistics will be compared between groups with t test or x test, as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* patients that underwent endovascular treatment for unruptured aneurysm

Exclusion Criteria:

* ruptured aneurysm
A Trial to Evaluate the Safety and Tolerability of a Novel Medical Food for Management of Iron Deficiency Anemia

This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel medical food utilizing a nutritional strain of yeast for management of Iron Deficiency Anemia.

The investigational product is a medical food and is the result of discoveries following extensive research on two preclinical models carried out by a team of researchers at Penn State University. This study will utilize the standard "3+3" rule-based dose-escalation schemes, which use predetermined dose levels and cohorts of three patients. The total time commitment for each subject is approximately three months.

Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin, (Hgb) 7-10 g/dL; transferrin saturation \<20%; and serum ferritin \<20ng/mL

Exclusion Criteria:

* Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (tubal ligation or otherwise be incapable of pregnancy, hormonal contraceptives, spermicide plus barrier or intrauterine device).
* Present consumption of iron supplements or multivitamins must be switched to vitamins not containing iron, such as the multivitamin Centrum Silver. No washout period is necessary since it will be apparent from the ongoing anemia that any current supplements are ineffective.
* Current anemia not attributed to immune deficiency, (ID) (e.g. other microcytic anemia or hemolytic, macrocytic, sideroblastic or myelosuppression or chemotherapy or radiotherapy induced anemia).
* Active malignancy within 1 year. Basal or squamous cell skin cancer is not exclusionary.
* Aspartate Aminotransferase, (AST) or Alanine Aminotransferase, (ALT) at screening greater than 1.5 times the upper limit of normal.
* Known positive hepatitis B with evidence of active hepatitis.
* Known positive HIV-1/HIV-2 antibodies (anti-HIV).
* Patient has a current diagnosis of asthma and is actively using an anti-asthmatic therapy.
* Received an investigational drug within 30 days of screening.
* Hemochromatosis or other iron storage disorders.
* Unregulated hypertension
* Chronic kidney disease.
* Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.
* Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of New York Heart Association, (NYHA) Class III or IV congestive heart failure.
* Smoking
* Irritable Bowel Syndrome
* Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
* Breastfeeding planned on or after enrolling in the study.
* Known allergy to yeast
* Currently on Monoamine oxidase inhibitors, (MAOI's) or Demerol
Mobility Assessment of Patients With Total Hip Arthroplasty

The purpose of this study is to describe the 3D joint biomechanics of the lower extremities of patients having had a total hip replacement or hip resurfacing surgery as compared to a healthy age and weight matched control group during level walking, stair ascent and descent, and entering and exiting the front seat of a car.

Much research has shown that patients are generally satisfied with pain relief in the months and years following a total hip replacement (THR) or hip resurfacing procedure. However, many express dissatisfaction with their ability to perform daily activities, a reduced walking ability and long-term lower extremity muscle weakness. Given the general lack of knowledge surrounding joint motion of the lower extremities in the THR population, there is a need to characterize the joint mechanics of people having undergone THR, so that interventions and rehabilitation strategies can be designed to reduce post-operative complications and improve mobility.

Eligibility Criteria:
Inclusion Criteria:

* 15 patients between the ages of 50 and 75 yrs having undergone a primary total hip replacement or hip resurfacing within 6 to 18 months of the study will participate, as well as an equal number of age, sex, height and weight matched healthy control participants.

Exclusion Criteria:

* Potential participants for the control group will be asked if they have had previous lower limb ailments or surgery, and if they have they will be excluded. Moreover, the THR participants cannot have had secondary hip replacement due to infection, revision surgery, or a concomitant surgical procedure (i.e., graft). Participants from both groups cannot have had any medical conditions which could affect physical movement such as a stroke.